Proposed Amendments to the Statute

Recommended Modifications to the Department of Justice Regulations

Introduction

Issues Relating to Compensation for Lung Cancer

Issues Relating to Compensation for Nonmalignant Respiratory Diseases

Appendix A. Establishment of Data-Based Criteria for Radon-Associated Lung Cancer

(2)Id. §§ 4, 5, 104 Stat. at 921-22.

(3)Id.

(4)Id. § 2(a)(3), 104 Stat. at 920.

(5)Id. § 5(b)(3), 104 Stat. at 923.

(6)Id. § 5(a), 104 Stat. at 922.

(7)Id. § 6, 104 Stat. at 923.

(8)See 57 Fed. Reg. 12428, 12429 (1992)(codified at 28 C.F.R. § 79).

(9)Advisory Committee on Human Radiation Experiments, Final Report 563-83 (Oct. 1995) [hereinafter cited as Final Report].

(10)Id. at 814.

(11)Id.

(12)Id. at 813. The Advisory Committee's recommendation regarding uranium miners is attached as Appendix B.

(13)The Committee is composed of three attorneys from the Department of Justice; two scientists (one physician and one biostatistician) from the National Institute for Occupational Safety and Health (NIOSH); and two scientists (a physician and a biostatistician) from the National Cancer Institute (NCI). The names and affiliations of the Committee members are listed at the front of this Report.

(14)For example, it is possible that some of the staff are not fully aware of congressional sentiments expressed during the passage of the RECA urging those who administer the program to treat liberally the claims of Navajo miners, particularly where historical medical documentation is ambiguous. See, e.g., 136 Cong. Rec. S11752-55 (daily ed. Aug. 1, 1990). On the other hand, the various administrative shortcomings we perceived appear to affect only a handful of claims.

(15)We would be remiss if we did not single out for mention Ms. Debra Hetrick, who provided the Committee with outstanding logistical support throughout our investigation. Her contribution and efforts are very much appreciated.

(16)P.L. 101-426, § 2(a)(3), 104 Stat. at 920. Uranium deposits exist in geologic formations in the five states designated in the Act. See D.R. Shawe, et al., Uranium and Vanadium Deposits, in [P-2] The Geology of North America 103-24 (H.J. Glustoker, et al. eds., 1991). Uranium is unstable, and naturally decays over time through a well-defined series of reactions in which various forms of radiation are emitted. One of the intermediate products of this so-called "uranium cycle" is radium, which decays to radon, a gas. The radon diffuses through the work environment and is inhaled by miners. Radon itself decays into a series of progeny or daughter products, which give off alpha radiation. The carcinogenic potential of radon derives from the progeny's emission of alpha radiation in the lung. Throughout this report, we use the terms "exposure to radon" and "exposure to radon progeny" interchangeably.

(17)A Working Level Month (WLM) is a time-integrated exposure measure. A working level is defined as any concentration of radon progeny that results in the release of 1.3 x 105 million electron volts (MeV) of alpha energy per liter of air. WLMs are calculated as the product of the number of months underground (170 hours/month) and the radon progeny concentration measured in WLs. See 28 C.F.R. § 79.30(c),(d).

(18)P.L. 101-426, § 5(a)(1), 104 Stat. at 922.

(19)28 C.F.R. § 79.31(f).

(20)Id. § 79.31(g). A pack-year of cigarette products is defined as smoking one pack of cigarettes (20) each day for one year.

(21)In addition to the problem of underinclusiveness, as we demonstrate infra, the current criteria also tend toward overinclusiveness (compensation to undeserving miners), by failing to consider attained age and time since last exposure, independent of smoking.

(22)See,e.g., Jonathan M. Samet, et al., Uranium Mining and Lung Cancer in Navajo Men, 310 New England J. of Medicine 1481 (1984); F.D. Lundin, Jr., et al., National Institute of Occupational Safety and Health-National Institute for Environmental Health Sciences, Joint Monograph No. 1, Radon Daughter Exposure and Respiratory Cancer, Quantitative and Temporal Aspects (1971). Two of the principal epidemiological studies defining the risks of radon are ongoing investigations of cohorts of uranium miners covered by the RECA. One study has focused on uranium miners employed underground in mines in the Colorado Plateau area. See Richard W. Hornung, et al., Modifiers of Exposure-Response Estimates for Lung Cancer Among Miners Exposed to Radon Progeny, 103 Envir. Health Persp. 49-53 (1995)(updating study); Robert J. Roscoe, et al., Lung Cancer

Mortality Among Nonsmoking Uranium Miners Exposed to Radon Daughters, 262 J. of the Am. Med. Assoc. 629 (1988)(updating study); Lundin, supra (original study). The second has focused on underground uranium miners in New Mexico. Jonathan M. Samet, et al., Lung Cancer Mortality and Exposure to Radon Progeny in a Cohort of New Mexico Underground Uranium Miners, 61 Health Physics 745-752 (1991)[hereinafter Lung Cancer Mortality in New Mexico Uranium Miners](updating study); Samet, Uranium Mining and Lung Cancer in Navajo Men, supra (original study).

(23)See Health Effects of Radiation Exposure Caused by Open Air Atomic Testing and Uranium Mining, Hearings before the Senate Committee on Labor and Human Resources, 101st Cong., 2d Sess. 25- 44 [hereinafter Hearings on Health Effects of Radiation Exposure](testimony of Victor Archer, M.D.); id. at 61-117 (appended studies); Impact of Past Uranium Practices: Hearings before the Subcomm. on Mineral Resources, Development and Production of the Senate Comm. on Energy and Natural Resources, 101st Cong., 2d Sess. 21-37 [hereinafter Hearings on Impact of Past Uranium Practices](testimony of Richard W. Hornung, Dr.P.H.); id. at 50-131 (testimony of Lynda Taylor, with supporting studies).

(24) See Samet, Lung Cancer Mortality in New Mexico Uranium Miners, supra note 22, at 745-752; Hornung, supra note 22, at 49- 53.

(25)Lubin, et. al, National Institutes of Health, Radon and Lung Cancer Risk: A Joint Analysis of 11 Underground Miner Studies (1994)(NIH Publication No. 94-3644).

