ML20055D042
| ML20055D042 | |
| Person / Time | |
|---|---|
| Issue date: | 06/27/1990 |
| From: | Carr K NRC COMMISSION (OCM) |
| To: | Graham B SENATE, ENVIRONMENT & PUBLIC WORKS |
| References | |
| FRN-53FR49886, RULE-PR-CHP1 CCS, NUDOCS 9007030134 | |
| Download: ML20055D042 (57) | |
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UNITED STATES i 4%
g NUCLEAR REGULATORY COMMISSION g,{-
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CHAIRMAN y.
The Honorable Bob Graham, Chairman Subecmittee on Nuclear Regulation Comittee on Environment and Public Works United States Senate Washington, D. C.
20510
Dear Mr. Chairman:
The huelear Regulatory Comission (NRC) is issuing a policy statement on Below
-?egulatory Concern (ERC).
regulations and licensing decisions which would exempt very low leve active material from regulatory controls where the Comission detennines that such centrols are not necessary to protect public health and safety.
This policy will provide a consistent and logical framework for review of exemptions and cleanup' decisions that have in the past been made on a case-by-case basis.
Copies of the policy statement, along with a press release and-infomation booklet, are enclosed.
Th'e intent of the policy statement-is to:
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~ Ensure that there continues to be adequate protection of the health and safety of all members of the public, Establish a broadly applicable risk-based framework to ensure consistency in future rulemaking and licensing i
L decisions and in the review of existing exemptions; and Allow the NRC, Agreement States, and licensees to focus their resources on reducing the most significant radiological risks.
There have been several comon misconceptions about the Comission's l
L BRC policy which we believe neeo to be clarified.
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The BRC policy is not self-executing.
Rulemakings or H
licensing actions will be required to implement the BRC policy.
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Public participation will be afforded in rulemakings and L
licensing actions if they differ from previous generic exemption provisions.
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Prior to granting an exemption for a given practice, the j
NRC will conduct a thorough technical review.
If an exemp-i tion is granted, a licensed activity producing an exempt
-material will continue to be subject to the full range of regulatory oversight, inspection, and enforcement actions
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up to and including the point of transfer to exempt status, i
We believe that the BRC policy will benefit the public by providing a l
Commission-approved framework for the development of regulations and guidance i
for cleanup of contaminated sites, a consistent level of safety for consumer i
products, and better use of resources for waste management.
The Comission considers this an important regulatory undertaking ano will hold publicly-noticed workshops in each NRC Region.
Sincerely, e *_M.
Kenneth M. Carr
Enclosures:
As stated Senator Alan K. Simpson cc:
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. t ve Identical letter sent to:
l The Honorable J. Bennett Johnston, Chairman i
Subcomittee on Energy and Water Development Committee on Appropriations United States Senate i
Washington, DC 20510 Senator Mark O. Hatfield cc:
The Honorable John Glenn, Chairman Committee on Governmental Affairs United States Senate Washington, DC 20510 v
Senator William V. Roth, Jr.
cc:
1 The Honorable Tom Bevill, Chairman Subcomittee on Energy anc Water Development Cormittee on Appropriations United States House of Representatives Washington, DC 20515 Representative John T. Myers cc:
i The Honorable Philip R. Sharp, Chairman Subcomittee on Energy ano Power Committee on Energy and Comerce United States House of Representatives Washington, DC 20515 Representative Carlos J. Moorhead cc:
The Honorable Morris K. Udall, Chairman Subcomittee or Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515 l-cc:
Representative James V. Hansen The Honorable Uunn Conyers, Jr., Chairman Committee on Government OperationsSubcomittee on Legislation a United States House of Representatives Washington, DC 20515 Representative Frank Horton cc:
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/"" 5 UNITED STATES i ', m,,,;
NUCLEAR REGULATORY COMMISSION
~i a Office of Govemmental anci Public Affairs
%...'.y j s,
.s Washington, D.C. 20556 No.
90-93 FOR IMMEDIATE RELE/SE Tel.
301/492-0240 (Wednesday, June 27,'.990)
NRC APPROVES POLICY STATENENT CN RADIATION LEVELS TO BE CONSIDERED FOR EXEMPTIONS Ct41rman Kenneth M. Carr of the U. S. Nuclear Regulatory Commission announcEc today the Corzission has approved a policy statement to guide its future deciclons on which radioactive materials are "below regulatory concern."
This would involve materials with levels of radioactivity so icw that they do not warrant the same regulatory controls to ensure proper protection of the public and the environment as do higher levels of radioactive materials.
The Below Regulatory Concern levels are about 3% of the 300 millirem dose people receive annually from naturally occurring sources such as cosmic radiation and radioactive material in the earth, including radon, j
In announcing the policy, Chairman Carr said:
" Currently, the hRC is enforcing the cleanup of nore than 40 contaminated nuclear sitt.s across the country and there will be many more in the comino decades.
Last year, when I appeared before Congressman Mike Synar, he.
questioneo me as tc why it has taken the Federal government so long to estab-
~11sh safe and consistent cleanup levels for these facilities.
I told him, as I am telling you today, I have no excuse for the past, but one of nly highest priorities is to establish safe levels of cleanup.
This will help ensure every operating facilit) will complete cleanup in a timely manner and will have adequate levels of funding to complete that cleanup.
"The policy I am announcing today'provides the framework for determining these si.fe levels. The country needs a safe Below Regulatory Concern policy today.
"I want to stress that the NRC will analyze and scrutinize each proposed exemption to ersure that any radiation doses will be extremely low. The safety of the-public and the environment will remain properly protected."
In the past, the Cormission has exempted, on a case-by-case basis, some types, uses, and small quantities of radioactive material from regulatory control.
Examples of exemptions that have already been granted by the Comis-sion include consumer products such as smoke detectors, as well as certain very low-level radioactive waste from hospitals and research institutions.
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The Commission emphasized that the policy statement is not the same as a regulation and does not constitute a decision to exempt any specific consumer product, waste, or other materials from regulatory control.
It is instead a general guiceline for the development of such exemptions and provides a uniform and consistent health and safety framework for considering whether to grant such exemptions.
It would cover such activities or products as (1) cleanup of decommissioned and decontaminated facilities, (2) consumer products containing small amounts of raoicactive traterial, (3) very low-level radioactive waste, and (4) recycled equipment ano materials with slight amounts of radiation.
The Comission has always recognized that the use of radiation or radio-active materials, like all of the activities society engages in, involves some risk. The levels of risk associated with exemptions are small, especially in corrparison to risk from our everyday activities.
For example, individuals are exposed te radiation doses of about 5 millirem when they take a single round-trip cross-country airplanc flight.
The NRC traditionally has sought to ersure that any radiation dose received by workers or members of the public is reduced to a level that is as low as is reasonably achievable.
However, as the level of this risk or dose becomes very small, spending resources to reduce the risk reaches a point where the costs of such efforts far outweigh any small benefits that might rescit. The Ccomission believes its regulatory efforts should be directed toward more important health and safety issues.
In its policy staterent, the Commission gives the criteria for making exemption decisions that will properly protect the public and the environment.
For indivicuals, the Commission hes deciced the radiation exposure from a single activity er product may be considered for exemption if it will result in an average dose of less than 10 millirem per year. Incividuals are exposed to similar levels when they chocse to live in a brick rather than a freme house (e difference that can exceed 10 millirem per year).
The Commission also recognizes that some situations coulo develop where an incividual could receive a raciation dose from several different activities or products.
Therefore, as en added assurance of safety, the Comission has cecidea to apply an interirn indivicual dose criterion of 1 millirem per year 1
for materiais or products involving widespread distribution of radioective materials in items such as consuner products or recycled material and i
equipent.
In addition to these criteria for individuals, the Corrmission also has establishec a criterion that will epply to collective dose--the sum of all the individual doses. The Commission believes if the collective dose resulting f rom an exempted practice is less than 1000 person-rem per year, the resources of the Commission and its licensees would be better spent to address rnore significant health and safety issues.
This criterion is equivalent to 100,000 individuals receiving 10 millirem per year or a million individuals receiving 'I trillirem per year.
Any licensee who produces materials containing very low levels of radioactivity that are exemptec f rom NRC controls would continue to be subjet t to the full range of NRC regulatory oversight, inspection and enforcement 1
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l actions to ensure compliance with any constraints, requirements, and conditions
?itablished by the Comission. For example, the Comraission may require some type of labeling so consumers can make ir. formed decisions about purchasing.a product containing exempted materials.
The NRC plans to hold pubilc meetings in each of the five regions around the country to ~ explain the Below fsegulatory Concern policy and answer questions.
The dates and locations of.these meetings will be announced later.
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The Nuclear Regulatory Or.mnission has published a new policy for determining when radiation levels are so low that they do not warmnt further regulatory control.The Bel <ne Regr</atory Ontrent, or "IIRC." policy is needed to ensure con-sistent NRC decisions on exemptions and to focus resources -
on the more significant risks posed by nuclear materials.
The policy establishes a framework for making future -
exemption decisions and for reviewing previous exemptions.
Ilowever, the llRC nlicy does not in itself exempt any radia-I tion levels from regulatory control. Instead, the Commission '-
will use the Imlicy in developing new rules or amending existing ones. evaluating petitions for exemptions that may be received from members of the public and taking specific licensing actions involving exemptions of nuclear materials.
l'ossible applications of Ihe llRC gmlicy include:
l Cleanup of contaminated sites.
- Distribution of consumer pnxlucts containing small l
amounts of nuclear materials.
- Disposal of very low-level radioactive waste and
- Recycle or reuse of slightly contaminated equipment L and materials.
This pamphlet summarizes the IIRC policy and describes why the policy is needed now how it will benefit the public.
what criteria the NRC will use in making IIRC decisions and -
how t he policy will be implemented. The aim of I his Imklet is to provide information almut the llRC policy. NRC believes that the policy will adequately inotect the public health and safety and the envimnment. Indeed. NRC does not expect any measurable adverse impact on the public health and safety as a iesult of the Imlicy. In thelong run. the llRC policy shonid enhance protection of the public and the enviromnent '
by allowing swiety to focus its limited resources on those nzii iabio rr0,:
E-tivities that pose the most signifie:mt risks.
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WHO IS NRC The Nuclear Regulatory Commission regulates the civil-ian uses of nuclear materials in the United States to protect C,omparison of below regulatory the public health and safety, the environment and the com-mon defense and security. This mission is accomplished ColiCerii closes to <1oses frorii ihrough: iirensing of nucicar raciiiiies and the possession. us-seleCle(I ollier radiation Sources and &simd of nucleannatedals; the dewloprnent and imple-l mentation of requirements goverm,ng h, censed activities; and inspection and enforcement activities to ensure compliance i
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WHAT IS BELOW REGULATORY-10 Brick vs. Wood Home CONCERN (BRC) l l
The"llelow Regulatory Concern,"or BRC, policy defines X'
5 Round-Trip radiation levels with such a small health risk that further -
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Cross-Country Flight regulatory efforts to reduce those levels are unwarranted and l
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may detract from our ability to address greater risks.
2 BRC Practice Affecting The BRC policy statement does not represent a dec;ian 3
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Limited Number of People to exempt any specific consumer products, wastes or other 10 l
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BRC Practice Affecting establishes the framework within which the Commission will l
rn ke dec,sions to exempt from some or all regulatory con-i P
Large Nambet of People trols certain products and activities mvolving radioactive inaterials that are below regulatory concern.
0 10 20 30 40 50 60 70 80 Radiation Dose (mrem)
WHY A BRC POLICY IS NEEDED NOW licre is h..u the slo-c rincria in the briow o nulatory concern polic v..m pat e u it h d..-cs nom <rlerted other radiation snurres.
In the past, NRC has exempted certam types, uses and
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All doses -hou n n. ept the niiline fhght ate in aserage millitems quantities of nuclear materials from regulatory control. As a pri s eat p.i nn!nnhut 'I he d.~c show n foi flyinn is from one regulatory agency serving the public. NRC always seeks to ionmi inn M ensure adequate protecfian of the public health and safety atul Ihe environment. licyond Ihis adequate protection thresh-ohl. NRC also continually seeks to improve the balance between t he risks associated wit h the use of nuclear materials and the bunten of regulations intended to ensure that those risks are adequately controlled. NRC has developed and impleinented a compichensive regulatory framework, the
lower end of which is lumnded by exemptions and other Anot her issue involved in the llRC policy is the manage-decisions that allow release of nuclear materials to the ment of wastes that contain very low levels of ndioactivity environnwnt. The NRC believes there is a need to ensure and that may not need to be disposed of in licensed disposal that existing and future exemption decisions are consistent facilities. In the 1,ow-I.evel Radioact;ve Waste Policy Amend-and continue to protect the public health and safety and ments Act of 1985. Congress directr d the N RC to consider the
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merits of "..t exempting) specific rmlioactive waste streams Implementation of the llRC policy should benefit th" from regulation...due to the presence of radionuclides..in putdic by allowing State and Federal agencies and others to sufficiently low concentration or quantities as to be below focus on the activities that imse greater risks to the public.
regulatory concem." N RC reslumded to t his direction in 1986 Specifically. Ihe public simuhl benefit tbrough:
with a specific imlicy statement on procedures for exempting
- Mor e timely ami consistent cle. map of contaminated sites.
liRC waste streams. The 1985 law and the 1986 inlicy state-
-Increased assurance that funds set aside to clean up ment laid the foundation for developing the framework and deconunission nuclear facilities are adequate, leflected in today's compr ehensive IIRC policy, which applies
- Reduced costs and overall risks to the public from man.
t he same yardstick in all cases.'li>gether with the 1986 policy, aging certain types of slightly radioactive wastes in a the new llRL pobey is needed now to help resolve issues nIanner conunensurate with their low radiological risk, associated with low level waste management in order to nuni- -
-Increased assurance of a consistent level of safety. for noze impacts on low-level waste dispos:d faciliSes m the S
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consumer pmducts containing nuclear matcrials.
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A foremost need for the llRC nlicy is related to NRC's I
responsibilit y for reguhyt mg the cleanup of contaminated com-In all of these areas, the NRC's principal goal is to ensure mercial nuclear fardities amund the country. I hiy can be that the public health and safety and the environment are d-d The NRC has selected criteria for the 4
hmadly cmegmized as the 'decomnu,ssmnm_ g issue. It arises r-d fmm NRL s need to ensme that the funds set asuk by licens-llRC policy, based on the latest scientific research and recom-ces today wd, l be adequate toclean up and(lose the facdities mendations, to establish the level at which nuclear materials at the end of their operating lifetimes. It also arises from the nmy be safely exempted fmm regulatory control.
I need to ensme that cleanup is performed in a consistent and aacquate manner. T, accomplish t hese nbjectives. N RC nceds to deter mine acceptable levels of resulual radioactivit y-how RADIATION: SOME BACKG,ROUND clean is clean enough. The liRC policy establishes the frame.
AND PERSPEC,I,IVE work foi developing these levels. It is imimrtant to develop these leveh now so that the companies responsible for Everyone is continually exposed to low levels of natu-l deconunissioning the facilities can plan, provide the neces-rally occuning radiation. The caith is continually bathed in l
sary resources and perfmm the cleanup needed to satisfy radiation from the sim and space.
l regulatory standaids.
