4th Annual
NATIONAL CONFERENCE
ON
RADIATION CONTROL
Save A Rad
April 30 - May 4, 1972
New Orleans, Louisiana
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TECHNICAL REPORTS
Technical reports of the Office of Regional Operations, Bureau of
Radiological Health (with the exception of the "Directory of Personnel
Responsible for Radiological Health Programs"), are available from the
National Technical Information Service, Springfield, Va. 22151, when a
PB number is indicated after the title. Microfiche copies are $0.95;
prices for paper copies are indicated after the PB number. Bulk order
prices are available from NTIS. The PB number should be cited when
ordering. Some reports are also available from the Superintendent of
Documents, U.S. Government Printing Office, Washington, B.C. 20402, as
indicated after the title.
Copies of the "Directory of Personnel Responsible for Radiological
Health Programs" may be obtained by writing to the Office of Regional
Operations, Bureau of Radiological Health, 1901 Chapman Avenue, Rock-
ville, Md. 20852.
Title
ORO 69-1 Directory of Personnel Responsible for Radiological
69-2 Health Programs, January and July 1969 (out of
print)
ORO 69-3 Report of State and Local Radiological Health Programs,
Fiscal Year 1968 (PB 188-262 $3.00)
ORO 69-4 Conference on Federal-State Implementation of Public
Law 90-602, March 24-26, 1969, Montgomery, Alabama
(PB 1S9-655 $3.00)
ORO 69-5 Radiation Sources in Secondary Schools. Report of a
Limited Survey, 1969 (PB 188-701 $3.00)
ORO 70-1 Directory of Personnel Responsible for Radiological
Health Programs, February 1970 (out of print)
ORO 70-2 State Radiation Control Legislation - 1969 (PB 193-
154 $3.00)
ORO 70-3 Directory of Personnel Responsible for Radiological
Health Programs, July 1970 (out of print)
ORO 70-4 Report of State and Local Radiological Health Programs,
Fiscal Year 1969 (PB 193-929 $3.00)
ORO 70-5 2nd Annual National Conference on Radiation Control,
April 26-29, 1970, Palm Beach, Florida (PB 196-444
$3.00)
ORO 70-6 A Study of Selected Aspects of State Control of
Radiation Hazards, September 1969 (PB 196-445 $3.00)
ORO 70-7 An Evaluation of the Compatibility and Uniformity of
State Regulations for the Control of Radiation,
September 1969 (PB 196-446 $3.00)
(continued on inside of.back cover)
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DHEW Publication (FDA) 73-8003
BRH/OBD 73-3
4th Annual
NATIONAL CONFERENCE
ON
RADIATION CONTROL
Save A Rad
^
April 30 - May 4, 1972 • New Orleans, Louisiana
£
July 1972
Co sponsored By
CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS
and
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RADIATION PROGRAMS
and
U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Public Health Service
FOOD AND DRUG ADMINISTRATION
Bureau of Radiological Health
Rockville, Maryland, 20852
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FOREWORD
The Bureau of Radiological Health continues to carry out a national
program designed to reduce man's exposure to ionizing and nonionizing
radiation. The Radiation Operations Staff, Division of Field Operations,
Executive Director of Regional Operations, Food and Drug Administration,
assists the Bureau Director on regional and State radiological health
activities. This Staff coordinates all radiological health activities
for the active Federal-State partnership to achieve and maintain compre-
hensive radiological health control. The Radiation Operations Staff
also guides and directs the State participation in Public Law 90-602.
The Bureau publishes its findings in Public Health Service numbered
reports, appropriate scientific journals, and technical report series
for the Bureau's divisions, offices, and laboratory.
The technical reports of the Office of Regional Operations (ORO) allow
comprehensive publishing of the results of intramural and contractor
projects. The reports are distributed to State and local radiological
health personnel, Bureau technical staff, Bureau advisory committee
members, university radiation safety officers, libraries and infor-
mation services, industry, hospitals, laboratories, schools, the press,
and other interested individuals. These reports are also included in
the collections of the Library of Congress and the National Technical
Information Service.
This report on the Fourth Annual Conference of Radiation Control
Program Directors was jointly supported by the Bureau of Radiological
Health, Food and Drug Administration, and the Office of Radiation
Programs, Environmental Protection Agency.
Your additional comments on these reports or requests for further
information are encouraged.
r\
C. Villfortl
ector
reau of Radiological Health
W. D. Rowe
Deputy Assistant
Administrator for Radiation Programs
Environmental Protection Agency
ill
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PREFACE
This publication contains the proceedings of the Fourth Annual National
Conference on Radiation Control, April 30-May 4, 1972, in New Orleans,
Louisiana. Cosponsors of this meeting were the National Conference of
Radiation Control Program Directors, the Bureau of Radiological Health,
Food and Drug Administration, and the Office of Radiation Programs,
Environmental Protection Agency. Two hundred and fifty local, State,
and Federal radiation control personnel attended.
This annual meeting serves as a primary mechanism for State and local
program directors to discuss mutual radiation control problems with
their counterparts elsewhere in the United States and with appropriate
Federal officials. Each year participants also convene workshops to
examine special problem areas, to develop solutions and to outline new
efforts for the coming year.
"Save A Rad" was the theme for the 1972 meeting which considered a
number of approaches to reducing the amount of radiation received by
the nation's population. Local, State, and Federal activities were
reviewed with special emphasis on ways in which various agencies can
combine efforts in a cooperative manner.
Our gratitude and appreciation is extended to all participants of the
meeting, especially to the officers of the Conference of Radiation
Control Program Directors, to the workshop chairmen, and to the staff
of the Louisiana Board of Nuclear Energy who made this meeting a
great success.
ames W. MillerV D.D.S.
Director
Radiation Operations Staff
Ronald E. Bales
Coordinator
Regional Operations for
Radiation Programs
Environmental Protection Agency
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CONTENTS
Page
FOREWORD [[[
PREFACE [[[ v
PARTICIPANTS [[[ xi
ABSTRACT [[[ xvii
OPENING SESSION [[[ 1
Moderator: Robert D. Siek ......................... 2
Welcome to Louisiana
Honorable James E. Fitzmorris ....................... 4
Partners in Protection
Charles E. Edwards , M.D ........................... 7
Accomplishments of the Conference of Radiation Control
Program Directors
Robert D. Siek ...................................... 16
X-RAY EXPOSURE SESSION
Moderator: Gerald S. Parker ....................... 19
The Environmental Protection Agency's Response to
Environmental Radiation Control Issues
David D. Dominick ................................... 22
X-Ray Exposure Study and Trends
Paul L. Roney ....................................... 35
Save Radiation - Make It Happen
John C. Villf orth ................................... 43
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Page
Test Method Development and Utilization
Gregoiy J. Barone 70
SEMINAR SESSION
Moderator: Jay S. Silhanek. 81
Current Status of Emergency Plans - Federal and State 82
ENVIRONMENTAL RADIATION SESSION
Moderator: Donald G. Gilbert 97
Mission of the Office of Radiation Programs
William D. Rowe "
Surveillance and Inspection Activities
Charles L. Weaver 103
Surveillance Guide Recommendations
Donald J. Nelson 112
National Quality Control Program
Edward J. Baratta 127
Data Analysis and Dose Model Development
Philip A. Cuny 133
Technology Assessment
Ernest D. Harward
Craig I. Roberts 141
Radiation Standards and Criteria
William A. Mills 151
SB1INAR SESSION
Moderator: Charles P. Froom 159
Revision of the Council of State Governments1 "Suggested
State Regulations for the Control of Radiation" 160
ADMINISTRATION OF RESOURCES SESSION
Moderator: Martin C. Wukasch 177
Vlll
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Page
Revenue Sources:
Occupational Health Funds
Vernon Lof tis .................................. 179
Atomic Energy Contracts
Charles A. Pelletier ........................... 184
Electric Utilities
Chester L. Nayfield, M.D ..................... 187
Alice Dolezal .................................. 189
Fees - Pros and Cons
John R. Stanton ................................ 193
To Fee or Not to Fee
William H. Aaroe .............................. -196
Fees - Pros and Cons
Simon Kinsman ............ . ..................... 199
Evaluation Techniques
A State X-Ray Program Effectiveness Index (SEI)
Robert H. Will ................................. 202
Nationwide Evaluation of X-Ray Trends
Ira Paul Leggett, Jr .......................... 216
Increasing Manpower Use
The Self-Regulation Concept
Sherwood Davies ................................ 228
SEMINAR SESSION
Moderator: Charles M. Hardin .................. 233
Optimum X-Ray Survey Procedures ................................. 234
CLOSING SESSION [[[ 239
Workshop Reports ................................ ...... • ......... 241
Resolutions [[[ 269
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Page
APPENDIX I 285
Program - Fourth Annual National Conference on Radiation
Control 287
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PARTICIPANTS
Aaroe, William H.
Ashe, Harry B.
Aulenbach, Donald B.
Bailey, Ed
Bales, Ronald E.
Baratta, Edmond J.
Barber, Donald E.
B arone, Grego ry
Bates, Lloyd
Beazley, Gala
Benson, James
Bevis, Herbert
Blackburn, James
Blanc, Gene
Bloch, Peter
Boeker, Elisabeth
Bohlinger, Hall
Bond, Aaron
Bradley, F. J.
Brennan, Joseph A.
Britain, Robert
Brown, Dayne H.
Brunner, Philip
Budnitz, Robert
Burnett, Bruce
Bunge, Ralph
Callis, Robert S.
Campbell, Charles
Cashman, Thomas J.
Chambers, F. W. , Jr.
Chanlett, Emil T.
Channell, James K.
Christian, John E.
Christiansen, Gene
Conlon, Michael J..
Childs, Norman
Cooper, James
Copeland, Henry
Corcoran, Robert E.
Cowan, J. Edward
Coyle, Charles
Cuny, Philip A.
New York, New York
Burlington, Vermont
Troy, New York
Austin, Texas
Rockville, Maryland
Winchester, Massachusetts
Minneapolis, Minnesota
Rockville, Maryland
Baltimore, Maryland
Montgomery, Alabama
Rockville, Maryland
Gainesville, Florida
Springfield, Illinois
AEC
Rockville, Maryland
Baton Rouge, Louisiana
Santa Fe, New Mexico
New York, New York
Atlanta, Georgia
Rockville, Maryland
Raleigh, North Carolina
Springfield, Illinois
California
Winchester, Massachusetts
Rockville, Maryland
Montgomery, Alabama
Iowa
Albany, New York
Atlanta, Georgia
Chapel Hill, North Carolina
San Francisco, California
Lafayette, Indiana
Bismarck, North Dakota
Chicago, Illinois
Montgomery, Alabama
Rockville, Maryland
Atlanta, Georgia
Baltimore, Maryland
Seattle, Washington
Rockville, Maryland
Rockville, Maryland
XI
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Dahl, Arve H.
Dalley, Dennis
Davies, Sherwood
DeBord, Seattle
DeVore, Robert
Dieckhoner, Jim
Dillard, Bobby L.
Dolezal, Alice
Dominick, David D.
Dunavant, Billy
Dzeiger, Ken
Easterly, David
Epperson, C, E.
Ferraro, Eugene R,
Fisher, Eugene
Flora, David H.
Francois, Pedrito
Frankel, Robert
Froom, Charles
Fry, Richard
Fuente, Eddie S.
Funderburg, Robert
Gaskill, Jerry
Geiger, Norman A.
Gerusky, Thomas
Gilbert, Donald C.
Godwin, Aubrey
Goodwin, James T.
Gorson, Robert
Greenfield, Moss A.
Gross, Richard
Guimond, Richard
Graham, J. A. "Bill"
Geiger, William L.
Hairr, Graham
Hallisey, Robert M.
Halperin, Jerome A.
Hanemann, Sheldon J.
Hardin, Charles H.
Hanson, Norman
Harris, Saul J.
Harvard, Ernest D.
Haughey, Francis
Rockville, Maryland
Salt Lake City, Utah
Albany, New York
Rockville, Maryland
Rockville, Maryland
Denver, Colorado
Minneapolis, Minnes ot a
Washington, D. C.
Gainsville, Florida
Minnesota
Montgomery, Alabama
Little Rock, Arkansas
Columbus, Ohio
New Jersey
Seattle, Washington
St. Thomas, Virgin Islands
Philadelphia, Pennsylvania
Rockville, Maryland
Kentucky
Jackson, Mississippi
Bois, Idaho
Rockville, Maryland
Phoenix, Arizona
Harrisburg, Pennsylvania
Phoenix, Arizona
Montgomery, Alabama
Atlanta, Georgia
Philadelphia, Pennsylvania
Los Angeles, California
Rockville, Maryland
Rockville, Maryland
Nashville, Tennessee
Phoenix, Arizona
Jacksonville, Florida
Boston, Massachusetts
Winchester, Massachusetts
New Orleans, Louisiana
Frankfort, Kentucky
Rockville, Maryland
Brooklyn, New York
Rockville, Maryland
Jacksonville, Florida
xii
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Heubner, Arthur T.
Hoxie, Donald C.
Huck, Mary
Jacobs on, Gerald A.
Jordons, Alvis
Kaufman, Edward
Keefer, Douglas
Keene, Byron
Reiser, Roy W., Jr.
Kephart, Emma
Kereiakes, James G.
Kinsman, Simon
Kraeger, James A.
Koenig, Robert R.
Krogman, Franklyn
Lacker, David
Landau, Emamuel
Lane, Richard
Lea, William L.
Leggett, Ira Paul, Jr.
Lemmons, John
Little, Marshall S.
Lloyd, Larry L.
Long, Jack M.
Lubenau, Joel
McBride, John
McCurry, Wendell D.
McDowell, Richard B.
McGee, Charles E.
McGrattan, Raymond
McHard, J. Dale
McTaggart, James A.
Matuszek, John
Menker, Don
Miller, James W.
Miller, Ken
Miller, Lois
Mills, William A.
Milligan, V. A.
Mittelstaedt, Stanley G.
Moen, Arnold J.
Muldoon, John M.
Meyers, Earl L.
Hartford, Connecticut
Augusta, Maine
Illinois
Kansas City, Missouri
Winchester, Massachusetts
Santa Fe, New Mexico
Atlanta, Georgia
Boston, Massachusetts
New Orleans, Louisiana
Cincinnati, Ohio
Berkeley, California
Chicago, Illinois
Schenectady, New York
Pierre, South Dakota
Austin, Texas
Rockville, Maryland
Philadelphia, Pennsylvania
Madison, Wisconsin
Washington, D. C.
Cheyenne, Wyoming
Rockville, Maryland
Helena, Montana
Austin, Texas
Winchester, Massachusetts
Las Vegas, Nevada
Carson City, Nevada
Rockville, Maryland
Philadelphia, Pennsylvania
Pennsylvania
Oklahoma City, Oklahoma
Dallas, Texas
Albany, New York
Miami, Florida
Rockville, Maryland
Missouri
Rockville, Maryland
Rockville, Maryland
Arkansas
Little Rock, Arkansas
Olympia, Washington
Lawrence, Kansas
Arlington, Virginia
xiii
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Nayfield, Chester L.
Neff, R. D.
Nelson, Clifford
Nelson, Donald J.
Oates, William H., Jr.
Paraskevoudakis, Peter
Parker, Gerald S.
Parker, Roy A.
Parrott, Marshall W.
Payne, Richard
Phillips, Charles
Pogue, Charles
Porter, Charles R.
Porter, Jim
Price, Charles
Priester, L. E., Jr.
Properzio, William
Resner, Ernie
Roberts, Craig
Robinson, D. H.
Roessler, Charles
Rogers, Jack C.
Roney, Paul
Rowe, William
Russo, John J.
Sanders, Marshall
Schiager, Keith J.
Schmidt, Gail
Schofield, Bryce P.
Scotton, John
Scribner, John
Seabron, Lavert
Seal, Morgan
Shaver, John
Shealey, Heyward
Shore, Moris
Showalter, Charles
Siek, Robert D.
Silhanek, Jay
Simon, Larry
Simmons, H. Ellis
Sirmons, Gary
Skrable, Kenneth W.
Slyfield, William F.
Jacksonville, Florida
College Station, Texas
San Francisco, California
Rockville, Maryland
Kansas City, Missouri
Mayaquez, Pureto Rico
Boston, Massachusetts
Baton Rouge, Louisiana
Portland, Oregon
Atlanta, Georgia
Montgomery, Alabama
Virginia
Montgomery, Alabama
Baton Rouge, Louisiana
Richmond, Virginia
Columbia, South Carolina
Rockville, Maryland
Washington, D. C.
Rockville, Maryland
Columbia, South Carolina
Florida
Los Angeles, California
Rockville, Maryland
Rockville, Maryland
Trenton, New Jersey
Washington, D. C.
Fort Collins, Colorado
Rockville, Maryland
Richmond, Virginia
Washington, D. C.
Juneau, Alaska
Rockville, Maryland
San Francisco, California
Raleigh, North Carolina
Columbia, South Carolina
Rockville, Maryland
Rockville, Maryland
Denver, Colorado
Rockville, Maryland
Baton Rouge, Louisiana
Lincoln, Nebraska
Rockville, Maryland
Lowell, Massachusetts
Baton Rouge, Louisiana
XIV
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Smith, David S.
Snelling, David S.
Spell, William H.
Stangler, M. J.
Stanton, John
Steele, James F.
Stein, E. Lee
Stocks, Hal
Terpllak, Michael S.
Vaclk, James P.
Van Farowe, Donald £,
Veater, Joel
Velez, Amalia
Villforth, John C.
Walters, James
Wagoner, David
Watson, Joseph A.
Weaver, Charles L.
Whatley, Alfred T.
Will, Robert C.
Wilms, Heinz
Wilson, Frank E.
Windham, Sam
Wolle, Robert
Woodruff, Richard
Wren, McDonald
Wukasch, Martin C.
Wuraftic, Joseph
Wykcoff, James
Wynd, James C.
Zellner, Leon
Zimbrick, John D.
Rockvllle, Maryland
Little Rock, Arkansas
Baton Rouge, Louisiana
Washington, D. C.
New Hampshire
Yankton, South Dakota
Dover, Delaware
Indianapolis, Indiana
New York, New York
Fargo, North Dakota
Lansing, Michigan
Frankfort, Kentucky
Santurce, Puerto Rico
Rockville, Maryland
Ocala, Florida
Pittsburgh, Pennsylvania
Rockvllle, Maryland
Lakewood, Colorado
Topeka, Kansas
Rockvllle, Maryland
Little Rock, Arkansas
Montgomery, Alabama
Tennessee
Alabama
New York
Austin, Texas
Providence, Rhode Island
Washington, D. C.
Columbus, Ohio
Chicago, Illinois
Lawrence, Kansas
xv
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ABSTRACT
This publication contains the proceedings of the Fourth Annual
National Conference on Radiation Control - Save A Rad - April 30-May 4,
1972, in New Orleans, Louisiana. Sponsors were the Conference of Radia-
tion Control Program Directors; the Bureau of Radiological Health, Food
and Drug Administration, Department of Health, Education, and Welfare;
and the Office of Radiation Programs, Environmental Protection Agency.
Participants representing State and major local radiation control
programs, as well as Federal agencies, discussed mutual radiation con-
trol problems. "Save A Rad" was the theme for the 1972 meeting, which
considered a nunber of approaches to reducing the amount of radiation
received by the Nation's population. In addition to formal presenta-
tions and educational seminars, the proceedings contain the reports
of Workshops and Resolutions by the Conference of Radiation Control
Program Directors.
xvii
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the mention of conroercial products, their source, or their use in
connection with material reported herein is not intended to be con-
strued as either an actual or implied endorsement of such products
by the sponsoring organizations.
The papers and discussions included in this Proceedings were com-
piled from transcripts or were submitted by the individual authors as
written versions of the papers presented at the Fourth Annual National
Conference on Radiation Control. Editorial changes in the papers and
transcriptions have been limited to minor modifications for style and
consistency. The opinions stated are those of the authors and partici-
pants and may not represent the policy of the sponsoring organizations.
xvlii
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OPENING SESSION
Moderator: Robert D. Siek
Welcome to
Honorable James E. Fitzmorris
Lt. Governor-elect of Louisiana
Ptuote.c£ion
Charles C. Edwards, M.D.
Commissioner
Food and Drug Administration
o£ the.
Control PtioQtuun ViJie.ctoit>
Robert D. Siek
Colorado Department of Health
Radiation
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FOURTH ANNUAL NATIONAL CONFERENCE ON RADIATION CONTROL
OPENING SESSION
Moderator: Robert D. Siek
Colorado Department of Health
MR. SIEK: I'd like to welcome you all here to the Fourth Annual Con-
ference of Radiation Protection. We are indeed happy to be here in
the State of Louisiana in the great City of New Orleans. To start the
meeting off--to open it officially--I'd like to call on Mr. Jim Porter
from here in Louisiana.
MR. PORTER: There are some other people here today who I think should
be recognized because they play an active part in the role that the
Board of Nuclear Energy has played in the State of Louisiana. These
people have been involved for approximately 12 years since the inception
of the idea of the Louisiana Board of Nuclear Energy. First of all I'd
like to have each of these stand when I introduce them.
The first one is Dr. Seymour Ochsner. He is a Board member of the
Board of Nuclear Energy and has been so since its inception. He has
served on the Board of Chancellors of the American College of Radiology.
The one thing we're most proud of, he has recently been: elected Presi-
dent of the American College. Dr. Ochsner.
The next person I would like for you to recognize is Dr. Jeansonne,
Dean of the LSU Dental School. He has been the representative of the
Dental Society on the Board. He has been very active in a supporting
role. Dr. Jeansonne.
Another person is Mr. John Hidalgo. He is a Board member of the
Board of Nuclear Energy; Director of the Radiation Laboratory at Tulane
University; Past President of the Society of Nuclear Medicine. We most
know him though as the one that appointed the MIRD Committee which many
of us are familiar with. He is also famous for the Hidalgo tables for
blood value determination. Mr. Hidalgo.
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Another Board member present--! saw him just walk in--is Malcolm
Meyn. A Board member and President of Delta Testing and Inspection.
He represents the industrial radiography profession on the Board.
Mr. Meyn.
The last individual I'd like to recognize is Dr. Les Evenson. He
is Chairman of our Medical Advisory Committee. He is also an Associate
Radiologist at Southern Baptist Hospital here in New Orleans and is past
President of the Louisiana Radiological Society. Dr. Evenson.
One other person I think deserves recognition, even though he is
not present. This is the present Lieutenant-Governor C. C. "Taddy" Aycock.
"Tad" Aycock has been very active since the inception of the Board and
has supported every endeavor that the Board has undertaken. So I think
that we should at least thank him for his 12 years of service to the
State as Lieutenant-Governor and he has also served on the Board of
Nuclear Energy. Governor Aycock.
I would like to express appreciation on behalf of Lieutenant-
Governor Aycock, Chairman of the Louisiana Board of Nuclear Energy;
the Board members; and the staff of the Louisiana Board; on the selec-
tion of New Orleans for the Fourth Annual National Conference on
Radiation Control.
To extend an official welcome to you, it is a pleasure to introduce
to you this afternoon a native New Orleanian who has had an active pub-
lic life for the past 20 years. In February of this year, he was over-
whelmingly elected to the position of Lieutenant-Governor of Louisiana.
This was by a vote of 77 percent of the total votes cast. Prior to his
election as Lieutenant-Governor, he served as Vice-President of the
Kansas City Southern Railway Company, having been associated with that
organization since 1940. On May 9, 1972, he resigned from this position
and is going to become Louisiana's first full-time Lieutenant-Governor.
In approximately 1 week, the Honorable James E. Fitzmorris will be
inaugurated Lieutenant-Governor of Louisiana. Governor Fitzmorris.
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WELCOME TO LOUISIANA
Honorable. Jamei E.
Lieutenant-Governor-elect of Louisiana
Thank you very much Jim. Mr. Chairman, Mr. Commissioner, distin-
guished guests, ladies and gentlemen. I'm certainly pleased to have
this opportunity today to welcome you to the international City of New
Orleans in the great State of Louisiana. I'm not going to make the
same mistake this afternoon that I made a couple of weeks ago. For the
first time I went to the State Penitentiary at Angola as a visitor.
You laugh but that's strange for some of our politicians here. When
I got there that day I said--they had gathered all the inmates who wanted
to meet the Lieutenant-Governor--! started off and I said "I'm delighted
to see so many of you here this morning." Obviously I realized I had
made a mistake and so I tried to counteract it real quickly and I said
"What I really meant to say was, it's a privilege to have such a cap-
tive audience." So they understood both ways. I'm not going to say
that today.
It's real interesting for me to see so many people here who are
connected with the State, connected with the Federal Government, or
with States and the Federal Government, particularly on a Sunday after-
noon. You know, there are so many people who believe those of us who
work for the convenience of the public service are 40-hour people. As
a matter of fact, there are many of them that don't believe we're really
40-hour people. I have been to City Hall and I have been to the State
Capitol and I have seen those lights burning late at night and I know
what it is for loyal and dedicated public officials to work at their
jobs. I am pleased that we have such an atmosphere in which we can
welcome you here.
Most of my adult life has been devoted to two major aims. Number
1 - serving the, public needs in developing my City and my State. With
this service as a background for my new responsibilities in the Office
of Lieutenant-Governor, the direction of my energy has been somewhat
channeled. But the prospects of occupying the second highest position
in our State has awakened me to the full scope of the needs of the
people of our State. Where the public demands for energy doubles in
10 years in other regions, the middle Southeast doubles every 7 years.
-------
Louisiana is a major resource processing State and is growing rapidly.
Yet we are told that the oil and gas which stokes the fires of our
growth is depleting to an alarming degree.
It is apparent that radiation must play an increasingly important
role as energy sources if we are to meet the needs of our nation. I
know that there are 23 nuclear power generating stations now operating
and that there are over 100 others on order. I note too that these
plants have some 100 megawatts of power, but are the vanguard of newer,
more efficient, and more environmentally safe reactors for the future.
I certainly recognize that there are many things that we in Louisiana
must do that we have not done as yet.
The Lieutenant-Governor of our State has been the Chairman of our
Nuclear Energy Board. I intend to play a very active role in this par-
ticular field and that's why I was so pleased that you've honored us by
coming today. I look forward to the opportunity of working with you
and more importantly, look forward to the opportunity of working for you.
Needless to say that there are many things that are taking place
around us. There are many changes that are going to be meaningful
changes in the weeks and months ahead. When we first started talking
about our nuclear energy power, our programs here in Louisiana, we were
planning for the 1980rs. But here we are in 1972, and we're well in
that program. I think we have just scratched the surface. As we meet
these problems, certainly we know there are going to be many obstacles
that we must overcome. Dedicated, and people of sincere interest, can
meet those objectives and overcome those obstacles. I want all of you
to know that I hope that we can lend our full effort and our support to
the program in which you are interested.
Once again, it's a real privilege to have you with us and I look
forward to meeting with you many times in the future. Thank you very
much.
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INTRODUCTION
MR. SIEK: It is indeed an honor to introduce our next speaker. He
honors us by his presence. He is a busy man. Dr. Charles C. Edwards,
Commissioner of the Food and Drug Administration, was born in Over ton,
Nebraska. Following graduation from public schools in Kearney, Nebraska,
he attended Princeton University from 1941 to 1943. He received his
Bachelors and Medical Degree from the University of Colorado in 1945
and 1948. In 1956 he earned his degree of Master of Science in Surgery
from the University of Minnesota. He spent five years in the private
practice of surgery from 1956 to 1961 and served as a consultant to the
Surgeon General of the United States Public Health Service during 1961
to 1962. Dr. Edwards was Director, Division of Socio-Economic Activi-
ties, American Medical Association from 1965 to 1967, and was the AMVs
Assistant Director on the Council on Medical Education and Hospitals
in 1962 and 1963. Dr. Edwards held a Surgical Fellowship from the Mayo
Foundation from 1950 to 1956; a Teaching Fellowship from the University
of Minnesota, 1949 to 1950; an Internship at St. Mary's Hospital in
Minneapolis, 1948 to 1949. Prior to joining the Department of Health,
Education, and Welfare in 1969, he was Vice President and Managing Offi-
cer, Health and Medical Division, in the firm of Booz, Allen, and Hamil-
ton, Inc.; Chicago, Illinois. Dr. Edwards is a Diplomat, American Board
of Surgery; Board of Trustees, Food and Drug Law Institute; Fellow,
American College of Surgeons; Fellow, American Public Health Association;
and a Member of the AMA; Illinois State Medical Society; and Cook County
Medical Society. He holds medical licenses in Minnesota, Colorado, Iowa,
and the District of Columbia. He served in the United States Navy from
1942 to 1946 as a Lieutenant in the United States Navy Medical Corps
assigned to the U.S. Marine Corps in Korea. He is married to the former
Sue Cowles Kruidenier of Des Moines, Iowa. They have 4 children—Timothy,
Charles, Nancy, and David. It is with great pleasure that I introduce
Dr. Edwards.
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PARTNERS IN PROTECTION
C.
Commissioner
Food and Drug Administration
Mr. Chairman, Mr. Porter, members of the Conference - first let me
say it is a real pleasure to be in New Orleans. I think you pick your
spots well. More importantly though, it is a real pleasure for me to
have this opportunity to meet for the first time with those of you who
are directly involved with the day-to-day control of manmade radiation.
For many of us, this is our first meeting. I would certainly per-
sonally like to feel that we meet not as total strangers, but as people
with mutual concerns and certainly mutual friends in our own Bureau of
Radiological Health.
It is my impression, at least, that your relationships with our
Bureau of Radiological Health have been excellent ones, and I can only
say that I hope that this same rapport continues between, not only the
Bureau of Radiological Health, but other elements of the Food and Drug
Administration with which you may have contact.
We would like this meeting to be remembered as the occasion for our
acceptance as a full member of an ongoing partnership known as the Con-
ference of Radiation Control Program Directors. Since its organization
4 years ago, the Conference has provided the leadership and has served
as a focal point for concerted action to protect the American people
against the hazard of radiation exposure. I can assure you that the
Food and Drug Administration is anxious to work with you in this most
essential mission.
Obviously, I have not come from Washington to talk with you concern-
ing an organization about which you know far more than I. My assignment
today, as I see it, is to discuss with you this relationship as it concerns
the new partner- -the Food and Drug Administration- -and how it seems to
me that the Food and Drug Administration must work with you in discharging
radiation protection responsibilities given us approximately a year ago.
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I am certain that all of us here today are aware of the magnitude
of our job. The American people are beginning to know about the hazards
of radiation and they expect to be protected from them. They are begin-
ning to understand that more than 90 percent of their exposure to man-
made radiation comes from diagnostic x-ray procedures. They expect--
and have every right to expect--this exposure to be reduced to an absolute
minimum consistent with good health care.
The American people want the very best x-ray diagnosis for the least
possible exposure. This is an objective we all share. John Villforth,
the Director of our Bureau of Radiological Health, will be talking with
you tomorrow about what he thinks we can do to meet this objective; how-
ever, the finest methods and perhaps even the highest motivation will
not alone suffice to get this job done.
We all need more resources. We need more men and women trained in
the radiological health sciences. We need more money. The need is es-
pecially urgent at local and State levels. Just about all resources for
Radiation Control Act administration, as many of you already know, have
been provided by transfer from other Bureau of Radiological Health pro-
grams.
When you consider how few of you there are--no more than, as I under-
stand it, a thousand full-time Federal, State, and local radiation workers
in total--in contrast with the approximately 220,000 x-ray machines in
use and, perhaps, subject to or needing inspection. We also think of
the thousands of equipment operators who ought to know more than they
do about taking x rays. Consider that every 2 or 3 years virtually every
person in this country of over 200 million receives at least one diagnos-
tic x-ray examination. When we consider that approximately 130 million
people in the United States will be x-rayed this year, I think the magni-
tude of the problem becomes self-evident.
Reflecting on these kinds of statistics--statistics of this magni-
tude--diagnostic x-ray protection is truly consumer protection. It is
true that the manufacturing of x-ray equipment is somewhat of a specialty
business for relatively few companies. It is also true that x-ray exami-
nations are conducted by a comparatively small number of medical profes-
sionals and allied health professionals. But the medical and dental x-ray
services that they provide will sooner or later be sought by every member
of our population.
Our work to improve the radiological health of the American people
is by no means confined to medical and dental x-ray exposures. The Act
requires control of the whole gamut of electronic product radiation whether
electromagnetic or sound. I would like to discuss with you in a bit more
detail how the Food and Drug Administration and our Bureau of Radiologi-
cal Health may help with the responsibilities for health protection in
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the use of either consumer products or products supplying consumer serv-
ices But first let us give our discussion some perspective by reflecting
for a few moments upon the change that has taken place in the last few
years both in national public health concepts and within the Food and
Drug Administration.
Medical research and improvement in the financing and distribution
of medical care had been our major concern for over two decades. During
Sif period preventive medicine and public health protection of necessity
took a back Lat. Now the pendulum is swinging back. We have been re-
discovering the wisdom of the old adage that an ounce of prevention is
worth a pound of cure. In the process, air and water pollution ^ws have
been strengthened, the Environmental Protection Agency has been established,
m^nSSkSg law has been adopted, the Atomic Energy Commission has
tee^t™ notice with respect to its environmental Duality responsibili-
ties, and occupational safety and health are being given an entirely new
emphasis .
Nowhere is the swing back to prevention and health protection more
striking than in the list of new responsibilities that have been given
£
Health and Safety Act of 1968.
Many of you may now be asking yourselves : where does the Bureau
of Radiological Health fit into this diverse and rather complex picture
of oeOTle protection responsibility? Let me say very emphatically that,
S fa? al we are concerned, the Bureau is the principal consumer radia-
tion protection agency in the Federal establishment. Its radiation con-
tration.
Back now for a moment- to the Food and Drug Administration's changing
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10
The current administration of the Agency is developing a new thrust for
scientific investigation to provide for an expanded problem-solving
capability. We are also strengthening our ability to take advantage
of our many opportunities to solve problems through public information
and public education.
The best demonstration of the problem-solving efficacy of education
is to be found in the preliminary results of the 1970 X-Ray Exposure
Study. You know that there has been a striking 35 percent drop in the
annual genetically significant dose--the index of the effect that diag-
nostic x ray may have on future generations. This was a most significant
achievement in the face of a 10 percent rise in the national rate of x-ray
examinations between 1964 and 1970.
Everyone has reason to be encouraged by the progress achieved in
just 6 years in diagnostic x-ray dose reduction. State radiological health
programs certainly played a major role in this very significant achieve-
ment. Without their efforts, the achievement would not have been possible.
But acknowledgement must also be made of the contribution that other organi-
zations and other groups have made; such as the American College of Radi-
ology, the American College of Chest Physicians, a number of our universi-
ties and colleges, and the training and medical radiation programs of
the Bureau of Radiological Health.
The fact that the beam restriction played such an important part
in diagnostic x-ray dose reduction spotlights the educational role in
this accomplishment. Restriction was practiced in less than half the
1964 x-ray examinations. Proper collimation was used in more than two-
thirds of the 1970 examinations. In addition, a substantial decline was
found to have occurred between 1964 and 1970 in the use of mobile chest
x-ray equipment. This also helped reduce unnecessary exposure, as you
know. What all this means, it seems to me, is that education does work,
that equipment users can be persuaded to adhere to good protective prac-
tices, as an informed society demands.
Our educative efforts, however, must not be allowed to languish.
They should, in truth, be redoubled. I think that it is apparent that
many people still have not acted upon the urgings to utilize exposure-
reducing equipment and methods. In this connection, let me call your
attention to our recent statement on the use of mobile x-ray equipment
for the mass screening of members of the general population for tuber-
culosis and other chest conditions. That statement, as most of you know,
was carefully prepared by the Bureau, the American College of Chest Phy-
sicians, and the American College of Radiology. We are aware of some
of the difficulties in persuading various private and public agencies
to stop using mobile equipment. However, we think that it is in the
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11
public interest to avoid unnecessary x-ray exposure. We certainly hope
that all of you will agree that you will use your efforts in bringing
about an end to this particular practice.
While preliminary results of the 1970 X-Ray Exposure Study are,
indeed, grounds for encouragement, we should not interpret the finding
too optimistically. Mich remains to be done to reduce human exposure
to diagnostic x rays. We still need to improve equipment and techniques
for maximizing diagnostic information while minimizing exposure levels.
We need to take all possible advantage of the availability of fast film
and other improvements in diagnostic x-ray technology. More frequent
use of gonadal shields seems obviously indicated. We need also to reduce
the number of unnecessary film retakes. We need, in addition, better
systems than we have today for storage and fast retrieval of existing
patient x-ray information. Furthermore, we must provide a more adequate
information basis for the exercise of professional judgment in prescribing
x-ray examinations.
It is our hope that our Bureau of Radiological Health will soon be
in a position to better support research that will provide in-depth infor-
mation to help physicians know when x-ray examinations are essential and
when they may be safely avoided. Such information is urgently needed
if we are to eliminate x rays taken primarily to obtain records for defense
against possible malpractice suits.
We have still another major approach to the solution of the diagnos-
tic x-ray problem. This is the soon-to-be-published Radiation Control
Act standard which will require new equipment to incorporate features
to reduce patient and operator exposure during the actual examination.
At least two provisions of the standard, as I believe you know, have
major significance. One would require stationary, general-purpose x-ray
machines to be designed to insure restriction of the beam to approxi-
mately the size of the body area to be examined. The other would require
film-using equipment to be able consistently to reproduce exposure and,
therefore, image quality for given settings for voltage, current, and
time. This would enable the technologist to know with greater confidence
than is now possible what results to expect at various settings and thus
avoid picture retakes. We all know that beam restriction failures and
unnecessary film retakes are among the commonest causes of unnecessary
exposure to diagnostic x ray.
The Bureau's Division of Electronic Products is hard at work on a
compliance program for the diagnostic x-ray equipment standard, and you
will be hearing tomorrow more about progress in this area. I simply want
to point out that the x-ray equipment standard is by far the most complex
proposed to date under the Radiation Control Act. I can also give you
complete assurance that we will very much appreciate your comments and
your assistance in this regard.
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The time will come, I believe, when all the good x-ray exposure
control capabilities--equipment and user practices--will be operative.
Obviously, exposure to x rays can never be brought to zero unless we wish
to deprive ourselves of the benefits of medical and dental diagnosis.
To do so would be foolhardy in the extreme. Generally speaking, the bene-
fits of a diagnosis today far outweigh the risks, and no person should
refuse an x-ray examination his or her physician believes is necessary.
When the day comes when we are satisfied that unnecessary diagnostic x-ray
exposure has been eliminated and our job is simply to see that proven
protective practices continue to be used, on that day we will have achieved
a major victory in the health protection of the American public.
With regard to other electronic products, we believe that the enforce-
ment of the TV receiver standard is functioning smoothly with good industry
cooperation. Some problems exist with respect to the microwave cooking
ovens, but these are expected to be overcome without much difficulty.
Microwave oven survey data obtained by the State radiation control agen-
cies have been found to be especially helpful and we thank you for this
assistance. Progress is being made, as you know, on standards for indus-
trial x-ray equipment and lasers and we expect to have something to pro-
pose for both categories of equipment before much more time is past.
A few moments ago, I mentioned the emphasis that we were placing on
both science and education to obtain a better balance in our traditional
regulatory responsibilities. This is not to say we intend to neglect
the program of enforcement. Let me assure you that the contrary is true.
The record of the Bureau of Radiological Health on radiation control
standards compliance is sound evidence of this fact.
More than 34,000 radiation-producing electronic products were modi-
fied by manufacturers last year as a result of the work of our electronic
products people. Corrective actions were taken by some 22 manufacturers.
Involved in the actions were about 15,000 television sets, 35 TV projec-
tion devices, 100 television monitors, 8,000 medical diagnostic x-ray
machines, and 200 x-ray diffraction and spectrographic units. All this
adds up to a good year's performance and speaks well for the Bureau's
relationship with industry since corrective action was, in many cases,
voluntary.
Product standards and good compliance programs, we all will agree,
can have only limited effect in reducing electronic radiation exposure.
The best equipment the -industry can produce will be of little avail if
improperly used. The enforcement of good user practices is beyond the
reach of the existing Federal law. This is a responsibility that must
be borne by the State and local agencies which have enforcement authority.
The Food and Drug Administration can and will provide all possible assis-
tance Our Northeastern Radiological Health Laboratory, for example,
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13
will try to develop data for guidance on effective user practices.
of this kind will be helpful.
Another matter of great interest to the States is the question of
radiopharmaceutical regulation. We share your concern about the present
system for regulating the production and use of accelerator-produced
radiopharmaceuticals as well as the more conventional reactor-produced
materials. These matters are receiving our very close attention.
In 1966, our Division of Oncology and Radiopharmaceuticals was estab-
lished in the Bureau of Drugs to conduct scientific evaluations and appro-
vals for new radioactive drugs. Recently a Radiopharmaceutical Advisory
Committee was formed to enhance communications with the nuclear medicine
community.
Our primary concern in the drug review process is safety and efficacy.
With radiopharmaceuticals we are also concerned about radiation to which
physicians, technologists, and others may be exposed. The Bureau of
Radiological Health has special expertise in this area and will support
the Bureau of Drugs in its evaluation process so that operator protection
and other health physics aspects are given proper consideration.
On November 3, 1971, the Agency published in the Federal Register
a revised statement on "New Drug Application Requirements" that reasserted
our control over reactor-produced radiopharmaceuticals. The first step
in the transfer of authority from AEC revoked the exemption from the in-
vestigational drug regulations of materials which appear on the Atomic
Energy Commission's 'Veil established" list. This means that the manu-
facturers must submit New Drug Applications for "well established" radio-
active drugs . The second step will be to remove the exemption for all
reactor-produced pharmaceuticals granted by the AEC-FDA agreement.
No exemption was ever in effect for accelerator-produced or naturally
occurring radioactive materials.
We have received a large number of new applications for radioactive
drugs . I assure you we will work with all concerned to bring about a
smooth transition of regulatory control without interfering with the
availability of previously exempted drugs, provided the interests of
patients are adequately protected.
Recently your Conference Chairman, Mr. Siek, wrote me concerning
the need for a cooperative Federal-State effort to control radioactive
drugs, with special emphasis on the accelerator-produced materials. I
am glad to see that this important matter will be discussed in the next
several days in one of the workshops at this conference.
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14
Another concern of Mr. Siek's is the production and distribution
of devices containing accelerator-produced radioactive materials or radium
within States that do not have licensing reciprocity with other States.
I am certain we can work with you to develop a mechanism to deal with
this problem.
The Food, Drug, and Cosmetic Act includes authority over medical
devices containing radioactive materials. While the Act does not provide
premarketing clearance provisions for medical devices, such authority
is contained in proposed legislation which enjoys Administration support.
When the decision was made recently not to classify sealed radio-
active medical sources as drugs under the action removing the exemption
of AEG materials, I directed the Bureau of Radiological Health to work
with our Associate Commissioner for Medical Affairs on developing a
radioactive medical devices program. A meeting was held recently with
a task force from the American College of Radiology to solicit its views
on this very important subject.
We are in the process of strengthening our program for health pro-
tection in the use of radioactive materials. The Bureau of Radiological
Health and the Bureau of Product Safety, for example, are working on a
standard covering the use of radium for luminous watch and clock dials.
The action would be taken under the Federal Hazardous Substances Act and
its objective would be effectively to discourage the production of radium
dial timepieces except for persons, such as night watchmen and others,
who especially need to be able to tell time in the dark.
As part of the strengthened program, the Bureau is accelerating
efforts to reduce exposure in the use of radioactive materials in disease
diagnosis. This work, as you may recall, has had some outstanding suc-
cesses. One of the best examples has been the development of procedures
that made it possible to reduce patient radiation dose resulting from
administration of radioactive iodine in thyroid gland problems to one
ten-thousandth of previous levels. To help reach our goal of the most
diagnostic information for the least exposure, a new Food and Drug Admin-
istration Nuclear Medicine Laboratory has been put in operation in Cin-
cinnati, Ohio. The laboratory will be dedicated May 5.
Radium, as you well know, can constitute a serious health hazard
when improperly used or stored. The radium problem is current and real,
as demonstrated by the fact that the Bureau, since 1960, has recorded
some 129 incidents involving radium, including loss, theft, contamina-
tion from ruptured sources, and overexposures to radium. The total num-
ber and health hazard potential of these occurrences cannot be determined
since, in the past, there has been little professional concern and no
Government requirement for reporting radium incidents. Most of the
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15
incidents involved sealed radium source losses that could have been pre-
vented by good accountability procedures and preventive measures such
as those required for radioactive materials controlled by the Atomic
Energy Commission.
There is no Federal regulatory authority over radium and accelerator -
produced radioactive materials. Such Federal control as does exist re-
lates only to such specific aspects of the problem as interstate carrier
shipments, adverse environmental impact, or use in consumer products.
We believe absence of Federal law in this field represents a serious
defect in our manmade radiation control capability. Consideration now
is being given to remedying this defect.
In closing, let me emphasize that the Food and Drug Administration
welcomes increased public demand for safer products and services of all
kinds, especially those which, like most radiation-producing materials
and equipment, confer benefits as well as degrees of risk. We are most
grateful, let me assure you, for the opportunity to become full partners
with the Conference of Radiation Control Program Directors in trans-
forming into reality all our expectations of the ultimate in manmade
radiation protection for the American people.
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16
ACCOMPLISHMENTS OF THE CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS
Robert P.
Colorado Department of Health
Thank you very much Dr. Edwards. There will be a change in the
program at this time. Mr. Dominick, who was scheduled to speak next, has
been delayed. His expected arrival is at 4:30, which would make it about
5:15 or so before he will arrive here. We will change the schedule to
allow Mr. Dominick to speak to us tomorrow morning at 8:15.
It is indeed a pleasure and an honor to have had Lieutenant-Governor
Fitzmorris and Dr. Edwards speak to us this afternoon, and of course, we
will look forward to hearing Mr. Dominick of EPA tomorrow morning. We
appreciate them opening this 4th Annual National Conference on Radiation
Control. The Conference of Radiation Control Program Directors appreci-
ates the support of both the Environmental Protection Agency and the
Bureau of Radiological Health. Without this support, it would be impos-
sible for the Conference to function. It becomes more apparent each year
that the need of the Conference for coordination, development, and imple-
mentation of Radiation Control Programs, both State and Federal, is
essential.
Looking back 4 years ago, in Montgomery, Alabama, at the first Con-
ference, the wisdom of developing a working Conference, one that is
designed to delve thoroughly into subjects of high priority in radiation
control, is clear. Not only are the results of the workshop sessions
of value to each of the States and to the Federal agencies in program
planning and administration, but they also provide a means of continuing
evaluation of complex problems in radiation control. This continuing
evaluation phase of the Conference was never more apparent than in the
work accomplished following last year's Conference in Scottsdale, Arizona.
The efforts expended by members of the Conference on Radiation Con-
trol Program Directors and by staff members of the EPA and the BRH in
certain task forces formed as a result of the Conference last year are
extremely gratifying. Each participant should be congratulated for the
great amount of time and energy that he gave to this important work.
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The notable accomplishments made as the result of recommendations
by the Conference last year, are the formation of a Bureau of Radiologi-
cal Health Conference task force entitled "NEXT" or Nationwide Evaluation
of X-Ray Trends. This task force developed from the workshop "Optimum
Components of X-Ray Inspections." The original charge, plus a broad
evaluation of x-ray trends, has evolved to allow the Bureau of Radio-
logical Health and the States to plan now to meet future needs in x-ray
exposure control. The NEXT task force will present a detailed report
on Wednesday of the results of their work over the past year.
Another outstanding job was done by the task force entitled "Evalu-
ation of State X-Ray Control Programs." This task force formulated a
system that can be utilized by States to assess the effectiveness of
their individual x-ray control program. Several States represented on
this task force have field-tested this sytem and a detailed report will
also be presented on Wednesday.
There have been Bureau of Radiological Health Conference activities
in developing model legislation for laser control. Expertise from
several of the States has been recruited to assist the Bureau in devel-
oping and reviewing these model regulations. It is evident that this
has been an example of cooperative effort to eliminate as many of the
inherent problems of regulation development as possible.
Another major Bureau of Radiological Health Conference effort has
been to revise the Council of State Government Regulations. States have
been selected because of individual talents to work with the Bureau in
this important endeavor. Results, of course, will be forthcoming as the
revisions are published.
EPA has cooperated with the Conference and the AEC to continue last
year's workshop efforts in emergency radiation response programs. A semi-
nar that will include a report of this task force's accomplishments will
be presented on Tuesday morning.
A multitude of other activites has been evident over the past year.
Requests by the Conference to the Food and Drug Administration, the Atomic
Energy Commission, and the Environmental Protection Agency regarding Fed-
eral funding participation of Agreement Programs; creation of a National
Medical Advisory Committee on accelerator produced radioisotopes; Federal
uniform control of nonagreement material; and improved comprehensive envir-
onmental surveillance programs with Environmental Protection Agency sup-
port, have set the stage to establish the State Radiation Control Program
image in improving radiological health in the United States.
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This cooperative development of programs by the States and Federal
Government results in radiation control programs that meet the need of
the entire nation and assure that the programs are workable and effective.
In addition to workshop and task force accomplishments, the Confer-
ence has also provided a pathway for communication among the States and
Federal agencies. The Conference, because of the representation of its
members, can speak effectively and authoritatively on problems faced by
State programs and bring attention to assistance or changes felt necessary
on the State or Federal level to make programs more effective. The Fed-
eral agencies, on the other hand, can present their problems and needs
directly to the State Program Directors for clarification or redirection.
In summary, the Conference of Radiation Control Program Directors
grows in effectiveness each year. The progress of the Conference in its
4 years of existence is encouraging. The goal of the Conference to work
cooperatively with the Environmental Protection Agency and the Bureau
of Radiological Health is now becoming a reality. In the future, this
cooperative approach to solving radiation control problems will continue
to mature and result in improved program management and a better direction
of program emphasis.
The setting of this year's meeting here in New Orleans should be
an incentive to make this Conference the most successful meeting in our
short history. The Louisiana Board of Nuclear Energy, Jim Porter and
his staff, deserve much credit for their tireless efforts in managing
all the details that go into a meeting of this size. Also special recog-
nition should be given to Heinz Wilms, Jim Miller, and John Villforth
of the Bureau of Radiological Health and Ronald Bales of the Environ-
mental Protection Agency. These men have dedicated themselves to work
with the Conference to assure a successful and meaningful meeting.
I welcome each of you to this 4th Annual Conference and encourage
complete participation in all of the planned activities. There appears
to be adequate relaxation recreation periods in this great City of New
Orleans that should add to the stimulation of the challenge of the tech-
nical problems facing us. Good luck, and have a good, productive
Conference.
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19
X-RAY EXPOSURE SESSION
Moderator: Gerald S. Parker
The, Environmental Piote-ction Agenct/'-A
to Environmental Radiation Control
David D. Dominick
Assistant Administrator, Categorical Programs
Environmental Protection Agency
X-fcu/ ExpoAu/ie, Study and Trend*
Paul L. Roney
Division of Medical Radiation Exposure
Bureau of Radiological Health
Save. Radiation — Make It Happen
John C. Villforth
Director
Bureau of Radiological Health
Implementation o£ the, X.-Ray PeA^o/unonc.e Standandb. . Robert G. Britain
Status - E^ect. on State* - Wew and
Otd Equipment ................ William S. Properzio
Method Ve.vnlopme.nt and Utilization. . . .Dr. Gregory J. Barone
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INTRODUCTION
MR. SIEK: It is a pleasure to have Mr. David Dominick with us today to
help us open this Fourth Annual Conference on Radiation Control. Mr.
Dominick of Cody, Wyoming, was nominated by President Nixon to be Assis-
tant Administrator for Categorical Programs, U.S. Environmental Protec-
tion Agency, June 1, 1971. From March 1969 until his appointment to the
EPA, Mr. Dominick served as Commissioner of the Federal Water Quality
Administration. Prior to that time he served as Legislative Assistant
to U.S. Senator Clifford P. Hanson of Wyoming from 1966 to 1969. While
serving on Senator Hanson's staff, he handled all staff matters relating
to the Department of the Interior natural resources and water issues.
He is a member of the Wyoming State Bar; the Colorado State Bar; the
American Bar Association, Natural Resources Section; the Sierra Club;
the Wyoming Wildlife Federation; and the Wyoming State Historical Society.
Again, I'd like to point out that Mr. Dominick has ties with Colorado.
He attended the University of Colorado Law School. I'd like at this
time to have Mr. Dominick address the group.
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THE ENVIRONMENTAL PROTECTION AGENCY'S RESPONSE TO ENVIRONMENTAL RADIATION
CONTROL ISSUES
David V.
Assistant Administrator
Categorical Programs
Environmental Protection Agency
I have a prepared text which I have given to Bob and it's available
here at the Headquarters and if there's anyone interested in that, I'm
-sure that you can obtain copies of it.
I'd like to speak this morning informally with you about a number
of issues as I see them, depart from the text a good deal, and stimulate
any questions which you might have of me and of EPA at this stage of
the game. This meeting and this Conference and this gathering together
of people who are vitally interested and vitally committed to the whole
field of radiation protection as professionals is most timely.
We at EPA are in the process of developing a national strategy
for radiation protection. We are attempting to build the conceptual
framework for radiation protection that will serve us in good stead for
the next years in this century. I feel that with the creation of EPA
we have a unique opportunity to view the nuclear fuel cycle and other
developments, such as the plutonium fuel cycle, in a total environmental
context, and a unique opportunity to evaluate'what the impact of those
developments are going to be on the environment and on human health and
to insure that adequate decisions are made with respect to the production
of energy in this country to insure that those decisions are made in the
light of the best efforts available in terms of health practices and in
terms of environmental impact.
I believe that the talk that is prevalent these days about the energy
crisis has much validity to it. We are in a very difficult state of
affairs here in this country with respect to production of energy.
That state of affairs has come about because there was not adequate long-
range planning on the part- of the energy sector, because adequate
consideration was not given to environmental effects from various energy
sources, and because the public at large has become much more interested--
much more concerned--in questions of national policies such as: What
will be our energy sources? What are the polluting effects of that energy?
What are the human health effects of that energy?
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It's going to take us time to sort out a number of those pressing
public questions. We may well see short-term shortages in this country
over the next 10 or 15 years. There may well be a continuing series of
crises, if you will--short supply in various parts of the country. There
will be a tremendous amount of pressure on all of us who are making
decisions to move to new sources of vast energy, such as the fast breeder,
and to move very rapidly.
The EPA role is to insure that those decisions are made with all of
the best available evidence. We created a task force in EPA to deal
solely with the question of energy. Dr. Joe Lieberman has been asked
to head that up. As you know, Joe was formerly the Deputy Assistant
Administrator of the Office of Radiation Programs in EPA.
The first and most pressing question facing that task force will be
to determine what the real supply-demand picture is from EPA's point of
view; to validate, if you will, the many estimates that are being thrust
forward by the private sector; by the oil companies; the coal companies;
the nuclear power companies; the utilities. All of those assessments
and projections are also being conducted at various agencies of the Federal
Government; the Department of the Interior; the Federal Power Commission;
the Office of Emergency Preparedness, and so forth. Cur role is to
evaluate their validity and merit, to see for ourselves what the real
demand picture may be, and then to assist other developmental agencies in
meeting that demand in the most environmentally acceptable way. As I see
it from my perspective, nuclear power will play a very large role in meeting
the energy demands of this country; and that role will accelerate as we
see short-term dislocations resulting from the unavailability of sufficient
power.
In developing our strategy, we in EPA have concentrated primarily on
the uranium fuel cycle associated with nuclear reactor operations, looking
at the whole cycle from mining on through to waste disposal. We have
determined that we will be addressing specific portions of that cycle with
particular thought and study. We feel that long term waste disposal may
be the Achilles heel of the nuclear industry at this time. We, as a
nation, have got to address this question of waste disposal and to assure
that adequate technologies and adequate facilities are developed for protec-
tion of the environment and the public for generations to come. To date, we
have not done enough in that area. One of the primary studies of the EPA
Radiation Office in the coming year will deal with the question of waste
disposal.
The other big issue looming on the horizon, connected with this whole
question of energy and meeting demand, will be the plutonium fuel cycle
connected with the fast breeder developments. Because of the particularly
hazardous nature of plutonium, we believe its use presents a potentially
adverse impact on the public health and the environment. The assessments
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24
that need to be done to weigh the total environmental impact of the fast
breeder are absolutely critical to decisions made by this country before
it launches on that course. There have to be full, factual presentations
made of what that impact will be; therefore, we view EPA's role as one of
carrying out a number of functions—an assessment of the problem; setting
of standards or guidelines that can be used by other agencies that have
responsibilities in this area, particularly the AEC; and then informing
the general public as to what the impact of many of these developments
will be on the public health and on the environment.
We feel that EPA is in a unique role in that we are independent.
We are not in the development business. We are not promoting one source
of energy over another, and we can take an objective view, and that objec-
tive view, I think, carries with it a tremendous amount of credibility.
In taking that objective view, if I might predict for a moment, as I say,
I do think that nuclear power will show up very well in terms of its
relationship to other kinds of energy production. The problems associated
with fossil fuels, the problems of extraction, processing, and finally
burning in power plants are known to all. We need to assess what that
impact is and then make a relevant assessment of what the impact from
nuclear power production would be; make those trade-offs and educate the
public as to what is best.
Other problems associated with the nuclear fuel cycle I'm looking
at, in cooperation with the AEC, is the whole question of transportation—
transportation of the spent reactor fuel to a processing plant; and on
through to final disposal. That has to be addressed as a generic issue.
You can't simply build one power plant here with all the attendant
controversies that go with it and say; all right, that power plant is going
to take care of itself. You've got to look at everything else that is
associated with the cycle. Transportation is one of those generic issues.
Another generic issue that we are discussing with the AEC is the
whole question of inplant reactor accidents. A major part of that highly
controversial question is now being aired in Washington in hearings on
Emergency Core Cooling Systems. We feel that EPA participation in the
assessment of environmental risks from such accidents is vital.
Other areas that EPA, and particularly the Office of Radiation Programs
is working in, will deal with naturally occurring radioactive substances.
I'm sure you're all familiar with our problem of mill tailings for construc-
tion purposes in at least 10 Western States. You are familiar with the
role that has been long standing of our desire to assist those States in
analyzing the scope and severity of that problem. We feel that there has
to be an assessment made of other kinds of materials which are finding a
way into our lives—construction materials and an assessment made of the
health implications of the use of those materials and perhaps a decision
is made about what is proper or what could be done to minimize risk.
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25
The whole question of nonionizing radiation, I think, is going to
become more and more significant in the years immediately ahead. Electro-
magnetic radiation is rapidly on the increase. The majority of the uses
are for communication and guidance systems. As of 1968, there were over
6 million transmitting devices authorized by the Federal Communications
Commission; and between the years 1960 and 1970, the number of radio
stations in the United States alone rose from 4,000 to 6,500. The FM
(Federal Aviation Administration) has recently begun a 5-year develop-
ment program of microwave landing units for service in the U.S. airports
by 1981. So we feel that EPA has a unique role here to assess the impact
of nonionizing radiation, and we are doing that in cooperation with a
number of other Federal agencies. I dare say that we are taking the
lead in that effort.
Finally, medical exposures. I think that it's highly significant
that Dr. Edwards spoke in such a forceful manner yesterday to you about the
impact of medical exposures and we're very encouraged by that development.
As I started out with my remarks, I think it is most timely that we
meet together to discuss where we should be going in terms of radiation
protection in the U.S.A. The State role here is exceedingly important. I
would say it's crucial to an adequate radiation protection program for the
people of this country. As you know, we are engaged with a number of
States, on a number of fronts, from air monitoring to quality control
services, to the indoor radon problem that I mentioned, to inspection
programs, to special studies at particular facilities around the country,
to special investigation of waste disposal problems and technical assistance
and emergency assistance wherever it is called for, whenever needed. Now
that's just the start, I believe, of what should be developed by way of
joint programs between the Federal Government and the States. It is just
a start of assigning relative roles and responsibilities to the States and
to various Federal agencies. I would hope that in this session, in this
Conference, you could develop, from the State point of view, your thoughts
about how the State role could be increased. State participation in
monitoring, in inspections, in a number of activities could be improved;
and the Federal Government could assist you in doing your job better.
I'm convinced that with an issue of this magnitude, the Federal
Government, as represented by people in Washington, simply is not going
to get the job done by themselves. I'm convinced that this has got to be
done on a State and local basis. I'm convinced that we need to think
through that State and local role much more carefully and much more
explicitly; and I would appreciate any expressions of desire, any expres-
sions of points of view, any-expressions of what you think could be done
better on your part. I feel that, in the field of radiation protection,
from my vantage point, having viewed a number of pollution problems, and
at the present time being responsible for not only radiation but solid
waste, pesticides, toxic substances, and noise, we are far ahead of the
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26
game in radiation protection. We are predicting things way before they
happen. We are providing adequate protection to the public health by
virtue of stringent standards, and we are making sure that what is done
is done in a clean and safe way before we have the kinds of pollution
problems that need to be cleared up retroactively, if you will, as we do
in the air and water area.
