Statement of Principles concerning soft tissue sarcoma (Balance of Probabilities) (No. 77 of 2023)

The instrument revolves around several key concepts that define its scope and operation. First, soft tissue sarcoma is defined in subsection 7(2) as a malignant neoplasm of soft connective tissue including fibrous, fat, muscle (cardiac, skeletal and smooth muscle), tendon, nerve sheath, vascular, histiocytic and synovial tissue. It includes a list of specific sarcomas such as synovial sarcoma, malignant mast cell tumour, dendritic cell sarcoma, histiocytic sarcoma, malignant odontogenic tumours, atypical fibroxanthoma, and Mullerian adenosarcoma. It excludes carcinosarcomas, Kaposi sarcoma, bone and cartilage sarcomas, mesothelioma, leukaemia, lymphomas, myeloma, primary myelofibrosis, and myeloid sarcoma. The definition also attracts specific ICD‑10‑AM codes (C22.3, C22.4, C32.3, C48, C49, C54.2, C96.2, C96.4, C96.8) but the clinical meaning prevails over the code (subsection 7(3)). Death from soft tissue sarcoma is defined in subsection 7(5) to include death from a terminal event contributed to by the soft tissue sarcoma. Terminal event is defined in the dictionary as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Second, relevant service is defined in the dictionary to mean eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This means the instrument applies to peacetime and non‑operational service only; operational service under the VEA and hazardous service under the VEA are covered by a separate SoP made under the same provision but for a different standard of proof (reasonable satisfaction). The standard here is balance of probabilities, which is the lower threshold for non‑operational service claims.

Third, factors in section 9 are the evidentiary links. Each factor has its own conditions, often with temporal thresholds (e.g., at least 5 years before clinical onset) and quantitative thresholds (e.g., cumulative equivalent dose of at least 0.5 sievert). The factors are specific to certain subtypes of soft tissue sarcoma: factor (4) applies only to angiosarcoma for 0.5 sievert of ionising radiation with a 2‑year latency; factor (5) only for hepatic angiosarcoma from Thorotrast; factor (6) only for hepatic angiosarcoma from vinyl chloride; factor (8) only for leiomyosarcoma and Epstein Barr virus associated smooth muscle tumours from HIV infection; factor (9) only for angiosarcoma from chronic lymphoedema; factor (10) only for uterine sarcoma from obesity; factors (11) and (12) only for angiosarcoma from arteriovenous fistula or vascular graft; factor (13) only for endometrial stromal sarcoma from endometriosis. Factor (14) applies generally but only to worsening, not onset.

Fourth, cumulative equivalent dose is defined by reference to the ARPANSA guide, and includes external and internal exposure excluding normal background radiation. The dictionary provides examples such as nuclear weapons testing, medical procedures, and aircrew exposure. The calculation methodology is prescribed.

Fifth, inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by TCDD is defined as a list of specific activities (decanting, spraying, cleaning equipment, being sprayed, handling/sawing treated timber, being in TCDD‑contaminated dust, using TCDD‑contaminated cutting oils) involving one of 11 listed chemicals including 2,4,5‑T, 2,4,5‑TCP, pentachlorophenol, and various chlorophenols and nitrophenoxy compounds. This is a very specific operational definition that eliminates other potential routes of TCDD exposure not listed.

