Statement of Principles concerning malignant neoplasm of the bladder (Balance of Probabilities) (No. 84 of 2019) (Cth)

Statement of Principles concerning MALIGNANT NEOPLASM OF THE BLADDER (Balance of Probabilities) (No. 84 of 2019) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

Dated 23 August 2019

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

Professor Nicholas Saunders AO 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 malignant neoplasm of the bladder (Balance of Probabilities) (No. 84 of 2019). 2 Commencement This instrument commences on 23 September 2019. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning malignant neoplasm of the bladder No. 97 of 2011 (Federal Register of Legislation No. F2011L01730) made under subsections 196B(3) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004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 malignant neoplasm of the bladder and death malignant neoplasm of the bladder. Meaning of malignant neoplasm of the bladder (2) For the purposes of this Statement of Principles, malignant neoplasm of the bladder: (a) means a primary malignant neoplasm arising from the epithelial cells of the urinary bladder, including the ureteric orifice and the urethral orifice of the bladder; and (b) includes urothelial carcinoma (also known as transitional cell carcinoma), squamous cell carcinoma, adenocarcinoma, small cell carcinoma and carcinoma in situ; and (c) excludes soft tissue sarcoma, carcinoid tumour, non-Hodgkin lymphoma and Hodgkin's lymphoma. (3) While malignant neoplasm of the bladder attracts ICD‑10‑AM code C67 or D09.0, in applying this Statement of Principles the meaning of malignant neoplasm of the bladder 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 malignant neoplasm of the bladder (5) For the purposes of this Statement of Principles, malignant neoplasm of the bladder, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's malignant neoplasm of the bladder. 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 malignant neoplasm of the bladder and death from malignant neoplasm of the bladder 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, malignant neoplasm of the bladder or death from malignant neoplasm of the bladder is connected with the circumstances of a person's relevant service: (1) smoking at least five pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of malignant neoplasm of the bladder, where smoking commenced at least ten years before the clinical onset of malignant neoplasm of the bladder; Note: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 – Dictionary. (2) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the bladder at least ten years before the clinical onset of malignant neoplasm of the bladder; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (3) inhaling, ingesting or having cutaneous contact with high concentrations of polycyclic aromatic hydrocarbons, through work involving the specified industrial or manufacturing process 1: (a) for a cumulative period of at least 3 500 hours before the clinical onset of malignant neoplasm of the bladder; and (b) where the first exposure occurred at least ten years before the clinical onset of malignant neoplasm of the bladder. Note: polycyclic aromatic hydrocarbons and specified industrial or manufacturing process 1 are defined in the Schedule 1 - Dictionary. (4) inhaling, ingesting or having cutaneous contact with an agent from the specified list of agents containing high concentrations of polycyclic aromatic hydrocarbons: (a) for a cumulative period of at least 3 500 hours before the clinical onset of malignant neoplasm of the bladder; and (b) where the first exposure occurred at least ten years before the clinical onset of malignant neoplasm of the bladder; Note: specified list of agents containing high concentrations of polycyclic aromatic hydrocarbons is defined in the Schedule 1 – Dictionary. (5) inhaling, ingesting or having cutaneous contact with an aromatic amine from the specified list of aromatic amines: (a) for a cumulative period of at least 2 000 hours before the clinical onset of malignant neoplasm of the bladder; and (b) where the first exposure occurred at least ten years before the clinical onset of malignant neoplasm of the bladder; Note 1: Inhaling, ingesting or having cutaneous contact with an aromatic amine does not include exposure due to cigarette smoke or hair dyes. Note 2: specified list of aromatic amines is defined in the Schedule 1 – Dictionary. (6) inhaling, ingesting or having cutaneous contact with a high concentration of an aromatic amine, through work involving the specified industrial or manufacturing process 2: (a) for a cumulative period of at least 3 500 hours before the clinical onset of malignant neoplasm of the bladder; and (b) where the first exposure occurred at least ten years before the clinical onset of malignant neoplasm of the bladder; Note 1: Inhaling, ingesting or having cutaneous contact with a high concentration of an aromatic amine does not include exposure due to cigarette smoke or hair dyes. Note 2: specified industrial or manufacturing process 2 is defined in the Schedule 1 – Dictionary. (7) inhaling, ingesting or having cutaneous contact with tetrachloroethylene for a cumulative period of at least 10 000 hours before the clinical onset of malignant neoplasm of the bladder, where the first exposure occurred at least ten years before the clinical onset of malignant neoplasm of the bladder; (8) being exposed to arsenic as specified before the clinical onset of malignant neoplasm of the bladder, where the first exposure to arsenic occurred at least ten years before the clinical onset of malignant neoplasm of the bladder; Note: being exposed to arsenic as specified is defined in the Schedule 1 – Dictionary. (9) working as a painter for a cumulative period of at least 10 000 hours before the clinical onset of malignant neoplasm of the bladder, where that work began at least ten years before the clinical onset of malignant neoplasm of the bladder; Note: working as a painter is defined in the Schedule 1 – Dictionary. (10) having renal stone disease or a bladder stone at least ten years before the clinical onset of malignant neoplasm of the bladder; (11) having chronic renal failure at least one year before the clinical onset of malignant neoplasm of the bladder; Note: chronic renal failure is defined in the Schedule 1 – Dictionary. (12) having an infection of the bladder with Schistosoma haematobium at least ten years before the clinical onset of malignant neoplasm of the bladder; (13) having an indwelling bladder catheter or other foreign body in the bladder for a continuous period (excepting routine catheter changes) of at least ten years, before the clinical onset of malignant neoplasm of the bladder; (14) having neurogenic bladder at least ten years before the clinical onset of malignant neoplasm of the bladder; Note: neurogenic bladder is defined in the Schedule 1 – Dictionary. (15) ingesting aristolochic acid as specified at least four years before the clinical onset of malignant neoplasm of the bladder; Note: ingesting aristolochic acid as specified is defined in the Schedule 1 – Dictionary. (16) consuming a total of at least 250 grams of phenacetin at least five years before the clinical onset of malignant neoplasm of the bladder; Note: phenacetin is defined in the Schedule 1 – Dictionary. (17) being treated with systemic cyclophosphamide or systemic ifosfamide, at least five years before the clinical onset of malignant neoplasm of the bladder; (18) being treated with chlornaphazine at least five years before the clinical onset of malignant neoplasm of the bladder; (19) inability to obtain appropriate clinical management for malignant neoplasm of the bladder. 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(19) applies only to material contribution to, or aggravation of, malignant neoplasm of the bladder where the person's malignant neoplasm of the bladder 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.