(26)This statistical risk model was developed in 1988 by the National Research Council's Committee on the Biological Effects of Ionizing Radiations (BEIR IV). The BEIR IV model was based on a pooled analysis of four epidemiological studies of underground miners, including the uranium miners of the Colorado Plateau and New Mexico. The 1994 NCI-led pooled analysis included approximately eight times the data available to the BEIR IV Committee.

(27)Final Report, supra note 9, at 814.

(28)Apparently, this is the same conclusion reached by the Advisory Committee. In its Final Report, the Advisory Committee recommended changes to the Act and regulations that it believed would provide compensation to all miners entitled under the "balance of probabilities" principle. See Final Report, supra note 9, at 814.

(29)The probability of causation (PC) can be thought of as the chance that a specific case of lung cancer in a subject population was caused by a given exposure. More formally, it is defined as the excess risk of lung cancer in the subject population (the risk in the exposed population minus the risk in the unexposed population) divided by the risk of lung cancer in the exposed population. See Ben Armstrong & Gilles Theriault, Compensating Lung Cancer Patients Occupationally Exposed to Coal Tar Pitch Volatiles, 53 Occupational Envir. Med. 160, 162 (1996).

(30)P.L. 101-246, § 2(a)(3), 104 Stat. at 920.

(31)Id. § 2(a)(5), 104 Stat. at 920.

(32)H.R. 5022, 100th Cong., 2d Sess. (1988).

(33)Hearings on Health Effects of Radiation Exposure, supra note 24, at 41. In a later colloquy with Senator Hatch, Dr. Archer made clear that in his opinion the association between lung cancer and radiation exposure for many miners was more than probable -- it was virtually certain:

Senator Hatch: And how would you rate the probability with regard to the contribution toward cancer? Would it also be a high probability?

Dr. Archer: Yes, extremely high.

Senator Hatch: To use your terms, almost a certainty?

Dr. Archer: Yes.

Senator Hatch: That's a fair statement?

Dr. Archer: Among those with higher exposures, yes, it is almost certainly due to radiation.

Id. at 43-44.

(34)Hearings on Impact of Past Uranium Practices, supra note 23, at 23, 31.

(35)H.R. 2372, 101st Cong., 2d Sess. § 5(a)(1) (1990).

(36)"I admit that I have some problems with the lack of a requirement for proof of causation under the Compensation program which this bill creates, however, I understand the difficulty in proving such claims. I am aware that there is some confusion among our medical experts today as to which diseases are caused by exposure to radiation and the inclusion of some of those diseases and the coverage of claims program set forth in this bills troubles me to some extent. However, I have no proof as to the medical certainties that will deny the coverage of certain of these diseases any more that I have proof that will confirm a need for coverage of these diseases and, therefore, I am willing to err on the side of compassion rather than on the side of denial to those who have become ill." 136 Cong. Rec. 12636 (1990)(statement of Rep. James).

(37)Id. at 12638 (statement of Rep. Hansan).

(38)136 Cong. Rec. S11752 (daily ed. Aug. 1, 1990).

(39)See id. at S11749-50 (substituting bill for H.R. 2372).

(40)Id. at S11752.

(41)136 Cong. Rec. H8276 (daily ed. Sept. 27, 1990).

(42)Id. at H8278. Indeed, the Senate amendments, excluding other possible causes for the various compensable diseases, apparently assuaged Representative James' concerns that claimants might be compensated though radiation was not the most likely or probable cause of the illness. During the House reconsideration of H.R. 2372, as amended, he stated that "I realize that this bill, as amended by the Senate, does include additional requirements for compensation. In this light, I would like to commend our colleagues in the Senate for their attempt to address the lack of requirement for proof of causation in the original House-passed Bill." Id. at H8275.

(43)S. 1994, 101st Cong., 1st Sess. § 2142(c)(1)(A)(ii)(I) (1989).

(44)S. 2466, 101st Cong., 2d Sess. § 2144(c)(1)(B)(ii) (1990).

(45)S. Rep. 101-264, 101st. Cong., 2d Sess. 23-27 (1990)(emphases added). The Report emphasized that the designated exposure level reflected a high degree of probability of association between exposure and disease:

Because of the possibility that any given cancer may or may not have been directly caused by low level radiation, and because

this legislation attempts to compensate those victims with the highest probability of cancer due to ... uranium mining, the requirements for filing a petition have been narrowly drawn. ... The uranium mines found in the ... listed states were those with the highest levels of radon. The time periods for ... working in the mines are those periods when the levels of radiation were at their greatest. And finally, only those cancers which have strong evidence of being caused by radiation are included in the list of diseases.

Id. at 29.

(46)S. 2466, 101st Cong., 2d Sess. § 2141 (1990).

(47)S.J. Res. 77, 99th Cong., 1st Sess. (1985)(Amendment 772).

(48)131 Cong. Rec. 32080-82 (1985). See also id. at 32079 (statement of Sen. Stafford); id. at 32085 (statement of Sen. McClure).

(49)We recognize that the legislative history is not without ambiguity, and is susceptible to at least one alternative reading -- that Congress sought to compensate miners with lung cancer who were exposed sufficiently to radon progeny to elevate the probability of causation above the background risk of lung cancer in the non-exposed population, even if that probability of causation was less than 50%. E.g., P.L. 101-426 § 2(a)(3), 104 Stat. at 920 (explicit congressional finding in RECA that "radiation released in underground uranium mines that were providing uranium for the primary use and benefit of the nuclear weapons program of the United States Government ... are presumed to have produced an increased incidence of lung cancer and respiratory disorders among ... miners.")(emphasis added). The Committee believes that when one considers the entire legislative history, and particularly the Senate rejection of S.J. Res. 77, this interpretation is less plausible than the one on which we rely.

(50)Indeed, the 1994 NCI-led analysis confirmed this conclusion. It found that a risk model dependent on a single, constant exposure level did not adequately fit the observed data in any of the eleven miner cohorts examined. This result also suggests, of course, that the statutory criterion holding all nonsmoking miners to a single exposure standard (200 WLM) is inconsistent with the known data.

(51)If the association is truly multiplicative, the proportional increase in the risk of lung cancer due to exposure

to radon (i.e., the relative risk) will be the same in smoking and nonsmoking miners. The lung cancer rate in smokers is significantly greater (10 times or more) than in nonsmokers. Consequently, the absolute increase in the risk (i.e., the number of excess lung cancer deaths) will be greater in smokers than in nonsmokers.

