[Federal Register Volume 69, Number 143 (Tuesday, July 27, 2004)]
[Proposed Rules]
[Pages 44614-44631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16758]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Parts 3 and 5

RIN 2900-AL70


Presumptions of Service Connection for Certain Disabilities, and 
Related Matters

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes to reorganize 
and

[[Page 44615]]

rewrite in plain language its regulations on presumptions of service 
connection for certain disabilities, and related matters. These 
revisions are proposed as part of VA's rewrite and reorganization of 
all of its adjudication regulations in a logical, claimant-focused, and 
user-friendly format. The intended effect of the proposed revisions is 
to assist claimants and VA personnel in locating and understanding 
these general provisions.

DATES: Comments must be received by VA on or before September 27, 2004.

ADDRESSES: Written comments may be submitted by: mail or hand-delivery 
to Director, Regulations Management (00REG1), Department of Veterans 
Affairs, 810 Vermont Avenue, NW., Room 1068, Washington, DC 20420; fax 
to (202) 273-9026; e-mail to [email protected]; or, through 
http://www.Regulations.gov. Comments should indicate that they are 
submitted in response to ``RIN 2900-AL70.'' All 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) 273-9515 for 
an appointment.

FOR FURTHER INFORMATION CONTACT: Bill Russo, Chief, Regulations Rewrite 
Project (00REG2), Department of Veterans Affairs, 810 Vermont Avenue, 
NW., Washington, DC 20420, (202) 273-9515.

SUPPLEMENTARY INFORMATION: The Secretary of Veterans Affairs has 
established an Office of Regulation Policy and Management (ORPM) to 
provide centralized management and coordination of VA's rulemaking 
process. One of the major functions of this office is to oversee a 
Regulation Rewrite Project (the Project) to improve the clarity and 
consistency of existing VA regulations. The Project responds to a 
recommendation made in the October 2001 Report to the Secretary of 
Veterans Affairs by the VA Claims Processing Task Force. The Task Force 
recommended that the Compensation and Pension regulations be rewritten 
and reorganized in order to improve VA's claims adjudication process. 
Therefore, the Project began its efforts by reviewing, reorganizing and 
redrafting the regulations in 38 CFR part 3 governing the Compensation 
and Pension (C&P) program of the Veterans Benefits Administration 
(VBA). These regulations are among the most difficult VA regulations 
for readers to understand and apply.
    Once rewritten, the proposed regulations will be published in 
several portions for public review and comment. This is one such 
portion. It includes proposed rules regarding presumptions of service 
connection and related matters.

Outline

Overview of New Part 5 Organization
Overview of Proposed Subpart E Organization
Table Comparing Current Part 3 Rules with Proposed Part 5 Rules
Content of Proposed Rules

Presumptions of Service Connection for Certain Disabilities, and 
Related Matters

5.260 General rules and definitions
5.261 Certain chronic diseases VA presumes are service connected
5.262 Presumption of service connection for diseases associated with 
exposure to certain herbicide agents
5.263 Presumption of service connection for non-Hodgkin's lymphoma 
based on service in Vietnam
5.264 Diseases VA presumes are service connected in former prisoners 
of war
5.265 Tropical diseases VA presumes are service connected
5.266 Compensation for certain disabilities due to undiagnosed 
illnesses
5.267 Presumption of service connection for conditions associated 
with full-body exposure to nitrogen mustard, sulfur mustard, or 
Lewisite

Service Connection for Diseases Due To Exposure to Ionizing 
Radiation

5.268 Service connection for diseases presumed to be due to exposure 
to ionizing radiation
5.269 Direct service connection for diseases associated with 
exposure to ionizing radiation
Summary and explanation for Removals
    38 CFR 3.379
38 CFR 3.813
Endnote regarding removals from part 3
Paperwork Reduction Act
Regulatory Flexibility Act
Executive Order 12866
Unfunded Mandates
Catalog of Federal Domestic Assistance Numbers
List of Subjects in 38 CFR Parts 3 and 5

Overview of New Part 5 Organization

    We plan to remove the compensation and pension benefit regulations 
from 38 CFR part 3 and relocate them in new part 5. We also plan to 
reorganize the regulations so that all provisions governing a specific 
benefit are located in the same subpart, with general provisions 
pertaining to all compensation and pension benefits also grouped 
together. We believe this reorganization will allow claimants and their 
representatives, as well as VA personnel, to find information relating 
to a specific benefit more quickly.
    The first major subdivision would be ``Subpart A--General 
Provisions.'' It would include information regarding the scope of the 
regulations in new part 5, delegations of authority, general 
definitions, and general policy provisions for this part.
    Subpart B--Service Requirements for Veterans'' would include 
information regarding a veteran's military service, including the 
minimum service requirement, types of service, periods of war, and 
service evidence requirements. This subpart was published as proposed 
on January 30, 2004. See 69 FR 4820.
    Subpart C--Adjudicative Process, General'' would inform readers 
about types of claims and filing procedures, VA's duties, rights and 
responsibilities of claimants, general evidence requirements, and 
general effective dates for new awards, as well as revision of 
decisions and protection of VA ratings.
    ``Subpart D--Dependents of Veterans'' would provide information 
about how VA determines whether an individual is a dependent and the 
evidence requirements for such determinations.
    ``Subpart E--Claims for Service Connection and Disability 
Compensation'' would define service-connected compensation, including 
direct and secondary service connection. This proposed subpart would 
inform readers how VA determines entitlement to service connection. The 
subpart would also contain those provisions governing presumptions 
related to service connection, rating principles, and effective dates, 
as well as several special ratings. Because of its size, proposed 
regulations in subpart E will be published in three separate NPRMs. 
This NPRM, which includes provisions governing presumptions related to 
service connection, is one such NPRM.
    ``Subpart F--Nonservice-Connected Disability Pensions and Death 
Pensions'' would include information regarding the three types of 
nonservice-connected pension: Improved pension, Old-Law pension, and 
Section 306 pension. This subpart would also include those provisions 
that state how to establish entitlement to each pension, and the 
effective dates governing each pension.
    ``Subpart G--Dependency and Indemnity Compensation, Death 
Compensation, Accrued Benefits, and Special Rules Applicable Upon Death 
of a Beneficiary'' would contain regulations governing claims for 
dependency and indemnity compensation (DIC); death compensation; 
accrued benefits; benefits awarded, but unpaid, at death; and various 
special rules that apply to the disposition of VA benefits, or proceeds 
of VA benefits, when a beneficiary dies.

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This subpart would also include related definitions, effective date 
rules, and rate of payment rules.
    ``Subpart H--Special Benefits for Veterans, Dependents, and 
Survivors'' would pertain to ancillary and special benefits available, 
including benefits for children with various birth defects.
    ``Subpart I--Benefits For Certain Filipino Veterans and Survivors'' 
would pertain to the various benefits available to Filipino veterans.
    ``Subpart J--Burial Benefits'' would pertain to burial allowances.
    ``Subpart K--Matters Affecting Receipt of Benefits'' would contain 
those provisions regarding determinations of willful misconduct, 
competency, and insanity, which may affect claimants' entitlement to 
benefits. This subpart would also contain information about forfeiture 
and renouncement of benefits.
    ``Subpart L--Payments and Adjustments to Payments'' would include 
general rate-setting rules, several adjustment and resumption 
regulations, and election-of-benefit rules.
    The final subpart, ``Subpart M--Apportionments and Payments to 
Fiduciaries or Incarcerated Beneficiaries'' would include regulations 
governing apportionments, benefits for incarcerated beneficiaries, and 
guardianship.
    Some of the regulations in this NPRM cross-reference other 
compensation and pension regulations. If those regulations have been 
published in this or earlier NPRMs, we cite the proposed part 5 
section. We also cite the Federal Register page where a proposed part 5 
section published in an earlier NPRM may be found. However, where a 
regulation proposed in this NPRM would cross-reference a proposed part 
5 regulation that has not yet been published, we cite to the current 
part 3 regulation that deals with the same subject matter. The current 
part 3 section we cite may differ from its eventual part 5 replacement 
in some respects, but we believe this method will assist readers in 
understanding these proposed regulations where no part 5 replacement 
has yet been published. If there is no part 3 counterpart to a proposed 
part 5 regulation that has not yet been published, we have inserted 
``[regulation that will be published in a future Notice of Proposed 
Rulemaking]'' where the part 5 regulation citation would be placed.
    In connection with this rulemaking, VA will accept comments 
relating to a prior rulemaking issued as a part of the Project, if the 
matter being commented on relates to both NPRMs. VA will provide a 
separate opportunity for public comment on each segment of the proposed 
part 5 regulations before adopting a final version of part 5.

Overview of Proposed Subpart E Organization

    This NPRM pertains to those regulations governing presumptions of 
service connection for certain disabilities, and related matters or 
conditions. These regulations would be contained in proposed subpart E 
of new 38 CFR part 5. While these regulations have been substantially 
restructured and rewritten for greater clarity and ease of use, most of 
the basic concepts contained in these proposed regulations are the same 
as in their existing counterparts in 38 CFR part 3. However, a few 
substantive changes are proposed.
    In 38 U.S.C. 1112, 1116, 1117, 1118, and 1133, Congress established 
presumptions that certain diseases or disabilities are service 
connected under the circumstances described in those statutes. The 
diseases fall into the following categories: Chronic diseases; diseases 
associated with exposure to certain herbicide agents; diseases specific 
to former prisoners of war; tropical diseases; diseases associated with 
exposure to ionizing radiation; and certain disabilities or undiagnosed 
illnesses associated with service during the Gulf War. Although 
Congress has established other statutory presumptions, such as the 
presumption of sound condition stated in 38 U.S.C. 1111, this notice 
does not affect the regulations implementing those other statutory 
presumptions. When we refer to presumptions in this notice we are 
referring to the presumptions of service connection for specific types 
of diseases or illnesses stated in 38 U.S.C. 1112, 1116, 1117, 1118, 
and 1133. We are also referring to the presumption of service 
connection associated with full-body exposure to nitrogen mustard, 
sulfur mustard, or Lewisite, in 38 CFR 3.316.
    In most situations, Congress limited the applicability of the 
presumptions by the provisions of 38 U.S.C. 1113, which states that the 
presumptions are rebuttable ``[w]here there is affirmative evidence to 
the contrary, or evidence to establish that an intercurrent injury or 
disease which is a recognized cause of any of the diseases or 
disabilities * * * has been suffered between the date of separation 
from service and the onset of any such diseases or disabilities, or the 
disability is due to the veteran's own willful misconduct * * *''
    The regulations implementing the statutory presumptions and the 
limitations presented by 38 U.S.C. 1113 are scattered throughout part 3 
of title 38, United States Code of Federal Regulations. All of the 
paragraphs of the initial implementing regulation, 38 CFR 3.307, 
contain general principles that apply to all of the presumptions of 
service connection, as well as specific rules that apply only to 
particular presumptions. For example, current Sec.  3.307(a) sets forth 
general rules but its subparagraphs contain specific rules that apply 
only to particular presumptions, such as the rules in Sec.  
3.307(a)(3)-(6) that each apply, in turn, to the presumption of service 
connection for chronic, tropical, and prisoner-of-war-related diseases 
or disabilities, and diseases or disabilities associated with exposure 
to certain herbicide agents. There are also presumption-specific rules 
included in other parts of Sec.  3.307. For example, Sec.  3.307(b) 
states the conditions under which VA considers certain diseases to be 
chronic diseases. On the other hand, current Sec.  3.309 consists of 
five paragraphs, each of which articulates specific rules that govern 
grants of service connection based on a specific presumption.
    Other rules that apply to grants of presumptive service connection 
are contained in Sec. Sec.  3.303 (principles relating to service 
connection), 3.308 (presumptive service connection; peacetime service 
before January 1, 1947), 3.316 (claims based on exposure to mustard gas 
and other agents), 3.317 (compensation for certain disabilities due to 
undiagnosed illness), and 3.379 (anterior poliomyelitis).
    We propose to establish a general rule, which would include the 
rules that are applicable to all presumptions, followed by several 
rules that would each contain the current rules specific to certain 
presumptions. We propose to codify these regulations in part 5 of title 
38, Code of Federal Regulations, at Sec. Sec.  5.260 through 5.269. 
Most of the basic concepts contained in these proposed regulations are 
the same as in their existing counterparts in 38 CFR part 3.

