Federal Registry Posts New Rules for VA Presumptions of Service Connections of 9 Infectious Diseases for Persian Gulf Service

8
1179

The VA has proposed to add 9 infectious diseases to presumptions for service connection for Gulf War Veterans. Nineteen years and the VA finally recognizing some illnesses that were tested for by the Comprehensive Clinical Evaluations that were done in the early 1990’s. The slowness that has been evident at the VA for nineteen years seems to be taking a turn. The questions remain of why it takes nineteen years to document you have a problem for your veterans? For nineteen years the veterans of the Gulf War, knew their test results but no education for the veterans or the staff of the VA hospitals and treatment was lacking/missing to counter the health effects.

The nine diseases are: Brucellosis, Campylobacter jejuni, Coxiella
burnetii (Q fever), Malaria, Mycobacterium tuberculosis, Nontyphoid
Salmonella, Shigella, Visceral leishmaniasis, and West Nile virus.

Comments must be received by VA on or before May 17, 2010.

[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Proposed Rules]
[Page 13051-13058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr10-24]

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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AN24

Presumptions of Service Connection for Persian Gulf Service
AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

———————————————————————–

SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend
its adjudication regulations concerning presumptive service connection
for certain diseases. This proposed 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 certain infectious diseases.
The intended effect of this proposed amendment is to establish
presumptive service connection for these diseases and to provide
guidance regarding long-term health effects associated with these
diseases.

DATES: Comments must be received by VA on or before May 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-AN24–Presumptions of Service
Connection for Persian Gulf Service.” 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: Chief, Regulations Staff (211D),
Compensation and Pension Service, Veterans Benefits Administration,
Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC
20420, (202) 461-9739. (This is not a toll free number.)

SUPPLEMENTARY INFORMATION:

I. Statutory Requirements

The Persian Gulf War Veterans Act of 1998, Public Law 105-277,
title XVI, 112 Stat. 2681-742 through 2681-749 (codified at 38 U.S.C.
1118), and the Veterans Programs Enhancement Act of 1998, Public Law
105-368, 112 Stat. 3315, directed the Secretary of Veterans Affairs to
seek to enter into an agreement with the National Academy of Sciences
(NAS) to review and evaluate the available scientific evidence
regarding associations between illnesses and exposure to toxic agents,
environmental or wartime hazards, or preventive medicines or vaccines
to which service members may have been exposed during service in the
Persian Gulf during the Persian Gulf War. Congress directed the NAS to
identify agents, hazards, medicines, and vaccines to which service
members may have been exposed during service in the Persian Gulf during
the Persian Gulf War.
Congress mandated that the NAS determine, to the extent possible:
(1) Whether there is a statistical association between exposure to the
agent, hazard, medicine, or vaccine and the illness, taking into
account the strength of the scientific evidence and the appropriateness
of the scientific methodology used to detect the association; (2) the
increased risk of illness among individuals exposed to the agent,
hazard, medicine, or vaccine; and (3) whether a plausible biological
mechanism or other evidence of a causal relationship exists between
exposure to the agent, hazard, medicine, or vaccine and the illness.
Section 1118 of title 38 of the United States Code provides that
whenever the Secretary determines, based on sound medical and
scientific evidence, that a positive association (i.e., the credible
evidence for the association is equal to or outweighs the credible
evidence against the association) exists between exposure of humans or
animals 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 Southwest Asia theater of
operations during the Persian Gulf War and the occurrence of a
diagnosed or undiagnosed illness in humans or animals, the Secretary
will publish regulations establishing presumptive service connection
for that illness. If the Secretary determines that a presumption of
service connection is not warranted, he is to publish a notice of that
determination, including an explanation of the scientific basis for
that determination. The Secretary’s determination must be based on
consideration of the NAS reports and all other sound medical and
scientific information and analysis available to the Secretary.

