Reacting to the difficulty in establishing causation based on alleged radiation exposure and the significantly small number of claims for service connection which had been allowed based on such exposure, Congress enacted in 1984 the Veteran's Dioxin and Radiation Exposure Compensation Standards Act, Pub. L. No. 98–542, 98 Stat. 2725 (1984) ("the Act"). Congress decided that there was enough of a statistical association between exposure to radiation and the manifestation of certain diseases such that those diseases should be recognized as "radiogenic." Accordingly, a stated purpose of the Act is:
to ensure that VA disability compensation is provided to veterans who were exposed to ionizing radiation in connection with atmospheric nuclear tests or in connection with American occupation of Hiroshima or Nagasaki, Japan, for all disabilities arising after that service that are connected, based on sound scientific and medical evidence, to such service (and that VA dependence and indemnity compensation is provided to survivors of those veterans for all deaths resulting from such disabilities).
Id. sec. 3.
The Act delineates specific findings underlying the new legislation. First, it is noted that, while many veterans who participated in atmospheric nuclear testing or the American occupation of Hiroshima or Nagasaki, Japan, are deeply concerned about possible long-term health effects of exposure to ionizing radiation, id. § 2(1), there is a great deal of scientific and medical uncertainty regarding such long-term adverse health effects. Id. § 2(2). Pursuant to the Act, Congress responded to this medical uncertainty by (1) assuring that priority medical care would be provided at VA facilities for veterans who were exposed to radiation and developed one of the listed radiogenic diseases, unless the disability was found to have a cause other than radiation exposure (Id. § 2(3)); (2) requiring that thorough epidemiological studies would be conducted of the health effects experienced by radiation-exposed veterans (Id. § 2(4)); and (3) requiring the development of radioepidemiological tables to track the probabilities of causation between various disabilities and radiation exposure. Id. Congress found that there is sufficient evidence that certain specific disabilities are linked to exposure to ionizing radiation; these disabilities include most types of leukemia; malignancies of the thyroid, female breast, lung, bone, liver, and skin; and polycythemia vera. Id. § 2(5).
It also was noted that the "film badges" which had been provided to members of the military in connection with atmospheric nuclear testing, and which had been the primary sources of dose information for veterans filing claims for disability compensation based on alleged exposure, often provided incomplete and inaccurate information and were not provided to most of the participants in nuclear test. Id. § 2(8), (9). Additionally, it was noted that the standards governing the reporting of dose information varied among the separate branches of the Armed Forces, and the VA had not promulgated permanent regulations setting criteria, standards, and guidelines for the adjudication of claims for disability compensation based on exposure either to herbicides containing dioxin or to ionizing radiation. Id. §§ 2(10), (11). Congress also recognized that radiation-based claims often involve long latency periods and present unique adjudicatory issues unlike those presented in non-radiation-based claims. Id. § 2(12). Finally, Congress took notice of the fact that in considering all of the evidence and material of record in support of a given claim for service connection, it has always been the policy of both the United States and the VA that the benefit of the doubt shall be provided to the veteran on each issue material to the determination of a given claim. Id. § 2(13).
In 1984, pursuant to the Act, a new subsection (a)(2) was added to 38 U.S.C. section 1154 which compelled the Secretary to promulgate regulations pertaining to service connection of disabilities in accordance with "the provisions required by section 5 of the ... Act." 38 U.S.C. § 1154(a)(2). Section 5 of the Act, in turn, provided the Secretary with specific directions on the requirements for and content of the new regulations dealing with radiation exposure-based claims. To promote consistency in claims processing and decisions, the Secretary was directed to prescribe regulations to (1) establish guidelines and (where appropriate) standards and criteria for the resolution of claims based on a veteran's exposure during service to ionizing radiation, id. §§ 5(a)(1)) and (2), ensure the appropriate application of the reasonable doubt doctrine to a veteran's radiation-based claim. Id. § 5(a)(2)).
The Secretary also was directed to include guidelines governing the evaluation of scientific studies relating to the possible increased risk of adverse health effects of exposure to ionizing radiation. Id. § 5(b)(1)(A). Such evaluations were required to be made by the Secretary after advice from the Scientific Council of the Veterans' Advisory Committee on Environmental Hazards (the "Advisory Committee") - a specially constituted advisory panel of experts - and the results of these evaluations were required to be published in the Federal Register. Id. § 5(b)(1)(B) and sec. 6. The Secretary also was directed to include provisions governing the use of such evaluations in the adjudication of individual claims. Id. § 5(b)(1)(C). Additionally, in prescribing the new regulations under this section, the Secretary was required to make determinations, based on sound scientific evidence with respect to each alleged radiation-based disease, as to whether service connection should be granted in the adjudication of individual cases. Id. § 5(b)(2)(A)(i).
