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Report of program activities : National Institutes of Health. Division of Research Services (Volume 1978) online

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gators here at NIH and 20 away from NIH. Also, a lecture on biohazards
control was given to 150 persons in Cincinnati.

Approximately 275 copies of the NIH Biohazards Safety Guide were distributed
to interested individuals outside NIH and 20 to NIH investigators. The
publication is being revised to incorporate standards set forth in the NIH
Guidelines.

A quarterly memorandum, "Biological Laboratory Hazards," was distributed to
more than 250 laboratories, including several overseas institutions. In
addition, miscellaneous biohazard control information was sent to over 50
investigators outside NIH.

PLANS

In general, the Branch will continue ongoing programs. Significant changes
in Branch production are not expected unless staffing levels increase.
Projected directions in program areas are listed below.

Administration and Environmental Planning

Measures taken by the Council on Environmental Quality will initiate a process
whereby DHEW, PHS, and NIH will examine existing NEPA policies and procedures.
A number of policy documents will be reviewed and issues resolved. The coming
year will see changes in existing NEPA programs.

Industrial Hygiene

A new chemical carcinogen questionnaire will be developed to obtain informa-
tion about NIH's usage of such chemicals; the data will be used for program
management in this complex area. In cooperation with the Occupational
Medicine Service, CC, a study of the impact of animal dander allergy on the
health of workers will be undertaken. It is anticipated that monitoring in
the work place will be augmented to document the degree of worker exposure
to various substances in the environment.

General Sanitation and Sanitary Engineering

The chemical destructor study will be completed and specific recommendations
made to NIH management. Automated water monitoring stations at the NIH

26



Animal Center will be updated to provide for telemetry of data and improved
data handling. Provision may be made for automated sampling and analysis of
NIH wastewater released to the Washington Suburban Sanitary Commission sewer
system. The chute system in the Clinical Center for solid waste transport
will be put into operation.

Biosafety and Contamination Control

Program emphasis will continue to be directed toward meeting NIH researchers'
needs concerning IMUA reviews and laboratory physical standard certifications
under the NIH Guidelines for Research Involving Recombinant DNA Molecules .
Annual recertification of laboratories is also required.

Training

Training programs developed this year will be implemented in the coming months.
It is hoped that we will be able to establish techniques to accurately measure
the impact such training has on employee awareness and accidents. In this
regard, we anticipate utilizing a safety questionnaire. The data collected
will serve to better define additional safety training needs.

During the coming year we will try to improve communication of safety infor-
mation. Included in this effort will be the reestablishment of a quarterly
safety publication, examination of alternative means of communicating safety
concerns, and the development of additional visual and audiovisual materials.

Safety Management

Shortly after the beginning of the fiscal year, the Safety Office will start
issuing safety shoes, now being handled by the Division of Engineering
Services. All safety-related equipment will be stocked and issued by the
Safety Office. In addition, the recently acquired respirator test booth will
be operated by the Safety Office staff.

Media and Glassware Production

Maximum effort will be directed to acquiring and phasing into production
automated equipment which will provide increased efficiency in high workload
areas. The need for additional automation., in container labeling became more
pressing with a requirement for labeling each agar plate, tube, and bottle of
media with the type of medium and expiration date. This change will meet
criteria for accreditation of the Clinical Pathology Department, which was
recently inspected by the College of American Pathologists.

The limulus amebocyte lysate assay, a test for endotoxins, will be considered
as an addition to our media quality control program. This test, shown to be
more sensitive than the USP rabbit test for endotoxins, is based on an
enzymatic reaction; endotoxin activation of a high molecular weight enzyme
converts a low molecular weight clottable protein to a gel.

The National Cancer Institute's animal rooms in the Clinical Center have
been consolidated into the B-l and B-2 corridors. The resultant



27



more stringent cagewashing requirements will necessitate a scheduling plan
to interface NCI needs with those of other organizations located in the
Clinical Center.

Program changes which may become necessary in the coming year because of
personnel shortages and space limitations are elimination of one-liter
media bottles, serum additions by the Media Unit to prepared media, and
contracting of demineralized water production.

