This is a notice that deserves attention by all veterans and veterans’ organizations. It will affect hundreds of thousands of gulf war (1990-91) veterans.
VT encourages the VA to start also posting any Federal Registry notice on the VA website to notify veterans on their website in addition to the Federal Registry because the majority of veterans do not access the Federal Registry for news that need action. These actions should be completely transparent to all and easily accessible and that means placing it on the VA website at the time it is submitted to the Federal Registry.
VT encourages feedback as directed by the Federal Registry and also welcomes submission of federal registry input on this topic to our comments section for this article.
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The Federal RegisterThe Daily Journal of the United States
GovernmentProposed RulePresumptive Service Connection for Diseases
Associated With Persian Gulf War Service: Functional Gastrointestinal
Disorders
A Proposed Rule by the Veterans Affairs Department on 11/17/2010
article has a comment period that ends in 29 days (12/17/2010) Submit a formal comment
Publication Date:
Wednesday, November 17, 2010
Action:
Proposed Rule.
Dates:
Comments must be received by VA on or before December 17, 2010.
Comments Close:
12/17/2010
Entry Type:
Proposed Rule
Page:
70162-70165 (4 pages)
Document Citation:
75 FR 70162
CFR:
38 CFR 3
RIN:
2900-AN83
Document Number:
2010-28707
Shorter URL:
http://federalregister.gov/a/2010-28707SummaryThe 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.Show citation box
Table of ContentsDATES:
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
National Academy of Sciences (NAS) Reports
FGIDs, Including, But Not Limited to, Irritable Bowel Syndrome (IBS) and
Functional Dyspepsia
Statutory Provisions
Regulatory Amendments
Other Illnesses
Paperwork Reduction Act
Regulatory Flexibility Act
Executive Order 12866
Unfunded Mandates
Catalog of Federal Domestic Assistance Numbers and Titles
Comment Period
Signing Authority
List of Subjects in 38 CFR Part 3
PART 3—ADJUDICATION
Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation
Authority:
DATES:
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Comments must be received by VA on or before December 17, 2010.Show
citation box
ADDRESSES:
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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).”Show citation box
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. Show citation box
FOR FURTHER INFORMATION CONTACT:
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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.)Show citation box
SUPPLEMENTARY INFORMATION:
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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.Show citation box
National Academy of Sciences (NAS) Reports
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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.Show citation box
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.Show citation box
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.Show citation box
Detailed information on the committee’s findings may be found at:
http://www.iom.edu/Reports/2010/Gulf-War-and-Health-Volume-8-Health-Effect
s-of-Serving-in-the-Gulf-War.aspx. The report findings are organized by
category and can be found under the heading, “Table of Contents.”Show
citation box
Statutory Provisions
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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.Show citation box
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.Show citation box
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.Show citation box
Regulatory Amendments
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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.Show citation box
Other Illnesses
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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.Show
citation box
Paperwork Reduction Act
This document contains no provisions constituting a collection of
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).Show
citation box
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.Show citation box
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.Show citation box
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.Show citation box
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.Show citation box
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.Show citation box
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.Show citation box
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.Show citation box
List of Subjects in 38 CFR Part 3
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Administrative practice and procedure, Claims, Disability benefits,
Health care, Veterans, Vietnam.Show citation box
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
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Subpart A—Pension, Compensation, and Dependency and Indemnity
Compensation
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1. The authority citation for part 3, subpart A continues to read as
follows:Show citation box
Authority:
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38 U.S.C. 501(a), unless otherwise noted.Show citation box
2. Amend § 3.317 by revising paragraph (a)(2)(i)(B)(3) to read as
follows:Show citation box
§ 3.317 Compensation for certain disabilities due to undiagnosed
illnesses.
(a) * * *Show citation box
(2) * * *Show citation box
(i) * * *Show citation box
(B) * * *Show citation box
(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.Show citation box
[FR Doc. 2010-28707 Filed 11-16-10; 8:45 am]
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