[Federal Register Volume 59, Number 15 (Monday, January 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1484]


[[Page Unknown]]

[Federal Register: January 24, 1994]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AG29

 

Claims Based on Chronic Effects of Exposure to Vesicant Agents

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend 
its adjudication regulations concerning compensation for disabilities 
or deaths resulting from the chronic effects of in-service exposure to 
mustard gas and other vesicant agents. This proposed regulation is 
based on a National Academy of Sciences (NAS) study of the long-term 
health effects of exposure to vesicant agents, commissioned by VA, 
which found a relationship between such exposure and the subsequent 
development of certain conditions. The intended effect of this proposed 
amendment is to expand and extend compensation eligibility.

DATES: Comments must be received on or before March 25, 1994. Comments 
will be available for public inspection until April 4, 1994. This 
amendment is proposed to be effective the date of publication of the 
final rule.

ADDRESSES: Interested persons are invited to submit written comments, 
suggestions, or objections regarding this amendment to Secretary of 
Veterans Affairs (271A), Department of Veterans Affairs, 810 Vermont 
Avenue, NW., Washington, DC 20420. All written comments received will 
be available for public inspection only in the Veterans Services Unit, 
room 170, at the above address between the hours of 8 a.m. and 4:30 
p.m., Monday through Friday (except holidays), until April 4, 1994.

FOR FURTHER INFORMATION CONTACT: John Bisset, Jr., Consultant, 
Regulations Staff, Compensation and Pension Service, Veterans Benefits 
Administration, (202) 233-3005.

