Federal Registry Notice Gulf War Illness Deadline December 17

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]