Mr. Chairman and Members of the Committee:

My name is Donald M. Remy. I am the Deputy Assistant Attorney General in charge of the Torts Branch of the Justice Department's Civil Division. I am pleased to appear before the Committee today to provide an overview of the Radiation Exposure Compensation Act and to present the views of the Department of Justice on Chairman Hatch’s discussion draft bill proposing to amend the Act. Although we agree with certain aspects of the proposal, we are concerned about other provisions and we would appreciate the opportunity to work with the Committee to address them. I will limit my comments today to the most significant aspects of the proposal.

We are most concerned about the provisions that would 1) add six additional diseases and eliminate certain prerequisites for currently compensable conditions under the downwinder and onsite participant provisions of the Act; 2) reduce the qualifying levels of exposure for uranium miners; 3) allow certain tests to serve as exclusive diagnostic tools to prove medical eligibility; 4) eliminate further medical review in certain cases where a person's medical condition is difficult to ascertain; and, 5) liberalize the use of affidavits.

Before I begin more detailed comments, I would like to provide a brief background of our very successful Program. On October 15, 1990, Congress passed the Radiation Exposure Compensation Act, which provides for compassionate payments to individuals, or their surviving beneficiaries, who contracted certain serious diseases as a result of exposure to radiation released during above-ground nuclear weapons tests or as a result of their exposure to radiation during employment in uranium mines. The Department is committed to Congress's goal of implementing a Program under this Act that provides humanitarian compensation for those Americans who sacrificed for the United States during the national security crises of the Cold War. Indeed, the administrative procedures established in the regulations implementing the Act are designed to utilize existing records so that claims can be resolved in a reliable, objective, and non-adversarial manner, quickly and with little administrative cost to the United States or to the person filing the claim.

Under the Act, there are three categories of claimants: downwinders, onsite participants, and uranium miners. The Act specifies a payment of $50,000 for eligible downwinders, $75,000 for eligible onsite participants, and $100,000 for eligible uranium miners. Before a claim can be approved, however, three eligibility criteria must be established: exposure to radiation, existence of a compensable disease, and identification of the proper party to file the claim.

To date, we have received 6,589 claims. Of these, 3,017 claims totaling $222,522,321 have been approved, 3,288 have been denied, and the remaining 284 are pending. Further, of the denied claims, only 7 have been appealed to federal district court. None of the Department's decisions has been reversed in district court. Those numbers reflect the positive experience the Department has had with this Program since we began receiving and paying claims in April 1992. The Radiation Program is efficient, easy and inexpensive for applicants to utilize.

Nonetheless, the Program can be improved and the Department is willing to support justified modifications. To that end, we support a few of the proposals included in this draft bill. For example, we support including male breast cancer as a compensable condition. The pathology of male and female breast cancer is nearly identical and there is no reason for excluding the male condition. Similarly, we support the inclusion of in-situ lung cancer and the elimination of low-coffee consumption as an excluding factor for pancreatic cancer. Additionally, we concur with the recommendation that the offset provision for other federal payments be limited to payments received from the Department of Veterans Affairs. We also support the section that expressly gives the Attorney General authority to request additional information. Finally, to allow claimants to submit an application up to three times is consistent with the present version of the Act and should be maintained.

Other improvements can be accomplished through the regulatory process. In fact, my office is currently reviewing final amendments to the regulations implementing the Act which will: (1) allow claimants to submit affidavits or declarations in support of a claim to establish smoking and alcohol consumption histories where no other records exist; (2) allow the use of pathology reports of tissue biopsies as additional means by which claimants can present evidence of a compensable non-malignant respiratory disease; (3) amend the definitions of "smoker" and "non-smoker" thereby allowing former smokers who develop lung cancer or one of the compensable non-malignant respiratory diseases to be considered as non-smokers for purposes of establishing the eligibility criteria; (4) include in situ lung cancers under the definition of primary cancers of the lung; and (5) consistent with current regulations, allow claimants who have been denied compensation prior to the implementation of these proposed regulations to file another three times. We hope these changes will be final in the near future.

Notwithstanding our support for some elements of the proposed bill, we found an overall lack of scientific support to justify many key elements.
I. Proposals impacting Downwinder and Onsite Participant provisions of the Act.