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). The regulation was 
based on a review of the available English language medical literature 
dealing with the effects of exposure to mustard gas by Veterans Health 
Administration (VHA) personnel. 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 that 
report, entitled ``Veterans at Risk: The Health Effects of Mustard Gas 
and Lewisite'', on January 6, 1993. We are proposing to amend 38 CFR 
3.316 based upon our review of that report.
    NAS findings confirmed VA's prior determination that there is a 
relationship between exposure to mustard gas and the subsequent 
development of the seven conditions previously mentioned. NAS also 
found that the evidence indicated a causal relationship between 
exposure to mustard gas and the subsequent development of ``recurrent 
corneal ulcerative disease'' and ``delayed recurrent keratitis of the 
eye.'' In our judgment the term ``corneal opacities,'' used in the 
current regulation, is broad enough to include corneal ulcerative 
disease and we do not propose to change the language in the current 
regulation. For reasons discussed below, this regulation will cover 
specified conditions whether onset occurred immediately after exposure 
or was delayed, and we find no reason to modify the term ``keratitis'' 
which appears in the current regulation.
    NAS also found that the evidence indicated a causal relationship 
between exposure to mustard gas and the subsequent development of 
nasopharyngeal, laryngeal, lung, and skin cancers, pigmentation 
abnormalities of the skin, and chronic skin ulceration and scar 
formation. We propose to add nasopharyngeal, laryngeal and lung cancer 
(except mesothelioma) to the list of conditions for which presumptive 
service connection may be granted based on exposure to mustard gas. We 
are proposing to exclude mesothelioma from the regulatory amendment, 
however, since the only known cause of that condition is asbestos 
exposure.
    Although NAS used the term ``skin cancer'' in the summary of its 
findings, in our judgment the body of the report, which refers to 
squamous cell and basal cell carcinomas of the skin but not malignant 
melanomas, does not support so broad a presumption of service 
connection. Although basal cell skin cancers were noted in some animal 
studies, these studies constitute evidence of carcinogenicity rather 
than evidence of skin cancer because there is no good animal model for 
human skin response to mustard agents. Likewise, the one occupational 
study that described basal cell carcinomas, Bowen's disease, and other 
hyperkeratotic skin lesions was too seriously flawed to establish a 
causal relationship with exposure to mustard agents. As the report 
notes, the workers in that study were exposed to all types of gases, 
not just mustard gas and Lewisite. Also, those individuals who 
participated in chamber and field testing suffered acute rather than 
chronic exposure like the chemical plant workers in the occupational 
study, which occurred for many hours each week over many years. The 
report states that ``cutaneous cancers following acute sulfur mustard 
exposure usually localize in scars,'' and scar cancers are squamous 
cell carcinomas, not basal cell carcinomas. Finally, since the 1973 
Jackson and Adams study, which is cited in the NAS report in reference 
to the occurrence of basal cell carcinoma and which included two cases 
of basal cell carcinomas in World War I veterans, is not an 
epidemiologic study, it is difficult to draw conclusions as to whether 
the findings represent an unusual rate for basal cell carcinoma. For 
these reasons, we propose to include only squamous cell carcinomas of 
the skin. 
    In our judgment, there is no reason to establish presumptive 
service connection for ``pigmentation abnormalities of the skin'' 
because these abnormalities would be obvious from the time of the 
exposure to vesicant agents rather than occurring many years after 
exposure, as in the case of cancer. Also, because the usual places for 
mustard gas burns are areas of the body which are not visible, i.e., 
moist areas of the body such as the groin and axilla, rather than 
exposed areas as in the case of sunburn, most pigmentation 
abnormalities resulting from these burns would not be considered 
disabling, unless they interfered with the veteran's ability to 
function. In this regard, there is no mention in the NAS report of 
vitiligo-type lesions, which are usually considered to be disabling 
because they are disfiguring. Since compensation is only payable for a 
disability resulting from an injury suffered or disease contracted in 
line of duty or from aggravation of a preexisting injury or disease 
contracted in line of duty (See 38 U.S.C. 1110, 1121, 1131, and 1310), 
and since exposure to vesicant agents does not cause a type of 
pigmentation abnormality which is disabling, we do not propose to 
include pigmentation abnormalities of the skin in the regulation. 
However, we propose to include scar formation in the regulation. 
    In addition to the respiratory conditions VA had previously 
recognized, NAS found that the evidence indicated a causal relationship 
between exposure to mustard gas and chronic obstructive pulmonary 
disease. NAS further found that all these respiratory conditions could 
also result from exposure to Lewisite, another vesicant agent. We are 
proposing to provide service connection for a chronic form of 
laryngitis, bronchitis, emphysema, asthma or chronic obstructive 
pulmonary disease, as a result of exposure to mustard gas or Lewisite.
    Additionally, NAS determined that the evidence indicated a causal 
relationship exists between exposure to nitrogen mustard and the 
subsequent development of acute nonlymphocytic leukemia. Based on that 
information, we propose to provide service connection for acute 
nonlymphocytic leukemia as a result of exposure to nitrogen mustard 
only.
    NAS also found evidence that indicates a causal relationship 
between mustard gas exposure and the subsequent development of bone 
marrow depression, immunosuppression, psychological disorders, and 
sexual dysfunction, but we do not propose to allow presumptive service 
connection for these conditions. Bone marrow depression and 
immunosuppression are acute effects that may have resulted in greater 
susceptibility to infections with a possibility of damage to vital 
organ systems. Since these acute effects would have resolved within a 
relatively short period, however, any related infection would have 
occurred in service or shortly thereafter and an adequate regulatory 
framework to establish direct service connection already exists. 
Psychological disorders may result from traumatic or stressful features 
of the exposure experience, but are not a toxic effect of the agents 
themselves. An adequate regulatory framework currently exists to 
establish service connection for post-traumatic stress disorder as a 
result of exposure to vesicant agents. Establishing a presumption of 
service connection for sexual dysfunction would serve no purpose, since 
sexual dysfunction is not compensated under VA's Schedule for Rating 
Disabilities (38 CFR Part 4) but rather under 38 U.S.C. 1114(k), which 
provides special monthly compensation for the loss or loss of use of a 
creative organ. Special monthly compensation is a benefit established 
by Congress, not by VA regulation, and is therefore beyond the scope of 
this rulemaking.
    There were two other categories of findings in the NAS report. NAS 
found that the evidence was ``suggestive'' of a causal relationship 
between exposure to mustard gas and reproductive dysfunction 
(genotoxicity, mutagenicity, etc.) and exposure to sulfur mustard and 
leukemia. NAS found insufficient evidence of a causal relationship 
between exposure to mustard gas and gastrointestinal diseases, 
hematologic diseases, neurological diseases, cardiovascular diseases, 
and for reproductive dysfunction as a result of exposure to Lewisite. 
As NAS itself indicates, further study in these areas is necessary and 
in our judgment, the scientific and medical evidence on the whole does 
not support the establishment of presumptions for these conditions. 
    Since the revised regulation will address the effects of Lewisite 
as well as mustard agents, we propose to revise the heading of 38 CFR 
3.316 to indicate that the regulation addresses claims based on chronic 
effects of exposure to vesicant agents rather than mustard gas only. 
The current regulation applies only to those veterans exposed while 
participating in secret tests of protective equipment during World War 
II; we propose to expand it to cover any verified full-body exposure 
during military service, which will allow veterans exposed to mustard 
gas under battlefield conditions in World War I, those present at the 
German air raid on the harbor of Bari, Italy, in World War II, and 
those engaged in manufacturing and handling vesicant agents during 
their military service to be eligible for consideration under this 
regulation.
    We are not proposing to include veterans who were exposed to 
vesicant agents via patch or drop testing. 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. These studies 
involved full-body exposure, not patch testing. The NAS report does not 
discuss any studies relevant to patch or drop testing. However, the NAS 
report concluded that the exposure of many participants in chamber and 
field tests was equivalent to that of soldiers in World War I, and 
therefore the NAS report concluded that the World War I and chronic 
exposure studies were relevant to the experience in the chamber and 
field tests. Since the NAS report only considered studies involving 
full-body exposure, we believe that the NAS findings regarding specific 
diseases are linked only to full-body exposure, and not to patch or 
drop testing.
    We also propose to amend 38 CFR 3.316 by adding a requirement that 
service connection will not be established if there is affirmative 
evidence that establishes a nonservice-related supervening condition or 
event as the cause of the claimed condition. The current regulation is 
based upon a literature search of the immediate and short-term effects 
of mustard gas exposure by the Veterans Health Administration, which 
revealed that nonfatal exposures to mustard gas result in an immediate 
acute injury. It was also reported that any chronic disability related 
to mustard gas exposure should appear shortly after the exposure and 
continue to the present. The NAS report, however, found that delayed 
effects of mustard gas exposure may appear even though no acute effects 
were noted. Because of this delay in manifestation of effects of 
mustard gas exposure reported by the NAS, during which time the veteran 
may have been exposed to other nonservice-related causative conditions 
or events, we have determined that it is reasonable to consider 
evidence of intervening cause which may exist, just as we do for other 
presumptive conditions (See 38 CFR 3.307(b)).
    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.

(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 October 22, 1993.
Jesse Brown,
Secretary of Veterans Affairs.

    For the reasons set out in the preamble, 38 CFR part 3 is proposed 
to be 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. 38 CFR 3.316 is revised to read as follows:


Sec. 3.316  Claims based on chronic effects of exposure to vesicant 
agents.

    (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 in paragraphs (a)(1) through (3) of 
this section together with the subsequent development of any of the 
indicated conditions is sufficient to establish service connection for 
that condition:
    (1) Any verified 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) Any verified 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) Any verified 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. 303).

[FR Doc. 94-1484 Filed 1-21-94; 10:00 a.m.]
BILLING CODE 8320-01-M