Table Comparing Current Part 3 Rules With Proposed Part 5 Rules

    The following table shows the correspondence between the current 
regulations in part 3 and those proposed or redesignated regulations 
contained in this NPRM:

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                                                    Based in whole or in part on 38 CFR part 3 section or paragraph (or, if not based on any current
     Proposed part 5 section or paragraph                                               provision, then ``New'')
--------------------------------------------------------------------------------------------------------------------------------------------------------
5.260(a)......................................  New.
5.260(b)......................................  3.307(b)-(c).
5.260(c)......................................  3.307(d); 3.309(a)-(e); 3.316(b); 3.317(c).
5.261(a)......................................  3.307(a), (a)(3).
5.261(b)......................................  3.307(a)(1), (2).
5.261(c)......................................  3.307(a)(2).
5.261(d)......................................  3.303(b); 3.307(a)(3), (b), (c).
5.261(d) (table)..............................  3.309(a).
5.261(e)......................................  3.309(a).
5.261(f)......................................  New.
5.262(a)(1)...................................  3.307(a)(6)(iii).
5.262(a)(2)...................................  3.307(a)(6)(ii).
5.262(b)......................................  3.307(a)(6)(i).
5.262(c)......................................  3.307(a)(1).
5.262(d)......................................  3.307(a)(6)(iii).
5.262(e)......................................  3.307(a)(6)(ii); 3.309(e).
5.262(e) Note 1...............................  3.309(e) Note 2.
5.262(e) Note 2...............................  3.309(e) Note 1.
5.263.........................................  3.313.
5.264(a)......................................  3.307(a)(1) (third sentence).
5.264(a)......................................  3.1(y); 3.307(a)(5); 3.309(c).
5.264(c)......................................  3.309(c).
5.265(a)......................................  3.307(a)(4), 3.308(b), 3.309(b).
5.265(b)......................................  3.307(a)(1).
5.265(c)......................................  3.307(a)(2).
5.265(d)......................................  3.309(b).
5.265(e)......................................  3.307(d)(1).
5.265(f)......................................  3.308(b).
5.266.........................................  3.317 (redesignated as described at the end of this rulemaking).
5.267.........................................  3.316 (redesignated as described at the end of this rulemaking).
5.268(a)......................................  3.309 (d)(3)(i).
5.268(b)......................................  3.309(d)(1)-(2).
5.268(c)......................................  3.309(d)(3)(ii), (iv), (vi), (vii).
5.268(d)......................................  3.309(d)(3)(iii).
5.268(e)......................................  3.309(d)(3)(v).
5.268 Note....................................  New (cross reference).
5.269(a)......................................  3.311(a)(1)(b)(1).
5.269(b) (introductory text)..................  3.311(b)(2).
5.269(b)(1)...................................  3.311(b)(2), (5).
5.269(b)(2)...................................  3.311(b)(3).
5.269(b)(3)...................................  3.311(b)(4).
5.269(c)(1)...................................  3.311(a)(1), (2).
5.269(c)(2)...................................  3.311(a)(1) (last sentence).
5.269(c)(3)...................................  3.311(a)(4)(ii).
5.269(c)(4)...................................  3.311(a)(4)(i).
5.269(c)(5)...................................  3.311(b)(1).
5.269(d)(1)...................................  3.311(a)(2)(iii), (c).
5.269(d)(2)...................................  3.311(a)(3).
5.269(e)(1)-(3)...............................  3.311(c).
5.269(e)(4)...................................  3.311(c)(2), (d).
5.269(e)(5)-(6)...............................  3.311(d)(3).
5.269(f)......................................  3.311(f).
5.269(g)......................................  3.311(g).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Readers who use this table to compare existing regulatory 
provisions with the proposed provisions, and who observe a substantive 
difference between them, should consult the text that appears later in 
this document for an explanation of significant changes in each 
regulation. Not every paragraph of every current part 3 section 
affected by these proposed regulations is accounted for in the table. 
In some instances other portions of the part 3 sections that are 
contained in these proposed regulations appear in subparts of part 5 
that will be published for public comment at a later time. For example, 
a reader might find a reference to paragraph (a) of a part 3 section in 
the table, but no reference to paragraph (b) of that section because 
paragraph (b) will be addressed in a future NPRM. The table also does 
not include material from the current sections that will be removed 
from part 3 and not carried forward to part 5. A listing of material VA 
proposes to remove from part 3 appears later in this document.

Content of Proposed Rules

Presumptions of Service Connection for Certain Disabilities, and 
Related Matters

Section 5.260 General Rules and Definitions
    Current 38 CFR 3.307 sets forth general rules that govern most 
adjudications of service connection based on presumptions established 
by 38 U.S.C. 1112 and 1116. Proposed Sec.  5.260 contains those general 
rules, as described in the paragraphs that follow. We propose to move 
rules in current Sec.  3.307 that are specific to particular

[[Page 44618]]

presumptions to the proposed rules that govern those particular 
presumptions.
    Proposed paragraph (a) of Sec.  5.260 would define how a 
``presumption of service connection'' operates for the purposes of the 
rules contained in this notice, as follows:

    A presumption of service connection establishes a material fact 
(or facts) necessary to establish service connection, even when 
there is no evidence that directly establishes that material fact 
(or facts). Examples of material facts include whether a disease or 
disability had its onset during a veteran's military service, or 
whether a veteran was exposed to certain herbicide agents during 
such service. The evidence must prove that the presumption applies 
to the claimant, but after such a showing there is no need for 
additional evidence of the material fact(s) established by the 
presumption.

    We believe that the proposed language reflects the intent of 
Congress and the historical application of presumptions in VA 
regulations and case law. For example, 38 U.S.C. 1112(a) states that a 
presumption establishes that a particular disease ``shall be considered 
to have been incurred in or aggravated by * * * service, 
notwithstanding that there is no record of evidence of such disease 
during the period of service.'' Our current rule, Sec.  3.303(a), 
recognizes that proof of the ``factors'' of service connection 
described by the regulation ``may be accomplished * * * through the 
application of statutory presumptions.'' Both of these descriptions 
discuss presumptions in terms of their effect on the burden of 
producing evidence. These descriptions are in accord with the seminal 
decision by the United States Court of Appeals for the Federal Circuit 
on the subject, which defined a presumption as follows: ``The 
presumption affords a party, for whose benefit the presumption runs, 
the luxury of not having to produce specific evidence to establish the 
point at issue. When the predicate evidence is established that 
triggers the presumption, the further evidentiary gap is filled by the 
presumption.'' Routen v. West, 142 F.3d 1434, 1440 (Fed. Cir. 1998).
    Proposed paragraph (b) clarifies the current requirement that 
certain presumptive diseases that must become manifest within a 
specific period need not be diagnosed within that period. We propose to 
clarify the following language from current Sec.  3.307(c), which 
states: ``This will not be interpreted as requiring that the disease be 
diagnosed in the presumptive period, but only that there be then shown 
by acceptable medical or lay evidence characteristic manifestations of 
the disease to the required degree, followed without unreasonable time 
lapse by definite diagnosis.'' 38 CFR 3.307(c) (emphasis added). The 
emphasized language must be considered in connection with the rule in 
current Sec.  3.307(b) that requires VA to consider ``[t]he chronicity 
and continuity factors outlined in Sec.  3.303(b)'' as evidence in 
support of a claim for presumptive service connection for a disease. In 
the context of presumptions, evidence of continuity of symptoms may be 
used to relate symptoms that manifested during a presumptive period to 
a current diagnosis made after that presumptive period ended. Section 
3.307(b) is helpful to veterans who had symptoms that manifested during 
a presumptive period but did not obtain a diagnosis within that 
presumptive period.
    A presumption relieves the party benefiting from the presumption of 
the obligation to prove the presumed facts. See Routen v. West, 142 
F.3d 1434, 1439 (Fed. Cir. 1998). For example, 38 CFR 3.309, ``Diseases 
subject to presumptive service connection,'' contains a list of 
diseases and disabilities for which incurrence or aggravation during 
service is presumed, so long as certain conditions are met. See also 38 
CFR 3.307, ``Presumptive service connection for chronic, tropical or 
prisoner-of-war related disease, or disease associated with exposure to 
certain herbicide agents; wartime and service on or after January 1, 
1947.'' Some regulations include presumptions that benefit the 
claimant, such as Sec. Sec.  3.307 and 3.309. Other regulations include 
presumptions that may have an adverse impact on a claimant such as 38 
CFR 3.23(d)(6), which presumes that a child's income is ``reasonably 
available'' to a veteran or a surviving spouse if certain other facts 
are shown. In such cases, the child's income would be included for 
purposes of determining whether a veteran or surviving spouse met the 
income limits for entitlement to Improved pension.
    In 38 U.S.C. 1113, ``Presumptions rebuttable,'' Congress has 
established that presumptions of service connection for certain 
disabilities may be rebutted by ``affirmative evidence'' to the 
contrary or evidence of an intercurrent disease or injury capable of 
causing the veteran's disability. The phrase ``affirmative evidence'' 
does not correspond to any of the three generally recognized standards 
of proof--i.e., the ``preponderance of the evidence'' standard, the 
``clear and convincing evidence'' standard, or the ``beyond a 
reasonable doubt'' standard. See Addington v. Texas, 441 U.S. 418, 423-
24 (1979), Gilbert v. Derwinski, 1 Vet. App. 49, 53-54 (1990). The term 
``affirmative'' is commonly defined to mean ``asserting the truth or 
validity of a statement'' or ``declaratory of what exists.'' Webster's 
Third New Int'l Dictionary 36 (1979). Accordingly, the term 
``affirmative evidence'' clearly requires evidence supporting the facts 
to be proven, but implies no particular standard of proof to specify 
how convincing the evidence must be.
    Neither the statutes nor current VA regulations state what the 
standard of proof for rebuttal will be in such cases. Pursuant to his 
general authority under 38 U.S.C. 501(a), to establish regulations 
``necessary or appropriate to carry out the laws administered by the 
Department,'' the Secretary will, as part of this rewrite project, 
propose a regulation to establish and explain a general standard of 
proof for rebutting presumptions of service connection. This new 
provision will be published in a separate NPRM. We believe that the 
addition of this new provision to fill this gap will provide helpful 
guidance to claimants and VA adjudicators.
    Additionally, section 1113 is implemented in current Sec. Sec.  
3.307(d), 3.309(a)-(c), (e), 3.316(b), which describe what evidence may 
be used to rebut presumptions related to incurrence or aggravation, 
i.e., (1) affirmative evidence to the contrary; (2) evidence of 
intercurrent (intervening) injury or disease which is a recognized 
cause of the disease or disability; and (3) evidence the disability is 
due to the veteran's own willful misconduct. We believe it is not 
helpful to have the criteria stated in multiple rules, especially 
because the criteria are stated slightly differently in each rule, 
which may lead users of the rules to conclude, mistakenly, that a 
different substantive rule applies in each situation. In order to 
clarify that one set of general rules on rebutting presumptions applies 
in all cases (except where specifically provided otherwise), we propose 
to place all of the generally applicable rebuttal rules in Sec.  
5.260(c), and therefore not to republish the general language in 
current Sec. Sec.  3.307(d), 3.309(a)-(c), (e), or 3.316(b).
    The presumption that a cancer was caused by exposure to ionizing 
radiation or herbicide agents (see 38 U.S.C. 1112(c) and 1116) may be 
rebutted by evidence that the cancer developed as a result of 
metastasis of a cancer which is not associated with exposure to 
ionizing radiation or herbicide agents. (See VA General Counsel Opinion 
VAOPGCPREC 18-97). We have therefore added Language to explain that if 
evidence establishes that a cancer (for which service connection is 
claimed under Sec.  5.262 or Sec.  5.268) originated in

