2016 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Proposed Rules 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 3 

RIN 2900–AN16 

Presumption of Service Connection for 

Osteoporosis for Former Prisoners of 

War 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) proposes to amend its 

adjudication regulation to establish a 

presumption of service connection for 

osteoporosis for former Prisoners of War 

(POWs) who were detained or interned 

for at least 30 days and whose 

osteoporosis is at least 10 percent 

disabling. The proposed amendment 

would implement a decision by the 

Secretary to establish such a 

presumption based on scientific studies. 

DATES: Comments must be received by 

VA on or before February 13, 2009. 

ADDRESSES: Written comments may be 

submitted through http:// 

www.Regulations.gov; by mail or handdelivery to the Director, Regulations 

Management (00REG), Department of 

Veterans Affairs, 810 Vermont Avenue, 

NW., Room 1068, Washington, DC 

20420; or by fax to (202) 273–9026. 

(This is not a toll-free number). 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AN16—Presumption of Service 

Connection for Osteoporosis for Former 

Prisoners of War.’’ Copies of comments 

received will be available for public 

inspection in the Office of Regulation 

Policy and Management, Room 1063B, 

between the hours of 8 a.m. and 

4:30 p.m., Monday through Friday 

(except holidays). Please call (202) 461– 

4902 for an appointment. (This is not a 

toll-free number). In addition, during 

the comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

http://www.Regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Copeland, Regulations Staff 

(211D), Compensation and Pension 

Service, Veterans Benefits 

Administration, Department of Veterans 

Affairs, 810 Vermont Avenue, NW., 

Washington, DC 20420, (202) 461–9685. 

SUPPLEMENTARY INFORMATION: The 

standard for creating a presumption of 

service connection for former POWs is 

set out in 38 CFR 1.18, ‘‘Guidelines for 

establishing presumptions of service 

connection for former prisoners of war.’’ 

The Secretary may establish a 

presumption of service connection for a 

disease where there is ‘‘at least limited/ 

suggestive evidence that an increased 

risk of such disease is associated with 

service involving detention or 

internment as a prisoner of war and an 

association between such detention or 

internment and the disease is 

biologically plausible.’’ 38 CFR 1.18(b). 

The term ‘‘limited/suggestive evidence’’ 

is defined in § 1.18(b)(1) to mean 

‘‘evidence of a sound scientific or 

medical nature that is reasonably 

suggestive of an association between 

prisoner-of-war experience and the 

disease, even though the evidence may 

be limited because matters such as 

chance, bias, and confounding could not 

be ruled out with confidence or because 

the relatively small size of the affected 

population restricts the data available 

for study.’’ Section 1.18(d) of title 38, 

Code of Federal Regulations, explains 

that ‘‘the requirement in paragraph (b) 

of this section that an increased risk of 

disease be ‘associated’ with prisoner-ofwar service may be satisfied by evidence 

that demonstrates either a statistical 

association or a causal association.’’ 

This proposed rule would establish a 

presumption of service connection for 

osteoporosis for any former prisoner of 

war (POW) who was interned or 

detained for a period of at least 30 days 

while on active duty and develops 

osteoporosis that manifests to a degree 

of 10 percent or more at any time after 

discharge from active military, naval or 

air service even though there is no 

record of such disease during service. 

Osteoporosis is a disease 

characterized by inadequate bone 

formation resulting in a decrease in 

bone mass and increased bone 

weakness. The Merck Manual of 

Diagnosis & Therapy 469 (17th ed. 

1999). The major clinical manifestations 

of osteoporosis are bone fractures. Id. at 

470. The cause of osteoporosis is 

generally related to a number of risk 

factors, including low calcium, 

phosphorus, and vitamin D intake, 

advanced age, hormone deficiency, 

genetic factors, and immobilization. Id. 

On October 8, 2008, the Under 

Secretary for Health advised the 

Secretary of Veterans Affairs that ‘‘there 

is at least limited/suggestive evidence 

that an increased risk of osteoporosis is 

associated with service involving 

detention or internment as a POW’’ and 

recommended establishing a 

presumption of osteoporosis for former 

POWs. The Secretary of Veterans Affairs 

agrees that the following reports 

constitute evidence of a sound scientific 

or medical nature that is reasonably 

suggestive of an association between 

prisoner-of-war experience and 

osteoporosis. 

The basis of the Under Secretary’s 

recommendation regarding establishing 

a presumption of service connection for 

osteoporosis for former POWs was a 

study conducted by Dr. Stanley M. 

Garn, Ph.D. of the University of 

Michigan Center for Human Growth and 

Development that found that, while in 

captivity, U.S. Air Force personnel 

imprisoned in North Vietnam, who were 

subject to malnutrition, proteindeficiency, recurrent dysenteries, 

vitamin deficiencies, and a variety of 

infectious diseases, suffered from 

serious bone loss long after their release 

from captivity. Stanley M. Garn, 

‘‘Researcher Says POWs Sustained Bone 

Loss,’’ 23 U. of Mich. Hospital Star (Oct. 

