Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015

Administered by Department of Veterans' Affairs

Legislation au F2015L00657 Not in force Legislative Instrument

Legislation content

Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015

made under subsection 196B(2) of the

Veterans' Entitlements Act 1986

Compilation No. 2  

Compilation date:   24 September 2018

Includes amendments up to: Veterans' Entitlements (Statements of Principles—Category 1B Stressor) Amendment Determination 2018 (No. 87 of 2018) (F2018L01188)

 

The day of commencement of this Amendment Determination is 24 September 2018.

About this compilation

 

This compilation

This is a compilation of the Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015 that shows the text of the law as amended and in force on 24 September 2018.

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.

Selfrepealing 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

 

 

 

Statement of Principles

concerning

 

GASTRIC ULCER AND DUODENAL ULCER

No. 61 of 2015

 

for the purposes of the

 

Veterans’ Entitlements Act 1986

and

Military Rehabilitation and Compensation Act 2004

Title

1. This Instrument may be cited as Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015.

Determination

2. The Repatriation Medical Authority under subsection 196B(2) and (8) of the Veterans’ Entitlements Act 1986 (the VEA):

(a) revokes Instrument No. 57 of 2006 concerning gastric ulcer and duodenal ulcer; and

(b) determines in its place this Statement of Principles.

Kind of injury, disease or death

3. (a) This Statement of Principles is about gastric ulcer and duodenal ulcer and death from gastric ulcer and duodenal ulcer.


(b)               For the purposes of this Statement of Principles:

"gastric ulcer" means a non-malignant circumscribed break in the mucosal surface of the stomach, with a diameter of three millimetres or greater, and which extends through the muscularis mucosa into the submucosa; and

"duodenal ulcer" means a non-malignant circumscribed break in the mucosal surface of the duodenum, with a diameter of three millimetres or greater, and which extends through the muscularis mucosa into the submucosa.

This definition excludes acute haemorrhagic gastritis, subepithelial haemorrhages, and acute superficial mucosal erosions of the stomach and duodenum.  This definition also excludes ulcer associated with diseases of the gastric or duodenal mucosa such as Crohn's disease, sarcoidosis, amyloidosis, systemic mastocytosis, eosinophilic gastroenteritis or associated with uraemic gastritis.

(c)                Gastric ulcer and duodenal ulcer attracts ICD-10-AM code K25, K26, K27 or K28.

(d)               In the application of this Statement of Principles, the definition of "gastric ulcer and duodenal ulcer" is that given at paragraph 3(b) above.

Basis for determining the factors

4. The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that gastric ulcer or duodenal ulcer and death from gastric ulcer or duodenal ulcer 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 Military Rehabilitation and Compensation Act 2004 (the MRCA).

Factors that must be related to service

5. Subject to clause 7, at least one of the factors set out in clause 6 must be related to the relevant service rendered by the person.

Factors

6. The factor that must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting gastric ulcer or duodenal ulcer or death from gastric ulcer or duodenal ulcer with the circumstances of a person’s relevant service is:

(a)                being a prisoner of war before the clinical onset of gastric ulcer or duodenal ulcer; or

(b)               having Helicobacter pylori infection of the stomach or duodenum at the time of the clinical onset of gastric ulcer or duodenal ulcer; or

(c)                smoking at least one half of a pack-year of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of gastric ulcer or duodenal ulcer, and:

(i)                 smoking commenced at least six months before the clinical onset of gastric ulcer or duodenal ulcer; and

(ii)              where smoking has ceased, the clinical onset of gastric ulcer or duodenal ulcer has occurred within one year of cessation; or

(d)               having a gastrin-secreting tumour at the time of the clinical onset of gastric ulcer or duodenal ulcer; or

(e)                having a critical illness or injury within the 30 days before the clinical onset of gastric ulcer or duodenal ulcer; or

(f)                being treated with a non-topical non-steroidal anti-inflammatory drug, including aspirin, at least every other day during a continuous period of at least eight days, within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or

(g)               being treated with an immunosuppressive drug within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or 

(h)               being treated with a drug or a drug from a class of drugs from Specified List 1 within the seven days before the clinical onset of gastric ulcer or duodenal ulcer; or

(i)                 being treated with a drug or a drug from a class of drugs from Specified List 2 for at least two weeks, within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or

(j)                 having a specified infection of the gastric or duodenal mucosa at the time of the clinical onset of gastric ulcer or duodenal ulcer; or

