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# _S^ ^ ENVIRONMENTA

L PROTECTIO N AGENC Y 

# [FRL-4883^-

e Q^^O " ' jOO

j W^'S399 B Pj j I
_______________ __ ] RIN2060-AE6 1 . L^/ ^ : " ^Ig T Federa l Radiation Protectio n Guidanc e for Exposur

e o f th e Genera ! Publi c A^ <P 3 -(-//

# 32T-/I-JAGENCY : U.S
. Environmenta l Protectio n Agency
. ACTION : Propose d recommendations , reques t fo r written comments , and notic e o f publi c hearings
. SUMMARY : Th e Agency i s proposin g to mak e recommendation s to th e President fo r ne w guidanc e t o Federa

l agencie s on radiatio n protectio n whic h woul d hav e tw o effects : -Jr-Ji t would caus e afive-fold reductio n in th e maximu mallowabl e ris k

of cancer fro man y Federall y regulate d activit y involving nuclea

r material s o r othe r source s o f radiation ; an

d Vi twoul

d decreas e th e cos t

o f Federal regulatio n of

radiatio n by promotin g unifor mtreatment

o f radiatio n by al l Federal agencies , and reducin g costly duplicativ e an d conflictin g requirements
. Th e ne w guidanc e would replac e thos e portion s o f previou s recommendation s tha t appl y to protectio n of

th e genera

l public , approve d by President s Eisenhowe r an d Kenned y i n 196 0 an d 1961 , respectively
. Ne

w Federa l guidanc e issued i

n 1987 replace d .thos e portion s o f the 196 0 and 196 1 guidanc e tha

t applie d t o protectio n of

workers
. Thes e propose d recommendation s are based o n areview o

f existin g guidanc e i

n ligh t o f curren t scientifi c understandin g of th e risk s of

exposur e t o ionizin g radiatio n an

d o f th e experienc e of

Federal agencie s i

n it s control
. The

y include bot

h qualitativ e guidanc e o

n radiatio n protectio n an

d numerica

l guide s fo r limitin g radiatio n dose s to th e genera l public
. The mos t significan t propose d change s ar e that : the Radiatio n Protectio n Guide (RPG) b e expresse d i n term s o f asingl e weighte d su

mo f dose s t o organs , an

d th e separat

e RPG s fo

r individua l organ s deleted ; th e curren t RPG s limitin g th e averag e geneti c dos e to member s o f th e U.S
.


## CP. 3

3 includ e a n outlin e of

th e topic s t o b e addressed , th e amoun t o f time requested , an d th e name s o f th e participants
. EPA ma y allo w testimon

y t o b e given a

t th e hearin g without

prio r notice , subjec t

t o time constraint s a

t th e discretio n of

th e hearin g officer
. FO RFURTHERINFORMATION CONTACT : Alla n Richardso n a

t th e abov e addres s (telephon e (202 ) 233-9213 ; FA X (202 ) 233-9629 ) concernin g thes e propose d recommendation s o r

th e publi c hearing
. SUPPLEMENTAR

Y INFORMATION : Introductio n Th e Administrato r

of th e Environmenta

l Protectio n Agency (EPA ) ha s th e responsibilit

y t o "...advis e th e President wit h respec t t o radiation matters , directl y o r indirectl y affecting health , includin g guidanc e fo r al l Federal agencie s i n th e formulatio n o f radiation standard s an d i n th e establishmen t an d executio n o

f program s of

cooperatio n wit

h States. " Thi s authorit

y stem s fro

mExecutiv e Order

10831 ; th e Atomi c Energ y Ac t of 1954 , a s amended ; an d Reorganizatio n Pla n No
. 3 of

