[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20229]


[[Page Unknown]]

[Federal Register: August 18, 1994]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AG29

 

Claims Based on Chronic Effects of Exposure to Mustard Gas or 
Lewisite

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) has amended its 
adjudication regulations concerning compensation for disabilities or 
deaths resulting from the chronic effects of in-service exposure to 
mustard gas and Lewisite. This regulation is based on a National 
Academy of Sciences (NAS) study of the long-term health effects of 
exposure to these vesicant (blistering) agents, commissioned by VA, 
which found a relationship between such exposure and the subsequent 
development of certain conditions. The intended effect of this 
amendment is to expand the list of conditions covered and apply the 
presumption to a broader group of veterans.

EFFECTIVE DATE: This amendment is effective January 6, 1993.

FOR FURTHER INFORMATION CONTACT:
Donald England, Chief, Regulations Staff, Compensation and Pension 
Service, Veterans Benefits Administration, Department of Veterans 
Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 273-7210.

SUPPLEMENTARY INFORMATION: On July 31, 1992, VA published a final 
regulation (38 CFR 3.316) authorizing service connection in claims from 
veterans who underwent full-body exposure to mustard gas during field 
or chamber experiments to test protective clothing or equipment during 
World War II, and who subsequently develop chronic forms of laryngitis, 
bronchitis, emphysema, asthma, conjunctivitis, keratitis, or corneal 
opacities (See 57 FR 1699-1700 and 57 FR 33875-77). VA also contracted 
with NAS to conduct a review of the world medical and scientific 
literature, including that published in languages other than English, 
to determine the long-term health effects of exposure to mustard agents 
and Lewisite. After reviewing almost 2,000 medical and scientific 
papers, consulting with outside experts, and conducting public 
hearings, NAS issued its report, entitled ``Veterans at Risk: The 
Health Effects of Mustard Gas and Lewisite'', on January 6, 1993.
    After reviewing the NAS report, VA published a proposal to amend 38 
CFR 3.316 to expand compensation eligibility based on the long-term 
health effects of exposure to vesicant agents in the Federal Register 
of January 24, 1994 (59 FR 3532-34). Interested persons were invited to 
submit written comments, suggestions or objections concerning the 
proposal on or before March 25, 1994. We received nine comments: One 
from the American Legion, one from the Disabled American Veterans, and 
seven from concerned individuals.
    One commenter stated that the proposed rule seems very confusing 
and is filled with terms that the normal citizen would not understand.
    Based on this comment we have revised the heading of the 
regulation, substituting the phrase ``mustard gas or Lewisite'' for the 
term ``vesicant agents,'' to make it easier for the average individual 
to identify the topic of the regulation from the table of contents. 
However, because the NAS study was based on a comprehensive review of 
scientific and medical literature that uses highly technical medical 
terms both for specific disabilities and for vesicant agents with 
different but similar chemical composition, we found it necessary to 
use the same terms in the regulation in order to accurately and 
precisely express the Secretary's decision. In simple terms, this 
amendment provides presumptive service connection for certain 
respiratory conditions, eye conditions and cancers based on full-body 
exposure to mustard gas and Lewisite.
    Two commenter stated that the proposed regulation does not 
adequately provide for veterans who have one of the requisite 
conditions but cannot verify exposure to mustard gas or Lewisite 
because they lack access to government records. One of them suggested 
that service connection not be denied if their is no clear and 
convincing evidence of intercurrent cause.
    VA does not concur. Generally, a presumption eases the burden of 
proof on a veteran by attaching certain consequences to the 
establishment of certain basic evidentiary facts. In the case of this 
regulation, establishment of certain basic evidentiary facts--full-body 
exposure to a vesicant agent during military service and the subsequent 
development of a specified disease--triggers the presumption that the 
disease is due to that exposure even where there is no medical evidence 
of an association between the veteran's disease and his or her military 
service.
    The presumption does not work in reverse, however. A presumption 
that the presence of a condition indicates prior exposure to a specific 
substance might be possible in the case of a condition associated 
exclusively or almost exclusively with a single cause. The only known 
cause of asbestosis or mesothelioma, for example, is exposure to 
asbestos. There is no basis for a presumption of in-service exposure to 
mustard gas or Lewisite based solely on the presence of any of the 
conditions specified in this regulation, however, because medical 
science recognizes other plausible causes for all of them.
    Another commenter, a medical doctor and professor of medicine, 
pointed out that Lewisite contains arsenic and stated that exposure to 
arsenic is associated with increased malignancy in humans. He 
suggested, based upon his own clinical experience with a patient 
exposed to potassium arsenite, that service connection based on 
exposure to vesicant agents be established for chronic leukemia, 
primary cancers of the liver, bronchogenic cancer and skin cancers 
(based on exposure to Lewisite), accelerated atherosclerosis, and 
neurasthenia. To support this suggestion, he cited a published case 
study: Regelson W., Kim U., Ospina J., Holland J.F., 1968. 
