[Federal Register: November 17, 2010 (Volume 75, Number 221)]
[Proposed Rules] [Page 70162-70165]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no10-28] ======================================================================= DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AN83
Presumptive Service Connection for Diseases Associated With Persian Gulf War Service: Functional Gastrointestinal Disorders
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
-----------------------------------------------------------------------
DATES: Comments must be received by VA on or before December 17, 2010.
ADDRESSES: Written comments may be submitted through http://
www.Regulations.gov; by mail or hand-delivery to Director, Regulations Management (02REG), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. (This is not a toll free number.) Comments should indicate that they are submitted in response to ``RIN 2900-AN83--
Presumptive Service Connection for Diseases Associated With Persian Gulf War Service: Functional Gastrointestinal Disorders (FGIDs).''
Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System at http://www.Regulations.gov.
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, (202) 461- 9727 (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: The Secretary of Veterans Affairs has determined that the available scientific and medical evidence presented in the National Academy of Sciences (NAS) April 2010 report, titled Gulf War and Health, Volume 8: Update on the Health Effects of Serving in the Gulf War is sufficient to warrant a presumption of service connection for FGIDs in individuals deployed to the Southwest Asia theater of operations during the Persian Gulf War. Pursuant to that determination, this document proposes to clarify that the Department of Veterans Affairs (VA) adjudication regulations (38 CFR Part 3), specifically 38 CFR 3.317, would include FGIDs as medically unexplained chronic multisymptom illnesses subject to presumptive service connection. FGIDs include, but are not limited to, such conditions as irritable bowel syndrome (IBS) and functional dyspepsia.
National Academy of Sciences (NAS) Reports FGIDs, Including, But Not Limited to, Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
The NAS issued its report titled
Gulf War and Health, Volume 8: Update on Health Effects of Serving in the Gulf War, on April 9, 2010. The NAS was asked to review, evaluate, and summarize the literature to determine if any of the health outcomes noted in its 2006 report, titled Gulf War and Health, Volume 4: Health Effects of Serving in the Gulf War, appear at higher incidence or prevalence levels in Gulf War-
deployed veterans. The NAS sought to characterize and weigh the strengths and limitations of the available evidence. The NAS Update committee reviewed over 1000 relevant studies and focused on over 400 relevant references, including the studies reviewed in the Volume 4 report.
The NAS determined that there is sufficient evidence of an association between deployment to the Gulf War and FGIDs, including, but not limited to, IBS and functional dyspepsia. The committee also noted that there is inadequate evidence of an association between deployment to the Gulf War and structural gastrointestinal (GI) disease.
FGIDs, such as IBS or functional dyspepsia, are syndromes characterized by recurrent or prolonged GI symptoms that occur together. They are distinguished from structural or ``organic'' GI disorders in that they generally are not associated with detectable anatomical abnormalities. The severity of FGIDs ranges from occasional mild episodes to more persistent and disabling symptoms. According to the NAS report, there have been numerous reports of GI disturbances in Gulf War veterans and the symptoms have continued to be persistent in the years since that war. All studies examined by NAS favored a greater prevalence of various GI symptoms and primary functional GI disorders, including IBS and dyspepsia. In NAS's opinion, there also was compelling emerging evidence of exposure during deployment to enteric pathogens leading to the development of post-infectious IBS.
The overall pattern of symptoms found in the primary and secondary studies NAS reviewed confirms an association between deployment to the Gulf War and functional GI symptoms, including abdominal pain, diarrhea, nausea, and vomiting. The NAS recommended that further studies be conducted to determine the role of prior acute gastroenteritis among deployed servicemembers in the development of FGIDs.
Detailed information on the committee's findings may be found at: http://www.iom.edu/Reports/2010/Gulf-War-and-Health-Volume-8-Health-
Effects-of-Serving-in-the-Gulf-War.aspx. The report findings are organized by category and can be found under the heading, ``Table of Contents.''
Statutory Provisions
Pursuant to 38 U.S.C. 1118, VA must establish a presumption of service connection for each illness shown by sound scientific and medical evidence to have 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. Because the recent NAS report was primarily a review of the prevalence of illnesses among Gulf War veterans, it generally did not state conclusions as to whether the illnesses are associated with the types of exposures referenced in Sec. 1118.
The NAS noted that there was significant emerging evidence that FGIDs may be associated with exposure to enteric pathogens during Gulf War deployments and recommended further study of that issue. However, NAS did not state a conclusion concerning the strength of the evidence of an association between FGIDs and exposure to enteric pathogens. VA has determined that resolution of that question is not necessary for purposes of this rule, because FGIDs are within the scope of the existing presumption of service connection for medically unexplained chronic multisymptom illnesses.
Section 1117 of title 38, United States Code, provides a presumption of service connection for ``qualifying chronic disability'' in veterans who served in the Southwest Asia theater of operations during the Persian Gulf War. The statute defines the term ``qualifying chronic disability'' to include ``[a] medically unexplained chronic multisymptom illness (such as chronic fatigue syndrome, fibromyalgia, and irritable bowel syndrome) that is defined by a cluster of signs or symptoms.'' 38 U.S.C. 1117(a)(2)(B).
The plain language of the statute makes clear that it applies to all medically unexplained chronic multisymptom illnesses including, but not limited to, the three conditions parenthetically listed as examples. VA recently amended its regulation at 38 CFR 3.317 to clarify that the presumption is not limited to the three listed examples. See 75 FR 61995.
FGIDs are medically unexplained chronic multisymptom illnesses within the meaning of the statute and regulation. These disorders are defined by clusters of signs and symptoms affecting GI functions. Further, FGIDs are ``medically unexplained'' because they are, by definition, disorders that cannot be attributed to observable structural or organic changes and the causes of the disorders are generally not known. Irritable Bowel Syndrome, which is a form of FGID, is expressly identified in the current statute and regulation as a medically unexplained chronic multisymptom illness. Because other FGIDs, such as functional dyspepsia and functional vomiting, also are medically unexplained chronic multisymptom illnesses, the current statute and regulation, as recently amended, provide a presumption of service connection for FGIDs in veterans who served in the Southwest Asia theater of operations during the Persian Gulf War. In view of the findings in the recent NAS report identifying FGIDs as prevalent and persistent illnesses among Gulf War Veterans, VA has determined that its regulations should be revised to expressly identify FGIDs as a type of medically unexplained chronic multisymptom illness within the scope of the existing presumption.
Regulatory Amendments
We propose to amend 38 CFR 3.317 to incorporate the more specific language regarding FGIDs. We propose to: Revise Sec. 3.317(a)(2)(i)(B)(3) by removing ``Irritable Bowel Syndrome'' and replacing it with ``
Functional gastrointestinal disorders, including, but not limited to, irritable bowel syndrome and functional dyspepsia (excluding structural gastrointestinal diseases)''; and add a Note with the definition of functional gastrointestinal disorders. The intended effect of this change is to clarify that FGIDs are medically unexplained chronic multisymptom illnesses and are thus within the scope of the presumption of service connection for such illnesses.
Other Illnesses
Labels: Presumptive, Ration, Service Connection, VA, VBA