I am encouraged by the foresight. I am encouraged by the profes-
sional competence of this group and of the professions in the field, and
I'm very happy to be with you and discuss matters of mutual concern. I
hope that we can keep a very strong dialogue going between this Conference
and our Office of Radiation Programs and our other programs in EPA. It's
a pleasure being with you. I suggest that I close here on these informal
remarks. As I said, there is a paper here, if you're interested in reading
it, and I would be happy to discuss with you any matters or concerns or
questions that you might have.
(Here follows Mr. Dominick's prepared paper.)
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27
The Environmental Protection Agency was established by Reorgani-
zation Plan No. 3 of 1970 with the broad mandate to protect human health
and ensure the quality of the environment. To assist in accomplishing
this mission a number of authorities were transferred to EPA from other
Federal agencies. With respect to radiation, EPA was given authorities
from the Department of Health, Education, and Welfare, the Atomic Energy
Commission, and the Federal Radiation Council. These authorities allow
EPA (a) to set generally applicable environmental radiation standards;
(b) to advise the President with respect to radiation matters, directly
or indirectly affecting health, including guidance for all Federal agen-
cies in the formulation of radiation standards and in the establishment
and execution of programs of cooperation with States; (c) to conduct
research and surveillance; and (d) to provide assistance to States.
The Environmental Protection Agency, as a result of its broad man-
date and its authorities has encompassing responsibilities which are
particularly unique to any Government agency. In establishing the Agency,
the President envisaged that those unique responsibilities would produce
three general benefits to the nation. First, it would permit response
to environmental problems in a manner beyond the previous capabilities
of our pollution control programs. Second, it would enable the estab-
lishment and enforcement of standards for air and water quality and for
individual pollutants, in concert with the States, which cannot be accom-
plished with a disjointed array of separate programs. And third, it
would centralize in one independent agency the responsibility for envir-
onmental protection and pollution abatement and control. Careful analysis
of EPA's mandate, authorities and responsibilities indicates that EPA
must provide the national leadership role where the environment and
human health are concerned. This role demands that it be exercised with
great care and wisdom and requires that EPA weigh the costs, including
the social and economic costs as well as the environmental costs, and
balance these against all the benefits before recommending specific
courses of action.
This type of analysis is readily apparent in recent testimony by
Mr. Rudcelshaus before the Joint Committee on Atomic Energy regarding
the Administration's bill to permit a limited suspension of the environ-
mental impact statement requirements of the National Environmental Policy
Act of 1969 for certain nuclear power plants. The Act requires all
Federal agencies to consider values of environmental protection in their
spheres of activity, and it prescribes certain procedural measures, in-
cluding the submission of a detailed environmental impact statement for
Federal actions significantly affecting the environment. These require-
ments were established to ensure that the values of environmental pro-
tection are in fact fully respected. In the testimony, Mr. Ruckelshaus
said that NEPA is one of the most powerful tools we have to protect the
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28
environment and in the absence of compelling circumstances, the provi-
sions of the Act should not be waived even on an interim basis. How-
ever, based on information we have received, it appears that serious
power shortages may occur in some areas of the country in 1972 and 1973
if adequate additional electrical generating capacity is not made avail-
able, and the AEC may be unable to complete the impact statement process
before this addition power is required.
Therefore, the Environmental Protection Agency supports the provi-
sions of the proposed bill as a reasonable and temporary interim measure.
However, we would not expect that operation will be allowed beyond the
point necessary to meet essential power needs. Furthermore, NEPA will
remain fully applicable to the issuance of the final operating permit,
and any requirements respecting radiation safety or environmental effects
which are determined to be necessary after completion of the environ-
mental impact statement must be complied with by the applicant at _ that
time, even though this may require backfitting. This example depicts
one action which required EPA to balance the costs versus the benefits
to insure that the environment is adequately protected and society has
the necessary electrical power. These types of cost-benefit analyses
must be made by EPA daily for a multitude of projects and proposals that
have numerous potential social, economic, and environmental consequences.
At the present time, ionizing radiation associated with nuclear
energy development is probably the best controlled environmental pol-
lutant. This is primarily a result of the early recognition of the
potential dangers and, therefore, effective source controls were exer-
cised to keep emissions at low levels. Consequently, in most instances,
it has not been necessary to establish pollution abatement schedules
to reduce the levels of environment radiation. This is a situation
that is sharply in contrast with other pollutants for which EPA has
programs.
With regard to radiation, the primary goal of the Environmental
Protection Agency is to prevent adverse effects to human health and
the environment and to reduce current risks resulting from radiation
exposure. To accomplish this goal, we have identified four general
radiation problem areas that we believe need particular attention. They
are: (1) Uses of nuclear energy such as nuclear power and the fuel cycles,
weapons testing, and Plowshare projects; (2) natural radiation from such
sources as construction materials including mill tailings, granite, and
others; (3) nonionizing radiation exposures including that from micro-
wave, radiofrequency and laser sources; and (4) medical and occupational
exposures.
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29
In accordance with its radiation goals, EPA currently has active
programs in standards and guidelines development, surveillance and in-
spection, technology assessment, environmental impact statement reviews,
training, and State assistance. These activities will be discussed in
detail later in the conference. To date, the activities have been essen-
tially oriented toward the nuclear fuel cycle, with a few peripheral
activities in other source areas. We believe that in order to afford
maximum environmental protection that EPA and other agencies, both Fed-
eral and State, have important roles in the development of nuclear
energy.
Problems, both real and potential, which are associated with the
uranium based fuel cycle, the plutonium based fuel cycle, radioactive
waste disposal, radiation accidents, and nuclear stimulation of natural
gas must be fully assessed in order to prevent adverse effects. In order
to foresee any environmental harm, not only must each individual facility
be examined for its environmental impact, but the consequences of entire
cycles of activities must be closely assessed to prevent adverse overlap-
ping or synergistic environmental effects.
With regard to the other problem areas, EPA believes that because
other sources of exposure were not developed with a goal of protecting
people and the environment from adverse effects that there is a signifi-
cant amount of public health protection that can be gained by positive
action in other radiation problem areas. Therefore, in the future we
plan to focus additional attention on these areas that have not received
enough evaluation.
Man's exposure to natural sources of radiation in the United States
is about 27 million man-rem per year while the integrated dose from all
current nuclear power plants is estimated at less than 1,000 man-rem
per year. Therefore, it is evident that even a minute increase in man's
"natural" exposure will far outweigh the total amount of exposure due
to current emissions from nuclear power operations. Likewise, if this
small increase were prevented or if the "natural" radiation were reduced,
the population dose savings would be substantial when compared to savings
as a result of regulation of nuclear power plants.
Man's radiation exposure to natural sources varies significantly
with his choice of environment including the geology and elevation of
his locale. In today's society, modern man finds that with greater
urbanization he spends more and more of his time in manmade environ-
ments such as offices, theaters, stadiums, his home, and other buildings.
Certain types of marble, granite, brick, and wallboard can cause greater
amounts of radiation exposure than alternative construction materials.
Therefore, depending on the construction materials, these manmade sur-
roundings can play a significant role in the total "natural" radiation
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30
exposure he receives from his environment. In taking steps to prevent
or reduce exposure from "natural" radiation I don't want to imply that
we are attempting to reduce the total natural radiation that either
strikes the earth or that is a part of the earth; nor are we planning
to advocate that Government decide where people should live relative
to their natural radiation exposure. Rather, EPA proposes that man should
be cautious in selecting his construction materials to ensure that most
of the natural radioactivity stays in or on the earth and is not removed
and built into his immediate manmade environment. Therefore, the bene-
fits of one type of construction material must be balanced against the
risks, whereas increased radiation exposure may be one of the risks.
In developing programs that will lead to the prevention and reduction
of the "natural" exposure, EPA is currently working to increase our knowl-
edge regarding the degree of exposure from materials containing natural
radioactivity.
The third problem area that we believe needs more attention is non-
ionizing radiation. Technologies involving nonionizing radiation is
the environment have by-and-large been applied without regard to long-
term environmental protection goals. Throughout the world, and especially
in the United States, the use of electromagnetic radiation is rapidly
on the increase. The majority of the uses are for communications and
guidance systems. As of 1968, the Federal Communications Commission
had authorized 6,425,209 transmitting devices {!). Between the years
of 1960 and 1970 the number of radio stations in the United States alone
rose from 4,000 to 6,500 (2). The Federal Aviation Administration has
recently begun a 5-year development program of a microwave landing sys-
tem which it hopes will be the landing system for the nation's airways
in the 1980's. Current estimates by FAA predict a total of 454 micro-
wave landing units in service at U.S. airports by 1981 (3).
New research in guidance control, communications, and other fields
is continuously resulting in new applications of lasers and other non-
ionizing radiation producing equipment. These radiations could very
well have some effect on the environment. We must have reasonable assur-
ance that the environmental effects of these technologies will be of
minimal consequence.
There is one primary difference in the environmental exposure situa-
tions between ionizing and nonionizing radiations. Man has always been
exposed to a continous background of ionizing radiation to which he was
exposed was essentially negligible. Therefore, the amount of environ-
mental nonionizing radiation to which segments of the population may
be exposed is probably many thousands of times greater than pre-World
War II nonionizing radiation background.
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31
While the biological effects of exposure to high power densities
of some nonionizing radiations are known, the bioeffects of low-level
exposures are virtually unknown. The Sovient literature does report some
psychological, behavioral, and morphological effects in plants and ani-
mals from low levels of nonionizing radiation exposure.
The Environmental Protection Agency and other organizations are doing
research and studies related to determining nonionizing radiation
biological and environmental effects. As a result of our work, we
believe that the potential impact of nonionizing radiation upon human
beings and the environment is not known with sufficient confidence.
Therefore, EPA believes that in order to successfully assess and control
environmental nonionizing radiation, a significant amount of work is
needed. To this end,,EPA is currently supporting about one-quarter of
the Federal effort in this area, and we are also participating in a coor-
dinated 5-year Federal program for the control of electromagnetic pol-
lution in the environment. This program was proposed by the President's
Electromagnetic Radiation Management Advisory Council (ERMAC) and is
being coordinated by the Office of Telecommunications Policy. The pur-
pose of the ERMAC program is to establish a scientifically directed focus
on environmental nonionizing radiation with the goal of establishing
the biological effects of nonionizing electromagnetic radiation, asses-
sing the environmental hazards and effecting adequate control mechanisms.
The program calls for expenditures of some $63 million allocated among
cognizant Federal agencies over a 5-year period (2).
The last problem area is medical and occupational uses of radiation
which undoubtedly contributes to man his greatest source of maranade radia-
tion exposure. The effects of these uses of radiation are of considerable
concern to all of us here today and this is relected by the agenda which
proposes to discuss this topic in great detail during the conference.
Although operational programs concerned with medical and occupational
exposure remain in the Department of Health, Education, and Welfare,
EPA has responsibilities to provide advice to the President concerning
these matters. The primary impact which EPA may have in these areas
would be in establishing guidance for use by Federal agencies. To date,
EPA has not undertaken any work in these areas but should it become neces-
sary for us to get involved we are prepared to do so.
The Environmental Protection Agency currently has numerous productive
relationships with the State radiation control agencies. To ensure that
environmental protection goals are being met, EPA operates environmental
surveillance networks with the cooperation of the States.
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32
As a part of the EPA National Environmental Radiation Monitoring
Program (NEKMP) we are contracting with States for timely surveillance
data for input into the NERMP program. There are 10 contracts either
awarded or pending and we are planning to negotiate with other States
as soon as possible.
Since 1968, EPA or its predeccesor components have been involved
in the problem of uranium mill tailings used for construction fill. The
principal area of concern is Grand Junction, Colo., where EPA has been
and is providing technical assistance to the State of Colorado in its
efforts to evaluate the problem. To date, the cooperative State-EPA-AEC
program has completed ganrna radiation surveys of almost 14,000 sites
and is currently conducting in-depth air sampling for radon daughters
in over 500 structures in Grand Junction.
A mobile scanner is being operated under the direction of EPA to
scan communities in 10 States where uranium mills are operating or were
operated in the past and where the potential exists for a uranium mill
tailings construction fill problem. Of the 10 States, mobile scanning
has been completed in seven States, with the exception of Salt Lake City,
Utah.
A model State regulation for the stabilization of tailings piles
containing radioactive material has been developed by EPA and was pro-
posed to the uranium milling States at the recent Colorado River Basin
Conference in February 1972.
EPA is currently developing its inspection program which will in-
spect various radiation producing facilities around the country to ensure
that environmental standards and guides are being met. We are now
working with State radiation control agencies to establish priorities
for future inspection activities.
EPA is also investigating the possibility of establishing contracts
with the six States that have private shallow land burial facilities.
The purpose of these contracts will be to obtain inventories of the
burial facilities for use by EPA in its activities related to radio-
active waste disposal.
The program and activities that I have mentioned are a few of the
continuing relationships EPA has with the States.
The resources of EPA are dedicated to the accomplishment of the
Agency's mission of protecting human health and the environment. These
resources, albeit limited, are totally available as collaborative assis-
tance to State and local control efforts in meeting environmental pro-
tection needs. The EPA resources most directly concerned with radiation
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33
control are in the Office of Radiation Programs; the Western Environ-
mental Research Laboratory, Las Vegas, Nev.; the Eastern Environmental
Radiation Laboratory, Montgomery, Ala.; and the Categorical Programs
Divisions in each of the 10 EPA Regional Offices.
EPA believes in attacking problems at their sources. To ensure
that EPA is truly responsive to environmental needs in every part of
the country, a strong field organization has been established by locating
Regional Offices at ten major cities. The Regional Offices are staffed
by specialists in each program area and they are headed by a Regional
Administrator who possesses broad authority to act for EPA in matters
within his jurisdiction.
For the States within each Region, the Regional Offices are the
focal point for radiation as well as other programs. Problem identi-
fication, plans for studies, scheduling of surveys, public information,
and in general, all operational activities should be coordinated through
the Regional Offices. EPA laboratories conduct research and provide
technical support to the Regional Offices in furtherance of the environ-
mental protection goals. The role of headquarters components are to
provide overall policy direction, technical expertise, and coordination
on a national scale.
The accomplishment of EPA's goals, in concert with those of State
control agencies requires that the laboratories, Regional Offices, and
headquarters work as a team in a spirit of cooperation to achieve the
best possible results. This team effort in conjunction with the activi-
ties of State control agencies will lead to a goal we all want--a
healthier and more beautiful environment.
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34
REFERENCES
(T) ELECTRCMAGNETIC RADIATION MANAGEMENT ADVISORY COUNCIL. Program for
Control of Electromagnetic Pollution of the Environment: The assess-
ment of Biological Hazards of Nonionizing Electromagnetic Radiation.
Office of Telecommunications Policy (December 1971).
(Z) FEDERAL COMMUNICATIONS COMMISSION. Broadcast Services, Information
Bulletin 2-B. Federal Communications Commission, Washington, D.C.
20554 (October 1970).
(3)- BYRNE, DONALD. FAA launches 5-year development of microwave landing
system. Microwaves (March 1972).
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35
X-RAY EXPOSURE STUDY AND TRENDS
VcwJL L. Roney
Division of Medical Radiation Exposure
Bureau of Radiological Health
I have been asked to report on some of the preliminary findings of
the 1970 X-Ray Exposure Study and to compare these findings with similar
estimates derived from the 1964 X-Ray Exposure Study.
The 1970 X-Ray Exposure Study was a cooperative venture among the
National Center for Health Statistics, the Bureau of Radiological Health,
and the State and local radiological health personnel. The National
Center for Health Statistics collected the basic data on the x-ray expe-
rience of the U.S. population; the Bureau of Radiological Health con-
tacted each of the facilities reported in the study to obtain technical
information on x-ray examinations that could not be obtained from the
household respondents; the State and local radiological health personnel,
all on a volunteer basis, assisted the Bureau of Radiological Health by
visiting the x-ray facilities that did not respond to our mail inquiry
during the Study. Without this personal contact, the value of the X-Ray
Exposure Study would have been seriously impaired. Altogether, the num-
ber of field personnel who visited x-ray facilities numbered 44 persons
throughout the United States, and, in my first opportunity to speak be-
fore the State Radiological Health Program Directors, I wish to say thank
you for your participation.
Figure 1 shows the principal estimates produced in the first phase
of both the 1964 and 1970 studies. You'll note that there has been an
increase in the number of persons with one or more x-ray procedures during
the year from 108 million in 1964 to 129 million in 1970, a 19 percent
increase. This increase might be viewed in the context of the population
increase of 7 percent, that is the population covered during the two
surveys--187 million in 1964 and 200 million people in 1970. These peo-
ple were involved in 143 million x-ray visits in 1964 and 179 million in
1970. During these visits, there were 173 million x-ray examinations
performed in 1964 compared to 210 million in 1970. The number of films
exposed during the examinations increased from 506 million in 1964 to
650 million in 1970.
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36
PHS X-RAY EXPOSURE STUDIES ANNUAL ESTIMATES
Baudot) U.S.Civilian NonirutiMional Population,
1964 and 1970
vum
U(4 • 108 •LLK* U?0-129»LUO«
1X4-U3IM.UM HH-17VM1M
FIUB
3f
UM-173MUKM U70-210HLLIM
UH-SOOXLLKW 1171 • 650 HILUO(I
tfn
Figure 1.
ANNUAL RATE Of MEDICAL X-RAY VISITS BY AGE,
U.S., 1964 and 1970
DM 1)71
SZ) lli.l
l)t SS.5
J I I I I
«
M run
• • X
Figure 2.
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37
Figure 2 represents the annual rate of medical x-ray visits per
100 population by age in the United States. As you can see, the in-
crease in the rate of examinations has been primarily in the older age
group. In the age group 45-64, the increase is about 12 percent, and
the increase in the 65 and over age group is 30 percent. This increase
is undoubtedly due to the advent of the Medicare program in 1967.
Figure 3 shows the rate of persons x-rayed by family income. The
general pattern in 1970 for persons x-rayed for both medical and dental
reasons is quite similar to that reported in 1964. The dental curve
appears to be highly dependent upon income with the lowest rates of per-
sons x-rayed in the lowest income group and the highest rates in the
highest income group. This contrasts sharply with the medical x-ray
rates which in 1970 appear to be practically independent of income.
This is due to the sharp increase in the rate of persons with medical
x rays in the income group under $2,000. Again, the pattern in 1970
probably reflects the current insurance programs which make it possible
for people of all income groups to seek medical care.
§
P 40
8
ESTIMATED ANNUAL RATE OF PERSONS X-RAYED
DURING MEDICAL AND DENTAL VISITS
by Family Income, U.S., 1964and 1970
j
0 12.000 S 4.000 56,000 11,000 i 10,000 S 12.000
FMULY INCOME
PHS x-,« £.„.,„.. ft.*
Preliminary Date
Figure 3.
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38
ESTIMATED ANNUAL RATE OF MEDICAL X-RAY PROCEDURES
by Type of Facility and Age of Patient, U.S., 1964 and 1970
I •
t
§ •
•
ui
i »
30 4J
ME
PMS X-roy E>(w»ur> Study
Figure 4.
Figure 4 is the rate of medical x-ray procedures by age of the
patient. You will note the general increase in the rates for hospital
x-ray exams in 1970 compared to the insignificant changes in the rate
of x-ray exams performed in other facilities. The increase, again, is
most pronounced for persons in the age group over 65.
Figure 5 shows the mean or the average ratio of beam area to film
area. The improvement is evident with decreases in the mean ratio of
beam area to film area ranging from 43 percent in private groups to 15
percent in facilities labeled "Health Agencies and Others." The lowest
ratio of 1.3 is shown for hospitals in 1970 compared to 1.9 in 1964.
The lowest ratio reported in 1964 was 1.8 in the private offices of
radiologists. This declined to 1.5 in 1970. In 1964, it was shown that
excessive beam size was the most important factor contributing to gonad
dose and to the estimate of genetically significant dose for the United
States. This figure implies that the programs of everyone concerned
with radiation protection and the improvement of radiologic practice
is succeeding but also shows that a good deal further progress must be
made to achieve this one goal of restricting the x-ray beam to the organ
of interest or the film size, whichever is the smaller area.
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39
ESTIMATED MEAN RATIO OF BEAM AREA TO FILM AREA
FOR RADIOGRAPHIC EXAMINATIONS
by Type of Facility, U.S., 1964 and 1970
u-
HOSPITALS fess
PRIVATE
GROUPS
PRIVATE
OFFICES
RADIOL-
OGISTS
PRIVATE
OFFICES
OTHER
HEALTH
AGENCIES
1
OTltERS
PHS X-foy E.po
Pf.li.inar> DcIO
MJ '•»
3-3
•EAN RATIO
Figure 5.
ESTIMATED MEAN GONAD DOSES FOR ALL
RADIOGRAPHIC EXAMINATIONS
by Age and Sex
U.S., 1964 and 1970
Figure 6.
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40
Figure 6 shows a dramatic reduction in the average testicular dose
in the age groups 15 to 44 years. At the same time these data indicate
an increase in the average ovarian dose in the age group 15 to 29. The
mean testicular dose from radiographic examinations in 1970 was 146 milli-
rads - a decrease of about 40 percent from the 1964 estimate of 239.
For females, the 1970 estimate is 79.millirads, which is approximately
12 percent higher than the average of 70 in 1964. These data reflect
the improvement noted in beam collimation, particularly for those proce-
dures for which it is practical to eliminate direct exposure to the
testes. The increase seen in the average ovarian dose seems due to
several factors, including an increase in the number of exposures per
examination, changes in the distribution of specific types of examina-
tions, or even changes in techniques. A more detailed analysis during
the next few months will shed some light on these questions.
Figure 7 shows the mean gonad dose for radiographic examination
of the abdomen. These exams are most likely to involve direct exposure
to the gonads. The decline in the average testicular dose is approxi-
mately 35 percent and is associated with decreases in most of the exami-
nations received by males with relatively large declines in doses associ-
ated with examinations of the lumbar spine, pelvis and hip. The increase
shown for the average ovarian dose is almost 7 percent and represents
changes both upward and downward for specific x-ray examinations received
by females.
ESTIMATED MEAN GONAD DOSES FOR RADIOGRAPHIC
EXAMINATIONS OF THE ABDOMINAL AREA BY SEX
U.S., 1964 and 1970
1250 i-
:.
= 500
1071
'-'
1570
MALE
FEMALE
PHS X-™, £•«,.,»
Pf«li»inwy Dow
torch 1970
Figure 7.
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41
Estimated Mean Annual Genetically Significant Dose
from Medical X-ray Examinations
U.S. 1964 and 1970
(millirads)
1964
1970
Total
Male
Female
Fetus
54.6
45.4
8.3
0.9
35.5
22.0
12.5
1.0
PHS X-ray Exposure Study
Preliminary Data
Figure 8.
March 1972
In figure 8 we are moving into the estimate of the GSD as opposed
to the gonad dose. On the basis of these preliminary data, the mean
annual genetically significant dose to the U.S. population in 1970 is
estimated at about 36 millirads. This represents a decrease of approxi-
mately 35 percent from the estimate of 55 millirads calculated for 1964.
As indicated here, the change is due primarily to the decline in the
male contribution from 45 millirads in 1964 to 22 in 1970 - a decrease
of somewhat over 50 percent. At the same time the data indicates an
increase in the female contribution from 8.3 to 12.5 millirads. The
fetal contribution in both years remains about the same.
Figure 9 illustrates the decline in the contribution of the GSD
by males, particularly in the age group 15 to 29. In 1964 this group
contributed 60 percent of the GSD. In 1970 the contribution was esti-
mated at approximately 38 percent. We also see here the decline in the
male contribution in each of the other three age groups when comparing
'64 and '70 estimates. The changes in the female contribution are con-
siderably different. Increases are noted in the age groups 15 to 29
and 30 to 44, although there was relatively no change in the age groups
under 15.
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42
ESTIMATED MEAN ANNUAL GENETICALLY SIGNIFICANT DOSE
CONTRIBUTIONS BY AGE AND SEX
US., 1964 and 1970
IMKU 15 a » « «S-M IMvU U-B » « *5
AGE cram
Figure 9.
Now the data I have shown here today are preliminary and will change
when final data are available, but the direction or trend in x-ray expo-
sure is clearly indicated and will not change on final analyses.
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43
SAVE RADIATION - MAKE IT HAPPEN
John C. miforth
Director
Bureau of Radiological Health
It's always a pleasure to have the opportunity to talk to you,
but this time it's more of a pleasure for several reasons. First, I
think that the Conference of State Radiation Control Program Directors
has reached a maturity that's reflected the program at this meeting.
Your activities and comnittee work developed at. the previous meeting
is now bearing fruit. Second, I think the enthusiasm with which you
have carried out the various functions at the State level has paid
off in protection to the public. The material that Mr. Roney has
just presented from the X-Ray Exposure Study is an indication of this
payoff. You should all have a sense of pride and I'd like to thank
you for what you did to make it happen. You took the action that
caused the results you saw in Mr. Roney's presentation. We took a
gamble when we started the 1970 study that progress could be demon-
strated, and the gamble has paid off.
Last year as you perhaps know, the States collectively invested
about 2-1/2 million dollars in the x-ray activities. This involves
about 155 man-years in trying to make medical x-ray protection a
reality. And I think it has paid off. When you consider that there
were about 40,000 medical x-ray machines and about 27,000 dental units
inspected last year--this, in fact, is a strong contribution. We thank
you. I think the public is going to thank you.
With regard to the title of this presentation, "Save Radiation -
Make it Happen" I suppose a better title would be "Saving Radiation--
We're Making It Happen;" however, when we talk about making "it" happen,
we have to define what "it" is. One example of the "it" is the end prod-
uct which was presented in the X-ray Exposure Study, the genetically
significant dose. We do not yet have the models or the programs to pro-
duce the other indices. We don't have the system that the Japanese have
of developing an LSD or a leukemogenic significant dose. We still don't
know where the active bone marrow is. We are going to be working on this,
and we have some models and approaches that we will be using. So right
now we are talking, only about one "it," the GSD.
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44
Now you must understand some of the frailties and the limitations
of the GSD. First of all, as Mr. Roney pointed out, the GSD results
just presented are preliminary. Not all of the data have been verified
and entered into the master tape. So it is possible that the final
value for the GSD may be changed slightly but I don't think it should
effect the implications of the results.
The GSD as you know is an index that was established by the United
Nations Scientific Committee on the Effects of Atomic Radiation. As we
cautioned before, it is directed at the genetic effect and as such, it
is derived only from the dose to the gonads; but when you subtract the
weight of the gonads from a 70 kilogram standard man, you still have
about 70 kilograms left. Therefore, there's a lot of standard man that
we have to worry about in addition to the gonads. What I 'm suggesting
is that we must continue to be concerned about the somatic effects of
radiation.
You know also that the calculating of the GSD includes corrections
for the age and child bearing potential of the individuals exposed.
Thus, any change in the pattern of producing offspring, is going to
have some impact on the GSD. And of course the GSD value is strongly
influenced by the dose delivered to the gonads.
If we look at the 1964 data, we will see that 61 percent of the GSD,
which was 55 millirads, was from the insult to males in the age group
15 to 29; and that 30 percent of the GSD was attributed to males who re-
ceived lumbar spines; therefore, this is a procedure which in 1964 con-
tributed a tremendous amount to the GSD.
It might be interesting to examine the contribution to the GSD esti-
mates from males, 15 to 29 years of age who received lumbar spine exami-
nations. In 1964, there were 9 cases that were in the population. In
1970, because we had a better base for our population and expanded the
number of special procedures, that nunber jumped to about 27 cases. If
we examine the testicular doses received in that age group, you'll find
some interesting results. This is because in the lumbar spine the testes
may be either in or out of the primary beam, depending on the size and
alignment of the field. There's a tremendous difference between the tes-
ticular dose from a good procedure and a bad procedure. For example,
in the 9 cases in the 1964 study, 5 of them had the testes in the beam.
The testicular doses ranged from 3 to 4 rads for those cases. For those
cases that were properly collimated and aligned, the doses were in the
tens of millirads.
The same situation, existed in 1970. But, collimation was more
frequent, so we find only 3 of the 27 cases had the testes in the
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45
primary beam. Therefore, the mean testicular dose in 1964, was 2,500
millirads from the lumbar spine procedure versus 712 millirads in 1970.
There's where the most striking reduction in dose occurred.
Now, when you look at the ovarian dose you'll find that in the lum-
bar spine procedures, the ovaries are not as affected by the consequence
of proper collimation. In 1964, the mean ovarian dose was about 420 milli-
rads for the lumbar spine in that age group, 15 to 29, whereas in 1970,
it was slightly increased to 560 millirads. This was also pointed out
by Mr. Roney when he showed the genetically significant dose for females
has increased around 50 percent (8.3 millirads in 1964 to about 12.5 milli-
rads in 1970). Now this is important, because this suggests there's more
photons in the direct beam; there are more photons going through the body
and they are less influenced by collimation. This suggests that perhaps
the same situation is occurring for other x-ray examinations as for the
lumbar spine. Therefore, the somatic effects need to be considered.
Genetic effects are still our number one priority but let's not become
overly confident with our success in that area and forget about our respons-
ibility to do something about the somatic doses.
Unfortunately, we don't have a good index for somatic doses; but
as a first approximation of an index, we might use the abdominal dose.
That would be the dose to a point located in the area of the ovaries.
Since the XES procedures calculate an ovarian dose for males and females,
we can use that value for the index. If you look at the ovarian or the
abdominal dose for the U.S. population that was exposed in 1964, you will
find it was 138 millirads; whereas in 1970, the abdominal dose was 153
millirads to the population exposed. Therefore, while we have been suc-
cessful in reducing the GSD we still have a long way to go as far as
having a comparable impact on the somatic dose.
Another concern I have is that we have a tendency to homogenize
the population--which is probably very normal as it relates to the GSD,
since we are looking at a genetic pool; and that, of course, involves
the entire population of child-bearing age. But when we look at the
somatic dose, we should not just homogenize the population. We, instead,
might need to be more specific about the populations at risk--whoever
they are. For example, we said the abdomen dose for about 75 million
people in 1970 was 153 millirads. We could adjust that number by dividing
it by the total U.S. population and therefore we would have 58 millirads
abdominal dose to the U.S. population. This is just another way of ad-
justing the numbers but it becomes a bit meaningless. I prefer to think
that we have a high risk group which we have not yet been able to define.
A high risk group would be those people who may be seriously injured or
chronically sick, who for one reason or another get more x rays then the
rest of us. We all know examples of people who have been in this situa-
tion and received multiple x rays.
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46
I examined the 1970 data to see how it reflects on the number of
people who received multiple examinations. I found, for example, there
are 1.7 million people who received 6 or more x-ray examinations during
the 3-month period in which XES was conducted in the field. That's an
appreciable number of people, and not all of these people were of the
older age groups. Some of you may be thinking that the older people have
degenerative breakdowns or diseases that require multiple exams. Actually,
40 percent of this group of 1.7 million people is less then 45 years of
age. Some examples from these cases are: a 37-year-old who received 10
chest x-ray exams during the 3-month period; a 25-year-old who received
11 exams involving the pelvis, skull, and chest; a 6-year-old who received
10 different extremity exams; and a 27-year-old who received 13 different
exams of the abdomen and chest including fluoroscopy.
Another example of multiple x-ray exams appears in the booklet pub-
lished by the Indiana Health Department and the university Medical Center
called "Pediatric Low Dosage Medical Radiography." I think many of you
have seen it. In it, there's a list of some pediatric patients who have
received significant examinations. The following table is taken from
that booklet:
ACCUMULATIVE PATIENT DOSAGE FROM MULTIPLE
PEDIATRIC RADIOLOGICAL EXAMINATIONS
CASE SEX
A F
B F
C F
D M
E F
F F
PERIOD
COVERED
2 years
13 years
2 years
10 years
2 years
9 years
AGE AT
FIRST EXAM
4 years old
2 years old
3 years old
3 years old
1 year old
1 year old
TOTAL
EXAMS
22
50
76
158
61
62
TYPE OF
EXAMS
Chests (21)
Heart Fluoroscopy
(2 minutes)
Spines (33), Chest
(3), Extremities (14)
Chest (48), KUB (5),
Tomograms (23)
Chest (4), KUB (86),
Spine (18), Extremities
(42), Myelogram (7),
Fluoroscopy
(5 minutes)
Chest (39)
KUB (22)
Chest (61)
Heart Fluoroscopy
(4 minutes)
LARGEST
SKIN DOSE*
Chest
3966 mr
Spine
3630 mr
KUB
15,240 mr
KUB
4128 mr
KUB
1144 mr
Chest
7954 mr
APPROX.
TOTAL
GONADAL
DOSE
906 mr
2250 mr
7524 mr
456 mr
623 ror
1811 mr
•Single area
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47
Although the gonadal doses are not as high as one might expect, the point
is that there is a small group in our population that do get "zapped"
and "zapped" frequently. There are others of us who, by reason of our
good state of health, don't get "zapped;" therefore, we must be very care-
ful about homogenizing somatic dose.
I don't have the solutions to these problems, but I want to just
leave you aware that we have not solved all the problems. We need to
place as much effort in the x-ray area in the future as we have in the
past, and perhaps even more. Specifically, the maintenance of good col-
limation is something that will require a constant effort on all of our
parts. The success that we have achieved in collimation, as witnessed
through the 1970 XES results, is something we can't let slip.
Although the X-ray Performance Standard, will certainly have an
important impact on equipment in the future, what I'd like to talk about
now are sane of the action programs that are going to have to take place
now. For example, we are going to have to work on some of the technical
factors that must reduce the doses. There's very little indication of
the use of gonadal shields in our X-ray Exposure Study results. Similarly,
there is very little indication of the use of gonadal shields on the films
that are presented at professional meetings or in the technical journals.
Our Northeastern Radiological Health Lab, with the efforts started at
the California project, is continuing to work in this area and hopefully
we will soon have some results that we can incorporate into educational
packages to alert all of the users.
The retake rate is something that is of concern to us, too. We don't
know the magnitude of the retake rate; what causes it; how much of it
is due to machine parameters; how much due to processing, or film variables;
and how much is due to the technicians lack of attention to details. The
Division of Electronic Products has completed a project to get the answers
to these questions as they relate specifically to machine parameters.
This project is going to be continued by our Northeastern Radiological
Health Lab, and we hope that the methodology will be something that might
be adopted by hospitals. It is also something that you should give some
consideration to, because it would be a very good quality control tool
to have within any facility, for quality control will reduce retakes.
The results at one institution that we have looked at, would indicate
that the overall retake rate is not as high as had been originally
anticipated—perhaps in the order of 4.7 percent overall retake rate
per film.
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48
Another area in which has the potential to reduce unnecessary dose
is in the technology of new equipment; for example, there are some exciting
things taking place with new intensifier screens. The Division of Elec-
tronic Products has looked at many of these new screens. Some of them
have promises of exposure reduction of a factor of 2. Electronic radi-
ography is also going to be improved and, I am sure, will make its
contribution.
Efficacy and technique are very important areas. I'd like to just
call your attention to some of the results that have come from the X-Ray
Exposure Study of 1970. They show some areas where we can make improve-
ment; for example, of the 135 different observations made for lumbar spine
exams in the 1970 study, the mean number of films was 2.9 per exam. How-
ever, there were some examinations which involved 8 and 9 films. Why
should most exams require 2 to 3 films, but others 8 or 9? Contrasted
to this are the results of the nuriber of films in the flat plate abdomen
exam in which there were 124 observations in the study. The mean number
of film per exam was 1.6; that is, 76 of the 124 people only had a single
film; 32 had 2 films, and 14 had 3 films. On the other hand, pyelograms
seem to be spread from 1 to 10 films per exam. Recognizing the complexity
of the procedures, the question still might be raised: Why is there not
more consistency in these examinations? The dental picture is also some-
thing that warrants attention. We all know the numbers of films for a
full-mouth dental series varies depending on what part of the country the
dentist was from or from what school the dentist was graduated. Dentistry
in the Southeast and East seem to involve 12 to 14 films per full-mouth,
whereas on the West Coast it involves 20 to 24 films. The question must
be raised as to why.
I think the answers to some of the questions will be gotten from
the NEXT project. I believe that some of the action programs for making
it happen are going to take place through NEXT. I think the model that
NEXT has come out with is particularly appropriate. This is a perfect
example of where the Conference has developed an action program, the re-
sults of which have many applications; for example, if one were to try
to examine the variabilities of the numbers of films per examination,
it's not unreasonable that this question, raised by NEXT, could be turned
back to the institution to have them ask themselves the question--How
do we compare with the national average? The NEXT effort is also an
excellent attempt to try and educate the user.
I recently received a copy of the Report to the General Assembly
of the World Health Organization dated April 20, 1972, regarding the
development of the medical use of ionizing radiation. The report makes
the following statement regarding radiation protection service:
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49
"In many cases, proper techniques can be insured only
by constant supervision. Measuring the radiation
doses administered to patients and received by
staff, is the most effective way of convincing the
user and improving techniques."
It seems to me that the NEXT system, of being able to rapidly determine
the dose from standard procedures, and using this information as an
educational tool, is an example of what the WHO report was referring
to.
With regard to efficacy of exams, this is an area that I don't
think that you at the State level or we at the Federal level, can do
very much in without the involvement of the medical profession.
Dr. Russell Morgan, in the recent issue of the Journal of Radiology,
states that 'Ve radiologists have generally assumed that all radiologi-
cal procedures are of clinical benefit, favorably influencing the clini-
cal course of the individuals on whom they have been performed. And that
all examinations are valuable regardless of cost. Recent studies have
shown that these assumptions are too often unfounded and that there is
urgent need for research critically evaluating the clinical benefits of
radiological procedures and the conditions under which they may be opti-
mally applied." I think the profession is quite aware that something
has to be done to examine the effectiveness of their procedures. We will
be working with them. We will hope that these sorts of efforts can be
turned back to action programs.
I think the recent statement on mass chest x-ray screening is an
example of efficacy. The point must be made here that spouting plati-
tudes about how one should discourage the use of mass-x raying of the
general population to identify tuberculosis is fine, but we still have
to convert these platitudes into action programs; therefore, we are going
to have to figure out ways of turning that statement into action. We
are going to have to figure out ways that will look at photofluorographic
exams for photofluorographic equipment and make specific recommendations.
I've asked the Northeastern Radiological Health Laboratory to develop
a procedure and a report on how we can survey photofluorographic equip-
ment, whether in mobile units or in a permanent facility. We must see
how we can reduce the excessively high doses that appear in these units
down to a dose that is more reasonable. In this regard, I might point
out that there are other areas (like mammography, low-back x-ray exami-
nations and special procedure examinations which require high doses)
that also have to be looked at. This type of function will be carried
on by our Northeastern Radiological Health Laboratory.
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50
In summary, we should all be pleased that so much progress has been
made at the State level in reducing exposure. This has stimulated us
to do more. If we have done anything worthwhile, it's because of the
ideas that have come out of these Conferences. There are numerous exam-
ples of ideas that have come from the Workshop (one couldn't begin to
name them all): I recall the step wedge technique that Arnold Moen has
developed and will be presenting here; the enthusiasm of the States in
developing amendments or changes in the model regulations that might be
applicable to such things as lined dental cylinders that Billy Graham
is considering in Tennessee; the exposure limitations that are under
consideration for dental exposures in Illinois; and the Georgia program
on its evaluation of x-ray programs. Every one of you has been thinking
and acting in these areas. I think it's mandatory that we work with you
as close as possible to make these things happen. The reduction in the
GSD is one index of one element in progress that has been made. I hope
that by working together we'll be able to report a lot more progress in
the other areas.
DISCUSSION
MR. MATUSZEK: I have a question for you Mr. Roney or John. On this
question of the dose increase for the female population, do you feel
that's a statistical claim in the number of cases that you've looked
at, or is it real, or is it something that may be improved dosimetry
for 1964 or 1970?
MR. RONEY: Well, the dose increase in ovarian has been relatively small
and on these preliminary estimates, I would not like to make the comment
on whether it is statistically significant or not. But I don't believe
there has been that much change in the type of dosimetry that we used
in the '64 and '70 study. We followed the same type of procedure except
that we used TLD's in the "70 study and film dosimetry in the '64.
MR. PARKER: I'll address a question to both Mr. Villforth and Mr. Roney
and to the Conference. I wonder sometime if we don't lose sight of some
of the other effects of some of our programs. When Dr. DuVal issued a
statement this past week regarding the mass surveys, many of us applauded
because we knew we would be reducing the dose of the people having to
get chest x rays. Mr. Roney didn't show us some of the other slides of
the 70 XES Study, which indicated a drop in the number of x rays of people
in the lower socio-economic groups, especially among Blacks. And I'm
wondering if this isn't one of the spinoffs--one of the unfortunate
spinoffs--that we have cut down the number of mass x rays but at the same
time, we have reduced the amount of diagnostic information being available
to a doctor among the lower socio-economic groups?
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51
MR. RONEY: At this time I really do not know in what socio-economic group
the PFG examinations decline. I would expect, based upon talking with
the Communicable Disease Center in Atlanta, and other persons who have
been following the PFG examinations for the last 20 years, that the ma-
jority of this decline will have occurred in the middle income group.
So I don't think it was in the lower socio-economic, but I can't prove
it at this time.
MR. VILLFORTH: If you're talking specifically about photofluorography,
I don't think we have the data to support your point. If you're talking
about x-ray examinations in general, I believe the data would show that
the elderly and the lower income groups are the ones that are actually
getting more examinations. These are people who prior to Medicare did
not have adequate medical examinations.
I don't know whether the DuVal statement is at all valid for the
total population. I think the point is, the use of mass screening to
identify new cases of tuberculosis, regardless of the technique, is of
questionable effectiveness.
MR. PARKER: One of the preliminary slides that was given in Boston at
the first presentation of the XES study, indicated that among the Blacks
between the ages of 20 and 35, the rate of x rays being taken have dropped
dramatically. And no one has been able to explain to us why. I just
wonder if anybody from your staff could tell us.
MR. VILLFORTH: What I think you may be referring to is the apparent
anomaly that we have not yet investigated, and that is the decrease in
extremity examinations for the black male, while the black female and
white male and female exams increased. It doesn't quite make sense. The
X-ray Exposure Study staff is going back to examine this in light of the
injury rate to see if there is any reduction in injuries to black males.
We don't have the answer yet.
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52
IMPLEMENTATION OF THE X-RAY PERFORMANCE STANDARDS
Robert 6.
Division of Electronic Products
Bureau of Radiological Health
Under the Radiation Control Act, Congress directed the Secretary
of H.E.W. to establish and carry out an electronic product radiation
control program which was designed to protect the public health and
safety from electronic product radiation; including the development
and administration of performance standards to control electronic
product radiation. These standards may include provisions for testing
of products and measuring their radiation, may require the attachment
of warning signs and labels, and may require the provision of instructions
for the installation, operation, and use.
A manufacturer wishing to introduce into commerce a product subject
to a performance standard must first certify that his product meets
the standard by attaching a certification label to it. This certification
is based on a manufacturer's testing and quality control program which
has not been disapproved by the Secretary.
If testing and inspection indicates a product does not meet an
applicable Federal standard, the Secretary may disapprove the manu-
facturer's testing and quality control program. That's an important
point. Such disapproval has the effect of prohibiting the manufacturer
from introducing his product into commerce. The Secretary may also
institute field correction or recall programs at the expense of the
manufacturer or for products already in commerce. Inasmuch as dealers
and distributors selling products subject to a Federal standard must
obtain information, from the product purchaser so as to be able to
locate the product if a field correction program is instituted, then
the Radiation Control Act provides a means of regulating dealers and
distributors.
The Federal diagnostic x-ray standard will soon be published as
a final rule in the Federal Register. One year later it will become
effective and require all manufacturers to adhere to its provisions.
Factory based manufacturers of x-ray system components will have to
certify that their components, when properly assembled, will meet all
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53
applicable provisions of the standard. A manufacturer will also have
to provide adequate assembly instructions and compatibility information
to installers who assent)le his components.
The x-ray machine installer is a manufacturer by definition because
the "Radiation Control Act" defines a manufacturer as any person engaged
in the business of manufacturing, assembling, or importing electronic
products. The Federal diagnostic x-ray standard directs the installer
to certify that he has assembled the x-ray system with components of
the type called for by the standard and in accordance with the manu-
facturer's instructions. Furthermore, the installer will have to
provide a copy of the certification to the purchaser, to the Bureau
and to the State, if the State indicates a desire to receive such
certificates.
As in the case of factory-based manufacturers compliance actions
can be taken against installers. If, through testing and inspection,
an x-ray installation is found to violate the Federal standard through
misassembly by the installer, the installer will be required to correct
or replace the equipment so that it does meet the standard.
If we consider Stage I manufacturing as that process which is
carried out at the component manufacturer's factory, then Stage II
manufacturing becomes the process of assembling certified components
into an x-ray system. While a Stage I manufacturer can be easily
defined, a Stage II manufacturer is not so readily identified.
Because we had some difficulties with this, the H.E.W. Office of
General Counsel was asked for a ruling on who, in fact, can be classified
as an assembler. A number of considerations are involved. First,
there is the individual who does not commercially sell his services
as an assembler, but as a normal part of his duties, is occasionally
called upon to assemble electronic product components (e.g., a hospital
x-ray technician charged with, responsibility for repairing and servicing
radiological x-ray equipment in the hospital). Second there is the
individual (usually a doctor and/or a radiologist) who assembles an
electronic product for his own subsequent professional use. Third,
there are circumstances wherein a person who is not paid, at least
partially, to engage in assembly activities, but who might reasonably
be expected to engage in such activities, who assembles electronic
products for his own use (e.g., one who purchases an electronic product
kit which he intends to assemble and use personally). These are the
three situations that are unclear. I did not go into the situations
that are clear, which are a factory or an assembler manufacturing for
proft--no question. The issue involved in any of the three foregoing
examples is whether the individual is "engaged in the business of...
assembling" within the meaning of the Act.
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54
It was the opinion of H.E.W. Office of General Counsel that the
requirements of the Act do apply to one who, as a normal part of his
employment duties, assembles any article which is an electronic product
within the meaning of the Act. Similarly, if an individual assembles an
electronic product and subsequently utilizes the product in conjunction
with offering his services on a commercial or professional basis to
others (e.g., a radiologist who assembles or adds a component to his
machine and then offers his services), the individual is bound by the
requirements of the Act.
General Counsel concluded by pointing out that Section 355(3) of
the Act, which contains the definition of manufacturer, can be in-
terpreted to apply to any person who is, in any fashion, compensated
for assembling electronic products, including compensation for services
rendered with the product after assembly, but that the section does
not apply to situations where the assembler assembles it for his own
personal, noncommercial use.
During January of this year, the Bureau solicited from States
answers to questions regarding the Federal diagnostic x-ray standard
and problems related to its enforcement. It was our hope that your
answers would be candid and straight forward and, indeed, most were.
Your replies will guide us in our quest for a viable State-Federal
enforcement program.
I will now highlight and summarize your responses. Data was
obtained from 41 States, the District of Columbia, Puerto Rico, New
York City, and Philadelphia for a total of 45 respondents.
In answer to the first question, "Does the State envision it
will have specific problems in its program after the x-ray performance
standards go into effect?" there were 17 affirmative answers, 23
negative replies, and 5 which were uncertain. Of those answering that
they would have a problem, the reasons given and the number giving the
reason are as follows:
(a) Problem with amending State regulations 3
(b) Problem with Federal and State standards
conflicting or dual jurisdiction with
respect to enforcement 9
(c) Increase in the workload of the State program 5
(d) Problem of obtaining necessary equipment and
training personnel 2
(e) Problem with variances 1
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I believe the foregoing are problems, but ones that can be
resolved. The States that answered negative either did not consider
these problems or thought them too minor to mention. Some of these
problems will be addressed later in this presentation or a subsequent
one.
In answer to the second question, "Does the State feel that x-ray
performance standards will help its program?" there were 38 affirmative
answers, 2 negative, and 5 uncertain. Of those who felt that the
performance standard would help their program, the reasons and the
number giving the reasons are as follows:
(a) x-ray equipment will be upgraded 17
(b) standards for x-ray equipment will be improved 2
(c) uniform standards will result 7
(d) other 14
Other reasons given, why the performance standard would help State
programs were that they would:
(a) Reduce the amount of time a State would have to spend
on inspections and leave more time for user oriented
problems;
(b) Aid in compliance and followup of deficiencies; and
(c) Help in the location of newly installed x-ray equipment.
We concur with these reasons you have given for the standard
assisting your program.
A reason given for the performance standard not being useful to
a State was that it does not provide for giving information concerning
new installations to the State. This point is being corrected in the
standard by directing installers to notify the States of all installation
of certified components.
In answer to the third question, "Does the State require
installation reports from installers, manufacturers, or service
representatives?" there were 15 affirmative answers, 30 negative
answers, while 11 stated they required reports on transfers of equip-
ment. Of the 15 States who answered yes, all required'installers
to notify them of an installation but only 3 reported that they held
the installers responsible for the equipment meeting the standards.
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Several States that do not require reports from an installer do
hold him responsible for seeing that the installation meets the require-
ment of the State standard. Several States which answered in the
affirmative with respect to requiring installation reports may in fact
only require transfer reports.
In answer to the fourth question, "Would the States like to receive
copies of the assembler's reports required under the Federal standard?"
there were 40 affirmative answers and only 5 negative. Reasons given
for wanting the assembler's report were:
(a) For registration, check-off purposes.
(b) For compliance purposes.
(c) For locating new equipment in the State.
Reasons for not wanting the assembler's report were that:
(a) The clerical task would be too great for the small
benefits derived.
(b) The vendor is already required to report to the State.
(c) The report would serve no useful purpose to the State.
By requiring all installers to notify the States of each new
installation, we believe there will be uniformity in reporting
especially by out of State installers. We are amending the proposed
standard to require this for States who wish to receive such notices.
In answer to the fifth question, 'Would the State be willing
to survey new equipment in light of Federal standards and report to
BRH noncompliance with the Federal standard?" there were 41 affirmative
replies, one negative and three undecided. Of the affirmative replies,
25 States said they may or will require financial assistance, 14 re-
ported they would need instrumentation, eight said they may or will need
training, and 10 reported they would need an inspection protocol.
Other limitations which the States listed were that:
(a) The regulations would need to be written to support a
practical radiation control program.
(b) Surveys would be performed within the limits of resources
of the State program and provided the workload did not
result in a significant reduction in the program to
improve older equipment.
(c) State capacity had to exist.
(d) The required information needed to be brief and easily
collected from personnel in the x-ray department.
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(e) Adequate personnel had to be obtained and sufficient
time provided for scheduling.
We are pleased with the affirmative response to this question
and appreciate the limitations which you may have to work under. I
would like to reserve comment on some of your specific limitations
until later.
Question six had five points. Question six asked the following:
"Would the State like to see incorporated in a revision of
the Suggested State Regulations the following:
a. "A requirement that if an owner of new x-ray equipment
modifies it in any way that he must certify to the State
that it still meets the Federal performance standard."
There were 30 affirmative answers, 11 negative, and 4
who did not give either a yes or no answer. Several
States stated they felt the responsibility should be
placed on the individual making the adjustments or modi-
fications and not on the owner.
b. "That when changes or modifications are made to equipment
that the owner notify the State radiation control agency,
of the changes that are made and the name of the installer
or service representative that made the change." There
were 33 affirmative replies, 6 negatives, and 6 who did not
take a position.
c. "Require the owner of new equipment to maintain the main-
tenance schedule provided by the manufacturer." There
were 25 affirmative answers, 11 negatives, and 9 who did
not answer. A number of States commented that this pro-
vision would be hard to enforce and could lead to a wind-
fall for the manufacturer or his representative.
d. "Require that installers of new equipment make installations
or modifications in accordance with the Federal standard."
There were 36 affirmative replies, 2 negative, and 7 who
did not answer.
e. "Are there other requirements that they feel should be
included?" Other requirements suggested for inclusion in
the suggested regulations were: (a) require minimum expo-
sure times on dental machines; (b) require the film speed
to be marked on each box of film in reciprocal roentgens:
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(c) require the installer to make such tests as necessary
to determine that each new machine installed does meet
the Federal performance standard; and (d) consider the
licensing of assembler.
Your answers to the five parts of question six have reinforced
our change to the proposed standard to require installers to submit
to you copies of their reports certifying that they have installed
certified x-ray components in accordance with the manufacturers'
instructions. Other points brought out by question six will be
covered by Mr. Properzio in the following presentation and should be
addressed by Workshop No. 1.
In answer to the seventh question, "Does the State have specific
problems in the development or changing of their regulations so that
they will be compatible with the Federal standard?" there were 16
affirmative answers, 22 negative, three undecided, and three who did not
respond to this question. Of the affirmative answers to this question,
three reported that public hearings are required before their regulations
can be amended and four reported that they expected a time delay in
getting the amendments adopted. I thj.nk we can all agree that amending
regulations is a time consuming and tedious tasls and unfortunately
there is not ,a great deal you can 4o to speed up your individual
regulation issuing process.
This is a summary and there were other answers I have not singled
out. All of your responses will be considered in amending the model
State regulations and in developing an enforcement program.
Many of you already know that Section 360F of the Radiation Control
Act speaks to pre-emption. This section makes clear that "no State or
political subdivision of a State have any authority either to establish,
or continue in effect, any standard which is Applicable to the same
aspect of performance of electronic products and which is not identical
to the Federal standard!" This means that when the Federal diagnostic
x-ray standard becomes effective, we estimate that about 90 percent of
the State regulations controlling new diagnostic x-ray equipment will
be pre-empted if, in fact, they are similar to those published by the
Council of State Governments.
During the past few months the Bureau has undertaken the revision
of the Council of State Governments' Regulations on diagnostic x-ray
equipment in order to eliminate any conflicts between old regulations
and the new Federal standard. Mr. William Properzio will provide
more details on this matter in the next presentation.
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I am now going to propose for your consideration an action plan
for the enforcement of the x-ray standard. The Bureau of Radiological
Health, in enforcing the Federal diagnostic x-ray standard, will re-
view and evaluate component manufacturers' testing and quality control
programs. It will also inspect and bring any necessary enforcement
actions against these same manufacturers. The Bureau, and eventually
Food and Drug Administration's Executive Director for Regional Operations
will maintain a small capability for carrying out compliance testing
of equipment in field locations, such as hospitals. This capability
will initially reside in headquarters and later in the regional
offices.
States enforcing their radiation control regulation will regulate
installer-assemblers of diagnostic x-ray equipment as many of you are
now doing. State regulations shall be amended to assure an ability to
regulate installers and to assure compatibility with the Federal standard.
We envision three types of field inspections to be performed at
an x-ray installation. The first would be visual to determine if
certified components have been installed and if they are of the type
called for by the standard. A second type of inspection would be
termed a field screening test, which would not have the sophistication
of a full-scale compliance test, but would provide an indication as
to whether the equipment was in or out of compliance. If the field
screening test indicated noncompliance and the State desired further
assurance of noncompliance, Federal inspectors would be available
with sophisticated compliance test gear to accompany a State inspector
for a followup inspection. This then would be the third type or full
compliance inspection.
The State may use such compliance data in its action against an
installer in violation of the State regulations. The Bureau would not
be involved in such action unless the State asked for its assistance.
In this regard, the Bureau can play a valuable role in bring enforce-
ment actions against "out-of-State" installers when a particular
State's jurisdiction is in question. Within this working agreement
for'an enforcement plan for diagnostic x-ray standard, we would ex-
pect to provide you with the training and equipment needed to do the
job We would also expect to develop an arrangement whereby we could
obtain State field inspection data just as we will provide you with
intelligence data from our program.
In conclusion, I trust you do not think that we have oversimplified
the situation. We know there are many problems to be overcome. We
know that not all States have the necessary regulations or even the
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enabling legislation to do the job. Many States indicated the need
for more resources in order to do an adequate job and at present the
Bureau is not able to provide such relief.
We also know that there will be approximately 5,000 new medical
x-ray and 5,000 new dental x-ray facilities installed within the next
year, while about 50,000 new certified components will be manufactured
and installed. To further complicate the future, the population of
installers numbers in the thousands (as Mr. Villforth previously pointed
out).
Combined State x-ray program funds last year totaled about 2.5
million dollars with 155 x-ray man equivalents. With that capability
your States were able to inspect a commendable 22,000 dental x-ray
units in 11,000 facilities and about 40,000 medical x-ray machines.
Your Workshop No. 1 faces quite a challenge in addressing itself
to the task of enforcement. I trust that all of you will give your
utmost consideration to the action suggestion I have presented. Out
of such careful consideration, I believe we can obtain uniformity of
enforcement and a control over the x-ray installers that has not been
attained on a nationwide basis.
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IMPLEMENTATION OF DIAGNOSTIC X-RAY PERFORMANCE STANDARD
Current Status
Effect on States
New and Old Equipment
S. Vn.opvi.zio
Division of Electronic Products
Bureau of Radiological Health
What I intend to do in this presentation is give a little more detail
about the specific requirements of the standard. I'll cover the current
status of the document, brief you with regard to its effects on the States,
and discuss the interrelationship of new and old equipment and what
standards specifically apply to each.
The Diagnostic X-Ray Standard was published on October 8, 1971, as
a Notice of Proposed Rule Making in the Federal Register. All of you who
are at all involved in an x-ray program I am sure are quite familiar with
the document and most likely have made some official written comment with
regard to its content. A review and analysis of comments received has
been made and it is now in process of legal review prior to final publi-
cation. (The Bureau's Office of Criteria and Standards has the responsi-
bility for shepherding this document and finally getting it into the
Federal Register.) At this time I would like to outline only those areas
where an anticipated change of direct interest to the States is proposed
to be made, or where a misunderstanding of the standard's intent may have
been common.
The individual comments received could be broken down into four
general areas:
1. Those which reflected general support or opposition to the
standard, but which did not suggest a specific response as
to proposed changes;
2. Those which reflected a misunderstanding or lack of clarity
in the standard;
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3. Those which suggest or propose alternative means of
achieving the desired degree of protection, and such
means would not increase the burden upon the groups
affected (component manufacturers, assemblers, users,
and so forth); and
4. Those which suggest and propose changes which, if accepted,
would substantially increase the burden imposed upon one
or more of the groups affected.
Actions taken in response to those comments which were accepted
can be summarized as follows: The proposed standard was revised to
clarify its intent and, where appropriate, to provide alternate means
of achieving the same degree of radiation protection. Changes which
would substantially increase the burden on any group subject to the
standard were deferred for further study and consideration as early
amendments to the standard and to provide opportunity for review with
those groups who may be affected.
One area requiring clarification was the applicability of the term
"assembler;" i.e., to whom does it apply, and who must file a "certification
of assembler" report.
The assembler has been defined as anyone engaged in the business
of assembly, and may include the owner of the installation, such as the
hospital or physician, who uses his own personnel or himself to perform
the assembly, or a manufacturer's representative who assembles an x-ray
system for a fee. The standard states that only those assemblers who
install one or more certified components into an x-ray system or
subsystem would be required to file this report. This interpretation
of "assembler" is necessary to insure that only components of the
type called for by the standard are installed and that they are
installed according to instructions.
It is important to recognize that this interpretation means that
the assembly of noncertified, either new or old, components as well as
periodic maintenance done on the equipment to keep it in proper operating
condition is not presently regulated under this Public Law 90-602
standard and is therefore left as a responsibility for the State or
local regulatory agency.
A number of comment letters suggested that copies of the assemblers'
reports be sent to the States. A provision has been added to the standard
to require that assemblers send a copy of reports to the responsible
State radiation control agency.
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The standard has also been changed in response to comments which
indicated that alternate means of achieving the same degree of
protection might be preferable, provided that such alternative means
could be immediately conceived, and provided also that there was
reasonable assurance that the change would not impose a substantial
additional burden on the affected groups. One of the major changes of
this type was made with respect to fluoroscopic exposure rate. The
requirement as previously published established an exposure rate limit
of 5 roentgens per minute at the point where the useful beam enters the
patient. The limit would apply except during recording of fluoroscopic
images or when an optional high level control was activated. In response
to several comments suggesting alternatives, the requirement has been
modified for fluoroscopic equipment having intensifiers with automatic
exposure controls. The revision would allow equipment employing this
automatic control feature to have an entrance exposure rate no greater
than 10 roentgens per minute under any condition in lieu of an optional
high level override control. It is believed that this change will not
significantly alter the degree of protection for the patient, yet will
resolve technical problems from the equipment design and use standpoint.
A number of questions were raised with respect to the variance
provisions of the standard. The Act states that the Secretary of DHEW
may exempt any electronic product from various provisions including
compliance with specific aspects of a standard, upon such conditions
as he may find necessary to protect the public health or welfare, for
the purposes of research, investigations, studies, demonstrations, train-
ing, or for reasons of national security. It is important that this
provision for exemption not be confused with the variance provision,
which is intended to be an integral part of the standard.
It would be impossible to establish a rigid code for all devices
covered by the standard and not prevent or inhibit technical equipment
development and clinical application. The variance section was added
to give this flexibility. As outlined in the standard a variance may
be granted for one of three reasons:
1. For a unit designed to have identifiable technical
advantages and which is to be used as a prototype
or experimental unit for clinical evaluation,
2. For equipment which is required to obtain diagnostic
information where equipment meeting all the require-
ments of the standard cannot be used; and
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3. For equipment utilizing alternate means for providing
protection at least equivalent to that provided by
equipment which conforms with the standard.
