2
Scientific Program Assessment: National Institute for Occupational Safety and Health

The committee reviewed the research priorities for the epidemiological projects, research project selection, dissemination of results of completed research, and contribution of research to the Department of Energy (DOE). The output of selected products of the Occupational Energy Research Program (OERP) of the National Institute for Occupational Safety and Health (NIOSH) program as of May 2006 is presented in Annex 2A. The remainder of this chapter presents material relevant to the committee’s statement of task as follows: (1) a review of selected but representative components of NIOSH’s research program for quality; (2) an evaluation of the research priorities to date; (3) a summary of the usefulness of the results of the NIOSH program and its impact on DOE policies and decisions; and (4) recommendations for enhancements of the NIOSH research program for the future.

To evaluate whether the research programs were of high scientific quality (i.e., methodologically sound, relevant, reasonable interpretation of results), the committee sampled research products at three DOE sites: Hanford, Oak Ridge National Laboratory (ORNL), and Los Alamos National Laboratory (LANL). The committee also reviewed selected multisite studies that included data from these three locations. These studies were judged by the committee to represent relevant combined analyses of occupational health DOE-wide and to be representative of the types of studies carried out across the program. In addition, because beryllium has been used extensively in various components and processes in the U.S. nuclear weapons industry since the 1940s, the committee reviewed the beryllium-related research performed under the Memorandum of Understanding (MOU).



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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services 2 Scientific Program Assessment: National Institute for Occupational Safety and Health The committee reviewed the research priorities for the epidemiological projects, research project selection, dissemination of results of completed research, and contribution of research to the Department of Energy (DOE). The output of selected products of the Occupational Energy Research Program (OERP) of the National Institute for Occupational Safety and Health (NIOSH) program as of May 2006 is presented in Annex 2A. The remainder of this chapter presents material relevant to the committee’s statement of task as follows: (1) a review of selected but representative components of NIOSH’s research program for quality; (2) an evaluation of the research priorities to date; (3) a summary of the usefulness of the results of the NIOSH program and its impact on DOE policies and decisions; and (4) recommendations for enhancements of the NIOSH research program for the future. To evaluate whether the research programs were of high scientific quality (i.e., methodologically sound, relevant, reasonable interpretation of results), the committee sampled research products at three DOE sites: Hanford, Oak Ridge National Laboratory (ORNL), and Los Alamos National Laboratory (LANL). The committee also reviewed selected multisite studies that included data from these three locations. These studies were judged by the committee to represent relevant combined analyses of occupational health DOE-wide and to be representative of the types of studies carried out across the program. In addition, because beryllium has been used extensively in various components and processes in the U.S. nuclear weapons industry since the 1940s, the committee reviewed the beryllium-related research performed under the Memorandum of Understanding (MOU).

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Specifically, the committee reviewed the following NIOSH research: Publications examining exposures at Hanford and ORNL in relation to cancer and non-cancer mortality—the committee also discusses the one single-site publication that used the LANL mortality data in a risk analysis; The U.S.-based multisite studies that include Hanford and ORNL data (the Childhood Leukemia Case-Control Study and the Female Nuclear Workers Study); The multisite case-control study of multiple myeloma and the ongoing multisite case-control study of leukemia; Non-radiologic health studies focused primarily on beryllium-related issues; and The contribution of DOE sites to international studies of cancer mortality among nuclear workers. COMPLEXITIES AND LIMITATIONS INVOLVED IN THE EPIDEMIOLOGICAL STUDIES One of the most contentious issues in the fields of radiation protection and radiation epidemiology relating to cancer causation is that of the linearity of the dose response and the related question of dose-rate effects, i.e., whether the same dose delivered over an extended period has different effects than a dose delivered instantaneously. High-dose studies, particularly the A-bomb survivor study, show unequivocally that radiation can cause cancer, including most leukemias and most solid tumors. Interpolation of the high-dose studies down to the levels of exposure that are experienced in today’s occupational settings indicates that workers exposed near the maximum levels (2 rem/year) allowed by DOE will experience perhaps a ½ percent to 1 percent increase in the relative hazard of all tumors (for each year of such exposure). Current radiation protection standards and compensation programs are based upon the results of this extrapolation of high-dose effects down to low dose. The considerable uncertainty, however, in this high-dose extrapolation provides the fundamental rationale for conducting epidemiological studies of occupational radiation. Direct studies of low-dose effects are desirable because there are scientific questions concerning the theoretical basis for extrapolation of human epidemiological data from acute radiation exposures in excess of about 200 mSv to lower doses delivered at the long-term chronic exposure rates experienced by most radiation workers. However, in direct studies of workers, the relatively low degree of excess risk poses enormous difficulties for epidemiological studies of current exposure levels, since even a perfect epidemiological study, where dose is known precisely and the chance for confounding is very limited, would require many decades of follow-up of hundreds of thousands of workers in order to accrue enough cases of cancer to have adequate statistical power to detect such relatively small increases. For example, to study the relationship between a spe-