The earth itself is also a source of rmliation; radioactive l
The cxemption of certain consumer products that mater ials exist nat umily in its soi!. mck and water. Thes e are i
contain nuch m materials is another area encompassed by a gicat many of these radioactive materials, the most com-l the Conunivioni I:RC policy. We must ensme that current mon being uranium. thorium, radium and the radioactive l
an i futme mmptions of these ymducts me consistent and forms of cmlon and potassium. Also connuon in nature is continue to pon ide an adequate level of safety to the people indon gas, a radioactive byptoduct of the small amounts of r
I w ho use !!wm. Impicmentation of Ihe I;RC policy will help inanium found in the soil and rock of many pmts of the country.
l achieve this goal.
Radiation consists of x-rays alpha and beta particles.
gamma rays and of her components. When they pass through i
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- i the human lawly, they may damage some cells in the lu uly. If The remaining 20 percent or so comes fnnu man-made damaged. some cells may not survive or repngluce normally.
sources of radiation including medical x-rays and nuclear Other damaged cells niay survive, but m a mixlified fonn.
medicine technologies, which together account for almut 15 which may later result,m a cancer. Other health effects from percent. and consumer pn ulucts. occupational exposures and radiation mclude birth defects and inhented diseases. \\ery various other sources. which account for the remaining large doses of radiation over short perimls may canse org:m percentage.
damage and, if high enough, death.1)oses associated with natural background radiation and the llRC criteria are thou-sands of times lower than the high doses that are so destruc.
Examples Of natural tive. At low doses the principal concern is the possible padja[jOn eXpOSUIt appearance of cancer years after the exposure to radiatmn.
Other effects such as birth defects and inherited diseases are f
less likely' f-
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FROM TIIE SKY-Almut A unit of radiati is called a.. rem. A..milb. rem (abbreviated mrem) gm dose.
30 millirem per year from is one-thousandth of a rem. Evidence cosmic radiation.
from high doses (from tens of rem) delivered quickly Jin
%.j seconds to hours) indicates that the probability of causmg cancer from radiation increases with the dose received. For doses in the range pn vluced by natur;d background radiation.
however, the probabihty of pnxluemg cancer has not been directly established, because it is impossible to distinguish
. FROM Tile AIR TilAT WE IIREATilE-Almut 6
cancers pn xtuced by such low levels of radiation from cancers 200 millirem per year.
m including radon.
7 pnvluced by other phenomena. Therefore, in estimating the "g
consequences of any exposure 1o radiation,it is assumed that the chance of developing cancer is linemly progational to m
dose and that there is no threshold below which there is no FROM OUR FOOD AND
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chance of cancer. This chance or risk is expressed in terms DRINK-Almut 40 milli-W of probability because a given dose of radiation does not mo g yr from natural
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pn xluce a cancer in all cases. The International Commission radioattive materials such on Radiological I'mtection t ICRI') and Ihe U.S. National Coun.
as tesiuman.
cil on Radiation l'rotection and Measurements (NCRI') have both endorsed the " linear. no-threshold" approach and the philosophy that radiation exposure should be kept as low as
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reasonably achievable. The U.S. Nuclear Regulatory Cmn.
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FROM SOII.S AND mission need Ihese piinciples in developing its llRC policy.
E g g g, g_ g e-BUH. DING M ATERIAl.S-About 30 millirem per W.e all teceive doses of naturally occurring radiat. ion every day. It romes from space the air we breath, the water
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rmclides such as manium.
we drink. the foint we cat the buildings we live and work in.
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and even our own bmhes and the people we hve and work with. Such sources contribute about 80 percent of the aver-Naturally occurring sources of radiat. ion are all around us.Th.is c an ows um aver ge annual radi bon dose fmm natural back.
age annual radiation dose received by the U.S. population.
ground sources.
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our lifestyles and daily activities vary these amounts to bricks are made. In addition, shouki your Imnye be in a certain some extent. For example, if you live in I)enver. "the Mile area of the country where there is nmre uramum or radium m Iligh City." rather than a sea level city such as Washington.
the soil you may have a high concentration of radon in your 1).C.. you receive an additional averag'e annual exposme of house. The dose from radon in the home averages 200 milli-some 70 millirem, because the dose from cosmic radiation rem per year in the United States. but can range up to several essentially doubles with each 6.600 feet of altitude and the thousand inillirem per year.
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soil of the Rocky Mountains contains higher concentrations of The N RC has created the framewor k for its new policy at natural radioactive materials. liy the same token. a flight on a a level of individual radiation dosage well below these varia-conuner cial airliner increases your exposure to cosmic rays at tions resulting from natural sources. It is at these very low the rate of about 5 millirem for the time spent in a single levels, involving cmrespondingly low risks, that the NRC '
round trip cross-country flight.
would consider exemptions from regulation and deem certain Also, if you choose to live in a brick home instead of one practices "below regulatory concern."
l made of wood you may add up to 10 millirem per year to your With this as background,let's turn to the specific princi-annual radiation exposure due to the naturally occurring ples and criteria that the NRC used in establishing a llRC j
thorium, uranium and radium found in the clays of which policy and how it plans to implement that inlicy.
Contribution of various radiation sources to the average radiation BRC CRITERIA dose in the U.S. population what leveis of radiation and risk piace products ana 10 internal activities in the category considered below regulatory con-g i
Terrestrial 11 %
Medical cern? And how did the NRC arrive at its new criteria, along 8%
x nays with its principles of exemption, for a fonnai HRC policy?
Costnic Nuclear First the principles: A major consideration in exempting 8%
Medicine any practice from regulatory control hinges on Ihe question of
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whether the control is necessary for protecting the public
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health and safety and the environment. The need for Consumer
- Products regulatory control decreases as the dose and its nsks to the exposed mpulation decrease. The NRC believes that the 3%
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granting of specific exemptions from regulatory controls Other <1%
Should depend essentially on an evaluation of whether the occupationai o.3 %
risks are sufficiently small and whether fur 1her reductions in Fa!!out
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dose justify the effort to achieve them. Therefore, the NRC believes that radiation dose criteria for Imth individuals and Radon uel ycle 0.1 %
t he exposed population should be basr features of its overall 55%
Miscenaneous 0.1%
policy. That policy should define the region where efforts to further reduce exposures are no longer warranted.
Mnut 82";of the average radiation dose in the U.S. impulation The question then is: llow low is low enough when it comes from natural sources. Of the remaining 18";. representing comes to risks and dose? At what point is it clearly unneces-man made radiation sources, the largest percentage is attributable sary to further reduce the risk or dose?
to medical x rays. t Used with permission of the National Council on In selecting the HRC dose criteria. the Commission noted Radiation protection and Measurements.)
that. even though there is significant uncertainty in calcula-
l limv do these dose levels translate into risks? The 10 tions of iisks fn,m low. level radiation, in general these nsks are hetter understewwl th:m the risks from of her haz:uds such inillirem per year cormspmds to an aimual risk of death from a nuliation iiuluced cancer of about 5 in 1 million. The I as toxic chenucals. In athlition radiation from natural bach-iHi h-is N a rid of about 5 in grouini is a fact of life and pmes intohmtary iisksIhat are the 10 miHion' l
s:nne as the kinds of risks posed by nuclear materials niuler va on to ty nuh.. lual dose en..teria. NRL. will also In mhho.
the N RC's jmisdiction.
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,l'he t.ommission believes that if the n. k to iiulivuluals ensure that 'he total unpact of an exemption is appropriately s
ini ized thmugh a collective dose criterion. The "colkc-l from a puuluct or activity umler consideration for exemptmn tiw"deisam m of theimpactof thepracticeonsocietv is comparalyh to other usks. knowingly ni unknowingly tolcr-as a whole. It is the sum of the individual doses.The Conunis-ated by u, nhvnluals because of factors such as their lifestyle
& Mi ves that if the collective dose nsulting from a given or where they live. then the level of prote:ction from that ice is less than 1.000 person rem per year (equivalent to activity should be adequate. Related to this, vanations in 1.000.000 individuals receiving i millirem per year).
natural harkground radiation such as the 40 nmlirem per year difference lletween average annual doses received in COmI)ariSOH Of helOW regulalOry Denver versus Washington,11.L. appaiently play no role m individuals' decisions on w hcie so live or wor k. Nor do people Concern dOSCS to doses from natural seem to be conceined almut the difference in doses between haCkgrOUnd and medical exposures htmg m a hn,ck or frame house, the 5 nullirem dose from a round-trip coast-to coast air flight, or the dose fiom other
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12 backgioond doses suggests that individual doses in the range aseman of 10 milliicm and below wouhl be appmpriate foi use as an 7//gj' 50 All Medical Exams individual dose criterion. Ilowever, the dose entena must 1
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also be selected so that thev are consistent with technological Natural Radioactive 9'gy 40
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Materials in the Body capabilities to monitor and assess doses. In addition, dose ciiter ia below those selected by the N RC conhl unnecessarily I
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diveit attention and resources from more significant healtii E Wah hdng 3g Limited Number of People and safety ; rograms.
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Taking all this into considention. NRC decided that an m
individual dow of 10 milliscm pn year would be appropriate y6 Chest X-Ray foi use as the Connniwion's llRC individual dose criterion.
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Ilowever, until more experience is gained with the potential j
BRC Practice Affecting foi individual exposme from multiple sources, the Conunis-Large Number of People sion decided that an intnim individual do>r niinion of I mil /ncm to n or uonhl be applied to those practices involv.
0 50 100 150 200 250 300 350 ing widespic.id disnibution of material containing radioac-Radiation Dose (mrem) tive substances. such as consumer products nr verycled mateiial and npiipment. The inteiim criterion provides addi-This rhmt compares levels of iadiation exposme established tional a+nt ance t hat public doses will r emain a small fraction by ihe Commission as below senulatory conerin IWClin levels of of background radiation and of generally recognized dose udiation esposme in natural background and to medical expo limits for meinhers of the public.
suos Mi dom show n except the chest x ray ate in asciage milb-iem twr year per itulisidual. The 6 inilbrem < hest vray dose is fm one sinnic x-ray for an iridicidual.
1 l
resources would be better spent addressing more significant In ddition. NRC would continue its comprehensive program health and safety issues. At this c611ective dose level, the oHu ensing. mspection and enforcement for that process.
annual number of health effects for an exempted practice is Issuance of the llRC policy statement does not repre-calculated at less than one and could be zero.
sent a decision to exempt any specific consumer products.
These values will provide a consistent risk basis for w stes or other materials or practices from regulatory contml.
fut ure s ulemaking or licensing decisions. making such imple-Rather the Imlicy statement is a framework for makmg mentation a practical undertaking. NRC believes that exernption decisions.
regulatory exemptions using the individual and collective The policy will be implemented principally through the 1
dose criteria will pmvide reasonable assurance that individ.
NRC's rulemaking process. Exemption decisions could also ual exposures to the public fmm all licensed activities and be made through specific licensing actions.
exempted practices will not exceed the generally recognized In the case of rulemaking, a proposal for exemption, dose criterion for members of the public of 100 mrem per whether initiated by the NRC or requested by outside parties year, given the Commission's intent to:
in a petition for i ulemaking, would have to be supported by an
- Imimse both individual and collective dose criteria, adequate technical basis. The Commission would review this
-Consider the total impact of a proposed activity tnot basis in deternyining wlyether the basic policy conditions have -
just a portion of a practice),
been satisfied m its decision. Such a proposa! would generally nave to address the mdividual and societal impact that could
- E, valuate the intential that people may be exposed t" result if the exemption were granted. To do this the prormsal more than one exempted practice, would have to consider the uses of the radioactive materials. *
- Evahiate intential eximsures over the lifetime of the their pathways of exposure and their levels of radioactivity. it
- practice, would also have to consider appropriate methods and con-g4
- Monitor and verify how exemptions are implemented straints for ensuring that the doses from the exempt practice 15 l under this policy.
remain sufficiently low.
- Verify dose calculations through licensing reviews and I'roposed rules will be published in the Federal Register rulemakings with full benefit of public review and to solicit public comments.The rulemaking action would also comment and inchide an appropriate level of envimnmental review under
- Inspect and enforce licensee adherence to specific con.
the National Environmental Policy Act to ensure that envi-ditions and constraints imposed by NRC on exempted ronmental impacts are adequately considered.
practices.
The second means of implementing the llRC policy would involve exemptions granted through licensing actions.
The public will be invited to comment on new licensing IlIK,101I0,7 IMI'I EMEN,l'A,I, ION actions on exemptions under the ilRC policy if they aiffer W ith 1I e ciit iUfor both individual and collective honi previous generic exemption decisions.
exposures. the NRC uill have a framework for reviewing if a podud or py u1 ice goes dnough aH me nuessary icquested cwmptions fo.ni segulatory contml for certain pmcedmes ayul nwi5cs an exemption, is it then free of further surveillance? No.,I he NRL will verify that licensees poulurts or acovitics llouever other specified conditions
- N'"'" '""X"*D'I"" C"nstramts and conditions through the will also have to be met, such as determining that the risk agency'slicensing.inepertion and enfoicement programs. As from an anid. nt m fmm misuse unnhl be very low. The pmduct, t he t." C""N"" 0"I *"ommissmn may reqtme some
"""*""Pk "I Conunission alxo may place reitain conditions on cotistsaints on the actis it s that genciates ni manufartmes the exempt inaterial such as limits on the total quantity of radioactisity
"" d'"I ""nsunuts can make y,nfonned dec,sions aMut Se i
junchase of a inoduct conta,nung exernptM materials. S,uch.
aint icstrictions on ihe transfer of materials to exempt status.
a, m.
- - - - - - -
=
= ~-. - mm:m.e m-
~r
,r s
-3 j s;,
~
labeling is inesently it;<ptired by the Cominission for sumki..
detectors containing radioacti6 inaterial; The NRC m:iv. determine nn the basis of risk estimiites atul associated tmcertainties that sgmcific practiies siinuld
- N not im considered candid:ites for ext mption A lnime Mato-
. ple wouhl luf the inttwtuitihn of radioactive materials into.
. pnnlucts to hit used pritiiarily by chihlren.?Such practices wouhl be specifically. evaluated tai determine if they could -
result in gr eater risk levels t9 expo <ed member s of the public' than those found ricceptable by the Commission lin formulat-
~
ing its itRC policy.
BRC AllNALTHOUGHT i
NRC believes that implementatiain of this policy will-2 adequately paitect public health and safety and the envimie ment. Also, its impleineiitation hill allow the NRC States and licensees to devote more of their limited time. trained personnel atul funds to nuclear-telatid matters that are t
associated with potentially higher phblic health risks. It may 16,,
also allow other organiiations in'.such fields as health care, ccientific research and the development of new and useful-pnnlucts and services, to dernte more of their resources to activities that contribiite to greater health arid safety protec-tion in addition to better serving the public.
Itut the success of any public policy depends largely on its understanding and acceptance by the public.
We hope Ihat this Imoklet and its explanation of our new below regulatory concern policy cont ribute toward these ends.
t 1
iRadiation do<c data in the charts in this painphlet are taken -
directly or deriwd fmm retorts of the National Council on Radia-tion l'rotection arul Measmements (NCRh. Itethesdai MI). The figure of to millhem a+hhtional dose imm living in a brick rather.
2:
Ih:m a frame home is driimi from NCRP Regwirt No,9 t."Eximsure of the 1%pulation in the_ l'ni?cd States and Canad;i from Natur.1-Itackno.und R.idution? 1987. Allother dataare from NCRP Repott No 9:. "lonizmg Radiation Esposure of tin Ibpulation of ti:e Iinited States.~ 19SD
~
i ei nioie infonnation contact:
I!X Noticas. Herut.uos y Commission.
Puhtic At tairs. Washington. IW 20555.
lhis twktet was pritated assin(
recycled paper.
