United States General Accounting Office

GAO Report to the Ranking Minority Member,

Committee on Governmental Affairs,

U.S. Senate

June 1995 HEALTH AND SAFETY

DOE’s Epidemiological

Data Base Has Limited

Value for Research

GAO/RCED-95-126

GAO United States

General Accounting Office

Washington, D.C. 20548

Resources, Community, and

Economic Development Division

B-260637 

June 6, 1995

The Honorable John Glenn

Ranking Minority Member

Committee on Governmental Affairs

United States Senate

Dear Senator Glenn:

During the 1980s, the dual role that the Department of Energy (DOE) played

by both producing nuclear weapons and assessing the potential health

hazards associated with this production raised serious concerns about the

credibility of the results of DOE’s research on the health of people working

at or living near DOE’s facilities. In early 1990, the Secretary of Energy

announced several initiatives to address these concerns based on

recommendations from a special panel of experts—the Secretarial Panel

for the Evaluation of Epidemiologic Research Activities.1

 One of these

initiatives was the development of a data base to store and retrieve data

from DOE on the demographics, health, and exposure of its workers and

the communities near its facilities. The data base, to be developed under

the guidance of the National Academy of Sciences, was expected to be a

valuable, comprehensive resource for those conducting long-term

epidemiological and other health studies. For the first time in DOE’s

history, these data would be accessible to independent researchers.

In 1992, DOE began releasing the data used in its past research on health

effects to outside researchers through a system it called the

Comprehensive Epidemiologic Data Resource (CEDR). However, you were

concerned that this system was not as comprehensive as originally

envisioned and might be of limited use. Consequently, you asked us to

determine (1) whether the current system functions as the comprehensive

repository of epidemiological data2

 about DOE’s workers and the

communities surrounding the Department’s facilities envisioned by the

Secretarial Panel and the National Academy of Sciences and (2) whether it

1

The panel, chaired by Kristine Gebbie, M.N., the then-Secretary of Health for the state of Washington,

includes professors from schools of public health, epidemiology, and law; several directors of state

health agencies; and representatives of the United Auto Workers union and the American Cancer

Society.

2

Epidemiological data include the medical, demographic, exposure, environmental, and other data

necessary to support many kinds of research activities, such as health surveillance and monitoring,

screening programs, studies of the incidence of diseases (morbidity studies), and long-term studies of

death rates (mortality studies). For individuals, such data can be drawn from employment history and

from information on demographics, health and medical history, and occupational and other exposures,

such as smoking and diet. Follow-up studies also provide data on individuals.

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meets their intended objectives of accessibility and utility for outside

researchers. You also asked us to determine DOE’s future plans for this

system.

Results in Brief The Comprehensive Epidemiologic Data Resource that DOE developed is

not the comprehensive data base for epidemiological research envisioned

by the Secretarial Panel and the National Academy of Sciences. The

system lacks uniform data on the exposure of DOE’s current laboratory

workers to radiation and other hazardous substances that might affect

their health, as well as data on the health of these workers and residents

near DOE’s facilities. These data have not been routinely collected or

maintained throughout the DOE complex. DOE is trying to standardize the

way its facilities collect and maintain these data and to develop a more

comprehensive health surveillance program on its employees, as

recommended by the Secretarial Panel, but is at least 3 years from

accomplishing these goals. Without these data, researchers cannot make

the kinds of comparisons that lead to findings on health effects. The data

that currently appear in the system are primarily the results of past DOE

studies of workers’ deaths and are of limited value for original research.

While the Comprehensive Epidemiologic Data Resource is easily

accessible, few independent researchers have used it because problems

with the data currently in the system limit its usefulness for new research.

Problems include the absence of updated or original data, the extent to

which some personal identifiers have been removed to protect the privacy

of DOE’s workers, missing and inconsistent data elements, and inadequate

documentation by the researchers who provided the data. Consequently,

new researchers have had to examine original records at DOE’s facilities,

where they have encountered some problems in obtaining these records.

DOE is uncertain whether the system will ever be the comprehensive data

base envisioned by the Secretarial Panel and the National Academy of

Sciences. DOE has not developed specific long-range plans that identify the

tasks, milestones, and resources necessary to develop a system that would

maintain and disseminate uniform data on the demographics, exposure,

and health of the Department’s workers and residents near its facilities.

Furthermore, DOE has not assessed alternatives to the current system and

does not know whether there is a more cost-effective and practical means

of providing independent researchers with access to data from its

epidemiological studies.

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Background Over the past 50 years, as a result of producing tens of thousands of

nuclear weapons, DOE’s facilities have also produced radioactive and other

toxic substances that pose potential health threats to DOE’s workers and

the communities located nearby. These substances include the

radionuclides uranium, plutonium, and cesium; toxic metals; organic

solvents; and chlorinated hydrocarbons. Epidemiological

research—research on the incidence, distribution, and control of disease

in a population—provides a scientific evaluation of the health effects of

exposing workers and the public to such potentially harmful materials.

