ML20206D709
| ML20206D709 | |
| Person / Time | |
|---|---|
| Issue date: | 10/25/1988 |
| From: | Grimsley D NRC |
| To: | Reese C BAKER & HOSTETLER |
| References | |
| FOIA-88-494 NUDOCS 8811170226 | |
| Download: ML20206D709 (3) | |
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R., : FO!A- 88-494 APPENDIX A REC 0x0S PARTIALLY WITHHELD _
NUMBER DATE DESCRIPTION & EXEMPTION _
- 1. 3/2/88 SECY-88-64. Naturally Occurring and Accelerator-Produced Radioactive Materials, (portions being withheld pursuant to Exemption 5) with enclos,res released in their entirety. (81pages) l 1
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"s. ?pr;; . y'+n . . . . . +0',e ec c POLICY ISSUE 8 (Notation Vote) O )
March 2. 1988 -
O.SECY-85 wn -6 4.
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The Commissionen For; - - -
Fres: Victor Stallo, Jr.
Executive Director for Operations sub.fect: NATURALLY OCCURRING AND ACCELERATOR-PRODUCED RADIOACTIVE .
MATERIALS
Purpose:
.To obtain Commissfoa approval of the staff recommetidations on the issue of whether NRC should seek legislative authority to regulate naturally occurring and accelerator produced radioactive mate. als (NARM).
Catego % This paper covers a major policy matter.
Introduction:
NARM is in the environment, in homes, .a consumer products, in industrial applications and 10 medical departments. Congress has never seen fit to expand Atomic Energy Commission / Nuclear Regulatory Cornission (ACC/NRC) jurisdiction into the NARM l arena, apparently because other agencies already have jurisdiction, and because the States have the primary responsibility for protecting the public health and safety. Thus, NRC's responsibilities and activities have remained linked to the neutron chain reaction.
1 In deciding whether NRC should seek legislative authority over i NARM, it is important to understand what NARM encompasses; how
! it is used; how the NARM risks compare to other reltted risks; previouc Congressional and Federal agency actions on radiation protection matters; and what the States are now doing to regulate NARM. Enclosure 1 to this paper is a renort on a detailed
~
examination of these matters.
Defining the universe of NARM is extremely important, since
- naturally occurring radioactive materials are ubiquitous.
l Radon-222 and radium-226 are significant sources of radiation to which the public is exposed. Radium can be unintentionally l , concentrated through *outine operations such as phosphate mining
Contact:
Dr. John H. Austin, NHSS I l -
492-0689 ]
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y 4 The Commissioners and purifying drinking water. Radium use in med. cal departments, in industrial gauges, and in consumer products appears to be diminishing. Thousands of cyclotrons produce NARM and NARM wastes in hospitals, and in industrial and research applications. Eight radionuclides important to the medical community are produced exclusively by cyclotrons. They are:
carbon-11; nitrogen-13; oxygen-15; cobalt-57; gallium-67; indium-111; iodine-123; and thallium-201. Two other important radionuclides produced through cyclotrons or nuclear reactors are fluorine-18 and strontium-87. Most of these isotopes have half-lives in the order of minutes to hours.
The quantities and concentrations of NARM form a continuum in the human world, and the potential hazards of NARM form a continuum ranging from background to potentially signif% ant ones in all facets of life. Thus, any effort to contrs- the risks from NARM calls for an integrated control program to ensure that the dominant hazards are appropriately addressed, without undue attention to the lesser har Js. However, incidents and problems involving NARM do ot always reflect a consistent and significant actual hazard associated with NARM.
To be sure, there have been significant incidents involving contamination of facilities, loss of materials, and inadvertent introduction of radium iato commerce, but significant exposures l of the public to discrete sources of radium rarely occur, based l on available data. One particular NARM problem is proper disposal of discrete radium sources, primarily radium needles.
Meager informacion exists on the hazards associated with cyclotron-produced radiopharmaceuticals, probably due mainly to their relatively infrequent use. Apparently, about 1% of the total misadministrations of diagnostic radiopharmaceuticals j involves cyclotron produced radionuclides.
Congress has already vested jurfsdiction over NARM in the Environmental Protaction Agency; the Consumer Product Safety Commission; ^.he Department of Health and Human Services; and the Department of Labor. In addjtion, the Departments of
. Agriculture, Commerce Energy, Housing i..d Urban Development, the Inta. ior, State, and Transportatio, ad the U.S. Postal Servico and the In'.erstate Commerce M iuion have possible or actual interests in e'xposures to - commerce in NARM.
There has never been an explicit decision on the Federal role
.versus the State role, in prote-ting the public from exposures to ionizing radiation, except that set out in Section 274 of the Atomic Energy Act of 1954, as amended. Fen ral a0encies exercise discretion regarding the degree to which thay implement their authorities to control exposures to ionizing radiation. Furthermore, Congressional mandatt', to the above l agencies vary so greatly that it is not clear whether the worst l
and most controllable exposures are being addressed without undue attention to lesser ones. As a consequence of all of the
- above, Federal controls over ionizing radiation, in general, and over NARM, in particular, are fragmented and uneven.
l All 29 Agreement States regulate and control discrete sources of
- NARM in the s ee way they do Atomic Energy Act materials. Of the 21 non-Agreement States, only 4 have a NARM licensing program.
Of the remainder, 2 s*,ates have voluntary or partial licensing programs, and 14 states have registration programs, leaving one state, Montana, with nothing. With regard to NARM inspections, all 29 Agreement States inspect NARM, as do 14 non-Agreemgnt States,
- whereas 4 states conduct partial inspections. Five states conduct l no' inspections. A comparison of the 19'/7 versus 1987 level of activity indicates that the states are inc.reasing the amount of l , attention they give to NARM. Nonetheless, on August 26, 1987, the Conference of Radiation Control Program Directors -(CRCPD) once again urged that the NRC seek l'egislative authority to regulate NARM. The August 26, 1987 position paper of CRCPO is reproduced I in Enclosure 2. ,- ,
Issues: Based on an analysis of the sources and uses of NARM, the l 1
incidents and problems with it, and the current jurisdictions and ;
t activities of other Federal agencies and the States, we believe >
j that the answers to'the following eight questions will clarify (
! the issue of whether NRC should seek regulatory authority over i
(
j NARM:
- 1. Is there a national problem with NARM? ,
- 2. Are there currently integrated Federal controls over NARH? !
- 3. Would NRC regulation of NARM overlap other Federal l agencies' programs? ,
4 4. Are the States' controls over NARM adequate? t
- 5. Is NARM a Federal, State, or professional responsibility? l S. Would Congress consider the NRC responsible for l i
controlling NARM hazards? t I
- 7. What are the resource implications? and l l 8. Would NRC responsibility for NARM regulation change :
the nature of NRC? -
These eight questions were examined through an extensive literature search, and are addressed in Section VII of :
Enclosure 1.
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. .e4 ibeCommissioners 5-Coordination: With rsgard to recommendation 1, we contacted the Chairman-of CIRRPC on February 11, 1988, and read that, recommendation to him. The Chairman concurred with the recommendation.
The Office of Governmental and Public Affairs participated in the development of the enclosed report and concurs in this paper and the enclosed report.
Note: . The Conference of Radiation Control Prcgram Directors has expressed an interest in meeting with the Commissioners, in an open meeting, to discuss their most recent urging that NRC seek legislative authority over NARM. We recommend a Commission meeting on this subject with an invitation to the CRCPD to participate. We believe benefits would derive from the Conference having this paper, and Enclosure 1, in advance of any such meeting with the Commission. If the Commissior, agrees, we will forward this paper, and Enclosure 1, to the Confertace in appropriate advance of the meeting. ,
t .' ' hG c, ctorSt[llo,J.
Executive Dire for Operattuns
Enclosures:
- 1. "Naturally Occurring and Accelerator-Produced Radioactive Materials -
The 1987 Review"
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Commissioners' consent should be provided directly to the Office of the Secretary by Monday, March 28, 1988 or two weeks after a Commission meeting, if the Commission decides to hold a meeting.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Monday, March 21, 1988, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected. ,
DISTRT.BUTION:
Commissioners OGC (H Street) ,
OI OIA GPA REGIONAL OFFICES EDO OGC (EP)
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NATURALLY OCCURRING AND ACCELERATOR-PRODUCED RADI0 ACTIVE MATERIALS - THE 1987 REVIEW .
John H. Austin ABSTRACT The issue of Federal controls over naturally occurring and accelerator produced radioactive materials (NARM) is very old and complex. NARM exists in the vnvironment, in homes, in workp1 Lees, in consumer products, and in medical capartments. Many Federal agencies already have jurisdiction over NARM, but the controls are fragmented and uneven. Historically, Congress,has never seen fit to expar.d Atomic Energy Commission / Nuclear Regulatory Commission (AEC/NRC) jurisdiction into the NARM arena, in part, because other agencies already have jurisdiction and, in part, because the States have the primary responsibility for protecting the public health,and safety. NRC's responsibilities and activities remain linked to the neutron chain reaction. -
This paper presents a. review of NARM sources and uses as well as incidents and problems associated with those materials. A review of previous Congressional and Federal agency actions on radiation protection matters, in general, and on NARM, in particular, is provided to develop an understanding of existing Federal regulatory activity in.ionizipg"radiation,and in control of NARM. The review of State contrcls over NARM reveals that their level of effort is increasing.
This paper examines eight questions' in terms of whether NRC should seek legisla-tive authority to regulate NARM:
- 1. Is there a national p'roblem with NARM?
- 2. Are there currently integrated Federal controls over NARM?'
- 3. Would NRC regulation of NARM overlap other Federal agencies' programs?
- 4. Are the State controls over NARM adequate?
- 5. Is NARM a Federal, State or Professional re3ponsibility?
- 6. Would Congress consider NRC responsible for controlling NARM hazards?
4 7. What are the resource implications? and
- 8. Would NRC responsibility for NARM regulation change the nature of NRC7 The, analyses of these issues serves as the bases for developing and evaluating five options, viz.
- 1. Status quo, but continue to encourage State efforts on NARM regulation,
, 2 '. Seek legislative authority over NARM,
- 3. Seek authority to regulate radium disposal,'
- 4. Seek authority to regulate cyclotron produced. radioisotopes for medical use only, .
- 5. Refer the issue of NARM regulation to the Committee on Interagency Radia-tion Research and policy Coordinat,1.on.
The evaluation of those options leads to two recommendations.
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! TABLE OF CONTENTS i
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[ ABSTRACT ............................................................. iii it d I. BACKGROUND .................................................... 1
, II. WHAT I S NA RM ? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 III. SOURCES AND USES OF NARM .....................................,. 5 A. Radium ....... ........................................ 5 B. Other Naturally Uccurring Radionuclides ....'.............. 7 C. Accelerator-Produced Radioactive Materials ............... 7
- 0. Trends ................................................... 9 E. Discussion ............................ .................. . 10 IV. PROBLEMS AND INCIDENTS WITH NARM .............................. 11 A. Radium and Raden ......................................... 11 B. NARM in General .......................................... 12 C.. Discussion ............................................... 15 THE FEDERAL GOVERNMENT AND NARM ...............................
V. 17 *
. A. Pre-Atomic Energy Act .................................... .17 B. The Atomic Energy Act of 1946, as Amended '
Through 1959 ............................................. 19 .
C. Federal Radiation Council, 1959-1961 ..................... 20
- 0. The Radiat' ion Control for Health and Safety .
Act of 1968 .............................................. 20 E. The Consumer Product Safety Act of 1972 .................. 21 F. The National Institute for Occupational Safety
- and Health Study of 1976 ................................. 22 G. The 1977 NRC Task For:e Review ........................... 22
- 1. Initial Review ...................................... 22
- 2. Response to the 1977 Review ......................... 24
- 3. Resolution cf the 1977 Review ....................... 2?
. H. The Interagency Task Force on the Health Effects of Ionizing Radiation - 1979 ............................. 25 I. The United States Radiation Policy Council from 1980 to 1982 ............... ....................... 25 J. The Consumer-Patient Radiation Health and Safety Act of 1981 ....................................... 26 K. Committee on Interagency Radiation Research and Policy Coordination from 1984 ............................ 26 L. The Low-Level Radioactive Waste Policy Amendments
. A t of 1985 ......................................... 4... 27 M. Advance Notice of Proposed Rulemaking - Definition uof High-level Waste in 1987 .............................. 27 N. U.S. Environmental Protection Agency Activities, 1984-Present ............................................. 28
. . iv .
TABLEOFCONTENTS(Continued)
Page
- 0. The United States Pharmacopeial Convention ............... 28 P. U.S. Nuclear Regulatory Commission ....................... 29 l Q. Discussion ............................................... 29 -
VI. THE STATES AND NARM ........................................... 31 VII. THE ISSUES REGARDING NRC AND NARM ............................. 35 A. Is There a National Problem with NARM? ................... 35 B. Are There Currently Integrated Federal Controls '
Over NARM? ............................................... 38 C. Would NRC Regulation of NARM Overlap Other Federal Agencies' Programs? .............................. 39
- 0. Are the State's Controls Over NARM Adequate? ............. 40 E. Is NARM a Federal, State, or Professional
. Responsibility? .......................................... 40 F. Would Congress Consider the NRC Responsible for -
Controlling NARM Hazards? ................................ -
41 G. What are the Resource Implications? ...................... 42 H. Would NRC Responsibility for NARM Regulation Change the Nature of NRC? ................................ '42 VIII. Q P TI O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 44 A. Status Quo i.............................................. 44 -
B. Seek LeyL-lative Authority over NARM ..................... 44 C. Seek Legis'lative Authority over Radium Disposal .......... 45 D. Seek Legislative Authority over Cyclotron-Produced
, Radionuclides for Medical Use,0nly......................... 45 E. Refer the Ir/;e of NARM Regulation to CIRRPC ............. 46 IX. DISCUSSION .................................................... 47 X. RECOMMENDATIONS ....'........................................... 48 4
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4 I. BACXGROUND NARM is in the environment, in homes, in consumer products, in industrial applications, and in medical departments. NARM is a very significant source of radiation exposure to the public. There are oth,er significant sources of radia-tion exposures, also. Thus, on the premise that it is wise and prudent to have an orderly Federal program on controlling harmful radiation exposures, the NARM issue is less one of regulating certain radioactive materials and more an issue of regulating exposures to ionizing radiation. A rational Faderal program on controlling risks would seek to address the worst and most controllable expo-sures to ionizing radiation first; to do otherwise would mean that the total .
amount of harm being prevented would be less than that which could be prevented, -
given a constant application of resources. (See: "Risk Assessment in the Federal Government: Managing the Process," National Research Council, National Academy Press, Washington, D.C. 1983.)
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The issue of Federal control over NARM is very old and very complex. It resurfaces with a recurrence interval of a few years, occasionally in the con-text of the question - what is the rationale for NRC regulating all but that small portion of nuclear medicine departments that involves radium and ,
accelerator produced radioactiv'e materials? The direct and short answer to why the Federal government has not Lken overall jurisdiction of NARM is ,
history.
It has.long been recognized that there is a fundariantal Federal / State /
Professional responsibility issue in this area. The issue of governmental con- .
trols over exposures to NARM is not whether the Federal government should
- create an authority to establish such controls, but, rath6r, an issue of whether the Federal government should preempt the authority the States already have. A preeminent purpose of the Federal government, in the creation of an organized community bound by common rules, is to promote the general welfare. Because aa nation's resources are limited, the Federal government must direct its cesources toward the actions that will produce the greatest reductions in risks to the public health and safety. If the risks of t.he same type (e.g. , risks of cancer from exposure to ionizing radiation) are to be regarded as comparable regardless of the route through which people are exposed to'them, then there should be an integrated approach to controlling exposures of people to such risks.
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Federal regulation of ionizing radiation is uneven and fragmented, with about 18 Federal agencies.having a role. Although the responsibilities of the Federal government ard State governments have shifted somewhat over time, there has been no explicit decision on what the Federal role is in protecting the public from exposures to ionizing radiation. For example, is it or should it be, a function of the Federal government to ensure that exposures of the public be as .
low as reasonably achievable? Likewise, assuming a general Federal role, at what exposure level does the Federal government believe exposures are below concern? Furthermore, there has been ne explicit decision of what is the Federal' role versus the State role on protecting the public from ionizing radiation, except that set out in Section 274 of the Atomic Energy Act of 1954,. as amended.
Absent a generally applicable policy on the Federal role in regulating exposures
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of the public to ionizing radiation, and absent a generally applicable Federal definition of de minimis exposures, there appears to be no prect:c rationale for bracketing the universe of NARM for possible regulation by the NRC. Depend-ing on any selected bracketing of the definition, as will te illustrated later, other Federal agencies may be involved.
In deciding whether NRC should seek legislative authority oser NARM, it is important to understand what NARM encompasses, how it is used and misused, how the NARM risks compare to other related risks, and what is now being done about those risks.
In the medical field, there are highe'r risks associated with otier sources of ionizing radiation than that which is apparent with accelerator-produced radio-active materials. -Congressional interests with respect to the quality of health care and problems in the health care delivery programs, including those involv-ing ionizing radiation, are much more important and fundamental than that repre-sented by a small percent of a nuclear medicine department. Even so, Congress ,
appears to be moving rather slowly on addressing these more important problems.
Thus, the issue of whether there should be' additional Federal conttols over NARM is an issue of what should be Congress' next target for reducing exposures of the public to ionizing radiation? (See, for example: "The Environmental Protection Agency Needs Congressional Guidance and Support to Guard the Public in a Period of Radiation Proliferation," GAO Report CE0-78-27, January 1978; "Unnecessary Exposure to Radiation from Medical and Dental X rays," U.S. House of Representatives. Committee Print 96-52, August 1980; "Nationwide Evalua' tion of X-ray Tren's,"
d lll15 PB 84-189281, April 1984; "Medical Technology and Costs of the Medicare Program," OTA-H-227, July 1984; "Federal P611cies and the Medical Devices Industry," OTA-H-230, October 1984; P.L.99-660 and Legislative l History on Health Programs; "Medical Devices: Early Warning of Problems is l Hampered by Severe Underreporting," GA0/PEMD-87-1, December 1986.)
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II. WHAT IS NARM?
The definition of the universe of NARM for possible Federal regulatory juris-diction is extremely important, since naturally occurring radioactive materials are everywhere in the environment. N atural radiation and naturally occurring radioactive materials are the dominant sources of human radiation exposure.
(See: "Ionizing Radiation Exposure of the Population of the United States,"
NCRP Report No. 93, November, 1987.) Naturally occurring radionuel Hes repre-senting a significant source of human radiation exposure include carbon-14, potassium-40, polonium-210', raden-222, and radium-226. Some of these radio-nuclides, particularly radium-226, can be unintentionally concentrated, through routine operations such as purifying drinking water (resins used to bring drinking water into compliance with the Environmental Protection Agency stand-ards remove and concentrate radium-226 on the resins) and ' transmission of oil and gas through pipelines (scale on the inside of the pipes trap and concentrate radium-226).