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services cific outcome (disease of interest, e.g., overall or cause-specific cancer mortality) and radiation, if 20 percent of workers in the industry were exposed to enough radiation to result in a 10 percent increase in the outcome, it would be necessary to observe over 5,000 cases of disease (in a cohort study) or over 10,000 cases (in a 1-1 matched case-control study) before there would be good statistical power to detect that this level of radiation was harmful. It would be expected that less than 2 percent of all cases would be caused by exposure. Currently the total workforce at a large DOE facility is on the order of 10,000 people. These risks are at the limit of what current epidemiological methods can achieve, especially given that no analytic observational study is free of confounders, and that doses are not perfectly measured. Furthermore, individuals, or even groups of individuals, may differ in their susceptibility to exposures. For certain cancers (e.g., some leukemias), the relative risks due to radiation exposure may be considerably higher, so that far fewer cases of cancer are required in a study. However, even though the fraction of these types of radiogenic cancers is correspondingly higher, the cancers are often quite rare requiring a lengthy surveillance of large numbers of workers. Going beyond the expected small excesses of radiation-caused cancers, other important issues increase the difficulty of the epidemiological studies performed under the MOU. For example, the extraordinary history of the weapons plants, including the speed at which the processes and weapons were first developed, the rate at which the DOE workforces grew in the early years, the urgency of their mission, the complexity of the research and industrial processes, the many decades that this work force has been in existence, and the potentially long-lived effects of exposure on risk, all contribute to the challenges of epidemiological investigations performed under the MOU from the 1990s to the present. Only one exposure of interest, namely external radiation, is demonstrably captured with any degree of completeness, and even for this exposure there are continuing uncertainties, related to the uniformity of monitoring requirements, monitor performance, recording practices, and record retention. The situation for chemical exposures and for internal dose estimation appears to be rather more difficult, with large “documentation” gaps affecting the ability to either directly study these exposures as a cause of disease, or to correct for them in the analysis of radiation effects. The same applies to lifestyle-related exposures, especially to tobacco, a known cause of some of the same diseases (e.g., lung cancer) that are also of interest as an effect of radiation exposure. In addition, the socioeconomic status of various types of workers (known to affect health and mortality) has a complex interplay with exposure as well, with most exposures at most sites being received by lower-status workers. Over these studies as a whole, therefore, the committee notes enormous challenges in the evaluation of existing records of exposure, especially chemical and internal radiation exposures, but also in many cases (generally for the early years) to external penetrating radiation.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services DOE SINGLE-SITE MORTALITY STUDIES Oak Ridge National Laboratory, Hanford, and Los Alamos National Laboratory Epidemiological Studies There are three major DOE sites in the Oak Ridge area: ORNL (formerly the site of the X-10 reactor), the K-25 gaseous diffusion plant, and the Y-12/TEC site (formally the site of the electromagnetic separator and later of specialized research projects). According to Frome et al. (1997), only workers at the ORNL site and a fraction of the workers at Y-12 had individualized external dosimetry data that could be used in dose-response analyses. Data from one ongoing case-control study of multiple myeloma at the K-25 facility, which began in 1995, have yet to be analyzed. Much of the work has focused on ORNL (X-10). Data from Y-12 has apparently been used in only one published dose-response analysis (Frome et al. 1997); Y-12 has not been chosen for inclusion in the multisite leukemia study described below, having not met that study’s requirement that the potential for internal exposure be minimized. For similar reasons Y-12 workers have not been included in the international pooled studies (Cardis et al. 1995, 2005). Work began at the Oak Ridge and Hanford sites quite early, so many of the publications on Oak Ridge and Hanford are reports of work that were started under contract to DOE and were later transferred to NIOSH after the MOUs were initiated. The Hanford operations were larger than those at ORNL. More workers were monitored for radiation exposure, and the average dose of workers who were exposed to radiation was higher at Hanford (26 versus 22 mSv), although the general dose distribution was similar (Gilbert et al. 1993a). The fraction of subjects exposed to greater than 100 mSv is also similar at the two sites. Early studies included workers initially employed at Hanford between 1944 and 1978 and at ORNL between 1943 and 1972. Several analyses and reanalyses of the data have been undertaken. These have involved (1) updating the follow-up from the mid-1980s (Wing et al. 1991; Gilbert et al. 1993a) to the early 1990s; (2) expanding the ORNL cohort to include women and non-white workers as well as others not included in some earlier studies; and (3) working to improve the dosimetry data, partly through efforts to capture additional historical records and partly through improvements in the statistical treatment of missing doses (Gilbert et al. 1996; Xue et al. 2004; Daniels and Schubauer-Berigan 2005; Daniels et al. 2006; Richardson et al. 1999). In addition some work on internal plutonium exposure has been performed for the Hanford cohort (Wing et al. 2004) although no formal dose-response analysis has been possible since internal measurements are available only for small numbers of potentially exposed workers. In general, however, the cohort of workers studied at ORNL and Hanford has been fixed, with no new subjects entering the studies after the middle to late 1970s. Overall there is limited evidence from these sites of an ionizing radiation dose-response relationship for all cancers. For example Gilbert et al. (1993b)