Further, the Secretary was required to include in the regulations provisions specifying the factors to be considered in adjudicating issues relating to whether or not service connection should be granted in individual cases and specifying the circumstances governing the granting of service connection for such diseases. Id. It was specifically noted, however, that the diseases referred to in section 5 of the Act included only those specified in section 2(5) of the Act, i.e., most types of leukemia, malignancies of the thyroid, female breast, lung, bone, liver, and skin, and polycythemia vera, and any other disease with respect to which the Secretary subsequently determined (after receiving and considering the advice of the Advisory Committee) that there existed sound scientific or medical evidence indicating a connection between the disease and exposure to ionizing radiation. Id. § 5(b)(2)(B).
In 1985, pursuant to the requirements outlined in the Act, the Secretary promulgated, after public review and comment, a detailed regulation, enumerated at 38 C.F.R. section 3.311b, governing the establishment of service connection for disabilities allegedly resulting from exposure to ionizing radiation.
The regulation specifically provides: "If any of the foregoing 3 requirements [have] not been met, it shall not be determined that a disease has resulted from exposure to ionizing radiation under such circumstances." 38 C.F.R. § 3.311b(b)(1)(iii). The regulation also provides specific guidelines concerning dose and exposure assessments for the recognized radiogenic diseases (section 3.311b(a)(1)), guides the veteran to the specific sources of dose information for particular recognized radiogenic diseases depending on the alleged source of exposure (section 3.311b(a)(2)), and provides for the referral of dose assessments to independent experts to reconcile any disputes (section 3.311b(a)(3)).
Based on specific recommendations of the Advisory Committee and scientific and medical evidence, the VA adopted a list of recognized "radiogenic diseases," enumerated at 38 C.F.R. section 3.311b(b)(2). The regulation indicates that the list is exclusive; the specific language of the regulation provides that:
For purposes of paragraphs (a)(1) (regarding dose assessments) and (b)(1) (listing three requirements for a well-grounded claim) of this section, "radiogenic diseases" shall only include the following:
(i) All forms of leukemia except chronic lymphatic (lymphocytic) leukemia;
(ii) Thyroid cancer;
(iii) Breast cancer;
(iv) Lung cancer;
(v) Bone cancer;
(vi) Liver cancer;
(vii) Skin cancer;
(viii) Esophageal cancer;
(ix) Stomach cancer;
(x) Colon cancer;
(xi) Pancreatic cancer;
(xii) Kidney cancer;
(xiii) Urinary bladder cancer;
(xiv) Salivary gland cancer;
(xv) Multiple myeloma;
(xvi) Posterior subcapsular cataracts; and
(xvii) Non-malignant thyroid nodular disease.
Id. Neutropenia (or leukopenia) is not included in the list of radiogenic diseases.
The regulation specifically excludes certain disabilities from the list of radiogenic diseases. See 38 C.F.R. § 3.311b(b)(3) (excluding polycythemia vera from list of radiogenic diseases). The regulation also specifies time periods within which the recognized radiogenic diseases must become manifest in order for a veteran to establish service connection.
(i) Bone cancer must become manifest within 30 years after exposure;
(ii) Leukemia must become manifest at any time after exposure;
(iii) Posterior subcapsular cataracts must become manifest 6 months or more after exposure; and
(iv) Other diseases specified in paragraph (b)(2) of this section must become manifest 5 years or more after exposure.
38 C.F.R. § 3.311b(b)(4).
The Secretary will amend the list of recognized radiogenic diseases when it is found that there is a significant statistical association between specific diseases and exposure to ionizing radiation. 38 C.F.R. § 1.17(c). Accordingly, over the years, based on advice provided to the Secretary by the Advisory Committee resulting from expanded scientific and medical knowledge, and after public review and comment, the Secretary has proposed various amendments to the list of radiogenic diseases. See, e.g., 57 Fed. Reg. 10,853 (1992) (proposing to add parathyroid adenoma); 54 Fed. Reg. 42,802 (1989) (proposing to add lymphomas, except Hodgkin's disease, and cancers of the pharynx, small intestine, bile ducts, and gall bladder so as to conform the radiogenic diseases listed in 38 C.F.R. section 3.311b with those listed in section 3.309, see infra ). Neutropenia (or leukopenia), however, has not been added to the list of radiogenic diseases.