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NUCLEAR REGULATORY COMMISSION Below Regulatory Concern; Policy Statement AGENCY:
Nuclear Regulatory Commission, waste in a manner commensurate with their low radiologi-cal risk; and (5) increased assurance of a consistent level ACTION:
Policy statement.
of safety for consumer products containing radioactive g
SUMMARY
- This policy st tement establishes the frame.
material under the Commission's jurisdiction.
work within which the Commission will formulate rules or EFFECTIVE DATE: July 3,1990 J
make licensing decisions to exempt from some or all regu-latoryy controls certain practices invohing small quantities of radioactive material. Opportunity for public comment ADDRESSES: Documents referenced in this policy state-will be provided with each rulemaking and each licensing ment are available for inspection in the NRC Public action where generic exemption provisions have not al-Document Room,2120 L Street, N. W. (Lower Level)'
ready been established. The exemptions may involve the Washington, DC' release of licensee-controlled radioactive material either FOR FURTIIER INFORMATION CONTACT:
to the generally accessible environment or to persons who would be exempt from Commission regulations. Practices The appropriate NRC Regional Office:
for which exemptions may be granted include, but are not limited to, (1) the release for unrestricted public use of Region 1 -
Dr. hfalcom Knapp, King of Prussia, lands and structures containing residual radioactivity;(2)
Pennsylvania; telephone (215) 337-5000 the distribution of consumer products containing small Region II - Mr. J. Philip Stohr, Atlanta, Georgia; tmounts of radioactive matenal; (3) the disposal of very low-level radioactive waste at other than hcensed disposal telephone (404) 331--4503 sites; and (4) the recycling of slightly contaminated equip-Region 111 - Mr. Charles E. Norelius, Glen Ellyn, ment and materials. As described in this policy statement, Illinois; telephone (708) 790-5500 NRC intends to continue exempting specific practices from regulatory controlif the application or continuation Region IV - Mr. Arthur B. Beach, Arlington, Texas; of regulatory controls is not necessary to protect the pub.
telephone (817) 860-8100 lic health and safety and the environment, and is not cost Region V - Mr. Ross A. Scarano, Walnut Creek, effective in further reducing risk. The pohcy statement defines the dose critena and other considerations that will California; telephone (415) 943-3700 be used by NRC in making exemption decisions. The Federal and State Government Officials may contact:
policy establishes individual dose criteria (1 and 10 mrem Mr. Frederick Combs, U.S. Nuclear Regulatory Commis-peryear [0.01 and 0.1 millisievert peryear])and a collec-sion, Washington, DC 20555, Office of Governmental tive dose criterion (1000 person rem peryear [10 person-and Public Affairs, telephone (301) 492-0325.
sievert per year]). These criteria, coupled with other con-siderations enumerated in the policy statement, will be Questions may also be directed to the following major factors in the Commission's determination on individuals at the U.S. Nuclear Regulatory Commission, whether exemptions from regulatory controls will be Washingtor, DC 20:55.
granted.
Dr. Donald A. Cool, Oifice of Nuclear Regulatory The policy statement establishes a consistent risk frame-Research; telephone (301) 492-3785 work for regulatory exemption decisions, ensures an ade-quate and consistent level of protection of the pubhc in Mr. John W. N. Hickey, Office of Nuclear Material their use of radioactive materials, and focuses the Na-Safety and Safeguards; telephone (301) 492-3332 tion's resources on reducing the most significant radio-Mr. L J. Cunningham, Office of Nuclear Reactor logical risks from practices under NRC's jurisdiction. The Regulation; telephone (301) 492-1086 average U.S. citizen should benefit from implementation of the BRC policy through (1) enhanced ability of NRC, SUPPLEMENTARY INFORMATION:
Agreement States, and licensees to focus resources on more significant risks posed by nuclear materials; (2) timely and consistent decisions on the need for cleanup of Statement of Polic}'
contaminated sites; (3) increased assurance that funds Introduction
- available to decommission operating nuclear facilities will be adequate: (4) reduced costs and overall risks to the Ionizing radiation is a fact of life. From the day we public from managing certain types of slightly radioactive are born until the day we die, our bodies are exposed to I
m
. BRC Policy Statement
-low levels of radiation emitted from a variety of natural policy translates the Commission's judgement on accept-cnd man-made sources,- including the cosmos, earth, able risk into explicit and practical criteria on which to -
building materials, industrial facilities, clothing, medi-base decisions to exempt practices from the full scope of eine,-food, air, and our own bodies. All materials exhibit NRC's regulatory program.The HRC criteria are neces-some degree of radioactivity.The consensus among scien-sary to ensure adequate and consistent decisions on ac-tists is that even low levels of radiation typical of the ceptab!c risks posed by decontaminated and decommis-natural environment pose some correspondingly low risk sioned nuclear facilitics, consumer products containing 2
of adverse health effects to humans. Recognition of the radioactive materials, and very low activity radioactive risk due to radiation exposure from natural sources pro-wastes.nese decisions will be implemented by the Com-vides perspective on the risks associated with human uses mission through rulemakings and licensing decisions of radioactive materials, based on carefut and thorough analyses of the risks associ-ated with specific practices to ensure that the public is Natural and man-made radionuclides are used in adequately protected, today's society in many forms for a variety of purposes,
- such as medical therapy and diagnosis, materials analysis, Under the regulatory approach used by the U.S.
and power generation. In general, the existing regulatory Nuclear Regulatory Commission (NRC), the use of radio-framework ensures that radioactive materials are con-active materials is subject to limits and conditions that r
trolled consistent with the degree of risk posed to the ensure the protection of the health and safety of both public and the environment. Some products such as werkers and members of the general public, and the emi-smoke detectors contain small quantities of radioactive ronment. For example, radioactive material is controlled materials that pose such a low risk that they have been by NRC and Agreement State licensees to ensure that widely distributed without continuing regulatory controls, dose limits are not exceeded. In addition, sources of radia.
To require that all radioactive materials be controlled in tion are designed, used and disposed of in a manner that the same strict manner regardless of the risks they pose ensures that exposures (o radiation or radioactive mate-would not be a sound use of limited National resources.
rial are as low as is reasonably achievable (ALARA),
Such strict control could also deprive society of the bene-economic ai / uial factors being taken into account.
fits already derived from appropriate uses of radioactive NRC has enconed the ALARA provision in regulatory materials and radiation. In addition, such ectrol would practice for a number of years (10 CFR Part 20). How-not sigr.ificantly reduce the risks associated with radiation ever, NRC has not yet provided criteria that wotil estab-l exposure from controlled sources compared with risks lish the basis for defining the level of residual risk at which associated with natural background radiation.Therefore, further regulatory control is no longer warranted.
responsible decisions need to be made on how radioactive materials are controlled based on a judgement about the The policy staternent in today's notice provides a levels of risk they pose and the effectiveness of regulatory unifying risk framework for making decisions about which control to reduce those risks, practices can be exempted from the full scope of NRC's comprehensive regulatory controls. Under the criteria Over the last several years, the Commission has and principles of this policy statement, exemptions of pursued development of a risk threshold to distinguish radioactive materials from regulatory controls would in-
-those radioactive materials that do not require the same volve the transfer of very small quantities of the materials stringent level of regulatory control as that imposed on from a regulated to an unregulated status. NRC will ana-potentially more hazardous materials. The Commission lyze each proposed exemption to ensure that doses result-recognized throughout this process that the threshold ing from the proposed transfer will be sufficiently low that would need to be low enough to continue to ensure ade-the public health and safety and the environment will quate protection of the public. The Commission also rec-
- emain adequately protected. A licensed activity produc-ognized that the threshold should be compatible with ing an exempt material would continue to be subject to
. technological and measurement capabilities so it could be the full range of regulatory oversight, inspection, and readily used in NRC's regulatory program for nuclear enforcement actions up to and including the point of materials. In addition, the Commission identified the transfer to an exempt status. The Commission.also in.
need to balance incremental reductions in risk below the tends to conduct research periodically to evaluate the safety threshold with the attendant expenditure of private effectiveness of this policy and to confirm the safety bases and public resources.
that support the exemption decisions.
In today's notice, the Coramission establishes a pol-Through appropriate rulemaking actions or licens-icy to guide its decisions on which radioactive materials ing decisions, the Commission will establish constraints,
~
are "below regulatory concern" (BRC) because the low requirements, and conditions applicable to specific ex-levels of risk they pose do not warrant regulation to the emptions of radioactive materials from NRC's regula-same degree as other radioactive materials to ensure ade-tions.The NRC will verify that licensees adhere to these quate protection of the public and the environment.This exemption constraints and conditions through NRC's li-2
a BRC Policy Statement censing, inspection, and enforcenient programs. For ex-their risks to the public and the emironment. The Food tmple, the Commission may promulgate regulations that and Drug Administration (FDA), for example, has ap-would require some type of labeling so that consumers plied sensitivity-of-method, risk based guidelines in con-
-l could make informed decisions about purchasing a prod-nection with the regulation of animal drugs, food con-uct containing exempted materials. Such labeling is pres-taminants, and trace constituents in some food additives.
ently required by the Commission for smoke detecters Sim!1arly, the Emironmental Protection Agency (EPA) containing radioactive material (ree 10 CFR 32.26), The established exemption or threshold levels based on indi-NRC ensures that manufacturers label the detectors in vidual risks in the regulation of pesticides and other toxic compliance with the labeling requirement through licens-and carcinogenic chemicals. For example, EPA employs ing reviews and inspections. Specific source controls and such a concept in defining hazardous waste through the exemption conditions are not discussed further in this new Toxicity Characteristic rule in 40 CFR Part 261 [55 policy because they will be more appropriately addressed FR 11798; March 29,1990].
m developing the exemption requirements for specific exemption proposals.
The Commission believes that the Below Regula-tory Concern policy is needed to establish a consistent, The concept of regulatory exemptions is not new.
risk-based framework for making exemption decisions.
The Atomic Energy Act of 1954, as amended, authorizes Specifically, this framework is needed to (1) focus the the Commission to exempt certain classes, quantities, or resources of NRC, Agreement States, and licensees on
-(
uses of radioactive material when it finds that such ex.
addressing more significant risks posed by nuclear matcri-emptions will not constitute an unreasonable risk to com-als; (2) ensure that beyond the adequate protection mon defense and security and to the health and safety of threshold potential benefits from additional regulation
~
the public. In the 1960s and 1970s, the Atomic Energy outweigh the associated burdens; (3) establish residual Commission used this authority to promulgate tables of radioactivity criteria and requirements for decommission-'
j exempt quantities and concentrations for radioactive ma-ing and cleanup of radioactive contamination at licensed terial. These exemptions allow a person or a licensee, and formerly licensed facilities; (4) ensure that licensee under certain circumstances, to receive, possess, use, decommissioning funding plans provide adequate funds transfer, own, or acquire radioactive material without a to cover the costs of cleanup of these facilitics to protect requirement for a license (30 FR 8185; June 26,1965 and people and the emironment; (5) ensure that the public is 35 FR 6425; April 22,1970).The Commission currently consistently protected against undue risk from consumer allows distribution of consumer products or devices to the products that contain radioactive materials under the general public and allows releases of radioactive material Commission's jurisdiction; (6) provide decision criteria to the environment consistent with established regula-for reviewing petitions to exempt very low-level radioac-l tions. For example, regulations currently specify the con-tive wastes in accordance with the Low-Level Radioactive l
ditions under which licensees are allowed to dispose of Waste Policy Amendments Act of 1985; and (7) ensure small quantities of radioactive material into simitary that existing exemptions involving radioactive matm-ials sewer systems (see 10 CFR 20.303).These existing regu-are consistent and adequate to protect the public, lations specify requirements, conditions, and constraints j
that a licensee must meet if radioactive materialis to be The Commission's BRC policy establishes an ex-l
" transferred" from r. regulated to an exempt or unregu-plicit and uniform risk framework for making regulatory -
l lated status, exemption decisions. 'Ihis policy will also be used by the Commission as a basis for reevaluating existing NRC ex-More recently, Section 10,0f the Low-Level Radio-emptions to ensure that they are consistent with the crite-active Waste Policy Amendments Act (LLRWPAA) of ria defined herein. In lieu of such a policy, the Commis-1985 directed the Commission to develop standards and sion could continue the current practice of evaluating procedures and act upon petitions "to exempt specific exemptions on a case-specific basis. Such an approach, radioactive waste streams from regulation... due to the however, does not ensure consistent evaluation and con-presence of radionuclides.. in sufficiently low concentra-trol of risks associated with exempted practices. For this tions or quantities as to be below regulatory concern."
reason and the reasons discussed above, the Commission The Commission responded to this legislation by issuing a has established the BRC Policy Statement. This policy policy statement on August 29,1986 (51 FR 30839).That supersedes the Atomic Energy Commission's policy l
policy statement contained criteria that, if satisfactorily statement on this subject [30 FR 3462; March 16,1965]
l addressed in a petition for rulemaking, would allow the Commission to act expeditiouslyin proposing appropriate The Commission recognizes that Agreement States relief in its regulations on a " practice-specific" basis con-will play an important role in the implementation of the sistent with the merits of the petition.
Below Regulatory Concern policy, specifically in the ar-eas of developing and enforcing compatible State regula.
W"al and State agencies have also developed and tions, regulating cleanup and decommissioning of certain implo "d similar exemptions based on evaluations of types of contaminated nuclear facilitics, and exempting 3
BRC Policy Statement certain low level radioactive wastes from requirements sites.The Commission is also concerned that inconsistent for disposal in licensed low-level waste disposal facilities.
regulation of BRC waste could in fact undermine State The Atomic Energy Act of 1954, as amended, gives to the and Federal efforts to manage low-level waste safely. A Federal government the exclusive authority to regulate uniform framework for exemption decisions is needed source, special nuclear, and byproduct materials to en-now to avoid disrupting State and compact development sure protection of the public health and safety. While of new disposal facilities close to Congressional mile-Congress subsequantly provided for Federal-State agree-stones in 1993 and 1996. Such a framework may also ments under Section 274b of the Atomic Energy Act facilitate the resolution of the mixed waste issues for through which States could assume regulatory responsi-these BRC wastes.
bilities in lieu of Federal regulation for certain classes of nuclear materials, it required that State radiation protec-The policy described in this document is intended to tion standards be coordinated and compatible with the provide the public health and safety protection frame-Federal standards for radiation protection, work that would apply to a wide spectrum of Commission exemption decisions. As such, it provides individual and NRC regulations exempting BRC wastes will not collective dose criteria, and discusses other important affect the authority of Stata or local agencies to regulate elements of the exemption decision. making process. Sec-BRC wastes for purposes other than radiation protection tion Il provides definitions of key terms and concepts used in accordance with Section 274b of the Atomic Energy in the policy statement.Section III presents the basic Act. Under the Atomic Energy Act, Congress intended elements of the policy, while Section IV discusses how the that there be uniformity between the NRC and Agree-policy will be implemented through rulemakings and li-ment States on basic radiation protection standards. Fu-censing actions and describes how the public will have an ture BRC Rulemakings will establish basic radiation pro-opportunity to comment on the Commission's exemption tection standards below which regulatory oversight is not decisions. Tnis section also notes NRC plans to review needed. The Commission will address compatibility is-past exemption decisions to ensure consistency with the sues in future rulemakings, in initiating proceedings to risk framework described in the BRC policy.Section V implement NRC's URC policy, the Commission will con-describes, in general terms, the information needed to tinue to consult with and seek the advice of the States.
support the exemption decision making process.
l Some States have expressed concerns that economic II. Definitions.
l and institutional impacts of actions resulting from the
. "ALARA" (acronym for "as low as is reasonably Commission's BRC policy may undermine their efforts to achievable") mcans making every reasonable effort to develop new disposal facilities for low level radioactive maintain radiatien exposures as far below applicable dose waste in accordance with the low-Level Radioactive limits as is practical, consistent with the purpose for which Waste Policy Amendments Act of 1985. These States the licensed activity is undertaken taking mto account the would prefer to establish their own standards for deter, state of technology, the economics of improvements tn mining which wastes should be exempted from regulatory relation to benefits to the public health and safety, and control rather than adopting standards that are compat-other societal and socioeconomic considerations and in ible with uniform Federal standards.The Commission has relation to utilization of nuclear energy and bcensed ma-oeveloped the DRC policy to provide a uniform and con, terials m the pubhc mterest.
sistent health and safety framework for exemption dec,
sions. In so doing, the Commission recognized the
,, means a"Y tate with which the S.
