[Federal Register Volume 60, Number 116 (Friday, June 16, 1995)]
[Notices]
[Pages 31726-31729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14772]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 559]
National Institute for Occupational Safety and Health; Chronic
Beryllium Disease Among Beryllium-exposed Workers
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1995 funds for a cooperative agreement
to develop a model program for the prevention, diagnosis, and treatment
of chronic beryllium disease (CBD) among individuals who have been
occupationally exposed to beryllium and/or beryllium compounds.
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of Healthy People
2000, a PHS-led national activity to reduce morbidity and mortality and
improve the quality of life. This announcement is related to the
priority area of Occupational Safety and Health. (For ordering a copy
of Healthy People 2000, see the Section Where to Obtain Additional
Information)
Authority
This program is authorized under Sections 20(a) and 22(e)(7) of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a) and
671(e)(7)).
Smoke-free Workplace
The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products,
and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities that receive Federal funds in which education,
library, day care, health care and early childhood development services
are provided to children.
Eligible Applicants
Applications may be submitted by public and private, non-profit and
for-profit organizations and governments, and their agencies. Thus,
universities, colleges, research institutions, hospitals, other public
and private organizations, State and local health departments or their
bona fide agents, federally recognized Indian tribal governments,
Indian tribes or Indian tribal organizations, and small, minority-,
and/or women-owned businesses are eligible to apply.
Availability of Funds
Approximately $400,000 is available in FY 1995 to fund one award.
It is expected that the award will begin on or about September 30,
1995, and will be
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made for a 12-month budget period within a project period of 3 to 5
years. Funding estimates may vary and are subject to change.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Purpose
The purpose of this cooperative agreement is to conduct a program
of applied research in the prevention of CBD among individuals who have
been occupationally exposed to beryllium and/or beryllium compounds.
The National Institute of Occupational Safety and Health (NIOSH) has
conducted studies of or is aware of a number of such cohorts which are
listed in the attached appendix. These cohorts, as well as other
beryllium- exposed cohorts not included in this list, may be identified
in the research proposal.
Within the past ten years, an in vitro test for identifying
sensitization to beryllium was developed. Currently, the blood
lymphocyte proliferation test (LPT also known as the lymphocyte
transformation test or LTT) to beryllium salts is available from a
limited number of laboratories in the U.S. The sensitivity,
specificity, positive predictive value, and negative predictive value
of this test with respect to CBD have been estimated based on its
application in a few occupational cohorts. However, these estimates
need to be confirmed in other groups of beryllium-exposed workers.
Also, it is not known whether interventions (e.g. removal from exposure
or early treatment with corticosteroids) impede the progression from
sensitization to clinical disease.
Although sensitization can occur after short-term exposure to
beryllium, the risk of sensitization appears to increase with more
exposure. These findings suggest that both individual susceptibility
and exposure conditions are important in the onset of CBD. To improve
the prevention of beryllium disease, several research areas need
exploration.
These include:
1. The characterization of the natural history of CBD;
2. Identification of specific beryllium compounds associated with CBD;
and
3. Evaluation of a possible dose-response relationship between CBD and
exposure to beryllium (with beryllium exposures characterized in
different manners, e.g., levels, duration, methods of handling, etc.).
In many of the published studies, the small number of sensitized
individuals and CBD cases has limited the power to discern process-
related risks and temporal patterns. In addition, past studies have
suffered from a lack of detailed exposure data. Larger sample sizes and
improved exposure data are needed to address these data gaps.
This program will identify applied research needs, formulate a plan
to respond to those needs, evaluate the effectiveness of the program
interventions, and disseminate research results. Specifically, this
cooperative agreement is intended to greatly improve prevention efforts
for CBD, including primary and or secondary prevention activities.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC/NIOSH will be responsible for
conducting activities under B. (CDC/NIOSH Activities).
A. Recipient Activities
1. Identify research needs relative to the prevention of CBD among
people who have been occupationally exposed to beryllium and/or
beryllium compounds.