The book "Radionuclides Production" (CRC Press, Vol. II, F. Helus Ed., 1983).
identifies 24 specific radionuclides that the biological and medical fields use most often. Of these, 14 are produced exclusively in nuclear reactors (thus, byproduct mater'ial); 8 exclusively in cyclotrons (carbon-11, nitrogen-13, oxygen-15, cobalt-57, gallium,-67, indium 111, iodine-123, and thallium-201),
and two are produced by either means (fluorine-18 and strontium-87). There are many other cyclotron produced radioisotopes being used in the medical, research and development fields. Most of the cyclotron produced radionuclides have .
relatively short half-lives, in the order of minutes to. hours; thus, they typi-cally decay away on-site or are disposed of with byproduct low-level wastes'.
Cobalt-57 with a half-life of 271 days, is an exception. In addition, there are some longer-lived gamma ray emitters, produced through accelerators, which are used in agricultural tracer studies (e.g. sodium-22 and manganese-52 with half-lives of 2.6 years and 312 days, respe~ctively). Another major excention with respect to the half-lives of accelerator produced radionuclides de' rives from accelerator targets and components. For example, over the decade from 1976 to 1986, the average annual anount of radioactive waste shipped from tne Fermilab was 7,700 cubic-feet per year. This volume of low-level waste is about as much as that gen (rated by a large power reactor. (See Department of Energy memo from L. Edward 'emple to Prospective Proposers on the Superconducting Super Collider, datec August 3, 1937.)
There is another issue that frequently surfaces in the context of NARM, and that has a bearing or the issue of whether risks of the same type are to be considered comparably, regardless of the route of exposure, i.e., the similar-ity of cobalt-60 teletherapy units and X-ray deyices. Both machines are used in radiation therap , but X-ray devices are replacing cobalt-60 units, because the linear accelerators are more versatile. (See: "Trends in Radiation Therapy Demographics - 1974 to 1983," J.J. Diamancl, et. al . , Int. J. Radiation Oncology B1ol. Phys., M , 1986, pp. 1673, 1674.)
NRC regulates the possession and use of cobalt-60, whereas.the Food and Drug Administration (FDA) regulates the manuf acture and assembly of medical devices, including X-ray devices and cobalt-60 teletherapy devices, but not the use.
Albeit, FDA has recommended quality assurance programs at user facilities (21 CFR 1000.55), but they are not requirements. Thus, the cobalt-60 and X-ray devices can stand side-by-side and the use of cobalt-60 devices is subject to 3
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Federal requirements (including the reporting of misad. ministrations) whereas This is a dichotomy equal to that of NRC the use of X-ray devices is not. !
regulating byproduct material used in nuclear medicine and not regulating NARM used in nuclear mediciac. However, X-ray teletherapy uriits are not strictly within the definition of NARM, Nonetheless, this dichotomy is surfaced as an example of the importance of having a clear logic on any extension of the scope of Federal controls over NARM beyond that which already exists.
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18I. SOURCES AND USES OF NARM A. , Radium First discovered in 1898, radium has been used longer than any other radioac-tive material. As an alpha- and gamma-emitter with a half-life of about 1600 years, and as a bone-seeker, radium is one of the most hazardous radionuclides to human beings. Until around the 1930's, radium was considered almost magical as a cure for cancer and other ailments. As a radioluminous material, radium cons'tituted the first application of radioactive materials in consumer products, including dials for aircraft instruments, religious articles, pull chains for electric lights, and knobs for chamber pot covers. Approximately 60 known (
deaths resulted from the use of radium in luminizing compounds. Before the dangers of radium came to be apprecia'ted, an unknown fraction of the total oro-duction was also used in quack medicine., resulting in additional cases of radium-induced bone cancers. For example, compresses used for miscellaneous aches and pains contained 0.1 mg of radium-226. (See: Environmental Radio-activity, Third Edition, Merril Eisenbud, Academic ' Press,1987, pp. 4 and 234.)
As an investment in the 1920's and 1930's,. radium was hoarded untti cheaper, !
substitute sources of ionizing radiation became availablo after the Manhattan Project. Doctors and others who bought it when the price was high were reluc-tant to let it'go at a small fraction of the purchase price, so some stored it in safe-deposit boxes and in attics.' (See: "Lost Radium... Killer at large,"
popular Mechanics, Feb. 1966.)
The total amount of radium produce'd world-wide by the time production . ceased in
, about the 1950's was little more than 3000 grams (See: Radionuclides produc_- I tion, Vol. I, Frank Helus, Ed., CRC press, 1983, p. 2). Of this amount,-accord-ing to the only extensive national survey of radium use, undertaken in 1968, approximately 1,300 grams (curies) of radium were sold in the United States.
- About 550 grams of radium were apparently sold as'a luminous compound for watenes, clocks,' aircraft dials, etc.; another 320 grams of racium were solc to '
the medical community; and 260 grams sold for nonmedical applications. In 1968, :
there were 152 grams under leases for medical and nonmedical uses. Although.
fraugnt with uncertainties, it appeared that in 1968, almost all major users of radium had been located. Not known are the possessors of small, but potentially
, ns:ardous :Lantities of radi;m. (Seo: "State and :eceral Control cf Haalin Hazards from Radioactive Materials Other than Materials Regulated under the Atomic Energy Act of 1954," FDA 72-8001, June 1971, pp. xi and 29, 43 and 44.) ,
Off and on from 1964 through 1982, FDA and EPA carried out a program to collect and dispose of radium sources that were no longer needed. In the summer of 1983, all of the radium collected during the program, 145 grams, was transfer-red to Hanford, Washington. (See: "NORM-EPA's Point of View," F..L. Galpin and 1 S. T. Windham, Conference of Radiation Control P,rogram Directors Meeting on May 21, 1987.)
The medical uses of radium generally involve brachytherapy treatments, but most observers believe such use is, declining. Industrial uses include soil density gauges, well logging, calibration standards, and radiography. Residential i uses of radium involve smoke detectors, and clocks and watches that are illumi-nated with radium. The estimated 550 grams of radium in luminous compounds are 5
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so dispersed, it is unlikely there could ever be an accounting for that source.
Radium, in conjunction with berryllium, becomes a neutron source, with applica-tions in activation analyses. Most observers believe this use of radium is being replaced by americium.
Four companies have been identified as marketing radium or radium-containing devices. The Thomas Register lists only one company marketing radium and, based on an informal contact with them, they indicate there is little interest in radium, and that companies are moving away from radium, Their total sales over the last year were between 0.5 and 1.0 curie of radium (f.e., about one-half to one gran' of radium). Most of the sources sold are in the few millicurie range, usually for level measurement gauges. Some standards solutions for calibrating instruments are sold each year containing either 0.5 microcuries or 5 microcuries of radium. The company obtains its radium through imports froc its parent company in the United Kingd?m. (See: private communicaticn with Dr. Bryan Baker, Amersham Corporation, Arlington Heights, Illinois, January 13, 1988.) One company in Wisconsin has been identified as still offering radium in its soil-density gauges, but it may chan'ge to another radionuclide for economic reasons. Another company in New York distributes lightning rods containing up to 80 microcuries of radium. Still another company owns 140 grams of radium, with most of that material housed in its facility in New York City. Since 1983, the State has banned all commercial operations at the site. (See: "Queens Radium Suppliar is Faulted on Safety," NYT, Oct. 4,1987.)
The Environmental Protect,fon Agency (EPA), has identified 70 specific NARM waste streams and has grouped these into'10 general NARM waste streams, ba wd on similarities in source type, waste form, and/or waste processing. EPA -
emphasizes that there are two very different types of NARM wastes. There are discrete sources of higher radioactive concentrations, such as radium needles used in medical practices, or radium-contaminated drinking water clean-up resins that have radioactivity characteristics similar to much of the byproduct low-level wastes. Second, there are lower activity diffuse sources such as
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residuals from mining and extraction industries and from bt.cning lignite coal.
The latter are produced on the order of hundreds of millions of tons oer year.
(See: "Low-Level and NARM Radioactive Wastes, Background Information Documents,"
EPA 520/1-87-012, August 1987.)
With regard to the diffuse sources of NARM, the following radium-226 concentra-tions have been measured in mineral eres: phosphate ores, from 3 to 50 picoeuries/
gram; titanium metal ores, from 12 to 15 picoeuries/ gram; zirconium ores, 13 pico-curies / gram, and alumina ores, 7.4 picoeuries/ gram. Depending on the processing technique used to extract the mineral, radium enhancement factors of perhaps 80 l may occur in going from ore to waste, resulting_in radium concentrations rang-ing from 100 to 2000 picocuries per gram. (See: "NORM in Mineral Processing,"
D. W. Hendricks, given at Conference of Radiation Control Program Directors Meeting of May 21, 1987.) .
Building ma' terials for homes and offices can contain potentially significant l concentrations of radium, including red-mud' brick (7.6 picoeuries/ gram), fly l ash (5.7 picoeuries/ gram), some tuff (6.5 picoeuries/ gram), some concrete (35 picoeuries/ gram) and phosphogypsum (17 picoeuries per gram). (See: "NORM: Is t it NORMAL or ABNORMAL 7", E.D. Bailey, Eighteenth Annual National Conference on l
Radiation Control, May 20, 1986.) _.
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For comparative purposes, %he EPA standards for remedial actions at inactive uranium processing sites call for cleaning up of the mi.11 tailings if the radium
, concentration is greater than 5 picoeuries/ gram within the top 15 centimeters of the surface, or if the radium concentration is greater than 15 picoeuries/
gram in any 15-centimeter layer below the surface. (See: 48 FR 592, January 5, 1983.) EPA has analyzed the wastes from 17 uranium mines to determine their radium concentration a1d found that 14 of the waste piles had at least one ~ '
sample measuring 20 p'coeuries radium per gram or more. (See: "Report to Congress: Wastes f r<,m the Extractions and Beneficiation of Metallic Ores, Phosphate Rock, Asbestos, Overburden from Uranium Mining, and Oil Shale,"
EPA /530-SW-85-033, December 1985, pp. 4-31.)
Some food oNducts concentrate naturally occurring radioisotopes. For example, Brazil Nts can contain up to 3 picoeuries radium per gram whereas legumes, .
leafy vegetables, fruits, and nuts can contain between 3 and 6 picoeuries potassium-40 per gram. (See: "CRC Handbook of Environmental Radiation,"
A. W. Klement, Jr. Ed. , CRC Press,1983.) Orinking water can also contain high ,
concentrations of radiiam-226, leaving some to ' state that "nature often violates !
Federal radiation standards." (See: Letters to the Editor, NYT, December 3, i 1987.)
- 8. Other naturally occurrino radioisotopes Exposures of t'he public to naturally occurring radon constitute 55 percent -
(200 millirem per year) of the average total dose the U.S.. population receives in a year. . Radon doses to the public are over twice that sf the combined man-made sources of radiation exposures through medical X-rays, nuclear medicine, and consumer products and may cause thousands of deaths each year. (See:
"Ionizing Radiation Exposure of the Population of the United States," NCRP Report No. 93, November 1987, and NYT, November 20, 1987.)
Polonium-210 is believed to' enter tobacco by ingrowth of lead-210 deoos4ted on tobacco leaves from the atmosonere. In addition, dietary habits that tend ,to favor broad-leaf vegetables or cther ' cods subject to surface depos4 tion c.ay influence the polonium-210 content of tissues. Of the two pathways, smoking [
is by far the more significant. However, it is very difficult to estimate the t effective dose equivalent resulting from tobacco use. One such estimate is 1 Z0 C lii em for the averige sxcher. (See: Envi-oscert:1 Racior:tivity, %d Edition, Merril Eisenbud, Academic press,1987, p. 148; and "lonizing Raciation
, Exp.osure of the Population of the United States," NCRP Report No. 93, November 1987.)
- l i And finally, for completeness, it is worth noti _ng that polonium-210 is used in p;roducts as a static eliminator. However, rather than separate polonium-210 as .
a naturally occurring radionuclide, the industrial sector obtains it through !
neutron irradiation of bismuth-210, thus making, possession and use of L polnium-210 subject to Atomic Energy Act provisions.
C. Accelerato.r-produced radioactive materials l
Some 40 cyclotrons have been installed in the United States. Generally, the machines bombard enriched stable isotopes with particles to produce over forty i different radioisotopes for the practice of medicine and for research and ,
development purposes. In addition, the I,os Alamos Heson Physics Facility and the Brookhaven Mational Laboratory produce important radionuclides for medical i
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applications, including berylliu -7, copper-67, strontium-82, and xenon-127.
(See: Letter from Kenneth B. Halliday, CTI Group, Knoxville, Tennessee to John Austin, VSNRC, dated November 10, 1987; Separated Isotopes: Vital Tools for Science and Medicine. National Academy Press, Washington, D.C.1982; and J. Nucl. Med. 28 [9] September 1987 pp. 1371-1382.)
Heavy fon accelerators are used in the industrial. sector as ion implanters, primarily to modify the properties of materials. The total number of these machines installed in semiconductor fabrication plants is nearly 3000. One of the potential hazards associated with these machines is exposure to ionizing radiation. Electrons are created by the interaction of positive ions with component parts of the implanter, which in turn produce x-rays upon decelerat-ing. Resulting dose rates can be 0.5 millirem per hour. We have not determined the extent to which these machines present a NARM waste stream. (See: "Design of Accelerators for Ion Implantation," 8. O. Pedersen, Nucl . Instr. and Methods in physics Res., B24/25, 1987, pp. 776-782; and "Radiation protection Considera-tions of Ion Implantation Systems," C. J. Maletskos and P.R. Hanley, IEEE Trans.
on Nucl. Sci., Vol. NS-30, No. 2, April 1983, pp. 1592-1596.)
Electron accelerators are used in radiation therapy. For those machines that operate above 10 million electron volts (Mev), neut ons can be produced through the electroproduction reaction, resulting in additional doses to patients and to operat.ing personnel from direct exposure both to neutrons and to'the result-ing residual radioactivity (i.e., NARM). (See: "Neutron Contamination from Medical Electron Accelerators," NCRP Report No. 79, November 1,1984.) .
Neutron generators fuse deuterium and tritium to yield a 14 Mev neutron and an alpha particle. The machines are useful for preparing short-lived radion0-clides only, through (n, p), (n, 2n) and (n, He) reactions. Over 50 radionu-
- clides can be produced this way with the more important medically useful radionuclides being fluorine-18, bromine-80, and mercury-199m. The costs of.
the generators are comparable to the costs of cyclotrons. (See: "Radionuclides production," Vol. II, F. Helus, Ed. CRC press,1983, pp. }53-160.)
Neutron generator machines are also used for neutron therapeutic treatment of cancer. Although there are probably no more than about 25 such active facil-ities, there is one estimate that as many as one-third of the yearly concer
! deaths in this country could 'be helped by neutron therapy. The neutron genera-
! tors have also been used for years for neutron activation analysis, using the conventional Cockcroft-Walton accelerators. In addition, accelerator well-
, logging devices, employing the T(d n)He reaction, are used for activation anal-1 ysis of boreholes, to give indications of the type of formations. (See:
"Industrial and Medical Applications of Accelerators with Energies Less Than
! 20 Mev," J.L. Duggan, IEEE Trans. Nucl . Sci . , Vol . NS-30, No. 4, August 1983, pp. 3039-3043.)
One significant source of cyclotron or accelerator produced radioisotopes is the Department of Energy (DOE), which compiles annually, its production and l distribution activities. (See, for example, "List of DOE Radioisotope Customers with Summary of Radioisotope Shipments, FY 1985, 0.A. Baker, PNL-l 5948, August 1986.) A comparison of 00E FY 1985 customers in non-Agreement States with NRC Headquarters and regional files on licensees revealed that all recipients of DOE radioisotopes, whether Atomic Energy Act materials or NARM,
! were holders of NRC byproduct Itcenses.
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Foreign countries export radioisotopes to this country, with Canada, Belgium, and Switzerland being the major exporters. Although Switzerland generates accelerator / cyclotron radioisotopes, it only exports them to neighboring countries, because of the short half-lives of the isotopes. (See: Letter from Hans Peter Hertiz, Embassy of Switzerland to John H. Austin, USNRC, dated November 19,1987.) Canada does export radium in very small quantities to the U.S. for use in instrument calibration, but information on the quantities is not readily available. We have been unable to determine the extent to which Canada exports cyclotron produced radioisotopes. However, the Atomic Energy Control Board of Canada has issued licenses to authorize exports to the U.S.
of cobalt-57, gallium-65, indium-111, iodine-123, and thallium-201. (See:
Letters from T.O. McGee, Canadian Embassy, to John H. Austin, USNRC, dated December 14 and 29, 1987.) Likewise, we have been unable to determine whether Belgium exports NARM to the U.S., but its situation is probably the same as Switzerland's.
Radioisotopes, both Atomic Energy Act materials and NARM materials, are used extensively in the medical field to diagnose ailments and to treat cancers.
New and emerging uses of radioisotopes include modalities, such as positron emission tomography (PET) and monoclonal antibodies. (See, e.g., Nuclear Medicine Technology and Technioues, D.R. Bernier, et al. Eds., C.V. Mosky Company, St. t.ouis, 1981; "Radiation Protection and New Medical Diagnostic Approaches," NCRP Proceedings No. 4, April 6-7,1982; and CRC Handbook of Radiobiology, X.N. Prasad, Ed., CRC Press, 1984; "Scientific Highlights.:
' Slices of Life,'" H.N. Wagner, J. Nucl. Med. 28 [8], August 1987, pp 1235- .
1245 and "Diagnosis and Treatment of Metastatic Tumors with Radiolabelled Monoclonal Antibodies: Experience with Lymphoma, Melanoma, and Colon Cancers,"
$. M. Larson, Nat'l Inst, of Health, Bethesda, Md., Eugene P. Pendergrass New Horizons Lefeture,1986.)
PET involves the injection of a beam of charged particles from a cyclotron into a "black box" containing the stable target which in turn becomes the activated chemical for quick injection into the patient who is being diagnoseo for a
'madical oroblem. The "black box" amounts to a het enemistry labo atery. TFe antire system is rather complex and must work together accurately to be success-ful. FDA now has under consideration the issue of whether che system is a medical device (and subject to the provisions of the Medical Device Amendments Act) or a dru; (and subje:t to the previsiens c' tbc cure Fcoc a9d Orug: A:t, as amended) or neither. (See: "Transcript of Radiopharmaceutical Drugs Advisory Com.mittee," FDA, public meeting on November 16, 1987.)
Should NRC regulate this aspect of NARM, it may be that the entire system (the cyclotron, the "black box" and the patient) wou]d have to be regulated, because the success of the PET diagnostic procedure depends on the entire system work-ing together successfully. Worth noting is the fact that the radiolabelled chemicals are, produced, used and generally decay away at the site, raising the 4
question of whether interstate commerce is involved in this modality.
O. Trends -
The trends and use of nuclear medicine in the United States have been surveyed 4 for the years 1972-1982. The results indicate that, while the nuclear medicinc procedures changed markedly in type over the decade, the overall frequency of examination doubled to 32 per thousand population. The growth was a esult of a markedly increased frequency of, for example, bone, livers lung, and 9
cardiovascular imagery. Such a. trend m'ay portend increased use of NARM.
