[Federal Register Volume 73, Number 185 (Tuesday, September 23, 2008)]
[Rules and Regulations]
[Pages 54691-54693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21998]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AN05


Presumption of Service Connection for Amyotrophic Lateral 
Sclerosis

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA) 
adjudication regulations to establish a presumption of service 
connection for amyotrophic lateral sclerosis (ALS) for any veteran who 
develops the disease at any time after separation from service. This 
amendment is necessary to implement a decision by the Secretary to 
establish such a presumption based primarily on a November 2006 report 
by the National Academy of Sciences Institute of Medicine (IOM) on the 
association between active service and ALS.

DATES: Effective Date: This interim final rule is effective September 
23, 2008. Comments must be received on or before November 24, 2008.
    Applicability Date: The provisions of this interim final rule shall 
apply to all applications for benefits that are received by VA on or 
after the effective date of this interim final rule or that are pending 
before VA, the United States Court of Appeals for Veterans Claims, or 
the United States Court of Appeals for the Federal Circuit on the 
effective date of this interim final rule. In accordance with 38 U.S.C. 
5110(g), the effective date of benefits awarded pursuant to this rule 
will be assigned in accordance with the facts found, but cannot be 
earlier than the effective date of this rule or the date one year prior 
to the date of application, whichever is later.

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 20042; or by fax to (202) 273-9026. 
Comments should indicate that they are submitted in response to ``RIN 
2900-AN05--Presumption of Service Connection for Amyotrophic Lateral 
Sclerosis.'' 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) 461-4923 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 (FDMS) at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Rhonda Ford, Chief, Regulation Staff 
(211D), Compensation and Pension Service, Veterans Benefits 
Administration, Department of Veterans Affairs, 810 Vermont Ave., NW., 
Washington, DC 20420, (202) 461-9739.

SUPPLEMENTARY INFORMATION: This interim final rule establishes a 
presumption of service connection for ALS for any veteran who develops 
the disease at any time after separation from service. ALS (also called 
Lou Gehrig's disease) is a neuromuscular disease that affects about 
20,000 to 30,000 people of all races and ethnic backgrounds in the 
United States and is often relentlessly progressive and almost always 
fatal. ALS causes degeneration of nerve cells in the brain and spinal 
cord that leads to muscle weakness, muscle atrophy, and spontaneous 
muscle activity. People suffering from ALS eventually lose the ability 
to move their arms and legs and to speak and swallow. The median 
survival period for people with ALS is 3 years from the onset of 
symptoms, and most people with ALS die from respiratory failure within 
5 years. Currently, there is no effective treatment for ALS.
    In November 2006, IOM issued the report Amyotrophic Lateral 
Sclerosis in Veterans: Review of the Scientific Literature, which 
concluded that ``there is limited and suggestive evidence of an 
association between military service and later development of ALS.'' 
The report summarized the findings of a 2005 ``high-quality cohort 
study'' by M.G. Weisskopf et al., entitled Prospective study of 
military service and mortality from ALS, 64(1) Neurology 32 (2005), 
which evaluated ALS risk among veterans with service prior to 1982, 
including veterans of service during World War II, the Korean War, and 
the Vietnam War, and concluded that these veterans, regardless of years 
of service, were at a statistically significant greater risk of 
developing ALS compared to civilians. The IOM report concluded that 
``[a]lthough the study has some limitations * * * overall it was a 
well-designed and well-conducted study'' that ``adequately controlled 
for confounding factors (age, cigarette use, alcohol consumption, 
education, self-reported exposure to pesticides and herbicides, and 
several main lifetime occupations).''
    The IOM report also noted that other studies corroborated the 
findings of the Weisskopf study, including 2003 studies by R.D. Horner 
et al. (Occurrence of amyotrophic lateral sclerosis among Gulf War 
veterans, 61(6) Neurology 742 (2003)) and R.W. Haley (Excess incidence 
of ALS in young Gulf War veterans, 61(6) Neurology 750 (2003)), which 
suggested that veterans of the 1991 Gulf War were at greater risk of 
developing ALS than civilians. IOM characterized the Horner study as 
``generally well conducted.'' In December 2001, based on pre-
publication announcements of these 2003 studies, Secretary of Veterans 
Affairs Anthony J. Principi made a policy decision to give special 
consideration to ALS claims by veterans of the 1991 Gulf War regardless 
of when the disease became manifest. The findings of the Weisskopf 
study, however, suggest that military service in general, and not just 
circumstances specific to the 1991 Gulf War, is related to the 
development of ALS.
    The cause of ALS is unknown, but these studies indicate that there 
exists a statistical correlation between activities in military service 
and development of ALS. Although the IOM report suggested that further 
studies may establish a more definite association between ALS and 
military service, the Secretary believes it is unlikely that conclusive 
evidence will be developed in the foreseeable future to establish the 
cause of ALS among military or civilian populations due to the rarity 
of this particular disease. After careful consideration of the studies 
referenced above and the fact that further research is unlikely to 
clarify this association between ALS and military service, the 
Secretary believes there is sufficient