(k)               undergoing a course of therapeutic radiation for cancer, where the stomach or duodenum was in the field of radiation, within the one year before the clinical onset of gastric ulcer or duodenal ulcer; or

(l)                 having received a cumulative equivalent dose of at least ten sieverts of ionising radiation to the stomach or duodenum within the one year before the clinical onset of gastric ulcer or duodenal ulcer; or

(m)             having received 90Yttrium microspheres as therapy for primary and metastatic liver tumours, within the one year before the clinical onset of gastric ulcer or duodenal ulcer; or


(n)               for gastric ulcer only:

(i)                 having partial gastrectomy within the five years before the clinical onset of gastric ulcer, where the ulcer occurs at the site of the surgical anastomosis; or

(ii)              having endoscopic mucosal resection or endoscopic sub-mucosal dissection of the gastric mucosa at the time of the clinical onset of gastric ulcer; or

(o)               having contact with a nasogastric tube or other foreign body at the site of the ulcer at the time of the clinical onset of gastric ulcer or duodenal ulcer; or

(p)               experiencing a category 1A stressor within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or 

(q)               experiencing a category 1B stressor within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or

(r)                having posttraumatic stress disorder within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or

(s)                having a clinically significant disorder of mental health as specified at the time of the clinical onset of gastric ulcer or duodenal ulcer; or

(t)                 having cirrhosis of the liver at the time of the clinical onset of gastric ulcer or duodenal ulcer; or

(u)               being a prisoner of war before the clinical worsening of gastric ulcer or duodenal ulcer; or

(v)               having Helicobacter pylori infection of the stomach or duodenum at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or

(w)             smoking at least one half of a pack-year of cigarettes, or the equivalent thereof in other tobacco products, before the clinical worsening of gastric ulcer or duodenal ulcer; and:

(i)                 smoking commenced at least six months before the clinical worsening of gastric ulcer or duodenal ulcer; and

(ii)              where smoking has ceased, the clinical worsening of gastric ulcer or duodenal ulcer has occurred within one year of cessation; or

(x)               having a gastrin-secreting tumour at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or

(y)               having a critical illness or injury within the 30 days before the clinical worsening of gastric ulcer or duodenal ulcer; or

(z)                being treated with a non-topical non-steroidal anti-inflammatory drug, including aspirin, at least every other day during a continuous period of at least eight days, within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or

(aa)            being treated with an immunosuppressive drug within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or 

(bb)           being treated with a drug or a drug from a class of drugs from Specified List 1 within the seven days before the clinical worsening of gastric ulcer or duodenal ulcer; or

(cc)            being treated with a drug or a drug from a class of drugs from Specified List 3 for at least two weeks, within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or

(dd)           having a specified infection of the gastric or duodenal mucosa at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or

(ee)            undergoing a course of therapeutic radiation for cancer, where the stomach or duodenum was in the field of radiation, within the one year before the clinical worsening of gastric ulcer or duodenal ulcer; or

(ff)              having received a cumulative equivalent dose of at least ten sieverts of ionising radiation to the stomach or duodenum within the one year before the clinical worsening of gastric ulcer or duodenal ulcer; or

(gg)           having received 90Yttrium microspheres as therapy for primary and metastatic liver tumours, within the one year before the clinical worsening of gastric ulcer or duodenal ulcer; or

(hh)           for gastric ulcer only:

(i)                 having partial gastrectomy within the five years before the clinical worsening of gastric ulcer, where the ulcer occurs at the site of the surgical anastomosis; or

(ii)              having endoscopic mucosal resection or endoscopic sub-mucosal dissection of the gastric mucosa at the time of the clinical worsening of gastric ulcer; or

(ii)               having contact with a nasogastric tube or other foreign body at the site of the ulcer at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or

(jj)               experiencing a category 1A stressor within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or 

(kk)           experiencing a category 1B stressor within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or

(ll)               having posttraumatic stress disorder within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or

(mm)      having a clinically significant disorder of mental health as specified at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or

(nn)           having cirrhosis of the liver at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or

(oo)           inability to obtain appropriate clinical management for gastric ulcer or duodenal ulcer.

Factors that apply only to material contribution or aggravation

7. Paragraphs 6(u) to 6(oo) applies only to material contribution to, or aggravation of, gastric ulcer or duodenal ulcer where the person’s gastric ulcer or duodenal ulcer was suffered or contracted before or during (but not arising out of) the person’s relevant service.

