VA Testimony of Under Secretaries for Health and Benefits before Congress on April 21, 1998

United States Department of Veterans Affairs

STATEMENT OF
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE
SENATE COMMITTEE ON VETERANS' AFFAIRS

April 21, 1998

Mr. Chairman, and Members of the Committee, we are pleased to be here this morning to discuss a number of issues concerning radiation-exposed, or "atomic" veterans. Your invitation letter of April 10, 1998, indicated that today's hearing would focus on the following items or issues: (1) S. 1385, a bill to amend title 38, United States Code, to expand the number of diseases presumed to be service connected with respect to radiation-exposed veterans, introduced by Senator Wellstone; (2) S. 1822, a bill to amend title 38, United States Code, to authorize provision of care to veterans treated with nasopharyngeal radium irradiation, introduced by the Chairman at VA's request; (3) current "dose reconstruction" policies that govern claims for service connection of radiation-related disabilities, and (4) the Federal government's response to the needs of atomic veterans.

Adjudication of Claims for Service Connection of Disabilities or Deaths Associated With Exposure to Ionizing Radiation

First, Mr. Chairman, we believe it would be beneficial to review how the Department of Veterans Affairs (VA) has responded to the needs of atomic veterans and to describe the process by which VA adjudicates claims for service connection of disabilities or deaths associated with exposure to ionizing radiation.

Approximately 195,000 U.S. servicemen were involved in the occupation of Hiroshima and Nagasaki during World War II. Another 205,000 participated at U.S. tests of atmospheric nuclear devices between 1945 and 1962. As more became known about the long-term health effects of exposure to radiation, these "atomic veterans" raised legitimate concerns about possible adverse consequences to their health. While there are still areas of uncertainty surrounding the long-term health effects of exposure, it is now generally agreed that many forms of cancer can be induced by ionizing radiation but may not actually become manifest until many years after exposure.

There have also been concerns raised about the accuracy of dose estimates provided from official military records. For example, many believe that the film badges issued in connection with atmospheric testing provide an incomplete measurement of exposure.

On October 24, 1984, the Veterans' Dioxin and Radiation Exposure Compensation Standards Act, Pub. L. No. 98-542, was enacted to ensure compensation to veterans and their survivors for disabilities or deaths related to exposure to ionizing radiation during atmospheric nuclear testing or the occupation of Hiroshima and Nagasaki. The law instructed VA to prescribe regulations setting forth specific guidelines, standards, and criteria for adjudicating compensation claims based on radiation exposure. (Pub. L. No. 98-542 also made similar provisions regarding Vietnam veterans exposed to herbicides containing dioxin, but Pub. L. No. 102-4, the Agent Orange Act of 1991, removed those provisions and substituted the requirements and procedures now codified at 38 U.S.C. § 1116.)

On September 25, 1985, VA published 38 C.F.R § 3.311b (now designated § 3.311) to implement the radiation provisions of Pub. L. No. 98-542. This regulation contains standards and criteria under which service connection is to be considered for diseases first appearing after service in radiation-exposed veterans.

A disability may be considered to be service connected if it results from injury or disease incurred or aggravated in line of duty during active military service. In the case of certain chronic diseases, disability may be considered to be service connected on a presumptive basis if the disease appears within a specific time period following active service. Under VA regulations, direct service connection may be established for disability from a disease first manifesting itself after active service, but not during any applicable presumptive period, when all evidence establishes that the disease is related to an in-service event. Section 3.311 is intended to assist veterans whose claims for compensation fall under this latter provision. Although the regulation does not provide presumptive service connection, its procedures offer the veteran a detailed, multilevel review.

Under section 3.311, several factors are taken into consideration in determining whether a veteran's disease resulted from exposure to ionizing radiation during service:

the probable radiation dose, including type, rate, and duration;
the relative sensitivity of the tissue involved to induction of the disease by ionizing radiation;
the veteran's gender and pertinent family history;
the veteran's 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 military service might have contributed to development of the disease.

