ML20043C045
| ML20043C045 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/1987 |
| From: | Spangler M Office of Nuclear Reactor Regulation |
| To: | |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010238 | |
| Download: ML20043C045 (16) | |
Text
_.
Y
@jj THE NEED FOR DE MINIMIS e
aa RISK STANDARDS IN 7@
REGULATORY DECISION i
MAKING:
l Environmental Health Risks:
AN INDIVIDUAL OR A l g s Assessment and Management SOCIETAL RISK CONCEPT?
Miller B. Spengler Special Assistentfor Poliry Development Office of Nuclear Reactor Regulation y'
U.S. Nuclear Regulatory Commission 1
Washington. DC USA 20333 f,
edited by R. Stephen McColl, Ph.D.
[~
ABSTRACT Institute for Risk Research. and Tw is a w iest in themsw ywe sws y \\
Department of Health Stude, s j,,,,,,,,,,,,,,,,,,,,,,,j,,,,,,f, y _ _ g,,,,,,,,,% 93,,,,,
g dentalfatalisy and latent concer risks. There are a seriety of noteds in dewloping such scenderds: (I) no echreer a sneerr efficient ellerotion of sociesel resources in emelysing er redencing those risks shot are deserwedly significent. (2) so ineepr=>we the sererneeenet ofenredty issors herween defferent persies of interest in regulerery actions. (3) so ach6rw greater aneiforneity of risk noenegeneene practices and policies enneeng verioens ;;, !-^:y
.?
ogenocies. and (41 no aid legislators and annres in reaching conclusions
~
regarding certain issanes ofinedioident oned societal risk.
l3 One issue deservinet accention is erhether a de oneieioneis risk stenderd een a
be established as acceptable evirhoent reroenese so e definitier risk-cost-benerfit enelysis to dernoonstrate the trifling neotore of a risk or a persice-x*%
for class of accident scenarios.
University of Waterloo Press
' e.
Another issac is whether e standard of de minimis risA sheenid deel
'4 \\
1987 esclusiwly with risk levels regarded as trifteng from en indowident per-k spec,#we or whe,her a sociesel persperrewe of essreyste risk should addi-tionnelly be considered.
(
9 N k%*
M4 '
N.
,f
(
206 Spangler De Minimis Risk Standards 207
- 1. TIIE NEED FOlt MEGUI.ATORY POIJCY ON Tile COMMON-USE Thus regulatory interest in establesinas acceptable standards of de sesamm-CONCEI'I' OF IW MINIMIS RISg is risk is, in large messere, a reactive mode of dealing with actevist pres-seres to reduce risk to a very smell, if not zero, level. Ansong the polecy t.1 tac Deriveries of a Ceasasee-Use Cearvpr of Dr Minimis Risa issues addressed by Joyce Davis (22) regardag the de nunnens regeletory cutoff concept are:
There is a growing recognition of the desirability in public policy-making for a cutoff standard of insignificaset risk. Jurisprudence has long recog.
I.
why is it needed' mied the principle of "de minimis non corst lem" (i e., the law does not concern itself with trifics). Such a standerd may be based on reference 2.
how could it be used?
values of common-ese, which roegMy chorecterire the levels of individual risk that are sufficiently negligible not to nierit additional personal expen-3.
who has recognized the need?
ditures to reduce them further (1-20). According to Clarke of the U.K.
Natumal Radiological Frotection Board, there is a widely held view that 4.
what econosme benefits would it provide?
few people would commit their own resources to reduce an annual risk of death of one chance in one hundred-thousand and that even fewer would 5.
how could it be estabhshed and : /-----G?
take action at a chance of one in a million per year of exposure to a given hasard (19).
For example. Davis soggests the followsag f -- _ are of specsel sig-nificance for the NRC and other Federal agencies concerned with regolet-The legal principle of de mimmis nose casret lex is centuries old. The ing radietson hazards:
recent attention of policy makers to the A. m esse concepts of de min-
[
For setting regelstory priorities.
j imis risk is an attempt to avoid the possibility of a wasteful commitment of societal resources to risks of marginal or trifling significance. The establishment of a supportable rationale for a cetnff standard in address-As a " floor
- for As Law As R-Mj Achievable (Af ARA) con-ing the policy issue of safety is also desired. Much of the movement siderations.
toward "zero-Icvel' risk standards has not taken due regard of the negligi-l As a cut-off level for collective dose assessments.
ble probabilities associated with some of the risk scenerios having " worst t
case" consequences (17). Nor has adequate regard beca paid to the gener-l For setting outer boundaries of.- _. 7
- roses.
ally observable condition that, as technology is anodified to yield lower levels of risk, the marginal cost per unit of risk reduction tends to to rise i
exponentially.
As a floor for definition of low level weste.
l Douglas and Wildavsky note that the corrent consideration of risk has As a,,--..;: ices of triviality in legal proceedings.
three peculiarities. The first is that disagreement about the problem is To foster adnumstrative and regelstory efficiency.
deep and widespread in the Western world (22). The second is that differ-ent people worry about different risks - war, pollution, eenployment, infla-Te prov,de perspective for pobhe enderstandmg. incledmg pohcy j
j tion. The third is that knowledge end action are often incomensurate.
Whatever programs are enacted to reduce risks, they conspecuously fail to judgments.
l follow the p*inciple of doing the niost to prevent the worst damage. In I
sum. substantial disagreement remains over what is risky, how risky it is.
1.2 DaneseseroNe leverest of rac Ceares de Dr Minimis RisA j
and what to do about it. They go en to state that most people cannot be Svendarde j
aware of most dangers at most times. Hence, no one can calculate precise-ly the total risk to be faced. How then do people decide which risks to 11e response of the environmental nuovenient to decades of societal meg-take and which to ignore? On what basis are certain dangers guarded lect in environenentel protection has led to a spese of legestation assned at against and others relegated to secosidary states? Obviously, cuiteral val-Protecting the envirossement and the public against herni. These laws in
' secreases in regulatory agency activities at i
ucs are important in this regard, as well as slic life-experiences of individ-term have led to, _ _
unh and their families and personal friends or acquaintances. The role of the Federal. State sad local levels. Concern over water and air pollution.
the medsa and activist groups also appears quite significant.
food contaminents, and heaards f.omi drogs and radiation have led to aaneel empenditwees of bothens of delines se reduce and vegelate these i
risks, and to pensee or defend theni egnenst esort actions.
A.
s
.f*
. r
^
208 Spangler De Minanis Risk Standards 209 Many of these laws were cast in general terms without specific standards death mome=ets Inter. This is tree whether one speaks of driving, swimming. flying or generating electricity froen of safety or sa fety. cost tradeoff criteria, and often were expressed in ambiguous or confusing language. Accordingly, regulatory agencies have coni. Each of these activities poses a calculable risk to struggled to make rea!istic interpretations of their intent, in terms of society and to individuals. Some of those who accept the establishing more specific rules and regolations, while minimiring the risk (or are part of a society that accepts risk) do not ser.
prospects of adverse court relings. The Delancey Clause amendment to.the
'i'e it We intend that no such accident (s) will occer, but l~ nod and Drug Act of 19511 often has been interpreted as requiring abso.
the possibility cannot be entirely eliminated.
lutely scro health risk from any additive to food that is found to induce cancer when ingested by man or enesnel; yet in recent years a de minimis Before leaving the, subject of establisheng threshold values (whether for (or non iero) level of such risk is regarded as permissible (23). A case in consequences. probebilities, or leveis of risk). it is desirable to point out point is the soft-drink bottic made with plastic (aerylonitrile polymer).
that at least two court decisions bearing on regulatory issues of risk man-Traces of acrylonitrile, which as a monomer is carcinogenic in animals, agemer:t lend support for establishing such thresholds. and provide encel-can leach into the acid soft. drink. In 1977. the Food and Drug Adminis_
lent, catensive discussions of the underlying issues. One of these is the tration (FDA) banned the bottic. In reviewing the case, the Court of II8-pege discussion in the Supreme Court decision on benzene risks in Appeals stated that the administrator of FDA can ignore de minimis risks.
OSifA's proposed standsrd [448 US. 607 (1990). pp. 607-724). A pertic-notwithstandmg the superficial rigidity of the Delaney Clause (24).
elarly instructive possage front this decision is the followsag statement i
from the opinion of Justice Stevens (concensed in by The Chief Justice In a report issued in May 1983 for public comment, the US. Nuclear and Jessice Stewart) that bears upon a useful appreech to de sommis i
Regulatory Commission (NRC) proposed a set of qualitative safety goals standards of acceptabic risk and its use in the face of scientirsc encertain-and quantitative design objectives in addressing the issue of how safe is ty; l
safe enough (25). This report states that insofar as NRC's statutory responsibilities are concerned, absolute safety or "rero risk" is not legally In this case the Agency l OSHA) did not have the beneret j
required. The Atomic Energy Act refers to adequate
- rather than of animal studies, because scientists have been enable as 1
" absolute' protection of the public heshh and safety. There is risk inhet.
yet to induce leukemie in esperimental animals as a j
i ent in nuclear power. just as there is in all technologies, including compet-result of benresse esposere. It did, however, have a fair ing energy technologies and in every personal activity in which people amoent of epidemiological ev,dence, includeng both posi-engage. T he intent of Congress empressed in that legislation is that nacicar tive and negative studies. Although the Agency stated power be developed ender a licensing system for safe commercial use to that this evidence was insufrecieset to construct a precise generate cIccaricity. Ilowever, the US. District Court decision in Nader v.
correlation between esposere levels and cancer risks, it Roy recognires some kind of balancing process:
would at least be helpful in determiaing whether it is more likely than not that there is a significant risk at 10 Absolute certainty or " complete".
- entire', or " perfect" ppm.
i safety is not required by the Atomic Energy Act, nor l
does nucIcar safety technology admit of such a standard.
The advantage of this approach is that by Fwst establishing a -
Al l
Power Reactor Development Co. v. International Union, threshold or limiting value (either as a technical specirecation, a safety i
lilectrical Workers. sopra; cf., Crowther v. Seaborg. 312 goal, a de minimis risk level or a de emnunes probability of hersnfet conse-F. Supp.1205.1235 (D. Colo.1970).
quences) the procedere then persets a E-aful discussion of both herd j
(i c., scientific) evidence and soft (i c., subjective or interpretive) informa-
[
Moreover, the Commission's report on safety goals makes an important tioet This velee serves as a besis for the subjective judgment that the tree
-distinction between " acceptable risks" and "acceptabic deaths" - a differ.
(but anknowabic) value might be greater or less then the -
- L.I seen-ence in perspectives between cm post and ex ante attitudes toward risk:
dard. In terms of the compica process of cognition, this would appear to be a more effective way to organize intellectuel discourse serm-G We want to make clear at the beginning of this section oncertainty than to ccepare information on causes and effects with a that no death attributable to nuclear power plant opera-qualitatively expressed standard or norm.
tion will ever be " acceptable" in the sense that the Com-mission would regard it as a routine or permissible event.
Another commendable discussion pertaining to the establishment and use We are discussing acceptable risks. not acceptabic deaths.
of the de nanimis concept.is found in the 89.pnge decision of the US.
In any fatal accident, a course of conduct posing an Court of Appeals. D.C. Circuit on risk snenegement issees of polletent acceptabic risk at one moment results in an unacceptable emesseons of coalfired electric generating faci 8: ties relative to the requi;c-t
De Minimis Disk Standards 211 Spangler 210 i
lish the regolatory methorities of Federst egencies to deal with risk. This ments of the Clean Air Act {636F.2d 323 411 (1979)l. Several key pas-was a serioes complaint by Justice Rehnquest in a review of the legislative sages are especially illuminating (Sections 121-123. 125 on ffealth and history of the Occupetionel Safety and Heshh Act of 1970, as found in I:nvironment):
the Septeme Court decision on OSHA's standard setting on benzene risk 1448 US. 607 (l*20), pp. 676685). The discussson by Justice Rehageist, The statutory 100-non threshold for defining a major Congress.nen, and respondents of the Act's pleraseology covered a gesnet emitting facility does not necessarily exceed a permissible of terms and concepts: zero risk ; econonsec, tec_1'eible-
- . and de minimis level for application of BACT {Best Available polnical* feasibility ; the h - * ; --ble use of " fee and Control Technology].- -
ender PSD [ Prevent reasonable ; any vs "meterint ;
to health; *essering, so Significant Deterioration] port of Clean Air Act Amend.
for as possible ; the difference between "fessible and *pensable ;
j ments of 1977, however, the EPA must follow a rational merginal or ensignirscent risks; the preference for safety over detters ;
approach to determine what level of emession is a de min.
the decisional criterion of adsenestrative difficohies ; best evesemble evi-imis amount and may siot merely adopt the state 5ery dence ; consenses standards ;
re=====bly necessery or appropriete cri-threshold Clean Air Act. Sec.165d(a)(3. 4).169(f. 3),
terion of standard setting ; eart the detc.sninetion of whether the 42 US C.A. Sec. 7475(a)(3. 4). 7479(I 3) economic effects of [the OSHA] stenderd bear a reasonable relation to the espected benefits. The need for a cicerer forsnelation and derenition A rational approach to determining what level of the of tersns m regolating beehh and safety was stated by Senator Sembe in emission is a de minimis assioent for purposes d PSD the Senate debate over the OSHA Act of 1970-requirements under Clean Air Act Amendments of 1777, including best available control technology, would consid-I believe the terms that we are posseng back and forth er the administrative burden with respect to each statuto.
are going to have to be identified. 116 Cong. Rec., at ry context: what level of emensson is de minimis for modi-26522. I.eg. Hist. 345.
fication arid what level de minimis for application of l
BACT. with agency looking at degree of adminestrative Thus the regulatory agencies, in the fece of such 1 tU:ies and lack of i
l burden posed by enforcement of various de minimis spectiic guidance in the laws governesig eincir sealsorities to regs!ste on threshold Icvels and taking into accomest (Inc facility's air cetoff limits on de smsomis risk, appear to have en open invitation by the pollution controls and possibly considering of statutory above court decessons (and others) to develop threshold seemistds of thresholds for new facilities.
