Determinations Concerning Illnesses Discussed in the Institute of Medicine Report on Gulf War and Health: Updated Literature Review of Depleted Uranium, 10867-10871 [2010-4882]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Pages 10867-10871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4882]


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DEPARTMENT OF VETERANS AFFAIRS


Determinations Concerning Illnesses Discussed in the Institute of 
Medicine Report on Gulf War and Health: Updated Literature Review of 
Depleted Uranium

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

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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, Public 
Law 105-277, title XVI, 112 Stat. 2681-742 through 2681-749 (codified 
at 38 U.S.C. 1118), has determined not to establish a presumption of 
service connection at this time, based on exposure to depleted uranium 
in the Persian Gulf during the Persian Gulf War, for any of the 
diseases, illnesses, or health effects discussed in the July 30, 2008, 
report of the Institute of Medicine (IOM) of the National Academy of 
Sciences (NAS), titled Gulf War and Health: Updated Literature Review 
of Depleted Uranium. This determination does not in any way preclude VA 
from granting service connection for any disease, including those 
specifically discussed in this notice, nor does it change any existing 
rights or procedures.

FOR FURTHER INFORMATION CONTACT: Nancy Copeland, Regulations Staff 
(211D), Compensation and Pension Service, Veterans Benefits 
Administration, Department of Veterans Affairs, 810 Vermont Avenue, 
NW., Washington, DC 20420, telephone (202) 461-9685. (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 (codified at 38 U.S.C. 
1118), and the Veterans Programs Enhancement Act of 1998, Public Law 
105-368, 112 Stat. 3315, previously directed the Secretary to seek to 
enter into an agreement with the NAS IOM to review and evaluate the 
scientific literature regarding associations between illness and 
exposure to specific 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.
    In 1998, IOM began a program to examine the scientific and medical 
literature on the potential health effect of specific agents and 
hazards to which Gulf War Veterans might have been exposed during their 
deployment. Five reports have examined health outcomes related to (1) 
depleted uranium (DU), pyridostigmine bromide, sarin, and vaccines 
(Volume 1); (2) insecticides and solvents; (3) fuels, combustion 
products, and propellants; (4) health effects of serving in the Gulf 
War irrespective of exposure information; and (5) infectious diseases. 
A sixth IOM report, Gulf War and Health, Volume 6: Deployment Related 
Stress, examined the physiologic, psychologic, and psychosocial effects 
of deployment-related stress.
    The present report updates the review of DU presented in Volume 1. 
When Volume 1 was published, few studies of health outcomes of exposure 
to DU had been conducted. Therefore, the IOM studied the health 
outcomes of exposure to natural and processed uranium in workers at 
plants that processed uranium ore for use in weapons. After evaluating 
the literature, the IOM concluded that there was inadequate or 
insufficient evidence to determine whether an association exists 
between uranium exposure and 14 health outcomes: lymphatic cancer; bone 
cancer; nervous system disease; reproductive or developmental 
dysfunction; non-malignant respiratory disease; gastrointestinal 
disease; immune-mediated disease; effects on hematologic measures; 
genotoxic effects; cardiovascular effects; hepatic disease; dermal 
effects; ocular effects; and musculoskeletal effects. The IOM also 
concluded that there was limited or suggestive evidence of no 
association between uranium and clinically significant renal 
dysfunction and between uranium and lung cancer at specified cumulative 
internal doses.
    Although previously used, the Gulf War marked the first time that 
DU munitions and armor were used extensively by the military. DU was 
used by the U.S. military for both offensive and defensive purposes in 
the

[[Page 10868]]