Although Pub. L. No. 98-542 mentioned only two sources of exposure, atmospheric nuclear testing and the occupation of Hiroshima and Nagasaki, the applicability of 38 C.F.R § 3.311 is not limited to these situations. The regulation's provisions cover veterans who were exposed from any source while on active duty. Hence, the claims of all veterans who were exposed occupationally or therapeutically may receive consideration under section 3.311.

For the purposes of section 3.311, a veteran is under no obligation to provide evidence establishing his or her presence at the site of exposure, so long as official military records are consistent with the claim that the veteran was present. If military records do not establish the veteran's presence or absence from the exposure site, we concede that the veteran was present.

If a veteran alleges exposure from atmospheric testing or from the occupation of Nagasaki and Hiroshima, our source for providing a dose reconstruction is the Defense Special Weapons Agency (DSWA), formerly the Defense Nuclear Agency. If other types of exposure are alleged, VA has responsibility for requesting preparation of a dose estimate from official military records. A veteran may submit an alternative dose estimate from a credible source (a person or organization certified to have the requisite scientific expertise). When it is necessary to reconcile a material difference between the dose estimate developed from official military records and that developed by a credible source, VA obtains a separate estimate prepared by an independent expert selected by the Director of the National Institutes of Health.

It should be emphasized that VA does not verify participation or provide radiation doses for atomic veterans. These are mandated responsibilities of the DSWA. Because many service personnel were not issued radiation badges and due to other problems with dose measurement, the DSWA frequently has to provide exposure estimates by dose reconstruction. It is our understanding that the DSWA philosophy is to overestimate ("high-side") doses rather than underestimate them. When the DSWA reports a dose range, VA uses the "upper bound" dose in formulating medical opinions.

Based on the information provided by DSWA, most veterans received relatively low radiation doses. The average dose for atmospheric nuclear weapons test participants was 0.6 rem and fewer than 1% participants received over 5 rem. The DSWA estimates that the maximum exposure for service personnel involved in the occupation of Hiroshima and Nagasaki was less than 1 rem.

Following the dose reconstruction development, a claim for compensation under 38 C.F.R. § 3.311 is referred by the regional office of jurisdiction to VA Central Office for review by the Director of the Compensation and Pension Service, who forwards each case for a medical opinion to the office of the Assistant Chief Medical Director for Public Health and Environmental Hazards. Upon receiving that opinion, the Director of the Compensation and Pension Service issues an advisory opinion whether it is at least as likely as not that the veteran's disease is the result of exposure to ionizing radiation during military service. The regional office of jurisdiction uses this opinion in reaching a final decision. If the Director of the Compensation and Pension Service is unable to conclude whether it is at least as likely as not that the veteran's disease is the result of exposure to ionizing radiation during military service, the claim may be referred to an outside consultant for another evaluation. The outside consultant is selected by the Under Secretary for Health upon the recommendation of the Director of the National Cancer Institute.

Currently, 38 C.F.R. § 3.311 specifies 22 diseases as radiogenic. We have published a proposed amendment to this rule to add "prostate cancer" and "all other cancers" as radiogenic diseases for purposes of section 3.311. The final amendment is now under Departmental review.

Originally, a veteran must have had one of the listed radiogenic diseases before the provisions of 38 C.F.R. § 3.311 would apply. In 1994, the U.S. Court of Appeals for the Federal Circuit ruled that VA did not have the authority to adopt an exclusive list of radiogenic diseases (Combee v. Brown). In addition, section 501(b) of Pub. L. No. 103-446 amended title 38, U.S.C. to allow veterans to pursue service connection on a direct basis for any diseases not considered "radiogenic." In February 1995, we amended section 3.311 to allow consideration of diseases other than those listed as radiogenic. However, if the claimed disease is not one of the listed diseases, the veteran must cite or submit competent scientific or medical evidence showing that it is radiogenic before consideration under the regulation may be made.

