2010-28707. Presumptive Service Connection for Diseases Associated With Persian Gulf War Service: Functional Gastrointestinal Disorders

AGENCY:

Department of Veterans Affairs.

ACTION:

Proposed rule.

SUMMARY:

The Department of Veterans Affairs (VA) is amending its adjudication regulations concerning presumptive service connection for medically unexplained chronic multisymptom illnesses associated with service in the Southwest Asia theater of operations for which there is no record during service. This amendment is necessary to implement a decision of the Secretary of Veterans Affairs that there is a positive association between service in Southwest Asia during certain periods and the subsequent development of functional gastrointestinal disorders (FGIDs), and to clarify that FGIDs fall within the scope of the existing presumption of service connection for medically unexplained chronic multisymptom illnesses. The intended effect of this amendment is to clarify the presumption of service connection for these illnesses based on service in the Southwest Asia theater of operations during the Persian Gulf War.

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 [phone]. (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 [phone] 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 § 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 § 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

This proposed rule does not reflect determinations concerning any illnesses other than those discussed in this proposal. The Secretary's determinations concerning other illnesses discussed in the NAS report will be addressed in other documents published in the Federal Register.

Paperwork Reduction Act

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

The Secretary hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This rule would not affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of §§ 603 and 604.

Executive Order 12866

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined and it has been determined not to be a significant regulatory action under the Executive Order because it would not result in a rule that may materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.

Unfunded Mandates

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This rule would have no such effect on State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance Numbers and Titles

The Catalog of Federal Domestic Assistance program numbers and titles for this proposed rule are 64.109, Veterans Compensation for Service-Connected Disability, and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

Comment Period

Although under the rulemaking guidelines in Executive Order 12866 VA ordinarily provides a 60-day comment period, the Secretary has determined that there is good cause to limit the public comment period on this proposed rule to 30 days. The current proposed rule does not create a new presumption of service connection. Consistent with 38 U.S.C. 1117, it clarifies that functional gastrointestinal disorders fall within the scope of the existing presumption of service connection for medically unexplained chronic multisymptom illnesses. Because this rule merely clarifies VA's interpretation of the existing statute and regulation, a public comment period is not required under the Administrative Procedures Act. However, because this clarifying rule relates to VA's response to a report referred to in 38 U.S.C. 1118, VA has determined that it is appropriate to provide for public comment as provided in that statute. A 30-day notice and comment period will enable the rapid issuance of final regulations providing the public and VA adjudicators with clear guidance regarding the interpretation of the existing statute and regulation as they pertain to FGIDs. This will ensure that Veterans suffering from FGID will receive a fair determination of benefit eligibility, and will promote rapid action on affected benefits claims.

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 October 18, 2010, for publication.

List of Subjects in 38 CFR Part 3

• Administrative practice and procedure
• Claims
• Disability benefits
• Health care
• Veterans
• Vietnam

Dated: November 9, 2010.

Robert C. McFetridge,

Director, Regulations Policy and Management, Department of Veterans Affairs.

For the reasons set out in the preamble, VA proposes to amend 38 CFR part 3 as follows:

PART 3—ADJUDICATION

Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation

1. The authority citation for part 3, subpart A continues to read as follows:

Authority: 38 U.S.C. 501(a), unless otherwise noted.

2. Amend § 3.317 by revising paragraph (a)(2)(i)(B)(3) to read as follows:

§ 3.317

Compensation for certain disabilities due to undiagnosed illnesses.

(a) * * *

(2) * * *

(i) * * *

(B) * * *

(3) Functional gastrointestinal disorders, including, but not limited to, irritable bowel syndrome and functional dyspepsia (excluding structural gastrointestinal diseases); or Note to paragraph (a)(2)(i)(B)(3): Functional gastrointestinal disorders are a group of conditions characterized by chronic or recurrent symptoms that were present for at least 6 months prior to diagnosis and have been currently active for 3 months, that are unexplained by any structural, endoscopic, laboratory, or other objective signs of disease or injury and that may be related to any part of the gastrointestinal tract. Common symptoms include abdominal pain, substernal burning or pain, nausea, vomiting, altered bowel habits (including diarrhea, constipation), indigestion, bloating, postprandial fullness, and painful or difficult swallowing. Specific functional gastrointestinal disorders include, but are not limited to, irritable bowel syndrome, functional dyspepsia, functional vomiting, functional constipation, functional bloating, functional abdominal pain syndrome, and functional dysphagia.