Hemangioendothelial Sarcoma of Liver from Chronic Arsenic Intoxication 
by Fowler's Solution. Cancer 21: 514-522.
    VA does not concur. The NAS report and recommendations which the 
Secretary relied upon were based upon a comprehensive literature review 
covering almost 2,000 medical and scientific papers including numerous 
epidemiological studies, industrial studies of workers in chemical 
factories, and studies of soldiers exposed to mustard gas in warfare. 
NAS found that there is so little literature of these types concerning 
the health risks associated with exposure to Lewisite that with few 
exceptions it is not possible to determine the relationship between 
Lewisite exposure and the onset of particular diseases. In essence, 
this commenter asks us to accept his medical judgment over that of a 
distinguished panel of experts in a wide range of specialties that had 
conducted an extensive literature search and review. In our judgment, 
the clinical experience of one person does not approach the probative 
weight of either the literature review conducted by NAS or the 
consensus opinion of the panel of specialists assembled by NAS. We also 
note that case studies, such as that submitted by the commenter, are 
anecdotal in nature and have no statistical significance. For these 
reasons, we find that the evidence is not sufficient to warrant 
presumptive service connection for the additional conditions 
recommended by this commenter.
    Another commenter suggested that no claim based on verified mustard 
gas exposure be denied solely because there is insufficient data to 
establish a correlation between the claimed conditions and exposure to 
vesicant agents. Other commenters suggested that VA recognize 
additional conditions stating that veterans should not be penalized 
because of gaps in the medical literature.
    VA does not concur. NAS found that there are few data to argue 
either for or against a casual relationship between exposure to 
vesicant agents and other conditions mentioned by the commenters, and 
recommended that VA conduct morbidity and mortality studies in order to 
resolve some of the remaining questions about the health risks 
associated with exposure to vesicant agents. The Veterans Health 
Administration is preparing to conduct morbidity and mortality studies 
as recommended by NAS. Should those studies indicate a relationship 
between exposure to vesicant agents and additional conditions, we will 
determine whether a regulatory presumption of service connection for 
those disabilities is warranted at that time.
    Another commenter recommended that VA recognize additional 
conditions by applying VA's benefit of the doubt doctrine and resolving 
all doubt in favor of veterans exposed to mustard gas or Lewisite.
    Again, we note that NAS found that there are few data to argue 
either for or against a casual relationship between exposure to 
vesicant agents and other conditions. VA regulations at 38 CFR 3.102 
(See also 38 U.S.C. 5107(b)) define reasonable doubt as a doubt which 
exists because of an approximate balance of positive and negative 
evidence which does not satisfactorily prove or disprove the claim; a 
substantial doubt within the range of probability as distinguished from 
pure speculation or remote possibility. Although the primary purpose of 
the regulation is to resolve doubt in favor of a claimant when there is 
a balance of positive and negative evidence, it was never intended for 
use when there is insufficient evidence to support a conclusion one way 
or the other.
    One commenter stated that even though VA indicated that the 
proposal represented a liberalization of the previous criteria, 
verified full-body exposure is, in fact, a higher standard and would 
place a greater burden of proof on veterans seeking benefits under this 
amendment.
    The requirement for full-body exposure was included in the July 31, 
1992, version of this regulation, and its retention does not place a 
greater burden of proof on those veterans seeking benefits under this 
regulation. We had proposed to add the word ``verified,'' but that 
change was intended as a clarification and represented no substantive 
change in VA's position on the type of evidence required to establish 
entitlement to the presumption of service connection set forth in this 
regulation. To avoid creating the impression that we have imposed a 
greater burden of proof, however, we have deleted the term ``verified'' 
from the final regulation.
    The regulation published on July 31, 1992, applied only to those 
veterans who experienced full-body exposure to mustard gas while 
participating in secret tests of protective equipment during World War 
II. This amendment expands that regulation to cover any full-body 
exposure to mustard gas or Lewisite during military service, and it now 
applies to veterans exposed under battlefield conditions in World War 
I, those present at the German air raid on the harbor of Bari, Italy, 
in World War II, those engaged in manufacturing and handling vesicant 
agents during their military service, etc. By expanding the number of 
conditions, vesicant agents, and veterans covered, this amendment 
clearly represents a significant liberalization of the previous 
criteria.
    Since July 1992 both VA and the Department of Defense (DoD) have 
initiated projects which will make it easier for veterans to establish 
entitlement to benefits under this regulation. DoD is searching its 
records for exposure data on mustard gas and Lewisite testing, to 
include the names of exposed military personnel, test protocols, etc., 
and will share the information it discovers with VA. VA has instituted 
a project, under the direction of the Environmental Epidemiology 
Service of Veterans Health Administration (VHA), to consolidate 
information about mustard gas testing as it becomes known into a 
central source. VHA officials have visited several locations where 
