Section 1 - Statement of Principles concerning malignant neoplasm of the oral cavity, oropharynx and hypopharynx (Reasonable Hypothesis) (No. 65 of 2021) - Statement of Principles concerning malignant neoplasm of the oral cavity, oropharynx and hypopharynx (Reasonable Hypothesis) (No. 65 of 2021)

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Statement of Principles

concerning

MALIGNANT NEOPLASM OF THE ORAL CAVITY, OROPHARYNX AND HYPOPHARYNX (Reasonable Hypothesis)

(No. 65 of 2021)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 21 May 2021

The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:<br>
<br> <br>Professor Nicholas Saunders AO<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 malignant neoplasm of the oral cavity, oropharynx and hypopharynx (Reasonable Hypothesis) (No. 65 of 2021).

2 Commencement

This instrument commences on 21 June 2021.

3 Authority

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.

4 Repeal

The Statement of Principles concerning malignant neoplasm of the oral cavity, oropharynx and hypopharynx No. 1 of 2013 (Federal Register of Legislation No. F2013L00016) made under subsection 196B(2) of the VEA is repealed.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 malignant neoplasm of the oral cavity, oropharynx and hypopharynx and death from malignant neoplasm of the oral cavity, oropharynx and hypopharynx.

Meaning of malignant neoplasm of the oral cavity, oropharynx and hypopharynx

(2) For the purposes of this Statement of Principles, malignant neoplasm of the oral cavity, oropharynx and hypopharynx:

(a) means a primary malignancy of the mucosa of the oral cavity, oropharynx or hypopharynx, which is the region that extends posteriorly from the lips (excluding the vermilion border and the skin of the lips) to the upper borders of the larynx and oesophagus, including the alveolar ridge, buccal mucosa, floor of the mouth, gums, hard and soft palate and tongue; and

(b) excludes:

(i) carcinoid tumour;

(ii) Hodgkin's lymphoma;

(iii) malignant neoplasm of the major or minor salivary glands or salivary gland ducts;

(iv) non-Hodgkin lymphoma; and

(v) soft tissue sarcoma.

Death from malignant neoplasm of the oral cavity, oropharynx or hypopharynx

(3) For the purposes of this Statement of Principles, malignant neoplasm of the oral cavity, oropharynx or hypopharynx, 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 oral cavity, oropharynx or hypopharynx.

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 malignant neoplasm of the oral cavity, oropharynx or hypopharynx and death from malignant neoplasm of the oral cavity, oropharynx or hypopharynx 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 malignant neoplasm of the oral cavity, oropharynx or hypopharynx or death from malignant neoplasm of the oral cavity, oropharynx or hypopharynx with the circumstances of a person's relevant service:

(1) having smoked tobacco products:

(a) in an amount of at least 2.5 pack-years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

(b) commencing at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

if smoking has ceased before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx, then that onset occurred within 15 years of cessation;

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(2) having been exposed to second-hand smoke:

(a) for at least 5,000 hours before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

(b) commencing at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

if exposure to second-hand smoke has ceased before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx, then that onset occurred within 15 years of cessation;

Note: having been exposed to second-hand smoke is defined in the Schedule 1 - Dictionary.

(3) the oral use of smokeless tobacco:

(a) on more days than not; and

(b) for at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

if the oral use of smokeless tobacco has ceased before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx, then that onset occurred within 15 years of cessation;

Note: smokeless tobacco is defined in the Schedule 1 - Dictionary.

(4) chewing betel quid or areca nut:

(a) in an amount of at least one betel quid or areca nut per day for a continuous period of at least 1 year before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

(b) commencing at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

if chewing of betel quid or areca nut has ceased before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx, then that onset occurred within 15 years of cessation;

(5) consuming maté:

(a) on more days than not; and

(b) for at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

if consumption of maté has ceased before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx, then that onset occurred within 15 years of cessation;

(6) consuming alcohol:

(a) in an amount of at least 50 kilograms within any 10 year period; and

(b) at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

if consumption of alcohol has ceased before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx, then that onset occurred within 40 years of cessation;

Note: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink.

(7) 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 malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

(b) where the first inhalation of asbestos fibres commenced at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an enclosed space may result in exposure to respirable asbestos fibres.

(8) 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 malignant neoplasm of the oral cavity, oropharynx or hypopharynx; and

(b) where the first inhalation of asbestos fibres commenced at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an open environment may result in exposure to respirable asbestos fibres.

(9) being exposed to mustard gas at least 5 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

(10) acquiring persistent infection of the oral cavity epithelium or oropharyngeal epithelium with human papilloma virus type 16 or 18 before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

(11) having infection with human immunodeficiency virus before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

(12) taking an immunosuppressive drug for organ or tissue transplantation at least 3 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx.

Note: organ or tissue transplantation is defined in the Schedule 1 - Dictionary.

(13) being obese for at least 5 years within the 20 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

Note: being obese is defined in the Schedule 1 - Dictionary.

(14) an inability to consume an average of at least 100 grams per day of any combination of fruits and vegetables, for a period of at least 5 consecutive years within the 20 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

(15) having periodontitis for at least 5 years within the 20 years before the clinical onset of malignant neoplasm of the oral cavity, oropharynx or hypopharynx;

(16) for malignant neoplasm of the oral cavity only, having an oral lesion at the affected site, from the specified list of oral lesions, for at least the 1 year before the clinical onset of malignant neoplasm of the oral cavity;

Note: specified list of oral lesions is defined in the Schedule 1 - Dictionary.

(17) for malignant neoplasm of the oral cavity only, having an oral lesion caused by systemic lupus erythematosus for at least the 1 year before the clinical onset of malignant neoplasm of the oral cavity;

(18) inability to obtain appropriate clinical management for malignant neoplasm of the oral cavity, oropharynx or hypopharynx.

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(18) applies only to material contribution to, or aggravation of, malignant neoplasm of the oral cavity, oropharynx or hypopharynx where the person's malignant neoplasm of the oral cavity, oropharynx or hypopharynx 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:

being obese means having a Body Mass Index (BMI) of 30 or greater.

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.

having been exposed to second-hand smoke means having been in an enclosed space and inhaling smoke from burning tobacco products or smoke that has been exhaled by another person who is smoking.

malignant neoplasm of the oral cavity, oropharynx and hypopharynx—see subsection 7(2).

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 the transplantation of:

(a) all or part of an organ or tissue; or

(b) a substance obtained from an organ or tissue.

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.

smokeless tobacco means tobacco products without combustion or pyrolysis at the time of use, including chewing tobacco and tobacco snuff.

specified list of oral lesions means:

(a) erythroplakia;

(b) leukoplakia;

(d) oral lichenoid lesions;

(e) oral submucous fibrosis; or

(f) proliferative verrucous leukoplakia.

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.

VEA means the Veterans' Entitlements Act 1986.

1Statement of Principles concerning malignant neoplasm of the oral cavity, oropharynx and hypopharynx (Reasonable Hypothesis) (No. 65 of 2021)

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