(See: . "Trends and Utilization of Nuclear Medicine in the United States,"
F.A. Mettler, et al., J. Nucl. Med. 26[2].1985,pp.201-205.)
E. Discussion As evident _from the above, sources and uses of NARM are ubiquitous. NARM is in the environment (and of interest to EPA); in the homes (and of interest to EPA and the Department of Housing and Urban Development); in consumer products (and of possible interest to the Consumer Product Safety Commission), in industrial applications (and of interest to the Department of Health and Human Services and the Department of Labor); and in medical departments (and of interest to the Department of Health and Human Services). The Departments of Agriculture, Commerce, Energy, the Interior, State and Transportation and the U.S. Postal Service and the Interstate Commerce Commission also have possible or actual interests in exposures to or commerce in NARM.
, The quantities and concentrations of NARM form a continuum in the human world, and thus the potential hazards of NARM form a continuum ranging from background j . to potentially significant ones, in all facets of life. Thus, to the extent that there is a' need for centralized controls over those hazards, there is a j need for an integrated control program to ensure that the dominant hazards are .
appropriately addressed without undue attention to the lesser hazards.
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IV. PROBLEMS AND INCIDENTS WITH NARM A. Radium and Radon Incidents involving radium have occurred since the earliest days of radium use, including losses, thefts, contamination from ruptured sources and over- ,
exposures of individuals. The total number and severity of such occur-
, rences cannot be determined, since the Federal government has never had the authority to control radium possession and use and there is no govern-mental requirement to report radium incidents.
The potential acute hazard associated with radium sources is well known.
A milligram (millicurie) of radium can expose a person in close proximity to about 100 millirems in an hour. The sources in therapeutic medical .
applications range from 1 to 50 milligrams, with concomitant exposures of 100 to 5,000 millirems per hour. Industrial sources may be as large as several hundred milligrams.
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From 1963 through about 1968, the Buretu of Radio 1ogical Health (BRH) of ,
the Publlc Health Service collected, analyzed, and disseminated radium l incident information for the purposes of determining the extent and causes of radium incidents and to devise preventive measures. BRH also assini- !
lated reports of earlier incidents, as reported in the literature, for example, The New York Times. All together, BRH collected information on 415 incidents which took place since 1905. BRH f~ound that.the apparent rate of occurrence of radium incidents increased almost continuously up -
to the early 1960's and then stabilized at about twenty to thirty reports .
annually. Sixty-five percent of the reported radium incidents involved losses of the source, with virtually all of them occurring at medical facilities. Of those sources eventually recovered, over half were found l in the conventional trash system, ge'nerally ,at the municipal disposal site or sanitary landfill. (See: "A Review of Radium Incidents in the United
- States of America," J.C Villfortn et al., IAEA-SM-119/26, 1969, p;: 389-398.)
l No single organization or agency has comoiled radium incidents since ,
i around 1969. In 1975, the Conference of Radiation Control Program Directors l l
(MD or ;5e 'Werence) ette'ishad Task ?)rct No. 7, Natural Radio- !
activity Contaminated Problems, to, among other reasons, define the cur-rer.tly known or suspected sources of materials containing possibly hazardous ;
! amounts of naturally occurring radioactive materials (NORM) and to recom- k l mend priorities for control programs to address such problems. Its last ,
I report was printed in 1981, and listed an extensive array of radiation l pithways from incidental NORM use. In that report, the Conference recom- [
- mended soil contamination guicelines for cleanup or control of selected ,
radionuclides. The concentration above which removal or controls would be l mandatory for radium-226 bearing residuals was 6 picoeuries per gram. !
! (See: "Natural Radioactivity Contamination Problems, Report No. 2,"
i Conference of Radiation Contro.1 Program Directors, August, 1981.)
The 1977 NRC Task Force that examined the regulation of NARM summarized ,
NARM incidents in the following manner: l i
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The available information indicates that radium is the NARM isotope which is most often identified in reports of incidents. However, the available information is incomplete. Present available information does not permit an overall assessment of the possible or actual impact or threat to the public health and safety. It is known that available data represents an under-reporting but the degree is unknown. (See: "Regula-tion of Naturally Occurring.and Accelerator-Produced Radioactive Materials," D.A. Nussbaumer, et al., NUREG-0301, July 1977.)
That Task Force report was updated in 1984, wherein the authors stated that since 1977, "...there continue to be numerous NARM incidents. The number of incidents reported to State agencies involving NARM (both medical and industrial users) range from 30 to 50 per year." That update also noted that'in 1981, numerous radioactive contaminated gold items were discovered in the northeast, apparently from inadvertently recycling gold seeds con taining radon-222 used in radiation therapy. (See: "Regulation of .-
. Naturally Occurring and Accelerator-Produced Radioactive Materials: An Update, " L. A. ' Bolling et al . , NUREG-0976, October 1984.)
NARM is inadvertently introduced into commerce in other ways. Fo r. ex amp 1'e , ,
in November 1984, a radiation alarm was triggered as a truckload of scrap' steel was entering a processor's facility in Pennsylvania. The source of r&diation was later identifie'd 'as a static eliminator bar that contained radium-226. (See: Letter to H. Cutler, Institute of Scrap Iron and Steel, from V. Miller, USNRC, dated August 12,1987.)
'In a more recent event in September 1987, samples of contaminated aluminum dross were found to contain radium-226, producing radiation levels at the surface of the rail cars containing the dross of 0.4 to 0.5 millirem oer hour. The dross material in the two box cars was later found to contain 2000 picoeuries racium-226 per gram. (See: Letter to Jerry Snyd2r, United Technology, from Jack A. Hind, USNRC, dated Septemoer 24, 1987.)
The primary national interest in radon is currently focused on indoor radon expcsures in :crtair strtarn are:s of the United States, s :5 as Pennsylvania and New Jersey, where radon lavels in houses are found to exceed levels used by the Federal Government to clean uo misused uranium mill tailings. As previously mentioned, inhalation of naturally occurring radon results in a significant contribution to the average radiation dose to the population of the United States. The hazard is so great that the Gommittee on Interagency Radiation Research and Policy Coordination, (CIRRPC) has selected radon as one of the major national ionizing-radiation issues and is urging an accelerated research pecgram as well as a national indoor radon survey. (See: "CIRRPC Third Annual Report," Of fice of Science and Technology Policy, Executive Office of the President, June 30, 1987.)
B. NARM in general ,
On October 22, 1987 the Conference requested all State radiation control programs to describe, by November 31, 1987, NARM incidents during the past five years. As of December 7 nine Agreement States, eight non-Agreement 12 .
States and one territory have responded, listing a total of about 91 NARM incidents. Thirteen States and one territory reported between one and .
four incidents over the five year period (for a total of 21 incidents) whereas the remaining four States reported a total of 70 incidents. The incidents range from false alarms (e.g. after investigation, no actual involvement of radioactive material was found), to lost sources, to radium sources appearing from "out of nowhere," to actual exposures and contami-nation problems. However, for most of the incidents, any exposures or contamination problems were not reported. The dominant radioisotope iden-tified in the incidents was radium. There were five significant occurrences of radium-contaminated facilities, requiring State intervention and involv-ing radium as a luminous paint. Three States reported 26 incidents of
- lost cobalt-57 sources almost always in the microcurie range, whereas a few other States reported an occasional loss. The one State with the most of these incidents (twelve) deemed the quantities so small that they did not pr.esent an environmental or public health hazard. One State reported substantial activation of concrete wall materials through use of an accelerator such that the facility could not be cleared as an uncontrolled area, and of activation of accelerator parts such as targets, turning mag-nets, and others. One State emphasized a problem with NARM in the oil and gas industries. .The pipes used in production wells accumulate deposits (scales) that must be periodically removed. The scales trap radium, thus making the deposits a source of highly contaminated waste. That State, recognizing that other States have the same experience, and recognizing that the scales are similar'to byprod.uct wastes, believes that there is a national issue here, which needs to be addressed by Congress and the Federal government. (The references for tMs paragraph are letters and enclosures from Charles M. Hardin, Executive Secretary of CRCPD to John H.-
Austin, USNRC, dated November 25, and with two on December 7, 1987.)
The United States Pharmacopeia.(USP) has since 1820 established national standards of. strength,' quality, and purity of medicinal products, and its expertise has ceen recognized in Congressional legislation since as early as 1848. More recently, the Medical Device.Amencrents of 1976 *eccgni:ed the articles of USP concerning mecical devices. Since 1980, USP has operated for the FDA the voluntary Problem Reporting Program for radiation therapy devices. From January 1, 1980 to June 1987, USP received a total o' 28 reports on preblems W th bra:bytharapy dav 4es, with five of trem apparently housing or intenced to house radium, and the rest involving cyproduct material. (It should be noted that the actual problems with the dev' ices did not necessarily involve the radioactive material.) In the same time-frame, there were 88 problems reported on cobalt-60 teletherapy units and 113 problems with linear accelerators. (See: "Problem Reporting Program for Radiation Therapy Devices, Summary'of Reports Received,"
National Center for Oovices and Radiological Health, FDA.)
Misadministrations to patients of cyclotron produced radioactive materials are not required to be reported to the NRC. However, if a patient is supposed.to receive cyclotron produced material, but actually receives byproduct mate, rial, then the licensee is required to report the misadven-ture to the NRC as a misadministration of byproduct material. (See:
45 FR 31704, May 14, 1980.) Such reports give an indication, albeit incomplete, of the degree of problems in handling cyclotron-oroduced mate-rials. Over the period January 1981 through December 1986, NRC received 13 .
s
2298 reports of misadministrations of diagnostic radioisotopes, generally from licensees in non-Agreement States. (Agreement States did not require, until recently, reporting of misadministrations.) Of these, there was one report involving cobalt-57, 14 reports on gallium-67, 12 on iodine-123, none on xenon-127, and 14 involving thallium-201. These five isotopes represent the bulk of the use of accelerator produced radioisotopes. For all of these cases, the patients were prescribed the indicated accelerator-produced radioisotope, but actually received a byproduct isotope, usually technetium-99m or another iodine isotope. Thus the apparent rate of mis-administration reports involving NARM is about one percent of the total number of reports. (See: Memorandum from Samuel Pettijohn to John H.
Austin, dated December 22,1987.) .
Misadministrations of byproduct radioisotopes in medical diagnostic procedures are estimated to occur at a rate of about one in 10,000 proce-dures. (See: "NRC Reports on Misadministrations and Unannounced Safety Inspections," N. L. McElroy, J. Nucl . Hed. E, July 1986, pp.1102-1107.)
To the extent that the above five radioisotopes reflect the set of appli-cations of cyclotron produced radioisotopes, it appears.that misadministra-tions of NARM in diagnostic procedures occur at a rate of about one in one million procedures. Noteworthy is that the NRC definition of misadministration does not necessarily mean any adverse reaction withi.n the patient.
The Society of Nuclear Medicine (SNM) and the FDA monitor adyerse reac-tions to radiopharmaceuticals, with the FDA also monitoring conventional pharmaceuticals. Over,the nine-year period encompassing 1976 tnrough 1984, SNM received 356 adverse reaction reports. Of these, about 70 percent involved technetium-99m labelled compounds and about five percent involved iodine-131, both being byproduct radioisotopes. Gallium-67, indium-111 and thallium-201 (all cyclotron produced isotopes) labelled radiophar-maceuticals, each accounted for about another five percent of the reported adverse reactions. (See: Essentials of Nuclear Medicine Science, William B. Hladik, Williams & Wilkins Co. 1986, pp. 310-311.)
Over the period of 1979 through 1987, FDA received tnrougn its Spontaneous Reporting System, 1239 reports, from domestic sources, of adverse reac-tions, asm.;iated with patient exposures to radiopharmaceuticals. (Adverse react Mas are essentially any adverse event a patient experiences in -
association with using an FDA-approved pharmaceutical or biologic product.)
Of these, 746 were reports of "no drug ef fect," presumably related to lack of imaging. Fifty-two of the reports were classified as serious. That is, the patient outcome was death, permanent disability, inpatient care (or prolonged hospitalization if the individuaLwas hospitalized when the reaction occurred); a report of cancer or a congenital ancmaly; or an adverse reaction occurring after a drug overdose. These 52-included 17 deaths over the nine year period with all of them apparently associated with radiopharmaceuticals tagged with technetium-99m. Of the remaining 35 reports of serious adverse reactions, one of them involved gallium-67 and two involved indium-111 as the radionuclides in the drugs. It is impor-tant to understand that although a serious adverse reaction report may be prepared in association with the use of a drug, that report does not neces-sarily imply causality. (See: Letter fro'm Janet B. Arrowsmith, M.D., FDA to John H. Austin, USNRC, dated December, 15, 1987.)
14
The Conference points out additional proble:s with NARM:
Non-uniform regulation of NARM sources and devices has caused considerable problems for Agreement States in their issuance of specific licenses for the use of such sources and/or devices when manufactured in a non-Agreement State. Since most non-Agreement States do not license the manufacture of such sources and devices, there is no mechanism to reciprocally recognize the manufacture of such. Consequently, the Agreement States for NARM sources and devices, must either
- license each and every source and/or device, or issue a license on the good faith that the manufac-turer will apply acceptable quality control in the .
manufacture of all sources and devices on the production line. (See: Attachment to letter from Charles M. Harcin Executive Secretary, CRCp0, to John H. Austin, dated November 25,1987.)
Informal contacts with manufacturers of radiopharmaceuticals '
containing cyci'otron produced radioisotopes indicate similar difficulties in marketing such materials in a non-uniform regulatory environment.
C. D'iscussion. .
The above collection of incidents and probless involving NARM does not -
always reflect a consistent and significant actual hazard associated with NARM. To be sure, there have been real problems with contamination of facilities, with the loss of the materials, and with the inadvertant
. introduction of radium into commerce,. but significant exposures of the public to discrete sources of radium rarely occur, based on available data. Some do involve interstate commerce. However, the information supplied to the CRCp0 in its survey of late !?S7 suggests that actual inaove ment exposures of peocle to radium or contamination problems are very infrequent events.
The real and known problem with NARM is the disposal of discrete radium sources.
Radium is net suitable f:r dinosal 19 sa.citary landfills, te:sase of itt .'s:ar:ws properties, some of which are similar to pli tonium. Radium is an alpna and gamma emitter, has a higher specific activity than plutonium, has a 1600 year half-life, is soluble, is a bone seeker, and has a radioactive daughter that is a gas. EPA has reported that a survey of the States by the Conference indicates that State regulatory agencies know of at least. 400 radium sources requiring disposal, whereas a preliminary survey for 00E shows over 500 high-activity commercial sources requiring disposal. (See: "Low-Level and NARM Radioactive Wastes, Background Information Document," EPA 520/1-87-012, August 1987, pp.
3-34.)
The Barnwell low-level waste site will not accept radium. The Hanford facility will.only accept discrete radium sources that are packaged with a total activity of less than 100 nanocuries per gram, precluding disposal of many radium sources. The Beatty facility will accept radium only in specially constructed sealed containers. The cost for packaging can range up to $2000 for one radium needle ~. ( S'ee: Preliminary Draf t "Economic
. Impact Analysis of Proposed Standards for Disposal of Low-level Radioac.tive
. 15
Waste," Putman, Hayes & Bartlett, Inc., for the USEPA Contract No. 68 7033, May 11, 1987, pp. 6-21.)
The State of Michigan legislature is considering a bill that would make Michigan the host State for a low-level waste disposal facility for the Midwest Compact. One of the Bills passed by the Michigan Senate on October 8, 1987 would define low-level waste as given in 10 CFR 61.55 and explicitly excludes NARM wastes. However, that Bilt mandates a study of whether NARM should be included in the definition of low-level waste.
(See: A bill to amend Act No. 368 of the Public Acts of 1978, entitled as amended "Fublic Health Code," Substitute for Senate Bill No. 65, October 8,1987.) .
There is incomplete information on the hazards associated with cyclotron-produced radiopharmaceuticals. It appears that their misadministration rate is about one percent of total misadministrations. However, serious adverse reactions associated with the use of radiopharmaceuticals seem to be far more significant than the "misadministrations" of them.
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V. THE FEDERAL GOVERNMENT AND NARM As indicated above, numerous Federal agencies have possible or actual interests in or jurisdiction over NARM. A review of past Congressional actions on radia-tion protection matters in general, and on NARM in particular, is important to a fuller understanding of Federal regulatory activity in ionizing radiation.
It would also be useful in deciding whether and where any additional Federal authority over NARM might be vested. Such a review is the purpose of this section.
A. Pre-Atomic Energy Act As first recognized, ionizing radiation was in the form of X-rays and emanations from. radioactive materials, primarily radium. In the first few decades of the twentieth century, uses and applications of ionizing radia-tion sources were primarily in the hands of physicians or researchers.
When physiological effects of radiation began to manifest itself, in terms of eye injuries and erythema, the user community quickly set about to '
develop protection standards. By 1928, the privately funded national organization called the Advisory Committee on X-ray and Radium Protection had been formed'to establish national prouttion standards; that organiza-tion evolved into what is now called the National Council on Radiation Protection and Measurem9nts (NCRP). In that time-frame, there was little or no Federal invcivement in developing safeguards against ionizing radta-
, tion, not withs_tanding the known harms and deaths to workers in the field.
(See: Radiatio'n Protection Standards, L.S. Taylor, CRC press,1971.).
In a major study for the U.S. Senate in 1977, regarding the history of Federal regulation, the Regulatory Reform Study Group of the Committee on Governmental Affairs observed:
First, prot'ecting citizens from harm and injury constitutes a fundamental concern of government, a major premise for creation of an organized community bound by common rules. To "promote i the general welfare" is a preeminent purpose of the Federal government, ranked only after
, justice and sacarity in the preamble of the j Constitution.
l ' Yet the general welfare clause aside, there is l no express provision of the Constitution for
! Federal jurisdiction over health and safety. -
! . Rather it is an implied power, emanating from l specific or enumerated constitutional responsi-bilities. Once a subject falls within an ,
l enumerated power, the Federal ability to legt.s-late over that activity is complete and compre- .
hensive. For example, the Constitution in j express terms grants to Congress the power to regulate interstate commerce; and that neces-l sarily involves considerations of public wel-
! fare in commerce between the states. The compre- .
l hensive' potential of Federal health and safety '
l .
l .
17 i .
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regulation, pur'suant to that authority is suggested by the scope of the interstate commerce clause, as sketched by Mr. Chief Justice Marshall in 1824:
It is the power to regulate; that is, to prescribe the rule by which commerce is to be governec,.
This power, like all others vested in Congress, is complete in itself, may be exercised to its utmost extent, and acknowledges no limitations, othar than are prescribed in the Constitution.
Federal legislation to protect the worker, the consumer and the environment rests upon that t'irm constitutional basis. (Footnotes removed.)
Congress was slow to exercise its power in health ,
and safety matters. "Vertical regulation" character-ized much of that legislation; that is, regulatory action directed at a specific hazard, or a certain occupation, or a particular concern--all too often '
with little consideration of the overall s.ituation'. I Comprehensive Federal regulation of a "horizontal" '
nature--that' is, regulacion directed across-the-board !
at the variety of hazards or industries--is largely a l development of tiv past 15 years or so. previously . :
i the power was not necessarily denied; rather, the potential went only partially realized. (See: Study of Federal Regulation, Vol.,V, Committee on Govern-mental Affairs, United States Senate, December, 1977, pp. 308, 309.)
f Thus, before the Atomic Energy Act, Congress left to the States anc orivate organizations development of *aciatfor o-ote:tien standards for wbekers, consumers, the public and the environment.