1970
. Guidanc e t o Federal agencie s ha s historicall y consiste d of

bot h qualitativ e an d quantitativ e recommendation s expresse d a s "Federa l Radiatio n Protectio n Guidance. " Th e guidanc e propose d here woul d replac e thos e portion s of

existin g Federal Radiatio n Protectio n Guidance , adopte d in 1960 (2 5 F R 4402 ) and 196 1 (2 6 F R 9057) , tha t apply t o protectio n of

th e genera

l public
. Th e purpos e o

f Federal guidanc e i s t o provid e acommo n framewor k t o help ensur

e tha t th e regulatio n of

exposur e t o ionizin g radiation i s carrie d out by Federal agencie s i

n a consistent an d adequately protectiv e manner . Although th e individua l Federal agencie s hav e determined , an d wil l continu e t o determine , th e detail s of specifi c regulations , i t

i s intende d tha t they adher

e t o thes e propose d recommendation s a s basic , minimu mrequirements
. It shoul d b e recognized , however , tha t i n som e situation s applicatio n of

thes e recommendation s ma y b e supersede d b y specifi c statutor y requirements
. Thes e propose d recommendation s hav e bee n develope d b y EPA i n cooperatio n wit h th e Department s of

Agriculture , Commerce , Defense , Energy , Healt h and Huma

n Services ,P. 4

5 healin g arts , an d o f

th e general publi c fro

maccidents
. They woul d apply , for example , t o exposure of

member s of

th e genera

l publi c du e to : (a) emission s of radioactive material s o r radiation fro

mindustrial , defense-related , an d scientifi c operations ; (b ) us e of radiation an

d radionuclides in consume r product s an d medicin e (excep t fo r beneficia l exposure o

f patients) ; (c ) minin g an#processin g of ore s tha t contai n naturally-occurrin g radioactive materials;(d ) disposa l of waste s generate d b y an

y of th e abov e operations ; and (e ) transportatio n of radioactive material s involve d i n an y of th e abov e operations
. Specifi c example s include , but ar e no t limite d to : nuclea

r installations , includin g mines , mills , and processor s of uraniumand thorium , nuclea r fue l fabricatio n plants , nuclea r reactor s (nuclea

r power plants , critical an d subcritica l facilities , an d research reactors), spen t fue l storag e and processin g facilities , an d weapon s production , testing , and storag e facilities ; x-ra y generator s an d radioactive sources ; irradiatio n installations , such a s particl e accelerator s an d larg e irradiator s for teletherapy , radiosterilization , an d commercia l produc t irradiation ; inspectio n device s in airports ; consume r product s suc

h a s stati c electricit

y eliminatio n devices , io n generatin g tubes , smok e detectors , and device s for producin g ligh

t o r a n ionize d atmosphere , suc h a s fo r dial s an d laborator

y measurements ; an d radioactive wast e installation s wher

e radioactive waste s ar e handled , treate d and conditioned , temporaril y stored , o r permanentl y dispose d of

. Thes e propose d recommendations als o addres s mos t terrestrial source s of

exposur e arisin g fro mhuma n activitie s (thes e principall y involv e naturally-occurrin g radioactive materials) , but

not exposur e du e solely t o backgroun d radiation o r du e t o globally-disperse d effect s o f pas t activitie s an d accidents
. Excluded , for example , i s consideratio n o f variation s i n exposure which result

fro mgeographi c location , a s wel l a s th e small annua l dos e increment fro mpas t weapon s test s an d residual globa l contribution s of

pas t nuclea r accidents , lik e tha t a t Chernoby l i n 1986 , becaus e i t i s no t practicabl e t o contemplat

e thei r control
. Fo r th e purpos e of

thes e recommendations , "backgroun d radiation" include s radiation o f cosmi c an d sola r origi n a t th e surfac e o

f th e eart h and radiation fro

mnaturally-occurrin g primordia l an d cosmogoni c radionuclides foun d i n th e earth' s crus t

o r produce d in th e upper

atmospher

e by cosmi c o r

sola r radiation (includin g radioactivity normally ingeste d i n food and water ) tha t i s no t enhance d by huma

n activities
.P. 5

. 7 ' building ) ma

y b e subjec t

t o direc t regulatory contro l o r

alleviatio n throug h Federal o r Stat e programs . Th e numerical limit s for

individua l dos e propose d i n thi s guidanc e d o no t includ e th e contributio n fro

