[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Pages 33059-33063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15960]
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DEPARTMENT OF ENERGY
Office of Environment, Safety and Health; Notice of Availability
of Funds and Request for Applications for Radiation Health Effects
Studies in the Russian Federation
AGENCY: Office of Environment, Safety and Health, DOE.
ACTION: Notice of availability of funds and request for applications.
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SUMMARY: The Office of International Health Programs, Office of Health
Studies, U.S. Department of Energy (DOE), announces that it is
accepting applications for cooperative agreements to support
population-based studies on low dose-rate radiation health effects in
the Russian Federation. This Notice is issued subsequent to the more
general Continuation of Solicitation for Epidemiology and Other Health
Studies Financial Assistance Program published in the Federal Register
(61 FR 53903) on October 16, 1996.
DATES: The deadline for receipt of formal applications is September 16,
1997.
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 and
application forms may be directed to Dr. Ruth Neta, Office of
International Health Programs (EH-63), U.S. Department of Energy,
telephone: (301) 903-1757; facsimile: (301) 903-1413. Applications may
be submitted to Dr. Neta at the above address.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Purpose
II. Background
III. Project Description
IV. Applications
V. DOE's Policy on Protection of Human Subjects Reviews
VI. Applicants
VII. DOE's Role
I. Purpose
The Office of International Health Programs funds, in partnership
with the Russian Federation, 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'') below
[[Page 33060]]
provides a description of the JCCRER and Section III (``Project
Description'') sets forth a description of the populations currently
being studied in the Russian Federation under research funded by DOE
and other U.S. agencies.
Relatively few U.S. scientists and institutions have collaborative
relationships with scientists and institutions in the Russian
Federation for radiation health effects studies. These relationships
have taken years to establish and are generally limited to traditional
epidemiologic studies of health effects. One purpose of this Notice is
to encourage U.S. scientists and institutions, who are on the cutting
edge of molecular biology and other newly developing approaches and
technologies, but who may not have an established record in radiation
health effects research or collaborative relationships with Russian
scientists, to apply these newly developed approaches and technologies
to health effects studies in the Russian Federation.
The following are examples of areas where newly developed
technology and new research approaches may be applied to ongoing
radiation health effects studies:
Molecular epidemiology;
Biomarkers and biodosimetry;
Biological tissue (including blood) sample banks; and
Epidemiology.
For example, molecular epidemiology studies could look for
potential molecular changes associated with low dose-rate, radiation-
induced carcinogenesis and other radiation-induced diseases (if they
exist) in the MAYAK cohorts described below in Section III.A.2.
(``MAYAK Workers Cohort''). Such new research holds promise for
identifying the molecular mechanisms and processes of radiogenic cancer
and other diseases. In addition, DOE is interested in identifying
biological markers of low dose-rate radiation exposures (biomarkers and
biodosimetry) and in projects that will provide a framework for
preserving biological samples and necessary records for future studies.
The other purpose of this Notice is to encourage research that
builds upon epidemiologic work conducted by the JCCRER that is already
underway (e.g., MAYAK cohorts), or that applies to epidemiologic
studies in the Russian Federation not currently coordinated by the
JCCRER (i.e., studies in the Russian Federation in which DOE is not
involved) but where epidemiologic and dosimetry data are available.
Here, cost and other economies can be realized because the
epidemiologic databases are already available. Augmenting ongoing
studies coordinated by the JCCRER or other epidemiologic studies in the
Russian Federation therefore will be a program policy factor considered
in the selection process. (See Section IV.B. ``Evaluation and
Selection'' below.)
Information from these augmented studies is expected to be of major
importance to DOE's mission to protect U.S. workers and populations
from risks of exposures that may be associated with the Department's
current and future activities. Studies funded under this Notice will be
conducted jointly with scientists from the Russian Federation.
II. Background
The JCCRER is a bilateral government committee representing
agencies from the United States and the Russian Federation 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 the Russian Federation. In
1948, a nuclear weapons production complex, ``MAYAK,'' was established
by the Soviet Union in Southern Urals, about 100 km northeast 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 operational facility 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 Ural's populations may provide an
opportunity to answer the question of whether chronic low-level
exposures pose a risk different from that previously assumed. Most of
DOE's knowledge of health effects and risks associated with radiation
exposures is based on studies of atomic bomb survivors in Japan and
patients treated with radiation therapy. These individuals, however,
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. Definitive studies on the Southern
Urals populations, 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. Thus, the preservation, restoration and analysis of
radiation exposure, medical and environmental data in the Southern
Urals are extremely important to the United States and to the world.
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. Centers for Disease Control and Prevention (CDC);
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 studies are the:
Nuclear Safety Institute (IBRAE) of Russian Academy of
Sciences, Moscow;
Branch #1 of Moscow Biophysics Institute (FIB-1), Ozersk;
``MAYAK'' Scientific and Production Association, Ozersk;
Urals Research Center for Radiation Medicine (URCRM),
Chelyabinsk;
[[Page 33061]]
Institute of Marine Transport Hygiene, St. Petersburg; and
Institute of Metal Physics, Ekaterinburg.
