1

Introduction

Atomic energy and nuclear weapons research and development in the United States began around 1939 and continued during World War II and throughout the Cold War. This effort was undertaken initially by the U.S. Corps of Engineers Manhattan Engineer District, more commonly referred to as the Manhattan Project. It was this effort that was ultimately responsible for the development of the atomic weapons used to help end World War II in 1945. After the war, the United States continued a massive effort to research, produce, and test nuclear weapons. The result was a large scale nuclear weapons industry. This effort encompassed a broad array of activities, including uranium mining, milling, and refining; nuclear reactor production and maintenance; chemical processing, and metal machining. Furthermore, maintenance facilities, laboratories, and testing sites were necessary to support this effort, often managed by contractors to the federal government (DOE, 1997).

At the peak of the Cold War, nearly 600,000 workers throughout the country were involved in the research and production of nuclear weapons (Silver, 2005). The workforce consisted of employees of the Department of Energy (DOE) or its predecessor agencies and various contractors who owned and operated mines and facilities or provided other goods and services in support of DOE’s nuclear weapons programs. With the dissolution of the Soviet Union in 1991 and the end of the Cold War, U.S. production of nuclear weapons was significantly reduced. The United States began to turn its focus from production and maintenance to addressing many issues related to the storage and decommissioning of its nuclear arms inventory and associated material. DOE efforts shifted to the remediation of waste sites, and the storage and destruction of nuclear warheads. Today many facilities remain active in research, storage, and management of radioactive



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1 Introduction A tomic energy and nuclear weapons research and development in the United States began around 1939 and continued during World War II and throughout the Cold War. This effort was undertaken initially by the U.S. Corps of Engineers Manhattan Engineer District, more commonly referred to as the Manhattan Project. It was this effort that was ultimately responsible for the development of the atomic weapons used to help end World War II in 1945. After the war, the United States continued a massive effort to research, produce, and test nuclear weapons. The result was a large scale nuclear weapons industry. This effort encompassed a broad array of activities, including uranium mining, milling, and refining; nuclear reactor production and maintenance; chemical processing, and metal machining. Furthermore, maintenance facilities, laboratories, and test- ing sites were necessary to support this effort, often managed by contractors to the federal government (DOE, 1997). At the peak of the Cold War, nearly 600,000 workers throughout the country were involved in the research and production of nuclear weapons (Silver, 2005). The workforce consisted of employees of the Department of Energy (DOE) or its predecessor agencies and various contractors who owned and operated mines and facilities or provided other goods and services in support of DOE’s nuclear weapons programs. With the dissolution of the Soviet Union in 1991 and the end of the Cold War, U.S. production of nuclear weapons was significantly reduced. The United States began to turn its focus from production and maintenance to addressing many issues related to the storage and decommissioning of its nuclear arms inventory and associated material. DOE efforts shifted to the remediation of waste sites, and the storage and destruction of nuclear warheads. Today many facilities remain active in research, storage, and management of radioactive 15

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16 REVIEW OF THE DOL’S SITE EXPOSURE MATRIX DATABASE materials, uranium production, and weapons assembly and disassembly (DOL, 2010a; GAO, 2010). During the Cold War, research indicated that workers in the atomic weapons production process may have long-term health effects as a result of their employ- ments. In the early years, some workers may not have been aware of potential health risks related to their jobs, nor did they necessarily know the identity of the materials with which they worked. Workers were often exposed to both radio- active and nonradioactive toxic substances.1 In many instances, the work was considered top secret and workers were cautioned not to reveal any work-related information to family members or others. As these workers experienced adverse health effects, they began to express their concerns that many of their illnesses resulted from their exposures to occupational hazards during their work at DOE facilities (DOL, 2010a; GAO, 2010). In 2000, in response to growing health concerns among former DOE workers, Congress passed the Energy Employees Occupational Illness Compensation Program Act (Public Law 106-398, Title XXXVI), referred to as EEOICPA. ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT In 1996, following congressional directives, DOE established the Former Worker Medical Screening Program (FWP) to provide medical screening for and health monitoring of former DOE workers (FY 1993 Defense Authorization Act [Public Law 102-484]). The program was to assist workers with determining whether they had health issues related to their prior work with DOE. The program included both site- and population-specific medical screenings (DOE, 2012). The FWP and former workers also garnered support for a federal compen- sation program to address the workers’ growing treatment costs and disability resulting from their employment. The DOE assistant secretary for environment, safety and health, along with local leaders and often Congressional representa- tives, heard testimony from former workers or their survivors about their work and the illnesses that had subsequently befallen many of them or their coworkers. These workers, many of whom had previously been reluctant to share their expe- riences and illnesses with anyone, motivated Congress in 2000 to pass EEOICPA to provide compensation and medical coverage to former DOE employees, con- tractors, and subcontractors (Executive Order 13179—Providing Compensation to America’s Nuclear Weapons Workers) (DOE, 2011). EEOICPA established two worker compensation programs: Part B and Part D. Part B compensates 1  The committee uses the term toxic substance to refer to any hazardous agent, including chemicals and biologics, that has the potential to cause adverse health effects in an organism. In this report, the terms toxic substance and hazardous agent are used interchangeably, as are the terms illness, disease, and health effects as is done in the Haz-Map and SEM databases.

