[Federal Register Volume 64, Number 153 (Tuesday, August 10, 1999)]
[Notices]
[Pages 43364-43366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20536]


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DEPARTMENT OF ENERGY


Request for Information on Potential Studies in the Russian 
Federation of Low Dose-Rate Radiation Health Effects

AGENCY: Office of Environment, Safety and Health, DOE.

ACTION: Request for information.

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SUMMARY: The U.S. Department of Energy (DOE), announces a request for 
information (RFI) on potential studies in the Russian Federation of low 
dose-rate radiation health effects. Specifically, DOE is interested in 
receiving information on new ideas for epidemiologic, dosimetric/
biodosimetric, and/or molecular epidemiologic studies that would: (1) 
Build upon collaborative research already conducted on workers and 
populations in the Southern Urals; or (2) utilize information on other 
similar cohorts in the Russian Federation. Information submitted in 
response to this RFI will be used to define the scope of a Request for 
Applications (RFA) that may be issued in late calendar year 1999.

DATES: The deadline for receipt of submissions is October 5, 1999.

ADDRESSES: U.S. Department of Energy, Office of International Health 
Programs, EH-63/270CC, 19901 Germantown Road, Germantown, Maryland 
20874-1290

FOR FURTHER INFORMATION CONTACT: Requests for further information on 
this announcement may be directed to Elizabeth White, Office of 
International Health Programs (EH-63), U.S. Department of Energy, 
telephone: (301) 903-7582; facsimile: (301) 903-1413; electronic mail: 
[email protected]. Responses may be submitted, preferably by 
electronic mail or facsimile, to Ms. White.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Purpose
II. Background
III. Description of Ongoing JCCRER Projects
IV. Submissions to this RFI
V. Disclaimer

I. Purpose

    The Office of International Health Programs, Office of Environment, 
Safety and Health, in partnership with ministries of the Russian 
Federation, funds epidemiologic studies of cohorts of workers and 
populations to evaluate the health consequences (cancer and other 
diseases) of exposure to low dose-rate ionizing radiation. These 
ongoing studies are coordinated through the Joint Coordinating 
Committee for Radiation Effects Research (JCCRER). Section II 
(``Background'') provides a description of the JCCRER and Section III 
(``Description of Ongoing Projects'') sets forth a description of the 
populations currently being studied in the Russian Federation under the 
auspices of the JCCRER.
    The purpose of this Notice is to encourage the submission of 
information on potential radiation health effects research. The Office 
of International Health Programs is interested in ideas for new 
epidemiologic, dosimetric/biodosimetric, and/or molecular epidemiologic 
studies that would: (1) Build upon low dose-rate radiation health 
effects research already conducted under the auspices of the JCCRER in 
the Southern Urals. In particular, DOE is looking for ideas for new 
projects involving the worker and population cohorts (See Section II) 
affected by radiation emitted from the Mayak Production Association; or 
(2) use other similar epidemiologic and dosimetric databases in the 
Russian Federation to further elucidate the health effects of chronic 
low dose-rate radiation exposure. In particular, we are interested in 
learning about other cohorts or potential cohorts of radiation-exposed 
workers and populations, and the potential scientific studies that 
could be developed for these cohorts.
    DOE, with the help of its standing Scientific Review Group, will 
review the information submitted in response to this RFI for use in 
defining the scope of an RFA that may be issued in late calendar year 
1999. DOE anticipates that approximately $1,000,000 may be available in 
fiscal year 2000 to initiate new feasibility projects.

II. Background

    The JCCRER is a bilateral Government committee representing 
agencies from the United States and ministries from the Russian 
Federation. It was established to implement the Agreement on 
Cooperation in Research on Radiation Effects for the Purpose of 
Minimizing the Consequences of Radioactive Contamination on Health and 
the Environment signed on January 1, 1994, by U.S. Secretary of State 
Warren Christopher and Russian Foreign Minister Andrey Kozyrev to 
support and facilitate joint cooperative research.
    Radiation research conducted jointly with the Russian Federation 
provides a unique opportunity to learn more about possible risks to 
groups of people from lengthy exposure to radiation. This could include 
people receiving exposure from uranium mining, operations of nuclear 
facilities, transport and disposal of radioactive materials, the 
testing and dismantling of nuclear weapons, radiation accidents, and 
grossly contaminated sites or facilities.
    Currently, the JCCRER and DOE are focusing on population and worker 
studies in the Southern Urals region of