[[Page 54692]]

evidence indicating a correlation between ALS and activities in 
military service that supports establishment of a presumption of 
service connection for ALS for any veteran with that diagnosis.
    Accordingly, the Secretary has decided to establish this 
presumption for ALS under his general rulemaking authority. Section 
501(a)(1) of title 38, United States Code, provides that ``[t]he 
Secretary has authority to prescribe all rules and regulations which 
are necessary or appropriate to carry out the laws administered by [VA] 
and are consistent with those laws, including * * * regulations with 
respect to the nature and extent of proof and evidence and the method 
of taking and furnishing them in order to establish the right to 
benefits under such laws.'' This authority is broad enough to encompass 
establishment of an evidentiary presumption of service connection under 
specified circumstances. In this case, the Secretary has determined 
that proof of active military, naval, or air service and the subsequent 
development of ALS is sufficient evidence to support a presumption that 
the resulting disability was incurred in the line of duty during active 
military, naval, or air service, i.e., to establish entitlement to 
service connection. See 38 U.S.C. 1110.
    Several circumstances unique to ALS warrant the establishment of a 
presumption of service connection for purposes of VA benefits. ALS is 
distinguishable from most other serious diseases because of its 
incurably debilitating, rapidly progressing, and invariably fatal 
characteristics. Most significantly, however, ALS is set apart from 
other diseases for purposes of establishing a presumption of service 
connection due to its statistically high development rate in veterans 
compared to the general population. Despite the high correlation with 
military service noted in the IOM report, the continuing uncertainty 
regarding specific precipitating factors or events that lead to 
development of the disease would present great difficulty for 
individual claimants seeking to establish service connection by direct 
evidence under generally applicable procedures in the absence of a 
presumption. This difficulty would be particularly profound in view of 
the rapid and devastating course of ALS and its impact on veterans and 
their families, which may inhibit their ability to participate in the 
development of evidence to support medically complex claims. 
Accordingly, the Secretary has determined that a presumption of service 
connection is warranted based on the available scientific and medical 
evidence and the unique circumstances surrounding ALS.
    VA would welcome comments on any relevant peer-reviewed literature 
concerning ALS that has been published since the November 2006 IOM 
report. VA will continue to monitor developments in the scientific and 
medical fields concerning ALS. If, in the future, developments in the 
scientific and medical fields sufficiently establish that ALS is not 
associated with activities in military service, VA would revisit at 
that time the appropriateness of this presumption.
    This interim final rule establishes a new Sec.  3.318 to provide 
that the development of ALS at any time after discharge or release from 
active military, naval, or air service is sufficient to establish 
service connection for that disease. Paragraph (b) of new Sec.  3.318 
provides that this presumption of service connection for ALS does not 
apply if there is affirmative evidence that ALS was not incurred during 
or aggravated by such service or affirmative evidence that ALS was 
caused by the veteran's own willful misconduct. We recognize that there 
is very little likelihood that either of those standards will be met 
with regard to any particular claim, but we believe these provisions 
properly reflect Congress' intent, as expressed in 38 U.S.C. 1113, that 
evidentiary presumptions of service connection should not operate when 
there is affirmative evidence to the contrary or evidence of willful 
misconduct.
    Paragraph (b) of new Sec.  3.318 also provides that a presumption 
of service connection for ALS does not apply if the veteran did not 
have active, continuous service of 90 days or more. Although the 
Weisskopf study relied upon by the IOM report concluded that veterans 
have an increased risk of developing ALS compared to civilians 
regardless of years of service, a minimum-service requirement of 90 
days would not be inconsistent with the study's findings because the 
study focused on veterans' ``years'' of service and did not consider 
minimum periods of service. We believe that 90 days is a reasonable 
period to ensure that an individual has had sufficient contact with 
activities in military service to encounter any hazards that may 
contribute to development of ALS. Under 38 U.S.C. 1112(a) and 38 CFR 
3.307(a)(1), the presumptions of service incurrence for various 
conditions, such as chronic diseases and tropical diseases, apply 
generally to eligible veterans with at least 90 days of active, 
continuous service. Thus, Congress considered 90 days to be the minimum 
period necessary to support an association between such service and 
subsequent development of disease. Consistent with that judgment, we 
believe that, for any shorter period, it is more likely than not that 
ALS was not associated with service.