A manufacturer requesting a variance must:
1. Describe the product and how it will be used;
2. Describe how compliance will inhibit the intended
use of the equipment;
3. Provide information on the precise manner in which
the equipment for which the variance is being
requested will deviate from the requirements of
the standard;
4. Describe the diagnostic advantages for such
deviation from the standard;
5. Provide detailed information on the actual means of
protection provided;
6. Provide information on the number of units to be included
under the variance and/or the time for which the variance
is requested to be effective; and
7. In those clinical or prototype units the actual location
of the unit.
The administrative review mechanism to be employed in the
evaluation of a variance application has yet not been finalized, but
will include in addition to review by Bureau personnel the use of
outside clinical consultants. The Bureau would also accept the input
from State radiological health departments when a variance would affect
equipment entering their jurisdictional authority.
A number of comment letters raised questions with regard to
Federal and State responsibilities in determining and enforcing
compliance with the standard. Section 360F of P.L. 90-602 states:
"...no State or political subdivision of a State shall
have any authority either to establish, or to continue in
effect, any standard which is applicable to the same aspect
of performance of such product and which is not identical
to the Federal standard ..."
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Therefore, any State standard which applies to the same aspect of per-
formance as the Federal standard and which is not identical to the
Federal standard would be rendered null and void for new equipment as
a result of this section. For equipment manufactured before the effec-
tive date of the Federal standard, however, the State requirements need
not necessarily be identical to the Federal standard. Furthermore, a
State which adopts the Federal standard as a State requirement could
enforce these requirements as they may apply within its jurisdiction.
Also, those elements of a State standard which apply to radiation control
not related to equipment performance would not be in conflict with
section 360F.
As the standard is applicable only to components manufactured after
the effective date (that is, 1 year following final publication), it
follows that each x-ray system manufactured before that date would con-
tinue to be subject to current regulations in force in the jurisdiction
in which it is located.
It appears, therefore, that the States will be living with two sets
of regulations for some years. This is but one of the problems that Work-
shop No. 1 will have to consider during this meeting. As further back-
ground, I would now like to outline in more detail some of the problems
and possible solutions that may result from the promulgation of this
Federal standard.
The Bureau may recommend that the States adopt regulations identical
to the substantive portions of the diagnostic x-ray standard (that is,
those requirements directly related to technical equipment specifications
as opposed to procedural requirements).
It has been suggested that State regulations identical to the Federal
standard would be redundant. I would point out that on the contrary
identical regulations at the State level are essential to an overall
program to control diagnostic radiation exposure.
P.L. 90-602 has imposed several limitations on a standard developed
under its authority which limit its effectiveness, if only enforced at
the Federal level. The greatest of these limitations is that it places
responsibility only on the manufacturer. Because of this limitation,
the Federal government has no control over the owner or user of the x-ray
system, thereby introducing a loophole in obtaining continued compliance
with the standard. For example, at the Federal level:
1. We cannot require the owner to maintain his equipment
in compliance;
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2. We cannot prevent him from removing or inactivating
filters, collimators, audible signals after the equipment
is installed;
3. We may in certain situations where a component or system
is both manufactured and assembled within a State and never
introduced into interstate commerce, be limited in our
ability to enforce the standard; and
4. We cannot currently provide for the mandatory upgrading
or phasing out of old equipment.
Most States are not so limited. The States can incorporate the
substantive requirements into their regulations and place responsibility
for maintaining compliance on the owner. In most cases, the States have
no problem of regulating assemblers involved in intrastate commerce.
Working with the Federal authorities who have full interstate authority
the States will be able to control the out-of-State assemblers that have
been a problem in many areas.
The question of old equipment is also an item not addressable under
P.L. 90-602 and may be one the States might want to consider. After a
reasonable grace period, it may be appropriate for the States to require
all diagnostic x-ray systems to meet the new equipment standard, or at
least to meet selected requirements contained in the standard that might
have the greatest potential of reducing excess radiation exposure.
With respect to used equipment, it is interesting to note that one
major manufacturer of medical x-ray equipment is establishing a corporate
policy that used equipment, with the possible exception of selected cur-
rent models less than 5 years of age and still considered to be up to the
standards, would not be resold.by this company. The impact of this action
is yet unclear, but it may create a larger market for the backroom used
equipment dealer or result in a greater transfer of equipment from phy-
sician to physician.
It is therefore clear that a number of loopholes can be filled by
State adoption of the Federal standard. It is hoped that most States
would be authorized to adopt the substantive requirements of the Federal
standard by reference. In this way any amendments to the standard, made
from time to time, would automatically become part of the State regulations,
In the event that the substantive requirements cannot be adopted by
reference, it is recommended that identical wording be adopted. The
wording of the standard was developed with great care, and changes in
wording may result in conflicts in interpretation contrary to the
intent of Section 360F.
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In addition to adopting the Federal requirements so that the States
can supplement and extend Federal compliance, there are a number of items
regarding the equipment that have not been addressed at the Federal level.
As you know, a P.L. 90-602 standard must be performance oriented. Because
of this limitation, certain equipment safety aspects that could not be
easily expressed in performance terms were omitted from the standard.
Nfost notable of these are scatter shields and bucky-slot covers for
fluor os copes.
The States can address this aspect since it is not addressed in the
Federal standard. In the present Council of State Governments suggested
regulations, bucky-slot covers and other scatter shields are required on
all fluoroscopes; and no exceptions are made. However, scatter shields
are often not practicable during certain special fluoroscopic procedures,
such as myelography or cardiac catherization, neither are they practi-
cable on all C-arm fluoroscopic systems. Thus it is necessary to amend
the Council requirement so that scatter shields are not mandatorily
required when certain special procedures are performed, and when alter-
nate means of protection can be provided.
The Federal standard contains an implicit requirement that the x-ray
system be installed on a power supply line which meets the manufacturer s
specifications (that is, "...shall install ... in accordance with instruc-
tions " 78 213-l(d)). However, additional equipment may be added to
this line at a later date which would degrade it. An inadequate line may
result in failure to meet the manufacturer's specifications for technique
factor accuracy as well as allowing noncompliance with the reproducibility
and linearity requirements that could in turn result in the necessity for
retakes and unnecessary exposure. In this area the States should develop
a requirement that would assure that equipment will be maintained on an
adequate power supply.
The Council of State Governments regulations contain some requirements
which may be considered "the same aspect of performance" by some and not
by others and the problem of Federal preemption under 360F must be con-
sidered. The Bureau is currently trying to get an official legal opinion
witt regard to these conflicts, an example of which is the suggested Coun-
cil regulations requiring open-ended shielded cones on dental equipment.
ScausTof a lack of information regarding the possible increase in cone
cutting and resultant retakes that have been reported with lined open-
ended Lies, no requirement for this type of cone was included in the
Federal standard when originally published. It is, therefore, my opinion
that this is an aspect of performance that was not addressed and one
which the States can continue with no Federal preemption.
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The Council regulations require a dead-man switch on radiographic
equipment. The Federal standard requires that the operator be able
to terminate the exposures at any time. Again, the Council requirement
is more restrictive. Is this the "same aspect of performance?"
The Council regulations require that the exposure control switch on
mobile radiographic equipment be so arranged that the operator can stand
at least 6 feet from the patient, the x-ray tube, and well away from
the useful beam. The Federal standard has no such requirement.
With respect to procedural requirements, the Federal standard
requires a report from an assembler who installs one or more certified
components into an x-ray system. As previously mentioned, the standard
will be amended to state that a copy of this report be sent to the
appropriate State regulatory agency.
In addition, we recommend that the Council regulations be amended
to accept this copy in lieu of the notification presently required by
Section B.7 of the Council requirements since this copy provides more
information than is presently required and no additional paperwork by
the assembler.
It is also recommended that the Council requirements be amended to
the effect that the States will not consider any deviation from the
regulations as a violation if such deviation is permitted by a variance
granted under the Federal standard. While this may be implicit in
Section 360F, it is well to spell it out for the information of those
concerned.
In the area of operational requirements, it is recommended that the
Council add the following amendments to the appropriate sections on
operational procedures:
1. Require owner to keep readily available all the information
required of the manufacturer to be supplied to the user
under section 78.213-l(h). This includes safety information,
maintanence information, plus all of the operational charac-
teristics of the component or system. This is of immediate
concern to the user when safety and maintenance are involved
and may be of interest to an inspector with respect to the
operational characteristics if he has to survey the equipment.
2. Require owner to keep a record of maintenance work performed
on each jc-ray system. This may be needed to help determine
whether failure to comply is caused by a defect in manufacture
or negligence in maintenance.
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3. Require that x-ray systems be appropriate for procedures to
be performed. Specifically:
a. Dental radiographic systems used for extraoral
projections or for podiatric use shall be
provided with proper beam limiting devices.
b. Equipment sold for veterinary use may not be
used on humans unless the components and
total system are certified to meet the
requirements of the Federal standard.
4. During operation of fluoroscopic systems on which the instal-
lation of scatter shields is not practicable, shields shall be
available to allow positioning between the patient and other
persons in the room. Such shields should not be substituted
for the wearing of protective aprons.
In closing, I would like to reemphasize the area of old equipment.
Components manufactured before the effective date of the new performance
standard cannot be expected to meet all aspects of this new Federal
requirement. The current regulations of the Council of State Governments
are still appropriate for this old equipment but must be modified in
a few areas.
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IMPLEMENTATION OF THE X-RAY PERFORMANCE STANDARDS
Test Method Development and Utilization
J.
Division of Electronic Products
Bureau of Radiological Health
As Mr. Britain had mentioned earlier, a complete program for the
enforcement of the diagnostic x-ray standard would include "testing"
on three levels. Two of these involve the use of test equipment to
evaluate performance with the third really being a visual inspection.
The first level we refer to as "compliance testing." The goal
of this type of testing is to obtain very precise and well-documented
compliance data, data with which we could confront manufacturers and
which we could make "stand up in court," if necessary. Unfortunately,
to obtain this type of data is a time-cons lining process, often in-
volving the use of relatively complex and costly instrumentation and
techniques. To give you some idea of this, I would like to discuss
some of the test equipment and methodology we propose to use for this
purpose.
We have divided the 23 basic performance requirements specified
in the diagnostic x-ray standard into three groups according to the
compliance test methods and equipment which they require. The first
group pertains to the exposure technique factors in an x-ray system,
including the x-ray tube kilovoltage and milliamperage, the exposure
time, and the milliampere-seconds exposure. The compliance test
equipment for the measurement of these factors includes such items
as high tension insulated resistance voltage dividers with dual trace
persistence oscilloscope readout, high tension insulted milliampere
and milliampere-second meters which can be inserted directly into the
secondary circuits of cable connected x-ray systems, x-ray pulse and
real-time counters for measurement of timer error, and multichannel ana-
lyzers incorporating lithium drifted germanium crystal detectors in
cryogenic containers for measurement of tube potential of x-ray systems
with self-contained tube heads.
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The second block of compliance tests pertains to all beam limiting
device requirements such as the correspondence of the x-ray field
size with that of the image receptor, alignment of the x-ray field
with the image receptor, alignment of the light localizer field with
the x-ray field, the illuminance level of light field localizers, the
contrast ratio of the edges of the light field, and the accuracy of
numerical field size indicators.
The beam limiting device performance evaluation system we use
includes a combination photometer/densitometer assembly, a scanning
densitometer stage with strip chart recorder readout, an x-ray field/
light field alignment test assembly, and a fluoroscopic alignment device.
Compliance testing for the remaining requirements involves measure-
ments of the quantity and/or the quality of the radiation emitted. This
includes the half-value layer of the primary beam, leakage radiation
from the diagnostic source assembly, radiation from sources other than
the x-ray tubes, standby radiation from capacitor discharge units, radia-
tion leakage through primary barriers of fluoroscopic assemblies, aluminum
equivalence of absorbers between the patient and the image receptor,
and the aluminum equivalent filtration of the components of the diagnostic
source assembly. For these measurements we use commercially available
laboratory x-ray monitoring equipment with a diversity of detectors in-
cluding made to order 100 cm2 entrance window ion chambers for leakage
measurements.
The basic methodology, and in many cases the equipment for these
compliance tests were developed in the X-ray Exposure Control Laboratory
of the Bureau's Division of Electronic Products.
However, since we have direct access within the Bureau to only
a limited number of x-ray units with little diversity of make and
model, in January of this year, we signed a contract with the
Memorial Hospital for Cancer and Allied Diseases in New York City for
further evaluation of these test methods. The goals of this contract
are to perform each of the tests in a clinical setting on a wide variety
of x-ray equipment, to establish their precision and accuracy under
these conditions, and to write detailed step-by-step procedures for each
test.
As the hospital evaluation of the individual tests are completed,
we plan to perform final evaluation with actual field inspection
teams. We have not as yet finalized our plans in this regard, however,
one idea under consideration would be to develop cooperative agree-
ments with several States, whereby our inspectors could utilize our
test methods and equipment in cooperation with State inspectors in
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the course of their routine x-ray visits. Shakedown of the test
gear and training and experience for compliance inspectors would be
the immediate goals of this field effort.
I have brought copies of the latest draft of the Test Methods with
me and will have them available for anyone interested at tomorrow's Table
Clinic. This document is similar to the March 15, 1971 draft of the
Test Methods which many of you already have. It is a conceptual descrip-
tion of the methods and equipment and the expected degree of accuracy.
This present draft has been revised, however, to reflect the latest
developments in our test methods and is keyed to the October 8th proposal
of the standard as published in the Federal Register. There are some
31 tests described.
UpoA completion of the Memorial Hospital Contract, we will develop
a second manual containing the detailed step-by-step procedures and
appropriate survey forms. This will be the working manual to be used
by inspectors in the field. We plan to set up all of our forms for
automatic data processing and may use such things as mark sensing forms
for this purpose to minimize keypunching operations which can introduce
error and are time-consuming.
I have been talking about 23 individual performance requirements,
not all of which pertain to any one single type of x-ray equipment;
however, in a typical radiographic/fluoroscopic room, we expect the
majority of these test methods would apply and estimate that it would
take two trained inspectors about 2 or 3 days to complete all the re-
quired tests. Obviously, we do not expect to do this type of testing
at user installations on a routine basis. For this purpose, we are
directing our efforts toward the development of screening tests; that
is, tests which are quicker and easier to use and require equipment
which is less costly and easier to maintain and is not as bulky as some
of the compliance test gear described earlier.
These screening tests, which comprise the second level of testing,
may have somewhat less precision, but hopefully will be designed to
fail safe; that is, they will tend to pick up all cases of noncompliance.
At that point in time, we believe we can develop satisfactory screening
tests for 18 of the 23 basic performance requirements. As examples of
some of these tests, I would mention the direct print paper about which
we published a Technical Note and samples of which we distributed to
each of the States. We believe this paper can be used as a screening
test for just about any of the beam limiting device requirements, in-
cluding those for fluoroscopy and spot film devices. We have not yet
worked out all the details of use including the cassettes and other
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associated hardware which may be required, but expect to do so in the
near future. Incidentally, we welcomed the conments we have received
from many of you concerning this paper and look for any further advice
you may have on it.
Other examples of screening test gear we have in hand or are pres-
ently working on would be simple pulse counters for timer accuracy mea-
surements , a kilovoltage measuring device based upon the K-edge principle
that is contained in a small box with direct meter readout, self-reading
dosimeters with good energy dependence characteristics for measurements
of table-top exposure and beam quality, simplified devices for measurement
of focal spot location and simplified techniques for assessing exposure
reproducibility and linearity. We would certainly appreciate any com-
ments and suggestions of techniques which you have found to be successful
for this type of inspection.
For the third level of "testing," we are developing inspection forms
for the 30 to 40 requirements in the standard which do not require actual
performance testing, but can be assessed by visual inspection. Included
would be such things as checking certification and labeling, assuring
that appropriate information has been supplied to the user by the manu-
facturers, verifying compatibility of components, checking for positive
filtration interlocks where necessary and assuring that components which
are installed are of the type called for by the standard (for example,
that positive beam limitation systems are installed on stationary general
purpose x-ray systems and that all general purpose systems, whether
mobile or stationary, have variable aperture collimators with appropriate
means for visual definition of the x-ray field, and so forth). This
type of inspection would also assure proper functioning of the visual
and audible indicators required by the standard, that visual indication
of technique factors has, in fact, been supplied; that the operator has
capability of terminating serial recording of images at any time, and
for fluoroscopic equipment, that continuous monitoring of kilovoltage
and tube current was available, and that accumulative timers with audi-
ble signals are provided.
This list is by no means complete, but does give an idea as to the
possible scope of comprehensive visual inspection.
In conclusion, I would like to briefly review the plan that was
stated earlier. We anticipate that State inspection resources will
play the major role in the implementation of both the visual inspection
and screening type of compliance testing to be carried on at user instal-
lations around the country. To assist in this effort, the Bureau expects
to provide equipment and training as necessary. In addition, Federal
inspection teams equipped with compliance test equipment would be avail-
able for followup inspections with State personnel, when requested.
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Examination and development of enforcement concepts, such as this, is
part of the charge of Task Force No. 1. Whatever plans are evolved,
however, the key to their success will be a spirit of cooperation rather
than competition, between State and Federal inspection personnel. Unless
we dovetail our efforts, the job will just not get done.
DISCUSSION
FRANK WILSON: I think probably this is more directed to Bill Properzio.
There are two questions I have here; both of them deal with other Federal
agencies that we deal with in the area of regulations and proposed regu-
lations. We have the Act which you are clearly under now in making your
proposals for regulations. Also, I think many of us now are dealing
with the William Steiger Act of 1970, which is under the auspices of
the Department of Labor. I'm not sure in my own mind if there are con-
flicts between these two Acts or not, and I don't know whether you do
at this point or not. Those of us who are contemplating going into agree-
ment with the Department of Labor, which covers basically the people
who fall under this Act, and as I understand it, this would be all hos-
pital employees; almost everyone. They are proposing that we probably
adopt these standards as part of their Act, and when we enforce these
and cite these people for violations of your Act, and consequently their
Act, this makes them liable for fines and other things. Have you all
taken a look at this to see if this is or is not so?
MR. PROPERZIO: I personally would not be prepared to answer that. As
I pointed out, the HEW's Office of General Counsel currently is in detail
reviewing all of these types of things which have to be done prior to
the final publication. I think maybe you're alerting us to what these
are, would get us to ask these questions specifically. I'm sure this
is the kind of thing that they're looking at. I, right now, am totally
unprepared to give you any kind of insight as to what this is.
MR. WILSON: Theirs is pretty encompassing, as yours is pretty encom-
passing; and I can see some errors here. It looks like maybe in the
Workshop this afternoon, it's something we might need to look at, because
I think we are going to be faced with it; each one of us individually.
It probably would be better if we can start talking this up among our-
selves to see where we do stand in this area.
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MR. BRITAIN: Just one point; I tried to put across the point that you
people, by amending your regulations, are enforcing your regulations.
You are not enforcing the Federal standard; Now, a lot of the Federal
standard's wording will,go into your regulation, but you people have
legislation and regulations to enable you to enforce a diagnostic x-
ray standard. Is this similar to this Labor thing? Are you going to
be enforcing Labor standards or State standards?
MR. WILSON: Well, we are going to do simply with them what you are asking
us to do with you. That is, they're asking us to adopt their regulations
and so are you.
MR. BRITAIN: We're asking you to amend your existing regulations.
MR. WILSON: Well to go it one step further, of course. The Agreement
States, not only do we have this and this, we've got our Agreement
Materials Regulations so enmeshed in this, that I'm not sure how we are
going to untangle all this bucket of worms. Because here we are with
three sets of Federal Acts, plus our State Acts, and we're trying to
uranesh all this.
MR. PARKER: I think the answer part is a mess and we are going to have
to let the legal counsels of the various departments work this but. I
don't think that the Bureau* from what I gathered from the speakers,
forbid this kind of answer to that question. Do you have your second
question?
MR. WILSON: The third part of the first question. One other thing.
I think we ought to propose this adoption by reference. I would alert
you to the fact that some of us in the Agreement States have already
done this with catastrophic results, particularly with the Department
of Transportation's regulations. I would suggest that maybe you not
propose this to us, because every time the Department of Transportation
says we got to have a different kind of tab or something on an inter-
state shipment, we suddenly find ourselves stuck with this on an intra-
state regulation to go from across the road. So I would caution you
to temper this recommendation with some second thoughts.
MR. PROPERZIO: I understand what you're saying. I'm not sure that the
difference that you experienced in the transportation problem that is
intrastate in just crossing the road, is the same thing as intrastate
x-ray equipment, which still has a person involved in it. I'm not sure
it is an actual analogy, but I understand what you are saying. I'd like
to say one other thing. The basic problem, as I mentioned, the advantage
of this adoption by reference, overcomes this problem of what I am told
from a lot of States is a quite lengthy promulgation period that you
have; the variance section, in particular. We have estimates of anywhere
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from a small number up into the thousands of these applications, so we
really don't know, until we republish, how many of these there are going
to be. Manufacturers have suggested that the only way that a variance
provision will be meaningful is if we can turn these around in a reasonable
length of time—give them a yes or no on these things. What they consider
reasonable, they have told us, is less than a month. A variance is an
active part of the standard. This would be one area we know, if we send
down to you every week modifications under this variance section, it
will drive you up the wall; but it's through this adoption by reference
that you pick up all of these, and are involved, of course, in the review
mechanism. We feel that that overcomes that problem. Here again, you
can solve one problem and you get another one.
MR. WILSON: I think there are some of us, and we happen to be one of
them, that can not adopt by reference in our State. So we'll just have
to adopt the whole thing as it comes out and amendments as it comes to
us. I don't know how many other States are faced with this. We just
have to adopt them, that's all. We can't do it by reference. We have
to do it word for word.
MR. ROESSLER: Ify question, I guess, is for Bob. I think you answered
the question, but I'm not sure that I got the answer. Consider the case
say of a hospital. They have a medical physics group, and they have
a good machine shop, an instrument shop available, and they decide they
wish to design and build a one-of-a-kind special purpose device incorpor-
ating x-ray tube heads. The radiation to be applied to humans, and they
are going to use new and/or used salvaged components. How do the standards
apply here? Where do they fit under the standards?
MR. BRITAIN: If they use certified components.
MR. ROESSLER: What if they use salvaged components?
MR. BRITAIN: That's old equipment. They are using old equipment which
we just can't cover.
MR. ROESSLER: Well, supposing they buy new certified components. Do
they come under this definition of a manufacturer and have the same re-
porting requirements?
MR. BRITAIN: Yes. If the physician or his staff assembled that piece
of equipment with certified components, and after such and such a date,
all that will be manufactured, are certified components. Now there is
going to be a lot of old stuff there that takes quite a few years to
finally weed out. But we don't have any retroactivity in our standard--
in our laws.
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MR. GRAHAM: I'd just like to make a comment on Frank Wilson's first
question regarding conflicts in the various Federal standards in the
Labor Department, the AEG, EPA, and so forth. From reading the Occu-
pational Safety and Health Act, I understand that AEG Agreement States
are exempt from this OSHA Act. And thereby, ionizing radiation programs
would not be affected by the OSHA Act.
MR. PARKER: Frank Wilson is shaking his head vehemently. Frank would
you go to the microphone and let us know if that's true or not.
MR. WILSON: It is true only that the agreement materials are exempt
from that Act--just the agreement materials.
MR. GRAHAM: I don't agree with that.
MR. PARKER: Lots of people would disagree with that. I really think
that we shouldn't get into this; because, obviously it is not clear to
all of us yet what the effect of these three groups would have on the
individual States. Billy thinks that your Agreement States are exempt.
Frank thinks it's the agreement material that is exempt. Marshall says
that's not so. I would suggest that we just leave it until the lawyers
get together and give us a ruling and then we'll give it to our attorneys-
general.
MR. ROGERS: It's related to the same problem but another phase of it.
You want to keep in mind that the OSHA Act provides for the adoption
of consensus standards. These consensus standards are adopted by them
as part of the enforcement of the labor code, and States have agreement
to enforce the provisions of the labor code within their States. They
also have provisions for reimbursement for carrying on of these activi-
ties at the rate of 50 percent of the operation of your program. What
is the Bureau of Radiological Health doing with reference to reimbursing
the States or local agencies that will be participating in these performance
standards to carry out an activity, which you have already implied, is
going to create a greater burden on the operating personnel, and perhaps
maybe even require additional personnel to carry it out?
MR. BRITAIN: The Division of Electronic Products is well aware that
some increased funding is necessary to do a good job; a more complete
job than we can do now. We have proposed, either through contracts or
some other means, to provide monies to the States, and we have been in-
formed that at this time this money is not available, and I think, as
far as money goes, you might direct your questions to Mr. Villforth from
here on.
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MR. KINSMAN: The question is, you said you were going to require certi-
fication of new equipment and there would be a method by affixing some
sort of a certification identification to the equipment. The question
is, have you thought what this would be; how you were going to do it;
to what part of the equipment you are going to affix this certification.
The reason I'm asking is, we're now going through a similar type of setup
with registration. We are going to require that the service companies
do not service any equipment that isn't registered with us and we would
want to affix identification like the registration number; if you have
decided where you're going to affix your certification, I think we prob-
ably ought to affix our registration in a similar location in order that
the inspector can see both of them when he comes in to inspect the equip-
ment.
MR. BRITAIN: The certification labels or stickers, whatever they turn
out to be, will be stuck to the components that are covered in the
standard, and they are listed. They are supposed to be in a "clearly
visible place," and I imagine this will have to be worked out with each
manufacturer. They will probably propose where they want it, and if
it's in a place that looks pretty good to us, we've got to let them put
it there. I don't think we have the authority to say, put it right there.
Now the assembler has another kind of certification, which is not a
sticker. It's a piece of paper where he swears he did such and such,
and leaves a copy with the owner. This is a certificate of assembler,
and this would not be attached to anything. I would hope that the owner
would keep it for reference and a copy of this would go to you and a
copy to us. So this particular piece of paper would not be stuck to
anything. But I can't tell you where all the other component labels
are going to be stuck.
MR. KINSMAN: I would think that the component label certification would
go to the owner or to the manufacturer; and that the owner would have
one certification sticker from the company he bought it from We're sug<-
gesting that we put this certificate thing affixed to the control panel
and the registration number there, because the fellow servicing the equip-
ment, at some time or another, is going to work with the control panel.
MR. BRITAIN: But they're different though. We require the factory base
manufacturer to certify that his component meets the standard when assem-
bled in accordance with the instructions; therefore, he has to put that
label on right there. An assembler may buy from several factories. So
he has to buy certified components, each one being individually certified.
So each one has to be certified in a visible place, and legibly.
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MR. PARKER: I hope you didn't mean to suggest that you're going to
allow each manufacturer to put his label in a different spot. I would
hope that the Bureau would require that each of the manufacturers, if
they're putting out tubes, they all would be required to put the certi-
fication number in the same place; if it's a fluoroscope, the same thing.
I can't imagine you're going to ask the States to remember the 12 dif-
ferent manufacturers are going to have their certification labels in
12 different places.
MR. BRITAIN: It probably will turn out that way because most of the
manufacturers will look for guidance on exactly where to put their label.
We are not just authorized to say, put it in "X" spot. It will probably
happen that that will be what happens.
MR. HARRIS: As long as everybody is assembled here, and we're discussing
Federal performance standards, Marshall Little and I thought we might
take a moment to mention that, coming along, in additon to the equipment
side, is the image receptor performance standards that we've been talking
about. Several of the States, in commenting on the x-ray equipment
standards, commented on the need for film speed information to be fur-
ther identified. We are at the moment considering seriously the develop-
ment of Federal standards, Federal regulations, for manufacturers of
image receptors to identify, on an absolute basis, what their systems
need in the way of roentgens to give a diagnostic image of good quality.
While you're all here, including the Bureau of Rad Health people, I'd
like to repeat a request I made sometime ago; that is, that all of you,
in discussing with the manufacturers of films, intensifying screens,
developers, image intensifiers, and so forth, ask the manufacturers to
provide you with data in some kind of absolute term. I think the time
has come to request that manufacturers don't say, this film, or this
system is twice as fast, or three times as fast, or one-third as fast,
and leave it at that. I think the customer is entitled to know, in some
actual frame of reference, like the reciprocal roentgen that was mentioned
by one of the speakers, what that absolute data might mean at a particular
kVp, mA developing system, and so forth, then you, or anyone in the room,
can divide that number by some other number and come up with an idea
whether it's twice as fast, one-third as fast, and so forth. I'm again
repeating that request. We'd like your cooperation. Motivate the indus-
try to provide absolute data on what they're doing so that when the equip-
ment is properly designed, and so forth, the receptor side of the equip-
ment will be compatible.
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SEMINAR
Moderator: Jay S. Silhanek
CuM&nt Statu& o& Em&iQwcy Plant - f&d&uit and State.
Panel
H. Richard Payne
Environmental Protection Agency
Region IV
Thomas E. Sembera
Office of Emergency Preparedness
Region VI
Arnold H. Moen
Department of Social and Health Services
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CURRENT STATUS OF EMERGENCY PLANS - FEDERAL AND STATE
MR. SILHANEK: I'm here to moderate a panel, essentially to bring_you
somewhat up to date on what we have been doing in emergency planning since
last year. In Arizona last year, we had a representative from the AEC
talk about their activities and I discussed some of our activities in
EPA at that time; so this panel essentially is to add a few things since
last year. If anybody has any questions, hopefully you will have some
time to discuss this with our panel.
First of all a few quick remarks about what we have been, doing in
emergency planning in the EPA Headquarters in Rockville, Maryland. In
1968, personnel from our Division developed a guide for the State health
departments to assist them in writing and developing a radiological re-
sponse plan. This document was reviewed by several States and our reg-
ional offices. It was not distributed for general use at that time.
Because of the current interest in developing radiological response
plans, it was felt that this document should be available for our regional
offices to provide to States. It was updated and sent to our Regions
for their information and distribution to the States. Those of you in
the State health departments either have them now or will be getting them
in the future. This is not considered a final document as far as what
we in EPA feel should be done in emergency planning. In fact, we have
some questions already on some of the numbers that are in that document.
Our Office is also involved in updating files of State emergency
plans with the assistance of the Regions. Upon request, we plan to
review State radiological response plans using the Guide as a basis for
this review, plus other information that would develop from this meeting.
We've also, by mutual agreement with the Bureau of Radiological Health,
been assigned the primary responsibility for providing emergency teams
to respond to requests for radiological assistance. We have revised and
updated procedures by which ORP and BRH will provide radiological assis-
tance to fulfill its obligations under our various agreements.
We have also had some discussions with our training activities at
our Eastern Lab and the Western Lab, concerning their course on manage-
ment of radiation accidents. What has happened is, we haven't been
really feeding information on what we have been doing into these labs
to provide in these courses. So we have tried to set up a system where
I will try to submit information to them; and in turn, they will keep
us informed about what their activities will be in training.
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We have also had several meetings with the Division of Oil and Haz-
ardous Materials, Office of Water Programs, EPA, to develop an EPA Envir-
onmental Emergency Contingency Plan. Our emergency notification procedures
will be a part of this overall EPA emergency contingency plan.
This Office has participated as a member of our Region TV Radiation
Emergency Response Committee. This Committee is to lay the groundwork
for the development of a regional (Southern States) Federal-State Coopera-
tive Emergency Response Plan to protect the health and safety of the pub-
lic in the event of accidents occurring at nuclear facilities. One of
our members, Richard Payne, is here from the Region IV Office to discuss
his plan.
MR. PAYNE: Thank you, Jay. I could think of nothing which would discredit
our program more than if we were to mishandle a nuclear accident. Certainly,
we have more and more nuclear facilities going on line all the time, and
the possibilities of accidents becomes more and more real; hence, we must
be ready for accidents as they surely will come. Jay has asked me to speak
on what's been going on in Region IV in this respect. First I would like
to give a little background of what we have done for the past few years,
having worked in Atlanta for about 10 years.
In September 1967, we held a symposium which we called "Offsite Pub-
lic Health Aspects of Nuclear Power Plant Operations." This was sponsored
by our Region IV Office. This was back in the days of the National Cen-
ter for Radiological Health. This was attended by radiological health
Program Directors of the Region IV States and representatives of utility
companies, which planned to construct nuclear power plants.
This was some 5 years ago; but even then, there was considerable
interest in radiation emergency planning and such fundamental items as
joint State-utility company planning, designation of authority and respon-
sibility, establishment of clear channels of communication, evacuation,
training of people, use of professional judgment (as opposed to cookbook
type procedures), and legal considerations.
Then in January of this year, the Region IV EPA Office, our Environ-
mental Branch, held a "Radiation Emergency Planning Symposium" in Atlanta
with representatives of the Atomic Energy Commission, Office of Emergency
Preparedness, Department of Transportation, Southern Interstate Nuclear
Board, Tennessee Valley Authority, Georgia Institute of Technology, and
State Radiation Protection Program Directors from all of our eight reg-
ional States, as well as New York and New Hampshire. The objectives were
fourfold; mainly, to discuss the organization and components of a radia-
tion emergency response plan, the responsibilities and relationships of
organizations having an interest in radiation emergency planning, the
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need for cooperative emergency planning between States having nuclear
facilities located on or near a common border, (and incidentally we have
several projects in the region coming up), and courses of action re-
quired to establish the most effective emergency response capability in
Region IV.
Now I could say that these objectives were fulfilled, in more or
less a broad brush fashion. We did establish better communications
between the agencies present, and an appreciation of the problems, con-
cerns, and responsibilities of each agency was achieved; however, in a
negative vein, the symposium fell into the same trap as many others have
.done over the past few years. That is, simply restating rather than
attacking the problem.
With this as a backdrop, our EPA office in Atlanta formed a Radia-
tion Emergency Response Committee, consisting of representatives from
the agencies which attended the January symposium. That is, the AEC,
QEP, DOT, WA, Southern Interstate Nuclear Board, Georgia Tech., and two
States, namely South Carolina and North Carolina, along with represen-
tatives from the nuclear power and the nuclear fuels processing industry.
The committee met in Atlanta March 23-24 and developed a proposed "South-
east Mutual Radiological Assistance Plan (SMRAP)," which reads as fol-
lows, and I might add that I would like to acknowledge the viork that Mr.
Jim Goodwin with the Southern Interstate Nuclear Board and Mr. Heyward
Shealey from South Carolina have done on this document.
First of all the plan objectives, and of course, this is the guts
of the entire plan. These are: "(1) to integrate State radiological
emergency planning within a flexible regional framework; and (2) to pro-
vide assistance to States in plan development and coordination, and to
extend the capability of each State by providing it with a regional re-
source upon which to draw during an emergency." So really, what we're
trying to do is to create an atmosphere in which an emergency may be
responded to with maximum effectiveness; and secondly, to develop a
State plan and capability where needed.
It was felt by the Radiation Emergency Response Committee that ade-
quate authority for development of a mutual assistance plan is provided
in the Southern Interstate Nuclear Compact under Public Law 87-563;
therefore, the coordination of a mutual assistance plan with the States
could be officially accomplished without--and this is important--without
new legislation, through the Southern Interstate Nuclear Board.
Now the SMRAP will initially include the eight southeastern States
with provisions for including additional States as needed. Participation
of public educational institutions will constitute an important aspect
of the plan.
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Industry will be included as a valuable resource. Since_the plan
is implemented by public organizations, industrial participation will
be limited to an advisory role in the development aspects of planning.
While industry can provide expertise and services for planning or imple-
mentation, no industry funds will be accepted or solicited for mutual
assistance. Liability protection for industry personnel will be pro-
vided by the industry and will not be covered under the Compact as will
be the States. For the most effective and efficient leadership in mutual
assistance planning, the industry's resources will be coordinated through
its State radiological health organization. These provisions for de-
lineating the role of industry also apply in the case of private educa-
tional institutions.
The role of Federal agencies will be limited to one of advice and
coordination unless otherwise requested by the States.
The States, working with the Radiation Emergency Response Committee,
can now work within the framework of the Southern Interstate Nuclear
Board's statutory authority. Limitation of State employee liability
during an emergency, when assisting in other than his home State, may
require an amendment to existing legislation.
Most Federal agencies can readily be included in the plan, as desired,
under their existing legislation which requires them to assist the States
during an emergency, and IRAP would be an example of this.
An analysis will be conducted of each participant's responsibility
and authority to facilitate proper notification and prompt action for
insuring health and safety during an emergency. This will be a continuing
function of the planning process.
Initial emphasis in preparing for plan development will focus on
identifying radiological resources and communications availability with-
in the planning region. Of course we know a lot of these already, but
the intention is to do a more complete job. The States will survey radio-
logical resources within their borders and compilation of those resources
will be made for use as a regional planning tool.
This phase will enable the Committee to evaluate regional resources
and devise a means for calculating regional needs. Additional reviews
will be conducted regarding needs, and that determination will be com-
pared with resource availability. This step will provide information
vdiich will enable the committee, or a plenary session of the States, to
reevaluate objectives, scope, methodology, and so forth, and arrive at
a work guide to culminate in the plan. It will also provide necessary
information and data with which to approach possible sources of funds
within the Government for assistance.
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As part of a State emergency plan and activities relating to emer-
gency preparedness, consideration should be given to a State radiological
training program. This program should be directed toward the State High-
way Patrol, fire marshalls, civil defense, ambulance services, and local
fire departments and rescue squads. The existence and capabilities of
local fire departments and rescue squads should be explored in each State,
particularly counties and communities that are near nuclear facilities.
The agency conducting the training program should briefly outline
the authority and responsibilities of all organizations which may become
involved with radiological incidents. For the time being, the Radiation
Emergency Response Committee will administer the plan and will meet
quarterly to carry out this responsibility.
This is where we stand as of now.
MR. SILHANEK: Thank you Dick. I think what I will do is to have each
panelist make their presentation and then ask for questions from the
audience for each panel member.
Our Office was requested by the Office of Emergency Preparedness
to serve on the Ad Hoc Federal Agency Committee for Nuclear Incident
Planning. This task group will provide technical planning, guidance,
and assistance to agencies and jurisdictions responsible for response
to a nuclear incident at a fixed facility. The product of this effort
will be a coordinated response plan or plans for the licensee, the local
government, the State, and appropriate Federal agencies. The power facil-
ity in Pope County, Arkansas, was selected as the site for development
of the prototype plan. Mr. Sembera from the Regional Office—the Office
of Emergency Preparedness in Dallas, Texas, is here to discuss this plan.
MR. SEMBERA: Mr. Payne has covered in broad form much of the information
we will discuss in looking at how we approached a prototype in Pope County,
Arkansas, to develop model guidance that might be useful to you in a uni-
form approach to planning for nuclear incident response in various States
and communities. The result of the Conference of the National Committee
(OEP, AEC, EPA, and OCD1), that Mr. Silhanek mentioned, was the develop-
ment of a national proposal for coordinated planning for response to
1 The Office of Civil Defense was disestablished on May 5, 1972,
with its staffing and functions transferred to the newly established
Defense Civil Preparedness Agency (DCPA).
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87
fixed facility nuclear incidents. The proceedings of that Conference
set out, in outline form, some of the anticipated responsibilities of
various agencies and designated a broad form approach to developing a
model plan focusing on a particular facility, such as the Arkansas Power
and Light Company Unit No. 1 on Dardanelle Reservoir in Arkansas. The
purpose is to develop a model approach that would be helpful to you in
developing your eventual plans for this new form of energy. We find now,
in multiplied proportions that the nuclear reactor is fast becoming the
new energy source for power generations for the immediate future. This
is a nationwide effort to relieve the crush on other means of supplying
electric power because of the storage of fossil fuels, and ecological
problems with other fuel sources.
To explain our prototype program, I would like to discuss two things.
First is the progress we have made in Pope County, and second is to give
you some idea of the planning developments and problems to this stage
in pursuing that project. First.to be considered is why Pope County,
Arkansas, might have been selected for this project. We recognize that
there are many nuclear facilities in the same general status as the Arkan-
sas Power and Light Company Unit Number 1 nearing completion. Because
of various considerations--the readiness of the industry, the location
of this particular facility in its relation to a type of community, the
general progress and development of the facility and its timetable--this
site was picked to be used as a model to develop the guidelines. (I
would be delighted if Mr. Payne had gotten this over in Atlanta somewhere,
but we were saddled with the project in the Southwest Region.)
In making our approach, we first set out to develop some type of
a game plan that would identify the various government and industry players
and fix responsibilities that would help us in coordinating the further
pursuit of the project. In analyzing this thing, I am sure you recognize
that the main line of action for a response for a nuclear incident starts
with the industry--with the facility itself as the original triggering
action with the problem overflowing from the industry into the community
area. Then it becomes a local government response capability that must
be developed in order to have mutual reaction that might offer timely
protection to the public. This involves a close coordination with the
State Health Department in its function of radiological defense for the
expertise in diagnosis, in assessing the nature of the problem (the ex-
tent of the problem). Their on-scene investigation must provide the
intelligence to measure into the inmediate decision the local government
officials or State government officials must make in order to determine
a course of action and expedite such action to provide the necessary pro-
tection in the face of whatever hazard the incident might impact on the
public.
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POPE COUNTY, ARKANSAS - NUCLEAR INCIDENT RESPONSE PLANS
RESPONSIBILITIES AND RELATIONSHIPS
oo
00
* Denotes Key Action Officials (For Planning) .
t Identifies Response Flans Required .
fc- Indicates direction of action flow by
key agencies.
0 B P
*(Tom Sembera) Dallas
P-L-A-N-N-I-N-G
AEC
*(Harold Collins) D.C.
1. Mobilize Task Group for combined planning effort by Federal,
State, and Local Governments and Power Industry.
2. Monitor and coordinate Federal agencies planning support.
3. Review and correlate related response plans for Integrated
joint operations.
C-0-O-R-D-I-N-A-T-I-O-N)
EPA
*(Jay Silhanek) D.C.
1. Define hazarll potential and threat.
2. Standards and Guidelines for Licensee
Facility opns\ plans and safety aspects.
3. Plant preparation^ to deal with Reactor
malfunction incidents.
4. Reporting & ttlerting\of Civil & Military
authorities on hazardous incidents.
5. Compliance with response requirements
1.R.A..C. plans. V
t 6. Prepare AEC Agency Responsfc Plan.
1.
2.
3.
4.
Determine & prescribe safe radiation exposure
tolerances for nucl»ar incidents affecting
public environment & people.
Prescribe public remedial actiofr-guidance for
serious radiation exposure levelsln^air,
water, land areas. ^"~\^
Assess radiation monitoring capability & publie\
safeguard preparations (iucl. public informa-
tion) for hazardous nuclear Incidents. (Coord.
with AEC 4 OCD) _^
Assist State (Health Dept.) in preparation-ST""
Radiation Response Annex. ^^. — '*"
OCD
*(Gaines West) Denton
1.
2.
3.
Planning gt
State & local Governments.
Guidance 01
Correlate i
Idartce & assistance to
Monitorlig Systems.
use of CD Warning & Radiation
11 CD aspects of community
safety, i vacuation, & care operations.
ARKANSAS STATE GOVERNMENT
DEPT. OF PLANNING
Act- D!T.\
t 5. Prepare EPA AgencyJJesptmse Plans (National &
Re
j DEPA AREA 10
|*(Carlos Love,DIr
I
i 1
INDUSTRY LICENSEE
PLANT OPERATOR - AP&L I
l*(Bill Cavanaugh, Nuc. Prod. Engrj
POPE COUNTY
(LOCAL COVT. CD. ORGN.)
*(Pon Rickard. Co. CD Dlr.)
(Ralph Moore,
Civil Defense
Director)
esponslbilities of State
for action response and
1. Plant safety & protection plans.
2. Monitor & predict facility radiation
intensities.
3. Alert procedures for Reactor incident.
4, Mututal assistance from local & Military
for flrefighting, security, medical, etc.
5. Decontamination & countenneasures.
4f 1. Prepare local Emergency Action
Plans for public warning, evac.,
public safety, & care of evacuees
& injured.
2. Develop response orgn. & capability to
protect health & safety of people &
property In affected area.
3. Public information & education.
It. Conmunity mutual aid support to Industry.
(Frank Wilson,
Health Dept.-
1. Estab. r
Agencl
m suppor :.
12. State pi inning assistance & guidance
* Lu lulAil government.
#3. Develop State Response Plants) to back
up local effort & coordinate
Federal assistance.
Figure 1.
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89
We have circulated for your reference a copy of what we call a kind
of "wiring diagram," as a graphic analysis of the project coordination
arrangements (figure 1). This chart gives, in a schematic form, the
approach that we are making in the Pope County, Arkansas Project. We
have tried to identify in this relationship chart, all of the key "players"
or agencies (the action officers) that are engaged in a concerted effort
to try to maintain a coordinated input, and to use the professional ex-
pertise of each agency as its authority would relate to any particular
action areas. This alignment has served to provide guidance and assis-
tance to the main line planning elements in developing their respective
response plans--to see that there is a concerted effort related to the
particular problems of detection and mobilizing a timely public response
system.
We in OEP maintain a position of being primarily responsible for
providing basic organization guidance to the project. Our authority
stems from Public Law 91-606, which provides for the development of con-
prehensive disaster response plans in the broad form of disaster pre-
paredness envisioned by the 1972 field program studies. Following the
authorities that Congress set out in the Disaster Act of 1970, the term
"disaster" now means almost any type of catastrophic incident that in-
volves a commitment of government resources in the public interest to
protect the public, to restore order, or to provide the necessary supple-
mental assistance by echelons of government to bring resources to bear
on a problem situation. So in this sense, a severe radiation incident
such as might be caused by a nuclear facility accident, is not much dif-
ferent from a tornado, or a hurricane, or an industrial accident that
might impact on a public environment--as we have approached this under
our regular programs.
In developing supplemental assistance from the Federal Government's
resources, we recognize that the initial immediate action is a local
government responsibility. The problem is there at that level. The
basic local resources must be committed initially at the scene. These
are organized under local authority, and we would presume under some
sort of plan to bring the nearest available resources to bear on the
immediate situation. As the response develops, these local resources
would then be augmented from the State level and from the Federal Govern-
ment level as the situation demands.
Our approach would be to encourage States and local governments to
pursue planning for this type of radiation incident along the same lines
that we are pursuing comprehensive disaster planning for response to any
type of emergency catastrophe, whether it be natural disaster, industrial
disaster, or whatever it might be. We recognize in the case of nuclear
reactors we do have a peculiar and particular type of radiation hazard.
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90
It must be designed by special expertise and identified as to the scope
of the problem, the various alternatives in the way of protective measures,
and the time of reactive response. As a result of that diagnosis by the
radiological experts, there is a "prescription" of actions, or remedial
measures. Whatever those actions might be would determine whether to
activate a quick mobilization of other State or local resources to pro-
vide the appropriate protective response. In this case it appears that
for a serious spread of radiation beyond the plant perimeter, the normal
response is move people, to evacuate or get out of the exposure area.
Anytime you mention evacuation, it becomes a special complex problem
beyond the immediate health department's normal resources and authority.
It involves mobilization of actions by State police, by the State highway
department, by State welfare officials, by the Red Cross in the care of
evacuees, and it becomes a whole cycle of coordinated actions from origin
to destination to take care of displaced people. This involves combined
State and local planning for a concerted and timely response by -all ele-
ments of government then that need to be involved in this type of reaction
in order to bring the necessary resources into direct focus for an immedi-
ate response to an incident of this kind.
The approach that we have set out here identifies those agencies
and a flow line of action for their particular interests. The main
action element, as I mentioned earlier, would be the industry licensee,
the plant operator, and the local government organization as far as the
public interest is concerned.
The Atomic Energy Commission, by its statutes and law as the Federal
licensing agency, would have the direct contact with industry for devel-
oping the onsite response and for carrying the offsite influence of the
industry planning to completion in order to satisfy the requirements of
AEC in accepting the fulfillment of industry plans for granting of licen-
ses. So AEC is the main Federal agency in direct contact and liaison
with the industry to assist it in bringing in whatever other agency influ-
ence or Government standards need to be recognized in developing the
industry plans.
The Environmental Protection Agency on the other hand, does not have
a direct communication with industry as such, although if does have main
coordination and control here through its review of the Environmental
Impact Statements that have to be completed satisfactorily before accep-
ting operation of any such facility. EPA's input again in this area
would generally be through coordination with the Atomic Energy Commission
in relation to the industry actions. The EPA has the direct assistance
role to the State health department or the radiological division of a
health department for guidelines in determining the State radiation
exposure tolerances for a nuclear incident. This includes developing
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91
technical standards that would indicate levels of exposure and related
protective action necessary to protect public interest, the agriculture
or consumer products or whatever else might be exposed under the con-
ditions of a nuclear incident. EPA makes recommendations for remedial
action that would be developed through its coordination with the health
department and for assisting in developing a capability for monitoring
and assessing the radiation through whatever mechanical systems have to
be developed. This includes determining the necessary instrumentation
and coordination for tying it into other prevailing radiation reporting
systems which have been extensively developed by Civil Defense from the
nuclear attack type of problem. We would hope that there will be some
parallel and adaptation of these reporting systems and for use of the
communication systems already developed from a radiation monitor source
back to a point of analysis for deciding the impact that the measurements
might have in a public environment. Then EPA would have the responsi-
bility of developing its own agency response plans, both national and
regional, for its response in case of a nuclear incident of any magni-
tude calling for Federal intervention.
The Office of Civil Defense (now the Defense Civil Preparedness
Agency) is appointed as the action agency for contact with the State
government. The action here, in relationship to our overall national
emergency planning, seems to involve most of those functions that we
define as "civil defense" functions in relationship to public protec-
tion. This involves a warning and alerting scheme; a community evacua-
tion procedure--all of the mechanics that go into evacuation from the
initial alerting to moving the people out, down the highway, getting them
into traffic patterns that lead them to a predetermined destination;
arranging at destination for necessary temporary shelter, welfare care,
feeding, and the usual social problems associated with moving and re-
locating people. These elements of the civil defense aspects are to be
coordinated through use of the Office of Civil Defense Regional Staff,
working in direct contact with State government action officials, to
further explore and correlate all of the CD aspects of community safety,
evacuation, and care operations leading into the public response effort.
The State government has a direct support role to local government,
using the expertise of State agencies; mainly those key agencies that
have special response capability for this type of incident. These are
mainly the Civil Defense Agency as the Governor's coordinating manage-
ment group; the Department of Public Safety, which has to do with the
evacuation and traffic control planning related to movement of popula-
tion; the State Highway Department and its traffic regulation procedure
for use of traffic routes; the State Welfare Department for care of
people and coordination of Red Cross assistance; and the State Health
Department as the principal agency that gets into the imme^^8****
and evaluation of the problem and becomes the central ^elligence oa the
that provides the triggering of whatever actions need to be taken.
scene
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92
In analogy to our normal disaster response efforts, compared to a
hurricane, or a tornado, the health department has a role very similar
here to what the National Weather Service has under the weather type of
problem where they detect, maintain close watch, and prescribe the pub-
lic safety actions in the face of an approaching incident and can recom-
mend and prescribe evacuation of areas in order to clear people from an
eminent hazard. The health department has a role here to make this de-
tection or to verify earlier reports and to recommend to appropriate
local and State operating authorities the course of action to protect
people from hazards involved.
We ran into some confusion in trying to determine exactly what is
the nature of the risk or hazard in defining the problem we face in a
fixed nuclear facility or a nuclear power generating facility. There
is a wide range of accident potential that has been discussed by AEG.
At no stage in our discussions have we seemed to develop the high proba-
bility for a heavy explosion-type accident that will involve instantan-
eous response. There is a sequence of types of design-based accidents
(DBA) that would lead to a spreading hazard from some type of malfunc-
tion of lesser magnitude, resulting in a release of radiation within or
escaping from the reactor containment area. Local protective planning
involves activation of industry resources for response from the stand-
point of the facility itself, and, in cooperation with the local govern-
ment, developing the necessarya communications with local government and
the local support elements for outside assistance that the industry must
depend on as part of their plans.
The industry's problems in this development involved a lot of com-
munity mutual support. There are several categories of support activi-
ties that are not available within the sources of the utility company.
They rely heavily on outside ambulance support services, on special hos-
pital treatment support services, on police security forces, on fire pro-
tection forces and equipment, and in many other areas. Since we have an
evacuation problem from the plant itself that crosses water, they have
to look to other local people in the area to see that they have means of
movement across water to handle evacuation from the immediate plant site
and the environs. Theirs is not only developing their facility response
plan, but community mutual support as well. Thus we are jointly involved
in this community mutual aid support as one of the cycles in their AEC
plan development. The Company will have its plan in revised draft form
for our review at an early stage. They are working closely through
agreements with the local county organization and with the Russellville
organization to develop all mutual support aspects.
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93
The local government has run into a handicap of lack of planning
staff capabilities, and this is presenting special problems because of
delays in the local development, which is supportive to the industry
efforts. Some special action is now needed to bring in more State plan-
ning assistance to assist the local government capabilities in the mech-
anics of organization and procedure drafting in order to keep the project
on schedule.
This summarizes what we are doing in Arkansas. Our progress has
not been sensational. About all that we can say that we have clearly
defined at this time is the planning approach, and action officers are
working at each level within the limitations I described. It would
appear that September would be the earliest we could anticipate coming
forward with a first draft product of the State and local parts of the
prototype plan.
MR. SILHANEK: Last year we had a workshop in Arizona on emergency plan-
ning and Mr. Arnold Moen from the State of Washington was Chairman of
that Comnittee. At this time he is going to present what has happened
since the meeting last year.
MR. MOEN: Jay said I'm supposed to tell you everything that has happened
since last year; that would be quite a chore. Let me summarize what I
believe is the current status of emergency planning.
As you know, in the 1950's, almost every Government, State, and Fed-
eral agency had an emergency plan. They were all interested in emergency
plans at that time. Our State plan, for example, was a complete plan
of some seven volumes on 8-1/2- by 11-inch paper, printed in two columns
on each side; about 40 pounds of paper; instructions covering every con-
ceivable emergency by every conceivable person in the State, even to
marking our graves properly. Some of these plans are rarely looked at
and have not been tested, I believe. So what is the status of State*
plans now?
I really don't know all the States' plans, but it does remind me of
an incident last winter. I visited a friend of mine in Richland. It
doesn't rain much in Richland but it was raining at that time and the
roof was leaking. He was collecting the drip in the living room in one
of his wife's cooking kettles and it worked fine. Last Thursday I was
in Richland again. I met the same fellow and we were talking and some-
how the roof came up. He hadn't done a thing about it. It hasn t rained
since, so no problem.
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94
Well, I think he should be doing some planning. A lot of States
are like this. We believe that a radiation emergency is always on the
other side of the border. Let the other fellow do it. Now that com-
mercial nuclear facilities are coming into the picture, interest is
building, and sane of the States are being forced into involvement in
emergency planning. There are many plans in effect. As far as I know
though, there seems to be a lack of a general plan in most of the States.
You've heard of the complexities of the plans--the planning involved--
and you just can't sit down for 10 minutes and work out an emergency
plan. There is yet no consensus as to what the best approach to a good
State plan is.
I think we need all the possible help we can get, from any source
we can get, in developing a State plan. Developing a State plan may not
work out in a particular State to be the responsibility of the radiation
program, but I do believe that each Radiation Director should see to it
that a plan is developed, that it is current, that it is operable, that
the public is aware of it, and certainly the radiation program in every
State should be involved in the plan for input, for resources, for per-
sonnel, and for operation. It's a lot easier to fix the roof before it
starts to rain. Radiation emergencies are caused by many things. Machine
failure is one; for example, we build safer cars every year, but we still
kill more people with them.
People error, I believe, is a big cause of radiation emergencies.
Some of these people we can never control. Some of these people are
going to cause emergency accidents. I believe the States are not as well
prepared as they should be. Many do not have a workable plan. I believe
it is time to take a look at our plans that we do have and actually devel-
op one that will work.
DISCUSSION
MR. WHATLEY: Everything I hear sounds like it's directed towards private
industry. What happens, would you believe, in the case in the West, of
the Rocky Flats, in the Nevada Test Site, in the Rulison Project (which
is a Federal installation) if something happens?
MR. SILHANEK: As far as facilities are concerned, these are Federal
facilities. I think a State would develop some plans with this facility
to take care of an incident, say at some place like Rocky Flats or one
of these large power reactors. Does that answer your question, or do
you want to direct a specific question to one of the panel members?
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95
MR. WHATLEY: I don't know whether it does or not. It's not clear to
me that an incident, which is strictly Federal, is going to be handled
in the same way as the conmercial power reactor. I guess that's what
I was trying to find out.
MR. SEMBERA: We only change the source of the problem. If it impacts,
if it overflows into a public area, it is the same responsibility to
take care of people, and the local government has to react accordingly.
In that case you get much more direct support from the Federal interest
involved, possibly, but otherwise the action on the environmental prob-
lem would be the same. Los Alamos is a case in point that has a very
extensive reaction plan for their city interest as well as the Govern-
ment interest, in a program that might involve nuclear problems.
MR. ROGERS: A very comprehensive plan has been shown here by Mr. Sembera
in discussing the need for planning. I'll take the devil's advocate
position and find out, what is the reaction when the public finds out
that there is this much planning needed to just lay out a nuclear reac-
tor in a facility at some location. If that much planning is needed for
an emergency, then perhaps the thing shouldn't have even gone in there
to begin with. We get this type of reaction from the public in the Cali-
fornia area all the time. There's a people's lobby working there now.
They have a "Proposition 9" saying "Ban the Nuclear Reactors;" and if
this much planning, on top of the normal planning of a community is
necessary, maybe there are some problems here, and how do you respond
to the public's reaction to something like this?
MR. SEMBERA: This is a very sensitive area, we recognize. It is no dif-
ferent in some aspects, though, than looking at a big chemical plant
industry that gets the same reaction from the.public, and you do have
a public information and a public education program to develop accept-
ance. In the case of Pope County for instance, and I'm sure this is true
of other utilities, they have been carrying on a very extensive public
relations program (T.V., radio, and otherwise) with releases coming on
to condition the public to the ramifications of the problem, to the nature
of developments, and the safety measures that are built in. Generally,
we get acceptance by the fact that even though you' re working with a
hazardous item, there is an extensive amount of the state-of-the-art,
developing the technology to insure protection of the public and give
them the assurance that they are not going to be directly involved.
MR. ROGERS: Can I react to that for a minute? In a large community,
such as Los Angeles, our plans are on a governmental level. We went
through an earthquake here a year and a half ago, and the planning was
within the governmental agencies. We responded in the way we would re-
spond any other time for any other type of incident. We have many haz-
ardous industries such as you speak of. The fire department is capable.
There is an interagency response. There are 74 cities in the County ot
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96
Los Angeles, and the interaction between the police, the sheriffs, the
fire departments, and the health agencies are such that we don't have
to create this furor of a special plan for a special situation. This
is what bothers roe. Here we make comprehenisve planning for a nuclear
reactor facility because we think something is going to happen there.
It's not any different really then any of our other emergency planning
that communities should have been planning for. I agree with the gentle-
man from Washington. This is normal planning that all agencies should
have been figuring for all the time; not because of a nuclear reactor,
but for general consideration of protection of the public.
MR. SEMBERA: You're singing my song. That's what we're trying to get
people to look at; that is, don't make a special problem out of this,
but make it another type of incident that you have developed for, and
get his reaction to, by the echelons of government that must respond in
the public interest. We're advocating this; not making a special case.
MR. MOEN: Nuclear reactors have triggered the interest in planning; but
take transportation of radioactive material, for instance. It's gone
up in the last 5 years from 200,000 shipments to about 800,000 shipments
a year. We don't have many accidents in transportation. Probably one
out of some 20,000 statistically. That's still a lot of nuclear inci-
dents and this plan should cover that also; so it isn't specific to
nuclear power plants.
MR. SILHANEK: I think we have time for one more question.
MR. KEENE: It's not a question. I think what has triggered the anti-
nuclear reaction was the question was brought up by the New England
Coalition Against Nuclear Pollution. I know this has been the case of
Jack Stanton of New Hampshire on the State Emergency Response Plans,
•vhere the intervening attorney spent the entire day questioning the State
Emergency Response Plans. I think this is wrong. Emphasis shouldn't
necessarily be put that way. We are getting forced into it.
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97
ENVIRONMENTAL RADIATION SESSION
Moderator: Donald C. Gilbert
oi tilt 0£jJ
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98
ENVIRONMENTAL RADIATION SESSION (continued)
Ernest D. Harward
Acting Director
and
Craig I. Roberts
Technology Assessment Division
Office of Radiation Programs
Environmental Protection Agency
Radiation Standard*, and
William A. Mills
Director, Criteria and Standards Division
Office of Radiation Programs
Environmental Protection Program
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99
MISSION OF THE OFFICE OF RADIATION PROGRAMS
WUUULtm V. Rowe
Deputy Assistant Administrator for Radiation Programs
Environmental Protection Agency
Thank you, Mr. Gilbert, and all the Radiation Control Program
Directors for an opportunity to speak to you as one of my initial duties
as the Deputy Assistant Administrator for Radiation Programs.
