Epidemiologic Studies

Hanford Site

INTRODUCTION

Overview

The primary purpose of this guide is to describe each series of records which pertains to studies of worker health and mortality funded by the U.S. Department of Energy (DOE) at the Hanford site. Additionally, the guide provides information on the location and classification of the records and how they may be accessed. History Associates Incorporated (HAI) prepared this guide as part of its work as the support services contractor for DOE's Epidemiologic Records Inventory Project.

This introduction briefly describes the Epidemiologic Records Inventory Project, HAI's role in the project, the history of the DOE and the Hanford site, and Hanford's organizational structure. It provides information on the methodology used to inventory and describe pertinent records stored in various onsite offices, in Hanford's Records Holding Area (RHA), and at the Seattle Federal Records Center (SFRC). Other topics include the methodology used to produce the guide, the arrangement of the record series descriptions, and information on accessing records repositories.

Epidemiologic Records Inventory Project

The Epidemiologic Records Inventory Project is indicative of DOE Secretary Hazel O'Leary's efforts to support openness initiatives in the areas of environment, safety, and health. In view of the importance of various administrative, organizational, and operational records to epidemiologic and health-related studies, a moratorium on the destruction of such records has been in effect since 1989.

In May 1992, the DOE Office of Epidemiology and Health Surveillance (EH-42), the office responsible for the coordination of all health-related activities throughout the DOE complex, directed each DOE and DOE contractor site to prepare an inventory of all records useful for worker or community health-related studies. EH-42 prepared and furnished each site with guidelines that defined epidemiologic records, provided instructions for describing record series, outlined the sites' role in inventorying epidemiologic records, and discussed the relationship of the epidemiologic inventory to DOE's comprehensive records inventory. The epidemiologic inventories should be completed in 1995. However, some of the information contained in the site records inventories, such as the location of active (still in use) records or the volume of the records, may change over time. The continued usefulness of the inventories and this guide depends on their systematic update.

Role of HAI

In August of 1993, DOE selected HAI as its support services contractor for the Epidemiologic Records Inventory Project. HAI, a professional records management, archives, and historical research services firm incorporated in 1981, has provided records management, historical research, and technical support for a number of DOE projects. HAI's role in the Epidemiologic Records Inventory Project includes verifying the accuracy, comprehensiveness, and quality of existing inventories, providing guidance to site records management teams, and, in some cases, performing additional records inventories.

BACKGROUND

History of the DOE

The DOE is responsible for developing and administering national energy programs and policies. Authorized by Congress in 1977, the history of the department's predecessor agencies and functions dates back to 1942, with the establishment of the Manhattan Engineer District (MED) of the U.S. Army Corps of Engineers. The MED spearheaded the development and manufacture of the first atomic weapons during World War II. In 1946, Congress passed the Atomic Energy Act, which reorganized the MED into the Atomic Energy Commission (AEC). Although the primary purpose of the AEC was to develop and manage the nation's expanding nuclear weapons production complex, the organization also reflected the nation's interest in developing broader commercial applications of atomic energy.(1)

For nearly three decades, the AEC directed the nation's nuclear program, from the development of nuclear weapons to the production of nuclear power. In 1974, Congress passed the Energy Reorganization Act, which split the AEC into the Energy Research and Development Administration (ERDA) and the Nuclear Regulatory Commission (NRC). ERDA assumed responsibility for nuclear research and development and oversight of the nuclear weapons program, while the NRC licensed and regulated the industrial and commercial use of radionuclides and nuclear power. ERDA also took charge of the energy research and development programs of other federal agencies, including the Bureau of Mines, National Science Foundation, and the Interior Department's Office of Coal Research. The creation of ERDA represented the Nixon Administration's interest in establishing a centrally directed national energy policy. Events such as the 1973 Arab oil embargo and the 1973-1974 price increases instituted by OPEC [Organization of Petroleum Exporting Countries] demonstrated the need to identify immediate energy needs and priorities and establish long range goals as a way to lessen the nation's dependency on foreign sources of energy.(2)

A shortage of natural gas during the winter of 1976-1977 further exposed the nation's vulnerability as an energy consumer. In response to the crisis, the Carter Administration urged Congress to reorganize ERDA and establish a cabinet-level organization to direct national energy policy. In August 1977, President Carter signed legislation creating the DOE. During the late 1980s, as Cold War tensions eased, the DOE restructured its priorities around nuclear waste management, environmental restoration, conservation, and the development of new energy sources.(3)

Site History

Hanford was selected in 1942 to be the site for the construction of facilities used to produce plutonium for the Manhattan Project. Originally called the Hanford Engineer Works, the site has also been known as the Hanford Reservation and the Hanford Plant. Located on approximately 560 square miles of land adjacent to the Columbia River in southeastern Washington state, Hanford was chosen as a production site because of its geographic remoteness and abundant supply of water and electrical power.