Administrative Procedure Act

    Pursuant to 5 U.S.C. 553(b)(3)(B) and (d)(3), we find that there is 
good cause to dispense with advance public notice and opportunity to 
comment on this rule and good cause to publish this rule with an 
immediate effective date. This interim final rule is necessary to 
implement immediately the Secretary's decision to establish a 
presumption of service connection for ALS for veterans with that 
diagnosis. Delay in the implementation of this presumption would be 
contrary to the public interest.
    Because the survival period for persons suffering from ALS is 
generally 5 years or less from the onset of symptoms, any delay would 
be extremely detrimental to veterans who are currently afflicted with 
ALS. Veterans with ALS may not be taking alleviating medications, 
participating in muscle and speech therapy, or receiving proper 
assistance for daily functions due to financial hardship or their lack 
of having service-connected status for their disability. Moreover, in 
all likelihood, some veterans will die from this rapidly progressive 
disease during a period for prior public comment. These veterans 
obviously would not receive any benefit from a presumption that is 
implemented after a public-comment period.
    In order to benefit veterans currently suffering from ALS as 
quickly as possible, it is critical that VA establish this presumption 
immediately. For the foregoing reasons, the Secretary is issuing this 
rule as an interim final rule with immediate effect.

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 an 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 given year. This rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

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

[[Page 54693]]

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, 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 
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 entitlement 
recipients; 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.
    VA has examined the economic, interagency, budgetary, legal, and 
policy implications of this interim final rule and has concluded that 
it is a significant regulatory action under Executive Order 12866 
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.

Paperwork Reduction Act

    This document contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this interim final 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. The rule could affect only VA beneficiaries and will 
not directly affect small entities. Therefore, pursuant to 5 U.S.C. 
605(b), this rule is exempt from the initial and final regulatory 
flexibility analyses requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance program numbers and 
titles for this rule are as follows: 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: August 1, 2008.
James B. Peake,
Secretary of Veterans Affairs.

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For the reasons set forth in the preamble, 38 CFR part 3 is amended as 
follows:

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity 
Compensation

0
1. The authority citation for part 3, subpart A continues to read as 
follows:

    Authority: 38 U.S.C. 501(a), unless otherwise noted.


0
2. Add Sec.  3.318 to read as follows:


Sec.  3.318  Presumptive Service Connection for Amyotrophic Lateral 
Sclerosis.

    (a) Except as provided in paragraph (b) of this section, the 
development of amyotrophic lateral sclerosis manifested at any time 
after discharge or release from active military, naval, or air service 
is sufficient to establish service connection for that disease.
    (b) Service connection will not be established under this section:
    (1) If there is affirmative evidence that amyotrophic lateral 
sclerosis was not incurred during or aggravated by active military, 
naval, or air service;
    (2) If there is affirmative evidence that amyotrophic lateral 
sclerosis is due to the veteran's own willful misconduct; or
    (3) If the veteran did not have active, continuous service of 90 
days or more.

(Authority: 38 U.S.C. 501(a)(1))

[FR Doc. E8-21998 Filed 9-22-08; 8:45 am]
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