8 3
concerns expressed by Congress when it enacted the Iow-Commission has entered into an effective agreement un-Level Radioective Waste Policy Amendments Act of 1985 der subsection 274(b) of the Atomic Energy Act of 1954, that health, safety, and environmental considerations as amended.
should take precedence over economic or institutional concerns (see Senate Report 99-199 that accompanied
" Byproduct material" means-S.1517, Senate Committee on Energy and Natural Re-sources, November 22,1985,99th Congress,1st Session (1) Any radioactive saaterial (excep' special nu-at page 9).
clear material) yielded in, or made radioactive by, exposure to the ra'Jiation incident to the The Commission is confident that waste exemption process of producing or utilizing special nu-decisions made in accordance with requirements that im-clear material; and plement its B RC policy will be adequate to ensure protec-tion of the public health and safety. The Commission is (2) The tailings or wastes produced by the extrac-concerned that inconsistent regulation of BRC wastes tion or concentration of uranium or thorium could result in differing levels of risks to the public and from ore processed primarily for its source ma-the environment through the application of different re-terial content, including discrete surface wastes sidual radioactive criteria in the cleanup of contaminated resulting from uranium solution extraction 4
BRC Policy Statement processes. Underground ore bodies depleted
" Natural background dose" means the dose received bv these solution extraction operations do not from naturally occurring cosmic and terrestrial radiation conotitute " byproduct material" within this and radioactive material but not from source, byproduct, i
definPion.
~j L
" Collective dc se"is the sum of the individual doses
" Practice" is a defined activity or a set or combina-(total effective doso equivalents) received in a given pc.
tion of a number of sirnilar coordinated and continuing riod of time by a specified population from exposure to a activities aimed at a given purpose that involves the po-specified source of radiation (or practice involving the use tential for radiation exposure. Disposal of specified types of radioactive materia 0. Note: The calculated collech of very low level radioactive waste; the release for unre-dose used to determine mmpliance with the ciiterion of stricted public use of lands and structures with residual this policy need not incluce individual don contributions levels of radioactivity; the distribution, use, and disposal
- received at a rate of less than 0.1 mrem per year (0.001 of specific consumer products containing small amounts mSv/ year).
of radioactive material; and the recycle and reuse of spe-cific types of residually contaminated materials and
" Committed effective dose equivalent" is the sum of equipment are examples of [iractices for which this policy the products _of weighting factors applicable to each of the will have potential applicability. (See Section Ill for fur-body organs or tissues that are irradiated and the commit.
ther discussion of practice).
ted dose equivalent to those organs or tissues.
" Rem" is the special unit of dose equivalent (1 rem -
" Deep dose equivalent" is the dose equivalent at a
- 0.01 sievert).
{
tissue depth of I cm.
" Risk," for purposes of this policy, means the annual l
" Dose" or " radiation dose" in this policy is the total or lifetime probability of the development of fatal cancer
[
fr m exposure to tomzmg radiation and is taken as the 1
effective dose equivalent, product of the dose received by an exposed individual and l
a e nyersion factor based upon the linear, no-threshold
" Exemption from regulatory control" refers to a de-hypothesis. The conversion factor for dose to risk is taken l
cision process that may allow radioactive material to be to be 5 x 10 fatal cancers per rem of radiation dose.The
]
transferred from a regulated status to an unregulated fatal cancer risk is considered, m general, to be more 3
i-status, in which the material will no longer be subject to y an ra tion mduced health effects and to -
l l
NRC requirements. Decisions to grant exemptions will be be the most severe outcome to an m, dividual. W,hile the based upon findings by reason of quantity or concentra-C mmission recognizes that the risks from exposure to tion that the radioactive material poses a small risk to radiation are greater for children than adults and that public health and safety and the environment and that the there are increased risks from exposure to the embryo /
small magnitude of the risk does not warrant expenditure fetus, the estimate of fatal cancer risk for all ages and both of additional resources of regulatory agencies and the sexes is considered to be an appropriate measure of risk l
regulated community in attempting to further reduce the fr m Practices bemg considered for exemption in accor-nsk.
dance with this policy statement (see Appendix).
l
" Exposure" means being exposed to ionizing radia-
" Source material" means -
tion or to radioactive matenal.
(1) Uranium or thorium, or any combination of j
" Licensed material" means source material, special uranium and thorium in any physical or chemi-t nuclear material, or byproduct material that is received, cal form; or 6
l
. possessed, used, transferred, or disposed of under a gen-l eral or specific license issued by the Commission or an (2) Orcs which contain, by weight, one-twentieth Agreement State.
of one percent (0.05 percent), or more, of ura-
. nium, thorium, or any combination of uranium
" Licensee" means the holder of an NRC or Agree-and thorium. Source material does not include l
ment State license, special nuclear material.
" Linear, no-threshold hypothesis" refers to the the-
"Special nuclear material" means -
ory that there is a proportional relationship between a given dose of radiation and the statistical probability of (1) Plutonium, uranium-233, uranium enriched in I
the occurrence of a health effect (such as latent cancers the isotope 233 on in the isotope 235, and any and genetic effects), and that there is no dose level below other material which the Coramission, pursu-which there is no risk from exposure to radiation.
ant to the provisions of Section 51 of the Act, 5
BRC Policy Statement determines to be special nuclear material, but Such practices should be specifically evaluated to deter-does not include source material; or mine if they could result in greater risk levels to exposed
{
members of the public than the levels found acceptable
' (2) Any material artificially enriched by any of the by the Commission in formulating this policy. These deci-foregoing but-does not include source material.
sions clearly fall within the Commission's purview to pro-tect the health and safety of the pubile.
" Total effective dose equivalent" rneans the sum of In formulating this policy statement, the Commis-the deep dose equivalent (for external exposures) and the sion deliberated at length on the need to consider committed effective dose equivalent (for internal expo.
whether practices must be rigorously justified in terms of
~
sures) expressed in rem or sievert.
societal benefit regardless of the level of risk they pose.
Justification of practice is recognized by health physics pr fessi nals and national and international organiza-III. PolicI Elements
- tions as one of the three fundamental tenets of radiation The purpose of this policy statement is to establish protection (justification, dose limits, and ALARA). The the risk framework within which the Commission will Commission has prepared this policy statement in confor-initiate the development of appropriate regulations or mance with these basic tenets as appropriate for exemp-make licensing decisions to exempt certain practices from tion decisions. Consistent with the position of the Inter-some or all regulatory controls. This policy is directed national Atomic Energy Agency in its Safety Series e
principally toward rulemaking activities but may be ap-Report No. 89, the Commission believes that justification plied to license amendments or license applications in-decisions usually derive from considerations that are volving the release of licensed radicxtive material either much broader than radiation protection alone.The Com-to the environment or to persons who would be exempt mission believes that justification decisions involving so-from Commission regulations. In either case, opportunity cial and cultural value judgments should be made by af-l for public comment will be provided with each rulemak-fccted elements of society and not the regulatory agency, ing and each licensing action where generic exemptions Consequently, the Commission will not consider whether
-provisions have not already been established.
a practice is justified in terms of net societal benefit.
It is the Commission's intent to broadly define spe-A.
Principles of Exemption.
cific practices so that the dfect of an exemption decision The principal consideration in exempting any prac-on any mdividual or population will be evaluated m, its tice from some or all regulatory controls hinges on the entirety and not in a piecemeal fashioncAt the same time, general question of whether the application or continu-the practice must be identified and described in terms ation of regulatory controls is necessary to protect the
' that will facilitate reasonable impact analyses and allow public health and safety and the environment. To decide imposition of appropriate, constraints, requirements, and f exemption is appropriate, the Commission must deter-t-
conditions as the radioactive matenal passes from a regu-mine if adequate protection is provided and one of the lated to an unregulated status (i.e., the material is n follow ng conditions is met:
longer required to be under the control of a licensee).
Under this policy, the definition of a " practice" in any 1.
The application or continuation of regulatory specific decision (rulemaking or licensing action) is a criti-controls on the practice does not result in any j
cal feature. The NRC will ensure that formulation of significant reduction in dose received by indi-exemptions from regulatory control will not allow delib' viduals within a critical group (i.e., the group
)
crate dilution of material or fractionation of the radiation expected to receive the highest exposure) and 1
or radioactive material for the purpose of circumventing by the exposed population; or controls that would otherwise be applicable. The defini-tion of the practice in any specific exemption decision will 2.
Thecostsof thecontrolsthatcould beimposed also provide the framework for taking into account tre for further dose reduction are not balanced by potential effects of aggregated exposure from that prac-the potential commensurate reduction in risk.
- tice together with other exempted practices, as well as the possible consequences of accidents or misuse or the po-At a sufficiently low level of risk, the Commission tential for other nonstochastic radiological impacts asso-believes the decision-making process for granting specific ciated with the exemption.
exemptions from some or all regulatory controls can be essentially reduced to an evaluation of whether the over.
The Commission may determine on the basis of risk all individual and collective risks from each particular estimatesand associated uncertainties that certain prac-practice are sufficiently small.The Commission believes tices should not be considered candidates for exemption, thiit individual and collective dose criteria should be basic such as the introduction of radioactive materials into features of its overall policy to define the region where products to be consumed or used primarily by children.
the expenditure of Commission resources to enforce re-6
y.
r BRC Policy Statement quirements for further dose reductions or licensee re-accepted as a fact of life and are identical to the kinds of sources to comply with such requirements is no longer risks posed by radiation from nuclear materials under warranted. These specific criteria include (1) values for NRC jurisdictionfl'hese facts provide a context in which
- the individual annual dose reasonably expected to be to compare quantitatively the radiation risks from various received as a result of the practice (e.g., an average dose practices and make radiation risk especially amenable to i
to individuals in a critical group) and (2) a measure of the use of the approach described below to define an -
radiclogical impact to the exposed population. In combi-acceptable BRC Icvel.
- nation, these criteria are chosen to ensure that, for the i
average dose to members of the critical population group from a given exempted practice, individuals will not be to m. The Comm.
ission believes that if the risk from doses exposed to a significant radiological risk and that the dividuals from a practice under consideration for population as a whole does not suffer a significant radio-exemption is comparable to other voluntary and myolun-log cal in pact.
tary risks which are commonly accepted by those same individuals without significant efforts to reduce them, then the level of protection from that practice should be it is important to emphasize that, in this policy, the adequate. Furthermore, for risks at or below these levels i
Commission does not assert an absence or threshold of there would be little merit in expending resources to risk at low radiation dose levels but rather establishes a reduce this risk further. The Commission believes the baseline level of risk beyond which further government definition of a llRC dose level can be developed from this regulation to reduce risks is unwarranted. As described in perspective.
the Appendix to this policy statement, the technical ra-tionale for the Commission's DRC criteria is explicitly based on the hypothesis that the risk from exposure to Variations la natural back round radiation aPPar-8 ently play no role m. mdividuals, decisions on common radiation is linearly proportional to the dose to an individ-matters such as places to live or work (e.g., the 60-70 ual. However, the presence of natural background radia-tion and variations in the levels of this background have mrem differences between average annual doses received been used to provide a perspective from which to judge g Denver, Colorado versus Washington, DC). In addi-tion, mdividuals generally do not seem to be concerned' the relative significance of the radiological risks involved about the difference m doses between living m a brick
?
in the exemption decision making process.
versus a frame house, the 5 mrem dose received durmg a typical roundtrip coast to-coast flight, or incremental The Commission notes that adoption of the individ-doses from other activities that fall well within common ual and collective dose criteria does not indicate a deci-variations in natural background radiation.These factors sion that doses above the criteria would necessarily pre-lead to the conclusion that differential risks correspond-clude exemptions.The criteria simply represent a range ing to doses on the order of 5-10 mrem (0.05-0.1 mSv)are of risk that the Commission believes is sufficiently small well within the range of doses that are commonly ac-compared to other individual and societal risks that fur-cepted by members of the public, and that this is an ther cost-risk reduction analyses are not required in order appropriate order,of magnitude for the Commission's to make a decision regarding the acceptability of an ex.
IlRC individual dose criterion.
emption. Practices not meeting these criteria may never-theless be granted exemptions from regulatory control on Although the uncertainties in risk estimates at such a case-by-case basis m accordance with the pnnciples low doses are large, the risk to an individual as calculated embodied within this pohey, if (1) the potential doses t using the linear, no-threshold hypothesis is shown in mdividual members of the pubhc are sufficiently small or Table 1 for various defined levels of annual individual unlikely;(2) further reductions in the doses are neither dose.The values in the hypothetical lifetime risk column readily achievable nor sigmficant in terms of protecting are based on the further assumption that the annual dose the ptiblic health and safety and the environment; and (3) s continuously received during each year of a 70-year the collective dose from the exempted practice is lifetime. To provide further perspective, a radiation dose
^ # ^~
of 10 mrem per year (0.1 mSv per year) received continu-ously over a lifetime corresponds to a risk of about 4
- 11. The Individual Dose Criterion.
chances in 10,000 (3.5 x 10")or a hypothetical increase of about 0.25% in an individ ual's lifetime risk of fatal cancer.
The Commission has noted that, although there is The Commission prefers to use factors of ten to describe significant uncertainty in calculations of risks from low-such low individual doses because of the large uncertain-level radiation, in general these risks are better under-ties associated with the dose estimates.The Appendix to stood than the risks from other hazards such as to:ic the policy statement provides a more complete discussion chemicals. Moreover, radiation from natural background of the risks and uncertainties associated with low doses poses involuntary risks (primarily cancers), which must be and dose rates.
7
r BRC Policy Statement i
Table 1
(
ll pothetical 3
incremental Hypothetical Lifetime Risk Incremental Annual Dose
- Annual Risk **
From Continuing Annual Dose" 4
[
100 mrem (1.0 mSv) 5 x 10-5 3.5 x 10 10 mrem (0.1 mSv) 5 x 10-6 3.5 x 10" I mrem (0.01 mSv) 5 x 10 3.5 x 10-5 4
0.1 mrera (0.001 mSv) 5 x 10-8 3.5 x 10-8 The expression of dose refers to the Total Effective Dose Equivalent. This term is the sum of the deep (whole body] dose equivMent for sources external to the body and the committed effective [whole body] dose equivalent for sources internal to the body,
- Calculated using a conservative risk coefficient of 5 x 10" per rem (5 x 10 2 per Sv) for low linear energy transfer radiation based on the results reported in " Sources, Effects and Risks of Iomzing Radiation," United Nations Sci-
- entific Committee on the Effects of Atomic Radiation (UNSCEAR),1988 Report to the General Assembly with Annexes and " Health Effects of Exposures to Iww Levels of Ionizing Radiation, UEIR V," 1990, Committee on
. Biological Effects of Ionizing Radiation, National Research Council (see also NUREG/CR-4214, Rev.1).
