Determinations Concerning Illnesses Discussed In National Academy of Sciences Reports on Gulf War and Health, Volumes 4 and 8, 21099-21107 [2011-8937]

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[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: http://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: http://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]


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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.

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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, 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: http://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: http://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]
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