Gulf War. Heavy-armor tanks have a layer of DU armor to increase 
protection. Offensively, DU is used in kinetic-energy cartridges and 
ammunition rounds. The U.S. Army used an estimated 9,500 DU tank rounds 
during the Gulf War. Ammunition containing DU was used in Bosnia-
Herzegovina in 1994-1995 and in Kosovo in 1999; about 10,800 DU rounds 
were fired in Bosnia-Herzegovina, and about 30,000 in Kosovo. Weapons 
containing DU were also used in Operation Iraqi Freedom (OIF), which 
began in 2003.
    Military personnel have been exposed to DU as a result of friendly-
fire incidents, cleanup and salvage operations, and proximity to 
burning DU containing tanks and ammunition. During the Gulf War, an 
estimated 134-164 people experienced ``level I'' exposure (the highest 
of three exposure categories as classified by the U.S. Department of 
Defense) through wounds caused by DU fragments, inhalation of airborne 
DU particles, ingestion of DU residues, or wound contamination by DU 
residues. Hundreds or thousands more may have been exposed to lower 
exposure through inhalation of dust containing DU particles and residue 
or ingestion from hand-to-mouth contact or contamination of clothing. 
Ten U.S. military personnel who served in OIF had confirmed DU detected 
in their urine; all 10 had DU embedded fragments or fragment injuries. 
When Volume 1 was published in 2000, few studies of health outcomes of 
exposure to natural uranium and DU had been conducted. Because DU 
continues to be used by the military, VA asked IOM to update its 2000 
report and take into consideration information published since Volume 
1.

II. Authority

    Section 1602 of Public Law 105-277 provides that whenever the 
Secretary receives a report under section 1603 of Public Law 105-277, 
the Secretary must determine whether a presumption of service 
connection is warranted for any illness covered by that report. The 
statute provides that a presumption will be warranted when the 
Secretary determines that there is a positive association (i.e., the 
credible evidence for an association is equal to or outweighs the 
credible evidence against an association) between 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 Southwest Asia theater of 
operations during the Persian Gulf War and the occurrence of a 
diagnosed or undiagnosed illness in humans or animals. When a positive 
association exists, the Secretary will publish regulations establishing 
presumptive service connection for that illness. If the Secretary 
determines that a presumption of service connection is not warranted, 
he is to publish a notice of that determination, including an 
explanation of the scientific basis for that determination. The 
Secretary's determination must be based on consideration of the NAS 
reports and all other sound medical and scientific information and 
analysis available to the Secretary.
    Although Section 1118 does not define ``credible evidence,'' it 
does instruct the Secretary to take into consideration whether the 
results (of any report, information, or analysis) are statistically 
significant, are capable of replication, and withstand peer review. See 
38 U.S.C. 1118(b)(2)(B). Simply comparing the number of studies that 
report a significantly increased relative risk to the number of studies 
that report a relative risk that is not significantly increased is not 
a valid method for determining whether the weight of evidence overall 
supports a finding that there is or is not a positive association 
between exposure to an agent, hazard, or medicine or vaccine and the 
subsequent development of the particular illness. Because of 
differences in statistical significance, confidence levels, control for 
confounding factors, and other pertinent characteristics, some studies 
are clearly more credible than others; and the Secretary has given the 
more credible studies more weight in evaluating the overall weight of 
the evidence concerning specific illnesses.

III. Prior NAS Report

    NAS issued its initial report, Gulf War and Health, Volume 1: 
Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines, on January 
1, 2000. In that report, NAS limited its analysis to the health effects 
of DU, the chemical warfare agent sarin, vaccinations against botulism 
toxin and anthrax, and pyridostigmine bromide, which was used in the 
Gulf War as a pretreatment for possible exposure to nerve agents. On 
July 6, 2001, VA published a notice in the Federal Register announcing 
the Secretary's determination that the available evidence did not 
warrant a presumption of service connection for any disease discussed 
in that report. See 66 FR 35702 (2001).

IV. Gulf War and Health: Updated Literature Review of DU

    On July 30, 2008, the IOM issued an updated report, Gulf War and 
Health: Updated Literature Review of Depleted Uranium. The report 
updated the review of DU that appeared in Volume 1. IOM conducted an 
extensive search of the scientific literature from among 3,500 titles 
and abstracts from which approximately 1,000 relevant articles were 
selected. These articles included epidemiologic, toxicologic, and 
exposure-assessment studies with additional information obtained from 
invited experts and the public.