However, although the language of 38 C.F.R. section 3.311b(b)(2) indicates that, for the purposes of establishing service connection based on exposure to ionizing radiation, the list of radiogenic diseases specified in the regulation is exclusive, the provision also refers the veteran to another subsection of the regulation—38 C.F.R. section 3.311b(h). Subsection (h), under the heading, "service connection otherwise established," provides:
Nothing in this section will be construed to prevent the establishment of service connection for any injury or disease otherwise shown by sound scientific or medical evidence to have been incurred or aggravated during active service.
The list of radiogenic conditions that appears at section 3.311b(b)(2) is meant to be exclusive. The current wording of section 3.311b(h) however, might be misinterpreted to mean that a veteran may attempt to prove that a disease not included on that exclusive listing resulted from exposure to ionizing radiation and is service connected based on "sound scientific or medical evidence." This interpretation of section 3.311b(h) would not conform to section 5(b)(2) of Public Law 98–542 which contemplates that VA will employ regulations which list each disease for which VA finds sound scientific and medical evidence of a connection of ionizing radiation.
In 1988, pursuant to the Radiation–Exposed Veterans Compensation Act of 1988, supra, Congress added subsection (c) to 38 U.S.C. section 1112 (implemented by 38 C.F.R. section 3.309). Section 1112(c)(1) provides for a presumption of service connection for certain diseases which become manifest in a radiation-exposed veteran within specified latency periods. It states in part:
A disease specified in paragraph (2) of this subsection becoming manifest in a radiation-exposed veteran to a degree of 10 percent or more within the presumptive period (as specified in paragraph (3) of this subsection) shall be considered to have been incurred in or aggravated during active military, naval, or air service, notwithstanding that there is no record of evidence of such disease during a period of such service.
Section 1112(c)(2) outlines the specific diseases for which the presumption of service connection will apply; these diseases are:
(A) Leukemia (other than chronic lymphocytic leukemia).
(B) Cancer of the thyroid.
(C) Cancer of the breast.
(D) Cancer of the pharynx.
(E) Cancer of the esophagus.
(F) Cancer of the stomach.
(G) Cancer of the small intestine.
(H) Cancer of the pancreas.
(I) Multiple myeloma.
(J) Lymphomas (except Hodgkin's disease).
(K) Cancer of the bile ducts.
(L) Cancer of the gall bladder.
(M) Primary liver cancer (except if cirrhosis or hepatitis B is indicated).
The statute and implementing regulation provide that the presumption period for the listed diseases is the 40–year period beginning on the last date on which the veteran participated in a defined radiation-risk activity. 38 U.S.C. § 1112(c)(3). The defined "radiation risk-activities" for purposes of the aforementioned presumptions specifically include the occupation of Hiroshima or Nagasaki, Japan, by United States forces during the period beginning on August 6, 1945, and ending on July 1, 1946. 38 U.S.C. § 1112(c)(4)(B)(2).
The Veterans' Radiation Exposure Amendments of 1992 (the 1992 Amendments), 106 Stat. 4774, Pub. L. No. 102–578 (S. 775) (Oct. 30, 1992), amended section 1112(c)(2) by including new subparagraphs "(N) Cancer of the salivary gland" and "(O) Cancer of the urinary tract" in the list of radiogenic diseases. The 1992 Amendments also amended section 1112(c)(1) by striking out the requirement that the diseases in section 1112(c)(2) become manifest in a radiation-exposed veteran to a degree of 10% or more within the presumption period. The 1992 Amendments also removed former section 1112(c)(3), i.e., the requirement that any disease presumed to be service-connected for radiation-exposed veterans be manifested within 40 years after exposure. Further, the 1992 Amendments required the Advisory Committee to investigate the effects of radiation exposure from military activities not covered by current law, and directed the Advisory Committee to review pertinent scientific data to determine whether bronchio-alveolar carcinoma should be added to the list of radiogenic diseases. Combee v. Principi, 4 Vet. App. 78, 84-88 (1993) rev'd sub nom. Combee v. Brown, 34 F.3d 1039 (Fed. Cir. 1994).