Statement of Principles concerning malignant neoplasm of the kidney (Balance of Probabilities) (No. 42 of 2021) made under subsection 196B(3) of the Veterans' Entitlements Act 1986 Compilation No. 1 Compilation date: 19 September 2022 Includes amendments up to: Veterans' Entitlements (Statements of Principles—definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022) (F2022L01128) The day of commencement of this Amendment Determination is 19 September 2022. About this compilation This compilation This is a compilation of the Statement of Principles concerning malignant neoplasm of the kidney (Balance of Probabilities) (No. 42 of 2021) that shows the text of the law as amended and in force on 19 September 2022. The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Name 3 Authority 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 Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history 1 Name This is the Statement of Principles concerning malignant neoplasm of the kidney (Balance of Probabilities) (No. 42 of 2021). 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 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 kidney and death from malignant neoplasm of the kidney. Meaning of malignant neoplasm of the kidney (2) For the purposes of this Statement of Principles, malignant neoplasm of the kidney: (a) means a primary malignant neoplasm arising from the renal tubular epithelium; and (b) includes renal medullary carcinoma; and (c) excludes: (i) carcinoid tumour; (ii) Hodgkin's lymphoma; (iii) malignant neoplasm of the renal pelvis; (iv) non-Hodgkin lymphoma; and (v) soft tissue sarcoma. Note: Malignant neoplasm of the kidney is also known as adenocarcinoma of the kidney, renal cell carcinoma, renal adenocarcinoma and hypernephroma. (3) While malignant neoplasm of the kidney attracts ICD‑10‑AM code C64, in applying this Statement of Principles the meaning of malignant neoplasm of the kidney 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 kidney (5) For the purposes of this Statement of Principles, malignant neoplasm of the kidney, 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 kidney. 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 kidney and death from malignant neoplasm of the kidney 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 kidney or death from malignant neoplasm of the kidney is connected with the circumstances of a person's relevant service: (1) having hypertension for a period of at least five years before the clinical onset of malignant neoplasm of the kidney; (2) being overweight or obese for at least five years within the 20 years before the clinical onset of malignant neoplasm of the kidney; Note: being overweight or obese is defined in the Schedule 1 - Dictionary. (3) having smoked tobacco products: (a) in an amount of at least 20 pack-years before the clinical onset of malignant neoplasm of the kidney; and (b) commencing at least ten years before the clinical onset of malignant neoplasm of the kidney; and if smoking has ceased before the clinical onset of malignant neoplasm of the kidney, then that onset occurred within 30 years of cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (4) inhaling, ingesting or having cutaneous contact with trichloroethylene: (a) for a cumulative period of at least 2,000 hours, within a consecutive period of ten years, before the clinical onset of malignant neoplasm of the kidney; and (b) where the first exposure occurred at least five years before the clinical onset of malignant neoplasm of the kidney; (5) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the kidney at least ten years before the clinical onset of malignant neoplasm of the kidney; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (6) having chronic kidney disease before the clinical onset of malignant neoplasm of the kidney; Note: chronic kidney disease is defined in the Schedule 1 - Dictionary. (7) for renal medullary carcinoma only, having sickle cell disorder before the clinical onset of renal medullary carcinoma; (8) an inability to consume an average of at least 200 grams per day of any combination of fruits and vegetables, for a period of at least five consecutive years within the 20 years before the clinical onset of malignant neoplasm of the kidney; (9) an inability to undertake any physical activity greater than three METs for at least 20 years within the 30 years before the clinical onset of malignant neoplasm of the kidney; Note: MET is defined in the Schedule 1 - Dictionary. (10) undergoing organ or tissue transplantation, excluding corneal transplant, before the clinical onset of malignant neoplasm of the kidney; Note: organ or tissue transplantation is defined in the Schedule 1 - Dictionary. (11) inability to obtain appropriate clinical management for malignant neoplasm of the kidney. 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(11) applies only to material contribution to, or aggravation of, malignant neoplasm of the kidney where the person's malignant neoplasm of the kidney 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: abnormality of kidney structure or function means: (a) having a glomerular filtration rate of less than 60 mL/min/1.73 m2 ; or (b) having kidney damage, as evidenced by renal biopsy, imaging studies, albuminuria, urinary sediment abnormalities or other markers of abnormal renal function; or (c) having had a kidney transplant. being overweight or obese means: (a) having a Body Mass Index (BMI) of 25 or greater; or (b) having a waist circumference of greater than 80 centimetres in women or greater than 94 centimetres in men. Note: BMI is also defined in the Schedule 1 - Dictionary. BMI means W/H2 where: (a) W is the person's weight in kilograms; and (b) H is the person's height in metres. chronic kidney disease means an abnormality of kidney structure or function that has been present for at least three months. Note: abnormality of kidney structure or function is also defined in the Schedule 1 - Dictionary 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. malignant neoplasm of the kidney—see subsection 7(2). MET means a unit of measurement of the level of physical exertion. 1 MET = 3.5 ml of oxygen/kg of body weight per minute, or 1.0 kcal/kg of body weight per hour, or resting metabolic rate. 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. organ or tissue transplantation means: (a) the transplantation of all or part of an organ or tissue; or (b) the transplantation of a substance obtained from an organ or tissue. 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. 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. Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation "(md)" added to the details of the amendment included in the amendment history. If a misdescribed amendment cannot be given effect as intended, the abbreviation "(md not incorp)" is added to the details of the amendment included in the amendment history. Endnote 2—Abbreviation key o = order(s) ad = added or inserted Ord = Ordinance am = amended orig = original amdt = amendment par = paragraph(s)/subparagraph(s) c = clause(s) /sub‑subparagraph(s) C[x] = Compilation No. x pres = present Ch = Chapter(s) prev = previous def = definition(s) (prev…) = previously Dict = Dictionary Pt = Part(s) disallowed = disallowed by Parliament r = regulation(s)/rule(s) Div = Division(s) exp = expires/expired or ceases/ceased to have reloc = relocated effect renum = renumbered F = Federal Register of Legislation rep = repealed gaz = gazette rs = repealed and substituted LA = Legislation Act 2003 s = section(s)/subsection(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) (md) = misdescribed amendment can be given Sdiv = Subdivision(s) effect SLI = Select Legislative Instrument (md not incorp) = misdescribed amendment SR = Statutory Rules cannot be given effect Sub‑Ch = Sub‑Chapter(s) mod = modified/modification SubPt = Subpart(s) No. = Number(s) underlining = whole or part not commenced or to be commenced Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions Statement of Principles concerning malignant neoplasm of the kidney (Balance of Probabilities) (No. 42 of 2021) 29 March 2021 27 April 2021 F2021L00359 Veterans' Entitlements (Statements of Principles—definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022) 26 August 2022 19 September 2022 F2022L01128 Endnote 4—Amendment history Provision affected How affected Section 2………………. rep LA s 48D Section 4………………. rep LA s 48C Subsection 9(3) note..... rs No. 94 of 2022 Schedule 1 – Dictionary – one pack-year...…….. rs No. 94 of 2022