II. Prior National Academy of Sciences Reports

The NAS issued its initial report titled, Gulf War and Health,
Volume 1: “Depleted Uranium, Sarin, Pyridostigmine Bromide,
Vaccines,” on January 1, 2000. In that report, NAS limited its
analysis to the health effects of depleted uranium, the chemical
warfare agent sarin, vaccinations against botulism toxin and anthrax,
and pyridostigmine bromide, which was used in the Persian Gulf War as a
pretreatment for possible exposure to nerve agents. On July 6, 2001, VA
published a notice in the Federal Register announcing the Secretary’s
determination that the available evidence did not warrant a presumption
of service connection for any disease discussed in that report. See 66
FR 35702 (2001).
The NAS issued its second report titled, “Gulf War and Health,
Volume 2: Insecticides and Solvents,” on February 18, 2003. In that
report, the NAS focused on the health effects of insecticides and
solvents that were shipped to the Persian Gulf during the Persian Gulf
War. The pesticides considered by the NAS were organophosphorous
compounds (malathion, diazinon, chlorpyrifos, dichlorvos, and
azamethiphos), carbamates (carbaryl, propoxur, and methomyl),
pyrethrins and pyrethyroids (permethrin and d-phenothrin), lindane, and
N,N-diethyl-3-methylbenzamide (DEET). The NAS considered 53 solvents in
eight groups: Aromatic hydrocarbons (including benzene), halogenated
hydrocarbons (including tetrachloroethylene and dry-cleaning solvents),
alcohols, glycols, glycol esters, esters, ketones, and petroleum
distillates. On August 24, 2007, VA published a notice in the Federal
Register announcing the Secretary’s determination that the available
evidence did not warrant a presumption of service connection for any
disease discussed in that report. 72 FR 48734 (2007).
The NAS issued an update on sarin in a report titled “Gulf War and
Health: Updated Literature Review of Sarin,” on August 20, 2004. In
that report, the NAS focused on the long-term health effects from
exposure to the nerve agent, sarin. VA published a Federal Register
notice announcing the Secretary’s determination that it was not
necessary to establish new presumptions of service connection for any
diseases based on the updated findings on long-term health effects from
sarin. 73 FR 42411 (2008).
The NAS issued its third report, titled “Gulf War and Health,
Volume 3: Fuels, Combustion Products, and Propellants,” on December
20, 2004. In that report, the NAS focused on the health effects of
hydrazines, red fuming nitric acid, hydrogen sulfide, oil-fire
byproducts, diesel-heater fumes, and fuels (for

[[Page 13053]]

example, jet fuel and gasoline). On August 28, 2008, VA published a
Federal Register notice announcing the Secretary’s determination that
the available evidence does not warrant a presumption of service
connection for any disease discussed in that report. 73 FR 50856.
The NAS issued its fourth report, titled “Gulf War and Health
Volume 4: Health Effects of Serving in the Gulf War,” on September 12,
2006. In that report the NAS focused on the health status of veterans
of the 1991 Gulf War. The report was intended to inform VA about
illnesses and clinical issues including possible relevant treatments,
which might have been overlooked among this population, regardless of
the specific underlying cause. VA is drafting a Federal Register notice
announcing the Secretary’s determination that the available evidence
does not warrant a presumption of service connection for any disease
discussed in that report.

III. Gulf War and Health, Volume 5: Infectious Diseases

The NAS issued its fifth report, titled “Gulf War and Health
Volume 5: Infectious Diseases” on October 16, 2006. This report
differs from prior NAS reports in that it implicates two tiers of
possible association between a hazard and resulting health outcomes.
Prior NAS reports generally addressed only one tier of possible
association–i.e., the association between exposure to a particular
hazard and the development of latent or long-term health effects. The
recent NAS report implicates (1) the possible association between
exposure to disease-causing pathogens and the subsequent development of
an infectious disease (the “primary infectious disease”) and (2) the
possible association between development of the infectious disease and
the development of secondary latent or long-term health effects (the
“secondary health effects”). The NAS report addresses only the second
tier of association. Specifically, it focused on scientific and medical
literature addressing the incidence of long-term health effects in
individuals who had been diagnosed with the primary infectious disease
and stated findings with respect to only the strength of the evidence
for associations between the primary infectious diseases and the
secondary health effects. The NAS evaluated the published, peer-
reviewed scientific and medical literature on long-term health effects
associated with infectious diseases pertinent to service in Southwest
Asia and those known to have been of special concern to veterans
deployed to that area. The NAS identified over 20,000 potentially
relevant scientific reports, and focused on 1,200 that had the
necessary scientific quality.
The NAS initially identified approximately 100 diseases that are
known to be endemic to Southwest Asia. Because those diseases would in
most instances become manifest within a relatively short time after
infection, NAS eliminated from consideration any disease that had never
been reported in any U.S. troops within a reasonable period following
Persian Gulf deployments. The NAS also eliminated from consideration
any diseases not known to produce long-term health effects. On that
basis, the NAS limited the list of diseases to the nine diseases
discussed below.
The committee selected nine infectious diseases that:
(1) Are prevalent in Southwest Asia,
(2) Have been diagnosed among U.S. troops serving there, and
(3) Are known to cause long-term adverse health effects.
The nine diseases are: Brucellosis, Campylobacter jejuni, Coxiella
burnetii (Q fever), Malaria, Mycobacterium tuberculosis, Nontyphoid
Salmonella, Shigella, Visceral leishmaniasis, and West Nile virus.
In its previous reports, the NAS focused primarily upon health
effects of exposure to hazards associated with service in the Southwest
Asia theater of operations, as that area was defined for purposes of
the 1991 Gulf War. That area was defined to encompass Iraq, Kuwait,
Saudi Arabia, the neutral zone between Iraq and Saudi Arabia, Bahrain,
Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of
Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace
above these locations. See Executive Order 12744 (Jan. 12, 1991); 60 FR
6665 (Feb. 3, 1995); 38 CFR 3.317(d)(2). In its 2006 report, at the
Secretary’s request, the NAS also reviewed infectious diseases that
might have affected U.S. troops who served in Operation Enduring
Freedom (OEF) and Operation Iraqi Freedom (OIF) in Southwest Asia,
including service in Afghanistan, which was designated a combat zone
effective September 19, 2001, by Executive Order 13239 (Dec. 12, 2001).
The NAS indicated that the nine infectious diseases are endemic to the
region including Afghanistan and the areas previously designated as the
Southwest Asia theater of operations.