1975). Garn and his associates examined 

the skeletal x-rays of 108 former POWs 

and found that, although the POWs 

seemed to be in relative ‘‘good health’’ 

upon release from captivity, the POWs 

nonetheless had ‘‘far less bone structure 

than is usual for their age, with bone 

losses averaging 10 percent and going as 

high as 45.8 percent.’’ Id. The study also 

found that many of the former male 

POWs ages 30 to 40 exhibited ‘‘a 

skeletal structure which might be 

expected in an 80-year old man.’’ Id. 

Although not published in peerreviewed literature, the study was 

presented as a paper on August 9, 1975, 

at the 10th International Congress of 

Nutrition, in Kyoto, Japan. Id. 

The Under Secretary also cited a 2001 

abstract of a study conducted at the 

Robert Mitchell Center for Prisoner of 

War Studies, Navy Personnel Command, 

that reported increased rates of 

osteopenia among former POWs with 

posttraumatic stress disorder (PTSD). 

Kenneth P. Sausen et al., ‘‘The 

Relationship Between PTSD & 

Osteopenia,’’ 63 Psychosomatic 

Medicine 144 (2001), http:// 

navmedmpte.med.navy.mil/nomi/rpow/ 

centcolresproj.cfm. Study participants 

included 131 repatriated male POWs in 

an ongoing medical follow-up program. 

The study showed that POW 

participants with PTSD were twice as 

likely to be osteopenic as POW 

participants without PTSD. In addition, 

the study showed that, without proper 

identification and intervention, POWs 

with PTSD may be at risk for 

osteoporosis and its attendant physical 

disabilities. ‘‘The Relationship Between 

PTSD & Osteopenia,’’ 63 Psychosomatic 

Medicine, at 144. 

An unpublished study by M.R. 

Ambrose et al., referenced by the Under 

Secretary showed increased rates of 

osteopenia in aviators who were POWs 

in Vietnam. 

The Under Secretary’s 

recommendation also cited an article, 


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Jerri W. Nieves, ‘‘Osteoporosis: the role 

of micronutrients,’’ 81 Am. Journal of 

Clinical Nutrition 1232S (2005), 

reporting that ‘‘[o]steoporosis and low 

bone mass are currently estimated to be 

a major public health threat’’ for U.S. 

men and women age 50 and older. The 

article explored the significance of 

adequate nutrition in the prevention 

and treatment of osteoporosis and stated 

that calcium and vitamin D are the two 

key micronutrients of ‘‘greatest 

importance.’’ Id. Nieves discussed the 

potential importance of Vitamin D in 

peak bone mass and recommended at 

least 600 International Units (IU) of 

vitamin D in persons over age 70 for 

optimal bone health. Id. at 1236S. 

Another source cited by the Under 

Secretary for Health, the National 

Osteoporosis Foundation (NOF) Web 

site, states that calcium is a ‘‘building 

block of bone’’ and vitamin D helps the 

‘‘body use calcium.’’ http:// 

www.nof.org/prevention/risk.htm. 

Without vitamin D, a person is ‘‘at much 

greater risk for bone loss and 

osteoporosis.’’ Id. Although calcium and 

vitamin D are the two most significant 

nutrients related to bone development 

and prevention of bone loss, NOF also 

reports that magnesium, vitamin K, 

vitamin B6, and vitamin B12 are other 

key minerals that enhance bone health 

and may prevent bone loss. Id. 

Dietary deficiencies have been 

recognized as a common feature of 

prisoner of war captivity across different 

conflicts. See H.R. Rep. No. 91–1166 

(1970), reprinted in 1970 U.S.C.C.A.N. 

3723, 3727–28 (noting prevalence of 

dietary deficiencies among POWs in 

World War II, the Korean Conflict, and 

the Vietnam War); Acree v. Republic of 

Iraq, 271 F. Supp. 2d 179, 185, 186 

(D.D.C. (2003) (finding that U.S. POWs 

held by Iraq between January 17, 1991, 

and March 1991 ‘‘were systematically 

starved’’ and suffered nausea, severe 

weight loss, dysentery), vacated 370 

F.3d 41 (D.C. Cir. 2004). 

The Under Secretary for Health 

advised the Secretary of Veterans Affairs 

that osteoporosis has apparently not 

been a major health and disability issue 

among former POWs until recently, 

probably because this condition usually 

does not manifest as a major medical 

condition until later in life. Since most 

former POWs are now in their 80’s, it is 

much more of a health problem among 

this cohort of veterans now than in the 

past. Undiagnosed and untreated 

osteoporosis may result in progressive 

bone loss and eventual fracture. 