Clean Air Act. Sec.
acceptable risk.
165(a)(3. 4),169(I. 3). 42 US.C.A Sec. 7475(a)(3. 4),
7479(f. 3).
1.3 The Nee of Life Versas she Egoiry Yater of Life Seing In establishing a de nonesms standard for apphcetion of As noted by Grahem and Veepel, the placing of vehse on homen Me by best availabic control technology to modifications of facil.
regelstory agencies is both a controverseel and emotionel sobrect (26):
l ities subject to PSD.-g- - - - -ue of Clean Air Act Amendments of 1971, a rational approach woorld consider Critics of bencree-cost emelyses of lifese,ing progre,ns i
whether the de minimis threshold shoeM very depending commonly desness such analyses with the guery bot how on the specific pollutant and the danger posed by increas-can you pet a deller value on a life? Some believe it is es in its emission.
Clean Air Act. Sec.165(a)(3. 4),
snorally and intellectually derscient- (27) to attesept to 169(1. 3).42 US C.A Sec. 7475(e)(3. 4). 7479(I. 3)._
monetire mortality. Other critics have observed that timere are, at least currently, no generally agreed upon estinentes i
in deciding on immediate PSD regeletion of pollutants of the socalled velee of a life and conseguently, es Nich-e I
other than sulphur dioside and perticulates the EPA clas AsMord of MfT has ergoed, easil society better under Clean Air Act Amendments of 1977, acted reason.
enderstands this volee, current snelytic veteetions of life ably in balancing feasibility in econossac mopect arge.
most always be --- ",
, and cannot be dweetly com-ments against the goal of protecting clean air acess.
pared with the _-
-y costs or benerses of a regeletion Clean Air Act Sec. 165. 166. 42 US.C.A. Sec. 7475.
(28).
7476.
Although it is tree that regoletery policies _ 14 % tradeoffs Substantial confusions, controversies, and. _ " _, inefficiencies seem have been construed as the eneral i ",
' of placing a price en from the inadequacies of sound
- word engmeering-in time laws that estel>
en
o 212 Spangler De Miniinis Risk Standards II) hfe". I feel that this is the wrong characterization of the snost appropriate For enample. the National E. _- u ;al Pohey Act (NEPA) includes a arena of debate. An anecdote illustrates this point. At the NATO number of phrases iseplying equity connederations in social decessen snek.
Advance Study Instetwee of Technology Assessment. Environmental ing:
Impa(t Assessment, and Risk Analysis held in 1983 at Les Arcs. France.
I had occasion to describe NRC's proposed safety goals. One guideline The objective of creating and maintaining conditions moder which was a safety-cost tradeoff criterion of $1000 per person-tem averted man and nevere can esist in predoctive harmoay-lSec. l(s)].
through options that would, if adopted, reduce the risk of severe nuclear To fulfill the " social, economic, sed other regesveneents of present gwwer plants accidents (25) This goedelene volve is rooglely equal to 57.4 milhon per fatahty averted using a ratio of 135 fatalities per million ased Intere generations af Ansericans" [Sec.10l(a)].
person-rems. This value is substr1tielly higher than the 1250.000 to To achieve s "belance between population sad resseree ese which 1500.000 per fatality averted used or referenced by other agencies in risk reduction decisions (29) will permit high standeeds of living and a wide sharing of life's amenitics' [Sec.101(b)(5)].
When told of the proposed standard and the inferred value its ese would To insere that " presently esquentified environmental amenities and i
place on saving a life, an objection was raised. "You're playing God'~ My rejomder was. "But doesn't God need helperst* That is to say. there are velecs may be given appropriete consideration in Af : ---king l
certain rehgious, cahical, or moral values entant in our society which cel-along with techaecal consederations" [Sec. iO2(b)).
aurally prescribe a more or less commonly understood seme of fairness l
and equity. Thus, the proper moral question to be addressed by regulatory To emptore the relationship between local short-term eses of neon's agencies is not whar valec should ec placed oor heem.wr life. Life is indeed environment med time sneeswenesce and enhancesseent of long-term priceless to those whose lives are cut sloort and to those who mourn. Rath-productivity" [Sec.102(2)(C)(iv)].
cr. the consideration of cost in conjunction with risk is imperati-c because of the common sense recognition that society has fenite resources to A long-standeng ethical princapie in social deesseen-oneking is what is devote to hie-saving or risk reduction investneents. Hence, an imposing referred to as the " greatest-good for-the-greatest-messeber". This principle ethical issac is whether en cacessive empenditore for risk reduction in one derives from fl.c fenoces work of time Enghsa paletical ec====== Jeremy area of human activity woesid inequitably deprive the ese of these same Bentleesse. As Iserreducricer so she Priseriples of Merels esed Isg(sterocer resources for risk reduction in other areas with espectations for possibly (1789). Benthem deGeed the principle of etility es "thet property in say saving even more lives. Moreover, society uses risk-benefit tradeoffs in obpect whereby it tends to produce piensore, good or ',,
. er to pre-achieving a balance between expenditores on behelf of risk redoction and vent the ' ; p_.
- et snischief, pois, evil er
' _,,: __ to the party the esse of financial resourctis to enhance the quality sad enjoyment of life weisse sneerest is <===hred*. He steen adveceeed thet slee ebyect of aN in numerous ways (30). Thus, in my view, an appropriate perspective for legislation most be the "grescent *,; _ ee of the geeseest neaster".
hioking upon n (dollar) Ggere of encrit for fatality reductie is not one of F;esese his utility deGeition recogssises ',;
ise both its peoitive sad puttmg a price on hic (a calloosed notion); but rather it is su be humanely negative forms, the term "gressest *,;
- is to be viewed as a art and ethically perceived as an egerity velse of saving liver.
concept which accommodates costs os weR as benefits.
Regarding public decessons in the cheece of ; ' "__ M shermetives, the
- 2. POI.lCY ISSUES OF AN INDIVIDUAL VERSUS A SOCIETAL option with the highest ratio of toest benefits to total costs would general-( ONCEI'T OF DE MINIMIS RISK ly agree with the tienthessesse preenple of slee geeseest snesseber essly if its costs and benefits are averaged ever a long sequesace of ;- _" " _. si 2.1 tac flernseey and Ceeffier of fedmdeel med Socieral Veters developenents. in which versees perties tone turns in being winners and i
losers. This is so because, for some kinds of
-?
'y proyects, time in several prior papers I have addressed etteical issees pertaining to the greatest benefits seney be
. /, local or regional ist nature; winerees the r._
harmony and conflict of individual ased societal velocs in relation to the costs, including subsidees, seney be deserstweed ever a le+ge nesseber of per-risks. costs, and benefits of technological options and the reconciliation of sons or tempeyers. Nose that flee Besethemseee principic of social decisseen confhctmg values (31-35). A key responsibility of regulatory agencies is to regeeres losises sninerities to sacriGce their intereses for the overell welfare seek alternative policy options that reduce conflect between different par-of the mobrity interests tecs of interest. This may occer between the individual-verses-notional lev-ci, of interest, and between identiGable and divergent interest groups at A seneewhat defferent ethical perspective is preveded by the :f' _ ". :,
the sub-national level.
role saggeseed by Vilfredo Pareto neer the begonneng of the twenseeth cen q
=
~
m
211 Spangler De Minimis Risk Stinderds 215 t
tury. Using the Pareto optimality principle, technological applications are reseh im reactor accidents should not esceed one-acceptable in those cases where some porties are &ctrer off and none er, tenth of one percent (0.1%) of the som of pronopt worse off. It is clear that this principle would also meet the Benthamite fatality risks resohing from other accidents to wheek test of the greatest good for the greatest number, since in this case only members of the U.S. population are generally good for all results from the developmental activity. However, it is diffi.
caposed.
cult to imagine any large developmental propect in which at least some individuals or groups would not regard themselves as losers. Nevertheless.
The risk to the population in slic wnne / area near a if a " social contract theory" were accepGed in which certain individuals
""Cl**r Power plant of cancer fatalities that neight are willing to be losers in some actsons - provided this is more than com.
reseh fran nuclear power plant operation should pensated for over a series of L "_
--I actions (in which other parties not enceed one-tenth of one percent (0.1%) of the may, in turn, be losers) - then " rogrammeric Pareto optimality may som of cancer fatality risks resuhing froni all other p
result.
casset Another approach, called a potenriel Pareto improvement, is defined by The first of these is denoted as an "individeel ris&" quantitative desegn Meshan (36) as a change which (if costless transfer of goods and/or mon-objective (QDO) and applees to the average prompt fatality risk to the ey among members of society are assumed) ces make e.c.,ec.c better off individual living or worksag within I asile of the socicar power plant site
- in other words, where it is possible for the winners out of their net ben -
boundary. The second goal is denoted as a "societet risk" QDO as applied efits to adequately compensate the losers without themselves becoming to flic population within 50 niiles of time plant site. As it terns out, since losers in the process. It has been suggested, for example, that nearby resi-the goal is stated as a risk act enceedsag 0.1% of the semi of the concer dents of a proposed nuclear power plant might be conspensated for the fatality risks from all causes, it is actually competed as an average indi-increments! risks they would be caposed to by offering them reduced elec-vidual rate of cancer risk. Thus it is not a true de smnemies risk standard tric rates. There are already being experienced certain local or regional that is aggregative of societal risk.
L benefits which may fmore or less) compensate nearby residents of electric power plants and.3 esin otlier technological installations for perceived The notion d aggregate societal risk as a perspective by which nuclear risks and other envuonmental costs. In this regard, regional income ard acculents are viewed is no longer a hypothetical one. The Soviet's own employment benefits may be significant. Moreover, for lightly-populated estimate of delayed cancer fatalities frone the Chernobyl nuclear accident
[
rural counties the siting of a major facility with investment costs of hon.
- I April 26, 1986 based on certain noodehng assumptions and sketchy dreds of millions of dollars may provide an isicrease of tax revenues of data on radiation esposeres (pest and future) is rooglity 45,000. Other two-to twenty-fold. The combination of ',-e/ community services and estimates place the aggregate number over a 50 to 70 year period at i
social infrastructure made possible by the increased tax revenues (together either a much lower or nisch higlier level. Whichever estimate is taken, with a reduced property tax rate) is a powerful stimelos to increased no estimates have yet been given that address alte geestion as to what property values benefitting homeowners arki other property holders.
fraction of this total is an aggregate of very small radiation caposures to given individuals and hence would be de minimis from a personal perspec.
2.2 A De Minimis RisA Stenderd Frese es fadivideaf Verses e II'* These womid yield sireable aggregate societal fatality estimates only
[
Socirraf Persperrivefor Present and Fntere Generesie,,
because a very large number of persons are caposed at doses so low as to
- y. eld personal fatality risk no greater then nemierces other cancer fatality A review of the literature revenIs that regulatory policy derived from a de or accidental risk's that persons accept with no special anniety (21).
minimis standard of insignificant risk is generally based on the perspective of an individual rather than a societal threshold. However, the question One way d framing the imlowy ine the pros and cons of an endevidual.
i needs to be addressed as to whether this preference is correct.
verses an aggregated societal perspective in establishing de snenimes stan-dards is: If the risk associated with a given herard is so smell as to be of in the report, Safety Goals for Nuclear Power Plant Operation, it is stat.
insignificant concern to the individual, why eben should society be con-ed (25):
cerned over the aggregate risk of all individuals exposed to the hazard' The Commission has decided to adopt the following two For example, if an individuel risk level of one chance in a miellson per year design objectives:
- I *sposere to a hazard is aggregated over slie present U.S. papeletion of 240 milhon persons, the. number of annual fatalities in the aggregate is l
The risk to an average individual in the vicinity of a 240 persons. (In Canada, the r
. C benchmark would be 25 per-e
- uclear power plant of prompt fatalities that might sons.) How, tinen, shouNI such a societal de sumsms noenber he dealt with en a deternweation of national priorities for allocating resources aangna a,
l M-J.
De Minimis Risk Standards
^217 216 Spangler A concern that an entensson of years to life beyond retiresnent age bre gamut of safety concerns regarding numerous technologies, medical serves as a drain on accumulated savings with at least three adverse services, research programs, national security needs, etc.?
consequences: a reduction in time overall national rate of capital for-mation due to the dissavings imphcated in such trends; less salteri-One problem with a de minimis benchmark of this kin.I is that for a gov-tance resources to transfer to the benefit of feiere generations; and a ernment official to state that an aggregate of, say,240 lives lost annually decline in the quality of lifestyle for the serviving elderly when the is "below regulatory concern" is to risk an image of callousness with its supplement to corrent empenditores,through dissaving can no longer attendant pohtical costs. Nor are regulators enmindful of the importance be sustained.
of alleviating political costs in policy decisions.. I suspect that in a number of instances where unusually high cents per life saved are required by reg-Yet there are also arguments indicating that the annual sparing of 240 ulatory d:cisions-or possibly excessive conservatisms are employed in esti-lives may yield certain positive aggregate societal effects as well as the mating risks-the heavy foot of political costs accompanying a different availability of alternative strategies beyond risk-related decisions to deal analysis or decision was felt upon the scales.
with the above concerns:
I rom a strictly macro-societal standpoint, one might argue the negative if the harards being reduced prianarily involve pron pt fatalities of e
side of the question of whether ti;e overall, or net, welfare of our society the working population or those who will yet enter the labor force, a is significantly greater for a population that is marginally larger by some net improvement in the worker /non-worker ratio is encoeraged.
small number such as 240 spared lives.' Indeed, there have been numer-ous anxieties or concerns raised since the late 1960's over a number of Since fatalities affect social values as well as economic values, slee trends related to population growth and the lengthening span of hfe:
saving of lives among retired persons prolongs the social services that may be performed in the manner of counsel or other services as e
A deteriorating relationship between growing population and a parents and grandparents or in community work, etc.
declining base of non-renewable resources.