A notable exception to this came in 1936, when the attehtion of the trans-
- pertatien authorities was fer:afully.d a.vn to the ft:t th:t ra:ict.:tivs i
substances and undeveloped photographic films were incompatible if shipped together. This lead te the first Federal dictates, through the Postmaster Gen'eral, over ionizing raatation: .
Radium, thorium or any other radiosctive substance or any materials containing radioactive sLtstance
I containing radium emanation, radium salts, radioactive minerals, or any radioactive material whatever, not permitted,in the mails. (See: "Physical, Biological, e L
and Administrative problems Associated with the Transportation of Radioactive Substances," R.O. Evans, !
National Academy of Sciences, Washington. 0.C. 1951.) ;
Thus, the first Federal excursion into the field of ionizing radiation came from economic considerations.
18 t
The Manhattan Project lead to shipments of increasing amounts of radioactive ,
materials and the need to protect transport workers. Shipping packages '
relied on massive lead shielding for radiation protection during shipments of radioisotopes from Oak Ridge to hospitals and universities. With a recognition of the need to minimize cargo weight and space without compro - ,
mising safety and under instructions from Congress in 1946, the Interstate Commerce Commission developed regulations governing transport of radioactive substances that took into account both safety of transport workers and economics. (See: "The Regulatory and Institutional Outlook on Meeting the r Challenge of the Future," J.G. Davis, Seventh Int'l. Sym. on Packaging snd Transportation of Radioactive Materials, May 15-20, 1983, p. 22.) i i
- 8. The Atomic Energy Act of 1946, as Amended through 1959. "
~ '
l The nuclear enterprise is unique in U S. history on two accounti. First, i the technology was created, owned, ana monopolized by the Federa: Government in the national security arena. Second, the Congress recognized from the beginning that this technology was inherently dangerous and required care-fully monitored development. Unlike other sectors of private anterprise
, where the Government awaits problems to develop before stepping in, the l Congress mandated that the nuclear industry would be regulated from the out-l set. (See: Controlling the Atom: The Beginnings of Nuclear Regulation -
, 1946-1962, George T. Mazuzan and J. Samuel Walker; University of i
- California Press, 1984.)
i In creating the Atomic Energy Commission (AEC) in 1946 through the Atomic ;
. Energy Act (AEA) and in encouraging widespread private development and use l of nuclear technology through amendments ta the AEA in 1954, the Congress !
mandated a very narrow framework of Federal regulation, f.e. directed to i fissionable materials, to source materials from which fissionable materials ~
j could be obtained, and to radioactive material yielded in, or made, radio-active by exposure to the fission process. At the same time, Congress directed that such regulation would be very deep, i.e., possession, use, owning, acquiring, delivering, or transfer. ing such materials would be regulated. This was in contrast to many other regulatory mandates tnat are ,
very broad (i.e. directed across-the-board at a particular hazard, such as l FDA regulating devices emitting ionizing radiation), but are shallow (i.e., <
! directed to the regulation of the manufacturer, but not the user). l 3
Naturally occurring radioactive materials (other than source materials) such as hadium were deliberately left outside the reach of the AEA. Also excluded !
- were the materials thit were fissionable, but could not sustain a chain !
, reaction (e.g., actinium-227). Any health and safety problems that might be !
posed by the radioactive materials the AEA did itot address were considered I
, manageable and relatively insignificant. There appeared to be nu urgent need ,
i - and, from the standpoint of the common defense and national security, no basis ;
a for Federal regulation of NA.RM. (See: "Regulati*on of Naturally Occurring and !
) Accelerator-Produced Radioactive Materials," 0. A. .;ussbaumer, et al., NUREG-0301, !
- July 1977; and "Anomalies of Nuclear Criticality," E.O. Clayt'on, PNL-$A-4868, I Rev. 5 June 1,979, p. 89.) {
i
into agreements with the Goverror of any State under which the Commission i i
would relinquish, and the State would assume, regulatory authority over :
! byproduct and source materials and special nuc1har material in small !
! quantities. (Set: P.L.86-373.) f
)
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In doing so, Congress stated:
First, the bill has been redrafted by the Joint Com.af ttee to make it clear that it does not attempt to regulate materials which the AEC does not now regulate under the Atomic Energy Act of 1954. Such other sources such as X-ray ma,.hines and radium also present substantial radia-tion hazards, but have been for many years the responsi-bilit) of the States, the Public Health Service, or other agencies. (See: Senate Report No. 870, September 1, 1959.)
C. Federal Radiation Cout 11, 1959-1961 Througl Public Law 86-373. a Federal Radiation Council was formed in 1959 to provide a Federal h,, cy on human radiation exposure. A major function of the Council was to "... advise the President with respect to radiation matters, directly or indirectly affecting health, including guidance for all Federal agencies in the formulation of radiation standtrds and in the establishment and execution of programs of cooperation with States...." The President approved and caused to be published in the Federal Register on May 18, 1960 the Council's first recommendation *. for the guidance of Federal agencies in the conduct of their radiatico protec-tion activities. Those guides, while significant in their time, were incomplete. They did not apply to radiat',a exposure resulting from natural background or purposeful exposure of p.atients by practitioners of the healing arts. The Council set as a guide for the individual in the popula-
. tion, an annual whole body dose of 500 mfilirems although recognizing that "there can .a no single permissible or acceptable level of exposure without regard to the r6ason for permitting the exposure." Those guides were -
advisory and the Counc*l left it to the individual agencies as to how and whether they would implement them. Each agency w allowed to, decide its -
own policy on Federal versus State responsibility for protecting the public from exposures to ionizing radiation. (See: F,R Ny 18,1960, p. 4402-3. )
In the Council's second report, it made recommendations for the guidance of Federal agencies in activities designed to limit exposures of the public from radioactive materials deposit'ed in the body as a result of their occurrence in the environment. Among the radionuclides, for wnich graded scales of actions were recommended, was radium-226.' Again, it was left to each agency to decide how or whether to implement the guidance, and there was no guidance on Federal versus State roles. (See: FR September 26, 19E.)
O. The Radiation Control for Health and Safety Act of 1968 In 1968. Congress declared that the public health and safety required pro-tection from the dangers of electronic product radiation through passage of the Radiation Control for Health and Safety Act. Among other things, -
that Act directed the Secretary of the Department of Health, Education, and Welfare (HEW) to conduct a "study of present State and Feceral control of health hazards from electrenic product radiation and other types of ionizing radiation, which study shall include, but not be limited to (a) control of health hazards from radioactive materials other than materials regulated under the Atomic Energy Act of,1954; (b) any gaps and inconsis-l tencies in pn .ent controls; ... (d) measures to assure consistent and 20 L _ _-
effective control of the aforementioned health hazards." (See: Sec. 357 of ,
P.L.90-602.)
The legislative history indicates that Congress believed that such a !
program on reducing unnecessary exposures to ionizing radiation could :
"best be ei'fectuated through the Department of Health, Education and Welfare - the Federal agency with primary responsibility for the protection of the public health." (See: Senate Report No. 1432, July 17, 1968 f That HEW study of the health hazards of NARM was sent to Congress' in 1971.
HEW concluded:
Responsibility fo'r the control of all non-Federal use of radium and accelerator-produced radionuclides resides in the States. While some States have adequatgly met these responsibilities, many haya not developed and enforced effective control programs. Not only have there been
. ineffective controls at' the State level, but there n.ay also be ineffe.ctive control at the Federal level, since no single Federal agency has been charged with the responsibility for developing uniform effective controls over all Federal us:: of the materials. (See: "State and Federal Control of Health Hazards from Radioactive Materials other than Materials Regulated under the Atomic Energy Act of 1954."' G.L. Pettigrew, et al . , FDA 72-8001, 1971, p. 63.). ,
The assessment lead to a HEW staff legislative proposal for a Radioactive Materials Control Act that addressed all sources of radioactive materials not covered by the Atomic Energy Act. The proposal was forwarded to the HEW Office of the Assistant Secretary for legislation, but no further action was taken. '(See: "Activitfiri and Accomplishments of the Bureau of Radiological Health in Contrelling Radioactivity in Consumer Products,"
D. Paras and A.C. Tacert, in NUREG/CP-0001,197S, e. 55. )
E, The Consumer Product Safety Act of 1972 Th n;5 Dublic Law 92-573, cf 1872, Cor:;ress co.,s:'idttet tr.e :or su. er health and safety mandates at the Federal level within the newly created Consumer Product Safety Commission (CPSC). In 1973, FDA's Product Safety Bureau and its functions under the Hazardous Substances Act were trans-ferred to the CPSC. .Since radium is a naturally occurring radioactive traterial not subject to regulation under the AEA, CPSC acquired jurisdic-t' ion over radium in consumer products. In July 1973, the FDA's Bures.u of Radiological Health formaily suomitted a request for action to the CPSC to regulate radium in consumer products. Althoogh acknowledging juri.scL. tion, the CPSC voted in May 1975 to deny the request for such regulation on the grounds that the "marginal nature of the hazard posed to consumers" made the action "unwarranted." The Bureau persisted and expressed disappohtment at the CPSC decision, noting that in 1975 there were an estinated one f million clocks and some 350,000 smoke detectors containing radium ir m s.
CPSC staff apparently reviewed thw mattet', but again concluded that %
"level of risk does not merit a scparate commission action on the rth-active hazards alone" in .these consurrer products. (See: Study on Fr.deral .
21
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Regulation, Vol. V," Committee on Goverament A'ffairs, U.S. denate, Dece eer 1977, p. 335.) 1 F. The National Institute for Occupational Safety and Health Study of 1976 Under Public Law 91-596, the Occupational Safety and Health Act of 1970, the Occupational Safety and Health Administration (OSHA) has responsibility for user compliance with radiation standards for sources not regulatcd by the AEC/NRC. Inspection of facilities containing such sources (e.g.,
radium and accelerators) was not a high priority. In 1976, the National Institute for Occupational Safety and Health (NIOSH) of HEW commissirM a study of the potential hazards of these sources to radiation workers. .ne data for that evaluation were ot,tained from the records of five Agreement States, five non-Agreement States, and the files of a commercial dosimetry service. That study concluded:
This study did not uncover any extraordin.ry occupational hazards from the use of industrial x-ray machines, acceler-ators, or radium sources. Most of the States surveyed appear to be controlling these sources, with no significant differences noted between NRC Agreement and non-Agreement .
States. In comparing the data collected from this study with NRC data, the effectiveness of the State programs in regulating these sources appears comparable to that of the NRC in regulating radioactive materials. . (See: "Evaluation of Occupational Hazards from Industrial Radiatica: A Survey of Selected States," 5.C. Cohen, et. al. HEV contract No. 210-75-0071, December,1976.)
G. The 1977 NRC Task Force Review
- 1) Initial Review Following an Octdber.1974 meeting; the /.greement States deve' coed several requests and recommendations for NRC (then AEC) action, including: s
. The Str as -a:c- ed that tha AEC, :r its :ue:25: agen:y, move immediately td bring accelerator produced and naturally occurring radioactive material under its
. jurisdiction.
Cn May 8, 1975, the Executive Committea of_ CRCPO met with the
, Ccmmissioners. One of the points discussed at the meeting"was later summari:ed by the Conference in a letter to then-Commissioner Richsrd T. Kennedy: .
There is concern on the part of several States regarding the need for Federal control of radio-active material not being regulatad by Agreement States or the NRC. Most Agreement States have included naturally occurring '.nd accelerator-produced radioactive material. under the same regulat_ory control as' materials coming under 22
J
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o the Atomic Energy Act when 'these agreements were signed. However, since there are 25 .j non-Agreement States, there is a definite gap l
, existing in the proper control of these ;
1 non-Agreement materials. Therefore, we strongly -
j urge the NRC to consider taking appropriate actions to place this type material under the same control as is now applied to materials falling under the Atomic Energy Act. ,
i In response, the NRC establithed a task force composed of representa- ;
I -ttves from all relevant offices to review the satter of regulation of i NARM. Resource persons representing Agreeme'.. and non-Agreement ,
States and Federal ager.cies also participated. Among the Task Force conclusions are: -
The regulation of naturally occurring and accelerator-produced radioactive triatorial (NARM) is fragmented, l
. non uniform and incomplete at both the Federal and State '
level. Yet, these radioactive materials are widely ;
used -- excluding thos@ who would be exempt from lican- .
6 sing, about 30 percent of all users of radioactive . !
materials use NARM. There are an estimated 6,000. . .
}
users of NARM at present. The use of accelerator- .
~
produced radiois'otopes, particularly in medicine,
- is growing rapidiy. .
j Because of the fragmented and non-unifo'rm controls ;
over radium and other NARM, information'on the !
impact of the use of NARM on public' health and !
safety is fragmentary. Thus, it is difficult to j know in an overall sense, whether oroper orotec- i tion is being proviced to workers and the public. ;
A nt.mear of the incidents involving NARM and othea data. however, wnich have come to the attention ;
of public health authorities give definite indi- l cations of unnecessary and possibly excessive !
rad'atten expcsure cf werhars anc.the pielic. !
The Task Force had one major reccmmendation: l I
The Task Force recommends that the NRC seek :
legislative authority to regulate naturally i occurring and accelerator produced radioactive l materials for the reason that these materials ;
present significant radiation exposure potential [
and present controls are fragmentary and l non uniform at both the State and Federal level. !
(The reference for this section is "Regulation of Naturally l Occurring and Accelerator-preauced Radioactive Materials," j D.A. Nussbaumer at al., NUREG-0301, July 1977.) ,
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- 2) Response to the 1977 Review l
The Commission approved publication of the Task Force report for public comment. The report was given wide distribution. A total of 25 comments was received, with 21 of the respondents expressing varying !
degrees of support for the Task Force recommendation. These included all of the six States and five of the seven Federal agencies that commented. EPA commented that it had adequate existing authority to regulate HARM, thus opposing the recommendation. FDA's Bureau of Radio-logical Health commented:
As a long-range goal, it appears logical to include all radioactive material under the authority of one agency with the intent of having one national, uniformly applied program to control user radiation safety and to set performance standards for products and devices, regard- l less of the origin of the radioactive material. 1 The FDA comments went on to say that "The report fails to note, however, that when specific actions were proposed at the Federal level, it was not possible to show that the us~e of NARM represents sufficient hazard to the public to warrant action when compared to othe'r agency priorities."
Importantly, FDA stated that "...the FDA has authority to regulate medical radiation sources under the Medica! Device Amendments of 1976 (Public Law 94-295, 90 Stat 539-583) of the Federal Food, Orug, and Cosmetic Act. This authority would include medical radiation sources containing NARM." Final'ly, FDA suggested deferring action until the voluntary FOA-State effort to control NARM had been implemented and its effectiveness had been evaluated. ,
. Based on its analyses of the comments, tne staff receased its re:om-mendation to' draft a bill that would give NRC regulato*y jurisdictier over NARM. The Commission took no action on the staff recomendation (SECY-78-211), but asked the staff to resut,mit it for reconsideration after addressing questions about the magnitude of NARM overexposure the cem;,ati iiMy of t1e prt:::sc N3.C -e;ulatory auth:rd ty atth :the-agencies, and other issues. (The references for this section are SECY-78-211 and its en:losens, "Firal Recommendations of the Task Force on Regulation of NARM," April 14, 1978; and memorandum dated June 30, 1978 from Samuel J. Chilk to Lee V. Gossick, regarding the SECY paper.) -
- 3) Resolution of the 1977 Review The staff responded to the' Commission directive on December 18, 1978, in SECY-78-667, without a staff consensus on what actions should be taken. The Executive Director for Operations highlighted four major issues that needed to be considered:
- 1. what is the risk to the public health and safety (the available data appeared insufficient); -
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what ,is the scope and cost of regulatory control (the NARM boundaries were thought to be broader than that suggested by the Task Force and the resource requirements may be far in excess of the estimated seven full time equivalents);
- 3. whether there is a regulatory c'onflict with other i Jeral agencies; and .
- 4. what is NRC's role in radiation protection.
Responding in a May 10, 1979, letter to the EDO, the Commission directed the staff to forward the findings of the Task Force to interested parties with a letter indicating that:
...NRC believes that this source of ractation exposure should be uniformly regulated and should urge that the matter be addressed promptly. It should note that,.
while NRC could logically regulate NARM- given legisla-tive authority--NRC is not pursuing that authority because it believes that such efforts should be inte-grated into the larger effort to properly allocate Federal responsibilities for radiation protection.
Ultimately, the issue of whether the Federal Government should regulate
.NARM was referred to the U.S. kadiation Policy Council.- This will be -
elaborated on later. ,
H. The Interagency Task Force on the Health Effects of Ionizing Radiation - 1979 An Interagency Task Force on the Health Effects of Ionizing Radiation was established in 1978 to carry out a Presidential directive to formulate a national program to, among other objectives, recuce acverse radiation execsures. NRC was represented'en the Task Ferce. Tne Task Ferce issued its report in June 1979, observing that virtually everyone agreed that
"...the Federal government should enhance its institutional capacity to develop clear and consistent policies on radiation matters." It, too, found gt:s snd inc:asistanc'ss tr. the controls over 'cnizing radiat dor, ia.ci d r; NARM, and made a numoer of recommendations for recucing overall exposures to. ionizing radiation. Significantly, the Task :orce recom. Tended estab-lishing an Interagency Federal Radiation Council that would be assigned numerous functions, including consideration of basic issues of policy relating to radiation protection as well as an_ evaluation of the overall direction and ef fectiveness of Federal activities in this regard. (See:
"Report of the Interagency Task Force on the Health Effects of Ionizing Radiation," June 1979.) ,
I. The United States Radiation Policy Council from 1980 to 1982 The President!s response to the above report was to create, through Executive Order 12194, the United States Radiation Policy Council (RPC),
in 1980, for the purposes of coordinating the formulation and implementa-
. tion of Federal policies relating to rgiation protection. In that year,
. the RPC adopted as a preliminary agenda, nine broad policy issues that 25 .
\
would be examined in the 1981-83 period. Those issues included the roles and responsibilities of Federal agencies, radiation exposure reduction, and Federal / State relationships. The RPC noted a perplexing number of Federal agencies involved with ionizing radiation. This resulted in a maze of functions and responsibilities, within the Federal establishment, that appeared to fragment Federal radiation protection efforts, created 3
undue administrative difficulties for those being regulated, and bewildered the public. PRC also observed that States have a major responsibility in radiation protection. The role of the Federal Government vis-a-vis the States was to be examined in the policy issue on the Federal / State rela-tionship, particularly as it had a bearing on NARM. However, RPC did not complete this task before its demise in about 1982. (See: "Progress Report and Preliminary 1981-83 Agenda," United States Radiation Policy Council, RPC-80-001, September 1980.)