testing is known to have been conducted and/or where records might be 
found. The information resulting from these visits is available to VA 
regional offices as they attempt to establish the exposures of veterans 
who have filed claims.
    There is an additional protection for veterans elsewhere in VA's 
regulations. If a claim is disallowed because exposure cannot be 
established but new evidence establishing exposure later becomes 
available from service department records, VA will reopen the claim and 
authorize benefits based on the date of the original claim. (See 38 CFR 
3.400(q)(2)).
    One commenter suggested that the regulation should apply to oral 
ingestion of vesicants; another suggested that exposure via drop or 
patch testing should also be covered. A third commenter, a medical 
doctor, agreed with VA that the presumption should apply only to full-
body exposures.
    As explained in the preamble to the proposed rule, the literature 
upon which the NAS report is based covered animal studies and two types 
of human studies: (1) Industrial studies of workers in chemical 
factories which manufactured mustard gas; and (2) studies of soldiers 
exposed to mustard gas in warfare, primarily during World War I. The 
subjects of these studies were subjected to full-body exposure and NAS 
determined that the exposures of participants in chamber and field 
tests were equivalent to the full-body exposure of soldiers in World 
War I. Since the NAS report addressed only full-body exposures, in our 
judgment there is no basis for applying the presumption of service 
connection to those who received less extensive exposures.
    Another commenter questioned why VA is restricting the presumption 
that acute nonlymphocytic leukemia is service-connected only to those 
veterans exposed to nitrogen mustard.
    The NAS report found that the evidence indicated a causal 
relationship between the development of acute nonlymphocytic leukemia 
and exposure to nitrogen mustard only (See Table 12-1, Summary of 
Findings Regarding Specific Health Problems, Veterans at Risk: The 
Health Effects of Mustard Gas and Lewisite, NAS). Because of the use of 
nitrogen mustard in cancer chemotherapy, there is an extensive body of 
literature concerning the effects of nitrogen mustard in humans after 
systematic administration. This literature documents an increased 
incidence of acute nonlymphocytic leukemia in patients who were treated 
with nitrogen mustard as a chemotherapeutic agent. NAS noted, however, 
that as a therapeutic agent nitrogen mustard has a different systemic 
pharmacology than sulfur mustard, and that it is difficult to make 
quantitative extrapolations to the carcinogenicity of sulfur mustard or 
to which tumors sulfur mustard would be expected to produce. For those 
reasons, we have limited the presumption that acute nonlymphocytic 
leukemia is service connected to only those veterans exposed to 
nitrogen mustard.
    Another commenter stated that the NAS report outlined and 
underscored a list of compelling ethical questions regarding the WWII 
tests of clothing and equipment that are now being ignored: why there 
was no formal long-term follow-up and medical monitoring in spite of 
clear evidence (as early as 1933) regarding delayed onsets of 
debilitating disease; why these subjects were treated so 
disrespectfully when they gave so much; and how many additional 
soldiers were physically harmed and morally abused from the end of 
World War II to 1975? The commenter decried the fact that these 
questions were not addressed by formal recommendations in the NAS 
report, although they caused the problems that have given rise to VA's 
efforts to expand compensation eligibility.
    It is unquestionably beyond VA's ability to modify historical 
events by regulation; however, we believe that this regulation is an 
appropriate government response to these issues. VA recognizes that 
because the tests were secret and no follow-up examinations were 
conducted, veterans who took part in them are at a disadvantage when 
attempting to establish entitlement to compensation. This regulation 
addresses that situation by establishing a regulatory framework which 
recognizes that specific conditions are likely to result from exposure 
to vesicant agents and relieves veterans of the burden of submitting 
evidence to establish those associations in individual claims.
    VA appreciates the comments submitted in response to the proposed 
rule which is now adopted with the corrections noted above, as 
corrected at 59 FR 10675, and with the following change to the 
effective date.
    The proposed rule stated that the amendment would be effective on 
the date of publication of the final rule. In a letter of May 12, 1994, 
the Honorable John D. Rockefeller IV, Chairman of the Senate Committee 
on Veterans' Affairs, expressed his concern over the delay in 
publishing the final regulation as well as his belief that VA could 
establish an earlier effective date for the amendments. We share 
Senator Rockefeller's concern over the delay in the rulemaking process, 
and have therefore determined that it would be both appropriate and 
more equitable for this amendment to be effective January 6, 1993, the 
date of the decision to modify 38 CFR 3.316.
    The Secretary hereby certifies that this 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 (RFA), 5 
U.S.C. 601-612. The reason for this certification is that this 
amendment would not directly affect any small entities. Only VA 
beneficiaries could be directly affected. Therefore, pursuant to 5 
U.S.C. 605(b), this amendment is exempt from the initial and final 
regulatory flexibility analysis requirements of sections 603 and 604. 
This regulatory action has been reviewed by the Office of Management 
and Budget under Executive Order 12866.
    The Catalog of Federal Domestic Assistance program numbers are 
64.109 and 64.110.