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services found non-significant negative dose-response relationships between external penetrating dose and either solid tumor or leukemia mortality in the Hanford cohort (follow-up through 1986). A few specific tumor sites (multiple myeloma, cancer of the pancreas, and non-Hodgkin’s lymphoma) appeared to be positively related to exposure at a marginally statistically significant level. The estimated excess relative risks (ERRs)1 per unit exposure were found early on (Gilbert et al. 1993a) to be much greater in the ORNL data than in either the Hanford data or the data for A-bomb survivors (Gilbert et al. 1993a). However, because the ORNL cohort was considerably smaller than the Hanford cohort, 95 percent confidence intervals for ORNL still overlap the values for Hanford and include the null value indicating that no association was found between an increase in cancer risk and protracted low-level exposures. Some reports (Mancuso et al. 1977; Wing and Richardson 2005) have found that exposures received by workers at older ages were more strongly related to cancer occurrence than exposures received at younger ages, which runs counter to certain other epidemiological data such as for thyroid exposure to 131I from Chernobyl, as well as high-dose exposures among the A-bomb survivors and all solid tumor cancer incidence and mortality, where age at exposure has been found to be inversely related to ERR (NRC 2006a). As described below, even the most recent international pooled study of Cardis et al. (2005) did not take into account all available follow-up data from these two sites only follow-up data for ORNL and Hanford through 1984 and 1986, respectively, were made available to the International Agency for Research on Cancer (IARC) for the international study. Although the cohorts at LANL and ORNL are approximately the same size, fewer findings have been published from the LANL cohort than either ORNL or Hanford because dosimetry data were unavailable until recently. Data from this cohort were not included in the international pooled studies (Cardis et al. 2005), but this site has been chosen for inclusion in the multisite leukemia case-control study. The one published report that the committee reviewed (Wiggs et al. 1994) analyzed cause-specific mortality for approximately 15,000 white male workers who were hired between 1943 and 1977 and followed through 1990. The study found limited evidence of any dose-response relationships for radiogenic cancers. As with the other DOE sites, investigators were not able to control for potential confounding with lifestyle factors or occupational exposures other than ionizing radiation. 1 The ERR is the rate of disease in an exposed population divided by the rate of disease in an unexposed population minus 1.0.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services MULTISITE EPIDEMIOLOGICAL STUDIES In the 1980s the need for joint analyses of occupational groups was recognized and studies were underway. IARC began the three country study (Cardis et al. 1995) and Gilbert in the United States (Gilbert et al. 1989), and investigators in the United Kingdom (Carpenter et al. 1998) had initiated joint analyses of occupational groups. A key criticism made by the “Dead Reckoning” monograph (PSR 1992) of pre-MOU occupational radiation exposure studies at DOE sites was their reliance on small sample sizes at single facilities rather than on an overall evaluation of hazards to the entire DOE workforce. Pooling efforts therefore have been given priority, both under the MOU and in the study of nuclear workers in general (Cardis et al. 1995, 2005). A key issue impeding pooling has been the degree of heterogeneity of the types of radiation exposures considered. Generally, data from sites where internal radiation exposures are expected to predominate, such as Fernald, have not been pooled with data from cohorts exposed primarily to external penetrating radiation. In addition, the Portsmouth Navy Shipyard (PNS), a non-DOE site that services nuclear submarines and their components, where workers are exposed exclusively to external radiation, has been included in NIOSH’s work under the MOU. There were efforts even before the MOU to conduct combined analyses, such as in combining Hanford, ORNL, and Rocky Flats (Gilbert et al. 1989, 1993a); the goal of combining homogeneous DOE data has not yet been fully realized, however (see recommendations). In this section the committee reviews two different types of multisite studies conducted under the MOU: Multisite studies aimed at either incorporating additional sites beyond Hanford and ORNL into the analyses and/or addressing questions regarding dose estimation and confounding whether by lifestyle or other occupational exposures; and Special multisite studies addressing specific questions that have arisen in relation to exposures and health of the DOE workforce or their families, but not specifically directed at improving or extending the understanding of radiation health effects on the workforce as a whole (e.g., female workers study, study of childhood leukemia). Multisite Leukemia Case-Control Study The ongoing multisite leukemia case-control study is important both with respect to the findings it may report and as a pilot study for future proposed NIOSH studies of solid tumors. The proposed studies would use similar methods but would require considerably larger numbers of cases and controls because of the lower risks caused by radiation. Leukemia is the most radiogenic of all cancers, although this differs by leukemia subtype, with chronic lymphocytic leukemia (CLL) generally consid-