After World War II, Hanford continued to manufacture plutonium as well as other nuclear materials and also participated in reactor research and development. At peak production, nine reactors were in operation at the plant. In 1989, the DOE, the Washington State Department of Ecology, and the Environmental Protection Agency (EPA) signed the Hanford Federal Facility Assessment and Consent Order (also known as the Hanford Tri-Party Agreement), which outlined a 30-year, multi-billion dollar cleanup plan to bring Hanford into compliance with state and federal environmental laws. The following year, DOE transferred responsibility for the Hanford site from the Office of Defense Programs (DP) to the Office of Environmental Restoration and Waste Management (EM). Since that time, the site has focused on cleanup, environmental restoration, and waste management.

Organization

In 1943, the Manhattan Engineer District hired the Du Pont Chemical Company as the contractor responsible for the design, construction, and operation of Hanford. Du Pont was succeeded as the primary contractor in 1946 by the General Electric Company. In 1953, J.A. Jones Construction Company became the site's construction and engineering contractor.

In 1965, the AEC decided to divide the operations of Hanford by function among several different contractors. Douglas Nuclear, Inc. (1965-1973), and United Nuclear Corporation Nuclear Industries (1973-1987) were successive contractors in charge of reactor operations. Atlantic Richfield Hanford Company (1967-1977) and Rockwell Hanford Company (1977-1987) were chosen as consecutive reprocessing operations contractors. In 1987, the DOE selected Westinghouse Hanford Company (WHC) and Boeing Computer Services, Richland, Inc. (BCS), as the operations and engineering contractors and Kaiser Engineers Hanford (KEH) as the architectural and engineering contractor. Bechtel Hanford, Inc. (BHI), was awarded the environmental restoration contract in 1994.

Since 1965, Batelle Memorial Institute has operated the Pacific Northwest Laboratory (PNL), Hanford's research and development center. In the same year, the Hanford Environmental Health Foundation (HEHF) began providing comprehensive occupational health services to site personnel. PNL and HEHF are the organizational units which are most directly involved with conducting DOE-funded epidemiologic research at Hanford.

Pacific Northwest Laboratory (PNL)

PNL's primary mission is to conduct scientific research in the areas of energy, national security, and the environment. In particular, PNL is concerned with waste management, environmental restoration, energy conservation, and global climate changes. PNL conducts more than 1,400 research projects annually for DOE, other government agencies, and private industry.

Hanford Environmental Health Foundation (HEHF)

Services provided by HEHF include primary health care for DOE and DOE contractor employees. In addition, HEHF is concerned with monitoring employee health, assessing exposure risk, and identifying potential work-related health hazards.

Occupational Epidemiologic Studies

Epidemiologic studies are conducted to explore the health characteristics shared by members of a population group. DOE-funded epidemiologic studies at Hanford generally focus on the relationship between health and occupational factors, particularly exposure to radioactive and chemical agents. Epidemiologists involved in these studies tend to refine the results of their research by recognizing the influence of confounding factors, including tobacco use and personal health history.

Epidemiologists utilize a variety of records to ascertain whether a relationship exists between employees' work environment and their health and mortality. The most frequently used occupational records include personnel, medical, and exposure files. Health researchers also utilize several different resources to determine the vital status of former employees. Until the mid 1980s, the Social Security Administration (SSA) provided important data to researchers, including information concerning whether an individual was employed, retired, or deceased. SSA data was supplemented by information from death certificates and motor vehicles records. Currently, mortality data are usually obtained from the National Death Index (NDI), various state departments of motor vehicles, and a commercial service called Equifax Government and Special Services, Inc.