PUBLICATIONS AND PATENTS

Herman, L.G. : Infection Control Through the Use of Sterile Reusable and
Disposable Patient Care Items. Infection Control in Health Care Facilities .
University Park Press, 1977.

Herman, L.G. : The Slow-Growing Pigmented Water Bacteria: Problems and
Sources. Advances in Applied Microbiology . 23: 155-171, • 1978.

A previous publication, The Hospital Environment: A Self- Evaluation Program,
by Lloyd G. Herman, Ph.D., was translated to German and republished in
Hygi e ne + Medizin . 2: 330-337, 1977, and 3: 5-9, 1978.

Karamian, N.A. : "Apparatus for Producing High- Purity Water, " U.S. Patent
(DHEW) 4,089,7-49, issued May 1.6, 1978.

Karamian, N.A. : "Method for Assaying Endotoxins," U.S. Patent 4,093,381,
issued June 6, 1978.



28



DIVISION OF RESEARCH SERVICES
RADIATION SAFETY BRANCH
October 1, 1977, through September 30, 1978
MR. MICHAEL MUSACHIO, Chief

The National Institutes of Health are authorized to procure and use radioactive
materials on the Bethesda reservation under a Type A specific license of
broad scope issued by the Radioisotopes Licensing Branch, Division of Materials
and Fuel Cycle Facility Licensing, U.S. Nuclear Regulatory Commission (NRC).
This license is contingent upon the existence of a Radiation Safety organiza-
tion. That function is fulfilled by the Radiation Safety Branch (RSB). In
size and scope the NIH Radiation Safety Program is one of the largest in the
world, being exceeded by only a few of the National Radiation Laboratories
operated by the Energy Research and Development Administration.

Some sources of ionizing radiation are not covered by the NRC License. They
include X-ray equipment, high-energy particle accelerators, and naturally
occurring or accelerator-produced radionuclides. Those sources are, however,
controlled by an Executive Order relative to compliance with rules and regula-
tions issued by the Occupational Safety and Health Administration of the U.S.
Department of Labor and Food and Drug Administration and NIH policy promulgated
upon the recommendation of the Radiation Committee, NIH.

The Radiation Safety Branch, under the direction of the NIH Radiation Safety
Officer, is responsible for:

1. General surveillance of all health physics activities, including both
personnel and environmental monitoring.

2. Furnishing consulting services to personnel at all levels of respon-
sibility on all aspects of radiation protection.

3. Receiving, delivering, and shipping all radioactive materials coming
to or leaving the NIH reservation.

4-. Assaying all radioactive materials to be used in human beings for
therapeutic purposes.

5. Monitoring all accelerators and other machines capable of producing
penetrating radiation. Calibrating the output of the machines as
requested.

6. Distribution and processing of personnel monitoring equipment. RSB
keeps records of internal and external radiation exposure of per-
sonnel, notifies individuals and their supervisors of exposures
approaching the maximum permissible amounts, and recommends
appropriate remedial action.



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7. Instructing personnel in proper procedures for the use of radioactive
materials.

8. Supervision and coordination of the waste disposal program, including
keeping records of waste storage and disposal.

9. Operation of the Isotope Laboratory, Building 21. This laboratory
is equipped for handling high levels of activity not normally per-
mitted in the typical NIH laboratory.

10. Storage of all radioactive materials not in current use.

11. Performing leak tests on all sealed sources.

12. Maintaining an inventory of all radioactive materials on the NIH
reservation.

13. Supervising decontamination in cases of accidents.

14. Continuously evaluating and eliminating environmental radiation
hazards.



PROJECTS AND ACCOMPLISHMENTS

Licensing

An application was submitted to the NRC for renewal of License 19-00296-10
(Type A Specific License of Broad Scope), which was scheduled to expire on
April 30, 1978. This license remains in effect pending action by the NRC on
the application.

License SNM-279 was permitted to expire as the result of the National Heart,
Lung, and Blood Institute terminating a study to evaluate nuclear-powered
cardiac pacemakers implanted in dogs. Thirty pacemakers were transferred to
the Argonne National Laboratory, in accordance with regulatory requirements,
at the conclusion of the study. The license also permitted the possession
and use of two plutonium-bery Ilium sources for calibration of neutron detection
instruments. With its termination, it was necessary to amend License 19-00296-
10 to permit the continued use and possession of these neutron sources.