Inclusion of Statements of Principles

8. In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Other definitions

9. For the purposes of this Statement of Principles:

"a category 1A stressor" means one of the following severe traumatic events:

(a)                experiencing a life-threatening event;

(b)               being subject to a serious physical attack or assault including rape and sexual molestation; or

(c)                being threatened with a weapon, being held captive, being kidnapped, or being tortured;

"a category 1B stressor" means one of the following severe traumatic events:

(a) killing or maiming a person;

(b) being an eyewitness to a person being killed or critically injured;

(c) being an eyewitness to atrocities inflicted on another person;

(d) participating in the clearance of a corpse or a critically injured casualty; or

(e) viewing a corpse or a critically injured casualty as an eyewitness;

"a clinically significant disorder of mental health as specified" means one of the following conditions, which is of sufficient severity to warrant ongoing management, which may involve regular visits (for example, at least monthly) to a psychiatrist, counsellor or general practitioner:

(a)                an obsessive compulsive disorder;

(b)               anxiety disorder; or

(c)                panic disorder;

"a corpse" means the human remains or body parts of one or more persons who have met a violent or horrific death; 

Note:      Examples of a violent or horrific death may include death due to suicide, gunshot, improvised explosive devices, natural and technological disasters, terrorist attacks or motor vehicle accidents.  Seeing a closed body bag or viewing a body in an open-casket coffin are excluded from this definition.

"a critical illness or injury" means any physical injury or illness requiring mechanical ventilation support or admission to an intensive care unit, or which causes septicaemia, adult respiratory distress syndrome, acute renal tubular necrosis, disseminated intravascular coagulation or multiple organ failure;

"a drug or a drug from a class of drugs from Specified List 1" means one of the following:

(a)             bisphosphonate, including alendronate;

(b)            chemotherapeutic agents delivered by hepatic arterial infusion; or

(c)             potassium chloride tablet (enteric coated or wax formulation);

"a drug or a drug from a class of drugs from Specified List 2" means one of the following:

(a)           clopidogrel;

(b)          corticosteroids, excluding topical or inhaled;

(c)           paracetamol of more than 2 grams daily; or

(d)          selective serotonin re-uptake inhibitors;

"a drug or a drug from a class of drugs from Specified List 3" means one of the following:

(a)             anticoagulants;

(b)             clopidogrel;

(c)             corticosteroids, excluding topical or inhaled;

(d)             paracetamol of more than 2 grams daily;

(e)             selective serotonin re-uptake inhibitors; or

(f)              spironolactone;

"a specified infection" means: 

(a)               Anisakis simplex infection (anisakiasis);

(b)               cytomegalovirus infection;

(c)               herpes simplex virus infection;

(d)               fungal infection;

(e)               Helicobacter heilmannii infection;

(f)                Mycobacterial infection (Mycobacterium tuberculosis, Mycobacterium avium intracellulare);

(g)               Strongyloides stercoralis infection (strongyloidiasis); or

(h)               Treponema pallidum infection (syphilis);

"an eyewitness" means a person who experiences an incident first hand and can give direct evidence of it.  This excludes persons exposed only to public broadcasting or mass media coverage of the incident;

"being treated with an immunosuppressive drug" means being treated with a drug or an agent which results in significant suppression of immune responses.  This definition includes corticosteroids other than inhaled or topical corticosteroids, drugs used to prevent transplant rejection, tumour necrosis factor-α inhibitors and chemotherapeutic agents used for the treatment of cancer;

"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.

"death from gastric ulcer or duodenal ulcer" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s gastric ulcer or duodenal ulcer;

"ICD-10-AM code" means a number assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification (ICD-10-AM), Eighth Edition, effective date of 1 July 2013, copyrighted by the Independent Hospital Pricing Authority, and having ISBN 978-1-74128-213-9;

"pack-year of cigarettes, or the equivalent thereof in other tobacco products" means a calculation of consumption where one pack-year of cigarettes equals twenty tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes.  One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight.  One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight.  Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination;

"relevant service" means:

(a)                operational service under the VEA;

(b)               peacekeeping service under the VEA;

(c)                hazardous 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;

"terminal event" means the proximate or ultimate cause of death and includes:

(a)               pneumonia;

(b)              respiratory failure;

(c)               cardiac arrest;

(d)              circulatory failure; or

(e)               cessation of brain function.

