Determinations Concerning Illnesses Discussed In National Academy of Sciences Reports on Gulf War and Health, Volumes 4 and 8, 21099-21107 [2011-8937]
Download as PDF
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
deemed ‘‘best qualified’’ will have to
undergo a Federal Bureau of
Investigation (FBI) fingerprint check.
‘‘Federally-registered lobbyists cannot be
members of the IRSAC.’’
Equal opportunity practices will be
followed for all appointments to the
IRSAC in accordance with the
Department of the Treasury and IRS
policies. ‘‘The IRS has special interest in
assuring that women and men, members
of all races and national origins, and
individuals with disabilities are
adequately represented on advisory
committees: and therefore, extends
particular encouragement to
nominations from such appropriately
qualified candidates.’’
Dated: April 6, 2011.
Candice Cromling,
Director, National Public Liaison.
[FR Doc. 2011–8992 Filed 4–13–11; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF VETERANS
AFFAIRS
Determinations Concerning Illnesses
Discussed In National Academy of
Sciences Reports on Gulf War and
Health, Volumes 4 and 8
AGENCY:
ACTION:
Department of Veterans Affairs.
Notice.
As required by law, the
Department of Veterans Affairs (VA)
hereby gives notice that the Secretary of
Veterans Affairs, under the authority
granted by the Persian Gulf War
Veterans Act of 1998, has determined
that there is no basis to establish any
new presumptions of service connection
at this time for any of the diseases,
illnesses, or health effects discussed in
the September 12, 2006, and April 9,
2010, reports of the Institute of
Medicine of the National Academy of
Sciences (NAS), respectively titled Gulf
War and Health, Volume 4: Health
Effects of Serving in the Gulf War
(Volume 4) and Gulf War and Health,
Volume 8: Update of Health Effects of
Serving in the Gulf War (Volume 8).
SUMMARY:
mstockstill on DSKH9S0YB1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Gerald Johnson, Regulations Staff
(211D), Compensation and Pension
Service, Veterans Benefits
Administration, Department of Veterans
Affairs, 810 Vermont Avenue, NW.,
Washington, DC 20420, telephone (202)
461–9727. (This is not a toll-free
number.)
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
I. Statutory Requirements
The Persian Gulf War Veterans Act of
1998, Public Law 105–277, title XVI,
112 Stat. 2681–742 through 2681–749
(set out as a note under 38 U.S.C. 1117
and codified in part at 38 U.S.C. 1118),
and the Veterans Programs
Enhancement Act of 1998, Public Law
105–368, 112 Stat. 3315, directed the
Secretary to seek to enter into an
agreement with the NAS to review and
evaluate the available scientific
evidence regarding associations between
illnesses and exposure to toxic agents,
environmental or wartime hazards, or
preventive medicines or vaccines to
which service members may have been
exposed during service in the Southwest
Asia theater of operations during the
Persian Gulf War. Under this agreement,
Congress directed NAS to identify
agents, hazards, medicines, and
vaccines to which service members may
have been exposed during the Persian
Gulf War. Congress required NAS, to the
extent that available scientific data
permits meaningful determinations, to
determine for each substance or hazard
identified: (1) Whether a statistical
association exists between exposure to
the substance or hazard and the
occurrence of illnesses, (2) whether
there is an increased risk of the illness
among exposed human or animal
populations, and (3) whether a plausible
biological mechanism or other evidence
of a causal relationship exists. Public
Law 105–277, 112 Stat. 2681–747.
In addition, Congress authorized VA
to compensate Gulf War Veterans for
diagnosed or undiagnosed illnesses that
are determined by VA to warrant a
presumption of service connection
based upon a positive association with
exposure, as a result of Gulf War
service, to a toxic agent, an
environmental or wartime hazard, or a
preventive medication or vaccine
known or presumed to be associated
with Gulf War service. 38 U.S.C. 1118.
Thus, upon receipt of each NAS report,
VA must determine whether a
presumption of service connection is
warranted for any disease or illness
discussed in the report. A presumption
of service connection is warranted if VA
determines, based on sound medical
and scientific evidence, that there is a
positive association between the
exposure of humans and animals to a
biological, chemical, or other toxic
agent, environmental or wartime hazard,
or preventive medicine or vaccine
known or presumed to be associated
with service in the Southwest Asia
theater of operations during the Gulf
War and the occurrence of a diagnosed
or undiagnosed disease or illness in
PO 00000
Frm 00160
Fmt 4703
Sfmt 4703
21099
humans and animals. 38 U.S.C. 1118(b).
If the Secretary determines that a
presumption of service connection is
not warranted, the Secretary shall
publish in the Federal Register a notice
of the determination. 38 U.S.C.
1118(c)(3)(A). Accordingly, this notice
announces VA’s determination that no
new presumptions of service connection
are warranted for any disease or illness
discussed in Volume 4 and Volume 8.
II. NAS Reports: Gulf War and Health
Series
The NAS has issued eight numbered
reports and two unnumbered ‘‘updates’’
in the Gulf War and Health series,
which examine the health effects of
exposure to specific chemical agents,
environmental and wartime hazards,
and preventive medicines and vaccines.
Federal Register notices have been
published on four of the eight numbered
reports and two unnumbered updates
announcing the Secretary’s
determination that the available
evidence does not warrant a
presumption of service connection for
any of the diseases discussed in the four
reports: Gulf War and Health, Volume 1:
Depleted Uranium, Sarin,
Pyridostigmine Bromide, and Vaccines
(66 FR 35702 (2001)); Gulf War and
Health, Volume 2: Insecticides and
Solvents (72 FR 48734 (2007)); Gulf War
and Health: Updated Literature Review
of Sarin (73 FR 42411 (2008)); Gulf War
and Health, Volume 3: Fuels,
Combustion Products, and Propellants
(73 FR 50856 (2008)); Gulf War and
Health, Volume 5: Infectious Diseases
(74 FR 15063 (2009)); Gulf War and
Health: Updated Literature Review of
Depleted Uranium (75 FR 10867 (2010));
and Gulf War and Health, Volume 6:
Physiologic, Psychologic, and
Psychosocial Effects of DeploymentRelated Stress (76 FR 2447 (2011)).
The Volume 4 report is covered in
this notice. The findings for Gulf War
and Health, Volume 7: Long-Term
Consequences of Traumatic Brain Injury
are currently under review. The latest
report, Volume 8, will also be covered
in this notice. Based on Volume 4 and
Volume 8, VA published a proposed
rule on November 17, 2010 to clarify
that FGIDs fall within the scope of the
existing presumption of service
connection for medically unexplained
chronic multisymptom illnesses. 75 FR
70162. Aside from that clarification, VA
has determined that no other changes to
the existing presumptions relating to
multisymptom illness, nor any new
presumptions, are warranted at this
time.
E:\FR\FM\14APN1.SGM
14APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
21100
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
III. Gulf War and Health, Volume 4:
Health Effects of Serving in the Gulf
War
The NAS issued its Volume 4 report
on September 12, 2006. This study
differs from previous NAS work in that
it compiles, evaluates, and summarizes
in one location peer-reviewed scientific
and medical literature on the current
status of health effects in Veterans
deployed to the Persian Gulf
irrespective of exposure information,
i.e., health responses associated with
deployment in the Gulf War Theatre
alone. The purpose of the study was to
inform VA of illnesses among Gulf War
Veterans that might not be immediately
evident. Based on this NAS report, the
Secretary has determined that the
scientific evidence presented in this
report and other information available
to the Secretary indicates that no new
presumption of service connection is
warranted at this time for any of the
illnesses described in Volume 4.
The NAS committee for Volume 4
(NAS committee) was charged to
review, evaluate, and summarize
scientific and medical literature
addressing the health status of Gulf War
Veterans. The committee’s objective was
to determine the prevalence of diseases
and symptoms in the Gulf War Veteran
population, based primarily on studies
comparing the health status of deployed
Gulf War Veterans with the health status
of their nondeployed counterparts. This
information is useful in identifying
areas of concern and needs of the Gulf
War Veteran population, and may assist
in guiding VA’s actions in the areas of
health care, compensation, and
research. Because this was a disease
prevalence study, the NAS committee
generally did not attempt to associate
diseases or symptoms with specific
biological or chemical agents or other
specific hazards of Gulf War service.
However, the NAS committee did
review certain studies that assessed
exposures in Veterans and the influence
of exposure information on the
interpretation of Veterans’ health.
The NAS committee conducted
extensive searches of epidemiologic
literature and extracted 850 potentially
relevant epidemiologic studies for
evaluation from a composite of over
4000 relevant references. The NAS
committee based its conclusion on only
peer-reviewed published scientific and
medical literature. The process of peer
review by fellow professionals increased
the likelihood of high quality analysis,
but did not guarantee the validity of a
study. The NAS committee presumed
neither the existence nor the absence of
illnesses associated with deployment. It
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
characterized and weighed the strengths
and limitations of available evidence.
The NAS committee read each study
critically and considered its relevance
and quality; however, the committee did
not collect original data nor did it
perform any secondary data analysis.
After securing the full text of the
selected peer-reviewed epidemiologic
studies, the NAS committee divided
them into primary and secondary
studies. Primary studies included
information about specific health
outcomes, demonstrated rigorous
methods, described its methods in
sufficient detail, included a control or
reference group, had the statistical
power to detect effects, and included
reasonable adjustments for confounders.
Secondary studies provided background
information or ‘‘context’’ for the report.
There was no attempt to link health
outcomes to exposures other than
deployment to the Persian Gulf theater,
for which there is no known animal
model, and, because the NAS committee
assessed disease prevalence rather than
causation, it did not comprehensively
review toxicologic, animal, or
experimental studies. The NAS
committee did evaluate the key animal
and epidemiologic studies cited in the
Research Advisory Committee on Gulf
War Veterans’ Illnesses (RAC) report.
Epidemiologic studies that attempted to
associate health effects with specific
exposures, such as oil-well–fire smoke
or nerve-gas agents, were also
considered by the committee.
The committee’s full report may be
viewed at: https://www.iom.edu/CMS/
3793/24597/36955.aspx.
IV. Gulf War and Health, Volume 8:
Update of Health Effects of Serving in
the Gulf War
The NAS issued its latest report,
Volume 8, on April 9, 2010. The charge
to the NAS update committee for
Volume 8 (NAS update committee) was
to review, evaluate, and summarize the
literature on the health outcomes noted
in Volume 4 that seemed to have higher
incidence or prevalence in Gulf War
deployed Veterans, namely: cancer
(particularly brain and testicular),
amyotrophic lateral sclerosis and other
neurological diseases (such as
Parkinson’s disease and multiple
sclerosis), birth defects and other
adverse pregnancy outcomes, and post
deployment psychiatric conditions. The
NAS update committee also reviewed
studies of cause-specific mortality in
Gulf War Veterans and examined
literature to identify emerging health
outcomes. The NAS update committee
limited its review to epidemiological
studies of health outcomes published
PO 00000
Frm 00161
Fmt 4703
Sfmt 4703
subsequent to the literature search for
Volume 4 and those studies included in
Volume 4. In order for a study to be
considered, the NAS update committee
required the study to compare the
health status of Gulf War Veterans to
nondeployed Veterans or Veterans
deployed in other locations.
The NAS update committee
conducted extensive searches of
epidemiological literature published
since 2005, employing the same search
strategies as used for Volume 4, and
retrieved over 1,000 potentially relevant
references. The titles and the abstracts
of the studies were assessed and then
narrowed down to focus on 400
potentially relevant epidemiological
studies for the review. Similar to the
policy utilized in the Volume 4 review,
the NAS update committee used only
peer-reviewed published literature as
the basis for its conclusions, with the
exception of some governmental reports.
As noted in regard to Volume 4, the
process of peer review by fellow
professionals increases the probability
of a high quality study, but does not
guarantee its validity. The NAS update
committee did not collect any original
data or perform any secondary data
analysis.
The NAS update committee also
reviewed the studies that had been
included in Volume 4 as either primary
or secondary studies. In Volume 4, the
NAS committee did not make
determinations as to the strength of the
association between deployment to the
Gulf War and the specific health effects.
Therefore, the NAS update committee
was asked to make such determinations
during its review. To make these
determinations, the NAS update
committee reviewed the studies
included in Volume 4 to ensure that
they would still be classified as either
primary or secondary studies.
The NAS update committee
collectively reviewed all of the relevant
studies cited in Volume 4 as well as the
new studies identified from the updated
literature. The NAS update committee
weighed the evidence, reached a
consensus and assigned a category of
association for each health outcome
considered in the report. This review
provides an update on the health effects
of serving in the Southwest Asia theater
of operations during the Persian Gulf
War. The purpose of this report was to
determine the strength of associations
between being deployed to the Gulf War
and specific health effects. Specifically,
the NAS update committee determined
whether there was sufficient evidence of
a causal relationship, sufficient
evidence of an association, limited/
suggestive evidence of an association,
E:\FR\FM\14APN1.SGM
14APN1
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
inadequate/insufficient evidence to
determine whether an association exists,
or limited/suggestive evidence that no
association exists between the health
outcome and deployment to the Gulf
War.