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services ered to be unrelated to radiation exposure (for an exception, see the recent study by Rericha et al. 2006). Excesses of leukemia have been observed at one DOE site, Savannah River (Cragle et al. 1988). Currently, the epidemiological evidence for effects of protracted exposure to low doses in elevating leukemia risk is somewhat equivocal. The 1995 international study (Cardis et al. 1995) found a significantly higher ERR estimate, but this weakened to borderline statistical significance in the 2005 update (Cardis et al. 2005). The committee’s evaluation of the multisite leukemia study is based on a protocol received from NIOSH, several published papers on methodology (Daniels and Schubauer-Berigan 2005; Daniels and Yiin 2006; Daniels et al. 2006), and a 2006 presentation by Mary Schubauer-Berigan (NIOSH) at the American Statistical Association’s 2006 radiation meeting. There have been important methodological findings from the multisite leukemia study. First, very little external dose was found to be “missed” because of either recording practices (e.g., round-off methods, detection limits) or missing records. For example, Daniels and Yiin (2006) presented a convincing case that only a few percent of total collective external dose was likely lost because of detection limit issues. Second, an intensive search for records on internal dose revealed a relatively small contribution (Daniels et al. 2006) to bone marrow dose from internal sources, although this contribution did appear to be positively correlated with external doses, leaving the possibility of some confounding of the effects of the two types of exposure. Finally, from the American Statistical Association presentation noted above, the investigators were successful in building a job exposure matrix to estimate exposure to carbon tetrachloride and benzene for cases and controls. These findings have relevance for evaluating the likelihood of success of proposed future work by NIOSH DOE sites (see recommendations). Furthermore, when properly combined with the IARC pooled analysis, this study could provide important information regarding leukemia risk as a function of protracted exposure to low-dose-rate radiation.2 Multisite Multiple Myeloma Study This study was undertaken by investigators at the University of North Carolina. The nested case-control method was used to assess exposure to radiation and chemicals, including benzene, among 98 cases with multiple myeloma and 391 controls. One published report (Wing et al. 2000) and an extensive final report3 2 About 30 percent of the cases in the multisite leukemia study are included in the IARC 2005 publication (NIOSH 1996, 2006). The multisite leukemia study had approximately 10 years more of follow-up from Hanford and ORNL and included four other sites (LANL, PNS, SRS, Zia) not included in the IARC publication. IARC analyzed 196 leukemia cases. This would be increased to approximately 340 in the combined analyses. 3 See http://www.cdc.gov/niosh/oerp/completed.html. Last accessed August 2006.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services were reviewed by the committee. The multisite multiple myeloma study found no overall excess risk due to exposure to external radiation. However, the investigators noted that doses received at older ages were positively related to risk, while doses received at younger ages were inversely associated with risk. The interpretation of this unexpected finding is not something about which the committee can make a judgment, but it could be a chance finding as a result of multiple comparisons. However, in light of findings in the ORNL and Hanford studies of positive associations for doses received at older ages and null associations at younger ages, this result does suggest that the issue of age interactions with exposure needs further investigation, possibly through pooling of studies, including DOE and international nuclear worker studies. One study that could potentially add valuable information to address this question is the multiple myeloma study being conducted at the K-25 (the Oak Ridge Gaseous Diffusion Plant) facility. This separate single-site study has a large number of cases of multiple myeloma for a rare cancer (63, according to the Agency for Toxic Substances and Disease Registry [ATSDR]4), but it has been considerably delayed from its original expected completion date of 2002. Multisite Female Nuclear Workers Mortality Study The pooled female worker study surveyed the mortality of approximately 68,000 female workers at 12 DOE sites (Wilkinson et al. 2000).5 The mean cumulative doses (external) for those monitored ranged from 0.6 mSv at Fernald to approximately 10 mSv at Savannah and the maximum lifetime dose for any monitored female worker ranged from 51 mSv at Fernald to 420 mSv at Los Alamos (Table 16). There was a total of 88 person Sv (Table 17) collective exposure in total for all monitored female workers at the facilities included in the study. The multisite female worker study sought in two ways to determine whether some lethal radiation effects may be unique to, or more common in, females: first, by an overall survey of death certificates, and second, as a follow-up on the one positive finding from the mortality survey, by a case-control study of mental disorders. Since approximately two-thirds of the women in the mortality survey did not have records of external radiation exposure, a “yes-no” surrogate for radiation exposure between badged and unbadged workers was used in many analyses. Overall mortality and overall cancer mortality, especially from lung cancer, were higher in the unbadged than the badged workers. In addition, a few positive associations between the yes-no surrogate and the risk of cancer or other diseases were noted, and death due to so-called mental disorders was elevated in the badged group. The general tendency for unbadged workers to have higher 4 See http://www.atsdr.cdc.gov/HAC/oakridge/phact/c_1.html#213. Last accessed August 2006. 