Yesterday, Mr. Dominick discussed the EPA goal with regard to
radiation, which is the prevention of adverse effects to human health
and the environment and the reduction of current risks resulting from
radiation exposure. There are four problem areas that he identified
of concern to us which are: (1) uses of nuclear energy such as nuclear
power and the fuel cycles, weapons testing, and the Plowshare projects;
(2) natural radiation from such sources as construction materials in-
cluding mill tailings, granite, and others; (3) nonionizing radiation,
which includes exposures from microwave, radiof requency, and laser
sources; and (4) medical and occupational exposures (which you discussed
yesterday in great detail).
My coining on board at this time I suspect implies change. I hope
the change implied is not a fruitless kind of change. The basis for
this change, an effort already started by the EPA Radiation Program, is
the development of a total strategy to approach radiation problems in a
total program focus.
Coming on board, I find that radiation protection is an area in the
environment we probably know more about than any other particular area
of environmental pollution. But because we know so much, it is also
necessary to ask more penetrating questions. This is what I think we
are faced with in developing the overall strategy.
Instead of looking at the problems piecemeal as they come up, we
are stepping back and taking an overview to provide direction for our-
selves and make the results visible to everybody else, so they can see
where we are going. At the same time, we are going to ask you - members
from States, the regions, and members of the related programs - to help
contribute to this strategy (and participate in it) so that it is as
much yours as it is ours. The object is for us to get some direction
where we can all pull in the same direction and not 3ust hit the prob
lems on a "firefighter" basis.
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100
The second thing I want to address is my philosophy towards what I
will call decentralization. I feel that the only way you solve problems
is by solving them where the problems occur - that means out in the field.
That means that the "first line" for solving the problems (taking care of
them as they occur) is at the county and State level. There just isn't
any other way that I know of.
But to decentralize, to put the resources where the problems are,
is something we can't do in a vacuum. Some of the problem approaches
I have seen provide decentralization with no direction or control. I
think this is what we are trying to rectify by developing a strategy
which will allow us some means for being able to decentralize on a
rational basis, and to take care of the problems where they occur, and
make sure the resources are flowing in the proper direction.
Before we do this we have to know where we are going; and that's
the purpose of our strategy.
I don't perceive any major changes in the organization of the EPA
Office of Radiation Programs at the present time. The present organi-
zation, which consists of the Criteria and Standards Division; the Tech-
nology Assessment Division; and the Surveillance and Inspection Division,
are going to remain; and be our main divisions. We believe that this
structure enables us to make the most effective use of our resources to
achieve the environmental protection goals that we are charged with. It
is the job of the Technology Assessment Division to determine and assess
the technological trends related to radiation and their impact on the
environment. This information is utilized for both the review of envir-
onmental impact statements and for input into standards development; and
further, it is input into the strategy that we are developing at the
present time. It is the role of the Criteria and Standards Division to
investigate and recommend criteria, guidance, and standards which will
help to effect the control of radiation. The Standards and Inspection
Division has the task of obtaining baseline data on the levels of exis-
ting environmental radiation; determining any change occurring in the
radiological quality of the environment; estimating population exposure
to radiation and thereby determining whether radiation criteria and
standards are being met.
During the course of the morning, six members of the Office of
Radiation Programs staff will talk to you in detail about a number of
topics we are involved in.
Since many of our programs are either directly or indirectly tied
to the State radiation control efforts, I think that the remarks of the
ORP personnel will be of particular interest to you, the State radiation
control personnel.
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101
Mr. Charles Weaver, the Acting Director of the Surveillance and In-
spection Division, will discuss the EPA activities as they relate to
radiation surveillance and inspection. These activities include the
various sampling networks, the National Environmental Radiation Monitoring
Program (NERMP), and planned inspections of various radiation producing
facilities including the upcoming inspection of the Monticello Nuclear
Power Plant.
Mr. Donald Nelson, Acting Chief of the Surveillance Branch, will
discuss the ORP Environmental Surveillance Guide and its recommendations.
The purpose of this guide is to recommend specific surveillance proce-
dures to ensure unformity of data reporting. The guide recommends the
basic minimum field sampling and analytical procedures for air, water,
and other environmental media necessary to monitor light-water-cooled
nuclear power facilities.
Mr. Edmund Barat'ta, the Acting Chief of the Analytical Quality Con-
trol Service, will discuss national quality control. The purpose of
this program is to provide a service to States and other parties to en-
sure the comparability and quality of analytical techniques and procedures.
Mr. Philip Cuny of the Surveillance Branch will discuss data analysis
and dose model development. As you know, the surveillance activities
and analytical control activities are only as useful as the quality of
the data analysis and the dose models that are utilized to project popu-
lation dose.
Mr. Dave Harward, the Acting Director of the Technology Assessment
Division and Mr. Craig Roberts, the Acting Chief of the Technology Im-
pact Review Branch, will discuss environmental impact statements, the
impact of the Calvert Cliffs decision, and overall technology assessment.
Dr. William A. Mills, the Acting Director of the Criteria and Stand-
ards Division, will discuss radiation standards and their development
primarily as they relate to light-water-cooled reactors and fuel repro-
cessing plants. His discussion will include general standards philosophy
and the status of the National Academy of Science review of all of the
scientific evidence bearing on the human risk as a result of exposure
to ionizing radiation, particularly at low levels of exposure.
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102
DISCUSSION
MR. LANDAU: I wonder perhaps you could tell me what are the medical and
occupational exposures that were represented in the environmental inter-
ests of EPA?
MR. ROWE: When EPA was formed, the responsibilities and functions of
the Federal Radiation Council were transferred to the EPA and we do have
the responsibility for viewing what's going on and making recommendations
under those conditions.
MR. LANDAU: Also, could you tell me what are the environmental uses of
laser sources, and EPA's interest in that?
MR. ROWE: I can think of several cases where there may be upcoming
interests, especially in the case where they're talking about laser
communication beams stretching across long distances and people being
able to walk through.
MR. MATUSZEK: Amongst your comments about fusing resources and respon-
sibility to the field, does this include greater efforts towards finan-
cial assistance to the States, or is this a tendency to be inhouse fusion?
MR. ROWE: As far as technical assistance is concerned, certainly I hope
we are going to be able to expand this. As far as financial assistance
is concerned, I think that has yet to be determined.
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103
SURVEILLANCE AND INSPECTION ACTIVITIES
L.
Acting Director
Surveillance and Inspection Division
Office of Radiation Programs
Environmental Protection Agency
A major component of the Environmental Protection Agency's moni-
toring and surveillance activities is the National Environmental Radiation
Monitoring Program for obtaining baseline data on levels of existing
environmental radiation. In carrying out these surveillance activities,
projects have been initiated to determine any changes occurring in the
radiological quality of the environment, the magnitude of such changes,
and the probable source of the environmental contaminants. The primary
function of our surveillance activities is to provide data for estimating
population exposure resulting from all sources of environmental radiation.
In conducting these activities the Surveillance and Inspection Division
is organized into four Branches and the functions are described below:
Supveillanae Branch: The Surveillance Branch conducts continuing
systematic studies of the environment to determine if changes of public
health significance have occurred in its radiological characteristics,
ascertains the magnitude of the change and the specific nature of the
contaminant, and operates surveillance networks to provide information
for the assessment of population radiation exposure. The Surveillance
Branch also: (a) coordinates surveillance to detect environmental radio-
activity resulting from weapons tests or other peaceful uses of nuclear
energy; (b) develops surveillance methodology oriented towards improvement
of surveillance operations to provide better data for assessment of popu-
lation exposure; (c) conducts and coordinates special studies in the gen-
eral area of the measurement and distribution of environmental radio-
activity; and" (d) provides technical assistance to State and Federal
agencies and the public and private organizations which plan and develop
protective action to reduce or prevent environmental contamination and
radiation exposure of people.
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104
Field Operations Branch: The Field Operations Branch conducts field
studies at operating nuclear facilities to investigate the mechanisms for
production, release, and disposal of radionuclides in the environment.
The Field Operations Branch: (a) measures the movement of radionuclides
through environmental media to determine the concentration factors and
effects of chemical state; (b) develops and tests radiation detection
equipment to identify and quantify radionuclide discharges from nuclear
facilities; (c) conducts special studies at selected nuclear facilities
to obtain data to evaluate the facility's operational performance to
determine if it meets the discharge criteria and environmental radiation
protection guides; and (d) provides analytical quality control services
to Federal and State Agencies and to nuclear facility operators.
Inspection Branch: The Inspection Branch conducts inspections to
determine if discharges of radioactive material from operating nuclear
facilities are within the general environmental radiation protection
standards of the Environmental Protection Agency. The Inspection Branch
also: (a) evaluates the effluent discharges by operating nuclear facil-
ities and users of radioactive materials; (b) obtains environmental sam-
ples from critical exposure pathways, and analyzes them for biologically
significant radionuclides; (c) provides program management for projects
to obtain independent data as an input into the National Environmental
Radiation Monitoring Program to assure validity and compatibility of
surveillance and monitoring information; (d) provides a coordination
point for emergency radiation surveillance and control operations, in-
cluding emergency radiological assistance and operational liaison with
Federal and State agencies.
Reports Branch: The Reports Branch publishes monthly Radiation
Data and Reports; reviews Surveillance and Inspection Division abstracts
and~manuscripts; prepares special radiation reports as required; and
maintains a national data bank of information on environmental radia-
tion levels from all sources.
Environmental Surveillance Networks
A national radiation surveillance network has been in operation by
the Office of Radiation Programs (formerly Bureau of Radiological Health)
since 1960. These networks were originally operated to provide data on
levels of radioactivity in the environment as a result of atmospheric
nuclear weapons tests. In 1971 a technical review was made of the net-
works and their functions to determine if any modifications were needed.
At this time it was concluded that the collection frequency and analyses
was adequate to meet the Office of Radiation Programs needs. Further,
because of their location, the data from the networks could be used as
controls when evaluating nuclear facility discharges of radioactive
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105
material to the environment. In order to improve the effectiveness of
the operation, it was decided that the analyses of the samples would be
divided between the Eastern Environmental Radiation Laboratory in Mont-
gomery, Alabama, and the Western Environmental Research Laboratory in
Las Vegas, Nevada. The networks are presently being operated as follows:
Network
Pasteurized Milk Network
Institutional Total Diet
Sampling Network
Tritium Surveillance
System
Radiation Alert Network
Number
of
stations
63
25
116
70
Frequency
of
sampling
Monthly
Weekly and
composited
for quar-
terly anal.
Surface
water: quar-
terly
drinking
water: quar-
terly
Daily
,
Analysis
Ganrna spectroscopy
Strontium- 89
Strontium-90
Carbon- 14
Gamma spectroscopy
Strontium -89
Strontium 90
Carbon- 14
Tritium
Gross beta
—
Regional Laboratories
The Office of Radiation Programs provides technical assistance to
States in the conduct of their environmental surveillance programs. The
Environmental Protection Agency regional laboratories located in Mont-
gomery, Alabama, and Las Vegas, Nevada, have provided technical assis-
tance to States for many years. These services to States are available
upon request through the EPA Regional Radiation Representatives. Because
of the workload at the regional laboratories, it is not possible to pro-
vide analytical services to a State for the conduct of a routine environ-
mental surveillance program. These services should be limited to the
analysis of environmental media which require nonroutine radiochemical
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106
procedures and/or gamma isotopic analysis. The primary function of EPA
regional laboratories is to carry out the research and development effort
required to establish procedures for analysis of environmental samples.
Once these procedures have been developed and tested they will be made
available for distribution to State radiological health programs for
their use in conducting laboratory analysis.
EPA Policy for Management of Monitoring
The Administrator, on April 18, 1972, made the following policy and
program decisions regarding the management of monitoring within the En-
vironmental Protection Agency:
Definitions:
EPA uses four types of monitoring:
1. Ambient Trend Monitoring, to measure conditions and trends in
the ambient environment in relation to standards and guidelines.
2. Source Monitoring, to locate and measure effluents/emissions,
and to assess the compliance status of pollution sources.
3. Case Preparation Monitoring, to gather evidence for enforcement
actions.
4. Research Monitoring, to support Office of Research and Moni-
toring's research activities.
Responsibi1ities:
These four types of monitoring meet a wide range of regional and
national needs. For each type, the office having the primary need will
consolidate requirements and issue guidance.
Ambient trend monitoring, and some source monitoring, enable program
and regional offices to:
. understand ambient conditions in setting or revising standards.
. estimate ambient pollution loads in setting regulatory criteria
and policies.
. review adequacy of abatement plans for achieving ambient
obj ectives.
. measure abatement progress, and report environmental trends.
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107
Goals and Policy Rationale:
EPA's goals for managing monitoring are:
. to assure that ambient trend and source monitoring priorities
reinforce programs to achieve maximum improvement in near-term
environmental quality.
. to assign monitoring operations (except for some research moni-
toring) to the Regions.
. to provide central guidance and assistance for quality control
and standardization; equipment and methods development; and
monitoring pollutants in two or more media.
Policy and Program Guidance:
The procedure for developing annual and incremental guidance for
ambient trend and source monitoring is summarized in the work flow chart
shown in figure 1.
RESEARCH
Set research
data needs
for trend
monitoring
Use Jala
for research
ENFORCEMENT
Issue source
monitoring
requirements
including
source checklist
Assess
status of
compliance
OAWP j
Set ambient
trend and
associated
source need:
t
Design
management
guidance
i
1
Issue
guidance
package
Assemble,
distribute
data
T
Assess
standards,
etc.
MONITORING
Assure tech.
feasibility,
add tech.
guidance
Assist and
audit qua).
control
REGION
\
Collect,
analyze data
1
Use for
operations
Figure 1. Ambient trend and source monitoring (air and water)
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108
1. The Region's responsibilities include:
. developing and operating regional monitoring programs which
raeet
-- regional objectives,
-- national objectives defined by headquarters guidance.
operating EPA monitoring stations and regional laboratories.
. acquiring technical expertise and overflow capacity from EPA
and other laboratories.
. integrating operations, where possible, to achieve optimum
use of resources.
. in cooperation with the Office of Air and Water Programs and
the Office of Categorical Programs:
-- developing joint monitoring plans with States, and
obtaining State data of suitable quality for EPA use,
-- selecting monitoring sites, frequencies, and sampling
patterns.
. with assistance and guidance from the Office of Monitoring,
implementing a total quality control program for EPA-collected
data.
2. The Office of Categorical Programs will provide planning and
program guidance for monitoring the toxic and hazardous pollutants (in-
cluding radiation and pesticides) for which it is responsibile, except
for monitoring which can be done by air or water ambient/source moni-
toring. In the latter case, the Office of Categorical Programs will sub-
mit its requirements to the Office of Air and Water Programs for incor-
poration in the consolidated guidance.
3. The Office of Monitoring in the Office of Research and Monitoring
will coordinate the technical aspects of monitoring for the Agency, and
assure the technical feasibility of planned monitoring activities. The
office will review and concur in all budgetary and planning actions in-
volving monitoring which require headquarters approval. Under this con-
cept it will also:
supplement monitoring guidance with technical guidance on:
-- quality control and standardization
-- analytic and sampling methods
•=•- techniques for improving utility of data for multiple
analytical purposes;
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109
- develop and implement a total quality control program;
- design and implement a program for improving and auditing
the quality of monitoring data, equipment, and laboratory-
techniques ;
- develop and demonstrate improved monitoring equipment and
methods, and recommend them to responsible program offices.
4. The Office of Research in the Office of Research and Monitoring
will plan and operate research monitoring. However, it should on its
own initiative identify opportunities to satisfy some research needs
through ambient/source monitoring planned by the Office of Air and Water
Programs and the Office of Categorical Programs.
Proposed Inspection Program for Light-Water-Cooled Reactors
The Environmental Protection Agency is developing an onsite inspec-
tion program of nuclear facilities to determine if the discharges of
radioactive materials to the environment result in radiation levels that
are within the prescribed standards. An Operating Plan has been developed
for the conducting of inspections at light-water-cooled reactors which
will be tested at the Monticello Nuclear Power Station in Monticello,
Minnesota. The objectives of the inspection program are to:
A. Determine the significant critical radiation exposure pathways
to man from the plant being inspected. Characterize and quantitate the
radioactivity levels in environmental media in these critical exposure
pathways in the vicinity of the plant site.
B. Estimate the radiation dose to the maximum exposed individual
and to*the general population in the immediate site environs which may
be attributable to plant operations. These estimates will be based upon
plant operating and environmental monitoring reports provided by the AEC
and upon field measurements made by the EPA in the off site environment.
C Estimate population exposure by use of a dose model and data
on specific radionuclide concentrations in the effluent, and compare with
dose estimated in item B. Determine if population dose is within the
EPA criteria.
D. Evaluate the adequacy of the plant's Environmental Monitoring
Program in providing information which can be effectively used in asses-
sing individual and population doses.
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110
E. Evaluate the effectiveness of procedures for sampling and
analysis of radionuclides in plant effluents and environmental media
for the purpose of suggesting improvements in both.
F. Publish the inspection findings for the information of the
general public.
In carrying out any inspection program it is essential that the
appropriate State and Federal agencies participate in the inspection
effort to the extent necessary to assure that their interests are ade-
quately represented. In this instance, the inspection activity involves
coordination with EPA's Office of Research and Monitoring, Regional Lab-
oratories, the Atomic Energy Commission, State agencies, and the utility
companies. The inspection activity involves review of operating reports
and environmental surveillance data. As needed, an independent measure-
ment program will be carried out to obtain data on specific environmental
pathways that have not been adequately covered in the reports submitted
for the particular facility. The results of the inspection will be col-
lated, evaluated, and interpreted in a comprehensive report upon comple-
tion of all field and analytical work. This report will emphasize calcu-
lated population doses and the supporting measurements.
DISCUSSION
MR. CASHMAN: I thought, Chuck, as far as the use of the laboratories
in EPA versus State laboratories: New York's experience has been that
we have, and are continuing to use, the Radiological Science Laboratory
in the State of New York. John Matuszek is here today as Director of
that Laboratory. We have had excellent cooperation from the EPA Regional
Laboratories, and as we have gone along with special samples sent out
to the Regional Lab. We have had cooperation in developing the capa-
bility within the State and have taken on some of the special analyses,
such as krypton and plutonium, and have developed the capability in the
State of New York. It would be our recommendation, as far as the Depart-
ment of Environmental Conservation is concerned, that the State continue
to develop its own capability for the routine analyses of environmental
samples. We are also taking inplant samples as part of an independent
measurement program under a contract with the Atomic Energy Commission.
We will be working closely with the Atomic Energy Commission Laboratory
people and Environmental Protection Agency on this matter, but I do
think the States should have their own capability for analyzing envir-
onmental samples. They can develop it gradually with the assistance and
support of the Environmental Protection Agency.
-------
Ill
MR. GILBERT: I think there was a discrepancy and misunderstanding on
the use of the word "Regional Labs." I think when we wrote the letter,
we had in our mind the existing labs that we heretofore had referred to
as Regional Laboratories. We did not intend our letter as a recommenda-
tion for the initiation of 10 new laboratories.
MR. SIMMONS: If the State does develop a capability, I think the EPA
is responsible for seeing that the environment is protected from radio-
activity. What does EPA do in this case?
MR. WEAVER: From your question I would interpret it to mean that if a
State does not have an ongoing radiological health program in which there
is a branch or an activity related to environmental surveillance, par-
ticularly with reference to nuclear facilities and nuclear power reactors,
what is EPA's position relative to this? The answer is that in order
to carry out our task of assuring the protection of the environmental
quality for providing environmental radiation protection, we must use
the resources that are available to assist States that do not have ade-
quate resources to develop an environmental radiation surveillance pro-
gram; therefore, we should enter into some early negotiations relative
to a contract. We also must remember that the Eastern Environmental
Radiation Laboratory and the Western Environmental Research Laboratory
would not handle the routine surveillance on a continual basis, but that
they are available on an on-call basis to provide some analytical support
during the initial phases of program development to get the particular
laboratory up to speed in carrying out its own activities. So I think
the answer is back to Dr. Jacdbson and back to our Office for financial
assistance.
MR. GERUSKY: The question I have is, if you have a contract with AEC,
how do you negotiate a contract with EPA to also get money for a program
that should be done and not a program that is being done? How can you
do it, without a problem?
MR. WEAVER: I think I see your problem. How do you avoid duplication
of effort? I believe we can resolve this issue by agreeing that EPA's
interest is in the environmental surveillance measurements outside the
boundary of the plant. The AEC, on the other hand, has a primary interest
in the inplant measurement and limited measurements outside the boundary.
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112
SURVEILLANCE GUIDE RECOMMENDATIONS
Vonatd J. Wesson
Surveillance and Inspection Division, ORP
Environmental Protection Agency
Charles Weaver has done a fine job of introducing our paper. We
do have two people here who are experts in the surveillance area. Ed
Baratta on ray right and Phil Cuny who is going to help me with this pres-
entation. They are concerned with the modeling and with the analytical
portion of the Surveillance Guide. My job here this morning will be to
try to quickly present to the group assembled, the Guide we have handed
out to you this morning. It is in prepublication form. We expect to
go to press as soon as we have the necessary final editing and clearances;
however, there will be time to consider carefully those comments you
might have with regard to omissions or changes we can make within the
next month or so.
Let's go quickly through the Guide. We'd like to first qualify and
indicate to you that the Guide is designed to monitor; to look at the
environmental radioactivity in the vicinity .of the light water nuclear
power reactor. We want to qualify our remarks so we don't mislead people.
It is for the routine surveillance operation. It may not be adequate
in terms of a recommendation for the abnormal or emergency situation where
we need to have special measurements; special sampling considerations;
special communications. The Guide, as presented here, is not capable
of finding the unsuspected radionuclide in a very protected environmental
niche or corner, and we would suggest if a program is set up, on the basis
of this paper, that every several years—let's say somewhere between 2
and 7 years--that a reactor facility be examined carefully in terms of
the radionuclide content of environmental media.
I hesitate to define "surveillance" to people here because it certainly
is, as you know, an important part of the radiological and radiation en-
vironmental protection programs of the States. No one concerned with
protection of the environment from radioactivity or radiation would want
to operate without data on environmental conditions.
-------
113
Now if we can move quickly to the Guide in terms of the recommenda-
tions. The principle ones are as follows: recommended is a preoperational
survey intended to identify the exposure pathways, locate the critical
population groups, and select the sample media and sample locations. The
preoperational survey, which is expected to be continued for approximately
1 year, should provide a reasonable interpretation of the data in terms
of radiation dose. We are asking for--suggesting--a TLD measurement,
thermoluminescent dbsimetry measurements, film badge, or ionization cham-
ber measurements. I think the question of instrumentation will be one
that we would like to have your comments on because instrumentation can
change quickly. We want to make sure that the recommendations adequately
consider the current state-of-the-art. Our basic recommendation for pre-
operational survey, in terms of instrumentation, is the gamma isotopic
analysis procedure, which is defined in the Guide as a quantitative mea-
sure of radionuclide content.
With respect to air samples, we have suggested for the preoperational
phase, both beta and gamma isotopic analysis, and the collection of water,
food, and biota along the critical dose pathways. This is intended to
define the radiation content in the environment prior to the operation
of the reactor; and we are using the gamma analysis procedure as the basic
instrumentation.
Figure 1 indicates the pathway that should be examined during the
preoperational survey. Figure 2 indicates another pathway, which is the
case of the aquatic or water environment. In the case of the reactor,
we should know fairly well what radionuclides are present and where they
go, so we're capable of designing our surveillance system properly. Fig-
ure 3 indicates the types of meteorological considerations and data that
you need to make intelligent decisions about where to set your sampling
points. Figure 4 is a suggested method of indicating where the samples
should be set up in typical surveillance conditions. These are not hard
and fast rules but we hope they will be helpful. Figure 5 indicates the
same considerations with respect to air particulate sites.
Figure 6 shows the manner of selecting water sampling locations,
and in looking at effluents at nuclear power facilities. This is sediment
situation.
To qualify our recommendations, in going through the Guide, earlier
drafts, we were faced with the decision of what to recommend with respect
to natural radioactivity values in the environment. There are some areas,
sites, geographies, where natural radioactivity is an important considera-
tion in terms of public exposure. It's not related to the nuclear facility
but it's certainly related to what the radiation situation is. One may
have to supplement our recommendations with gross alpha or gross beta
determinations during the preoperational phase to find unusual situations
in the environment. This procedure is also suggested.
-------
114
DIRECT RADIATION-
INGESTION-
Figure 1. Pathways between radioactive
materials released to the atmosphere
and man.
RADIOACTIVE
MATERIAL
'•
SOIL
SURFACE or
GROUND 1ATER
t
RADIOACTIVE
MATERIALS
1
*
Sand and
Sediment
u_
Irription
Hater
— « 1
i » —
i '
Aquatic
Plants
-^ lr
1 1
Aquatic
Animals
Fishincand L
" Sports Gear ^
'
Land „
Plants
^ ^^r^^^
ion — ^ ,
|
1 . LJ^
f Animal
{MilkV*
! ^^-^
IMeat|->-
— itir.FSTinN
*• MAN
Figure 2. Pathways between radioactive
materials released to ground and sur-
face waters (including oceans) and
man.
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115
Posquili Atmospheric Stobility Condi)
A Extremely unstable
6 Moderately unstable
C Slightly unstable
D Neutral
E Slightly noble
F Moderately stable
Figure 3. Estimated distance of maximum ground
level concentration as a function of
Pasquill atmospheric stability conditions
and stack height in meters.
Condition 'B'
Wind rose dolo plotted OS a (unction of
Posqotll atmospheric stobilil, conditions
Condition 'D'
bos d on annual
aveirnge wind rose
Figure 4. Air particulate sample
sites around a nuclear power
facility based on Pasquill
atmosphere stability conditions.
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116
Annual average
wind rose
mple 2
Using 3 prevail
and srobiEity ce
fiaure 3
( o ) Nucleoi
( b ) Sample
< c ) Sample
( d ) Sample
I , 1 Sample
( f ) Control
( 5 ) Sample
ih) Sample
( i ) Sample
wind directions Using the prevailing wind direction
lion 'B' from ond stability conditions B,C, & D
from figure 3
wer facility site
; ot populction center
• at 0.6 km north based on stability condition 'B'
! at 0.6 km southwest based on stability condition '&'
; at 0.6 1cm northeast based on stability condition *B*
t at >20 miles
e ot Q.6 km north based on stability condition 'B'
•at 1.5km north bused on stability condition *C'
e at 3 km north based on stability condition 'D'
Figure 5. Air particulate sample
sites around a nuclear power
facility based on annual average
wind rose data.
Relative Surface
Water Velocity Profiles
(a) Upstream site above plant influence
(b) Directly downstream of outfall
(c) Downstream site where flpw is greatest
(e) River widening
(0 At dam
(g) Fresh water-salt water interface
Figure 6. Suggested sediment sampling locations,
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117
Within the Guide, Table 1 summarizes the recommendations for sampling
and analysis and collection frequency; these will be outlined for you
quickly. There are a few changes in the draft I'd like to make verbally
for you here; the first change is related to the recommendation on air
particulates. The recommendation is for three sampling stations at the
sites of predicted annual maximum offsite ground level concentrations
of airborne effluents. The current draft of the Guide has a phrase which
says: "In the prevailing wind direction." We are suggesting the deletion
of that phrase. We're recommending air particulate sampling spots at
each population center within a 10-mile radius and we're suggesting one
at a 20-mile distance as a control for the least prevalent wind direction.
Finally the recommendations are as listed--gross long-life beta at filter
change and composite for gamma isotopic analysis, and, as indicated,
radiostrontium analysis.
Air iodine is collected by means of a charcoal cartridge. Essentially
the same sampling locations are suggested for air iodine. Here is, what
I consider, a balance of our requirements; the iodine collection is not
continuous in terms of the analysis--it is continuous in terms of the
collection. The people that are responsible for offsite surveillance
are going to have to rely on data from the reactor itself in order to
trigger a shorter frequency in terms of analysis.
The next entry shows the direct radiation measurement. For the light
water operated reactor, this can be a very important measurement. It
is probably the most important in terms of predicting what the exposure
might be under the expected conditions. We're recommending at least six
sites, depending upon wind direction and maximum offsite dose situations;
two additional ones at the point of maximum population exposure; and one
at greater than 20 miles in the least prevalent wind direction.
Although a gamma dose periodically is a recommendation here, we should
consider the possibility of a rotation of these samples in order to pro-
vide a continuous record of external levels of radiation; that is, we
might wish to stagger the collections in order to get a more frequently
measured dose.
Next to the sampling at surface water. The minimum collection require-
ment is one upstream, one downstream; monthly collection frequency. The
isotopic analysis I will ask Ed Baratta to comment on if you have questions.
The gross beta and the gamma isotopic analysis is monthly, and a composite
for tritium and radiostrontium. This is in relation to existing standards
in the water radioactivity area.
-------
Table. 1.
ope/ut&.mj
caolzd
powe/t
00
Operation or
sample type
Approximate number of samples and
their locations
Collection
frequency
Analysis typea and
frequency
Air particulates 3 sites at location of predicted
annual maximum offsite ground
level concentration of airborne
effluents.
1 at each population center
within 10-mile radius.
1 at greater than 20-mile
radius in least prevalent
wind direction.
Same sites as for air
particulates.
Air iodine
Direct
radiation
At least 6 sites at location of
predicted annual maximum offsite
dose at ground level, including
one or more in each prevailing
downwind direction.
2 at point of maximum popula-
tion exposure.
1 at greater than 20-mile
radius in least prevalent
wind direction.
Continuous collec-
tion- -filter change
as required.
Continuous collec-
tion- -canister
changes as required.
Quarterly
Gross long-lived
at filter change.
Composite for gamma
isotopic analysis
and radiostrontium
analysis^ quarterly.
Standby (analyze
weekly when radio-
iodine is indicated
by stack monitor).
Gamma dose quarter-
ly-
See footnotes at end of table.
-------
Ta6£e /.
Surface water
opvt&tinQ tight-wat
-------
J.
op&icuting ti
Operation or
sample type
Approximate number of samples and
their locations
Collection
frequency
Analysis type and
frequency
Milk
Fish and
shellfish
Fruits and
vegetables
1 sample at nearest offsite dairy
farm in the prevailing downwind
direction.
1 sample of milk from local dairy
representative of milkshed for
the area.
1 of each of principal edible
types from vicinity of outfall.
1 of each of the sample types
from area not influenced by
the discharges.
1 each of principal food
products grown near the
point of maximum predicted
annual ground concentration
from stack releases and from
any area which is irrigated
by water in which liquid
plant wastes have been dis-
charged.
1 each of the same foods grown
at greater than 20 miles dis-
tance in the least prevalent
wind direction.
Monthly
Semiannually
Gamma isotopic analy-
sis and radiostrontium
analysis monthly .
Gamma isotopic analy-
sis semiannually.
Annually
(at harvest)
Gamma isotopic analy-
sis annually.
Annually
(at harvest)
See footnotes at end of table.
-------
Tabte. 1.
auwexXfconcc ofi operating tiQht-wa£&i-c.oole.d nudtzcUi pow&i
(c.ont'd)
Operation or
sample type
Approximate number of samples and
their locations
Collection
frequency
Analysis type and
frequency
Meat and
poultry
Quality,
control
Meat, poultry, and eggs from each of
the principal types fed on crops
grown within 10 miles of the
facility at the prevailing down-
wind direction or where drinking
water is supplied from a down-
stream source.
Samples as required for accurate
sampling and analysis.
Annually during or
immediately follow-
ing grazing season.
Gamma isotopic analy-
sis annually.
Minimum frequency —
annually.
Gamma isotopic analysis means identification of gamma emitters plus quantitative results for
radionuclides that may be attributable to the facility.
Particulate sample filters should be analyzed for gross beta after at least 24 hours to allow
for radon and thoron daughter decay.
GRadiostrontium analysis is to be done only if gairnia isotopic analysis indicates presence of
cesium-137 associated with nuclear power facility discharges.
T'or facilities not located on a stream, the upstream sample should be a sample taken at a
distance beyond significant influence of the discharges. The downstream sample should be taken in
an area beyond the outfall which would allow for mixing and dilution. Upstream samples taken in a
tidal area must be taken far enough upstream to be beyond the plant influence when the effluent is
actually flowing upstream during incoming tides.
'If gross beta exceeds 20 pCi/liter.
-------
Tabtt /. O^Ux, AuAvexX&ince o£ ope/totcng tigkt-wat
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123
One or two samples of ground water are recommended from the sources
most likely to be affected. You will note that the requested analyses
are gross beta, gamma isotopic analysis, and tritium quarterly.
The table also covers the drinking water sampling requirements; any
supplies that could be affected within 10 miles. This we consider to
be a very important measurement. We're recommending continuous propor-
tional samples, but the provision is for interim use of a grab sampling
if you can find proper reasons why continuous proportional samples are
not available.
Sediment samplers, we think may be indicators of long-term buildup,
to make sure that we don't have an unusual situation in the environment.
We're relying again on the gamma isotopic analysis on a semiannual basis.
Milk sampling is recommended. If the reactor system is working as
it should, we should see little or no radioactivity in milk, although
any departure from normal may open up the iodine pathway with its possi-
bility of reconcentration. The milk sampling situation needs to be con-
sidered. The milk pathway needs to be covered and one sample at the near-
est dairy and one sample which is representative of the milk shed is
suggested. Monthly sampling is required. I think if you examine this,
this is a reasonable requirement in terms of prevention.
Fish and shellfish sampling is recommended. If there are any really
important points that should be raised here, we sure would like to have
them. We plan to quickly go to press with this and these figures are
the basic recommendations. Here is a change in the Guide, we are de-
leting "and tritium" from Table 1 in the analysis area. We think there
is very little need for tritium in shellfish unless there has been a
problem shown.
Table 1 also contains the fruits and vegetables sampling recommenda-
tion, as well as that for meat and poultry. The recommendations here
are to include a collection of samples from poultry where there is the
question of the use of the drinking water as a supply and within a radius
of 10 miles.
Quickly some estimates of cost and we'll ask for your comments on
these also. We estimate the cost of this sampling program will range
between $100,000 to $150,000 with 2 man-years of effort during the first
year. That's assuming you're setting up your own radioanalytical capa-
bility and setting up the sample collection system. With respect to the
continuing annual operating cost, we think of something like 1.5 man-
years and a range of $30,000 to $50,000. It may be possible to do this
for less on a different basis, but we believe this is a reasonable esti-
mate. I'd like to have your suggestions. We won't go into the recom-
mendations on sampling techniques, which are in the text.
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We think an environmental radioactivity surveillance program for
reactors is an important part of radiation control programs. We believe
that the reactor operator and, of course, the Atomic Energy Commission,
through its licensing responsibility, needs to look very carefully at
the radionuclide inventory and the procedures for containment at the
reactor site. We also believe that the reactor operations--the indus-
try—should provide accurate measurements of the radionuclide discharges
quantitatively and make a reasonable effort to project these discharge
data to population dose. We would also expect that the Environmental
Protection Agency and the State agencies would want to see what the dose
would be to the population, based on the available data from the plant.
This program should be supplemented with an environmental radio-
activity monitoring program such as has been suggested here today, and
it should be coordinated and controlled, and its quality checked by a
proper system of analytical quality control services, and there finally
should be good interpretation of the data and public reporting on the
environmental radioactivity data and the population dose values.
DISCUSSION
MR. MATUSZEK: I will make my comment and question for Marshall Parrott's
benefit. Don, you are a member of the Committee called "Environmental
Surveillance and Analytical Control." We had a 3-hour meeting yesterday
afternoon discussing just these problems. My question is, where were
you and where was your Guide when we needed just this kind of discussion
on what to do and how much?
MR. NELSON: We got in late yesterday. Phil Cuny, Ed Baratta, and I will
be happy to meet with you, either separately or at any time during the
remainder of this session.
MR. MATUSZEK: There's another meeting at 1:30 this afternoon.
MR. NELSON: We plan to be there.
MR. GERUSKY: Two questions. One, your estimates on cost. Were they
based on one reactor or a number of reactors; $30,000 to $50,000 per
reactor, or per year; and how do you arrive at that number?
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MR. NELSON: The initial cost in terms of setting up, I think, is largely
a matter of instrumentation, and so forth. We took the 1.5 man-years--
that is sort of a salary situation. You're talking about say $50,000
or $20,000 in terms of the salaries for the people involved. This may
not be the individual. So just something less than $10,000 for operating
cost, just samples and travel.
MR. GERUSKY: Per reactor?
MR. NELSON: We are assuming that you may have to set up a program for
a single site. There may be multiple reactors at the site.
MR. GERUSKY: We are talking about per site $30,000 to $50,000.
MR. NELSON: You think they're too high?
MR. GERUSKY: No. I think they're too low. As far as 13 sites, what
kind of money are you talking about per year for your kind of program?
MR. NELSON: I would suggest that if you have complicated sites, separated
sites, travel costs, you could very easily run the cost up. We made an
estimate.
MR. GERUSKY: Everybody has. But it would be nice to use it in a budget
proposal. The second question I had was on your iodine dose surveillance
program. Let's face it. With present reactors, under normal operating
conditions, you're not going to find any iodine in your milk sampling
in a dairy. Why not the "maximum cow" probability? Find the maximum cow;
sample him; in addition to the other. It's been discussed at a few sites,
and if you can find a cow downwind that is eating the grass, it might
be the most important measurement that we make to find something.
MR. NELSON: You have raised a good point Tom. This is designed for the
minimum program for the routine situation. There is no reason why, if
you can find supplementary or alternate means which give you a better
answer at a lower cost, or provides the necessary data, to go that route.
MR. GERUSKY: This should be in addition to the general dose surveillance
program, but I think if you want to find what the worst possible case
is, you try to find the cow that is downwind eating the grass.
MR. NELSON: I think we try to do this by calculation or hypothetically
or by prediction. But to try to do this by actual test measurements in
the field, it might be quite expensive. If. you can afford it, fine. It
sounds like a good idea.
MR. GERUSKY: One cow?
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MR. NELSON: Finding that cne cow might be rather expensive.
MR. CASHMAN: We haven't had the benefit of looking over your Guide and
you indicated that you were going to try to rush it into print. I would
suggest that you give us an opportunity in the States to review it and
to get comments back to you.
MR. NELSON: How much time would you like?
MR. CASHMAN: I would think in the neighborhood of 3 to 4 weeks.
MR. NELSON: You've got it.
MR. CASHMAN: From this standpoint, that as you put this out, and you
begin to talk of this as a minimum requirement, it will quickly become
an imposition. As somebody pointed out at public hearings, there will
be questions as to why this hasn't been done if it isn't being done
already. There are some places, such as your silt samples. You may have
quite a few of those called for and we need to know if they're necessary.
There are problems of placing these at the point of maximum exposure,
and I think we need to discuss how we calculate where your maximum expo-
sure is before you begin to put some identification out. I think we need
3 to 4 weeks.
MR. WEAVER: New York commented on this Guide. John commented on it.
This Guide was sent out to all the Regions.
MR. MATUSZEK: No. I didn't get the whole Guide. I only got Phil Cuny's
bit and I made my comments about that.
MR. WEAVER: This particular Guide was distributed to the Regional Repre-
sentatives and to all the States 4 or 5 months ago. Everybody had an
opportunity to comment on it.
MR. NELSON: unless there are serious objections, let's keep the record
open for a month.
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NATIONAL QUALITY CONTROL PROGRAM
Edmond J. Basuvbta.
Surveillance and Inspection Division
Office of Radiation Programs
Environmental Protection Agency
Winchester, Massachusetts
The Analytical Quality Control Program provides radiochemical stan-
dards and quality control for analytical and radiation measurements to
the EPA laboratories and State radiological health programs in connection
with measurement of radioactivity in environmental samples as a result
of radioactive fallout. Because of the increased use of power reactors,
this program has been redirected to provide services to evaluate the
quality of the environmental radiation surveillance data obtained by
Federal and State agencies and utility companies and/or their contrac-
tors in the vicinity of operating nuclear facilities. It has also_been
extended to assure that the data resulting from the reporting require-
ments under the AEC Safety Guide 21 are of sufficient quality so that
they may be used for estimating population dose.
Participation in these programs by the nuclear facilities or their
contractors is expected to increase significantly in the future. In
order to perform this program the Analytical Quality Control Service
(AQCS) operates several types of cross-check programs for the analysis
of radionuclides in environmental media such as milk, food, water, air,
and soil.
The purpose of these cross-check programs is to enable these lab-
oratories in the field of radiation to assure the quality of their data.
Water Program: The water program was originally designed to cross-
check water samples received from the interstate carrier water program.
The nuclides of interest at that time were gross alpha and beta measure-
ments, strontium-90, and radium-226. With the advent of the nuclear
reactors, tritium was added to the nuclides. This program has expanded
rapidly during the past year in that participants, such as States, nuclear
facility operators, national radiation laboratories, and so forth, need
to assure themselves that their data meet the established criteria. The
samples are submitted on a bimonthly basis and reported immediately to
the laboratories upon receipt of their data so that they may make cor-
rections when necessary.
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128
The Water Program, also includes a sample for the analysis of gamma
emitters usually found from reactor effluents. The radionuclides pres-
ently included in this program are cesium-134, cesium-137, cobalt-58,
cobalt-60, and zinc-65. Other nuclides such as chromium-51, ruthenium-103
or 106, and cerium-141 and others will be added in the near future. Mock
reactor solutions containing these nuclides plus others, such as mangan-
ese-54, "iron-59, and yttrium-88, will also be submitted. These mock
solutions will be submitted to the participants in a routine program and
as possible technical experiments.
A tritium technical experiment is normally conducted annually. In
addition to the routine participants, other agencies, such as hospitals,
private laboratories, and so forth, participate. This technical experi-
ment enables the participants to evaluate the methods and instrumentation
used in their analyses. It normally carries a critical level of radio-
activity and includes a biological sample.
Milk Cross-Check Program: The milk cross-check program provides
quality assurance for results obtained from the National Environmental
Radiation Monitoring Program. The samples are submitted on a monthly,
bimonthly, or quarterly basis depending upon the needs of the partici-
pating laboratories. The analyses requested for this program are cesium-
137, barium-140, iodine-131, strontium-89, and strontium-90. These are
the nuclides normally found in milk from fallout or from reactors. In
addition, a technical experiment is conducted annually in order to pro-
vide assurance to those laboratories not normally participating on a
routine basis so that their data may also be evaluated. This technical
experiment also provides further input into the operation of each lab-
oratory by allowing them to assess the operational condition of their
equipment and their methology.
Food Cross-Check Program: The food cross-check program was designed
to augment the nationwide institutional diet network program. The sam-
ples are sent out on a quarterly basis and consists of synthetic foods
made up and spiked similar to the milk samples. While it still serves
this purpose, it also enables the States and utility companies to assess
the environmental media in a form of foodstuffs which are obtained from
surveillance points around these nuclear facilities. The nuclides of
interest are similar to milk with the addition of manganese-54, zinc-65,
and zirconium-niobium-95. These are normally found in fallout also.
Soil Samples: Soil samples are distributed on a triannual basis.
The radionuclides of interest are similar to those of the water gamma
sample. In addition these samples contain naturally occurring radium
and thorium; however, we normally send out background samples so that
these two interfering nuclides may be eliminated in the analysis.
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129
Plutonium Environmental Samples: The plutonium environmental sam-
ples are sent out to the EPA laboratories and selected State and Federal
laboratories. The plutonium samples consist of a synthetic sea water
sample, a soil sample in which the plutonium has been oxidized, and an
air filter sample. These are distributed on a bimonthly basis with each
environmental medium being distributed three times a year.
New and Projected Programs
Gaseous Analyses: The first cross-check krypton-85 sample was sent
out in January 1972. This sample served a dual purpose. It was a
krypton-85 standard carried on natural krypton gas containing environ-
mental levels of krypton. This sample served as both a krypton-85 gas
standard and cross-check sample. The sample was sent to the Western
Environmental Research Laboratory, Eastern Environmental Radiation Lab-
oratory, Radiochemistry and Nuclear Engineering Laboratory, New York
State Health Department, and the SID Field Operations Branch at Winchester,
Presently an economically feasible container is being developed for
distribution to the utility companies and State health departments that
have requirements for measurement of krypton-85. This program will con-
sist of environmental krypton-85 and krypton-85 effluent from nuclear
reactors. The former type will be for those laboratories having the
capability of handling the krypton-85 for either liquid scintillation
or gaseous counting. The latter type will permit the utility companies
and other participating laboratories to perform gamma analyses for
krypton- 85.
The cross-check sample for xenon-133 gases is in the preliminary
stages. The sample has been obtained and standardized. It is being
distributed to selected participants prior to being submitted as a
cross-check sample. The container used for krypton-85 cross-check
program will also be employed for the xenon gas cross-check program.
Nuclear Facilities Discharge Effluent Cross-Check Program: The
levels for the offsite nuclear facilities surveillance programs present
no problem since they are in the same range as the previous fallout sam-
ples. The discharge effluent type samples within the nuclear facilities
are at a much higher level. A study of this problem is being undertaken
and is being integrated into the Analytical Quality Control Program.
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130
Radionuclide Distribution and Calibration Program
Radionuclide Distribution: The Analytical Quality Control Service
distributes low-level radioactive standards in order to augment its cross-
-check program. These levels are in a magnitude of 25,000-100,000 dpm
per gram solution with an accuracy of 1 to 2 percent at a 2-sigma level.
Since these low-level nuclides are not commercially available, the AQCS
has been providing these standards to the participants of its cross-check
programs in order that they may be able to calibrate their equipment
prior to receiving samples for analysis. The utility companies and/or
their contractors are also supplied these nuclides so that they may also
meet the criteria established by the AQCS for cross-check samples. The
standards that are available commercially are of a magnitude of 10 or
higher and it has been found that many mistakes have been made through
dilutions of these higher level standards resulting in poor calibration
of equipment and poor standardization of their methodology.
The EPA laboratories are provided with certain nuclides which are
short-lived and are not normally carried in their stock.
Calibration Services: The calibration services are maintained in
order to assure the accuracy and precision of dilutions made from the
higher level standards received from commercial suppliers. In addition,
short-lived nuclides, which are not available commercially, may also be
standardized.
Reference calibration of gamma standards by sodium iodide detectors
is made by AQCS to insure the integrity of the dilutions and the accuracy
of the purchased standards. Standards are gamma scanned for radiochemical
impurities either on sodium iodide or on germanium-lithium drifted crys-
tal detectors. Primary standardization is performed on 4-pi alpha and
beta counters for alpha and beta standards, respectively. Secondary
standardization or comparative counting is also performed on sodium
iodide crystals by AQCS on short-lived radionuclides, such as iodine-131
and barium-140. The AQCS has recognized that the National Bureau of
Standards is the Federal agency with the responsibility for providing
primary standards to users for a reasonable fee. As a result, AQCS will
use the MBS as its source for this nuclide when they are available, and
it is also in the process of establishing traceability to NBS.
State Participants
Relation with States: Presently there are 27 States participating
in the AQCS cross-check programs. A total of 39 are also included in
the radionuclide distribution program. They are also provided upon re-
quest with technical assistance in the area of quality control. The
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131
cross-check programs are designed to fit the needs of the State lab-
oratories in that the range of environmental media covered and radio-
nuclides found are suited for analyses from surveillance around nuclear
facilities and from fallout where background levels are determined prior
to the operation of proposed nuclear facilities.
Technical Assistance: The AQCS offers a followup service to the
States participating in the cross-check program or in a technical experi-
ment. Whenever a laboratory exceeds the prescribed control limits, the
AQCS will contact them. If the laboratory feels that it needs technical
assistance either in calibration, radiochemistry, or methodology, it
should contact the EPA Regional Radiation Representative. The EPA
Regional Radiation Representative will consult the AQCS or one of the
EPA area laboratories to obtain assistance for the State laboratory.
Utility Companies
The AQCS maintains liaison with the utility companies in the opera-
tion of their environmental radiation programs around reactors either
with the company itself or with their designated contractors. Four utili-
ty companies take part in the AQCS cross-check program. Presently there
are eight contractors taking part in the nuclear cross-check program.
Between the four utility companies and the eight contractors, all of the
operating reactors now take part in one or more of the programs. In
addition, we have provided 16 utility companies with standards for in-
ternal calibration. It is proposed to eventually conduct a program to
assure the data from within the plant.
Collaborative Studies
In order for the AQCS to properly carry out its mission and to
remain in the forefront of Radiation Quality Control, it is necessary
for the program to assist in the development and promulgation of stan-
dard methods. The AQCS assists the societies in this area by conducting
round-robin testing of methods for the acceptance by the societies. The
AQCS assists the following societies: American Society for Testing Mate-
rials, American Public Health Association, and Association of Official
Analytical Chemists, Through these societies, the AQCS maintains con-
tacts with other private laboratories, universities, and other Federal
agencies. The Office of Monitoring has recently recognized AQCS as the
primary program to carry out method standardization for the EPA in
radiation.
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132
Activities with Other Agencies
The AQCS maintains liaison through its cross-check programs with
other Federal and international agencies. This includes the Army operated
nuclear reactors and the Air Force Radiological Health Laboratory at
Wright-Patterson Air Force Base. The U.S. Geological Survey in Denver,
Colo., also takes part in the water cross-check program. There are pres-
ently three national radiation laboratories participating in some phase
of our water cross-check programs. These are Brookhaven, Argonne, and
Lawrence-Livermore. Also, the AQCS maintains cross-check programs with
the national radiation laboratories of Canada and New Zealand in the milk,
food, water, and soil cross-check programs. The AQCS has contacts with
the IAEA in Vienna and the International Reference Center for Radioactiv-
ity, WHO, in France. AQCS has liaison through personal contacts with the
Bureau of Standards in Washington and with the Radiochemical Centre at
Amersham, England.
DISCUSSION
MR. BUDNITZ: I'd like to make the point that the Federal Government,
through the EPA and the AEC, has tremendous leverage over the States,
the utilities, and the national laboratories, on data reporting. I
think that one very essential requirement would be that contracts and
cooperation should be contingent upon full cooperation with this type
of program and that data reporting which is not in agreement with it,
and which should not be public controlled by this program, should be
discarded; not because it's not good data (we'll store it somewhere),
but because that's a useful mechanism for forcing the reluctant States,
reluctant utilities, to use this quality control. Quality control is
the essence of all data reporting.
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DATA ANALYSIS AND DOSE MODEL DEVELOPMENT
PluLcp A. Cany
Surveillance & Inspection Division
Office of Radiation Programs
Environmental Protection Agency
The Surveillance and Inspection Division is responsible for obtain-
ing baseline data on the levels of existing environmental radiation,
determining any changes occurring in the radiological quality of the
environment, determining the magnitude of this change and the nature
and probable sources of contaminant, and providing data for estimating
population exposure. It is further responsible for publishing periodi-
cally environmental radiological data which is obtained from Federal,
State, and utility surveillance programs.
To discharge these responsibilities, the Surveillance and Inspec-
tion Division is establishing an automatic data processing system called
the National Environmental Radiation Data System or the NERADS.
The NERADS will provide a data management capability for the manage-
ment of environmental data and an environmental modeling capability for
the calculation of population dose.
If one reviews each of the responsibilities shown in figure 1, it
becomes obvious that the solution to each requires the collection and
processing of a lot of data. In recognition of the requirement to pro-
cess data, a systems design study for a data management system was con-
ducted under contract by the Battelle Pacific Northwest Laboratories.
This study was started August 1971 and was completed at the end of last
January.
This study provided a basic design for a system for the collection,
storage, and manipulation of environmental radiation data necessary to
accomplish our division's responsibilities. As envisioned in the study,
the system would serve as a central source of environmental radiation
data for the United States which would be used to assess the impact of
environmental radioactivity upon man. The system would be used to assist
in the analysis of radiological conditions for any area of the United
States and would provide information for the detection of trends, long-
term buildup of radioactivity, and to assess the influence of nuclear
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134
RESPONSIBILITIES
• OBTAIN BASELINE DATA ON THE LEVELS OF EXISTING
ENVIRONMENTAL RADIATION;
• DETERMINE CHANGES IN THE RADIOLOGICAL QUALITY
OF THE ENVIRONMENT;
• DETERMINE THE MAGNITUDE AND NATURE OF THE
CHANGE IN THE ENVIRONMENT;
• IDENTIFY PROBABLE SOURCES AND TYPES OF
CONTAMINENT;
• ESTIMATE POPULATION EXPOSURE;
• PUBLISH RADIOLOGICAL DATA OBTAINED FROM
FEDERAL, STATE AND UTILITY SURVEILLANCE
PROGRAMS.
Figure 1
industry effluents on environmental conditions. Included in the study
was a survey of models and the development of recommendations for a
model which might serve our purpose.
I have mentioned several times that the system will be required to
process a large amount of data. I would now like to define the data
that the system must handle.
Shown in figure 2 are the general categories of information the
system must handle.
To acquire nuclear facility surveillance data, we are negotiating
contracts with States for data that they collect under their State pro-
grams to monitor nuclear power facilities. An Environmental Surveillance
Guide has been prepared and contains general guidance concerning sur-
veillance and types of data that should be gathered to monitor nuclear
facilities. A description of the NERADS has been also prepared in draft.
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135
NERADS DATA
• Nuclear Facility Surveillance Data (Including
Inspection Data)
• EPA Network Data
• Population Data
• Demographic Data
• Meteorological Data
• Hydrological Data
• Nuclear Facility Source Term Data
Figure 2
The draft has been circulated for comment to those States which currently
have operating nuclear facilities and a second draft has been prepared.
I have not sent that draft out for comments as yet for reasons that I
will get into a little bit later.
At the present time there is a considerable amount of data stored
on magnetic tapes concerning the Pasteurized Milk Network, the Institu-
tional Diet Network, and the Human Bone Network. These data are main-
tained and updated and processed for us by the Bureau of Radiological
Health. We would like to pick up this information and place it into
our system.
In order to calculate population exposure we basically need the
remaining five items shown in figure 2. We need population data for
population distribution, we need demographic data, we need meteorologi-
cal data to find out where our effluents are going, we need hydrological
data to calculate what's happening in water transport models, and of
course we need source term data which can be obtained from the AEG
Safety Guide 21 reports.
These then are the general categories of information which will
serve as input and be stored in the NERADS data base.
I will now discuss the concept of information flow in the NERADS
from the collection of a sample to the output of information.
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136
Information concerning the results of sample analysis will be gene-
rated at analytical laboratories--either Federal, State, utility, or
contractor--and forwarded to the NERADS data processing facility. Because
some sample sites will be located in areas under the influence of nuclear
facilities and others outside these areas, the information forwarded
to the data processing facility will thus provide data concerning the
impact of nuclear facilities on the environment and also provide back-
ground information.
At the data processing facility reports will be screened and edited
prior to input to the NERADS data management system.
The data management system will consist of a generalized computer
information management system which will allow retrieval of data from
its data base in formats tailored to user requirements.
The design goals of the data management system will be to provide
the capabilities shown in figure 3.
NERADS SYSTEM DESIGN
GOALS
• Retrieval of data on a selective basis
• Geographic retrieval
• Retrieval of data arranged for pathway analysis
• Presentation of trends and long term buildup
• Statistical analysis.
Figure 3
A capability to selectively retrieve data is desired. Essentially
we desire the ability to retrieve data by media (for example milk, air,
water, desposition, vegetation, and animal) and by site, groups of sites,
counties, standard metropolitan statistical areas, States, surveillance
agencies, or by EPA networks.
A capability to retrieve data on a geographic basis is also required.
The geographic retrieval would allow one to specify a geographic area
by latitude and longitude boundaries and retrieve specified data that
has been reported for that area.
Data which will allow analysis of critical pathways to facilitate
environmental analysis activities would obviously be useful.
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137
The ability to determine trends and detect the buildup of environ-
mental radioactivity are necessary outputs. The use of a computer system
is well suited for these purposes.
Lastly, the system must have the ability to perform statistical
analyses, and present raw data required for standard reports and to
meet the requirements of special studies. An example of standard reports
would be the network data normally presented in Radiation Data and
Reports.
In addition to the data management capabilities I have just discussed,
the NERADS will also include an environmental modeling capability.
There are a number of models in existence which have been designed
to calculate the dose to man from nuclear power facilities. These models
range in ability from relatively simple models, which only consider the
dose to man from immersion and inhalation effects from air, to highly
complex models, which attempt to consider all pathways. Figure 4 shows
those areas, for which models have been developed.
MODEL CAPABILITIES
* Air Pathway * j00
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Figure 5 presents requirements a model or models should possess
for our use.
The first two requirements are similar; however, the models we have
reviewed to date generally fall into two different classes. One class
which I'll call the regional model is designed to accomplish the first
requirement. The AEC Year 2000 Dose Model falls in this class and is
not as well suited as other models for the second requirement.
MODEL REQUIREMENTS
• Calculate regional and national dose
• Calculate dose to critical populations
• Verify and supplement surveillance data
• Estimate environmental impact
c Support inspection activities.
Figure 5
Models can also be used to guide surveillance activities and verify
results. Because concentrations in the environment may fall below detec-
table limits, models offer the means to assess the dose contribution
from a number of low-level concentrations.
A model which will allow assessment of the impact of future nuclear
power facilities would be useful in the determination of the environmental
effects of future facilities.
Finally, a highly detailed model could be used to support inspection
activities. Such a model could be used to help determine sampling
locations, as well as calculate dose.
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Although there are models available in the form of computer programs
which can be used for environmental modeling, we to date have found no
single model capable of meeting all of our requirements. For the calcu-
lation of a regional or national dose the Year 2000 Dose Model with modi-
fications seems to be the best currently available. There are several
other odels to assess the dose to the critical population close to
facilities which might be used to meet our other requirements. One item
I would like to mention, which is common to all models, is the problem
of developing a data base of meteorological, hydrological, demographic,
and population data upon which the model, using source term data as in-
put, operates to calculate dose. For instance the exjansion of the data
base for the Year 2000 Dose Model, which is now limited to the upper
Mississippi River Basin, to include the remaining area of the United
States has been estimated to be a 4 to 5 man-year effort.
So far today I have spoken about our plans and requirements for a
data management system and dose modeling capability. I would now like
to discuss the status of our efforts.
As I mentioned earlier, the Battelle Northwest Contract furnished
a recommended system design for the management of surveillance data and
a generalized computer data management system to implement the design.
We have evaluated the design and recommendations.
At the present time several proposals in response to a headquarters
EPA request for proposal for a single data processing facility are being
evaluated. The net results of this evaluation insofar as our program
is concerned will be to define our choice of computer data management
systems. Upon the completion of the evaluation of proposals and selec-
tion of a vendor we will proceed to set up the initial data management
capability for our program. Likely candidates for the data system are
the STORET system used by the water quality office, the Inquery and Re-
trieval System, IRS, used by NIH and EPA and whatever system is offered
by the selected vendor. In the meantime we are going to direct our efforts
to the development of input data and system test data.
In the areas of modeling, we plan to continue our evaluation of
several more models and then decide upon an appropriate course of action.
Our initial efforts for the data management system will be the col-
lection of data resulting from new State contracts and placing the data
in the system. These data will be mostly concerned with nuclear facility
surveillance although some other data may be collected. Our next step,
which may be concurrent with the collection of State data, will be the
incorporation of EPA network data into the system.
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In conclusion, I would like to summarize the points I have covered.
1. The NERADS is being developed to provide a central source for
the collection, assimilation, and manipulation of environmental radiation
surveillance data. It will include a modeling capability to assist in
the calculation of dose, assess the impact of future facilities, and
support surveillance and inspection activities.
2. In the area of data management, we have concluded the system
study and developed our detailed requirements of surveillance and re-
porting of surveillance data. The implementation of the data manage-
ment system on hardware will be made upon the completion of the evaluation
of the new proposal for an EPA headquarters computer facility. This
evaluation should be completed by the first of July. Once the data manage-
ment system is established it will serve as a source of information for
both EPA and the States.
3. Concurrently with the construction of the data management system,
we will develop our model capability and that will be used to calculate
dose, determine the impact of future facilities, and finally, to assist
in the surveillance and inspection activities.
DISCUSSION
MR. HARDIN: It appears from your discussion that the model was basically
designed for entire facilities. I'm wondering, is consideration given,
and how would the model apply to shallow waste burial sites?
MR. CUNY: I haven't really looked at this so much. But I think back on
the model capabilities, they do do things such as ground water, and if
this would be a transport mechanism for it, we might be able to model
waste. There's a lot to do in the way of modeling. We haven't looked
at that particular problem yet.
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TECHNOLOGY ASSESSMENT
V.
Acting Director
and
CMU.Q I. Robwte
Technology Assessment Division
Office of Radiation Programs, EPA
Mr. Harward: In our present technological society, the words "Techno-
logy Assessment" are so-called "buzz" words. "Technology Assessment"
as described by the House Subcommittee on Science, Research, and Devel-
opment chaired by Congressman Daddario, is a method "to characterize
the socio technical research that discloses the benefits and risks to
society emanating from alternative courses in the development of scien-
tific and technological opportunities." Technology Assessment, in its
current usage within the Office of Radiation Programs, denotes the
advance evaluation of all forms of radiation technology that is being
developed or that might be developed to determine its future impact on
the environment and on society.