[[Page 44619]]

another area of the body and then spread to one of the specific areas 
listed in Sec.  5.262(e) or Sec.  5.268(b), then the presumption of 
service connection will be rebutted.
    The proposed rules would not use the phrase ``affirmative 
evidence,'' which appears in 38 U.S.C. 1113 and current regulations. As 
stated above, we intend to adopt a generally applicable rebuttal 
standard of proof in a separate NPRM, which will apply to matters 
governed by section 1113. We believe that retaining the term 
``affirmative evidence'' may cause unnecessary confusion as to whether 
it implies a different standard that may be less favorable to 
claimants. Further, inasmuch as the term ``affirmative evidence'' does 
not clearly impose any requirement other than that the evidence tend to 
prove a fact, we believe it is unnecessary to use the term. We believe 
that evidence sufficient to meet the generally applicable rebuttal 
standard we intend to propose will necessarily be affirmative of the 
relevant fact.
    We propose not to include in Sec.  5.260 the current regulatory 
requirement of 38 CFR 3.307(d) that ``medical judgment will be 
exercised in making determinations relative to the effect of 
intercurrent injury or disease.'' We believe that this language could 
be read to imply that a VA employee making an adjudicative decision in 
such a case would use his or her own medical judgment. This would be a 
violation of the holding by the U.S. Court of Appeals for Veterans 
Claims in Colvin v. Derwinski, 1 Vet. App. 171, 172 (Vet. App. 1991), 
overruled in part on other grounds, Hodge v. West, 155 F3d 1356, 1360 
(Fed. Cir. 1998), that in making decisions, VA must consider only 
``medical evidence to support [its] findings rather than provide [its] 
own medical judgment.'' Moreover, we believe the language in Sec.  
3.307(d) quoted above is now unnecessary in light of the fact that 
cases described by Sec.  5.260(c) are subject to VA's duty to assist 
requirements. These are reflected in 38 U.S.C. 5103A(d) and 38 CFR 
3.159(c)(4), which states, in pertinent part, ``In a claim for 
disability compensation, VA will provide a medical examination or 
obtain a medical opinion based upon a review of the evidence of record 
if VA determines it is necessary to decide the claim.''
    The proposed regulation pertaining to presumptions of service 
connection for certain tropical diseases, Sec.  5.265, incorporates the 
material in current Sec.  3.307(d) on rebutting these presumptions. The 
material is not in the proposed general regulation, Sec.  5.260, 
because the material is specific to the tropical-disease presumptions.
    The statutory authority for the current 38 CFR 3.307(a), (c), and 
(d), as well as the proposed rule, is 38 U.S.C. 501(a), 1112, and 1113. 
We propose to add 38 U.S.C. 1137 as the statutory authority enabling VA 
to extend the presumptions to persons with peacetime service after 
December 31, 1946.
Section 5.261 Certain Chronic Diseases VA Presumes Are Service 
Connected
    Currently, Sec. Sec.  3.303(b), 3.307(a), 3.308(a), and 3.309(a) 
all contain rules that are specific to service connection for chronic 
diseases on a presumptive basis. VA proposes to consolidate these 
provisions into one new regulation, designated as Sec.  5.261. The 
proposed regulation would neither enlarge nor diminish the existing 
rules.
    Proposed Sec.  5.261(a) restates the presumption of service 
connection for chronic diseases set forth in current Sec. Sec.  
3.307(a) and (a)(3). Proposed Sec.  5.261(a) states that VA will 
presume service connection for a disease listed in paragraph (d) of 
this section, although not otherwise established as incurred or 
aggravated in service, if it first became manifest to a degree of 10 
percent or more within a year of separation from a qualifying period of 
service or within such other time as provided in paragraph (d) of this 
section, called the presumptive period.
    Proposed paragraphs (b) and (c) restate the identification of 
qualifying periods of service and the presumptive period set forth in 
current Sec.  3.307(a)(1) and (a)(2). Current Sec.  3.307(a)(2) states 
that for certain veterans, their date of separation will be the end of 
the wartime period in which they served. We believe it is important to 
note that this provision only applies to veterans who had a combination 
of wartime and peacetime service prior to World War II. We have 
therefore proposed to clarify that this rule applies only to ``claims 
based on service ending before December 7, 1941.''
    Proposed Sec.  5.261(d) lists what diseases are chronic for the 
purposes of the presumption of service connection. Although there is no 
statutory or regulatory definition of a chronic disease, section 
1101(3) of title 38, U.S. Code, provides a list of diseases that 
Congress has determined to be chronic for the purposes of granting 
presumptive service connection. Current Sec.  3.307(b) states ``The 
diseases listed in Sec.  3.309(a) will be accepted as chronic, even 
though diagnosed as acute because of insidious inception and chronic 
development * * * unless the clinical picture is clear otherwise, 
consideration will be given as to whether an acute condition is an 
exacerbation of a chronic disease.'' Proposed paragraph (d) restates 
this concept, but substitutes the phrase ``slow onset and persistent 
progress'' for the phrase ``insidious inception and chronic 
development.'' We believe these words better explain the nature and 
character of the diseases listed in 38 U.S.C. 1101(3) and 1112(a)(1). 
We also propose to delete the examples of disabilities which might 
result from ``intercurrent causes'' because we believe they are not 
very helpful to the understanding of the concept.
    The introductory text to proposed paragraph (d) states that ``VA 
will not apply the presumption of service connection where there is 
evidence that the disease preceded service to a degree of 10 percent or 
more. However, VA will apply the presumption where there is evidence 
that the disease preceded service to a degree of less than 10 
percent.'' This language is new and conforms to section 1112(a) of 
title 38, U.S. Code, and codifies the holding of the U.S. Court of 
Appeals for the Federal Circuit in Splane v. West, 216 F.3d 1058, 1069 
(Fed. Cir. 2000).
    Proposed paragraph (d) lists the diseases that currently appear in 
Sec.  3.309(a), with the changes described below. We propose to 
alphabetize the listed diseases in a chart designating the appropriate 
presumptive period for each disease. Some additional explanatory 
material concerning cardiovascular-renal disease has been moved to a 
separate paragraph designated (e). We propose to add the terms ``acute 
or chronic'' in a parenthetical to modify ``Leukemia.'' In doing so, we 
are able to remove the sixth sentence of current Sec.  3.307(b), which 
is redundant of the parenthetical language.
    Current Sec.  3.309(a) contains the following parenthetical 
explanation regarding ``Ulcers, peptic (gastric or duodenal''):

    (A proper diagnosis of gastric or duodenal ulcer (peptic ulcer) 
is to be considered established if it represents a medically sound 
interpretation of sufficient clinical findings warranting such 
diagnosis and provides an adequate basis for a differential 
diagnosis from other conditions with like symptomatology; in short, 
where the preponderance of evidence indicates gastric or duodenal 
ulcer (peptic ulcer). Whenever possible, of course, laboratory 
findings should be used in corroboration of the clinical data.

    We believe that the principles stated in this parenthetical apply 
equally to any evidence of a diagnosis, not just a diagnosis of an 
ulcer. The current parenthetical might cause confusion by

[[Page 44620]]

leading readers to believe that these principles apply only regarding 
ulcers, and we therefore propose to remove this language.
    Proposed paragraph (f) restates the holding of VA General Counsel 
Precedent Opinion 1-90 (Mar. 16, 1990), that service connection is 
available for hereditary or familial diseases listed in proposed 
paragraph (b) if the disease first manifested to a degree of 10 percent 
or more within the applicable presumptive period following discharge or 
release from service, subject to the rebuttable presumption provisions 
of Sec.  3.307(d).
    The statutory authority for this section is 38 U.S.C. 501 and 
1101(3), which lists chronic diseases; 38 U.S.C. 1112(a)(1), which 
establishes the presumption of service connection for chronic diseases; 
and 38 U.S.C. 1137, which governs presumptions for peacetime veterans.
Section 5.262 Presumption of Service Connection for Diseases Associated 
With Exposure to Certain Herbicide Agents
    Proposed Sec.  5.262 contains the rules established by 38 U.S.C. 
1116 and subject to 38 U.S.C. 1113 relating to the presumption of 
service connection for certain diseases associated with exposure to 
certain herbicide agents.
    Current Sec.  3.307(a)(6)(iii) states, in pertinent part: ``Service 
in the Republic of Vietnam'' includes service in the waters offshore 
and service in other locations if the conditions of service involved 
duty or visitation in the Republic of Vietnam.'' The current rule is 
based on 38 U.S.C. 1116(f), which requires that a veteran have served 
``in the Republic of Vietnam'' to be eligible for the presumption of 
exposure to herbicides. As stated in the preamble to the final rule on 
Type 2 diabetes (66 FR 23166, May 8, 2001) in interpreting similar 
language in 38 U.S.C. 101(29)(A), VA's General Counsel has concluded 
that service aboard a deep-water vessel in waters offshore the Republic 
of Vietnam does not constitute service ``in the Republic of Vietnam.'' 
(See VAOPGCPREC 27-97). VA's regulatory definition of ``Service in the 
Republic of Vietnam'' predates the enactment of what is now section 
1116(f) (see former 38 CFR 3.311a(a)(1) (1990)), and we find no basis 
to conclude that Congress intended to broaden that definition.
    We are not aware of any valid scientific evidence showing that 
individuals who served in the waters offshore of the Republic of 
Vietnam or in other locations were subject to the same risk of 
herbicide exposure as those who served within the geographic land 
boundaries of the Republic of Vietnam. Furthermore, we are not aware of 
any legislative history suggesting that offshore service or service in 
other locations are within the meaning of the statutory phrase, 
``Service in the Republic of Vietnam.''
    Based on the foregoing, proposed Sec.  5.262(a)(1) would more 
clearly state the limits of the presumption of exposure and the 
presumption of service connection based on exposure to certain 
herbicide agents. We propose to revise this language to make it clear 
that veterans who served in waters offshore but did not enter Vietnam, 
either on its land mass or in its inland waterways cannot benefit from 
this presumption. It would state: ``For purposes of this section, 
`Service in the Republic of Vietnam' does not include service in the 
waters offshore or service in other locations, but does include any 
service in which the veteran had duty in or visited in the Republic of 
Vietnam.''
    It has previously been suggested that VA should define ``Service in 
the Republic of Vietnam'' to include service in inland waterways, 
because veterans who served there were sometimes exposed to herbicides. 
(See Disease Associated With Exposure to Certain Herbicide Agents: Type 
2 Diabetes (final rule at 66 FR 23166, May 8, 2001)). We agree that 
veterans who served in the inland waterways may have been exposed to 
herbicides (see ``Characterizing Exposure of Veterans to Agent Orange 
and Other Herbicides Used in Vietnam: Final Report'', page 1 (2003, 
National Academies Press)). Further, we believe that service on inland 
waterways constitutes service in the Republic of Vietnam within the 
meaning of 38 U.S.C. 1116(f), and believe it would be helpful to 
clarify that in our regulations. We therefore propose to include such a 
provision in proposed paragraph (a)(1) that would state: ``* * * which 
includes service on the inland waterways.''
    Proposed paragraph (b) is derived from current Sec.  
3.307(a)(6)(i), except that we propose not to include the following 
phrase from that rule: ``* * * in support of the United States and 
allied military operations in the Republic of Vietnam during the period 
beginning on January 9, 1962, and ending on May 7, 1975.'' We believe 
that that language is unnecessary, because the regulation specifies 
which agents are considered herbicide agents.
    We have also added text to implement Splane v. West, 216 F.3d 1058 
(Fed. Cir. 2000), in which the Federal Circuit interpreted the 
following language from 38 U.S.C. 1112(a):

    [M]ultiple sclerosis developing a 10 percent degree of 
disability or more within seven years from the date of separation 
from such service * * * shall be considered to have been incurred in 
or aggravated by such service, notwithstanding there is no record of 
evidence of such disease during the period of service.

    The Federal Circuit held that the words ``or aggravated by'' 
indicate that Congress meant section 1112(a) to apply to those 
situations where multiple sclerosis predated entry into the service and 
became disabling to a compensable degree within the presumptive period 
following service. The ``or aggravated by'' language also appears in 38 
U.S.C. 1116(a)(1)(B), which provides the authority for the presumptions 
based on herbicide exposure. Therefore, we propose to add language to 
clarify that presumptions may apply to a listed disease that preexisted 
service but first became manifest to a degree of 10 percent or more 
within the presumptive period following service. We note that if the 
condition preexisted service to a degree of 10 percent, for example, 
and after service the condition was 20 percent disabling, the veteran 
may be able to establish service connection using the presumption of 
aggravation in 38 U.S.C. 1153.
Section 5.263 Presumption of Service Connection for Non-Hodgkin's 
Lymphoma Based on Service in Vietnam
    Proposed Sec.  5.263 is based on current Sec.  3.313, ``Claims 
based on service in Vietnam.'' The only change we propose is the 
addition of the phrase, ``For purposes of this section,'' at the 
beginning of paragraph (a). We believe this change will help clarify to 
readers that the definition of service in Vietnam in this rule is 
distinct from the definition of service in the Republic of Vietnam in 
current Sec.  3.307(a)(6)(iii) and proposed Sec.  5.262(a)(1).
Section 5.264 Diseases VA Presumes Are Service Connected in Former 
Prisoners of War
    Proposed Sec.  5.264 restates current Sec. Sec.  3.307(a)(5) and 
3.309(c) pertaining to presumptive service connection for diseases 
specific to former prisoners of war.
    Prior to December 16, 2003, 38 U.S.C. 1112(b) provided that ``a 
veteran who is a former prisoner of war and who was detained or 
interned for not less than thirty days'' was entitled to a rebuttable 
presumption of service connection for certain diseases that became 
manifest to a degree of 10 percent or more after service. The statute 
listed 15 disabilities that qualified for that presumption.

