[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]
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