III. Project Description
A. Description of Cohorts
Two different epidemiologic research directions currently are
supported by the JCCRER: studies of populations who live near the Techa
River and studies of workers at the MAYAK facility.
1. Techa River Population Cohort
The liquid discharges to the Techa River from the MAYAK operational
facility (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 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 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 of 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:
------------------------------------------------------------------------
Years hired Average exposure
------------------------------------------------------------------------
1948-53................................ 1.57 Gy.
1954-58................................ 0.57 Gy.
1959-63................................ 0.27 Gy.
1964-72................................ 0.15 Gy.
------------------------------------------------------------------------
More than 1,800 occupational diseases were diagnosed by 1959, 92
percent of which were noted between 1949 and 1953. Eighty-three percent
of these were diagnosed as ``chronic radiation sickness'' caused by
radiation exposures of 1 to 10 Gy. Forty-one 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 projects to study the Techa and MAYAK
cohorts called Directions. Direction 1 studies the Techa population and
Direction 2 studies the MAYAK workers. These 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''
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.
Project 1.2, ``Risk Estimation of the Carcinogenic Effects in the
Population Residing in the Region of the Industrial Association
``MAYAK''
Objectives: To conduct studies to determine the risk of cancer in
population groups exposed to 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.
Direction 2: ``Medical Consequences of Occupational Exposure to
Radiation''
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 MAYAK on deceased people with occupational exposure to
radiation. The results would be useful for validating and improving
radiation protection standards.
Project 2.2, ``Risk Estimation for Cancerous 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.
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 facility.
Applicants are encouraged to augment any of the projects in
Directions 1 and 2.
C. Structure of Cooperative Agreements
Cooperative agreements funded under this announcement will
generally have two phases. Initial funding for each new cooperative
agreement will be for a phase I feasibility assessment. Up to 15
cooperative agreements may be awarded, totalling approximately $1.5
million. Phase I may last up to one (1) year. Phase II, if warranted,
will be funded through continuation awards under the same cooperative
agreement. Phase II could continue up to four (4) years, renewable
annually. Continuation awards for phase II, if made, will be based on
the results from phase I, the availability of funds, and negotiation of
the costs for phase II. Only those who participate in phase I will be
eligible to participate in phase II.
Phase I
During phase I, awardees will conduct a feasibility assessment. The
feasibility assessment will include a review of site-specific
information and an analysis of this and other information to
demonstrate the feasibility of conducting the proposed research. DOE
will play an active role in facilitating awardees' access to Russian
scientists as described in Section VII (``DOE's Role'') below. During
phase I, investigators will conduct the following tasks:
1. Establish cooperative relationships with Russian scientists
and institutions;
2. Identify existing information relevant to exposure and health
outcomes among target populations;
3. Determine the most significant impediments to conducting the
proposed project and propose strategies to overcome them;
[[Page 33062]]
4. Demonstrate the feasibility of conducting the proposed
project;
5. Develop a detailed technical proposal and budget for phase
II; and
6. Attend annual DOE-coordinated meetings to share information
on projects.
Using the information developed in tasks 1-4, investigators will be
expected to produce a feasibility assessment, as well as a technical
proposal and proposed budget for phase II. The feasibility assessment,
technical proposal, and proposed phase II budget should be delivered to
DOE at least sixty (60) days prior to the conclusion of phase I. The
process and the criteria used by the DOE to review these documents will
be described in detail in the award documents for phase I. This process
is intended to provide a seamless transition to phase II.
Phase II
DOE will determine the need for phase II activities as described
above and, if appropriate, will support these efforts through
continuation awards. Where phase II plans are approved by DOE, the
investigators will conduct the following tasks:
1. Conduct the research project developed in phase I;
2. Periodically communicate results to the DOE;
3. Publish the research results in peer reviewed scientific
journals; and
4. Attend annual DOE-coordinated meetings of researchers to
share information on projects.
IV. Applications
This Notice of Availability is issued pursuant to DOE regulations
contained in 10 CFR part 602: ``Epidemiology and Other Health Studies
Financial Assistance Program,'' as published in the Federal Register on
January 31, 1995 (60 FR 5841). The Catalog of Federal Domestic
Assistance number for 10 CFR part 602 is 81.108, and its solicitation
control number is EOHSFAP 10 CFR part 602. 10 CFR part 602 contains the
specific requirements for applications, evaluation, and selection
criteria. Only those applications following these specific criteria and
forms will be considered. Application forms and information on the
Russian institutions currently participating in JCCRER-coordinated
studies, set forth in Section II (``Background''), may be obtained at
the address cited above.
A. Proposal Format
The formal proposal shall contain two sections, technical and cost.