Such research uses health, exposure, environmental monitoring, and

personnel records to analyze health effects and evaluate methods to

protect people and prevent harm. As such, epidemiological research is

essential to a comprehensive occupational and environmental health

program.

DOE and its predecessor agencies have a long history in epidemiological

research, starting with studies of the survivors of the atom bomb. In the

past, much of this research was conducted by DOE or its contractors in

secret and concentrated on the correlation between the rates of

cancer-related deaths of workers at DOE’s nuclear weapons complex and

their exposure to ionizing radiation. A number of separate mortality

studies—studies of death rates—have been conducted on approximately

420,000 workers over the past 30 years. However, because the records that

researchers needed to study the health effects of working in DOE’s facilities

were maintained differently at each facility and were difficult to locate, the

types and quality of epidemiological research that could be conducted

were limited. To alleviate these problems and facilitate epidemiological

research on the health effects of exposure to radiation and other hazards,

the Secretarial Panel recommended that DOE continue developing CEDR as

a comprehensive repository of data on its workers.

In addition, to break down what was perceived as “a wall of secrecy” and

to help establish the credibility of and maintain independence in the

conduct of DOE’s epidemiological research, the Secretarial Panel

recommended opening this research and its supporting data to external

investigation and scrutiny. Among other things, the Secretarial Panel

recommended that DOE execute a memorandum of understanding with the

Department of Health and Human Services (HHS), making HHS responsible

for long-range, analytic epidemiological studies, while DOE remained

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responsible for descriptive epidemiology.3 As a result, much of the

epidemiological research on DOE’s facilities is now managed by HHS. Within

HHS’ Centers for Disease Control and Prevention, which implemented this

memorandum of understanding, the National Institute for Occupational

Safety and Health was made responsible for occupational health research

(i.e., research on workers employed by DOE and its contractors), while the

National Center for Environmental Health was made responsible for

research involving the environment, including communities near DOE’s

facilities.

The Secretarial Panel also called for greater outside scrutiny by

recommending that the National Academy of Sciences (NAS) play a key

role in overseeing and monitoring the development of CEDR. In response to

the Secretarial Panel, as well as a concurrent request from DOE to provide

general scientific advice on the status and direction of DOE’s

epidemiological programs, NAS established a Committee on DOE Radiation

Epidemiological Research Programs.4

 In 1990, this committee issued a

report making a number of recommendations about access to data for

researchers outside DOE, the types of data to be included in CEDR, and its

future development.5

 The report also noted that use of CEDR will depend on

ease of access to the information it contains and researchers’ perception

of its value.

Beginning in 1990, a DOE contractor facility, the Lawrence Berkeley

Laboratory, in Berkeley, California, constructed a prototype, known as

preCEDR, to serve as the basis of CEDR. In 1992, DOE made data available

through this system. In August 1993, DOE published a catalog of data

available in CEDR to assist current and potential users in identifying data

sets6

 for potential use and to provide instructions on how to obtain access

to these data. Through fiscal year 1994, DOE had received $14.35 million in

appropriations for CEDR, of which it had spent $9.45 million for CEDR and

3

Analytic epidemiological studies are designed to test causal hypotheses; for example, the correlation

between exposure to specific substances and illness among groups of people. Descriptive

epidemiology uses basic data on exposure, demographics, work history, and other factors to identify

patterns of illness and exposures among groups of people without determining a specific causal

relationship.

4

The committee’s full title is Committee on DOE Radiation Epidemiological Research Programs, Board

on Radiation Effects Research, Commission on Life Sciences, National Research Council.

5

Providing Access to Epidemiological Data: First Annual Report, Committee on DOE Radiation

Epidemiological Research Programs, National Research Council (National Academy Press: 1990).

6

A data set is a collection of logically related data files. CEDR contains two types of data sets:

(1) working data sets that contain data extracted by researchers from original records, such as payroll,

personnel, or dosimetry records, and (2) analytic data sets that contain composites of working data

that have been merged and analyzed by researchers to answer specific questions. (See app. I.)

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related expenses and redirected the remaining $4.9 million to other

activities.7 CEDR is budgeted at $1 million for fiscal year 1995, of which

$500,000 was funded as of February 1995.

Lack of Important

Epidemiological Data

Limits CEDR’s Value

DOE does not have available the uniform demographic, exposure, medical,

and environmental data that would make CEDR a comprehensive and

valuable epidemiological resource for independent researchers. The

Secretarial Panel recommended in 1990 that DOE define a minimum set of

data necessary for epidemiological research and routinely maintain and

collect these data at all DOE facilities. As part of this effort, in May 1992 DOE

requested that each of its facilities, within 3 years, complete an inventory

of 123 specific types of records that the Department believed were

important for conducting epidemiological studies. We reported on this and

other DOE efforts to manage records in a May 1992 report.8 DOE officials

told us that when completed, this records inventory would be included in

CEDR and would more easily identify for researchers where these specific

types of records are located. Meanwhile, DOE is waiting for its facilities to

complete their records inventories, which may take until 1996, before it

takes steps to routinely collect and maintain the types of records it has

already identified as important.