1 J. The Consumer-Patient Radiation Health and Safety Act of 1981 Through Public 1.aw 97-35, the Consumer-Patient Radiation Health and
- Safety Act of 1981, the Congress directed the Secretary of the Department of Human and Health Services (HHS) to promulgate standards for the accreditation of educational programs to train' personnel to perform radiologic procedures
, and for tne certification of such individuals. On July 12, 1983, HHS issued a Notice of Proposed Rulemaking (NPR) that would establish standards for five occupations: radiographers, dental hygienists, dental assistants, radiation therapy technologists, and nuclear medicine technologists. The "
NPR made no distinction between NARM and AEA materials. The standards are intended to assist those States that desire to regulate the education and j practice of radiologic personnel. HH! 7bserved that, "While the standards were developed by the Department, the Act praserves the traditional peroga-1 tives of States in the approval of education programs and in regulation of personnel." The rule was made final on December 11, 1985, essentially l as proposed. At the end of 1986, 16 States licensed'radiegraohers; 12 5tates licensed radiation therapy technologists; anc seven States licensed l nuc' ear medicine technologists. (See: Report te CMgrest, "Cc :liance by .
tne States with tne Censumer-Patient Radiation Health and Safety Act of 1981:
Annual Report for 1986," HHS, September 10, 1986.)
l' K. S-mittee ca ! rte-mn:y hd'stior Rasat :h 3-d P:l f:y *. : :i u t'c9 from 1984 i The RPC appeared unable to significantly improve Federal policy coordina-1 tion. In view of this continuing need, Senator John Glenn introduced i 1,egislation in 1982.that would create a Federar Council on Radiation Pro-tection. The Administration's position was that legislation was not necessary. In May 1984, the Adminfstration created the Committee on Interagertcy Radiation Research and Policy Coordination (CIRRPC) under the
- Of fice of Science and Technology Policy (OSTP) for the purposes of, among I other things, coordinating radiation matters between agencies, and advising j OSTP on issuet involving Federal radiation policy. ,
i 1 At the first meeting of CIRRPC on May 25, 1984, each of the then 15 member i agencies, including NRC, was requested to respond to a questionnaire for j identification of current issues of concern to each agency. The 34 specific issues identified were condensed into ten major national' issues dealing -
)
j 26
+ .
-._.---,..,,__-_....__n. . _ - _ _ - -. . . _ - - - , _ - . .
with ionizing radiation. NARM was not on the list, but radon was. (See:
"CIRRPC Report on Identification of. Federal. Radiation Issues," OSTP, March 1986.)
L. The low-Level Radioactive Waste Policy Amendments Act of 1985 NRC sought legislative authority over NARM wastes, in connection with Congressional action of what became the Low-Level Radioactive Waste Policy Amendments Act of 1985. In commenting on H.R. 1083, the Commission noted that neither Section 3(a) on State responsibilities nor 3(b) on Federal responsibilities specified responsibility for the disposal of NARM wastes.
The Commission went on to say that without clear statutory direction iden-tifying the responsibility for disposing of these wastes, neither NRC, the A;reement States, nor waste generators would be able to assure tha,t all NARM wastes would eventually be accepted for disposal. The Commission proposed conforming language for NARM disposal authority to no avail. (See: Letter from N.J. Palladino, Chairman, USNRC, to the Honorable Morris K. Udall, Chairman, Committee on Interior and Insular Affairs, U.S. House of Representatives, dated June 4, 1985.) -
In early versions of what became the Act, Congress debated a potential requirement of the Department of Energy to prepare a report on "orphan wastes." Such a report would have included a study of NARM. The NARM issue was specifically debated la.the Senate Subcommittee on Energy Research and Development, Committee on Energy and Natural Re, sources, with-out final resolution. The Act did not assign responsibilities for NARM wastes e'ither to the States or to the Federal government. The final language in the Act did not require any Federal agency to. study the NARM i s sue .' Although not explicit in the legislative history, it appears that the provision for a study of NARM vis-a-vis LLW was dropped because the j magnitude of the issue appeared almost unbounded. (See: "The low-Level Waste Handbook: A User's Guide to the Low-level Radioactive Waste Policy
, Amenc-ments Act of 1985," Holmes Brown, National Governor's Association, November, 1936, pp. 17-23; and letter frem Ja?es W. Vaugnan, Jr., DOE. to
- Charles M. Hardin, CRCPO, dated July 22, 1986.)
M. Advance Notice of Procosed Rulemaking - Definition of High-level Waste in 'w i
An' Advance Notice of Propesed Rulemaking (ANDR) was published for coraert.
announcini the Commission's intent to modify the definition of high-level radioactise waste. (See: 52 FR 5992-6001, February 27,1987.) The ANPR
- solicited public comment on the following question
When the Commission carries out its analyses to identify "other highly radioactive material that...' requires permanent l 1 solation," should NARM be included in the analysest I
l Some 21 commentators addressed this question.* Generally, the commentators favored inclusion of NARM in the analyses, with most observing tnat materials of like ha::ards should be disposed of in similar fashions.
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27
- 1 U.S. Environmental Protection Agency Activities. 1984-Present N. l In 1984, State representatins and others indicated to the EPA that the exclusion of NARM from EPA's low-level waste (LLW) standards was the most I serious deficiency in its program. They expressed to EPA concern that l l NARM wastes presented a radioactive waste disposal problem with a great l potential for harm, and without existing Federal direction or means of l ensuring consistent interstate control. Since then, EPA has been develop- '
ing a proposed rule that would include NARM in its LLW standard, under the authority vested in EPA through the Toxic Substances Control Act (TSCA) i of 1976. TSCA authorizes EPA to prohibit, restrict, or regulate the manu- ,
facture, processing, distribution in commerce, use or disposal of any '
substance that presents "an unreasonable risk of injury to health or the !
environment." (See: USEPA memorandum from F.L. Galpin to R.J. Guimond .
dated June 6, 1986, and 15 U.S.C. 2601 et seq.)
- The recent approach EPA'has been taking on the rulemaking is that the regulations would be limited to only higher activity, low-volume NARM wastes.
. Apparently there will be a concentration cutoff of about 2 nanocuries per gram. Wastes below this value would not be deemed LLW. The regulations
! would require the disposal of NARM. wastes (greater than two nanocuries per gram) in licensed LLW facilities in a manner similar to comparable AEA wastes. One major issue in this effort is how to enforce the standards.
An option under consideration is to include provision for the States to assume the inspection and enforcement functions of the, regulations. (See:
"Inclusion of NARM in the EPA LLW Standard,'" M.S. B:ndrowski et al.,
Presented at the Eighth Annual DOE LLW Management Forum, Denver, Colorado, .
September 22-26,1986.) However, another option under active consideration is to look to the NRC for inspecting and enforcing the NARM disposal regulations. Of course, we do not now have authority to do so.
- With regard to the lower limit.concentra' tion of 2000 picoeuries radium-226 I per gram, as the possible definition of LLW, EPA has establishec stancarcs j for protection against uranium mill tailings that call fer cleaning u
- of the mill tailings if tne radium concentration is greater than 4tve pico-
! curies per gram within the top 15 centimeters of the surface. (See:
48 F_R 592, January 5, 1983.)
1
, With regard to racon in dwellings, a science panel of CIRRPC, chaired by the Department of Labor, has issued a report "Radon Protection and Health
, Effects," which contains a number of recommendations. Among them are
! accelerating research on the health risks from indoor radon and performing a national indoor radon survey. (See: CIRRPC Third Annual Report, OSTP, i
J,une 30, 1987.) EPA has assumed a major role in this Federal program of
- sufficient magnitude and importance to create a Division in the Office of
- Radiation Programs devoted solely to the radon problem. Of course, EPA, the Department of Interior, and other agencies have interests in radon as it exists in mines, caves, and elsewhere.
O. The United States pharmacoceial Convention i
As previous.ly mentioned, the United States Pharmacocetal Convention (USP) i has since 1820 established national standards of strength, quality, and purity of medicinal products, together with the standards for their -
28 .
b production ~, dispen:;ation, and use. Both Congress and the States recognize ;
the USP as an "official compendium." In addition, the Medical Device Amendments Act' of 1976 recognized that the articles in the USP may' con- J stitute devices under the terms of the Act. As part of its activities, USP prepares monographs for radiopharmaceuticals, including cyclotron-produced isotopes, such as cyanocabalamin (cobalt-57) oral solutions; gallium-67 citrate injections; sodium.todide-123 capsules; and thallous (T1-201) chloride injections. Thus, national standards have been and are being developed governing the production and use of radiopharmaceuticals containing cyclotron produced radionuclides. (See: The United States Pharmacopeia, Twenty-first Revision and its supplements.)
P. U.S. Nuclear Reculatory Commission -
Although Congress has never explicitly authorized the NRC to regulate NARM (with the one special exception of radium in uranium mill tailings only),
the Commission's regulations do address NARM in several places. For example, Part 20 specifies the standards for protection against radiation Section 20.101(a) states that no "individual in a restricted area (is) to receive in any period of one calendar cuarter from radioactive material and other sources of radiation, a total occupational dose in excess ofh the specified standards. That is, occupational doses from radium and/or X-ray ma' chines must be added to the doses from NRC licensed materials in determining' compliance. Similar language appears in Section 20.105(a) regarding permissible levels of radiation in unrestricted areas. With regard to permissible concentrations of radionuclides in effluents released to "arestricted areas, Appendix B of Part 20 limits licensee releases of radh *o the air or in the water effluents. Furthermore, Section 20.203(e) requires that licensee areas or rooms containing radioactive materials
...in an amount exceeding 10 times the cuantity of such material specified in Appendix C..." shall be posted with the radiation caution symbol, among other requirements. A quantity of 0.01 microcurie of radium-226 is listed in Appendix C. Finally, the packaging and transportation of radium is governed by part 71. Thus. NRC can to a degree, control li:ensee activities involving NARM, but individuals who are not licensees and possess NARM would not be controlled by NRC regulations.
Nothing in NRC's regulations prohibits disposal of NARM in li:ensed LLW sites.
The Agency's authority is sufficient to dictate whatever controls over chemicals, forms, etc., are necessary to ensure that the safety of the site is not compromised. License conditions and/or regulatory guidelines might be employed that specify the concentrations and forms of NARM that may and may not be disposed of in a licensed LLW site.
Q. Discussion The above indicates that, in general, the States have the primary jurisdic-tion over the health and safety of the public. The issue of governmental controls over exposure to NARM is not whether the Federal government should create an authority to establish such controls, but is really a matter of whether the Federal government should preempt the authority the States already have. The interstate commerce clause of the Constitution provides for Federal preemption of such State responsibilities in order to "promote the general welfare." The Congress exercised this power in creating the
. 29 .
3 A
Atomic Energy Commission to regulate fissionable material, source material and byproduct materials.
The above review of Congressional actions supports a conclusion that over the years, Congress has consciously chosen not to broaden the AEC or NRC reach into the NARM arena, leaving it to the States or other Federal agencies.
In fact, in 1968, Congress looked to then HEW, as the Federal agency with
! primary responsibility for protecting the public health and safety, when l it mandated an examination of the regulatory controls over NARM. In creat-l ing the OSHA in 1970 Congress mandated Federal controls over NARM in the workplace through OSHA, provided that the jurisdiction FDA had over devices emitting radiation remained with FDA, In creating the Consumer Product Safety Corr. mission, in 1972, Congress vested Federal control over NARM in consumer products with that Commission, again provided-that FDA retain its existing authorities. In the Medical Device Amendments of 1976, Congress vested with FDA the authority to regulate medical radiation sources, including those containing NARM. EPA has the authority to regulate NARM in the environment. And, in 1976, Congress authorized EPA to regulate ,
essentially all aspects of any hazardous substance to the public or to the environment. Thus, there currently exists Federal authority to control exposures to NARM in the environment, in consumer products, in the workplace, in homes and in the medical field. However, there is no uniform and consistant Federal policy on the degree to whi'.n the Federal agencies will exercise their authorities to contrcl exposures. As a consequence, Federal controls are fragmented and uneven. In fact, this is true for exposures to
- ionizing radiation in general. Finally, the Unit'ed States Pharmacopetal Convention, a Congressionally and State recognized expert organization, has '
developed and continues to develop, national standards governing the production and use of, among other items, radiopharmaceuticals containing cyclotron produced radioisotopes.
There hat never been an exolicit decision on the ce deral role versus State role in prctecting the puolic from exposures to ionizing radiation except
- nat set out ir Sect'en 274 of the Atom (; Ene*gy Act of 195c, as amenda:.
Furthermore, the mandates Congress nas given to agencies vary so greatly that it is not clear that tne worst and most controllable exposures are being addressed without undue attention to lesser ones. We now turn to tb3 State programs 'er :ortrollir; NAF.M.
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VI. THE STATES AND NARM State radiation control programs began devel'oping in the 1950's and .1960's. In about 1968, a group of program directors began realizing that the States were
. developing differing regulations, primarily dealing with X-ray sources, and that each State was trying individually to cope with common concerns. They agreed mutual benefits would accrue through exchanges of information, which eventually lead to the 1970 incorpot ation of the Conference of Radiation Control Program Directors (CRCPO), comprhed of all 50 States, the territories, and some large municipal agencies. Among that organization's purposes is to "Foster uniformity of radiation control laws and regulations."
In its 1971 report to Congress on the State'and Federal controls over NARM, HEW observed:
The only non-AEC controlled radioactive materials of commercial or health consideration are radium and its daughter products, and accelerator produced radio- '
nuclides. The production of radium in the United States was stimulated in the early 1900's when the U.S. Bureau
. of Mines undertook with private incustry the development of a refining process to extract radium from carnotite ore. .
Unlike the development of atomic energy by the Manhattan project some 30. years later, there was little recognition of the hazards of exposure to radium and radiation pro- .
tection controls were not instituted by the Federal, govern-ment. The regulation and control of radium and accelerator-produced materials has been a part of the traditional State function of protecting ste health of the public. (See: "HEY Report FDA 72-8001, June 1971. p. 5.)
In 1974, as previously mentioned, the Agreement States urged the AEC/NRC.to seek legislative authority over NARM, as did tne CRCPO in 1975. Also in 1975, the States formed a task force, c:m:osec :f CRCPC reereseatativar as well as representatives from NRC, EPA, and FDA, to develop a set of N MM Guices as part of a nationwide system for the uniform evaluation and control of products containing NARM. Those NARM Guides were first published in
!?' aad ir.clu:f ad sugges ed State regulations. The State: thr:s;b the CRCPD indicated their support of the NARM Guide program. (See: Letter from J.P. Hile, HEV, te Secretary of the Commission, NRC. dated Septemcer 22, i 1977.)
l In 1977, all of the then 25 Agreement States and five non-Agreement States had licensing programs covering NARM users, The Agreement States' programs for regulating NARM were oeemed comoarable to their programs for regulating i AEA materials under agreements with NRC. However, there were seven States
! that exercised no regulatory control over NARM users, whereas the remaining 1 States had control programs of varying scope. (See: "Regulation of Naturally Occurring ano Accelerator-Produced Radioactive Materials," 0.A.
j Nussbaumer, et al., NUREG-0301, July 1977.)
i At the end of 1987, all 29 Agreement States regulated and controlled NARM in the same way they do AEA materials. Of the 21 non-Agreement States, only four have a NARM licensing program. Of the remainder, two States have l
2 -
31
voluntary or partial licensing programs, and 14 States have registration programs, leaving one State, Montana, with nothings With regard to NARM inspections, all 29 Agreement States inspect NARM as do 14 non-Agreement States, whereas four States conduct partial inspections. Five States conduct no inspections. (See: Conference of Radiation Control Program Directors. "Position Paper on NRC Regulatory Control of NARM," August 24; 1987 revision; and "Profile of State and Local Radiation Control Programs in the United States for Fiscal Year 1985," Conference Publication 87-3.)
Comparing the 1977 versus 1987 level of activity indicates that the States are increasing the amount of attention to NARM.
In 1983, because there was no mechanism to recogniz'e those States which have a comprehensive program for the regulation and control of NARM, the CRCPD instituted a procedure to recognize such State programs. To be a .
"CRCPD Recognized NARM Licensing State," a State must specifically request recognition and must meet the CRCPD criteria, which are basically the criteria used by the NRC to evaluate an Agreement State. To date a total of. ten States (all Agreement States) are CRCPD Recognized NARM Licensing States. (See: CRCPD Recognition of Licensing States for Regulation and Control of NAk:4, CRCPD LS-1, Rev. 4/28/87: and private communication from ~
Charles M. Hardn, Executive Secretary of CRCPD on December 15,1987.)
In FY 1985, the States expended a total of 1037 full-time equivalents (FTEs) on their radiation programs with about 180 FTEs applied to radio-active materials. The size of the individual radiation programs ranged . .
from 1.6 FTEs in Alaska to 125 FTEs in Illinois. The 180 FTEs oversaw about 15,000 materials licenses, and inspected over 6200 of them. (See:-
"Profile," Conference Publication 87-3.)
The CRCPD has been active in facilitating disposal of discrete radium sources. They have worked with the U.S. Department of Transportation (007) in obtaining an exemption from its regulations. That exemption authorizes the use of specially sealec 00T scecification 2R containers in concrete-
'illec drums for one-t he trar soort for discesal of not more thar 500 millicuries of radium-226 in normal or special form, without each shipper keeping a package test performance certification file. This exemption is estimated to reduce the costs of packaging by an order of magnitude. CRCPO ha: al:e prepared directions for packa;ing u d tas e ked with the it:ta :f Nevada to ease disposal of radium sources at the Beatty site. (See: USDOT-E 9488 (First Revision), April 13, 1987; and letter with attachments fren Charles M. Hardin, CRCPD to All Program Directors, regarcing the CRCPD Radium Disposal Project, Februa ry 27, 1987.)
The CRCPD attaches some urgency to this program:
Since NARM is not addressed in the ..ow-Level Waste Policy Amendments Act and is not included Jnder the definition of low-level waste in any of the Crmpacts, this may be the last opportunity to dispose of racium sealed sources in a reasonable manner. (See: kLd. )
The CRCPD has also been develop % a suggested regulation for disposal of naturally occurring radioactio. materials (NORM). These efforts grew from requests by private companies to States to use. phosphate fertilizer tails ,
. 32
and slag and coal ash in road and railroad bases, in concrete and in cinder blocks. The States expressed concerns about such uses since the NORM
... content / concentrations far exceed those that can be considered de minimis, and exceed the levels proposed by the USEPA for inactive uranium mill cleanup and those adopted by the USNRC for active uranium recovery facilities." Radium is the primary radionuclide of concern. The States observed that many of the proposed uses of these wastes involved products or commodities that were to be introduced into interstate commerce, thus warranting uniform regulation. (See: "Rationale: Part N " SSRCR, Oraft 5, undated.)