(52)This is also the approach presently taken by the Environmental Protection Agency in devising appropriate risk models to estimate the lung cancer risk from residential radon exposure. See EPA, Technical Support Document For 1992 Citizen's Guide to Radon (1992)(EPA Publication 400-R-92-011).

(53)Oversight of Radiation Exposure Compensation Act: Hearings before the Senate Committee on Labor and Human Resources, 103rd Cong. 1st Sess. 19, 21-22 (1993)[hereinafter Hearings on Oversight of RECA].

(54)Final Report, supra note 9, at 814 ("[The NCI] analysis finds little evidence to support a distinction between smokers and nonsmokers ....").

(55)The converse is not necessarily true: selecting a submultiplicative association does not necessarily disadvantage smoking miners. If one develops compensation criteria for smokers based on data segregated by smoking status, the resulting exposure levels are not appreciably greater than levels generated for the combined data sets. This is because the majority of uranium miners were smokers. See Hornung, supra note 22, at 52 (83% of miners in the Colorado Plateau cohort reported they are current or former smokers as of 1986).

(56)Our analysis of the cohort data suggested that there may be a somewhat greater exposure-response effect in Native American (Navajo) miners than in non-Native American miners. Thus, an equivalent exposure to radon progeny in the mines may increase the relative risk of lung cancer in Native American miners more than in non-Native American miners. However, the difference in the effect of radon was estimated very imprecisely and was not close to statistical significance. In the pooled data from the two cohorts, there was a total of 35 Native American lung cancer cases -- too few to determine to an acceptable degree of confidence any statistically different effects in Native American miners.

(57)This measure is different from the uncertainty due to the inaccuracy or imprecision of any individual miner's computed exposure to radon progeny. See infra pp. 40-41. The potential error introduced by the use of the mine data arises from the fact that the measured exposure level may not be a true measure of the miner's exposure. The uncertainty associated with statistical sampling, which we account for here, is due to the process of randomly sampling data.

(58)The interval defined by the amount of uncertainty, of course, covers values both greater than and less than the listed criterion. Thus, it is equally probable that the miner's true relative risk lies above the criterion than below. Nonetheless, we recommend that the upper boundary be used because it minimizes the number of false negatives, i.e., claimants rejected though their true relative risk is equal to or greater than the designated criterion. As a consequence, of course, there will be an increase in the number of false positive claims compensated.

(59)Final Report, supra note 9, at 814; Hearings on Oversight of RECA, supra note 53, at 20, 22 (testimony of Jonathan Samet, M.D., M.P.H.); Richard W. Hornung & Theodore J. Meinhardt, Quantitative Risk Assessment of Lung Cancer in U.S. Uranium Miners, 52 Health Physics 417, 422-24 (1987)(quantifying the error in mine exposure data).

(60)The Program calculates a claimant's cumulative exposure by aggregating exposures in mines where the claimant can prove employment over the period of employment. Exposure levels in a given mine and for a given year are generated by an algorithm developed by Dr. Archer and his colleagues for use in the Public Health Service study of the Colorado Plateau Miners. Actual measurements are used for a mine and year, where they exist; where no measurements exist for any given year in the mine, measurements from the same mine within a span of adjoining years (in either direction) are averaged and used. Where there is insufficient data for interpolation or projection, an average of measurements from mines in the same locality are used. Estimates of radon levels before 1950, when a systematic sampling program began, are based on knowledge of ore bodies, ventilation practices and earliest measurements. 28 C.F.R. § 79.34(g); see Lundin, supra note 22, at 32.

(61)As noted above, we accept the Advisory Committee's suggestion that the Act be modified to incorporate a threshold criterion based on duration of employment, as opposed to exposure to radon progeny. See Final Report, supra note 9, at 813. The data indicate, however, that a model based on a single factor such as duration of employment does not accurately describe the relative risk of lung cancer in miners. Cf. supra note 50 and accompanying text. Including the variables noted above enhances the accuracy of the relative risk model, ensuring a fairer distribution of compensation.

(62)In this analysis, we used calendar year of first employment underground as a surrogate for each calendar year of underground employment. The data on the relevant mining cohorts reveal that only a small proportion of miners had significant exposure-free time periods in their work histories. Although it is reported that many miners were itinerant, gaps in work history were generally a matter of months. Because the radon levels in the mines generally declined over a miner's period of employment, the use of calendar year of first employment as a surrogate likely overestimates any given miner's exposure to radon.

Moreover, the experience of the Program, from what we have been told, suggests that for most miners, employment history and year of first mining can be determined with some accuracy -- at least greater accuracy than cumulative exposure to radon based on the historical mine measurements. Consequently, there is much less chance that a miner will be misclassified using these criteria.

(63)The criteria defined by Tables 3 and 4 were applied to the 470 known lung cancer cases occurring in the pooled Colorado Plateau and New Mexico data to determine how many would be eligible for compensation. Using the model based on cumulative

exposure: 388 cases (83%) would be eligible under Table 3(a)(no modification for uncertainty); 401 cases (85%) would be eligible under Table 3(b)(80% level of assurance); and 403 cases (86%), would be eligible under Table 3(c)(90% level of assurance). See Tables 5(a)-(c). Using the model based on duration of employment: 349 cases (74%), would be eligible under Table 4(a); 394 cases (84%) under Table 4(b)(80% assurance); and 408 (87%) under Table 4(c)(90% assurance). See Tables 6(a)-(c). Under the present RECA criteria, 68% of the observed lung cancers would be attributed to radon exposure and compensated.

(64)28 C.F.R. § 79.31(f).

(65)Id. § 79.31(g).

(66)Id. § 79.37(a).

(67)Id. § 79.37(b).

(68)The Program has imposed this presumption to force claimants to submit the "six months documents" when no or incomplete smoking information is available. Absent the presumption, a claimant who was a smoker is unlikely voluntarily to submit the necessary medical records documenting smoking. It seems reasonable to assume that some reference as to the claimant's smoking history will be made by a physician in the appropriate medical records within six months of the date of diagnosis of lung cancer. If no such reference exists, it seems reasonable to assume the claimant is a nonsmoker.