[[Page 44621]]

VA's current implementing regulation, 38 CFR 3.309(c), incorporates the 
requirement for 30 days of detention or internment in order to qualify 
for the presumption of service connection for any of the listed 
diseases.
    Section 201 of the Veterans Benefits Act of 2003, Pub. L. 108-183, 
117 Stat. 2651 (Dec. 16, 2003), amended 38 U.S.C. 1112(b) to eliminate 
the 30-day requirement for psychosis, any anxiety states, dysthymic 
disorders, organic residuals of frostbite and post-traumatic arthritis. 
Section 201 of the Act also codifies cirrhosis of the liver as a 
disability which is presumptively service connected for a former POW 
who was interned for at least 30 days. (On July 18, 2003, VA published 
a final regulation adding cirrhosis of the liver to the list of 
conditions presumptively service connected for former POWs. (68 FR 
42602)) We propose to incorporate these statutory amendments in Sec.  
5.264.
    In addition, we propose to amend the phrase ``any of the anxiety 
states'' on the list of diseases presumed to be service connected under 
this section to specify that any mental disorder classified as an 
anxiety disorder by 38 CFR 4.130, the rating schedule for mental 
disorders, including post-traumatic stress disorder, will be presumed 
service connected. As amended, proposed paragraph (b) would include 
``[a]ny of the anxiety disorders, as listed in Sec.  4.130, including 
post-traumatic stress disorder.''
5.265 Tropical Diseases VA Presumes Are Service Connected
    Proposed Sec.  5.265 restates current Sec. Sec.  3.307(a)(2), 
(a)(4), (d)(1), 3.308(b), and 3.309(b) pertaining to presumptive 
service connection for tropical diseases. Current Sec.  3.307(a)(2) 
states that for certain veterans, their date of separation will be the 
end of the wartime period in which they served. We believe it is 
important to note that this provision only applies to veterans who had 
a combination of wartime and peacetime service prior to World War II. 
We have therefore proposed to clarify that this rule applies only to 
``claims based on service ending before December 7, 1941.''
    Proposed paragraph (e) would include the material in the last two 
sentences of current Sec.  3.307(d)(1) specifically regarding the 
rebuttal of the tropical-disease presumption.
    We propose to insert the word ``presumptive'' before the word 
``period'' in the first of these sentences, to clarify the period to 
which the regulation refers. The statutory authority for paragraphs 
(a)-(d) is 38 U.S.C. 1101(4), which lists tropical diseases, and 38 
U.S.C. 1112(a)(2), which establishes the presumption of service 
connection for a tropical disease.
Section 5.266 Compensation for Certain Disabilities Due to Undiagnosed 
Illnesses
    We propose to redesignate without substantive change current Sec.  
3.317 relating to compensation for certain disabilities due to 
undiagnosed illnesses as Sec.  5.266.
    We propose to make the following nonsubstantive changes to the 
provisions redesignated as Sec.  5.266. First, we propose to replace 
the term ``active military, naval, and air service,'' as used 
throughout the regulation, with the shorter term ``active military 
service.'' As part of the Regulations Rewrite Project, we have proposed 
regulations defining ``active military service'' to include qualifying 
duty in any of the Armed Forces. See 69 FR 4820. This will eliminate 
the need to repeat the cumbersome phrase ``active military, naval, or 
air service'' throughout the regulations in part 5 of title 38 of the 
CFR. Second, we propose to remove the adjective ``affirmative'' as used 
in the provisions of current Sec.  3.317(c)(1)-(3) to describe the 
evidence that may defeat a claim for benefits for certain undiagnosed 
illnesses. As explained in the portion of this notice discussing 
proposed Sec.  5.260(c), we believe that term is unnecessary and may 
improperly imply that evidence need only be ``affirmative'' in order to 
bar a claim for benefits under this section. As stated in this notice, 
VA will propose separate regulations specifying the standard of proof 
evidence must meet in order to justify the denial of a claim for 
benefits. Third, we propose to rearrange alphabetically the list of 
signs or symptoms in current Sec.  3.317(b), to make it easier to 
locate each item.
    Currently, Sec.  3.500(y) specifies the effective date for a 
reduction or discontinuance of compensation for certain disabilities 
due to undiagnosed illnesses. Because this provision is simply a 
restatement of the general effective date rule for reductions and 
discontinuances (as found in 38 U.S.C. 5112 and 38 CFR 3.500(a)), this 
might cause a reader to mistakenly believe that the rule in Sec.  
3.500(y) somehow differs from the general rule. To avoid this 
confusion, we propose to remove Sec.  3.500(y).
Section 5.267 Presumption of Service Connection for Conditions 
Associated With Full-Body Exposure to Nitrogen Mustard, Sulfur Mustard, 
or Lewisite
    Proposed Sec.  5.267 would reorganize and clarify the current 
presumption of service connection for conditions associated with full-
body exposure to nitrogen mustard, sulfur mustard, or Lewisite. We 
propose to change the title of the regulation to specify the mustard 
agents to which it is applicable.
    The general rules on rebuttal of the presumption of service 
connection contained in Sec.  3.316(b), would not be contained in Sec.  
5.267 because such rules are set forth in proposed Sec.  5.260, as 
discussed above.
    Currently, there is no statutory authority listed for Sec.  3.316. 
The Secretary determined in 1992, when this regulation was first 
proposed by VA, that special circumstances surrounding the World War II 
programs in which these mustard agents were tested placed veterans who 
participated in the tests at a disadvantage when attempting to 
establish service connection based on exposure to these agents. 57 FR 
1699 (1992). Consistent with the authority of 38 U.S.C. 501(a), the 
Secretary of Veterans Affairs created a presumption of service 
connection for veterans exposed to certain mustard agents who 
contracted specified diseases. We therefore propose to add 38 U.S.C. 
501(a), establishing VA's general authority to establish rules and 
regulations to implement the law, as the authority citation for this 
regulation.

Service Connection for Diseases Due to Exposure to Ionizing Radiation

    Current Sec. Sec.  3.309(d) and 3.311 contain the rules for 
adjudicating claims based on exposure to ionizing radiation in service. 
We propose in Sec. Sec.  5.268 and 5.269 to rewrite and reorganize 
those existing rules in order to improve their clarity and to organize 
them in a way that will make them easier for claimants to understand 
and for VA to implement.
    Under the provisions of current Sec.  3.309(d), a presumption of 
service connection arises when the evidence establishes that a veteran 
participated in a radiation-risk activity, as defined in the 
regulation, and either has one of the diseases listed in that 
regulation, or died as a result of one of them. If these criteria are 
not met in a particular case, VA then considers the claim under the 
alternate provisions in current Sec.  3.311 to determine if service 
connection can be granted.
    The alternative method in current Sec.  3.311 consists of an 
extensive evidentiary-development process, including reviews by the 
Under Secretary for Benefits (USB) and the Under Secretary for Health 
(USH), or their representatives. Furthermore, Sec.  3.311(b)(2) 
contains a list of radiogenic diseases applicable to adjudications 
under that provision, and Sec.  3.311(b)(5) contains specific time-
frames in which

[[Page 44622]]

those diseases must have manifested. Some of the diseases on this list 
are also on the list in Sec.  3.309(d). However, the manifestation 
periods and rules for claims development contained within Sec.  3.311 
are applied only when service connection cannot be presumed under Sec.  
3.309(d).
    Additionally, under current Sec.  3.311(b)(4), VA will consider any 
disease to be a radiogenic disease--regardless of whether it is listed 
in Sec.  3.311--if the claimant has cited or submitted competent 
medical or scientific evidence that the disease is radiogenic. Again, 
this provision is independent of Sec.  3.309(d) and applies only in 
claims that do not meet the requirements for the presumption of service 
connection under that rule.
    In our view, the current regulatory framework--consisting of two 
regulations with three distinct sets of criteria for establishing 
service connection for a disease claimed to be caused by exposure to 
ionizing radiation `` is difficult for the reader to understand, 
particularly in light of the multiple cross references in the 
regulations. We propose a regulatory framework that clearly 
differentiates between the different methods available for establishing 
service connection.
Section 5.268 Service Connection for Diseases Presumed To Be Due to 
Exposure to Ionizing Radiation
    We propose in Sec.  5.268 to state the rules applicable to the 
presumption of service connection for diseases associated with ionizing 
radiation exposure established under 38 U.S.C. 1112(c).
    Proposed paragraph (a) states the service requirements that are 
unique to claims for service connection for diseases presumptively 
associated with ionizing radiation exposure under this section.
    Proposed paragraphs (c) through (e) contain definitions of terms 
used in this section. We recognize that it is unusual to provide 
separate paragraphs for definitions; however, in this case, the 
definitions do more than simply clarify the meaning of a particular 
term. For example, the definition of ``operational period'' essentially 
sets forth a list of operations to which the presumption applies. 
Currently, these key terms are listed without headings. We believe that 
providing the definitions in separate paragraphs will make it easier to 
locate the definitions of these terms.
    We propose to add guidance in a ``Note'' at the end of Sec.  5.268 
that states: ``If this section does not apply in a particular case, VA 
will consider service connection under Sec.  5.269 of this part.'' We 
believe this guidance will assist readers in determining which rule and 
criteria apply in select circumstances.
Section 5.269 Direct Service Connection for Diseases Associated With 
Exposure to Ionizing Radiation
    Proposed Sec.  5.269 is based on current Sec.  3.311, containing 
the rules for establishing service connection for diseases caused by 
ionizing radiation when the presumption of service connection does not 
apply. Although these regulatory provisions do not pertain to 
establishing a presumption of service connection, we believe that it is 
helpful to place them directly after proposed Sec.  5.268 because VA 
considers the claim under these provisions when it cannot establish 
service connection on a presumptive basis. In order to clarify that 
proposed Sec.  5.269 does not describe a presumption of service 
connection, we propose to have the title of the rule read, ``Direct 
service connection for diseases associated with exposure to ionizing 
radiation.''
    Proposed Sec.  5.269(a) states that this section does not establish 
a presumption of service connection and in paragraphs (a)(1) through 
(3), states the basic elements of a claim adjudicated under current 
Sec.  3.311. If the provisions of paragraphs (a)(1) through (3) are not 
met, then the claim cannot be granted under this section.
    Proposed paragraph (b) lists the diseases recognized as associated 
with exposure to ionizing radiation, and would include the provision in 
current Sec.  3.311(b)(4) permitting claimants to show that a disease 
not listed is nevertheless associated with such exposure based on 
competent scientific or medical evidence that the claimed condition is 
a radiogenic disease.
    Proposed paragraph (c)(1)(iii), based on current Sec.  3.311(a)(2), 
states the types and sources of records which VA will attempt to obtain 
concerning a veteran's exposure to ionizing radiation. We also propose 
to add the following new sentence: ``If neither the Department of 
Defense nor any other source provides VA with records adequate to 
permit the Under Secretary to prepare a dose estimate, then VA will ask 
the Department of Defense to provide a dose estimate.'' This would 
reflect the fact that it is impossible to estimate the likelihood that 
ionizing radiation exposure caused a claimed condition in the absence 
of a numerical ionizing radiation dose estimate and that VA would be 
unable to prepare a dose estimate if it has not received any records on 
which to base such an estimate. Proposed paragraph (c)(1) also 
clarifies, consistent with existing statutes and regulations regarding 
delegations of authority, that as used in this section, ``the Under 
Secretary for Health'' includes his or her designees.
    Proposed paragraph (c)(4) restates current Sec.  3.311(a)(4)(i), 
which states that VA will concede a veteran's presence at a site at 
which exposure to ionizing radiation is claimed to have occurred when 
military records neither confirm presence at nor absence from the 
claimed site. This concession is for the purposes of proposed Sec.  
5.269 only and does not confer entitlement to the presumptive 
provisions of proposed Sec.  5.268.
    Proposed paragraph (c)(5), based on 3.311(b)(1), describes the 
circumstances for forwarding dose data and any other evidence, along 
with the claims folder, to the Under Secretary for Benefits for review. 
The U.S. Court of Appeals for Veterans Claims held in Wandel v. West, 
11 Vet. App. 200, 205 (1998), that referral to the Under Secretary for 
Benefits is not required absent competent evidence that a veteran was 
exposed to radiation. In Wandel, the dose estimate was reported as 
``zero.'' Therefore, we propose to add to the regulation a provision 
that states that the claims file will not be referred by the agency of 
original jurisdiction to the Under Secretary for Benefits for review if 
VA determines that the claimed disability or disease is not radiogenic, 
that the veteran was not exposed to ionizing radiation in service as 
claimed, or if the actual or estimated dose is reported to be zero rem 
gamma.
    Proposed paragraph (d) states the procedures for review by the 
Under Secretary for Benefits. Proposed paragraph (d)(1) states that 
``[t]he Under Secretary for Benefits will review all the evidence of 
record and may request an advisory medical opinion from the appropriate 
office of the Under Secretary for Health as to whether the veteran's 
disease resulted from exposure to ionizing radiation in service.''
    Proposed paragraph (e) restates the process, described in current 
Sec.  3.311(c) and (d), for the Under Secretary for Benefits to review 
ionizing radiation claims and, if necessary, refer the case to an 
outside consultant for an expert opinion on whether veteran's radiation 
exposure caused his disability. Current Sec.  3.311(d)(3) states that, 
``The consultant shall evaluate the claim under the factors specified 
in paragraph (e) of this section and respond in writing, stating 
whether it is either likely, unlikely, or approximately as likely as 
not the veteran's disease resulted from exposure to ionizing radiation 
in service.'' We propose to change this to require the consultant to 
opine whether it is ``likely,

