[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Proposed Rules]
[Pages 70162-70165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28707]


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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.

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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

[[Page 70163]]

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 (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

[[Page 70164]]

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

    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 Sec. Sec.  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

[[Page 70165]]

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.

0
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 Sec.  3.317 by revising paragraph (a)(2)(i)(B)(3) to read 
as follows:


Sec.  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.

[FR Doc. 2010-28707 Filed 11-16-10; 8:45 am]
BILLING CODE 8320-01-P