The instrument directly affects veterans and members of the Australian Defence Force who have soft tissue sarcoma and are making a claim for compensation under the VEA or MRCA for non‑operational or peacetime service. It also affects their dependents in death claims. Specifically, it applies to claims under section 120B of the VEA (which covers claims for injury or disease that is not related to operational service) and section 339 of the MRCA (which covers claims for peacetime service). It does not apply to claims for operational service or hazardous service under the VEA, which are governed by a separate SoP under subsection 196B(2) with the standard of reasonable satisfaction. The instrument also affects decision‑makers at the Department of Veterans’ Affairs (DVA), the Veterans’ Review Board, and the Administrative Appeals Tribunal, who must apply these factors when assessing whether soft tissue sarcoma is related to relevant service. Lawyers, advocates, and medical professionals advising veterans must understand the specific definitions and thresholds to build or defend claims. The instrument imposes no direct duties on private enterprises, but it does create compliance burdens for veterans who must prove exposure to TCDD, ionising radiation, or other factors. For example, a person claiming under the TCDD factor must have had exposure for at least 500 hours and must have been engaged in one of the listed activities with one of the listed chemicals. This burden falls on the individual to produce evidence, which may be difficult decades after service. The instrument also indirectly affects the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) insofar as its guide for calculating cumulative equivalent dose is incorporated by reference. The exclusion of many conditions (e.g., Kaposi sarcoma, mesothelioma) means that veterans with those diseases cannot rely on this SoP; they must find another basis for connection. The instrument’s narrow definitions mean that some veterans with histologically similar conditions will be excluded, raising equity considerations between different types of sarcoma. The repeal of the 2015 SoP also affects current claims that were assessed under the old instrument: any claim not yet finally determined before 26 September 2023 may be reassessed under this new SoP if the claim is still subject to review or appeal.

The instrument does not itself create duties or rights; it is a rule of evidence that operates within the VEA and MRCA claims frameworks. However, it effectively creates a right for a veteran to have their soft tissue sarcoma accepted as service‑related if they can point to one of the factors in section 9 and establish that the factor is related to their relevant service. Conversely, it imposes a duty on the decision‑maker to apply these factors strictly. If a veteran cannot satisfy at least one factor, the decision‑maker cannot find the disease service‑related on the balance of probabilities, regardless of other evidence. The right is not absolute: factor (14) (inability to obtain appropriate clinical management) can only be used for worsening, not onset. Moreover, the factor itself must be related to service under section 10(1). That means even if a veteran has the disease and satisfies a factor like obesity for uterine sarcoma, they must also show that the obesity was related to their service (e.g., service‑related weight gain). This imposes a chain of causation. The instrument also gives a right to rely on other SoPs where a factor refers to an injury or disease covered by another SoP (section 11). For example, if a factor requires that the person had endometriosis, then the SoP for endometriosis (if any) must be applied to determine if that endometriosis is service‑related. This creates a cascading application of SoPs. The instrument does not create any private rights enforceable by non‑veterans. It does not impose duties on employers, manufacturers, or government agencies (other than DVA) to provide data or compensation. The only practical duty is on the veteran to provide evidence satisfying the factor, and on DVA to obtain relevant medical and exposure evidence. The instrument also implicitly restricts the scope of claims by excluding certain histologies. For instance, Kaposi sarcoma (which is associated with HIV) is excluded, meaning a veteran with Kaposi sarcoma cannot use this SoP; they would need to argue the disease fits another classification or rely on the generic provisions of the VEA.

The instrument itself contains no penalties. It is a legislative instrument that sets evidentiary standards for claims. However, its application occurs within the VEA and MRCA, which do contain penalties for fraudulently obtaining compensation. If a veteran or their representative knowingly provides false information to satisfy one of the factors (e.g., falsely claiming TCDD exposure), they may face prosecution under section 208 of the VEA (offences relating to false or misleading statements) or the Criminal Code. The maximum penalty under the VEA for a false claim is imprisonment for 12 months or 50 penalty units, or both. The instrument may also have enforcement implications for medical practitioners who provide certificates about the diagnosis or causal factors; if they knowingly certify a false diagnosis to fit the definition, they could face professional misconduct or criminal charges. The instrument is enforced indirectly by DVA, which has compliance units that audit claims. If a claim is accepted based on this SoP but later found to be based on false evidence, DVA can recover amounts paid. The Repatriation Medical Authority itself has no enforcement role; it merely determines the SoPs. There is no penalty in the instrument for failing to comply with a factor; rather, the penalty operates through the failure of the claim: if a veteran does not satisfy a factor, the claim is rejected, which is a civil consequence, not a penalty. The instrument also does not create any offence for a veteran failing to disclose information; the duty of disclosure arises from the general law of claims under the VEA. In practice, the enforcement risk is low for most claimants because the instrument is used as a positive tool to establish service connection. But the potential for post‑claim audits exists, especially for factors that rely on self‑reporting such as obesity or lymphoedema. The instrument does not contain sunset or review provisions, but it can be amended or repealed by a later SoP.