mindoo r rado n produce d b y eithe r o f th e abov e categorie s of

sources . EP

A and th e Center s for

Diseas e Contro l hav e provide d separat e advic e t o th e publi c for protectio n agains t

exposure t o indoo r

radon i n A Citizen' s Guide T o Rado n (EP A documen

t 402-K92-001 , Ma

y 1992 , an d subsequen

t editions ) an d EP

A ha s publishe d aserie s o f other 'technica l publications , pursuant t o Pub
. L
. 100-55 1 (Oct
. 28 , 1988 , 10 2 Stat
. 2755 , amendin g th e Toxi c Substance s Contro l Act , 1 5 U.S.C
. §§2601-2692)
. Tha t advic e i s consistent wit h thi s propose d guidance , wher e applicable
. Finally , thes e recommendation s apply only t o th e managemen t of normal operation s of facilitie s an d device s tha

t ma y expos e member s of

th e publi c t o radiation: tha t is , to controllabl e exposure t o radiation an d releases o f radionuclides tha

t ma y expos e th e genera

l public
. Norma

l operation s includ e bot

h thos e condition s tha

t ar e expecte d t o occur

wit h certaint y a s wel l a s thos e tha

t ma y b e predicte d t o occur

wit h areasonably larg e probabilit y (e.g
. anticipate d operationa l occurrence s a

t nuclea r reactors), but

no t condition s wit

h aver y lo w probabilit

y of occurrence , suc

h a s th e unintende d re-entry of asatellit e containin g radioactive materials
. Thes e recommendation s als o d o no t apply to nuclea

r incidents , suc

h a s amajor accident a t anuclea r facilit y o r th e result of terroris t activity , o r

t o exposure resulting fro

mact s of war . Guidanc e for

establishin g radiological emergenc y response plan s and for makin g radiatio n protectio n decision s durin g nuclea r incident s ha s been provide d by EP A i n th e Manua

l of Protectiv e Actio n Guide s an d Protectiv e Action s for Nuclea r Incident s (EPA-520/1-75-001-A) , pursuant t o regulations issue d by th e Federal Emergenc y Managemen

t Agenc y (4 7 FR 10758 , Marc h 11 , 1982)
. Additiona l guidanc e ha s been provide d by th e Foo d and Dru g Administratio n o n th e prophylacti c us e of potassiu miodide durin g radiologica

l emergencie s (4 7 FR 28158 , Jun e 29 , 1982) an d o n th e us e o f food and animal fee d contaminate d by a

n incident (4 7 F R 47073 , Octobe

r 22 , 1982 , and , jointl y wit h th e Department

o f Agriculture , 5 1 F R 23155 , Jun e 25 > 1986)
. Exposur e t o radiation a s amedica l patient , which ma

y occur for diagnosti c o r

fo r therapeuti c purposes , i s no t covere d by thes e recommendations. Recommendation s o f th eP. 6

9 dat ao n healt

h risk s o f low level s o f

ionizin g radiation i n 197 2 an d agai n in 1980 2

. Portion s o f th e informatio n presente d i n th e latte r report wer e expande d i n a198 8 publicatio n o n risks fro mexposure t o alph aradiation 3 . A comprehensive , majo r ne w review wa s complete d i n 19904

. Simila

r reviews hav e bee n publishe d by th e Unite d Nation s Scientifi c Committe e o n th e Effect s o f