A 3,450-curie cobalt-60 teletherapy source and its depleted uranium shield
(License 19-00296-16) were transferred from the Radiation Oncology Branch, NCI,
to Neutron Products, Inc., Dickerson, Maryland, in preparation for shipment
• to the Cancer Institute in Cairo, Egypt. Since the unit was not replaced,
the license was terminated. A subsequent inspection by a represenxative of
the NRC indicated that the transfer was accomplished in accord with all
applicable regulatory requirements.



30



An application was submitted to the NRC to amend License 19-00296-17 so as to »
permit the. possession and use of two additional cesium-137 irradiators. If
approved, NIH will have a total of five cesium-137 irradiators with a
possession limit of 10,400 curies.

A major NRC inspection was conducted relative to licenses 19-00296-10 and
19-00296-17 on April 18-20, 1978. At the same time, an investigation was
made of a possible personnel overexposure which was reported earlier to the
NRC in accordance with the provisions of 10 CFR 20.4-03. The investigation
indicated that the possible overexposure was due to a contaminated film badge
and was not an actual personnel exposure. As a result of the inspection, NRC
requested NIH to reexamine: its policy for monitoring the extremities of
phosphorous-32 workers, its administrative procedures for assuring radiation
safety training to all radiation workers, and its policies to limit access to
radioactive materials in unrestricted areas.

The Radiation Safety Branch reviewed over 200 applications for authorization
to purchase and use radioactive materials (NIH Form 4-65-1) and forwarded 182
applications to the Radiation Committee with recommendations for approval.
This brings the total number of authorized active users at NIH to 812. In
addition, an examination was developed and administered to several applicants
who claimed to have had training equivalent to the "Radiological Health for
Radionuclide Users" course. RSB also reviewed 76 applications for renewal of
radionuclide authorization. These authorizations are valid for 3 years. In
addition to updating their training and experience, applicants for reauthori-
zation must attend a "Radiation Safety Review" program presented by RSB .

The Radiation Committee instigated a policy to reevaluate on an annual basis
all protocols that exceed the maximum activity permitted for routine laboratory
use under NIH guidelines. Of the 51 reviewed, 28 were renewed and 23 retired.
Five planned projects were submitted for RSB review before consideration by
the Radiation Committee.

Radionuclide Receipt and Delivery

A total of 167,149 millicuries of radioactive materials (excluding nuclear
pacemakers) in 13,44-4 shipments was received during the year. The value of
the materials was $2,532,062.

The Radiation Safety Branch also prepared 184 packages of radioactive materials
for shipment from NIH investigators to authorized domestic and foreign
licensees.

Radioactive Waste Disposal

Radioactive waste pickup, processing, packaging, and disposal activities are
conducted under contract. However, under the provisions of NRC License
19-00296-11, NIH bears the ultimate responsibility for the safe and proper
handling of licensed radioactive waste until it is transferred to another
authorized licensee. That occurs as soon as the contractor takes the waste
off the NIH reservation. The contract is working well with radioactive



31



waste generally being removed from the laboratory within 24 hours after
request for pickup. However, a number of difficulties have been encountered
in the solicitation of bids and award of this contract on an annual basis.
Therefore., an effort is being made to provide NIH with the option of renewing
the contract at the end of the year, if contractor performance is satisfactory.

During the reporting period 67,981 trays of liquid scintillation vials, each
containing 100 vials, were collected and packaged for disposal. The vials
were packed with adsorbent material in 2,266 fifty-five gallon steel drums
for burial. There is continuing concern regarding an alternative means of
disposal of this very low-level waste as it uses a large volume of the avail-
able burial space at radioactive waste disposal sites. Another 700 drums of
compacted radioactive solid waste and solidified liquids were also disposed
of by burial.

Clinical Services



Health physics services were provided for 11 patients receiving therapeutic
doses of radioactive materials, primarily Iodine-131. The services included
radioassay of material administered, assistance with administration of the
material, contamination control measures, steps to minimize personnel exposure,
training and education of patients and patient care personnel, personnel
monitoring, and determination of the patient's body burden for discharge and
radiological protection purposes.

