[Federal Register Volume 63, Number 185 (Thursday, September 24, 1998)]
[Rules and Regulations]
[Pages 50993-50995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25546]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AI00


Claims Based on Exposure to Ionizing Radiation (Prostate Cancer 
and Any Other Cancer)

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA) 
adjudication regulations concerning compensation for diseases claimed 
to be the result of exposure to ionizing radiation. This amendment 
implements a decision by the Secretary of Veterans Affairs that, based 
on all evidence currently available to him, prostate cancer and any 
other cancers may be induced by ionizing radiation. The intended effect 
of this action is to relieve veterans, or their survivors, seeking 
benefits under the provisions of the Veterans' Dioxin and Radiation 
Exposure Compensation Standards Act of the burden of having to submit 
evidence that a veteran's prostate cancer or any other cancer may have 
been induced by ionizing radiation.

DATES: Effective Date: September 24, 1998.

FOR FURTHER INFORMATION CONTACT: John Bisset, Jr., Consultant, 
Regulations Staff, Compensation and Pension Service, Veterans Benefits 
Administration, 810 Vermont Avenue, NW, Washington, DC 20420, telephone 
(202) 273-7230.

SUPPLEMENTARY INFORMATION: The Veterans' Dioxin and Radiation Exposure 
Compensation Standards Act, Pub. L. 98-542, required VA to develop 
regulations establishing standards and criteria for adjudicating 
veterans' claims for compensation for diseases arising from exposure to 
ionizing radiation during service. Pub. L. 98-542 also required that 
the Secretary of Veterans Affairs, after receiving the advice of the 
Veterans Advisory Committee on Environmental Hazards (VACEH), determine 
which conditions should be considered service-connected on the basis of 
exposure to ionizing radiation and include those conditions in VA's 
regulations.
    In September 1985, VA published 38 CFR 3.311b, since redesignated 
as 3.311, to implement the radiation provisions of Pub. L. 98-542. As 
threshold requirements for entitlement to compensation under this 
regulation, a veteran must have been exposed to ionizing radiation 
during atmospheric testing of nuclear weapons, the occupation of 
Hiroshima and Nagasaki, Japan, during World War II, or through other 
activities as claimed, and must have subsequently developed a 
radiogenic disease. VA defines the term ``radiogenic disease,'' for 
purposes of Pub. L. 98-542, to mean ``a disease that may be induced by 
ionizing radiation'' (38 CFR 3.311(b)(2)). Since 1985 VA has added a 
number of diseases to the original list of radiogenic diseases at 38 
CFR 3.311(b)(2).
    Once the regulation was published, VA denied claims for conditions 
that were not specifically listed in the regulation as radiogenic 
diseases. On September 1, 1994, however, the United States Court for 
the Federal Circuit held in Combee v. Brown, 34 F. 3d 1039 (Fed. Cir. 
1994), that Pub. L. 98-542 did not authorize VA to establish an 
exclusive list of radiogenic conditions.
    VA published a proposal to amend 38 CFR 3.311(b)(2) to add prostate 
cancer and ``any other cancer'' to the list of diseases VA recognizes 
as being radiogenic under the provisions of Pub. L. 98-542 in the 
Federal Register on September 25, 1996 (61 FR 50264-65).

[[Page 50994]]