In Section 2(b), the proposed bill would add six additional cancers and eliminate certain prerequisites for currently compensable conditions under the downwinder and onsite participant provisions of the Act. The added cancers are: salivary gland, urinary bladder, brain, colon, ovary, and chronic lymphocytic leukemia. Based on scientific evidence, it cannot be said that any one of these illnesses is more likely than not caused by exposure to low-level ionizing radiation. Moreover, because there is little to no data about the relationship between radiation exposure and cancers of the salivary gland, urinary bladder, brain, colon, and ovary, we do not believe there is sufficient foundation for adding these cancers to the Program. In fact, the prepublication copy of the Biological Ionizing Effects of Radiation (BIER) VI report, does not contain evidence supporting these additions. We have consulted with experts at the National Cancer Institute ("NCI"), who fully support this position.

The proposed legislation also calls for the elimination of certain restrictions as they apply to some of the diseases that are presently compensable under the current provisions of the Act, particularly: - Thyroid cancer: striking "provided initial exposure occurred by age 20." - Female breast cancer: striking "provided initial exposure occurred by age 40." - Esophagus: striking "provided low alcohol consumption and not a heavy smoker." - Stomach: striking "provided initial exposure occurred before age 30." - Pharynx: striking "provided not a heavy smoker." - Pancreas: striking "provided not a heavy smoker."

With respect to the "initial exposure" requirements for cancers of the thyroid, female breast, and stomach, NCI experts stated that scientific evidence does not support the removal of these prerequisites because there is an inverse relationship between age at exposure and susceptibility to radiation carcinogenesis. Because the risk of disease is greater with exposure at younger ages, the Department must support these initial exposure requirements. Similarly, regarding the alcohol and smoking restrictions, NCI has advised that scientists do not know how smoking and alcohol, both proven risk factors, interact with radiation as causal factors for cancers of the esophagus, pharynx, and pancreas. Also, concerning chronic lymphocytic leukemia (CLL), it is accepted in the medical community that CLL is generally not associated in any way with radiation. Finally, with respect to leukemia, the requirement that leukemia claims be paid only if onset occurred between two and thirty years after first exposure is appropriate and should apply to both childhood and adult-onset leukemia claims.
II. Proposed changes impacting the Uranium Miner Provisions of the Act.
A. 40 WLMS.

Section 2(c) would reduce the qualifying levels of exposure for uranium miners to 40 working level months ("WLMs"). As with the above, my office has previously consulted with an NCI expert on this issue and they indicate that a single "doubling dose" for all underground uranium miners is not supported by scientific evidence. Rather, numerous factors contribute to whether an individual's employment in underground uranium mines is more likely than not the cause of a particular illness.

The President's Advisory Committee on Human Radiation Experimentation ("President's Advisory Committee") did preliminary research into this issue and found that further research was necessary to ensure that the Department's implementing regulations were compatible with the objectives of the Act and consistent with current scientific evidence. As a result, the RECA Committee, comprised of government scientists and attorneys, was established to study the RECA provisions relating to underground uranium miners and the Department's implementing regulations. In considering risk analysis, the RECA Committee concurred with the President's Advisory Committee that the BEIR-IV/NCI model is the best available tool by which to judge whether RECA criteria fairly compensate lung cancer claims. The RECA Committee adapted the BEIR-IV/NCI model and included more recent data from Colorado Plateau and New Mexico cohort studies in order to derive risk models based on the most current scientific findings; these models take into consideration a number of variables.

In its analysis of available data, the RECA Committee found that no single exposure figure, whether it be 40, 200, 300, or 500, is appropriate to establish a point at which it is more likely than not that all uranium miners' exposure was the cause of their lung cancer. The risk model used by the RECA Committee indicates that 40 WLMs is sufficient exposure to warrant compensation only under certain conditions. Specific variables that affect the relative risk of lung cancer have been considered, including: age at diagnosis, exposure, time since last exposure, and smoking history. Thus, for a sub-population of miners, such as non-smokers diagnosed with lung cancer at a certain age within a certain period after last exposure, 40 WLMs could be sufficient exposure to justify a presumption of causation. Providing compensation in every case based on exposure to only 40 WLMs, however, ignores accepted scientific research techniques that take into account other relevant risk factors and background rates of incidence.