Presumptively Service-Connected Illnesses

Although the NAS report focused on the association between a
primary infectious disease and secondary health effects, we believe it
is necessary to address the issue of the association between exposure
to disease-causing pathogens in service and the development of the
primary infectious diseases. We do this for two reasons. First, 38
U.S.C. 1118 contemplates that VA will establish presumptions of service
connection when there is a positive association between exposure to
certain pathogens in Gulf War service and the development of a disease
or illness. Second, establishing presumptions of service connection for
the primary infectious diseases would facilitate grants of service
connection for the secondary health effects identified in the NAS
report because, when VA grants service connection for a primary
disease, all secondary conditions proximately caused by that disease
are also service connected. See 38 CFR 3.310.
VA proposes to establish new presumptions of service connection for
veterans who have served in the Southwest Asia theater of operations or
Afghanistan during certain periods, and who subsequently develop one of
the nine diseases known to have long-term adverse health effects.
The NAS did not state specific conclusions regarding the strength
of the evidence linking the nine primary infectious diseases to Persian
Gulf service. However, its report reflects the view that those diseases
and the pathogens that cause them are associated with Persian Gulf
service due to their prevalence in Southwest Asia and their incidence
in deployed U.S. troops. As the NAS report reflects, the identified
disease pathogens, which generally are specific types of bacteria, are
known to cause the identified infectious diseases. Accordingly,
exposure to those pathogens is necessarily associated with the
incurrence of the infectious diseases.
The NAS noted that visceral leishmaniasis is endemic to Southwest
Asia and is transmitted by sand fly bites, which are exceedingly common
in that region. The NAS noted that malaria is endemic in portions of
Southwest Asia, including many parts of Afghanistan, accounting for
approximately 6 million cases and 59,000 deaths annually in Southwest
and South Central Asia, and that Iraq experienced an epidemic in the
wake of the 1991 Gulf War. The NAS noted that West Nile virus is
endemic in Afghanistan and other countries in Southwest Asia. The NAS
noted that diarrheal diseases were the most common illnesses manifest
during the 1991 Gulf War and that studies had

[[Page 13054]]