2. Develop a research protocol that reviews the pertinent CBD
literature and describes the study methodology, the data to be
collected and the proposed analysis of the data. Present the protocol
to a panel of peer reviewers and revise the protocol as required for
final approval by CDC.
3. Conduct all required medical and laboratory tests on workers
participating in the study; collect necessary exposure and identifying
data on workers; analyze data.
4. Prepare a final report summarizing the study methodology,
results obtained, conclusions reached and recommendations for
preventing CBD, and additional research needs.
5. Where appropriate, collaborate with CDC/NIOSH scientists who are
working in complementary research areas.
6. Report research results to the scientific community via
presentations at professional conferences and articles in peer-reviewed
medical journals.
B. CDC/NIOSH Activities
1. Provide scientific, epidemiologic, engineering, environmental,
industrial hygiene, and clinical technical assistance.
2. Identify reviews and/or clearances that must be fulfilled by the
recipient, and identify and convene Peer Review Panel to review draft
study protocol.
3. Assist in formulating the study design, the analysis of the data
collected, interpretation of the results, and preparation of the
written reports.
4. Engage in scientific collaboration in research areas of mutual
interest and investigation.
5. Assist in the reporting of research results to the scientific
community via presentations at professional conferences and articles in
peer-reviewed medical journals.
Evaluation Criteria
The application will be reviewed and evaluated according to the
following criteria:
1. Understanding of the Problem (25%)
Responsiveness to the objective of the cooperative agreement
including: (a) applicant's understanding of the research needed to
prevent CBD and the objective of the proposed cooperative agreement,
and (b) relevance of the proposal to the objective.
2. Study Design and Project Planning (35%)
Steps proposed in planning and implementing this project, and the
respective responsibilities of the applicant for carrying out those
steps the proposed approach to the study and the outline of the study
protocol. The applicant's schedule proposed for accomplishing the
activities to be carried out in this project and for evaluating the
accomplishments.
3. Program Personnel (30%)
Qualification and time allocation of the professional staff to be
assigned to this project and applicant's ability to provide
knowledgeable staff required to perform the applicant's
responsibilities in this project, and the approach to be used in
carrying out those responsibilities.
4. Facilities and Resources (10%)
The adequacy of the applicant's facilities, equipment, and other
resources available for performance of this project.
5. Budget Justification (not scored)
The budget will be evaluated to the extent that it is reasonable,
clearly justified, and consistent with the intended use of funds.
Executive Order 12372 Review
Applications are not subject to the review requirements of
Executive Order 12372, Intergovernmental Review of Federal Programs.
[[Page 31728]]
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.283.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by the cooperative agreement will be subject to
review and approval by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act.
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the DHHS Regulations, 45 CFR part 46,
regarding the protection of human subjects. Assurance must be provided
to demonstrate the project will be subject to initial and continuing
review by an appropriate institutional review committee. The applicant
will be responsible for providing assurance in accordance with the
appropriate guidelines and form provided in the application kit.
In addition to other applicable committees, Indian Health Service
(IHS) institutional review committees also must review the project if
any component of IHS will be involved or will support the research. If
any American Indian community is involved, its tribal government must
also approve that portion of the project applicable to it.
Application Submission and Deadline
The original and two copies of the application PHS Form 398 (OMB
No. 0925-0001) must be submitted to Henry S. Cassell, III, Grants
Management Officer, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), Mailstop E-
13, 255 East Paces Ferry Road, NE., Room 300, Atlanta, GA 30305, on or
before July 21, 1995.
1. Deadline: Applications will be considered as meeting the
deadline if they are either:
(a) Received on or before the deadline date, or
(b) Sent on or before the deadline date and received in time for
submission to the independent review group. Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks will not be acceptable as proof of timely mailing.
2. Late Applications: Applications which do not meet the criteria
in 1.(a) or 1.(b) above are considered late applications. Late
applications will not be considered in the current competition and will
be returned to the applicant.
Where To Obtain Additional Information
To receive additional written information call (404) 332-4561. You
will be asked to leave your name, address, and telephone number and
will need to refer to Announcement 559. You will receive a complete
program description, information on application procedures, and
application forms.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Oppie Byrd, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
13, Atlanta, GA 30305, telephone (404) 842-6546.