Laboratory and Environmental Surveillance

There were 5,257 radiation surveys conducted in laboratories using radioactive
materials. Approximately 50 percent of the surveys were conducted by contract
and the remainder by RSB staff. In addition, 4, 4-69 air samples were collected
and analyzed for radionuclide concentrations in laboratories and effluent air.

Efforts to establish a waste water monitoring system to determine radionuclide
concentrations in NIH sewage effluent have been largely unsuccessful. This
system is essential to provide assurances to the NRC that sewage concentrations
and total releases of radioactive materials do not exceed applicable regulatory
requirements. Currently, these values are derived by computation. The
difficulty is with the long delays experienced in the procurement of a multi-
channel gamma spectrometer and associated computer and delays in designing
and installing the sampling station. The former is needed for radionuclide
identification and quantitative analysis, and the latter to assure that
representative samples are collected proportional to sewage flow and also to
monitor and record waste water flow.

Contractors made 129 surveys of X-ray equipment. In addition, 47 sealed
sources or radioactive foils and 184 radium-226 needles were checked for
leakage semiannually in accordance with License 19-00296-10. None of the
tests indicated removable contamination greater than the action level of 0.005
microcuries .



32



Personnel Monitoring

Film dosimeters for the evaluation of personnel exposure to external sources
of radiation are supplied and processed "by a commercial source. The number
of NIH employees on the monthly monitoring service increased from approximately
2,500 at the beginning of ' last year to 3,000 at present, a 20 percent increase.
Approximately 4-00 of these individuals are also issued one or more extremity
monitors in addition to the whole-body dosimeter. A total of 2,192 additions,
deletions, or other film badge service record changes were required during the
year. Employees at the Rocky Mountain Laboratory and two Arizona field
stations are also covered by this service. Radiation exposure records are
maintained for approximately 200 additional NIH employees working at other
"off-site" locations.

There were 1,257 radioassays of urine from persons working with beta-emitting
radionuclides. Although RSB has developed an automatic data processing system
to review radionuclide receipts and generate requests to investigators for
bioassays and whole-body counts, considerable staff time is required for
f ollowup .

Whole-body or thyroid counts were also requested for 572 authorized users and
laboratory personnel working with gamma- emitting radionuclides. The evalua-
tions are made by the Whole Body Counting Section, Nuclear Medicine Department;
Clinical Center; it is estimated that approximately 2,400 separate in vivo
measurements were made at the request of this Branch.

Radiation Safety Training

Approximately 13,000 hours of training were provided to over 1,000 NIH
employees. In addition, a number of visitors from other agencies and NIH
contractors attended the "Radiation Safety in the Laboratory" training course.
Major training sessions and attendance figures are summarized below:

Course Number of Times NIH Staff in Visitors

Course Presented Attendance

Radiological Health 2 125

for Radionuclide Users
(9 days)

Radiation Safety Review 4 76

for Authorized Users
(1 i days)

Radiation Safety in the 12 599 79

Laboratory

(1 day)



33



<



Course Number of Times NIH Staff in Visitors

Course Presented Attendance

Radiation Safety for 6 97

Nurses

( 1 hour )

Radiation Safety for 1 125

Housekeeping Staff
(l hour)

In addition, radiation training courses were presented at the Rocky Mountain
Laboratory, National Institute of Allergy and Infectious Diseases, Hamilton,
Montana, and the Phoenix Clinical Research Center, National Institute of
Arthritis, Metabolism, and Digestive Diseases. Branch staff also participated
in several laboratory safety courses presented in various locations through-
out the country by the Center for Disease Control and the National Institute
of Occupational Safety and Health.

Other Radiation Safety Services

The laboratories in Building 21 were used to conduct 978 radionuclide
experiments under the supervision of RSB health physicists. The experiments
involved higher levels of radionuclide activity than are generally permitted
in a typical NIH research laboratory.

A detailed evaluation was made of the shielding design for the proposed
Diagnostic Radiology Department in the new Ambulatory Care Research Facility.
Modifications were suggested to obtain the required level of protection at
the most reasonable cost.