(69)The significant majority of Native American underground uranium miners were Navajo, see Victor E. Archer, et al., Respiratory Disease Mortality Among Uranium Miners, 271 Annals N.Y. Acad. Sci. 280, 290 (1976)(780 non-Whites in Colorado Plateau cohort, majority of which were Navajo); see also Robert J. Roscoe, et al., Mortality Among Navajo Uranium Miners, 85 Am. J. of Public Health 535, 536 (1995)(update of Colorado Plateau cohort; 775 of 779 non-Whites in cohort as of 1990 were Native Americans, majority of which were Navajo), and we have therefore focused on data specific to that Tribe. Because few non-Navajo Native Americans are represented in the underground mining cohorts, we have phrased this recommendation with specific reference to the Navajo.

(70)See Jonathan M. Samet, et al., Mortality From Lung Cancer and Chronic Obstructive Pulmonary Disease in New Mexico, 78 Am. J. of Public Health 1182-1186 (1988); Samet, Uranium Mining and Lung Cancer in Navajo Men, supra note 22, at 1483; Maurice L. Sievers, Cigarette and Alcohol Usage by Southwestern American Indians, 58 Am. J. of Public Health 71-82 (1968).

(71)Samet, Uranium Mining and Lung Cancer in Navajo Men, supra note 22, at 1383. While it is arguable that the low incidence of smoking among Navajo generally does not translate to the Navajo males who mined uranium, this report suggests the contrary. The report was a population-based case-control study of 32 lung cancer cases among Navajo males. Of the 32 subjects with lung cancer, 23 reported uranium mining employment. Smoking data were available on 21 of the 23 uranium miners: 8 were never smokers, 8 consumed less than 3 cigarettes/day; and 5 consumed 4- 8 cigarettes/day. Id.

(72)The background rate of lung cancer among Navajo is quite low -- much lower than the rate for non-Hispanic Whites. See Charles L. Wiggins, et al., Cancer Mortality Among New Mexico's Hispanics, American Indians, and Non-Hispanic Whites, 1958-1987, 85 J. of the Nat'l Cancer Inst. 1670, 1672 (1993). During the period 1958-62, the rate of cancer of the respiratory system (including cancers of the lung, trachea and bronchus) among all New Mexico Native Americans, a category composed primarily of Navajo, Pueblo and Apache, was 5.3/100,000; the rate among Non- Hispanic Whites was 30.1/100,000. Id. at 1670. During the period 1983-87, the rate among New Mexico Native Americans had increased to 13.1/100,000; the rate among New Mexico Non-Hispanic Whites had increased to 57.4/100,000. See also New Mexico Tumor Registry, U. of New Mexico Cancer Research and Treatment Center State of New Mexico: Malignancies Diagnosed 1993.

(73)American Thoracic Society, Cigarette Smoking and Health, 153 Am. J. of Resp. Crit. Care Med. 861, 864 (1996).

(74)Ian T. Higgins & Ernst L. Wynder, Reduction in Risk of Lung Cancer Among Ex-smokers with Particular Reference to Histologic Type, 62 Cancer 2397, 2401 (1988); Eugene Rogot & James L. Murray, Smoking and Causes of Death Among U.S. Veterans: 16 Years of Observation, 85 Pub. Health Rep. 213, 219 (1980).

(75)See Lawrence Garfinkel & Edwin Silverberg, Lung Cancer and Smoking Trends in the United States Over the Past 25 Years, 41 CA-A Cancer Journal for Clinicians 137, 143-44 (1991); U.S. Department of Health and Human Services, The Health Benefits of Smoking Cessation 122-126 (1990).

(76)Garfinkel & Silverberg, supra note 75, at 143; Higgins & Wydner, supra note 74, at 2398.

(77)See Higgins & Wydner, supra note 74, at 2398.

(78)In its commentary accompanying Recommendation 7, the Advisory Committee noted that the compensation criteria for uranium miners in RECA are "far more stringent" than for the other two groups eligible for compensation. Final Report, supra note 9, at 814. The effect, the Advisory Committee noted elsewhere, is to set a much higher risk threshold for compensation for the miners than for either the downwinders or the on-site participants. Id. at 578. The exposures to ionizing radiation of residents of surrounding areas were likely lower than those of personnel stationed at the test sites. The disparity in comparable risk for compensation is greatest, therefore, between miners and downwinders. For this reason, we focus on downwinders and not on on-site participants.

(79)The Act requires the claimant to have been physically present in any of eight counties in Utah, six counties in Nevada, or a defined geographic area of Arizona for either a period of at least two years during the period January 21, 1951 to October 31, 1958, or for the entire period beginning June 30, 1962 and ending July 31, 1962. P.L. 101-426, § 4(a)(2), 104 Stat. 921.

(80)See 131 Cong. Rec. 32075-77 (1985) (statement of Sen. Hatch).

(81)136 Cong. Rec. S11752 (daily ed. Aug. 1, 1990).

(82)See John D. Boice, Jr. & Jay H. Lubin, Occupational and Environmental Radiation 15-18 (April 23, 1996)(manuscript submitted for publication; on file with the Committee)(citing studies).

(83)There are substantial differences between the two populations in both the effective dose of radiation received and the resulting cancer risk at threshold doses for compensation. It is estimated that 97% of the downwind population received an effective external radiation (gamma) dose of less than .01 Seivert (Sv); the 200 WLM exposure minimum in the Act corresponds to an effective dose of 1 Sv. Jonathan M. Samet & Fred A. Mettler, Jr., The Radiation Exposure Compensation Act: Well Intended But Needing Revision 5-6 (unpublished manuscript on file with the Committee). Miners are not compensated, therefore, until they have been subject to an effective dose 100 times that of downwinders.

Additionally, an exposure of 500 WLM, the statutory minimum for most smoking miners, (assuming a 30 year-old miner exposed at a constant rate of 100 WLM for 5 years, and using the 1994 NCI risk model), increases a miner's estimated lifetime lung cancer risk, conservatively, by approximately 20 percent. Id. An effective dose of .01 Sv, on the other hand, is estimated to raise a downwinder's lifetime cancer risk by approximately .05 percent. Id. The incidence of lung cancer among uranium miners in the Colorado Plateau cohort is over 5 times the expected rate in the area population. Robert J. Roscoe, An Update of Mortality Among Uranium Miners from the Colorado Plateau Study Group, ___ Am. J. of Indus. Med. (forthcoming 1996). On the other hand, the incidence of the compensable malignancies (including childhood leukemia and thyroid cancers) in the downwind population is not significantly elevated. See Boice & Lubin, supra note 82, at 15- 18 (citing studies).