In view of the uncertainties involved in risk assess-straints and conditions imposed by the Commission on ment at low doses and taking into account the aforemen-exempted practices.
tioned risk and dose perspectives, the Commission finds that the average dose to individuals in the critical group The Commission intends that only under unusual should be less than 10 mrem per year (0.1 mSv per year) circumstances would exemptions be considered for prac.
for each exempted practice. In addition, an interim dose tices that could cause continuing radiation exposure to criterion of 1 mrem per year (0.01 mSv per year) average individuals exceeding a small fraction of 100 mrem per dose to individuals in the critical group will be applied to year (1 mSv per year). In rare cases, exempJons of such those practices involving widespread distribution of radio, practices may be granted if, tJter conducting a thorough active material in such items as consumer products or analysis of the proposed exemption, the Commission de-termines that doses to members of the publicare ALARA recycled material and equipment, until the Commission and that additional regulatory control is not warranted by gains more experience with the potential for individual further reductions in individual and collective doses, exposures from multiple licensed and exempted prac.
tices. These criteria provide individual dose thresholds C.
The Collect.ive Dose Criterion, below which continued regulatory controls are unneces.
sary and unwarranted to require further reductions in The Commission believes that the collective dose individual doses.The Com mission considers these criteria (i.e., the sum of individual total effective dose equiva-to be appropriate given the uncertainties involved in esti-lents) resulting from exposure to an exempt practice mating doses and risks, and notes that these criteria should be ALARA. However, if the collective dose re-should facilitate straightforward implementation of this sulting from an exempted practice is less than an expected po: icy in future rulemakings or licensing decisions.
value of 1000 person rem per year (10 person-Sv per year), the resources of the Commission and its licensees could be better spent by addressing more significant The Commission believes that, notwithstanding ex-health and safety issues than by requiring further analysis, emption of practices from regulatory control under these reduction, and confirmation of the magnitude of the col-entena, it still has reasonable assurance that exposures to lective dose. The Commission notes that, at this level of mdividual members of the public from alllicensed activi-collective dose, the number of hypothetical health effects ties and exempted practices will not exceed 100 mrem per calculated for an exempted practice on an annual basis year (1 mSv peryear) given the Commission's intent (1) to would be less than one.
define practices broadly; (2) to evaluate potential expo-sures over the lifetime of the oractice; (3) to evaluate the The National Council on Radiation Protection and potential for aggregated ex osures from multiple ex-Measurements recommends in its Report No. 918 that p
empted practices; (4) to impose both individual and col-collective dose assessments for a particular practice lective dose criteria;(5) to monitor and verify how exemp-tions are implemented under this policy; (6) to verify dose
' Recommendations on Limits for Exposure to lonizing Radiation, calculations through licensing reviews and rulemakings NCRP Report No. 91, National Council on Radiahon Prolection h"Og7QS7ios;,h".9[odjntYv. hu$tIl with full bencfit of public review and comment; and (7) to inspect and enforce licensee adherence to specific con-Hethesda, MD 20814 8
4 9
BRC Policy Statement should exclude consideration of those individuals whose ing that the assumptions used to define a practice remain annual effective dose equivalent is less than or ec,ual to appropriate as the radioactive materials move from a 1 mrem peryear (0.01 mSv per year). In the sensitivity-of-regulated to an unregulated status. Any such rulemaking measure, risk-based guidelines used by EPA and FDA, a action would follow the Administrative Procedure Act, 10-' lifetime nsk of cancer has been used as a quantitative which requires publication of a proposed rule in order to criterion of insignificance. Using an annual risk coeffi-solicit public comment on the rulemaking action under cient of 5 x 10" health effects per rem (5 x 10-2 per consideration. The rulemaking action would include an sievert), as discussed in the Appendix, the 10 lifetime appropriate level of environmental review in accordance risk value would approximate the calculated risk that an with the Commission's regulations in 10 CFR Part 51, individual would incur from a continuous lifetime dose which implement the National Environmental Policy Act.
rate in the range of 0.01 to 0.1 mrem (0.0001 to 0.001 mSv) per year.
If a proposal for exemption results in a Commission regulation containing specific requirements for a particu-As a practical matter, consideration of dose rates in lar exemption, a licensee using the exemption would no the microrem per year range and large numbers of hypo-longer be required to apply.the ALARA principle to thetical individuals potentially exposed to an exempted reduce doses further for the exempted practice provided practice may unduly complicate the dose calculations that that it meets the conditions specified in the regulation.
will be used to support demor.:trations that proposed The promulgation of the regulation would, under these exemptions comport with the criteria in this policy. The circumstances, constitute a finding that the practice is Commission believes that inclusion of individual doses exempted in accordance with the provisions of the regula-below 0.1 mrem per year (0.001 mSv per year) introduces tion and that ALARA considerations have been ade-unnecessary complexity into collective dose assessments quately addressed from a regulatory standpoint. The and could impute an unrealistic sense of the significance Commission in no way wishes to discourage the vo;untary and certainty of such dose levels. For all of these reasons, application of additional health physics practices which the Commission concludes that 0.1 mrem (0.001 mSv) per may, in fact, reduce actual doses significantly below the year is an appropriate truncation value to be applied in BRC criteria or the development of new technologies to the assessment of collective doses for the purposes of this enhance protection to the public and the environment.
policy.
This is particularly pertinent in the area of decontamina-tion and decommissioning, where the Commission antici-pates that emerging technologies over the next several IV. Implementat. ion.
decades should enhance existing technical capabilities
- The Commission's BRC policy will be implemented and further reduce doses to workers and the publie principally through rulemakings; however, exemption and where other Federal agencies are in the process of decisions could also be implemented through specific li-developing standards which may affect those receiving censing actions, exemptions.
In the first case, a proposal for exemption, whether The second means of policy implementation could initiated by the NRC or requested by outside parties in a involve exemptions that would be granted through licens-petition for rulemaking, must provide a basis upon which ing actions, such as determinations that a specific site has the Commission can determine if the basic policy criteria been sufficiently decontaminated to be released for unre-have been satisfied.The Commission intends to initiate t stricted public use. The NRC intends to develop guidance number of rulemakings on its own (e.g., to establish a dos:
regarding the implementation of the DRC criteria to en-criterion for decommissioning) and may initiate others ts sure that such site-specific actions adhere to the criteria a result of NRC's review of existing codified exemptions and principles of this policy statement. New licensing (e.g., consumer product exemptions in 10 CFR Parts S0 actions that transfer radioactive material to an unregu-and 40). Rulemakings may also be initiated in response to lated status will be noticed in the Federal Register if they petitions for rulemaking submitted by outside parti's, differ from previous generic exemption decisions.
such as a BRC waste petition submitted in accordarce with Section 10 of the Imw Level Radioactive Waste Pol-One of the principal benefits of the policy is that it icy Amendment Act of 1985. In general, rulemaking ex-provides a framework to evaluate and ensure the consis-emption proposals should assess the potential health 4nd tency of past exemption decisions by the Commission, safety impacts that could result if the exemption were to With the adoption of this BRC policy, the NRC will be granted.
initiate a systematic assessment of exemptions currently existing in NRC's regulations to ensure that the public is The propmal should consider the uses of the radio-adequately and consistently protected from the risks asso-active materials, the pathways of exposure, the levels of ciated with exempted practices. In addition, the NRC will, radioactivity, and the methods and constraints for ensur-on a periodic basis, review the exemptions granted under 9
5
~
a BRC Policy Statement l
this policy to ensure that the public health and safety volume distribution). Mass-and volume-averaged con-continue to be protected adequately, centrations should also be presented. The variability of radionuclide concentration, distribution, or type as a V. Information To. Support Exemption-function of process variation or variations among licen.
Decisions.
sees should be addressed and bounded, as appropriate.
Aa. General.
- 2. Nonradiological properties. The nonradiological pr perties of the materials to be exempted should be The information required to support an exemption described to ensure complete characterizat,on of the i
' decision in a rulemaking or licensing action should pro-pr perties of the material and consideration of any ad-vide the basis for the proposed exemption in accordance verse impacts associated with these properties. An NRC with Section III of this policy. In addressing the radiologi-qxemption, based on radiological tmpacts, would not re-cal health and safety impacts, potential individual and lim nsges from compliance with applicable rules of collective doses attributed to the practice under consid-other agencies which cover nonradiological properties. A cration should either meet the policy's dose criteria or description,of thematerials,includingthetrorigin,chemi-otherwise be demonstrated to be low enough to ensure cal composition, physical state, volume, and mass should protection of the public health and safetyand ALARA. In be provided. The variability and potential changes m, the addition to the impacts of routine exposures, realistic m terials as a function of process variation should be impacts resulting from potential misuse or accident sce-addressed. The variation among licensees should be de.
narios should also be evaluated and demonstrated to be scribed and bounded, as applicable, insignificant. The NRC may reject proposals for exemp-tions if they do not provide a sufficient technical basis t C.
Practice Characterization support analysis of the potential exemption.
.!. Totalimpact. A regulatory action taken under this Practices should be defined with respect to the geo.
policy is likely to be generic and may be nationwide in graphic and demographic areas to which the exemption scale.Therefore, to the extent possible, an estimate of the will apply. In some cases, an exemption will be limited to number of NRC and Agreement State licensees that pos-one particular locality or area. However, many practices sess the radioactive material considered for exemption, will have national applicability and should be character, the annual volumes and masses, and the total quantities ized accordingly. Information on these issues will be nec.
of each radionuclide that would be a part of the exempted essary for determinations regarding which individual dose Practice should be given. The estimates should include criterion should be applied.
the current situation and the likely variability over the reasonably foreseeable future. A geographical descrip-The Commission believes that the implementation tion would be a helpful t_oolin characterizing the distribu-guidance provided with its " General Statement of Policy tion of radioactive material involved in the exemption and Procedures Concerning Petitions Pursuant to a2.802 decision. Such distribution, submitted as part of the prac-for Disposal of Radioactive Waste Streams Below Regu.
tice characterization, should be used to assess realistic latory Concern," published August 29,1986, 51 FR impacts of the practice,in addition to conservative bound-30839, generally defines the types of information needed ing estimates that tend to overestimate human exposures to support an exemption decision. However, not all of the and doses. In any case, the typical quantities produced per information.may be applicable to the broader range of practice (e.g., number of units of a particular consuruer practices considered for exemption under this policy. Ap-product) and an estimate of the geographic description of plicants should examine potentially relevant guidance the practice should be described. The potential for short-available at the time the exemption proposal is being and long-term recycle or reuse of the product containing prepared and provide the information which is relevant to the exempted radioactive material should also be ad-the particular typa of exemption decision being re-dressed. Both the resource value (e.g., salvageabic met-als) and the functional usefulness (e.g., usable tools) quested.
should be examined.
- B.
Material Charaeterization.
- 2. Basisfor assessment. A description of bases for the
- 1. Radiologicalproperties. The radiological properties materials and practice characterizations should be pro-of the materials to be exempted should be described, vided. Monitoring and analytical data and calculations including, as appropriate, the concentration or contami-should be specified and provided in support of the charac-nation levels and the half-lives, total quantities, and iden-terization. Actual measurements or values that can be tities of the radionuclides associated with the exempted related to measurements to confirm calculations are im-l' practice.The chemical and physical form of the radionu-po,rtant and should be provided. The description should l-clides should be specified. All radionuclides present or address the quality assurance program used in data collec-potentially present should be specified. The distribution tion and analysis and supporting information. If any sur-of the radionuclides should be noted (e.g., surface or veys were conducted, they should be described. Market i
i 10 i
IIRC Policy Statement information may be useful in characterizing a practice on accurate. Average doses to this group are the controlling a national basis.
factors limiting individual doses and risk, and should be compared with the mdividual dose criteria, as appropri-
- 3. As low as is reasonably achievable (ALARA). An ate. The critical group should be the segment of the analysis should be provided that demonstrates that radia-population most highly exposed to radiation or radioac-tion exposure and radionuclide releases associated with tive materials associated with the use of radioactive mate.
the exempted practice overall will be A1 ARA consistent rial under unregulated conditions.'the second part of the with the criteria in this policy. The AIARA principle population exposure is the general population exposure, referred to in 10 CFR Part 20 applies to efforts by licen-exclusive of critical group exposure. For this group, the sees to maintain radiation exposures and releases of ra-individual exposures should be smaller, and the assess-dioactive materials to unrestricted areas as low as is rea-ment will often be less precise. 'Ib impacts analysis.
sonably achievable. Appendix I to 10 CFR Part 50 de-should present an estimate of the distribution of doses scribes A1 ARA for radioactive material releases from within the general population. In situations where trunca-e light water reactors (nuclear power plants). Exemption tion of the collective dose calculation is done under the proposals should describe how AIARA considerations provisions of this policy, the basis for applying the trunca-j have been applied in the design, development, and imp-tion provision should be provided.
lementation of controls for the proposed practice. Licen-i see compliance with the A1 ARA principle must remain The evaluation of radiological impacts should distin-in effect up to and including the point at which the materi-guish between expected and potential exposures and -
als are transferred to an unregulated status in accordance events. The analysis of potential exposures in accident or with an exemption grar.ted under this policy.
misuse scenarios should include all of the assumptions, data, and results used in the analysis in order to facilitate D.
Impact Analyses.
review The culuation should provide sufficient informa-tion to allow a reviewer to independently confirm the -
- To support and justify a request for exemption, each results. The potential for reasonable mteractions be-petitioner or licensee should assess the radiological and tween the exempted radioactive material and the pubhc nonradiologicalimpacts of the proposed exemption.The should be assessed.
analyses should be based on the characterizations de.
scribed previously and should cover all aspects of the 7
andysis of other radiological-proposed exempt practice, including possession, use, i
sdah h mspimM%
transfer, ownersh,p, and d,sposal of the matenal. NRC processing, and disposal of exempted materials should be i
i consideration of Ihe exemption proposal and any enytron-evaluated. Nonradiological impacts on humans and the mental assessments and regulatory analyses required !
environment should also be evaluated in accordance with implement the exemption will be based on the impact NRC requirements in 10 CFR Part 51. The analysis analyses and supporting characterizations.
should also consider any adverse impact of the measures taken to provide nonradiological protection on radiation L Radiologicalimpacts. The evaluation of radiologi-exposure and releases of radioactive material. Any NRL, cal impacts should clearly address the policy's individual action to exempt a practice from further regulatory con-and collective dose criteria or provide a ' sufficient trol would not reheve persons usmg, handhng, process-AIARA evaluation supporting the exemption. In either ing, wning, or disposing of the radioactive material from case, the following impacts should be assessed:
other requirements applicable to the nonradiological pr perties of the material.
- - Average doses to the critical population group; E.
Cost llenefit Considerations (as required).