Atomi c Radiatio n in 1977 , 1982 , 1986 , an d 1988 5

. Th e mos t importan t results fro

mthes e reviews, carrie d out ove r aperio d of

mor e tha n tw o decades , ar e that , althoug h estimate s of

th e nature an d genera

l magnitude of

th e risk s fro

mradiation hav e not undergon e fundamenta

l revision, estimate s o f

th e principal risk , tha

t of cancer , hav e increase d roughly threefol d and hav e become more certain
. Whil e ou r knowledg e of

th e effects of

radiation ha s becom

e more definitive , th e ' extent of ou r us e of radiation ha s increase d an d our policie s for

regulating i t

hav e evolved
. Prio r t o 1960 , major

use s of radiation wer

e limited , and th e primar

y concer n o f radiation protectio n wa s t o ensure tha t dose s t o thos e fe

w individual s tha

t were affected di d not

excee d limit s o n dos e fro

mal l source s combined
. Sinc e then , th e number s an d type s of man-made radiation source s hav e greatl y increased , and , a t th e sam e time , publi c concer

n about * environmenta

l contaminant s of

al l kind s ha s becom

e a n important

influenc e i n thei r management . O f

particula r significanc e i s tha

t th e focu s o f

th e man y environmenta

l policie s an d law s tha

t hav e emerge d durin g th e pas t tw o decade s ha s been mor e o n improvin g th e level s o f contro l o f

individual

source s o f

contaminatio n tha

n o n establishin g asingl e acceptabl e leve l o f

risk to individual s fro

mall source s combined
. Thi s shif t of concer n ha s le d t o th e development

o f ne w concept s for

determinin g th e appropriate leve l o f contro l o f
Th e Effect

s o n Populations o f

Exposur e t o Low Level s o f

Ionizin g Radiation . Nationa l Academ y o f Sciences , Washington , D.C , 1972 ; The Effect s o n Population

s o f Exposur e t o Low Level s o f

Ionizin g Radiation : 1980 . Nationa l Academ y Press , Washington^D.C , 1980 . Th e Healt h Risk s o f Rado n an d Othe r Internall

y Deposite d Alpha-Emitters . Nationa l Academ y Press , Washington, D.C , 1988 . Healt h Effect s o f Exposur e t o Lo w Level s o f

Ionizin g Radiation . Nationa l Academ y Press , Washington , D.C , 1990 . Source s an

d Effect s n f Ionizin g Radiation . United Nations . New York , 1977 ; Ionizin g Radiation : Source s an d Biologica l Effects . United Nations , Ne w York, 1982 ; Genetic an d Somati c Effect s o f Ionizin g Radiation . Unite Nations , Ne w York , 1986 ; Sources . Effects , an d Risk s of Ionizin g Radiation . United Nations , New York , 1988 .P. 7

1 1 Al l o f th e abov e development s ~ improve d estimate s o f radiatio n risk , experienc e i n regulating th e constantly expandin g complex of application s o f

ionizin g radiation, and th e evolutio n o f

improve d basi c concept s an d methodolog y fo r radiation protectio n - - hav e contribute d t o th e nee d for thi s propose d revision of

th e 1960 guidance
. Effect s o f Radiatio n O

n Huma n Healt h Effect s o n huma

n healt h o f concer n fro mexposur

e to lo w level s of

ionizin g radiation ma y b e divide d int o thre e categories 9

. Th e firs t o f thes e encompasse s al l form s o f cancer (includin g leukemias)
. Cancer s associate d wid i radiation ar e no t

distinguishabl e fro

mthos e associate d wit

h othe r causes . Althoug h radiogenic cancer s ar e observe d in human s over a rang e o f higher doses 10 , i t

i s necessar

y t o infe r th e ris k of cancer a t th e exposur

e level s normally encountere d by member s of th e publi c becaus e there i s insufficien t informatio n t o dra w direc t conclusion s base d o n observation s of cancer a t thes e levels
. Th e second categor

y encompasse s hereditar

y effect s (mutations ) induce d in th e reproductiv e cell s of

expose d individual s an d transmitte d t o thei r descendants
. Th e severit y of hereditar y effect s range s fro

minconsequentia

l t o debilitatin g o r

fatal
. Although suc

h effect s ar e observe d i n studie s of animal s a t hig h doses , exces s hereditar y effect s hav e no t yet been confirme d i n epidemiologica l studie s of

th e descendant s of

expose d huma

n populations
. Bot h cance r an d hereditar

y effect s ar e postulate d t o b e cause d b y "stochastic " (i.e
. random) direc t