(84)Hearings on Oversight of RECA, supra note 53, at 18, 21 (testimony of Jonathan Samet, M.D., M.P.H.).

(85)See Final Report, supra note 9, at 579.

(86)For example, the Act can be modified so that the level of compensation for miners is proportionate to the calculated probability of causation. Under this scheme, a miner would receive some percentage of a maximum amount depending on the strength of the causal association -- an estimate of the likelihood that the miner's exposure to radon caused his disease. This is apparently the approach recommended by a number of expert scientific bodies, including the National Council on Radiation Protection and Measurements. See Hearings on Oversight of RECA, supra note 53, at 18-19 (testimony of Jonathan Samet, M.D., M.P.H.); Samet & Mettler, supra note 83, at 6. Cf. Armstrong & Theriault, supra note 29, at 162. This solution, however, does not directly address the issue of the comparability in the level of risk required for compensation among the various eligible groups.

(87)P.L. 101-426, § 5(b)(3), 104 Stat. at 923. The Advisory Committee did not specifically identify any of the nonmalignant disease provisions in the Act, or implementing regulations, as possibly unjust or inappropriate. Neither did the Interagency Working Group in its charge to the Committee. Nonetheless, we were confronted with numerous criticisms of the nonmalignant disease statutory provisions and corresponding regulations during our investigation, many of which raised issues of obvious importance to the administration of the Act. To perform our function competently, we conclude, we must address these issues.

(88)Id. § 5(a), 104 Stat. at 922.

(89)See 28 C.F.R. § 79.34 (1995).

(90)Id. § 79.33.

(91)See id. § 79.34.

(92)Id. § 79.36.

(93)Id. § 79.36. Claimants who are or were part of the PHS or NIOSH health studies, or any other federally-funded health study, may not need to submit medical documentation. The Program will accept as proof of medical condition verification by the PHS, NIOSH or federally-funded study that they possess medical records of the claimant containing a diagnosis of a compensable

nonmalignant disease. Id. § 79.36(b),(c). Further, the regulations do not necessarily require proof of both physical abnormality and functional impairment in the case of a deceased miner. Surviving beneficiaries of a deceased miner are required to submit chest radiographs alone, or if they do not exist, other trustworthy medical records containing appropriate statements of diagnosis; proof of functional impairment is not required for obvious reasons. Id. § 79.36(d)(i). The regulations do require proof of both disease and functional impairment from all living miners. Id. § 79.36(d)(ii).

(94)Id. § 79.36(d)(ii).

(95)The Act designates both pulmonary fibrosis and fibrosis of the lung as compensable nonmalignant diseases. These terms refer to the same disease process. We recommend that the term "fibrosis of the lung" be deleted from the Act as redundant.

(96)See P.L. 101-426, § 5(a)(2)(A),(B), 104 Stat. at 922.

(97)Oversight of Radiation Exposure Compensation Act: Hearings Before the Senate Committee on Labor and Human Resources, 103rd Cong., 1st Sess. 19, 22 [hereinafter Hearings on Oversight of RECA](testimony of Jonathan Samet, M.D., M.P.H.).

(98)There appears to be very limited historical data on dust levels in the mines during much of the time period covered by the statute. Therefore, it is questionable whether a direct quantitative assessment of the association between uranium mining and nonmalignant respiratory diseases can be estimated. It is possible, though by no means obvious, that data from other hard rock mining can be used to generate appropriate criteria.

(99)Health Effects of Radiation Exposure: Hearing Before the Senate Committee on Labor and Human Resources, 101st Cong., 2nd Sess. 35 (1990) [hereinafter Hearings on Health Effects of Radiation Exposure].

(100) See,e.g., Victor E. Archer, et al., Respiratory Disease Mortality Among Uranium Miners, 271 N.Y. Acad. Sci. 280-293 (1976); Joseph K. Wagoner, et al., Mortality Patterns Among United States Uranium Miners And Millers, 1950 Through 1962; Preliminary Report in, 1 Radiological Health and Safety in Mining and Milling of Nuclear Materials 37-48 (1964); Victor E. Archer, et al., Pulmonary Function Of Uranium Miners, 10 Health Physics 1183-1194 (1964); Victor E. Archer, et al., Epidemiological Studies of Some Non-Fatal Effects of Uranium Mining, in 1 Radiological Health and Safety in Mining and Milling of Nuclear Materials 21-35 (1964).

(101)See Impact of Past Uranium Practices: Hearings Before the Subcomm. on Mineral Resources, Development and Production of the Senate Committee on Energy and Natural Resources, 101st Cong., 2nd Sess. at 59-60 (1990)[hereinafter Hearings on Impact of Past Uranium Practices](testimony of Lynda Taylor). This same witness appended to her testimony a paper by Dr. Joseph K. Wagoner, S.D. Hyg., explaining these findings in some greater detail, and listing all appropriate references. See id. at 69-71, 96-97 (testimony of Lynda Taylor).

(102)Hearings on Health Effects of Radiation Exposure, supra note 99, at 43-44.

(103)See id. at 46-49.

(104)Id. at 46-47.

(105)Id. at 41 (emphasis added).

(106)See Jonathan M. Samet & Steven Q. Simpson, Review of Silicosis and Other Pneumoconioses in Underground Uranium Miners (Aug. 7, 1992)(Final Report Task 1); Jonathan M. Samet & Marion V. Morgan, Review of Silicosis and Other Pneumoconioses in Underground Uranium Miners: A Review of Data Sources (Aug. 7, 1992)(Final Report Task 2).

Section 12 of the Act specifically provides that:

The Secretary of Health and Human Services shall submit a report on the incidence of radiation related moderate or severe silicosis and pneumoconiosis in uranium miners employed in the uranium mines that are defined in section 5 and are located off the Indian reservations.

P.L. 101-426, § 12(a), 104 Stat. at 926.