V. Categories of Strength of Association

    The IOM used the evidence in the scientific literature to draw 
conclusions about associations between exposure to DU and specific 
adverse health outcomes. Those conclusions are presented as categories 
of strength of association. The categories have been used in many 
previous IOM studies, and they have gained wide acceptance by Congress, 
government agencies, researchers, and Veteran groups. In its report, 
IOM classified the evidence of an association between exposure to a 
specific agent and a specific health outcome in the categories 
summarized as follows:
     Sufficient Evidence of a Causal Relationship: This 
category means that the evidence is sufficient to conclude that a 
causal relationship exists between the exposure to uranium and a 
specific health outcome in humans. The evidence fulfills the criteria 
for sufficient evidence of an association and satisfies several of the 
criteria used to assess causality: strength of association, dose-
response relationship, consistency of association, temporal 
relationship, specificity of association, and biological plausibility.
    IOM did not find any health outcomes that met the criteria for this 
category.
     Sufficient Evidence of an Association: This category means 
that the evidence is sufficient to conclude that there is an 
association. That is, a consistent association unlikely to be due to 
sampling variability has been observed between exposure to uranium and 
a specific health outcome in human studies that were free of severe 
bias and that controlled for confounding.
    IOM did not find any health outcomes that met the criteria for this 
category.
     Limited/Suggestive Evidence of an Association: This 
category means that the evidence is suggestive of an association 
between exposure to uranium and a specific health outcome, but the body 
of evidence is limited by

[[Page 10869]]

insufficient avoidance of bias, insufficient control for confounding, 
or large sampling variability.
    IOM did not find any health outcomes that met the criteria for this 
category.
     Limited/Suggestive Evidence of No Association: This 
category means that the evidence is consistent in not showing an 
association between exposure to uranium of any magnitude and a specific 
health outcome. A conclusion of no association is inevitably limited to 
the conditions, magnitudes of exposure, and length of observation in 
the available studies.
    IOM did not find any health outcomes that met the criteria for this 
category.
     Inadequate/Insufficient Evidence to Determine Whether an 
Association Exists: This category means that the evidence is of 
insufficient quantity, quality, or consistency to permit a conclusion 
regarding the existence of an association between exposure to uranium 
and a specific health outcome in humans.
    IOM concluded that there is inadequate/insufficient evidence to 
determine whether an association exists between exposure to uranium and 
each health outcome described in the report because well-conducted 
studies showed equivocal results, the magnitude or frequency of the 
health outcome may be so low that it cannot be reliably detected given 
the sizes of the study populations, and the available studies had 
limitations that prevented the IOM from reaching clear conclusions 
about health outcomes. The health outcomes are discussed below.

VI. Uranium and DU

    Uranium is a dense, radioactive element that occurs naturally in 
soil, rocks, surface and underground water, air, plants, and animals. 
It also occurs in trace amounts in many foods and drinking water as a 
result of its presence in the environment. Uranium is the heaviest 
naturally occurring element. Its density is 19 times that of water and 
1.65 times that of lead. The primary civilian use of uranium is as fuel 
for nuclear power plants.
    DU is a byproduct of the uranium enrichment process used to 
generate fuel for nuclear power plants. As a byproduct of uranium 
enrichment, DU is abundant and inexpensive. The U.S. Army began 
researching the use of DU for military applications in the early 1970s, 
and DU is now used both offensively and defensively. In the Gulf War, 
heavy-armor tanks had a layer of DU armor to increase protection, and 
DU was used in kinetic-energy cartridges and ammunition rounds by the 
U.S. Army, Air Force, Marine Corps, and Navy.
    After reviewing approximately 1,000 articles, the IOM focused on a 
number of relevant health outcomes on which to draw conclusions. The 
selected health outcomes were ten types of cancer and several non-
malignant diseases or conditions. The types of cancer were lung cancer, 
leukemia, lymphoma, bone cancer, renal cancer, bladder cancer, brain 
and other central nervous system cancers, stomach cancer, prostatic 
cancer and testicular cancer. The non-malignant diseases or conditions 
included renal disease, respiratory disease, neurologic disease, and 
reproductive and developmental effects. With the exception of prostatic 
and testicular cancers, the health outcomes were selected by the IOM 
because there are plausible mechanisms of action (for example, lung 
cancer and respiratory disease were selected because inhaled insoluble 
uranium oxides lodge in the lung). Prostatic cancer is the most 
frequently diagnosed cancer in all men in the U.S., and any slight 
increase in risk could result in large numbers of cases and deaths. 
Testicular cancer, the most common cancer in young men, is of special 
interest to Gulf War Veterans, and some recent studies of Veterans 
suggested a higher but non-significant risk in Gulf War Veterans than 
in their nondeployed counterparts.