In addition, the NAS committee stated that CEDR should be capable of

supporting many kinds of epidemiological studies, including long- and

short-term health surveillance, monitoring studies, screening programs,

and long-term mortality studies. However, as we reported in December

1993,9 DOE probably will not establish a comprehensive health surveillance

program until at least 1998. Such a program would standardize the

documentation of workers’ occupational exposures to radiation and other

industrial hazards—such as chemicals, gases, metals, and noise—and

could identify trends in workers’ illnesses and injuries that might be

related to these exposures. Until such a program is in place, the

comprehensive data on health effects and exposure needed for important

epidemiological research will not be available for placement in CEDR.

Moreover, DOE’s Assistant Secretary for Environment, Safety, and Health

7

Of the $9.45 million spent, $7.12 million was used for direct expenses for CEDR, and $2.33 million was

used for “related expenses.”

8

DOE Management: Better Planning Needed to Correct Records Management Problems

(GAO/RCED-92-88, May 8, 1992).

9

Health and Safety: DOE’s Implementation of a Comprehensive Health Surveillance Program Is Slow

(GAO/RCED-94-47, Dec. 16, 1993).

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told us in October 1994 that standardization of data at DOE’s facilities was a

problem that would take several years to resolve.

Without the important data necessary to support many types of

epidemiological research, CEDR today mainly contains the limited data

from DOE-sponsored mortality studies of workers at DOE’s facilities at Oak

Ridge, Tennessee; Rocky Flats, Colorado; Hanford, Washington; and

elsewhere. Of the 37 data sets in CEDR, 36 contain the retrospective

information—data on past incidents—used to conduct these studies. (See

app. I.) Some new data will be included when certain ongoing studies are

completed. These studies include mortality studies of DOE’s workers at the

Idaho National Engineering Laboratory and the Portsmouth Gaseous

Diffusion Plant in Ohio; a study of cancer incidence among workers at

Rocky Flats by the National Institute for Occupational Safety and Health;

and studies from the National Center for Environmental Health, including

estimates of the effect of the radiation from Hanford on the air and water

in the surrounding area. While adding the results of these studies will

make some of the data in CEDR more current, the system will still lack the

comprehensive data discussed above that would make it the valuable

resource that the Secretarial Panel and NAS recommended.

According to many NAS committee members and CEDR users we spoke

with, the current lack of comprehensive epidemiological data limits CEDR’s

value for research. The Secretarial Panel cautioned DOE that retrospective

data would have limited value for future research. Also, members of the

NAS committee told us that the data on mortality that CEDR currently

contains limit the types of studies that can be done and have minimal

value for future research on health effects. NAS noted in its 1994 report that

the scope of the data currently in CEDR limits the type of research that can

be conducted.10 The data restrict researchers by defining the groups that

can be studied, the variables that can be examined, and the analytic

methods that can be applied. Officials at the National Institute for

Occupational Safety and Health and the National Center for

Environmental Health also stated that CEDR would be of greater value if it

contained data on chemical exposures and health effects. These data will

not be available until DOE’s health surveillance program is completed.

Since CEDR contains only limited retrospective data, researchers who need

more information must still locate records at DOE’s facilities, where the

records are not consistently maintained. However, despite CEDR’s limited

value for health effects research, several NAS experts, current users, and

10Epidemiologic Research Programs at the Department of Energy: Looking to the Future, Committee

on DOE Radiation Epidemiological Research Programs, National Research Council (National Academy

Press: 1994).

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DOE officials believe that it has significant value as a teaching tool for

students of epidemiology.

CEDR Is Easy to

Access, but

Limitations Impair Its

Utility to Researchers

DOE has made data from its mortality studies easy for outside researchers

to access through CEDR, and thousands of people have accessed the system

to see what basic data are available. However, few researchers have used

the data for original studies on health effects. In addition, some members

of the NAS Committee on Epidemiological Research and some researchers

we interviewed noted problems that impair the usability of the data.

Difficulties include a lack of data that have not been previously modified

by other researchers to meet their specific research needs, data that are

hard to work with because they have been edited to protect the privacy of

the workers, and data that are not current. In addition, some researchers

have encountered problems with the quality of the data, including missing

and inconsistent data and inadequate documentation of the studies

included. For these reasons, some CEDR users need to review original

records at DOE’s facilities but find the records difficult to obtain.

CEDR Is Easy to Access For the first time in its history, DOE has made the data used to support its

epidemiological research accessible. DOE has created a system that allows

researchers easy access to the epidemiological data that were used to

conduct its mortality studies, as recommended by both the Secretarial

Panel and NAS. In addition to data from past studies, CEDR contains

summary information, such as the 1992 annual summary of

epidemiological surveillance data from Brookhaven National Laboratory.