Obviously, we in the Office of Radiation Programs are not living
in the past with respect to technology assessment, but the required
NEPA assessments related to the radiological impact of current projects
has substantially limited our program activities to the present for the
time being.
It is important when we utilize or apply technology that we know
what the character and degree of its impact on the environment will be.
The National Environmental Policy Act of 1969 was a major step forward
in this direction. Craig Roberts will have a lot to say about the work
we have done under NEPA to evaluate the impact of nuclear power stations
and other radiation related facilities.
At the present time, the majority of our efforts with the Technology
Assessment Division are directed to responding to the requirements of
NEPA by reviewing and commenting on environmental impact statements. At
last year's conference, Floyd Galpin, the other branch chief in the Tech-
nology Assessment Division, described the environmental statements for
nuclear power stations required by NEPA and the review they are given by
EPA. Since that time, major changes have taken place largely because of
the so-called Calvert Cliffs decision that have had widespread effects.
The program of my division, for example, has been overwhelmed by the
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review requirements that have come from that decision. Mr. Roberts will
discuss NEPA and the problems related to nuclear power plants in a few
moments. First, however, I would like to indicate to you the breadth
and scope of our impact review activities to give you a perspective of
the total problem we are attempting to tackle.
In addition to nuclear power plants, we, of course, receive environ-
mental impact statements from the regulatory side of AEC on fuel repro-
cessing plants , uranium mills , and fuel fabrication plants . From the
General Manager's side of the AEC we receive statements from major
proposed or modified facilities which include a variety of projects such
as the Rocky Flats plutonium facility, Lyons, Kansas high-level waste
repository, nuclear gas stimulation tests, LMFBR demonstration plant,
the bed-rock waste storage facility, and an assortment of other highly
complex eye-openers. Added to this are NASA satellites and space probes
containing radioactive power sources, and an occasional radar installation
from the Department of Defense. All in all, we do not suffer from lack
of variety.
The principal point I wish to make is that to do a reasonable job
of technology assessment of these radiation-related projects requires
considerable broad expertise and an opportunity to look ahead to ade-
quately evaluate new uses of radiation before they descend upon us in
the form of impact statements that must be reviewed and reported upon
within 30 days. In other words, our time needs to be better utilized
in developing the assessment of technical issues that can be used in
impact statement comments rather than a full-fledged review effort merely
to meet a deadline. I will go a bit more into these considerations a bit
later, but first, Craig Roberts, who is in charge of our Technology and
Impact Review Branch within the Technology Assessment Division is going
to provide you with an up-to-date story on the Calvert Cliffs decision
and the resulting nuclear power plant review activity.
Mr. Roberts: One of the most powerful means of assessing the environ-
mental impact of a technology that is currently available is provided
by the National Environmental Policy Act (NEPA) . NEPA states that for
every major federal action that could significantly affect the quality
of the human environment, a detailed environmental impact statement must
be prepared by a responsible official. In the case of civilian nuclear
power stations, for example, the responsible official is interpreted to
be the Director, Division of Regulation, AEC. NEPA further states that
the detailed statement should include a discussion of (1) the environ-
mental impact of the proposed action;- C2) any adverse environmental
effects which cannot be avoided should the proposal be implemented; (3)
alternatives to the proposed action; (4) the ^lationshiPa^t!°lt
short-term uses of man's environment and the maintenance and enhancement
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of long-term productivity; and (5) any irreversible and irretrievable
commitments of resources which would be involved in the proposed action
should it be implemented.
In July of 1971, the U.S. Court of Appeals for the District of
Columbia Circuit and Calvert Cliffs Coordinating Committee vs. AEG, pro-
vided the decision of a Federal appellate court construing Section 102
of the NEPA. The court's decision, in summary, does the following:
1. It strikes down the grandfather clause (excluding consideration
of NEPA issues) for hearings pending at the time AEC regulations of
December 3, 1970, are adopted.
2. It requires that AEC implementation of NEPA in all licensing
proceedings after January 1, 1970, take into account an independent AEC
assessment of water quality and other environmental factors; that is,
AEC cannot rely on EPA or State water quality certification or on estab-
lished Federal and State standards in other environmental areas but must
be prepared to make an overall balance of project benefits and environ-
mental costs.
3. It requires that AEC hearing boards give independent substantive
review of NEPA matters in uncontested as well as contested cases. The
Court states specifically that this independent review of the NEPA envir-
onmental statement and an "independent balancing of factors in an uncon-
tested hearing will take some time; if it is done properly, it will take
a significant amount of time."
4. AEC must give prompt NEPA consideration to facilities for which
permits and licenses were issued after January. 1, 1970, where NEPA mat-
ters were not substantively considered in the original licensing deter-
mination. The AEC must order such facility alterations as this review
indicates--but even these alternations may not save the facilities permit
from later judicial reversal.
5. With respect to construction permits issued before January 1,
1970, (for example, the Calvert Cliffs facility) AEC must promptly con-
sider on its own (and be prepared to entertain a show cause request from
a third party) any significant nonradiological environmental impact and
to direct such facility alterations as may be indicated thereby. This
NEPA consideration is not to be deferred until the operating license
review.
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6. The Court does not direct suspension of any permits or licenses
already issued but leaves suspension to AEC's discretion saying AEC
"should consider very seriously the requirement of a temporary halt in
construction pending AEC review and backfitting of technological inno-
vations."
The Court's decision affected 104 nuclear power stations, or all
but four of the nuclear power plants that are operating, being built, in
the design stage, or that have been announced. Four plants, Dresden I,
Yankee Rowe, Hamboldt Bay, and Big Rock Point were granted operating
licenses before January 1, 1970, and therefore do not require a so-called
expanded environmental impact statement.
' The first impact statement issued after the Calvert Cliffs decision
was prepared by TVA for the Sequoyah Plant and issued on October 19,
1971. The first AEC environmental statement after the Calvert Cliffs
decision was issued on December 13, 1971, for the Oconee nuclear power
station. The delay between the date of the decision and the first envir-
onmental impact statement following the decision reflects the greatly
increased effot required in the preparation of a post-Calvert Cliffs
or expanded environmental statement. In terms of EPA's workload, the
effect of the delay was to compress the processing of over 60 expanded
environmental statements into a time frame of approximately 7 months.
The preparation of supplemental and/or expanded environmental impact
statements for 104 nuclear power stations imposed a very heavy workload
on the AEC and a priority ranking of stations was required. The AEC
identified 64 plants which would be delayed if not reviewed in FY 1972.
The Federal Power Commission and the AEC further identified 19 units
whose operations are vital if power shortages are to be averted and
which for that reason should receive first attention. These plants are:
Name of Facility Location
1. Calvert Cliffs 1 Lusby, Maryland
2. Calvert Cliffs 2 Lusby, Maryland
3. Fermi 2 Lagoona Beach, Michigan
4. -Midland 1 Midland, Michigan
5. Midland 2 Midland, Michigan
6. Oconee 1 Seneca, South Carolina
7*. Palisades South Haven, Michigan
8. Pilgrim Station Plymouth, Massachusetts
9. Point Beach 2 Two Creeks, Wisconsin
10. Quad Cities 1 Cardoon, Illinois
11. Quad Cities 2 Cardoon, Illinois
12. Surry 1 Gravel Neck, Virginia
13. Turkey Point 3 Turkey Point, Florida
14. Turkey Point 4 Turkey Point, Florida
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Name of Facility Location
15. Maine Yankee Wicasset, Maine
16. Fort St. Vrain Plattevilie, Colorado
17. Indian Point 2 Indian Point, New York
18. Shoreham Brookhaven, New York
19. Vermont Yankee Vernon, Vermont
Environmental statements for the first 15 have been issued and
we have completed our review of them. Three of the remaining four have
been issued and are now in the review process. In addition, TVA has
issued statements for three stations, Sequoyah, Browns Ferry, and Watts
Bar.
It might be useful to summarize our experience with these statements
since the Calvert Cliffs decision. I will confine these remarks to
the radiological review. Our Division performs the principal radiologi-
cal review. We also coordinate the coranents from other components of
EPA on issues such as water and air quality, noise, and so forth. We
in the Office of Radiation Programs are not involved in these other issues
except as a coordination point within the Agency. In conducting the
radiological portion of the impact review, we have identified a number
of topics which we believe are important to a thorough assessment of
nuclear power plant impact statements. These are:
1. Gaseous Waste treatment systems
2. Liquid waste treatment systems
3. Solid wastes
4. Meteorology and radiation doses
5. Monitoring and surveillance
6. Emergency planning
7. Nuclear plant accidents
8. Transportation accidents
9. Decommissioning.
Circumstances have forced us to give priority attention to three
of the nine topics, viz:
1. Nuclear plant accidents
2. Transportation accidents
3. Radiological source term and radwaste evaluation.
It was determined by the Council on Environmental Quality, Atomic
Energy Commission, and EPA that the first two of these topics have "gen-
eric aspects" which should be resolved on a general basis for all nuclear
plants rather than on a case-by-case basis. We have started to develop
an EPA position on these issues.
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As mentioned earlier, the impact statements which must be prepared
under NEPA constitute one of the most powerful tools available for asses-
sing technological impact. It should be noted at this point that the
tool is not being used to its maximum potential at the present time.
In our review of impact statements, we find ourselves evaluating
the potential environmental impact of plants that, in some cases, are
almost ready to operate or certainly whose construction is well advanced.
If we find some aspect of the plant objectionable we can recommend the
retrofitting of some corrective feature. Such actions are always expen-
sive and we must be quite sure that the expense is justified. Basic
issues, such as the suitability of the site, must essentially be ignored
because there is no way of justifying the cost of not using a completed
plant. We really should be directing our attention to the acceptability
of future actions, such as the siting of plants, which will not be de-
signed for some time to come and while the full range of options for
that plant are still available. In other words, the first environmental
impact evaluation should influence the site selection and plant design.
There is nothing new or profound in this thought. In fact, practically
the same thought was expressed by Judge J. Skelly Wright in his Calvert
Cliffs decision and a power plant siting bill with similar provisions
has been proposed by the Administration. The bill would require that a
utility anticipate the demand for power it must supply and its broad
plans for meeting the demand 10 years in advance. Power plant sites
would have to be publicly identified 5 years in advance of construction
and specific plants would have to be allocated to specific sites 2 years
in advance of construction. In the immediate future, however, we can
expect the present crisis in power plant review will be followed by a
succession of subsequent crises, and that for some time to come we will
be reacting rather than developing a pattern of growth that we can live
with.
There are several other deficiencies in the present system that
should be mentioned briefly. The present system of impact statement
review evaluates individual facilities and does not take into account
the regional growth of nuclear power and the regional effects. Also,
each component of the nuclear fuel cycle is considered independently
of the other components. Thus the environmental impact of reprocessing
spent fuels from a reactor is not considered at the time that the impact
of the reactor plant is evaluated. Several improvements in the system
are sorely needed. The review effort that is now going into impact state-
ment review should be redirected, much as possible, into the development
of guidelines for the acceptable growth of nuclear power which can be
used directly in the preparation on review of impact statements. The
complete development of such guidelines will require information not
now available. Studies should be started immediately to develop the
information.
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The limited number of people qualified to prepare and evaluate the
potential impact of nuclear power plants increases the importance of
directing as much of the expertise as possible toward developing policies
and guidelines for future development, and minimize the time spent on
evaluating existing situations about which we can do very little. The
AEG forecasts a tenfold increase over the next 10 years in the installed
capacity of nuclear power plants, which further points up the importance
of our looking toward the future.
The question is how can we do today's work and still find time to
plan for the future. I think the only answer is to streamline our present
efforts. One possibility might be to determine the environmental impact
of standard plants; for example, 800 and 1,000 MWe pressurized and boiling
water units with and without cooling towers. Each new plant could then
be given a cursory review to see if it differed in any significant way
from a standard plant. It would be necessary to evaluate only the dif-
ferences rather than the entire plant in each case.
The standard plant concept would seem to be quite valuable in siting
future plants. The potential impact of standard plants could be eval-
uated in selecting the most suitable site. Later, when the plant design
is completed, any differences with the standard plan could be evaluated.
The standard plan might also be a means of including the total im-
pact of the entire fuel cycle into the evaluation of individual compo-
nents. If, for example, the impact of a standard, say 4 tons per day,
fuel reprocessing plant were known, its impact could be prorated over
the number of reactors it could serve. The evaluation might not be ab-
solutely accurate but it should be good enough to decide whether plants
are acceptable or not.
Mr. Harward: I would like to add a word to what Craig said relative to
accidents pertaining to nuclear power plants and the transportation of
spent fuels and high-level wastes and their consideration in the "generic"
sense. There are, of course, many aspects of these problems that can
and should be handled on a general basis so that they would not have
to be reviewed on a plant-by-plant basis. There are also certain aspects
that are site-related and can only be handled on a plant-by-plant basis.
We in the Office of Radiation Programs are certainly not going to
become nuclear reactor safety experts or experts on spent reactor fuel
shipping containers comparable to that expertise within the AEC. This
is an AEC responsibility; however, there are problem areas related to
these issues where EPA, as an agency responsible for environmental pro-
tection must be knowledgeable in order to properly assess the conse-
quences that might result from accidents occurring in the nuclear power
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industry. We have had discussions with the AEC on these issues and are
trying to determine how best to relate to the Commission relative to
them. Also, EPA does have responsibilities that were transferred from
the former Federal Radiation Council with respect to radiation protection
guidance which would include that related to accidents. The Surveillance
and Inspection Division also carries out EPA responsibilities relative
to emergency response capabilities. You can be sure, therefore, that
the problems of nuclear accidents are certainly not going to be ignored
by EPA. However, it will take time for adequate program development in
all these areas that are consistent with EPA's responsibilities.
I would now like to briefly discuss some of the future problem areas
where we visualize a need for increased effort on the part of TAD and the
other ORP divisions:
1. Long-Term Waste Storage
As we look into the future, it appears that long-term waste storage
may be one of the greatest environmental problems in the radiation field.
Adequate control, siting criteria, and source monitoring is essential,
not only for high-level wastes but for intermediate and low-level as
well. The so-called low-level disposal sites are going to receive in-
creasing volumes of radioactive waste from the nuclear power industry,
not only due to growth of the industry, but because the new augmented
waste treatment systems at nuclear facilities will increase the quantity
of the material that formerly ended up in the environment.
2. Liquid Metal Fast Breeder Eeaotor
The IMrBR appears to be the power reactor technology of the future.
Therefore, extensive efforts will be required now in order to adequately
assess the overall impact of the plutonium fuel economy of the future.
. Because of the extreme hazardous nature of plutonium, much effort will
be required in order that health and environmental protection agencies
at all levels of government will have the expertise and knowledge to
adequately do the job that will be required in the 1980's. The Tech-
nology Assessment Division has already underway some preliminary work
to develop information to enable EPA to better evaluate the LMFBR demon-
stration plants that are now scheduled to begin construction within
2 to 3 years.
3. Impact on Area and Regional Basis
The total impact of different components of the uranium fuel cycle
needs to be evaluated to see what effect would be expected on large areas
or regions. As Craig has already mentioned, the current licensing mode
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is based on the review of individual plants. The AEC is conducting their
"Year 2000" study that relates to this problem and we will be following
their studies quite closely and will undoubtedly do some of our own.
4. Nuelear Gas Stimulation
An evaluation needs to be made on a national basis to determine the
total cost-benefit of this program.
I would like to now discuss briefly with you some of our program
plans that have an effect on both the Regional office operations and on
State program effort. We are participating in a workshop on environ-
mental impact statement review to determine what ORP's role should be
in relation to State and EPA regional program efforts. As you know, the
nuclear facility review program started out in the Public Health Service
as a State assistance function. The passage of NEPA has made it neces-
sary for our small staff in TAD to divert our primary efforts from that
of providing technical assistance to States except where such has been
requested by individual States. I would like to say that we will still
do our best to provide any assistance to States within our capability.
It is also our policy to provide the concerned State agency with a copy
of EPA comments on impact statements for nuclear projects. If there are
specific problems or policy questions in this area, the workshop that is
going on for impact statements would be an excellent place for this to
undergo discussion. Jim Dieckhoner from our Division will be available
as a resource for these sessions.
Now a work relative to regional!zation; except for radiation-related
facilities, the review of most environmental impact statements are decen-
tralized to the Regions. Because of the limited and unique technical
capability required, the decision was made that the Office of Radiation
Programs would coordinate the Agency review of impact statements of radi-
ation significance. It is our plan for the coming months to develop and
propose to the Office of Federal Activities in EPA a workable method
whereby the Regions will handle this function for nuclear power plant
statements. It will take some time for this to be accomplished because
our staff will be busy with the continuing workload. It is not our
intention, at least initially, to place on the Regions the burden of
preparing the radiological portion of the review until we have had ade-
quate opportunity to work with the Regions to formulate a method for
providing maximum assistance. Craig mentioned the review guides he
plans to develop. When developed, this would assist the Regions in
the radiation review. This is a subject which we can discuss at some
of the ORP program meetings that are scheduled this week.
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DISCUSSION
MR. HARRIS: Dave, are you people looking into the ultimate disposal of
radioactive waste by transmutation of long-live activity? I think there
are some projects that have already started within the Comnission that
would be of interest to you and you ought to keep in touch with them.
Some Brookhaven reports were prepared about 4 years ago on this. They
seem to show that it may be economical to separate out chemically long-
live radioactive waste and process them by nuclear transformation rather
than just storing them, praying that they never leak out.
MR. HARWARD: I've heard of this work, Saul; in fact, I talked to a man
in the AEC recently who was quite surprised to hear that work was going
on in this area. I'd like to find out a little bit more about this my-
self.
MR. HARRIS: There's a paper that is going to be presented at the Ameri-
can Nuclear Society by people from Oak Ridge on this and they have all
of the little pieces of paper about what's been going on for many years
on this particular subject. And the Manowitz group at Brookhaven Labora-
tory has done quite a bit of it - Meyer Steinberg.
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RADIATION STANDARDS AND CRITERIA
A.
Criteria and Standards Division, ORP
Environmental Protection Agency
I feel very strongly about the standards responsibility of EPA.
I think sufficient authority was granted to us when the Agency was
formed. We have the responsibility for such things as guidance, cri-
teria, statements of national policy, or whatever in order to provide
environmental radiation protection. To me it's where the action is.
It culminates the efforts of technology assessments, of looking at all
the risk evaluation activities, of attempting to balance benefit versus
the risk, putting it all together, and trying to make some sense out
of it. This is something that I feel very strongly about and will
attempt to do something about it in the next year.
I think the theme of the Conference--Save a Rad--has two meanings
really. It refers not only to the reduction of exposure but also, if
there is such a thing as a threshold for biological effects, it also
means let's save the rad for those things which are really necessary.
So this, I think, is a trademark that we should adhere to in looking
at standards and in national policies. I won't try to go over all the
alternatives for standards that we have open to us, such as getting
standards on the basis of the best available technology. Rather, I'd
like to concentrate just a few moments on the problem that we went
through the first part of this year having do with the light-water-cooled
reactor standard, and particularly in reference to the Appendix Guide
Part 50 of the AEG Proposed Regulations for Design Criteria. Figure 1
indicates one of the approaches that we explored in trying to analyze
the emissions from light-water-cooled reactors (in this case, it's for
the PWR), and trying to arrive at some reasonable basis for cost effec-
tiveness as a function of what might be risk. In this regard, as far
as risk is concerned, we adhere to, and I see no reason at this present
stage of the game for most effects to deviate from this, the radiation
nonthreshold approach. The effect that we projected takes into consid-
eration the linear hypothesis and also some extrapolations from ICRP
numbers of what the risks are from radiation. We obtain a number which
is theoretically 1 cancer for 7,000 man-rem. Recognize, of course, that
the man-rem concept has a great deal of difficulty in interpretation
and can be widely misinterpreted.
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18,000
16.000
i4,000
12,000
D 10,000
Ik
g 8,000
£
6.000
4,000
2.000
60 Days
Cryogenic Removal
\ 45 Days
. Proposed Standard
30 Days
y_15Days ms....,- —-
L
0 0.1 0.2 0.3 0.4 0.5 0.6
ANNUAL NUMBER OF PROJECTED HEALTH EFFECTS REMAINING
Figure 1.
On this basis, and also taking into account not only the cancer
induction, but allowing an equal number of risks from the life shortening,
genetic changes, or what have you, this number then turns out to be 1
risk per 3,500 man-rem. This is the basis of the approach shown here.
In looking at the technology, we arrived at the conclusion that
the application of cryogenic systems, as applied to the light-water-cooled
reactors, would not be in the public interest and would result in large
expenditures for a small reduction in risk. I only show this as a kind
of actvitity that I think is necessary in looking at some of these very
controversial questions of where one sets numbers.
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Figure 2 shows another part of this analysis that we went through
in terms of looking at what reactors might do. I think this is extrap-
olated to the number of reactors proposed by 1980, and where they would
fall if we were to look at the total man-rem per gigawatt-year of elec-
tricity produced. As you can see, most of the reactors fall down below
50 man-rems.
50-r
MAN-REMS PER GIGAWATT-YEAR
Figure 2.
Having gone through this type of analysis, in which we proposed a
standard and developed arguments for a number, we then considered the
public health impact of our proposed standard. The conclusion was reached
that our proposed standard would not improve the public health impact
above that resulting from the AEC's proposed Appendix I.
We are now looking at the fuel reprocessing plant in a similar
fashion to see what we would do if we were put in a position of setting
a standard.
I think there are two important things resulting from our standard-
setting activities so far. One, we demonstrated within the Agency that
we can take a very complex question like this of standard-setting for
radiation protection, analyze it with competence, and come out with some
meaningful results. The other thing I find very important
have to show the public health impact.
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This Agency will certainly move forward in this standard-setting
area. We feel we have the mission. We have enough authority. And I
hope by next year we can discuss some very specific standards, or guid-
ance, or criteria; criteria, for example, on the siting problem, guides
for decommissioning of reactors, and this type of thing.
I should say, since it was indicated that I would say something
about the National Academy of Science review, this is supposed to be
completed by July. As most of you know, this is a jointly funded sup-
port activity of BRH and OKP. In the analysis we ran through here, I
do not believe that the NAS review would seriously change the risk esti-
mates that we used.
(Here follows Dr. Mills prepared paper.)
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I speak to you today on a subject matter that I believe to be the
heart of radiation protection. Establishing standards, criteria, guid-
ance or simply a statement of policy on radiation problems, existing or
projected, requires that all the technology we can assess, all the knowl-
edge on health or environmental risk we can evaluate, and all the aware-
ness of benefits we can derive be brought together and publicly stated.
Following this public declaration must be the operational programs which
assure that the public mission as stated is being met.
The theme of this conference, "Save a Rad," can be met with articu-
lation of our problems and public acceptance of our proposed methods of
solution. Where radiation exposure can be reduced effectively and eco-
nomically, thereby saving a rad, we must provide guidelines for doing so
and establish standards when necessary. The general problems described
by Mr. Dominick and the focus of our efforts in Criteria and Standards
will be in another context to save our rads for those radiation require-
ments which are beneficial to mankind and his environment. Thus, the
theme "Save a Rad" can be employed in two facets, reduction of exposure
and saving for the necessary benefits.
What is the scope of our responsibilities for radiation standards
and guidance in EPA? It is, in fact, quite broad. When we were formed,
just over a year ago, two key authorities were transferred to EPA so as
to create a new national focus for environmental standard setting and
guidance.
The first of these authorities came from the AEC. It provides for
protection of the general environment, which includes man, from the
effects of those radioactive materials covered by the Atomic Energy Act
through the issuance of standards to limit the levels of these materials
in the environment. The second authority resulted from the abolition
of the Federal Radiation Council and the transfer of its broad functions
to EPA. These include providing guidance to other Federal agencies in
the formulation of radiation standards, as well as establishing and exe-
cuting programs of cooperation with the States. Thus EPA's responsi-
bilities encompass standards for radiation protection on both a general
and source-related basis, and can be carried out directly by issuance
of EPA standards, or through cooperation with other Federal agencies or
the States.
Our first major exercise in standards setting has been to take a
careful look at the nuclear power industry. This task could have been
approached in several different ways. EPA could have relied upon exis-
ting guidance for recommended maximum doses to general populations and
then attempted to assure, through a standard, that the sum of doses from
all parts of the fuel cycle would satisfy this guidance, both now and in
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the foreseeable future. This approach has, however, at least three im-
mediately obvious difficulties. It ignores the dictum accompanying guid-
ance for populations that these doses should also be "as low as practi-
cable." It also requires some sort of apportionment of doses from the
nuclear power industry so as to permit the possibility of other uses of
radioactive materials. Although we have not fully examined this approach,
intuitively I believe the apportionment concept would be difficult to
apply. Finally, a general overall guidance could dilute EPA's responsi-
bility to make its own independent analyses and judgments on the accept-
ability of radiation levels in the environment.
Another possible approach was to adhere strictly to the "as low as
practicable" dictum. Current and near-future capabilities for waste man-
agement of radioactive materials are extensive, and we would probably,
using waste management systems that are technologically quite "practicable,'
reduce emissions from all of the various parts of the fuel cycle to levels
defying detection--if cost were no object. But, if "environmental pro-
tection" and "ecology" are to remain popular household words we must show
some measurable benefit for the dollars spent on the pollution control,
and not just pursue control of emissions to well below levels of conse-
quence, irrespective of cost.
These considerations lead to the point of view we have adopted as
an initial approach for determining acceptable levels of radioactive
emissions from the nuclear power industry--cost/effectiveness balancing
or cost/benefit balancing--us ing benefit in a limited public health sense
denoting potential risk reduction. Cost/benefit balancing is an impor-
tant and, incidentally, a difficult and elusive concept that continually
injects itself into considerations involving man and his use of the en-
vironment. For standards setting this is a two-step process. First, it
must be demonstrated that the benefits flowing from the activity outweigh
the costs (in this case health risk from radiation) at some demonstrably
attainable level of emission control. This, we feel, can be reasonably
assumed for the very low level of risk associated with chronic emissions
from the nuclear power industry. We also assumed in this case that the
benefit is a valid requirement for electrical energy. Then one must con-
duct an optimization of risk reduction versus the cost of emission con-
trol. We have carried out this exercise for light-water-cooled nuclear
reactors, and are now looking at the fuel reprocessing industry. Fur-
ther down the road of analysis may lie such components of the fuel cycle
as fuel fabrication, ultimate waste disposal, and plant decommissioning.
Figure 1 (page 152) shows the analysis for a pressurized water reactoi
(PWR). Plotted is the risk remaining versus the ratio of change in cost
for control to produce a change in risk for different numbers of days of
gaseous emission holdup times and cryogenic removal. To derive this
curve we have utilized the assumption of linear dose-effect response
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without threshold and taken our basis of risk to be 1 health effect per
3,500 man-rems of dose. The risk index of 1 effect per 3,500 man-rems
is based upon an extrapolation from published data. Although this gives
us a number handle with which to examine relative risk for various tech-
nologies, it is not an absolute number, and therefore the extrapolation
must, of course, be viewed with extreme caution in its application since
we obviously are extending the available data way beyond its experimental
conditions. From the curve, it certainly appears that 30-day holdup time
for normal operation of the reactor is warranted, but that the requirement
of a cryogenic system is not.
In Figure 2 (page 153), we have shown what we consider to be a pro-
jection of the distribution of number of reactor sites (proposed to 1980)
as a function of total population dose in man-rems per gigawatt-year of
electrical power generated. Clearly, this shows that under normal ope-
rating conditions nuclear power plants meeting AEC's proposed Appendix I
to Part 50 will result in very low total population exposure.
In summary, we found the guides for design and operation that have
been proposed by the AEC, if properly implemented, would result in limits
indicated by our own analysis.
We are now involved in developing a similar analysis and possible
guidance for acceptable levels of emissions from fuel reprocessing plants.
These plants pose some real challenges. Most of the krypton-85 and
tritium produced by the fuel cycle is released during fuel reprocessing.
These isotopes result in worldwide distributions with corresponding world-
wide commitments for radiation dose extending over many decades. It has
been estimated that 90 percent of the dose due to krypton-85 releases
will be delivered outside our national boundaries, and only 10 percent
to the U.S. population. Upon what basis does one make value judgments
about risk commitments imposed by one nation's effluents on others?
Plutonium and iodine-129 pose a different sort of difficulty. How does
one quantitate the environmental commitment implied by the release of
a radioisotope having a 24,000 year half-life, as for plutonium-239, or
a 16 million-year half-life, as in the case of iodine-129? I hope that
at next year's conference we will have some progress to report—but if
not, the problem will certainly stay around long enough for someone else
to take a crack at it.
Basic to the activities described above is the best available assess-
ment of the risks associated with the exposure of populations to ionizing
radiation. As you all know, the National Academy of Sciences has had
underway since 1970 an indepth review of the scientific evidence available
to us in this area; a review jointly supported by BRH and EPA. We expect
that the report will be available by early fall of this year. Although
we do not have the detailed results of this study, it is probably fair
to say that the results will not change significantly any of our analyses.
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Whether or not this source-by-source approach to setting standards
should be applicable to every situation will require continuing considera-
tion. Nevertheless, the type of analyses that we are performing is re-
quired by EPA to fully document its rationale for any position it may
take on controversial radiation problems.
Radiation is unique among the many different kinds of environmental
pollutants, in the amount of knowledge we have gathered about its effects,
in our ability to detect minute quantities of it in the environment, and
in the degree of control that man has been able to exercise over its re-
lease. If we cannot use this vast reservoir of knowledge and experience
to provide reasonable guidance--reasonable from the point of view of pub-
lic acceptance of its reasonableness--then there is little hope indeed
that we can rationally order man's use of the vast array of other sub-
stances that he has introduced into the biosphere. For example, if we
wish to have a balanced public consideration of the merits and hazards
of public uses of nuclear energy, we must investigate the trade-offs in
benefits and risks for alternate nonnuclear technologies, such as the
fossil fuel based production of electric power. Since public confidence
is a key issue in this area, it is particularly important for us to
consider the public health trade-offs for the nonnuclear alternatives
that may be adopted because of public attitudes about radiation.
It has been argued that present lack of public confidence in radia-
tion protection guidance and reluctance to accept the small levels of
radiation risk implied by current operations is due to failure to lay
out sufficiently for public discussion our best assessments of the real
risks and the real costs for control of radiation emissions. We in EPA
intend to make a contribution to this necessary public discussion.
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SEMINAR
Moderator: Charles P. Froom
the, COIWCA£ o£ State.
State. Regu£a££onA ^on. the. Contsiot
Radiation"
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REVISION OF THE COUNCIL OF STATE GOVERNMENTS' "SUGGESTED STATE REGULATIONS
FOR THE CONTROL OF RADIATION"
MR. FROOM: The last revision of the Model Regulations was in 1969 and
since that time there have been a few happenings which indicate a pos-
sible need for revision of the Model Regulations. The Public Health
Service Act was amended with Public Law 90-602 and went into effect about
that time. There have been several new NCRP reports that have come out;
NCRP 33 was out at the time, but Reports 34 through 40 have since come
out. There have been some Federal agencies and other standard-setting
groups that have passed standards; for example, the Department of Labor,
under the Occupational Safety and Health Act, and the American National
Standards Institute with their standard on particle accelerators. There
have been a number of newly emerging radiation problems; for example,
in the area of particle accelerators, analytical x-ray equipment, and,
of course, the whole area of nonionizing radiation.
Many of the States have expressed to us that there were gaps in
the suggested State Regulations and that there was a need for revision.
A preliminary planning meeting was held in Rockville, in which the AEG
and the Conference had representatives present. We wanted to involve
the States at an early planning stage in the development of model regu-
lations since actually you people are directly involved in their use
and know more as to what is needed in the way of revision. Don Gilbert
has been representing the Conference at these early planning meetings,
and at this time I'd like for him to discuss with you the State partici-
pation in this early planning.
MR. GILBERT: We did have, after the last Executive Committee Meeting
in Rockville, a short meeting with the Bureau and a group, if you will,
to try to get some input by the States. Following that, Mr. Siek asked
that I contact various States and set up a mechanism whereby we could
get some direct input. Consequently, some of you received a letter ad-
dressing, if you will, our interest to a specific part of the regulation.
We didn't mail it to 50 States. We tried to get a person first who we
felt dealt in that area more than another and, secondly, someone who
would really work on it. Theoretically, all of these comments are in.
I understand that some of them may or may not be in the Model Regs, but
I'd like you to understand this is a" first draft and if we want State
input, now is the time. I think we can compromise some things.
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MR. FROOM: What we have passed out here is just a rough preliminary-
draft. This hasn't been reviewed in depth or approved by either the
Bureau or AEC. It was rushed through to get it out for distribution at
the Conference. I'm sure you will find a lot of errors in it, but we
did want to get this to you here at the Conference so the States would
be involved, not only in planning, but also in early input.
We have attached to each of the parts, a comment sheet. We attempted
to indicate the new sections that have been added and those sections
that have been revised so it would be easier for you to go through and
pick these out. The comment sheet indicates in most cases the reasons
for the changes that have been made. We thought this would be helpful
to you in reviewing it.
We have a problem in consistency of the various parts of suggested
State Regulations between the radiation machines and the radioactive
materials parts. We still have to do more in this area. Some of the
State people have mentioned this to us.
We are proposing to divide the Regulations into two major cate-
gories; ionizing and nonionizing. We will have these included within
the same binder. In talking with State people, they indicated that they
would like to have them kept separate; one on ionizing, the other on
nonionizing. Our plan is to develop these separately; separate set of
definitions in each category, and so forth.
Our schedule for completion of the Model Regulations, according
to our plan of development, is December of '72. Since development of
the plan by Mr. Wilms and Mr. Little, we have added some additional parts
to the Regulations. Therefore, we are going to have to scope these out
and determine a logical completion date. We have tentatively set Sep-
tember of this year for a rough draft on these new parts.
What we plan to do this morning is to discuss some of the high-
lights or some of the areas that we think might be of interest to you
that have been revised. We don't have time to go into detail on all
of it. We will give an opportunity for each of the State counterpart
people, or Conference representatives, to comment on each part at the
end of that discussion if they would like to. Some of the workshops
may have had a discussion on this and also we have discussed it infor-
mally with some of you; hopefully, we will have an opportunity to dis-
cuss it more throughout the Conference.
Part A on General Provisions was revised by John Munzer in the
Bureau in cooperation with Gene Christiansen of North Dakota. In the
revision, our definitions have been changed or revised based on the new
NCRP reports, as well as the ICRU, particularly ICRU Report No. 19.
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We've attempted to Jkeep the definitions as understandable as possible
and also consistent for use in regulations. People who were involved
in revising the other parts of the Regulations have suggested new terms
that should be included in the definitions. We realize that there may
be other definitions that should be included, and we appreciate comments
from those of you in the States as to what other needs or definitions
should be included in Part A.
One of the terms that we had a real problem with, and I'm not sure
that we have found a good solution to it yet, is with the term "exposure."
As you know, there are two ways in which this is used. We tried to de-
fine it in these two senses; first of all, it is a quantity, and is spe-
cifically for "x" or gamma radiation in air (that is, the charges col-
lected in air), and secondly, to define it in the general sense (that
is, exposure to any type of radiation). As we moved along in this, we
realized you couldn't have two definitions for the same word in the Regu-
lations; thus, we have just included the specific definition in terms
of a quantity. Wherever "exposure" was used in a general sense for
all types of radiation, we tried, where possible, to change this to "to
expose" or "expose to" or "exposing." I don't know how successful this
is going to be or if this will be the final solution. Maybe we need
to make up a new term for this quantity rather than "exposure"; but this
is the approach we're taking right now.
We have changed the symbols based on the S.U.N. Commission Report,
which we used as our guide for symbols in the document. In the case
of "dose," used throughout the document, it means either the quantity,
absorbed dose, or the quantity, dose equivalent, and then we've gone
on to define what we mean by these two quantities. According to NCRP 39,
this may be done as long as the distinction is clear and the meaning
is understood from the context.
We have also changed over to the MKS system, although we've also
included the CCS units; for example, in the case of the rad, we've all
been accustomed to using 100 ergs per gram in any absorbing material,
so we've also included the CGS units. In such things, for example, as
the definition of "physician," we've left that up to the individual
States, because we found that this varies from State to State. As far
as new definitions, just to give you an idea, we have added the word
"facility" which is included because of a change in Part B--a new ap-
proach there that we will discuss with you. "Particle accelerator" has
been added because of that new part. We have also added the term "oc-
casionally exposed individuals;" those people who enter a controlled
area but are not actually classified as radiation workers.
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You will also notice that at the end of the definitions, we have
included a table of prefixes; "milli," "micro," and so forth. We de-
cided to do this rather than include the prefix with every unit that
was defined; this takes up less space and is a little more organized.
At the State Ad Hoc Comnittee Meeting for the development of the
laser regulations, one of the States mentioned that they had run into
a problem in the definition of the word "person." There was a question
of whether a referee in a bankruptcy case was included in this defini-
tion. I understand there was a radioactive source involved, and a ques-
tion of whether the State had authority over this. I don't know of any
other States that have run into this particular problem. We have not
redefined the term as yet, but if any other States have run into a prob-
lem here, let us know.
I think that's all the coranents I will make about Part A. If Gene
Christiansen would like to add anything else at this time, we'd be glad
to hear any additional comments.
MR. CHRISTIANSON: I have nothing to add at this time but I would like
to say that if any State has any comments pertaining to Part A, that
they submit these comments to me.
MR. FROOM: I will just mention a few things about Part B on Registra-
tion of Radiation Machines, Facilities, and Services. This was written
and revised by Heinz Wilms of ORO and John Shaver in North Carolina.
One of the problems that we encountered here was with the term
"radiation machines." For some reason, some people didn't like this
term. We tried to come up with a better term. We discussed this at
some of our meetings, but most of those that we came up with were rather
unwieldy; so we retained the word "radiation machines." If you have
any suggestions on this, please let us know.
One of the main features in Part B that has been changed is that
we are registering facilities, or proposing to register facilities,
rather than individual x-ray units or x-ray tubes. Evidently this is
current practice in many of the States at the present time.
The other thing is registration of services. We are proposing to
register those individuals who are in the business of providing serv-
ices on x-ray equipment or other radiation machines. These services
would include such things as installation or servicing. It would in-
clude calibration of radiation machines and radiation measuring instru-
ments. The services would include radiation protection surveys, or
health physics consultation, and also personnel dosimetry services.
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Under the category of "Exemptions," in the previous draft as you
know, we specified TV receivers as being exempt. Here we haven't men-
tioned TV receivers specifically, but we have indicated that all elec-
tronic equipment which produce radiation incidental to its operation
for other purposes is exempt provided the dose equivalent at 5 centi-
meters is not greater than 0.5 millirem per hour. Also, you will notice
in the registration of the radiation machine facility, it requires the
designation that an individual be responsible for radiation protection
at that facility. On the form, they need to specify that that individual
is knowledgeable as to hazards and precautions; that he has read and
understands the regulations; that the operation of equipment will not
be permitted except by persons who have been instructed in the safe use;
and that surveys will be conducted to determine compliance with the regu-
lations. Registration of services is not required if the individual
providing the services is covered by a specific licensing document. In
the registration, it must be specified that the person has read and under-
stands the regulations and is qualified by training and experience to
discharge these services.
You will also notice that registration is divided into two parts.
First of all, the individual puts in an application for registration.
Once this is received, then- the State reviews this and if the applica-
tion meets the requirements, the State then issues a Notice of Registra-
tion. So there are two parts to this registration process. At this
time, let me ask either Heinz or John Shaver if they would like to add
some comments on this since they were involved in the development of
this. I understand John contacted several of the States in Region IV.
MR. SHAVER: I have no comments at this time, unless there are some
questions.
MR. GERUSKY: Aren't you, in effect, now licensing machines with this
new approach?
MR. SHAVER: There's an implied legal difference between registration
and licensing. Your observation is correct. This appears to move the
registration a little close to a license. What I did was try to change
this myself to parallel what we are actually doing. We are trying to
put a little more teeth in our registration program. What I didn't like
before is that it implied that registration was something that any person
in the State was automatically entitled to, with no review of qualifica-
tions or anything else. Whether the way we have this set up here is
consistent with the intent of the enabling legislation, I'm not com-
pletely sure. But I think each State in this country has an active
registration program and is administering it the way we have it set
up here.
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MR. PARROTT: My specific problem happens to be with the registration
of facilities. I could see the amount of work doubling if you register
facilities. The reason I say this is because we have a law in our State
which requires a fee for registration of machines. If we add a print-
out for facilities registration, we still have to have a printout for
registration of an individual machine.
MR. SHAVER: I don't think there's going to be that big a problem de-
pending on how administrative you want to have it. Are you right now
issuing a piece of paper that identifies all the equipment in one par-
ticular location?
MR. PARROTT: Each machine must have a certification for itself and when
this machine is traded in, he has to tell us where it went, and he has
to tell us he received a new machine, and we register it by virtue of
complete identification of that particular machine. We register panels,
not tubes. In other words, some dental offices run a half a dozen off
a single panel. If he removes that panel, then he has to re-register.
MR. SHAVER: You register machines instead of tube heads?
MR. PARROTT: Yes.
MR. WILMS: I think that we did discuss this difference between the regis-
tration of individual tubes or machines, and registration of facilities.
If you list the numbers of machines at that particular facility, you
could base your fee on the information contained in that form. In fact,
in the discussion, it was felt that registration of facilities should
lighten the workload for most States, because they have less pieces of
paper or fewer registration numbers. But in your case, this may give
you a problem.
MR, PARROTT: It gives us a problem inasmuch as, if we have inspected
a particular facility on a specific machine that is not in compliance,
and we insist it be corrected, the owner may say, "Well the hell with
it, I'll sell the machine." We want to know where that particular mach-
ine goes. As you know, he may not sell that machine unless it has been
corrected to meet the requirements.
MR. WILMS: This draft version does have a requirement for notification
of disposal or transfer to someone else.
MR. PARROTT: You're talking about a single machine.
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MR. WILMS: Yes. Because it's part of the information contained in the
registration form and any tine there's a change in the registered infor-
mation, the registrant must submit a new application for registration.
MR. PARROTT: You'll have to think about this at length.
MR. WILMS: We would like to get your comments on this. If this is a
problem with other States as well, we are going to have to change it.
If this is an individual case, maybe we can work with you in coming up
with some administrative procedures that can accoimodate you.
MR. PARROTT: Well, I think you will find that most States will go to
a fee system and if they're strange like ours, set a flat fee and that's
it.
MR. WILMS: Is your fee schedule based on a charge per registration,
or a change per machine or control panel?
MR. PARROTT: Per machine. This is one of the reasons we administra-
tively sneaked around this. They said registration was $10 per x-ray
machine; so we took it opon ourselves to make it per panel. Some offices,
dental offices in particular, would be charged $50.
MR. WILMS: I'm not that familiar with your program. But it would seem
to me that perhaps you could still base that kind of a charge using one
form for everything in the facility, rather than individual forms. But
the charge per machine would still be valid.
MR. PARROTT: We have a single form in a facility. And then we have
several lines on which you register this. I think we are all going to
go to a fee system. It's due. I urge everybody to look at it very
cautiously. If you change this "registration," and use the word "licens-
ing," all of my medical machines will be exempt.
MR. WILMS: We don't want to use the word "licensing." You will notice
too, in the draft, we don't have a grace period. Currently, a guy may
have 30 or 60 days to register his machine once he decides to go in the
x-ray business. Ihis draft, however, requires notification to the State
before he begins. This may be idealistic. It may be impractical, or
it may be very practical. We would be interested in your comments. Ob-
viously, a State may still wish to have a grace period, which they could
incorporate in their regulations.
MR. SHAVER: The way I interpreted that portion or would interpret it,
if you have a pending application for a facility prior to its going ope-
rational and becoming a real radiation facility, that would meet the
intent of the regulations. One other item was the section we've had
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for some time on "renewal." We want to have a 2-year renewal period
for registration. I think we've had a little more flexibility in the
way we have it set up now, in that the State can put a date of expira-
tion on the certification of registration and could use a variety of
periods of time for different categories of users if one wished to do
that. All we'd simply say is that the registration expires on the date
stated on the Notice of Registration, which I think adds a lot of flexi-
bility to what we are presently doing.
MR. VAN FAROWE: As I understand it, you're planning to register instal-
lers of x-ray equipment. I think that in our State this would not be
permissible except by a special act permitting registration, which is
the same as licensing, because engineers, architects, and so forth are
all registered in our State and this is a very difficult type of legis-
lation to get passed, because everyone wants to be registered or licensed.
It creates a parameter around this particular activity, and no one can
operate then within this scope once you have a licensing or a registra-
tion established.
MR. SHAVER: There are variations in enabling legislation among the
States, as we all know. Our particular registration, which I think is
similar to many States, states that we can run a registration program
of such scope as the agency sees fit, but that registration programs
are directed toward the transfer, disposal, transportation, and use of
radiation machines. Now, our Attorney General is not delighted with
our particular portion either, but he says one can look at the instal-
lation of an x-ray machine as indeed a disposal. That man has disposed
of it, by transferring it. It would be best to strengthen that portion
to clarify what you mean, but if you have that language, you might en-
courage that interpretation, if you're interested in this. I think that
active, vigorous regulation of offenders is something that is going to
be crucial for the States to do, not only in upgrading our own program,
but any activity that we may wish to perform with the Bureau in the im-
plementation of the new performance standard. Also, we need to amend
our regulations to be compatible with the Federal law.
MR. PARROTT: Can I throw in one more. This business of Notice of In-
tent. As I read this thing, it says that I am going to see if a parti-
cular individual is qualified to use an x-ray machine. If he has M.D.
on his name, he'll never get it by the Oregon Medical Association. Be-
cause we do put any of our licensing, or any of our regulations up for
public comment, and I am assured that if it says anywhere in there that
if we have to evaluate somebody's particular ability, then it's going
to be very difficult unless it specifies that anybody who is trained
in that particular ....
MR. GILBERT: You just administratively answered your own question.
You've already determined that an M.D. is qualified.
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MR. FROOM: Let's go on to Part C, D, and G on Licensing of Radioactive
Materials; Standards for Protection Against Radiation;' and Uses of Sealed
Sources in the Healing Arts. These parts were developed by Gail Schmidt
and Al Tapert of the Radioactive Materials Branch in the Bureau, in co-
operation with Al Hazel in Colorado, Dave Snelling in Arkansas, and Dale
McHard in Oklahoma. At this point, Gail Schmidt, who is Chief of the
Radioactive Materials Branch, will discuss these parts.
MR. SCHMIDT: Sections C, D, and G contain probably the largest revision
of the Model. As we proposed, they are certainly to be considered as
a rough draft and we would like you to consider that these proposals
are an attempt to provoke comment from the States. Please offer sug-
gestions or changes in the revisions, complain or congratulate us if
we did something right. I also would like to suggest one thought here
which we have found useful in working with standards groups. If you're
going to comment on a section, put down some proposed changes. Don't
just say, I don't like this section. Suggest words if you can, or at
least ideas as to what should be incorporated here. If you don't like
it, give a basis for why you don't like it, so that we have some basis
of documentation upon which we can either accept or reject your comment.
I will run through this very briefly and try to hit some of the
maj or points:
Starting off with Part C on Licensing. I would say basically, the
changes that we have proposed here are to incorporate radiun and the
accelerator produced radionuclides fully in this section. I 'm not sure
we've done this in all cases at this time. As Chuck indicated, this
version is hot off the press and we ourselves have not had a chance to
go back through this and look at it for consistency and completeness
in coverage in all cases.
The first changes come up in C.5 b(2), and this relates to the
exemption on timepieces. We are proposing a specific activity value
for exemption of radium timepieces. The values are basically those pro-
posed by the International Atomic Energy Agency. I might mention also
that the Bureau is working with the Bureau of Product Safety in FDA,
to propose a standard for radiun timepieces. This comes under the Fed-
eral Hazardous Substances Act and again in this case, what we're pro-
posing to implement is basically the IAEA recommendations on quantity
limit of radium in timepieces, as well as the prohibition of radium to
be used in pocket watches.
Another exemption comes in C.4(d) under gas and aerosol detectors.
Again we're proposing to include radium here. This is one that is cur-
rently a hot item. It has caused some difficulty because of the dif-
ference between the Agreement State and non-Agreement State provisions;
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where the manufacturer is located in a non-Agreement State, how is the
sale in Agreement States covered or is it covered under the present
regulations? The regulations in the suggested model basically assume
that all States would have equivalent regulations, and the exemption
for specific products was based on this assumption; that the product
is manufactured under a license authorizing its distribution as an ex-
emption product. We have discussed this somewhat in the Workshop--
Radioactive Materials and Nuclear Medicine. We have not come to any-
thought s about changes in the wordage in the present regulation, but
I think this may be an appropriate topic to be considered when we re-
view this section.
We've also added in C.4(e), equivalent words from the AEC's regu-
lations on various self-luminous products for radium. I don't think
I need to comment any further here.
C,4(f) on Exempt Quantities is one that has frequently raised dif-
ficulties. This, in fact, resulted from the change in the AEC regula-
tions when generally licensed quantities were converted to exempt quan-
tities. At that time, the AEC made the decision that exempt quantities
would not include the long half-life alpha emitters. We agreed with
the AEC at that time and excluded radium from this group. I think many
of the States have continued to cover radium either in the exempt status
or as a general license, with one-tenth microcuries as being an exempt
quantity of radium. We have again accepted the criteria that long half-
life alpha emitters will not be classified as exempt quantities. What
we have tried to do in preceding sessions here, is to provide specific
exemptions for radium, for calibration sources, as I mentioned, for time-
pieces, or for gas and aerosol detectors if they meet specific criteria.
MR. GERUSKY: Gail, can you give a reason for that? We've got so much
radium around.
MR. SCHMIDT: The reason is still based on the basic philosophy proposed
here as to what should be allowed as an exempt quantity that is com-
pletely out of control. For both products and individual quantities,
the general philosophy is that this material should decay away within
a given period of time, or on a product basis, that the half-life is
somewhat related to the useful life of the product. Radiu, obviously
is an exception here. Its extremely long half-life will be present in
the environment essentially forever; so I feel this is sound radiation
protection rationale. This is one that I know we would get a lot of
comments on, and we certainly want to hear your comments. As I indi-
cated, we have added some specific exemptions for radium, either as gen-
erally licensed or exempt quantities.
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C.22 contains suggested provisions on general license for static
eliminator devices, and also on radium and calibration sources. Still
staying in the timepiece area, in C.22(i), we have suggested a general
license for the watch repairman for horological uses. We have seen this
in a proposed State regulation. I think in most cases, most States have
ignored this situation where the individual watch repairmen have either
painted dials or hands on a limited basis and/or worked with quantities
of radium and, of course, tritium since it's come on the market. We
have proposed some general criteria in that section relating to the quan-
tities and the conditions of use and that if a watch repairman exceeded
these limits it would be expected that they would be specifically licensed.
In the appendices or the schedules attached to Part C, we are pro-
posing that these be updated to cover radon and accelerator-produced
radionuclides; we have proposed values only in a few cases. But we
would like your input, your comments, your suggestions, as to what iso-
topes should be included in these schedules.
MR. GODWIN: Did you have specific manufacturers requirements for your
watch dials?
MR. SCHMIDT: Are you asking this in terms of the suggested Regs?
MR. GODWIN: Right. Similar to the requirements for drug manufacturers
for distribution to your general licensed physicians as a specific series
of requirements for these. Is there anything like that for your watch
dials?
MR. SCHMIDT: We have not put this in, although we have noted this com-
ment regarding the criteria for the evaluation of watches. This would
be, in part, the criteria in Part 32 of the AEG regulations. In the
past we have had some comments both ways. Some States have said this
should be handled strictly on an administrative basis as guidance to
use for evaluation; others have said, include it. At the moment it has
not been incorporated.
Part D on Radiation Protection has basically been updated in terms
of the NCRP recommendations that have come out in the past several years,
as well as we have tried to simplify in some places, maybe clarify. I'm
not sure this has always been accomplished. In D.101, we tried to in-
clude basically all of the recommended criteria for radiation doses from
NCRP 39, and this includes both occupational limits as well as those
for the general public. Chuck mentioned one case and this was the
"occasionally exposed individual" in terms of a definition. We have
added this category here and a definition of what is an "occasionally
exposed individual." NCRP 39 says the "occasionally exposed individual"
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is the individual that enters the radiation area infrequently and one
that does not have training in radiation protection and may not be given
a film badge or monitoring services. The dose limit then is 0.5 rem
per year for this individual.
In D.202, there is the provision which requires the use of person-
nel monitoring if the doses are likely to exceed 25 percent. Here we
suggested wordage that would require the licensee to demonstrate that
his personnel do not exceed this value if they are not monitored. We
have also, in D.202, a requirement related to personnel monitoring in
the brachytherapy in medical institutions. In D.204, there are the
posting provisions, we are trying to put in here some revised posting
and in conjunction with Part G. on the medical use of radioactive mate-
rials, clarify the recommendations of the NCRP and require some sort
of labeling (posting) that is more consistent with the general radiation
protection practices, rather than making a blanket exemption for posting
in the medical hospital environment.
MR. AAROE: Has the AEG been asked to comment on this draft yet?
MR. SCHMIDT: They have received a preliminary draft copy for review and
will send us their comments. They are aware of what we are doing, and
what is being proposed here has not been finally reviewed at this time
by either BRH or the AEG. So I'm sure they will have strong comments
on some of these areas.
In D.207, we included some limits on contamination. This is another
subject that I'm sure is controversial both on the specific values as
well as the incorporation, but there are some State regulations that
have incorporated contamination limits as well as State proposals.
I wanted to mention that in Part G, Sealed Sources in the Healing
Arts, these provisions are basically an incorporation of NCRP 37 and
40, and to some extent 39. We have tried to interpret NCRP Guidance
as it should apply in that Section with regard to monitoring, posting
of the room, the bed, where a patient is receiving radiation therapy,
as well as some of the records that have to be kept in this area.
MR. PARROTT: I don't see anything here on exposure of the fetus of an
occupational working mother. A pregnant female worker.
MR. SCHMIDT: I thought it was there. I will have to go back and look.
That may be one exception we've made, from NCRP No. 39 criteria.
MR. WILMS: It's included in Table 1, Dose Limits, on page D.2.
MR. SCHMIDT: This is what I thought. We have taken the Table from
NCRP 39 essentially in its entirety.
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MR. HARRIS: I really think it's time that the State people, and this
may not be an appropriate panel, to pick up this question that was raised
by several of the State people about the attitude of physicians auto-
matically being considered competent to do certain things, prescribing
the use of radiation is one thing and using radiation is another. The
precedent seems to have been well accepted that the physician's use of
nuclear materials under a separate license is valid, and the question
is logical, why is the physician's use of x-ray just as logically to
be determined in the same pattern? And I think for maybe 10 or 20 years
we've all been ducking it. And maybe this is the time to stop ducking.
MR. WILMS: When is F scheduled to be prepared and ready? And did you
say why it was not included in this?
MR. FROOM: This is the next section we are going to discuss. Let's
go on to these four parts--E, F, H and I. Industrial Radiography, X-ray
in the Healing Arts, Analytical X-rays, and Particle Accelerators. These
parts are either new or are being revised quite extensively, and Bill
Properzio, who is head of the Task Force on implementation of the Federal
X-Ray Standard, will comment on these.
MR. PROPERZIO: The answer specifically to your question is that they're
either in the area of hardware, accelerators, diffraction equipment,
or in the area of x-ray. This new Federal standard has just changed
everything so much we haven't had time to gather forces and sort it all
out. First of all, on Part E--Radiation Safety Requirements for Indus-
trial Radiographic Operation--the working group in this area includes
Jim Porter from Louisiana and Ed Miller from the Bureau. The status
is that we feel that the present regulations do not adequately address
the requirements of installations of industrial x-ray equipment. The
major emphasis in the existing recommendations is the gamna-ray area.
The emphasis of the revision will be directed to strengthening require-
ments for cabinet and shielded room installations and field radiographic
survey procedures. The requirements will be developed around NBS Hand-
book 93, which is currently being developed by the ANSI Committee N.43.
N43.7 is also developing design criteria, and as you may know, the Bureau,
under P.L. 90-602, has done some work in the area of enclosed cabinet
radiographic equipment that will be included. We do not have a draft
at the present time.
Part F deals with the use of x-rays in the healing arts. The working
group presently has Arnold Moen from Washington as the State representa-
tive, and Jerry Levine from the Bureau working on the user aspect of
this problem, and it was Dave Snavely, but we have increased this within
the Division of Electronic Products to about three or four of us who
are working on the equipment requirements. Because of the new Federal
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173
standard, this is probably the area of the greatest concern, and the
one which will require the greatest effort to make the new and old equip-
ment requirements compatible.
On Monday, I indicated some of the problems which must be considered;
for example, since the new Federal standard is applicable only to new
equipment, we are going to be saddled for some time it appears, with
two sets of regulations; one for old equipment manufactured before the
effective date of the new standard and the P.L. 90-602 standard.
Questions as to what should be done to correct this have to be con-
sidered. Is it feasible to have dual sets of standards; one for new
equipment and one for old? I believe not. I think some time frame
should be established for bringing all equipment into uniformity.
Should the State force the user to follow some kind of a preventive
maintenance schedule on their equipment, or should they ignore the user
and try to solve the noncompliance problems by intensive equipment sur-
vey programs? I think the preventive maintenance schedule type of thing
is something that should be considered.
How should the States particularly adopt the new Federal standard
in areas where you wish to maintain a regulatory authority. Section
360(f) of P. L. 90-602 states that if your requirements are not identi-
cal, your standards are null and void.
What is the proper way that we should be advising, or that you should
be adopting these new Federal standards where they apply to this new
equipment? As I mentioned on Monday, the easiest and most appropriate
way, where possible, is to adopt by reference. Certain States have
problems with this, and if this is the case, what should be their course
of action? If you can not adopt by reference; if you have to publish
the complete Federal standard, how do you, from time to time, pick up,
on a reasonable time schedule, the amendments and the variances that
will be granted under the standard? The amendments probably won't be
coming out at too fast a clip but we expect that variances will be acted
upon in a very short period of time, and the problem of, if a variance
is granted, the machine going into your State, how do you make sure that
your Regs allow this?
There are also a number of particular equipment requirement areas
that require change in the-current Council of State Governments. I
know that Tennessee has been in the state of revising their regulations
based upon the current Council requirements, and have run up against
some problems; for example, in special procedure equipment used in car-
diac catheterization, and in certain other surgical procedures where
sterilization is a problem. In these cases, the drape shields on a
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174
fluoroscopy may not be appropriate, but this is a mandatory requirement
in the current Council requirement. There has to be a more meaningful
way of approaching this. In the area of dental cones, the current re-
quirements for lined open-ended dental cones may require revision. There
are design approaches, such as the cone incorporating the so-called
"scatter-guard," which would not meet the current Council requirements.
We feel this design approach for the open-ended attenuated cone is appro-
priate, but the current Council requirements do not include it.
With the recent policy statement on photofluorographic equipment,
it may be appropriate that the States adopt some kind of performance
criteria in this area. The Public Law 90-602 standards are going to
be considering this as a future amendment, but it won't apply to the
vast majority of old, slow types of cameras that are presently out there;
so this has to be considered. Currently, this old equipment can only
be handled through requirements such as those of the Council of State
Governments.
Recently, there has been some concern brought up about the require-
ments on beam quality. Specifically, I reference the mammography situ-
ation. The current requirements for manmography, which is usually per-
formed at less than 50 kVp, states that you must have 0.5 millimeters
of aluminum in the beam. Following all the filtration requirements,
there is a clause stating that they must be complied with unless counter-
indication deems otherwise. I understand some people have interpreted
that mammography done with a beryllium window tube, x-ray tube is a
technique where a counter-indication may exist. On the contrary, if
you reference NCRP, ICRP, and IEC, with respect to this beryllium win-
dow tube situation this counter-indication does not exist. The revision
of the Council requirement will want to clarify and strengthen if neces-
sary in this filtration area.
During our discussions in Workshop No. 1 during this week, a num-
ber of these items have been discussed and in its Report to the Council
on Thursday, I expect a means for getting more State input into this
area will be suggested.
Going on now to Part H - The Suggested Regulation for X-Ray Dif-
fraction Equipment--the working group here is Tom Moore from the Bureau,
Bill Aaroe from New York, and Donald McDonald from Pennsylvania. The
subject is not identified, as I said before, in the current suggested
regulations. NBS Handbook 93, for nonmedical x ray, briefly mentions
diffraction equipment, but doesn't go into any detail of specification.
Several of the States have adopted regulations already, but, as you look
at it in nuribers, a great minority are currently doing anything in this
area.
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The ANSI N43.1 has developed a standard--Radiation Safety Standards
for X-Ray Diffraction and Fluorescence Analysis Equipment. This will
be published soon. I don't know when that publication date is, but it's
been approved and I think it's in the final publication stages, and that
particular document, plus a detailed review of the States that have re-
quirements, will be the basic source material in this area.