Programmatic technical assistance may be obtained from Paul K.
Henneberger, Sc.D., Division of Respiratory Disease Studies, National
Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention (CDC), Mailstop 234, 1095 Willowdale Road,
Morgantown, WVA 26505-2845, telephone (304) 285-5756.
Please refer to Announcement 559 when requesting information and
submitting an application.
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report, Stock No. 017-001- 00473-1) referenced in the Introduction
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: June 12, 1995.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC).
Appendix
Beryllium-Exposed Worker Cohorts
Below is a listing of facilities in which workers are or have
been known to be exposed to beryllium.
Beryllium Production Facilities
NIOSH conducted a cohort mortality study of employees at the
Cabot Berylco plants in Reading and Hazelton, Pennsylvania, and at
the Lorain, Perkins, Lucky, St. Clair, and Elmore, Ohio plants of
the Brush-Wellman Company (Ward, Am. J. Indust. Med. 1992). These
seven plants represent all of the beryllium production plants that
have been in operation in the United States. Collectively, the
plants cover 57 years of beryllium exposure history, with the oldest
facility beginning operations in 1935 and the most recent beginning
in 1963. Approximately 9200 workers have been employed at these
facilities. The names, location, and years of operation of these
plants are listed in Table 1.
Defense Nuclear Facilities
Facilities at which there are or were beryllium operations are
listed in Table 2. Of these, the major beryllium operations sites
are/were Rocky Flats, Ames, Argonne National Laboratory, Y-12,
Lawrence Livermore National Laboratory (LLNL), and Los Alamos
National Laboratory (LANL). Because the criteria for designation as
a ``beryllium worker'' have differed within and between facilities,
it is difficult to state the size of the worker population at these
facilities exposed to beryllium. However, it has been estimated that
more than 10,000 persons may have qualified at some time as a
beryllium worker at these facilities.
Table 1.--Beryllium Production Plants in the United States
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Date start Date end
Company Plant production production
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Lorain, Ohio.......... 1935 1948
Lucky, Ohio........... 1950 1958
Elmore, Ohio.......... 1952 (\1\)
........... (\2\)
Brush Wellman......... Perkins (Cleveland, 1937 1963
Ohio).
St. Clair ( Cleveland, 1963 1973
Ohio).
Kawecki-Berylco/Cabot. Reading, Pennsylvania. 1935 (1)
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Berylco NGK Metals.... ...................... ........... ...........
Hazelton, Pennsylvania 1958 1978
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\1\Presently.
\2\Operating.
Table 2.--Defense Nuclear Facilities With Current and/or Historical
Beryllium Operations
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Defense nuclear facility Location
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Y-12 Plant......................... Oak Ridge, Tennessee.
Oak Ridge National Laboratory (X- Oak Ridge, Tennessee.
10).
Inhalation Toxicology Research Albuquerque, New Mexico.
Institute.
Pantex Plant....................... Amarillo, Texas.
Mound Laboratory................... Miamisburg, Ohio.
Kansas City Plant.................. Kansas City, Missouri.
Los Alamos National Laboratory..... Los Alamos, New Mexico.
Pinellas Plant..................... Largo, Florida.
Rocky Flats Plant.................. Golden, Colorado.
Sandia National Laboratory......... Albuquerque, New Mexico.
Ames Laboratory.................... Iowa State University, Ames, Iowa.
Argonne National Laboratory........ University of Chicago Metallurgical
Laboratory and Idaho National
Engineering Laboratory.
Hanford Site (Westinghouse), Richland, Washington.
Pacific Northwest Laboratories.
Lawrence Livermore National Livermore, California.
Laboratory.
Lawrence Berkeley National Berkeley, California.
Laboratory.
Atomic International, Canoga Park.. Santa Susana, California.
Knolls Atomic Power Laboratory..... Schenectady, New York.
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[FR Doc. 95-14772 Filed 6-15-95; 8:45 am]
BILLING CODE 4163-19-P