Federal Register / Vol. 73, No. 185 / Tuesday, September 23, 2008 / Rules and Regulations 54691 

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] 

BILLING 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:// 

www.Regulations.gov, by mail or handdelivery 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 welldesigned and well-conducted study’’ 

that ‘‘adequately controlled for 

confounding factors (age, cigarette use, 

alcohol consumption, education, selfreported 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 prepublication 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 


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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 


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Federal Register / Vol. 73, No. 185 / Tuesday, September 23, 2008 / Rules and Regulations 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 ServiceConnected 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: 

§ 3.318 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] 

BILLING 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-LanguageHearing 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 


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