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

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).

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

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