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INTRODUCTION 17 DOE workers who are suffering from adverse health effects as a result of their exposures to beryllium, ionizing radiation, and silica during the course of their nuclear weapons-related employment. Part D authorized DOE to enter into agree- ments with states to assist DOE contractor employees in filing state workers’ compensation claims for various illnesses related to their work at DOE facilities. Since that time, claimants and advocates have raised many concerns about the inconsistent administration and application of EEOICPA Part D by the indi- vidual states. In 2004, Congress directed the Government Accountability Office (GAO) to investigate these concerns. The GAO report found that the DOE got off to a slow start in processing Part D claims and faced a large backlog of more than 25,000 cases (GAO, 2004). It recommended a dramatic restructuring of the pro- gram, including transferring responsibility of the administration of the program to the Department of Labor (DOL). In response, on October 28, 2004, Congress passed an amendment to EEOICPA, which replaced Part D with a new program called Part E. All claims previously filed under the Part D program were trans- ferred to the Division of Energy Employees Occupational Illness Compensation (DEEOIC), within the DOL Employment and Standards Administration’s Office of Workers’ Compensation Programs (OWCP). DEEOIC would now determine and administer the Part E compensation program. DOE transferred the backlog of Part D cases to DOL for consideration under EEOICPA Part E (Personal commu- nication, Shelby Hallmark, DOL, May 21, 2008). The following section provides a brief overview of both Part B and Part E of EEOICPA. Part B Part B of EEOICPA provides compensation of up to $150,000 to DOE employees and eligible survivors, and $50,000 to uranium workers covered by the Radiation Exposure Compensation Act (RECA) (Table 1-1), as well as medi- cal benefits for accepted conditions (Table 1-2). Part B covers three categories of employers: atomic weapons employers, defined as “an entity, other than the TABLE 1-1  Employment Covered by EEOICPA Part B and Part E Types of Covered Facilities Part B Part E DOE facilities:   DOE employees Yes No   DOE contractors and subcontractors Yes Yes Atomic weapons employers Yes No Beryllium vendors Yes No RECA Section 5 facilities Yes Yes SOURCE: Adapted from Anders, 2012.

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18 REVIEW OF THE DOL’S SITE EXPOSURE MATRIX DATABASE TABLE 1-2  Illnesses Covered by the EEOICPA Part B and Part E Part B Part E Radiogenic cancers All of the covered illnesses in Part B Chronic beryllium disease and chronic silicosis as defined in EEOICPA Beryllium sensitivity and RECA (Section 5) + Any illnesses resulting from exposure to toxic illnesses substances SOURCE: Adapted from Anders, 2012. United States, that processed or produced, for use by the United States, mate- rial that emitted radiation and was used in the production of an atomic weapon, excluding uranium mining and milling” (42 U.S.C. § 7384l); the DOE; and beryl- lium vendors, defined as processors or producers of beryllium. RECA, passed in 1990 and expanded in 2000, provides monetary compensation to individuals who contracted certain cancers or other specific diseases following exposure to radia- tion by way of habitation or work proximity to nuclear weapons testing sites and uranium nuclear weapons production sites (42 U.S.C. § 2210). Part B pertains to specific illnesses and medical conditions caused by exposure to radiation, beryl- lium, and silica. As of November 2012, $4.5 billion in total compensation has been paid to Part B claimants (DOL, 2012a). The causation standard for Part B states that cancer, for example, is compen- sable if it is “at least as likely as not” to have been caused by exposure to ionizing radiation during the period of employment at the covered facility using the “upper 99 percent confidence interval of the probability of causation” (42 U.S.C. § 7384l; Anders, 2012). The “at least as likely as not” probability for cancer is determined by DOL from the dose reconstructions performed by the National Institute for Occupational Safety and Health (NIOSH). DOL has also established Special Exposure Cohort classes, whose members can be administratively approved and given a presumption of causation if they meet the employment requirements and have a diagnosis of any one of 22 specified cancers (Anders, 2012). Part E Part E of EEOICPA provides medical coverage and compensation of up to $250,000 for DOE contractors and subcontractors or their eligible survivors and workers also covered by RECA for illnesses resulting from exposure to toxic sub- stances at DOE facilities. The amount of benefits paid up to the $250,000 maxi- mum is based on the level of impairment or years of qualifying wage loss related to the covered illness. Part E covers all illnesses stipulated in Part B, but also includes any illness resulting from exposure to toxic substances present at DOE facilities. Part E defines a toxic substance as “any material that has the potential to