identified shigella, campylobacter, and nontyphoid salmonella bacteria,
all endemic in the region, as the pathogens involved in a number of
cases (and the only ones known to cause long-term health effects). The
NAS noted that the Middle East, including Iraq, Kuwait, and Saudi
Arabia, is one of three major endemic zones for brucellosis. Finally,
the NAS noted that Q fever is endemic in Southwest Asia, and that
tuberculosis is highly endemic in that region. The NAS findings that
those diseases are endemic to Southwest Asia reflect well-established
and documented facts.
Veterans who were diagnosed with any of these nine infectious
diseases while they were serving on active duty will be able to
establish direct service connection for their illness and any related
health complications. Most of the infectious diseases that were the
focus of the NAS were comparatively rare during the 1991 Gulf War, OEF,
and OIF. Because these acute infectious diseases are generally quite
serious, most cases of these infectious diseases would be diagnosed
during service. For example, during the 1991 Gulf War, 20 veterans were
diagnosed with cutaneous leishmaniasis, which can cause significant
morbidity if left untreated. However, no additional cases have been
diagnosed since the end of that conflict. Although diarrheal diseases
were one of the most common major infectious disease problems for
troops during the 1991 Gulf War, diagnosis of these diseases is defined
in large part by their acute and obvious symptomatology.
However, some of the nine infectious diseases reviewed by the NAS
might be diagnosed only after the veteran separates from active duty.
Furthermore, a service member’s initial, in-theater infection may not
be detected or reported in the service member’s treatment records. That
is, in some instances, cases might be overlooked or misdiagnosed while
the service member is still on active duty in Southwest Asia. For
example, the NAS report describes how tuberculosis infection may remain
asymptomatic such that the initial infection might not be expected to
be documented in the service member’s treatment record. Similarly,
visceral leishmaniasis can be initially asymptomatic. Tuberculosis and
visceral leishmaniasis can each manifest as an acute infectious disease
years or even decades (for tuberculosis) following an initial
asymptomatic infection.
Therefore, to respond to concerns of overlooked or delayed
diagnoses, we propose to establish new presumptions of service
connection for veterans who are initially diagnosed with one of these
nine infectious diseases during the defined period discussed below
following their military service in Southwest Asia. Such a presumption
will benefit Southwest Asia veterans who experienced an initial
asymptomatic infection that was not documented in their service
treatment records, so long as the condition was later diagnosed within
the presumptive period. This would be consistent with existing
presumptions of service connection set forth at 38 CFR 3.307 and 3.309
and discussed in greater detail below.
We propose to make the presumptions applicable to veterans who
served in the Southwest Asia theater of operations, as currently
defined in 38 CFR 3.317(d) (which we propose to redesignate as
3.317(e)), and to veterans who served in Afghanistan on or after
September 19, 2001, the date specified in Executive Order 13239 as the
date combatant activities commenced in that country. This is based on
the findings in the NAS report that the nine infectious diseases are
endemic in those regions and were experienced by servicemembers in the
1991 Gulf War, OEF, and OIF.
Some of these nine infectious diseases associated with service in
Southwest Asia are already recognized as presumptively service
connected for veterans who served during a war period or after 1946.
Although this would include veterans who served in the 1991 Gulf War,
OEF, and OIF, VA believes there is value in developing new presumptions
of service connection that recognize these veterans specifically.
Chronic and tropical diseases that are presumed to be service
connected when they become manifest within a specified time period in
certain veterans are listed at 38 CFR 3.307 and 3.309 in accordance
with 38 U.S.C. 1112(a). Sections 3.307(a)(3) and 3.309(a) include
active tuberculosis if manifested to a degree of 10 percent or more
within 3 years from the date of separation from service, and Sec. Sec.
3.307(a)(4) and 3.309(b) include leishmaniasis and malaria if
manifested to a degree of 10 percent or more either within 1 year from
date of separation from service “or at a time when standard accepted
treatises indicate that the incubation period commenced during such
service.” 38 CFR 3.307(a)(4). Because the current presumptions for
tuberculosis, leishmaniasis, and malaria are available to veterans who
served in the 1991 Gulf War, OEF, and OIF, it may not seem to be
necessary to establish new presumptions of service connection for these
three diseases. However, we find that establishing new presumptions of
service connection for such veterans serves to acknowledge the specific
health risks experienced by this group.
Except as provided below for three diseases, we propose that a
covered infectious disease be manifest within 1 year following service
in the Southwest Asia theater of operations or Afghanistan in order to
qualify for presumptive service connection. This 1-year period would be
consistent with the general 1-year presumptive period for tropical
diseases currently in 38 U.S.C. 1112(a)(2) and Sec. 3.307(a)(4) and
would be consistent with medical principles, reflected in the NAS
report, that those diseases ordinarily would be manifest within a short
period following infection. We believe this 1-year period would be
sufficient to encompass infectious diseases that are likely to have
resulted from infection during service in the Southwest Asia theater of
operations or Afghanistan.
With respect to malaria, we propose to adopt the same presumptive
period as provided for malaria in 38 U.S.C. 1112(a)(2) and Sec.
3.307(a)(4), which require malaria to become manifest within 1 year of
service or at a time when standard or accepted treatises indicate that
the incubation period commenced during service. This standard would
promote consistency with existing law and is consistent with medical
principles. The NAS noted that all known cases of malaria in veterans
of OEF and OIF were diagnosed between 1 and 399 days after leaving the
theater of operations, but that malaria may relapse up to 5 years after
initial infection.
We propose no time limit on the presumption for visceral
leishmaniasis. We note that the existing presumption of service
connection for leishmaniasis in 38 U.S.C. 1112(a)(2) and Sec.
3.307(a)(4) requires the disease to become manifest within 1 year of
service or at a time when standard or accepted treatises indicate that
the incubation period commenced during service. That flexible standard
may encompass latency periods significantly greater than 1 year.
However, because the NAS noted that the period of latent infection with
visceral leishmaniasis organisms may be long, and that a period of 10
years is commonly cited, we believe that an open-ended presumption
period is justified and will be clearer to claimants and adjudicators.
To the extent that VA receives a claim under Sec. 3.307(a)(4), the
claimant may rely on “Gulf War and Health Volume 5: Infectious
Diseases” as a standard treatise indicating the potentially lengthy
latency period for leishmaniasis.
The proposed presumption for tuberculosis also would not be time-