[[Page 44623]]

unlikely, or at least as likely as not * * *'' This will make the 
provision consistent with the terminology in current Sec.  3.311(c)(1) 
and (c)(2) and proposed Sec.  5.269(e)(1) and (e)(4).
    Proposed paragraph (f) restates the content of current Sec.  
3.311(f), which states that decisions under that section will be made 
based on standard principles of adjudication. Because current Sec.  
3.311(f) does not clearly state what entity within VA actually makes 
the determination of service connection under this section, proposed 
paragraph (f) clarifies that the ``agency of original jurisdiction will 
adjudicate the claim.''
    Proposed paragraph (g) restates current Sec.  3.311(g), which 
provides that service connection will not be established if a disease 
is due to the veteran's own willful misconduct, or if evidence 
establishes that a supervening, nonservice-related condition or event 
is more likely the cause of the disease. We propose to also state that 
service connection is barred if the disease is due to the veteran's 
``abuse of alcohol or drugs.'' This information may be relevant to 
readers and makes the regulation consistent with Sec.  5.266.
    The statutory authority for this rule continues to be Pub. L. 98-
542 and 38 U.S.C. 501, the authority for current Sec.  3.311.

Summary and Explanation for Removals

38 CFR 3.379
    Current Sec.  3.379 concerns service connection of the disease 
anterior poliomyelitis. It states:

    If the first manifestations of acute anterior poliomyelitis 
present themselves in a veteran within 35 days of termination of 
active military service, it is probable that the infection occurred 
during service. If they first appear after this period, it is 
probable that the infection was incurred after service.

    We believe the need for Sec.  3.379 is eliminated by the operation 
of proposed Sec.  5.261 relating to the presumption of service 
connection for chronic diseases. Congress identified ``myelitis'' as a 
category of chronic diseases in 38 U.S.C. 1101(3). ``Myelitis'' is part 
of the presumptive service connection provisions under 38 CFR 3.309(a). 
Anterior poliomyelitis, is a subcategory of ``Myelitis''.
    Pursuant to 38 U.S.C. 1112(a)(1), 38 CFR 3.307(a) and Sec.  
3.309(a) provide a presumption of service connection for chronic 
diseases (including myelitis) manifested to a compensable degree within 
one year of separation from service. According to 38 CFR 4.124a, the 
schedule of ratings for neurological conditions and convulsive 
disorders, anterior poliomyelitis manifested as active febrile disease 
warrants a 100 percent rating under Diagnostic Code 8011. Moreover, 
minimum residuals of anterior poliomyelitis warrant a 10 percent rating 
under Diagnostic Code 8011. There is no zero percent rating under 
Diagnostic Code 8011. Therefore, a veteran with any manifestations of 
acute anterior poliomyelitis within the one-year presumptive period 
(whether or not within 35 days of termination of active military 
service), would qualify for the presumption under Sec.  3.309(a). Based 
on the above provisions, we believe that any veteran who would benefit 
from the requirements of current Sec.  3.379 would also meet the 
requirements of current Sec.  3.309(a). Therefore, we propose to remove 
Sec.  3.379.
38 CFR 3.813
    Currently, 38 CFR 3.813 provides for interim benefits for 
disability/death due to chloracne or porphyria cutanea tarda. These 
provisions were established pending a determination as to whether or 
not the conditions were related to herbicide exposure in the Republic 
of Vietnam. Subsequently, these conditions were recognized as related 
to such herbicide exposure and the Secretary revised the list of 
presumptive conditions listed in current Sec.  3.309 to include these 
two conditions. However, as noted in Sec.  3.813(e), interim disability 
benefits were payable only for the period October 1, 1984 through 
September 30, 1986. Because this regulation is no longer pertinent to 
the adjudication of claims, we propose to remove it from part 3.

Endnote Regarding Removals From Part 3

    For the reasons shown in the preceding supplementary information, 
the amendments proposed in this document would, if adopted, result in 
removal of current Sec. Sec.  3.307, 3.308, 3.309, 3.311, 3.316, 3.317, 
3.379, and 3.813. This would be the case because those part 3 sections, 
or portions of sections, would be replaced by new part 5 sections or 
they would be removed entirely. Readers are invited to comment both on 
these part 3 removals and on the proposed new part 5 rules at this 
time.
    NPRMs frequently include formal ``amendatory language'' listing the 
sections, or portions of sections, that would be removed if the 
proposed amendments are adopted. However, we have not included such 
``amendatory language'' in this NPRM because of the nature of this 
Project. Because of the very large scope of the Project, we are 
publishing proposed amendments in several NPRMs. In the last NPRM, VA 
will propose to remove all of part 3, concurrent with the 
implementation of part 5.

Endnote Regarding Redesignation From Part 3

    We propose to redesignate current Sec.  3.313 ``Claims based on 
service in Vietnam'' as new Sec.  5.263 ``Presumption of service 
connection for non-Hodgkin's lymphoma based on service in Vietnam.''

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 regulatory 
amendment 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 amendment would not 
affect any small entities. Only individuals could be directly affected. 
Therefore, pursuant to 5 U.S.C. 605(b), this proposed amendment is 
exempt from the initial and final regulatory flexibility analysis 
requirements of sections 603 and 604.

Executive Order 12866

    This document has been reviewed by the Office of Management and 
Budget under Executive Order 12866.

Unfunded Mandates

    The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that 
agencies prepare an assessment of anticipated costs and benefits before 
developing any rule that may result in an expenditure by State, local, 
or tribal governments, in the aggregate, or by the private sector, of 
$100 million or more in any given year. This proposed amendment would 
have no such effect on State, local, or tribal governments, or the 
private sector.

Catalog of Federal Domestic Assistance Numbers

    The Catalog of Federal Domestic Assistance program numbers for this 
proposal are 64.100-102, 64.104-110, 64.115, and 64.127.

List of Subjects in 38 CFR Parts 3 and 5

    Administrative practice and procedure, Claims, Disability benefits, 
Health care, Pensions, Radioactive materials, Veterans, Vietnam.


[[Page 44624]]


    Approved: April 20, 2004.
Anthony J. Principi,
Secretary of Veterans Affairs.

    For the reasons set forth in the preamble, VA proposes to amend 38 
CFR chapter I as set forth below:

PART 5--COMPENSATION, PENSION, BURIAL, AND RELATED BENEFITS

    1. Part 5, as proposed to be added at 69 FR 4820, January 30, 2004, 
is further amended by adding subpart E to read as follows:
Subpart E--Claims for Service Connection and Disability Compensation

Presumptions of Service Connection for Certain Disabilities, and 
Related Matters

Sec.
5.260 General rules and definitions.
5.261 Certain chronic diseases VA presumes are service connected.
5.262 Presumption of service connection for diseases associated with 
exposure to certain herbicide agents.
5.263 [Reserved]
5.264 Diseases VA presumes are service connected in former prisoners 
of war.
5.265 Tropical diseases VA presumes are service connected.
5.266 [Reserved]
5.267 Presumption of service connection for conditions associated 
with full-body exposure to nitrogen mustard, sulfur mustard, or 
Lewisite.

Service Connection for Diseases Due to Exposure to Ionizing Radiation

5.268 Service connection for diseases presumed to be due to exposure 
to ionizing radiation.
5.269 Direct service connection for diseases associated with 
exposure to ionizing radiation.

    Authority: 38 U.S.C. 501(a) and as noted in specific sections.

Subpart E--Claims for Service Connection and Disability 
Compensation

Presumptions of Service Connection for Certain Disabilities, and 
Related Matters


Sec.  5.260  General rules and definitions.

    (a) The purpose of presumptions of service connection. A 
presumption of service connection establishes a material fact (or 
facts) necessary to establish service connection, even when there is no 
evidence that directly establishes that material fact (or facts). 
Examples of material facts include whether a disease or disability had 
its onset during a veteran's military service, or whether a veteran was 
exposed to certain herbicide agents during such service. The evidence 
must prove that the presumption applies to the claimant, but after such 
a showing there is no need for additional evidence of the material 
fact(s) established by the presumption. Presumptions of service 
connection are set forth in Sec. Sec.  5.261 through 5.268, and the 
general rules in this section apply to those sections, except as 
otherwise provided.
    (b) Diseases that must manifest within a specified period need not 
be diagnosed within that period. (1) Certain presumptions apply only 
when a disease becomes manifest to a degree of 10 percent or more (as 
defined by the rating criteria in 38 CFR part 4, Schedule for Rating 
Disabilities) within a prescribed time period, called the ``presumptive 
period.'' This does not mean that the disease must have actually been 
diagnosed during that period. Symptoms shown during the presumptive 
period may reflect the existence of a disease during that period. 
Therefore, a presumption of service connection applies when the 
evidence shows symptoms during the presumptive period sufficient to 
support a finding that a later-diagnosed disease or disability was 
actually present to the required degree during the presumptive period. 
This includes instances where the principles of continuity of 
symptomatology in Sec.  3.303(b) establish a link between symptoms 
during the presumptive period and a subsequent diagnosis. It also 
includes instances where manifestations during the presumptive period 
are followed by a medical diagnosis within a reasonable time. What 
constitutes a reasonable time depends on the nature and course of the 
disease and any other relevant factors. (Simply because a disease is 
far advanced when diagnosed does not mean that it was at least 10 
percent disabling during the presumptive period).
    (2) Whether a disease became manifest during a presumptive period 
may be established by medical evidence, competent lay evidence or both. 
Medical evidence should set forth the physical findings and 
symptomatology shown by examination within the presumptive period. Lay 
evidence should describe the material and relevant facts as to the 
veteran's disability observed within such period, not merely 
conclusions based upon opinion.
    (c) Rebutting a presumption of service connection for a disease. VA 
cannot grant service connection under this section when the presumption 
has been rebutted by the evidence of record.
    (1) Except as otherwise provided, the presumption of service 
connection for a disease will be rebutted when any one or more of the 
following conditions occurs:
    (i) Evidence establishes that the disease or disability was caused 
by an intervening or nonservice-related injury or disease; or
    (ii) Evidence establishes that the disease or injury was caused by 
the veteran's own willful misconduct (see Sec. Sec.  3.1(n) and 
3.301(b)); or
    (iii) Evidence establishes that the disease or disability was not 
incurred in service or, in the case of a preexisting disease, was not 
aggravated in service; or
    (iv) Evidence establishes that a cancer (for which service 
connection is claimed under Sec.  5.262 or Sec.  5.268) originated in 
another area of the body and then spread to one of the specific areas 
listed in Sec.  5.262(e) or Sec.  5.268(b).
    (2) Any evidence competent to indicate the time a disease existed 
or started may rebut a presumption of service connection that would 
otherwise apply. For a discussion of the standards of proof for 
rebutting a presumption, see Sec.  5.4(e).

(Authority: 38 U.S.C. 501(a), 1112, 1113, 1137)


Sec.  5.261  Certain chronic diseases VA presumes are service 
connected.