5 See http://www.cdc.gov/niosh/oerp/pdfs/2001-133g17.pdf. Last accessed October 2006.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services cancer mortality than badged workers is likely due to differences in lifestyle factors, particularly smoking, that could not be controlled for in this analysis. The significant finding for mental disorders was followed up in a case-control study in which individual dose estimates were obtained (Sibley et al. 2003). While a marginally significant dose response for this outcome was observed, the biological basis of such an effect if it is confirmed is unclear. However, since many outcomes were surveyed, multiple comparisons may have produced a chance finding. Among approximately 21,000 women with external monitoring data, statistically significant positive dose responses, based on a total of 11 deaths, were observed for leukemia and suggestive results were obtained for all cancer mortality and breast cancer mortality. To increase sample size, female workers from 12 DOE sites were considered in the analysis. As noted by the authors, workers received both internal and external radiation exposures. Therefore the exposures may have been both more heterogeneous and less well measured by radiation badges than in studies such as the multicenter leukemia case-control study, which concentrated on DOE sites where external exposures were expected to predominate. In addition, lack of control for confounding and lack of any quantitative dosimetry for most workers limit the contribution of this study to understanding worker-related adverse health outcomes or sex-specific response to radiation. Multisite Offspring Leukemia Study The committee reviewed one case-control study of childhood leukemia in relation to pre-conception parental exposure among children living in locations near three DOE nuclear facilities (Idaho, Oak Ridge, and Hanford) (Sever et al. 1997). This study was designed to follow-up on the well-known Sellafield study (Gardner et al. 1990) that found an association between pre-conception paternal radiation exposure at the Sellafield nuclear plant in the United Kingdom and risk of childhood leukemia. A total of 233 cases of childhood cancer with either parent employed at any one of three DOE sites were identified from hospitals, cancer registries, and death certificates, and 4 controls were chosen for each case from among parents of children without cancer working at the same DOE sites. The comparison of cases and controls gave no indication of a positive association between childhood leukemia and parental dose, since for all three worksites the mean dose to the fathers of cases prior to conception was lower than the mean dose to the fathers of controls prior to conception. This study made a significant contribution to a topic of interest. While limited in statistical power, the results of the study were consistent with subsequent similar studies that also did not support the findings at Sellafield.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services International Collaborative Study of Nuclear Industry Workers This study conducted by IARC was partially funded by NIOSH through the OERP extramural research program. The study updated the earlier IARC study (Cardis et al. 1995) of mortality data from nuclear workers in 3 countries, expanding it to include data for worker cohorts from a total of 15 countries (Cardis et al. 2005). The stated goals of the study were to include data from existing cohorts with individual monitoring data for external penetrating exposures and with follow-up for mortality for all cohort members. This study included data from three DOE sites: Idaho National Laboratory (INL), Hanford, and ORNL. IARC and its collaborators conducted a series of studies of dosimetry practices (Gilbert et al. 1996) exposure conditions, and dosimeter response (Thierry-Chef et al. 2002) in support of the efforts to meaningfully combine radiation dosimetry data from all 15 countries and the various facilities therein. While this study of approximately 600,000 workers (which included approximately 5,000 deaths from cancer in the main analyses) is the largest study in existence of low-dose external penetrating exposure to workers, it does necessarily suffer from many of the same drawbacks as do the DOE studies. While facilities where internal radiation doses were the predominant source of exposure were likely excluded from study, the potential for confounding by chemical and tobacco exposure and other workplace exposures remains a serious concern. Overall, a positive dose response for solid tumors was reported, amounting to approximately a 1 percent increase in the relative risk of solid tumor mortality for each 10 mSv of cumulative exposure. The confidence intervals for this estimate remained wide, however, and thus the estimated risk is not inconsistent with the (lower) risk estimates from the A-bomb survivors. It is especially notable that approximately 43 percent of cancers were at tumor sites considered to be smoking-related. Since risk estimates for these tumor sites may be seriously biased if tobacco use and radiation exposure are correlated, additional analyses were conducted restricted to solid tumor sites unrelated to smoking. These showed somewhat smaller risk estimates and were not statistically significant. For leukemia, not including CLL, a non-significant positive slope was estimated. In the committee’s overall appraisal, the IARC study is regarded as important, but as described below, there are important gaps related to the contribution or exclusion of data from specific DOE cohorts, and the length of mortality follow-up used for Hanford and ORNL. Non-Radiologic Health Studies As highlighted in NIOSH public information documents, workers at DOE facilities have been exposed to a variety of chemical and physical hazards (e.g., solvents, gases, metals and other toxicants, loud noises, heat, non-ionizing radia-