Technical proposals shall be no more than twenty-five (25) pages in
length; resumes of proposed key personnel should be submitted as an
appendix to the technical proposal and will not be counted against the
page limit. Cost proposals shall have no page limit. It is imperative
that the proposals be organized into phase I and phase II. Because the
scope of phase II is dependent on the results of phase I, the technical
description for phase II may be less specific than that for phase I,
but must clearly demonstrate a capability to conduct phase II. The
following format must be followed:
a. Abstract--This should be a 1 page summary of the specific aims,
background, significance, and research design and methods.
b. Specific Aims--State the long-term objectives and describe what
the specific research in this plan is intended to accomplish and the
hypothesis to be tested.
c. Project Description--Describe the research design and the
procedures to be used to accomplish the specific aims of the project.
At a minimum, the tasks listed under Section III.C. above (``Structure
of Cooperative Agreements'') must be described (in detail for phase I
tasks and more generally for phase II tasks). The project description
must include clear statements of what is known, what is uncertain, and
what new knowledge would be added by the proposed study.
d. Personnnel--Proposals must demonstrate the competency of
research personnel and the adequacy of resources. Proposals must
demonstrate that the applicant has the experience and capability to
plan, organize, manage, and implement the proposed work. Proposals must
identify the technical and scientific staff that will actually conduct
the studies and detail their professional experience. Proposals must
demonstrate that the offeror has a demonstrated skill in planning and
scheduling projects of comparable magnitude to the project it is
proposing under this Notice.
e. Cost--The cost proposal for phase I must include a summary
breakdown of all costs and provide a detailed breakdown of costs on a
task-by-task basis. Costs for phase II tasks may be more general
estimates since the initial award will be for phase I only. Any
expectation concerning cost sharing with non-DOE entities must be
clearly stated. The cost proposal for phase I shall include an estimate
of the costs of Russian scientists and institutions.
B. Evaluation and Selection
Formal applications will be subjected to formal merit review (peer
review) and will be evaluated against the following criteria listed in
descending order of importance and codified at 10 CFR 602.9(d):
1. Scientific and technical merit of the proposed research;
2. Appropriateness of the proposed method or approach;
3. Competency of research personnel and adequacy of proposed
resources; and
4. Reasonableness and appropriateness of the proposed budget.
Formal applications will be peer reviewed by evaluators apart from
DOE employees and contractors as described in the Office of
Environment, Safety and Health's Merit Review System (57 FR 55524,
November 25, 1992) and at 10 CFR 602.9(c). Submission of an application
constitutes agreement that this is acceptable to the investigator(s)
and the submitting institution. In accordance with 10 CFR 602.9(e), and
as described in above in Section II (``Background''), a program policy
factor for DOE that will be considered in selection is the economies
introduced when a project builds upon existing epidemiologic studies.
Specifically, DOE will not consider funding new radiation health
effects studies ``starting from scratch'' where most of the
epidemiologic and dosimetry data need to be developed de novo.
V. DOE's Policy on Protection of Human Subjects Reviews
The Federal Policy for the Protection of Human Subjects, in 10 CFR
part 745 (the ``Common Rule''), has special provisions for
international research which apply to any awards made under this Notice
of Availability. DOE approval of research conducted outside of the
United States is subject to the ``Common Rule,'' or equivalent laws and
regulations of the country in which research is conducted, whichever
represents the greater level of protection for the research subject.
DOE will work with awardees during phase I, as necessary, to ensure
that research conducted by Russian scientists collaborating with phase
I awardees comports with the required level of protection of human
subjects and adequately addresses the issue of informed consent.
Information on protecting human research subjects (within DOE) can be
obtained from Dr. Ruth Neta at the address listed above.
VI. Applicants
Applicants for the cooperative agreements may include domestic
nonprofit and for profit organizations, universities, medical centers,
research institutions, other public and private organizations,
including small, minority or women-owned businesses. Consortiums of
interested organizations
[[Page 33063]]
are encouraged to apply. Awardees for each study will need to work
cooperatively with Russian scientists, and governmental and non-
governmental institutions and organizations.
VII. DOE's Role
For DOE to use cooperative agreements for these studies, there must
be substantial involvement between DOE and any awardee. DOE established
the subject area for these projects, the core tasks for phase I and
prepared this Notice of Availability. DOE will conduct the evaluation,
selection, and award process for applications submitted pursuant to
this Notice. If necessary, DOE will facilitate contact between phase I
awardees with scientists and institutions in the Russian Federation
listed in Section II (``Background''). DOE will evaluate the results of
phase I and, where warranted and subject to available funding,
authorize and fund phase II continuation awards. In addition, DOE will
establish requirements for data collection and handling. DOE also will
consult with project investigators and coordinate annual meetings.
Finally, DOE will monitor and evaluate the results of the projects to
determine how these studies will contribute to DOE's ongoing efforts to
improve health and safety programs for its workers.
Issued in Washington, D.C., on June 10, 1997.
Paul J. Seligman,
Deputy Assistant Secretary for Health Studies.
[FR Doc. 97-15960 Filed 6-17-97; 8:45 am]
BILLING CODE 6450-01-P