The committee’s full report may be
viewed at: https://www.iom.edu/Reports/
2010/Gulf-War-and-Health-Volume-8Health-Effects-of-Serving-in-the-GulfWar.aspx.
mstockstill on DSKH9S0YB1PROD with NOTICES
V. Report Summaries for Volume 4 and
Volume 8
The different approaches used by the
NAS committee in evaluating Volume 4
and the NAS update committee in
evaluating Volume 8 are reflected in the
separate conclusions reached by each
committee. The task of the NAS
committee was to catalog the health
outcomes that appeared to have greater
prevalence in Veterans who had been
deployed to the Gulf War in comparison
with Veterans in the military at that
time who were not deployed to the Gulf
War. In Volume 4, the NAS committee
did not specifically evaluate the
strength of the association between Gulf
War deployment and the specific health
outcomes. The Volume 4 studies
generally did not associate any observed
health effects with exposure to specific
hazards of Gulf War service, and
therefore provide no basis for
establishing new presumptions under
38 U.S.C. 1118 based on exposure to
specific agents, hazards, or medicines
associated with Gulf War service.
The NAS update committee reviewed
epidemiologic studies of health
outcomes published after the literature
search conducted for the Volume 4
report as well as the studies included in
Volume 4. The purpose of this report
was to determine the strength of
associations between being deployed to
the Gulf War and specific health effects.
The NAS update committee reviewed
only studies that compared the health
status of Gulf War Veterans with those
of non-deployed Veterans and Veterans
deployed to other locations, and then
characterized the strength of the
evidence for an association between
Gulf War deployment and the specific
health outcome. Based on the NAS
update committee’s findings, VA
determined that Volume 8 did not
present a basis for establishing new
presumptions under 38 U.S.C. 1118
based on exposure to specific agents,
hazards, or medicines associated with
Gulf War service. Specific findings of
Volume 4 and Volume 8 are discussed
below.
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
Multisymptom Illness
The NAS committee for Volume 4
found that Veterans of the Gulf War
report higher rates of symptoms or sets
of symptoms than their non-deployed
counterparts. The committee found that
29 percent of Gulf War Veterans meet a
case definition of ‘‘multisymptom
illness,’’ compared to 16 percent of nondeployed Veterans. Among the
symptoms most often reported by Gulf
War Veterans are fatigue, memory loss,
confusion, inability to concentrate,
mood swings, somnolence,
gastrointestinal symptoms, muscle and
joint pains, and skin conditions. Gulf
War Veterans also reported more
instances of chronic multisymptom
illness, including chronic fatigue
syndrome, fibromyalgia, and multiple
chemical sensitivity.
Under current law at 38 U.S.C. 1117
and 38 CFR 3.317, Gulf War Veterans
are entitled to compensation for chronic
disabilities associated with signs or
symptoms of disabilities such as those
described above or associated with
chronic multisymptom illness. The
findings in Volume 4 support the
policies of the current presumptions
and warrant no change to the existing
regulatory presumptions of service
connection in 38 CFR 3.317.
In a November 2008 report, the RAC,
a Federal advisory committee
established to provide research
recommendations to VA, indicated that
current medical and scientific evidence
provides support for the theory that the
increased symptomatology reported by
Gulf War Veterans may be attributable
to exposure to pyridostigmine bromide
(PB) in pills given to U.S. troops as a
protection against nerve gas and
pesticides. The RAC found that several
studies provide evidence of an
association, including a dose-response
relationship, between PB and
multisymptom illnesses consistent with
‘‘Gulf War Illness,’’ and between
pesticide exposure and such
multisymptom illness. The RAC noted
also that animal studies had identified
significant effects of exposure to
combinations of PB, pesticides, sarin,
and stress, at dosage levels similar to
those experienced by Veterans in the
Gulf War, although there is relatively
little information from human studies
concerning the effects of such combined
exposures.
The NAS update committee for
Volume 8 reviewed the literature cited
in the RAC report, but disagreed with
the RAC’s conclusion that chronic
multisymptom illness is caused by
exposure to PB and pesticides. The NAS
update committee concluded that
PO 00000
Frm 00162
Fmt 4703
Sfmt 4703
21101
current available evidence was not
sufficient to establish a causative
relationship between multisymptom
illness and any specific drug, toxin,
plume or other agent, either alone or in
combination. The NAS update
committee noted that some studies had
found associations between selfreported exposures to PB, pesticides,
nerve gas, and mixtures thereof, but that
several well-designed studies have
concluded that no associations exist for
such exposures. The update committee
also stated that, although some studies
have found that central nervous system
(CNS) disorders may persist following
acute pesticide exposure, there is no
evidence that Gulf War Veterans
experienced such acute exposures and
no significant evidence of chronic CNS
effects from low-level exposures. Based
on its review of the available evidence
from both human and animal studies,
the NAS update committee found
insufficient support for the conclusion
that pesticides, PB, insect repellants, or
combinations thereof are responsible for
multisymptom illnesses in Gulf War
Veterans.
Based on review of the information in
the reports of the NAS and the RAC, VA
has determined that the evidence for an
association between multisymptom
illnesses and specific exposures, such as
PB, pesticides, and combinations
thereof, is not equal to or greater than
the evidence against such an
association. VA emphasizes, however,
that this conclusion has no effect on
VA’s ability under existing law to
provide compensation for such
illnesses. Under 38 U.S.C. 1117 and 38
CFR 3.317, VA pays compensation for
such illness without regard to its cause.
VA will continue to evaluate
developments regarding the possible
causes of Gulf War Veterans’ chronic
multisymptom illnesses, which may
affect the understanding and treatment
of these illnesses.
The NAS update committee accepted
multisymptom illness as a diagnostic
entity and assessed the association
between symptom reporting indicative
of multisymptom illness and
deployment to the Gulf War, instead of
attempting to determine whether there
appears to be a unique illness that could
be defined by the symptoms. Most
studies indicate an increased reporting
of multisymptom illness among
deployed Gulf War Veterans, which
occurred in multiple studies from
several countries, but were subjective
with inconsistent findings on physical
examinations and laboratory testing
requiring further analysis. The NAS
update committee determined that there
is sufficient evidence of an association
E:\FR\FM\14APN1.SGM
14APN1
21102
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
between deployment to the Gulf War
and chronic multisymptom illness, but
noted that the basis for the relationship
is unclear, and recommended further
research. These findings support the
policy in existing law to provide
compensation for Gulf War Veterans’
chronic multisymptom illnesses.
Psychiatric Symptoms
The NAS committee concluded that
deployment places Veterans at
increased risk for symptoms that meet
the diagnostic criteria for certain
psychiatric illnesses, including posttraumatic stress disorder (PTSD),
anxiety, depression, and substance
abuse. In Volume 6, the NAS committee
explained that the increased risk of
psychiatric symptoms has been
associated with deployment during any
period of war and is thus not limited to
Gulf War deployments.
The NAS update committee
determined that there is sufficient
evidence of association between
deployment to the Gulf War and several
other psychiatric disorders, including
generalized anxiety disorders,
depression, and substance abuse. The
results of long-term follow-up studies
indicate that psychiatric disorders were
still evident 10 years after deployment
and were shown to be more than two
times higher in deployed Veterans
compared to non-deployed Veterans.
The NAS update committee further
noted that an inference can be made that
the high prevalence of medically
unexplained disability reported by Gulf
War Veterans cannot be reliably
attributed to any known psychiatric
disorder. Lastly, the NAS update
committee determined that traumatic
war exposure experienced during
deployment in the Gulf War is causally
related to PTSD. The NAS update
committee explained that though the
evidence available from the Gulf War is
somewhat limited, it is sufficient to
support the conclusion of a causal
relationship between combat exposure
and the development of PTSD. The NAS
committee further noted that similar
evidence obtained from other wars is
also supportive of their conclusion that
combat exposure and PTSD in the Gulf
War are causally related.
VA regulations at 38 CFR 4.125(a)
require that mental disorders, including
PTSD, be diagnosed in accordance with
the Diagnostic and Statistical Manual:
Fourth Edition (DSM–IV). Under the
DSM–IV, the diagnosis of PTSD requires
evidence of a pre-morbid traumatic
exposure. In order for PTSD to be
service connected, that traumatic
exposure must have occurred during a
period of military service. The NAS
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
Update committee did not find a causal
relationship between mere deployment
to the Gulf War theater and PTSD, nor
did it find PTSD to be associated with
exposure to a particular toxic agent,
hazard, medicine, or vaccine. Rather, it
found a causal relationship between
PTSD and the traumatic war exposures
experienced during deployment to this
war zone. Further, these types of
exposures are not unique to the Gulf
War, but are common to all episodes of
combat. Consequently, we do not
believe there is a sound basis for
establishing a presumption of service
connection for PTSD that is limited to
Veterans of Gulf War combat service.
Such a presumption would treat Gulf
War combat Veterans differently than
combat Veterans of other wars, without
a rational basis for such disparate
treatment.
Although the NAS committee found
PTSD to be associated with ‘‘traumatic
war exposure,’’ and the NAS update
committee found a causal relationship
between ‘‘traumatic war exposures’’
experienced during Gulf War
deployment and PTSD, PTSD could not
be associated with the types of exposure
outlined in 38 U.S.C. 1118, involving
exposure to hazardous substances
known or suspected to be associated
with Gulf War service. VA interprets the
use of the phrase ‘‘traumatic war
exposures’’ used in the reports as being
a general reference to the exposures to
the dangers of service in a combat area,
including risk of death or injury due to
enemy attacks. Accordingly, VA does
not believe that the reference to
‘‘traumatic war exposures’’ identifies an
association between PTSD and a
specific ‘‘exposure’’ within the meaning
of section 1118.
VA also concludes that it is
unnecessary to create a presumption for
PTSD for all combat Veterans based on
VA’s general rulemaking authority. VA’s
current regulations afford combat
Veterans essentially the same liberalized
standard of proof that a presumption
would provide. When a Veteran has
been validly diagnosed with PTSD,
service connection will be granted if the
PTSD is associated with an in-service
‘‘stressor.’’ As noted above, the Veteran
must identify a stressor before a valid
diagnosis of PTSD can be made. Under
VA regulations at 38 CFR 3.304(f), if a
Veteran engaged in combat and the
claimed stressor relates to combat, VA
will accept the Veteran’s lay statement
as sufficient evidence of the stressor.
Further, under a recent amendment to
that regulation, even if the Veteran did
not engage in combat the Veteran’s own
statements alone may establish the
occurrence of the claimed in-service
PO 00000
Frm 00163
Fmt 4703
Sfmt 4703
stressor if the claimed stressor is related
to the Veteran’s fear of hostile military
or terrorist activity and is confirmed as
adequate to support a diagnosis of
PTSD, the Veteran’s symptoms are
related to the claimed stressor, and the
claimed stressor is consistent with the
places, types, and circumstances of the
Veteran’s service. 75 FR 39843 (July 13,
2010). Accordingly, a Veteran whose
claimed stressor relates to the perils of
deployment to a war zone generally
need not submit any evidence of a
stressor beyond the statements made for
purposes of the diagnosis of PTSD. A
presumption of service connection for
PTSD based on traumatic war exposures
in the Gulf War theater would neither
increase the likelihood of a legitimate
claim being accepted, nor speed the
process by which claims are
adjudicated.
For similar reasons, VA has
determined that the finding of increased
prevalence of other psychiatric
disorders in Gulf War Veterans does not
warrant a presumption of service
connection under section 1118. In
Volume 4 and Volume 8, NAS found
that psychiatric disorders are associated
with deployment to the Gulf War, but
did not find such disorders to be
associated with any particular type of
exposure during the Gulf War. In its
Volume 6 report, NAS found that an
increased risk of psychiatric disorders is
associated with deployment to any war
zone, and that the prevalence and
severity of those disorders were
associated with the level of combat
experienced. This suggests that the
increased prevalence of psychiatric
disorders is more likely associated with
the inherent perils of combat in any war
than with exposure to specific agents,
hazards, medicines, or vaccines
associated with the Gulf War.
Section 1118(a)(2)(A) and (b)(1)(B)
require VA to determine whether a
presumption of service connection is
warranted by reason of a disease having
a positive association with exposure to
a biological, chemical, or other toxic
agent, environmental or wartime hazard,
or preventive medicine or vaccine
‘‘known or presumed to be associated
with service in the Armed Forces in the
Southwest Asia theater of operations
during the Persian Gulf War.’’ We
conclude that the statutory phrase
‘‘associated with service in the Armed
Forces in the Southwest Asia theater of
operations during the Persian Gulf War’’
is most reasonably construed to refer to
a relationship between the substance or
hazard and the specific circumstance of
service in the Southwest Asia theater of
operations during the Persian Gulf War,
as distinguished from features of
E:\FR\FM\14APN1.SGM
14APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
military service that are not unique to
service in the Gulf War. Section 1118
reflects the Government’s commitment
to addressing the unique health issues
presented by Gulf War Veterans, by
establishing a process for identifying
diseases and illnesses that may be
associated with Gulf War service. The
requirement that the substances or
hazards at issue be ‘‘associated with’’
Gulf War service makes clear that VA’s
task is to examine the unique exposure
environment in the Persian Gulf during
the Persian Gulf War. Establishing
presumptions of service connection
under section 1118 applicable only to
Gulf War Veterans based on the general
circumstance of deployment which is
shared by significant other groups of
Veterans would not significantly further
the statute’s purpose, but would create
significant inequities in the Veterans’
benefits system that Congress could not
have intended.