Potential users of CEDR can obtain basic information about the system’s

contents and file structure (but cannot access the actual data) through

DOE’s published catalog of available data or via a computer link with CEDR

directly or through the Internet.11 The summaries, which do not provide

detailed research data, are available to all Internet users. We were able to

access CEDR directly from personal computers using communication

software and found the instructions relatively easy to follow. According to

the CEDR staff at the Lawrence Berkeley Laboratory, computer logs show

that thousands of people have accessed CEDR to find out what basic data

are available.

11The Internet is an interconnected web of thousands of computer networks, cooperating to transport

a variety of information to millions of users worldwide. Authorized users can also access CEDR by

using their computers to dial directly into the telephone connections at Lawrence Berkeley

Laboratory.

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To view or obtain the actual data on DOE’s workers, a user must receive

authorization from DOE. Getting such authorization is a relatively simple

process. The required forms, including confidentiality agreements, are

provided in the CEDR catalog. Authorization generally takes about a month.

Approved users can obtain data from the Lawrence Berkeley Laboratory

via electronic tape or diskette, or through direct transmission if they have

specialized equipment. Users we talked with reported no major problems

in obtaining data from CEDR.

Few Researchers Are

Using CEDR

Despite the system’s accessibility, few independent researchers have

sought approval from DOE to become authorized CEDR users. In addition,

some authorized users have never obtained data from CEDR. DOE provided

us with a list of 22 primary users as of September 1994.12 Some of the users

listed, however, were not independent researchers but worked for DOE or

its contractors. Some of these users were involved only in loading, testing,

and maintaining the system. We identified 13 independent researchers

who were primary users and may have obtained data from CEDR. (See table

1.) We confirmed that nine independent researchers had obtained data

from CEDR. Three of these users worked on studies funded by the National

Institute for Occupational Safety and Health, three worked on university

research projects, two conducted research for public health institutes, and

one was a private consultant.

Table 1: Primary CEDR Users as of

September 1994 Type of user Number

DOE employees and contractors 4

GAO evaluator 1

Independent researchers

Researchers using CEDR dataa 9

Researchers not using data 4

Researchers not contactedb 4

Total 22

aThese nine researchers represented seven projects, two of which had two primary users each.

bWe were unable to contact some users despite repeated attempts and did not attempt to contact

those located in Europe.

12A primary user establishes a CEDR account and receives data from the Lawrence Berkeley

Laboratory. A primary user is allowed to share data with assistants on the same research project, who

are authorized as secondary users on the same CEDR account. We interviewed primary users listed as

of September 1994. In October 1994, DOE told us that the number of primary users had increased by

10, to a total of 32.

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Usefulness of Data in

CEDR Is Limited

Researchers using CEDR have encountered a number of problems with the

data in the system, limiting the value of these data for their research.

Although four of the nine researchers we spoke with found the quality of

the data satisfactory for their research purposes, the other five researchers

reported the following problems:

• Original data, not previously edited by other researchers, are not available

through CEDR.

• To protect workers’ privacy, key data elements important for certain

research have been removed.

• The data in the mortality studies are frequently old and have not been

updated.

• Research is hindered by problems with the quality of the data, including

missing and inconsistent data and inadequate documentation of studies by

prior researchers.

Data as Originally Recorded at

DOE’s Facilities Are Often

Unavailable

It is difficult to conduct research beyond DOE’s initial studies or to fully

validate the results, according to many of the researchers we spoke with,

because CEDR may not contain data as they were originally recorded at

DOE’s facilities. Instead, it generally contains data that have been

assembled and edited by prior researchers to answer specific research

questions. Some independent researchers using data in CEDR stated that

they need the original records to conduct their studies. Two CEDR users

conducting studies under contracts with the National Institute for

Occupational Safety and Health stated that their research was hampered

because the working data sets available in the data base were not original

data but had already been edited by prior researchers. Answering new

research questions would require obtaining the original records directly

from DOE’s facilities. Another CEDR user conducting research for a public

health institute told us that the best data for research are the original

records found at DOE’s facilities. An official of the National Institute for

Occupational Safety and Health, as well as a member of the NAS

committee, stated similar views.

Researchers Have Difficulties

With Data That Have Some

Personal Identifiers Removed

The extent to which some personal identifiers have been removed from

the data in CEDR to protect the privacy of workers has made it difficult for

some CEDR users to do more precise calculations or compare records. For

example, DOE replaced identifying data elements, such as names and social

security numbers, with pseudo-identifiers. DOE also rounded some key

dates in workers’ files, such as birth date, hiring date, and death date, if

applicable. In contrast, an official from the National Institute for

Occupational Safety and Health stated that while the Institute replaces

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identifying data elements, such as the name and social security number, in

data that it releases to the public, it does not truncate dates.