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services tion), some of which are unique to specific DOE facilities.6 In fact, NIOSH points out that “the chemical exposures may actually be the primary concern for certain health outcomes.” The stated objectives of NIOSH studies include estimating uncertainties and biases in exposure assessments and conducting more comprehensive exposure assessments of chemicals. Few studies have focused on site-specific non-radiological hazards. The unpublished chemical worker study is an exception; the primary studies that have been performed to date related to chemical and physical hazards have focused primarily on beryllium and to a lesser extent on mercury and excessive heat exposure. Beryllium A listing of DOE sites with current or past beryllium work includes Hanford, ORNL, and LANL, as well as the Ames Laboratory, Argonne East, Argonne West, Brookhaven National Laboratory, Energy Technology Engineering Center, East Tennessee Technology Park (K-25), Fermilab, Kansas City, Lawrence Livermore National Laboratory (LLNL), Mound, Nevada Test Site, ORNL, Pantex, Rocky Flats Environmental Technology Site, Sandia National Laboratory (SNL), Savannah River, Stanford Linear Accelerator Center, and Y-12.7 In a 1996 survey of current beryllium use at DOE facilities, both ORNL and LANL, as well as Allied Signal-Kansas City Plant, Fermilab, LLNL, Pantex, Rocky Flats, SNL, and Y-12, reported potential worker exposures to beryllium. Even short-term exposures to beryllium fumes, dust, or metal oxides can result in beryllium sensitization and subsequently chronic beryllium disease in some workers.8 As part of an epidemiological research review provided to DOE in 1989, the National Research Council (NRC 1989) recommended that DOE make efforts to quantify exposures to and effects from agents in addition to ionizing radiation. The NRC also urged DOE to begin cautiously developing and using molecular markers of chemicals in future studies (NRC 1994). The ongoing DOE epidemiological studies that were transferred to NIOSH in 1991 under the first MOU did not include any epidemiological studies focusing on beryllium. However, the participants at a 1991 workshop devoted to developing an energy-related epidemiological research agenda recommended the completion of health studies related to beryllium exposures. At the initial Advisory Committee on Energy-Related Epidemiological Research (ACERER 1993) meeting, the NIOSH 6 See http://www.cdc.gov/niosh/2001-133a.html. Last accessed August 2006. 7 See http://www.eh.doe.gov/administration/training/be/BerylliumSites.pdf. Last accessed August 2006. 8 DOE (U.S. Department of Energy). 2006. Final Draft. DOE Beryllium Information Survey Report. DOE Facility Experience from 1994 to 1996. [on-line]. Available: http://www.eh.doe.gov/be/docs/96survey.pdf. Last accessed October 2006.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Mortality among a cohort of white male workers at a uranium processing plant Fernald Feed Materials Production Center, 1951-1989 Cragle DL, Watkins JP, Ingle JN, Robertson-Demers K, Tankersley WG, West CM [1995]. Mortality among a cohort of white male workers at a uranium processing plant: Fernald Feed Materials Production Center, 1951-1989. Oak Ridge, TN: Center for Epidemiological Research, Oak Ridge Institute for Science and Education; unpublished; 29 pp. Study of the health effects of exposure to elemental mercury Y-12 plant in Oak Ridge Departments of Behavioral Sciences and Health Education and of Environmental and Occupational Health; Rollins School of Public Health of Emory University, and Center for Epidemiological Research Environmental and Health Sciences Division Oak Ridge Associated Universities [undated]. A study of the health effects of exposure to elemental mercury: a followup of mercury exposed workers at the Y-12 plant in Oak Ridge, Tennessee. Available from the NIOSH/HERB, Cincinnati, OH; 134 pp. Mortality among workers employed between 1945 and 1984 at a uranium gaseous diffusion facility Oak Ridge Dupree EA, Wells SM, Watkins JP, Wallace PW, Davis NC [1994]. Mortality among workers employed between 1945 and 1984 at a uranium gaseous diffusion facility. Oak Ridge, TN: Center for Epidemiological Research Medical Sciences Division. Available from NIOSH/ HERB, Cincinnati, OH; 24 pp. Job task analysis quality assessment 14 sites Ertell K, Takaro T, Shorter C, Stove B, Beaudet N, Barnhart S, Rabito F, White LE [2000]. Results of employee job task analysis (EJTA) quality assessment: Combined analysis for fourteen Hanford contractors. Seattle, WA: University of Washington; 34 pp. Occupational magnetic field personal exposures Seattle metro transit’s electric trolley system EM Factors [1999]. Study of occupational magnetic-field personal exposures associated with Seattle metro transit’s electric trolley system. Richland, WA. Available from NIOSH/HERB, Cincinnati, OH; 67 pp. Evaluation of dosimetry data   Fix JJ [2001]. Interim final report: evaluation of dosimetry data for National Institute for Occupational Safety and Health (NIOSH) Collaboration with the International Agency for Research on Cancer (IARC) Nuclear Worker Study. Richland, WA: Pacific Northwest National Laboratory; 65 pp.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Subject Site if Applicable Reference Dose validation study Multisite Fix JJ, Scherpelz RI, Strom DJ, Traub RJ [2005]. Dose validation for NIOSH/HERB multisite leukemia case control study. PNWD-3538. Richland WA: Battelle Pacific Northwest Division, 218 pp. Mortality in an ethnically diverse radiation-exposed occupational cohort Los Alamos National Laboratory Galke GA, Johnson ER, Tietjen GL [1992]. Mortality in an ethnically diverse radiation exposed occupational cohort. Los Alamos, NM: Los Alamos National Laboratory; unpublished; 70 pp. Occupational magnetic field personal exposures   Kaune WT [1999]. Study of occupational magnetic-field personal exposures of non-flying airline employees. Richland, WA: EM Factors. Available from NIOSH/HERB Cincinnati, OH; 52 pp. Method for estimating occupational radiation dose to individuals Oak Ridge National Laboratory Mitchell RJ, Ostrouchov G, Frome EL, Kerr GD [1993]. Amethod for estimating occupational radiation dose to individuals, using weekly dosimetry data. Oak Ridge, TN: Oak Ridge National Laboratory; 46 pp.     