VA has also decided not to establish
a presumption of service connection for
psychiatric disorders in Veterans of any
period of deployment to a combat zone
under VA’s general rulemaking
authority. The category of psychiatric
disorders encompasses a diverse array
of diagnoses. Further, psychiatric
disorders are widespread and may be
triggered by many life events, including
those occurring before and after service.
Although the NAS reports indicate that
psychiatric disorders are associated
with combat deployment, they provide
no basis for evaluating whether
Veterans’ psychiatric disorders are more
likely caused by wartime deployment
than by any of the many other risk
factors that are also associated with
such disorders or for evaluating possible
differences in the degree to which the
numerous specific types of psychiatric
disorders may be associated with
wartime deployment. Accordingly, a
general presumption of service
connection for psychiatric disorders
would be overly broad.
VA believes that VA psychiatric
examinations are a more effective way
of evaluating whether psychiatric
disorders are related to military service
than applying a broad presumption that
would apply to all Veterans deployed to
the Gulf War. VA routinely provides
psychiatric examinations to Veterans
claiming service connection for
psychological disorders and believes
that this process is effective.
Cardiovascular Disease, Diabetes,
Arthralgia or Hospitalization
The NAS committee concluded that
the evidence did not show that Gulf War
Veterans have an increased risk of
cardiovascular disease, diabetes,
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
arthralgia, or hospitalization in
comparison to non-deployed Veterans.
The NAS update committee found that
there is limited or suggestive evidence
of no association between Gulf War
deployment and mortality from
cardiovascular disease in the first 10
years after war. The NAS update
committee further found that there is
insufficient or inadequate evidence to
determine whether an association exists
between Gulf War deployment and
endocrine, nutritional, and metabolic
diseases, including diabetes, and Gulf
War deployment and musculoskeletal
system diseases, including arthralgia.
The NAS update committee did not
review hospitalization as a separate
category as reviewed in Volume 4;
rather, the committee included
hospitalization as a factor in each
specific health outcome reviewed.
In order for a presumption to be
warranted the Secretary must establish
that there is a ‘‘positive association’’
between ‘‘the exposure of humans or
animals to a biological, chemical or
other toxic agent, environmental or
wartime hazard, or preventive medicine
or vaccine known or presumed to be
associated with service in the Armed
Forces in the Southwest Asia theater of
operations during the Persian Gulf War;
and [] the occurrence of a diagnosed or
undiagnosed illness in humans or
animals.’’ 38 U.S.C. 1118(b)(1)(B). An
association is considered ‘‘positive’’ if
the credible evidence for an association
is equal to or outweighs the credible
evidence against the association. 38
U.S.C. 1118(b)(3). For the conditions
listed above, the NAS committee
concluded that there was not an
increased risk, and the update
committee found that there was
inadequate or insufficient evidence to
determine whether an association exists
or limited or suggestive evidence of no
association with deployment to the Gulf
War. Therefore, VA concludes that the
evidence of an association for these
conditions does not equal or outweigh
the credible evidence against an
association. Based on this analysis, VA
has determined that no presumptions of
service connection are warranted for
any of the above-mentioned outcomes
based on Gulf War service.
Cancer
The NAS committee concluded that
the evidence did not show that Gulf War
Veterans have an increased overall risk
of cancer. However, in one study in
Volume 4 an association of brain-cancer
mortality with possible nerve-agent
exposure was observed. The NAS
committee noted that this finding
should be interpreted with caution due
PO 00000
Frm 00164
Fmt 4703
Sfmt 4703
21103
to concerns about the exposure
modeling and the fact that the study
period was not within what is believed
to be the usual latency period for brain
cancer. Further, Volume 4 reported
mixed results as to whether an
association exists between testicular
cancer and deployment to the Gulf War.
The NAS update committee
determined that there was insufficient
or inadequate evidence of an association
between Gulf War exposures and brain
cancer. The NAS update committee did
not identify any new studies relating to
testicular cancer. The NAS update
committee noted that many Veterans of
the Gulf War are still too young for
cancer diagnoses and that the follow-up
period following the Gulf War has
probably been too short to expect
significant results. Thus, the NAS
update committee recommends further
follow-up in order to make a conclusion
about whether there is an association
between deployment during the Gulf
War and cancer outcomes. Based on the
information provided in Volume 4 and
Volume 8, the Secretary has determined
that no new presumptions relating to
cancer are warranted at this time.
Mortality From External Causes
The NAS committee noted that
studies provided evidence that Gulf War
Veterans had an increased risk of
transportation-related injury and
mortality in the first several years after
such service when compared to nondeployed service members. The NAS
committee found no evidence that this
result was related to a specific exposure
in Gulf War service or that it was related
to a specific disease or illness.
The NAS update committee identified
four new studies of external cause
mortality and determined that the
evidence indicates a modestly higher
mortality from transportation-related
causes among Gulf War deployed
Veterans than other Veterans. The
increase was due to motor-vehicle
accidents which diminished or
disappeared over time. The NAS update
committee concluded that there is
limited or suggestive evidence of an
association between deployment to the
Gulf War and increase in mortality from
external causes primarily motor vehicle
accidents, in the early years after
deployment.
VA notes that VA and other
researchers have documented this
transitory post-combat-deployment
health effect among Veterans of other
combat deployments, including
Vietnam. Further, the findings of
Volume 4 and Volume 8 do not identify
an ‘‘illness’’ or a specific identified risk
factor (e.g., a particular exposure)
E:\FR\FM\14APN1.SGM
14APN1
21104
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
known or suspected to be associated
with Gulf War service. Without these
conditions, 38 U.S.C. 1118 does not
authorize VA to establish a presumption
for the increased risk of transportationrelated injury or death. Because this
phenomenon has not been connected to
a disease or injury incurred or
aggravated in service, VA has no
statutory authority to compensate
Veterans or their survivors through a
new presumption, absent new
legislative authority. See 38 U.S.C. 501
and 1110. Thus, after careful review of
the findings of mortality from external
causes, primarily motor vehicle
accidents, in the early years after
deployment, the Secretary has
determined that the scientific evidence
presented in Volume 4 and Volume 8
indicates that no presumption of service
connection is warranted at this time.
mstockstill on DSKH9S0YB1PROD with NOTICES
Skin Conditions
The NAS committee found that some
studies provided evidence that Gulf War
Veterans have a higher incidence of
certain skin conditions (atopic
dermatitis and warts) than nondeployed Veterans, but that the findings
were not consistent among the relevant
studies. The NAS committee identified
no evidence linking those conditions to
any particular exposure in Gulf War
Service. The NAS update committee
determined that there was insufficient
or inadequate evidence of an association
between deployment to the Gulf War
and skin disorders and noted that the
inconsistency in the studies suggests
that the few positive findings may be
due to chance. Based on the
inconsistent evidence of an association
between deployment to the Gulf War
and skin disorders and because these
skin conditions have not been attributed
to any particular exposure in the Gulf
War, VA has determined that no new
presumption of service connection is
warranted for dermatological
conditions.
Amyotrophic Lateral Sclerosis
The NAS committee and the NAS
update committee found that some
studies indicate that Gulf War Veterans
may have an increased risk of
amyotrophic lateral sclerosis (ALS). In
another report issued in November
2006, titled Amyotrophic Lateral
Sclerosis in Veterans: Review of the
Scientific Literature, a separate NAS
committee concluded that there is
evidence of an increased risk of ALS in
Veterans of all periods of service.
In September 2008, VA issued
regulations establishing a presumption
of service connection for ALS following
any period of qualifying service. 73 FR
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
54691 (Sept. 23, 2008). Because this
presumption applies to all Gulf War
Veterans, there is no need for a separate
presumption that is applicable only to
Gulf War Veterans.
Other Diseases of the Nervous System
The NAS committee found that
available studies generally did not
provide evidence of an increased
prevalence among Gulf War Veterans of
peripheral neuropathy. The NAS update
committee found that available studies
generally did not provide evidence of an
increased prevalence among Gulf War
Veterans of peripheral neuropathy,
multiple sclerosis, other neurological
diseases such as Alzheimer’s disease,
dementia and Parkinson’s disease, or
other neurological outcomes. The NAS
update committee therefore concluded
that there was inadequate or insufficient
evidence to determine whether an
association exists between deployment
to the Gulf War and multiple sclerosis,
other neurological diseases, or other
neurological outcomes, and that there is
limited or suggestive evidence of no
association between such deployment
and peripheral neuropathy. Based on
the committees’ findings, the Secretary
has determined that no new
presumptions are warranted for these
conditions.
Neurocognitive and Neurobehavioral
Performance
The NAS committee defined primary
studies as ‘‘high quality studies that
used neurobehavioral tests that had
previously been used to detect adverse
effects in population-based research on
occupational groups.’’ The findings
compared neurobehavioral performance
in deployed Veterans and non-deployed
Veterans. The NAS committee
concluded that the primary studies of
Veterans deployed to the Gulf War
compared to Veterans not deployed to
the Gulf War do not demonstrate
differences in cognitive and motor
measures as determined through
neurobehavioral testing. However, the
NAS committee did conclude that Gulf
War Veterans who had at least one
symptom commonly reported by Gulf
War Veterans (such as fatigue, memory
loss, confusion, inability to concentrate,
mood swings, somnolence,
gastrointestinal distress, muscle or joint
pain, or skin or mucous membrane
complaints) had poorer performance on
cognitive tests than returning Veterans
who did not report any such symptoms.
The NAS update committee reviewed
two additional studies that were
classified as secondary. Primary studies
of deployed Gulf War Veterans versus
non-deployed Veterans did not
PO 00000
Frm 00165
Fmt 4703
Sfmt 4703
demonstrate differences in cognitive
and motor measures to determine the
neurobehavioral testing. The NAS
update committee concluded that there
is inadequate or insufficient evidence to
determine if an association exists
between deployment to the Gulf War
and neurocognitive and neurobehavioral
performance.
Decreased neurocognitive or
neurobehavioral performance is not in
itself a disease or illness for which
service connection may be established.
Further, Volume 4 and Volume 8 did
not find evidence of an association
between such decreased performance
and any Gulf War exposure.
Accordingly, VA has determined that no
presumption relating to neurocognitive
and neurobehavioral performance is
warranted at this time.
Sexual Dysfunction
The NAS committee reviewed one
primary study on self-reported sexual
dysfunction in Volume 4. In this study
the self-reported sexual problems were
verified through physician interviews.
The NAS committee found that Gulf
War Veterans consistently report an
increased prevalence of sexual problems
when compared to nondeployed
Veterans.
The NAS update committee did not
consider any new primary studies, but
considered seven additional secondary
studies in Volume 8. The NAS update
committee noted that in one study,
assessing exposures specific to Gulf War
service, there was no association
between nerve agent exposure and
reported sexual problems among
Veterans deployed to the Gulf War. The
NAS update committee further noted
that all of the studies relied exclusively
on survey responses except for the
primary study reviewed in Volume 4.
The NAS update committee
acknowledged that studies assessing the
prevalence of sexual problems are
generally limited to self-reported
symptoms, but warned that these
studies should be interpreted with
caution given concerns about their
susceptibility to selection and reporting
biases. The NAS update committee
concluded that there was limited or
suggestive evidence of an increased
prevalence of self-reported sexual
difficulties among Gulf War Veterans.
Although the NAS update committee
found limited or suggestive evidence of
an increase in self-reported sexual
dysfunction, it did not find an increase
in any specific or verified disease, nor
did it find evidence associating any
such condition with a particular Gulf
War exposure. Accordingly, VA has
determined that a presumption of
E:\FR\FM\14APN1.SGM
14APN1
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
service connection for sexual
dysfunction is not warranted at this
time.
mstockstill on DSKH9S0YB1PROD with NOTICES
Other Genitourinary Outcomes
The NAS committee did not discuss
other genitourinary conditions in
Volume 4. In Volume 8, the NAS update
committee found that studies showed an
increased incidence of self-reported
genitourinary symptoms or diseases
among Veterans of Gulf War
deployments. It found that such studies
were limited by self-reported outcomes,
lack of clinical confirmation, potential
recall bias, and generally poor response
rates. The NAS update committee
identified no reports based on
confirmed diagnoses showing increased
incidence of genitourinary conditions
among Veterans of Gulf War
deployments. The NAS update
committee also found that
hospitalization studies provide evidence
that hospitalizations for genitourinary
conditions were not increased in that
population. Accordingly, the NAS
update committee concluded that there
was inadequate or insufficient evidence
to determine whether an association
exists between Gulf War deployment
and specific conditions of the
genitourinary system, and that there is
limited or suggestive evidence of no
association between Gulf War
deployment and hospitalization for
genitourinary diseases. Accordingly, VA
has determined that a presumption of
service connection for genitourinary
conditions is not warranted at this time.