[[Page 13055]]

limited as the current presumption for that disease is by statutory
direction. However, we do not believe this would result in a
significant inconsistency. The existing 3-year presumptive period for
service connection for tuberculosis in 38 U.S.C. 1112(a) applies to all
veterans regardless of period or location of service. That presumption
reflects the apparent conclusion that when tuberculosis is manifest
within a relatively short time after service, it is reasonable to
assume that it had its onset in service, even if there is no identified
precipitating factor in service. In contrast, the proposed presumption
period is based on a specific risk factor in service (service in the
Southwest Asia theater of operations or Afghanistan), rather than a
purely temporal relationship. Because tuberculosis may manifest decades
after an initial infection, we believe it is reasonable to presume that
tuberculosis manifest at any time after such service is related to the
known risk factor in service unless the evidence shows otherwise.
With respect to the presumptive periods for visceral leishmaniasis
and tuberculosis discussed above, we solicit comments on the following
matters. First, whether it would be clearer to claimants and
adjudicators to have the same presumptive periods as prescribed in
Sec. 1112(a) apply to the presumptions proposed for these two
diseases. Second, whether NAS’s statement that the period of latent
infection with visceral leishmaniasis organisms may be long, and that a
period of 10 years is commonly cited, justifies an open-ended
presumption period. Third, whether the risk factor of service in the
Southwest Asia theater of operations or Afghanistan justifies an open-
ended presumption period for tuberculosis.

Secondary Health Effects

In its report, the NAS identified 34 different long-term health
effects that might appear weeks to years after initial infection,
associated with the nine infectious diseases. Most, if not all,
identified long-term health effects are well known to be associated
with the initial acute infection. If service connection is granted for
a primary infectious disease pursuant to this proposed rule, any
secondary health effects proximately due to or caused by the primary
infectious disease will also be service connected under existing
regulations.
We do not propose to establish presumptions of service connection
for the secondary health effects discussed in the NAS report. As
explained above, the findings in the NAS report pertained to
individuals who had actually developed a primary infectious disease.
Those findings thus do not support a presumption that the identified
secondary health effects are independently associated with in-service
exposure to the disease-causing pathogen in the absence of the primary
disease.
Section 1118 of title 38, United States Code, does not direct VA to
establish presumptions of service connection for conditions secondarily
caused by a primary service-connected disease or illness. Rather, it
requires presumptions for disease or illness associated with “exposure
to a biological, chemical, or other toxic agent, environmental or
wartime hazard, or preventive medicine known or presumed to be
associated with service in the Armed Forces in the Southwest Asia
theater of operations during the Persian Gulf War.” With respect to
infectious diseases endemic to the Southwest Asia theater of
operations, the relevant “exposure” is exposure to the pathogens that
cause the primary infectious disease. The incurrence of the primary
infectious disease is not, separately, an “exposure” within the
meaning of the statute.
Any long-term health effects among troops serving in Southwest Asia
who suffered an initial serious acute infectious disease should in
general be addressed via the conventional direct-service-connection
route. For example, if an active duty service member were diagnosed
with Q fever (Coxiella burnetii) while serving in Southwest Asia, and
was diagnosed years later with endocarditis, which is known to be
associated with Q fever infection, then that veteran would have a
reasonable case for establishing a direct service connection for any
related disability.
Chronic long-term health effects associated with these infectious
diseases generally would be compensable under the diagnostic code
assigned to the service-connected disease or would be considered
proximately due to that disease under 38 CFR 3.310(a) (secondary
service connection) and rated separately.
As noted above, the NAS’s findings concerning the secondary health
effects of the nine infectious diseases generally reflect well
established medical knowledge. However, to ensure that claimants and VA
raters are aware of the NAS findings regarding the potential long-term
health effects of the nine infectious diseases associated with service
in Southwest Asia, we propose to include information about the long-
term health effects in the regulation. The table in proposed paragraph
(d), entitled “Table to Sec. 3.317–Long-Term Health Effects
Potentially Associated With Infectious Diseases,” summarizes the long-
term health effects that the NAS reported as associated with the nine
infectious diseases. These health effects and diseases are listed
alphabetically and are not categorized by the level of association
stated in the NAS report. We propose to provide in the regulation that,
if a veteran who has or had an infectious disease identified in column
A also has a condition identified in column B as potentially related to
that infectious disease, VA must determine, based on the evidence in
each case, whether the column B condition was caused by the infectious
disease for purposes of paying disability compensation.