In those cases where the risks primarily affect lightly populated The impetus of growing population to the expansion of industrial rural regions, the fatalities could detract from economics of scale e
and other activities affecting air and water pollution as well as other essociated with a condition of mader-popelerion rather than the over-adverse impacts on environmental quality.
popeferion presumption as stated above.
The intensification of urban congestion and restricted access to spe-Technological advances that would snake available econosmcally via-cial kinds of recreational or cultusal reseserces from population pres-ble substitute resources to replace non-renewabic resources as well as family planning practices would tend to moot the concerns of over-sures.
A decline in the worker /non-worker ratio in our society if the har-o ards in question apply principally to fatality rates among the elderly There are numeroes oncertainties in comparing the negative versus posi-(as in latent cancer risk) rather than the younger age cohorts that tive aggregate societal impacts in reaching a decesson as to wisetleer an are more prominently involved in prompt, accidental fatalities.
individual risk perspective or one of societal risk should prevail in estalF lishing a regulatory standard of de minimis risk. Nevertheless, that there Growing concerns over the fiscal stability of Medicare and other are arguments on both sides of the societal risk perspective tends to molti-e health insurance programs due to a prolonged life capectancy and fy or reduce the importance of a societal standard of de minemes risk. Of the increased financial burden on the working population to pay for course, it is understood that the negative or positive aspects of 240 addi-such programs along with old-age survivors insurance.
tional lives in our society discussed above only have much nicammg if aggregated over a multiplicity of policy decisions for a wide variety of harards producing risks at a lower Icvel than one chance in a snillion of
' This focus on the overall (or net) welfare to society of a larger versus individual fatahty per year of esposure.
smaller population must be kept strongly in mind in the discussion to follow since the welfare arguments may come out quite differently Before deciding on an appropriate standard of de minimis risk, it would from the standpoint of individuals whose lives may be cut short or thes' be useful to assess the aggregate societal risks to health and safety in relatives and friends. There is no intent here to build a case for eutha-comparison to the net benefits of the technological option. By net benefits nana or to justify an indifference of regulatory policy to individud (as is meant the gross benefits to society mines the total of socioeconom:c opposed to societal) welfare in the establishment of de minimis c:an-d.irds of fatality risk.
De Midmis Risk Standards 219.
Spangler 218 TeMe 2:
Monctired risk of severe reactor accidents at ladian Point costs other than risks to safety and health. The critical comparison of Unit (37) (After fim design, evac reloc/ late reloc emergency risks to net benefits is facilitated if reasonable dollar values are used to monetire the health effects involved in the risks, as well as the various response) elements of costs and benefits that comprite net benefits. A number of f
tee seis se onese.as er such monetary conversion factors exist in the hierature. Table I shows a dye '"5 p'r seer ***ctor-seer j
set of hypothetical values as employed in the testimony of Frank Row-i some at the 1981 NRC-mandated hearings at the Indian Point Nuclear
'*ector ser" ta=
nedlem men cem - - e
,se.ce,or Plant near Peckskill.' New York (37),These values along with a weighted l
average of expected
- losses from various severe accident scenarios were used as a basis for assessing espected losses in dollars per year of opera-o{s f
e s tion (see Table 2)-
- r. totent oncer 5
fatanettes 2.se I.lt 3e.9 st.7 ses.e
- 4. algn testetemet esses, 3.33 i'.th re.3 ar.e so3.e
- 3. sometic effects s.7s L ToMr J:
Ilypothetical values of the economic incentives to reduce
- 5. terly 9. jeer s.ns < -sL:
1.1 3.6 19.0 l
2' 1.2 3.s is.s 1 omcws 4.29 Gl?
4.3 tr.,
43.e reactor accident health risks (37).
- "a'"'ca'*cerees thyteld 7.
ma-o 1.43 l SJ 4.3 12.9 43.0 f.6 f.6 f.s
- 8. necket screestag cor.s 99.s let.e get.g Los nedt.se utgh 5eetetal: heelth effects /yr.
389.9 281.0 201.9
- 9. property demoge terly fatettty (each)
$300.000 $1,000.000
$5.000.000
- 10. tegate petamer toteretcteen 190.0 198.9 194.0
- e. wie retteet 53.9 s3.9 S3.9 intent center fetality
$100.000 $ 300.000
$1.000.000
- 6. via tesamet unitterengh Settetal: offstte cleese, costs 530.9 528.9 Ste.t l
Genetic ef fect S 30.000 $ 100.000
$ 300.000 987.0 799.9 1.125.0 t
Total erfstte redfelegical Doses requiring supportive ordical l
tree tsent
$ 30.000 $ 100.000
$ 300.000 3*
3 **#
1.[.9 I *" '
3*M*******""
~
1.054.4 terly injury
$ 10.000 $
30.000
$ 100.000
- 2. Omstte cleemup 3.084.9 2.984 A 2.964 A 2.984 A 1
Interdiction of contemtnoted
$1000 per persen-rum y.g.:
egne costs /yr.
reservetrs er rivers (11guld pathueys) projected if me toterdic-ties were to tote place fetal offstte and omstte losses /pr.
3.151.0 3.273.0 3.889.0
)
hon-fetal concors
$ 10.000 $ 30.000
$ 100.0(.!
- Source: Table IllCS. staff teettsemy se C08.
t
)
non-concereus thyroid modules 1 3.000 $
10.000 30.000 g Sones that meeld **esit to early retalettes to the ehesace of supportive medical Medical streening costs
$1 per persen-ree projected treatmoet.
f i
The perspedive provided in Table 2 (using the medeem estienetes) is that the monetired espected values per year of operation of Indian Point-Unit 2 of early fatalities and latent cancer fatalities together (at $77.500) are cely about 2.4% of the to.at of offsite and onsite losses aggregating to
$3.27 million. A substantial fraction of the aggregate latent cancer fatali-An " expected" value (or loss) is equal to the consequences of a poste-ties on which the monetired value was based would be et such leur radiol-2 lated event times its probability. That the expected losses are fairly ogical doses (and, hence, leur espected fatality rates) as to constitute a de l
small in Tab!c 2 is principally due to very small estimated probabilities minimis level of individual risks, at the levels that are -
., used to i
of the various severe accident scenarios. The use of an expected value describe this risk. Thus their aggregate value would scarcely be e====-
for fatality risk holds certain advantages in cost-effectiveness or risk /
quential to regulatory decisions regeriting safety improvements. Accordeng-net benefit analysis. However, a disadvantage is that, standing alone, ly, it is rather debetsble whether such latent cancer fatalities in a fairly l
such an espected value does not adequately reflect the societal resilien.
siacable population receiving small radiation doses esceed a de seinianis
^
cy and other penalties to society of catastrophic fatalities versus the level of individual risk. However. locking such a de minesnes stenderd, the same number of fatalities from chronic causes dispersed over space and time (31).
- 6 220 Spangler De Minimis Risk Stondards 22I estiman-< 4
- 1y fatalities and latent cancer fatalities on which the ms- -
sees of Table 2 were based included levels of individual l
[ggiipM%q 3 h rist a r il both below and above a common-use value for individ-i gpggggg g le a
ual de umims risk.
As noted above, it is desirable to compare risk to net benefits in setting a l
[$339@$f 3 i
de minimis standard, whether an individual or societal risk perspective is j ggggggg js s
employed. No risk, however small, is worth taking if there is no percep-tion of net benefits. The cost estianates of Tabic 2 (exclusive of the risk l
estimates of fatalitics) are componenta of this determination. The net ben-
- ; g l
I@MMhW 3g g
efits ol' a technology to society cannot be determined without a compari-5 g
l gg\\gglll j 55 son of its costs and benefits with other viable technological options m meeting the same primary societal need (34). In an NRC report of August 1980, the methodology of making cost comparisons of a coal-fired l
IDE.E 3I i
generating plant with those of a nucicar power plant of equivalent capaci-l [$A%snMssM le ty is described (38).
Using this methodology, the comparative estimates of the present value I
(i c., discounted) cost for 30 years of operation for an equivalent capacity l Insh%VM lgg s '
i of nuclear and coal-fueled power plants are shown in Figure I for the period 1990-2020. The most realistic cost comparisons are those involving the "no recycle" assumption for nuclear power plants and the DOE gy y
adjusted" assumption for coal-fueled plants. The cost differentials between iib %A% 1 D N l g, j
i S
i 3
the coal and nucIcar alternatives vary between regions. Taking the New t-y!
j York /New Jersey Region, the net economic benefit of the nuclear over g
! l.
i the coat option for 2400 MW-e capacity is a present value of about 13.3 billion over a 30-year period, or $110 million per year. This is a net eco-
! IbN_ Y-YN-3 s
nomic benefit of $35 million year if scaled down to the 849 MW-e capaci-d*
l
[ggg 3g Q I ty of Indian Point-Unit 2. These numbers are used here only for illustra-i frame than the plants postulated m Figure I.
gg
---g gk tive purposes since the Indian Point-Unit 2 was built in a different time 3
g1
-F l
ggggA3y 3 gi E j Nevertheless, if the comparative cost estimates are regarded as crudely i
anainable - and there is currently a serious question over this (40,41) -
l gggg-g' g j gj jg it would mean that the espected value of total offse,te and onsite losses
~"'
due to a severe nucIcar accident estimated at $3.3 million per year in dE
' Table 2 would be roughly 10 percent of the hypothetical net economic i
=a ~
l
[AQ@hM 3g 4 I
3 benefits of the nucicar versus the coal option Deducting these expected i..
l g' g g g-"g g!
losses in this illustration would still leave a net economic benefit of 530 g&
million per year to compare with the monetired fatality risk estimates in jg Table 2. The latter would thus be about one-fourth of I percent as large gig!j!jjjjjjjjj.g as the net economic benefit m thes allestration, and looms even less impor-tant as a decision consideration, being well within the " noise level" of the range of uncertainty of input estimates to these calculations.
figere I:
Sommary of present value cost of 30 years operation for The latter statement should not be taken to mean that the NRC does not nuclear and coal-feeled power plants, 1990-2020, millions of take seriously its primary responsibility to protect the safety and health of dollars.
the public as well as occupational workers. Indeed, the aforementioned quantitative design objectives in NRC's proposed safety goals provide a n
~
--a
223 De Minimis Risk Standards Spangler 222 target for design and operation of nuclear power plants. These imply risk l
levels lower than the one chance in a mdlion of fatality per year of empo-Ie***"sUsN.e,e""* nan."ne'aNe Iu*s.a't**NeN*e"a.'"
sure commonly mentioned for an individual de minimis risk standard:
I r
f caeres rete capites en m inents e e esa ce,ecity rect w.
The background data on prompt (or accident) fatalities freen aff I.
2.
ine saani et.ee eneren ter n.ciew sacinee e.23 maiss/ team for prompt causes in the Un, seed States show that en 1982 there were 93.000 l
n=
et/essenatitas n 2o20. tw entweete escamatutensas metmeen testa-deaths in a population of 231 meillion, or a fatality rate of 4 m e
l nientsas er eate esas =tta eene,ee reseni) eno c.at.e.te se e,,ca sset*'r 10*/yr. At 0.1% of this level, the prompt fatality QDO is a risk j
standard of 4 x 10'/yr.
f rer tne as recycie cue, u,o costs were escenetes et as per year to 3.
s ac at for ns n ersee.reas m meurce empieteen en seestse. to ene m In 1983 an estimated 440,000 persons died of cancer e,n the Unit-e
, r yu r fee eenerei tattetten. vee carrytna energes en f.et, concatetee 2.
cd States, or about five times time nelnber of M dealIts-et tes. we aceletee et a sw yeer a eerfect eoes euenetw et s,o e
costs eieng =ttn SE for esaores sofietsen.
F.c the recycie case, 9,0*
costs, reco.ered e-235 creett, see recoeoree ce creest more.eceisted et Th.is is a rate of 1.9 cancer deaths per shoesand papelation. At n pu yew tw rue.rce empietsen in enesteen te sne sa fee so. ore 0.1% of ibis background rate, the second QDO for severe nuclear satietsea. ce,ryias ener,n en e.i.e,e ewonetes et a per yeer sa accident risk is 1.9 m 10 per reactor year of operatiost This 4
eastsson to tne ss tw generen serietsen.
QDO is substantially less lisniting than the pecenyt fatality QDO, N eens. wee cosi coets are asses en set *e f. roc et contasmee sa the as it aPProPrintely sitoisld be in view of time fact that latent cancer 4.
maa n i sepe t to ceaorm s, aprsi tops. vne mesesmetes est re ore.. ore s
fatalities ' involve Stsbstantiaily ies iire sitoriening tiia i pro net m
acetated et su pw yeer t tese to acceane ter es wei serietten.ta centrei res ens, saci.e e ses incree,en pt the ee.tsesest one nor adjustee DOE figures for ein rentens enceor tne meet three ye w s in the r.,,;;,;es, s
roe stae pesca projectee a reesis tres tne esas semer centract of spreas, 197e. plus 3 per year roen escenetsen ese to espi.tsen of nfgn grade eres Moreover, it shoesld not be assoffied lltat llte stoneti28 tion of ilbe fatality risks of a severe mesClear SCCideftt ignores the Inor$I is8ees of Iife and in omettson to the SX for generen infietsen. [There ss me correcteen costs to acce.nt for roen escenetsen en esse imber con-tracts (i.e., sect.asse.e escreesse eine i@er precoctt, tty), roei escene-death. As stated above, a safety <ost tradeoff criterson as readily defensi-tactueem en cae teen em to oorestas tse reti transputetsen eyetans er panssas pet atten ble as an equity value for saving the anost lives in an efficient allocation i.eisiette.n peticy sattnets.es.] te se e,entser enet ene a m i g
g for whicit the w lives aet set. reti account et sn u e asp i,premente op.oce pree-can be saved per unit of expenditore. This criterion, of course, can work tacum dkh h Table I it = M m impe a dealer @lesta so see e.1 esis/ensi en a cost peso e., ee-se k
g different types of fatalities and otiter health effects. On time other hand,if 5.
me has a stet ecomenttC societal Met over itS aIteraatives of, oneteCh Y
N.neej.sted 80f 199e cost teste were estoistes et W per peer o.or the so y a r este er ene pient te ecce==t ter sonoret snesetten ene et.ceentes say, one bilhon dollars per year, these savings could be used at the choice 6.
vne seraesatee-ts e areeme of society - cither as espenditsee decessons of individual citimesis or gov-at man te esteen 1,so pr m at sei.ee.