Collective doses to the critical population group and the total exposed population (under A cost / benefit analysis is an essential part of both conditions defined in Section III); and environmental and regulatory impact considerations.The analysis should focus on expected exposures and realistic The potential for and magnitude of doses asso-concentrations or quantities of radionuclides. The cost /
ciated with accidents, misuses, and recon-benefit analysis should compare the exposures and eco-centration of radionuclides.
nomic costs associated with the regulated practice and alternatives not subject to regulation, llenefits and costs The collective doses should be estimated and should be considered in both quantitative and qualitative summed in two parts: total dose to the critical population terms. Costs of surveys and compliance verification dis-group and total dose to the exposed population. The cussed under item V.G. should also be covered. Anylegal critical group is the relatively homogeneous group of indi-or regulatory constraints that might affect an exemption viduals whose exposures are likely to be the greatest and decision should be identified. For example, one such con-for whom the assessment of doses is likely to be the most straint might stem from Department of Transportation 11
BRC Policy Statement (DOT) requirements for labeling, placarding, and mani-example requirements and show their effectiveness and i
festing radioactive materials in 49 CFR Part 173.
feasibility. For site-specific license amendments, the ex-i emption proposal should provide specific requirements F.
Constraints, Requirements, or Conditions on for Quality Assurance / Quality Control and Reporting that have been tailored to the licensee's program.
Exemptions, In most cases, the characterizations of the material
- 1. Quality assuranec/ quality control. The program to and the assessment of impacts will be based on either ensure compliance with specific exemption constraints, explicit or implicit constraints, such as limitations on the requirements, or conditions should be defined. The re-amount of radioactive materialin a consumer product. In cords of inventory, tesis, surveys, and calculations used to order for an exemption decision to take credit for these demonstrate compliance with the exemption constraints constraints, the exemption proposal should specifically should be maintained for inspection. Such programs are identify appropriate constraints, such as quantity limits, necessary to provide the NRC and the public reasonable concentration limits, and physical form characteristics.
assurance of conformance with the constraints and The bases on whid these constraints are to be ensured of adequate protection of human health and the should also be discussed. In general, constraints should be environment.
verifiable in order to provide the basis for an exemption decision.
- 2. Reports. Reports may be required from licensees who, by rule orlicense, are permitted to release materials exempted from regulatory control. Associated record-G.
Quality Assurance and Reporting.
keepm, g to generate the reports should be defined. Mim-This portion of the exemption proposal should be mum information in the reports could include volume, tailored to either a generie petition for rulemaking or isotope and curie content. More detailed recordkeeping specific proposal for a license amendment. For generic and reporting requirements may be imposed to address petitions for rulemaking, the proposal should provide and uncertainties in projecting future volumes or amounts of justify generic requirements for Quality Assurance / Qual-exempted materials and to consider the cumulative im-ity Control and Reporting. Such proposals should include pacts of multiple exemptions.
12
IIRC Policy Stat 2 ment API'ENDIX-DOSE AND llEALTil EFFECTS ESTIMATION 1.
Dose Estimation from the observed effects at much higher doses and dose rates.* ' Itis results in significant uncertainty in risk esti-In estimating the dose rates to members of the pub-mates as reflected by the views of experts m the field.1,or lic that might arise through various practices for which example, the Committee on the Iliological Effects of exemptions are being considered, the Commission has I ntzmgRadiation(11EIRli!)of theNational Academyof decided to apply the concept of the " total effective dose Science cautioned that the risk values atc,... based on equivalent."'lhis concept, which is based on a comparison mcomplete data and involve a large degree of uncertainty, of the delayed health effects of ionizing radiation expo-especially m the low dose region. This Committee also sures, permits the calculation of the whole body dose stated that it...does not know whether dose rates of equivalent of partial body and organ exposures through gamma or ways Oow IEr; low linear energy transfer use of weightirig factors.The concept was proposed by the radiation)of about 100 mrads/ year (1 mGy/ year)are,det.
International Commission on Radiologkal Protection rtmentaltoman. More recently,thellEIR VCommittee (ICRP) in its Publication 26 issued in 1977. Since that of the National Academy of Science / National Research time, the concept has been reviewed, evaluated, and C uncil stated that it ' recognizes that its risk estimates adopted by radiation protection organizations throughout buome more uncertain when applied to veiy low doses, the world and has gained wide acceptance. The " total Departures from a linear model at low doses, however, effective dose cquivalent" concept is incorporated in "Ra-c uld either increase or dectcase the [ estimation ofl risk diation Protection Guidance to Federal Agencies for Oc.
l'he Comm,ssion understands that the Mr unit dose.
i cupational Exposure-Recommendations Approved by C mmittees statements reflect the uncertainties in-the President," that was signed by the President and pub-v lvedin estimating the risks of radiaJan exposure and do lished in the Federal Register on J anuary 27,1987 (52 FR not imply either the absence or presence of detrimental 2822). The Commission recognizes that, in considering cunts at sxh low dose levels, specific exemption proposals, the total effective dose equivalent must be taken into account.
The United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) stated in th:ir II. Estimating Ilealth Effects From Radiation 1988 Report to the General Assembly that "...there was a Exposure need for a reduction factor to modify the risks (derised at A. Individual Risks.
high doses and dose rates)...for low doses and dose rates....[ A)n appropriate range (for this factor) to be ap-In the establishment of its radiation protection poh,'
plied to total risk for low dose and dose rate should be cies, the Commission has considered the three major between 2 and 10."This factor would icad to a risk coeffi-4 4
types of stochastic (i.e., random) health effects that can be cient value between 7 x 10 and 3.5 x 10-* per rad (7 x 10 caused by relatively low doses of radiation: cancer, genetic and 3.5 x 104 per Gy) based on an UNSCE AR risk coeffi-effects, and developmental anomalies in fetuses. The cient of 7.1 x 10-4per rad (7.1 x 10 per gray)for 100 rad 4
NRC principally focuses on the risk of fatal cancer devel-(I gray) organ absorbed doses at high dose rates. The opment because (1) the mortality risk represents a more report also stated, "The product of the risk coefficient severe outcome than the nonfatal cancer risk, and (2) the appropriate for individual risk and the relevant collective mortality risk is thought to be higher than the risk associ-dose will give the expected number of cancer deaths in the ated with genetic effects and developmental effects on exposed population, provided that the collective dose is at fetuses.2 llowever, even though radiation has been shown least of the order of 100 person Sv (10,000 person rem).
to be carcinogenic, the development of a risk factor appli-If the collective dose is only a few person Sv (a few hun-cable to continuing radiation exposures at levels equal to dred person-rem), the most likely outcome is zero natural background 3 requires a significant extrapolation deaths."
i ksIfl iI l a$iat) " Nited f t $n Scient in December 1989, the IlEIR V Committee pub-Cornmittee on the liffects of Atornic Radiation (UNSCliAR).
lished a report entitled "licalth Effects of Exporure to 1988 Report to the General Assembly with Annexes.
Iow Levels of lonizing Radiation," which contaitied risk hasEngI$N.InaYrYt$"cIg"o'u*nNa'tN'tcx luYnhI" estimates that are, in general, similar to the findings of don) results in indrvidual dmes of nhout 90 mrem per year (0.9 mSvtyr), while in Denver. Colorado, the value is about 16u mrem
- The health effects clearly attributable to radiation have occurred pu nar (1 t, mSv/yr). In both wn naturally occurring radniac.
prmeipally among early radiation workers, smvivors of the tivs matenalin the human body e.ributes approximately 40 atonue bomb exolosions at throshima and Nagasaki, individuals mrem per year. Radiahon from inhalation of the daughter pmd.
expmed for medeal purposes, and laboratory animals. Natural l
ucts of nufon contributes an average additional dose of 200 background radiation causes an annual dose that is at least two mrem per yeart2 mSvtyr) to members of the U.S. population orders of magnitude less than the dose received by human popu.
(NCRP Report No. 9 A "lonizmy. Radiation fixpvure of the lations from which the cancer rnks are denved. lapenments at Population of the United States y the cellular level, however. provide similar indications of biologi-cal effects at hm doses.
13
BRC Policy Statement the 1988 UNSCEAR report. The HEIR V report's esti-based on the further assumption that the annual dose is mate of lifetime excess risk of death from cancer follow-continuously received during each year of a 70-year life.
ing an acute dose of 10 rem (0.1 Sv) of low lET radiation time. To provide further perspective, a radiation dose of was 8 x 10.Taking into account a dose rate effectiveness 10 mrem per year (0.1 mSv per year) received continu.
4 factor for doses occurring over an extended period of ously over a lifetime corresponds to a hypothetical in-time, the risk coefficient is on the order of 5 x 10" per crease of about 0.25% in an individual's lifetime risk of rem, consistent with the upper level of risk estimated by cancer death. Ten millirem per year (0.1 mSv per year)is
- UNSCEAR, also a dose rate that is a small fraction of naturally occur-ring background radiation and comparable to the tempo-In view of this type of information, the NRC, the ral variations in natural background radiation due to fluc-Environmental Protection Agency, and other national tuntions that occur at any specific location.
cnd international radiation protection authorities have established radiation protection standards defining rec-The Commission prefers to use factors of ten to
. ommended dose limits for radiation workers and individ-describe such low individual doses because of the large ual members of the public. As a matter of regulatory uncertainties associated with the dose estimates. Use of prudence, all these bodies have derived the value pre-values such as 0.7 or 12 imputes a significance and sense 1
sumed to apply at lower doses and dose rates associated of certainty that is not justified considering the levels of
'~
with the radiation protection standards by a linear ex.
uncertainty in the dose and risk estimates at these !ow trapolation from values derived at higher doses and dose levels.Thus, order of magnitude values such as 1 and 10 J
rates. This model is frequently referred to as the linear, are preferable to avoid providing analysts and the public no. threshold hypothesis, in which the risk factor at low with a sense of certainty and significance that is not com-l doses reflects the straight line (linear) dose-effect rela-mensurate with the actual precision and certainty of the tionship at much higher doses and dose rates. In this estimates.
respect, the llEIR V report notes that "in spite of evi-dence that the molecular lesions which give rise to so' H.
Collective or Population Risk matic and genetic damage can be repaired to a consider-l able degree, the new data do not contradict the hypothe.
In the application of the fundamental principles of i
ris, at least with respect to camcer induction and heredi.
radiation protection, collective dose provides a useful way l
tary genetic effects, that the frequency of such effects to express the radiological impact (i.e., potential detri-l increases with low level radiation as a linear, non thresh.
ments)of a practice on the health of the exposed popula.
old function of the dose."
tion. Because of the stochastic nature of risk, analysis of exposures of large groups of people to very small doses ne Commission, in the development of the URC may result in calculated health effects in the population at pohty, is faced with the issue of how to characterize the large. Collective dose is the sum of the individual total individual and population risks associated with low doses effective dose equivalents resulting from a practice or j
end dose rates. Although the. uncertainties are large, use-source of radiation exposure it is used in comparative i
fut perspective on the bounding risk associated with very cost benefit and other quantitative analytical techniques L
low levels of radiation can be provided by the linear, and, therefore, is an important factor to consider in bal-no-threshold hypothesis. Consequently, such risk esti-ancing benefits and societal detriments in applying the mates have been a primary factor in establishing individ.
ALARA principle. For purposes of this policy, individual ual and collective dose criteria associated with this policy, total effective dose equivalents less than 0.1 mrem per The estimations of the low risk from potentially exempted year (0.001 mSv peryear) do not need to be considered in practices can be compared to the relatively higher poten-the estimation of collective doses. The Commission be-l tial risks associated with other activitics or decisions over lieves consideration of individual doses below 0.1 mrem j
which the NRC has regulatory responsibility. Through per year imputes a sense of significance and certainty of such comparisons, the Commission can ensure that its their magnitude that is not justified considering the inher-radiation protection resources and those of its licensees ent uncertainties in dose and risk estimates associated cre expended in an optimal manner to accomplish its with potentially exempted practices. De Commission public health and safety mission.
also notes that doses in the range of 0.01100.1 mrem per i
year correspond approximately to lifetime risks on the In this context, the risk to an individual as calculated order of one in a million. The NRC has used collective i
using the lincar, no-threshold hypothesis is shown in Ta-dose, including rationales for its truncation, in a number ble 1 for various defined levels of annual individual dose, of rulemak,ing decisions and in resolving a variety of ge-
_ j l
The values in the hypothetical lifetime risk column are neric safety issues.
i 14 E
j c
IIRC Policy Statement I
Table 1 Ilypothetical Incremental flypothatical 1,1fetime Risk incremental Annual Dose
- Annual Risk" I' rom Continuing Annual Dose" 100 mrem (1.0 mSv) 5 x 10-8 3.5 x 10-8 10 mrem (0.1 mSv) 5 x 10-'
3.5 x 10-4 1 mrem (0.01 mSv) 5 x 10-'
3.5 x 10-8 0.1 mrem (0.001 mSv) 5 x 10-8 3.5 x 10-'
'Ihe expression of dose refers to the Total Effective Dose Equivalent."Ihis term is the sum of the deep [whole body) dose equivalent for soarces external to the body and the cornmitted effective (wholc body) dose equivalent i
for sources internal to the body.
Risk coefficient of 5 x 10-4 per rem 5 t 10-2 per Sv) for low linear energy transfer radiation has been conserva-tively based on the results reported (m 1.,NSCEAR 1988 (Footnote 2) and BEIR V (see also NU Rev.1).
Ill. Dose and Risk Estimation Commission would consider exempting from regulatory control must be based on input of these measurements
'lhe Commission recognizes that it is frequently not into exposure pathway models, using assumptions related possible to measure risk to individuals or populations to the ways in which people might become exposed.These directly and, in most situations, it is impractical to meas.
ute annual doses to individuals at the low levels associ.
assumptions incorporate sufficient conservatism to ac-ated with potential exemption decisions. 'Iypically, count for uncertainties so that any actual doses would be radionuclide concentrations or radiation dose rates can expected to be lower than the calculated doses. The Com-only be measured before the radioactive material is re-mission believes that this is an appropriate approach to be leased from regulatory control. Estimates of doses to taken when determiningif an exemption from some or all members of the public f rom the types of practices that the regulatory controls is warranted.
The additional views of Commissioner Curtiss and Chairman Carrr's comments are attached.
i Dated at Rockville, Maryland, this day of _ _.
_,1990.
i F r the Nuclear Regulatory Commission.
(
2
.N.
Secretary of 1 te Commission.
15 a
BRC Policy Statcment
'i Additional Views of Commissioner Curtiss I strongly endorse going forward with a comprehensive high, when viewed in the context of other risks that we policy that will establish a disciplined and consistent regulate and in view of the fact that the purpose of this framework within which the Commission can define those Policy Statement is to establish a framework for identify-practices that, from the standpoint of radiological risk, we ing those practices that the Commission considers to be consider to be below regulatory concern (BRC). The prin-below regulatory concern.
cipal advantage of such a policy, in my view, is that it will bring much-needed discipline and technical coherence to lleyond this, if the collective dose criterion is to be de-the patchwork of BRC regulatory decisions that have fined as the floor to AIARA (as I would propose below),
been rendered to date, providinr a clearly articulated, a more conservative approach to establishing a collective dose criterion is warranted in view of the fact that doses risk based approach for reaching decisions on matters such as-(l) the release for unrestricted public use of may be truncated in the calculation of collective dose and lands and structures contair'ing residual radioactivity, (2) the collective dose criterion may be applied to single the distribution of cone.. r products containing small licensing actions.
amounts of radioactive material,(3) the disposal of very Ior these reasons, I do not support a, collective dose low-level radioactive waste, and (4) the recycling of cntenon of 1000 pc son-rem. Instead, in view of what slightly contaminated equipment and materials. A coher-appears to be the prevailing techmcal view on this matter, ent, risk based policy is urgently needed to provide the I w uld endorse a collective dose critenon of 100 person-foundation for future regulatory actions in each of these rem?
areas. Accordingly, I strongly support this initiative.
