[Federal Register Volume 75, Number 52 (Thursday, March 18, 2010)]
[Proposed Rules]
[Pages 13051-13058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5980]


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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.

[[Page 13052]]


ACTION: Proposed rule.

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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.

[[Page 13058]]

 
                                            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]
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