Finally, the Particle Accelerator area, Part I, is being worked
on by Tom Gerusky of Pennsylvania, and Bod Jacobs from the Bureau. The
regulations will be based upon some present DEP efforts under Public
Law 90-602. We have not yet, nor will we probably in the immediate future,
be putting out a P. L. 90-602 standard, but we have an active program,
and we are developing criteria; also, existing State regulations and
the reconmendations of ANSI N43.4. Presently, I believe there are seven
States that have requirements on particle accelerators, so that these will
be the resource areas for this particular standard. I'd like to go back
through these things and call upon the individual State person, we might
want to conment. First of all, the particle accelerator area. Tom, do
you have any specific comments or questions that you might want to solicit
from the group?
MR. GERUSKY: Right now, we're one of the States that have regulations
as a result of the Gulf accident, and we really have not done an evalu-
ation of those regulations as to whether they have been effective. One
of the things I'm having the staff do, is go through the files and update
the inspection to find out whether the requirements we have are legiti-
mate. We found some problems with some of them, and I'd like, in those
States that have particle accelerator regulations, that they drop me
a line concerning any problems they found with theirs, and we_could get
this thing done pretty quickly. I have a question on the definition
of "particle accelerator" already. It's the first time I've seen it.
If you read the definition of "particle accelerator," I don't think that
it covers all the particle accelerators we're talking about.
MR. PROPERZIO: As I said, anything that has been put out so far, I don't
think even has your input. I wouldn't think this is too early a time
to comment. To go back to the x-ray diffraction equipment, Bill Aaroe,
do you have any comnents in this area?
MR. AAROE: One thing. We welcome your comments.
MR. FROOM: The definition of "particle accelerator" I believe, came
from the South Carolina regulation. Maybe we can get together with those
people and Tom and discuss this a little bit during the Conference. Just
in closing, I want to thank all of the State Conference representatives
for their help in developing these regulations to date. We look forward
to receiving comments from all of the States in regard to the draft that
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has been developed so far. After we receive comments from the States,
we are hoping to get together with the State Conference representatives
to discuss these comments in detail and to have them help determine the
content of the next draft that comes up.
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ADMINISTRATION OF RESOURCES SESSION
Moderator: Martin C. Wukasch
Revenue Sources
Oc.c.up
-------
178
ADMINISTRATION OF RESOURCES SESSION (continued)
Revenue Sources
To Fee on. Hot to Fee
William H. Aaroe
Office of Radiation Control
City of New York, N.Y.
Fee* - Plo& and Con*
Simon Kinsman
California State Department of Public Health
Evaluation Techniques
A State. X-Ray PiogJiam
Index (SEI)
Robert C. Will
Chief, Radiation Control Section
Kansas Department of Health
T>t.em£6
Ira Paul Leggett, Jr.
District of Columbia Department of
Environmental Service
Increasing Manpower Use
Tfie Se£j$-Regu£a£ton Concept
Sherwood Davies
Director, Bureau of Radiological Health
New York State Department of Health
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179
REVENUE SOURCES: OCCUPATIONAL HEALTH FUNDS
1/eAnon
Occupational Safety Health Administration, Region VI
Department of Labor
The Occupational Safety and Health Administration's State programs
are concerned, as the name implies, with dealing with the various States
in developing individual State plans under section 18Q>) of the Williams-
Steiger Act of 1970.
Generally, an individual State plan will include the concepts spelled
out in the Federal Occupational Safety and Health Act. The State plan
should be as comprehensive as the Federal law in the areas of compliance,
standards, and enforcement. It should cover the same issues in both
occupational safety and occupational health.
The purpose of a State plan is to furnish, on a State level, a means
of providing a safe and healthful work environment or workplace that
is reasonably free from recognized hazards. This requires the estab-
lishment of standards for health and safety that are as effective as
those adopted by the occupational safety and health administration last
year.
Let me take a moment to explore with you the concept of "as effec-
tive as" as applied to safety and health standards in relation to a
given State's development and enforcement activities. "As effective
as" means that the State's standards will have the same result in pro-
viding a safe workplace as the corresponding standard under the Federal
law and under Federal administration. An even better situation would
be for the State to develop standards that go beyond that idea and estab-
lish better standards than those developed and currently being revised
by the occupational safety and health administration. Let me make clear,
that making better standards is not required - the only thing you have
to do is have the same result as the Federal standard on any particlar
issue.
What is an "issue"? The Act and the State Plan Regulations, 29
CFR 1902, define the scope of a State plan in terms of "issues" with
respect to which a Federal standard has been promulgated. The State
Plan Regulations (CFR 1902) present a basic definition of an issue as
"an industrial, occupational, or hazard grouping which is at least as
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180
comprehensive as a corresponding grouping contained in (1) one or more
sections in subpart B or R, of part 1910 of this chapter or (2) one or
more of the remaining subparts of part 1910." Subparts B and R of part
1910 primarily include "vertical" standards related to a particular in-
dustry such as construction work (1910.12); longshoring (1910.16); tex-
tiles (1910.262); and pulpwood logging (1910.266). With the exception
of agriculture these federally defined vertical issues also include all
applicable horizontal standards. Longshoring is a specific occupational
grouping but is also closely identified with a particular industry. The
remaining subparts of part 1910 generally relate to "horizontal" standards,
that is, a standard in broad hazard categories applicable to many, or
all, industries. Examples are subpart G - Occupational Health and Envir-
onmental Control (1910.93 through 1910.100). Subpart H - Hazardous Mate-
rials (1910.101 through 1910.116) - Subpart I - Personal Protective
Equipment (1910.132 through 1910.140) and Subpart K - Medical and First
Aid (1910.151). These are horizontal standards applied to all industries,
even though a vertical standard might apply also.
The State Plan Regulations also provide that, for cause shown, a
plan may be approved which relates to other industrial, occupational,
or hazard groupings with respect to which Federal standards have been
promulgated if these groupings are administratively practicable and do
not conflict with the purposes of the Act. As indicated earlier, an
industrial grouping is considered a vertical issue; that is, the standards
can only be applied to the industry so delineated. Hazard groupings,
on the other hand, are considered horizontal issues and the standards
can be applied whenever appropriate, regardless of the industry involved.
As an example of a horizontal issue that relates to radiological
control, the OSHA standards package that was published in the Federal
Register on May 29, 1971, contains in 1910.96 standards on ionizing
radiation and another in 1910.97 for nonionizing radiation, including
microwaves.
This brings up the matter of OSIIA's relationship with the Atomic
Energy Commission. As you know, under section 4(b)(l) of the Occupa-
tional Safety and Health Act, it states as follows: "Nothing in this
Act shall apply to working conditions of employees with respect to which
other Federal agencies and State agencies acting under section 274 of
the Atomic Energy Act of 1954, as amended, exercise statutory authority
to prescribe or enforce standards or regulations affecting occupational
safety or health." At the present tin*. 23 States have such agreements
with AEC.
The major question now arises as to the availability of funds to
the various States through the section 23(g) Grant Procedures. To put
it another way, when a State has an operable 18(b) plan in force on either
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a complete or developmental basis, will 50-50 matching money be available
to the State?
As the gentleman from AEG will probably tell you, there are a number
of presently unresolved questions on this problem. I understand that
discussions are going on in Washington between OSHA and AEC on the en-
tire problem that was created by section 4(b)(l) of the OSHA bill. Fund-
ing is being given serious consideration in the National Office of State
Programs, and it has been predicted we will not fund any standards against
radiation hazards posed by source materials covered by the Atomic Energy
Act. It has also been predicted that funds will be available for standards
against radiation hazards not related to source material covered by the
Atomic Energy Act and certainly in those areas where we have standards
and where the State develops standards. Of course, any funding would
be contingent upon the State meeting our criteria for inclusion of this
"issue" in their State plan.
DISCUSSION
MR. PARROTT: Do I understand you to say that agreement material, by-
product material, will not be funded, but all other sources of radiation
will be funded?
MR. LOFTIS: Let me answer that this way. If it's included in the 18-B
Plan for the State, it can receive 50-50 funds, but it can not be on
standards under authority of the Atomic Energy Commission.
MR. PARROTT: What if the State administratively is broken up in such a
way that the occupational section and the radiation control part are
separate, and the radiation control part is not included in this? May
an amendment be filed so that radiation sources can be included in the
18-B Plan, or is only one individual responsible for writing this and
it comes from a single location?
MR. LOFTIS: The State has a designee in that agency, designated by the
Governor of that State, to handle this. This is where you'll have to
find out if they are including you or not. If they're not, if that
designee so desires, he can apply for an amendment to the planning grant
to incorporate this in the plan. And he can receive necessary funds for
this plan, if it's been left out completely.
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MR. PARROTT: Is there any criteria by which you go, that would say that
if the radiation control is missing in the application, then the total
application is not complete?
MR. LOFTIS: No. Because there are several applications that don't spell
out what they're for as far as the planning of this. In their planning
stage, the States should be checking with all agencies in the State--
yours and everybody else--to see if they are in full agreement; every-
thing the State wants. The State may not want radiation in their plan.
They could leave it out. We don't care. They can have a plan on one or
more sections in subpart B or R; or, one or more of the remaining sub-
parts in 1910. That's all they have to cover to have their plan. They
can leave everything else out but the Federal hazard in the standard.
MR. PARROTT: Would you then be responsible for that that is not covered?
MR. LOFTIS: Yes. The Federals would be responsible for everything else.
MR. PARROTT: That's disturbing then.
MR. LOFTIS: It might be disturbing to you, but it's not to me.
MR. PARROTT: My only concern is, that the person who has written the
State of Oregon for a particular request, seems to be somewhat reluctant
to include radiation, because we've been such a strong organization (I
use that loosely), according to them. They are afraid that if radiation
is included, then they will not have sufficient funds for occupational,
other than radiation in the occupation. They're really quite concerned
about this. Can I take an answer back?
MR. LOFTIS: No. Not through me. You're going to have to talk to the
people in that region and find out what's the matter in your own par-
ticular State.
MR. PARROTT: I wanted to make sure that we still maintiain control.
MR. LOFTIS: If they don't include it in their plan, the Federal Govern-
ment is going to maintain control.
MR. PARROTT: Then will the Federal Government come in and begin checking
radiation machines?
MR. LOFTIS: That's right.
MR. ROGERS: I have been deeply involved in this in the State of Cali-
fornia under the State plan, and I may clarify something for you here.
This question came up earlier this week and there again I said that only
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183
the byproduct material that you indicated is covered under the exemption
under the OSHA Act. And the concern of States of losing money because
of including radiation programs into the 18-B agreement is fallacious,
for the simple reason that the program for OSHA, as I understand it, is
on a 50-50 basis, on what they say they will do that is a mandate for
Congress to the Labor Department to carry out certain functions. If the
State wants to do it, they will be reimbursed at the rate of 50 percent
of the total cost of the program. If Oregon has a radiation program, it
seems to me that if that were included as part of the 18-B agreement,
they will get 50-percent reimbursement for that portion of the program
that will not impinge on the occupational health activities of the State
of Oregon. This will be an additional thing to whatever their program
may be. I don't see any problem of agencies within a State vying for
money, because based on their cost, they will get 50-percent reimburse-
ment.
MR. LOFTIS: This is true but they have to have it covered in their plan.
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REVENUE SOURCES: ATOMIC ENERGY CONTRACTS
A. P&fcdetce*
U.S. Atomic Energy Commission
I thought it might be useful to look at our overall contract prog-
ram in the area of effluent environmental measurements. With regard
to effluent measurements, we consider that the licensee has the primary
responsibility for measuring the radioactive effluents leaving his plant.
Our job is to provide reasonable assurance that the licensee is doing
his job well.
We can divide the measurement of effluents in two parts; sampling
and analysis. With regard to sampling, we handled that in the following
way. During the licensing process, provisions for sampling or monitoring
are incorporated in the licensee's technical specifications.
Recently the AEC published Guide 21, on how AEC thought this should
be done. In a nutshell, this Guide provides for the measurement of all
significant radionuclides leaving the plant. In the past, we've been
concerned with gross activity. If the gross activity is less than stron-
tium-90, or some other hazardous nuclide, you know where to go. This
Guide provides for the measurement of all significant radionuclides
leaving the plant.
Prior to startup, and during startup, inspections are made to insure
that the tech specs are being followed, and that effluents are, indeed,
being sampled properly. During operation, periodic inspections are made
to see that good sampling is maintained. Fairly recently, we instituted
a program in which we are measuring ourselves, and at some depth, not
only the sources of effluents, but also setting up parallel sampling
to verify licensee sampling methods. We are also doing such things as
developing methods for inplace testing of sampling systems.
With regard to analysis, once the samples are taken, which are repre-
sentative of what is being released, the next area of concern is to pro-
vide reasonable assurance that the samples are being analyzed correctly.
This is one of the areas in which we're asking for your help.
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Our program is centered around the splitting of effluent samples
with independent analyses by the licensee, the AEG, and/or the State.
When discrepancies in analytical results are uncovered in licensee data,
or in the State's data, or our own data for that matter, we follow up,
find the cause, and try to correct it. For planning purposes, we assume
a splitting schedule of four times the first year, and reducing that
schedule depending on the results, but not less than twice a year in
succeeding years.
The other area that we're concerned with is environmental measure-
ments. The AEG handles environmental measurements much the same way
as effluent measurements. Environmental programs are written into the
technical specifications of each licensee, then licensee programs are
inspected to assure that the provisions in the tech specs are being
carried out.
Beginning about 1968, the AEG started an independent measurements
program. This program was composed of independent environmental measure-
ments around five types of nuclear facilities. These measurements were
fairly comprehensive. We measured around a PWR, a BWR, a fuel reproces-
sing plant, a fuel fabrication plant, and a supplier of radioisotopes.
It was decided, late last year, to forego that program in favor of a
program to perform these measurements around each nuclear power plant,
although the scope of the measurements is less extensive than any pre-
vious program.
We are also considering other types of nuclear facilities other
than nuclear power plants. This is also an area in which we are asking
for your help. One of the aims of this program--when I say this program,
I mean the program of environmental measurements'--is to provide reasonable
assurance that the licensee is doing his job properly; and in this regard,
by independent measurements, one is able to check not only the analysis,
but also the sampling. If you set up air samplers side by side, you
automatically check not only the licensee's analysis, but his sampling
as well. The other aim is to obtain independent measurements, per se.
Of course, these two aims are not mutually exclusive. It is entirely
possible that measurements should be made which have absolutely no tech-
nical justification, and a measurement which is not made by the licensee.
In such cases, we would make these measurements ourselves, as part of
the program.
What can we pay for this help? We have estimated what this program
would cost the AEG in operating funds to do it all. These estimates
are based on experience we've had in our sample splitting of effluents,
and in our independent environmental measurements program. For a non-
operational plant, we estimate about 150 samples or analyses per year,
of which about two-thirds are gross type analysis, plus 160 TLD's. We
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estimate it would cost about $10,000 per site in laboratory support to
analyze the above s amples and report the data. With the State labora-
tories helping, we estimate we can save approximately one-half of this
$10,000; therefore, the general funding level we are considering, is
on the order of $5,000 per site. This schedule is not inflexible. Cer-
tain States have certain needs, but it does give you an idea of the level
of funding that we are able to provide.
DISCUSSION
MR. WILSON: That's fine for the lab for analysis. Who's going to col-
lect the sample, and how much are you going to pay for that?
MR. PELLETIER: We, in our independent measurements program, were able
to contract with a local science teacher to go and collect our samples,
and the average for the five programs that we had going on, is about
$1,000 a year. Half of this, I think, is included in this estimate.
This is not fixed. Five thousand dollars a year is just an order of
magnitude, but there should be some money in that $5,000 for sample
collection.
MR. WILSON: If I understand you right, you want some science teacher
out there to go collect this sample and put it through this laboratory
system? Is that what you're saying?
MR. PELLETIER: No. I'm saying that's what we did. And that is the
program on which we based an estimate of funding.
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REVENUE SOURCES: ELECTRIC UTILITIES
I. HaykieJtd, M.P.
Florida Division of Health
I don't know how unique this is, but we have started from the ground
on this system of cooperative agreements. We do not look at this as
a revenue source, actually, because these are (as I have mentioned) agree-
ments, rather than fixed fees. The monies involved are received as part
of a special budget from each utility with all funds earmarked for defi-
nite expenditures per the agreement. Any additions to the line items
in each budget must be mutually approved by both signatories and then
the electric utility provides the additional funding for these changes.
The program has been expanding in scope because of AEC requirements so
that additional personnel and materials, as well as expenses had to be
considered.
The first agreement was approved in September 1969, with the Florida
Power and Light Company of Miami, which had announced two proposed sites--
Turkey Point and Hutchinson Island. The second agreement was approved
in June 1970, with the Florida Power Corporation, which announced one
proposed site at Crystal River.
It is considered one of our program functions of our environmental
radiation program to have a knowledge of the activity which could have
an influence on the health of our citizens. As part of this responsi-
bility, we have been working with the national air, water, milk, and
food surveillance program as well as the Medical Liaison Officer Network.
These agreements provided us with the opportunity to increase our
knowledge of radiation background levels in the State and simultaneously
provide an important service to our electric utilities. With a usual
program under utility control, we would consider it mandatory to dupli-
cate from 10 percent to 25 percent of the environmental samples collected
by the utility to check on their accuracy and assure that a true picture
was available for future comparisons under operating conditions. With
existing staff and equipment, we were unable to meet our obligations
of this program and on this basis the agreements were developed and re-
ceived enthusiastically by both parties. This provided the responsible
agency a means of meeting its functions in the program and preventing
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a sizeable duplication of effort. Also it would result in a financial
saving to the utilities which we hope would be reflected in the consumers
bills.
To meet the requirements of the programs at these three sites, the
utility companies have funded four positions; one Public Health Physi-
cist II, one Public Health Physicist I, one Chemist II, and one Secre-
tary II. With the expanding program, commitments have been made to pro-
vide funding for an additional Public Health Physicist II. Funds were
also provided for incidental expenses as well as travel to meet program
needs. The present budgets are obligated on a 66-33 percent basis accor-
ding to the sites involved and the power company's budget. This ope-
rating budget presently amounts to approximately $51,000 per annum. With
old and outdated equipment being present in our radiological laboratory,
the utility companies agreed to donate certain electronic and other neces-
sary equipment to update our capabilities. This equipment was provided
as direct gifts and will, after an agreed period of time, become the
property of the Division of Health. To the present date, the value of
this equipment physically present in the laboratory represents a value
of approximately $160,000, which includes the computer-analyzer which
has become fully functional in the last week, it is the only one of its
kind in the IMted States, I understand. It provides a very expeditious
type of laboratory analysis. Discussions are now being held to have
a mobile emergency laboratory provided and equipped for any severe radio-
logical contaminations which could occur. The cost of this unit is esti-
mated at $40,000. All of this equipment was donated by the utilities
and no restrictions as to its use was tied in to this donation and can
be regarded as general equipment for our Statewide programs.
Both utility companies and the Division of Health are very pleased
with this arrangement. Our future plans include support for legislation
which would provide a fee system for licensing radioactive materials
and x-ray machines and also charge a specified fee to the utilities to
cover this service. This bill has failed to pass the legislature the
last two sessions but each time it did proceed further through the legis-
lative process. We hope that our third attempt next year will be suc-
cessful.
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REVENUE SOURCES: ELECTRIC UTILITIES
Acting Chief, Section of Radiation Control
Minnesota Department of Health
Minnesota has an agreement somewhat similar to the agreement Florida
seems to have. It was initiated during the formulation of a preopera-
tional environmental monitoring program to determine background radiation
as part of the preparation for the operation of the Monticello Nuclear
Generating Plant. A comprehensive program was designed that would re-
quire extensive sampling, elaborate laboratory counting equipment, and
sufficient manpower and supplies. Obtaining adequate funds to maintain
such a program was a problem. The Minnesota Department of Health has
a well-established environmental laboratory and could absorb the work
if sufficient funds were obtained to purchase the necessary equipment
and supplies. Through frequent communication with the power company,
with whom the State Department of Health has a good working relation,
the suggestion that data be gathered and shared was explored. Details
were formulated and a workable plan was written. Essentially, according
to the plan the Health Department would provide laboratory materials,
supplies and equipment, technically qualified personnel, and facilities
for the services to be performed. The power company would furnish, in-
stall, and maintain all sampling equipment and assist, under the super-
vision of the Health Department, in the collection of the samples. The
Health Department would also maintain exclusive control of the technical
supervision of the sampling and analytical services.
A complete copy of the data gathered under this agreement would be
provided for the power company but it would not own or have exclusive
rights to the data. Because of this, the funds are regarded as a gift
rather than as a contract for services.
When all the details had been arranged, the State's Governor,
Treasurer, and Auditor were contacted and informed of the possibility
of obtaining a gift for the purpose of environmental monitoring. Since
the policy of the State in accepting gifts is through formal acceptance
by the Governor, State Auditor, and State Treasurer, the signatures were
obtained for accepting the gift.
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Although the initial gift agreement was for a period of 1 year, it
was written into the agreement that comparable arrangements are contem-
plated for succeeding annual periods. It is not necessary that a new
agreement be signed each year.
Upon completion of the preoperational environmental monitoring plan,
the operational environmental monitoring plan was initiated even though,
because of delays, the plant was not yet in operation. Although there
were some differences between the preoperational and operational pro-
grams, the basic pattern was the same and only minor adjustments in
funding were required.
Shortly after the Monticello Nuclear Generating Plant environmental
surveillance program was in effect, construction for a second nuclear
generating plant was approved at a different site (Prairie Island, Minn.)
The preoperational survey program for this site is similar to the one
completed for the Monticello Nuclear Plant and it was initiated under
the same arrangement. The funding was handled in a manner similar to
the established agreement. A separate agreement covering the Prairie
Island plant was signed, however. Because the equipment had been pur-
chased under the earlier agreement, the amount of money required for the
Prairie Island monitoring program is considerably less.
In order to continually update the techniques and equipment to main-
tain "the state-of-the-art," constant vigilance for improvement is main-
tained. Whenever possible, more sensitive and accurate equipment is
installed. If these improvements are related to the environmental moni-
toring program, some of the funds may come from the agreement with the
power company.
Recently there has been a move by the Environmental Protection
Agency to encourage States to build into their monitoring programs the
gathering of data that will assist in determining critical pathways and
population dose in areas around the plant. To implement this program,
some alterations in sampling and possibly in equipment will be necessary.
The power company has expressed interest in this type of program and no
difficulty is anticipated regarding the agreement; however, the altera-
tions may necessitate a rewording and resigning of the agreement.
The initial contract was signed in 1968. Thus far we have found
it a workable agreement and anticipate that the agreement will be main-
tained for some time to come.
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DISCUSSION
MR. WILMS: You didn't mention the dollar amounts that are involved in
your contracts did you?
MISS. DOLEZAL: No, there's no set amount. This is negotiable.
MR. WILMS: How much has it been?
MISS DOLEZAL: In the first years of getting the equipment set up and
things like this, it ran perhaps close to $20,000. This was with the
one plant--Monticello--and in carrying it on, as the Prairie plant was
developed, it amounts to approximately $30,000 a year; so taking it from
'68, we received approximately $30,000 a year.
MR. SHAVER: It would appear that the operating monies that Florida and
Minnesota have secured from utilities are adequate to offset the necessary
surveillance that needs to be done. But I doubt that the States are
making a profit. It would seem inconsistent for the Commission to expect
that only $10,000 is adequate when we're talking of funds substantially
larger than that in other areas. Would you like to comment on that?
MR. PELLETIER: One thing that we did not include in this estimate is
equipment costs, or building costs, except indirectly. Equipment is not
included in these operating costs. I tried to make that clear. There
is some saving as you know in doing a lot of these, of course. When you
are talking about one laboratory doing this--it must have been 150 (that's
the number of plants that we're talking about someday)--you have a savings.
MR. BOND: Do you anticipate any difficulty or'problem in utilizing the
information you obtain by this method in an enforcement action?
MISS DOLEZAL: We do not anticipate any difficulty of that nature. We
feel that, according to the original agreement, the data would be col-
lected so that the health department would have, not only access to it,
but could disseminate it. In turn, the power company was getting the
data also. But as far as any kind of enforcement, we feel that we have
the independence here that would be needed. If we decided to do some-
thing different, we could go ahead and enforce.
MR. SHAVER: The question that I had was what about the possibility of
an*attorney general or somebody saying that you can't utilize this kind
of evidence because it might be construed to be self-incriminating. Has
your Attorney General commented on that possibility?
MISS DOLEZAL: Not directly to my knowledge.
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MR. MATUSZEK: I have a question to Florida's group. The reason for my
comnent is obvious. Are you in a circumstance where a particular nuclide
may be. rated in significant quantities and you start detecting it; just
how hard are you going to lean on your benefactors, who apparently are
providing a substantial amount of your total dollars? I don't know what
your budget is, but I would guess that based on the numbers that Jack
was tossing out on, say, $30,000 per site, that that FDL money represents
just about the bulk of the funds that you need to do that specific part
of the program. Just how hard would you lean on FDL at this stage?
MR. NAYFIELD: We don't have that problem right now because it's all
preoperational surveillance, and it is in the agreement, as it is with
Minnesota, that any information we obtain will be used as though we ob-
tained it ourselves, in spite of the fact that they provided some of the
funds which were used to obtain this information. When we become opera-
tional, I think the aspect may change a little bit. But we always assure
the power company that we would use that information, whatever we get,
as though it was not funded by them. This is definitely understood.
Presently, under preoperational surveillance it is to the advantage of
both the health department and the utilities, to find the existing levels
and determine them accurately so that when they get into operational
procedures, they would not be accused of putting some radioactivity into
the environment which already had been there.
MR. MATUSZEK: Coining from an industrial organization, just recently
being with the State, and having done a lot of work for power companies
in the past as an "independent" laboratory, I also realize the pressures
that are placed on the independent contractors by the management of
power companies (not necessarily the health physicist who's happy to get
good data; he wants to know that things are clean). When bad numbers
start to float up through the hierarchy, it touches all kinds of sensitive
nerves, and that's where your money is coming from--where the nerve centers
are, not down at the health physics level.
MR. NAYFIELD: That's why I mentioned in my paper that this presents a
duplication of effort; but we would have to check on these independent
companies that are subcontractors with the power companies, and do any-
where from a 10 to 25 percent check of their samples to assure accuracy.
MR. MATUSZEK: You are not a contractor.
MR. NAYFIELD: No, we're not contractors. We have agreements, and this
information is used just as though we had obtained it ourselves.
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REVENUE SOURCES: FEES - PROS AND CONS
John R. Stanton
New Hampshire State Department of Health and Welfare
Fee scheduling can be accomplished by one of two ways - either by
degree of hazard or by anticipation of licensing or registration costs.
The two probably become synonymous when one considers the usual increased
frequency of inspection with the degree of hazard.
When our fee schedule was initiated in 1965 (fig. 1), we had little
feel for the actual cost which might be incurred in the administration
of licenses or registrations of various types, and therefore went more
or less the degree of hazard route. The fee for radioactive material
licenses (including source and special nuclear material) for what might
be termed "private use" depends solely on the number of users named on
the license; whereas fees for so-called "commercial" licenses, such as
radiography, manufacture, or distribution, are fixed fees. In a class
all by itself stand the teletherapy license - at a fee which we now con-
sider terribly exhorbitant in comparison to other types of licenses, no
matter which criterion is applied.
This same inconsistency crops up when we consider x-ray registrations.
Industrial x-ray units are taxed at 2-1/2 times the rate of medical diag-
nostic units. This does not appear to be unnreasonable when one considers
the fact that these units generally experience more "on-time" and that
they undergo more frequent tube changes which, more often than not, re-
sult in requests for resurvey. Again, however, the therapy units bear
what we now feel is an unresonable share of the fee revenue burden.
Tucked away (not-so-neatly) under x-ray registrations is an item
entitled "Any device containing radioactive material not classified
above . . .$10.00." This was an attempt by the Agency in its infancy
to extract revenue from still another source--the generally licensed
(but registered) item. It would appear that the intent was to leave as
few loopholes as possible when the legislative package, including the
fee schedule was proposed. It didn't take long for us to realize the
folly of tacking a $10 annual charge on every static eliminator brush
and every instrument check source in the State. No fees have ever been
collected under this clause in the law and it is doubtful that any ever
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will. The clause, properly qualified, may have seme merit in a fee sys-
tem; but, as this one stands, probably ought to be repealed during our
next legislative session, since we are technically violating our own law
by not attempting to register and collect.
RADIATION CONTROL AGENCY
DIVISION OF PUBLIC HEALTH SERVICES
DEPARTMENT OF HEALTH AND WELFARE
CONCORD, NEW HAMPSHIRE
LICENSING ADO REGISTRATION FEES SCHEDULE
The New Hampshire State Radiation Control Agency shall assess annual fees
for the licensing and/or registration of sources and devices capable of emitting
ionizing radiation in accordance with the fol lotting schedule:
Radioactive Materiel Licenses
1. Each individual user named on a specific license issued by the Agency.
except radiographers, teletherapy units, and manufacturers and/or
distributors of devices containing radioactive material ------------- $10.00
2. Radiographer employing radioactive material and licensed by the
Agency $50.00
3. Manufacturer and/or distributor of devices containing radioactive
material and licensed by the Agency $50.00
It. Teletherapy units $100.00
X-ray Registrations
1. 01 agnostic-type X-ray machine, including medical, medical fluoro-
scopic, dental, chiropractic, veterinary, or similar uses $10.00
For each additional machine at the same address — $5.00
2. Therapeutic-type X-ray machine capable of being operated at
potentials not above 500,000 volts (per unit) $25.00
3. Therapeutic-type X-ray machine capable of being operated at
potentials above 500,000 volts — (per unit) $100.00
**. Industrial X-ray machine. Including fluoroscopic and X-ray
diffraction units — (per unit) $25.00
5. Any device containing radioactive material not classified above $10.00
License - Registration Combination
Any person or organization may elect to pay a combination license and registra-
tion fee of $200.00 in lieu of a multiplicity of separate license and/or registration
fees. The combined fee shall coverall specific licenses and/or registrations issued
to the person or organization located at one location or address by the Agency.
Authorized by Chapter 336. Laws of 1965
Effective date July I, 1965
Figure 1
Speaking of legislative sessions, we would like to offer a suggestion
to any of you who may be considering the implementation of such a. fee
schedule. When our original proposal was made in 1965 it met with vir-
tually no opposition from potentially affected parties. Experience over
the next few years indicated that we were recovering approximately 25
percent of our program costs from fees collected. As the Federal Gov-
ernment's contribution to the program is about 50 percent, this meant
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that the remaining 25 percent had to be taken from State general funds.
A recent attempt was made to increase the fee schedule to make the State
portion of the program "pay for itself" so to speak. During these few
years, since the inception of the fee schedule, some of the affected
parties began to equate amount of fee with amount of service and perhaps
felt a little cheated or otherwise came to regard this annual collection
as somewhat of an annoyance. At this legislative session opposition to
raising of the fees was strong--strong enough to cause the bill to die
in committee without ever having come to the floor for a vote. Our word
of advice is that anyone contemplating such a schedule should ask for
whatever amount is needed the first time around.
I mention the fact that some consider the fee an annoyance. By and
large the schedule appears to be reasonably well accepted by the licen-
sees and registrants; nevertheless, there are those who do object. The
objection is done in kind of a quiet manner, they simply don't pay. From
fiscal 1966 to fiscal 1971 we experienced what I consider an alarming
11 percent decrease in registration fees collected (I'm sure that many
people didn't move out of the State). Our agency sends reminders and
so-called "final" notices, but it is a radiation control agency and not
a collection agency. There must be a solution to this problem, but we
have neither the time nor the personnel to pursue that solution.
The topic for discussion here is "Fees - Pros and Cons." Perhaps
my remarks have appeared generally negative; they weren't meant that way
but were designed to point out pitfalls that we have experienced in the
implementation of this system. My personal feeling is that licensing
and registration fees schedules, equitably formulated and properly ad-
ministered, are definitely a source of revenue to be considered in the
funding of any radiation protection program.
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REVENUE SOURCES: TO FEE OR NOT TO FEE
Wigtown H.
Office of Radiation Control
City of New York, N.Y.
To fee or not to fee, that is the question! Whether 'tis nobler
to silently suffer the indignities of a mini-budget or to take arms
against the slings and arrows of outraged fee-payers and by opposing,
end them.
The fiscal austerity that has prevailed in most radiation control
programs, over the past 2 to 3 years, has proved to be restrictive and
has adversely affected the quantity and quality of work output in prac-
tically every instance. There has been a growing feeling that costs for
regulating users of sources of radiation should be borne by those being
regulated. Whether you concur with this philosophy or not it must be
admitted that it is straightforward in approach. It is appropriate to
point out that strict adherence to such a "fee for service rendered"
approach could result in fees of many thousands of dollars for x-ray
equipment regulation and additional fees of many thousands of dollars
for radioactive materials regulation. These large fees would, of course,
pertain to only the very largest, highly active institutions.
I remind those who oppose the concept of "fees in general," or the
concept of "fees to equal costs," that the latter is the basis of private
enterprise with the "profit" angle stripped out.
Would it be reasonable to expect the Government to subsidize the
manufacture or repair of your color TV set? Why should you pay driver's
license or car registration plate fees? Where does one concept stop and
the other begin?
What part of your driver's license fee pays for regulating the safe
operation of motor vehicles? What part of your car registration plate
fee pays for assuring the existence of safe vehicles on the roads and
highways; what part pays for tracing stolen vehicles? Stolen vehicles
have only a peripheral involvement with the safe operation of motor
vehicles.
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Recommendations
If one is to adopt fees, or make fee adjustments, the following are
helpful points to be considered:
1. A detailed, accurately maintained optimal Program Plan and
Budget Analysis should be prepared as an initial step. These documents
are indispensible for proper planning and conducting efficient operations.
When properly prepared, they will accurately apportion resources (person-
nel, equipment, travel funds, maintenance costs, and so forth) and make
compliance with items #3, #5, and #7 relatively simple.
2. Be sure to include sufficient resources (staff, equipment,
operating expenses, and so forth) to carry out operations designated in
your optimal Program Plan (and not the plan you are currently operating).
This could mean a substantial increase over the resources currently
available to you.
3. Make certain that all operations are conducted in the most
efficient manner possible.
4. Learn to think as a Cost Accountant.
5. Only consider as costs those expenses directly related to the
regulatory function performed. Proper items include fee collection,
machine records processing, office rental, and employee fringe benefits.
Particular care should be exercised to not include general overhead items
and unrelated administrative and research and development costs.
6. In addition to the angle of fairness of treatment, the most
important reason for the exercise of great care under items #3, #5, and
#7 is to assure a defensible position, should the fee schedule adopted
be challenged in legal proceedings. An example of nondefensible fees
are those charged for State motor vehicle registrations and driver li-
cense fees where administrative and program costs typically average only
about 15 percent of the fees collected.
7. The cost of "regulating" a Priority II license is less than
"regulating" the number of Priority IV licenses that would be replaced
by the Priority II license. Initial cost reductions are due to less
"paperwork"; further reductions are possible as broad licensees "mature"
and require less regulatory attention. Priority II license fees should
reflect these reduced costs and will provide an incentive toward broad
license applications for appropriate institutions. One analysis of fee
costs gave ratios of 15:20:12 for Priority II, IV, and V licenses,
respectively.
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8. Be prepared to visit installations on a regular basis and to
deal promptly with all matters arising. People paying fees expect serv-
ice and become irate if they think they have been slighted.
9. Last but not least, reasonable assurance should be obtained
that the fees collected can be reserved for radiation control purposes,
very important for facilitating proper funding. If this cannot be
arranged, suffering the "slings and arrows" of irate, potential fee-
payers may not be the wisest course of action.
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REVENUE SOURCES: FEES - PROS AND CONS
Simon
California State Department of Public Health
This panel was charged with the source of revenue, discussing pros
and cons. You've heard the pros and cons and now you'll hear the in-
between. I don't think there are any con people in the room, and I'm
sure, therefore, you're all for a fee schedule. And whether you like
it, or whether you admit it or not, our entire program is based on a
fee schedule. It just depends on who's paying the fee. The general
public has been paying the fee for our program all these many years,
and some people say there should be a service with the fee. I think
we have given the public some service, because our programs are radia-
tion protection, and we are protecting the public. The time has come
now, in that it's the trend that the user and sometimes the middle man
here, is assessed a fee. This again is just a little differentiation
in who is actually paying.
In the case of the fee for the registration of a machine, you know
that the physician is not going to absorb that himself. He's going to
pass it on. And I think most of you realize that it's passed on many-
fold.
When we were trying to get a fee schedule in for the physicians
to operate their equipment, they complained bitterly. We pointed out
that the fee schedule we were trying to charge of $15.00 a registration,
was only something on the order of less than a cent for each radio-
graph that was taken. But you couldn't convince the physician of that,
and he knocked our fee schedule down by 66 percent, and it was a case
of either having no law or reducing it. We finally got the fee schedule
in, and the cost is something on the order of a cent or less per radio-
graph; but if you look at the increased cost in the charges for radio-
graphs by virtue of that registration, you have two or three orders of
magnitude there on the actual cost.
Be that as it may, I think that the fee schedule should be in effect,
and I don't think it should pay the total cost of the program. And may-
be the reason I'm saying that is historical. We have, and I'm sure most
of the rest of you have, about three components in your Rad Health Pro-
gram. One of them is environmental surveillance. We started the fee
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200
in accord with my primary context--to the general public. That money
comes out of general funds on appropriation.
We charge a fee for the other two programs--the licensing of radio-
active materials. That fee is a sliding schedule on the amount of radio-
active material they are using or possessing, or in accord with the
hazard, as New Hampshire said. The other program is one of x-ray--both
registration and certification. We have a fee for those, and I don't
think anybody objects to the practice of charging a fee for a certifi-
cation. This is done for certification, or licensing, or registration,
of people--whatever you want to call it. The nurses are registered;
the physicians are licensed; and because the physicians were licensed,
and we included the physicians in this program, they suggested that we
use certification rather than having to have two licenses to practice
medicine in the State. Whatever name you use, it's the same idea. I
don't think there's a great deal of objection to paying a fee for a certi-
fication of individuals to indicate that they have had to acquire some
sort of competency to do the work. To acquire a fee schedule, once you
haven't had one, may be difficult. If you go for a fee schedule when
you're coming in with a program, you risk the chance of not having the
program, because some of them may knock it down on account of the fee
schedule.
The Atomic Energy Commission has set a precedent here. They didn't
have a tee schedule when they started licensing their material. Now
they do have a fee schedule. And since this precedent has been started,
I don't see any objection to any other State going with that type of
a fee schedule. We looked over the AEC's fee schedule and decided in
some cases the money looked like it was pretty high, but their source
of revenue, if we adopted it exactly as it is, would not provide as much
revenue as our fee schedule does. In the case of the certification of
the registration, or as I said, that the fee should not support the entire
progmam, I recommend that the general public pay some of this, and at
least pay for the starting of a program. It will enable you to get off
the ground a lot better if you have some sort of an appropriation, which
is collecting the fee from the general public, for the registration or
certification. This should be written in the original document, to pro-
vide some money to get the program going. We were very unfortunate in
not having any appropriation attached to the bill, and we couldn't get
going until the money started coming in. The money won't start coming
in until you're ready to issue a certificate or provide an examination,
or do a registration and put a number on it; and, therefore, we were
under a terrible handicap. If you have an appropriation in there to
carry the program for a year or two, until the registration or the cer-
tification starts, then you can gear up and get your staff; and you can
have your regulations, and your standards, and everything all ready to
go. When the individual (the consumer) starts paying his money, then
you can begin to give him some real service.
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DISCUSSION
MR. PARROTT: I have some general comments, mostly in agreement with
Si and the others. Fees will be instituted. Face it now--you are going
to have to collect it. The difficulty John had in collection of fees
is, he is not a collection agency. We're not a collection agency. So
what we do is to simply pass on to the District Attorney in a given county,
our material, saying, these people have not paid their fee for 1,2,
or 3 years. The District Attorney sends them a letter, and practically
everybody pays instantly. It's really incredible. The network of com-
munication is very surprising. You only have to institute this on three
or four people in your State and everybody knows it. We went from 250
licenses initially--think of this when you're calculating how much reve-
nue you will derive—to 111 licenses in the institution of a fee program.
The prestige symbol apparently was not worth $50. We went from 2,700
machines to 2,475 machines. This is interesting inasmuch as those machines
were registered, but were not in use. So we lost just a very few x-ray
machines. I would say generally speaking, that the fee program, when
it comes to x-rays, will hold up, along with radioactive materials, should
have a big hold temporarily. We are right now up to 143 licenses. We
are gaining back, after a period of 2 years, over 25 percent of what
we lost--50 percent increase to our initial base.
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202
A STATE X-RAY PROGRAM EFFECTIVENESS INDEX (SEI)
Rob&it C.
Chief, Radiation Control Section
Kansas Department of Health
If my introductory remarks appear to be redundant, let me assure
you that they are - with purpose. I want very much to make certain
that all of you understand what the proposed State X-Ray Effectiveness
Index is, and even more importantly, what it is_ not. Based on the
premise that radiation control program di re ct ors shoul d have some means
whereby they can determine whether progress is being made in the reduc-
tion of exposure to radiation to patients during diagnostic x-ray exami-
nations , Workshop No . 2 at the Scottsdale Conference was charged with
developing a State X-Ray Program Effectiveness Index. The guidelines
for the workshop were:
1. that the system must not be complicated,
2. that it be within the control of the program director, and
3. that it must relate to the x-ray exposure of patients.
While it is important that the program director know the number
of facilities and devices inspected, and the number of those which are
in compliance with the regulations , it is more important that he know
whether the inspection program has, in fact, been effective in attaining
the prime objective - reduction of unnecessary radiation exposure to
patients during the process of medical diagnostic x ray.
An evaluation of the efficacy of his program is also important in
the determination and justification of manpower and budgetary require-
ments and as a guide for setting program priorities.
The State Effectiveness Index proposed herein is a method for deter-
mining whether progress is being made within the limits of current man-
power utilization and program expenditures.
Even by reviewing data accumulated from existing inspection records,
it is difficult to determine whether there has been, in fact, a quanti-
tative reduction in radiation exposure; therefore it is proposed that
a uniform method of assembling and evaluating the data be adopted so
that the results of successive inspections can be compared to a standard
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203
or baseline. Simply put, the proposed formula will enable a program
director to utilize existing x-ray survey data to arrive at a baseline
SEI number for his program. From succeeding inspections of the same
facilities and machines, a similar SEI number is then derived from the
survey data, and compared to the first.
The index is_ not an evaluation of program resources and capabilities,
of radiation dose assessment, of compliance status, nor is it a com-
parison with programs of other State or local radiation control agencies.
It is, on the other hand, an index for self-evaluation, derived from
data specific to one State program only. The index directly indicates
whether there has been an increase or decrease in exposure to x radiation
in medical uses in that State. It is, in effect, a standard by which
the program director can determine whether his program objectives have
been achieved within the limits of those resources which are available
to him.
Obtaining the index for a specific jurisdiction is relatively simple
and requires a minimum of extra effort on the part of the radiological
health staff. It does not require additional equipment or unusual radia-
tion measurements. In most States the data necessary to determine a
baseline SEI number for future comparisons can be obtained from existing
survey records.
The following is an explanation of the mechanics of deriving a
State Effectiveness Index, with projections of the appropriate tables
and forms to be used, along with an example index worked up from the
Kansas records. The tables, forms, and an example appear as an appendix
to this paper.
Procedures
There are four elements for determining the State X-Ray Program
Effectiveness Index:
1. Selection of a representative sample of facilities and
machines for inclusion in the survey.
2. Obtaining data on the amount of radiation used by a
facility to perform selected procedures with a radio-
graphic, dental, 'or fluoroscopic machine.
3. Application of a standard table of assigned weighted
values to the parameters used in determination of the
index.
4. Calculation of the SEI number.
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204
A. Selection of Samples
Three types of x-ray equipment are considered: radiographic machines
that are normally used for chest procedures; fluoroscopic machines; and
dental radiographic machines. Care should be taken to include a represen-
tative sample of each type of machine proportionate to the total number
of that type of machine in the State.
There are a variety of ways in which the sample of each type of
machine can be selected. However, it is important to obtain a statis-
tical sample size that will attain at least a 90-percent-confidence level
and represent machines used in all types of medical facilities and pri-
vate practice offices, in both rural and metropolitan areas of the State.
Thus, a random selection of a statistical sample of each group of facili-
ties; that is, large medical centers, small hospitals, private offices,
private practitioners, and so forth, is made. Next, for each facility
selected, all x-ray machines used for chest procedures, fluoroscopic
exams, and dental radiography are considered in the determination of
the index. Table 1 may be used to determine the number in each group
of facilities which should be included in determination of the index.
For example, if it is found that in a State there are:
Large facilities -- hospitals with over 100 beds 40
Small facilities -- hospitals with under 100 beds 160
Private practice offices 1,600
then, referring to table 1, it can be determined that a sample of 25
large facilities, 36 small facilities, and 50 private offices should
be included. Again, all machines in each of the facilities which are
used for chest diagnoses, fluoroscopy, and dental should be included
in the sampling.
B. Collection of radiation usage data
For each machine included in the sample, proceed as follows:
I. Radiograpkie maohine(s):
a. Determine the actual mAs, using average machine settings,
for making a radiograph of 20 cm chest at 72 inches (non-
phototimed).
Determine the weighted value from table 2.
b. If gonadal shielding is used with that machine, assign a
value of 10; if no shielding is used assign a value of 0
(table 2).
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205
c. As recommended by NCRP No. 33, if collimation is used,
assign a weighted value of 30; if not assign a value of
0 (table 2).
d. As recommended by NCRP No. 33, if filtration is adequate,
assign a weighted value of 10; if inadequate, assign a
value of 0 (table 2).
II. Dental machine (s):
a. Determine the R/film, or mAs/film (select option in
accordance with your State's procedures), measured
at the end of cone for a radiograph of an upper first
molar, and determine the weighted value from the
appropriate column in table 2.
b. Determine adequacy of gonadal shielding, collimation,
and filtration, as for radiographic machine, above, and
assign appropriate weighted value (table 2).
III. Fluoroscapic machines:
a. Determine the actual R/min at the table top, using the
machine setting for an average upper GI examination, and
assign the weighted value from table 2.
b. Determine collimation, gonadal shielding, and filtration,
as for radiographic machine, above, and assign appropriate
weighted value (table 2).
C. Calculation of SEI
Consolidate the data on each machine included in the sample on a
Form #1, Data Report (Figure 1).
Total the indices for dental, fluoroscopic, and radiographic machines,
and divide by the number of machines of each type in the sample so as
to obtain the average index for each type. Finally, calculate the State
X-Ray Effectiveness Index by totaling the indices for each type, as
follows:
SEI = El + El + El
Rad Dent Fluoro
A State index using this method will not exceed 300.
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206
The interim conmittee which worked out this version of the State
Effectiveness Index discussed one further recommendation when it met
in Rockville last fall. It is obvious that, if an inspection program
were to be 100 percent effective and if all deficiences in shielding,
collimation, and filtration were to be corrected as a result of the
program, the score attained by any sample group would be at, or near,
the optimum for at least those three factors at the time of the second
and succeeding inspections. It should remain at a fixed level unless
and until the device itself were altered in such a way as to effect any
one of those three factors.
Thus, it is recommended that a permanent committee be appointed
by the Conference for the purpose of reviewing the results of index
studies and determining whether there is a need for setting new para-
meters. There are a myriad of factors, such as film speeds, processing
techniques, appropriate use of grids, or possibly positioning techniques,
which have bearing on the quantitative problem of unnecessary exposure.
These could be exchanged from time to time for the current parameters.
The program director cculd, then, after he is satisfied that the inspec-
tion program has achieved the desired results, determine a new index
for the same sample group, using a different set of parameters.
Marshall Parrott, Henry Copeland, and Jack Rogers (all of whom have
worked closely with us) have some comments to make.
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207
facilities
1 - 24
25 - 54
55 - 59
60 - 64
65 - 71
72 - 78
79 - 86
87 - 94
95 -105
106 -116
117 -130
131 -147
Nuniber to be included
in sample
all
25
26
27
28
29
30
31
32
33
34
35
Number of
facilities
148 - 167
168 - 191
192 - 222
223 - 262
263 - 316
317 - 394
395 - 514
515 - 725
726 -1,192
1,193 -5,000
5,001 -10,000
10,001 and over
No. to be included
in sample
36
37
38
39
40
41
42
43
44
50
100
200
Table, 2
Radiographic
mAs/film
0-3
>3-5
>5-10
>10-15
>15-20
>20
Dental
mAs/filma
0-1
>l-2
>2-5
>5-10
>10-15
>15
Dental
R/filma
0-0.5
>0. 5-1.0
>1.0-1.5
>1. 5-2.0
>2.0-2.5
>2.5
Fluoroscopic
R/min
0-1
>l-2
>2-3
>3-4
>4-8
>8
Gonadal shielding used
Weighted
value
50
45
30
20
10
0
10
Collimination adequate 30
Filtration adequate 10
option in accordance with your State's procedures (see page
-------
FORM 1
ts>
O
00
1. X.-MUJ piogtum e^ecX-tvenew -tnctex
Vata
Facil-1
ity
Totals
Weighted
Value
Average
Type of2
Machine
Weighted values
Radia-3
tion
output
Colli-4
mation
Filtra5
tion
Shield-
ing
Weighted values totals
7
Radio -
graphic
Dental8
Fluoro-
scopic
Average Weighted Value Column 7 = El for Radiographic Machines
Average Weighted Value Column 8 = El for Dental Machines
Average Weighted Value Column 9 = El for Fluoroscopic Machines
State El = El + El + El
Rad Dent Fluoro
1. Enter the name of facility, repeat the name for each machine.
2. Type of Machine: D - dental, F - fluoroscopic, R- radiographic.
Use separate line for each machine in a facility.
3. R/Film* for dental units, mAs radiographic, R/min Fluoroscopic,
4,5,6. Enter appropriate weighted value.
7,8,9. Enter the total of weighted values for the appropriate type of x-ray machine.
*mAs may be used (see page 4)
(Final form would extend to full page)
-------
EXAMPLE OF THE METHOD OF DETERMINATION OF
SEI'S FOR SAMPLE YEARS 1964 and 1970
STEP I - DATA IS COLLECTED AS FOLLOWS:
209
No Name 1 1964
1970
No Name 2 1964
1970
No Name 3 1964
1970
No Nane 4 1964
1970
No Name 5 1964
1970
No Name 6 1964
1970
Type of
machine
R
R
R
R
D
D
D
D
F
F
F
F
Radiation
output
13 mAs
5 mAs
15 mAs
10 mAs
15 mAs
3.6 mAs
22.5 mAs
2.5 mAs
5 R/min
1.6 R/min
9.5 R/min
.8 R/min
Colli-
mation
No
Ok
No
Ok
No
Ok
Ok
Ok
No
Ok
Ok
Ok
Filtra-
tion
No
Ok
No
Ok
No
Ok
Ok
Ok
Ok
Ok
Ok
Ok
Shield-
ing
No
Ok
No
Ok
No
Ok
Ok
No
No
Ok
Ok
Ok
STEP II - TABULATION
Data is tabulated on a Form 1 (see pages 2 and 3 ff) and weighted values
assigned and totalled.
STEP III - CALCULATIONS .
Calculations are made, using the totals of the weighted values as follows:
1964
20
25
35
1970
88
75
98
SEI 1964 = 80
SEI 1970 =261
-------
FOEM 1
1970
X-RAY PROGRAM EFFECTIVENESS INDEX
DATA REPORT
EXAMPLE
ts)
M
O
Facil-1
ity
No name 1
No name 2
No name 3
No name 4
No name 5
No name 6
TOTALS
AVERAGE
Type of
machine
R
R
D
D
F
F
Weighted values
Radiation
output
45
30
30
30
45
50
Colli-4
mat ion
30
30
30
30
30
30
Filtra-5
tion
10
10
10
10
10
10
Shield-6
ing
10
10
10
0
10
10
Weighted values totals
Radio-7
graphic
95
80
175
88
Dental8
80
70
150
75
Fluoro-
scopic
95
100
195
98
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211
MR. PARROTT: I'm sorry that we didn't submit this information sooner.
I have a thing set out for the different kinds of breakdowns that we
would recommend in this. We siad that, in comparing the inspections of
certain types of facilities, a major consideration must be the frequency
at which these facilities are inspected. Our suggested frequencies for
SEI were: Hospitals: use only data for those hospitals surveyed 2 years
ago, plus or minus a half a year (so it's one and a half to two and a
half). Private offices would be the same as hospitals; private prac-
titioners, the same as hospitals; and dentists - 3 years, plus or minus
a half a year. The type of practice in the healing arts must be con-
sidered separately; that is, D.C., M.D., Podiatrist, D.O., D.M.D, or
D.D.S. The radiologists should be considered separately fromM.D.'s.
Consideration must be given to the workload of the facility. The
workload must be precisely defined as patients exposed per week, as
distinct from individuals exposed per week, procedures per week, or
films per week, and so forth.
Consideration should be given to using, as an index, the number
of patients or individuals exposed to unnecessary radiation per week.
This is what we really hang our entire program on; for example, a pri-
vate practice M.D. facility has two radiographic machines. On machine
#1, 40 patients are exposed per week for chest films. On machine #2,
30 patients per week are given chest films. If machine #1 has inade-
quate filtration, then the noncompliance chest workload is 40 patients
per week, not 70.
We suggest unnecessary radiation, in roentgens, rem, or gram-rads,
can be determined for noncompliance workloads. In the example above,
if the entrance close for chest films with inadequate filtration was
40 mrem, and if this dose was reduced to 10 mrem by adding the proper
filter, the unnecessary radiation would be 30 mrem per patient. Since
the noncompliance chest workload was 40 patients per week, unnecessary
radiation amounts to 1,200 mrem, or 1.2 man-rem per week; times 52
weeks, and you have over 50 rem.
For collimation noncompliances, we would like man gram-rads per
week of unnecessary radiation, which could be found by measuring the
entrance dose and then the field size before and after noncompliance
correction. The scatter from different field sizes is neglected.
Unnecessary radiation could be found as described above, for the
following standard procedures:
a. Chest films - collimation noncompliance; filtration noncompliance.
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212
b. 14- x 17-inch Table Top Exposures - collimation; filtration
noncompliance.
c. Fluoroscopic (Upper GI, for an example) - collimation;
fiItration noncompli ance.
d. Dental Films - The workload is dependent on the number of
films per week, per patient, which has to be an estimate.
Total unnecessary radiation eliminated by the inspectors in man-
rem per year or man gram-rad per year, could be estimated by the Direc-
tor of the X-Ray Regulatory Program by considering the above items,
which involve obtaining: total workloads and noncompliance workloads;
noncompliance workloads based on collimation, filtration; and doses before
and after the correction of these noncompliances, which many of us do
in the field.
I have an estimate of what our results were for 1970-71 in this
type of exposure. We calculate this as a minimum value. We would like
to get into your kind of a business of--the same one that we did in '70
with everybody--multiplying it by the total average number of films.
What we did was only assume a single film per patient. In Oregon, we
have an unusual situation in that we have about 30 percent more machines
than the average, nationally. The amount of unnecessary radiation in
1970-71 from 303 medical x-ray machines was 17,500 roentgens. Out of
this, 15,250 roentgens were eliminated by inserting filters. Now, this
is a very impressive number that you can hand to your legislators to
continue a program. Especially if you consider comparing 15,250 roent-
gens with 5 millirem per year from a power plant.
MR. COREL AND: I was a member of the Workshop in Arizona and worked on
the State Index of Effectiveness determination. I found out when I got
back to Georgia, after the meeting last year, that our Program Director,
Mr. Dick Fetz, had supported the original idea 4 years ago of having
a workshop come up with the index of effectiveness for the State programs.
I think that the State effectiveness index program is a good plan,
as far as it goes. It is a workable plan. We did a trial run of this
idea in July of last year, and were able to arrive at an index number.
This is the first time that this has been accomplished. It is a plan
that can be used now and it can be done without the use of a computer.
In doing the trial run, or the pilot run on this program, we dis-
covered two things. The first was in regard to the use of mAs per film
for dental x-ray machines, in comparison with the use of "R" per film
for those same machines. The original recommendation, I think, of the
Committee was to use "R" per film. It was changed later such that one
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213
had the option of using mAs per film. We discovered that there may be
pitfalls in the use of mAs per film. One could have the situation where
the dentist with a fairly new machine is using a factor of 10 mAs and
a constant kVp in his exposures, and as his machine ages, he may dis-
cover that he has to increase his exposure time to twice what he for-
merly used. It then would appear that he's up to 20 mAs per film. This
could be erroneous, because if the output of his machine has decreased
by 50 percent, he is still, in reality, shooting at 10 mAs per film.
That would be recorded on an effectiveness index calculation as 20,
which may not be correct. If, on the other hand, one measures "R" per
film, one avoids this problem.
Another complication that I can see, is that a dentist could pos-
sibly have a high output machine, and he could have a normal exposure
time. The patient then, might receive a higher exposure than necessary.
This would not show up on an mAs per film basis. It would show up, if
one measured output directly.
The second thing that we discovered about this trial run, was that
we needed an extra column in our calculation sheets, which indicated
compliance or noncompliance. The purpose was to show where we felt that
we could improve the various machines which needed improvement. It would
also give us a goal of increasing the index number in future trial runs,
or future determinations, of this index. I would like to recommend that
other States try this plan to see how it works for them. We like it.
It appears to be successful.
MR. ROGERS: I looked at this a little differently than the other two
speakers. First place, working on a local level, I immediately changed
the title to a Self-Evaluation Index. By using the same letters (SEI),
there was no problem. So I'm still working with the SEI index. Another
item of concern on this index is evaluating gonadal shielding. This
is something that can only be evaluated by the inspector out in the field,
and the idea of his giving either a "go" or a "no-go" signal to gonadal
shielding based on collimation, I feel, really does not reflect the true
evaluation index in reference to this item.
The third thing that we did was to use this more as a supervisory
tool rather than as Henry indicated, of trying to get some rem dose from
this index. I think the program that is presented here this week on
NEXT, would provide such data much easier than to attempt to obtain
such information from this evaluation index. By using it as a super-
visory tool, we have accomplished that. We inspected about 65 tubes
as part of our study that I was able to summarize. Strangely enough,
out of those tubes evaluated, 10 showed a worse situation than on a
previous inspection. Many of our facilities are in the second inspec-
tion phase, and we were able to take the data from our initial inspection,
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214
run this up on the evaluation index, compare it to a subsequent inspection,
and see how the two compared. I say I use this as a supervisory tool
to find out how effective has been the inspection in the first place.
What was accomplished? We keep on visiting facilities, time after time,
and what are we really trying to do as far as radiation protection is
concerned. I felt an evaluation index such as this would give me some
handle on the effectiveness of our program.
We found that out of these 10 that showed a worse situation--one
was a fluoroscopic installation; nine of them were radiographic. To
give you some idea of our findings, the nine radiographic installations
identified the major area of variation as the gonadal shielding and the
high mAs per chest film. This showed an increase. Having these done
on a hand-tabulated basis, as was indicated previously, we were able
to go back into the folder and find out why the facility decreased in
their responsiveness to proper radiation control. Even though they were
written up, and requirement letters were written on them, and the men
complied with the standards for radiation protection at the time of the
last visitation, somehow or other they didn't maintain that status be-
tween the last inspection and the inspection that ran up the evaluation
index. Apparently our messages aren't getting across in at least a few
of the cases. I was glad to see that 36 at least showed no change; 19
showed that they had improved; but those that showed a worse situation
are the ones we better put a handle on. This is the way I look toward
the utilization of the Self-Evaluation Index: as a supervisory tool.
DISCUSSION
MR. HARRIS: One comment is of course whether or not the benefit side
is staying constant. As long as the exposure side goes down, that's
one thing; but if the benefit side goes down with it, you know, you
could have zero dose, but you have zero benefit. There's been some
criticism about this whole idea; just measuring effectiveness only by
dose reduction.
MR WILL- In answer to all comments, I would like to repeat what the
Workshop guidelines were: "The system must not be complicated." We tried
to get it done at this very basis; the least parameters that we can pos-
sibly use, it must be within the control of the Program Director, and
it must relate to patient x-ray exposure. I think, Marshall, I rather
got the idea that you were talking about occupational exposure too, as
well as patient.
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215
MR. PARROTT: Well, principally we're talking about patient exposure.
After you fix the noncompliance, you have the difference between a dose
prior to repair, and the dose after repair, and the difference between
these two is the amount of radiation saved to the patient.
MR. WILL: Well, again, any State can take the index and do with it what
the Director might want to do. There are no rules on it. It is just
a suggested index. The one thing I would like to impress upon you is
that it is not a real number. It's an abstract number.
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216
NATIONWIDE EVALUATION OF X-RAY TRENDS
lux. VojjJL Leggett, 3n.
District of Columbia Department of Environmental Services
The Task Force for Nationwide Evaluation of X-Ray Trends (NEXT)
was formed in August 1971, and is a joint creation of this Conference
and the Bureau of Radiological Health. It came from a recommendation
of a Workshop which was held in Scottsdale last year.