o r indirec t interaction s of

ionizin g radiation wit

h th e geneti c material s in livin g cells
. I n view of

th e extensive , albei t

incomplete , scientifi c evidenc e supportin g thi s view , includin g much theoretica l and experimenta

l radiobiology, i t

i s commonly assume d tha t

9 A fourt h categor y o f effects , designated "non-stochastic, " occur s a tdos e level s higher tha

n thos e addressed b

y thes e recommendations . The y ar e o f importanc

e for managin

g the respons e t

o nuclea r accident s (se e EPA-520/1-75-001-A , op . cit.) . , 1 0 W e us e th e genera l ter m "dose " t

o mea n the dos e equivalent , effectiv e dos e equivalent , committed dos e equivalent, o r committed effectiv e dos e equivalent , wit h the precis e meanin

g t o b e inferre

d fro m the text . Whe

n precisio n i s important , w e us e th

e ful l term . I n 199 0 the Internationa

l Commission o

n Radiologica

l Protection adopte

d ne w terminology (an

d definitions ) for thes e quantities : equivalen tdos e in plac

e o f dos e equivalent , an

d effectiv e dose i

n place o f effectiv e dos e equivalent . Althoug h thes e term

s ar e simpler an

d ar e acceptabl e fo

r use , w e us e th e older , mor e explici tterms .P. 8

1 3 Agency believe s tha

t i t i s appropriate , for

radiatio n protectio n purposes , t o assum e tha t a t an d jus t abov e th e leve l o f

natura l backgroun d th e risk

of cance r an d mos t seriou s hereditar

y effect s increase s linearl y wit h increasin g dose , without athreshold
. Tha

t is , w e assum

e tha t an y increas e i n exposure ro ionizin g radiation carrie s th e potential fo r causin g har

mt o health
. Thi s assumptio n ha s been employe d i n th e developmen t o f thi s guidance , an d i s consisten t wit h curren t a s wel l a s historica

l practic e for

radiation protectio n world-wide
. Th e thir d categor

y of healt h effect s involve s thos e expose d i s utero . I t ha s lon g bee

n believe d tha

t th e unbor n are mor e sensitiv e tha

n are adult s t o th e inductio n of cancer b y radiation. Th e unbor

n ar e als o subject

t o variou s radiation-induced physica l malformations 12

. Recen

t studies , however , hav e draw n renewe d attentio n t o th e apparentl y greate r risk o f severe menta

l retardation fro

mexposure o f

th e unborn
. Thes e studie s indicate tha t th e sensitivit

y o f th e fetu s i s greates t

durin g th e perio d fro

m8 week s t o 1 5 week s afte r conception , an d continue s at alower leve l durin g th e perio d 1 6 t o 2 5 weeks 4

. Th e risk o f les s sever e menta l retardation ~ manifeste d a s alowere d Intelligenc e Quotien t - i s similarl y elevate d durin g thes e periods
. Althoug h i t i s no t clea r t o wha t extent th e occurrenc e an d degre e of retardation ar e proportional t o th e dos e (o r whethe r there i s athreshol d dos e fo r thes e effects) , i t

i s prudent

t o assume , for

regulatory purposes , tha

t ther e i s alinear , non threshol d relationshi p between thes e effect s an d th e dos e delivere d t o th e fetu s durin g thes e periods
. . Fo r radiation protectio n purpose s EP A assumes , usin g alinear , non-threshol d model , a n estimate d risk

to a n averag e membe

r of th e U.S
. populatio n of

5 x IO"