Draft 5 of the proposed regulation calls for a three-tier approach to regulating NORM. The.first tier would exempt, from any requirements, disposal of radium at a concentration of less than five picoeuries per gram, i.e. below regulatory concern. For concentrations above this level, but below levels requiring a specific license, a general license would be '
issued to, among other things, use and dispose of NORM. However, that general license would not authorize the manufacturing or distribution of products containing, among other materials, radium in concentrations greater than five' pi m uries per gram. With regard to the disposal of NORM wastes, the proposed regulation stipulates that:
Each person subject to the general license in N.10 shall '
manage and dispose of wastes containing NORM in accordance '
- with the applicable requirements of the U.S. Environmental protection Agency for disposal of such wastes (or in a
, manner equivalent to the requirements for uranium and thorium byproduct materials in 40 CFR 192 or shall transfer wastes for disposal to a land disposal facility licensed by the U.S. Nuclear Regulatory Commission or ,
an Agreement State pursuant to 10 CFR 61 or equivalent -
regulations]. ,
a s mentioned above, EPA is considering a regulatory definition cf low-leve' waste as a material containing, for example, radium at a concentration above 2000 picoeuries per gram. Thus, there appears to be emerging significant differences between Feceral and State definitions of low-level wastes and, m:41y, what constitutes radiatien levels "below regt.latcry :orcern."
(See: "Part N: Regulation and Licensing of Naturally Occurring Radioactive Materials (NORM)," Draf t 5 undated.) -
In September 1981, the National Governor's Association (NGA) undertook a -
comprehensive review of the NRC's Agreement State Program. The NGA report on that effort was publisned in January 1983 and contained the following recommendation:
The Atomic Energy Act should be amended to authorize the regulation of radioactive materials not presently affected by the act, that is, naturally occurring and ,
accelera}or produced radioactive material (NARM).
Since such legislation would broaden the scope of the Agreement State functions, that recommendation is not entirely consistent with the NGA find-ing that:
33
The necessity of meeting NRC review criteria sometimes -
directs state resources'towards those areas on which-they will be judged by NRC and away from what states consider more pressing problems.
The NGA has taken no formal action on the above rec'ommendation. (See: "The Agreement State Program: A State Perspective," Holmes Brown, NGA, January 1983.)
On August 26, 1987, the Conference once again urged that the NRC seek legislative authority to regulate NARM:
The Conference strongly urges the Nuclear Regulatory Commission to begin,the appropriate actions necessary to regulate this hazardous radioactive material in the states which art not ,
currently regulating NARM. It is our belief that because (1) there is no single federal agency where uniform .
guidance on NARM is provided and that (2) in some States there is no control of NARM, the re'sulting potential for puh.lic health exoosure and environmental contamination presents an
- intolerable situation. We believe a uniform regulatory program operated by the NRC is the best solution. The i details of our rationale for NRC control of NARM is ,
clearly described in our position paper. (See: Letter from .
T. R. Strong, chairman, CRCPD, to H. R. Denton, USNRC, '
dated August 26,1987.) ,
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VII. THE TSSUES REGARDING NRC AND NARMt The foregoing establishes that NARM is pervasive in the environment and all facets of life. However, no clear picture emerges on the risks to society given the presence of NARM, with the possible exception of radon. Many Federal agencies already have been granted, through the Congress, jurisdiction over nearly all aspects of the NARM hazards. Finally, the foregoing establishes that the level of State regulation of NARM is increasing.
The purpose of this section is to address the issues involved in NRC seeking legislative authority to regulate NARM. We see the following eight issues:
.1. Is there a national problem with NARM7
- 2. Are there currently integrated Federal control's over NARM7
- 3. Would NRC regulation of NARM overlap other Federal agencies' programs?
- 4. Are the State controls over NARM adequate?
- 5. Is NARM a Federal, State, or professional responsibility?
- 6. Would Congress consider NRC responsible for controlling NARM hazards?
- 7. What are the resource implications? and
- 8. Would NRC responsibility for NARM change the nature of NRC?
The analysis of these issues serves as the bases for developing options for NRC regarding NARM, A. Is there a national problem with NARM? .
The collection of incidents involving NARM given in section IV does not give a clear picture on the degree of hazards associated with NARM.
At issue is whether those past problems are of sufficient magnitude to warrant Federal intervention in a general way. Many, if not most, observers believe incidents involving radium are declining in part because of increased awareness of its hazards, in part because of the availability o'f replace-ment radionuclices, and in pa'rt be:ause of the actions by many States, by the Conference and by the EPA and FDa in rou* ding up existing *adium s:urces and in discouraging continuec use of racium. Nonetheless, the Conference concludes that there "...is the potential for radiation exposure and/or contamination from the misuse of these sources and devices. The misuse, irchding Wrecer st:rsge, 9 NARM s:urces and cevices reay represant i very significant public health problem." (See: Attachment to letter from Charles M. Hardin, Executive Secretary CRCPD to John H. Austin, USNRC, cated Novemoer 25, 1987.) .
\
The most significant national problem with NARM is radon in cwellings. 'As ;
already stated, radon constitutes the populattin's chief exposure to radiation. .
Such exposures are over twice that of all man-mace sources such as meoical l X-rays, nuclear medicine procedures and consumer products. EPA and other Federal agencies and the States alreacy have sv6stantial programs underway for radon monitoring and for promoting remedial action where elevated levels of radon are founc in residences. ,
The next most significant national pecclem with NARM concerns radium, but there are two aspects to it. First, there is the national proolem with how 35 r i
to dispose of the discrete radium sources that were scattered throughout the country largely during the 1920's through the 1950's, without any central control. Radium in a concentrated form is not suitable for disposal in sanitary landfills, because its hazards are equivalent to or greater than the low-level radioactive wastes we require to be disposed of in a site licensed under the' Atomic Energy Act provisions. According to the CRCPO, no State compact formed under the provisions of the Low-Level Waste Policy Act incorporates radium into its definitions of waste the compact will accept. The Beatty LLW site in Nevada is accepting radium for now. The EPA has jurisdiction over the disposal of radium and is developing regulations governing such disposal, but there is an issue of who will enforce the regulations. Candidates are EPA, the States, and the NRC. There appears to be nothing in NRC's regulations that would prohibit disposal of radium in licensed LLW sites. Further, NRC could facilitate EP's forthcoming regulations through establishing license conditions and/or regulatory guidance to preclude disposal of certain'large con-centrations of radium and low concentration, high-vol.ume sources in LLW sites for safety and environmental reasons, and to avoid filling up licensed burial grounds with low activity materials just as we preclude disposa! of certain hazardous chemica'l and waste forms. By such specific exclusions we state what is suitable and unsuitable for LLW sites and radium could be one such specification. However, since we do not address radium disposal at LLW sites and since State Compact's are patterning their regulations after NRC's, radium is continuing to be an orphan waste by not being incorporated into the State laws governing LLW sites. Radium dis-posal is an area for possible NRC involva.,ent and is included in the options section of this paper.
The second aspect of radium has to do with diffuse sources such as residuals from mineral extraction industries. The concern is two-fold:
a) whether the wastes need to be cleaned up; and b) whether those waste streams can be used in construction materials, such as wall boards, bricks, and roadways. On tne cleaning concern, EPA already nas jurisdic-tion; and on the waste stream use concern, etser ederal agencies sucr as CPSC, 00L, HUD, or 007 nave or coule have jurisdiction. inus, there appears to be no role for NRC on this aspect of radium.
The*e may be an e ergir$ ped!em im olving pessible differe*.:es b2t m n Federal agencies' anc States' regulatory definitions of what constitutes LLW and what constitutes radiation levels that are "belos regulatory c o n c e rn . A national consensus on these cefinitions appears warranted.
There does not seem to be a significant problem with radium in the work-
- p. lace. The NIOSH study of 1976 (described in Se~ction V.F) supports this observation. Further. OSHA maintains a data bank on its inspections.
From FY 1973 through mid-FY 1987, there were a total of 24 serious violations of its radiation regulations in the health services industry, a major location of radium. Based on our audit of serious, violations in the health services industry anc in other industries citaci by OSHA, the violations foynd generally involved X-ray machines (e.g., not posting the regulations or not wearing radiation film badges) or in a few cases b,v-product material. None of the OSHA field offices we contacted could S
E 36
identify problems involving radium, although some recalled hearing of problems. (See: Letter from John A. Kalalinas, Dir. Office of Management Data Systems, OSHA, to John H. Austin, USNRC, dated October 5, 1987 and November 4,1987.)
Polonium-210 in cigarettes causes significant radiation doses to the lung and represents a major n.ational problem. However, for this and other reasons, the CPSC and HHS have substantial efforts targeted to this consumer product,
. so there is no need for NRC to become involved.
The other naturally occurring radioactive materials appear to have no major national problems associated with them.
Accelerator / cyclotrons are used extensively in industry. Although data on safety or environmental problems are sparse, what data are available support a conclusion that the machines are generally not causing health, safety or environmental problems rising to a level warranting Congressional action.
A growing application of cyclotrons is within medical departments, where short-lived radioisotopes are generated for performing diagnostic procedures.
Most, if not all, observers believe these materials are treated in the same manner as byproduct materials. Misadministrations of NARM in diagnostic procedures appear to be approximately one percent of the total misadminis-trations. This does not mean any actual harm to the patient occurred.
- To.
the contrary, available data suggest there is' a very low likelihood of a-diagnostic misadministration causing harm. Thus, in terms of health and safety, there appears to be no significant cational problem with cyclotron-produced radioisotopes. Notwithstanding this, the option of NRC seeking legislative authority over such materials will be considered below because of the apparent logical incons,istency of NRC not regulating that aspect of nuclear medicine departments. -
Based on an estimatec numoer of clinical procedures performed in diagnostic imaging (20 million cee year) and the estimate: misa:iWistration rate (1 in 10,000) and an estimated misseministratoc dose of 100 mrem, there would be about, statistically, one one-huncrectn cancer death each year due to diagnostic misacministrations. NARM misadministrations might be a:so:iated with, stat sti:sily, one u n-th:Usan:t can:er death per yta-8 This is in contrast with an average of about two deaths oer year, actuarially, associated with the use of technetium-labelled raciopharmaceuticals. Again, the association does not necessarily imply causality, but the latter would much more appear to warrant further study than the former. FDA indicates it is examining those reports, since FDA aoprosas the safety and efficacy of drugs, including radiopharmaceuticals. (NRC rules governing use of radiopharmaceuticals are tied to FDA approvals. See: 10 CFR 35.100, 35.200, and 35.300.) Although there have been a few serious adverse reactions reported over the past nine years in association with the use of cyclotron produced radiopaarmaceuticals, none of the reports listed death as the outcome. -
~
Another measure of the relative hazards in the medical field is the number of injuries and illnesses contracted by hospital personnel and reported to OSHA that involve disability for some period of time. The Bureau of Labor Statistics compiles such data.from the IS states participating in their 37
Supplementary Data System Program. For 1983, there were a total of 40,370 reported cases of employee disability occurring in hospitals for all categories of the nature of injuries or illnesses. Among the categories, 00L identifies as being the nature of the injury or illness are radiation effects, non-ionizing radiation, microwave, X-rays, and radioisotopes.
Within the 40,:70 cases, there were four injuries or illnesses reported in assoication with radiation efforts, or 0.01 percent of the cases; and three reported in association with non-ioni:ing radiations, also 0.01 percent of the cases; and no reports in the other subcategories identified above. This suggests that radiation in hospitals is far from a signifi-cant contributor to hospital employee hazards. (See: Transmittal note and enclosures from William W. Cloe, 00L, to John Austin, dated September 16, 1987.)
A comparison of nuclear medicine misadministrations and prescribed general drug misadministrations in U.S. hospitals on an annual basis reveals that general drugs are misadministered in 15 percent of the prescriptions
. whereas nuclear medicine misadventures occur in 0.01 percent of the cases.
(See: "One Yeac's Experience with Misadministration Reporting." L. A.
Roche, SNM Newsline, March 1982.)
The above are some of the examples of the need to have an integrated Federal program for controlling risks and of the fact that NARM in hospitals is not a dominant risk.
B. Are there currently integrated Federal controls over NARM? ,
NARM is an important source of radiation exposures of the pubite. There are other significant sources of radiation exposure. Thus, on the~ premise that it's wise and prudent to have an orderly Federal program on controlling harmful radiation exposures, the NARM issue is less one of regulating certain radioactive materials and more an issue of regulating exposures to ioni:1ng radiation. A rational Federal program on controlling rists woulc seek to address the worst and eest control'stle ex:osces fi*st; te co otherwise would mean that the total amount of narm being prevented would be less than that which could be prevented.
Cr. the issue of wnether the*e cuarartl, exist ir.te;'attd 23:e al contco's over NARM, the answer is no. This is also true for Federal controls of exposures to ionizing radiation in general. Congress has amply vested jurisdiction over NARM ha:Ards in agencies other than NRC. However, tne mandates to those agencies and the priorities established within the agencies have resulted in fragmented and unever. regulation of NARM.
There exists integrated guidance to Federal agencies on controlling exposures to the public through the Federal Radiation Council recommenda-tions of 1960 and 1961. However, because of the great variation in the Congressional mandates to the agencies, because of the variation in the ways the agencies have implemented that guidance and because there is no uniform policy on the Federal roles versus State roles, there exists a need for a coordinated Feceral approach to regulating NARM vis-a-vis other ionizing radiation hazards. Such coordination is a logical function of the Committee on Interagency Radiation Research and policy Cooroination (CIRRpC). Thus, an option for NRC is to refer the mattar of additional 38
Federal regulation of NARM Bo CfRRPC for appropriate coordination and priority setting. .
C. Would NRC regulation of NARM overlap other Federal agencies' programs?
As previously indicated, Congress has already granted to other Federal agencies authority to control exposures to NARM in the environment, in consumer products, in the workplace, in homes, and in the medical field.
Thus, any NRC regulation of NARM would overlap other Federal agencies' jurisdiction. With regard to the programs being implemented by those other agencies, generally NARM seems to be a low priority, relative to their other 3
programs. However, few if any other Federal regulatory agency regulates an activity as deeply as NRC does, when NRC regulates the possession, use, transfer, cwnership, disposal, etc., of byproduct materials. So, if NRC were to regulate NARN, there would be much more vertical regulation of those materials than occurs now.
There are many Federal agencies and private organizations that have juris-diction over or interest in the quality of health care delivery programs.
NRC is but one among the many, but, because of its Congressional mandate, NRC regulates not only possession of nuclear medicines, but also the uses.
Other Federal agencies avoic, either through policies or through their mandates, regulating the providers of health care. For example, the HHS 4
has promulgated standards for the accreditation of radiology education programs and for the certification of individuals.such as nuclear medicine and radiatton therapy technologists. In doing so, HHS observes; "While the standards were developed by the Department, the (Consumer-Patient Radiation Health and Safety) Act preserves the traditional prerogatives of States in the approval of education programs and in regulation of. person-nel." Further, Congress and the States recogni:e the USP as the expert organization for establishing national standards for the production, packaging, labellin'g, and use of pharmaceuticals, including radio-pnarmaceuticals. USP is an unbiasec and private organization of experts that constantly revises and adds to its star. cards, as the situation 4 warrants, a process that is easier and probably better than formal rule-makings. HHS relies on USP standards. Since USP has developed and
- continues to develop standards governing radiopharmaceuticals containing c ycletron-p-ocuced radiois
- :::ts, NR 's regulation Of these ;r::da:ts would overlap USp and HHS activities.
There is overlap and conflict between HHS' and NRC's policies and programs
- as they deal with health care programs, raising the Question of whether NRC is over-regulating nuclear medicine programs at the expense of other health care programs. There exists a need to examine the issue of whether or not, or the extent to which NRC's regulation of nuclear medicine departments is consistent with or in conflict with other Federal agencies' regulation of the medical profession. We should determine the extent to which NRC regulatory activities detract from quality of care in conven-tional. medical programs, through possible misappropriation of resources, by directing attention to areas where the payof f is not optimum. Such an examination would be beneficial in advance of any NRC decision to seek j additional legislative authority to regulate NARM.
39
O
. 0 0.. Are the States' controls over NARM adequate?
The States' radiation control programs are well matured now, compared to the programs of 1974, the year when the Agreement States first urged the AEC/NRC to seek legislative authority over NARM. The Conference of Radiation Control Program Directors has prepared, with the assistance of NRC, EPA, and FDA, a set of NARM guides as part of a nationwide system for uniform regulation of NARM. The Conference recently created a program leading to "CRCPD Recognized NARM Licensing State" as a way of encouraging and recognizing those States that have implemented comprehensive control programs for NARM. A State must specifically request such recog-nition and must meet the CRCPD criteria. To date, ten States (all Agreement States) have been so recognized. -
At this time, all 29 Agreement States regulate and control NARM in the same' way they do AEA materials. Of the 21 non-Agreement States, only four have a NARM licensing program. Of the remainder, two States have voluntary or -
partial licensing programs, and 14 States have registration programs, '
leaving only one, Montana, with nothing. With regard to NARM inspections, all 29 Agreement States inspect NARM users as de 14 non-Agreement St'ates, whereas four States conduct partial inspection. Five States conduct no inspection. Comparing this level of activity with that of 1977, it .
appears that tho States are increasing the amount of attention to.NARM.
The States' response to the October CRCPD request for a listing of.all NARM incidents over the east five years does not support a conclusion that the. ;
States' controls over NARM are inadequate.
The Conference is actively pursuing a NARM disposal program and heightening awareness of the need to properly dispose of radium. There appears to be '
emerging differing views between the States and Federal agencies regarding .
the definitions of what constitutes LLW and radiation exoosures "below regulatory concern." Additional coordination is needed in tnis regare.
L An cotton for the NRC is to prepare a policy statement fully supporting the "CRCPD Recognized NARM Licensing State" program, An alternative or addition to this is the Commission writing to the Governors of those Itstes that ce mot regd ats PRV.. The ;ue::se cf that let.ee w:ule de t.
inform them that, although CRCPD has again urged NRC to regulate NARM, tne Comission has chosen not to seek such authority but believes the States should adopt the CRCPD suggested regulations for NARM and to urge the States to become a "CRCPO Recognized NARM Licensing State."
7 E. Is NARM a Federal, State. or Professional resoonsibility? '
With regard to radium disposal, neither the Federal government nor the States have assumed responsibility. Discrete radium sources are an orphan waste. l
- Althougn EPA.is working on a regulation addressing NARM disposal, enforcement of that regulation remains open. NRC is a candidate, so an option is l to seek legislative authority limited to enforcing the forthcoming EPA l regulation, assuming there is no way we could do that under our existing .
authorities. This will be discussed later under options. l
. With regard to Federal / State / Professional responsibilities over NARM use r in the medical field, there is a real and fundamental issue. NRC appears ;
40 .
-- ---- ---- -~-- ------
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unique in the Federal governcent in the depth of its regulation of byproduct materials. Other Federal' agencies generally recognize the historic State prerogatives of regulating personnel in the medical field. Any NRC regulation of NARM would further preempt these traditional State responsi-bilities. With regard to professional responsibilities in the medical field, in a pleading to the FDA, one physician observed:
The responsibility for the final drug product quality rests on the shoulders of the pharmacists and physicians who put their professional competence on the line when they prepare these compounds for human use. It doesn't matter whether they use a cyclotron, an automated synthesis machine, a centrifuge, or chromatography equipment.