.a sej.stee cut.eisen socerporates cost sacrosees ese to the 197e es"*
ernative imber centract, esceneted et 3 per year to ecce.nt rer rose.rce espietsen ernmental agencies - to save 1000 lives.f the average cost i
ene iegressas et the treascwtetsen eyeten sa sentisen te sa pw yeer for life-saving opportettities were elle Inillioft dollafs Per life saved.
there is me correctlen sace ees for roen ecceletten en seneren fattetten.
esae later contracts (s.o., facreases or escreesee mine imber precocts. sty),
There are of course other " net benefits" of a store intangible notere en time aer to reen ucatesw em to penetne er potents : tesistetten en peticy nuclear-versus-coal options, which are not included in the above estimates.
s nitiet e.u.
The saving of coal resources for possibly store valuable uses of Figure I:
Explanatory notes to Figure I.
I.
future generations (and perhaps in our own lifetimes) such as liquid-fuel conversion, syngas snanufacture or as setetstetes for petro <hemicals in the manufactere of plastics, fertilizers, etc.
Redeced risk of scid-rain and g.-
' - effects on property val-2.
wes and income losses, verses the possibly lesser increased risk of property value ased encome losses attaining to the nuclear option (31).
The possible net reduction of future ansiety (or psychic) costs 3.
over limits to growth and other energy-related fears during the
+
e
22.t Spangler De Minimis Risk Sitnd:rds 225.
period of transition from dependency on depletable energy cer fatality rates using model mill assumptions' is given as 25 percent of resources to renewable or ubiquitous energy resources.
background risk for a single mill and Ja percent for a mill closter (42).
There is a significant body of professional opinion that a one-third or so increase in radiation dose relative to natural background radiation can be
- 3. APPL.ICATION OF DE MINIMIS RISK CONCEPI'S TO regarded as a de minimis level of individual risk (21). For esemple, the RADIOAGIVE WASTE DISPOSAL PRAGISES average available background radiation dose in Colorado from commec and terrestrial radiation is 124 meem/yr. This is 2.4 times the 52 nwem/yr.
There is also the policy issue surrounding the fact that radioactive wastes estimated for the lowest state (Florida). Richard Wilson pointa out that a and toxic chemical wastes can pose a hasard for hundreds or thousands of resident in a state with a low level of cosmic backgreemd radiation years if not properly managed. Thus, the aggregative societal impact of increases his or her risk of premature fatality by one part in a niillion der-such risks over many generations is of concern in establishing a de minim-ing a two month visit to Denver, the same as for the increased level of is risk standard. NRC's Office of Nacicar Material Safety and Safe.
dosage from cosmic radiation jet flying for 6,000 miles at 35,000 ft. alti-guards had addressed these problems for eranium mines and mills in issu-tude (14). Moreover, a comparison of state data for annual cancer fatality ing the Final Generic Environmental Impact Statement (GEIS) on rates with estimates for natural background suggests, if anything. en Uranium Mdling (42). Management of mill tailings after milling opera-inverse correlation at these low rates of radiation doses. For esemple, the tions cease, involving about 600.000 tons / year of low specific-activity sin highest states in terms of total cosmic and terrestrial radiation (Colo-material, is the primary consideration in decommissioning these facilities.
rado, Montana, Wyoming, Utah Idaho, and New Mexico) with estimates Although the concentration of radioactivity in the tailings is relatively ranging from gg to 124 mrem /yr. have cancer death rates of 91 to 162 l
low, control measures are deemed necessary because of the large quanti-per 100,000 population that are appreciably ecfow the U.S. annual rate of ties involved, and because of the long half-life of the parent radionuclides 187. It is interesting t'o note that four of these states (New Mexico, Wyo.
that are present. The management of mill tailings has received increasing ming, Utah and Colorado) have many active eranium mines and mills and attention and interest in recent years front involved Federal and State are estimated collectively to possess 70 percent of the probable eranium agencies and from environmental conservation groups. This interest has resources of the United States (42).
arisen from studies carried out during the last decade which have indicat-ed that uranium mill tailings, if not properly managed and controlled, This negative correlation is not to suggest that low doses of radiation tould present a potential public health hazard. The most vivid example, of might be beneficial to one's health, but rather it is most likely due to the course, is the situation that occurred in Grand Junction, Colorado. The masking effects of far more important causal contr Ntions to cancer fatal.
remedial actions necessary to correct the misuse of tailings in the con-ity rates that would captain variations between states. These include struction of homes, schools, and other public structures are a continuing demographic and socio<conomse factors, dictory habits, smoking and oth-substantial cost to the Federal Government and the State of Colorado.
er lifestyle differences, and environmental chemical and radiation carcino-gens of artifactual or natural origin (21).
With respect to overall health impacts, the critical mill-released radiono-clides and their primary sources are, in descending order of importance:
Analysis of cancer fatality data has been performed from the large sempic j
Rn-222 from the tailings pile; Ra-226 and Pl>2iG from the tailings pile; of A-bomb survivors of Hiroshima and Nagasaki, as well as smaller sub-and U-238 and U-234 from yellowcake operations. Health impacts from populations of industrial workers or medical patients exposed to sebatan-
[
Rn-222 result from inhalation of redon daughters and ingestion of the tial doses of radiation. This evidence suggests that a doec of 10 rem es ground-deposited longlived daughter Pb-210. Because Rn-222 is released still sufficiently small that detection of an increase above the normal in gaseous form, it is transported long distances, exposing large popula-background incidence of cancer cannot generally be demonstrated with tions albeit at entremely small levels above background. The impacts of statistical precision, even in a large caposed population (43,44). Thus the Ra-226 and Pb-210, released in particulate form from the tailings pile, jury is still out on whether the levels of radiation doses estimated above result primarily through mgestion pathways (dispersed Ra-226 also consti-for the model mill cases might shimately be accepted as de minimis risk tutes a secondary source of Rn-222 release). Emissions from impounded according to common-use concepts of individual esposure-tailings materials have an enhanced importance due to their persistence beyond the operational lifetime of the mill itself. Yellowcake emissions result in significant localized impacts, primarily via inhalation, but essen-tially terminate when the mill shuts down.
Model mill assumptions in the GEIS were based on mills in operation The estimated integrated risk assessment for an offsite individual for can-in the 1970s. Both the technology and regulations governing mill opera-tions and mill tailings treatment have changed since then to increase radiological protection for offsite population.
.M.,-
\\
l l
227 Spangler De Minimis Risk Standards 276 Should health risks occurring far in the future be valeed as 2.
The potentially most useful (and possibly controversial) apphcation of a though they were occurring now? And if not, how should heshh de minimis risk standard would be as a cutoff concept for low levels of risks be valued?
risk posed by mill tailings for future generations, as well as for long dis-tances from mill tailing sites. In principle, the relevant ethical issues are Is it really worth reducing risks which, on an individual basis, are 3.
not wholly dissimilar from those associated with multi-generational effects at least extremely small and may even be zero?
of long-term storage of high-level wastes from spent fuel of nuclear plants (45). Ilowever, since the ratio of the tonnage of mill tailings produced is Should present generations be permitted to bequeath a legacy of 4.
10,000 times as large as the spent fuel from generating electricity.
continuing undeserved radiation exposure?
about fuel can affordably be -ap== led and buried at depths and the spent locations that would merit less concern for cumulative effects on fraure The dollar values and ranges of parameters used in this risk-cost-benent generations than mill tailings.
analysis of alternatives for increased d " Al protection are shown in Table 3. After grappling with the above ethical issues in the soberug con-The following estimates in the GEIS provule helpful perspective on the text and complexities of risk-cost-benel'et analysis, the GEIS did reach cer-risk issues related to mill tailings:
sein regulatory conclessons, and developed new.-p..u " for proce-deres costing tens of millions of dollars to increase radiologecal protection The most significant impact front mill operations under the base beyond former practices. The details of the alternative procedores consed-case would occur from persistent raden releases from the tailings.
cred in the analysis, and the inephcations of the new requirements for dif-About 6000 premature deaths are predicted over the period 1979 to ferent types of mining and niilling nyerations, are beyond the scope of this 3000 in the United States Canada, and Mexico, from tailings which paper. However, the resolution of timese regulatory.,- -- =s left open would be generated by time full operation of mills in the U.S.
the geestion of a future NRC position on de minimis risk, and whether through the yesr 2000.
such a concept should be established at the level of individual de nunenus risk or the aggregate level of societal risk.
The cumulative potential health impacts constitute a 1.2 x 10' frac-tion of the overall U.S. incidence of cancer. Furthermore, the effects of releases from milling can be compared with those occurring from Values and ranges of parasseters used in redon flux opti-Table 3:
natural and technologically enhanced sources of radon. 3pecifically, miration parameters and values used (42).
l exposures from milling reden releases would be about 0.3. 0.2,3 and I
10 percent of exposures cecorring froen releases from natural soils,
==
building interiors, evapotranspiratsoa and talhas of soil, respectively.
e e.,
=. -
=
.e.in
- "'***"*"****hd**""""
8'*****
's The continuing annual rate of premature deaths from this volenne of S
""*"'*****'d=*--**"
tailings is estimated to be about sin per year. This annual rate could e.s as o.
a**"=--"**"*--
be used to develop estimates of health effects beyond 1000 years if i
""*=d'**"***"
I this were desired; this would require making very uncertain assump-
,,,,,,,'*,,llgl' * * *==' *=*
,,,,,,,,p tions on long4erm factors such as climate, population growth, and the like (42, p. 5).
- m.m
- e. w =.
- * *""" *" swe e ts m' =. mn. -
As noted above, the base case for these estianates pertained to milling
- *** *=; g gl,7,,*,,',=,,,-=;g";,,,",",,*;=,",,r,,'lg g;"gll?l0;"j;*glll$,,,
l a
operations in the 1970s, and do not reflect currcs protective measures to g,,,,,,, ;,*,*,',,;;; g,*,gg,'ap * *===='ae a w *"**= " *
- reduce these risks under the new regulatory requirements. In developing these requirements, the GEIS used an ALARA type of cost-benefit bal-ancing that sought to address the following issues (42. Vol. lit, pp. U-6, U-7):
Accordeng to Cunningham (12), recognition of the importance of the de Ca=======
menews risk concept emerged from the Neclear Re,,J _ 7 Should available societal resources be committed to protection in a series of licensing decessons, which concerned the release e( reden ges 1.
from tailings <manated redon when greater benefits might derive attribetable to the meineng and nielleep if uraniene needed se feel certain from other applications?
nuclear power reactors. The issue in tuue cases arose onder the Noteenal Environmental Policy Act rather than the Atomic Energy Act. However,
l De Minimis Risk St:ndzrds k
Spangler 228 This report proposed a fondamental criterion for radienc-becas:;c the decisions concerned the potential health effects of the release e
m W & das imo k b gg g
g g
of radioactive radon gas, they are closely related to the issue of a de min-imis concept in radiation protection.
have long half-lives, they will be capable of irradiating populations for hundreds and thousands of years into the In a proueding to determine whether permission to construct a nuclear future. While the effects on one generation might be f acil ty should be granted, the NRC's Licensing Board considered the sig-the mhnvc diecu over m genermies g s
i mficance of radon gas releases,n the content of an environmental st-g g,
- g~
e benefit ana ysis. The Licensing Board found that the calculated health effect that might result - half a death per year in a population of 300 Thus, a fundainental criterion for radioactive waste dia-ide'm M % imerguermiend milhon - was a mmimal impact. Properly stabilized erut tailings piles and t
reclaimed uranium mines would make the impact 100 times lower. The irrWimin ad in dfem board concluded that the best means of characterizing the sigmficance of radon releases attributable to operation of the facility was to compare The conciensions of economists like [Talboel Page and phi-rs Q
w a ided god fw w them with those associated with natural background radiation and its fluc-tuations. The incremental releases attributable to the facility were s radioactive weste programming: an equal opportunity cri-small as to be completely undetectable. Thus, the Board concluded that serion, implemented through a neutral allocation of ben-their impact could not be significant l8 NRC g7 (1978)]'
efits and risks to future Gnerations. In appealing to this ideal, we reject arguments that a present commitment to In several other licensing cases involving the same issue, the NRC's nuclear power is fair because current investments in a Appeal Board referred to the Licensing Boei-d's decision as employing a e
iM & via poh wiH bendit se "dc tmmmes approach' l13 NRC 487 (1981)). In a more recent decisico future by enhancing society more than they harm it concerning the health effects of radon gas releases, the Appeal Board through, for example the proliferation of nuclear weap-
.made no reference to the de mmimes rationale. However, they retained ons and waste hazards. This argumem requires weighing the comparison to natural background radiation, and concluded that "the benefits now versus costs later to make an allocation that me-rental health risk to the population stemming from the fuel cycle is k afs The mWiy ided may be w-crnam (if indeed there,s any) is vanishingly small" [16 NRC 1528 tainable, but is essential to minimize unfairness by the i
( Noverr.be r 19. 1982)]. The Appeal Board found that the redon releases closest possible approach to neutrality with the future.
st:riburat,w to a single 1000 MW-e nuclear reactor would cause an wresse n dose to the bronchial epithelium of from 0.0005 to 0.005 milli-a diffm a g&nsive via d se socid. poli 6cd rem m year. This is Ier below the I millirem per year that the draft
'"d " " *I I'****;
cvision of NRC's regulations in 10 CI'R Part 20 proposes as a de minim-s level of exposure to an individual from any licensed source.