IV. Regulatory Amendment

After considering all of the evidence as discussed above, the
Secretary has determined that there is a positive association between
the exposure to a biological, chemical or other toxic agent,
environmental or wartime hazard, or preventative medicine or vaccine
known or presumed to be associated with service in the Armed Forces in
the Southwest Asia theater of operations during certain periods and the
occurrence of Brucellosis, Campylobacter jejuni, Coxiella burnetii (Q
fever), Malaria, Mycobacterium tuberculosis, Nontyphoid Salmonella,
Shigella, Visceral leishmaniasis, and West Nile virus. Accordingly, the
Secretary has determined that a presumption of service connection for
these nine diseases is warranted pursuant to 38 U.S.C. 1118. Therefore,
we propose to amend 38 CFR 3.317 to incorporate the new presumptions.
The major changes we propose are:
To revise the title of the regulation to better reflect
the content of the regulation and better reflect the authorizing
statute (38 U.S.C. 1117).
To remove current Sec. 3.317(a)(2)(i)(C). This statement
is a blanket statement regarding service connection for diagnosed
illnesses determined to be presumptively service connected. Because we
are establishing presumptive service connection for specified diseases,
we propose to create separate sections to address these diseases. We
propose to add the new sections at new Sec. 3.317(c) and (d) and
redesignate current Sec. 3.317(c) and (d) as Sec. 3.317 (a)(7) and
(e) respectively.
To establish presumptions of service connection for nine
infectious diseases becoming manifest within a specified time after
service in the Southwest Asia theater of operations or Afghanistan
during certain time periods.

[[Page 13056]]

V. Other Diseases

This proposed rule does not reflect determinations concerning any
diseases other than those discussed in this proposal. The Secretary’s
determinations concerning other diseases 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 proposed 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 proposed rule would not affect any small entities.
Only VA beneficiaries could be directly affected. Therefore, pursuant
to 5 U.S.C. 605(b), this proposed rule is exempt from the initial and
final regulatory flexibility analysis requirements of sections 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 to be a significant regulatory action under the Executive
Order because it is likely to result in a rule that may raise novel
legal or policy issues arising out of legal mandates, the President’s
priorities, or the principles set forth in the Executive Order.

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 proposed 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 rule are 64.009, Veterans Medical Care Benefits;
64.100, Automobiles and Adaptive Equipment for Certain Disabled
Veterans and Members of the Armed Forces; 64.101, Burial Expenses
Allowance for Veterans; 64.106, Specially Adapted Housing for Disabled
Veterans; 64.109, Veterans Compensation for Service-Connected
Disability; and 64.110, Veterans Dependency and Indemnity Compensation
for Service-Connected Death.

List of Subjects in 38 CFR Part 3

Administrative practice and procedure, Claims, Disability benefits,
Health care, Pensions, Radioactive materials, Veterans, Vietnam.

Approved: December 9, 2009.
John R. Gingrich,
Chief of Staff, 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. Revise Sec. 3.317 to read as follows:

Sec. 3.317 Compensation for certain disabilities occurring in Persian
Gulf veterans.

(a) Compensation for disability due to undiagnosed illness and
medically unexplained chronic multisymptom illnesses. (1) Except as
provided in paragraph (a)(7) of this section, VA will pay compensation
in accordance with chapter 11 of title 38, United States Code, to a
Persian Gulf veteran who exhibits objective indications of a qualifying
chronic disability, provided that such disability:
(i) Became manifest either during active military, naval, or air
service in the Southwest Asia theater of operations, or to a degree of
10 percent or more not later than December 31, 2011; and
(ii) By history, physical examination, and laboratory tests cannot
be attributed to any known clinical diagnosis.
(2)(i) For purposes of this section, a qualifying chronic
disability means a chronic disability resulting from any of the
following (or any combination of the following):
(A) An undiagnosed illness;
(B) The following medically unexplained chronic multisymptom
illnesses that are defined by a cluster of signs or symptoms:
(1) Chronic fatigue syndrome;
(2) Fibromyalgia;
(3) Irritable bowel syndrome; or
(4) Any other illness that the Secretary determines meets the
criteria in paragraph (a)(2)(ii) of this section for a medically
unexplained chronic multisymptom illness.
(ii) For purposes of this section, the term medically unexplained
chronic multisymptom illness means a diagnosed illness without
conclusive pathophysiology or etiology that is characterized by
overlapping symptoms and signs and has features such as fatigue, pain,
disability out of proportion to physical findings, and inconsistent
demonstration of laboratory abnormalities. Chronic multisymptom
illnesses of partially understood etiology and pathophysiology will not
be considered medically unexplained.
(3) For purposes of this section, “objective indications of
chronic disability” include both “signs,” in the medical sense of
objective evidence perceptible to an examining physician, and other,
non-medical indicators that are capable of independent verification.
(4) For purposes of this section, disabilities that have existed
for 6 months or more and disabilities that exhibit intermittent
episodes of improvement and worsening over a 6-month period will be
considered chronic. The 6-month period of chronicity will be measured
from the earliest date on which the pertinent evidence establishes that
the signs or symptoms of the disability first became manifest.