Brief summaries of the epidemiologic studies represented by records series in this guide are provided below:

Breast Cancer Incidence Study

HEHF implemented the Breast Cancer Incidence Study in response to a preliminary examination of data from the Epidemiologic Surveillance System (see below). Findings suggested that a higher breast cancer rate existed among female employees at Hanford who worked in the nuclear trades (e.g., reactor operators, radiation monitors, fuels technicians, waste workers, and decontamination and decommissioning workers) than among those who did not. The study utilized data from 1984-1989 relating to nineteen Hanford employees diagnosed with breast cancer and to a control group consisting of 71 women either employed at Hanford or from the general population. HEHF researchers also considered smoking habits, employment histories, childbirth patterns, and other lifestyle characteristics of the women under analysis. The study concluded that there was no evidence that the discerned excess in number of cancer diagnoses were linked to radiation exposure, but it recommended continued studies of women employees. An article which describes the methods of data collection and analysis used for the Breast Cancer Incidence Study was published in a 1993 issue of Health Physics.(5)

Epidemiologic Surveillance System (ESS)

HEHF supports the DOE-Headquarters Epidemiologic Surveillance System (ESS) by collecting relevant data elements for the Hanford site. The purpose of the ESS is to provide the DOE with a timely means of identifying new or unexpected health hazards which may occur as a result of occupational exposures at any of its nuclear facilities. Formerly known as the Health Surveillance System (HSS), the ESS maintains data concerning employee illnesses and injuries involving seven or more consecutive days of absence; incidences of disabilities; new diagnoses of malignancies; and causes of death and disabilities among active workers. These events are identified through a daily review of HEHF medical records and personnel data obtained from other contractors for workers at the Hanford Site.

DOE Health and Mortality Studies

AEC Feasibility Study

For the study, Mancuso located and identified original records at the Hanford and Oak Ridge sites and at offsite federal and other record repositories. In addition, through agreements with the SSA and state vital records offices, Mancuso obtained demographic information necessary to determine the vital status of the workers, that is, whether workers were still living at the time of the survey. Death certificates served as the primary source for this determination. As the project progressed, Mancuso found that the data did not meet his initial expectations but required further editing, verification, and other processing to assure the comprehensiveness and epidemiologic validity of his data analyses. During this period, Mancuso also expanded the data set to include AEC facilities at Los Alamos, Rocky Flats, and Mound.

AEC Health and Mortality Study

Dr. Samuel Milham of the Washington State Department of Social and Health Services reported increased mortality within the Hanford work force from several cancer types in 1974. His findings were part of a broader examination of occupational mortality throughout Washington state from 1950 to 1971. Milham's study encouraged Mancuso to conduct his own analysis of mortality at Hanford, the results of which were published in 1977. Mancuso's results, in which he purported to show increased risks for several types of cancer with increased radiation doses, received substantial criticism. Other epidemiologists and biostatisticians reanalyzed Mancuso's data set and repudiated many of his conclusions, with the exception of his findings concerning the elevated risk of multiple myeloma in individuals exposed to low-level radiation.

In 1975, ERDA decided not to renew Mancuso's status as the prime contractor for the Health and Mortality Study. At the beginning of fiscal year 1978, ERDA transferred specific aspects of the HMS to Oak Ridge Associated Universities (ORAU), Los Alamos National Laboratory (LANL), and HEHF and PNL at Hanford. ORAU epidemiologists, with the support of the University of North Carolina School of Public Health, were placed in charge of data analyses for uranium workers at Oak Ridge, Paducah, Portsmouth, Fernald, Mallinckrodt, Niagara Frontier sites, and, later, the Savannah River Plant. In addition, ORAU was assigned responsibility for the management of the DOE/SSA interface for the three sites and for related data collection, especially the retrieval, processing, and storage of death certificates. LANL assumed responsibility for DOE's National Plutonium Workers Study and for other site studies of workers routinely monitored for exposure to plutonium. HEHF/PNL epidemiologists continued to collect, process, and analyze data associated with the health and mortality of workers at the Hanford site.