    (a) Eligibility. VA will presume service connection for a disease 
listed in paragraph (d) of this section, although not otherwise 
established as incurred or aggravated in service, if it first became 
manifest to a degree of 10 percent or more:
    (1) Within a year of separation from a qualifying period of 
service; or
    (2) Within such other time as provided in paragraph (d) of this 
section.
    (b) Qualifying period of service. A qualifying period of service 
is:
    (1) A period of 90 days or more of active, continuous service that 
began before December 31, 1946 and included service during a period of 
war; or
    (2) Any period of 90 days or more of active, continuous service 
after December 31, 1946.
    (c) Service ending before December 7, 1941. In claims based on 
service ending before December 7, 1941, for the purpose of determining 
whether a chronic disease manifested within a presumptive period under 
this section, the date of separation from wartime service will be the 
date of discharge or release during a war period, or if service 
continued after the war, the end of the war period.
    (d) Diseases presumed service connected. VA will grant service 
connection on a presumptive basis for any chronic disease listed in 
this paragraph where a symptom becomes manifest to a degree of 
disability of 10

[[Page 44625]]

percent or more within the applicable presumptive period for the 
disease. For the purposes of this section, VA will consider the 
diseases listed in the table at the end of this paragraph to be chronic 
because of slow onset and persistent progress, even if they are 
initially diagnosed as acute. Unless the clinical picture clearly shows 
the condition was only acute, VA will consider whether an acute 
condition was an exacerbation of a chronic disease. VA cannot apply the 
presumption of service connection when the evidence shows that the 
disease existed prior to military service to a degree of 10 percent or 
more disabling (as defined by the rating criteria in 38 CFR part 4, 
Schedule for Rating Disabilities). However, VA will apply the 
presumption where there is evidence that the disease existed prior to 
entry into service to a degree of less than 10 percent disabling.

------------------------------------------------------------------------
                                       Disease must manifest to a degree
                                       of 10 percent or more within this
                                       period following either discharge
               Disease                   or release from service under
                                        paragraph (a) or end of the war
                                      period under paragraph (c) of this
                                                    section
------------------------------------------------------------------------
Anemia, primary.....................  Within 1 year.
Arteriosclerosis....................  Within 1 year.
Arthritis...........................  Within 1 year.
Atrophy, progressive muscular.......  Within 1 year.
Brain hemorrhage....................  Within 1 year.
Brain thrombosis....................  Within 1 year.
Bronchiectasis......................  Within 1 year.
Calculi of the kidney, bladder, or    Within 1 year.
 gallbladder.
Cardiovascular-renal disease,         Within 1 year.
 including hypertension. See
 paragraph (e) of this section.
Cirrhosis of the liver..............  Within 1 year.
Coccidioidomycosis..................  Within 1 year.
Diabetes mellitus...................  Within 1 year.
Encephalitis lethargica residuals...  Within 1 year.
Endocarditis (this term covers all    Within 1 year.
 forms of valvular heart disease).
Endocrinopathies....................  Within 1 year.
Epilepsies..........................  Within 1 year.
Hansen's disease....................  Within 3 years.
Hodgkin's disease...................  Within 1 year.
Leukemia (acute or chronic).........  Within 1 year.
Lupus erythematosus, systemic.......  Within 1 year.
Multiple sclerosis..................  Within 7 years.
Myasthenia gravis...................  Within 1 year.
Myelitis............................  Within 1 year.
Myocarditis.........................  Within 1 year.
Nephritis...........................  Within 1 year.
Organic diseases of the nervous       Within 1 year.
 system.
Osteitis deformans (Paget's disease)  Within 1 year.
Osteomalacia........................  Within 1 year.
Palsy, bulbar.......................  Within 1 year.
Paralysis agitans...................  Within 1 year.
Psychoses (see Sec.   3.384 of this   Within 1 year.
 part).
Purpura idiopathic, hemorrhagic.....  Within 1 year.
Raynaud's disease...................  Within 1 year.
Sarcoidosis.........................  Within 1 year.
Scleroderma.........................  Within 1 year.
Sclerosis, amyotrophic lateral......  Within 1 year.
Syringomyelia.......................  Within 1 year.
Thromboangiitis obliterans            Within 1 year.
 (Buerger's disease).
Tuberculosis, active (see Sec.        Within 3 years.
 3.371 of this part).
Tumors, malignant...................  Within 1 year.
Tumors, of the brain or spinal cord   Within 1 year.
 or peripheral nerves.
Ulcers, peptic (gastric or duodenal)  Within 1 year.
------------------------------------------------------------------------

    (e) Cardiovascular-renal disease, including hypertension. The term 
``cardiovascular-renal disease'' applies to combination involvement of 
arteriosclerosis, nephritis, and organic heart disease. VA will 
consider hypertension which was 10 percent or more disabling within the 
1-year presumptive period as a chronic disease.
    (f) Hereditary disease. For the purposes of granting service 
connection of a chronic disease on a presumptive basis, VA will presume 
that an inherited or familial disease listed in paragraph (d) of this 
section was incurred in or aggravated by service, if the disease first 
became manifest to a degree of 10 percent or more within the applicable 
presumptive period following discharge or release from active military 
service.

(Authority: 38 U.S.C. 501, 1101(3), 1112(a), 1137)

Sec.  5.262  Presumption of service connection for diseases associated 
with exposure to certain herbicide agents.

    (a) General--(1) Presumption of exposure. VA will presume that a 
veteran who served in the Republic of Vietnam during the period 
beginning on January 9, 1962, and ending on May 7,

[[Page 44626]]

1975, was exposed to an herbicide agent. VA will presume that the last 
date on which such a veteran was exposed to an herbicide agent is the 
last date on which that veteran served in the Republic of Vietnam 
during that period. For purposes of this section, ``Service in the 
Republic of Vietnam'' does not include active military service in the 
waters offshore and service in other locations, but does include any 
such service in which the veteran had duty in or visited in the 
Republic of Vietnam, which includes service on the inland waterways.
    (2) Presumption of service connection. VA will presume service 
connection where a veteran who was exposed to an herbicide agent during 
active military service is diagnosed with a disease listed in paragraph 
(e) of this section that becomes manifest to a degree of 10 percent or 
more within the time period described in paragraph (e) of this section.
    (b) Definition of herbicide agent. For the purposes of this 
section, the term ``herbicide agent'' means 2,4-D; 2,4,5-T and its 
contaminant TCDD; cacodylic acid; or picloram.
    (c) No minimum period of service required. Any period of active 
military service involving presumed or established exposure to an 
herbicide agent is sufficient for the purpose of establishing 
presumptive service connection of a specified disease under this 
section.
    (d) Rebutting the presumption of exposure. Unlike the presumption 
of service connection described in paragraph (a)(2) of this section, 
the presumption of exposure under paragraph (a)(1) is not subject to 
rebuttal under Sec.  5.260(c) (general rule describing rebuttal of 
presumptions of service connection). The presumption of exposure 
applies unless evidence establishes that the veteran was not exposed to 
an herbicide agent during active military service.
    (e) Diseases presumed service connected. The following table lists 
the diseases that VA will presume to be service connected based on this 
section. VA will not apply the presumption of service connection where 
the evidence shows that the disease existed prior to active military 
service to a degree of 10 percent or more disabling (as defined by the 
rating criteria in 38 CFR part 4, Schedule of Rating Disabilities). VA 
will apply the presumption where there is evidence that the disease 
existed prior to entry into such service to a degree of less than 10 
percent disabling.

----------------------------------------------------------------------------------------------------------------
                Disease                          Disease must manifest to a degree of 10 percent or more
----------------------------------------------------------------------------------------------------------------
Chloracne or other acneform disease      Within one year after the last day of exposure.
 consistent with chloracne.
Chronic lymphocytic leukemia...........  Any time after exposure.
Hodgkin's disease......................  Any time after exposure.
Multiple myeloma.......................  Any time after exposure.
Non-Hodgkin's lymphoma.................  Any time after exposure.
Peripheral neuropathy, acute and         Within 1 year after the last day of exposure.
 subacute. \1\.
Porphyria cutanea tarda................  Within 1 year after the last day of exposure.
Prostate cancer........................  Any time after exposure.
Respiratory cancers (cancer of the       Any time after exposure.
 lung, bronchus, larynx, or trachea).
Soft-tissue sarcoma (other than          Any time after exposure.
 osteosarcoma, chondrosarcoma, Kaposi's
 sarcoma, or mesothelioma). \2\
Type 2 diabetes (also known as Type II   Any time after exposure.
 diabetes mellitus or adult-onset
 diabetes).
----------------------------------------------------------------------------------------------------------------
\1\ For purposes of this section, the term ``acute and subacute peripheral neuropathy'' means transient
  peripheral neuropathy that appears within weeks or months of exposure to an herbicide agent and resolves
  within two years of the date of onset.
\2\ The term ``soft-tissue sarcoma'' includes the following:
Adult fibrosarcoma.
Alveolar soft part sarcoma.
Angiosarcoma (hemangiosarcoma and lymphangiosarcoma).
Clear cell sarcoma of tendons and aponeuroses.
Congenital and infantile fibrosarcoma.
Dermatofibrosarcoma protuberans.
Ectomesenchymoma.
Epithelioid leiomyosarcoma (malignant leiomyoblastoma).
Epithelioid sarcoma.
Extraskeletal Ewing's sarcoma.
Leiomyosarcoma.
Liposarcoma.
Malignant fibrous histiocytoma.
Malignant ganglioneuroma.
Malignant giant cell tumor of tendon sheath.
Malignant glomus tumor.
Malignant granular cell tumor.
Malignant hemangiopericytoma.
Malignant mesenchymoma.
Malignant schwannoma, including malignant schwannoma with rhabdomyoblastic differentiation (malignant Triton
  tumor), glandular and epithelioid malignant schwannomas.
Proliferating (systemic) angioendotheliomatosis.
Rhabdomyosarcoma.
Synovial sarcoma (malignant synovioma).

(Authority: 38 U.S.C. 501(a), 1116)


Sec.  5.263  [Reserved]


Sec.  5.264  Diseases VA presumes are service connected in former 
prisoners of war.

    (a) Eligibility. Any period of active military service is 
sufficient for establishing presumptive service connection for a 
specified disease under this section. There are certain requirements 
for the length of internment as a prisoner of war (POW). A veteran is 
eligible for the presumption if the veteran:
    (1) Is a former POW under Sec.  3.1(y); and
    (2) Is diagnosed as having a disease listed in paragraph (b) or (c) 
of this section that first became manifest to a degree of 10 percent or 
more at any time after discharge or release from active military 
service, even if there is no

[[Page 44627]]

record of such disease during such service.
    (b) Diseases presumed service connected following any period of 
internment. VA will presume service connection for the following 
diseases if the criteria of paragraph (a) of this section are met:

    Any of the anxiety disorders as listed in Sec.  4.130, including 
post-traumatic stress disorder.

Dysthymic disorder (or depressive neurosis).

    Organic residuals of frostbite, if the Secretary determines that 
the veteran was detained or interned in climatic conditions 
consistent with the occurrence of frostbite.
    Post-traumatic osteoarthritis.
    Psychosis.

    (c) Presumption of service connection following not less than 30 
days of internment. VA will presume service connection for the 
following diseases if the veteran was interned for 30 days or more and 
the criteria of paragraph (a) of this section are met:

    Beriberi.
    Beriberi heart disease, including ischemic heart disease if 
localized edema experienced during captivity.
    Chronic dysentery.
    Cirrhosis of the liver.
    Helminthiasis.
    Irritable bowel syndrome.
    Nutritional deficiency, including avitaminosis and malnutrition.
    Optic atrophy associated with malnutrition.
    Pellagra.
    Peptic ulcer disease.
    Peripheral neuropathy except where directly related to 
infectious causes.

(Authority: 38 U.S.C. 1112)


Sec.  5.265  Tropical diseases VA presumes are service connected.

    (a) Eligibility. VA will presume service connection for any disease 
listed in paragraph (d) of this section, although not otherwise 
established as incurred in or aggravated by service, if it first became 
manifest to a degree of 10 percent or more:
    (1) Within 1 year from separation from a qualifying period of 
service; or
    (2) Within a period that indicates (based on accepted medical 
treatises) that the incubation period began during such service.
    (b) Qualifying period of service. A qualifying period of service 
is:
    (1) A period of 90 days or more of active, continuous service that 
began before December 31, 1946 and included service during a period of 
war; or
    (2) Any period of 90 days or more of active, continuous service 
after December 31, 1946.
    (c) Claims based on service ending before December 7, 1941. In 
claims based on service ending before December 7, 1941, for the purpose 
of determining whether a tropical disease manifested within a 
presumptive period under this section, the date of separation from 
wartime service will be the date of discharge or release during a war 
period, or if service continued after the war, the end of the war 
period.
    (d) Tropical diseases presumed service connected. VA will presume 
service connection for the following diseases if the criteria of 
paragraphs (a) through (c) of this section are met. For any disease 
service connected under this section, VA will also service connect the 
resultant disorders or diseases originating because of therapy 
administered in connection with such a disease or as a preventative 
measure against such a disease.