[[Page 13057]]

(5) A qualifying chronic disability referred to in this section
shall be rated using evaluation criteria from part 4 of this chapter
for a disease or injury in which the functions affected, anatomical
localization, or symptomatology are similar.
(6) A qualifying chronic disability referred to in this section
shall be considered service connected for purposes of all laws of the
United States.
(7) Compensation shall not be paid under this section for a chronic
disability:
(i) If there is affirmative evidence that the disability was not
incurred during active military, naval, or air service in the Southwest
Asia theater of operations; or
(ii) If there is affirmative evidence that the disability was
caused by a supervening condition or event that occurred between the
veteran’s most recent departure from active duty in the Southwest Asia
theater of operations and the onset of the disability; or
(iii) If there is affirmative evidence that the disability is the
result of the veteran’s own willful misconduct or the abuse of alcohol
or drugs.
(b) Signs or symptoms of undiagnosed illness and medically
unexplained chronic multisymptom illnesses. For the purposes of
paragraph (a)(1) of this section, signs or symptoms which may be
manifestations of undiagnosed illness or medically unexplained chronic
multisymptom illness include, but are not limited to:
(1) Fatigue.
(2) Signs or symptoms involving skin.
(3) Headache.
(4) Muscle pain.
(5) Joint pain.
(6) Neurologic signs or symptoms.
(7) Neuropsychological signs or symptoms.
(8) Signs or symptoms involving the respiratory system (upper or
lower).
(9) Sleep disturbances.
(10) Gastrointestinal signs or symptoms.
(11) Cardiovascular signs or symptoms.
(12) Abnormal weight loss.
(13) Menstrual disorders.
(c) Presumptive service connection for infectious diseases. (1) A
disease listed in paragraph (c)(2) of this section will be service
connected if it becomes manifest in a Persian Gulf veteran, as defined
in paragraph (e)(1) of this section or a veteran who served on active
military, naval, or air service in Afghanistan on or after September
19, 2001, provided the provisions of paragraph (c)(3) of this section
are also satisfied.
(2) The diseases referred to in paragraph (c)(1) of this section
are the following:
(i) Brucellosis.
(ii) Campylobacter jejuni.
(iii) Coxiella burnetii (Q fever).
(iv) Malaria.
(v) Mycobacterium tuberculosis.
(vi) Nontyphoid Salmonella.
(vii) Shigella.
(viii) Visceral leishmaniasis.
(ix) West Nile virus.
(3) The diseases listed in paragraph (c)(2) of this section will be
considered to have been incurred in or aggravated by service under the
circumstances outlined in paragraphs (c)(3)(i) and (ii) of this section
even though there is no evidence of such disease during the period of
service.
(i) With three exceptions, the disease must have become manifest to
a degree of 10 percent or more within 1 year from the date of
separation from a qualifying period of service as specified in
paragraph (c)(3)(ii) of this section. Malaria must have become manifest
to a degree of 10 percent or more within 1 year from the date of
separation from a qualifying period of service or at a time when
standard or accepted treatises indicate that the incubation period
commenced during a qualifying period of service. There is no time limit
for visceral leishmaniasis or tuberculosis to have become manifest to a
degree of 10 percent or more.
(ii) For purposes of this paragraph (c), the term qualifying period
of service means a period of service meeting the requirements of
paragraph (e) of this section or a period of active military, naval, or
air service on or after September 19, 2001, in Afghanistan.
(4) A disease listed in paragraph (c)(2) of this section shall not
be presumed service connected:
(i) If there is affirmative evidence that the disease was not
incurred during a qualifying period of service; or
(ii) If there is affirmative evidence that the disease was caused
by a supervening condition or event that occurred between the veteran’s
most recent departure from a qualifying period of service and the onset
of the disease; or
(iii) If there is affirmative evidence that the disease is the
result of the veteran’s own willful misconduct or the abuse of alcohol
or drugs.
(5) If a veteran presumed service connected for one of the diseases
listed in paragraph (c)(2) of this section is diagnosed with one of the
diseases listed in column “B” in the table set forth in paragraph (d)
of this section within the time period specified for the disease in
that same table, if a time period is specified or, otherwise, at any
time, VA will request a medical opinion as to whether it is at least as
likely as not that the condition was caused by the veteran having had
the associated disease in column “A” in that same table.
(d) Long-term health effects potentially associated with infectious
diseases–A report of the Institute of Medicine of the National Academy
of Sciences has identified the following long-term health effects that
potentially are associated with the infectious diseases listed in
paragraph (c)(2) of this section. These health effects and diseases are
listed alphabetically and are not categorized by the level of
association stated in the National Academy of Sciences report. If a
veteran who has or had an infectious disease identified in column A
also has a condition identified in column B as potentially related to
that infectious disease, VA must determine, based on the evidence in
each case, whether the column B condition was caused by the infectious
disease for purposes of paying disability compensation. This does not
preclude a finding that other manifestations of disability or secondary
conditions were caused by an infectious disease.