DOE authorized ORAU in 1979 to expand the scope of the HMS to include all active and inactive workers throughout the entire Energy complex. Under this phase of the HMS, approximately 600,000 workers from 76 sites were eligible for eventual inclusion in the study. Of this population, 360,000 present and former workers are the basis for ongoing studies currently conducted by ORAU, LANL, and Hanford. Since the expansion of the HMS, ORAU has conducted the Five Rem Study, which examined workers who were exposed to five or more rems of radiation in the course of a single employment year. It also launched the Oak Ridge Facility Comparison (ORFCOM) Project, which analyzed the relationship of occupational, lifestyle, and health variables among specific occupational cohorts. (6)

In 1990, a Memorandum of Understanding (MOU) between DOE and the Department of Health and Human Services (HHS) transferred responsibility for the management and conduct of energy-related epidemiologic research to HHS's Centers for Disease Control and Prevention (CDC). Under the terms of this MOU, the National Institute for Occupational Safety and Health (NIOSH), a part of CDC, is responsible for conducting the major worker health studies for DOE sites. That same year, the collection and analysis of information that would be necessary to update the Hanford study ceased. Copies of electronic files of data supporting the Hanford epidemiologic studies are available on DOE's Comprehensive Epidemiologic Data Resource (CEDR), a public-use database. (7)

Lung Cancer, Ionizing Radiation, and Tobacco Smoking Among Males at Hanford Case-Cohort Study

Goodtime, Trauma, and Timeout Studies

Overview

NARA is responsible for overseeing the management of records by federal agencies and for storing federal records. Headquartered in Washington, DC, NARA operates regional branch offices. NARA and its branches permanently store valuable archival records and also assist patrons in conducting research in historical records.

In addition, NARA's Office of Federal Records Centers operates regional records centers. Federal agencies have the option of storing their inactive records at one or more of the federal records centers. The records stored in these facilities, however, remain the property of the agency. As such, they may be recalled by the custodial agency at any time, and may or may not be returned to the center. In addition, permission to review records stored in the federal records center must be granted by the custodial agency.

Records Locations

Permanent records, when transferred to NARA's Office of the National Archives, become the property of NARA. Researchers are not required to have the originating agency's approval to review unclassified records held by NARA. Following a review of the Guide to Records in the National Archives-Pacific Northwest Region, HAI determined that, as of 1989, NARA did not have records relating to Hanford in its custody. (10)

Records Retention and Disposition Schedules

Records retention and disposition schedules are important resources for understanding the life cycle of records. Following an initial inventory and appraisal of an office's records, records management staff create schedules, the primary function of which is to provide the disposition authority that governs the length of time records are to be maintained. NARA reviews and approves the records retention and disposition schedules of all federal agencies.

Record scheduling at all DOE sites are governed by two main sets of guidelines: the General Records Schedules (GRS) and the DOE Records Schedules (DOERS). (11) The GRS provides retention periods for records that are common to all federal offices, such as those pertaining to procurement, civilian personnel, printing, communications, and other routine functions. The GRS does not address the disposition of DOE program records, which are unique to that agency. These records are regulated by the DOERS. The two records schedules should be considered together to gain an understanding of the universe of DOE recordkeeping requirements. For further information, see NARA's Disposition of Federal Records and DOE Order 1324.2A. (12)

RIDS Database

RHA-MIS Database

NARA Standard Form 135s

HAI traveled to the Hanford site for one week during November 1994 to inventory records pertaining to DOE-funded epidemiologic studies. While at Hanford, HAI worked cooperatively with site personnel and representatives of NIOSH and ORAU (a contractor of NIOSH). HAI located pertinent records utilizing records inventories and schedules prepared by site records management personnel. HAI inventoried 81 cubic feet of PNL, HEHF, and other contractor inactive records stored in the RHA and SFRC; 63 cubic feet of active records retained in offices of PNL and HEHF; and electronic files maintained by PNL and HEHF. HAI also conducted nine interviews with DOE and DOE contractor personnel concerning the records. Once the site visit was completed, HAI staff analyzed and compiled the inventory forms and wrote the records series descriptions. In addition, HAI reviewed record inventories and informational literature from repositories in Pittsburgh, Pennsylvania; Washington state; California; and the Washington, DC, area. HAI determined that the records in these repositories are, for the most part, of tangential interest to the focus of this guide.

Data Elements

In accordance with the guidelines in Information Required by the Department of Energy for Epidemiologic and Health Studies, DOE developed a list of 123 (later revised to 86) data elements to assign to record series descriptions. In general, the data elements consist of terms pertaining to contractor organizations, individual employees, industrial hygiene activities, and facility characteristics that help describe the major information contained in a record series. The HAI team, as part of its inventory and description of records, determined which data elements were pertinent to each record series for both active and inactive records. A list of the data elements is included as part of this guide in Appendix B. Please note that the list is arranged topically, not numerically.