J&
dh wa me ht ee pob-Iem of radioactive waste dispoest was trivial, the error of
.The concept of including the aggregate risk to future generations of the present raay be to presume that it is ethically deci-It c de importance d respasible radiological hazards from mill tailings, spent nuclear fuel, etc. in regulato-ry decision making (although individually de mimmes and growing smaller dpi d mW e to chim ht neitk view is with each passing year) is often cast as a moral imperative for the ade-quate protection of future generations. The merits of this position cannot h fa & mps d rdiac6ve e is pamypi-properly be determined without considering the effects of what such a pol-M d h h facig a rapidh diplying hmuity icy would yictd for the efficient (and moral) application of societal resources to save the greatest number of lives - with the finite resources d a mWin ht h direct imphemions fw it is willing to commit to such purposes-versus other uses of available g
,;,, ;, g, g,,,
resources to enhance the quality and enjoyment of life.
Examples aboiind. Tonic chemical wastes, the nascent imbalance of carbon dioside in the alsnosphere, and An informative dialogue on criteria for intergenerational equity in coping
""*I'*' **'I* '' I"*'***"8 I ***'** **"8I '*' "'***
I with the issues of neclear waste management was contributed by Thomas come readily to mind.
Cochran and David Bodde in a study sponsored by the National Science l'oundation (45). The following are some of the key elements of Cochran's position:
_ _ - _ _ _ _ = _ - _ _ _.
231 230 Spangler De Miximis Risk Strnd:rds year. Opportunities also exist to reduce travel deaths on caisting lughways While the disposal of radroactive waste is prototypical of of all types at relatively modest costs per life saved by improved Inghway l
these concerns, it is only prototypical. There is nothing inherent in the problem to warrant attention out of pro.
maintenance practices (520.000); guardrail improvements (530,000); road skid resistance (540,000); road rescue belicopeers (570,000); impact-l l
portion to the other societal dangers that face us. In this absorbing roedside devices ($110,000); breakaway signs and lighting posts l
essay, I contend that if our moral concern is the preserva-tion of equal opportunity for future generations - and I (5120,000); road median berrier i__ ants (5230,000); and highway rescue cars (5420,000) (46). Much of the safety gains of past and current personally believe this to be correct - then our duty is to investments in these highways and expenditures for research on highway create solutions to the disposal of radioective waste in the safety technology will be availabic for the substantial benefit of fu,ture context of the other threats to human existuice, rather than in isolation. This impbes a more holistic approach generations, as well as the present society making these investaments.
than has heretofore been taken. It implies balancing our in using a population perspective that h aggregated over many years into attention and resources in proportion to the magnitude the future, there is also a danger of creating societal anxieties out of all and nearness of the danger, proportion to those merited by scientific analysis. For example, U.S. auto-mobile deaths are cursently occurring at an annual rate of 46,000. Multi-While this dialogue is illuminating, neither position went for enough to develop a satisfying in-depth perspective on the complex nature of equity plied by 100 years (or about 4 generations) this aggregates to 4,600,000 fatalities. Investments in research and improved highways over the nemt issues, involving the proposed neutrality criterion of equal opportunity for decade that would reduce this annual fatality rate by 10 percent would l
present and future generations. If the risk to each succeeding generation from the longterm storage of high-level nuclear wastes is small - and save about 400,000 lives over this period. In sinieler vein, there are cur-probably de mir.imis from an individual standpoint - scientific knowledge rently 440,000 concer deaths per year in the United States. Multiplyms concerning the climatic and sea level changes from the greenhouse effect this number by 100 years, yields an aggregate of 40 million fatalities. A 10 percent reduction in these fatalities theough investments in snedical i
does not permit us to dismiss these as cumulatively small. Nor do these research or earlier detection of cancers could spare considerable life-l appear individually de minimis in terms of their potentially tragic conse-shcaening for 4 million souls over the neat four generations. An alernung ti quences for property values, incomes, and employment. It is less clear estimate of fatalities can be realized for almost any kind of risk by niehi-t J
whether the induced changes of a greenhouse effect would exact a toll in l
lives from sudden drought or permanently drier conditions created by cli-plying the annual societal risk by 100 years let alone 1,000 or 100,000 years! The crucial decision perspective must be one of relative priorities matic changes (27).
for risk reduction, given the limitation of societal resources for such ps,e Nor is it correct to infer that only the present generation stands to benefit poses.
from the nuclear option, while future generations principally reap the har-ards of that policy. An additional view is that the present generation is
- 4. CONCLUSIONS subject to the risk of severe nuclear accidents and other fuel cycle risks in technological development (including investments in L
pioneering a A true ethical perspective in pohcies for regulating technologies to provide research), which would make is safer for the use of future as well as improved protection for health and safety must be made in a more holistic present generations. Moreover, the presence of nuclear power in a mix of perspective of societal values, opportunity costs, and comparative techno-energy supplies will likely yield to future generations the additional ben-logical impact analyses. In my view, the combmetion of a safety. cost efits of a spared amount of coal consumption for possibly more valuable tradeoff criterion (i.e., an equity value of saving lives cutting screas differ-uses in liquid fuel conversion, syngas manufacture, and substitute stock cat opportunities for life saving) in conjunction with a de menenus stan-for manufacturing petrochemicals, plastics, and fertilizers.
dard of risk from an individual perspective are important cornerstones in the effective management of society's resources. We may then schieve an A cutoff concept using an individual perspective for establishing a de min-appropriate belance for investments in saving lives, and in achieving other imis risk standard, together with a safety-cost tradeoff criterion would benefits that improve the quality of life both for present and future gener-doubtless save uncalculated billions of dollars that could be used to save a 6
much greater amount of lives if spent wisely. Nor can it be assumed that l
ations.
such expenditures today only benefit the present generation. For exampic,
~
in 19f12 the mileage death rate on the nation's turnpikes was 1.3 deaths I
per 100 million vehicles miles, or about one-third the rate of 4.1 on other rural roads. In addition, the 42,000 miles of the U.S. Interstate highway system have reduced the number of deaths by an estimated 4700 per y
8'"
d
-s
s
.c 233' Spangler De Minimis Risk Stzndtrds 232 13.
CLARKE, R.II. and FLEISHMAN, A. (1984). The Est ' fisk-
- 5. REFERENCES ment of De Minimis Radioactive Wastes. IRPA 6th Co.
ess.
West Berlin.
I.
KFSSLER, D.A. (1974K Food Safety: Revising the statute. Sci-ence 223, March 9.
WILSON, R. (1984). Commentary: Risks and their acceptability.
14.
Sci. Tech. Numan Values 9, 2, 11-22.
2.
POCillN, SIR E.E. (1975). De minimis risk. Bnt. Mrd. Sull. 31 184.
WillPPLE, C. (1984). Apphcation of the De Minimis Concept in 15.
Risk Management. A paper presented to the Joint Session of the 3.
WEBB, G.A.M. and McLEAN, AS. (1977). Insignificant Levels American Nuclear Society and Health Physics Society, New of Dose: A Practical Seggestion for Decision-Making. NPRB.R62.
~
Orleans, June 6.
National Protection Radiation Board, United Kingdom.
MEINIIOLD, C.B. (1984). Criteria for a De Minimis Level. A 4.
AIF (1978). De Minimis Concentrations of Solid Radioactive 16.
paper presented to the Joint Session of the American Nuclear Wastes. NESP 016. Report of the Atomic Industrial Forum.
Society and Health Physics Society, New Orleans, June 3-8.
5.
USNRC (1978). Plan for Reevoimation of NRC Policy on SPANGLER, M.B. (1984). Policy issues Related to Worst Case Decommissioning of NucIcar Facilities. NUREG-0436 Revision 17.
Risk Analyses and the Establishment of Acceptable Standards of 1.
De Minimis Risk. A paper preser,ted at the 4th Annual meeting 6.
COM AR, C. (1979). Risk: A pragmatic de minimis approach.
of the Society for Risk Analyses on Uncertainty in Risk Analysis.
Knoxville, TN, October 2.
Science 203,4378 January 26.
7.
FRIEDELL, H.L (1979). Radiation Protectioer Concepts and 18.
FlKSEL, J., BARAM, MS., COX, LA. and MlYARES, J.R.
Tradeoffs. Lecture No. 3. Lauriston S. Taylor Lectures in Radia-(E984). Principlesfor Use of De Minimis Concepts in Risk Regu-larion. A report to the Division of Policy Pescarch and Analysis, tion Protection and Measurements. National Council on Radiation Natiocal Science Feendation, November,133 pp.
Protection and Measurements. Washington, D.C., September.
8.
EISENBUD, M. (1980). The Concept of "De Minimis" Dose.
19.
CLARKE, R.H. (1985). Rashological Protection Aspects of Esemption Levels in the Neclear Feel Cycle. Seminar on Inter-Quantitative Rist in Standards Setting. Proceedings of the Six-face Questions in Neoclear Health and Safety sponsored by the teenth Annual Meeting of the National Council on Radiation Pro-OECD Nuclear Energy Agency Paris, Apri! I6-18.
tection and Measurements,7910 Woodmont Avenue, Washington, D.C. 20014. April 3.
BENINSON, D. end LINDELL, B. (1985). Bases and Trends in 20.
Radiation Protection Policy. Semener on Interface Questions in 9.
DAVIS, J.P. (1981). The Feasibility of Esta6 fishing a -De Min-NucDear Health and Safety sponsored by the OECD Nuclear imis* frvel of Radiation Dose and a Regulatory Cut-off Policy for Nuclear Regulation. General Physics Corporation Report Energy Agency Paris, April 16-18.
GP-R-33040 Columbia, MD, December 31.
SPANGLER; M.B. (1985). The Assessment of BacAgreemd Data 21.
10.
WILSON, R. (1982). Letter to Samuel Chilk, Secretary, US.
for NRCSafety Goal Evaluerion. A draft report prepared for the Nuclear Regulatory Commission. RE: Proposed policy on safety U.S. Nuclear Regeistory Commission April 24,102 pp.
goals for nuclear power plants (45 FR 71023), dated May 17.
DAVIS, J. (I984). The Dr Mininess Regulatory Cut-Off Con-22.
repts. Testimony before the Advisory Committee on Reactor II.
BAKER, R.E., COOL, W.S. and MILLS, W.A. (1983). NRC Safeguards, U.S. Nuclear Regelstery Commission, February 9,23 Draft Revision of 10 CFR Part 20. Cutoff Level for Regulatory Concern (De Minimis), p.17.
pp.
12 CUNNINGIIAM, G.ll., Ill (1983). The De Minimis Concept in 23.
MARRARO, C (1982). Regulating food additives and containi-Radiation Protection. ' A paper presented at the Annual Meeting nants. In Quantitarire Risk Assessment in Regulation, edeced by of Nuclear Safety Research Association of Japan Tokyo, June L. Lave. The Brookings Institution, Washington, DC, 213-23i.
16, 26 pp.
234 Spangler De Minimis Risk StIndstds 235 24.
MONSANTO, et al., v. KENNEDY (FDA) (1979). 613 F 2nd 36.
MISH Af*f. EJ. (1973). Economics for Social Decisions-Elements 947 (DC Circuit).
of Cost-Benefts Analysis. Praeger. New York, p.14.
1 25.
USNRC (1983). Safety Goals for Nuclear Power Plant Opera-37.
ROWSOME, F.H. (1983). Direct Testimony of Frank Rowsome tions. NUREG-0880, Rev. I, May, and Roger Blond Concerning Comnussion Question 5. US.
Nuclear Regulatory Commission Before the Atomic Safety and 26.
GR AII AM J.D. and VAUPEL, J.W. (1981). Value of a life:
Licensing Board in the Matter of Consolidated Edison Company What difference does it make? Risk Analysis 1. I,89-95.
of New York (Indian Point. Unit 2) and Power Authority of time 1
State of New York (Indian Point. Unit 3), Docket Nos.
27.
BARAM. MS. (1979). Regniation of Health. Safety and Envi-50-247-SP and 50 286-SP, March 22. Appendix One to the Direct ronmental Quality and the Use of Cost-Benefit Analysis. Final Testimony of Frank H. Rowsome.
report to the Administrative Conference of the United States.
March I, 27.
38.
SPANGLER, M.B. (1980). United States Experience in Envirpn-mental Cost-Benefit Analysis for Nuclear Power Plams with 28.
ASIIFORD. N. (1980). Benefits of Environmental. Health, and Implications for Developing Countries. NUREG4701. US.
Safety Regulation, prepared for the Senate Government Affairs Nuclear Regulatory Commission, August,187 pp.
Committee. Center for Policy Alternatives. MIT. March 26,19.
39.
ROBERTS. J.O., DAVIS. S.M. and NASH. D.A. (1978). Cool f
29.
EPA (1976). Environmental Radiation Protection Requirements and Nuclear: A Comparison of the Cort of Generating Baseload for Normal Operations of Activities in the Uranium Fuel Cycle.
Electricity. by Region. USNRC Report NUREG-0480. US.
l Environmental Impact Statement for establishing 40 CFR 190 Nuclear Regulatory Commission. December 22-23.
EPA 520/4-76-016. Vol.1.
49.
COOK, J. (1985). Nuclear follies. Forees February II.82-100.
' 30.
WILSON. R., and CROUCH, E. (1982). Risk /8enefit Analysis.
Ballinger, Cambridge, MA.
4L STARR. B. (1985). Europe takes lead in nuclear power-Regels-tory and economic climate is more favorable than in US. Enrope 31.
SPANGLER, M.B. (1985). An international perspective on risk March / April, 20-21.
and equity issues associated with the coal and nuclear fuci opsions. J Public and Emernet. Affairs 5, t,101-121.