A1 ARA There are certain aspects of this policy, however, with I would define the individual and collective dose criteria which I must reluctantly disagree. My views on these as floors to AIARA.2 Unfortunately, the Policy State-matters follow:
ment is equivocal on this issue, suggesting at one point that the individual and collective dose criteria should be Individual Dose Criteria construed as floors to ALARA -
I support the individual dose criteria of 10 millirem per year for practices invoNing potential exposures to limited
[ A] licensee... would no longer be required numbers of the public and 1 millirem per year for wide-to apply the ALARA principle to reduce spread practices that tnvolve potential exposures to large doses further for the exempted practice numbers of the public. In view of the potential for multi-provided that it meets the conditions speci-ple exposures from widespread practices, however, and in fied in the regulation.
the interest of administrative finality, I believe that the Commission should establish the 1-millirem criterion as a but then going on to send what I consider to be a conflict-final criterion, rather than an interim value, ing and confusing message about what the Commission expects -
Collective Dose Criterion
.Ihe Commission in no way wishes to dis-i do not support the establishment of a collective dose courage the voluntary application of addi-criterion at a level of 1000 person rem. This level is an tional health physics practices which may, in order of magnitude higher than the IcVel recommended fact, reduce actual doses below the BRC cri-in I AEA Series No. 89, as well as the level recommended teria or the development of new technolo-by most other international groups. Furthermore, it is an gies to enhance protection to the public and order of magnitude higher than the 1986 collective dose the environment (emphasis added),
to members of the public due to effluents from alloperat-ing reactors, the most recent year for which figures are if the Commission intends to say, as I believe it does in this Policy Statement, that those practices that fall within available.
' [y*, M'ti 3$ lh (haWhe A collective dose criterion of.1000 person rem would I clive ose is I for mean, for example, that if, pursuant to this Policy State-agven practice. erefore, adoption of the lower I AEA value of a $ N 1d N d#' d'[ 5"###*' $
ment, the Commission were to exempi on the order of QdISYn#d d ' '
mi oi fifteen separate practices with collective doses at or near approve practices such as smoke detectors that involve large the exemption level of 1000 person-rem-not an unrea-numbers of potentgly,, exposed members of the public, sonable expectation, given previous practice-we would
- U[,7,',,']g^,Mthe're'u5toryYliffindividtiEn to rfN project somewhere between 5 and 10 excess health ef-ALARA analyses below these levels doses are 1 millirem /10 milbrem and the collective dose is 100 person-rem.
fccts annually. I consider this level to be unacceptably 16 7 - -- -.
--m--
^
BRC Policy St:tement the individual and collective dose criteria can be desig-from all other practices, will inevitably lead to confusion.
nated below regulatory concern, it is unclear why the Moreover, this approach poses the very real potential Commission would thert go on to say that it expects addi-that the Commission could, on the one hand, reject a tional steps to be taken to keep exposures ALARA. As a practice invohing children (e.g., baby food, pacifiers, and general matter, I do not object to the ALARA concept, the like) on the ground that the risk posed by such a Indeed, I support the notion that collective dose and practice is too high, yet authorize a practice directed at ALARA analyses should be performed in a manner that the general public that could, coincidentally, expose an O consistent with basic national and international radia-even greater number of children, even though the prac-tion protection principles. But in the. context of a Policy tice itself is not specifically directed at children.
.i Statement on Below Regulatory Concern, for the Com-mission to say on the one hand that the individual and in my view, tha ambiguity should be resolved in favor of a 1
collective dose criteria reflect levels below which no regu.
clear and unequivocal statement endorsing the principle latory resources should be expended, while at the same of justification of practice. While I acknowledge that the time encouraging voluntary ALARA efforts to achieve principle of justification of practice calls upon the Com-lower doses, sends a confusing regulatory message.8 For mission to make decisions invohing so called questions of 1
the sake of regulatory clarity, I would explicitly identify
" societal value," that is an insufficient reason,in my view, the individual and collective dose criteria as floors to to step back from this widely accepted health-physics ALARA.
principle. Indeed, the Commission already takes such considerations into account, either explicitly or implicitly, Justification of Practice in many of the decisions that it renders.
7 On the issue of justification of practice, the Policy State.
Accordingly, in view of the central role that the justifica-ment is unclear as to when and under what circumstances tion of practice principle has played in health physics the Justification of practice prmciple would be applied. At practice, as well as the complexity and confusion that will one point, the Policy Statement provides that:
invariably result from the approach set forth in the Policy Statement, I would state explicitly in this Policy State.
The Commission believes that justification ment that the Commission retains the prerogative to de-decisions invohing social and cultural value termine that specific practices may be unsuitable for ex-judgments should be made by affected cle-emption, regardless of risk, documenting such determina-j ments of society and not the regulatory tions on a case-by-case basis.
agency, Consequently, the Commission will not consider whether a practice is justified Agreement State Compatibilitv l
in terms of net societal benefit.
i With one exception,I concur in the general approach that At another point, the Policy Statement indicates that:
this Policy Statement takes on the issue of Agreement l
State compatibility. The one area where I disagree in-i The Commission may determine on the ba.
volves the treatment of matters involving low. level radio-j sis of risk estimates and associated uncer-active waste disposal.
l tainties that certain practices should not be considered candidates for exemption, such As l understand the position of the majority, the approach as the introduction of radioactive materials established in this Policy Statement, and to be imple-into products to be consumed or used pri-mented in the context of subsequent rulemaking initia-marily by children.
tives, will be considered a matter of strict compatibility for Agreement State programs. As a consequence, the ap-This bifurcated approach to justification of practice, proach taken by individual Agreement States on BRC which appears to distinguish practices invohing children issues must be identical to the approach taken by the Commission. I disagree with this approach for the follow-g Masont I am also concerned that the approach to AIARA set forth in
'8 the Pohey Statement appears to be motivated. in part, by a concern that the Emironmental Protection Agency may at some When Congress enacted the low Level 1(adioact,ve i
future point set more stringent eriteria for BRC. Of particular Waste Policy Amendments Act of 1985 (L1 RWPAA),it note is the statement that-g 3
g
- g
%is[ approach to AIARA]is particularly pertinent low level radioactive waste disposal capacity. Indeed, the in the arca of decontamination and decommission-Congress recognized at the time that the States were
'",8;'d'p[n,Ii,n$arYwhic 11h Uniquely equipped to handle this important responsibil-
d o
ay aff e-eching exemptions.
ity. Accordingly, the States were given a great deal of latitude in deciding how best to proceed with the develop-i NNtiYe#'MformutNg^aI[u*n'o fd dYfer$b$N5f Nathe#
ment, construction, and operation of new low-level waste
- ^
r than with an eye towards trying to anticipate what p cy f:PA disposal facilities. To take one exampie, congress might establish in the future.
17 i
L GRC Policy Statement i
i recognized that some States may decide to construct fa-rather than requiring such waste to be transported acro'ss cilities that, from a technical standpoint, go beyond the the country to a licensed low-level waste disposal facility.
i requirements established in 10 CFR Part 61 for shallow if examples such as this constitute the basis for declaring land burial facilities: for this reason, Congress directed that a health and safety concem exists such that the Com-the NRC to develop guidance on alternatives to the shal-mission should, in turn, prohibit a State from requiring low land burial approach reflected in Part 61 (see Sec-such waste to be disposed of in a licensed low-level waste tion 8 of P.L 99-240). Similarly, should a State decide to disposal facility, then a more disciplined and persuasive -
require radioactive wastes beyond those defined by the presentation of the argument is needed. To date, I have NRC as Class A B, and C wastes to be disposed of in a yet to see such a case.6 In tbc absence of a health and regional disposal facility, the Act permits the States that safety concern, it is incongruous, in my judgment, to say option as well (see Section 3(a)(2) of P.L 99-240).4 In that the risk from a particular waste stream can be so short, the 11RWPAA grants States a great deal of lati-insignificant as to be below [NRC's] regulatory con.
' tude in deciding what kind of facility to build and what cern," but at the same time insist that we nevertheless types of waste will be disposed of in that facility, so long have a sufficient interest to dictate how a State might as-(l) the facility complies with the requirements of otherwise wish to handle that waste stream.e 10 CFR Part 61 and (2) the State provides disposal capac-ity for Class A, B, and C wastes.
For the foregoing reasons, I would not treat the Federal policy on below regulatory concern, as set forth in this if one interprets the Lt.RWPAA in this manner, as I do, Policy Statement and subsequent rulemakings, as a mat-4 then in my judgment it is consistent with this general ter of compatibility for Agreement States when it comes 4
approach to conclude that this Policy Statement (and the to issues involving commerciallow level radioactive waste subsequent rulemaking initiatives implementing the Pol-
- disposal, icy Statement) should not be considered matters of com.
I patibility. The result of such an approach would be that
- Dis kind of information nmy well be a part of the waste stream individual States would be allowed the option of deciding petition that the nuclear utihties are rep)rtedly p eparing for,
whether low level wastes designated BRC by the Com-
"""N Ya'nd dhe $ " i n$"fil d.
thfs ti ve u
que ty justification that would support a get to see a health and sa mission under this Policy Statement should nevertheless
",i* %*Eted frI'm tY"Nn o*f7e'q'u'iIfo$*a"eYtNns* designa be disposed of in a licensed low-Icvel radioactive waste disposal facility.
lII C under this policy latement to be disposed of in licensed low-level radioactive waste dispmal facilitier.
The argument, as I understand it, that is advanced in
- ne argument has been made that 7isposed iin licens rmittin states the tion of i
t uiring IIRC waste streams to be low-l support of the approach taken in the Policy Statement-I "8
'i d
P a jf pic$ o"n thh m eWgp that the Commission's position on BRC should be a mat-ndoh n
crs ter of compatibility - ts that States should be foreclosed Indeed, this appears to have been one of the principal concerns i
from departing in any way from the approach established advanced in the Comrnission's 1986 policy statement on llRC,
,I by the Commission. To take the most visible and contro-
- herfm t],ie tfn [l ion" fn$ f r pa e nconcept should b n
n e
versial example that has arisen to date, this would lead to fhsgual] sites and the (111
,, e 9 the result that a State could not require that low-level
- d;,",in 'd#'d$cemE"th ja'g $t,cm works o,n n,ats a
, d tI at u
l,_ n,
hi cnnon waste streams designated BRC by the Commission never-that the Commission decla ed in the 1986 pol y Statement that theless be disposed of in a licensed low level radioactive future "[rjulemakin ranting petitions [on llRt] will be made n matter of compatib for Agreement States."(policy Statement, waste disPO3al facilit7' that approach might have had at the time,I m). Whatever 51 FedReg 30839, 840 (August 29,1986)
I am not aware of any public health and safety rationale two renom: (1) Congress has vested states with the res nsibility v'
1 i' r invoking low-level waste disposal that has been advanced jd nIcNd'5Sd*n'Nu*"h0 d fnc$u"l is, est pr as a basis for the NRC to instst that the Commission's ing decisions about whether states prefer to require llRC waste N,",,'^i,$^n'M^u"dped of in licensed low-lev streams to be dis position on BRC should be a matter of compatibility for fnc*o'fd$' Ic'a '" ty u Ner ten #( k h
Agreement States. One hears the anecdotal information the resent time and, for this reason,7hc concern about bmen a c
usband-
-about reducing exposures to truck drivers by allowing to k nt.
i dds I pa y onge BRC waste streams to be disposed of in local landfills, jn8 '*l['he
,d dispose of radium waste m its regional d posal facility seems to
- Indeed. the Commission did not object when the Rocky hioun-
@st 9geet of p 8
dd ca city a
g } y di e
e, tain compact proposed to dispose of radium waste m the Rocky comidemum hiountam compact site.
i 1
I 18 g
l
s BRC Policy Statement r
Chairman Carr's Response to Commissioner Curtiss' Views on the BRC Policy Statement k
I am proud of the Commission's accomplishment in interim Individual Dose Criterion completing a comprehensive Uclow Regulatory Concern On the first issue. Commissioner Curtiss would pre-polig statement. I appreciate Commissioner Curtiss' en-fer to establish the 1 milhrem,per year criterion as a final thusiasm and strong support for the policy. Commission criterion, rather than an mterim value, deliberation of such views has helped to forge a compre-hensive risk framework for ensuring that the public is protected at a consistent level of safety from existing and As stated in the llRC policy, the Commission is tuture exemptions and releases of radioactive materials to establishing the 1 millirem per year criterion as an in-the general environment, %c framework should also be terim value until after it develops more experience with helpfulin allowing NRC, States, and the public to focus the potential for individual exposures from multiple li-resources on reducing the more significant risks under censed and exempted practices.The widespread practices NRC's jurisdiction. I offer the following response to to which this criterion applies are primarily consumer Commissioner Curtiss' thoughtful views in the spirit of products, which could involve very small doses to large the constructive process that has culminated in the BRC numbers of people The 1 millirem criterion was selected policy.
specifically to address the possibility that members of the public may be exposed to several exempted practices.
As with many of the issues that the Commission Simply put, cxposurc of an individual to a handful of
- deals with, there were ;; cry few right and wrong solutions exempted practices could result in annual doses close to to the issues associated with the llRC policy. The Com-100 millirem if each practice were allotted individual mission reached its decisions on the policy by selecting doses up to 10 millitem per year. This is highly improb-preferred solutions from among a spectrum of possible able given the Commission's plans to closely monitor any
. policy options, hese decisions were made based on the overlap of exposed populations from exempted practices Commissions technical analysis of the issues associated as well as the aggregate dose to the public from exemp-with regulatory exemptions, legal interpretation of gov-tions. Nevertheless, NRC does not presently know how crning legislation, and regulatory experience in approving many exemption requests will be submitted by the public, exemptions since the birth of civilian uses of nuclear how many will be approved, and what types of doses will materials in the 1950's. I believe Commissioner Curtiss' be associated with the exemptions. If few exemptions are views on selected issues constitute part of the continuous requested and granted, the probability of multiple expo-spectrum of policy options. Ilowever, for the reasons sures from exempted and Ecensed practices exceeding a articulated below, I affirm the Commission's decision to substantial fraction of 100 millirem per year is consider-approve the policy statement in its present form and ably reduced. Therefore, the 1 millirem-per year crite-reject tt e differing views put forth by Commissioner Cur-rion may be too restrictive and the regulatory resources tiss.
associated with its implementation may be better spent to control more significant risks. Consequently, the 1 mil-lirem per-year criterion was selected as an interim indi-Commissioner Curtiss clearly endorses the policy vidual dose criterion to ensure that the sum of all expo-and the concept of establishing a comprehensive frame-sures to an individual from exempted practices does not work for making decisions on regulatory exemptions.
exceed a substantial fraction of 100 millirem per year, llowever, he takes issue with five elements of the policy:
This criterion will remain an interim value until after the
-(l)the interim nature of the 1 millirem per yearcriterion Commission gains experience with the potential for mul-for practices with widespread distribution,(2) selection of tiple exposures to exempted and licensed activities, the 1000 person-rem per-year criterion for collective dose. (3) the manner in which the Commission views the The initial rulemakings to implement the policy, BRC criteria as a " floor" to ALARA, (4) omission of the particularly in the area of consumer product exemptions, principle of justification of practice, and (5) making HRC should provide valuable insights into the validity and ap-rules an item of compatibility for Agreement State pro-propriateness of the 1 millirem criterion in terms of its grams.These issues were fully considered by the Commis-need to protect the public against multiple exposures to sion and the NRC staff in the course of developing the nuclear materials..Although I agree with Commissioner DRC policy, indeed Commissioner Curtiss voted in Sep-Curtiss that a final criterion would be desirable from the tember 1989 to approve the HRC policy, the essence of standpoint of " administrative finality,"it would be prema-which is preserved in the final BRC policy in today's ture to establish the I-millirem criterion as a final crite-notice.
rion until after the Commission gains more experience 19
BRC Policy Statement with exemptions of practices with widespread distribu-constrain decisions on exemptions without an adequate tion.
health and safety or environmental basis.