Fertility Problems
In Volume 4 and Volume 8, the NAS
committee and the NAS update
committee assessed fertility problems
such as semen parameters,
hospitalization for infertility or
genitourinary system diseases, selfreported difficulties in achieving a
pregnancy, and serum concentrations of
reproductive hormones in males. The
NAS committee reviewed two primary
studies in Volume 4. The NAS
committee found that, although it
appears that there is no difference in the
prevalence of male fertility problems or
infertility between Veterans deployed to
the Gulf War and nondeployed
Veterans, it is difficult to draw any
conclusions due to the small number of
available studies.
The NAS update committee
additionally reviewed one primary
study and four secondary studies in
Volume 8. The NAS update committee
found that there was no evidence of
significant differences in concentrations
of male reproductive hormones between
Gulf War Veterans and nondeployed
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
Veterans, but noted that this question
was only addressed by one study. The
NAS update committee further noted
that, although it appears that infertility
problems are reported more frequently
among Gulf War Veterans compared to
their nondeployed counterparts, these
findings should be interpreted with
caution because of the small number of
available studies and their susceptibility
to reporting bias and selective
participation. The NAS update
committee concluded that there was
inadequate or insufficient evidence to
determine whether an association exists
between deployment to the Gulf War
and fertility problems. Based on the
NAS committee and the NAS update
committee’s findings, VA has
determined that no presumption of
service connection for fertility problems
is warranted at this time.
Adverse Pregnancy Outcomes
The NAS committee and the NAS
update committee reviewed studies
concerning adverse pregnancy
outcomes, such as the prevalence of
spontaneous abortions, stillbirths,
ectopic pregnancies, preterm births, low
birth weight, and macrosomia, in the
pregnancies of Gulf War deployed and
nondeployed men and women. In
Volume 4, the NAS committee reviewed
one primary study and two secondary
studies. The primary study was the only
study of adverse pregnancy outcomes
that used hospital discharge records
rather than relying exclusively on selfreported outcomes.
In Volume 8, the NAS update
committee reviewed five additional
secondary studies evaluating the effect
of deployment on adverse pregnancy
outcomes. The NAS update committee
found that one of the primary studies
reviewed in Volume 4 noted an
increased risk of spontaneous abortion
and ectopic pregnancy among activeduty personnel admitted to military
hospitals for pregnancy-related
diagnoses, but that these results may not
be generalized to Veterans who have left
service or to pregnancy-related
admissions to nonmilitary hospitals.
The NAS update committee observed
that such findings for spontaneous
abortion were not replicated in the four
secondary studies of female Veterans
reviewed in Volume 8. The NAS update
committee further observed that, in
Volume 8, the one secondary study that
addressed ectopic pregnancies did not
indicate any increased incidence among
either male or female Veterans of Gulf
War deployments. The NAS update
committee found that, among males
reporting on their female partners, there
was no consistent association for
PO 00000
Frm 00166
Fmt 4703
Sfmt 4703
21105
abortions, spontaneous abortion,
preterm birth or low birth weight, but
three studies showed a modest increase
in self reported miscarriages among
deployed males reporting on their
female partners. The NAS update
committee concluded that there was
inadequate or insufficient evidence to
determine whether an association exists
between deployment to the Gulf War
and adverse pregnancy outcomes. Based
on the NAS committee and the NAS
update committee findings, VA has
determined that a presumption of
service connection for adverse
pregnancy outcomes is not warranted at
this time.
Birth Defects
In Volume 4, a study identified birth
defects among infants of military
personnel born from January 1, 1989, to
December 31, 1993, from populationbased birth defect registries in six
States: Arizona, Hawaii, Iowa, Arkansas,
California, and Georgia. The study
compared 48 selected congenital
anomalies diagnosed from birth to the
age of 1 year between Gulf War
Veterans’ and non-deployed Veterans’
infants conceived before, during or after
the war; and between infants conceived
by Gulf War Veterans before and after
the war. The study found three cardiac
defects and one kidney defect among
infants conceived after the war to Gulf
War Veteran fathers. The study also
found a higher prevalence of
hypospadias, a genitourinary defect
among sons conceived post-war to Gulf
War Veteran mothers compared to their
non-deployed counterparts. Aortic valve
stenosis, coarctation of aorta, and renal
agenesis and hypoplasia were also
elevated among infants conceived by
Gulf War Veteran fathers post-war
compared to those conceived prior to
the war.
The NAS update committee reviewed
the studies identified in the Volume 4
report and considered a study by Doyle
et al. (2004) as a primary study due to
medical confirmation of self-reported
outcomes. The Doyle study was
considered a secondary study in the
Volume 4 report. The study evaluated
the prevalence of self-reported birth
defects among the offspring of Veterans
deployed to the Gulf and among the
offspring of non-deployed Veterans who
responded to a postal questionnaire. No
significant associations with birth
defects were found for infants of
mothers deployed to the Gulf, although
the analyses were limited.
Based on the primary studies of both
reports and the availability of medical
confirmation in those studies, there is
some suggestion of increased risk of
E:\FR\FM\14APN1.SGM
14APN1
21106
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
birth defects among the offspring of Gulf
War Veterans. However, there is no
consistent pattern of higher prevalence
of birth defects among offspring of male
or female Gulf War Veterans, and no
single defect, except urinary tract
abnormalities, has been found in more
than one well-designed study. The NAS
update committee concluded there is
inadequate or insufficient evidence to
determine whether an association exists
between deployment to the Gulf War
and specific birth defects. Accordingly,
VA has determined that there is no basis
for a presumption relating to birth
defects of the offspring of Veterans
deployed to the Gulf War. VA notes
further that it has no authority under 38
U.S.C. 1118 or other statutes to pay
benefits for disability in the children of
Gulf War Veterans.
Respiratory Symptoms
The NAS committee found that the
reporting of respiratory symptoms, but
not specific respiratory illnesses, is
more prevalent in deployed Gulf War
Veterans than in their non-deployed
counterparts. The NAS committee
identified five primary studies that
examined the association between
pulmonary conditions and deployment
to the Gulf War. The committee found
that respiratory symptoms, but not
specific respiratory illnesses, are more
prevalent in deployed Gulf War
Veterans than in their non-deployed
counterparts. Two of these studies
analyzed data of Gulf War Veterans and
non-deployed Veterans derived from a
cohort of randomly selected participants
from a previous 1995 study who had
completed the earlier mailed
questionnaire on self-reports of health
conditions. One study reported on the
prevalence of self-reported asthma,
bronchitis, and emphysema and found
no significant differences between the
Gulf War Veterans and non-deployed
Veterans after adjusting for smoking and
demographic variables. An additional
study applied spirometry and symptom
interviews to a random selection of Gulf
War deployed Veterans compared to
non-deployed Veterans. A 2004 study
found that only a history of smoking
and wheezing among the respiratory
outcomes studied were significantly
elevated in the deployed Veterans.
Spirometric measurements also show no
significant difference between the Gulf
War deployed Veterans compared to
non-deployed Veterans. The study also
looked at the effect of potential
exposure to the Khamisiyah nerve gas
releases by selectively comparing
Veterans deployed into the geographic
areas potentially affected, and no
significant differences were noted in the
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
measured pulmonary functions of these
Veterans when compared to nondeployed Veterans who were not
exposed to the nerve gas. The last study
examined the pulmonary function
parameters of Gulf War Seabees and
non-deployed Seabees and found no
significant difference between the two
groups, but respiratory symptoms and
shortness of breath were more common
among deployed Veterans compared
with non-deployed Veterans.
Additional primary studies examined
the association between exposure to
smoke from the Kuwaiti oil-well fires
and respiratory outcomes. One study
examined the effect of exposure to oilwell–fire smoke using exposure
estimates based on troop locations and
National Oceanographic and
Atmospheric Administration modeling.
The NAS committee found that the risk
of physician-diagnosed asthma
increased with increasing exposure and
self-reported exposure. There were no
pulmonary function tests conducted and
the study did not distinguish
preexisting asthma from new onset
asthma.
The NAS committee found that no
study using objective estimates of
exposure to nerve agents due to the
destruction of a munitions site at
Khamisiyah, Iraq, in 1991 found any
increased risk of respiratory disease or
other problems with pulmonary
function. Based on the information in
Volume 4, VA has determined that a
presumption of service connection for
respiratory disease with exposures at
Khamisiyah is not warranted at this
time.
The NAS update committee identified
three additional primary studies of
respiratory outcomes and the
deployment to the Gulf War. The
studies found a non-significant increase
in respiratory disease hospitalizations
for Veterans deployed to Southwest
Asia after the Gulf War and no excess
deaths due to diseases of the respiratory
system among Gulf War Veterans versus
non-deployed Veterans. The third study
identified no increase in mortality risk
due to respiratory diseases among
Veterans exposed to the chemical
munitions destruction at Khamisiyah
compared to the unexposed Veterans.
One study found a non-significant
increase in respiratory disease
hospitalizations for Veterans deployed
to Southwest Asia after the Gulf War as
compared to Gulf War Veterans. The
NAS update committee found that
studies based on self-reported
symptoms and self-reported diagnoses
related to respiratory disease have
inconsistently but frequently shown an
increase among Gulf War Veterans.
PO 00000
Frm 00167
Fmt 4703
Sfmt 4703
There appears to be no increase in
respiratory disease among Gulf War
Veterans when examined with objective
measures of disease. Pulmonary
function studies and mortality studies
have shown no significant excess of
lung function abnormalities or of death
due to respiratory disease among Gulf
War Veterans. The NAS update
committee concluded that there is
inadequate or insufficient evidence to
determine whether an association exists
between deployments to the Gulf War
and respiratory disease. The NAS
update committee further concluded
that there is limited or suggestive
evidence of no association between
deployment to the Gulf War and
decreased lung function in the first 10
years after the war.
Current VA regulations at 38 CFR
3.317 provide a presumption of service
connection for chronic disability due to
signs or symptoms affecting the
respiratory system. Because chronic
respiratory signs and symptoms are
already included in § 3.317 and because
an association between deployment to
the Gulf War and either respiratory
disease or decreased lung function
could not be established, VA has
determined that a presumption of
service connection for respiratory
disease is not warranted at this time.
Diseases of the Blood and BloodForming Organs
The NAS committee in Volume 4 did
not specifically address blood diseases.
The NAS update committee in Volume
8 found that available studies did not
show an increased incidence of diseases
of the blood and blood-forming organs
in Gulf War Veterans. Accordingly, the
NAS update committee concluded that
there was inadequate or insufficient
evidence to determine whether an
association exists between deployment
to the Gulf War and such diseases.
Based on the NAS update committee’s
findings, the Secretary has determined
that no new presumption relating to
diseases of the blood and blood-forming
organs is warranted at this time.
Structural Gastrointestinal Diseases
The NAS committee and the NAS
update committee found that studies
showed an increased incidence of selfreported gastrointestinal symptoms or
disorders among Veterans of Gulf War
deployments. As noted above, the NAS
update committee found sufficient
evidence of an association between
deployment to the Gulf War and
functional gastrointestinal disorders and
VA has addressed that finding in a
separate rulemaking. 75 FR 70162
(proposed Nov. 17, 2010). The NAS
E:\FR\FM\14APN1.SGM
14APN1
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
update committee also found that there
was inadequate or insufficient evidence
to determine whether an association
exists between Gulf War deployment
and structural gastrointestinal diseases,
such as peptic ulcer and inflammatory
bowel disease (which includes
ulcerative colitis and Crohn’s disease).
Although some of the reviewed studies
found increased incidence of self
reports of certain structural
gastrointestinal diseases, the NAS
update committee noted that the lack of
diagnostic testing to validate those
results was a significant confounding
factor, because physicians not
infrequently place an organic disease
label (such as gastritis or peptic ulcer)
on a patient’s symptoms without
performing diagnostic studies. The NAS
update committee also noted that
studies did not find an increased
incidence of hospitalization or death
due to gastrointestinal disease in
Veterans of Gulf War deployments.
Based on these findings, the Secretary
has determined that no new
presumption relating to structural
gastrointestinal diseases is warranted at
this time.
VI. Conclusion
After careful review of the findings of
Volume 4 and Volume 8, the Secretary
has determined that the scientific
evidence presented in these reports
indicates that no new presumption of
service connection is warranted at this
time for any of the illnesses described
in the NAS 2006 and NAS update
committee’s 2010 reports. It is important
to note that VA’s determination that
presumptions of service connection are
not warranted at this time for the health
effects in question is not intended to
suggest that they are irrelevant to further
investigations of Gulf War Veterans’
health or that they may not in any
circumstances form the basis for
presumptions of service connection
under Public Law 105–277. In the event
future evidence links any illnesses to
exposures associated with Gulf War
service, VA may establish presumptions
of service connection for such illnesses
pursuant to Public Law 105–277. It is
equally important to note that VA’s
determinations not to establish
presumptions do not in any way
preclude claimants from seeking and
establishing service connection for these
diseases and illnesses or any other
diseases or illnesses that may be shown
by evidence in an individual case to be
associated with service in the Gulf War.
Signing Authority
The Secretary of Veterans Affairs, or
designee, approved this document and
VerDate Mar<15>2010
20:32 Apr 13, 2011
Jkt 223001
21107
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs. John
R. Gingrich, Chief of Staff, Department
of Veterans Affairs, approved this
document on March 31, 2011, for
publication.