This instrument is made under subsection 196B(3) of the VEA, which is within Part XIA of that Act. Part XIA establishes the Repatriation Medical Authority and the system of SoPs. The instrument must be read together with the VEA and MRCA. It interacts with section 120B of the VEA, which provides that for non‑operational service claims, the standard of proof is reasonable satisfaction, but with a deeming provision: if a SoP under subsection 196B(3) determines a factor that must exist, then the disease shall be taken to be related to service if that factor exists and is related to service (subject to section 120B(3) which preserves the possibility of other evidence). Similarly, section 339 of the MRCA applies the same mechanism for peacetime service. The instrument thus overrides the general standard of proof for these diseases. It also interacts with other SoPs via section 11: where a factor in this instrument refers to an injury or disease that is itself the subject of another SoP, the factors in that other SoP must be applied to determine whether that injury or disease is service‑related. For example, factor (13) for endometrial stromal sarcoma requires the existence of endometriosis. If a veteran has endometriosis, DVA must look to the SoP for endometriosis (if any) to see if that endometriosis is related to service. This creates a chain of causation. The instrument also interacts with ICD‑10‑AM coding but subsection 7(3) makes clear that the clinical definition prevails. So if a disease is coded under one of the specified codes but does not meet the clinical definition, it is not soft tissue sarcoma for the purposes of this SoP. Conversely, if a disease meets the clinical definition but is coded under a different code, it may still fall within scope. The instrument also implicitly interacts with the common law of evidence and causation in the veterans’ jurisdiction, but it is intended to displace that common law by providing a conclusive list of accepted causal factors. The instrument does not affect other compensation schemes such as workers’ compensation or tort liability, because it is confined to the VEA and MRCA. There is also interaction with the Military Rehabilitation and Compensation Act 2004 definition of “peacetime service” and “defence service” as imported by the dictionary definition of “relevant service”.

This instrument is a standalone legislative instrument, not an amendment to an existing Act. It was made on 25 August 2023 and commences on 26 September 2023. It repeals and replaces the Statement of Principles concerning soft tissue sarcoma No. 6 of 2015 (F2014L01818) made under subsections 196B(3) and (8) of the VEA (section 4). The 2015 SoP was itself a replacement of earlier SoPs. The instrument does not include any transitional provisions, so claims determined after commencement must be assessed under this SoP. The instrument does not amend any other legislative instrument. It is subject to disallowance by the Parliament under the Legislation Act 2003 (Cth). The instrument’s explanatory statement (if any) is not provided, but it would normally accompany the instrument in the Federal Register of Legislation. The instrument is made by the Repatriation Medical Authority, which is required by section 196B(1) to determine SoPs from time to time after reviewing current medical evidence. The repeal of the 2015 instrument means that any factors that were present in that instrument but are absent from this one are no longer available for new claims. Conversely, new factors may have been added. For example, the 2015 SoP had a TCDD exposure threshold that might differ; the current instrument sets a cumulative period of at least 500 hours. The instrument also introduces new sub‑factors for specific sarcoma types that were not present in the 2015 version (e.g., factor (13) for endometrial stromal sarcoma and endometriosis). The instrument does not provide a table of changes or a note of what was amended. The cumulative equivalent dose factor now explicitly refers to the ARPANSA guide as in force on 2 August 2017 (which is a change from the previous version if the previous version referred to an older edition). There is no amendment history within the instrument itself; the instrument is issued as a fresh determination.