Finally, the Under Secretary relied on 

a 2003 World Health Organization 

(WHO) report on osteoporosis. World 

Health Org. Scientific Group, Technical 

Rep. Series 921, ‘‘Prevention and 

Management of Osteoporosis’’ (2003). 

The report stated that ‘‘[e]arly 

osteoporosis is not usually diagnosed 

and remains asymptomatic; it does not 

become clinically evident until fractures 

occur.’’ Id. at 2. WHO also stated that, 

‘‘[u]ntil recently, osteoporosis was an 

under-recognized disease’’ and 

‘‘[i]mprovements in diagnostic 

technology over the past decade now 

means that it is possible to detect the 

disease before fractures occur.’’ Id. at 7. 

The referenced studies are suggestive 

of a link between osteoporosis and 

internment or detention as a POW for a 

period sufficient to result in nutritional 

deficiency. Further, the fact that 

osteoporosis has been shown in the 

medical literature to be associated with 

nutritional deficiency establishes the 

biological plausibility of a link between 

osteoporosis and internment or 

detention as a POW. After careful 

consideration of the scientific evidence 

referenced above, the Secretary of 

Veterans Affairs believes there is 

limited/suggestive evidence that an 

increased risk of osteoporosis is 

associated with detention or internment 

as a POW and that an association 

between such detention or internment 

and osteoporosis is biologically 

plausible. The Secretary therefore is 

establishing a presumption of service 

connection for osteoporosis for former 

POWs who were interned or detained 

for not less than 30 days and whose 

osteoporosis is manifest to a degree of 

10 percent or more at any time after 

discharge or release from active service. 

38 CFR 1.18; 38 U.S.C. 501(a)(1). 

Accordingly, this proposed rule 

would amend 38 CFR 3.309(c)(2) to add 

osteoporosis as a presumptive disease 

for former POWs who were interned or 

detained for not less than 30 days and 

whose osteoporosis is manifested to a 

degree of 10 percent or more at any time 

after discharge from active duty service. 

As a result of such presumption, 

osteoporosis would be considered to 

have been incurred in or aggravated by 

internment or detention for at least 30 

days, even though there is not evidence 

of osteoporosis during such service. The 

requirement of internment for at least 30 

days would conform to policies 

embodied in current statutes and 

regulations, which require at least 30 

days of internment as a POW as a 

prerequisite for presumptive service 

connection for diseases associated with 

nutritional deficiencies, but require no 

minimum period of internment for 

presumptive service connection of 

diseases associated with acute physical 

or psychological trauma. 38 U.S.C. 

1112(b); 38 CFR 3.309(c). As explained 

above, nutritional deficiencies play a 

primary role in the incurrence of 

osteoporosis. The 1975 study finding 

increased bone loss among former 

POWs discussed the bone loss observed 

in persons who had been interred as 

POWs for periods of years and suggested 

that nutritional deficiencies over such 

periods may be the cause of the 

observed bone loss. VA has reviewed 

the scientific literature on osteoporosis 

and it does not disclose how long a 

period of malnutrition may cause the 

disease. Although we have no specific 

scientific information upon which to 

define the duration of malnutrition 

necessary to cause osteoporosis, we also 

have no scientific basis for 

distinguishing osteoporosis from the 

other nutrition-related disabilities 

identified in 1112(b)(3), for which 

Congress has determined that a 30-day 

period is appropriate. In the absence of 

evidence supporting a different result, 

treating osteoporosis the same as other 

nutrition-related disabilities is the 

fairest result. Therefore, VA proposes to 

set a 30-day internment requirement for 

this presumption. If new scientific 

evidence shows that a shorter or longer 

period of malnutrition may cause 

osteoporosis, VA reserves the right to 

change the required internment period. 

Accordingly, consistent with other 

presumptions for diseases associated 

with nutritional deficiencies, the 

presumption for osteoporosis would 

apply to periods of at least 30 days 

internment as a POW. 

This presumption would be rebutted 

if there is affirmative evidence that 

osteoporosis was not incurred during or 

aggravated by such service or 

affirmative evidence that osteoporosis 

was caused by the veteran’s own willful 

misconduct. 38 U.S.C. 1113; 38 CFR 

3.307(d) and 3.309(c)(2)(ii). 

Administrative Procedure Act 

The Secretary has determined that 

there is good cause to limit the public 

comment period on this rule to 30 days. 