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INTRODUCTION 19 cause illness or death because of its radioactive, chemical, or biological nature.” It is possible to receive compensation under both Part B and E of the program; however the maximum aggregated benefit is $400,000 plus medical benefits for accepted conditions. As of November 2012, $2.7 billion in total compensation had been paid to Part E claimants and total compensation and medical bills for both Part B and Part E claims exceeded $8.6 billion (DOL, 2012a). For Part E, the causation standard is “it is at least as likely as not that expo- sure to a toxic substance at a Department of Energy facility was a significant fac- tor in aggravating, contributing to, or causing the illness; and it is at least as likely as not that the exposure to such toxic substance was related to employment at a Department of Energy facility” (Public Law 108-375 § 3161). In its administra- tion of Part E, DOL recognized that claims examiners needed a tool to provide information on covered sites and the toxic substances that may have been used at those sites. DOL created the Site Exposure Matrix (SEM) database to organize toxic substance information for all facilities covered by Part E and to give DOL claims examiners easy access to this information (DOL, 2010b). Claimants and their family members, as well as worker advocates, had little information about what toxic substances may have been present in DOE facilities in which they worked, although they bore the burden of proof in the claims process. In response to claimants concerns about the information in SEM, it was eventually made available to the public. In addition to SEM, claims examiners may also consult with a District Medical Consultant to assist in evaluating the medical evidence for a claimant’s illness (DOL, 2012b). SITE EXPOSURE MATRIX DATABASE The SEM database was designed to function as a repository of information about toxic substances present at facilities covered by Part E to “assist claim- ants and claims examiners by putting toxic substances present at DOE sites and scientifically established illness and disease links information in one convenient location” (DOL, 2012c). According to the DOL claims examiner manual, SEM details possible toxic substances that may have been present at a DOE facility, and describes the relationship between a specific toxic substance and a covered illness (DOL, 2012b). The manual states that “the SEM is not used to establish or deny causation by itself, but is used as a tool to assist in the evaluation of cau- sation in light of the evidence as a whole” (DOL, 2012b). DOL procedures and regulations indicate that SEM is only one of many tools, such as occupational history and medical records, used by claims examiners to evaluate the evidence as a whole to determine the existence of a causal link between employment at a DOE facility, exposure to a toxic substance, and a resultant illness arising from such exposure. As of October 2012, the database consists of information on more than 13,000 toxic substances that are or have been used at covered sites,

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20 REVIEW OF THE DOL’S SITE EXPOSURE MATRIX DATABASE and health effect information, if available from the Haz-Map database, which is described briefly below and in detail elsewhere in this report. SEM contains information in profiles for each DOE site. These contain infor- mation on the toxic substances that may have been present, organized by facil- ity, area, building, process, labor category, and incidents. Information on toxic substances includes chemical identification, physical properties, and specific health effects, as well as references and a record history. The database may be queried and filtered based on these fields to help claims examiners and claimants determine potential exposures that may have caused a diagnosed disease in an exposed worker, based on the individual’s work history. All links between a toxic substance and possible occupational disease are imported solely from the Haz- Map database that is published by the National Library of Medicine (NLM). This database lists more than 7,000 toxic substances and their potential health effects. Although the DOE and DOL have made efforts to streamline and enhance the EEOICP claims process, including the development and use of the SEM, claimants continue to have concerns about the links between the toxic substances that are included in SEM and their illnesses. These concerns have prompted investigative reports in the popular press (particularly the Rocky Mountain News in Denver, Colorado), congressional inquiries, a GAO report, and several reports on the EEOICP claims process from the DOL Ombudsman’s office. It is this series of reports and recommendations that prompted the DOL to look for an assessment of SEM. COMMITTEE’S CHARGE To address the scientific issues highlighted in the GAO report, as well as concerns from advocacy groups and claimants, the DOL DEEOIC approached the Institute of Medicine (IOM) in June 2010 to conduct a study of the scien- tific rigor of the causal relationships between exposure to toxic substances and occupational diseases cited in SEM. IOM was requested to “provide independent guidance on the scientific and technical information used to comprise SEM and to make recommendations on ways in which the SEM database can be improved.” To complete its task, the IOM formed an ad hoc committee of experts from a range of disciplines—including occupational medicine, toxicology, epidemiol- ogy, industrial hygiene, public health, and biostatistics—to conduct an 18-month study to review the scientific rigor of the SEM database. The committee was asked to address the issues and questions specified in Box 1-1. COMMITTEE’S APPROACH Over the course of the 18-month study, the committee held five meetings. Two of the meetings were open to the public and provided the committee the opportunity to hear from DOL, its contractors, and the public (see Appendix C).