42.
USNRC (1980). Final Environnerntal Impact Statement on Ure-nium Milling. NUREG-0706, 3 Vols. US. Nuclear Regulatory 32.
SPANGLER M.B. (1980). Syndromes of risk and environmental Commission. September.
protection: The cceflict between individual and societal values.
Environ. Prof 2, 3/4, 274-91.
43.
PETERSEN H.T., Jr. (1984). Regulatory implications of radia-tion dose-effect relationships. Neolds Phys. 47. 3. 345-59.
33.
SPANGLER, M.B. (1985). Henristic opinion and preference eval-i uation research for assessing technological options: A user's view.
44.
KATO, H. and SCHULL WJ. (1982). Studies of the neortality In Environmental Impact Assessment. Technology Assessment of A-bomb survivors, Part 1. Cancer mortality. Radiat. Res. 90 and Risk Analysis, edited by V. Covello. J. Mumpower. P. Stal-395-432.
len and V. Uppulari. NATO Advanced Study Institute. Springer-Verlag. Heidelberg, West Germany. 917-952.
45.
MacLEAN. D. and BROWN, P., eds (19'i?). Energy and the Future. Rowman and Littlefield, Totowa. NJ 34.
SPANGLER. M.B. (1983). A critique of methods in the quantifi-i cation of risks, costs and benefits in the societal choice of energy 46.
SIDDALL, E. (1981). Risk, Fear ar.d Public Safety. Atomic l
options. Ann. Nuct Energy 10, 3/4. 119-51.
Energy of Canada. Limited. April. 39-43.
i 35.
SPANGl.ER. M.B. (1982). The role of interdisciplinary analysis in bridging the gap between the technical and human sides of rist assessment. Risk Analysis 2. 2, 101-14.
l
/.?7 t
L! /
hs
_f M
.O f
s m
s.
l W8%
l.
~
L MEMORANDUM FOR:
Victor Stello, Jr.
L Executive Director for Operations FROM:-
Robert M. Birnero Acting Director Office of Nuclear Material Safety and Safeguards i
SUBJECT:
BASIS FOR NONCONCURRENCE BY NMSS ON THAT PORTION OF THE BRC POLICY STATEMENT WHICH DISCUSSES THE APPLICATION OF A 10 HREM PER YEAR DOSE LEVEL The Office of Nuclear Material Safety and Safeguards does not concur with that -
portion of the Below Regulatory Concern (BRC) Policy Statement which selects 10 mrom per year as the dose level for which exemptions could be granted without further analysis. Such a decision assumes that a dose of 10 arem per year is " insignificant," 1.e. below concern, and that there is no need to further consider the ALARA principle. The Policy Statement, which covers matterp guch as consumer products, recycled contaminated materials, and waste disposaf,'as well as deconnissioning actions, is simply too broad for. a dose level of 10 mrem to be dismissed without more detailed analysis.
There is a widely held view, although speculative, that few geople wguld connit' their own resources to reduce an annual risk of death of 10" to 10'. This translates to a radiation dose of 10 mrem per year and represents the sum of radiation doses which might be dismissed as insignificant. ' There is not an evident basis, however, to conclude that people would dismiss an accumulated radiation dose greater than 10 mrem as insignificant simply because the dose results from multiple practices, each of which is no more than 10 mrom.
The National Council.on Radiation Protection and Measurements (NCRP), Nuclear Energy Agency of the Organization for Economic Cooperation and Development (hEA), and the International Atomic Energy Agency (IAEA) have. recognized the potential for multiple exposures and, accordingly, have selected a lower value of 1 mrem as the " insignificant" dose with the expectation that individuals could be subject to many exemptions granted under the 1 mrom criteria.
While other countries and U.S. agencies have selected values between 10 mrem ano 1 mrem for certain situations, e.g. Canada (5 mrem for certain waste streams) and EPA (4 mrem for drinking water), these have been for rather specific applications, not for broad policy as is proposed by the NRC Policy Statement. The United Kingdom National Radiological Protection Board (NRPB) recomends a value of 0.5 mrem for inoividual dose in a context similar to the NRC Policy Statement.
]y03iMCi[] NAMF
L m.
i l
Victor Stello, Jr.
2-c L
fMSS recognizes that the collective dose criteria of 100 person-rem is an L
additional limiting factor when determining if exemptions could be granted p
without further analysis, but notes that the limitation of collective dose does e
not afford a reasonable assurance that individual doses will not accumulate as a result of multiple practices. The main purpose served by the 100 person-rem criterion is to prevent extensive environmental contanination through the exempt l
disposal of large quantities of radioactive material, either in dilute fom or in small portions over extended periods of time.
' Heretofore, the staff has applied the ALARA principle in approval of consumer products, resulting in most doses being 1 mrom or less, and has taken a l
conservative view on what is a justified practice. However, exemption dose criteria of 10 mres/100 person-rem as evidently ALARA, coupled with a more liberal view on justified practices, e.g., gemstones, could open new approaches for radioactive consumer products.
The staff can only speculate on what these consumer products might be.
In the past, for example, we have turned down or discouraged radioactive fish lures,10 curie tritium batteries for wristwatches.
neptunium timers in watches, and uranium pellets in shotgun shells. Possibil-ities range from large light sources using substantial quantities of tritium or higher energy radioisotopes to perhaps small radioisotope powered batteries simila'r*fo those originally designed for pacemakers. Many of these could involve specialized uses which would not necessarily result in a collective dose of 100 person-rem.
If a small comunity (less than 100,000 people) located near a reactor station
-is examined, assuming candidate waste streams are authorized with the 10 mrom/100 person-rem criteria, as well as taking into account present NRC authorized exemptions, some members of the population could be in several critical groups simultaneously. Potential exposures might be as follows: 5 mrtm from each reactors release, 10 mrem each from four exempted reactor waste stream
+
practices (i.e., dry active waste, waste oil, contaminated soil, secondary ion exchange resins),10 mram from incinerated hospital waste (expanded limit over presentyules).and10mremtotalfromacombinationofexistingconsumer products. These can accumulate to an individual dose that is a significant L
fraction of the 100 mrem per year dose limit for members of the public. Coupled with r.ew initiatives for consumer products, some individual doses could approach or exceed the 100 mrem per year dose limit. Thus, if 10 mrem is used as the L
individual dose criterion, then individuals subject to multiple exposures could approach the dose limits, leaving 'little room for exposures by future sources of much greater societal value. Such a circumstance would bo far less likely if the Policy Statement were limited to 1 mrem per year.
L I
The NCRP, in Report No. 93, concluded that the average annual effective cose equivalent to a member of the U.S. population from consumer products ranges from about 6 to 12 mrem per year. Not all members of the public are exposed to all sources of censumer products, and not all consumer prooucts are regulated by the NRC.
=,..
,s p
3-Victor Stello, Jr.
An additional basis for nonconcurrence'is the question of need for the 10 mrom criterion. - The Policy Statement would allow exemption of practices at levels above the listed individual and collective dose criteria, so long as an appropriate demonstration of justification and ALARA had been made. Further, we anticipate that the use of a 1 mrom individual dose criterion would have broad application. For example:
1.
NCRP ReDort 93 indicates that many consumer products, including smoke detectars, luminous watches and clocks, and thorium products such as.
fluorescent lamp starters and gas mantles result in average annual.
dose equivalents to the exposed population of less than 1 mrem, i
2.
With reasonable dose modeling, it is anticipated that a large fraction of waste streams which are candidates for exemptions would result in l-doses on the order of magnitude of 1 mrem for critical groups within the general population. The present biomedical waste rule was based on estimates that average doses to the critical group would be 1 arem l
or less.
lt 3.
The distribution of neutron irradiated gemstones which was recently
- " authorized by the Consnission has been calculated to result in e
effective whole body dose equivalents of less than-1 mrom to individuals wearing such gems as jewelry.
In addition to these considerations, there are several technical points that -
signal caution with respect to the application of the 10 mrem individual dose criterion, a.
The scientific community is currently perfonning a reexamination of the Hiroshima and Nagasaki atomic bomb dosimetry and epidemiology.
Although not complete, the reexamination indicates that risk conversion factors-might be low by a factor of two or three.
If so, this could cause exempted items to produce a level of risk at or above the level of risk considered acceptable by most individuals.
b.
Once waste streams and products are exempted, it will be difficult to correct problems they create in the environment. While assumptions for modeling are usually conservative, experience has indicated that once an exemption is granted the analyzed situation may not remain accurate because of unexpected ways in which the products are handled and disposed of..The policy Statement provides for opportunities to assess the impact of an exempted practice or combinations of exempted practices. However, in past experience this approach has not provided a practical mechanism for identifying and correcting problems.
l c.
The Policy Statement refers to the maximum individual annual dose in reference to the individual dose criterion. We believe that a better l
r05;ulatory approach is to use the critical group concept rather than the maximum exposed individual for applying the individual dose -
threshold criteria because it more accurately reflects the actual Y
a
t j <:
lL:
Victor' Stello, Jr.
4-l
i impact to those at greatest risk from a practice. A critical group is defined as the group of individuals expected to receive the greatest exposure from the practice. The concept of maximum individual dose is subject to differing interpretations, but usually carries with it certain assumptions that could produce a dose I
considerably greater than that experienced by the critical group.
l Thus, application of the maximum exposed individual concept could result in the reduction of the pennissible concentrations and quantities of radioactive material allowed under an exemption to the point of being useless.
In summary, if it is necessery to select a single dose level which,might be considered as below regulatory concern for the very broad NRC Polic we believe that 1 mrem per year is the more appropriate dose value.y Statement, The provisions in the Policy Statement concerning BRC can accommodate higher doses.-
Using this approach, it is also possible to reconcile and amplify previous positions on specific types of practices. For example the Commission in its Policy Statement on exemption for disposal of slightly contaminated radioactive waste material provided procedures for expeditious handling of petitions involvin would b#g individual dose on the order of a few arem per year. Such an approach consistent with a broad NRC Policy Statement using an individual dose criteria described as being on the order of 1 mram per year.
M Ao6ed W 8ernero Robert M. Bernero, Acting Director Office of Nuclear Material' Safety and Safeguards cc:
E. S. Beckjord, RES T. E. Murley, NRR H. R.~Denton, GPA DISTRIBUTION:
NLThompson RMBernero DACool WLahs, RES RECunningham BMorris, RES GLSjoblem JHickey FCongel, NRR JAustin RFonner, OGC MLamastra LRoche, EDO IM0B R/F NRC File Center IMNS Central hMSS r/f HMSS Office r/f
- SEE PREVIOUS CONCURRENCE
.x orc:
IMO "1Mus
- 1 MAS
= rr;s MNs r.ss g N hE$
/jp5HkehkustnGSJ
[RECunI[
RBernero
.................................. g,/88 DATE: 9/ f/88 9/8 /88 9/8 /86 ' / i 7 /r/88 9/9/88 CFFICIAL RECCRD COPY
REFER TO:
M880629A UNITED STATES N
N',[ "*%
NUCLEAR REOULATORY COMMISSt0N
- hg.,
'\\
'-. ;F W ASHINGTON,0.C, NHS Cy$. Ste11o g,,
Taylor July 22, 1988 k...* /
o TMurley eppCE et THE -
EBeckjord esenstany Mcdonald CIRMfl0NROUTING0NLY l
Dr. Dade W. Moeller, Chairman THOMP90tMORANDUM POR:
Advisory Committee on Nuclear Waste BERNER0 WilliamC.Parler,Geners) ounsel FUNCHES Samuel J. Chilk, Secre STAFF REQUIREMENTS - INIT:
BRIEFING SY TEE
- b ECT:
ADVISORY COMMITTEE ON NdCLEAP WASTE, 10:00
!R:
A.M., WEDNESDAY, JUNE 29, 1988, COMMISSIONERS' CONFERENCE ROOM, ONE WRITE FLINT WORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)
The Coasnission* was briefed by the Advisory Committee on Nuclear Waste on prioritization of issues and administrative matters.
i The commission made the following requests:
The first item of business for the Committee should be to seet with the staff and develop procedures for getting 1.-
To the extent that conserva-timely closure of issues.
L tisms can bound the uncertainties of an~ issue and can be practicably accommodated, the issue should be closed.
(ACNW)
(SECY Suspense 10/28)
L Review the staff's tentative U.S. position on "below
" prior to the meeting.with the Commis-l 2.
regulatory concern, Provide cosaments to the Commission sion on this subject.
on the staff's proposed tentative position and discuss how The Commission's intention is differences were resolved.
to work towards a consensus U.S. position for discussion at the October international meeting on the subject.
(ACNW)
(SECY Suspense 9/88)
Work with OGC to develop a legislative package for making 3.
the ACNW a statutory committee,,
(OGC/ACNW)
(SECY Suspense:
12/88)
The Committee should assess the adequacy of NRC resources 4.
to regulate nuclear waste and materials.
(ACNW)
(SECY Suspense 6/89)
- Commissioner Rogers was not present.
f 0 2.}D yp
.. _. _ _ _. _. ~.
.\\i,
(,0 5.
The Comunittee should make every offort to communicate with t
staff on an ongoing basis on priority issues, reviewing issues.at-an early stage and in a timely fashion so that the Comunission is advised of any concerns as early as possible.
6.
A mechanism should be established for communication with feedback the commissioners' assistants to provide timely'and to the Commission on the Committee's activities relative priority of issues.
Such'information is valuable l-to the Commission at an early.date of a process so that its input-can be effectiv,e.
7.
During the coming year, the Committee should meet with the
~
Commission at frequent intervals, e.g., every 3-4 months.
(ACNW/SECY)
(SECY Suspense:
TBD) 8.
The Comunittee's highest priority activity should be the review cnd oversight of NRC's licensing activities of DOE's high level waste repository.
Other near tera priorities of the conunission were comununicated to the I
l-Committee in a' letter of June 27, 1988.