VII. Conclusions

A. Lung Cancer

    Lung cancer is the leading cause of cancer deaths in the U.S. and 
the second-most common cancer in both American men and women. Tobacco-
smoking is the predominant risk factor, and it is thought to account 
for about 87 percent of lung-cancer deaths.
    Twenty-three studies of uranium-processing workers examined the 
association between exposure to uranium and lung cancer, as did three 
studies of military populations and three studies of residents. In the 
studies reviewed, the IOM found no consistent evidence of an effect of 
exposure to natural uranium or DU on lung-cancer incidence. Even 
considering the evidence from the studies with the strongest designs, 
the pattern among the studies varied: some studies show increases in 
risk of lung cancer, and other show decreases. A major shortcoming of 
the studies is the lack of individual data on smoking, a primary risk 
factor for lung cancer.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and lung cancer exists.

B. Leukemia

    Leukemia originates in the bone marrow and is a malignant blood 
disease. Leukemia is a relatively uncommon malignancy, so large study 
populations are generally needed to demonstrate any significant 
moderate effects. The studies reviewed by the IOM generally did not 
have adequate sample size. The results of only 1 of 23 studies reviewed 
by the IOM achieved statistical significance, indicating a reduction in 
mortality from leukemia. However, that study was limited by a lack of 
exposure data and information on other risk factors. The remaining 22 
studies showed both increases and decreases in risk associated with 
exposure to uranium, all of which were non-significant. There was no 
consistent evidence of effect, and the pattern among studies was highly 
varied. The same pattern was observed after restriction of 
consideration to larger studies. On the basis of the evidence to date, 
the IOM would assign a low priority to additional study of an 
association between exposure to DU and leukemia.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and leukemia exists.

C. Lymphomas

1. Hodgkin Lymphoma
    Hodgkin Lymphoma (also known as Hodgkin's disease) is a very rare 
cancer that originates in lymphatic tissue. The studies considered by 
the IOM split virtually evenly between showing an increase in risk of 
Hodgkin Lymphoma associated with exposure to natural uranium or DU and 
showing no change or a decrease in the risk of Hodgkin Lymphoma 
associated with uranium exposure. Only one study achieved a 
statistically significant finding, showing a significant increase in 
the risk of Hodgkin Lymphoma. Most of the smaller studies show a non-
significant decrease in risk of incidence or death. The IOM noted that 
the pattern among the studies was highly varied, as would be expected 
if there truly were no effect in the population.
2. Non-Hodgkin Lymphoma and Other Lymphatic Cancers
    Non-Hodgkin Lymphoma (NHL) encompasses the types of cancers of the 
lymphatic tissues that remain after exclusion of Hodgkin lymphoma. IOM 
evaluated 24 published studies of a possible relationship between 
exposure to natural uranium or DU and NHL. Most of the studies showed 
that the exposed subjects experienced a risk of

[[Page 10870]]

NHL equal to or lower than that in unexposed subjects.
    On the basis of the available evidence, the IOM concludes that 
there is a lack of strong and consistent evidence of an association 
between uranium exposure and lymphatic cancers. Although the available 
evidence does not justify further consideration of a possible 
association between DU and lymphatic cancers, IOM concludes that 
further study of this type of cancer may be warranted on biologic 
grounds, given that uranium is known to accumulate in the lymph nodes.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and lymphomas exists. This 
conclusion applies to both Hodgkin Lymphoma and NHL.

D. Bone Cancer

    Twelve studies of uranium-processing workers, one study of a 
deployed population, and two residential studies assessed bone-cancer 
outcomes. In most of the studies, the risk of bone cancer was the same 
or decreased after exposure to natural uranium or DU. Only one study 
had a significant finding: a statistically significant increase in 
bone-cancer incidence--four cases--in a Danish military population 
deployed to the Balkans. However, because three of the four cases 
occurred within the first year after deployment, it is unlikely that 
deployment-related exposure was a factor, given the latency of cancer. 
The studies generally did not have adequate sample size to detect any 
significant moderate effects. Overall, the available studies did not 
provide clear and consistent evidence of an association between natural 
uranium or DU, and bone cancer.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and bone cancer exists.