The Branch is working closely with the Nuclear Medicine Department, Clinical
Center, in developing capability for a positron imaging program. The RSB
will have input into the safety aspects of the procedures to synthesize and
label compounds with the short-lived positron-emitting radionuclides.
The plan is to initially obtain these radionuclides from cyclotrons
located in the area. However, long-range plans will probably result in the
installation of a cyclotron on campus.

PLANS

Additional emphasis will be placed on the following activities during the
coming year:

1. Securing compliance with those items noted in the most recent NRC
inspection. Specifically, improving the security of radioactive
materials in unrestricted areas and developing more effective
procedures to assure that new radiation workers receive proper
radiation safety training before beginning work with radionuclides.



34



2. Implementation of a computerized Radiation Safety Management
Information System in cooperation with the Division of Computer
Research and Technology and the Office of Management Analysis, DRS.

3. Implementation of a waste water monitoring system to assure the NRC,
Washington Suburban Sanitary Commission, and Montgomery County
Government that radioactive materials that may enter the sewer
system at NIH are below regulatory limits.

-4. Developing plans for enlarging or modifying Building 21 so that

it may be safely used for labeling compounds for positron emission
tomography studies.

5. To the extent that resources permit, providing increased levels of
surveillance and technical assistance to NIH employees working at
locations other than the Bethesda reservation.



35







DIVISION OF RESEARCH SERVICES

LIBRARY BRANCH

October 1, 1977, through September 30, 1978

RUTH C. SMITH, Chief

The mission of the Library Branch is to operate an efficient comprehensive
library in support of NIH research and administrative programs. The Library
selects, acquires, organizes, maintains, and circulates literature pertinent
to the programs and provides interlibrary loan, reference, bibliographic,
translating, and copy services.

A new on-line search capability of scientific data bases of interest to NIH
investigators was introduced by the Library during FY 78; The circulating
journal collection was included in the Automated Circulation Control System,
which has operated effectively for the book collection. Consultative surveys
were provided the National Cancer Institute regarding facilities and future
plans of the Scientific Library of Frederick Cancer Research Center, which is
operated by Litton Bionetics for NCI. The Lemuel W. Diggs Collection on
Sickle Cell Disease was presented to the Library by Dr. Diggs, noted pioneer
in sickle cell disease research. . Cb

An acute space problem has necessitated drastic measures. In order to pro-
vide shelving space for 1978 journals, little used journals are boxed for
storage elsewhere. Approximately 9,-400 old, unused, and unneeded books have
been eliminated from the collection, and some 68,000 cards representing them
were withdrawn from the Library's catalogs. A major critical problem re-
sulted from this summer's reroofing of the terrace outside the Library when,
during and after rains, water dripped from multiple places in the ceiling in
the Lower Level area where the monograph collection is located. Every
attempt was made to prevent the books from being damaged.

PROGRAMS AND ACCOMPLISHMENTS

Technical Services

The operations of procurement, organization, and processing of books in-
creased approximately 30 percent in FY 78. Contributing factors included a
program to reduce work backlog and the attainment of a full professional
staff. Operations for journals remained stable.

Books on bioethics were given a separate classification (R724) so that they
may be shelved together. The section Includes new acquisitions as well as
volumes on the subject already held by the Library.

Bar coding of all circulating journals in the collection, recording the

required bibliographic data, and entering the data into the Library's %>



36



Automated Circulation Control System were completed by the end of the fiscal
year. Now circulating journals are loaned through an automatic procedure
as books have been during the last two years.

The substantial project of changing or withdrawing Library records, computer
file data, and catalog cards to reflect the status of books weeded out has
continued for each batch as soon as decisions have been made.

Readers Services

Operations of circulation and nonprint media remained relatively stable.
Self-service copy service increased slightly over the FY 77 level, and
interlibrary loans to NIH investigators decreased hy 30 percent. The decrease
was due to the greater availability of volumes on the shelves. Shelving of
new books and journals and those used by readers has been maintained on a
current basis. Interlibrary loan requests from other libraries remained at
the FY 77 level.

Lack of shelving space continues to be an acute problem requiring an
enormous amount of volume shifting and the new activity of boxing as many


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