The Committee should also raise other issues which should come to the Commission's attention.
j.
L The Committee should advise the Connaission if it finds l'
itself overburdened with issues under its charter.
t 9.
Whenever differences of opinion occur, both sides of the problem should be presented to the Conunission.
cc Chairman Zech Consnissioner Roberts Commissioner Carr Commissioner Rogers ACRS l
EDO GPA PDR - Advance DCS - P1-1247 9'
- eame w=e wa he
~.^...........L.......
.........:........-+.............
/
pp.
1 1
s
^
NOV t 8198g MEMORANDUM FOR: : Victor Stello, Jr., Executive Director for Operations Eric S. Beckjord, Director, Office of Nuclear Regulatory FROM:
Research ADVANCE NOTICE AND PUBLIC MEETING ON POLICY STATEMENT OH-
SUBJECT:
EXEMPTIONS FROM REGULATORY CONTROL
-Enclosed for your signature is a Federal Register Notice (FRN) containing-a meetir,g notice and an-advance notice of the development of a Commission policy on-exemptions from regulatory control for practices whose public health and staff in response to the staff requirements memoranda (SRM) prepar This FRN.was safety impacts are below regulatory concern.
dated September 29, 30, 1988. The body of the advance notice portion of the FRN 1988 and September is as drafted by the Commission and returned to the staff with the second of these SRM which responded to SECY-88-257.
This " advance notice" has already been made available in the Public Document Room as_ instructed by the Commission. The FRN also contains a tentative agenda
~
These actions are in keeping with the Commission paper for'the public meeting.
recently transmitted to you concerning the proposed schedule for action on this issue..
The Office of the General Counsel has no legal objection to the publication of i
The Division of Freedom of Information and Publications Services, this FRN.
ARM, has been consulted on the development of this FRN. The Office of Governmental and Public Affairs will issue a public announcement concerning the meeting and advance-notice a few weeks prior to the meeting.
l.-
L
\\s\\ -
Eric S.- Beckjord, Director l
Office of Nuclear Regulatory Research -
[
Enclosure:
Federal Register Notice Distribution: [ NOTICE FOR MEETING /CMATTSEN)
/' il L
subj-circ-chron DFRoss DHopkins JAustin, NMSS ' V '
Reading Files BMorris RBernero, HMSS KDragonette, NMSS l
ESBeckjord ZRosztoczy RFonner, OGC JCunningham, NRR l
FCongel, NRR RCunningham, NMSS TPSpeis Wlahs o
( p. -
p CMattsen DCool, NMSS Ofc: 'RDB:DRA:RES R :DRA:RES R B: RA:RES
' ne:- CMattsen:rg Wlahs DHopkins
' te:
11/@/88 11/ /BA 11/2.1/88 i
'fc:
DRA:RES DRA:REh7s DD/R RE5 ? DD 1:RES D:RE
- me:
Rosztoczy Morris DFRos's' \\ TP99 's ESBeckjord
,ite:
11/ /88 1/2//88
,li/ /88 11/M/88 11/28/88 OFFIC1jt RE' CORD COPY g
v " t 00) )
'~
[7590-01) t NUCLEAR REGULATORY COMMISSION 10 CFR Chapter I
. Policy Statement on Exemptions from Regulatory Control s
AGENCY: Nuclear Regulatory Comission.
[
ACTIONS: Advance notice of proposed policy statement and meeting.
SUMMARY
- The NRC is in the process of developing a broad policy on exemptions from regulatory control for practices whose health and safety impacts could be considered below regulatory concern.
This policy statement would provide for L
more efficient and consistent regulatory actions in connection with exemptions from various specific Comission requirements. The Comission, in formulating this Advance Notice,-is seeking public input on some specific questions which are key considerations in developing such a policy. The NRC staff will conduct a meeting-to inform the-public of its intentions, specifically to clarify and L
answer questions concerning the advance notice, and to hear preliminary views
,concerning a policy for exemptions with emphasis on-the specific questions
= raised by the Comission.
L L
L DATES:- Meeting to be held on January 12, 1989. Written coments should be submitted by January 30, 1989.
Coments received after this date will be considered if it is practical to do so, but assurance of consideration can only be given as to coments received on or before this date.
ADDRESSES: Meeting will be held at the Holiday Inn, 8120 Wisconsin Avenue,
.Bethesda, MD 20814 (4 blocks north of the Bethesda Metro Station). Telephone:
'(301)652-2000,1-800-465-4329. Mail written coments to:
Secretary, U.S.
L Nuclear Regulatory Comission, Washington, DC, 20555, Attention: Docketing and Service Branch.
Comments may be delivered to 11555 'Rockville Pike, Rockville, MD between 7:30 a.m. and 4: 15 p.m. weekdays.
Copies of the comments received may be examined and copied for a fee at the NRC Public Document Room at 2120 L Street, NW, Washington, DC.
'FOR FURTHER INFORMATION CONTACT:
Catherine R. Mattsen, telephone (301)492-3638, 1
[7590-01) ll
orWilliamR.Lahs, telephone (301)492-3774 Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC, 20'555.
SUPPLEMENTARY INFORMATION:
International Workshop In addition to conducting this public meeting, the Comission has sought input from the international regulatory community through an international workshop on exemptions from regulatory control which was held October 17-19, 1988 in Washington, DC. The importance of such interaction stems from the fact that many existing and potential exemptions involve radioactive materials purposefully used in consumer products or introduced into various products or materials through-the recycling of contaminated scrap, either of which may enter international trade.
Even effluents and waste disposal can involve exposures to people in countries other than those from which the effluent or waste originated.
This aspect is a significant issue in the European community. Thus, some degree of consistency internationally is desirable, since exemption decisions can affect populations outside each country's border.
It is hoped that exchanges of ideas and information such as occurred at the international workshop will, besides providing one avenue of input to the Commission's actions, lead toward a greater degree of consistancy in such exemptions world-wide. At the international workshop, the " Advance Notice of the Development of a Commission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety Impacts are Below Regulatory Concern", presented in this notice, was made available for discussion.
The transcript of the international workshop which includes all the papers presented at the meeting may be examined and copied for a fee at tne NRC Public Document Room at 2120 L Street, NW, Washington, DC.
Advance Notice of the Development of a Commission Policy Introduction and Purpose l
Over the last several years, the Commission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of
~
2
[7590-01]
radioactive materials from regulatory control. To address this need, the Connission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, Use of Byproduct Material and Source Material, dated March 16, 1965; 47 FR 57446, Licensing Requirements for Land Disposal of Radioactive Waste, dated December 27, 1982; and 51 FR 30839, General Statement of Policy and Procedures Concerning Petitions Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986).
The expansion includes the development of an explicit policy on the exemption from regulatory control of practices whose public health and-safety impacts are below regulatory concern.
A practice is defined in this policy as an activity or a set or combination of a number of similar sets of coordinated and continuing activities aimed at a given purpose which involve the potential for radiation exposure.
Under this policy, the definition of " practice" is a critical feature which will assure that the formulation of exemptions from regulatory control will not allow deliberate dilution of material or fractionation of a practice for the purpose of circumventing controls that would otherwise be applicable.
The purpose of this policy statement is to establish the basis upon which the Connission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control persons who receive, possess, use, transfer, own, or acquire certain radioactive material.
This policy is directed principally toward rulemaking activities, but may be applied to license amendments or license applications involving the release of licensed radioactive material either to the environment or to persons who would be exempt from Connission regulations.
It is important to emphasize that this policy does not assert an absence or threshold of risk but rather establishes a baseline where further government regulation to reduce risks is unwarranted.
The concept of regulatory exemptions is not new.
For example, in 1960 and 1970, the Commission promulgated tables of exempt quantities and concentrations for radioactive material which a person, under certain circumstances, could receive, possess, use, transfer, own, or acquire without a requirement for a license (25 FR 7875; August 17, 1960 and 35 FR 6426; April 22, 1970).
Other exemptions allowing distribution of consumer products or other devices to
.the general public, or allowing releases of radioactive material to the 3
[7590-01) environment, have been embodied in the Comission's regulations for some time.
More recently, the Low Level Radioactive Waste Policy Amendments Act of 1985 directed the Commission to develop standards and procedures for expeditious handling' of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Comission determined to be below regulatory concern. The Commission responded tc this legislation by issuing a policy statement on August 29,1986(51FR30839).
That statement contained criteria which, if satisfactorily addressed in a petit. ion for rulemaking, would allow the Commission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.
The Commission believes that these " practice-specific" exemptions should be encompassed within a broader fiRC policy which defines levels of radiation risk below which specified practices would not require NRC regulation based on public health and safety interests.
For such exempted practices, the Commission's regulatory involvement could therefore be essentially limited to licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt status.
The Commission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an important implementation role.
In the past, States have been encouraging findings that certain wastes are below regulatory concern and the Commission believes that States-will support an expansion of these views to all practices involving exempt distribution or release of radioactive material.
The Commission intends that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement States.
Consequently, any ruitmakings that evolve from this policy will be coordinated with the States.
Advisory and scientific bodies have offered diverse views to the Commission in anticipation of this Policy Statement. There is no clear consensus based on existing scientific evidence or research regarding the selection of numerical criteria for use in this Policy Statement.
Further, the Commission is aware that there are differing views within the NRC staff on the selection of numerical criteria for ERC.
4
f
[7590-01)
-In the absence of a scientific consensus, it is the Comission's task to assess the diversity of views in establishing a responsible BRC policy.
The authority and responsibility to make the final selection of criteria rests with the Comission.
Criteria selected must:
- 1) provide reasonable assurance that public health and safety will be protected, and 2) consistent with such assurance, permit practices in-the public domain which involve the use of radioisotopes for which society perceives a demand.
It is recognized that there is a delicate balance here.
Criteria can be set sufficiently restrictive such that there is absolute assurance that health and safety will always be protected, no matter what events might transpire.
However, in doing so, the regulator may then place undue and unnecessary restrictions on practices which should be permitted because of otherwise reasonable social, economic, or industrial considerations.
There is always the danger of over-regulation which results in effects that are felt in areas where the NRC does not have authority and responsibility. Moreover, the Atomic Energy Act does not require absolute assurances of safety in the
.use of radioactive material and licensed facilities.
The numerical criteria ultimately selected will have significant impact on nuclear regulation here in the United States and potentially in the international community.
The values under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries. The Commission has carefully reviewed those alternate criteria, and does not find significant scientific evidence that would dictate preferential selection of any of those views over what is proposed in this Policy Statement.
Radiation Protection Principles The Commission recognizes that three fundamental principles of radiation protection have historically guided the formulation of a system 1
l of dose limitation to protect workers and the public from the potentially harmful effects of radiation. They are (1) justification of the practice, which requires that there be some net benefit resulting from the use of radiation or radioactive materials, (2) dose limits, which define the upper l
l l
5 l
[7590-01) boundary of adequate protection for a member of the public which should not be exceeded in the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account.
The term, ALARA, is an acronym for As Low As is Reasonably Achievable.
The Comission is interested in assessing how these principles should be applied in establishing appropriate criteria for release of radioactive materials from regulatory control.
Because of the absence of observed health effects below 5 rem / year (50 mSv/ year), scientific experts including the International Comission on Radiological Protection (ICRP) and the National Council on Radiation Protection and Measurements (NCRP) make'the assumption that the frequency of occurrence of health effects per unit dose at low dose levels is the same as at high doses (10 Rad (0.1 Gy)) where health effects have been observed and studied in humans and animals.
This linear non-threshold hypothesis assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose, no matter how small the dose might be.
The coefficient used in the model as a basis for estimating statistical health risk is on the order of 2x10 risk of fatal cancer per person-rem of radiation dose (2x10-2 per Sv). The Commission recognizes that it is a conservative model based upon data collected at relatively high doses and dose rates which is then extrapolated to the low dose and dose rate region where there are no statistically reliable epidemiological data available.
Alternative hypotheses L
have been proposed and reevaluations of the data base at higher doses continue.
l-The Commission believes that,use of the linear non-threshold hypothesis allows the theoretical establishment of upper limits on the number of health effects that night occur at very low doses which are the subject of the exemption policy.
1 i
The risk of death to an individual, as calculated using the linear model, is shown in Table I for various defined levels of individual dose.
A radiation i
exposure of 10 mrem per year (0.1 mSv per year) for a lifetime corresponds theoretically to an increase of 0.1% of the individual's annual risk of cancer l
death.
The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70-year lifetime.
6
i
[7590-01)
In estimating the dose rates to members of the public that might arise through J
the use of various practices for which exemptions are being considered,-the Commission has decided to apply the concept of the "ef fective dose equivalent."
This concept, which is based on a comparison of the delayed mortality effects of ionizing radiation exposures, permits through use of weighting factors, the calculation of the whole body dose equivalent of partial body exposures.
This 1
approv.h was originally developed by the International Comission on Radiological Protection and was first expressed in its Publication 26 issued in 1977.
Since that time, the concept has been reviewed and evaluated by radiation protection organizations throughout the world and has gained wide acceptance.
Table l' incremental incremental Lifetime Risk from Annual Dose Annual Risk Continuing Annual Dose i
0 100 mrem ***
2 x 10'6 1 x 10 1 x 10'4 10 mrem **
2 x 10 7 1 x 10-5 2 x 10'8 1
mrem 0.1 mrem -
2 x 10-1 x 10-6 Risk coefficient of 2 x 10'# per rem (2x10-2 per Sv) based upon publications of the ICRp.
For purposes of comparison, the annual risk to an individual of dying from cancer from all sources in the U.S. is 1 in 500.
The additional risk to an individual of dying from cancer when exposed to 10 mrem (0.1mSv)is2inonemillion.
- Unless otherwise indicated, the expression of dose in mrem refers to the Total Effective Dose Equivalent.
This term is the sum of the deep dose equivalent for sources external to the body and the committed effective dose equivalent for sources internal to the body.