    Amebiasis.
    Blackwater fever.
    Cholera.
    Dracontiasis.
    Dysentery.
    Filariasis.
    Leishmaniasis, including kala-azar.
    Loiasis.
    Malaria.
    Onchocerciasis.
    Oroya fever.
    Pinta.
    Plague.
    Schistosomiasis.
    Yaws.
    Yellow fever.

    (e) Rebuttal of presumption. The fact that the veteran had no 
active military service in a locality having a high incidence of the 
disease may be considered evidence to rebut the presumption. Residence 
during the applicable presumptive period in a region where the 
particular disease is endemic may also be considered evidence to rebut 
the presumption. VA will consider the known incubation periods of 
tropical diseases in determining whether the presumption of service 
connection has been rebutted.

(Authority: 38 U.S.C. 1101(4), 1112(a)(2), 1137).

    (f) Claims for service connection of tropical diseases based on 
peacetime service before January 1, 1947. This paragraph applies to 
veterans with peacetime service before January 1, 1947, who served 6 
months or more. The requirement of 6 months or more of service means 
active, continuous service, during one or more enlistment periods. Any 
such veteran who develops a tropical disease listed in paragraph (d) of 
this section, or a disorder or disease resulting from therapy 
administered in connection with a tropical disease or as a 
preventative, will be considered to have incurred such disability in 
active military service if it is shown to exist to the degree of 10 
percent or more:
    (1) Within 1 year after discharge or release from active military 
service; or
    (2) At a time when accepted medical treatises indicate that the 
incubation period commenced during active military service unless shown 
by clear and unmistakable evidence that the tropical disease was not 
contracted as the result of active military service.

(Authority: 38 U.S.C. 1133)

Sec.  5.266  [Reserved]


Sec.  5.267  Presumption of service connection for conditions 
associated with full-body exposure to nitrogen mustard, sulfur mustard, 
or Lewisite.

    (a) VA will presume service connection for a disease or disability 
when the evidence of record establishes that the veteran:
    (1) Underwent full-body exposure to nitrogen mustard, sulfur 
mustard, or Lewisite during active military service; and
    (2) Subsequently developed a condition associated with that 
specific agent, as shown in paragraph (b) of this section.
    (b) List of conditions associated with full-body exposure to 
nitrogen mustard, sulfur mustard, or Lewisite.

----------------------------------------------------------------------------------------------------------------
                                       Associated with nitrogen   Associated with sulfur      Associated with
        Disease or disability                   mustard?                 mustard?                Lewisite?
----------------------------------------------------------------------------------------------------------------
Acute nonlymphocytic leukemia........  Yes.....................  No.....................  No.
Asthma...............................  Yes.....................  Yes....................  Yes.
Chronic bronchitis...................  Yes.....................  Yes....................  Yes.
Chronic conjunctivitis...............  Yes.....................  Yes....................  No.
Chronic laryngitis...................  Yes.....................  Yes....................  Yes.
Chronic obstructive pulmonary disease  Yes.....................  Yes....................  Yes.
Corneal opacities....................  Yes.....................  Yes....................  No.

[[Page 44628]]

 
Emphysema............................  Yes.....................  Yes....................  Yes.
Keratitis............................  Yes.....................  Yes....................  No.
Laryngeal cancer.....................  Yes.....................  Yes....................  No.
Lung cancer (except mesothelioma)....  Yes.....................  Yes....................  No.
Nasopharyngeal cancer................  Yes.....................  Yes....................  No.
Scar formation.......................  Yes.....................  Yes....................  No.
Squamous cell carcinoma of the skin..  Yes.....................  Yes....................  No.
----------------------------------------------------------------------------------------------------------------


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


Service Connection for Diseases Due to Exposure to Ionizing Radiation


Sec.  5.268  Service connection for diseases presumed to be due to 
exposure to ionizing radiation.

    (a) Eligibility. This section applies to a ``radiation-exposed 
veteran,'' who is any individual who, while serving on active duty or 
as a member of a reserve component of the Armed Forces during a period 
of active duty for training or inactive duty training, participated in 
a radiation-risk activity.
    (b) Diseases presumed service connected. VA will presume service 
connection under this section for the following diseases becoming 
manifest in a radiation-exposed veteran at any time after service.

    Bronchiolo-alveolar carcinoma.
    Cancer of the bile ducts.
    Cancer of the bone.
    Cancer of the brain.
    Cancer of the breast.
    Cancer of the colon.
    Cancer of the esophagus.
    Cancer of the gall bladder.
    Cancer of the lung.
    Cancer of the ovary.
    Cancer of the pancreas.
    Cancer of the pharynx.
    Cancer of the salivary gland.
    Cancer of the small intestine.
    Cancer of the stomach.
    Cancer of the thyroid.
    Cancer of the urinary tract (for the purposes of this section, 
the term ``urinary tract'' means the kidneys, renal pelves, ureters, 
urinary bladder, and urethra).
    Leukemia (other than chronic lymphocytic leukemia).
    Lymphomas (except Hodgkin's disease).
    Multiple myeloma.
    Primary liver cancer (except if cirrhosis or hepatitis B is 
indicated).

    (c) Radiation-risk activity. For the purposes of this section, 
``radiation-risk activity'' means:
    (1) Onsite participation in a test involving the atmospheric 
detonation of a nuclear device. For purposes of this section, ``onsite 
participation'' means:
    (i) During the official operational period of a nuclear test, 
(defined in paragraph (e) of this section), presence at the test site, 
or performance of official military duties in connection with ships, 
aircraft or other equipment used in direct support of the nuclear test.
    (ii) During the six month period following the official operational 
period of a nuclear test, presence at the test site or other test 
staging area to perform official military duties in connection with 
completion of projects related to the nuclear test including 
decontamination of equipment used during the nuclear test.
    (iii) Service as a member of the garrison or maintenance forces on 
Eniwetok during the periods June 21, 1951 through July 1, 1952; August 
7, 1956 through August 7, 1957; or November 1, 1958 through April 30, 
1959.
    (iv) Assignment to official military duties at Naval Shipyards 
involving the decontamination of ships that participated in Operation 
Crossroads.
    (2) Service during the occupation of Hiroshima or Nagasaki, Japan, 
by United States forces during the period beginning on August 6, 1945, 
and ending on July 1, 1946. This includes official military duties 
within 10 miles of the city limits of either Hiroshima or Nagasaki, 
Japan, which were required to perform or support military occupation 
functions such as occupation of territory, control of the population, 
stabilization of the government, demilitarization of the Japanese 
military, rehabilitation of the infrastructure or deactivation and 
conversion of war plants or materials.
    (3) Internment as a prisoner of war in Japan (or service on active 
duty in Japan immediately following such internment) during World War 
II that resulted in an opportunity for exposure to ionizing radiation 
comparable to that of the United States occupation forces in Hiroshima 
or Nagasaki, Japan, during the period beginning on August 6, 1945, and 
ending on July 1, 1946. This includes former prisoners of war who at 
any time during the period August 6, 1945, through July 1, 1946:
    (i) Were interned within 75 miles of the city limits of Hiroshima 
or within 150 miles of the city limits of Nagasaki; or
    (ii) Can affirmatively show that they worked within the areas set 
forth in paragraph (c)(3)(i) of this section although not interned 
within those areas; or
    (iii) Immediately following internment, performed official military 
duties described in paragraph (c)(2) of this section; or
    (iv) Were repatriated through the port of Nagasaki.
    (4) Service in which the veteran was, as part of his or her 
official military duties, present during a total of at least 250 days 
before February 1, 1992, on the grounds of a gaseous diffusion plant 
located in Paducah, Kentucky, Portsmouth, Ohio, or the area identified 
as K25 at Oak Ridge, Tennessee, if, during such service the veteran:
    (i) Was monitored for each of the 250 days of such service through 
the use of dosimetry badges for radiation exposure at the plant to the 
external parts of the veteran's body; or
    (ii) Served for each of the 250 days of such service in a position 
that had exposures comparable to a job that is or was monitored through 
the use of dosimetry badges.

    Note to paragraph (c)(4): For the purposes of this paragraph 
(paragraph (c)(4)), the term ``day'' refers to all or any portion of 
a calendar day.

    (5) Service before January 1, 1974, on Amchitka Island, Alaska, if, 
during such service, the veteran was exposed to ionizing radiation in 
the performance of duty related to the Long Shot, Milrow, or Cannikin 
underground nuclear tests.
    (d) Atmospheric detonation. For the purposes of this section, the 
term ``atmospheric detonation'' includes underwater nuclear 
detonations.
    (e) Operational period. For the purposes of this section, for tests 
conducted by the United States, the term ``operational period'' means:
    (1) For Operation TRINITY the period July 16, 1945 through August 
6, 1945.
    (2) For Operation CROSSROADS the period July 1, 1946 through August 
31, 1946.

[[Page 44629]]

    (3) For Operation SANDSTONE the period April 15, 1948 through May 
20, 1948.
    (4) For Operation RANGER the period January 27, 1951 through 
February 6, 1951.
    (5) For Operation GREENHOUSE the period April 8, 1951 through
    June 20, 1951.
    (6) For Operation BUSTER-JANGLE the period October 22, 1951 through 
December 20, 1951.
    (7) For Operation TUMBLER-SNAPPER the period April 1, 1952 through 
June 20, 1952.
    (8) For Operation IVY the period November 1, 1952 through
    December 31, 1952.
    (9) For Operation UPSHOT-KNOTHOLE the period March 17, 1953 through 
June 20, 1953.
    (10) For Operation CASTLE the period March 1, 1954 through May 31, 
1954.
    (11) For Operation TEAPOT the period February 18, 1955 through June 
10, 1955.
    (12) For Operation WIGWAM the period May 14, 1955 through May 15, 
1955.
    (13) For Operation REDWING the period May 5, 1956 through August 6, 
1956.
    (14) For Operation PLUMBBOB the period May 28, 1957 through
    October 22, 1957.
    (15) For Operation HARDTACK I the period April 28, 1958 through 
October 31, 1958.
    (16) For Operation ARGUS the period August 27, 1958 through 
September 10, 1958.
    (17) For Operation HARDTACK II the period September 19, 1958 
through October 31, 1958.
    (18) For Operation DOMINIC I the period April 25, 1962 through 
December 31, 1962.
    (19) For Operation DOMINIC II/PLOWSHARE the period July 6, 1962 
through August 15, 1962.


    Note to Sec.  5.268: If this section does not apply in a 
particular case, VA will consider service connection under Sec.  
5.269.

(Authority: 38 U.S.C. 1112(c), 1137)


Sec.  5.269  Direct service connection for diseases associated with 
exposure to ionizing radiation.

    (a) General. This section does not establish a presumption of 
service connection. It establishes standards and procedures VA will 
apply when a claim for service connection for a disease based on in-
service exposure to ionizing radiation cannot be granted using the 
presumption of service connection under Sec.  5.268. Under this 
section, if:
    (1) The veteran was exposed to ionizing radiation as a result of 
participation in the atmospheric testing of nuclear weapons, the 
occupation of Hiroshima or Nagasaki, Japan, from September 1945 until 
July 1946 or any other claimed in-service event;
    (2) The veteran subsequently developed a radiogenic disease; and
    (3) Such disease first became manifest within the period specified 
in paragraph (b) of this section, then the VA agency of original 
jurisdiction will refer the claim, before adjudication, to the Under 
Secretary for Benefits for further consideration in accordance with 
paragraph (d) of this section. If any of the requirements of this 
paragraph have not been met, service connection will not be granted 
under this section.
    (b) Radiogenic disease. For the purposes of this section, 
``radiogenic disease'' means a disease that may be induced by ionizing 
radiation.
    (1) Listed diseases. The following table lists diseases that VA 
will consider radiogenic when they manifest within the associated 
manifestation period.