Researchers funded by the National Institute for Occupational Safety and

Health noted that truncating key dates makes it difficult to do precise

calculations of exposure, for which it is necessary to know the exact

numbers of days a worker is exposed to a hazard. In addition, replacing

identifying data elements makes it difficult to compare various records on

workers by, for example, consulting a state or national cancer registry.

Consulting such registries is often necessary to obtain a worker’s complete

health history.

Mortality Data Are Not Updated Several NAS committee members and current CEDR users told us that CEDR

would be more useful for follow-up studies if mortality data were updated,

especially data on those exposed to radiation. The mortality studies

included in CEDR were conducted on various workers who were employed

between 1942 and 1988 at different DOE facilities. In many of these studies,

the most recent mortality data are more than 10 years old. Researchers are

unable to follow up on the results of the mortality studies without

significant additional work. Researchers we spoke with explained that

because the chronic effects of exposure to low doses of radiation may not

occur until decades afterwards, workers who have been exposed to

radiation should be studied over lengthy periods. One epidemiologist, a

member of the NAS committee, stated that unless the workers in a study

are monitored until the cause of death has been determined, the results of

the study are not conclusive. Other epidemiologists and health physicists

from the Centers for Disease Control and some DOE contractors also

agreed that the data in CEDR would be more useful if the information on

mortality were updated. DOE’s Assistant Secretary for Environment, Safety,

and Health said that while she considers it the responsibility of the

Department to update these radiation studies, she is not sure that the

funding necessary to do this will be available, given the current emphasis

on funding research on the occupational health effects of hazardous

chemicals rather than radiation.

Quality of Some Data Is

Questionable

Some researchers working with CEDR have encountered additional

problems with the quality of the data. Five primary users we interviewed

had encountered missing, inconsistent, or inaccurate data. Measuring

exposure was a major problem for these users. Examples provided by the

data base manager of a research project sponsored by the National

Institute for Occupational Safety and Health included the following:

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• In one file, the researchers identified data on 115 workers that conflicted

with other information in the file about the amount of radiation to which

these workers had been exposed. The researchers could not determine

which data were correct.

• In another file, researchers found 1,000 people listed as never having been

monitored for plutonium exposure. Nevertheless, a date was entered in

the field for “first date monitored for plutonium exposure.” The

researchers could not tell which information was correct.

One CEDR user, who had served on the NAS committee, expressed concern

that inexperienced researchers could draw erroneous conclusions on the

basis of the data currently in CEDR. In her opinion, DOE should not widely

publicize access to CEDR for research until some of the problems with its

data have been addressed.

In an attempt to identify problems with the quality of the data, DOE is

setting up a computer bulletin board for CEDR users to communicate with

each other and point out problems they have uncovered. DOE cannot be

sure, however, that users will take the time to point out these problems.

Studies Are Inadequately

Documented

The Secretarial Panel noted that an important element of epidemiological

studies is documentation from the original researcher explaining the

study’s methodology, assumptions made, and limitations of the data. While

both the Secretarial Panel and the NAS committee recommended that all

studies provided to CEDR should be supported with documentation, some

researchers using CEDR have found insufficient documentation, making the

studies difficult to reconstruct. In one case, a university researcher had to

go to the facility that was the subject of the study to resolve problems with

the documentation. Researchers using CEDR for the two studies sponsored

by the National Institute for Occupational Safety and Health also noted

problems caused by inadequate documentation.

The staff at the Lawrence Berkeley Laboratory responsible for developing

CEDR told us that the researchers who provided the studies often did not

comply with documentation guidelines. DOE has recently issued revised

guidelines in an attempt to improve compliance. However, this measure

will not correct inadequate documentation of those studies already in

CEDR, and it is unknown whether future data providers will be more

responsive to this revised guidance.

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Records Are Hard to

Obtain From DOE’s

Facilities

Because of the limitations of the data in CEDR, some researchers seek to

obtain original records from DOE’s facilities, but they report encountering

difficulties. Researchers using CEDR for the two studies sponsored by the

National Institute for Occupational Safety and Health reported that

difficulties in obtaining original records are inhibiting their research. The

two researchers told us that when requesting such records from DOE sites,

they encountered either uncooperative contractor staff or a lack of

adequate staff resources to service their requests.

According to DOE’s Assistant Secretary for Environment, Safety, and

Health, CEDR is not really intended to be the sole source of data for

epidemiological researchers from the National Institute for Occupational

Safety and Health, who are likely to require the original records from DOE’s

facilities. She was aware that these researchers and others have had

difficulties obtaining records from some DOE sites, and she was attempting

to work with the contractors to resolve specific problems on a

case-by-case basis.