List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Handicapped, Health 
care, Pensions, Veterans.

    Approved: July 15, 1994.
Jesse Brown,
Secretary of Veterans Affairs.

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

PART 3--ADJUDICATION

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

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

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

    2. Section 3.316 is revised to read as follows:


Sec. 3.316  Claims based on chronic effects of exposure to mustard gas 
and Lewisite.

    (a) Except as provided in paragraph (b) of this section, exposure 
to the specified vesicant agents during active military service under 
the circumstances described below together with the subsequent 
development of any of the indicated conditions is sufficient to 
establish service connection for that condition:
    (1) Full-body exposure to nitrogen or sulfur mustard during active 
military service together with the subsequent development of chronic 
conjunctivitis, keratitis, corneal opacities, scar formation, or the 
following cancers: Nasopharyngeal; laryngeal; lung (except 
mesothelioma); or squamous cell carcinoma of the skin.
    (2) Full-body exposure to nitrogen or sulfur mustard or Lewisite 
during active military service together with the subsequent development 
of a chronic form of laryngitis, bronchitis, emphysema, asthma or 
chronic obstructive pulmonary disease.
    (3) Full-body exposure to nitrogen mustard during active military 
service together with the subsequent development of acute 
nonlymphocytic leukemia.
    (b) Service connection will not be established under this section 
if the claimed condition is due to the veteran's own willful misconduct 
(See Sec. 3.301(c)) or there is affirmative evidence that establishes a 
nonservice-related supervening condition or event as the cause of the 
claimed condition (See Sec. 3.303).

[FR Doc. 94-20229 Filed 8-17-94; 8:45 am]
BILLING CODE 8320-01-M