The consequences of carelessness a~re lawsuits against the institution and malpractice charges against the pharmacist and physician. These are strong deterrents to sloppiness. They are all that is needed. (See:
Letter from Carol S. Marcus, Ph.D., M.D. Harbor-UCLA Nedical Center to Robert Temple, M.D., FDA, dated July 20, 1987.) ,
That letter also recognizes-th'e role of the States in assigning responsi-bilities to the pharmacists and physicians: "This is entirely within the bounds of laws set out by the various States regarding the practice of pharmacy and the practice of medicine."
Thus, an option for NRC is the status quo.
C. Would Congress censider the NRC -esconsible for controlliae NARM na: arcs?
Congress has consistently looked to entities other than the NRC for the generalized functions of protecting the public health and safety. Histori- -
cally, Congress recognizes that the States have the primary responsibility
':r easuring such crotect %r., Generalty, v an a so:tetal o :blea in. @ 'eg interstate cornerce arises, Congress can and does enact legislation orgeepting such State functicns and establisning, to some degree, Federal jurisdiction over the problem to promote the general welfare. In the case of NARM hazards in particular, Congress has historically refused to broaden the regulatory functions of the AEC/NRC. Rathir, to the extent that Congress has found a need to acdress NARM hazards, it has delegated such functions to, for example EPA, CPSC, 00L, HHS and others. Furthermore, Congress, as well as other Federal agencies other than the NRC, has explicitly recognized the State role in this regard. Ample regulatory authority has already been given to other Federal agencies to control any NARM hazards; there exists only the matter of whether the NARM hazards rise above other hazards to warrant increased regulatory oversight. At least implicitly. -
the other Federal agencies appear to say they do not. Thus, the burden would fall on NRC to establish that other agencies are not properly performing their responsibilities if NRC were to seek legislative authority to regulate NARM more than it is now.
41
G. ,What are the resource implications?
The resource implications of NRC regulating NARM range from* inconsequential to enormous, depending on how broad such regulation would be, since the quantities and concentration of NARM. form a continuum in the human world, and since the potential hazards form a continuum ranging from background to potentially significant ones in all facets of life. Should.NRC seek to regulate only the disposal of discrete sources of radium, the resource implications would likely amount to less that five FTEs per year, since such regulation would represent a small addition to this Agency's LLW activities. However, should NRC seek jurisdiction over diffuse sources of radium, the resource implications would jump by multiples, perhaps orders of magnitude, because of the ubiquitous nature of radium.
Likewise, should NRC seek legislative authority over accelerator-produced radioactive materials the resource implications would be substantial, probably tens of FTEs, because there are thousands of accelerators /
cyclotrons in use. Large resources would be required, since the machines must function as intended, and must be properly maintained to minimize doses to employees, and to minimize the generation of NARM wastes, and NRC would probably have to regulate not only the materials activated by the machines, but the devices themselves. Even if NRC were to try to carefully bracket the definition of NARM to only that produced tri nuclear medicine departments, the agency would probably have to regulate not only the patients, the practitioners, and the materials, but the cyclotrons themselves, since all -
must work together properly for there to be success., Although there is no precise formula for predicting necessary resources to do so, we judge that regulation of such a narrow definition of NARM would require around ten FTEs to maintain the program. Substantially more FTEs would be requirad to establish the program. It would probably involve research, rule development and the hiring and training of staff to deal with cyclotron technology, expending perhaps several tens of FTEs per year, and one million dollars Der year for five years. But, the resource imolications mignt not stop there.
With a limited ex:a9sion of NRC regulatcry reach into these kinds of devices comes the potential for a further expansion into otner sources of exposures to ionizing radiation, with concomitant resource implications.
Fce pe spective, the eatt e testing NtC r,ateriais _l' censing sne inspection programs expend 35 to 90 FTEs per year and one to two million dollars. (See: Memorandum from Robert B. Loach, Division of Budget and Analysis, NRC. to John H. Austin, NMSS NRC, dated January 21,1988,)
H. Would NRC responsibility for NARM regulatien change the nat'are of NRC7 The regulatory authority of NRC/AEC has been relatively stacle for several decades. All of NRC activities and responsibilities have a link to the neutron chain riaction, with a large amount of its resources directed to preventing accidents with very large consequences. Seeking jurisdiction over NARM would be an unprecedented extension of NRC's activities into the realm of generalized concerns over exposures to ionizing radiation, a province heretofore the domain of other Federal agencies and the States.
NRC would likely have to regulate the operation of cyclotrons / accelerators, the extraction industries that generate NARM wastes, water purification plants that concentrate ra,dium, and oth~ers. Even if NRC were to seek a 42 .
< . + .
limited jurisdiction over certain aspects of NARM, such a departure from '
- the. historic role NRC/AEC has had, opens the potential for a further i expansion of responsibilities at a later date.
1 As previously indicated, the Positron Emission Tomography (PET) procedure involves cyclotron produced radioisotopes with half-lives in the order of
- minutes to hours. The radioisotopes are created on site, used on site for j diagnostic purposes, and decay away on site. Thus, those radioisotopes l are not in interstate commerce. FDA has yet to decide whether the system is a medical device, or a drug, or neithir. If FDA ultimately decides not i to regulate the PET procedure, and NRC decides to regulate cyclotron-produced 4 radioisotopes, then NaC would have to rule on the safety and efficacy of the PET modality in order to get around the provisions of 10 CFR 35.100 '
and 35.200, which require FDA acceptance or approval of diagnostic radio-j pharmaceuticals.
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VIII. OPTIONS Based on the analysis of the issues identified above, we see five options regard-ing possible NRC involvement with NARM:
- 1) Status quo,'but continue to encourage the CRCPO efforts on NARM regulation,
- 2) Seek legislative authority over NARM .
- 3) Seek regulatory authority over radium disposal,
- 4) Seek, regulatory authority over cyclotron produced radionuclides for medical use only, and
.5) Refer the issue of NARM regulation to CIRRPC.
Each is evaluated below. .
A. Status quo Selecting the status quo option would recognize that many other Federal agencies already have jurisdiction over NARM as it exists in the environ-ment, in homes, in the work place, in consumer products, and in medical departments. This option also recognizes that there is no major national problem with NARM that is going unaddressed, and that the States are increas-ingly exercising their traditional prerogatives to protect the public health and safety. Further, maintaining the status quo preserves the historic function of NRC of only regulating activities that have a link with the neutron chain reaction and avoids the potential of NRC becoming involved in generalized regulation of ionizing radiation. Finally, the status quo option has no resource impact.
On the other hand, this option might result in radium continuing to be an orphan waste and could cortinue the existing uncertainty over whether radium can or should be disposed of in LLW site). Further, maintaining the status quo could leave the impression that NRC does not support the significant efforts of the States to better control the radiation hazards associated with NARM.
Also, on the negative side, the status quo would mean that manufacturers of NARM sources in non-Agreement States, who are not required to apply accept-able quality control procedures, may ship su:5 sources to individuals in non-Agreement States, without'checkin'g to see if such individuals are properly qualified to handle radioisotopes. Furthermore, some States (e.g. , Texas and Colorado) will not authorize receipt of NARM that is manufactured in a State that does not regulate NARM, in part, because of the lack of assurance that appropriate quality control procedures were used. Some State representatives believs this problem, which is largely economic, may grow.
Finally, the status quo does not ensure consistent Federal and State defiaitions of NARM low-level wastes and NARM concentrations "below regu-latory concern." .
B. Seek legislative authority over NARM Should NRC seek and obtain legislative authority over NARM, there would be an advantage of one single Federal agen~cy having jurisdiction over all 44
radioactive caterials, with centralized and uniform regulation of their hazards.
No longer would there exist gaps in and uneven regulation of similar risks associated with radioactive materials. Nuclear medicine departments wculd be totally regulated, excepting the use of X-ray devices.
On the other hand, this option seeks to correct what appears to be a non-problem, when one compares the NARM hazards with other greater hazards in, for example, hospitals. NRC jurisdiction over NARM would duplicate existing responsibilities of many other Federal agencies, and because our Congressional mandate is to regulate very deeply, there would be enormous resource ramifica-tions. The nature of NRC would fundamentally change. The burden would be on i
NRC to convince Congress that the Federal agencies already having jurisdiction over NARM are not doing an adequate job. This option would ignore the many ongoing and substantial programs to control and improve the quality of care in the medical field including those of individual States, HHS, the Joint Commission on Accreditation of Healthcare Orgasiizations, the USP, and the numerous Associations and Societies representing the health care practitioners. Standard, guides, selection criteria, and peer review groups are all being used and further developed and expanded to ensure cuality in health care delivery programs, i
Finally, this option would divert Federal r9 sources from greater hazards.
C. Seek legislative authority over radium disposal -
EPA is currently developing regulations for radium disposal, and one of its options is to %ok to NRC for enforcement of them. Since discrete radium sources are now an orphan waste, there would be a definite benefit in ensuring
- that this very hazardous material is properly disposed of. NRC and Agreement
, State licensed LLW sites are suitable locations for discrete radium sources, but not diffuse sources. Thus, any legislation would have to bracket the authority to cover only discrete sources. This option would further ensure that hazards of similar kinds are treated similarly. If NRC does not have
- authori
- ation to regulate radium discosal, then we could not cite those
- individuals who improcerly dispose of radium, We do not believe the resource imolications of this option are significant, since radium disposal would be a
! small addition to our ongoing activities on LLW.
On the re;ative side, bacause NRC's mandate is to regulate possessica., use, ,
i transfer, or ownership of byproduct materials, our regulation of radium disposal might entail regulation of the generators of discrete sources of radium (e.g.,
As mentioned previously, we could, through license water purification plants).
conditions and/or regulatory guidance, specify the quantities, concentrations, and forms of radium that are and are not suitable for LLW sites, just as we specify chemical disposal, for safety reasons. -This argues against seeking i legislative authority, but would leave unaddressed enforcement action against those that dispose of discrete radium sources in, for example, sanitary landfills.
D. Seek legislative authority over cyclotron-creduced radionuclides e for mecical use only This option rehoves the logical' inconsistency of NRC regulating all of the radioisotopes in nuclear medicine departments except the cyclotren produced ones. (If NRC seeks such legislative authority, it might as well request 45 1
s
- authority over radium in nuclear medicine departn nts.) This option whuld provide for uniform regulation of cyclotron produwd radiopharmaceuticals, removing the competitive disadvantage the manufacturers have if they were located in States that do not regulate NARM. Although not necessarily an
, advantage, seeking such authority would allow NRC to regulate materials that may cause, statistically, one-ten thousandth death per year. Finally, this option would better ensure t. hat all radionuclides in nuclear medicine departments are uniformly treated.
On the negative side, regulating the cyclotron-produced materials would require hiring and training of individuals schooled and trained in cyclo-trans. We may have to judge the safety and efficacy of the PET modality, if FDA does not. This option would remove the link t.etween NRC responsi-bilities and the neutron chain reaction, and replace it with a link to generalized concerns over ionizing radiation. The nature of NRC would l
change. As with the second option, this option ignores the ongoing and substantial programs to control and improve the quality of care in the medical field; those programs involve Federal, State, local, and private organizations. Ten FTEs mignt be needed to maintain the . program. If these materials result in a statistical one-ten-thousandth death per year, that translates,to about 510 billion per life saved, assuming that NRC regulation would change the incidence of misadministrations to any signi-ficant degree. This option could duplicate the jurisdiction FDA already h'as ove'r these materials, and NRC would have to establish wny FDA is not doing an adequate job. Finally, the United State Pharmacopetal Conven-tien, a. Congressionally and State recognized expert organtration, has developed and continues to develop, national standards governing the production and use of, among other items, radiopharmaceuticals containing cyclotron produced radioisotopes'. NRC.would nave to establish why that .
program is not adequate.
E. Refer the issue of NARM reculation to CIRRpC I
Tre Committee on Interagen:y Radiation Resea ch arc Deli:y Coc-dination (CIRRPC) was created for the pur:ese of coordinating radiation matters between agencies and to acvise tne Office of Science and Technology Policy on issues involving Federal radiation policy. NARM cuts across existing i b r'stict'o ef et.e= !;t9:1es. '53re i s a r.end ':- ar. ' ts;t: sf c:r: :'
program over ionizing radiation in general, and NARM in particular, to ,
ensure that the dominant hazards are appropriately addressed without unoce attention to the lesser hazards. Thus, CIP.RPC is the logical entity to resolve the NARM issue. In fact, in 1979, the Comission referred the NARM issue to the predecessor of CIRRPC, but action was rever ccmpleted.
T'he only negative side of tnis option would be that NARN might bec me lost in CIRRPC because of higher priority issues, but that would say something about tne NARM hazards.
I 46
IX. DISCUSSION .
The evaluation of the above options leads to the conclusion that, given that many Federal agencies already have jurisdiction o.or NARM, and given that :
States are increasing their regulation of NARM, the unregulated NARM risks are not rising to a level that they should be the next target of Congressional legislation. Radium disposal is the subject of a forthcoming EPA regulation, and NRC can facilitate that regulation by specifying acceptable and unacceptable concentrations of radium for disposal at low-level waste sites. There are many l more important problems in hospitals than those associeted with NARM. NRC regulation of NARM in hospitals would divert the limited resources of the hospitals to the lesser problem (NARM) at the expense of the greater problems.
There is a need for an integrated approach to controlling exposures to ionizing radiation, in general, and to NARM, in particular; NRC is not the agency to do that integrating. ,
The States are increasing their regulation of NARM. NRC has worked with the :
States in the past and should continue with such assistance and support.
The conflicting. ways NRC and HHS regulate medical applications of ionizing
, radiation raises the question of whether NRC is over-regulating nuclear medicine pregrams at the expense of other health care, programs. Examination of this
~
issue would be beneficial in advance of any NRC decision to seek additional legislative authority to regulate NARM.
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X. RECOMMENDATION We have ;3e following two recommendations:
- 1) Refer tne issue of NARM regulation to CIRRPC for the purposes of developing an integrated policy and agency assignments on NARM, in particular, and ionizing radiation, in general, in those situations where agency jurisdic-tiens everlap (e.g., in the Federal regulatory pro; rams dealing with health care activities). ,
- 2) Inform the Governors of the states not within the "CRCPD Recognized NARM Licening States" program that.NRC is not going to seek legislative outhority to regulate NARM, becaust such regulation is a responsibility of the States, and because other Federal agencies already have juris-diction over most facets of NARM aazards; urge those Governors to take the necessary actions and to assign appropriate isources to become
. such recognizad States.
Although not directly within the scope of this assignment, it sh'ould be noted that inform &t;an gathered during the conduct of this study suagests that the depth to which NRC regulates nuclear medicine is inconsisten< with Federal regulation of medicine in general. There is a need for better integration, within the Federal government, to ensure that the dominant hazards associated with medical practice are being appropriately addressed without paying undue attention to lesser-hazards associated with nuclear medicine. Furthermore, because of the varying Congressional mandates of the numerous agencies having jurisdiction over ionizing radiation, because of the varying and conf.licting priorities and programs among those agencies, and because there has never been in explicit and consistent determination of the Federal rola.versus the. State role in protecting the public from exposures to ionizing radiation, there is a
, need for bettar integration of the numerous Federal programs governing exposures
- to ionizing radiation. ,
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- August 26, 1987 k . .
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, Harold R, Denton, Director o
Office of Governmental and Public Affairs
- U.S. Nuclear Regulatory Comission l Washington, D.C. 20555 i
Dear Mr. Danton:
l
' The' purpose of this letter is to formally share with you and the Nuclear Regulato y Comission the position of the Conference of Radiation
( Program Directors on naturally occurring and accellerator produced
- y radioacive material (NARM). .
l !
The issue, simply stated, is that NARM radioactive material is not
, adequately or uniformly regulated in the United States, and cs a result,
[ has the potential for.significant exposure to the public and for
- contamination c.f the environment.
The concera for nonuniform controi og AM.has been voiced by st. ate L
radiation control directors since the i;.rly 1960's and has been brought
+ to the attention of the NRC on many occasions over the lest several '
- years. This same concern has been ex#ressed by the Agreement States, as L
a group, and by the Conference of Radiation Control Program Directors, I Inc. (CRCPD), which represents both Agreement and non-Agreement states.
s Let me also draw your attention to the June 26, 1987, letter to Samuel Chalk from Warren Sinclair, President of NCRP, in which Mr. Chalk specifically addresses the NARM issue. A copy is enclosed.
The most recent action on the NARM issue taken by the Conference is the l adoption of a "Position Paper on NRC Regulatory Control of NARM," which s was approved by the membership at our 1985 annual meeting. The 1985
- position has been updated to reflect current concerns. A copy of our position paper is enclosed.
e The Conference strongly urges the Nuclear Regulatory Comission to begin I i the appropriate actions necessary to regulate this hazardous radioactive
- j. material in the states which are not currently regulating NARM. It is t our belief that because-(l) there is no single federal agency where i
uniform guidance on NARM is provided and that (2) in some states there l is no control of NARM, the resulting potential for public health -
8 exposur : and environmental contamination presents an intolerable f situation. We believe a uniform regulatory program operated by the NRC l \I .
. . Harold R. Dent.a August 26, 1987 Page Two is the best solution. The details of our rationale for NRC control of NARM is cleerly described in our petition p;;;r.
The Conference is developing a compilation of recent incidents involving NARM which we will share with you as soon as possible. In the meantime, we believe the position paper adequately describes the need for NRC action.
The Conference is ready and willing to present its position to the Cantission as the NARM issue is considered. Please do not hesitate to contact me at (206) 753-3468 or Chuck Hardin, our Executive Secretary,
, at (502) 227-4543.
Sin ely,
- e
. R. S ong / .
Chairman I TRS/db Enclosure i
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Revised August 24, 1987 CONFEGNCE OF RADIATION 02GROL PROGRN4 DIRECTCRS POSITICH PAPIR CH
)RC RHALUCRY OMERCL OF NARM Introduction t
The Atanic Energy Act of 1954, as amended, authorizes the U.S. Nuclear Regulatory Ccrrmission ()RC) to control the manufacture, transfer, ingcet, expvst, use and digd of radioactive natorials classified as byproduct, source and special nuclear natarials. The Act does not provide for the regulatory control.by the NRC of naturally occurring and accelerator produced radioactive material (HARM)'. This 1954 decision to exclude NARM was based on the fact that controliing the radioactive m terials associated with weapons develc5 men us the nation's only significant concern. Even when the use of NARM became more videspread, this emission was never cun W M . Reference 1 (see page 15) has a mces emplete legislative history en why 1%RM was never included under the Atenic Energy Act.
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HARM represents the same types of public health and safety risks, and in fact t includes scene of the identical radionuclides. which are rwyllatad by the NRC 1 i
under the Atcmic Energy Act.
Due to these similar characteristics, and in ;
order to ensure the adequate protection of the public health and safety, the Conference of Radiation Control Fr v ie Directors believe NARM should be controlled in the same way other radioactive materials are regulated under the Atcmic Energy Act. .