I'd like to start out by reading three of the recommendations from
that Workshop's final report. The first recommendation was that current
methods and procedures utilized by State x-ray control programs should
be reviewed in conjunction with recent State and Federal requirements
in a concerted effort to design a uniform program for surveys of x-ray
facilities throughout the country. Secondly, that the objectives of
such a program include the production of meaningful, timely information
for planning and evaluating x-ray control programs at the State, regional,
and national levels. The third recommendation was that the Executive
Board of the Conference designate at least six State representatives
to serve on a task force to work with the Bureau of Radiological Health
towards the achievement of these goals.
Tomorrow morning, Chuck Hardin will speak on the development of
standardized x-ray survey procedures. Today I'd like to speak on what
the Committee has done regarding the second objective; namely, that of
providing a method to produce meaningful, timely information for planning
and evaluating x-ray control programs at the State, regional, and national
levels.
In August, at the first meeting, the Task Force set forth at its
initial session, the following objectives:
1. To identify the optimum components of a survey (this will be
presented by Chuck Hardin tomorrow morning);
2. To provide for uniform data collection;
3. To provide a system to assign program priorities; and
4. To provide a parameter to measure program effectiveness.
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The members of the Task Force agreed at this initial meeting that
any procedures or systems that were developed, should (1) provide the
necessary information to calculate specific organ dose indexes for se-
lected x-ray examinations, (2) provide for the generation of current
and timely reports for program action and budget justification, (3) be
in a flexible and open-ended format, (4) be directly related to people
protection, and (5) provide for an increase in the "visibility" of rad
health programs.
To meet these needs, the Organ Dose Index System was developed.
This system is a quality control procedure which, when used on a statis-
tically representative sample of the x-ray facilities in a State, pro-
vides the user with a measure of the effectiveness of his State program's
efforts to reduce unnecessary radiation exposure during diagnostic
radiography. The system was not designed to replace survey procedures
not in use for compliance, but to serve as an adjunct to these procedures.
The Task Force members believe that the State Radiation Control Programs
must justify their programs in terms of their people-related impact.
Reports of "units in compliance" and "machines with deficient filtra-
tion" are not meaningful to public officials responsibile for planning
resource allocations to various programs. People-oriented data is de-
manded; hence, the development of a system to provide specific organ
doses for selected x-ray procedures, called Organ Dose Indexes, which
can be correlated with the program's efforts to reduce unnecessary radia-
tion exposure.
The Organ Dose Index is obtained for radiographic procedures by
preselecting a "standard patient" (and his associated physical dimen-
sions) , and then requesting that the x-ray machine operator, using the
parameters and technique factors which he would normally employ, set
the machine up for a specified x-ray projection or view of such a patient.
The projections selected are those most frequently performed by the ope-
rator. Msasurements are made of key components of the exposure. A Mean
Ovarian Dose and Absorbed Testicular Dose are then calculated from the
measurement data.
The term "Index" has been appended to "Organ Dose" because the
values calculated are not an average, or representative of the public's
dose. They are organ doses only for an individual who exactly fits the
physical characteristics of our "standard patient." This "standard
patient," by the way, was one individual in the Johns Hopkins Study that
determined the scatter/primary exposure ratios; Organ Dose Index, is,
therefore, a people-related quantity. Since it reflects a "standard
patient," its potential for evaluating variations by type of facility,
techniques, operator training, beam size and shape, time, and so forth
is enormous.
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218
At the present time, procedures and mathematical models for deter-
mining Organ Dose Indexes are limited to Mean Ovarian Dose, and Absorbed
Testicular Dose, resulting from radiographic examinations from fluoro-
scopic procedures are being developed. The data collected can also be
used to calculate Organ Dose Indexes for bone marrow, lens of the eye,
and thyroid. These system outputs have been requested by menfoers of
the Task Force but must await development of the required mathematical
models.
Figure 1 shows the timetable that the Task Force has set. We had
our first meeting in August when the objectives were formulated. In Sep-
tenfcer, we completed the detailed systems analysis, and survey proce-
dures were started. In February, the draft of the survey procedures
were sent out and the pilot study was planned. April through June '72 -
the pilot study; that is an ongoing thing right now. We have about 3
weeks worth of input from this radiographic pilot study, and at the
TASK FORCE TIME SCHEDULE
MAY 71
JUNE 71
JULY 71
AUGUST 71
SEPTEMBER 71
OCTOBER 71
NOVEMBER 71
FEBRUARY 72
APRIL-JUNE 72
JULY 72
OCT.-DEC. 72
JANUARY 73
PRESENT TO CONFERENCE
ESTABLISH BRH RELATIONSHIPS
ORGANIZE TASK FORCE
DEFINE OBJECTIVES IN OPERATIONAL TERMS
COMPLETE DETAILED SYSTEM ANALYSIS
DEVELOP SURVEY METHODS AND PROCEDURES
COMPLETE DRAFT OF PROCEDURAL MANUAL
AND DISTRIBUTE FOR REVIEW
REVISE DRAFT AND PLAN PILOT STUDY
CONDUCT PILOT STUDY
ANALYZE RESULTS OF PILOT STUDY
REVISE PROCEDURES, PILOT STUDY OF
FLUORO PROCEDURES
GO OPERATIONAL
Figure 1.
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219
Table Clinic last night, you could see some of the outputs and results
from our prepilot study. In July '72, after the pilot study is over,
we will analyze the results and firm up the procedures. October through
December - the procedures will be revised and the fluoroscopic portion,
which is presently not in the system, will be finalized. Hopefully by
January '73, the system will be able to go operational.
The pilot study of the Organ Dose Index system began in four States
(North Carolina, New Jersey, Massachusetts, and Kentucky) and the Dis-
trict of Columbia on March 20, 1972. Upon completion, an indepth evalu-
ation will be made of the whole system. Procedural and system changes
will be made where needed, and as I say, hopefully in January '73, we
will be able to go operational.
How do we go about collecting data to determine an Organ Dose Index
that will assist you in evaluating x-ray trends in your State? Remem-
ber that we want uniform data collection so we use a uniform form -
"Uni-form." We have a uniform method of reporting data. Additionally,
we must have a uniform method of collecting the data. For that we need
a "gizmo," or as we call it, the "NERHL Test Stand," (fig. 2). It
standardizes the measurement distance. The top, which has a hole in
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220
it, is made of lead to cut down scatter. This Test Stand is presently
designed to accept three types of detectors; either the Condenser R
chamber, the Victoreen 666, or the LED. The Stand can be disassembled
and packed into a briefcase. This is essentially all you need. The
Test Stand can be used with a wide range of radiographic units. In
figure 3, the Stand is on a table with the unit positioned properly
above it. You see the detector in place, at a standardized distance.
You make your half-value layer measurements by adding aluminum filters.
When you have finished, you take your output measurement. This one
uses a low-energy dosimeter. Other standardized holders would accept
the Victoreen 666 or the Condenser R chamber. Figure 4 shows its use
on a dental unit, and as you can see, sometimes we have to improvise
in the field using trash cans and briefcases to set it up. You will
notice also that the distance for the detector is decreased for dental
Figure 3.
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221
Figure 4.
units. This reduces the total amount of e:xposure you have used. Again
you see the added filtration in place, and the half-value layer determi-
nations. In addition to the half-value layer determinations and output
measurements, the NERHL Test Stand is also used to determine beam size.
you do is put, right on top of the Test Stand, the X-Ray Sensitive
Kodak Linograph paper packed in light-proof cardboard cassettes. The
cassette is zapped at 70 kVp and 100 mAs to get the beam size at this
distance. This data goes to the computer where the calculations are
made to give a beam size at the target to film distance actually used
by the operator.
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The exact procedure for a NEXT survey is really quite simple. The
surveyor first collects the data on the machine and the operator. He
then asks the operator to set the unit up for the most frequent standard
projections listed, giving the operator the necessary physical measure-
ments for our "standard patient." Then the surveyor positions the tube
over the NERHL Test Stand. He takes the output and half-value layer
readings and then exposes the Kodak Linograph paper to determine the
beam size. This data is then sent to BKH where it is processed and a
proof list is printed out (fig. 5). This proof listing is sent to the
Rad Health Program where it is reviewed by the surveyor, prior to the
printout of the final tabs and graphs. The turnaround time on this proof
listing is estimated at about 1 week by BFH. This means that 1 week
after they receive the form, the proof list will be on its way back to
the surveyor. So far in the pilot study, they have been able to keep
to this schedule. This is excellent turnaround time, and it's possible
because of an expanded BRH computer capability--both in hardware and
in personnel.
What outputs will we get back in the States? How often will we
get them, and how will they be useful in meeting the stated objectives?
The first one will be the proof listing. This is sent back to the State
about 1 week after the data reaches BBH. Some of the highlights of this
proof list are shown here in figure 5. Figure 5, for example, conies
from a chiropractic installation, where data on four radiographic pro-
jections were collected for our "standard patient." For this particular
exam, a lumbo-sacral exam, we see that the mean absorbed ovarian dose
index was 48 millirad and the absorbed testicular dose index was 81 milli-
rads for our "standard patient." I'd appreciate no comments on the fact
that we're calculating both gonad doses for him.
Now the second type of output that a State will get will be a table
of mean dose indexes from your State by type of exam (fig. 6). The ex-
ample is taken from the four-page table that showed information for the
four States in the pilot study. The information here is extracted from
that data. You will notice, for example, that 271 or 270.8 is the mean
dose index for lumbo-sacral spines for New Jersey, whereas it's 501 for
all States. This type of output will be received on a quarterly basis
by all States submitting data. Those States doing representative sam-
pling can use this information on an annual basis to provide a repre-
sentative picture of the x-ray dose indices for their entire State.
Those States that are not choosing the facility for inspection on a
representative sampling basis, can only use this Table of Dose Indices
to compare the facilities covered by the table. The table in this case
is not representative of the State as a whole and will be marked accor-
dingly when it goes back.
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223
RUN DATE: MARCH 21, 1972
STATE
29
FACILITY
1234567
SURVEY DATE
03/09/72
FIELD
TUBE NO.
01
NATIONWIDE EVALUATION OF X-RAY TRENDS
PROOF LISTING
STATE: NEW JERSEY
PROJ.NO.
1 OF 4
FACILITY
DATA
TUBE
DATA
PROJECTION
DATA
* COUNTY
* ZIP CODE
TYPE OF FACILITY
TYPE OF PRACTICE
NO. OF TUBES IN 'NEXT' SURVEY
* PRIOR 'NEXT1 SURVEY?
* DATE OF LAST 'NEXT1 SURVEY
* TYPE OF EQUIPMENT
* LEVEL OF OPERATOR TRAINING
MONTHS OF FORMAL TRAINING
TYPE OF CERT/REGIS.
YEARS OF EXPERIENCE
TOTAL TUBE WORKLOAD
* TOTAL FILTRATION
* NUMBER OF PROJECTIONS CODED
* EXAM-PROJECTION CODE
* EXAM-PROJECTION WORKLOAD
SOURCE TO FILM DISTANCE (SFD)
TUBE POTENTIAL
TUBE CURRENT
TIME
MEASUREMENT DISTANCE
EXPOSURE 1
EXPOSURE 2
EXPOSURE 3
FOR EXPOSURE 4
FOR EXPOSURE 5
ADDED FILT
EXPOSURE 4
ADDED FILT
EXPOSURE 5
ESTIMATED HVL
BEAM SHAPE
BEAM WIDTH (OR DIAMETER)
BEAM LENGTH
X-ALIGNMENT
Y-ALIGNMENT
FIELD
INPUT CODE DESCRIPTION
153
44278
07
08
02
2
XX XX
1
1
XX
X
XX
0300
5.5
4
08
030
040.0
096
0100
0.300
012.0
0148
0140
0144
2.5
0108
5.0
0078
6.0
2
04.2
05.1
+0.2
-0.1
VALUE
CALCULATED
VALUES
* MEAN OF EXPOSURES 1.2.AND 3 144
* EXPOSURE AT SKIN ENTRANCE 84
COMPUTED HVL 5.7
BEAM DIAMETER AT SFD (CIRCULAR) NA
BEAM WIDTH AT SFD (RECTANGULAR) 14.1
BEAM LENGTH AT SFD (RECTANGULAR) 17.1
X-ALIGNMENT AT SFD 0.7
Y-ALIGNMENT AT SFD -0.2
* MEAN ABSORBED OVARIAN DOSE INDEX 48
* ABSORBED TESTICULAR DOSE INDEX 81
PRIVATE LABORATORY
CHIROPRACTIC
TUBES
NO
NOT APPLICABLE
RADIOGRAPHIC (STATION)
PRACTITIONER
NOT APPLICABLE
NOT APPLICABLE
NOT APPLICABLE
PROJECTIONS/WEEK
MM OF AL. EQUIV.
PROJECTIONS
(A/P) 14X17
LUMBO SACRAL SPINE
PROJECTIONS/WEEK
INCHES
KVP
MA
SECONDS
INCHES
MILLIROENTGENS
MILLIROENTGENS
MILLIROENTGENS
MM OF AL.
MILLIROENTGENS
MM OF AL.
MILLIROENTGENS
MM OF AL. EQUIV.
RECTANGULAR
INCHES
INCHES
INCHES
INCHES
UNITS
MILLIROENTGENS
MILLIROENTGENS
MM OF AL. EQUIV.
INCHES
INCHES
INCHES
INCHES
INCHES
MILLIRADS
MILLIRADS
Figure 5.
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224
TESTICULAR DOSE INDEX
Lumbo-Sacral Spine
A/P 14" X 17"
New Jersey No. Cases 4
Mean Dose Index 270.8
Std. Error of Mean 10.5
Std. Deviation 78.2
All States No. Cases 23
Mean Dose Index 501.7
Std. Error of Mean 20.5
Std. Deviation 395.5
Figure 6.
Remember, the 81 millirad dose index on the proof listing. This,
as it turned out, was well below the New Jersey mean of 271, and the
mean for all the States was 502. Looking at this facility, we see a
low exposure and a high beam half-value layer. This is the reason that
this particular exposure of 81 was so far below the average of the other
facilities. This points out a good facility. A poor facility would
be pointed out in essentially the same way. The data in the mean table
is by no means truly representative, because this was just the infor-
mation that we get in during the initial pilot run and it contains data
from only 162 tubes. In the second place, the tubes that were inspected
were not chosen on a representative sampling basis. For example, North
Carolina picked some of their worst facilities. In the District of Colum-
bia, all of the tubes we surveyed were at B.C. General Hospital. This
is a City hospital, and our program works pretty closely with them. The
table gives you an idea of what this type of output will show.
The third type of output a State will get will be graphs (fig. 7).
These will be graphs for your State, and they will be received quarterly
and provide a pictorial summary of the data in the Table of Means. This
particular one shows the ovarian organ dose index for a KUB abdomen taken
in B.C. Of course, they are not representative of all units. The dose
index was 30 millirads, compared to the average of 81 millirads for all
States that were in the survey. This will represent essentially the
information for 1 year. Later we'll see how future years could be used
with this type of information.
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225
N.E.X.T. TRENDS
OVARIAN DOSE
Abdomen KUB
A/P 14" x 17"
State "A"
Optimum
MM/,
73 74 75 76
YEAR
Figure 7.
Other tabs are available as requested by the individual States.
This is the reason for collecting some of the additional information
on the form; for example, the mean dose index by type of facility and
type of exam, or Mean Dose Index by years of operator experience can
be shown.
How do we meet the objectives that were outlined originally for
this program? Are we really providing a measure of program effective-
ness, and a system to assign program priorities? In assigning program
priorities, we must identify the cause and effect relationships and
choose the ones that we can control. The output data from NEXT allows
a State to compare selected Organ Dose Indices with other individual
States, with the average for other States, and eventually, with an
optimum range for selected diagnostic exams.
BRH has been requested by the Task Force to determine experimen-
tally the minimum exposure necessary to produce a good radiograph.
Dr. Edwards of FDA mentioned "good user practice" on Sunday. I hope
this is the same type of program. This optimum range can then be used
as a yardstick to assess program priorities by highlighting those exams
where your State average is significantly above the optimum range or
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above the average for all States. The word "trend" in NEXT comes from
the fact that annual outputs will indeed show a trend over several years.
Figure 7 for State "A" shows the ovarian dose from an abdomen KUB. Back
in 1973, the State was very high compared to all States and also compared
to this optimum range; but as the years progressed and the State worked
on the problem, the "trend," as shown by succeeding data points, came
down to where it was actually below all States, and well into the opti-
mum range of representative exposures. You will notice that all the
States were reduced over this time. Hopefully, this trend will show
a reduction in the organ dose indices as a result of radiological health
program activities--just as the 1970 GSD has shown a reduction from the
1964 GSD. This can be readily understood by both the public and also
by the most tight-fisted appropriation committee.
We mentioned representative sampling several times and have pointed
out that only with representative sampling will the outputs reflect the
trends over your whole State. Without representative sampling, you can
still draw conclusions on those units included in the survey. You do
not have to do representative sampling to participate in NEXT, but the
advantages of this system are only utilized with representative sampling.
How many facilities are required to give you a representative sample?
The statisticians tell me that it takes about 100 facilities based on
the results of the preliminary pilot study; 60 of these medical and 40
dental, having a total of 160 tubes. This would comprise a representa-
tive sample. This would cost your program approximately 150 to 200 man-
hours per year. That's 5 man-weeks or about one-half hour a day; thus,
representative sampling is not an unattainable goal for any State.
Even without representative sampling, the proof listings and Table
of Means by themselves will provide a State with a useful tool for estab-
lishing program priorities and showing program effectiveness. This time-
table for the completion of the radiographic pilot study is June 1972.
The results will then be analyzed. The f luoroscopic procedures will
be developed, and a pilot survey on the fluoroscopes will be conducted
during October through Decenber. Next January, NEXT will be ready to
go operational nationwide.
Your participation in this program is necessary to make it a suc-
cess. If you're interested, please contact your regional representative.
Try it - you'll like it!
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DISCUSSION
DR. NELSON: I would like to suggest that before a final determination
is made on this NEXT approach, that an additional tab be considered.
That chiropractor, for example, while he's stressing the 81 millirads
per film, apparently seemed not to take account of the 300 projections
a week, or approximately 15,000 projections a year that that facility
integrates against those 81 millirads. When you integrate those two,
it would seem to me that that becomes a rather significant integrated
nuiiber. That type of tabulation would help to highlight that reference
to various important factors. Otherwise, that facility compared against
another, with perhaps a higher gonadal dose, but only doing one film
a year, would not be recognized. From a public health standpoint, I,
for one, have no way of knowing what the age distribution of patients
at that chiropractor's office is, but if they're all over age 60, I
think that's of less public health significance than in the case where
the population is more homogenous, or is composed mainly of younger
people. If there were a clue as to the age distribution of the popula-
tion exposed, then you might have very meaningful data to integrate the
dose and the volume and have some clue about the age as well.
MR. WILMS: With regard to Dr. Nelson's comment on the workload aspect,
this is going to be considered in the data. We are collecting workload
data to give us weighted average of the impact of all facilities that
go into the system, so that we're not giving undue emphasis to either
the very busy or the very low activity facility. I don't think that we
gave any consideration to the age of the patient. Maybe that's some-
thing we want to consider. Of course, one of the features of NEXT is
that it is open-ended. We may find that other -x-ray examinations are
of more importance as time goes on. It's expandable.
MR. SHAVER: The reason age is not looked at that closely is the diffi-
culty of obtaining those records. It is most difficult to obtain work-
load data in general, and the number of times a button was pushed a week,
and then try to determine who it was fired at, you get an inspector
sitting in that facility watching every patient in the radiographs. It's
just not practicable to try to collect that information. We did not
overlook the usefulness of it.
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THE SELF-REGULATION CONCEPT
Director, Bureau of Radiological Health
New York State Department of Health
The New York State Health Department's x-ray inspectional program
is decentralized. To date, our 43 full-time local health departments -
30 counties, nine districts, and four cities exclusive of New York
City, have responsibility for registration and inspection of x-ray
installations under the State's Ionizing Radiation Code. Staff of
the Bureau of Radiological Health provide training, guidance, and
assistance to these full-time units. The nine district offices are
staffed by State personnel whereas county and city health units pro-
vide their own staffing. Number of staff in the local health units
and the population served varies considerably. Seven local health
units serve a population of less than 50,000, and five local units
serve a population in excess of 500,000.
The State Sanitary Code applies throughout the State. X-ray In-
spection Reports are submitted quarterly to the Bureau of Radiological
Health for data processing. In 1971, we found that eight local health
units carried out an adequate x-ray program, 25 were inadequate or
marginal, and 12 had no radiological program. Many units were unable
to carry out an effective program because of a shortage of trained
personnel, implementation of programs with higher priorities, in-
adequate funding or too few units to warrant adequate expertise. We
considered a number of alternatives and finally concluded that those
units electing to carry out an adequate program should be permitted
to do so and that in the rest of the State the operator be required
to have the x-ray installation surveyed by a private consultant.
In January 1972, the State Public Health Council promulgated an
amendment to Part 16 of the State Sanitary Code which now requires
that after August 31, 1972, the owners or operators of radiation
equipment must have a radiation equipment safety officer, who is
certified by New York State, periodically conduct surveys of their
installations to ensure compliance with regulations and to minimize
radiation hazards. The certified radiation equipment safety officers
are not governmentally employed but serve through private employment
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229
arrangements as consultants or employees with the installation owner
or operator who retain them. Charges for surveys are required by the
Sanitary Code not to exceed fair and reasonable amounts as determined
by the Department. This "self-regulation" program is in effect only
in those geographical areas where the full-time local health unit,
county or city health department having jurisdiction does not conduct
an inspection program certified by the State Department of Health. To
date 12 of our full-time local health departments have indicated intent
to continue an x-ray inspectional program. These 12 units represent
64 percent of the total number of registered x-ray installations
throughout the State and 84 percent of the amount of money spent in
radiological health by all full-time local health departments.
Fifty-seven written comments were received from societies, industry,
and individuals commenting on our radiation code. More comments oppos-
ing "self-regulation" were received than those favoring "self-regulation.1
The following summarizes some of the comments:
1. Operator would seek more lenient private consultants.
2. Private consultants paid so much per survey would be motivated
to make more surveys rather than better surveys.
3. Difficult for the Department to supervise private consultants.
4. Shortages of private consultants.
5. The public's health and welfare does not lend itself to con-
trol by competitive business enterprise where profit or motivation
could jeopardize the safety of the public.
6. A decrease in surveys by State and City surveyors would in-
evitably lead to a deterioration of radiation protection to the public
and patients. X-ray installation operators would tend to seek out
more lenient consultants.
7. Fees that well-qualified consultants would have to charge for
surveys in order to adequately cover their costs and provide a fair
return would be more expensive than most physicians and dentists would
consider acceptable.
The present program of x-ray inspection by public health personnel
has been effective in those areas of the State where adequate funding
and staff were provided. In other areas the shortcomings of the
program can be blamed directly on inadequate funding and staff. "Self-
Regulation" appears to offer a more direct route for funding.
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230
Effective August 31, 1972, operators of radiation installations
must register biennially with the State Health Department instead of
the full-time local health department, and the Department will issue
a "Certificate of Registration" if it finds that the installation is
in compliance with the regulations. X-ray installations must be sur-
veyed by a certified radiation equipment safety officer as follows:
hospital, clinic, and radiologist installations at least once every
year; dental, podiatry, and veterinary installations at least once
every 3 years; and all other installations at least every 2 years.
Followup surveys to be made at intervals of 60 days or less for
the correction of any violation found during a survey and remaining
uncorrected at the conclusion thereof. The Department may establish
a schedule of required surveys of any installation different from the
schedule specified. A certified radiation equipment safety officer
must furnish a survey report signed by the person who made the survey
to the operator of the installation and a copy to the Department.
The requirements for certification as a radiation equipment safety
officer are as follows:
1. Graduation from a regional accredited college or university
or one recognized by New York State with a bachelor's degree in physical
or natural science, mathematics or engineering, 4 years satisfactory
full-time paid experience in radiation protection or control or an
equivalent combination of the education or experience.
2. Successful completion of an examination prescribed by the
Department.
3. At least 3 years of satisfactory full-time paid experience in
radiation protection or control including at least 1 year of experience
dealing with radiation equipment. Satisfactory education may be sub-
stituted on a year-for-year basis except for the 1 year of experience
in radiation protection or control dealing with radiation equipment.
The Department may accept, in lieu of the educational requirements
and the completion of the examination, a certificate in radiation
protection or control issued by the American Board of Health Physics,
American Board of Industrial Hygiene, the American Inter Society Academy
for the Certification of Sanitarians, the American Board of Radiology,
or the Environmental Engineering Intersociety Board.
Individuals who do not meet all requirements, except for experience,
can be certified with the restriction that he perform surveys under the
supervision of a certified radiation equipment safety officer. Certi-
fications are issued for a period not to exceed 2 years and eligibility
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231
for renewal is based upon a work record as a certified radiation equip-
ment safety officer satisfactory to the Department.
Bureau staff currently are developing new registration forms, in-
spection survey forms, procedures, manuals, and a curriculum for training
courses. We have contacted 77 in-State and 149 out-of-State individuals
who have been certified by one or more societies to determine their
interest in certification. Columbia University is assisting us in
developing a training course for these consultants.
We are now embarked on a "self-regulation" x-ray program and expect
that 10 to 15 of the local health departments will elect to provide for
inspection of radiation installations in their jurisdiction. This will
represent about 60 to 70 percent of all the x-ray installations in up-
state New York. The remainder of the installations will be required to
retain a certified radiation equipment safety officer to survey the
installation.
DISCUSSION
MR. LITTLE: I wanted to ask Sherwood if you would say something about
the way in which you will control the quality of inspections. I see how
you are going to evaluate your inspectors. But how do you assure that
you get a uniform type of inspection, and one that is adequate?
MR DAVIES: We prescribed the form that will be used and the data that
will be provided on the form. On the front sheet there will be the recom-
mendations of the results of this inspection that have been made, and
this will be provided to us. We also intend periodically to make inves-
tigations or inspections on our own, as staff permits, both without pos-
sibly the individual that made the inspection and conceivably with him.
This is quite dependent upon the staffing that we would be provided.
MR. HARRIS: Do you want to comment briefly on the "CRISO." The person
who is fully employed by a major installation doing the same kind of work.
MR DAVIES- This requirement for inspection in our code permits an indi-
vidual who is employed within the hospital or the installation and who
would be qualified to make these inspections. Md he is actually making
the inspection. The hospital or the facility would be his boss. So he
would be providing results of the survey to us.
MR. BRITAIN: Is it possible that one of these inspectors could possibly
be also an installer?
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MR. DAVIES: If he meets the qualifications, yes.
MR. BRITAIN: Well that would cause some problem I would think.
MR. WUKASCH: I want to thank all the speakers for their excellent
presentations and I want to thank you for being a good audience. You've
heard different people talk about various methods of using funds and
obtaining funds. You've heard about different survey techniques, and
last night at the Table Clinic there were all different educational and
instrumentation techniques. I think I would leave you with one thought;
let's not overlook our people problem. We have to deal with a lot of
people; our superiors, the general public, in everything else; and you're
wondering why this people problem exists. I think it's best exemplified
by a little toast I heard recently and I'd like to share it with you:
"Here's to the little bumblebee whose sex is
mighty hard to see. It's hard to tell a she
from he. But she can tell and so can he. The
bumblebee is a busy soul. With little time for
birth control. And that is why in times like
these, we have so many sons-of-bees."
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SEMINAR
Moderator: Charles M. Hardin
Optimum X-Rcu/ SuAv&y
Charles M. Hardin
Kentucky State Department of Health
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OPTIMUM X-RAY SURVEY PROCEDURES
M. UafuLin
Kentucky State Department of Health
At last year's meeting in Scottsdale, a workshop was conducted
entitled "Optimum Components of X-ray Installation Inspections." The
report from that workshop stated that "x-ray survey programs should lend
themselves to the retrievability of comparable data so that both the ade-
quacy of the radiation control programs, and the justification for their
existence, could be evaluated." I think the important words that were
made in that statement are "comparable data."
The report went on to further state that data that is uniformly col-
lected may be more adequately evaluated and utilized for budget assess-
ment, for program effectiveness, and the establishment of program priori-
ties. Additionally, priorities can better be set at the regional and
national levels relative to your survey procedures. From that workshop
in Scottsdale came three recommendations. I would like to read these
recommendations.
1. Current methods and procedures utilized by State x-ray
control programs should be reviewed in conjunction with
recent State and Federal requirements in a concerted
effort to design a uniform program for surveys of x-ray
facilities throughout the country.
2. The objectives of such a program include the production
of meaningful, timely information for planning and
evaluating x-ray control programs at the State, regional,
and national levels.
3. The incoming Executive Board of the Conference of State
Radiation Control Program Directors designate at least
six State representatives to serve on a task force to
work with the Bureau of Radiological Health staff to
design such a program.
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Only 3 months after the submission of these recommendations, recom-
mendation No. 3 was implemented. A task force was formed composed of
seven Conference members representing the States of Arizona, Illinois,
Kentucky, Massachusetts, North Carolina, Pennsylvania, and the District
of Columbia, with seven members representing the Bureau of Radiological
Health. This newly formed task force is a direct product of our efforts
at these annual meetings.
In the past, many of us have complained that many excellent recom-
mendations and resolutions have been developed at these meetings, but that
little or no implementation of these recommendations had been seen. The
NEXT Task Force's formation is a true implementation of recommendations.
The Task Force proceeded to implement the other two recommendations of
the Scottsdale report.
Yesterday, Paul Leggett spoke to you on the "mean organ dose index"
system. The application of this system to your program should produce
meaningful, timely information data for the planning and evaluating of
your radiation control program. In addition to this very exciting sys-
tem (and I say exciting because the more I study the system, the more
enthusiastic I get and the more potential I see from it), the NEXT Task
Force also implemented the first recommendation; that of designing a uni-
form program for surveys of x-ray facilities.
The Task Force, in the name of the Conference, has completed a draft
manual entitled "Suggested Optimum Survey Procedures for Diagnostic X-Ray
Equipment." I think before I go into my discussion with this, I'd like
to define what the Task Force believes to be optimum. Optimum Survey
Procedures, as defined by the members of the Task Force is "the most
accurate and precise procedure to make the determination for the available
money and time to perform the measurement."
This Manual presents the type of survey equipment, and specific pro-
cedures for conducting your routine x-ray study program. It's not to be
confused with the procedures that you may have seen at the Table Clinic
relative to dose index. It's for your routine procedural work. It not
only includes procedures for x-ray equipment surveys, but includes pro-
cedures relative to structural shielding measurements and diagnostic film
screen considerations. It also includes various useful tables. Parti-
cularly important is Appendix D, which identifies 13 parameters that the
members of the Task Force believe to be the minimum requirements for radio-
graphic survey procedures. Preliminary draft procedures are also included
for fluoroscopic surveys; however, the Task Force has not yet had time
to agree upon the minimum requirements for fluoroscopic survey procedures.
I say not yet agreed upon, because the intent is for us to continue
meeting and attacking this problem of fluoroscopic procedures.
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I want to emphasize at this point that the manual is only in a draft
status. It has been given to you for your review and comment. We're
asking that you carefully review it, and any comments that you may have
relative to its revision, be submitted to LaVert Seabron in BRH, by June
15. At that time, the Task Force members will come back together for
discussion of the revisions and comments that are needed and adjust it
accordingly.
Probably the most significant point that we should not overlook about
this Manual is the manner in which it is assembled. It was purposefully
placed into a loose-leaf notebook so that modifications or revisions could
easily be done by slipping out a piece of paper and putting in another
piece of paper with the modification. We are very much aware that BRH
is working on specific procedures for the performance standard. You have
seen some specific procedures for the organ dose index that were developed
by the Task Force. These are not in the manual. But again, because of
the way it's constructed, the intent will be that when these procedures
for the performance standard are completed, or when the procedures, as
shown by the organ dose index have been field tested adequately, that
this could be easily added.
It is the intent that this manual be published in the name of the
Conference. After receiving comments, we will ask the executive board
of the Conference to adopt this manual as the official publication of
the Conference, and that any revisions that are made thereto shall be
in the name of the Conference and approved by the Conference.
I might indicate that the Task Force charge is to continue working
on procedures, one of which will be fluoroscopic procedures; eventually,
possibly procedures for therapeutic installations. This morning it was
suggested that the Task Force may want to tackle procedures relative to
photofluorographic units in light of the recent BRH policy statement.
I might ask in closing, if there's any expression about which the group
would prefer that the Task Force attack first - fluoroscopic procedures
or procedures relative to photofluorography.
I feel the document could be very useful. One of the more important
reasons being for uniformity, and the acquisition of data that we can
use to compare activities reasonably from State to State and nationally.
As you well know, some States conduct surveys differently from others
using different types of equipment. The data that is acquired may or
may not be comparable. I believe if optimum survey procedures are adopted,
and we perform our surveys in a more uniform manner, the data that we
have between each other can be better compared and we will be able to
better justify what we are doing.
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DISCUSSION
MR. AAROE: I go for the fluoroscopy rather than the PFG.
MR. HARRIS: Of course the State people aren't the only ones that do sur-
veys. And when anything like this, that seems to be so valuable is coming
along, it would be well to tie it in with this Committee that Stewart
Bushong is heading as a Joint Committee with the Health Physics Society
in the AAPM, with regard to the surveys. When the final document is made
available, it ought to be kept in mind that consulting health physicists
might want to avail themselves of the same document, so when they gene-
rate data on their own surveys it will tie into what the States want in
the way of information. Perhaps you're doing this already. But the docu-
ment ought to be considered that it will become a public document for
these people to buy. In other words, make sure that the document is
useable, not only by the program, but by the outside consultants.
MR. HARDIN: I think that's a good point. Not much consideration, to
my knowledge, has been given in this regard to making it a public document.
I would think this has to be presented to the Board and they decide what
they are going to do with it.
MR. SHAVER: I don't think there were too many States that even had writ-
ten survey procedures. We'd like this thing to be a definite living
breathing document. Not just some paper that stays here and it's impos-
sible for us to change. As Chuck pointed out, as new procedures are
developed, we need to disseminate them very quickly and insert them in
here. All I wanted to say is, I think for the first time, all States
can now have written survey procedures, which I think is a big step forward.
MR LUBENAU- In response to Saul's question, Stewart Bushong is a repre-
sentative of the AAPM-HPS Joint Committee to develop survey procedures.
He is acting as a liaison between that Committee and ours and the infor-
mation is flying back and forth. Also, I'd like to request if any of
the States do have procedures for special kinds of equipment, like tomog-
raphy for PFG, and so forth, we would like to urge you to send them to
LaVert and we will insert them and make them available to everyone. In
this way everyone can benefit from each others experiences and not have
any duplication of efforts.
MR HARDIN: Again, I want to emphasize to you members of the Conference
that I believe that this is one of the few times, at least that I've seen,
that we do have true implementation of the workshop recommendations. 1
nope" to see this type of implementation done in the future for the resolu-
tions in workshops with recommendations coming forth.
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CLOSING SESSION
Moderator: Donald C. Gilbert
Wonk&kop
SumnaAy and
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WORKSHOP REPORTS
MR. GILBERT: What we will do is take the report from the workshop, any
recommendations each workshop has, consider each individually, move through
these, and then come back and go through the resolutions. There has been
a slight change in the resolutions. It seems that we don't have a Resolu-
tions Review Committee. The resolutions will be voted off the floor and
will be reviewed by the Executive Committee for content and semantics.
WORKSHOP NO. 1 - X-RAY EQUIPMENT PERFORMANCE STANDARDS
Chairman: John J. Russo, New Jersey
Robert Gorson, Philadelphia
Harry P. Copeland, Georgia
Larry Lloyd, Montana
Joseph Wuraftia3 Rhode Island
William H. Aaroe, New York City
John W. Shaver 3 North Carolina
Ray MaGratton, Philadelphia
Ira Paul Leggett3 Jr.3 District of Columbia
MR. RUSSO: The charge to this workshop was to evaluate the impact of
the new Federal X-Ray Equipment Performance Standards on existing State
programs.
The workshop identified the following problem areas:
1. Compatibility of existing State regulations with Public Law
90-602 as it concerns new equipment.
2. The need for increased training and improved instrumentation
to adequately enforce the new performance standards.
3. Delineation of jurisdictional problems between Federal and
State agencies as related to manufacturers, assemblers,
installers, and users of new x-ray equipment.
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4. Funding to cover the cost of the additional workload created
by the required initial inspection to determine compliance
with the new Federal X-Ray Equipment Performance Standards.
5. The shifting of existing State program priorities to allow
implementation and enforcement of their new standards.
The workshop then discussed the problem areas and concluded that
the following recommendations should be approved by the Conference.
The recommendations are as follows:
1. That a standing Federal-State Committee of Conference Members
be established to develop revisions of the model regulations
for the Council of State Governments.
2. That each State revise its current regulations and/or adopt
new regulations as may be necessary to make such regulations
compatible with new Federal performance standards as necessary
to meet the requirements of Section 360 F of Public Law 90-602;
for example, the Council of State Governments and/or existing
State regulations should include in the revision of their
regulations, appropriate requirements controlling the assemblers
and installers of medical x-ray equipment.
3. That the chairman of the Fourth National Conference of Radiation
Control Program Directors direct a letter on behalf of the
Conference, to the Commissioner of the Food and Drug Adminis-
tration indicating the States' concern as expressed in the
proposed resolution.
4. That a study be undertaken by the Bureau to determine the
need and/or cost of upgrading old x-ray equipment to meet the
new performance standards in a reasonable time period and
report the results of the study to the Conference by the time
the proposed Council of State Government's model regulations
are completed.
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WORKSHOP NO. 2 - EFFECTING THE SAFER USE OF X-RAY
Chairman: Arnold J. Moen^ Washington
Alice Dolezal* Minnesota
Beattie L. De Bord, West Virginia
Jan Soribnerj Alaska
Hal Stocks 3 Indiana
Sherwood Davies, New York
Kenneth Miller , Missouri
William Geiger^ Arizona
Charles Price ^ Virginia
Robert Funderberg, Idaho
Virginia Milligan, Arizona
Richard Woodruff3 Alabama
MR. MOEN: First I want to thank the members of ray group who worked so
hard at this. They were really great people. We did change the title
of our assignment. It was given to us as "Effecting the Safe Use of
X-Rays"; we put "Safer" use.
To effect the safer use of x-ray is simply applying the knowledge
we already have of radiation protection in the use of x-ray equipment.
Medical x ray contributes 95 percent of the exposure to the public from
manmade sources and, since over 50 percent of this exposure is unneces-
sary, medical x ray is the target area of highest priority. This target
area covers a wide range of uses that contribute varying degrees of haz-
ard. Motivating the users of x rays to obtain the desired results with
the lowest possible exposure is the bull's-eye of this target. The en-
forcement of compliance to equipment standards is an important step in
the process, but is only a start. There should be serious consideration
given to defining the various uses and establishing the order of degrees
of hazards so that effort can be directed more effectively. Many factors
enter into a regulatory program and some receive more than their fair
share of attention. These factors may be administrative problems of
budgets, personnel, or equipment; and public, political, or Federal pres-
sures. Our point is that the individual State radiation control program
should be objectively evaluated and adjusted to apply major effort in
the medical x-ray area--the area offering the greatest opportunity to
save not only a rad, but thousands of rads.
It is therefore recommended that the Federal and State control pro-
grams direct a significantly greater emphasis toward reducing unnecessary
x-ray exposure by the following:
1. Establishing and enforcing reasonably uniform standards,
guides, and regulations.
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2. Motivating professional practitioners, radiological technolo-
gists, equipment service personnel, and regulatory agencies
to minimize human exposure through persuasion, education, and
training. This involves including subjects on radiation pro-
tection in the long-term or formal education of the users.
States should assist in the planning and presentation of this
material. Short-term education should include current and up-
dated continuing education materials for the users.
3. Making realistic performance evaluations under the leadership
of BRH, in cooperation with the user professions, on all
x-ray procedures. Those with little or no clinical justifi-
cation should be eliminated.
4. Developing optimal x-ray examination techniques providing
maximum diagnostic information with the least possible
exposure and encouraging the use of these techniques.
It is further recommended that this report be submitted to the
Executive Committee for consideration and action.
i
DISCUSSION
MR. HAIRR: It seems like the workshop addressed itself to the education
areas, and the user of x-ray equipment is primarily the technologist.
My comment and question is, have we done enough; have we done anything;
what else can we do in the area of training with respect to the schools
of x-ray technology? In this regard, I'm wondering whether a technolo-
gist who graduates from a school of x-ray technology this June, actually
has a much better radiation hygiene attitude than the technologist that
graduated 5 or 10 years ago.
MR. MOEN: I personally have no qualms about the qualifications of recent
graduates of the technology schools. They are accredited schools inspected
by AMA and they include radiation protection subjects. I think we all
know that many of the operators of x-ray equipment are not technologists.
In a sense, they are not trained technologists, since many of them are
self-trained or are trained by the physician himself, who may have no
academic training in radiation. This is why long-term education by users,
including practitioners as well as technologists, should be implemented
in the medical schools, dental schools, and so forth.
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MR. LLOYD: Arnold, you mentioned that it would be highly desirable to
eliminate radiographs which are on the borderline of medical value. I
think this is quite idealistic. We would like to eliminate these, but
how can we do it without infringing on medical practices?
MR. MOEN: One example of how this can be done would be similar to the
way chest x-ray mass screening, which you've all seen recent publicity
against, was handled. This was promoted by medical profession organi-
zations, such as the American Medical Association, American College of
Radiology, as well as Federal agencies. We have to have agreement from
the medical comnunity to do this. They have to be involved in the evalu-
ation, also. But such things as low-back x ray for preemployment; when
in some areas, even the clerical people are x-rayed; the many legal
reasons; is it really necessary to take x rays from a legal standpoint
in some cases where no clinical reason really exists for insurance;
accidents; whatever?
MR. HARRIS: I guess you all know the reason for the slogan for the
meeting that we're here for, "Save a Rad." And really, to "Save a Rad"
is the ultimate objective of the "Save a Roentgen" proposal. Now the
Bureau is working to do what this workshop suggested, and it hasn't sur-
faced yet completely. By the time of the next meeting of this group,
you will have more information on it. We are planning, or considering
seriously, a "Save a Roentgen" type campaign for the radiologic tech-
nologist- -not just to qualify, but to marginally qualify as well—by which
we will try to motivate, through action themes (direct short blunt themes)
that will carry the message that you want carried directly to the uni-
forms of the technologist, to the control panels, to the bulletin boards,
and to the schools of radiologic technologists. We think we will have
something that will be very helpful in carrying out the concept of this
workshop in the near future. If anybody in the group wants to submit
some suggestions for action themes, please feel free to do so.
MR. MOEN: The operators of x-ray machines themselves many times cannot
determine what x-ray examinations they're taking. They're asked to make
certain exposures that they know are not necessary; and this, I think,
has to be approached too.
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WORKSHOP NO. 3 - RADIOACTIVE MATERIAL CONTROLS
rh*i *.****. David K. Looker, Texas
-uiai rmen : «,.-,. „ „ -m-
N. Brunner, Illinois
Gene Christians on , North Dakota
Will-icon Sly field, Louisiana
Dennis Valley, Utah
William Lea, Wisconsin
James Wynd, Ohio
Dale McHard, Oklahoma
Amalia Velez, Puerto Rico
Eddie Fuente, Mississippi
Dr. Frank Bradley, New York
Graham Hccirr, Florida
MR. B RUNNER: Because our workshop has considered two important things,
we did separate it out.
The scope of discussion in Workshop No. 3 concerned a broad overview
of the problems of controlling radiopharmaceuticals and devices in which
naturally occurring and/or accelerator-produced radionuclides are used.
After a general discussion concerning radiopharmaceuticals and devices
was held, the workshop was separated into two groups to deal with these
specific problems. This section of Workshop No. 3's presentation concerns
the discussion of nonagreement material control of radionuclides used
in devices or sources.
During the discussion, the following problems were identified as
viable with regard to the existing control of nonagreement material
devices:
1. There is an inadequate amount of information available to
the States regarding the existence, manufacture, and dis-
tribution of these devices.
2. There is an apparent lack of Federal jurisdiction regarding
naturally occurring and accelerator-produced products .
3. There is a lack of exchange of timely information among
State jurisdictions which is more pronounced outside of
the Agreement States.
4. There has been a lack of information provided to the Bureau
of Radiological Health for adequate maintenance of the
Radioactive Materials Reference Manual.
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5. There is no established mechanism for evaluation of non-
agreement material devices and sources in non-Agreement
States to meet the regulatory requirements of licensing
States.
In light of the discussion that ensued during our workshop and con-
clusions that were drawn, our section of the workshop offers the following
as general recommendations to the Conference:
1. The Bureau of Radiological Health should assume the role
of coordinator to effectuate an adequate administrative
and technical control program.
2. An evaluation criteria guideline for these devices should
be developed.
3. Mechanisms should be investigated to assure maximum distri-
bution of information to all States. Although the workshop
concentrated on problems of exempt devices, all nonagreement
material devices should be considered.
4. Specific Federal Legislation may be necessary; however,
alternatives should be evaluated to meet present needs.
The workshop also makes the following specific recommendations:
1. That the FDA/BRH bring all nonagreement radioactive materials
(naturally occurring and accelerator-produced) , which might
be distributed as a consumer product, under the Federal
Hazardous Substances Act. These products should include,
but not be limited to self-illumination devices, compasses,
static eliminators, smoke and gas detectors, exempt quantities,
and so forth.
2. That a standard procedure for evaluation of the radiological
hazard associated with these products be developed.
3. That the FDA/BRH coordinate their approval activities with
the radiological health programs in the State(s) in which
the product manufacturer is located.
4. That when the product is evaluated and approved for dis-
tribution as a consumer-type product by the FDA/BRH, a
"Sealed Source and Device Catalog Sheet" will be made up
and distributed to the 50 States and all other appropriate
jurisdictions.
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5. That the FDA/BRH will continue to act as a coordinating
body for information on sealed sources and devices con-
taining nonagreement radioactive materials which is dis-
tributed to either specific licensees, general licensees
or registrants in the 50 States, or in other appropriate
jurisdictions.
Although we will not present verbally to the Conference a suggested
format for analysis of consumer-type products containing nonagreement
radioactive materials, we will, through this presentation, present
officially this information in written form.
Our Committee respectfully requests that the Executive Board of
the Conference consider our recommendations so that they will receive
full consideration by the agencies identified within this presentation.
Although our Committee did consider recommending that a Task Force be
developed, it was the consensus that the Executive Board of the Con-
ference could act as the vehicle for the consideration and implementation
of our recommendations.
MR. GILBERT: I'd like to bring something to the floor's attention. A
good piece of this workshop recommendation, if one will remember, was
contained in a couple of recommendations as far back as Montgomery, Ala-
bama. Secondly, another portion might be well added. There's another
thing that we discussed in our business session yesterday and Si brought
it up. We will also urge the FDA, the EPA, or whoever, to look at their
own facilities; make arrangements to take care of those; like VA hos-
pitals, Public Health hospitals, or whatever; there seems to be some
discrepancy there.
MR. BRUNNER: Now I'll turn it over to Dave Lacker and he'll take care
ot our other section.
MR. LACKER: The radiopharmaceutical subgroup of the workshop met with
the objective of determining the impact of the recent FDA pronouncement
regarding radioactive drugs upon State Radiation Control Programs. We
agreed that immediate action is necessary to determine appropriate Federal-
State interface for establishing an efficient cooperative mechanism for
regulating the production and use of radiopharmaceuticals. I might add
parenthetically here that in our discussions, we pretty well determined
that you can't really separate the agreement and nonagreement materials
in radiopharmaceuticals, since the Bureau of Drugs is handling all of
these under NBA now, as they remove the exemptions that existed previously.
Three basic issues were identified:
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1. The States are generally unfamiliar with the regulations
of the FDA.
2. Existing means for exchange of information can be redirected
to provide essential data for these agencies to conduct their
respective regulatory functions.
3. Joint compliance activities may be an appropriate means for
achieving the most effective and efficient control of radio-
pharmaceuticals.
Discussion of the above issues demonstrated that there may be legal
problems that could not be resolved within the framework of this work-
shop. These relate to the proprietary nature of some of the information
required by both State and Federal regulatory agencies in the conduct
of their respective programs. Furthermore, the format must be adequate
to supply sufficient, but not unnecessary, information to conduct autho-
rized activities. We also concluded that it would be essential to estab-
lish regional workshops to provide appropriate agency personnel with a
better understanding of both Federal and State laws, regulations, and
functions. Therefore, the Workshop on Radioactive Materials, radiopharma-
ceutical subgroup, urgently requests the Conference to immediately estab-
lish a task force to:
1. Identify the types of information available from FDA to
the States.
2. Review and study the mechanisms for dissemination of infor-
mation on new drugs.
3. Establish the lines of communication for exchange of infor-
mation between appropriate agencies.
4. Review, evaluate, and interpret the laws and regulations with
regard to Investigational New Drug and New Drug Applications.
5. Plan regional workshop training sessions for FDA, State, and
other personnel that may need such training.
6. Investigate the desirability and capability of joint com-
pliance activities.
The workshop recommends that the task force membership include repre-
sentatives of the Bureau of Radiological Health, the Bureau of Drugs,
and the Executive Director Regional Operations of FDA; the Atomic Energy
Commission; and a minimum of six States, or an equal number to the Federal
representation, whichever is greater.
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Because of the importance of this information to the agencies in-
volved, it is requested that the task force be appointed as soon as pos-
sible and institute resultant activities as soon as practicable, but not
later than the 1973 annual meeting of the Conference.
WORKSHOP NO. 4 - STATE AND LOCAL TRAINING NEEDS
Chai rman: Aaron L. Bond^New Mexico
Si-man Kinsman, Ph.D., California
Robert C. Will, Kansas
Franklin Krogman, South Dakota
Martin C. Wukasoh, Texas
Richard H. Fetz, Georgia
Lee Stein, Delaware
MR. BOND: I noticed that nearly all of the other workshops addressed
themselves to training needs--training needs are definite and they are
very vital to each of us. Our workshop considered the problem of identi-
fying the needs related to short- and long-term State radiation control
training and user training, and how to recommend effective solutions to
meet these needs.
Our workshop identified and discussed three basic issues. They are
as follows. Issue No. 1 is Current Specific User Training Needs. As a
result of radiation problems within the States and the evolution of both
State and Federal radiation control programs, there is a current trend
for State sponsored user training to effect the reduction and prevention
of radiation exposure to the public. The radiation problems will also
vary. All of the training needs to effect solutions to the radiation
problems can not be identified by this workshop because of the individual
State variations; however, because of some specific similarities in the
radiation problems of many States, this workshop has identified that there
is a necessity to train certain specific users including practitioners
and technologists in the safe use of radiation sources, and local authori-
ties for emergency response capabilities.
Consequently, it is the recommendation that the Conference of Radi-
ation Control Program Directors, with the assistance of EPA, BRH, and
other Government agencies, develop radiation training materials for use
by the States in training technologists and practitioners in the safe
use of radiation sources, and local authorities including firemen, police-
men, and ambulance personnel for emergency response capabilities.
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251
The second issue that was identified is the National Training Needs
Assessment. In the past, the training needs of the States have been
assessed by primarily subjective methods. This has not been effective
because it prevents specific quantification of needs which would enable
the States and Federal agencies to properly assess the problems and de-
velop meaningful solutions. As a result, many training needs are quite
nebulous and it is difficult to accurately determine whether the needs
are being met. This workshop has determined that possibly the greatest
factor contributing to this situation is the lack of a systematic method
for use by the States to assess the training needs.
It is therefore the recommendation of this workshop that the Con-
ference of Radiation Control Program Directors establish a task force
to develop guidelines for self-assessment of the short- and long-term
State radiation control program training needs and submit its report
to the Conference at the Fifth Annual Meeting in 1973.
The third issue that we discussed was the Coordination and Implemen-
tation of All Training Related Activities. This issue refers to the inter-
State, intra-State, and Federal-State coordination and implementation
of all training related activities including training needs assessment
and the establishment of courses, workshops, seminars, and materials to
meet its needs. Currently these activities are handled in a great dis-
array of methods. In some instances the Federal regional representative
coordinates and attempts to implement solutions to the needs; in some
cases, State radiation control personnel provide the coordination and
implementation capabilities; in many cases, it is not done at all; and
in most cases, it is not being done effectively.
Therefore, it is the recommendation of the workshop that there be
established a Radiation Control Program Directors Training Committee in
each Federal region. That the committee would be made up of one repre-
sentative of each State and one representative from both BRH and EPA.
The Committee would have the following responsibilities:
1. Implement the recommendations of the Conference task force
on guidelines for training needs assessment.
2. Identify, quantify, and "prioritize" specific training needs
within the Region.
3. Establish training activities, such as seminars, workshops,
short courses, and training materials for use within the
Region in meeting its training needs.
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4. Coordinate with Federal, State and local agencies, industry,
and universities, to ensure that the State radiation control
program training needs are being met.
5. Report annually to the Conference on their findings, activities,
and their recommendations regarding training.
Our fourth recommendation is closely tied in with the other issue.
And that is, that the Conference of Radiation Control Program Directors
select one Regional Control Program Directors Training Committee to
determine the feasibility of establishing par a-professional training
within the secondary school systems to provide manpower for State and
local agencies.
DISCUSSION
DR. BARBER: I have been involved in a number of training needs studies;
manpower studies; call them what you will. These are involved in work
that is extremely difficult to quantify in the scientific sense. I think
that we do have to be willing to accept, at least in part, subjective
assessment of the situation. I would not leave it entirely to the stati-
sticians and the surveyors who are the surveyors of questionnaires; not
that I would discourage this approach, because it needs to be done con-
tinually. It has been our experience in the Health Physics Society, just
to name one organization that attempted to examine its needs and quantify
those needs, that by the time the statistics are all compiled, the way
things move these days, they're obsolete and you find yourself turning
once again to "gut" reactions, if you will, based on the opinions of
experienced men in the field coining to a collective judgment, as we have
tried to do in one of the workshops at this Conference. So I wouldn't
belittle subjective judgments, nor would I belittle quantitative data.
I would just offer a caution in that regard and hope that we would not
throw out subjective judgments.
MR. BOND: I think we would agree with you. It is very difficult, at
least when we consider the number of people that need radiation training
in all industries, to arrive at a good estimate of training needs; but
we feel that as Radiation Program Control Directors, we can do a better
job than we have done in identifying our own needs.
DR. ROESSLER: At the meeting of the Training Grants Project Directors,
they expressed a great concern as to whether the training projects were
tied in to the needs, and so I just suggest that in establishment of com-
mittees to evaluate training needs. You might consider keying in your
university training grant projects, perhaps selectively, or inviting
participation by members of the project that are concerned about whether
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we are meeting both the short-term, long-term, undergraduate, graduate
leve, technician level, training needs.
MR. GILBERT: Training is and has been a definite problem at various levels,
and I think the Conference is very right, and I think you people that
make your comments are very right, in addressing yourself to doing some-
thing with it; and assure yourself, we will look into it, and hopefully,
very realistically.
WORKSHOP NO. 5 - RADIOACTIVE WASTE DISPOSAL
Chairman: Charles HardLn, Kentucky
Wendell McCurry, Nevada
Edward Kaufman, New Mexico
James Blackburn, Illinois
Bryae Sdhofield, Virginia
Heyward Shealey, South Carolina
MR. HARDIN: I would like to express my appreciation to Workshop No. 5.
One could not have asked for a more conscientious group.
The members of this workshop recognize the disposal of radioactive
waste as being one of the more serious issues facing both the nuclear
industry and State and Federal regulatory agencies. In view of the
limited time available to this workshop, it was decided that this work-
shop would only discuss matters relating to shallow land burial of radio-
active waste. Our objectives were to identify-the more significant prob-
lems facing the States regarding the disposal of radioactive materials,
and to make recommendations relative to the solutions of the identified
problems.
Among the problems identified were the following:
1. Full review is needed to assess the current procedures used
to evaluate the environmental impact of shallow land waste
burial sites.
2. There is insufficient State involvement in the decisions
concerning disposal of radioactive waste.
3. The criteria and policies for the operation of the various
State and Federal shallow waste burial facilities differ
significantly.
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4. Under present conditions the proliferation of shallow waste
disposal facilities, in the absence of a national waste
disposal plan, may result in reducing the viability of
soundly planned and properly operated facilities.
5. Very little information is available concerning the hazardous
conditions that may result from the burial of radioactivity
in association with chemically toxic materials.
6. Inventory data is not available to adequately anticipate
future waste burial requirements and to evaluate potential
environmental problems.
7. The value of waste disposal sites has not been adequately
balanced against the resource commitment and potential
environmental effects. The data base is not available
for such a cost-benefit analysis.
After consideration of the above problems, along with many others
not identified above, the members of Workshop No. 5 recommend the
following:
1. That the Executive Board of the Conference of Radiation Control
Program Directors establish a continuing task force of at
least six State representatives to work with the Environmental
Protection Agency, the Atomic Energy Commission, and other
appropriate agencies and organizations. The duties of this
task force should be:
a. The identification and coordination of the solutions of
the radioactive waste management problems facing the
States and the Nation.
b. A report to the Fifth Annual Conference on the progress
achieved.
2. The Conference urge the development of a national plan and
policy on the management of radioactive waste and that the
development of such be done with Conference participation.
DISCUSSION
MR. GILBERT: I agree wholeheartedly with the concept of this talk and
the results of this workshop. Probably the single most important thing
about the nuclear industry today is the management of waste.
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MR. CASHMAN: I have a comment. The American National Standards Insti-
tute has a standards group, N101-7, that has been working on establishing
standards on waste management, and Jerry Parker and I are cochairmen
of N101-7.5 task force. Their task force assignment is "land burial site
criteria for solid radioactive waste." I will be meeting with Dr. Cyril
Slansky in Washington on Tuesday of next week, and we have two other mem-
bers of the Conference on our task force--Tom Gerusky and Charlie Amato.
We recognize that it is an important job and it needs much more effort
than we have been able to put in it, and any assistance we can get from
the group that is put together here, would certainly be appreciated.
WORKSHOP NO. 6 - ENVIRONMENTAL IMPACT STATEMENT REVIEW GUIDELINES
Chairman: Thomas J. Cashman, New York
Jack Long, Texas
Ken Dzugan, Minnesota
Arthur Eeubner, Connecticut
Robert Corcoran, Maryland
H. Ellis Simmons, Nebraska
Lamar Pries ter, South Carolina
MR. CASHMAN: Just a brief comment before I read the paper of our work-
shop. In looking at environmental impact statements, they cover, of course,
radiation, thermal pollution, and so forth. We have limited our recommenda-
tions to procedural recommendations that cover the entire report, and
then more specific recommendations, as far as control of radioactivity,
as we felt this was the intent of this Conference, We have not addressed
ourselves to questions such as thermal pollution.
The topic is the Environmental Impact Statement Review Guidelines.
Workshop No. 6 of the Fourth Annual National Conference on Radiation
Control presents the following recommendations for consideration.
These actions are designed to maximize the usefulness of the environmental
statements issued by the Atomic Energy Commission for nuclear facilities
in accordance with the requirements of NEPA.
Procedural Recommendations:
1. The Governor of each State should be encouraged to designate
the specific agency or agencies that will formally reply to
the AEC's request to the State for comments on the draft
detailed environmental statement. This action will maximize
the time available for actual review of the AEC draft state-
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ment, and is essential for the orderly development of conments
within the very limited time period of 30 days available for
comment.
2. The applicant should involve the appropriate State agencies
as early as possible during their site selection process.
3. The applicant for an AEC construction permit should initiate
discussions with the appropriate State agencies in the early
phases of their assessment of the potential environmental
impact of the facility. This action will assist the appli-
cant in developing the scope of his efforts in preparing his
environmental report.
4. EPA and its regional offices should routinely furnish copies
of their comments on the Atomic Energy Commission's draft
detailed environmental statements to the appropriate agencies
of all States which may be affected by, or have an expressed
interest in, the proposed nuclear facility.
5. A recent decision by the Atomic Energy Commission redefines
and severely limits the site preparation activities allowed
prior to the formal issuance of the construction permit.
The intent of the AEC in this matter; namely, to eliminate
the environmentally irreversible site preparation activities,
and the accompanying permanent monetary investment; is com-
mendable and is supported by this workshop.
6. As a useful tool in minimizing the unnecessarily repetitive
review activities expended on nuclear power plants, which
have similar design features, it is suggested that the AEC
consider addressing such design features on a general basis.
Examples would be transportation, accidents, and the liquid,
gaseous, and solid waste treatment systems of current light
water reactors.
7. The AEC should seriously consider presenting, perhaps through
the vehicle of a generalized impact statement, a characterization
of the total impact of the growth of nuclear power on major
rivers, lakes, and regions.