2 fata l cancer s pe r sievert 1 3 ( 5 x 10*

* fata l cancer s pe r

rem) delivere d a

t low dos e rates 14

. (Tha

t is , w e

1 2 Thes e includ e smal

l hea d circumference (microcephaly) , brai n siz e (microencephaly) , ey e malformations , an d intrauterin

e growt h retardation . 1 3 The traditiona

l specia l uni tfor dos e equivalentha

s been the rem . The special uni tsievert(Sv ) i

n th e Internationa

l Syste m o f Units , adopte

d in 197 9 b

y the Genera

l Conference o n Weight

s an d Measures , i s now i

n genera l use throughou

tthe world . The RPG

s recommended her

e ma y b e expresse d in eithe r o f thes e units . On

e siever ti s equa l t o 10 0 rem . Th e prefi

x "milii " (m ) mean

s one thousandth . "Lo w dos e rates " her

e mean s dos e rate

s o n the order o f

o r les s tha

n thos e fro

m backgroun

d radiatio n (se e footnot e 11) . Thi s value for th

e ris k fro m suc h dose s incorporates a dos e rat e effectivenes s factor of

two .____ _

1 5 principle s tha

t hav e governe d radiation protectio n for man y decade s i n th e Unite d State s an d i n mos t othe r countries
. Althoug h th e precis e formulatio n o f thes e principle s ha s evolve d over th e years , thei r

intent ha s remained essentially unchanged
. Th e firs t principl e i s tha

t an y activit y involvin g th e exposur

e of peopl e t o ionizin g radiation shoul d b e sufficientl y beneficia

l t o societ y t o warrant

th e exposure ; i.e. , afinding shoul d b e made tha

t a n activit y causin g exposure i s "justified. " Th e second i s that , for

justifie d activities , exposur e o f peopl e shoul d b e "a s low a s reasonably achievable. " Thi s principl e commonly ha s bee n designate d b y th e acrony m "ALARA " in th e Unite d States , an d i s calle d "optimization " of radiation protectio n in internationa

l practice
. Th e thir d i s that , eve n fo r justifie d an d optimize d exposures , th e maximu mdos e t o an y individua

l shoul d b e limite d s o a s no t t o excee d a

n acceptabl e leve l of

risk. Thi s i s referred t o a s "limitation. " Th e objectiv e of

th e first tw o principle s i s t o minimiz e (consisten t wit h benefit s and costs ) th e estimate d total har m(i.e
. healt

h detriment) i n th e entire populatio n fro meach sourc e o f exposure ; they d o not , however , limi t th e wa y tha t har mi s distribute d amon g individuals
. The

y are , in thi s sense , "source-related " radiation protectio n requirements. Th e purpos e of

th e third principle , tha

t of limitatio n o f

th e maximu

mallowe d dose , i s to provid e a n upper boun d o n risk

t o individuals
. Thi s principle , whic h i s an "individual-related " requirement, ma

y b e carrie d ou t

i n tw o ways : first , throug h limitatio n o f th e potentia

l dos e fro mal l source s o f

exposure combined , an d second , throug h additiona l mor e specifi c limitation s o n th e dose s fromindividua l sources . Th e followin g seve

n propose d recommendations directl y express , expand upon , and ' implemen t thes e thre e basi c principle s i n light o f curren t improve d knowledg e o

f th e risks o

f radiation an d of

th e variet y an d extent

of use s o f radiation. I n particular , the y reflect lowe r uppe r limit s o n dos e t o individual s fro mal l source s combined , they mak e explici t th e nee d fo r furthe r limitatio n of

dose s fro mindividua

l (o r classe s of ) source s of

exposur e tha t i s mor e restrictive tha

n tha t for al l source s combined , an d they introduc e improve d method s fo r assurin g tha

t al l o f th e variou s component s o f risk associate d wit

h radiatio n exposur

e are accounte d for

in radiation protectio n requirements fo r limitin g exposure o

f th e public
.P.1 0

1 7 achieve
. Th e decisio n wa s simplifie d in tha t exampl e becaus e th e risk s an d benefit s accrue d t o th e sam

e individuals
. Thi s i s usually no t th e case . I n extreme case s th e determinatio n ca n b e fa r more complex
. Fo r

amajo r industria l applicatio n of

radiation, for

example , th e determinatio n ma

y involv e no t

only th e benefit s an d th e cost s (direct , health , an d environmentaftro f

construction , operation , wast e disposal , accidents , an d eventua l decommissioning , but