Characteristics and Use of LRM Most ccamen substances contain sna11 quantities of naturally occurring radica-active materials. For clarification, the radicactive materials proposed to to added the the authority granted by the Atmic Diergy Act would (1) be thoes naterials either emcentrated in nature as a result of man's activities or deliberately ccccentrated for their ra'dioactive isegwi.ies; or (2) discrete scurces. ,
Diffusa sources such as phosphate residues, nonuranium cres, and l slags are not intended to be included. The NRC would be required to determino which materials pose a potential threat to public health and safety and which
'should therefore be covered under the Act.
p The most ecmnon exanple of HMM is Raditzn-226. Radita is considered to be one of the nest hazardous of all radionuclides for at least t.c reasons: it has a 1600 year half-lifa and it decays to the radioactive gas Raden-222. Radium also has one of the lowest allovable concentrations of any radionuclide in water.
It hu been estimated that about 20 ;+.xcwit of all radioactive material i
F Page 3 Revised 8/24/87 users possess Raditan sources. Between 1912 and 1961, nearly 2,000 grams (2000 curies) of Radium were prer=W in, or inported into, the United States. A recent survey of 'all state radiation centrol programs identified about 130 curies of Radium currently registered. Since less than 200 curies have been disposed in licensed dispceal facilities, this may indeed be a significant public health and safety problems, due largely to the inem sistant regulation of NARM. n -== Raditan is the $ cst ccamen NARM and presents the greatest of potential problens, it will receive most of the attentice in the discussica that follows.
There are ntanarous other radionuclides considered to be NARM (sise Reference i for specific exangles). HARM is used in evry state in the United States. In the areas of medicine, NARM 1A used for applications such as diagnostic nuclear medicine imaging where ,the radienuclide is injected into the patient, and in i therapeutic applications where sealed ' sources are used to treat cancercus tumors. HARM is used in industry for things like integral parts of gauges, in devices for various measurements, and in the academic field for various research and teaching applications. There is currently estimated to be about
-10,000 users and F-m of NARM in the United States. The use of Raditen in i most applications appears to' be declining,- thus creating a disposal problem to l
be discussed later. At the same time, it appears that the use of accelerator-i
! produced radionuclides is growing.
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Present Control of NARM The regulation of NARM is fragmented, nonuniform, and inocr@lete at both the federal and state levels. Absent a federal mandate, most states have established see Jort of program for the control of NARM. However, these programs vary greatly in their degree of regulatory responsibility and control.
The Atmic Energy Act provides for states after they qualify to asmans regula-tory control for radioactive s tarials specified in the Act. Twenty-eight states have agreenants with the mc for full regulatory omtrol of ein i
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radioactive ma'irials as allowed under the act. These MC Agreenant States i
regulata and control NARM in the same way they do for Atmic Diergy Act.
m terials for which they have regulatory responsibility and authority. !
i These statas which have not entered in'to agroements with the NRC have widely differing regulatory authority and czntrol over NARM,2 and this is where the major problem lies.
of the twenty-two non-MC Agreement States, only five havo a NARM licensing program. Of the remirder, two states have voluntary or l
partial licensing programs, while 15 have very limited initial registration requirementa.., At the same time, the interstate transportation of NARM is covered by giforni U.'s. Dor regulations.
1 In the area of NARM inspections, the regulatory picture is scr:awhat better2, (
In non-M C Agreement Statas, fourteen have inspection programe while four i
states conduct partial inspections. TgestatesconductnoNARMinspections.
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Page 5 Revised 8/24/87 De Conference of Radiation Control Program Directors (CRCPD) has attapted to correct this nonunifom regulatory control situation at the state level by developing a "NARM Licensing State" qualification program. 21s ps,am is intended to provide a thorough review of NARM regulatory control in both Agreenant and Non-Agreenent States using consistent review criteria. It is assumed that a state which has bqw.n certified as a "Licensing State" has a .
pK4u.ain ca patible with the requirements of an NRC agreement. Because of this prow.arn, and to alleviate the emcarns of ses states which would not othervise support the positice, it is recemnended that an amendnent to the Atmic Energy Act provide for recognitian of the NARM regulatory programs in those non-Agreenent States which do not want to enter into a full agreement. It would be-desirable to provide for a mechanise for these states to continue this adequate p vw.am withcut the additional adninistrative burden of applying for tRC Amt State status. '
2e lacP. of unifom licensing and regulatory control at both the federal and state level has led to a variety of problans which present both potential and real public health and safety threats. Sme of these problens are described asfoliows.
2ere have been numerous incident roi.crts dealing with NARM. Most have involved Radium sources. Frm 1966 to 1969 the Federal Bureau of Radiological Healch conducted a voluntary psvuram to document NARM incidents in the states. During this period, there was an average of
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twenty-nine incidents per year involving Radiun alene, most of which involved loss o# the natariali . Because of nonunifom regulations, this is believed to be an underestimate of the probl e. In more recent years, the frequency appears to be decreasing. However, with-out unifom regulations and the uniform 1% ting systan which this would require, the real threat and inpact to public health and safety cannot be detemined. -
As with Atcmic n ergy Act materials, there have also been misadmin-istrations of NARM radiopbamar=51cals. However, these events are not being captured in any national incident iwting systas, and lessons learned are not adequately shared.
.The nonunifom state-to-state regulation of NARM creates interstate ccanerce problems. If a mriufacturer in a state with an adequate NARM regulatory program ships NMM sources to a state not regulating HARM, or vice versa, control over how this source vill be used can bo lost. This has lead sme states to deny reciprocal regulatory agrements to states not designated as "Licensing States". -
Where NARM sealed sources and devices containing NMM are manufac-tured in or distributed frca states without adequate NARM control programs, such sources and devices (which can include medical sources) probably have not undergone a regulatory review for adequacy of radiation safety design and .mnufacturing controls.
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. Page 7 Revised 8/24/87 NRC regulations allow for the distribution to the public of very
. stall quantities of radioactive materials contained in ocnsumer products, such as smoke detectors. These u terials are called "generally licensed", (i.e., no "specific" license is required), and an evaluatim must be performed to show that this general distrilution -
vill not result in risks to health and safety. Predacts that include ,
HARM may not receive adequate evaluation and these consumer products may create health and safety problems.
Due to the lack of adequate regulatory control, various instrwents and devices containing raditan have been nanufactured in the past for the military without any' distribution limitations or arkings.
. Such devices have been found in numerous instances in the public's
.msmsion and my have caused significant radiation exposures.
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In nco-Su.si.r:iit States with KnRM inspectim programs, about 70 percent of the NARM users are also licensed by the Mtc to possess and
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use u terial i. This requires both State and NRC inspectors to inspect the same facility, in nany cases duplicating efforts and wasting already limited resources.
Ensuring the r w disposal of NARM is probtbly the greatest end !
inost visible prob 1m that has been exacerbated by nonuniform regulation. ,, ,
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Discosal of NARM Since most a' ccelerator prvv6M radienuclides have relatively short half-lives, they are typically stored on-site for decay and do not present a disposal problen. The exceptions to this my be acoolerator targets and other can-ponents; however, nonuniform eT.ing requirunants again make data ga hering difficult. Therefore, the focus of this section vill be ai. naturally occurring radionuclides, particularly Radiun. It should be noted that the proposed Super collider is estimtad to separate fran 10,000 to 40,000 cubic feet of IIRW annually, which will be classified as NARM.
one of the mjor problens with dig-l is that although states have made a.
strong case for it, NARM was not included as a low-level radioactive waste
'l covered by the Low-tavel Radioactive Waste Policy knendnents Act of 1985. Like mixed vastes, this a terial was left as an orphan vaste stream. As a result, it is very uncertain how it vill be properly disposed. Note that none of the ccrrpact regierts has included NARM as a low-level waste for which it rust be responsible.
Because Radiun is considered by any to be as toxic as transuranic mterials, '
it is currently very' difficult to dispose in a licensed low-level radioactive I waste disposal site. The Barnwell site vill not accept any discrete Radium sources. The Hanford site has inposed limits for disresal of Radius more stringont than are those for transuranics. Although the Beatty site vill 4
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. Page 9 Revised 8/24/87 accept Radita, other problems beyond the scope of this paper have limited sucti di p in.
Inclusion of NARM under the Atmic Energy Act would require that
. the NRC include Radium in its vasta classification system. Such classifica-tion would leed to the setting of uniform standards for acceptance of Raditsa at the diel sitse. It would also serve to establish a Class C limit for Radita whicts would specify the assignment of responsibility, either state ce federal goverrment, for disposal' .
It should be noted that the Conference of Radiation control Program Directors is in the process of establishing a di&1 mechanima for discrete Raditsa . .
sources.
It is hosied that through this program many Radita sources, now being stored because disposal is difficult, can be properly disposed.
It should also be noted that forced Radita storage creates other radiological hazards.
Unwanted or unneeded Radita m.tst be stored if di&_1 in a licensed low-level radioactive vaste site is difficult, ig ractical, or too expensive.
Storage requires adequate shielding and px w security. In addition. Radium sources frequently leak and boccam contaminated.
% In addition to sealed sources, there are other discrete Radita ceritaminated waste W)ich will probably be generated in increasing quantities and require safe di e l. Ihese include clean-up resins fram drinking water supplies Y
contaminated with Radita, and scale on piping used for oil and gas collection and transmissicn which has been discovered to trap relatively large concentra-
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tions of RaditN) Unifona regulation of NARM will provide assurance that these sources and others will be puvpsrly controlled and safely disposed in the future.
- The Resource 0
- nservation and Recovery Act (RCRA) exempts natarials which are covered under the Atanic hergy Act. .1he h vi m .. .tal Protection Agency (EPA) is authorized to regulate NARM under RCRA but has not proposed regulations to do so. It is strongly believed that discreta NARM scuroes should not be regulated under RCRA because (1) this would not provide for the up-front
. . i control of its use, and (2) it would not adequately solve the di & 1 l l
problems. Diffuse NARM, such as phosphate residues, nonuranitsa cree and slags, '
is probably rcre awswsiately regulated under RdRA.
It is strongly believed that }RC disposal regulations are auch more awsws-late !
for discreta HARM vaste than are RCRA disposal regulations. If discrete NARM I is not included under the Atcmic Energy Act, then it would probably eventuaHy cene under the control, of RCRA. Not ,only A d th Q crp te a , regulatory (l problem at those disposal sites vtl ich ctgynntig acceQNARM, it would also ,
create a dual regulatory problern in those Agreement States which regulate NMM l
under regulations which HRC represents to ber ocrrpatible with radioactive materials covered by agreerents with tRC. This would lead to a situation similar to'the one which currently exists with mixed vastes. [
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'Ihe Crsng .ss has provided authorization to the U.S. Environmental Protection 1
Agency to "clean-up" areas contaminated by hazardous substances. This authority is provided by the Hazardous Substances Respmse Trust Mad, established under the C-v..hensive Envircrvnental Response Cenpensation and !
Liability Act (CDKS:A) of 1980.
Some areas and facilities which have been contaminated with NARM have received funding for "clean-up" under this Act.
A question has been raised:
If the Atemic Energy Act is amended to include NARM would such amenchent affect or restrict the use of CUKIA fu ocntaminated areas or facilities?. To clarify the issue, a new sectice is pau,-: ed in CatCIA which would allow the cxmtinuation of such funding for NAMI contaminated areas and facilities.-
9thyc Studies and ooiniens :
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Over the past several years other organizations and groups have taken the
. position that NMM should be included under NRC regulatory control.
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The Mtc Agrw rit States, folleving their October 1974 meeting.
rE... 1 Wed that NRc bring NARM under its regulatory control. l i
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- e The ccnference of Radiatica 1975, letter to the then NRC Cen for NARM to be regulated at th om e federa: level A task force established in
. recemnande'd that IRC seek leg ve authority The National covernors' Asso c atica, in its pel Acreenent State Procram; states, "The Atcmic Energy Mt regulation of radioactive retarialould Act, that is, naturally-ax:u s not presently radioactive raterial (HARM)."rring'and A 1984 survey (NURECH)976) df th (then) tventy-seven Agreem e states by 100 s?ni nonagreenent states supported th remining seven, caly four vers c regulat pposed to }RC regula tvo undecided andreply. ens with no At the October 1984 nesting of vas again adepted Wich called uthe tRC Atcmic Diergy Mt. pco the IRC to i!x:lude 9
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- In May 1985, the omference of Radiation Control FI,- Directers again adopted a position that HARM should be included under the Atmic Energy Act control.
At the October 1986 meeting of the Agreement States, the attending states again advocated inclusion of respcasibility to regulate NARM in the Atmic Ihergy Act.
Conference Positi,gg The Conference of Radiation Control Fr, Directors has evaluated the NARM issue in the United States and has observed that the use of NARM is ocemen and videspread throughout the country and that the centrol of NARM is varied and fragmented. The resulting nonunifoca control of NMH croatas confusion on the part of users and vasta generators, arid creatas a potontial for excessive radiation exposure to both radiation workers and the general public.
i Based on the infornation contained in this paper and in a 1985 ccnference
- resolution, the Conference rh.. .iids that the Atmic Energy Act of 1954 be amended to authorize the Nuclear Regulatory Cc m ission to regulate discrete sources of naturally-occurring and accelerator 1rtvtM radioactive uterials in the same way it is authorized to regulata other radioactive material l
identified in the act.
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hp 14 Revised 8/24/87 The Conference concludes that there are scme ncc-tRC Wt St: ate radiation control programs adequately protecting the public through the regulation and control of NARM. Since the tvanty-eight 4-4t States control and regulate NARM in the same manner as traterial currently identified in the Atcmic hergy Act, the NRC Agreement State members roccmnand that NRC establish W-:+1m to naintain the continuation of NARM regulatory authority and control imediately following amendnent of the Act.
Suggested language amending the Atanic hergy Act is attatted to this Positica Paper.
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SUGGINIID M4DO4Dfr for The AKMIC DGRGY ACT of 1954 to Alf1HCRI2Z THE U.S. NUGEAR REDUIAERY ComISSION I
tu REDUIATE NATURALLY-CCXNRRING & ACCEIRATCR-PRCDUCID RADICACIIVE MA21 RIAL,(NARM)
The following suggested changes in the Atanic Energy Act wtuld authorize the U.S. Nuclear Regulatory Comission to regulate and control Eaturally-occurring
& &ccelerator PsveM &ndicactive Haterial (NARM) in a similar manner as radioactive material currently authorized by the Act.
Note: Bracketed word or words indicate the word (s) are to be deleted. Underlined words or words, indicate new word (s) are to be added.
- 1. Ref: Chapter 2, Section 11 e. '
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Add a new (3) with the following wording:
- e. The tens "byproduct storial" means (1) any radioactive material
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(except special nuclear material) yielded in or mde radioactive by exposure to the radiation incident to the process of producing or i utilizing special nuclear material, [and) (2) the tailings or wastes :
- produced by the extraction'or ocncentration of uranium or thoritra ;
from any are processed primarily for its source material content, l i
. Page 2 and. f3) discrete naturally-occurrina or accelerator W M radioactive storial (NARM) as detemined by the Comission.
- 2. Ref: Chapter 2, Section 11 Add a new definiticri to read as follows, then re-alphabetize appropri-ately:
Be tem "naturally-acurrino radioactive mtarial" means a eteripi or substance that is radioactive as it exists in nature.
- 3. Ref: Chapter 2, Section 11 Add a new definition to read as follows, then re-alphabetize a s vg i- l ately:
1 Re tem "accelerator +wtcod radioactive mterial" neans a reterial or substance nede radioactive by exeosure to the radiation of a particle accelerator.
- 4. Ref: Chapter 2, Section 11 i Md a new definition to read as follows, then re-alphabetize appropri-ately;
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Page 3 The tem "particle accelerator" means any achine m=Me of accelerating electrons, pretens, douterons, or other charged particles in a vacuum, and of discharging the resultant particulate or other radiatica into a medita at energies usually excess of 1 MeV.
- 5. Ref: Ompter 14 Add a new Section to read as follows, then re-ntater appropriately:
]he camission shall. en January li_1992utsame_rtaulatorY responst-bility for the reaulation and control of b e d m terlate as defined in Section II e (3) and shall by this date have established rules reaulations. and standards to oevern the rm -= ion and use of byproduct m terials as defined in Section II e (3).
Prior to January 1.1992. any reference nede to byeroduct sterials2 l when a specified tyre of byproduct starials is not mentioned, shag nean byproduct materials as defined in Section II e (1) and (2). qi January 1 11132. and thereafter, any references m de to byproduct storials when a scecific tves of h materials is not mentioned. shall mean byproduct u terials as defined in Section II c, (1) . (2), and (31.
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- 6. Ref: Chapter 19, Section 274b.
Add a new sub-itaa (3) with the following wording, and re-nebering as aww inte.
b.
Despt as provided in subsection c., the Ccmaissica is authorized to entar into agreements with the acrJ-,s of any state providing fee discontinuance of the regulatory authority of the 0:maission under chapters 6, 7, and 8, and section 151 of this Act, with respect to any one or more of the following s torials within the State-(1) byproduct s torials as defined in section 11 e. (1);
(2) by W m terials as defined in section'11 e. (2);
111 byoroduct uterials as defined in %: tion 11 e (3);
((3)) .i sourou m terials -
((4)) i special nuclear storials in quantities not sufficient to fem a critical mas.
- 7. Ref2 Chapter 19. Section 174 Add a nw =Wien to read as follows, and re-alstabetize as appropri-ak.
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the Ocznmission shall on January 1.1992. assume resoonsibility for the i reculation and control of bMrt mterials as identified in subsection b (3) of Section 274. No moreanent Dursuant to byproduct materials as 12titified in subsection b (3) of Section 274 shall t+xi- effective crier to January L 1992.
. Acr ai-nts entered into orier to January 1. 1992. Dursuant to b M M mterials as identified in 94=ardien b (1) of Mien 274 aball as of January 1.1992. be deemed to also inclivia bvoredwM: materiale as identified in st= action b (3) of Mien 274 unl-- the mission sigtgunines to the contrary haw on oublic haalth and safety czmsidera-tions, or unless the State Wich has entered into six:h an aareenent oriot to January 1. 1992. determines that it does not desire reculatory authority over byproduct m terials as identified in s @ action b (3) of section 274.
The Ccmnission shall establish a hv wiure to reintain the continuation of,
, reculatory authority for those natorials identified in s W-ien b (3) of, section 274 in a state which has not entered into an aci n ent orter to January 1. 1992.
- 8. Reft Chapter 19, Section 274 Add a new subsection to read as follows, and re-elphabeti::e as aty 4si-ate.
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I h-.aits entered into curem_nt to subsection b shall not exc!ude stattis, frm beina elicible for the ===artion of claims aaninst the Ha9 C m Substance Resoonse Trust Mand established under the G m d s ive Envixw. & tal Rosconse Cmcensation nnd Liability Act of 1980 when such claims relate to any of the materials incitM in the acreenents.
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' Office of Nuclear Material Saftety and Safeguartiv, )RC
, Ramilation of ,
Naturally wrina and h+1erate M tr+j Radioactive Matala1 =: A Taak Faw Review, NLRID-0301, July,1977.
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Office of State Programs. }RC, Raoulation of Naturally el r -
-rina an'd_ !
Accelerator vt = i Radioactive Materials:An (Edste. NLRE>4976, i
4 October, 1984.
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H. Brown, lhe Aareement State ham:
A State "am ective., Natietal Govat'nors' Association Washington, D.C.,' January, 1983 .
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