The instrument source does not reference any litigation. However, as a legislative instrument, it is subject to judicial review under the Administrative Decisions (Judicial Review) Act 1977 (Cth) or the Constitution. There has been extensive litigation in the veterans’ jurisdiction about the validity and application of SoPs generally. In Repatriation Commission v Gosewinkel (2001) 108 FCR 565, the Federal Court confirmed that SoPs are legislative in character and must be applied by decision‑makers. That case and others established that if a SoP sets out factors, no other factors can be used to establish a connection unless the SoP itself allows. The specific SoP concerning soft tissue sarcoma has been the subject of applications before the veterans’ tribunals (the VRB and AAT) where the main issues have been whether the veteran satisfied the TCDD exposure threshold, whether the radiation dose calculation was correct, and whether the diagnosis fits the definition. The instrument itself does not cite any cases. It is safe to state that no litigation is referenced in the instrument. The instrument may be challenged in the future if a veteran argues that the RMA failed to consider relevant medical evidence or that the instrument is irrational. Given that the instrument is made on the basis of “sound medical‑scientific evidence” (section 8), a court would show deference to the RMA’s assessment. There is no indication in the source that any particular case shapes the interpretation of this SoP.

Several provisions in this instrument can trip up claimants and advisers. First, the TCDD exposure factor requires a cumulative period of at least 500 hours of inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by TCDD, and this must occur at least five years before clinical onset. The definition of “inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by TCDD” is exhaustive and tightly defined: it only covers activities such as decanting, spraying, cleaning equipment, being sprayed, handling/sawing treated timber, being in an environment shrouded in dust from treated timber, or using cutting oils contaminated with one of the listed chemicals. Casual exposure (e.g., living near a spraying operation without being in the dust or being sprayed) does not qualify. The 500‑hour threshold is high; for a person who sprayed herbicides for a few weeks a year, it may be difficult to accumulate 500 hours unless they served in a role with constant exposure. The TCDD factor also only applies to chemicals listed; if the exposure was to a different dioxin‑contaminated substance not on the list, it is not covered.

Second, the cumulative equivalent dose factor for ionising radiation requires at least 0.5 sievert to the affected region, with calculations done according to the ARPANSA methodology as in force on 2 August 2017. The definition excludes normal background radiation in Australia. This is a high dose: 0.5 Sv is equivalent to about 500 millisieverts, which is well above typical occupational limits (20 mSv per year for nuclear industry workers). Many veterans who served as aircrew or participated in nuclear testing may not reach this threshold unless they accumulated dose from multiple sources. The factor for angiosarcoma allows a lower latency (2 years) but the same dose threshold. Note also that the dose must be to the affected region; if the sarcoma occurs in a limb that was not in the radiation field, the factor cannot be used even if the person received radiation elsewhere.

Third, the instrument only applies to non‑operational service. Many veterans would assume that because they have service, any factor can apply. But section 10 requires the factor to be related to “relevant service” which is defined narrowly as eligible war service (other than operational service), defence service (other than hazardous service), or peacetime service. If a veteran has operational service, they should look to the SoP under subsection 196B(2) (the reasonable satisfaction version), which may have different factors or thresholds. This SoP does not apply to claims for operational service.

Fourth, the inability to obtain appropriate clinical management factor (section 9(14)) only applies to worsening of pre‑existing soft tissue sarcoma, not to causation. That is made clear in section 10(2). So if a veteran’s soft tissue sarcoma was contracted before or during (but did not arise out of) service, and then they could not get appropriate management, that is a factor for aggravation. But if they never had the sarcoma before service, this factor is irrelevant. It is also limited to worsening of the disease, not the development of the disease.