E. Renal Cancer

    The IOM considered 20 studies of an association between natural 
uranium or DU and renal cancer. None of the published results 
demonstrated a significant increase in risk after uranium exposure. One 
study indicated a statistically significant decrease in renal-cancer 
mortality associated with uranium exposure. That study did not include 
exposure assessment or information on other risk factors. On the basis 
of the available evidence, the IOM would assign a low priority to 
further study of an association between exposure to DU and renal 
cancer.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and renal cancer exists.

F. Bladder Cancer

    The IOM evaluated 20 published studies of a potential association 
between exposure to natural uranium or DU and bladder cancer: 14 
uranium-processing studies, two studies of military populations, and 
four residential studies. Most of the studies reported the same or 
reduced bladder-cancer mortality or incidence in exposed subjects. Only 
one finding achieved statistical significance, a reduction in bladder-
cancer incidence. That study is limited by a lack of data on internal 
radiation exposure and other risk factors. Overall, the IOM finds 
little evidence that exposure to natural uranium or DU increases the 
risk of bladder cancer. The IOM would assign a low priority to further 
study of an association between exposure to DU and bladder cancer.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and bladder cancer exists.

G. Brain and Other Central Nervous System Cancers

    Of the 20 published studies of an association between uranium 
exposure and brain and other central nervous system cancers reviewed by 
the IOM, almost all failed to demonstrate statistically significant 
associations. The studies are roughly evenly split between those 
showing increases in and those showing the same or decreases in 
mortality or incidence. The two studies that had statistically 
significant results showed decreases in risk after uranium exposure.
    The published studies show inconsistent results that do not lead to 
a conclusion of an association between natural uranium or DU and 
cancers of the central nervous system. Studies of some other cancers 
(for example, bladder cancer) showed an equal or reduced risk after 
exposure, but the distribution of studies of brain and other central 
nervous system cancers is more balanced. Because of that pattern, the 
IOM believes that further study of an association between DU and 
central nervous system cancers may be warranted but should not be 
assigned a high priority.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and cancers of the central 
nervous system, including brain cancer, exists.

H. Stomach Cancer

    The IOM considered 21 published studies of a possible association 
between natural uranium or DU, and stomach cancer, including 16 
processing studies, one study of military populations, and four 
residential studies. All but three had statistically non-significant 
results, and most demonstrated the same or decreased mortality or 
incidence. The three studies that had statistically significant results 
all showed a decrease in mortality or incidence. Overall, the IOM finds 
little evidence to suggest that exposure to natural uranium or DU 
increases the risk of stomach cancer.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and stomach cancer exists.

I. Male Genital Cancers

1. Prostatic Cancer
    The IOM evaluated 19 published studies of a potential association 
between exposure to natural or depleted uranium and prostatic cancer, 
including 14 processing studies, two studies of deployed populations, 
and three residential studies. Only one reported a statistically 
significant finding: a significant reduction in prostatic-cancer 
incidence, but not mortality. This study is limited by a lack of data 
on internal radiation exposure. Three other studies of processing 
workers reported increased prostatic-cancer mortality, but none of the 
standard mortality rates were statistically different from the null 
value, indicating no effect (Ritz, 1999; Beral et al., 1988; Loomis and 
Wolf, 1996).
    Of the 19 studies considered, none demonstrated a significant 
increase in the risk of prostatic cancer after exposure to uranium, and 
one showed a significant decrease in cancer incidence but not 
mortality. On the basis of the available evidence, IOM would assign a 
low priority to further study of an association between exposure to DU 
and prostatic cancer.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and prostatic cancer exists.
2. Testicular Cancer
    IOM considered 15 published studies for a possible relationship 
between exposure to natural uranium or DU and testicular cancer, 
including 11 studies of uranium-processing workers, three studies of 
military populations, and one study of residents living near a nuclear 
facility in Pennsylvania. None of the results achieved statistical 
significance,

[[Page 10871]]

although all occupational cohorts had lower mortality. IOM finds no 
consistent evidence that uranium exposure increases the risk of 
testicular cancer. Testicular cancer, although very rare in the general 
population, is common in young adult males and therefore prevalent in 
deployed Veterans. Despite the inconsistent evidence, testicular cancer 
is of special interest to Gulf War Veterans. The IOM believes that 
further study of an association between DU and testicular cancer may be 
warranted, but should not be assigned a high priority.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and testicular cancer exists.