Future of CEDR Is

Unclear

Although DOE is adding to the contents of CEDR, doubt remains whether the

data base will become the system that NAS and the Secretarial Panel

envisioned, containing uniform and useful demographic, exposure,

medical, and environmental data. The DOE Assistant Secretary responsible

for the CEDR program acknowledged the system’s current limitations and

told us CEDR may not become this comprehensive data base. Moreover, DOE

has not attempted the long-range planning needed to achieve this vision.

The Secretarial Panel had recommended that DOE, under the guidance of

NAS, establish a clear statement of CEDR’s intended goals and uses and an

orderly plan for implementing the system. Such a plan would define the

steps to be accomplished, milestones for completing the work, and

resources needed. NAS committee members told us they were not aware of

any long-range planning for CEDR. DOE officials with the Office of

Epidemiology and Health Surveillance told us they did not have any

long-range plans that identified the specific tasks, priorities, time frames,

or resources necessary to develop CEDR into a comprehensive data base

containing the types of data that NAS had recommended. DOE currently

does not know when comprehensive epidemiological data will be available

to put into CEDR, how much it will cost to place these data in CEDR, or how

many researchers will potentially use these data.

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DOE is making progress toward standardizing and maintaining data on the

exposure of its current laboratory workers to radiation and other hazards

that might affect their health. Rather than develop CEDR into a

comprehensive data base, the DOE Assistant Secretary said DOE may

consider that the data base’s current function of providing the public with

access to its existing epidemiological research data is sufficient. In

addition, the Assistant Secretary told us in October 1994 that the budget

for CEDR—$1 million in fiscal year 1995—will be reevaluated if usage does

not increase substantially. Even with increased usage, however, it is not

clear whether CEDR is the most cost-effective and practical means of

accomplishing the more limited objective of providing access to DOE’s

epidemiological data and data gathered under the memorandum of

understanding with HHS. Some researchers and others we spoke with

suggested that a far less expensive clearinghouse arrangement might meet

this need just as effectively. For example, a clearinghouse might simply list

the name of the study, the type of data it contained, and the location of the

data. These data would remain at the facility where they were collected.

Conclusions CEDR was originally intended both to help dispel public fears about

secretive research at DOE and to be a valuable resource for independent

researchers studying the long-term epidemiological and other health

effects of working at or living near DOE’s facilities. The current system has

removed the “wall of secrecy” surrounding DOE’s epidemiological research

by making some of the data available to outside researchers. However, as

it now stands, CEDR has limited utility as a research data base. DOE is years

away from routinely collecting and maintaining the epidemiological data

on its workers that are needed to help make CEDR a comprehensive

resource.

Consequently, CEDR appears to be at a crossroad, and an overall

assessment of the system would help DOE better ensure that it is spending

its limited funds wisely. If DOE decides to pursue the original vision for

CEDR, it cannot be assured of an orderly implementation without a

long-range plan that sets forth the required time frames, resources, and

costs and takes into account the ongoing efforts to uniformly collect and

maintain epidemiological data throughout DOE’s facilities. If DOE decides

not to develop a comprehensive epidemiological data base, it could either

maintain or abandon the current system. However, maintaining the current

system may not be the most practical and cost-effective means of

providing the epidemiological data used in DOE’s past studies and those

currently being conducted by HHS. Resolving the problems impairing the

Page 13 GAO/RCED-95-126 GAO’s Epidemiological Data Base
B-260637 

usefulness of the data in the current system could cost DOE still more.

Finally, if DOE decides to abandon the system, continued openness and

public access to its health effects research cannot be ensured without

identifying alternative means of collecting and disseminating

epidemiological data.

Recommendations We recommend that the Secretary of Energy, in consultation with the

Secretary of Health and Human Services, the National Academy of

Sciences committee, and representatives of the research community,

determine whether the Comprehensive Epidemiologic Data Resource is

the most practical and cost-effective means of providing epidemiological

data for research on health effects. The assessment should cover the costs,

benefits, and time frames for including more comprehensive data on

health effects in the data base, as well as alternative means of making

these data available to outside researchers.

If the Secretary determines that the Comprehensive Epidemiologic Data

Resource is not the most practical and cost-effective means of compiling

epidemiological data, DOE should determine whether continued funding is

appropriate.

Agency Comments As requested, we provided a draft of this report to DOE for comment.

Although DOE did not provide a written response, the Acting Director of

the Office of Epidemiology and Health Surveillance did express her views

on the report.

Overall, she agreed with the problems we identified with the data.

However, she maintained that such limitations are inherent in data

collected from historical studies and that these data on former workers

are nevertheless important and useful. She noted that DOE is making

efforts to update and review these data to resolve inconsistencies. She

further noted that DOE is required to remove personal identifiers to protect

the identities of individual workers. We fully agree that workers’ privacy

must be protected. Nevertheless, as we stated in our report, unlike the

National Institute for Occupational Safety and Health, DOE truncates

(abbreviates or shortens) key dates, an action that can limit the usefulness

of the data.