[[Page 43365]]

the Russian Federation. In 1948, a nuclear weapons production complex, 
the Mayak Production Association, was established by the Soviet Union 
in Southern Urals, about 100 km northwest of the city of Chelyabinsk. 
Large amounts of radioactive materials were released into the 
environment between 1948 and 1957. Liquid discharges into the Techa 
River from the Mayak Production Association occurred from 1949-1956. As 
a result, thousands of square kilometers have been contaminated and 
hundreds of thousands of people have received significant radiation 
exposures. Furthermore, because of limited and inadequate (by today's 
standards) radiation protection measures and procedures, thousands of 
MAYAK workers and the population along the Techa River were seriously 
overexposed to radiation.
    The studies of Southern Urals' and other Russian Federation 
populations may provide an opportunity to answer the question of 
whether chronic low-level exposures pose a risk different from that 
previously assumed from studies of atomic bomb survivors in Japan and 
patients treated with radiation therapy. The atomic bomb survivors were 
exposed to very short bursts of external radiation, unlike the pattern 
of exposure normally encountered or expected in the nuclear industry 
and with other uses of radiation. The Southern Urals' populations 
experienced chronic exposures over a much longer period. The exposures 
were also from both external radiation and internally deposited 
radioactive compounds. Studies on these and similar populations in the 
Russian Federation, coupled with comparisons with U.S. nuclear worker 
data, may prove to be a key factor in future development of radiation 
protection standards and regulations in the United States and 
worldwide.
    The current U.S. JCCRER members are the:

--U.S. Department of Energy (DOE);
--U.S. Nuclear Regulatory Commission (NRC);
--U.S. Department of Health and Human Services (HHS);
--U.S. Department of Defense (DoD);
--U.S. National Aeronautics and Space Administration (NASA); and
--U.S. Environmental Protection Agency (EPA).

    The current Russian JCCRER members are the:

--Ministry for Civil Defense Affairs, Emergencies and Elimination of 
Consequences of Natural Disasters (EMERCOM);
--Ministry of Atomic Energy (MINATOM); and
--Ministry of Health (MINZDRAV).

    The Russian institutions currently participating in JCCRER-
coordinated radiation health effects research are the:

--Branch Number 1 of Biophysics Institute (FIB-1), Ozersk;
--Mayak Production Association, Ozersk;
--Urals Research Center for Radiation Medicine (URCRM), Chelyabinsk; 
and
--Institute of Marine Transport Hygiene, St. Petersburg.

III. Description of Ongoing JCCRER Projects

A. Description of Cohorts

    Two different epidemiologic research directions currently are 
supported by the JCCRER: (1) studies of populations who live near the 
Techa River; and (2) studies of workers at the MAYAK facility.
1. Techa River Population Cohort
    The liquid discharges to the Techa River from the Mayak Production 
Association (due to inadequate storage of radioactive waste) occurred 
from 1949-56, with 95 percent released in an 18-month period (March 
1950 to November 1951), for a total release of about 3 million Ci.
    The cohort registry consists of individuals born in 1949 or 
earlier, who lived for at least one (1) month during 1950 to 1952 in 
the villages along the Techa River. The cohort includes 28,000 
individuals, about 20 percent of which have been estimated to have had 
average effective doses of exposure of more than 0.5 sievert (Sv). 
Thirty (30) percent of the cohort members were 0 to 14 years old at the 
time of exposure.
    The external exposure was due from contaminated sediments in the 
river; the internal exposure (measured by whole body counts and 
conducted for half of the members of the cohort) was mainly due to 
intake of river water and milk and included Sr 89, 90, and Cs 137.
    Published reports indicate a statistically significant increase in 
leukemia in the exposed versus control populations. Other cancers, 
including stomach, esophagus, and lung were also studied, but the 
results have not been conclusive.
2. Mayak Workers Cohort
    The computerized registry of 19,000 Mayak Production Association 
workers contains: occupational histories; vital status; current place 
of residence or date and causes of death; annual and cumulative data 
doses; plutonium body burdens; and internal doses to the main organs 
(lungs, liver and bone marrow). In this cohort, 14,000 have known vital 
status; 4,000 are dead; 1,000 died of cancer; and more than 4,000 have 
known plutonium body burdens. The average value of the equivalent dose 
to the lung for all workers with measured plutonium (Pu 239) body 
burden is 7.06 Sv, with external gamma doses of 0.88 gray (Gy) for all 
workers included in the registry. Radiation doses decreased 
significantly with time, for example:

------------------------------------------------------------------------
                                                                Average
                         Years hired                           exposure
                                                                 (Gy)
------------------------------------------------------------------------
1948-53.....................................................        1.57
1954-58.....................................................        0.57
1959-63.....................................................        0.27
1964-72.....................................................        0.15
------------------------------------------------------------------------

    More than 1,800 occupational diseases were diagnosed by 1959, 92 
percent of which were noted between 1949 and 1953. Eighty-three (83) 
percent of these were diagnosed as ``chronic radiation sickness'' 
caused by radiation exposures of 1 to 10 Gy. Forty-one (41) cases were 
diagnosed as ``acute radiation syndrome,'' four of which were fatal. 
Burns and other local radiation injury were reported for 188 workers. 
In addition, 110 cases of pnemosclerosis (66 in individuals whose 
internal lung exposure exceeded 4.0 Gy) were diagnosed.

