[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