The Commission recognizes that it is impossibit to measure risk to individuals or populations directly, and, that in most situations, it is impractical to measure annual doses to individuals at the low levels implied by exemption decisions. Typically, radioisotope concentrations or radiation levels from the material to be exempted are the actual measurements that can be made, and doses 7
e a
[7590-01) l i
are then estimated by exposure pathway analysis combined with other types of assumptions related to the ways in which people might become exposed.
Under such conditions, conservative assumptions are frequently used in modeling so that the actual dose is on the low side of the calculated dose.
The Comission believes that this is the appropriate approach to be taken when determining if an exemption from regulatory controls is warranted.
Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure. By assigning collective dose a monetary value, it can be used in cost benefit and other quantitative analysis techniques.
It is a factor to consider in balancing benefits and societal impact.
Considerations in Granting Exemptions from Regulatory Control The following elements are being considered by the Comission as a basis for evaluating practices which are proposed to be exempt from regulatory control.
These practices. if approved, would result in products containing low levels of
. radioactive material being distributed to the general public and radioactive effluents and solid waste.being released to areas of the publicly-accessible environment.
o Justification - The Commission seeks coment on the extent to which exposures resulting from any practice should be justified. As lower levels of radiation exposure are orojected, should lower levels of benefit be required for practice justification?
In establishing its exemption policy, should the Comission exclude certain pra.ctices for which there appears to be no reasonable justification? In considering proposals for exemptions, should the Comission evaluate the social
. acceptability of proctices? Should the Comission determine a practice to be unjustified if nonradioactive economical alternatives exist?
o Dose Limits and Criterion - Individual doses from practices exempted under this policy should not be allowed to exceed 100 mrem per year (1 mSv per year).
This is the dose limit for members of the public specified in the final revision of 10 CFR Part 20, Standards for Protection Against Radiation.
The dose limits in the final revision of 10 CFR Part 20 apply to all sources of radiation exposure under a licensee's control (natural 8
P.'
[7590-01) background and medical exposures are excluded).
Because of the small risksinvolved,a10 mrem-(0.1mSv)individualdosecriterionisproposed as the basis for exemption decisions based on simple analysis and judgements.
The Commission specifically seeks connent on the need for establishing a collective dose limit in addition to an individual dose criterion.
If such a collective dose criterion is needed, what is the basis for this need? If the Comission decides that a collective 1
dose = criterion is needed, what approaches allowing truncation of f
. individual dose in calculation of collective dose or weighting factors for components of collective dose would be appropriatet What alternatives-should be, considered for assessing societal impact?
1 o
ALARA - The ALARA principle generally applies to determining dose levels below which exemptions may be granted on a cost-benefit basis.
- However, it is the purpose of this policy to establish criteria which would, in effect, delineate achievement of ALARA without cost-benefit analysis, t
Although it is possible to reasonably project what the dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some degree of loss of control.
The Comission believes that a key consideration in establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the question of whether individuals may experience radiation exposure approaching the limiting values through the cumulative effects of more than one practice,-even though the exposures from each practice are only-small fractions of the limit. The Comission specifically seeks coment on the issue.
By appropriate choices of exemption criteria and through its evaluations of specific exemption proposals in implementing the policy, the Commission intends to assure that it is unlikely that any individual will experience exposures which exceed the 100 mrem per year (1 mSv per year) limit.
1 Principles of Exemption A major consideration in exempting any practice from regulatory control hinges on the general question of whether or not application or continuation of 9
[7590-01) regulatory controls are necessary and cost effective in reducing dose. To determine ~if exemption is appropriate, the Commission must determine if one of the following conditions is met:
1.
The application or continuation of regulatory controls on the practice does not result in any significant reduction in the dose received by individuals within the critical group and by the exposed population or; 2.
The costs of the regulatory controls that could be imposed for dose reduction are not balanced by the commensurate reduction in risk that could be realized.
For purposes of implementing its policy, the Commission recognizes th:t only under unusual circumstances would practices which cause radiation expo:,ures approaching the 100 mrem per year (1 mSv per year) limit be considered as candidates for exemption. The Commission will consider such circumstances on a case specific basis using the general principles outlined in this' policy statement.
However, as the doses and attendant risks to members of the exposed population decrease, the need for regulatory controls decreases and the analysis needed to support a proposal for exemption can-reasonably be somewhat simplified.
The Commission is evaluating the use of two numerical criteria in defining the region where Al. ARA has been achieved They are (a) a criterion for the maximum individual annual dose reasonably expected to be received as a result of the practice and (b) a measure of societal. impact to the exposed population.
These criteria are being considered to assure that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact.'
If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared with other societal risks.
The Commission believes that annual individual fatality risks below approximately 10 (onein100,000) are of little concern to most members of. society, providing for some nargin below this level, the Comission proposes 10 mrem (0.1 mSv) as the level of annual individual exposure. The l
10
[7590-01,1 incremental annual individual cancer fatality risk associated with an exposure level of 10 mrem per year (0.1 m$v per year) is about h104 (,two in one million) as indicated in Table 1 and of the order of 0.1 percent (one in one thousand) of the overall risk of cancer death.
In evaluating the need for a collective dose criterion, the Comission recognizes that this criterion could be the limiting consideration for practices involving very small individual doses to very large numbers of people.
It is also recognized that in such cases the collective dose criterion would, in effect, apply the ALARA concept to individual doses less than the below regulatory concern level of 10 mrem per year to the individual.
Conversely, where the collective dose criterion would ont be limiting, it would serve no purpose.
The Commission requests coments on this issue, including coments on what the magnitude of the collective dose criterion, if any, should be.
If the dose is less than the below regulatory concern criteria, then the risk from a practice would be considered to be ALARA without further analysis.
The Comission stresses that adoption af the criteria should not be construed as a decision that smaller doses are necessary before a practice can be exernpted, while doses above the criteria would preclude exemptions. On the contrary, the criteria simply represent a range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that a cost benefit analysis is not required in order to make a decision regarding the
. acceptability of an exemption, practices not meeting these criteria may be granted exemptions on a case by-case basis in accordance with the principles embodied within this policy. To further emphasize the Comission's recognition that a rigid limitation on collective dose would be inappropriate, it notes that for some practices, such as use of smoke detectors, appreciable benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose.
The Commission is aware that existing regulations of the Environmental Protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy. With regard to its own regulations, the Comission will evaluate whether there are exemption criteria 11
1
[7590-01) i embodied therein for which modification, according to the principles of this policy, would be beneficial.
Exclusions from Exemptions The Comission's March 16, 1965, notice on the Use of Byproduct Material and sourceMaterialProductsIntendedforusebyGeneralPublic(ConsumerProducts)
(30 FR 3462) provides the basis for the Comission's approval of the use of these materials in consumer products without regulatory control on the consumer-user.
This is accomplished by case-by case exemption of the possession and use of approved items from applicable licensing requirements.
Approval of a proposed consumer product depends upon an assessment of exposures of persons to radiation as well as an evaluation of the usefulness of the product.
Certain practices involving radiation or radioactive materials have been judged by NRC to be socially unacceptable regardless of how trivial the resulting dose might be and, therefore, have been excluded from exemption.
Excluded practices include, but are not limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the skin (such as cosmetics).
In addition to socially unacceptable uses of radioactive materials, a question also arises ragarding uses where there are clear economical alternatives, and no unique benefits exist from using radioactive material. Where risks are trivial, the regulatory prohibition of such uses could pose an unnecessary regulatory burden by interfering with the conduct of business.
The Comission seeks comments on whether practices should be categorically excluded based on the Comission's judgement regarding social acceptability or the existance of alternatives.
An alternative to categorical exclusion could be a case specific determinatie based on a safety analysis.
12 4
-, - ' " ' ~
[7590-01)
Proposals for Exemption A proposal for exemption must provide a basis upon which the Comission can detennine if the basic conditions described above have been satisfied.
In general, this means that the proposal should address the individual dose and societal impact resulting from the expected activities under the exeinption, including the uses of the radioactive materials, the pathways of exposure, the levels of activity, and the methods and constraints for assuring that the assumptions used to define a practice remain appropriate as the radicanive materials move from regulatory control to an exempt status.
If a proposal for exemption results in a rule containing generic requirements, a person applying to utilize the exemption would not need to address justification or ALARA.
The Comission decision on such proposals will be based on the licensee's meeting the conditions specified in the rule. The promulgation of the rule would, under these circumstances, constitute a finding
~
that the exempted practice is justified, and that ALARA considerations have teen dealt with. This approach is consistent with past practice, e.g.,
consumer product rules in 10 CFR Part 30.
In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard to the potential that some individuals may receive doses near the l
100 mrem per year (1 mSv per year) limit when doses from other practices are also taken into consideration.
If exposures from multiple practices can occur which are significantly beyond the individual dose criterion (10 mrem per year (0.1 mSv per year)), the exemption will not be granted without further analysis.
As experience is gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposures to the public remain well below 100 mrem per year (1 mSv per year).
In addition to considerations of expected activities and pthways, the Commission recognizes that consideration must also be given to the potential for accidents and misuse of the radioactive materials involved in the practice.
l A proposal for exemption of a defined practice must therefore also address the l
potentials for accidents or misuse, and the consequences of these exceptional conditions in terms of individual and collective dose.
13 L
[759001)
]
Verification of Exemption Conditions 4
The Commission believes that the implementation of an exemption knder this broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic considerations under which an exemption was issued remain valid.
In most cases, the products or materials comprising an exempted
)
practice will move frcm regulatory control to the exempt status under a defined set of conditions and criteria.
The monitoring and verification program must therefore be capable of providing the Comission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being observed.
The Comission will determine comp 11aace with the specific conditions of an exemption through its established licensing and inspection 1
program and will, from time to time, conduct studies as appropriate to assess the impact of an eFempted practice or combinations of exempted practices.
Tentative Meeting Agenda 1.
Introduction and Summary-NRC Staff 11.
Discussion of Specific Questions-Brief HRC Staff sumary and presentations l
or questions from scheduled participants.
A.
Application of principle of justification including the questions:
1.
As lower levels of radiation exposures are projected, should l
i lower levels of benefit be required for justification of a practice which is a candidate for exemption?
2.
In establishing exemption policy, should the Comission exclude certain practices for which there appears to be no reasonab,le justification?
l 3.
In considering proposals for exemption, should the Commission evaluate social acceptability of the practice?
l 4
Should the Commission determine a practice to be unjustified if l
non radiological economical alteratives exist?
-B.
Individual dose criterion for determining achievement of the "ac low as reasonably achievable" (ALARA) principle in exemption decision-making:
1.
Is the 10 mrem / year criterion proposed by the Commission appropriate?
14
(7590-01)
)
i 2.
Is the appropriateness of this number affected by the decision
]
regarding whether a collective dose criterion should be used I
with the individual dose criterion?
I 3.
Should the individual dose criterion be chosen on the basis of negligible risk as is done internationally (i.e. IAEA Safety SeriesNo.89)orcanasomewhathighernumberbeusedb4sedona Commission policy decision regarding a level of individual risk for which expenditure of resources is not warranted?
4 4
How important is international consistency in choosing an l
individual dose criterion?
C.
Use of a collective dose criterion for determining achievement of the ALARA principle in exemption decision making:
1.
Is a collective dose criterion needed in addition to an individual dose criterion?
2.
If so, what is the basis of that need?
3.
If the Commission decides a collective dose criterion should be used, what should its magnitude be?
4 What alternative to a collective dose criterion should be considered for assessing societal impact?
l S.
In calculating collective dose, what approaches allowing i
truncation of individual doses or the use of weighting factors for components of collective dose are appropriate?
D.
Approaches for assuring total exposures of individuals from multiple practices will not exceed the 100 mrem / year limit.
1.
Is the approach of generally limiting individual doses from each source or practice to a fraction of the overall limit appropriate?
2.
Although most exempted sources would be expected to involve individual doses which are a small fraction of the overall limit, should flexibility be maintained by considering exemptions on a cost-benefit basis above 10 mrem / year?
3.
Is the evaluation of collective dose important in considering the multiple exposure issue?
15
[7590-01) 4.
Will the application of justification of practice help to maintain a smaller number of sources making it easier to control overall exposures?
5.
How important is monitoring to maintaining assurance that individual exposures do not exceed the overall limit?
111.
General Discussion / Question Period-Comments or questions by scheduled participants. Open to the floor es time permits.
i Those members of the public who wish to participate by speaking at the meeting should notify one of the contacts listed above, so that they can be scheduled in the agenda.
Dated in Rockville, Maryland, this_ day of 1988.
For the Nuclear Regulatory Comission.
Victor Stello, Jr.,
Executive Director for Operations i
16
_ _ - - - _ - _ - _ _ ~
[+
[7590-011 4
Will the application of justification of practice help to maintain a smaller number of sources making it easier to control overall exposures?
5.
How important is monitoring to maintaining assurance that individual exposures do not exceed the overall limit?
General Discussion / Question Period-Comments or questions by scheduled participants.
Open to the floor as time permits.
Those members of the public who wish to participate by speaking at the meeting should notify one of the contacts listed above, so that they can be scheduled in the agenda.
l Dated in Rockville, Maryland, this day of 1988.
For the Nuclear Regulatory Comission.
l I
Victor Stello, Jr.,
l Executive Director for Operations Distribution:
[POLICYSTATEMENTONEXEMPTIONS:
subj-circ-chron DFRoss CMattsen Reading Files SHorris RFonner, OGC ESBeckjord ZRosztocry EDO TPSpeis WLahs e
q..-
L 0ffc:
' tame:
RFonner VStello, Jr.
Date:
1 y /88
/ /88
'Offe:
RD A
5 RD DR RES DRA:RES DRA:R
'DD/R:
0, 1:RES D:RES
?
DFR s TPS is ESBeckjord "Ama:
CMattsen:rg Wlahs Rosztoczy Morr,is
,,,, u,.
,,,,,,,n
,,4
.