----------------------------------------------------------------------------------------------------------------
                   Disease                                            Manifestation period
----------------------------------------------------------------------------------------------------------------
Bone cancer..................................  Within 30 years after exposure.
Cancer (any other not listed)................  5 years or more after last exposure.
Leukemia (all forms except chronic lymphatic   At any time after exposure.
 (lymphocytic)).
Lymphomas other than Hodgkin's disease.......  5 years or more after last exposure.
Non-malignant thyroid nodular disease........  5 years or more after last exposure.
Parathyroid adenoma..........................  5 years or more after last exposure.
Posterior subcapsular cataracts..............  6 months or more after exposure.
Tumors of the brain and central nervous        5 years or more after last exposure.
 system.
----------------------------------------------------------------------------------------------------------------

    (2) Polycythemia vera. Public Law 98-542 requires VA to determine 
whether sound medical and scientific evidence supports establishing a 
rule identifying polycythemia vera as a radiogenic disease. VA has 
determined that sound medical and scientific evidence does not 
establish that polycythemia vera is a radiogenic diseases under this 
regulation. Even so, VA will consider a claim based on the assertion 
that polycythemia vera is a radiogenic disease under the provisions of 
paragraph (b)(3) of this section.
    (3) Other diseases. If a claimant claims compensation for a disease 
based on ionizing radiation exposure and that disease is other than one 
of those listed in paragraph (b)(1) of this section, VA will consider 
the claim under the provisions of this section provided that the 
claimant has cited or submitted competent scientific or medical 
evidence that the claimed condition is a radiogenic disease.
    (c) Development of dose data by a VA agency of original 
jurisdiction. (1) In all claims for service connection based on a 
radiogenic disease under this section, VA will request dose data to 
determine the likelihood that in-service ionizing radiation exposure 
caused the veteran's disease. The agency of original jurisdiction will 
request dose data as follows:
    (i) Atmospheric nuclear weapons test participation claims. In all 
claims based upon participation in atmospheric nuclear testing, dose 
data will be requested from the appropriate office of the Department of 
Defense.
    (ii) Hiroshima and Nagasaki occupation claims. In all claims based 
on participation in the American occupation of Hiroshima or Nagasaki, 
Japan, prior to July 1, 1946, dose data will be requested from the 
appropriate office of the Department of Defense.
    (iii) Other exposure claims. In all other claims involving ionizing 
radiation exposure, a request will be made for any available records 
concerning the veteran's exposure to ionizing radiation. These records 
normally include, but are not limited to, the veteran's Record of 
Occupational Exposure to Ionizing Radiation (DD Form 1141), if 
maintained; service medical records; dose records from the radiation 
dosimetry office of the specific military service; and other records 
which may contain information pertaining to the veteran's ionizing 
radiation dose in service. All such records will be forwarded to the 
Under Secretary for Health, who will be responsible for preparation of 
a dose estimate, to the extent feasible, based on available 
methodologies. As used in this section, ``the Under Secretary for

[[Page 44630]]

Health'' includes his or her designees. If neither the Department of 
Defense nor any other source provides VA with records adequate to 
permit the Under Secretary to prepare a dose estimate, then VA will ask 
the Department of Defense to provide a dose estimate.
    (2) When dose estimates obtained under paragraph (c)(1) of this 
section are reported as a range of doses to which a veteran may have 
been exposed, VA will presume exposure at the highest level of the 
range reported.
    (3) Neither the veteran nor the veteran's survivors may be required 
to produce evidence substantiating exposure if the information in the 
veteran's service records or other records maintained by the Department 
of Defense is consistent with the claim that the veteran was present 
where and when the claimed exposure occurred.
    (4) Presence at a nuclear site. For purposes of paragraph (c)(1)(i) 
(Atmospheric nuclear weapons test participation) and paragraph 
(c)(1)(ii) (Hiroshima and Nagasaki occupation), if military records do 
not establish presence at or absence from a site at which exposure to 
ionizing radiation is claimed to have occurred, VA will concede the 
veteran's presence at the site. Conceding presence under this section 
does not confer entitlement to the presumptive provisions of Sec.  
5.268.
    (5) Submission to the Under Secretary for Benefits. After the 
development in paragraphs (c)(1) through (c)(4) has been completed, the 
agency of original jurisdiction will forward dose data and any other 
evidence, along with the veteran's claims file, to the Under Secretary 
for Benefits for review. The claims file will not be submitted for 
review when development establishes that the claimed disability or 
disease is not radiogenic (as provided in paragraphs (b)(1) through 
(b)(3) of this part), that the disease did not become manifest during 
the time period specified in paragraph (b)(1), or that the veteran was 
either not exposed to ionizing radiation in active military service as 
claimed or that the actual or estimated dose exposure was reported to 
be zero rem gamma. In such cases, the agency of original jurisdiction 
will decide the claim based on general principles of service 
connection.
    (d) Review and action by the Under Secretary for Benefits. (1) The 
Under Secretary for Benefits will review all the evidence of record and 
may request an advisory medical opinion from the appropriate office of 
the Under Secretary for Health as to whether the veteran's disease 
resulted from exposure to ionizing radiation in service. In claims 
subject to paragraph (c)(1)(iii) of this section, the Under Secretary 
for Health will also be responsible for reviewing any records obtained 
as a result of the development procedures in that paragraph and 
preparing a dose estimate, to the extent feasible, based on available 
methodologies.
    (2) Prior to referral to the Under Secretary for Health, the Under 
Secretary for Benefits will reconcile any material difference between 
dose data obtained through the development process in paragraph (c)(1) 
of this section and dose data submitted by or on behalf of the 
claimant.
    (i) The Under Secretary for Benefits will request an opinion from 
an independent expert when it is necessary to reconcile a material 
difference between dose data from a credible source submitted by or on 
behalf of a claimant and dose data derived from official military 
records. The Director of the National Institutes of Health is 
responsible for selecting the independent expert. The estimates and 
supporting documentation of record will be forwarded to the independent 
expert who will prepare a separate radiation dose estimate for 
consideration in adjudicating the claim. For purposes of this 
paragraph:
    (A) The difference between the claimant's estimate and dose data 
derived from official military records shall ordinarily be considered 
material if one estimate is at least double the other estimate.
    (B) A dose estimate shall be considered from a ``credible source'' 
if prepared by a person or persons certified by an appropriate 
professional body in the field of health physics, nuclear medicine or 
radiology and if based on analysis of the facts and circumstances of 
the particular claim.
    (ii) [Reserved]
    (e) Opinion of the Under Secretary for Benefits. (1) Upon receipt 
of a medical opinion by the Under Secretary for Health, the Under 
Secretary for Benefits will review it, along with all the evidence of 
record. If the Under Secretary for Benefits is convinced that sound 
scientific and medical evidence supports the determination that it is 
at least as likely as not that the veteran's disease resulted from 
ionizing radiation in service, the agency of original jurisdiction will 
be informed of this determination in writing. The Under Secretary for 
Benefits will set forth the rationale for the determination, including 
an evaluation of the claim based on the following factors:
    (i) The probable dose, in terms of dose type, rate, and duration as 
a factor in inducing the disease, taking into account any known 
limitations in the dosimetry devices employed in its measurement or the 
methodologies employed in its estimation;
    (ii) The relative sensitivity of the involved tissue to induction, 
by ionizing radiation, of the specific pathology;
    (iii) The veteran's gender and pertinent family history;
    (iv) The veteran's age at time of exposure;
    (v) The time-lapse between exposure and onset of the disease; and
    (vi) The extent to which exposure to ionizing radiation, or other 
carcinogens, outside of service may have contributed to development of 
the disease.
    (2) For purposes of paragraph (e)(1) of this section, the term 
``sound scientific evidence'' means observations, findings, or 
conclusions that are statistically and epidemiologically valid, are 
statistically significant, are capable of replication, and are capable 
of withstanding peer review. The term ``sound medical evidence'' means 
observations, findings, or conclusions that are consistent with current 
medical knowledge and are so reasonable and logical as to serve as the 
basis of management of a medical condition.
    (3) If the Under Secretary for Benefits determines there is no 
reasonable possibility that the veteran's disease resulted from 
ionizing radiation exposure in service, the agency of original 
jurisdiction will be informed in writing, setting forth the rationale 
for this conclusion.
    (4) The Under Secretary for Benefits will request an opinion from 
an outside consultant when, after review of all the evidence, including 
the opinion of the Under Secretary for Health, the Under Secretary for 
Benefits is unable to determine whether it is at least as likely as 
not, or whether there is no reasonable possibility, that the veteran's 
disease resulted from ionizing radiation exposure in service. The 
consultant will be selected by the Under Secretary for Health from 
outside the VA, upon recommendation of the Director of the National 
Cancer Institute. The written request to the consultant will include 
copies of pertinent medical records and, where available, dose 
assessments from official sources, credible sources and independent 
experts. The request will identify the following:
    (i) The disease, including the specific cell type and stage, if 
known, and when the disease first became manifest;
    (ii) The circumstances, including date, of the veteran's exposure;
    (iii) The veteran's age, gender, and pertinent family history;
    (iv) The veteran's history of exposure to known carcinogens, 
occupationally or otherwise;

[[Page 44631]]

    (v) Evidence of any other effects ionizing radiation exposure may 
have had on the veteran; and
    (vi) Any other information relevant to determination of causation 
of the veteran's disease.
    (5) The consultant will evaluate the claim based on the factors 
specified in paragraph (e)(1) of this section. The consultant will 
provide his or her opinion in writing and state whether it is either 
likely, unlikely, or at least as likely as not that the veteran's 
disease resulted from exposure to ionizing radiation in service. The 
rationale supporting the opinion is required.
    (6) The consultant will send the opinion to the Under Secretary for 
Benefits who will review it and transmit it with any comments to the 
agency of original jurisdiction for use in adjudication of the claim.
    (f) Adjudication of claim. The agency of original jurisdiction will 
adjudicate the claim under the generally applicable provisions of this 
part, giving due consideration to all evidence of record, including any 
opinions provided by the Under Secretary for Benefits, the Under 
Secretary for Health, or any outside consultants, and the evaluations 
published pursuant to 38 CFR 1.17, ``Evaluation of studies relating to 
health effects of dioxin and radiation exposure.'' With regard to any 
issue material to consideration of a claim, the provisions of Sec.  
3.102 of this title apply (any reasonable doubt on any issue will be 
resolved in favor of the claimant).
    (g) Willful misconduct and supervening cause in claims based on 
exposure to ionizing radiation. In no case will service connection be 
established if the disease is due to the veteran's own willful 
misconduct or the abuse of alcohol or drugs, or if evidence establishes 
that a supervening, nonservice-related condition or event is more 
likely the cause of the disease.

(Authority: 38 U.S.C. 501; Pub. L. 98-542)

PART 3--ADJUDICATION

    2. The authority citation of part 3, subpart A, continues to read 
as follows:

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

    3. Section 3.313 is redesignated as Sec.  5.263.
    4. Newly designated Sec.  5.263 is amended by:
    a. Revising the section heading; and
    b. In paragraph (a), removing ``Service in Vietnam includes'' and 
adding, in its place, ``For purposes of this section, service in 
Vietnam includes''.
    The revision reads as follows:


Sec.  5.263  Presumption of service connection for non-Hodgkin's 
lymphoma based on service in Vietnam.

* * * * *
    5. Section 3.317 is redesignated as Sec.  5.266.
    6. Newly designated Sec.  5.266 is amended by:
    a. In paragraph (a)(1)(i), removing ``military, naval, or air 
service'' and adding, in its place ``military service'';
    b. In paragraph (a)(5), removing ``part 4 of this chapter'' and 
adding, in its place, ``38 CFR part 4, Schedule for Rating 
Disabilities'';
    c. Revising paragraph (b);
    d. In paragraph (c), removing ``affirmative'' each time it appears; 
and by removing ``military, naval, or air service'' and adding, in its 
place ``military service''; and
    e. In paragraph (d)(1), removing ``military, naval, or air 
service'' and adding, in its place ``military service''.
    The revision reads as follows:


Sec.  5.266  Compensation for certain disabilities due to undiagnosed 
illnesses.

* * * * *
    (b) 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:

    Abnormal weight loss.
    Cardiovascular signs or symptoms.
    Fatigue.
    Gastrointestinal signs or symptoms.
    Headache.
    Joint pain.
    Menstrual disorders.
    Muscle pain.
    Neurologic signs and symptoms.
    Neuropsychological signs or symptoms.
    Signs or symptoms involving the respiratory system (upper or 
lower).
    Signs or symptoms involving skin.
    Sleep disturbances.
* * * * *
[FR Doc. 04-16758 Filed 7-26-04; 8:45 am]
BILLING CODE 8320-01-P