[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 

[[Page 31727]]
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       
------------------------------------------------------------------------
                                                 Date start    Date end 
        Company                  Plant           production   production
------------------------------------------------------------------------
                        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)

[[Page 31729]]
                                                                        
Berylco NGK Metals....  ......................  ...........  ...........
                        Hazelton, Pennsylvania         1958        1978 
------------------------------------------------------------------------
\1\Presently.                                                           
\2\Operating.                                                           



   Table 2.--Defense Nuclear Facilities With Current and/or Historical  
                          Beryllium Operations                          
------------------------------------------------------------------------
      Defense nuclear facility                     Location             
------------------------------------------------------------------------
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.             
------------------------------------------------------------------------

[FR Doc. 95-14772 Filed 6-15-95; 8:45 am]
BILLING CODE 4163-19-P