VA receives advice on the relationships of various diseases to ionizing radiation from the Veterans' Advisory Committee on Environmental Hazards, which was established by Pub. L. No. 98-542. The Committee is composed of medical and scientific authorities in fields related to the health effects of ionizing radiation; individuals recognized as authorities in such fields as epidemiology and other scientific disciplines pertinent to assessing the health effects of ionizing radiation; and members of the general public, including at least one disabled veteran, with interest and experience relating to veterans' concerns about exposure to ionizing radiation.

Currently, the Committee has nine members and includes several distinguished scientists and physicians who have extensive involvement in the issues related to ionizing radiation. Three of the members recently served on the President's Advisory Committee on Human Radiation Experiments. All members, past and present, have brought with them experience and expertise that have served us well since 1985. The Committee has met 29 times since then, most recently on January 21 and 22, 1998. The next meeting is scheduled for May 20-21 of this year.

Mr. Chairman, the procedures established by 38 C.F.R. § 3.311 are for application regardless of either the source or level of exposure to ionizing radiation. The regulatory criteria apply to claims in which service connection cannot be established under other provisions of law. Through application of the regulation's detailed standards in each individual case, it is our intent to establish service connection for all veterans whose diseases are shown by the scientific and medical evidence to be related to radiation exposure while on active duty.

Despite the passage of Pub. L. No. 98-542 and its implementation in

38 C.F.R § 3.311, Congress remained concerned that these measures were insufficient to compensate all deserving veterans and survivors for disabilities and deaths resulting from exposure to ionizing radiation. Therefore, further legislation was enacted.

Pub. L. No. 100-321, effective May 1, 1988, (codified at 38 U.S.C. § 1112(c)) provided compensation on a presumptive basis for radiation-exposed veterans who developed one of 13 specified diseases to a degree of 10 percent or more within 40 years following participation in a radiation risk activity. The presumptive period for one of the 13 diseases, leukemia, was set at 30 years.

The law defined a radiation-risk activity as:

on-site participation at the atmospheric detonation of a nuclear device;
occupation of Hiroshima and Nagasaki; and
internment as a POW in Japan during World War II, resulting in an opportunity for exposure.

Pub. L. No. 100-321 is implemented by VA regulations at 38 C.F.R § 3.309(d). Subsequent legislation has expanded or modified the original provisions of this law. Pub. L. No. 102-86 (enacted August 14, 1991) increased the presumptive period for leukemia to 40 years and expanded eligibility for presumptive service connection to persons who participated in radiation-risk activities during a period of active duty for training or inactive duty for training.

Pub. L. No. 102-578 (enacted October 30, 1992) added cancers of the salivary gland and urinary tract to the list of presumptive diseases, effective October 1, 1992. VA has defined "urinary tract" as the kidneys, renal pelves, ureters, urinary bladder, and urethra. Pub. L. No. 100-578 also removed both the requirement that a disease be 10 percent disabling at the time it first appears and the 40-year presumptive period. The diseases may now appear at any time following exposure to ionizing radiation for the presumption to apply.

Section 501(a) of Pub. L. No. 103-446 (November 2, 1994) also clarified the intent of Congress that onsite participation at the atmospheric detonation of a nuclear device was not to be limited to participation in a test conducted by the United States.

The presumptive provisions in statute are more limited in their applicability than 38 C.F.R. § 3.311, affecting only those "radiation-exposed" veterans who participated in atmospheric nuclear testing, those involved in the occupation of Hiroshima and Nagasaki, and some who were prisoners of war in Japan. However, so long as participation in a radiation-risk activity and the existence of one of the presumptive diseases can be established, service connection can be granted. The extensive development for information and the detailed examination of the various factors required by 38 C.F.R § 3.311 are not part of the framework of 38 C.F.R. § 3.309(d).