Dated: April 11, 2011.
By direction of the Secretary.
William F. Russo,
Director of Regulations Management, Office
of General Counsel.
Dated: April 8, 2011.
William F. Russo,
Deputy Director, Regulations Policy and
Management, Department of Veterans Affairs.
DEPARTMENT OF VETERANS
AFFAIRS
[FR Doc. 2011–8937 Filed 4–13–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF VETERANS
AFFAIRS
Veterans’ Rural Health Advisory
Committee; Notice of Meeting
The Department of Veterans Affairs
(VA) gives notice under Public Law 92–
463 (Federal Advisory Committee Act)
that the Veterans’ Rural Health Advisory
Committee will conduct a
teleconference meeting on Thursday,
April 21, 2011, from 2 p.m. to 4 p.m.,
in Room GL20, 1722 I Street, NW.,
Washington, DC. The toll-free number
for the meeting is 1–800–767–1750, and
the access code is 57165#. The meeting
is open to the public.
The purpose of the Committee is to
advise the Secretary of Veterans Affairs
on health care issues affecting enrolled
Veterans residing in rural areas. The
Committee examines programs and
policies that impact the provision of VA
health care to enrolled Veterans residing
in rural areas and discusses ways to
improve and enhance VA services for
these Veterans.
The Committee will discuss the
Committee’s Annual Report to the VA
Secretary, VA Veteran Centers services,
rural women Veteran health care, and
the meeting agenda and planning for the
Committee’s upcoming June 2011
meeting in Helena, Montana.
A 15-minute period will be reserved
at 3:40 p.m. for public comments.
Individuals who wish to address the
Committee are invited to submit a 1–2
page summary of their comments for
inclusion in the official meeting record.
Members of the public may also submit
written statements for the Committee’s
review to Christina White, Designated
Federal Officer, Department of Veterans
Affairs (10A5A), 810 Vermont Avenue,
NW., Washington, DC 20420 or e-mail at
rural.health.inquiry@va.gov. Any
member of the public wishing to attend
or seeking additional information
should contact Ms. White at (202) 461–
7100.
PO 00000
Frm 00168
Fmt 4703
Sfmt 4703
[FR Doc. 2011–9087 Filed 4–13–11; 8:45 am]
BILLING CODE P
Advisory Committee on Prosthetics
and Special-Disabilities Programs;
Notice of Meeting
The Department of Veterans Affairs
(VA) gives notice under Public Law 92–
463 (Federal Advisory Committee Act)
that a meeting of the Advisory
Committee on Prosthetics and SpecialDisabilities Programs will be held on
May 3–4, 2011, in room 230, at VA
Central Office, 810 Vermont Avenue,
NW., Washington, DC. The sessions will
convene at 8:30 a.m. on both days, and
will adjourn at 4:30 p.m. on May 3 and
at 12 noon on May 4. The meeting is
open to the public.
The purpose of the Committee is to
advise the Secretary of Veterans Affairs
on VA’s prosthetics programs designed
to provide state-of-the art prosthetics
and the associated rehabilitation
research, development, and evaluation
of such technology. The Committee also
provides advice to the Secretary on
special disabilities programs which are
defined as any program administered by
the Secretary to serve Veterans with
spinal cord injuries, blindness or visual
impairments, loss of extremities or loss
of function, deafness or hearing
impairment, and other serious
incapacities in terms of daily life
functions.
On May 3, the Committee will be
briefed by the Acting Assistant Deputy
Under Secretary for Clinical Operations
and Management; Chief Consultant for
Social Work Service; Director of Blind
Rehabilitation Service; and Chief
Consultant for Spinal Cord Injury &
Disorders Strategic Healthcare Group.
On May 4, the Committee will be
briefed by the Chief Consultant for Care
Coordination, and Chief Consultant for
Rehabilitation Services.
No time will be allocated for receiving
oral presentations from the public.
However, members of the public may
submit written statements for review by
the Committee to Mr. Larry N. Long,
Designated Federal Officer, Veterans
Health Administration, Patient Care
Services, Rehabilitation Services (117D),
Department of Veterans Affairs, 810
Vermont Avenue, NW., Washington, DC
20420, or by e-mail at lonlar@va.gov.
E:\FR\FM\14APN1.SGM
14APN1
Agencies
[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 21099-21107]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8937]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
Determinations Concerning Illnesses Discussed In National Academy
of Sciences Reports on Gulf War and Health, Volumes 4 and 8
AGENCY: Department of Veterans Affairs.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As required by law, the Department of Veterans Affairs (VA)
hereby gives notice that the Secretary of Veterans Affairs, under the
authority granted by the Persian Gulf War Veterans Act of 1998, has
determined that there is no basis to establish any new presumptions of
service connection at this time for any of the diseases, illnesses, or
health effects discussed in the September 12, 2006, and April 9, 2010,
reports of the Institute of Medicine of the National Academy of
Sciences (NAS), respectively titled Gulf War and Health, Volume 4:
Health Effects of Serving in the Gulf War (Volume 4) and Gulf War and
Health, Volume 8: Update of Health Effects of Serving in the Gulf War
(Volume 8).
FOR FURTHER INFORMATION CONTACT: Gerald Johnson, Regulations Staff
(211D), Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue,
NW., Washington, DC 20420, telephone (202) 461-9727. (This is not a
toll-free number.)
SUPPLEMENTARY INFORMATION:
I. Statutory Requirements
The Persian Gulf War Veterans Act of 1998, Public Law 105-277,
title XVI, 112 Stat. 2681-742 through 2681-749 (set out as a note under
38 U.S.C. 1117 and codified in part at 38 U.S.C. 1118), and the
Veterans Programs Enhancement Act of 1998, Public Law 105-368, 112
Stat. 3315, directed the Secretary to seek to enter into an agreement
with the NAS to review and evaluate the available scientific evidence
regarding associations between illnesses and exposure to toxic agents,
environmental or wartime hazards, or preventive medicines or vaccines
to which service members may have been exposed during service in the
Southwest Asia theater of operations during the Persian Gulf War. Under
this agreement, Congress directed NAS to identify agents, hazards,
medicines, and vaccines to which service members may have been exposed
during the Persian Gulf War. Congress required NAS, to the extent that
available scientific data permits meaningful determinations, to
determine for each substance or hazard identified: (1) Whether a
statistical association exists between exposure to the substance or
hazard and the occurrence of illnesses, (2) whether there is an
increased risk of the illness among exposed human or animal
populations, and (3) whether a plausible biological mechanism or other
evidence of a causal relationship exists. Public Law 105-277, 112 Stat.
2681-747.
In addition, Congress authorized VA to compensate Gulf War Veterans
for diagnosed or undiagnosed illnesses that are determined by VA to
warrant a presumption of service connection based upon a positive
association with exposure, as a result of Gulf War service, to a toxic
agent, an environmental or wartime hazard, or a preventive medication
or vaccine known or presumed to be associated with Gulf War service. 38
U.S.C. 1118. Thus, upon receipt of each NAS report, VA must determine
whether a presumption of service connection is warranted for any
disease or illness discussed in the report. A presumption of service
connection is warranted if VA determines, based on sound medical and
scientific evidence, that there is a positive association between the
exposure of humans and animals to a biological, chemical, or other
toxic agent, environmental or wartime hazard, or preventive medicine or
vaccine known or presumed to be associated with service in the
Southwest Asia theater of operations during the Gulf War and the
occurrence of a diagnosed or undiagnosed disease or illness in humans
and animals. 38 U.S.C. 1118(b). If the Secretary determines that a
presumption of service connection is not warranted, the Secretary shall
publish in the Federal Register a notice of the determination. 38
U.S.C. 1118(c)(3)(A). Accordingly, this notice announces VA's
determination that no new presumptions of service connection are
warranted for any disease or illness discussed in Volume 4 and Volume
8.
II. NAS Reports: Gulf War and Health Series
The NAS has issued eight numbered reports and two unnumbered
``updates'' in the Gulf War and Health series, which examine the health
effects of exposure to specific chemical agents, environmental and
wartime hazards, and preventive medicines and vaccines. Federal
Register notices have been published on four of the eight numbered
reports and two unnumbered updates announcing the Secretary's
determination that the available evidence does not warrant a
presumption of service connection for any of the diseases discussed in
the four reports: Gulf War and Health, Volume 1: Depleted Uranium,
Sarin, Pyridostigmine Bromide, and Vaccines (66 FR 35702 (2001)); Gulf
War and Health, Volume 2: Insecticides and Solvents (72 FR 48734
(2007)); Gulf War and Health: Updated Literature Review of Sarin (73 FR
42411 (2008)); Gulf War and Health, Volume 3: Fuels, Combustion
Products, and Propellants (73 FR 50856 (2008)); Gulf War and Health,
Volume 5: Infectious Diseases (74 FR 15063 (2009)); Gulf War and
Health: Updated Literature Review of Depleted Uranium (75 FR 10867
(2010)); and Gulf War and Health, Volume 6: Physiologic, Psychologic,
and Psychosocial Effects of Deployment-Related Stress (76 FR 2447
(2011)).
The Volume 4 report is covered in this notice. The findings for
Gulf War and Health, Volume 7: Long-Term Consequences of Traumatic
Brain Injury are currently under review. The latest report, Volume 8,
will also be covered in this notice. Based on Volume 4 and Volume 8, VA
published a proposed rule on November 17, 2010 to clarify that FGIDs
fall within the scope of the existing presumption of service connection
for medically unexplained chronic multisymptom illnesses. 75 FR 70162.
Aside from that clarification, VA has determined that no other changes
to the existing presumptions relating to multisymptom illness, nor any
new presumptions, are warranted at this time.
[[Page 21100]]
III. Gulf War and Health, Volume 4: Health Effects of Serving in the
Gulf War
The NAS issued its Volume 4 report on September 12, 2006. This
study differs from previous NAS work in that it compiles, evaluates,
and summarizes in one location peer-reviewed scientific and medical
literature on the current status of health effects in Veterans deployed
to the Persian Gulf irrespective of exposure information, i.e., health
responses associated with deployment in the Gulf War Theatre alone. The
purpose of the study was to inform VA of illnesses among Gulf War
Veterans that might not be immediately evident. Based on this NAS
report, the Secretary has determined that the scientific evidence
presented in this report and other information available to the
Secretary indicates that no new presumption of service connection is
warranted at this time for any of the illnesses described in Volume 4.
The NAS committee for Volume 4 (NAS committee) was charged to
review, evaluate, and summarize scientific and medical literature
addressing the health status of Gulf War Veterans. The committee's
objective was to determine the prevalence of diseases and symptoms in
the Gulf War Veteran population, based primarily on studies comparing
the health status of deployed Gulf War Veterans with the health status
of their nondeployed counterparts. This information is useful in
identifying areas of concern and needs of the Gulf War Veteran
population, and may assist in guiding VA's actions in the areas of
health care, compensation, and research. Because this was a disease
prevalence study, the NAS committee generally did not attempt to
associate diseases or symptoms with specific biological or chemical
agents or other specific hazards of Gulf War service. However, the NAS
committee did review certain studies that assessed exposures in
Veterans and the influence of exposure information on the
interpretation of Veterans' health.
The NAS committee conducted extensive searches of epidemiologic
literature and extracted 850 potentially relevant epidemiologic studies
for evaluation from a composite of over 4000 relevant references. The
NAS committee based its conclusion on only peer-reviewed published
scientific and medical literature. The process of peer review by fellow
professionals increased the likelihood of high quality analysis, but
did not guarantee the validity of a study. The NAS committee presumed
neither the existence nor the absence of illnesses associated with
deployment. It characterized and weighed the strengths and limitations
of available evidence. The NAS committee read each study critically and
considered its relevance and quality; however, the committee did not
collect original data nor did it perform any secondary data analysis.
After securing the full text of the selected peer-reviewed
epidemiologic studies, the NAS committee divided them into primary and
secondary studies. Primary studies included information about specific
health outcomes, demonstrated rigorous methods, described its methods
in sufficient detail, included a control or reference group, had the
statistical power to detect effects, and included reasonable
adjustments for confounders. Secondary studies provided background
information or ``context'' for the report.
There was no attempt to link health outcomes to exposures other
than deployment to the Persian Gulf theater, for which there is no
known animal model, and, because the NAS committee assessed disease
prevalence rather than causation, it did not comprehensively review
toxicologic, animal, or experimental studies. The NAS committee did
evaluate the key animal and epidemiologic studies cited in the Research
Advisory Committee on Gulf War Veterans' Illnesses (RAC) report.
Epidemiologic studies that attempted to associate health effects with
specific exposures, such as oil-well-fire smoke or nerve-gas agents,
were also considered by the committee.
The committee's full report may be viewed at: https://www.iom.edu/CMS/3793/24597/36955.aspx.