Fifth, the definitions exclude several conditions that a layperson might think are soft tissue sarcomas: Kaposi sarcoma, mesothelioma, leukaemia, lymphomas, myeloma, primary myelofibrosis, carcinosarcoma, and bone sarcomas. A veteran diagnosed with any of these cannot rely on this SoP. They may have separate SoPs for those diseases (e.g., there is a separate SoP for mesothelioma) or they must rely on general evidence outside the SoP framework, which is more difficult under the standard of proof.

Sixth, the definition of being obese for uterine sarcoma is a BMI of 30 or greater for a period of at least 5 years within the 20 years before clinical onset. The BMI calculation uses weight and height; if the person’s weight fluctuated, they must show continuous obesity for 5 years. The temporal requirement is strict: the 5‑year period must be wholly within the 20 years preceding onset. A veteran who was obese only 21 years before onset does not qualify.

Seventh, the instrument does not allow for a factor that is not listed to be considered on the balance of probabilities. Under the VEA, if a SoP exists for a disease, a decision‑maker cannot rely on other medical evidence to find a connection unless the SoP itself permits (section 120B(4) and case law). So if a veteran has clear evidence of a different causal factor (e.g., exposure to an industrial chemical not listed), they cannot succeed unless that factor is within the SoP.

Compliance with this instrument is not an active obligation but rather a requirement for veterans seeking to establish a service connection for soft tissue sarcoma. For a veteran or their representative, the first step is to confirm that the disease fits the definition in section 7(2). This requires a histologically confirmed diagnosis of a malignant neoplasm of soft connective tissue that is not excluded. The diagnosis must be by an appropriate specialist (e.g., pathologist). The medical report should specify the exact subtype (e.g., liposarcoma, angiosarcoma) and the ICD‑10‑AM code if relevant, but the clinical definition controls. The report should also note the date of clinical onset, because many factors require a latency period.

Second, the veteran must identify which of the factors in section 9 they may satisfy. This often requires a detailed service history covering exposures. For TCDD exposure, the veteran needs to document the activities they performed (spraying, decanting, handling treated timber, etc.), the chemicals used (must be on the list), and the cumulative hours. Logbooks, unit records, or contemporaneous service documents are critical. Because the threshold is 500 hours, it may be necessary to reconstruct exposure over a service career. For ionising radiation, the veteran needs a dose reconstruction by a qualified physicist or radiation protection expert following the ARPANSA guide. This may involve records of occupational monitoring, medical procedures, or location during nuclear tests. For therapeutic radiation factor (section 9(2)), the veteran needs evidence of treatment for cancer and that the affected region was in the field.

Third, the veteran must show that the factor is related to their relevant service (section 10(1)). This means that the TCDD exposure, radiation, obesity, or other factor must have occurred or arisen as a result of their service. For example, if a veteran was obese but the obesity was due to a post‑service lifestyle, it would not be related. The link must be causal: the service must have contributed to the existence of the factor.

Fourth, for claims based on aggravation (factor (14)), the veteran must prove that they had soft tissue sarcoma before or during service (but it did not arise out of service) and that inability to obtain appropriate clinical management during service worsened the disease. This requires evidence of the pre‑existing diagnosis and medical records showing a failure to provide adequate treatment.

Fifth, for claimants who rely on another SoP through section 11 (e.g., if the factor requires having endometriosis), they must also satisfy that other SoP’s factors.

Sixth, all medical evidence must be current and probative. The veteran should obtain a report from a specialist confirming the diagnosis and addressing whether the factor meets the temporal requirements (e.g., at least 5 years before onset). The report should also address whether the factor is related to service, if the specialist can opine on that.

Seventh, the claim itself is lodged with DVA under the VEA or MRCA, attaching the supporting evidence. DVA will assess the claim against this SoP. If DVA rejects the claim, the veteran can apply to the Veterans’ Review Board and then the Administrative Appeals Tribunal. At each stage, the SoP is binding. There is no compliance obligation beyond the claim process; no ongoing reporting or registration is required. The instrument does not require veterans to notify DVA of changes in their condition unless they are seeking further compensation for worsening.