Interested persons were invited to submit written comments on or before 
November 25, 1996. We received four comments: one from the National 
Council on Radiation Protection and Measurements; one from a professor 
of health physics at Arizona State University; and two from concerned 
individuals.
    One commenter pointed out that the Veterans' Advisory Committee on 
Environmental Hazards (VACEH) considered exposure to ionizing radiation 
to be a contributing factor in the development of any malignancy. The 
commenter therefore suggested that we amend the list of radiogenic 
diseases to include any other ``carcinoma or sarcoma'' rather than 
``cancer,'' which is often synonymous with only carcinoma.
    We intend to include both carcinoma and sarcoma in this rule, and 
in our judgment using the broadest possible term, i.e., ``cancer,'' is 
the clearest way of expressing that intent. As the commenter points 
out, Dorland's Medical Dictionary 255 (28th ed. 1994) defines cancer as 
including both carcinoma and sarcoma. Furthermore, when not referring 
to specific conditions such as leukemia or multiple myeloma, the 
current list of radiogenic diseases in 38 CFR 3.311(b)(2) uses the term 
``cancer'' of specified organs. Introducing other terminology into the 
rule might imply a difference that we do not intend. For these reasons, 
we make no change based on this suggestion.
    Another commenter stated that VA should use radiation dose, rather 
than radiation exposure, as the index to measure the risk of a 
particular health outcome.
    Once it is determined that a veteran has a radiogenic disease, 
radiation dose is a factor to be considered under 38 CFR 3.311(e)(1) in 
determining whether a veteran's disease resulted from exposure to 
ionizing radiation in service. VA obtains an assessment of the size and 
nature of the radiation dose to which the veteran was exposed during 
military service (Sec. 3.311(a)(2)) and considers the probable dose and 
several other factors in determining whether the disease resulted from 
that exposure (Sec. 3.311(e)).
    One commenter stated that while prostate cancer is possibly 
radiogenic, the probability that it is related to virtually any level 
of radiation exposure is ``vanishingly small.'' The commenter also 
noted that the National Institutes of Health Radioepidemiology Tables 
are a better means of estimating the probability that a cancer was 
caused by radiation with any given dose. Another commenter stated that 
a significant statistical association between exposure to ionizing 
radiation and cancer of the oral cavity, esophagus, rectum, gall 
bladder, pancreas, ovary, prostate, and brain and central nervous 
system has not been demonstrated. The commenter pointed out that, 
according to the Hiroshima and Nagasaki Life Span Study, compiled by 
the United Nations Scientific Committee on the Effects of Atomic 
Radiation (UNSCEAR), the excess relative risks for these cancers are 
not statistically different from zero. The commenter also relies upon 
an analysis of the risk of cancer in Japanese survivors of the atomic 
bombings, prepared by the Radiation Effects Research Foundation, that 
supports the UNSCEAR findings that these cancers are not induced by 
exposure to ionizing radiation.
    As explained in the notice of proposed rulemaking, when the 
Secretary of Veterans Affairs determines that a significant statistical 
association exists between a disease and exposure to ionizing 
radiation, and after receiving the advice of the VACEH, and applying 
the reasonable doubt doctrine as set forth in 38 CFR 1.17(d)(1), the 
regulations regarding service connection must be amended. A 
``significant statistical association'' exists when ``it is at least as 
likely as not that the purported relationship between a particular type 
of exposure and a specific adverse health effect exists.'' (38 CFR 
1.17(d)(1)). In addition, according to 38 CFR 3.17(f), a significant 
statistical association may be deemed to exist ``if, in the Secretary's 
judgment, scientific and medical evidence on the whole supports such a 
decision.''
    The VACEH concluded in April 1995 that it would be appropriate to 
consider prostate cancer as being associated with radiation exposure. 
The VACEH also expressed its agreement with the statement ``[o]n the 
basis of current scientific knowledge, exposure to ionizing radiation 
can be a contributing factor in the development of a malignancy.'' We 
therefore believe that the Secretary's decision to add prostate cancer 
and any other cancer to the list of radiogenic diseases in 38 CFR 
3.311(b)(2) is supported by scientific and medical evidence.
    We note as well that VA's inquiry does not end once it is 
determined that the claimant meets the threshold requirements of 38 CFR 
3.311(b)(1). VA then obtains an assessment of the size and nature of 
the radiation dose to which the veteran was exposed during military 
service. In determining whether the disease resulted from that 
exposure, VA considers: the probable dose in terms of dose type, rate 
and duration as a factor in inducing the disease; the relative 
sensitivity of the involved tissue; gender and pertinent family 
history; age at time of exposure; the time-lapse between exposure and 
onset of the disease; and the extent to which exposure to radiation, or 
other carcinogens, outside of service may have contributed to 
development of the disease.
    VA appreciates the comments submitted in response to the proposed 
rule which, based on the rationale set forth in the proposal and this 
document, is now adopted without change.
    The Secretary hereby certifies that this final rule 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 final rule does 
not directly affect any small entities. Only VA beneficiaries are 
directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final 
rule is exempt from the initial and final regulatory flexibility 
analysis requirements of section 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, Disability benefits, 
Health care, Pensions, Veterans, Vietnam.

    Approved: June 15, 1998.
Togo D. West, Jr.,
Secretary of Veterans Affairs.

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

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. In Sec. 3.311, paragraph (b)(2)(xxi) is amended by removing 
``and''; and paragraph (b)(2)(xxii) is amended by removing ``.'' and 
adding, in its place, ``;''; and new paragraphs (b)(2)(xxiii) and 
(b)(2)(xxiv) are added to read as follows:


Sec. 3.311  Claims based on exposure to ionizing radiation.

* * * * *
    (b) * * *
    (2) * * *
    (xxiii) Prostate cancer; and

[[Page 50995]]

    (xxiv) Any other cancer.
* * * * *
[FR Doc. 98-25546 Filed 9-23-98; 8:45 am]
BILLING CODE 8320-01-P