IV. Gulf War and Health, Volume 8: Update of Health Effects of Serving
in the Gulf War
The NAS issued its latest report, Volume 8, on April 9, 2010. The
charge to the NAS update committee for Volume 8 (NAS update committee)
was to review, evaluate, and summarize the literature on the health
outcomes noted in Volume 4 that seemed to have higher incidence or
prevalence in Gulf War deployed Veterans, namely: cancer (particularly
brain and testicular), amyotrophic lateral sclerosis and other
neurological diseases (such as Parkinson's disease and multiple
sclerosis), birth defects and other adverse pregnancy outcomes, and
post deployment psychiatric conditions. The NAS update committee also
reviewed studies of cause-specific mortality in Gulf War Veterans and
examined literature to identify emerging health outcomes. The NAS
update committee limited its review to epidemiological studies of
health outcomes published subsequent to the literature search for
Volume 4 and those studies included in Volume 4. In order for a study
to be considered, the NAS update committee required the study to
compare the health status of Gulf War Veterans to nondeployed Veterans
or Veterans deployed in other locations.
The NAS update committee conducted extensive searches of
epidemiological literature published since 2005, employing the same
search strategies as used for Volume 4, and retrieved over 1,000
potentially relevant references. The titles and the abstracts of the
studies were assessed and then narrowed down to focus on 400
potentially relevant epidemiological studies for the review. Similar to
the policy utilized in the Volume 4 review, the NAS update committee
used only peer-reviewed published literature as the basis for its
conclusions, with the exception of some governmental reports. As noted
in regard to Volume 4, the process of peer review by fellow
professionals increases the probability of a high quality study, but
does not guarantee its validity. The NAS update committee did not
collect any original data or perform any secondary data analysis.
The NAS update committee also reviewed the studies that had been
included in Volume 4 as either primary or secondary studies. In Volume
4, the NAS committee did not make determinations as to the strength of
the association between deployment to the Gulf War and the specific
health effects. Therefore, the NAS update committee was asked to make
such determinations during its review. To make these determinations,
the NAS update committee reviewed the studies included in Volume 4 to
ensure that they would still be classified as either primary or
secondary studies.
The NAS update committee collectively reviewed all of the relevant
studies cited in Volume 4 as well as the new studies identified from
the updated literature. The NAS update committee weighed the evidence,
reached a consensus and assigned a category of association for each
health outcome considered in the report. This review provides an update
on the health effects of serving in the Southwest Asia theater of
operations during the Persian Gulf War. The purpose of this report was
to determine the strength of associations between being deployed to the
Gulf War and specific health effects. Specifically, the NAS update
committee determined whether there was sufficient evidence of a causal
relationship, sufficient evidence of an association, limited/suggestive
evidence of an association,
[[Page 21101]]
inadequate/insufficient evidence to determine whether an association
exists, or limited/suggestive evidence that no association exists
between the health outcome and deployment to the Gulf War.
The committee's full report may be viewed at: https://www.iom.edu/Reports/2010/Gulf-War-and-Health-Volume-8-Health-Effects-of-Serving-in-the-Gulf-War.aspx.
V. Report Summaries for Volume 4 and Volume 8
The different approaches used by the NAS committee in evaluating
Volume 4 and the NAS update committee in evaluating Volume 8 are
reflected in the separate conclusions reached by each committee. The
task of the NAS committee was to catalog the health outcomes that
appeared to have greater prevalence in Veterans who had been deployed
to the Gulf War in comparison with Veterans in the military at that
time who were not deployed to the Gulf War. In Volume 4, the NAS
committee did not specifically evaluate the strength of the association
between Gulf War deployment and the specific health outcomes. The
Volume 4 studies generally did not associate any observed health
effects with exposure to specific hazards of Gulf War service, and
therefore provide no basis for establishing new presumptions under 38
U.S.C. 1118 based on exposure to specific agents, hazards, or medicines
associated with Gulf War service.
The NAS update committee reviewed epidemiologic studies of health
outcomes published after the literature search conducted for the Volume
4 report as well as the studies included in Volume 4. The purpose of
this report was to determine the strength of associations between being
deployed to the Gulf War and specific health effects. The NAS update
committee reviewed only studies that compared the health status of Gulf
War Veterans with those of non-deployed Veterans and Veterans deployed
to other locations, and then characterized the strength of the evidence
for an association between Gulf War deployment and the specific health
outcome. Based on the NAS update committee's findings, VA determined
that Volume 8 did not present a basis for establishing new presumptions
under 38 U.S.C. 1118 based on exposure to specific agents, hazards, or
medicines associated with Gulf War service. Specific findings of Volume
4 and Volume 8 are discussed below.
Multisymptom Illness
The NAS committee for Volume 4 found that Veterans of the Gulf War
report higher rates of symptoms or sets of symptoms than their non-
deployed counterparts. The committee found that 29 percent of Gulf War
Veterans meet a case definition of ``multisymptom illness,'' compared
to 16 percent of non-deployed Veterans. Among the symptoms most often
reported by Gulf War Veterans are fatigue, memory loss, confusion,
inability to concentrate, mood swings, somnolence, gastrointestinal
symptoms, muscle and joint pains, and skin conditions. Gulf War
Veterans also reported more instances of chronic multisymptom illness,
including chronic fatigue syndrome, fibromyalgia, and multiple chemical
sensitivity.
Under current law at 38 U.S.C. 1117 and 38 CFR 3.317, Gulf War
Veterans are entitled to compensation for chronic disabilities
associated with signs or symptoms of disabilities such as those
described above or associated with chronic multisymptom illness. The
findings in Volume 4 support the policies of the current presumptions
and warrant no change to the existing regulatory presumptions of
service connection in 38 CFR 3.317.
In a November 2008 report, the RAC, a Federal advisory committee
established to provide research recommendations to VA, indicated that
current medical and scientific evidence provides support for the theory
that the increased symptomatology reported by Gulf War Veterans may be
attributable to exposure to pyridostigmine bromide (PB) in pills given
to U.S. troops as a protection against nerve gas and pesticides. The
RAC found that several studies provide evidence of an association,
including a dose-response relationship, between PB and multisymptom
illnesses consistent with ``Gulf War Illness,'' and between pesticide
exposure and such multisymptom illness. The RAC noted also that animal
studies had identified significant effects of exposure to combinations
of PB, pesticides, sarin, and stress, at dosage levels similar to those
experienced by Veterans in the Gulf War, although there is relatively
little information from human studies concerning the effects of such
combined exposures.
The NAS update committee for Volume 8 reviewed the literature cited
in the RAC report, but disagreed with the RAC's conclusion that chronic
multisymptom illness is caused by exposure to PB and pesticides. The
NAS update committee concluded that current available evidence was not
sufficient to establish a causative relationship between multisymptom
illness and any specific drug, toxin, plume or other agent, either
alone or in combination. The NAS update committee noted that some
studies had found associations between self-reported exposures to PB,
pesticides, nerve gas, and mixtures thereof, but that several well-
designed studies have concluded that no associations exist for such
exposures. The update committee also stated that, although some studies
have found that central nervous system (CNS) disorders may persist
following acute pesticide exposure, there is no evidence that Gulf War
Veterans experienced such acute exposures and no significant evidence
of chronic CNS effects from low-level exposures. Based on its review of
the available evidence from both human and animal studies, the NAS
update committee found insufficient support for the conclusion that
pesticides, PB, insect repellants, or combinations thereof are
responsible for multisymptom illnesses in Gulf War Veterans.
Based on review of the information in the reports of the NAS and
the RAC, VA has determined that the evidence for an association between
multisymptom illnesses and specific exposures, such as PB, pesticides,
and combinations thereof, is not equal to or greater than the evidence
against such an association. VA emphasizes, however, that this
conclusion has no effect on VA's ability under existing law to provide
compensation for such illnesses. Under 38 U.S.C. 1117 and 38 CFR 3.317,
VA pays compensation for such illness without regard to its cause. VA
will continue to evaluate developments regarding the possible causes of
Gulf War Veterans' chronic multisymptom illnesses, which may affect the
understanding and treatment of these illnesses.
The NAS update committee accepted multisymptom illness as a
diagnostic entity and assessed the association between symptom
reporting indicative of multisymptom illness and deployment to the Gulf
War, instead of attempting to determine whether there appears to be a
unique illness that could be defined by the symptoms. Most studies
indicate an increased reporting of multisymptom illness among deployed
Gulf War Veterans, which occurred in multiple studies from several
countries, but were subjective with inconsistent findings on physical
examinations and laboratory testing requiring further analysis. The NAS
update committee determined that there is sufficient evidence of an
association
[[Page 21102]]
between deployment to the Gulf War and chronic multisymptom illness,
but noted that the basis for the relationship is unclear, and
recommended further research. These findings support the policy in
existing law to provide compensation for Gulf War Veterans' chronic
multisymptom illnesses.
Psychiatric Symptoms
The NAS committee concluded that deployment places Veterans at
increased risk for symptoms that meet the diagnostic criteria for
certain psychiatric illnesses, including post-traumatic stress disorder
(PTSD), anxiety, depression, and substance abuse. In Volume 6, the NAS
committee explained that the increased risk of psychiatric symptoms has
been associated with deployment during any period of war and is thus
not limited to Gulf War deployments.
The NAS update committee determined that there is sufficient
evidence of association between deployment to the Gulf War and several
other psychiatric disorders, including generalized anxiety disorders,
depression, and substance abuse. The results of long-term follow-up
studies indicate that psychiatric disorders were still evident 10 years
after deployment and were shown to be more than two times higher in
deployed Veterans compared to non-deployed Veterans. The NAS update
committee further noted that an inference can be made that the high
prevalence of medically unexplained disability reported by Gulf War
Veterans cannot be reliably attributed to any known psychiatric
disorder. Lastly, the NAS update committee determined that traumatic
war exposure experienced during deployment in the Gulf War is causally
related to PTSD. The NAS update committee explained that though the
evidence available from the Gulf War is somewhat limited, it is
sufficient to support the conclusion of a causal relationship between
combat exposure and the development of PTSD. The NAS committee further
noted that similar evidence obtained from other wars is also supportive
of their conclusion that combat exposure and PTSD in the Gulf War are
causally related.
VA regulations at 38 CFR 4.125(a) require that mental disorders,
including PTSD, be diagnosed in accordance with the Diagnostic and
Statistical Manual: Fourth Edition (DSM-IV). Under the DSM-IV, the
diagnosis of PTSD requires evidence of a pre-morbid traumatic exposure.
In order for PTSD to be service connected, that traumatic exposure must
have occurred during a period of military service. The NAS Update
committee did not find a causal relationship between mere deployment to
the Gulf War theater and PTSD, nor did it find PTSD to be associated
with exposure to a particular toxic agent, hazard, medicine, or
vaccine. Rather, it found a causal relationship between PTSD and the
traumatic war exposures experienced during deployment to this war zone.
Further, these types of exposures are not unique to the Gulf War, but
are common to all episodes of combat. Consequently, we do not believe
there is a sound basis for establishing a presumption of service
connection for PTSD that is limited to Veterans of Gulf War combat
service. Such a presumption would treat Gulf War combat Veterans
differently than combat Veterans of other wars, without a rational
basis for such disparate treatment.
Although the NAS committee found PTSD to be associated with
``traumatic war exposure,'' and the NAS update committee found a causal
relationship between ``traumatic war exposures'' experienced during
Gulf War deployment and PTSD, PTSD could not be associated with the
types of exposure outlined in 38 U.S.C. 1118, involving exposure to
hazardous substances known or suspected to be associated with Gulf War
service. VA interprets the use of the phrase ``traumatic war
exposures'' used in the reports as being a general reference to the
exposures to the dangers of service in a combat area, including risk of
death or injury due to enemy attacks. Accordingly, VA does not believe
that the reference to ``traumatic war exposures'' identifies an
association between PTSD and a specific ``exposure'' within the meaning
of section 1118.
VA also concludes that it is unnecessary to create a presumption
for PTSD for all combat Veterans based on VA's general rulemaking
authority. VA's current regulations afford combat Veterans essentially
the same liberalized standard of proof that a presumption would
provide. When a Veteran has been validly diagnosed with PTSD, service
connection will be granted if the PTSD is associated with an in-service
``stressor.'' As noted above, the Veteran must identify a stressor
before a valid diagnosis of PTSD can be made. Under VA regulations at
38 CFR 3.304(f), if a Veteran engaged in combat and the claimed
stressor relates to combat, VA will accept the Veteran's lay statement
as sufficient evidence of the stressor. Further, under a recent
amendment to that regulation, even if the Veteran did not engage in
combat the Veteran's own statements alone may establish the occurrence
of the claimed in-service stressor if the claimed stressor is related
to the Veteran's fear of hostile military or terrorist activity and is
confirmed as adequate to support a diagnosis of PTSD, the Veteran's
symptoms are related to the claimed stressor, and the claimed stressor
is consistent with the places, types, and circumstances of the
Veteran's service. 75 FR 39843 (July 13, 2010). Accordingly, a Veteran
whose claimed stressor relates to the perils of deployment to a war
zone generally need not submit any evidence of a stressor beyond the
statements made for purposes of the diagnosis of PTSD. A presumption of
service connection for PTSD based on traumatic war exposures in the
Gulf War theater would neither increase the likelihood of a legitimate
claim being accepted, nor speed the process by which claims are
adjudicated.