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INTRODUCTION 21 BOX 1-1 Statement of Task The Institute of Medicine will convene a panel of experts to review the scientific rigor and organization of the Site Exposure Matrix (SEM) database. The committee’s focus will be on the occupational disease links to chemical usage/exposure; the National Institutes of Health’s (NIH’s)/National Library of Medicine’s (NLM’s) review process with re- gard to Haz-Map, and the review process used by Haz-Map developer when including information in the Haz-Map database. Haz-Map is an occupational health database about the health effects of exposures to chemicals and biologicals at work; it links jobs and hazardous tasks with occupational diseases and their symptoms. The committee will identify strengths and weaknesses of the SEM and make recommendations for addressing any weakness. Additionally, the following questions, here de- scribed as tasks, will be addressed in the report issued by the committee. Tasks: 1. What, if any, occupational diseases that might have affected the DOE contractor workforce are missing from SEM? 2. What, if any, links between occupational diseases and toxic substances present at the Department of Energy (DOE) sites are missing from SEM? 3.  there additional literature (preferably human epidemiological Is in nature) that might be incorporated into SEM to strengthen or add to the existing links between toxic substances and occupa- tional diseases? Are the existing links sufficiently robust? 4. What, if any, other occupational disease databases might be used to supplement the Haz-Map information in SEM? 5. How scientifically rigorous are the disease links contained in the SEM and Haz-Map? 6. What are the strengths and weaknesses of the NIH/NLM peer review process with regard to Haz-Map? How might this pro- cess be improved? 7. Can any known (epidemiologically significant) synergistic effects between chemicals/chemicals or chemicals/radiation be placed in SEM? If so, what are the sources of these links and are they occupational in nature? 8. What consistent process or approach could be used to consider a disease or cancer established when studies are inconclusive, inconsistent, or conflicted in some way?

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22 REVIEW OF THE DOL’S SITE EXPOSURE MATRIX DATABASE At its first meeting, the committee heard presentations on the SEM database from DEEOIC, the DOL SEM contractor, and the Haz-Map database developer (who receives money from DOL through its SEM contractor for research on toxic sub- stances of interest to DOL) (Stalnaker, 2012). In addition, the committee heard from EEOICP claimants and their advocates regarding their concerns about SEM. The committee also submitted written questions to DOL about the content and functionality of SEM and Haz-Map and their role in the EEOICP compensation process. DOL and its contractors, including the Haz-Map developer, provided written responses to these questions. The committee also received written com- ments and materials from claimants and their advocates.2 Committee members spent many hours searching the Haz-Map database (http://hazmap.nlm.nih.gov), the Haz-Map website (http://www.haz-map.com) that provides background infor- mation on the database, and the SEM database (http://www.sem.dol.gov). Throughout the course of this study, the committee kept in mind that the benefits provided by EEOICPA have a real impact on current and former DOE workers, contractors, and their families. It recognizes that any improvements to the program, including SEM, are likely to have tangible effects on those benefi- ciaries. During its open sessions, the committee was informed about EEOICPA, its compensation structure, and the claims adjudication process to better under- stand SEM in context. However, the committee was not tasked with examining or evaluating the claims adjudication process nor was it asked to comment on other aspects of SEM including the site-specific information. Therefore, the com- mittee did not address issues of compensation; the DEEOIC claims processes, or the training of DEEOIC staff. While these are important issues for developing and maintaining an efficient and fair compensation program, they were outside of the committee’s scope. Furthermore, the committee did not evaluate either the administration of Part B or the technical or scientific merit of NIOSH’s process for radiation dose reconstruction. Most importantly, with more than 13,000 toxic substance profiles in SEM, the committee did not conduct an exhaustive or comprehensive evaluation of every toxic substance or potential health outcome that may be associated with exposures at an EEOICPA-covered facility. Rather, it sought to give advice on how to improve the substance–disease links contained in the SEM and to provide guidance for a better and more scientifically sound decision-making process using representative examples. The committee did not review the SEM database structure, as that was considered to be proprietary by DOL, but it did comment 2  All information submitted to the committee, including responses to the committee’s questions can be accessed online in the public access file for this report. For information on accessing the public access file, visit http://www8.nationalacademies.org/cp/projectview.aspx?key=49417. The written responses to the committee’s questions from the Department of Labor and its contractors may also be found at http://www.iom.edu/Activities/PublicHealth/SEMDatabaseReview/2012-MAR-16.aspx.