(107)Samet & Simpson, supra note 106, at 31-33.

(108)Id. at 31-33.

(109)Id. at 24-25, 33.

(110)Id. at 27-29, 32.

(111)See P.L. 101-426, § 5(a)(2)(A),(B), 104 Stat. at 922.

(112) Id.

(113) See,e.g., Hearings on Oversight of RECA, supra note 97, at 22.

(114)See id. at 16 (testimony of Louise Abel, M.D.)("[T]he Reservation does not have any particular patent on causing silicosis. ... We have many uranium miners -- not many, some of the uranium miners who worked all over the Southwest, travelled around and worked off the reservation, who contracted silicosis ....); id. at 19 (testimony of Jonathan Samet, M.D., M.P.H.)("I certainly concur with Dr. Abel's statement concerning the requirement that those who receive compensation for silicosis have worked in the past on Indian Reservation lands. Certainly, silicosis extends well beyond the boundaries of the reservation.").

(115)Pneumoconiosis is the condition characterized by the deposition in the lung of substantial amounts of particulate matter, usually dust of occupational or environmental origin, and

the subsequent tissue reaction. Dorland's Illustrated Medical Dictionary 1318 (27th ed. 1988). Silicosis is the specific pneumoconiosis associated with inhalation of silica dust (crystalline silicon dioxide). See Marvin R. Balaan & Daniel E. Banks, Silicosis, in Environmental and Occupational Medicine 345 (William N. Rom ed., 2d ed. 1992). The Committee did not hear any information suggesting that uranium miners are at an increased risk of any pneumoconiosis other than silicosis. Consequently, compensation standards for silicosis are all that are recommended.

(116)136 Cong. Rec. S11752 (daily ed. Aug. 1, 1990). See also id. at S11753 (statement of Sen. DeConcini); id. at S11752 (colloquy between Senators Hatch and Domenici); 136 Cong. Rec. H8276 (daily ed. Sept. 27, 1990)(statement of Rep. Rhodes). The various congressional statements supporting the addition of these two diseases focus on the risk to Native Americans. Nonetheless, Congress heard testimony from a number of witnesses that both Native American and non-Native American uranium miners were at an increased risk of developing silicosis. See Hearings on Impact of Past Uranium Practices, supra note 101, at 10-11, 17 (testimony of Leonard Haskie, Interim Chairman of the Navajo Tribal Council); id. at 59 (testimony of Lynda Taylor); Hearings on the Health Effects of Radiation Exposure, supra note 99, at 35 (testimony of Victor Archer, M.D.); id. at 46-47 (testimony of Leon Gottlieb, M.D.).

(117)See supra pp. 62-63.

(118)Hearings on Impact of Past Uranium Practices, supra note 101, at 10-11.

(119)Id. at 59 (testimony of Lynda Taylor).

(120)D.R. Shawe, et al, Uranium and Vanadium Deposits, in [P-2] The Geology of North America 103-24 (H.J. Gluskoter, et al., eds., 1991).

(121)Id.

(122)See Samet & Simpson, supra note 106, at 2.

(123)Id. at 31.

(124)Id. at 31.

(125)See supra p. 61.

(126)See 28 C.F.R. § 79.36(d)(1)(ii). If the claimant is deceased, the eligible beneficiary(ies) need only submit one of a list of appropriate medical records containing a diagnosis of the compensable nonmalignant disease or sufficient information from which experts designated by the Department can make a diagnosis of the disease. Id. § 79.36(d)(1).

(127)See id.

(128)P.L. 101-426, § 5(a)(2)(A),(B), 104 Stat. at 922(emphasis added).

(129)Id. § 5(b)(3), 104 Stat. at 923.

(130)See 28 C.F.R. § 79.36(d)(1)(ii)(C); see also infra pp. 71-72.

(131)In fact, it is well established that there is a limited correlation between radiographic evidence of pneumoconiosis and functional impairment. See W.G.B. Graham, Silicosis, 13 Clinics in Chest Medicine 253 (1992); J.M. Peters, Silicosis, in Occupational Respiratory Diseases 227 (J. Merchant ed. 1986).

(132)There is no single, official definition of mild, moderate or severe pulmonary impairment. The existing regulations define moderate or severe impairment as a reduction in pulmonary function equal to or greater than 25%. See 28 C.F.R. § 79.36(d)(1)(ii)(B). The American Thoracic Society (ATS) guidelines, on the other hand, recommend that a patient be categorized as suffering mild impairment if their pulmonary function is reduced by 21% to 40%; moderate impairment if their pulmonary function is reduced by 41% to 49%; and severe impairment if the reduction in function exceeds 50%. American Thoracic Society, Evaluation of Impairment/Disability Secondary to Respiratory Disorders, 133 Am. Rev. Respir. Dis. 1205-06 (1986). These standards are consistent with those recommended by the American Medical Association. See AMA, Guidelines to the Evaluation of Permanent Impairment § 5.3, at 161-163 (4th ed. 1993). While the decision to adopt a slightly more stringent standard at the outset of the Program is understandable, the Committee recommends that the regulations be modified to adopt the ATS definitions of disease. Consistent with the well-documented healthy worker effect, there is reason to believe most of the miners had above- average pulmonary function, and therefore, have to suffer a greater than average reduction in function to meet the definition of moderate impairment. This supports using the more liberal definitions recommended by the ATS.

(133)136 Cong. Rec. S11753 (daily ed. Aug. 1, 1990).

(134)138 Cong. Rec. S1322 (daily ed. Feb. 7, 1992)(emphasis added).

(135)See D.E. Midthun & J.R. Jett, Clinical Presentation of Lung Cancer, in Lung Cancer: Principles and Practice 421-435 (H.I. Pass, et al., eds., 1996)(5 year survival rate of 15%).

(136)The compensable diseases for the two other classes of claimants covered by the Act -- downwinders and on-site participants -- are, subject to certain limitations, leukemia (other than chronic lymphocytic leukemia); multiple myeloma; lymphomas (other than Hodgkin's disease); and primary cancer of the thyroid, female breast, esophagus, stomach, pharynx, small intestine, pancreas, bile ducts, gall bladder and liver. P.L. 101-426, § 4(b)(2), 104 Stat. at 922. With the exception of childhood leukemia and cancers of the thyroid and female breast, the 5-year survival rates for these malignancies is 50% or less. For cancer of the pancreas, bile ducts, liver, gall bladder and esophagus, the 5-year survival rate is 10% or less. American Cancer Society, Cancer Journal for Clinicians 5-27 (1996).