VIII. Non-Cancer Outcomes

A. Non-malignant Renal Disease

1. Mortality
    Fourteen studies assessed the association between occupational 
exposure and renal-disease mortality. In many of the 14 studies, the 
computed death rates included all genitourinary conditions instead of 
focusing on renal diseases. In several of the plants, uranium exposure 
coexisted with other relevant heavy-metal or chemical exposure. 
Generally, most researchers were unable to isolate the effects of 
uranium exposure alone. Four studies found an excess mortality that was 
not statistically significant. One study reported a statistically 
significant decrease in mortality. Other studies also reported a 
decrease or no difference in mortality after uranium exposure.
2. Morbidity
    IOM concludes that there is inadequate/insufficient evidence to 
determine whether an association between exposure to uranium and non-
malignant renal disease exists.

B. Non-maligant Respiratory Disease

    IOM evaluated 16 studies of exposure to uranium and non-malignant 
respiratory disease. The results of several of the studies support an 
effect of employment in uranium-processing facilities on nonmalignant 
respiratory disease, but their applicability to military DU exposure is 
limited by the extent of concomitant coexposure of such workers to 
other respiratory toxicants. Several other studies found decreases in 
lung-disease mortality in exposed populations. On the basis of the 
evidence, IOM would assign a high priority to further study of an 
association between exposure to DU and nonmalignant respiratory 
disease.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and nonmalignant respiratory 
disease exists.

C. Neurologic Effects

    Overall, the published studies of neurologic outcomes are either 
negative studies that do not find any evidence of health effects of 
exposure to DU or relatively small studies that find inconstant 
associations. On the basis of the available evidence, IOM would assign 
a high priority to further study of an association between exposure to 
DU and neurologic effects.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and nonmalignant respiratory 
disease exists.

D. Reproductive and Developmental Effects

    A few studies examined the effects of natural uranium or DU on 
human reproduction and development. Relatively large populations are 
generally necessary to demonstrate significant but subtle reproductive 
or developmental effects. The studies reviewed generally had too few 
subjects or relied on insufficiently precise exposure assessment to 
support definitive conclusions. On the basis of the available evidence, 
IOM would assign a high priority to further study of an association 
between exposure to DU and reproductive and developmental effects.
    IOM found inadequate/insufficient evidence to determine whether an 
association between exposure to uranium and reproductive and 
developmental effects exist.

IX. Other Health Outcomes

    For other health outcomes, IOM found that the effects of exposure 
to natural uranium or DU have not been studied in detail in humans, and 
that the evidence from which to draw conclusions is sparse. 
Consequently, IOM found inadequate/insufficient evidence to determine 
whether an association exists between exposure to uranium and 
cardiovascular effects, genotoxic effects, hematologic effects, 
immunologic effects and skeletal effects.

Summary

    The likelihood of detecting an association between exposure and a 
health outcome depends on several factors. For the health outcomes 
discussed, IOM concluded that exposure to uranium is not associated 
with a large or frequent effect. Nevertheless, it is possible that DU-
exposed Veterans will have a small increase in the likelihood of 
developing the disease. Typically, extremely large study populations 
are necessary to demonstrate that a specific exposure is not associated 
with a health outcome. IOM's evaluation of the literature supports the 
conclusion that a large or frequent effect is unlikely, but it is not 
possible to state conclusively that a particular health outcome cannot 
occur.
    IOM concluded that there is inadequate/insufficient evidence to 
determine whether an association exists between exposure to uranium and 
the following health outcomes: lung cancer; leukemias; lymphomas; bone 
cancer; renal cancer; bladder cancer; brain and other central nervous 
system cancers; stomach cancer; male genital cancers (prostatic and 
testicular cancers); non-malignant renal disease; non-malignant 
respiratory disease; neurologic effects; reproductive effects; and 
other health outcomes (cardiovascular effects, genotoxicity, 
hematologic effects, immunologic effects, and skeletal effects).

Conclusion

    After careful review of the findings of the IOM Report, Gulf War 
and Health: Updated Literature Review of Depleted Uranium, the 
Secretary has determined that the scientific evidence presented in the 
2008 IOM 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 the 2008 IOM report.

    Approved: March 1, 2010.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
[FR Doc. 2010-4882 Filed 3-8-10; 8:45 am]
BILLING CODE 8320-01-P