Based on these provisions, the Commission selected Collective Dose Criterion the value of 1000 person-rem / year as a level of collective Commissioner Curtiss would have preferred to dose that ensures less than one health effect per practice.
adopt a collective dose criterion of 100 person-rem / year in selecting this value, the Commission relied on contem-because of his view that this value is more consistent with porary recommendations of expert national and interna.
the prevalent techrucal view on this matter.
tional bodies.These includec the 1988 conclusions of the United Nations Scientific Committee on the Effects of For the reasons discussed below, I believe that a Atomic Radiation (UNSCEAR) that collective dose cal-collective dose criterion of 1000 person-rem / year is more culations only provide reasonable estimates of health consistent with the prevalent techmeal view on this mat-risks if the collective dose is at least of the order of 10,000 ter and provides a sounder regulatory basts for making person-rcm.This value is an order of magnitude greater exemption decisions. The Commission considered two than the value of the collective dose criterion selected by fundamental questions associated with the collective dose the Commission. UNSCEAR also stated that the most criterion:(1)is there a need for a collective dose critenon I kely outcome of collective doses on the order of a few and,if so,(2) what should the value of that criterion be?
hundred person-tem is zero deaths.
The Commission initially questioned the very need The Commission also considered the magnitt. des of for a collective dose criterion for the types of practices colicctive doses associatcd with practices, primarily con-that would be considered as potential candidates for ex-sumer products, that huc vacady been exempted by the emption. This questioning was based on a number of Commission. This was core to provide a benchmark for factors that indicated that the Commission may not need the vt.he of the collective dose criterion based on histori-to consider collective dose in making exemption deci-cal decisions that the public found acceptable.The Com-sions.These factors included:
mission found that the magnitudes of the collective doses for these exempted practices fellin the range of the 1000
- 1. There is considerable uncertainty associated with person-rem / year dose. Specific examples include 1200 the validity of risk estimates based on projections of col-person-rem / year from watches whose dials are adorned lective doses composed of small to very small doses to with paint containing tritium,800 person-rem / year from large numbers of people.
smoke detectors containing radioactive materials, and 8600 person-rem / year from gas mantles for lanterns that
per year, coupled with the other provisions of the policy (e.g., broad definition of practice), should ensure a consis-In addition, the Commission considered the magni-tent and adequate level of protection of members of the tud e of collective deses associated with licensed activities, public from all exempted and licensed practices.
such as discharge of effluents from nucicar power plants.
The Commission established A1 ARA design objectives
- 3. Although collective dose has been considered in for effluent treatment systems for power plants in Ap.
evaluating environmental impacts and in assessing the pendix t to 10 CFR Part 50. The Commission noted that effectiveness of ficensee ALAR A programs, NRC's regu-the dose values established in the design objectives are latory program has not traditionally placed specific con-generally consistent with a collective dose criterion with a straints on collective doses associated with regulated ac-magnitude of 1000 person-rem / year, However, the Com-tivities.
mission also recognized that licensees have performed better than required in accordance with Appendix l'.sy
- 4. Based on comments submitted to the Commis-reducing estimated collective doses from reactor raant sion on its proposed BRC policy, including comments effluents to 110 person-rem peryear in 1986, which is the presented by the Health Physics Society, the prevailing most recent year for which the data have been completely technicalview opposed adoption of a collective dose crite-assessed (see NUREG/CR-2850, Vol. 8).
rion in the BRC policy.
Finally, the Commission and its staff are only begin-Despite these considerations, the Commission also ning to evaluate specific details of how the BRC policy recognized the benefit of a collective dose criterion in will be implemented tiuough subsequent rulemakings limiting the total population dose associated with ex-and licensing decisions. Even at this preliminary stage, empted practices and in evaluating environmental im-the Commission has identified substantive implementat-pacts and the effectiveness of ALARA programs. Conse-ion issues pertaining to the application of the collective quently, the Commission decided to estabhsh a collective dose criterion. For example, an issue has been identified dose criterion as a part of the BRC policy, provided that it regarding how the collective dose criterion would be ap-was based on valid scientific analysis and that it did not plied in making decisions about appropriate levels of 1
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BRC Policy Sttement cleanup for contaminated sites. Specifically, does the col.
practice. In this regard, I agree with Commissioner Cur-lective dose criterion apply generically to the practice of tiss because the truncation of further efforts to reduce decommissioning or would it be applied on a site-specific doses is one of the principal regulatory motivations for basis? Similarly, how sho'uld the collective dose criterion establishing the BRC policy.
be applied in cases where nuclear operations have con-taminated groundwater resources that could potentially However, I disagree with the rest of Commissioner
. supply municipal drinking water systems? Resolution of Curtiss' view on this issue. It would be inappropriate to these and other issues could cause the Commission to tell the regulated community that they cannot reduce revise its selection of the magnitude of the collective dose doses below the BRC criteria. In short, although we will criterion through future rulemakings and development of not require licensees to reduce doses further, we do not generic guidance. However, based on the technical infor, war.t to discourage !beir efforts to do so either.This would mation and recommendations currently before the Com.
be tantamount to telling a licensee how to operate his or mission,1000 person-rem / year appears to be an appro-her business regardless of whether any health or safety priate magnitude for the collective dose criterion.
issues are involved. Such a direction would be inappropri-ate because it clearly falls outside of the health and safety For all of these reasons, the Commission established focus of the NRC.
a collective dose criterion of 1000 person-rem / year for cach practice.
In formulating the BRC policy, the Commission rec.
ognized that new technologies being developed today AIARA pr mise to reduce doses, and therefore risks, at lower costs than present technologies. Indeed, technological Commissioner Curtiss would prefer to define the and cost considerations are explicitly recognized in the individual and collective dose criteria as " floors" to definition and application of the term " ALAR A.".%us,1 A1 ARA, that is, that the regulated community and NRC beheve it would be inappropriate to tell licensees that are relieved from the regulatory obligation to perform they cannot implement new technologies and health further ALARA analyses below these levels if individual physics practices to further reduce doses if they want to.
doses are 1 millirem /10 millirem and the collective dose is 100 person-rem. Specifically, Commissioner Curtiss be-Justification of Practice lieves that the BRC policy sends a confusing message by Commissioner Curtiss would prefer to endorse the encouraging voluntary efforts to achieve doses below the principle of justification of practice (i.e., whether the BRC criteria.
potential impacts of a practice are justified in terms of net societal benefits) and retain the prerogative to reject ap-In respcmding to Commissioner Curtiss' view on th.is pl cations for exemptions regardless of the risk they pose.
I_
issue, it ts important to begm from the definition of the term ALARA. AIARA is the regulatory concept that I disagree with Commissioner Curtis' view on this mdiation exposures and effluents should be reduced as matter because it puts the Commission in a position of low as is reasonably achievable taking into account the making decisions in areas outside the normal arena of its state of technology, and the economics of improvements expertise, where the agency would be especially vulner.
in relation to the benefits to public health and safety and able, perhaps justifiably so, to criticism. Consistent with other societal and socioeconomic considerations, and in the mission of the NRC, the Commission should base its relation to the utilization of atomic energy in the public judgments on an explicit, objective, and rational consid.
interest (10 CFR 20.1(c)). The ALARA concept is one of cration of the health,. safety, and environmental risks the fundamental tenets of radiation protection and has associated with practices, rather than on what many been a keystone in NRC's regulatory framework. Public would perceive as personal preferences of the Commis-
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comments on the proposed BRC policy statement and on sioners. Such an approach fosters long-term stability in proposed revisions to 10 CFR Par t 20 urged the Commi 6-regulatory decisionmaking on potential exemptions.
sion to define " floors" to ALARA or thresholds below which NRC would not regt' ire further reductions in dosc3 Decisions on justification of practice involve social or effluents, and cultural considerations that fall outside the Commis-sion's primary focus and expertise for ensuri g adequate The Commission responded to these comments in protection of the public health and safety from the use of the policy by stating that "... a licensee using the exemp-nuclear materials. Such decisions should be made by af-tion would no longer be required to apply the ALARA fected elements of society, such as residents near a con-principle to reduce doses further for the exempted prac-taminated site, potential customers, suppliers, and other tice provided that it meets the conditions specified in the members of the general public, rather than NRC. I be-regulation" established for a particular exemption. In lieve that this position is consistent with regulato y prac-other words, the BRC criteria and implementing regula-tices of other Government agencies that generally do not tions will provide " floors" to AIARA for the exempted regulate on the basis of whether a particular practice is 21
I CRC Policy Statement justified in terms of net societal benefit. For example, to The low Level Radioactive Waste Policy Amend-the best of my knowledge, the Environmental Protection ments Act did not change the regulatory framework ap.
Agency does not question whether the genemtion of haz-plicable to Atomic EnerEy Act materials. On the contrary, ardous wastes is justified in terms of net societal benefit, the Act specifically recognized the importance of that even though the agency promotes the minimization and framework by including provisions such as the following:
elimination of such wastes to reduce risks.
Sec. 4(b)... (3) EITECT OF COMPACTS ON I believe that Commissioner Curtiss misinterprets FEDERAL LAW.-Nothing contained in this Act the BRC policy when he claims that it embodies a bifur, or any compact may be construed to confer any new cated approach on the principle of justification of prac.
authority on any cornpact commission or State-tice. As clearly indicated in the policy, the Commission
"(A) to regulate the packaging, generation, may determine that certain practices should no,t be con-treatment, storage, disposal, or transporta-sidered candidates for exemption on the basis of risk g,g g
estimates or associated uncertainties. Rejection of such nerincompatible with the regulations of the an application should be based on the risks posed by the Nuclear Regulatory Commission...;
practice, rather than whether the practice is justified m terms of net societal benefit. He types of conc,crns he
"(B) to regulate health, safety, or environ-raises about risks to children and the general pubhc would mental hazards from source rnatcrial, be critically evaluated by the Commission in rulemakings byproduct material, or special nuclear ma-to determine whether particular practices should be ex-terial'-
empted. Herefore, I believe that the Commission has established an appropriate BRC policy that does not con-sider whether a proposed practice is justified in terms of societal benefit.
"(4) FEDERAL ALTillORITY.-Except as ex-pressly provided in this Act nothing contained in this Agreement State Compatibility Act or any compact may be construed to limit the applicability of any Federal law or to diminish or Commissioner Curtiss also disagrees with the Com-otherwise impair the jurisdiction of any Federal mission majority view on the need for uniformity between aE*nCY' "*
basic radiation protection standards established by NRC and Agreement States. He indicates that he would not Unlike thc Uranium MillTailings Radiation Control treat the Commission's policy on below regulatory con-Act of 1978, as amended. the Iww-Level Radioactive tern as a matter of compatibility for Agreement States Waste Policy Act, as amended, does not authorize States with respect to disposal of commercial low--level radioac-to establish more stringent standards.The Act also spe-tive waste. He reaches this conclusion in part because he cif cally directed the Commission to establish standards reads the low-Level Radioactive Waste Policy Amend-for exempting specific radioactive waste streams from ments Act of 1985 as giving States a great deal of latitude regulation due to the presence of radionuclides in such in deciding how to proceed with the development, con-waste streams in sufficiently low concentrations or quan-struction, and operation of new low-level waste disposal tities as to be below regulatory concem. If,in response to facilities. Drawing upon this interpretation, he concludes a request to exempt a specific waste stream, the Commis-that individual States should be allowed the option of s on determines that regulation of a radioactive waste deciding whether low-level waste designated B RC should stream is not necessary to protect the public health and be disposed of in a licensed low-leve: radioactive waste safety, the Commission is directed to take the necessary disposal facility, steps to exempt the disposal of such radioactive material from regulation by the Commission. Thus, the Act did This policy statement in and of itself does not make not, in my view, grant any particular latitude to the States any compatibility determinations; as indicated in the to determine which waste streams were of regulatory statement, compatibility issues will be addressed in the concern. Rather, it reaffirmed the existing roles of the context of individual rulemakings as they occur. But I NRC and the States in determining regulatory standards believe it is important to respond to Commissioner Cur-for low-level waste and specifically defined the Commis-tiss on this issue in two respects. First, I do not read the sion's authority in this regard as including designating 1Aw-Level Radioactive Waste Policy Amendments Act as waste streams which are below regulatory concern.
giving the States particular latitude let alone specific authority in the area of waste to establish radiation stan-The respective roles of the Commission and the dards different from those of the Commission. Second, !
, States with respect to the licensing and regulation of do not believe that the issue of BRC for waste disposal Atomic Energy Act materials. including the disposal of can casily be divorced from BRC in other areas such as low-level radioactive waste received from other persons, decommissioning.
are governed by the provisions of Section 274 of the 22
BRC Policy Statement c
Atomic Energy Act of 1954, as amended. Absent t'he lhe potential problems from conflicting standards execution of a Section 274b Agreement with the N1'C,a identified by the JCAE in 1959 are fully apparent in the State is preempted by Federal law f rom exercising reg ila-context of BRC and demonstrate why the scope of com-tory authority over the radiological hazards of these mae-patibility findings to be made by the NRC cannot be rials. The Co.1 mission is authorized to enter into an drawn to enclude low-level radioactive waste disposal.
agreement with a State only upon a finding that the State For instance, the Commission intends to use the risk program is, compatible with the Commission's program criteria identified in the policy statement to establish for regulation of radioactive materials and adequate to decommtssionmg enteria, that is, the level at which a
. protect the public health and safety. Section 274d.(2).
i rmerly licensed site may be released for unrestricted The legislative history of Section 274 stresses throughout the importance of and the need for continuing compati, use. If the States are permitted to require that low-level.
bility between Federal and State regulatory programs. In waste streams designated BRC by the Commission be comments on the legislation, the Joint Committee on disposed of in a low-level waste facility, it could result in a Atomic Energy (JCAE) stated that site in one state being released for unrestricted use,while s il r materials in an adjacent State at ' hat level would be
- 5. The Joint Committee believes it important to required to be confined in a low-level waste facility. If a emphasize that the radiation standards adopted byStatesundertheagreementsof thisbillshould patchwork of disposal critcria were to dcyclop, it would be either be identical or compatible with those of virtually tmpossible to establish decommissionmg funding -
the Federal Government. For this reason the requirements that would be adequate to assure that all committee removed the language 'to the extent licensed facilities will set aside sufficient funds over the
- I feasible'in subsection g. of the original AEC bill life of a facility to pay for decommissionint The resulting considered at hearings from May 19 to 22,1959.
confusion from these conflicting standard' could well re-1he committec recognizes the importance of the sult in delays in adequate decommissioning of contami-testimony before it by numerous witnesses of the nated sites and certainly in unnecessary concern on the dangers of conflicting, overlapping and inconsis-part of the public. I continue to believe that reserving to tent standards in different jurisdictions, to the the NRC the authority to establish basic radiation protec-hindrance of industry and jeopardy of public tion standards, including designating which wast e streams
- safety, are below regulatory concern, is fully justified to ensure Sen. Rept. No. 870, September 1,1959,86th Cong.,1st.
an adequate, uniform and consistent level of protection of Sess.
the public health, safety and the emironment.
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