(137)See infra pp. 84-89.

(138)Cf. Pierre A. Gevenois, et. al., Low Grade Coal Worker's Pneumoconiosis: Comparison of CT and Chest Radiography, 35 Acta Radiologica 355 (1994)(the functional significance of parenchymal abnormalities seen only on HRCT remains unknown); Lynell C. Collins, et al., High Resolution CT in Simple Coal Workers' Pneumoconiosis, 104 Chest 1156, 1160 (1993); Catherine A.Staples, et al., High Resolution Computed Tomography and Lung Function in Asbestos-Exposed Workers With Normal Chest Radiographs, 139 Am. Rev. Resp. Dis. 1502, 1507 (1989)(same).

(139)See 28 C.F.R. § 79.26(d).

(140)Id. § 79.36(d)(1)(i).

(141)Id. § 79.36(d)(1)(ii)(A).

(142)See James A. Merchant & David A. Schwartz, Chest Radiography for Assessment of Pneumoconiosis, in Environmental and Occupational Medicine, supra note 115, at 216-17. The scheme is known by the initials of the organization that established and periodically updates the guidelines, the International Labor Office (ILO). Under the ILO system, the reader also classifies the size and shape of the small opacities, and the extent of the profusion (the areas of the lung in which the opacities are observed). Id. at 216-17.

(143)See M. Remy-Jardin, et al., Computer Tomographic Evaluation of Silicosis and Coal Worker's Pneumoconiosis, 30 Radiological Clinics of North America 1155, 1174 (1992); Gevenois, supra note 138, at 355.

(144)28 C.F.R. § 79.36(d)(1)(i)(A).

(145)See AMA, supra note 132, § 5.1, at 158; see also 28 C.F.R. § 79.31(r).

(146)See, e.g., S. Padley, et al., Review Article: Current Indication for High-Resolution Computer Tomography Scanning of the Lung, 68 British Journal of Radiology 105 (Feb. 1995); David D. Hansell & Ian H. Kerr, The Role of High Resolution Computer Tomography in the Diagnosis of Interstitial Lung Disease, 46 Thorax 77 (1991); N. L. Muller & B. N. Ostrow, High-Resolution Computer Tomography of Chronic Interstitial Lung Disease, 12 Clinics in Chest Medicine 97 (March 1991); see also infra p. 85 (factors limiting sensitivity of radiographs).

(147)See Peters, supra note 131, at 227; see also Staples, supra note 138, at 1507 (citing studies).

(148)See Stuart M. Garay, Pulmonary Function Testing, in Environmental and Occupational Medicine 183, 187 (William N. Rom, ed., 2d ed. 1992).

(149)Richard W. Hornung, et al., Modifiers of Exposure- Response Estimates for Lung Cancer Among Miners Exposed to Radon Progeny, 103 Environ. Health Perspect. 49, 52 (1995); F.D. Lundin, Jr., et al., National Institute of Occupational Safety and Health-National Institute for Environmental Health Sciences, Joint Monograph No. 1, Radon Daughter Exposure and Respiratory Cancer, Quantitative and Temporal Aspects 19-20. Data suggest that dust or other agents in the mining environment can significantly increase the severity of impairment otherwise resulting from some obstructive lung diseases. M.R. Becklake, The Work Relatedness of Airways Dysfunction, in Proceedings of the 9th International Symposium on Epidemiology in Occupational Health (1994)(National Institute for Occupational Safety and Health, DHHS Publication No. 94-112). The Act does not compensate miners for any obstructive lung diseases.

(150)Cf. Padley, supra note 146, at 105 (reporting that in patients with suspected silicosis who smoke, pulmonary function correlates more accurately with the severity of underlying emphysema than with profusion seen on a radiograph).

(151)28 C.F.R. § 79.36(d)(1)(ii)(A).

(152)See Muller & Ostrow, supra note 146, at 97.

(153)Staples, supra note 138, at 1507; Remy-Jardin, supra note 143, at 1173; Gevenois, supra note 138, at 351.

(154)Hansell & Kerr, supra note 146, at 77; Muller & Ostrow, supra note 146, at 97.

(155)See supra pp. 73-74. Chest radiographs have also been found to have a significant false positive rate. Studies suggest that in as much as 10-20% of cases, if not more, a diagnosis of interstitial lung disease by chest radiograph is proved incorrect. See Padley, supra note 146, at 105; Gevenois, supra note 138, at 355.

(156)Padley, supra note 146, at 105; Hansell & Kerr, supra note 146, at 84; Muller & Ostrow, supra note 146, at 100-01.

(157)See Gevenois, supra note 138, at 352-55; Remy-Jardin, supra note 143, at 1174.

(158)Gevenois, supra note 138, at 355.

(159)A limited and unscientific sample of hospitals with HRCT capability in the Southwest Colorado-Northwest New Mexico area indicates that the average cost is approximately $660.

(160)See Joan F. Leonard & Philip A. Templeton, Pulmonary Imaging Techniques in the Diagnosis of Occupational Interstitial Lung Disease, 7 Occupational Medicine: State of the Art Reviews 241-42 (1992); Muller & Ostrow, supra note 146, at 99-100.

(161)Remy-Jardin, supra note 143, at 1157. Some advocates have expressed concern that HRCT equipment may not be sufficiently available in the areas with significant claimant populations. This is clearly an appropriate consideration, but the Committee believes the technology is sufficiently available in the area covered by the statute to be of benefit to many claimants. We have confirmed that HRCT scanners are available at facilities in Denver, Durango and Grand Junction, Colorado; in Albuquerque and Farmington, New Mexico; and at the Indian Health Service Hospital (Northern Navajo Medical Center) in Shiprock, New Mexico.

(162)In those circumstances where HRCT evidence is accepted, of course, there is the possibility that the more powerful diagnostic tool will reveal that the source of the claimant's physiological impairment is a noncompensable disease process. Thus, HRCT use will benefit the Program by reducing the risk that a claimant is improperly compensated because of a false positive diagnosis of fibrosis or silicosis.