Since 1985, we have tracked radiation claims, as well as other issues, in our Special Issue Rating System, or SIRS. This data base was established as a means of collecting information about claims that fall into categories of special interest to the Department and Congress. It was intended as a tool for identifying the number of claimants and the type of disabilities claimed in each special category. Prior to the establishment of SIRS, VA maintained information in a similar automated data base operated by an independent contractor, who was responsible for input of information from rating sheets provided by the regional offices. The data in this system served as the foundation for the records initially entered into SIRS. The following information is based on data concerning radiation cases tracked in SIRS.

As of April 14, 1998, we have received radiation-related compensation claims from 19,885 veterans and survivors. In 2,406 cases we have established service connection for at least one condition claimed to have resulted from exposure to ionizing radiation. Presumptive service connection has been established in 498 of these cases. They are broken down as follows:

Exposure from atmospheric testing 321

Exposure from Hiroshima and Nagasaki

(including prisoners of war) 177

In the remaining 1,908 cases, our data base does not specify that service connection was necessarily established under the criteria of 38 C.F.R § 3.311, as opposed to other provisions of statute or regulations. However, the

distribution of grants is as follows:

Exposure from atmospheric testing 1,057

Exposure from Hiroshima and Nagasaki

(including prisoners of war) 351

Occupational or therapeutic exposure 300

Other types of exposure 200

SIRS was not intended to provide the level of information that is required to answer the questions that are now recurring with increasing frequency and increasing urgency. We recognize that answers to these questions could enhance the overall effectiveness of the programs we have in place to assist veterans. Therefore, we have taken steps to implement an improved version of SIRS that will allow us to provide more detailed and sophisticated information about the claims in each of the special categories.

VHA Ionizing Radiation Program

Mr. Chairman, we would also like to provide information about the Veterans Health Administration's (VHA) Ionizing Radiation Program. Currently the Ionizing Radiation Program is available to veterans who potentially were exposed to radiation following the atomic bombing of Hiroshima and Nagasaki, Japan, and participants of U.S. atmospheric nuclear weapons tests.

The Ionizing Radiation Program consists of two components. First, atomic veterans are eligible to participate in the Ionizing Radiation Registry Examination Program. This includes a complete medical history, physical examination, standard diagnostic tests, and additional specialized tests and consultations if needed. Approximately 22,000 Ionizing Radiation Registry examinations have been performed as of December 1997.

It should be emphasized that the Ionizing Radiation Registry program basically fulfills a clinical care purpose by offering atomic veterans a free health examination which potentially serves as an entry point for VA care. Because the participants are self-selected and the historical information is not verified, the registry database cannot be used for epidemiological research.

Second, these veterans now have special eligibility for treatment of the 26 diseases currently covered by "presumptive" legislation and/or recognized by VA as potentially radiogenic by regulation. Prior to the enactment of the Veterans' Health Care Eligibility Reform Act of 1996 (Pub. L. No. 104-262), atomic veterans had special eligibility for treatment of any condition except those determined to result from a cause other than the radiation exposure. Care for these conditions is provided without regard to the veteran's age, service-connected status, or ability to defray the cost of medical care, and no co-payment by the veteran is required.

In other words, even if an atomic veteran has never filed a compensation claim or if the claim has been denied, the veteran can still receive free care for potentially radiogenic diseases. In general we believe that this program is working satisfactorily. We have received a few complaints from veterans that some VA medical centers were not familiar with the special programs available to radiation-exposed veterans. The VHA's Office of Public Health and Environmental Hazards has provided additional information to medical centers throughout the VA system. Also, VA's proposal in S. 1822 (discussed below) would make veterans treated with nasopharyngeal (NP) radium irradiation during military service eligible for the VHA Ionizing Radiation Program.