Newman LS [2002]. Final performance report: beryllium disease natural history and exposure-response. Denver, CO: Division of Environmental and Occupational Health Sciences, National Jewish Medical and Research Center; 17 pp. Lung fibrosis in plutonium workers   Newman LS, Mroz MM, Ruttenber JA [2002]. Lung fibrosis in plutonium workers. Division of Environmental and Occupational Health Sciences, National Jewish Medical and Research Center, Denver, CO. Available from NIOSH/HERB, Cincinnati, OH; 19 pp. Adequacy of vital status follow-up in the Hanford Worker Mortality Study Hanford Omohundro E, Gilbert E [1993]. An evaluation of the adequacy of vital status follow-up in the Hanford Worker Mortality Study. Richland, WA: Hanford Environmental Health Foundation. Available from NTIS, Springfield, VA; DE94005179, 40 pp.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Dose estimation Oak Ridge National Laboratory Ostrouchov G, Frome EL, Kerr GD [1998]. Dose estimation from daily and weekly dosimetry data. Oak Ridge, TN: Oak Ridge National Laboratory. Health effects of downsizing in the nuclear industry Idaho National Engineering and Environmental Laboratory Pepper L [2000]. The health effects of downsizing in the nuclear industry: findings at the Idaho National Engineering and Environmental Laboratory. Boston, MA: Boston University School of Public Health. Available from NIOSH/HERB, Cincinnati, OH; 129 pp. Health effects of downsizing in the nuclear industry Los Alamos National Laboratory Pepper L [2000]. The health effects of downsizing in the nuclear industry: findings at the Los Alamos National Laboratory. Boston, MA: Boston University School of Public Health. Available from NIOSH/HERB, Cincinnati, OH; 135 pp. Health effects of downsizing in the nuclear industry Nevada Test Site Pepper L [2000]. The health effects of downsizing in the nuclear industry: findings at the Nevada Test Site. Boston, MA: Boston University School of Public Health. Available from NIOSH/HERB, Cincinnati, OH; 125 pp. Health effects of downsizing in the nuclear industry Pantex Pepper L [2000]. The health effects of downsizing in the nuclear industry: Pantex. Boston, MA: Boston University School of Public Health. Available from NIOSH/HERB, Cincinnati, OH; 133 pp. Health effects of downsizing in the nuclear industry Y-12 Plant, Oak Ridge Pepper L [2000]. The health effects of downsizing in the nuclear industry: findings at the Y-12 Plant, Oak Ridge Reservation. Boston, MA: Boston University School of Public Health. Available from NIOSH/HERB, Cincinnati, OH; 129 pp. Radon and cigarette smoking Fernald Pinney S [2004]. Radon and cigarette smoking assessment in Fernald workers. Cincinnati, OH: University of Cincinnati; 103 pp. United Brotherhood of Carpenters Health and Safety Fund   Rosenman KD, Gardiner J, Cameron W, Anger KW [2000]. United Brotherhood of Carpenters Health and Safety Fund. Available from NIOSH/HERB, Cincinnati, Ohio; 76 pp.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Subject Site if Applicable Reference Chronic beryllium disease among beryllium-exposed workers   Rosenman KD, Hertzberg VS, Rice C, Rossman M. 2001. Final performance report: chronic beryllium disease among beryllium-exposed workers cooperative agreement; 25 pp. Sentinel exposure event surveillance   Ruttenber AJ, LaMontagne AD, Van Dyke MV, Martyny JW [2004]. Final performance report: sentinel exposure event surveillance and evaluation for DOE sites. Denver, CO: University of Colorado Health Sciences Center; 5pp. Epidemiological analyses of Rocky Flats production workers Rocky Flats Ruttenber AJ, Schonbeck M, Brown S, Wells T, McClure D, McCrea J, Popken D, Martyny J [2003]. Report of epidemiological analyses performed for Rocky Flats production workers employed between 1952-1989: Available from NIOSH/HERB, Cincinnati, OH; unpublished; 75 pp. Epidemiological evaluation of childhood leukemia and paternal exposure to ionizing radiation   Sever LE, Gilbert ES, Tucker K, Greaves J, Greaves C, Buchanan J [1997]. Epidemiological evaluation of childhood leukemia and paternal exposure to ionizing radiation. Seattle, WA: Battelle Memorial Institute. Available from NIOSH/HERB, Cincinnati, OH; 51 pp. Mortality among workers at Oak Ridge National Laboratory: follow-up through 1990 Oak Ridge National Laboratory Shy C, Wing S [1994]. A report on mortality among workers at Oak Ridge National Laboratory: followup through 1990. Oak Ridge, TN: Oak Ridge Associated Universities, 21 pp. Exposure assessment Fernald Stevens GW, Back DA [1996]. Hazardous waste, decontamination and decommissioning, and clean-up workers exposure assessment feasibility study at the Department of Energy’s Fernald site—Phase I: report; 156 pp. Exposure assessment Mound Plant Stevens GW, Back DA [1997]. Remediation workers’ exposure assessment feasibility study at the Department of Energy’s Moundsite—Phase I: report; 218 pp.