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INTRODUCTION 23 on the functionality of SEM insofar as these factors were relevant to the commit- tee’s review of its content. During the course of the study, the committee realized that information in both Haz-Map and SEM was periodically updated and, in the case of Haz-Map, reformatted. The committee emphasizes that it reviewed databases that were not static, but were continually evolving. ORGANIZATION OF THE REPORT The committee’s examination of SEM and evaluation of its scientific rigor required considerations at the intersection of diverse fields, including environ- mental and occupational health, toxicology, epidemiology, and industrial hygiene. The committee’s specific charge was to examine the scientific rigor and organiza- tion of the database and it was tasked with evaluating the completeness and valid- ity of links between the toxic substances listed and their potential health effects. The following chapters provide some brief, fundamental background on these topics as a basis for the committee’s discussions and recommendations. Chapter 2 discusses Haz-Map, the source of occupational disease links in SEM and describes its content, processes, and approaches. The committee considers the strengths and weaknesses of Haz-Map as well as alternative approaches to the use and interpretation of health effects information. Chapter 3 discusses SEM in greater detail, including its function and content, the specific health effects recorded in it, how it is updated, and its strengths and weaknesses. The committee also describes its efforts to identify toxic substance–occupational disease links that are missing from the database and highlight some additional information sources that would strengthen the information it provides. Chapter 4 summarizes the committee’s findings and provides recommendations to improve and supple- ment SEM. Overall, the committee focused on ways to enhance the process for linking exposures with disease outcomes in a credible and practical manner. REFERENCES Anders, K. 2012. Energy Employees Occupational Illness Compensation Program Overview. Presen- tation at First Committee Meeting, January 23, Washington, DC. DOE (Department of Energy). 1997. Linking Legacies: Connecting the Cold War Nuclear Weapons Production Processes to Their Environmental Consequences. Washington, DC: DOE. DOE. 2011. Former Worker Medical Screening Program 2010 Annual Report. Washington, DC: Of- fice of Health, Safety and Security. DOE. 2012. Former Worker Medical Screening Program. http://www.hss.energy.gov/HealthSafety/ FWSP/FormerWorkerMed/ (accessed March 16, 2012). DOL (Department of Labor). 2010a. 2010 Annual Report to Congress. Office of the Ombudsman for the Energy Employees Occupational Illness Compensation Program. Washington, DC: DOL. DOL. 2010b. US Department of Labor Adds New Information to Site Exposure Matrices Website About Toxic Substances at Nuclear Weapons Facilities. http://www.dol.gov/opa/media/press/ OWCP/OWCP20101462.htm (accessed February 12, 2012).

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24 REVIEW OF THE DOL’S SITE EXPOSURE MATRIX DATABASE DOL. 2012a. EEOICP Program Statistics. http://www.dol.gov/owcp/energy/regs/compliance/ weeklystats.htm (accessed November 11, 2012). DOL. 2012b. Establishing Toxic Substance Exposure. Chapter 2-0700 in The Federal (EEOICPA) Procedural Manual. DOL. 2012c. Site Exposure Matrix (SEM). www.sem.dol.gov/expanded (accessed February 12, 2012). GAO (Government Accountability Office). 2004. Energy Employees Compensation: Even with Needed Improvements in Case Processing, Program Structure May Result in Inconsistent Ben- efit Outcomes. GAO-04-515. Washington, DC: GAO. GAO. 2010. Energy Employees Compensation: Additional Independent Oversight and Transparency Would Improve Program’s Credibility. GAO-10-302. Washington, DC: GAO. Silver, K. 2005. The Energy Employees Occupational Illness Compensation Program Act: New legislation to compensate affected employees. American Association of Occupational Health Nurses Journal 53(6):267-279. Stalnaker, K. 2012. U.S. DOL Site Exposure Matrices, EEOICPA Part E. Presentation at First Com- mittee Meeting, January 23, Washington, DC.