S. 1385

Mr. Chairman, S. 1385, the "Justice for Atomic Veterans Act of 1997," would amend section 1112(c) of title 38, United States Code, by adding 10 new diseases to the list of diseases in that section that are presumed to be service connected for radiation-exposed veterans. Currently, there are 15 cancers for which this presumption is provided: leukemia (other than chronic lymphocytic leukemia); cancer of the thyroid, breast, pharynx, esophagus, stomach, small intestine, pancreas, bile ducts, gall bladder, salivary gland, and urinary tract; multiple myeloma; lymphomas (except Hodgkin's disease); and primary liver cancer (except if cirrhosis or hepatitis B is indicated). S. 1385 would add to this list the following diseases: lung cancer, bone cancer, skin cancer, posterior subcapsular cataracts, non-malignant thyroid nodular disease, ovarian cancer, parathyroid adenoma, tumors of the brain and central nervous system, and rectal cancer. The amendment to section 1112(c) would be effective on the date of enactment of the Act.

Mr. Chairman, VA opposes this bill. VA has never advocated presumptions of service connection for radiation-related claims. The extent of exposure to ionizing radiation experienced by atomic test participants and Hiroshima/Nagasaki occupation forces has been thoroughly studied, and the results peer reviewed. The military services have documented that individual exposures were, for the most part, so low as to pose little health risk to most former members -- as dose-responses are currently understood from decades of observations of exposed populations, primarily the Japanese atomic-bomb survivors. We are aware that these data are not without their critics, but if the doses were significantly higher than reported to VA or the health risks much greater from the reported doses, the effects would be observable when sizable populations of exposed veterans have been studied. Yet, studies such as the 1996 Institute of Medicine's "Mortality of Veteran Participants in the CROSSROADS Nuclear Test," which analyzed causes of death among 40,000 test participants, have not borne this out. The authors of that report determined that exposure to ionizing radiation did not contribute to increased mortality among this sizable study population.

We have concluded that, under the circumstances, blanket presumptions of service connection for cancers suffered by atomic veterans would be vastly over-inclusive, and that the more responsible policy is to afford claimants case-by-case determinations based on the individual merits of their unique cases. If evidence ever comes to light suggesting this approach poses substantial risks of causing injustices to claimants, we would, of course, rethink our position.

S. 1385 is subject to the pay-as-you-go requirement of the Omnibus Budget Reconciliation Act of 1990, and if enacted, it would increase direct spending. VA's preliminary estimate indicates that enactment of S. 1385 would result in a benefits cost of $287 million in fiscal year 1999, and a 5-year total cost, through fiscal year 2003, of $1.7 billion. We estimate further that the enactment of this bill would result in an administrative cost of approximately $6.4 million in fiscal year 1999, and a 5-year total cost of $9 million.

S. 1822

Finally, Mr. Chairman, we would like to discuss S. 1822, which would authorize provision of health care to veterans treated with nasopharyngeal radium irradiation. We would like to thank you, Mr. Chairman, and Senator Rockefeller and other Members of the Committee who cosponsored this VA proposal.

S. 1822 would authorize participation in VA's ionizing radiation program by veterans who were treated with nasopharyngeal radium irradiation many years ago. During the 1940s and 1950s, the military administered nasopharyn-geal radium treatments to thousands of submariners and air crew members to prevent ear injury during the severe pressure changes they encountered on the job. Scientific study now suggests that treated individuals may be at increased risk for development of head and neck malignancies. It is also possible that the treatment may cause other types of diseases and disorders.

With the current state of knowledge regarding the possible consequences of nasopharyngeal radium treatment, it is appropriate for VA to provide needed health care for cancers and other diseases and disorders that might be associated with such exposure to radiation. Accordingly, our bill would authorize treatment for the same diseases and disorders that the law currently authorizes for veterans who may have been exposed to ionizing radiation during weapons testing or during the occupation of Japan following World War II. It would also authorize VA to examine any veteran treated with radium irradiation and include any findings in the Department's radiation registry.

Mr. Chairman, that concludes VA's testimony.