```

[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Proposed Rules]
[Pages 2016-2018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-587]

[[Page 2016]]

=======================================================================
-----------------------------------------------------------------------

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 hand-delivery 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 Sec.  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-of-war 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, protein-deficiency, 
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 peer-reviewed 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,

[[Page 2017]]

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,

[[Page 2018]]

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 
Service-Connected 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 Sec.  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:

Sec.  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
```