This proposed rule is necessary to 

implement the Secretary’s decision to 

establish a presumption of service 

connection for osteoporosis for veterans 

who are former POWs. Due to the 

advanced age of many veterans who 

would benefit from this presumption, 

any delay in implementing this 

presumption would be contrary to the 

public interest. In April 2006, the VA 

Office of Policy and Planning identified 

29,350 living POWs. Statistical data 

shows that development of osteoporosis 

is correlated to advanced age, thus any 

delay in implementation would be 

extremely detrimental particularly to 

former POWs of World War II, Korea, 


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2018 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Proposed Rules 

and Vietnam, who are currently afflicted 

with osteoporosis. Therefore, in order to 

ensure that as many former POWs as 

possible benefit from this presumption, 

it is critical that VA take action as soon 

as practicable. Accordingly, the 

Secretary has provided a 30-day 

comment period for this rule. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in an 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

given year. This rule would have no 

such effect on State, local, and tribal 

governments, or on the private sector. 

Executive Order 12866 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Executive Order classifies a ‘‘significant 

regulatory action’’ requiring review by 

the Office of Management and Budget, 

as any regulatory action that is likely to 

result in a rule that may: (1) Have an 

annual effect on the economy of $100 

million or more or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or interfere with 

an action taken or planned by another 

agency; (3) materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of entitlement 

recipients; or (4) raise novel legal or 

policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

VA has examined the economic, 

interagency, budgetary, legal, and policy 

implications of this proposed rule and 

has concluded that it is a significant 

regulatory action under Executive Order 

12866 because it is likely to result in a 

rule that may raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. 

Paperwork Reduction Act 

This document contains no provisions 

constituting a collection of information 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3521). 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this proposed rule will not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. This 

proposed rule would not affect any 

small entities. Only VA beneficiaries 

could be directly affected. Therefore, 

pursuant to 5 U.S.C. 605(b), this 

proposed rule is exempt from the initial 

and final regulatory flexibility analysis 

requirements of sections 603 and 604. 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance program numbers and titles 

for this rule are as follows: 64.109, 

Veterans Compensation for ServiceConnected Disability; and 64.110, 

Veterans Dependency and Indemnity 

Compensation for Service-Connected 

Death. 

List of Subjects in 38 CFR Part 3 

Administrative practice and 

procedure, Claims, Disability benefits, 

Health care, Pensions, Veterans, 

Vietnam. 

Approved: November 5, 2008. 

James B. Peake, 

Secretary of Veterans Affairs. 

For the reasons set forth in the 

preamble, VA proposes to amend 38 

CFR part 3 as follows: 

PART 3—ADJUDICATION 

Subpart A—Pension, Compensation, 

and Dependency and Indemnity 

Compensation 

1. The authority citation for part 3, 

subpart A continues to read as follows: 

Authority: 38 U.S.C. 501(a), unless 

otherwise noted. 

2. Amend § 3.309(c)(2) by: 

(a) In the list of diseases, adding 

‘‘Osteoporosis.’’ after ‘‘Cirrhosis of the 

liver.’’. 

(b) Revising the authority citation at 

the end of the paragraph. 

The revision reads as follows: 

§ 3.309 Disease subject to presumptive 

service connection. 

* * * * * 

(c) * * * 

(2) * * * 

Authority: 38 U.S.C. 501(a) and 1112(b). 

[FR Doc. E9–587 Filed 1–13–09; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R08–OAR–2007–1031; FRL–8754–6] 

Approval and Promulgation of Air 

Quality Implementation Plans; Utah’s 

Emission Inventory Reporting 

Requirements 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed Rule. 

SUMMARY: EPA is proposing to approve 

State Implementation Plan (SIP) 

revisions submitted by the State of Utah 

on September 7, 1999, and December 1, 

2003. The revisions add the 

requirements of EPA’s Consolidated 

Emission Reporting Rule (CERR) to the 

State’s SIP. The intended effect of this 

action is to approve only those portions 

from the State’s submittals that add 

CERR requirements. This action is being 

taken under section 110 of the Clean Air 

Act. 

In the ‘‘Rules and Regulations’’ 

section of this Federal Register, EPA is 

approving the State’s SIP revisions as a 

direct final rule without prior proposal 

because the Agency views these as noncontroversial SIP revisions and 

anticipates no adverse comments. A 

detailed rationale for taking this action 

is set forth in the preamble to the direct 

final rule. If EPA receives no adverse 

comments, EPA will not take further 

action on this proposed rule. If EPA 

receives adverse comments, EPA will 

withdraw the direct final rule and it will 

not take effect. EPA will address all 

public comments in a subsequent final 

rule based on this proposed rule. EPA 

will not institute a second comment 

period on this action. Any parties 

interested in commenting must do so at 

this time. Please note that if EPA 

receives adverse comment on an 

amendment, paragraph, or section of 

this rule and if that provision may be 

severed from the remainder of the rule, 

EPA may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

DATES: Any written comments on this 

proposal must be received on or before 

February 13, 2009. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R08– 

OAR–2007–1031, by one of the 

following methods: 


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