B. JCCRER Directions

    The JCCRER has initiated areas for study called Directions. 
Direction 1 focuses on the Techa River population and Direction 2 
focuses on the MAYAK workers. All projects are jointly conducted by 
both U.S. and Russian principal investigators and their respective 
teams of researchers, and are summarized below.
Direction 1: ``Medical Aspects of Radiation Exposure Effects on 
Population''
1. Project 1.1: ``Dose Reconstruction for the Population Subjected to 
Radiation in the Urals''

    Objectives: To reconstruct, validate and analyze data on individual 
radiation doses received by the population so that these can be used in 
studies assessing the risks of developing cancer in exposed 
populations. (U.S. support from DOE, with supplements from NASA and 
EPA.)

2. Project 1.2: ``Risk Estimation of the Carcinogenic Effects in the 
Population Residing in the Region of the Mayak Production Association''

    Objectives: To conduct studies to determine the risk of cancer in 
population groups exposed to

[[Page 43366]]

radioactive contaminants in the region, to characterize the quality and 
validity of the data for conducting such studies, and to preserve the 
existing data using modern technologies. (U.S. support from DOE on 
cancer incidence and data preservation projects; from National Cancer 
Institute (HHS) on cancer mortality project.)

3. Project 1.3: ``Retrospective Reconstruction of Radionuclide 
Contamination of Techa River Caused by Liquid Waste Discharge from 
Radiochemical Production at the Mayak Production Association: 1949-
1956''

    Objectives: To supplement the population dose reconstruction study 
by determining source term of radioactive materials released into the 
Techa River. (U.S. support from DOE.)
Direction 2: ``Medical Consequences of Occupational Exposure to 
Radiation''
1. Project 2.1: ``Metabolism and Dosimetry of Plutonium Industrial 
Compounds''

Objectives: To conduct a joint analysis of the data collected by the 
U.S. Transuranium and Uranium Registry (USTUR) and the dosimetry 
registry at the First Institute of Biophysics/MAYAK on deceased people 
with occupational exposure to radiation. (U.S. support from DOE.)

2. Project 2.2: ``Risk Estimation for Stochastic (Carcinogenic) Effects 
of Occupational Exposure''

    Objectives: To determine risk estimates for cancer as a result of 
prolonged occupational exposure to radiation, from both external 
sources and internally-deposited radioactive compounds. (U.S. support 
from DOE.)

3. Project 2.3: ``Non-cancerous Effects of Occupational Exposure to 
Radiation''

Objectives: To validate and analyze the data on acute and chronic 
effects of radiation, other than cancer, observed in a large number of 
workers at the Mayak Production Association. (U.S. support from NRC.)

4. Project 2.4: ``Reconstruction of Individual Doses of Exposure to 
Mayak Production Association Workers''

    Objectives: To develop an electronic database of reconstructed 
doses for external and internal exposures received by the Mayak worker 
cohort. (U.S. support from DOE.)
DOE Office of International Health Programs-Funded Direction 2 
Molecular Epidemiology/Biodosimetry Projects
    The Office of International Health Programs awarded five 
cooperative agreements in August 1998 for 15-month feasibility studies 
to support ongoing joint U.S.--Russian population-based studies in the 
Southern Urals on low dose-rate radiation health effects. These new 
studies are aimed at adding a molecular epidemiology/biodosimetry 
component to the ongoing epidemiologic and dose reconstruction work of 
the JCCRER. The feasibility studies have been jointly conducted by the 
FIB-1 in Ozersk and U.S. institutions, and the following three are 
being considered for long-term study:

1. ``Improved Dosimetry and Risk Assessment for Plutonium-Induced Lung 
Disease Using a Microdosimetric Approach''

    Objectives: To evaluate the potential for determining plutonium 
distribution in relation to pathology in preserved tissues.

2. ``Establishment of a Repository Containing Tissues and Organs of 
Deceased Workers of the Mayak Production Association Who Were Exposed 
to Actinide Elements''

    Objectives: To begin establishing a human tissue repository for 
cytogenetic and molecular biological research at the First Institute of 
Biophysics in Ozersk

    3. ``Molecular Epidemiology and Lung Cancer in Workers''

    Objectives: To examine the potential to use molecular epidemiology 
approach in establishing in the MAYAK workers' cohort of association of 
lung cancer, smoking and radiation exposure.

IV. Submissions to this RFI

    There are no eligibility requirements for this RFI. Responses 
should be no longer than 3 pages and should contain 2 sections: (1) A 
brief description of the cohort(s) and data available for study; and 
(2) a short summary of potential research topics. As is noted in 
Section I of this RFI, responses will be used to define the scope of an 
RFA that may be issued in late calendar year 1999.
    Since DOE may use information submitted pursuant to this RFI to 
define the scope of an RFA, responses should not include business 
confidential or any other proprietary information.

V. Disclaimer

    This RFI should not be construed as: (1) A commitment by the 
Department to enter into any agreement with any entity submitting 
response(s); (2) a commitment to issue any RFA concerning the subject 
of this RFI; or (3) an RFA.

    Issued in Washington, DC, on August 4, 1999.
Paul J. Seligman, M.D., M.P.H.
Deputy Assistant Secretary for Health Studies.
[FR Doc. 99-20536 Filed 8-9-99; 8:45 am]
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