(163)See, e.g., W. R. Webb, High Resolution Computed Tomography of the Lung: Normal and Abnormal Anatomy, 26 Seminars in Roentgenology 110 (1991).

(164)We leave to the Program the development of an appropriate protocol for selecting and reading the HRCT scans. We note that similar panels have been devised for diagnosing asbestos-related diseases in administrative compensation schemes settling class action litigation. We appreciate the concerns expressed by some miners and their representatives over the creation of some distant, nameless "Supreme Court" for diagnostic purposes. We believe this concern can be met simply by devising a fair system for selecting independent, acknowledged experts to serve on the panel, including, as appropriate, experts from the five mining states specified in the Act.

(165)28 C.F.R. § 79.36(d)(1)(i)(A).

(166)Id. § 79.36(d)(1)(ii).

(167)See, e.g., Padley, supra note 146, at 105; Leonard & Templeton, supra note 160, at 241-42; Muller & Ostrow, supra note 146, at 100-01.

(168)In light of our recommendation above that the Program accept HRCT evidence, we expect that few claimants will need to submit biopsy results. Cf. Jonathan B. Orens, et al., The Sensitivity of High-Resolution CT in Detecting Idiopathic Pulmonary Fibrosis Proved By Open Lung Biopsy, 108 Chest 109, 109 (1995)(because of resolving power of HRCT, necessity of performing biopsy to establish diagnosis of interstitial lung disease questioned); Hansell & Kerr, supra note 146, at 84 (HRCT may obviate the need for lung biopsies in patients with clinical evidence of lung abnormality and a normal chest radiograph).

(169)See supra pp. 50-51, 71-72.

(170)See 28 C.F.R. § 79.36(d)(1)(i)(C), (d)(1)(ii)(A). The regulations advertise that a list of certified readers is available from the Program. Id. § 79.31(r).

(171)See generally supra pp. 81-82, 85 & note 155.

(172)See supra pp. 79-80, 84.

(173)See supra p. 86.

(174)The rate of misdiagnosis and, consequently, the greatest degree of interreader variability, occurs at the lower profusion scores (less than 1/0), which indicates, in most cases, a milder stage of disease. See Leonard & Templeton, supra note 160, at 241-42; Remy-Jardin, supra note 143, at 1174. It is precisely in these cases, of course, that we recommend HRCT evidence be accepted. This, again, all but eliminates the risks to the claimant posed by faulty "B" readings.

(175)We wish to reiterate that we have seen no credible evidence indicating the Department is biased against compensation or seeks to deny claims wherever possible. In fact, from what we have seen, and what we have been told by many credible sources, the exact opposite is true. It appears to us that the Program goes to some lengths to assist claimants, particularly those not represented by counsel, to gather the necessary proof to establish eligibility. We are of the impression that where deserving claimants are denied compensation, it is not the good faith of the Program staff that is in question, but the statutory criteria or regulations.

(176)See 28 C.F.R. § 79.36(d)(1)(ii)(A).

(177)As an additional security measure, the interval between audits for any given "B"-reader could vary, as well. The interval could be randomly selected each time within a defined range.

(178)This review would be something akin to the "abuse of discretion" standard employed by appellate courts reviewing a variety of lower court determinations. Under this standard, for example, an appellate court may reverse the factual findings of a district court only if it finds the findings "clearly erroneous." See Cooter & Gell v. Hartmarx Corp., 496 U.S. 384, 401 (1990). This standard requires the appellate court to uphold any lower court determination that falls within the range of permissible conclusions. Id. at 400.

(179)We do not mean to imply by these suggested audit procedures that the Program should be stripped of the ability to audit readings under any other circumstances. The Program should have the right to have any given reading audited if there is evidence, other than the identity of the reader, to suggest it is untrustworthy.

(180)28 C.F.R. § 79.36(d)(1)(ii).

(181)Id. § 79.36(d)(1)(ii)(B),(C).

(182)See 28 C.F.R. § 79.36(d)(1)(ii)(B). More precisely, these tests provide a quantitative assessment of the volume changes achieved by various breathing maneuvers. Garay, supra note 147, at 189. They provide information for an analysis of volume-time and flow-volume relationships, allowing an assessment of the respiratory system in action. Id. See generally American Thoracic Society, Standardization of Spirometry - 1987 Update, 136 Am. Rev. Respir. Dis. 1285-98 (1987).

(183)Bruce A. Shaffer, et al., Prediction of Lung Function in Hispanics Using Local Ethnic-Specific and External Non-ethnic- specific Prediction Equations, 147 Am. Rev. Respir. Dis. 1349, 1349 (1993).

(184)28 C.F.R. § 79.36(d)(1)(ii)(B).

(185)See R.J. Knudson, et. al., Changes in the Normal Maximal Expiratory Flow-volume Curve With Growth and Aging, 127 Am. Rev. Respir. Dis. 725 (1983).

(186)See AMA, supra note 131, at 160; Arnold D. Renzetti, et al., Evaluation of Impairment/Disability Secondary to Respiratory Disorders: ATS Statement, 133 Am. Rev. Respir. Dis. 1205, 1206 (1986)(official statement of the American Thoracic Society).

(187)See Robert O. Crapo, et al., Normal Spirometric Values in Healthy American Indians, 30 J. of Occupational Med. 556 (1988). The authors derived "normal" predicted pulmonary function values for Native Americans by performing spirometry for 300 Native Americans. Of the test group, 75% of the women and 85% of the men were Navajo. Id. at 557. The overwhelming number of Native American underground uranium miners were Navajo. See supra note 68.

(188)Id. at 559.

(189)Id. at 560.

(190)The age distribution of the male subjects in the study ranged from 18-66. The median age of the male subjects was 33.9 +/- 12.8 years. Id. at 558.

(191)Id. at 559.

(192)See 136 Cong. Rec. at S11754 (daily ed. Aug. 1, 1990) (colloquy between Senators Hatch, DeConcini, Inoyue and McCain).

(193)Renzetti, supra note 186, at 1206.

(194)Id. See supra note 132.

(195)See 28 C.F.R. § 79.36(d)(1)(ii)(B).

(196)See supra p. 82.