Regarding the need to include data on current workers and residents in

CEDR, the Acting Director agreed that the information is vital and will be

Page 14 GAO/RCED-95-126 GAO’s Epidemiological Data Base
B-260637 

included as new studies are completed. However, while adding the results

of these studies will make some of the data more current, the system will

still lack the comprehensive data—such as uniform health, exposure,

environmental monitoring, and personnel data—that would make it the

valuable resource for new research on health effects that the Secretarial

Panel and NAS recommended.

The Acting Director also expressed concern about our recommendation

that the cost-effectiveness of CEDR be evaluated, noting that most of the

costs for CEDR have already been incurred. However, these costs are the

costs of the present data base, which contains historical information. DOE

does not know what it will cost to include the types of health surveillance

data in CEDR that the Secretarial Panel and NAS recommended. If CEDR will

not include these data, even the costs of maintaining the current system

may not be justified.

Finally, the Acting Director told us that DOE has added five primary users

of the data base since we completed our audit work and has added over

100 files in the last year. We did not verify or evaluate this information.

We also discussed the facts presented in this report with CEDR program

officials at the Lawrence Berkeley Laboratory, who generally agreed that

these facts were accurate. They provided updated information on users of

CEDR and data sets in the system, which we incorporated into the report.

We performed our review between February 1994 and May 1995 in

accordance with generally accepted government auditing standards. In

performing this review, we interviewed officials at DOE headquarters,

including the Assistant Secretary for Environment, Safety, and Health. We

also interviewed the personnel at the Lawrence Berkeley Laboratory,

Berkeley, California, responsible for designing and operating CEDR. We

spoke with eight of the nine members of the NAS committee responsible for

monitoring progress on CEDR, officials at the National Institute for

Occupational Safety and Health and the National Center for

Environmental Health, and all authorized CEDR users we were able to

contact. (See app. II for details of our scope and methodology.)

As arranged with your office, unless you publicly announce its contents

earlier, we plan no further distribution of this report until 30 days after the

date of this letter. At that time, we will send copies to the Secretary of

Page 15 GAO/RCED-95-126 GAO’s Epidemiological Data Base
B-260637 

Energy and other interested parties. We will also make the report available

to others on request.

Please call me at (202) 512-3841 if you or your staff have any questions.

Major contributors to this report are listed in appendix III.

Sincerely yours,

Victor S. Rezendes

Director, Energy and

 Science Issues

Page 16 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Page 17 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Contents

Letter 1

Appendix I 

Data Sets Included in

CEDR

20

Appendix II 

Scope and

Methodology

23

Appendix III 

Major Contributors to

This Report

24

Tables Table 1: Primary CEDR Users as of September 1994 8

Table I.1: Data From DOE-Sponsored Studies on Workers

Available Through CEDR as of November 1994

21

Abbreviations

CEDR Comprehensive Epidemiologic Data Resource

DOE Department of Energy

GAO General Accounting Office

HHS Department of Health and Human Services

NAS National Academy of Sciences

Page 18 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Page 19 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Appendix I 

Data Sets Included in CEDR

The Comprehensive Epidemiologic Data Resource (CEDR) provides a

repository of data that have been used to support epidemiological studies

conducted on workers at Department of Energy (DOE) facilities. DOE has

funded studies on various groups of workers of DOE or its contractors from

the 1940s through the 1990s at facilities involved in the production of

nuclear weapons. (See table I.1.) More than one study has been included in

CEDR for several of these facilities.

As of November 1994, CEDR contained a total of 37 data sets, or logically

related data files. Table I.1 lists the 36 data sets covering DOE-sponsored

studies on workers; an additional data set covers a 1990 study of atom

bomb survivors. Of the 36 data sets in CEDR as of that date, 29 are analytic

data sets from past studies at DOE’s facilities and 7 are working data sets.

Of the 29 analytic data sets from DOE sites or facilities, 28 are from

mortality studies. The remaining set came from a morbidity study that

examined the incidence and cause of respiratory disease among workers.

Page 20 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Appendix I 

Data Sets Included in CEDR

Table I.1: Data From DOE-Sponsored Studies on Workers Available Through CEDR as of November 1994

Analytic dataa Working

data

Facility or site

Number

of data

sets

Latest

study

Number

of

workersb

Period of

employment

Latest

mortality

data

Number of

data sets

Fernald, Ohio 1 1983 4,101 1952-72 1977 1c

Hanford, Washington 4 1993 44,101b 1944-85 1989 1

Los Alamos, New Mexico 3d 1988 5,424b 1943-88 1988 2d

Linde, Missourie 1 1987 995 1943-49 1979 1c

Mallinckrodt, Missourie 1 1994 2,542 1942-66 1988 1c

Mound, Ohio 3 1991 4,697b 1942-79 1984 1

Oak Ridge, Tennessee 11 1993 28,008b 1943-82 1984 1c

Pantex, Texas 1 1985 3,564 1951-78 1978 1

Rocky Flats, Colorado 1 1987 5,413 1951-79 1979 2

Savannah River, South Carolina 1 1988 9,860 1952-74 1980 1c

Multiple sites 2 1993 59,995b 1944-86 1986 none

Total 29 7

aAll analytic data sets listed are from mortality studies except the Fernald data set, which is from a

morbidity study. Two of the data sets added near the end of 1994 are also from morbidity studies.