Now for our recommendations on the content of the draft statements:
1. The environmental impact statement should be expanded to
include a presentation of the environmental costs, attributable
to the individual plant of interest, arising from all com-
ponents of the fuel cycle. This should include the mining,
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milling, fuel fabrication, fuel reprocessing, and ultimate
waste disposal components. The use of generalized environ-
mental statements covering each of these components, and the
apportionment of their total impacts among the several nuclear
power facilities they service, is suggested as a useful
approach to this problem.
2. The impact statements for specific nuclear power facilities
should be expanded to include a discussion of any plan for
the ultimate decommissioning of the facility. A discussion
at this time, although it may be considered premature in
light of the projected 40-year operational life of the
facility, will be extremely useful in assuring that no de-
commissioning options will be prematurely foreclosed before
specific plans are finalized.
3. The review of the environmental impact of routine releases
of radioactivity is based on the assumption of effective
operation of the radwaste system, and the predicted quantity
and concentration of radioactivity in the liquid and gaseous
releases. It is recommended that the draft environmental
impact statement include the proposed numerical limits for
the plant's technical specification concerning the quantity
and concentration of radioactivity released to the environ-
ment. This will assist the State in commenting on the
draft environmental impact statement.
4. A complete analysis of the radiological effects should include
an estimate of the effluents from secondary sources, in
addition to those from the radwaste system, and the off site
dose contribution from these sources.
5. Where monitoring of radioactive effluent streams involves
alarms that notify operators who then shut off the appropriate
discharge pathways, estimates of the amount of time that will
elapse, and a rough estimate of the amount of activity that
will escape before shut off occurs should be presented.
We have another topic - Other Concerns.
In the course of its deliberations, the participants of this work-
shop identified an item of general concern regarding nuclear power facil-
ities which, although it is not directly concerned with impact statement
evaluation, nevertheless was felt to warrant comment. It was strongly
felt that the subject of the frequency of occurrence and magnitude of
the potential environmental costs of abnormal operations at nuclear power
facilities is of special concern to State agencies charged with protecting
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the public health and the environment. In this regard, it is recommended
that the facility operator immediately report any deviation from tech-
nical specification discharge limits to the appropriate State agency and
to advise of the steps to be taken to bring these levels into compliance
with the limits expressed in the Technical Specifications for the facility.
DISCUSSION
QR. BARBER: In your deliberations concerning the demolition of nuclear
facilities, did you consider making any recommendations with regard to
the assessments and permissible activities of demolished materials to
be disposed of? We have this problem in Minnesota right now. As you
know, it is the first State to really tear a nuclear reactor apart and
throw it away; and the question has arisen, where do all these tons of
concrete go--to radioactive waste, or do they go to the sanitary landfill?
Well, you can set up all types of measurement techniques and measure this
stuff by the truckload as it comes out. Most of us here are aware of
the technical problems associated with doing this. I wonder if there
might be a way of recommending in the preliminary studies for these facil-
ities, that the preoperational surveys include surveys of activity in
structural materials. Have you considered that at all?
MR. CASHMAN: I think you're stuck with a problem. The question of de-
commissioning was on our agenda. We did not get into the details other
than recognizing it is a problem that we feel should be addressed at the
time of site selection. This would require the applicant to provide some
recommendations as to how he would decommission the facility; for example,
if the facility is contaminated to the point where the applicant couldn't
completely demolish it and ship it offsite, he would therefore have to
keep the facility and maintain it perpetually. The applicant should indi-
cate whether he will expect the State to take on that responsibility.
We did not try to come up with the answers, but we urged that it be con-
sidered prior to site selection.
MR. GILBERT: I think that particular subject was also addressed in one
of the morning sessions in the schematic laid on the screen from the
gentleman from EPA.
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WORKSHOP NO. 7 - EMERGENCY RESPONSE PLANNING
Chairman: E. F. Wilson, Arkansas
Dayne H. Brcwn, North Carolina
John Stanton, New Hampshire
Aubrey Godwin, Alabama
Bill Spell, Louisiana
Chester Nay field, Florida
Charles Price, Virginia
Robert Voile, Tennessee
Tom Gerusky, Pennsylvania
Dave Snelling> . Arkansas
Ed Bailey, Texas
MR. SNELLING: The overall objectives of Workshop No. 7 were "to develop
guidelines for State and local plans for response to a radiation emergency."
Particular attention was given to each of the following main topics:
1. The organization and content of the radiological response
plan;
2. The interstate cooperation and assistance necessary for
responding to a radiation emergency;
3. The responsibilities of various State and local agencies
involved in the response; and
4. The establishment of lines of communication between State
and local agencies.
The workshop reviewed the Environmental Protection Agency's draft of
the Guide for Development of State Radiological Response Plans, dated
March 31, 1972. Review of the Guide and the objectives of the workshop
have resulted in five recommendations.
The workshop therefore recommends to the Conference that:
1. The State-Federal guidance for the preparation of emergency
plans consider the problem of swift and effective response
to radiation emergencies and also to the possibility of the
nonavailability of.adequate State resources at the time of
the accidents.
2. Support of the Conference be given to the Response Plan format
as proposed in the Guide for Development of State Radiological
Response Plans and tHat~tEe"radiological response plan become
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an integral part of the overall State Emergency Operations Plan.
3. Appendix III of the Guide, dated March 31, 1972, entitled
"Radiation Exposure Evaluation Criteria," specifically
Tables I and II, be reevaluated on the basis of the NCRP
and FRC recommendations for the exposure of the general
public.
4. Provisions for mutual assistance between States should be an
integral part of emergency plans for major nuclear accidents,
and that a workshop be established for the next annual meeting
to consider in depth this aspect of response planning.
5. A task force be appointed from the Conference specifically to:
a. Work with the Environmental Protection Agency and the
Atomic Energy Commission in continuing the development
of the draft Guide for Development of State Radiological
Response Plans, under consideration~"Ey the EPA;
b. Investigate the problems associated with interstate assis-
tance, specifically the relationship between SINE, WINC,
and those States without compact association; and
c. That the task force submit a report of their findings to
the Conference at the next annual meeting.
DISCUSSION
MR. DAVIES: I believe you made mention in the report to an NCRP report
for general exposure of the public. As I recall, there is really not
an NCRP report; no specific dose relating to emergencies. I may be in-
correct. Second question. I'm wondering why you did not factor in--
I believe they're applicable—the FRC Reports No. 5 and 7 having to do
with emergency levels?
MR. SNELLING: I think basically here, and Mike Terpilak may check me
out on this, people in EPA are not happy with the numbers that are pre-
sently in these tables. They are the ones who are reevaluating them
themselves. Basically, we wanted to reemphasize that they should be
evaluated in the light of all these things. It was probably an omission
that we did not include the FRC reports in these recommendations.
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MR. TERPILAK: I believe, Sherwood, we're extremely unhappy about
Tables 1 and 2. And basically what we tried to do here is simply to
initiate a task force to reevaluate the numbers and take into consider-
ation the NCRP recommendations and other recommendations of other com-
mittees, and this will likewise include FRC. But at this time, it was
an omission.
WORKSHOP NO. 8
ENVIRONMENTAL SURVEILLANCE AND ANALYTICAL CONTROL
Chairman: Marshall W. Parrott^ Oregon
Harry B. Ashe, Vermont
Donald Hoxie, Maine
John L. Lemmons, Wyoming
Donald E. Van Farowe, Michigan
Charles Campbell, Iowa
Pedrito Francois, Virgin Islands
MR. PARROTT: When our workshop assembled itself, we started out with
the 12 members listed. We had in the neighborhood of 30 most of the time;
apparently there is a great interest in environmental surveillance and
I'm not sure whether the interest is the availability of money or the
fact that this is critical to everybody. We tried to address ourselves
to four specific points. I think everybody was very sincere about what
they were saying and the help that we received from EPA and the AEC was
incredible.
We addressed ourselves to the Federal support for environmental
radiation surveillance programs; specifically, in States that were under
the influence of nuclear facilities. Then we briefly discussed the expan-
sion of regional laboratories for the use by States that were not under
the influence of a nuclear facility and did not anticipate this. We
addressed ourselves thirdly to inter- and intra-laboratory quality con-
trol; standardization of analytical methods; high quality, low-level
radioactive standards; and the standardization of units for reporting.
We then addressed ourselves, as part of our program, to the certification
of commercial environmental radiation survey programs for nuclear facility
operators or the facility's subcontractors.
We spent approximately an hour and a half, almost 2 hours the first
day, in just broad coverage, and then specifics. The second day of this
particular program, we were handed a 46-page document and were asked to
recommend this document. It's called "Environmental Radiation Surveil-
lance Guide," dated April 1972. We had not seen this before, and the
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Committee wants to take the time to review it before they make any recom-
mendations. We necessarily had to drop the Federal support part of this
because their funds, as we all know, are limited. The Atomic Energy Com-
mission, by virtue of what Charlie Pelletier explained, that the price
to be paid to a State who will do inplant surveillance, apparently will
go from $5,000 to $10,000. We're still limited to $15,000 from EPA for
environmental surveillance.
We have sane recommendations, and in one case we addressed ourselves
specifically to something that is not a recommendation. We would love
to demand such a thing as this (this was by unanimous vote); that the
Committee choses to say that every laboratory providing radiation surveil-
lance data in or around a nuclear facility shall participate in a quality
assurance program. The inplant shall be administered by the Atomic Energy
Commission, and they have such a facility to set up now to do this. Off-
site shall be administered by the EPA. The quality assurance laboratories
of EPA and AEC shall be traceable to a suitable primary standard. We
were unable to specify NBS in this case because they do not have a suf-
ficient number of suitable standards to cover all of the samples that
are required at this time.
Secondly, we recommend that the AEC and the EPA develop standard
sample collection procedures for radiation surveillance. The Committee
will defer recommendations on the acceptance of the EPA prepublication
copy of the "Environmental Radiation Surveillance Guide" for a period
of 60 days following this date, at which time we would like to submit
those recommendations.
We did not address ourselves sufficiently, I think, to some of the
items, like the units of reporting. We did not have enough time in some-
thing as broad as this, to really cover it adequately, because the infor-
mation was coining in daily. I'm very disappointed that the Conference
lasts such a short time when this workshop, I think, could have accom-
plished a great deal more; but with 30 people, all providing valuable
information, it takes a considerable period of time to evaluate this and
put it down as a recommendation.
DISCUSSION
MR. GILBERT: Did you lead me to believe early in your statement that
you recommend or suggest that we not seek some type of assistance at
the State level, through EPA or AEC, or whatever source, for funding
of support programs?
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MR. PARROTT: No, I didn't say this. What has actually happened is that
EPA and AEG are coming to the individual States and saying, we would like
to do this. We will provide the funds.
DR. BUDNITZ: In the whole question of environmental surveillance, the
key, of course, is instrumentation. I have the impression that through-
out the Federal establishment of the AEC and other agencies, there are
large sums of money being spent on instrumentation development. The AEC
itself might come to several hundred thousand a year. It might even be
millions for all I know, because it's diversified so much; for example,
millions have been spent, down through the years, on personnel dosimetry
research and development. I don't think that this group here, 50 State
Radiation Control Program Directors, has significant formal input to the
decisions that are made on funding instrumentation research. I think
it would be a very important thing to establish, not a workshop which
makes recommendations, and not a task force which makes recommendations,
but a permanent standing committee of this group, with rotating member-
ship, consisting of hardware people who could establish priorities, and
an input from the people here on what they think ought to be developed
by agencies like the Atomic Energy Commission, National Bureau of Standards,
Environmental Protection Agency, Bureau of Radiological Health, and many
others. How this money is spent really affects what we can do to measure
the rad. Right now, I think, we know that there are a lot of areas where
we can't measure properly, but in which your input is not adequately taken
into account; except individually, but not as a formal group. I would
like to recommend that a permanent standing committee be considered by
the Executive Committee. The second point is that, of course, throughout
this Conference, people haven't talked too much about the other area;
and that is nonionizing radiation. This whole area in which the method
was discussed last year and the previous years, really ought to be given
quite a lot of consideration in the future.
FEDERAL WORKSHOP NO. 1
(No Report)
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FEDERAL WORKSHOP NO. 2
EFFECTING THE SAFE USE OF X RAYS
Chairman: Mr. Bruce Burnett
Mr. Arve Dahl
Mr. Jerry Gaskill
Mr. Norman Geiger
Mr. Alvis Jordans
Dr. Emanuel Landau
Dr. Clifford Nelson
Mr. Paul Roney
Mr. Lavert Seabron
Dr. Moris Shore
Mr. Charles Showalter
Mr. Gary Sirmons
MR. BURNETT: BRH Federal Workshop No. 2 was charged with the title
"Effecting the Safe Use of X Rays" and, as did State Workshop No. 2,
we discussed a title change and have concluded that we really wish to
speak to the "responsible" use of x rays, and what the Bureau can do
in that area.
The members of Federal BFH Workshop No. 2 believe that, since any
exposure to radiation carries some burden, radiological health personnel
should be concerned about the "responsible" use of x rays. Concern
about only the "safe" use of x rays would fail to include concern about
many important aspects of radiological health.
Action programs to effect the responsible use of x rays are con-
cerned not only with equipment and facilities, but also include optimum
techniques for the efficient use of x rays, as well as the use of
appropriate judgmental factors in determining when and how x radiation
should be used. The overall program objective of the Bureau is to guide
all elements of the Nation's economy using x radiation in the protection
of man and the elimination of unnecessary exposure.
Radiological health action programs for "Effecting the Responsible
Use of X Rays" encompass five major areas:
1. Assessment of systems of medical, industrial, or other
x radiation use;
2. Development and promulgation of recommendations, criteria,
and standards;
3. Action program development to improve quality control in
the use of x rays;
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4. User qualifications and performance; and
5. The necessary technical studies and consultation to
support the previous four categories.
Assessment of the systems of healing arts and industrial use of
x radiation is essential to provide basic information for determining
program priorities and measuring effectiveness. BFH Workshop No. 2
recommends that, in addition to assessment programs currently underway,
the Bureau institute studies of the efficacy of specific x-ray exami-
nations .
The development and promulgation of recommendations, criteria, and
standards is required to provide essential guidelines to promote the
responsible use of x radiation. In addition to the promulgation of
standards under specific authorizing legislation, it is recommended that
the BRH continue the development and promotion of voluntary standards
through cooperative programs with professional and technical organizations.
In the area of action program development, a key factor which we
identified, and which was identified by previous workshops, was to do
something in the Federal establishment itself. It was the recommenda-
tion of this workshop that an important program in this area is the
development and conduct of a program to provide coordination of radiation
control activities of other Federal agencies, and this would include
inspection of x-ray facilities in the Federal Government.
With respect to improvement of user qualifications and performance
and insure an adequate supply of qualified personnel, it is recommended
that programs must be established to upgrade personnel already involved
in the ordering and/or use of x radiation. This may be accomplished
through continuing education and training program activities.
In addition to present Bureau activities, it is recommended that
new high-priority programs be directed toward the training and educational
efforts involving these individuals and groups that are most likely to
be involved with the ordering or conduct of those x-ray examinations that
are significant contributors to unnecessary population dose.
Finally, in the technical studies and consultation support area,
the wide range and variety of studies required, necessitates that this
activity not be limited to the Federal establishment alone. States and
local governments can, and must, play a vital role. It is recommended
that the participation of the professional societies,voluntary organi-
zations, and the like continue to be emphasized.
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WORKSHOP OF THE BRH TRAINING GRANT PROJECT DIRECTORS
Chairman: Dr. Charles E. McGee, Pennsylvania
Dr. Moses A. Greenfield, California
Dr. James G. Kereiakes, Ohio
Dr. Keith J. Sahiager, Colorado
Dr. Billy G. Dunavant, Florida
Lloyd Bates, Maryland
Dr. James P. Vacik, North Dakota
Dr. Joseph A. Watson, Pennsylvania
John E. Christian, Indiana
Dr. Robert J. Lovell, Tennessee
Dr. Peter Paraskevoudakis, Puerto Rico
Dr. Kenneth W. Skrable, Massachusetts
Enrna Kephart, Maryland
DR. MCGEE: We, as a group, considered six major items, which we would
like to present to the Conference. I'd like to take No. 6 first.
6. The BRH Training Grant Project Directors wish to go on record
as expressing sincere appreciation for the opportunity to meet with the
Fourth National Conference on Radiation Control in what has been a most
informative and productive session. Going back now to the first item.
1. Whereas it is apparent that the need exists to react more closely
with the State Radiation Control Program Directors, it was moved, seconded,
and passed unanimously that the Training Grant Project Directors petition
the National Conference on Radiation Control for permission to meet during,
and be a part of, the 1973 Annual National Conference, along with repre-
sentatives from BRH, FDA, HEW; EPA; and so forth.
2. The BRH Training Grant Project Directors urge BRH to encourage
in any way possible, the establishment of the next annual meeting con-
current with the National Conference.
3. The BRH Training Grant Project Directors request assistance in
improving communications with individual State Radiation Control Program
Directors and BRH regional representatives in their regions. One spe-
cific example is the opportunity to meet at future State and regional
conferences on radiation control. I'm glad to hear other people in other
sessions talking about the training problem.
4. The BRH Training Grant Project Directors request in the interest
of public health, that the definition, justification, and projected num-
bers of Federal, State, and local trained manpower requirements for the
immediate future and the longer term be compiled and forwarded to Project
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Directors. Such information as can be made available will be of great
assistance to the future planning of the training programs. It is re-
quested that the State Radiation Control Program Directors, BRH, and
EPA, actively participate in supplying such pertinent information.
The Training Grant Project Directors will participate in studying
the manpower requirements for medical, industrial, educational, and
other institutions.
5. The BRH Training Grant Project Directors, and the State Radia-
tion Control Program Directors, should make every effort possible to
provide for practical and meaningful job descriptions and specifications
EPA TRAINING GRANT WORKSHOP
Chairman: Dr. Donald E. Barber, Minnesota
Dr. Herbert Be vis, Florida
F. W. Charters, Jr., Georgia
Dr. McDonald E. Wren, New York
EmiZ T. Chanlett, North Carolina
Dr. Donald B. Auleribach, New York
Dr. Frank Haughey, New Jersey
Dr. R. D. Neff, Texas
James H. Walters, Florida
Donald W. Broun, Oklahoma
DR. BARBER: Eleven of the sixteen radiological health training programs
supported by the Environmental Protection Agency were represented in this
workshop. The group was pleased to meet concurrently with the Conference
of Radiation Control Program Directors because it provided the opportun-
ity to compare the objectives and productivity of training programs with
the needs of State and Federal radiation control programs. The group
gratefully acknowledges the invitation to convene with the Conference
this year and hopes that mutually productive meetings of a similar nature
can be arranged in future years.
The workshop gave primary attention to the potential impact of a
projected reduction in the EPA training grant budget. The budget for
fiscal year 1973 is expected to be only 65 percent of the amount bud-
geted for fiscal year 1972. Such a drastic reduction will have an effect
on the supply of qualified people for radiation control programs which
cannot be ignored. Accordingly, the workshop prepared a resolution for
consideration by the Conference of Radiation Control Program Directors.
Hopefully, the resolution will be endorsed by the Conference expressing
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and justifying the need for continuance of radiological health training
grant support at its present levels as a minimum.
Training project directors will compile program productivity and
employment information for EPA to assist with evaluation of the effec-
tiveness of and need for continuation of training programs in EPA. The
workshop concluded that drastic reductions of financial support of edu-
cational programs in radiological health and other areas of environmental
control will result in an irretrievable loss of professionally qualified
people. The anticipated loss would be most unfortunate because the prin-
cipal benefactors of existing programs have been and probably will con-
tinue to be Federal, State, and local governmental organizations.
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RESOLUTIONS
MR. GILBERT: At the beginning of the session, we mentioned that we had
failed to provide a resolutions review committee; therefore, the resolu-
tions presented on this floor will be presented to the Executive Committee
for their consideration, rewording, and so forth. The Executive Committee
will review the resolutions, put them in a form, adjust the semantics
so that no one becomes offended by the language, put a cover letter on
the resolution, and send them forward to the attention of the recipient
indicated.
We'll go right back to the workshops and I'll call for resolutions
from Workshop No. 1 - X-Ray Equipment Performance Standard.
MR RUSSO: Pursuant to recommendation No. 3, Workshop No. 1, which re-
quested that a letter be directed to FDA indicating the Program Directors
concern to implement its responsibilities under Public Law 90-602, the
following resolution is presented.
Whereas, the implementation and enforcement of the Federal perfor-
mance standards for diagnostic x-ray equipment will require the active
participation of State and local radiological health personnel in the
inspection and surveys of new x-ray equipment covered by these standards
according to Federal evaluation procedures; and
Whereas, such additional workload on existing State radiological
health programs will require additional funding resources not available
within the States; and
Whereas Public Law 90-602 in Section 360E authorized the Secretary
of the Department of Health, Education, and Welfare to reimburse the State
and local jurisdications for enforcement services required by the act;
Be it resolved that, the National Conference on Radiation Control
make it a matter of record, its concern that the State and local radia-
tion control programs will not be able to embark on the additional in-
spection requirements imposed by the Federal standard without assurance
that such necessarily expanded programs will be reimbursed on a basis
to be negotiated with such individual jurisdications.
MR GILBERT: Gentlemen, you heard the reading of the resolution from
Workshop No. 1. Those in favor, indicate by saying aye. Opposed. Ayes
have it - so ordered.
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Workshop No. 2 - Effecting the Safer Use of X Rays
MR. MOEN: We do not have a formal resolution as such. We did recom-
ment that this report be submitted to the Executive Committee for action.
MR. GILBERT: The Executive Committee will consider that as indicated in
the report.
Resolutions from Workshop No. 3 - Two chairmen - Radioactive
Material control - Phil Brunner.
MR. BRUNNER: Mr. Chairman, we do not have a resolution and our presen-
tation indicated to the Executive Board what action we would like to take.
MR. GILBERT: Thank you; Dave lacker.
MR. LACKER: Mr. Chairman, we did not make a formal resolution, but we
included in our reports the urgent recommendation of establishment of
a task force, and we would appreciate the Executive Committee imple-
menting this task force.
MR. GILBERT: lhe Executive Committee will meet on these things immedi-
ately following the adjournment of this session.
Workshop No. 4 - State and Local Training Needs
MR. BOND: Our workshop did not formalize any resolutions for our pres-
entation to the Conference. We wish to express, however, that the Exec-
utive Committee give consideration to the recommendations that were made.
Workshop No. 5 - Radioactive Waste Disposal
MR. HARDIN: We have no resolution but again, we would like the recom-
mendations in our report to be submitted to the Executive Board for
appropriate action.
Workshop No. 6 - Environmental Impact Statement Review Guidelines
MR. CASHMAN: We did not have a formal resolution to present to the group.
The report can be utilized by each of the States because it involves
several action groups, including the applicants, the EPA, and the AEC.
The Executive Board might want to look at the recommendation that we had
to suggest that the technical specifications include numerical limits
based very closely on plant capability.
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Workshop No. 7 - Emergency Response Planning
MR. SNELLING: We did not have a formal resolution; however, we did
request that the Executive Board appoint a task force.
Workshop No. 8 - Environmental Surveillance and Analytical Control
MR. PARROTT: Can I poll ray coranittee? Would my committee agree that
this environmental surveillance laboratory quality assurance program be
submitted as a proposal? (The committee indicated agreement.) In view
of the public health implications of environmental radiation surveillance
data, we would like the Executive Committee to inform the AEC and the
EPA that every laboratory providing radiation surveillance data in or
around a nuclear facility, shall participate in a quality assurance pro-
gram provided by the Atomic Energy Commission and the Environmental Pro-
tection Agency; and that unless such quality assurance is guaranteed,
they will not accept the data from these laboratories.
MR. GILBERT: Thank you Marshall. Is that in the form of a resolution
or a recommendation?
MR. PARROTT: Yes.
MR. GILBERT: Could we have a copy of that please?
MR. GILBERT: Federal Workshop BRH No. 2 - Bruce Burnett. (No report.)
Then we have the Training Branch workshops and the resolutions that came
out of those.
DR. MCKEE: Not being a member of the Conference, I don't think we can
propose a resolution. We would like to petition the National Conference
on Radiation Control for permission to meet yearly and be a part of the
1973 National Conference.
MR. GILBERT: Thank you very much.
MR. BARBER: The EPA Training Project Directors prepared a resolution.
I am not prepared to report on it this morning but it is in the hands
of your resolutions committee.
MR. GILBERT: I now have some other resolutions off the floor.
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MR. SHAVER: Whereas, the Department of Health, Education, and Welfare
issued on April 24, 1972, a policy statement entitled "The Chest X-Ray
as a Screening Procedure for Cardiopulmonary Disease" endorsed by the
American College of Radiology, the American College of Chest Physicians,
and the National Tuberculosis and Respiratory Disease Association; and
Whereas, the Conference of Radiation Control Program Directors has
reviewed this statement and attendant press releases and finds signifi-
cant confusion in the interpretation of the following items:
1. The intended audience (medical community, public health
agencies, x-ray machine users, or the general public);
2. The x-ray equipment included (photofluorographic, mobile,
portable, and conventional fixed radiographic);
3. The type of facilities included (mobile vans and stationary
facilities such as clinics); and
Whereas, State radiation control programs are directly affected by
the interpretation of this policy statement;
Be it hereby resolved, that the Department of Health, Education,
and Welfare clarify this policy statement in the areas outlined above,
and
Be it further resolved, that the Department of Health, Education,
and Welfare, in cooperation with the Conference of Radiation Control
Program Directors, review the need to develop performance criteria and
survey methodologies for photof luorographic machines.
MR. GILBERT: Gentlemen, we have a resolution on the floor. Those in
favor indicate by saying aye. Those opposed. (One opposed.)
MR. RODGERS: I voted against it because I felt some discussion was needed
rather than push it through. I'm not too sure that the resolution that
John read, was read in its entirety. Our Department has taken the stand,
prior to the action of the Federal Government, on some preliminary infor-
mation that we had gotten that such a statement may be coming forth in
the future. It was in a rough draft form, that nothing was being done
on the Federal level, and I thought that the statement was directed to
the indiscrimate use of photof luorographic units for mass chest x-ray
screening. If that's so, then the public has been inadvertently exposed
to x rays which are unnecessary for diagnostic procedures; and therefore,
we, within our Department, came out with a statement against the indis-
crimate use of photofluorographic x ray for mass chest x-ray screening.
And I'm not too sure from what was read in the resolution, whether the
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whole picture was presented as we saw it, because we've gone into detail
on it. In principle, I felt that it was a justifiable attitude on the
part of people who are concerned with x-ray protection.
MR. SHAVER: Jack, in response to your comments, this resolution is not
taking exception to the policy statement other then asking that it be
clarified. The interpretation and the press releases that have described
this particular policy statement have been confusing. What I'm asking
the Department to clarify is, is this resolution intended for public health
agencies? If you read the preamble of the policy statement, it states
that the public health problem of tuberculosis is concentrated in the age
group 45 years or older, and that skin tests should be used on population
groups below age 21. It goes on to point out that mobile vans should
not be used indiscrimately. Now, for whom is this information intended?
Is this telling the general public, don't get yourself x-rayed routinely
in a mobile van? Is this telling the physician, don't do this? Is this
a charge to public health agencies to discourage the use of PFG units?
Who is this policy statement intended for? And I asked, since we are
directly affected by it, and I think we're all interested in discouraging
use of photofluorographic units for mass screening, that we could get
mileage out of it. But before I feel we can get mileage out of it, we
need to know exactly what the Department, in conjunction with ACR, ACCP,
and the National TB Association, actually are saying. This is all we're
asking for in this resolution.
MR. DAVIES: I feel I'm on a railroad and I'm not sure where I'm going.
I am sure that the resolution should be considered by the Executive Com-
mittee or the Resolutions Committee. But I would move, Mr. Chairman,
that the resolutions now being received be reviewed by the Executive
Committee, and that those that need action between now and the next
meeting, such action be taken on behalf of this Conference, and those
that might well be carried over until next year, they be done and reviewed
by the Resolutions Committee or the Executive Board.
MR. GILBERT: Sherwood, let me explain. The resolutions as presented
today are doing exactly that. They're just clearing the floor to be re-
viewed by the Executive Committee because we did not have, as you know,
an established resolution review committee prior to the meeting. So if
anyone has specific comments to a resolution, I suggest they get a copy
from the man who is submitting it, and submit their comments for our con-
sideration.
MR. LITTLE: With respect to Mr. Shaver's comments, I'd like to say, on
behalf of the Bureau of Radiological Health, FDA, that we welcome such
comments. We have recognized that there are some areas of confusion with
respect to the mass screening policy statement, and there will be cor-
respondence very shortly going out to the States asking for further
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comments and also to get some information of what action has been taken
since the official release of the policy statement. There also will be
further guidelines provided to try to clear up any confusion.
MR. SCHOFIELD: I think a little problem is arising here in that some
people are beginning to wonder if we are allowing ourselves sufficient
time and a proper mechanism for the Conference formally to take a posi-
tion on an issue, and it usually is an issue or it wouldn't come to us
at this time, expressed as a formal resolution. I think that this is
something that does need the attention of the officers, and the Executive
Council of the Conference. Now, might I make a suggestion, and it's un-
fortunate that this issue is getting mixed in with John's attempt to
introduce a resolution. But might I make the suggestion that perhaps
John's submission does not have to be in the form of a resolution passed
on by the entire Conference, but rather, in the form of a question ad-
dressed to the Bureau, which we all approve of. In other words, it's
not quite as formal as a resolution.
MR. GILBERT: In the latter case, it would probably be more effective
than a resolution, but that's just a personal opinion. A resolution,
as you know, I don't hold much faith in; however, there's a resolution
on the floor. Do you propose what you just said as an amendment to that
resolution?
MR. SCHOFIELD: I'm not sure whether it would work as an amendment. That's
up to John. Would you accept it John, as an amendment to your resolution?
MR. SHAVER: I'm not quite sure how the amendment will read. I recognize
the problem you identified, Bryce. I think we all do. I think it's un-
fair for someone to hop up and read a two page resolution that nobody
can follow in their head as it's being read, and then have the guts to
ask somebody to vote on it. We do need this mechanism such that everyone
has before him this type of information. In this case I felt this was
an issue that should be brought before the Conference's attention. I
felt the strongest move we could make would be in the area of a formal
resolution. Unfortunately, because of the time restraints here, we were
unable to get this information distributed to everybody. This was written
rather late last night. I would still like to call this resolution to
a vote. But I would hope everyone would understand what we're saying.
We're simply asking the Department to clarify its policy statement. And
that, to me, is a rather simple, innocuous request that the Conference
can make. I think that this policy statement is most important to all
State health departments and local public health agencies in the area
of radiation control. It's important before we start spouting this state-
ment, that we clearly understand its intent. I'm simply asking that it
be clarified.
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MR. GILBERT: In the world of compromise which we all live in, will it
be acceptable to this body that the Executive Committee accept this with-
out a vote and distribute it to each man listed currently on Parker's
list, and solicit your comments, to be received no later than our first
meeting which we tentatively scheduled for September, and at that time
take action?
MR. SHAVER: I hate to put this much time into this, but I think time
is such that we can't afford to delay that long. I think we would like
to have the Department clarify this pronto. We heard Marshall Little
from the Bureau, and I think we can have other Bureau people stand up
and agree that, yes, there is some confusion, even among the Bureau. I
would still like to call it to a vote if possible.
MR. PARKER: I think we've already accomplished our goal here. The
Bureau has been alerted to the fact that the State people are dissatisfied
with what came out because there is some confusion as to what they actu-
ally said. I think what you recommended is right, Don; that we'll put
this out to the membership. Let them comment to us, and we'll discuss
it further. But in the meantime, the people in the Bureau understand
that we want something to happen very quickly to clear up the confusion,
not only in the minds of the public but in our own minds.
MR. SCHOFIELD: I'd like to ask John if he would be willing to amend his
resolution to simply ask that we asked for a clarification?
MR. MATUSZEK: Since John has made a succinct statement of what he's
looking for, why not make the resolution that? Leave out all the whys,
wherefores, parentheses, and quotations, which are irrelevant. The main
point is, you want clarification. Make that the resolution.
MR. SHAVER: Let me read it without all the "jazz." All it says is:
Be it hereby resolved that the Department of Health, Education, and Wel-
fare clarify this policy statement. That's all the resolution says. One
other thing. You have to identify what this policy statement is, and
I identified that, and I identified the areas of confusion we wanted clari-
fied. Understanding that, Don, if I may, I would just take a second to
read it again because I think as it stands, I've said everything that
we're talking about.
Whereas, the Department of Health, Education, and Welfare issued on
April 24, 1972 a policy statement entitled "The Chest X-Ray as a Screening
Procedure for Cardiopulmonary Disease" endorsed by the American College
of Radiology, the American College of Chest Physicians, and the National
Tuberculosis and Respiratory Disease Association; and
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276
Whereas, the Conference of Radiation Control Program Directors has
reviewed this statement and attendant press releases and finds signifi-
cant confusion in the interpretation of the following items:
1. The intended audience (medical community, public health
agencies, x-ray machine users, or the general public);
2. The x-ray equipment included (photofluorographic, mobile
portable, and conventional fixed radiographic);
3. The type of facilities included (mobile vans and stationary
facilities such as clinics); and
Whereas, State radiation control programs are directly affected by
the interpretation of this policy statement;
Be it hereby resolved, that the Department of Health, Education,
and Welfare clarify this policy statement in the areas outlined above,
and
Be it further resolved, that the Department of Health, Education,
and Welfare, in cooperation with the Conference of Radiation Control
Program Directors, review the need to develop performance criteria and
survey methodologies for photof luorographic machines.
MR. GILBERT: Further discussion?
MR. STEIN: It seems that one word was brought out - the '-'indiscriminate"
use of x rays. This allows the free latitude of interpretation by who-
ever is utilizing photofluorographic equipment; be it the health officer
of the State, or the mobile units that are located in private or public
type clinics. It seems to me that this is a matter of definition as to
whether it's indiscriminate use of x ray; be it political, economic, or
face saving. This is one of the areas that is not defined in "indiscrim-
inate" use of x rays. You got a strong statement. So if we're really
against it, let's make a positive statement and say what indiscriminate
use is.
MR. GILBERT: Further comments? The resolution is on the floor. I call
for the vote. Those in favor, say aye. Those opposed. The ayes have
it - so ordered.
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SUWARY AMD ADJOURNMENT
James W. Miller, D.D.S.
Director
Office of Regional Operations
Bureau of Radiological Health
Joseph P. Hile
Executive Director of Regional Operations
Food and Drug Administration
Ronald E. Bales
Regional Operations for
Radiation Programs
Environmental Protection Agency
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SUMMARY AND ADJOURNMENT
W.
Office of Regional Operations, BRH
?, H-lte.
Executive Director of Regional Operations, FDA
Ronatd E. Bate*
Regional Operations for Radiation Programs, EPA
MR. GILBERT: We now come to the summary and adjournment. For this
session we have two speakers. Dr. James Miller from the Bureau of
Radiological Health and Ron Bales from the Office of Radiation Programs,
EPA. As we meet here, we're very proud to have the support of the Bureau
and EPA. We hope it continues. Several people, I think, put in an
extreme amount of effort to make this happen. One in particular has
never been given the recognition that he should be given; that's our
secretary, Jerry Parker, who has held the job for 4 years; and his
counterpart at the head table, Dr. James Miller.
DR. MILLER: This has been a great meeting. And I can only echo Heinz
Wilms remarks last night about the tremendous job that has been done
by Jim Porter and his staff; all the hard-working secretaries; and the
labors of Ron Bales, Heinz, and Bob Siek on the Program Committee. Any-
one who has been involved in a meeting of this type knows the amount
of work it requires. Recognition is also due the Executive Committee
of the Conference which has really toiled diligently over the past year.
Everyone said this has been the greatest meeting so far. I thought
about that for quite a while last night and I believe that is a true
statement.
When I think back on the four meetings we've had to date, they've
all been great. Each one has some memorable aspect about it. This
Conference is starting to jell, to mature; and I think it's because
we are getting to know each other. We're meeting as friends, not as
strangers; and we're starting to get things done. I feel that the qual-
ity of the workshop reports today is an indication of that. We are
starting to really work together and I'm real pleased. I was quite
concerned for the first few years of this organization wondering whether
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you were going to make the grade, but I feel you're over the hump now.
Of course, a lot of that may be due to the experience that we gained
through the years.
I do believe it's important that all members of the Conference share
in supporting the Executive Conmittee, and not let just a few carry the
bulk of the work. Most of you are doing your part, but there are still
a few who, I feel, could contribute a little more than they have in
the past. I think the theme of this meeting was very apropos. "Save
a Rad" is what we are all trying to do. This is our business--whatever
we call it--"Save a Roentgen," or some other slogan. What we're inter-
ested in is protecting people; and this can't be just a 1 day or 1 week
job. It has to be our theme throughout the year.
One of the subjects that John Villforth covered in his talk on
Monday morning was changes within the Bureau. As he mentioned, there
are going to be some changes from what we now call the Office of Regional
Operations in the Bureau of Radiological Health. The plan, to be effec-
tive July 1, 1972, is to have the regional representatives in BRH,
instead of reporting to me, report to the Regional Food and Drug Director.
My office in Washington, will be placed intact under the FDA's Executive
Director for Regional Operations. We are going to become a truer part-
ner with the entire FDA. In doing this, we are asking you to accept
another member into our existing partnership. The man who represents
this part of the organization is Mr. Paul Hile, the Executive Director
of Regional Operations. Paul came to New Orleans this morning. He
is here in the audience and I would like to introduce him to you and
ask him to say a few words, because I think you ought to get to know and
recognize him. I don't believe anything is going to change in our re-
lationships, as a result of this organizational rearrangement. Paul,
would you say a few words to the Conference?
MR. HILE: Thank you, Jim. Mr. Chairman, ladies and gentlemen. It's
a pleasure and a privilege to have an opportunity to speak to you for
a few minutes, particularly in that I came in just at the very end of
your meeting. I hope that you will not feel that my arrival in rela-
tionship to your meeting reflects in any way my interest, my concern,
and enthusiasm, over your program.
As many of you know, I have had as my personal representative here,
Maurice Kinslow, who is one of our senior Regional Food and Drug Direc-
tors , and Don Martin and Chuck Pogue from my office at Headquarters.
I must apologize, but as most of you who are program managers know,
appropriation hearings most often take priority over everything else,
and that is where I have been spending the majority of my time the last
week or 10 days.
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I think the important thing to convey to you is that the interest,
the enthusiasm, and the support for the program is agency-wide. Dr.
Edwards met with you last Sunday. When we saw him on Monday, he remarked
how impressed he had been about the program that you represent. He
commented about the dedication and enthusiasm of the State officials
involved in the program. And, of course, he sees daily that same dedi-
cation and enthusiasm in the Bureau of Radiological Health. Certainly
I have been impressed.
I've been impressed ever since I met John Villforth and Jim Miller
and members of his staff, and since we have been working together. I'm
delighted, and selfishly so, that the 10 regional representatives and
Jim and his Headquarter's staff will be joining the EDRO organization;
but my enthusiasm and interest also relates to the State aspects of
your programs, because it was my privilege to attend the Region IV Con-
ference in Louisville last fall, and meet and deal on a personal basis
with many of the State representatives. The important thing, I believe,
that I would like to convey, in addition to the fact that it's an agency
commitment to the program, is that my organization currently is composed
of some 2,200 people. If our appropriation hearings are successful,
it will go to almost 3,000. The important thing is that by combining
into the field organization of the Food and Drug Administration, respon-
sibility in the Rad Health area, we are not in any way sacrificing what
has been accomplished to date. But rather, moving to bring into the
program some 3,000 additional supporters for what we are trying to do
in this area. It is my intention, and it will be the intention of the
Regional FDA Directors working with their regional representatives,
to continue unchanged the programs that they have developed, and we
will continue to strengthen them where appropriate.
It is a privilege to announce that we will be moving into an ex-
panded program with the Bureau in areas that are complementary to those
within the Federal-State programs that you have had in the past. We
will be doing more work with John, for example, in relieving regional
representatives of some of the more routine technical jobs that they
have had to do in the past, and free them to work more directly with
you in expanding many of the programs that we have together.
So let me just summarize by saying that it is a real privilege
and pleasure to have people of the caliber of Jim Miller, Heinz Wilms,
Norm Geiger, and the regional representatives, join with the EDRO organi-
zation. I give you my personal commitment that we will move forward
and have as strong, or even stronger program in the Rad Health area
than we have had in the past.
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DR. MILLER: Thank you Paul. In closing let me say that I have enjoyed
working with Bob Siek and the Executive Committee and all the State
folks during the past year. I am looking forward to greater things
from the Conference in the future. I want to thank each and every one
of you for your participation; your dedication; your hard work in the
workshops; the excellence of the table clinics; the quality of the
speakers; it has all been tremendous. It has been a productive and
profitable meeting.
MR. GILBERT: Thank you Jim. And I want to thank you Paul for taking
time to come by. I want you to be sure that this Conference will pro-
pose its support to be of assistance in any manner, and it will also
pledge its support to continue to work as we have this year and in the
years past. Speaking of working, Ron Bales is liaison with the Executive
Committee of the Conference; the Bureau; with the AEC. He has been
on a Planning Committee, I think, of both this and the last meeting.
He handled financing, and he has been kind of a "jack-of-all trades"
at our level of EPA. It's a pleasure to introduce Ron Bales.
MR. BALES: First of all, I am especially delighted personally to be
able to say that we have had a very successful and productive meeting.
And I would also like to say immediately, that the EPA staff heartily
endorses all of the words of appreciation that Jim has just related.
Working with Bob Siek and the Executive Committee and with the Bureau
staff has been a pleasure during this past year. In conclusion, I
would like to comment very briefly on some of the highlights of accom-
plishment of this 1972 Conference. I certainly hesitate to presume
at this point in the game that I really know much about what has gone
on totally during this week. From our standpoint at any rate, the
recognition of the value of this Conference and the contribution that
it can make to attain the goals of radiation control--in the total
efforts of EPA--is very important, as well as the indication of the
continued support of the Conference and its work, as indicated by our
Assistant Administrator for Categorical Programs of the Environmental
Protection Agency, Mr. David Dominick; and also the support that was
indicated by Mr. Bill Rowe, the newly appointed Deputy Assistant
Administrator who will direct the Office of Radiation Programs; as well
as the support that has been indicated by other members of the Office
of Radiation Programs staff this week. We look forward to these
prospects of strengthened support of Conference activities with con-
siderable enthusiasm. The Conference serves well our continuing mutual
need for improved communication in the relations of State and Federal
agencies.
There has been a genuine appreciation expressed by the Training
Grant Project Directors for the opportunity to meet in conjunction with
this Conference. I am certain that as a result of the meeting this
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week, we shall see a much greater rapport and closer relationship
between the educators and the State Radiation Control Programs, as
well as closer ties with our Regional Offices.
An observation worthy of mention is the general enthusiasm of the
workshop chairmen and their dedication to their tasks in developing
and conducting their work; the workshop reports. The fact that they
worked to identify the "gut" issues that we must deal with; the fact
that they recommended solutions to these problems; are certainly high-
lights of this Conference. The workshops make this Conference especially
worthwhile.
Last, we should recognize that the serious attempt to provide
a publication of these proceedings soon is in itself a highlight of
this Conference, and we have much to gain by early publication of
these proceedings. Early publication remains dependent upon the rapid
response to Mr. Coyle's request for assistance from each of the
speakers. I urge you to respond expeditiously to his request.
MR. GILBERT: Thank you very much Ron. We have a couple of announce-
ments from the floor. For those of you who don't know, the election
took place yesterday. I'd like to point out the new Committee. Leav-
ing the Committee, after being of much help to the Conference, I think,
is Martin Wukasch. Arriving on the Executive Committee in his place
is Arnold Moen from Washington. Bob Siek will be the member-at-large
now, and will be Chairman of the Nominating Committee. Jim Porter was
elected Chairman-elect. Jerry Parker will remain in his capable posi-
tion as Secretary. And I got the shaft.
It has been said, time and time again, that it takes a lot of
effort to put something like this together, and it does. It takes a
lot of cooperative effort amongst everybody. I think the most visible
thing to me this year, contrary to the years going back to Montgomery,
is that we had no bloody noses pool side over differences in points of
view, and so forth. I think the pettiness is leaving. I think that
we all have in-house problems. It's very refreshing to hear that
everybody--our sponsors in the Bureau, FDA, and EPA, are now enthused.
We will work even harder in this next year.
And in working harder, I think in closing I want you to know two
people who have been with us every day, all day. One is Sandy Orkin.
The other is Chuck Coyle. And I'd like to give a round of applause
to a very capable man and my predecessor - Bob Siek.
Gentlemen, thank you for a very successful Conference. This
session is adjourned.
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APPENDIX I
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NATIONAL CONFERENCE
ON
RADIATION CONTROL
Save A Rad
Fontainebleau Motor Hotel
New Orleans, Louisiana
April 30-May 4,1972
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Sponsored By
Conference of Radiation Control Program Directors
Bureau of Radiological Health
Food and Drug Administration
U.S. Department of Health, Education, and Welfare
Office of Radiation Programs
Environmental Protection Agency
Proceedings will be published
and made available to the participants
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SUNDAY. APRIL 30. 1972
12:00-5:00 p.m. REGISTRATION Mezzanine Foyer
3-00-5:00 p.m. OPENING SESSION Grand Ballroom
Moderator: Robert D. Siek
Colorado Department of Health
"Welcome to Louisiana"
Honorable James E. Fitzmorris
Lt. Governor-elect of Louisiana
"The Food and Drug Administration-State
Partnership—A New Dimension"
Charles C. Edwards, M.D.
Commissioner
Food and Drug Administration
"The Environmental Protection Agency's Response
To Environmental Radiation Control Issues"
David D. Dominick
Assistant Administrator
Categorical Programs
Environmental Protection Agency
"Accomplishments of the Conference of Radiation
Control Program Directors"
Robert D. Siek
5:30 - 7:00 p.m. RECEPTION Napoleon Room
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2
MONDAY, MAY 1, 1972
8:00 a.m. - 12:00 Noon REGISTRATION Mezzanine Foyer
9:00 a.m. - 12:00 Noon X-RAY EXPOSURE SESSION Grand Ballroom
Moderator: Gerald S, Parker
Massachusetts Department of
Public Health
9:00 - 9:45 a.m. "Save Radiation—Make it Happen"
John C. Villforth
Director
Bureau of Radiological Health
9:45 - 10:00 a.m. "X-ray Exposure Study and Trends"
Paul L. Roney
Division of Medical Radiation Exposure, BRH
10:00 - 10:15 a.m. COFFEE BREAK
10:15 - 12:00 Noon "Implementation of the X-ray Performance
Standards"
Robert G. Britain
William S. Properzio
Gregory J. Barone, Ph.D.
Division of Electronic Products, BRH
12:00 - L:30 LUNCH
1:30 - 1:45 p.m. WORKSHOP ASSIGNMENTS Grand Ballroom
Moderator: Robert D. Siek
Colorado Department of Health
1:45 - 4:00 p.m. WORKSHOP MEETINGS Assigned Rooms
5:00 - 8:30 p.m. NIGHT-ON-THE-TOWN Bus Transportation
Riverboat Tour on the at Hotel Entrance
Mississippi
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291
TUESDAY, MAY 2, 1972
8:00 - 12:00 Noon REGISTRATION Mezzanine Roan
8:00 - 8:50 a.m. SEMINAR
Moderator: Jay S. Silhanek
Surveillance § Inspection
Division, ORP, EPA
Panel: H. Richard Payne, Region IV, EPA
Representative from OEP
Arnold J. Moen
Washington Department of Social and Health
Services
"Current Status of Emergency Plans - Federal
and State"
9:00 - 12:00 Noon ENVIRONMENTAL RADIATION SESSION
Moderator: Donald C. Gilbert
Arizona Atomic Energy Commission
9:00 - 9:20 a.m. "Mission of the Office of Radiation Programs"
William A. Mills, Ph.D., Acting Deputy Assistant
Administrator, Office of Radiation Programs, EPA
9:20 - 9:35 a.m. "Surveillance and Inspection Activities"
Charles L. Weaver, Acting Director
Surveillance § Inspection Division, ORP, EPA
9:35 - 9:55 a.m. "Surveillance Guide Recommendations"
Donald J. Nelson
Surveillance S Inspection Division, ORP, EPA
9:55 - 10:15 a.m. "National Quality Control Program"
Edmond J. Baratta
Surveillance § Inspection Division, ORP, EPA
10:15 - 10:30 a.m. "Date Analysis and Dose Model Development"
Philip A. Cuny, Surveillance Branch
Surveillance § Inspection Division, ORP, EPA
10:30 - 10:45 a.m. COFFEE BREAK
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292
TUESDAY, MAY 2, 1972 (Continued)
10:45 - 11:30 a.m. "Technology Assessment"
Ernest D. Harward, Acting Director,
Technology Assessment Division, ORP, EPA
Craig I. Roberts, Technology Assessment
Division, ORP, EPA
11:30 - 12:00 Noon "Radiation Standards and Criteria"
Paul C. Tompkins, Acting Direction. Criteria
and Standards Division, ORP, EPA
12:00 - 1:00 p.m. LUNCH
1:00 - 3:30 p.m. WORKSHOP SESSIONS Assigned Rooms
4:00 - 5:00 p.m. RESOLUTIONS COMMITTEE MEETING Assigned Rooms
5:00 - 7:00 p.m. TABLE CLINICS Napoleon Rooms
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293
WEDNESDAY, MAY 5, 1972
8:00 - 8:50 a.m. SEMINAR Grand Ballroom
Moderator: Charles P. Froom
Office of Criteria and Standards, BRH
Revision of the Council of State Governments
"Suggested State Regulations for the Control
of Radiation"
9:00 - 12:00 Noon ADMINISTRATION OF RESOURCES
SESSION Grand Ballroom
Moderator: Martin C. Wukasch
Texas State Department of Health
9:00 - 10:15 a.m. REVENUE SOURCES:
Occupational Health Funds
Howard M. Gray
Assistant Regional Administrator for State Programs
Occupational Safety Health Administration, Region VI
Department of Labor
Atomic Energy Contrasts
Charles A. Pelletier
U.S. Atomic Energy Commission
Eleotrio Utilities
Chester L. Nayfield, M.D.,
Florida Division of Health
Alice Dolezal,
Minnesota Department of Health
Fees—Pros and Cons
John R. Stanton,
New Hampshire State Department of Health and Welfare
William H. Aaroe,
New York City Department of Health
Simon Kinsman, Ph.D.,
California State Department of Public Health
10:15 a.m. COFFEE BREAK
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294
WEDNESDAY. MAY 3. 1972 (Continued)
10:30 - 11:40 a.m. EVALUATION TECHNIQUES
- State Effectiveness Index
Robert H. Will, Kansas Department of Health
- Natiovuide Evaluation of X-ray Trends
Ira Paul Leggett, Jr., District of Columbia
Department of Environmental
Services
11:40 - 12:00 Noon INCREASING MANPOWER USE
- The Self-Regulation Concept
Sherwood Davies, New York State Department of Health
12:00 - 1:00 p.m. LUNCH
1:00 - 4:00 p.m. WORKSHOP MEETING Assigned Rooms
4:00 - 5:00 p.m. BUSINESS MEETING
Conference of Radiation Control
Program Directors Grand Ballroom
6:30 - 7:30 p.m. RECEPTION
(Cask Bar) Grand Ballroom
7:30 p.m. Banquet Grand Ballroom
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295
THURSDAY, MAY 4, 1972
8:00 - 8:50 a.m. SEMINAR Grand Ballroom
Moderator: Charles M. Hardin
Kentucky State Department of Health
OPTIMUM X-RAY SURVEY PROCEDURES
9:00 - 11:30 a.m. CLOSING SESSION Grand Ballroom
Moderator: Donald C. Gilbert
Arizona Atomic Energy Commission
WORKSHOP REPORTS
RESOLUTIONS
11:30 - 12:00 SUMMARY AND ADJOURNMENT
James W. Miller, D.D.S.
Bureau of Radiological Health, FDA
and
Ronald E. Bales
Office of Radiation Programs, EPA
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296
WORKSHOPS
1. X-ray Equipment Performance Standard
Chairman: John J. Russo
New Jersey Department of Environmental Protection
2. Effecting the Safe Use of X-rays
Chairman: Michael Christie
Idaho Department of Health
3. Radioactive Material Control
Cochairmen: David K. Lacker
Texas State Department of Health
and
Philip Brunner
Illinois Department of Public Health
4. State and Local Training Needs
Chairman: Aaron Bond
New Mexico Environmental Improvement Agency
5. Radioactive Waste Disposal
Chairman: Charles M. Hardin
Kentucky State Department of Health
6. Environmental Impact Statement Ftevieu Guidelines
Chairman: Thomas J. Cashman
New York State Department of Environmental Conservation
7. Emergency Response Planning
Chairman: E. Frank Wilson
Arkansas Department of Health
8. Environmental Surveillance and Analytical Control
Chairman: Marshall W. Parrott
Oregon State Board of Health
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297
TABLE CLINICS
1. Test Methods and Equipment for Enforcement of the Diagnostic!
X-ray Equipment Performance Standard
Gregory J. Barone, Ph.D.
William S, Properzio
Charles K. Showalter
Division of Electronic Products
Bureau of Radiological Health
2. Nationwide Evaluation of X-ray Trends (NEXT)
Alvis E. Jordans
Joel 0. Lubenau
Northeastern Radiological Health Laboratory
Bureau of Radiological Health
Gerald W. Gaskill
Data Systems and Mathematics Staff
Bureau of Radiological Health
3. Training Packages for State Use
James S. Benson
Mark H. Barnett
Office of Training
Bureau of Radiological Health
4. Illinois Data Management System
James Blackburn
Philip Brunner
Division of Radiological Health
Illinois Department of Public Health
5. Environmental Radiation Monitoring Instruments
Robert J. Budnitz, Ph.D.
Lawrence Radiation Laboratory
University of California
Berkeley
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298
10
TABLE CLINICS (Continued)
6. Calibration Services and Standard Services Available
to States from the National Bureau of Standards
James M. Wyckoff
Radiation Safety Coordinator
National Bureau of Standards
7. North Carolina Miniature Electronic X-ray Pulse Counter
Dayne H. Brown
Radiation Protection Program
North Carolina State Board of Health
8. Washington State-Step Wedges in Dental X-ray Surveys
Arnold J. Moen
Radiation Control Section
Washington Department of Social 3 Health Services
9. Uranium Mill Tailings Problems
Robertson S. Augustine, Ph.D.
Office of Radiation Programs
Environmental Protection Agency
David Duncan
Western Environmental Research Laboratory
Environmental Protection Agency
Robert D. Siek
Division of Occupational § Radiological Health
Colorado Department of Health
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299
NOTES
We wish to acknowledge the assistance
in local arrangements provided by:
Louisiana Board of Nuclear Energy
Division of Radiation Control
B. James Porter, Director
ft U. S. GOVERNMENT PRINTING OFFICE : 1972 723-4H/492
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The ABSTRACT CARDS below are designed to facilitate document retrieval using
Coordinate Indexing. They provide space for an accession number (to be
filled in by the user), suggested keywords, bibliographic information and
an abstract.
The Coordinate Index
concept of references
material filing is
readily adaptable to
a variety of filing
systems. Coordinate
Indexing is described
in the publication
"IBM Data Processing
Techniques - Index
Organization for
Information Retrieval"
(C 20-8062). Copies
are available through
IBM Branch Offices.
The cards are furnished
in triplicate to allow
for flexibility in their
use (for example, author
card index, accession
number card index).
Accession No.
Sponsors: Conference of Radiation
Control Program Directors; the
Bureau of Radiological Health, Food
and Drug Administration, DHEW; and the Office of
Radiation Programs, EPA. FOURTH ANNUAL NATIONAL CON-
FERENCE ON RADIATION CONTROL - SAVE A RAD.
U.S. Department of Health, Education, and Welfare, PHS,
EDA, Bureau of Radiological Health - DHEW Publication
(FDA) 73-8003 (BRH/OBD 73-3) (July 1972) 299 pp.
(limited distribution).
ABSTRACT: This publication contains the proceedings of
the Fourth Annual National Conference on Radiation Con-
trol - Save A Rad - April 30-May 4, 1972, in New Orleans,
Louisiana. Sponsors were the Conference of Radiation
Control Program Directors; the Bureau of Radiological
(over)
Sponsors: Conference of Radiation
Control Program Directors; the
Bureau of Radiological Health, Food
and Drug Administration, DHEW; and the Office of
Radiation Programs, EPA. FOURTH ANNUAL NATIONAL CON-
FERENCE ON RADIATION CONTROL - SAVE A RAD.
U.S. Department of Health, Education, and Welfare, PHS,
FDA, Bureau of Radiological Health - DHEW Publication
(FDA) 73-8003 (BRH/OBD 73-3) (July 1972) 299 pp.
(limited distribution).
ABSTRACT: This publication contains the proceedings of
the Fourth Annual National Conference on Radiation Con-
trol - Save A Rad - April 30-May 4, 1972, in New Orleans,
Louisiana. Sponsors were the Conference of Radiation
Control Program Directors; the Bureau of Radiological
(over)
Accession No.
Accession No.
|Sponsors: Conference of Radiation
Control Program Directors; the
Bureau of Radiological Health, Food
and Drug Administration, DHEW; and the Office of
Radiation Programs, EPA. FOURTH ANNUAL NATIONAL CON-
FERENCE ON RADIATION CONTROL - SAVE A RAD.
U.S. Department of Health, Education, and Welfare, PHS,
FDA, Bureau of Radiological Health - DHEW Publication
(FDA) 73-8003 (BRH/OBD 73-3) (July 1972) 299 pp.
(limited distribution).
ABSTRACT: This publication contains the proceedings of
the Fourth Annual National Conference on Radiation Con-
trol - Save A Rad - April 30-May 4, 1972, in New Orleans,
Louisiana. Sponsors were the Conference of Radiation
Control Program Directors; the Bureau of Radiological
(over)
-------
Health, Food and Drug Administration, Department of
Health, Education, and Welfare; and the Office of Radia-
tion Programs, Environmental Protection Agency.
Participants representing State and major local radia-
tion control programs, as well as Federal agencies, dis-
cussed mutual radiation control problems. "Save A Rad"
was the theme for the 1972 meeting, which considered a
number of approaches to reducing the amount of radiation
received by the Nation's population. In addition to
formal presentations and educational seminars, the pro-
ceedings contain the reports of Workshops and Resolutions
by the Conference of Radiation Control Program Directors.
KEYWORDS: Conference of radiation control program
directors; radiation control; State; Bureau of Radiolog-
ical Health; environmental radiation control issues;
x-rav performance standards; emergency plans; fees;
manpower use; Environmental Protection Agency. .
Health, Food and Drug Administration, Department of
Health, Education, and Welfare; and the Office of Radia-
tion Programs, Environmental Protection Agency.
Participants representing State and major local radia-
tion control programs, as well as Federal agencies, dis-
cussed mutual radiation control problems. "Save A Rad"
was the theme for the 1972 meeting, which considered a
number of approaches to reducing the amount of radiation
received by the Nation's population. In addition to
formal presentations and educational seminars, the pro-
ceedings contain the reports of Workshops and Resolutions
by the Conference of Radiation Control Program Directors.
KEYWORDS: Conference of radiation control program
directors; radiation control; State; Bureau of Radiolog-
ical Health; environmental radiation control issues;
x-ray performance standards; emergency plans; fees;
manpower use; Environmental Protection Agency.
Health, Food and Drug Administration, Department of
Health, Education, and Welfare; and the Office of Radia-
tion Programs, Environmental Protection Agency.
Participants representing State and major local radia-
tion control programs, as well as Federal agencies, dis-
cussed mutual radiation control problems. "Save A Rad"
was the theme for the 1972 meeting, which considered a
number of approaches to reducing the amount of radiation
received by the Nation's population. In addition to
formal presentations and educational seminars, the pro-
ceedings contain the reports of Workshops and Resolutions
by the Conference of Radiation Control Program Directors
KEYWORDS: Conference of radiation control program
directors; radiation control; State; Bureau of Radiolog-
ical Health; environmental radiation control issues;
x-ray performance standards; emergency plans; fees;
manpower use; Environmental Protection Agency.
-------
ORO 70-8
ORO 71-1
ORO 71-2
ORO 72-1
ORO 72-2
BRH/OBD 73-1
BRH/OBD 73-2
BRH/OBD 73-3
TECHNICAL REPORTS
(continued from inside of front cover)
Title
Model Legislation for Users of Ionizing Radiation in the
Healing Arts (PB 196-447 $3.00)
State Radiation Control Legislation - 1970 (PB 198-374
$3.00)
Report of State and Local Radiological Health Programs,
Fiscal Year 1970 (Sup Docs Stock No. 1715-0014, $1.00)
(PB 200-265 - microfiche only)
Directory of Personnel Responsible for Radiological
Health Programs - November 1971
3rd Annual National Conference on Radiation Control -
New Horizons - May 2-6, 1971, Scottsdale, Arizona,
December 1971
Directory of Personnel Responsible for Radiological
Health Programs - July 1972.
State Radiation Control Legislation - 1971 (July 1972)
(in press).
4th Annual National Conference on Radiation Control - Save
a Rad - July 1972
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