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

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