SCOPE

This guide reflects the status of records as of November 1994, when they were reviewed and inventoried by HAI. It contains series descriptions for records created mostly by the Operations Analysis Department of HEHF and the Epidemiology and Biometry Group of PNL, the organizational units most directly involved with conducting DOE-funded studies. For the most part, HAI targeted records which document data collection, integration, and analysis rather than raw data records. HAI described only those electronic files which were the most complete. Researchers also should be aware that HAI did not attempt to verify the comprehensiveness of the site record inventories and schedules used to identify and locate relevant records.

Because of time constraints and the large volume of files, HAI did not inventory electronic files which were created for the Three-Mile Island (TMI) Fund, International Agency for Research on Cancer (IARC), and the Comprehensive Epidemiologic Data Resource (CEDR). These are data files in which all employee identifiers have been removed. The same data, with employee identifiers, are found in electronic record series described in this guide.

HAI had originally intended to inventory and describe records relating to two separate DOE-funded studies of congenital malformations among children born between 1968 and 1980. The first study focused on children of Hanford workers and the second was devoted to children born in Benton and Franklin counties in southeastern Washington. Unfortunately, HAI was unable to review these records because they were being used by a researcher offsite. The conclusions of both of the congenital malformations studies were published in a single issue of the Journal of Epidemiology.(14)

HAI has included, as Appendix C, additional sources of information which may be useful to researchers.

Administrative Contacts

I. Administrative and General

II. Database Management

III. Data Collection

IV. Data Analysis

V. Electronic Record Series

HAI has arranged the electronic records described in this section into the following subcategories: Master Files, Personal Information Files, Work History Files, Occupational Radiation Exposure Files, and Vital Status Files. Master Files contain all data found in the other files. The Personal Information Files pertain primarily to employee name changes, social security numbers, and family histories. In addition to personal data, the Work History files contain dates, titles, and codes for jobs held; work locations; and organization codes. Occupational Radiation Exposure Files consist of employee external and internal exposure data, most of which were extracted from dosimetry and bioassay records. Vital Status Files contain dates and causes of death for current and former Hanford employees. In cases where records may fit into more than one subcategory, HAI placed them in the most appropriate file subcategory.

Under these subcategories, the records have further been divided by four file types: analysis, raw data, supporting, or working files. Analysis files contain the data on which study results were based; raw data files contain data which have not been manipulated by researchers; supporting files are used to define or explain variables contained in other files; working or intermediate files contain data which have been manipulated and may sometimes be a combination of several raw data files. HAI placed the records into the file type which it determined to be the most appropriate. Individual electronic records have been further organized under these four file types alphabetically by file name.

To facilitate research, HAI has also listed record series titles into general categories by record type. Record types include project case files, source records, project management and working records, input records, analysis files, raw data files, and computer-generated reports. See Appendix D for this list.

DATA ITEMS IN RECORD SERIES DESCRIPTIONS

Record Series Descriptions

Access Restrictions

Access to Hanford's records is also determined by the government security classification system. Researchers should note that all of the records described in this guide are unclassified. However, certain procedures must be followed to gain access to Hanford's unclassified records. The DOE onsite records management department has issued an access procedure which outlines steps to be followed by health researchers interested in unclassified records as well as in classified, Privacy Act, and proprietary records. See Appendix E for a copy of this procedure. Researchers should also be aware that some unclassified records are stored in buildings or areas which cannot be entered without proper security clearances.

For additional information concerning the security classification system and other restrictions that govern access, researchers may consult DOE's Understanding Classification (17) and Security Education and Awareness Overview Handbook(18).

Accession/Other Identification Number

Container Numbers and Disposition Authorities that correspond to these accession/identification numbers also are listed sequentially and are inclusive. For example, accession number 1) 35006-35008 corresponds to container number 1) 350006-35008; accession number 2) 434-83-0301 corresponds to container number 2) 35115. In the case of disposition authority, accession number 1) 35006-35008 corresponds to disposition authority 1) DOE (1980) C19.5; accession number 2) 434-83-0301 corresponds to disposition authority 2) DOE (1988) 1.3.

Arrangement

Condition

Container Number

Data Elements

Disposition Authority

Duplication

Finding Aids

Medium

Originating Office

Scanning Suitability

Series Description

Title and Inclusive Dates

Volume

Electronic Record Series Descriptions

Access Restrictions

Data Elements

Directory Name

Disposition Authority

File Description

File Name

File Type

Hardware/Software

Location

Office/Program Supported

Originating Office