[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
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1. The authority citation for part 3, subpart A continues to read as
follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
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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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