Federal Register Vol 73, No 185Tuesday, September 23, 2008
54691 Federal Register/Vol. 73, No. 185/Tuesday, September 23, 2008/Rules and Regulations
requirements, Security measures, Waterways.
PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS ■For the reasons discussed in the preamble, under authority of 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1, the interim rule amending 33 CFR part 165 that was published at 73 FR 37835 on July 2, 2008, is adopted as a final rule without change.
Dated: September 9, 2008.
Lonnie P. Harrison, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Savannah.
[FR Doc. E8–22138 Filed 9–22–08; 8:45 am] BIL L ING CODE 4910–15–P
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. 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://
https://www.wendangku.net/doc/666480988.html,, 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://
https://www.wendangku.net/doc/666480988.html,.
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
54692 Federal Register/Vol. 73, No. 185/Tuesday, September 23, 2008/Rules and Regulations
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 §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 §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 §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
54693 Federal Register/Vol. 73, No. 185/Tuesday, September 23, 2008/Rules and Regulations
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.
■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
■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. Add §3.318 to read as follows:
§3.318Presumptive 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]
BIL L ING CODE 8320–01–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 4
RIN 2900–AM75
Schedule for Rating Disabilities;
Evaluation of Residuals of Traumatic
Brain Injury (TBI)
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
SUMMARY: This document amends the
Department of Veterans Affairs (VA)
Schedule for Rating Disabilities by
revising the portion of the Schedule that
addresses neurological conditions and
convulsive disorders. The effect of this
action is to provide detailed and
updated criteria for evaluating residuals
of traumatic brain injury (TBI).
DATES: Effective Date: This amendment
is effective October 23, 2008.
Applicability Date: The amendment
shall apply to all applications for
benefits received by VA on or after
October 23, 2008. The old criteria will
apply to applications received by VA
before that date. However, a veteran
whose residuals of TBI were rated by
VA under a prior version of 38 CFR
4.124a, diagnostic code 8045, will be
permitted to request review under the
new criteria, irrespective of whether his
or her disability has worsened since the
last review or whether VA receives any
additional evidence. The effective date
of any increase in disability
compensation based solely on the new
criteria would be no earlier than the
effective date of the new criteria. The
effective date of any award, or any
increase in disability compensation,
based solely on these new rating criteria
will not be earlier than the effective date
of this rule, but will otherwise be
assigned under the current regulations
governing effective dates, 38 CFR 3.400,
etc. The rate of disability compensation
will not be reduced based solely on
these new rating criteria.
FOR FURTHER INFORMATION CONTACT:
Rhonda F. Ford, Chief, Regulations Staff
(211D), Compensation and Pension
Service, Veterans Benefits
Administration, Department of Veterans
Affairs, 810 Vermont Ave., NW.,
Washington, DC 20420, (727) 319–5847.
(This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On
January 3, 2008, VA published in the
Federal Register (73 FR 432) a proposal
to amend VA regulations to revise the
material under diagnostic code 8045,
Brain disease due to trauma, in 38 CFR
4.124a (neurological conditions and
convulsive disorders) in the VA
Schedule for Rating Disabilities (the
rating schedule). Interested persons
were invited to submit written
comments, suggestions, or objections on
or before February 4, 2008. We received
comments from the following groups
and associations: American Optometric
Association, Brain Injury Association of
America, American Speech-Language-
Hearing Association, Moss TBI Model
System Centers, Senate Committee on
Veterans’ Affairs, The American Legion
and National Veterans Legal Services
Program, Disabled American Veterans,
Department of the Army Surgeon
General, National Organization of
Veterans Advocates, Blinded Veterans
Association, Veterans Outreach of the