For similar reasons, VA has determined that the finding of
increased prevalence of other psychiatric disorders in Gulf War
Veterans does not warrant a presumption of service connection under
section 1118. In Volume 4 and Volume 8, NAS found that psychiatric
disorders are associated with deployment to the Gulf War, but did not
find such disorders to be associated with any particular type of
exposure during the Gulf War. In its Volume 6 report, NAS found that an
increased risk of psychiatric disorders is associated with deployment
to any war zone, and that the prevalence and severity of those
disorders were associated with the level of combat experienced. This
suggests that the increased prevalence of psychiatric disorders is more
likely associated with the inherent perils of combat in any war than
with exposure to specific agents, hazards, medicines, or vaccines
associated with the Gulf War.
Section 1118(a)(2)(A) and (b)(1)(B) require VA to determine whether
a presumption of service connection is warranted by reason of a disease
having a positive association with exposure to a biological, chemical,
or other toxic agent, environmental or wartime hazard, or preventive
medicine or vaccine ``known or presumed to be associated with service
in the Armed Forces in the Southwest Asia theater of operations during
the Persian Gulf War.'' We conclude that the statutory phrase
``associated with service in the Armed Forces in the Southwest Asia
theater of operations during the Persian Gulf War'' is most reasonably
construed to refer to a relationship between the substance or hazard
and the specific circumstance of service in the Southwest Asia theater
of operations during the Persian Gulf War, as distinguished from
features of
[[Page 21103]]
military service that are not unique to service in the Gulf War.
Section 1118 reflects the Government's commitment to addressing the
unique health issues presented by Gulf War Veterans, by establishing a
process for identifying diseases and illnesses that may be associated
with Gulf War service. The requirement that the substances or hazards
at issue be ``associated with'' Gulf War service makes clear that VA's
task is to examine the unique exposure environment in the Persian Gulf
during the Persian Gulf War. Establishing presumptions of service
connection under section 1118 applicable only to Gulf War Veterans
based on the general circumstance of deployment which is shared by
significant other groups of Veterans would not significantly further
the statute's purpose, but would create significant inequities in the
Veterans' benefits system that Congress could not have intended.
VA has also decided not to establish a presumption of service
connection for psychiatric disorders in Veterans of any period of
deployment to a combat zone under VA's general rulemaking authority.
The category of psychiatric disorders encompasses a diverse array of
diagnoses. Further, psychiatric disorders are widespread and may be
triggered by many life events, including those occurring before and
after service. Although the NAS reports indicate that psychiatric
disorders are associated with combat deployment, they provide no basis
for evaluating whether Veterans' psychiatric disorders are more likely
caused by wartime deployment than by any of the many other risk factors
that are also associated with such disorders or for evaluating possible
differences in the degree to which the numerous specific types of
psychiatric disorders may be associated with wartime deployment.
Accordingly, a general presumption of service connection for
psychiatric disorders would be overly broad.
VA believes that VA psychiatric examinations are a more effective
way of evaluating whether psychiatric disorders are related to military
service than applying a broad presumption that would apply to all
Veterans deployed to the Gulf War. VA routinely provides psychiatric
examinations to Veterans claiming service connection for psychological
disorders and believes that this process is effective.
Cardiovascular Disease, Diabetes, Arthralgia or Hospitalization
The NAS committee concluded that the evidence did not show that
Gulf War Veterans have an increased risk of cardiovascular disease,
diabetes, arthralgia, or hospitalization in comparison to non-deployed
Veterans. The NAS update committee found that there is limited or
suggestive evidence of no association between Gulf War deployment and
mortality from cardiovascular disease in the first 10 years after war.
The NAS update committee further found that there is insufficient or
inadequate evidence to determine whether an association exists between
Gulf War deployment and endocrine, nutritional, and metabolic diseases,
including diabetes, and Gulf War deployment and musculoskeletal system
diseases, including arthralgia. The NAS update committee did not review
hospitalization as a separate category as reviewed in Volume 4; rather,
the committee included hospitalization as a factor in each specific
health outcome reviewed.
In order for a presumption to be warranted the Secretary must
establish that there is a ``positive association'' between ``the
exposure of humans or animals to a biological, chemical or other toxic
agent, environmental or wartime hazard, or preventive medicine or
vaccine known or presumed to be associated with service in the Armed
Forces in the Southwest Asia theater of operations during the Persian
Gulf War; and [] the occurrence of a diagnosed or undiagnosed illness
in humans or animals.'' 38 U.S.C. 1118(b)(1)(B). An association is
considered ``positive'' if the credible evidence for an association is
equal to or outweighs the credible evidence against the association. 38
U.S.C. 1118(b)(3). For the conditions listed above, the NAS committee
concluded that there was not an increased risk, and the update
committee found that there was inadequate or insufficient evidence to
determine whether an association exists or limited or suggestive
evidence of no association with deployment to the Gulf War. Therefore,
VA concludes that the evidence of an association for these conditions
does not equal or outweigh the credible evidence against an
association. Based on this analysis, VA has determined that no
presumptions of service connection are warranted for any of the above-
mentioned outcomes based on Gulf War service.
Cancer
The NAS committee concluded that the evidence did not show that
Gulf War Veterans have an increased overall risk of cancer. However, in
one study in Volume 4 an association of brain-cancer mortality with
possible nerve-agent exposure was observed. The NAS committee noted
that this finding should be interpreted with caution due to concerns
about the exposure modeling and the fact that the study period was not
within what is believed to be the usual latency period for brain
cancer. Further, Volume 4 reported mixed results as to whether an
association exists between testicular cancer and deployment to the Gulf
War.
The NAS update committee determined that there was insufficient or
inadequate evidence of an association between Gulf War exposures and
brain cancer. The NAS update committee did not identify any new studies
relating to testicular cancer. The NAS update committee noted that many
Veterans of the Gulf War are still too young for cancer diagnoses and
that the follow-up period following the Gulf War has probably been too
short to expect significant results. Thus, the NAS update committee
recommends further follow-up in order to make a conclusion about
whether there is an association between deployment during the Gulf War
and cancer outcomes. Based on the information provided in Volume 4 and
Volume 8, the Secretary has determined that no new presumptions
relating to cancer are warranted at this time.
Mortality From External Causes
The NAS committee noted that studies provided evidence that Gulf
War Veterans had an increased risk of transportation-related injury and
mortality in the first several years after such service when compared
to non-deployed service members. The NAS committee found no evidence
that this result was related to a specific exposure in Gulf War service
or that it was related to a specific disease or illness.
The NAS update committee identified four new studies of external
cause mortality and determined that the evidence indicates a modestly
higher mortality from transportation-related causes among Gulf War
deployed Veterans than other Veterans. The increase was due to motor-
vehicle accidents which diminished or disappeared over time. The NAS
update committee concluded that there is limited or suggestive evidence
of an association between deployment to the Gulf War and increase in
mortality from external causes primarily motor vehicle accidents, in
the early years after deployment.
VA notes that VA and other researchers have documented this
transitory post-combat-deployment health effect among Veterans of other
combat deployments, including Vietnam. Further, the findings of Volume
4 and Volume 8 do not identify an ``illness'' or a specific identified
risk factor (e.g., a particular exposure)
[[Page 21104]]
known or suspected to be associated with Gulf War service. Without
these conditions, 38 U.S.C. 1118 does not authorize VA to establish a
presumption for the increased risk of transportation-related injury or
death. Because this phenomenon has not been connected to a disease or
injury incurred or aggravated in service, VA has no statutory authority
to compensate Veterans or their survivors through a new presumption,
absent new legislative authority. See 38 U.S.C. 501 and 1110. Thus,
after careful review of the findings of mortality from external causes,
primarily motor vehicle accidents, in the early years after deployment,
the Secretary has determined that the scientific evidence presented in
Volume 4 and Volume 8 indicates that no presumption of service
connection is warranted at this time.
Skin Conditions
The NAS committee found that some studies provided evidence that
Gulf War Veterans have a higher incidence of certain skin conditions
(atopic dermatitis and warts) than non-deployed Veterans, but that the
findings were not consistent among the relevant studies. The NAS
committee identified no evidence linking those conditions to any
particular exposure in Gulf War Service. The NAS update committee
determined that there was insufficient or inadequate evidence of an
association between deployment to the Gulf War and skin disorders and
noted that the inconsistency in the studies suggests that the few
positive findings may be due to chance. Based on the inconsistent
evidence of an association between deployment to the Gulf War and skin
disorders and because these skin conditions have not been attributed to
any particular exposure in the Gulf War, VA has determined that no new
presumption of service connection is warranted for dermatological
conditions.
Amyotrophic Lateral Sclerosis
The NAS committee and the NAS update committee found that some
studies indicate that Gulf War Veterans may have an increased risk of
amyotrophic lateral sclerosis (ALS). In another report issued in
November 2006, titled Amyotrophic Lateral Sclerosis in Veterans: Review
of the Scientific Literature, a separate NAS committee concluded that
there is evidence of an increased risk of ALS in Veterans of all
periods of service.
In September 2008, VA issued regulations establishing a presumption
of service connection for ALS following any period of qualifying
service. 73 FR 54691 (Sept. 23, 2008). Because this presumption applies
to all Gulf War Veterans, there is no need for a separate presumption
that is applicable only to Gulf War Veterans.
Other Diseases of the Nervous System
The NAS committee found that available studies generally did not
provide evidence of an increased prevalence among Gulf War Veterans of
peripheral neuropathy. The NAS update committee found that available
studies generally did not provide evidence of an increased prevalence
among Gulf War Veterans of peripheral neuropathy, multiple sclerosis,
other neurological diseases such as Alzheimer's disease, dementia and
Parkinson's disease, or other neurological outcomes. The NAS update
committee therefore concluded that there was inadequate or insufficient
evidence to determine whether an association exists between deployment
to the Gulf War and multiple sclerosis, other neurological diseases, or
other neurological outcomes, and that there is limited or suggestive
evidence of no association between such deployment and peripheral
neuropathy. Based on the committees' findings, the Secretary has
determined that no new presumptions are warranted for these conditions.
Neurocognitive and Neurobehavioral Performance
The NAS committee defined primary studies as ``high quality studies
that used neurobehavioral tests that had previously been used to detect
adverse effects in population-based research on occupational groups.''
The findings compared neurobehavioral performance in deployed Veterans
and non-deployed Veterans. The NAS committee concluded that the primary
studies of Veterans deployed to the Gulf War compared to Veterans not
deployed to the Gulf War do not demonstrate differences in cognitive
and motor measures as determined through neurobehavioral testing.
However, the NAS committee did conclude that Gulf War Veterans who had
at least one symptom commonly reported by Gulf War Veterans (such as
fatigue, memory loss, confusion, inability to concentrate, mood swings,
somnolence, gastrointestinal distress, muscle or joint pain, or skin or
mucous membrane complaints) had poorer performance on cognitive tests
than returning Veterans who did not report any such symptoms.
The NAS update committee reviewed two additional studies that were
classified as secondary. Primary studies of deployed Gulf War Veterans
versus non-deployed Veterans did not demonstrate differences in
cognitive and motor measures to determine the neurobehavioral testing.
The NAS update committee concluded that there is inadequate or
insufficient evidence to determine if an association exists between
deployment to the Gulf War and neurocognitive and neurobehavioral
performance.
Decreased neurocognitive or neurobehavioral performance is not in
itself a disease or illness for which service connection may be
established. Further, Volume 4 and Volume 8 did not find evidence of an
association between such decreased performance and any Gulf War
exposure. Accordingly, VA has determined that no presumption relating
to neurocognitive and neurobehavioral performance is warranted at this
time.
Sexual Dysfunction
The NAS committee reviewed one primary study on self-reported
sexual dysfunction in Volume 4. In this study the self-reported sexual
problems were verified through physician interviews. The NAS committee
found that Gulf War Veterans consistently report an increased
prevalence of sexual problems when compared to nondeployed Veterans.
The NAS update committee did not consider any new primary studies,
but considered seven additional secondary studies in Volume 8. The NAS
update committee noted that in one study, assessing exposures specific
to Gulf War service, there was no association between nerve agent
exposure and reported sexual problems among Veterans deployed to the
Gulf War. The NAS update committee further noted that all of the
studies relied exclusively on survey responses except for the primary
study reviewed in Volume 4. The NAS update committee acknowledged that
studies assessing the prevalence of sexual problems are generally
limited to self-reported symptoms, but warned that these studies should
be interpreted with caution given concerns about their susceptibility
to selection and reporting biases. The NAS update committee concluded
that there was limited or suggestive evidence of an increased
prevalence of self-reported sexual difficulties among Gulf War
Veterans.
Although the NAS update committee found limited or suggestive
evidence of an increase in self-reported sexual dysfunction, it did not
find an increase in any specific or verified disease, nor did it find
evidence associating any such condition with a particular Gulf War
exposure. Accordingly, VA has determined that a presumption of
[[Page 21105]]
service connection for sexual dysfunction is not warranted at this
time.
Other Genitourinary Outcomes
The NAS committee did not discuss other genitourinary conditions in
Volume 4. In Volume 8, the NAS update committee found that studies
showed an increased incidence of self-reported genitourinary symptoms
or diseases among Veterans of Gulf War deployments. It found that such
studies were limited by self-reported outcomes, lack of clinical
confirmation, potential recall bias, and generally poor response rates.