One important variable in determining causation of lung cancer is smoking. After careful consideration, the RECA Committee determined that the most appropriate risk model to be used for the purposes of RECA would be one which accounts for the sub-multiplicative effect between exposure to radon progeny and smoking. This position is supported by the data from the NCI analysis and the Colorado Plateau and New Mexico cohort studies. Unlike the BIER-IV/NCI model, which takes smoking and other relevant factors of various sub-populations into account, using a single exposure figure to represent the presumptive level of causation for all miners ignores significant risk factors within various sub-populations of the entire at-risk population.

The RECA Committee did not have the time nor resources necessary to search for, and examine, potential data sources which might assist in determining whether the current exposure criteria required by the regulations are consistent with current scientific evidence regarding a causal relationship between radon exposure and non-malignant respiratory diseases (NMRDs). In establishing the current criteria of 200, 300, and 500 WLMs, Congress consulted with leading scientific and medical experts. Their recommendations were considered when establishing the current criteria. Because of the various exposure conditions which are believed to be associated with NMRDs, such as silica, diesel exhaust, dust, and other particles and gases, it is difficult to isolate the causal factors of those diseases. Moreover, it is unclear if smoking and/or age at diagnosis will affect relative risk.

Thus, in the absence of sufficient scientific findings linking specific exposure levels to certain diseases, we find it inappropriate to replace the current exposure criteria for miners with NMRDs. If the objective of alternative exposure criteria is to provide a more accurate method for establishing the point at which exposure more likely than not was the cause of specific diseases, than that objective cannot be met with this proposal. Given the numerous factors which must be considered when establishing causation of such diseases, more conclusive studies are needed before alternative exposure criteria can be developed.
B. Section 2(c)(2) Definitions.

The proposed amendment would allow miners to prove their medical eligibility by providing qualifying arterial blood gas studies ("ABGs") and one of the following qualifying medical records: B-readings, high-resolution computed tomography ("HRCT") scans, pathology reports, or qualifying pulmonary function tests ("PFTs"). Thus, according to the proposed amendments, live miners could establish their medical eligibility by merely providing qualifying PFTs and ABGs. This provision has insufficient medical or scientific basis. PFTs and ABGs, which are useful in measuring impairment, are not sufficient tools alone for diagnosing structural changes within the lungs consistent with compensable non-malignant respiratory diseases. Impairment reflected in PFTs and ABGs can be symptomatic of numerous respiratory conditions, only a tiny fraction of which can be considered mining related. The current Federal Regulations, which were based on the recommendations of experts at the National Institute for Occupational Safety and Health ("NIOSH"), require that each live miner must provide ABGs or PFTs in addition to a chest x-ray and two B-readings in order to establish the existence of a compensable disease. The Department does not think there is evidence supporting a departure from that current system.
C. Written Documentation.

The bill also states that chest x-rays and accompanying interpretive reports shall "be considered to be conclusive" in establishing the existence of a compensable disease. Because the subsequent provision provides for "a fair and random audit procedure," to verify the accuracy of these records, consideration of any particular evidence as "conclusive" seems unnecessary and inappropriate. Similarly, the proposal provides that a written diagnosis by a doctor of the Indian Health Service ("IHS") or Department of Veterans' Affairs ("VA"), accompanied by other reliable documents be considered conclusive evidence as well. Although the Program is non-adversarial, some scrutiny must be allowed in order to address reasonable concerns raised by the evidence and protect the integrity of the process. In many cases, medical conditions of claimants are difficult to ascertain. We often receive conflicting information, including situations where competing diagnoses of different diseases are made. In complex cases, the Department must be able to consult with experts who can authoritatively determine by a preponderance of the evidence whether a claimant contracted a compensable disease.
D. Affidavits.

The proposed amendment includes a provision allowing individuals to submit affidavits, without supporting contemporaneous documentation, to establish employment in underground uranium mines as long as the affidavit is made by someone other than the individual filing the claim. Based on our experience administering the Program, we see no reason to allow affidavits as proof of employment. There are abundant contemporaneous sources which provide reliable information about individual mining histories. It is very uncommon that individuals are unable to verify alleged periods of employment. Quite simply, this provision could create a condition ripe for fraud by an unscrupulous individual, which the Department would have little or no way of preventing. Additionally, because the proposal to use affidavits without supporting contemporaneous documentation to establish the Act's exposure criteria does not apply to downwinders and onsite participants, disparity would be created.

I appreciate the opportunity to present the Department's views on this proposal.