Application

10. This Instrument applies to all matters to which section 120A of the VEA or section 338 of the MRCA applies.

Date of effect

11. This Instrument takes effect from 1 June 2015.

 

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)

    /subsubparagraph(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

SubCh = SubChapter(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 gastric ulcer and duodenal ulcer No. 61 of 2015

 

7 May 2015

 

F2015L00657

1 June 2015

 

 

Veterans' Entitlements (Statements of Principles—Cumulative Equivalent Dose) Amendment Determination 2017 (No. 58 of 2017)

 

22 August 2017

 

F2017L01067

 

18 September 2017

 

 

Veterans' Entitlements (Statements of Principles—Category 1B Stressor) Amendment Determination 2018 (No. 87 of 2018)

 

28 August 2018

 

F2018L01188

 

24 September 2018

 

 

 

Endnote 4—Amendment history

 

Provision affected

How affected

Clause 9 '"cumulative equivalent dose"……'

rs. No. 58 of 2017

Clause 9 '"a category 1B stressor"……………'

rs. No. 87 of 2018

Clause 9 '"an eyewitness"……………'

rs. No. 87 of 2018

Clause 9 '"a corpse"….'

ad. No. 87 of 2018

 

 

Overview

The Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015 was enacted to address the problem of establishing a clear connection between gastric ulcer, duodenal ulcer, and the relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Australian Defence Force under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA). This legislative instrument was issued under the authority of the Repatriation Medical Authority pursuant to subsection 196B(2) of the VEA and revokes the previous Statement of Principles No. 57 of 2006. The policy objective of this Statement of Principles is to provide a comprehensive framework to determine the factors that must be related to the service of veterans, ensuring that medical-scientific evidence is used to establish the relationship between the service and the onset or aggravation of gastric ulcer and duodenal ulcer, thereby facilitating the provision of appropriate compensation and rehabilitation benefits.

Scope and Application

The Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015 applies to matters governed by section 120A of the Veterans' Entitlements Act 1986 (VEA) and section 338 of the Military Rehabilitation and Compensation Act 2004 (MRCA). It pertains to veterans, members of Peacekeeping Forces, and members of the Forces under the VEA, or members under the MRCA, who have suffered from gastric ulcer, duodenal ulcer, or death from these conditions. The principles outline the medical and service-related factors that must be considered in determining whether a gastric ulcer, duodenal ulcer, or death from these conditions is related to the person's service. This includes specific medical conditions and exposures that must be linked to the relevant service to establish a connection. The principles also define terms such as "critical illness or injury," "immunosuppressive drug," and "cumulative equivalent dose" for the purposes of this Statement of Principles. The Instrument took effect from 1 June 2015, and subsequent amendments have refined certain definitions and expanded the scope of traumatic stressors.

Key Provisions

The Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015 (the Statement) establishes the criteria for determining whether gastric ulcer, duodenal ulcer, or death from these conditions can be related to relevant service under the Veterans' Entitlements Act 1986 (VEA) or the Military Rehabilitation and Compensation Act 2004 (MRCA). This Statement revokes the previous Instrument No. 57 of 2006 and applies to all matters governed by section 120A of the VEA or section 338 of the MRCA. It took effect from 1 June 2015. Under the Statement, the Repatriation Medical Authority has determined that there is sufficient medical-scientific evidence linking gastric ulcer, duodenal ulcer, and death from these conditions to relevant service. For a reasonable hypothesis to be raised that a person's gastric ulcer or duodenal ulcer is related to their service, at least one of the specified factors must exist. These factors include being a prisoner of war, having a Helicobacter pylori infection, smoking habits, presence of a gastrin-secreting tumour, experiencing a critical illness or injury, medication use, radiation exposure, and other specified conditions or events. Additionally, the Statement includes specific factors that apply only to cases of material contribution to, or aggravation of, gastric ulcer or duodenal ulcer where the condition was suffered or contracted before or during service but not arising out of service. The Statement imposes obligations on parties by specifying the factors that must be related to relevant service for a claim to be considered. For example, the person must demonstrate that at least one of the outlined factors was present at the time of the clinical onset or worsening of the condition. The Statement also includes detailed definitions for terms such as "category 1A stressor," "category 1B stressor," "clinically significant disorder of mental health," and "corpse" to ensure clarity in the application of these criteria. Failure to comply with the requirements set out in this Statement may result in the denial of a claim for benefits related to gastric ulcer or duodenal ulcer under the VEA or MRCA. There are no explicit offences, penalties, or civil/criminal consequences stated within the text of the Statement itself; however, any breach of the criteria could lead to the rejection of a claim, thereby denying the individual the benefits to which they might otherwise be entitled. The potential consequences of non-compliance are primarily related to the administrative process of claim assessment and the potential denial of benefits rather than specific legal penalties.

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