The NAS update committee identified no reports based on confirmed
diagnoses showing increased incidence of genitourinary conditions among
Veterans of Gulf War deployments. The NAS update committee also found
that hospitalization studies provide evidence that hospitalizations for
genitourinary conditions were not increased in that population.
Accordingly, the NAS update committee concluded that there was
inadequate or insufficient evidence to determine whether an association
exists between Gulf War deployment and specific conditions of the
genitourinary system, and that there is limited or suggestive evidence
of no association between Gulf War deployment and hospitalization for
genitourinary diseases. Accordingly, VA has determined that a
presumption of service connection for genitourinary conditions is not
warranted at this time.
Fertility Problems
In Volume 4 and Volume 8, the NAS committee and the NAS update
committee assessed fertility problems such as semen parameters,
hospitalization for infertility or genitourinary system diseases, self-
reported difficulties in achieving a pregnancy, and serum
concentrations of reproductive hormones in males. The NAS committee
reviewed two primary studies in Volume 4. The NAS committee found that,
although it appears that there is no difference in the prevalence of
male fertility problems or infertility between Veterans deployed to the
Gulf War and nondeployed Veterans, it is difficult to draw any
conclusions due to the small number of available studies.
The NAS update committee additionally reviewed one primary study
and four secondary studies in Volume 8. The NAS update committee found
that there was no evidence of significant differences in concentrations
of male reproductive hormones between Gulf War Veterans and nondeployed
Veterans, but noted that this question was only addressed by one study.
The NAS update committee further noted that, although it appears that
infertility problems are reported more frequently among Gulf War
Veterans compared to their nondeployed counterparts, these findings
should be interpreted with caution because of the small number of
available studies and their susceptibility to reporting bias and
selective participation. The NAS update committee concluded that there
was inadequate or insufficient evidence to determine whether an
association exists between deployment to the Gulf War and fertility
problems. Based on the NAS committee and the NAS update committee's
findings, VA has determined that no presumption of service connection
for fertility problems is warranted at this time.
Adverse Pregnancy Outcomes
The NAS committee and the NAS update committee reviewed studies
concerning adverse pregnancy outcomes, such as the prevalence of
spontaneous abortions, stillbirths, ectopic pregnancies, preterm
births, low birth weight, and macrosomia, in the pregnancies of Gulf
War deployed and nondeployed men and women. In Volume 4, the NAS
committee reviewed one primary study and two secondary studies. The
primary study was the only study of adverse pregnancy outcomes that
used hospital discharge records rather than relying exclusively on
self-reported outcomes.
In Volume 8, the NAS update committee reviewed five additional
secondary studies evaluating the effect of deployment on adverse
pregnancy outcomes. The NAS update committee found that one of the
primary studies reviewed in Volume 4 noted an increased risk of
spontaneous abortion and ectopic pregnancy among active-duty personnel
admitted to military hospitals for pregnancy-related diagnoses, but
that these results may not be generalized to Veterans who have left
service or to pregnancy-related admissions to nonmilitary hospitals.
The NAS update committee observed that such findings for spontaneous
abortion were not replicated in the four secondary studies of female
Veterans reviewed in Volume 8. The NAS update committee further
observed that, in Volume 8, the one secondary study that addressed
ectopic pregnancies did not indicate any increased incidence among
either male or female Veterans of Gulf War deployments. The NAS update
committee found that, among males reporting on their female partners,
there was no consistent association for abortions, spontaneous
abortion, preterm birth or low birth weight, but three studies showed a
modest increase in self reported miscarriages among deployed males
reporting on their female partners. The NAS update committee concluded
that there was inadequate or insufficient evidence to determine whether
an association exists between deployment to the Gulf War and adverse
pregnancy outcomes. Based on the NAS committee and the NAS update
committee findings, VA has determined that a presumption of service
connection for adverse pregnancy outcomes is not warranted at this
time.
Birth Defects
In Volume 4, a study identified birth defects among infants of
military personnel born from January 1, 1989, to December 31, 1993,
from population-based birth defect registries in six States: Arizona,
Hawaii, Iowa, Arkansas, California, and Georgia. The study compared 48
selected congenital anomalies diagnosed from birth to the age of 1 year
between Gulf War Veterans' and non-deployed Veterans' infants conceived
before, during or after the war; and between infants conceived by Gulf
War Veterans before and after the war. The study found three cardiac
defects and one kidney defect among infants conceived after the war to
Gulf War Veteran fathers. The study also found a higher prevalence of
hypospadias, a genitourinary defect among sons conceived post-war to
Gulf War Veteran mothers compared to their non-deployed counterparts.
Aortic valve stenosis, coarctation of aorta, and renal agenesis and
hypoplasia were also elevated among infants conceived by Gulf War
Veteran fathers post-war compared to those conceived prior to the war.
The NAS update committee reviewed the studies identified in the
Volume 4 report and considered a study by Doyle et al. (2004) as a
primary study due to medical confirmation of self-reported outcomes.
The Doyle study was considered a secondary study in the Volume 4
report. The study evaluated the prevalence of self-reported birth
defects among the offspring of Veterans deployed to the Gulf and among
the offspring of non-deployed Veterans who responded to a postal
questionnaire. No significant associations with birth defects were
found for infants of mothers deployed to the Gulf, although the
analyses were limited.
Based on the primary studies of both reports and the availability
of medical confirmation in those studies, there is some suggestion of
increased risk of
[[Page 21106]]
birth defects among the offspring of Gulf War Veterans. However, there
is no consistent pattern of higher prevalence of birth defects among
offspring of male or female Gulf War Veterans, and no single defect,
except urinary tract abnormalities, has been found in more than one
well-designed study. The NAS update committee concluded there is
inadequate or insufficient evidence to determine whether an association
exists between deployment to the Gulf War and specific birth defects.
Accordingly, VA has determined that there is no basis for a presumption
relating to birth defects of the offspring of Veterans deployed to the
Gulf War. VA notes further that it has no authority under 38 U.S.C.
1118 or other statutes to pay benefits for disability in the children
of Gulf War Veterans.
Respiratory Symptoms
The NAS committee found that the reporting of respiratory symptoms,
but not specific respiratory illnesses, is more prevalent in deployed
Gulf War Veterans than in their non-deployed counterparts. The NAS
committee identified five primary studies that examined the association
between pulmonary conditions and deployment to the Gulf War. The
committee found that respiratory symptoms, but not specific respiratory
illnesses, are more prevalent in deployed Gulf War Veterans than in
their non-deployed counterparts. Two of these studies analyzed data of
Gulf War Veterans and non-deployed Veterans derived from a cohort of
randomly selected participants from a previous 1995 study who had
completed the earlier mailed questionnaire on self-reports of health
conditions. One study reported on the prevalence of self-reported
asthma, bronchitis, and emphysema and found no significant differences
between the Gulf War Veterans and non-deployed Veterans after adjusting
for smoking and demographic variables. An additional study applied
spirometry and symptom interviews to a random selection of Gulf War
deployed Veterans compared to non-deployed Veterans. A 2004 study found
that only a history of smoking and wheezing among the respiratory
outcomes studied were significantly elevated in the deployed Veterans.
Spirometric measurements also show no significant difference between
the Gulf War deployed Veterans compared to non-deployed Veterans. The
study also looked at the effect of potential exposure to the Khamisiyah
nerve gas releases by selectively comparing Veterans deployed into the
geographic areas potentially affected, and no significant differences
were noted in the measured pulmonary functions of these Veterans when
compared to non-deployed Veterans who were not exposed to the nerve
gas. The last study examined the pulmonary function parameters of Gulf
War Seabees and non-deployed Seabees and found no significant
difference between the two groups, but respiratory symptoms and
shortness of breath were more common among deployed Veterans compared
with non-deployed Veterans.
Additional primary studies examined the association between
exposure to smoke from the Kuwaiti oil-well fires and respiratory
outcomes. One study examined the effect of exposure to oil-well-fire
smoke using exposure estimates based on troop locations and National
Oceanographic and Atmospheric Administration modeling. The NAS
committee found that the risk of physician-diagnosed asthma increased
with increasing exposure and self-reported exposure. There were no
pulmonary function tests conducted and the study did not distinguish
preexisting asthma from new onset asthma.
The NAS committee found that no study using objective estimates of
exposure to nerve agents due to the destruction of a munitions site at
Khamisiyah, Iraq, in 1991 found any increased risk of respiratory
disease or other problems with pulmonary function. Based on the
information in Volume 4, VA has determined that a presumption of
service connection for respiratory disease with exposures at Khamisiyah
is not warranted at this time.
The NAS update committee identified three additional primary
studies of respiratory outcomes and the deployment to the Gulf War. The
studies found a non-significant increase in respiratory disease
hospitalizations for Veterans deployed to Southwest Asia after the Gulf
War and no excess deaths due to diseases of the respiratory system
among Gulf War Veterans versus non-deployed Veterans. The third study
identified no increase in mortality risk due to respiratory diseases
among Veterans exposed to the chemical munitions destruction at
Khamisiyah compared to the unexposed Veterans. One study found a non-
significant increase in respiratory disease hospitalizations for
Veterans deployed to Southwest Asia after the Gulf War as compared to
Gulf War Veterans. The NAS update committee found that studies based on
self-reported symptoms and self-reported diagnoses related to
respiratory disease have inconsistently but frequently shown an
increase among Gulf War Veterans. There appears to be no increase in
respiratory disease among Gulf War Veterans when examined with
objective measures of disease. Pulmonary function studies and mortality
studies have shown no significant excess of lung function abnormalities
or of death due to respiratory disease among Gulf War Veterans. The NAS
update committee concluded that there is inadequate or insufficient
evidence to determine whether an association exists between deployments
to the Gulf War and respiratory disease. The NAS update committee
further concluded that there is limited or suggestive evidence of no
association between deployment to the Gulf War and decreased lung
function in the first 10 years after the war.
Current VA regulations at 38 CFR 3.317 provide a presumption of
service connection for chronic disability due to signs or symptoms
affecting the respiratory system. Because chronic respiratory signs and
symptoms are already included in Sec. 3.317 and because an association
between deployment to the Gulf War and either respiratory disease or
decreased lung function could not be established, VA has determined
that a presumption of service connection for respiratory disease is not
warranted at this time.
Diseases of the Blood and Blood-Forming Organs
The NAS committee in Volume 4 did not specifically address blood
diseases. The NAS update committee in Volume 8 found that available
studies did not show an increased incidence of diseases of the blood
and blood-forming organs in Gulf War Veterans. Accordingly, the NAS
update committee concluded that there was inadequate or insufficient
evidence to determine whether an association exists between deployment
to the Gulf War and such diseases. Based on the NAS update committee's
findings, the Secretary has determined that no new presumption relating
to diseases of the blood and blood-forming organs is warranted at this
time.
Structural Gastrointestinal Diseases
The NAS committee and the NAS update committee found that studies
showed an increased incidence of self-reported gastrointestinal
symptoms or disorders among Veterans of Gulf War deployments. As noted
above, the NAS update committee found sufficient evidence of an
association between deployment to the Gulf War and functional
gastrointestinal disorders and VA has addressed that finding in a
separate rulemaking. 75 FR 70162 (proposed Nov. 17, 2010). The NAS
[[Page 21107]]
update committee also found that there was inadequate or insufficient
evidence to determine whether an association exists between Gulf War
deployment and structural gastrointestinal diseases, such as peptic
ulcer and inflammatory bowel disease (which includes ulcerative colitis
and Crohn's disease). Although some of the reviewed studies found
increased incidence of self reports of certain structural
gastrointestinal diseases, the NAS update committee noted that the lack
of diagnostic testing to validate those results was a significant
confounding factor, because physicians not infrequently place an
organic disease label (such as gastritis or peptic ulcer) on a
patient's symptoms without performing diagnostic studies. The NAS
update committee also noted that studies did not find an increased
incidence of hospitalization or death due to gastrointestinal disease
in Veterans of Gulf War deployments. Based on these findings, the
Secretary has determined that no new presumption relating to structural
gastrointestinal diseases is warranted at this time.
VI. Conclusion
After careful review of the findings of Volume 4 and Volume 8, the
Secretary has determined that the scientific evidence presented in
these reports indicates that no new presumption of service connection
is warranted at this time for any of the illnesses described in the NAS
2006 and NAS update committee's 2010 reports. It is important to note
that VA's determination that presumptions of service connection are not
warranted at this time for the health effects in question is not
intended to suggest that they are irrelevant to further investigations
of Gulf War Veterans' health or that they may not in any circumstances
form the basis for presumptions of service connection under Public Law
105-277. In the event future evidence links any illnesses to exposures
associated with Gulf War service, VA may establish presumptions of
service connection for such illnesses pursuant to Public Law 105-277.
It is equally important to note that VA's determinations not to
establish presumptions do not in any way preclude claimants from
seeking and establishing service connection for these diseases and
illnesses or any other diseases or illnesses that may be shown by
evidence in an individual case to be associated with service in the
Gulf War.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. John R.
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this
document on March 31, 2011, for publication.
Dated: April 8, 2011.
William F. Russo,
Deputy Director, Regulations Policy and Management, Department of
Veterans Affairs.
[FR Doc. 2011-8937 Filed 4-13-11; 8:45 am]
BILLING CODE P