Table to Sec. 3.317–Long-Term Health Effects Potentially Associated With Infectious Diseases
——————————————————————————————————————————————————–
B
—————————————————————————————————————–
Associated
Long-term
A Health Effect
Disease (Period for
Manifestation,
if Any, Noted
in Italics)
—————————————————————————————————————————————— —————-
Brucellosis………………………… Arthritis.
Cardiovascular, nervous, and respiratory system infections.
Chronic meningitis and meningoencephalitis.
Deafness.
Demyelinating meningovascular syndromes.
Episcleritis.
Fatigue, inattention, amnesia, and depression.
Guillain-Barr[eacute] syndrome.
Hepatic abnormalities, including granulomatous hepatitis.
Multifocal choroiditis.
Myelitis-radiculoneuritis.
Nummular keratitis.
Papilledema.
Optic neuritis.
Orchioepididymitis and infections of the genitourinary system.
Sensorineural hearing loss.
Spondylitis.
Uveitis.
Campylobacter jejuni………………… Guillain-Barr[eacute] syndrome if manifest within 2 months of the infection.
Reactive Arthritis if manifest within 3 months of the infection.
Uveitis if manifest within 1 month of the infection.
Coxiella burnetii (Q fever)………….. Chronic hepatitis.
Endocarditis.
Osteomyelitis.
post-Q-fever chronic fatigue syndrome.
Vascular infection.
Malaria……………………………. Demyelinating polyneuropathy.
Guillain-Barr[eacute] syndrome.
Hematologic manifestations (particularly anemia after falciparum malaria and splenic
rupture after vivax malaria).
Immune-complex glomerulonephritis.
Neurologic disease, neuropsychiatric disease, or both.
Ophthalmologic manifestations, particularly retinal hemorrhage and scarring.
Plasmodium falciparum.
Plasmodium malariae.
Plasmodium ovale.
Plasmodium vivax.
Renal disease, especially nephrotic syndrome.
Mycobacterium tuberculosis…………… Active tuberculosis.
Long-term adverse health outcomes due to irreversible tissue damage from severe forms
of pulmonary and extrapulmonary tuberculosis and active tuberculosis.
Nontyphoid Salmonella……………….. Reactive Arthritis if manifest within 3 months of the infection.
Shigella…………………………… Hemolytic-uremic syndrome if manifest within 1 month of the infection.
Reactive Arthritis if manifest within 3 months of the infection.
Visceral leishmaniasis………………. Delayed presentation of the acute clinical syndrome.
Post-kala-azar dermal leishmaniasis if manifest within 2 years of the infection.
Reactivation of visceral leishmaniasis in the context of future immunosuppression.
West Nile virus…………………….. Variable physical, functional, or cognitive disability.
——————————————————————————————————————————————————–

(e) Service. For purposes of this section:
(1) The term Persian Gulf veteran means a veteran who served on
active military, naval, or air service in the Southwest Asia theater of
operations.
(2) The Southwest Asia theater of operations refers to Iraq,
Kuwait, Saudi Arabia, the neutral zone between Iraq and Saudi Arabia,
Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the
Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the
airspace above these locations during the Persian Gulf War.

Authority: 38 U.S.C. 1117, 1118.

Editorial Note: This document was received in the Office of the
Federal Register on March 15, 2010.

[FR Doc. 2010-5980 Filed 3-17-10; 8:45 am]
BILLING CODE P

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