bThe number of workers studied excludes other workers at the site who were not subjects of the

study. For sites with more than one study, the number shown is from the study covering the

largest number of workers.

cWorking data from the Oak Ridge Institute for Science and Education on approximately 420,000

people who worked at DOE’s facilities between 1943 and 1991. Also included as part of this data

set are working data for Fernald, Linde, Mallinckrodt, and Savannah River.

dThe three analytic and two working data sets for Los Alamos include two data sets of workers of

the Zia Company (a previous contractor) at Los Alamos, one analytical data set from an

unpublished study, and one working data set that overlaps some of the working data set on Los

Alamos in general.

eThe Linde plant and the uranium facility at Mallinckrodt Chemical Works are no longer

operational.

Source: Based on information from DOE.

We analyzed the contents of CEDR as of November 10, 1994. During our

review, DOE was adding new data sets and updating others already in the

system. For example, DOE added new analytic data sets from 1994 studies

on workers at Fernald, Oak Ridge, Mallinckrodt, Savannah River, and

other facilities and updated several working data sets, including data on

workers at the Mound plant. In addition to the 36 data sets shown in table

I.1, seven new analytical data sets, including two from multiple-site

Page 21 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Appendix I 

Data Sets Included in CEDR

studies, were added. A total of 44 data sets were available through CEDR as

of December 31, 1994. More additions and updates are planned for 1995.

DOE intends to make all the studies that it funds on exposures in or near

DOE’s facilities available through CEDR. DOE officials told us that during 1995

they plan to add new data sets to CEDR and update some of the existing

data. Among the new data DOE plans to add are analytic data sets from

additional studies of workers at several DOE facilities, a summary data set

of epidemiological surveillance data for one or more sites, a data set on

workers who painted radium dials, and data on exposures at DOE’s Nevada

Test Site. Updates are planned to the working data sets for at least two

sites and the dosimetry data for several others.

Page 22 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Appendix II 

Scope and Methodology

To determine how well CEDR meets its intended objective of being a

comprehensive resource, we (1) reviewed recommendations from reports

by the Secretarial Panel for the Evaluation of Epidemiologic Research

Activities and National Academy of Sciences (NAS) on designing and

implementing CEDR; (2) interviewed officials at DOE

headquarters—including the Assistant Secretary for Environment, Safety,

and Health; the Acting Director of the Office of Epidemiology and Health

Surveillance; and the CEDR Program Coordinator—and contractor staff at

the Lawrence Berkeley Laboratory concerning the current status of CEDR;

(3) reviewed relevant DOE directives, program plans, progress reports, and

documentation on CEDR; (4) interviewed eight of the nine members

(attempts to contact the ninth member were unsuccessful) of the NAS

committee responsible for monitoring and reporting on DOE’s progress on

CEDR; and (5) interviewed the officials from the National Institute for

Occupational Safety and Health and the National Center for

Environmental Health who were responsible for the studies conducted

under the memorandum of understanding between DOE and the

Department of Health and Human Services (HHS).

To determine how accessible and usable CEDR is for outside researchers

we also (1) obtained authorization from DOE to become CEDR users and

accessed and reviewed various files in the system and (2) interviewed

CEDR users about their experiences with the system. We also discussed

these issues with the officials on the NAS committee and at HHS mentioned

above.

We performed our review between February 1994 and May 1995 in

accordance with generally accepted government auditing standards. We

discussed the facts presented in this report with CEDR program officials at

the Lawrence Berkeley Laboratory and officials at DOE headquarters and

incorporated their views where appropriate. As requested, we also

provided a draft of this report to DOE for comment. Although DOE did not

formally respond within the 15 days allowed, the views expressed by the

Acting Director of the Office of Epidemiology and Health Surveillance and

our evaluation of them are presented in the Agency Comments section of

this report.

Page 23 GAO/RCED-95-126 GAO’s Epidemiological Data Base
Appendix III 

Major Contributors to This Report

Resources,

Community, and

Economic

Development

Division, Washington,

D.C.

Bernice Steinhardt, Associate Director

Alice G. Feldesman, Assistant Director

Carolyn K. McGowan, Assignment Manager

San Francisco

Regional Office

Margie K. Shields, Regional Management Representative

Randolph D. Jones, Evaluator-in-Charge

Daniel F. Alspaugh, Evaluator

Jonathan M. Silverman, Communications Analyst

(302111) Page 24 GAO/RCED-95-126 GAO’s Epidemiological Data Base
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