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Measurement error methods   Stram DO [2001]. Measurement error methods for underground miner studies. Available from NIOSH/HERB, Cincinnati, OH; 4pp.b Potential exposure profile system users’ guide   Tankersley WG [1997]. Potential exposure profile system (PEPS) users guide. Oak Ridge, TN: Oak Ridge Associated Universities; 34 pp. Exposure assessment feasibility study Savannah River site Tankersley WG, West CM, Gray FE [1998]. Hazardous waste, decontamination and decommissioning and clean-up workers exposure assessment feasibility study at the Department of Energy’s Savannah River site.Cincinnati OH; 142 pp. Exposure assessment feasibility study Oak Ridge Tankersley WG, West CM, Gray FE [1999]. Hazardous waste, deactivation, dismantlement, and cleanup workers exposure assessment feasibility study at the Department of Energy Oak Ridge reservation; 134 pp. Mortality of 244 male workers exposed to plutonium Los Alamos National Laboratory Voelz GL, Johnson ER, Lawrence JNP [1993]. Mortality of 244 male workers exposed to plutonium. Los Alamos, NM: Los Alamos National Laboratory; unpublished; 16 pp. Acute radiation syndrome in Russian nuclear workers   Wald N, Day R, Shekhter-Levin S, Vergona R, Aimin Z [2001]. Acute radiation syndrome in Russian nuclear workers. Pittsburgh, PA: University of Pittsburgh. Available from NIOSH/ HERB, Cincinnati, OH; 59 pp. Time-related variables in occupational epidemiology studies   Watkins JP, Frome EL, Cragle DL [2004]. Evaluating time-related variables in occupational epidemiology studies. Final project report. Oak Ridge, TN: Oak Ridge Associated Universities; 57 pp. + 3 appendixes. Estimating dose and chemical exposure   West CM, Rutherford BF, Tankersley WG [1997]. Current programs for estimating dose and chemical exposure: Volume I. Oak Ridge, TN: Oak Ridge Associated Universities; 124 pp.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Subject Site if Applicable Reference Estimating dose and chemical exposure   West CM, Rutherford BF, Tankersley WG [1997]. Current programs for estimating dose and chemical exposure: Volume II. Oak Ridge, TN: Oak Ridge Associated Universities; 107 pp. Mortality among female nuclear weapons workers   Wilkinson GS, Trieff, N, Graham, R [2000]. Final report: Study of mortality among female nuclear weapons workers. Buffalo, NY: State University of New York at Buffalo; 447 pp. Time-related factors in radiation-cancer dose-response   Wing S, Richardson D [1997]. Time-related factors in radiation-cancer dose response. Chapel Hill, NC: University of North Carolina School of Public Health; 226 pp. Ionizing radiation and mortality Hanford site Wing SB [1999]. Ionizing radiation and mortality among Hanford workers. Chapel Hill, NC: University of North Carolina School of Public Health; 1 p. Case-control study of multiple myeloma among workers exposed to ionizing radiation and other physical and chemical agents   Wing SB, Wolf SH, Crawford-Brown D, Kotecki M, Mihlan GJ, Todd L, Emery J, Pompeii L, Wood JL, Olshan A, Shy CM [1997]. Case-control study of multiple myeloma among workers exposed to ionizing radiation and other physical and chemical agents. Chapel Hill, NC: University of North Carolina, School of Public Health; 203 pp. Correcting for measurement errors in radiation exposure   Xue X [2002]. Correcting for measurement errors in radiation exposure. Available from NIOSH/HERB, Cincinnati, OH; 16 pp. Remediation workers exposure assessment feasibility study Hanford site Zimmerman TD [1999]. Remediation workers exposure assessment feasibility study at the Department of Energy’s Hanford site—Phase I: Report; 204 pp. Remediation workers exposure assessment feasibility study INEEL Zimmerman TD, Moore AM [2000]. Remediation workers exposure assessment feasibility study at the Department of Energy’s INEEL Site—Phase I: Report; 217 pp.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services NIOSH Health Hazard Evaluations (HHEs) Within the OERP Hazard evaluation and technical assistance report Idaho Falls, Idaho NIOSH [1994]. Hazard evaluation and technical assistance report: Protection Technology Idaho Inc., Idaho Falls, Idaho. Cincinnati, OH: NIOSH Hazard Evaluation and Technical Assistance (HETA) Report No. 93-0740; 19 pp. Hazard evaluation and technical assistance report Lockheed Martin, Piketon, OH NIOSH [1996]. Hazard evaluation and technical assistance report: Lockheed Martin Utility Services, Inc., Piketon, Ohio. Cincinnati, OH: NIOSH HETA Report No. 94-0077-2568; 41 pp. Hazard evaluation and technical assistance report LANL NIOSH [1998]. Hazard evaluation and technical assistance report: Los Alamos National Laboratory, Los Alamos, NM. Cincinnati, OH: NIOSH HETA Report No. 98-0240; 6 pp. Hazard evaluation and technical assistance report Portsmouth Gaseous Diffusion Plant NIOSH [2000]. Hazard evaluation and technical assistance report: Portsmouth Gaseous Diffusion Plant, Piketon, Ohio. Cincinnati, OH: NIOSH HETA Report No. 96-0198-2651. aWhile NIOSH lists the 15-country as “Intramural” for NIOSH record-keeping purposes, the funding for the study came from multiple sources. bDan Stram, a member of the authoring committee of the present report, conducted exposure measurement error analysis in the Colorado Plateau Uranium Miners cohort and the Hanford Thyroid Disease Study with extramural funding from NIOSH. That funding terminated prior to the inception of this study (end date 5/31/2002). Those studies were not a part of this review. NOTE: Publications that acknowledge whole or partial funding by DOE through the NIOSH Occupational Energy Research Program. From this body of work the committee selected for review publications either directly related to its three sites (Hanford, ORNL, and LANL) or multisite studies that included data from at least one of the three sites. Excludes intramural proceedings, extended abstracts, and submitted publications not in press as of May 2006. Table is current as of information received May 9, 2006.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Wing, S., D. Richardson, S. Wolf, G. Mihlan, D. Crawford-Brown, and J. Wood. 2000. A case control study of multiple myeloma at four nuclear facilities. Ann Epidemiol 10(3):144-153. Wing, S., D. Richardson, S. Wolf, and G. Mihlan. 2004. Plutonium-related work and cause-specific mortality at the United States Department of Energy Hanford Site. Am J Ind Med 45(2):153-164. Xue, X., and R.E. Shore. 2003. A method for estimating occupational radiation doses subject to minimum detection levels. Health Phys 84(1):61-71. Xue, X., R.E. Shore, X. Ye, and M.Y. Kim. 2004. Estimating the dose response relationship for occupational radiation exposure measured with minimum detection level. Health Phys 87:397-404.