[Federal Register: January 14, 2009 (Volume 74, Number 9)]
[Proposed Rules]
[Page 2016-2018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja09-25]
[[Page 2016]]
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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.
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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,
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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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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