als o th e tradeoff

s between th e activit

y an d th e economic , societal , environmental , an d resource implication s of alternativ e mean s t o achiev e th e sam e result. I n an y case , fo r amajo r activit y th e analysi s shoul d mak e areasonable demonstratio n tha t th e benefit

associate d wit

h di e propose d activit

y clearl y outweigh s th e risks associate d wit h th e us e o f

ionizin g radiation , includin g thos e associate d wit h norma l operations , reasonably possibl e incorrec t operatio n o r

management , an d disposa l of waste s ove r

th e lif e cycl e of th e activity
. When th e consequence s ca n b e significant , th e analysi s shoul d includ e low probabilit

y event s an d exposure pathways
. Th e proces s o

f balancin g thes e factor s ma y eventually involv e congressional , executive , an d judicia l inputs
. One vehicl e for assistin g suc

h decision-makin g i s th e Nationa l Environmenta

l Polic y Ac t

of 196 9 which , i n effect , requires Federal agencie s t o asses s and conside r th e abov e factor s for

an y majo r Federal actio n tha

t coul d significantly affec

t th e qualit y of th e huma n environment
. Other s includ e th e regulatory analysi s proces s pursue d b y Federal agencie s (Executiv e Order 12866 ; 5 8 FR 51735 , Octobe r 4 , 1993) , and decisio n processe s of

publi c an d professiona

l bodies , such a s publi c utilit y commission s an d professiona

l medica l groups . However , i n makin g thes e recommendations EP A doe s not propos e t o specif

y ho w o r b y whomjustificatio n shoul d b e determined , but simply tha

t th e detrimental effect s o f

radiation, a s wel l a s othe r detrimenta

l effects , shoul d b e considere d alon g wit h th e benefit s in an

y situatio n wher

e a n initia l decisio n i s bein g mad

e tiiat involve s significan t exposur e of th e genera

l publi c t o radiation
. Recommendatio n 2 : A sustaine d effor

t shoul d b e mad

e to ensure tha

t dose s t o individual s and to population s ar e maintaine d a s lo w a s reasonably achievable
.P.1 1

1 9 feasibilit y an d overal l economi c impac t o f controls
. I n rare cases , th e optimizatio n proces s coul d result

i n th e nee d t o mak

e tradeoff s between large r

dose s t o afe

w individual s (within th e limit s specifie d in Recommendation s 3 an d 4 ) an d man y small dose s in larg e populations
. A t th e dos e level s involve d i n th e compariso n o f alternative s fo r

determinin g ALAR

A levels , linearit

y i s assumed , an d effect s o n publi c healt h ma y b e estimate d fro

mth e collectiv e dos e i n populations
. I n case s wher e i t i s necessar

y t o estimat

e th e total publi c healt

h detrimen t fro mlong-live d radionuclides , collectiv e dos e wil l ofte n hav e t o b e projecte d into th e future , o r

in distant populations
. Regulator

y decision s o n ALAR

A level s shoul d tak

e int o account suc h projection s whe

n thei r contributio n i s bot

h asignifican

t par t o f th e total collectiv e dos e fro

mth e activit

y under examinatio n and it s uncertaint y i s no t larg e compare d t o th e difference s in collectiv e dos e amon g th e alternative s bein g examined
. I n som e cases , i t ma y b e appropriat e t o estimate effect s o n publi c healt h a s afunctio n o f

tim e o r distance , an d to take thei r

distributio n i n tim e o r

distanc e into accoun

t in decisionmaking
. However , i t wil l never b e appropriate t o apply a n arbitrary cutof

f t o such projection s base d solely o n th e leve l o f dos e to individuals , o r

o n th e distanc e fro

mtii e sourc e o r

in time ; such cutoff

s woul d hav e th e effec

t of preemptin g th e decision-makin g proces s befor e th e magnitude and distributio n of

th e avoidabl e impac t

o n healt h ha s been estimated
. I n som e situations , adecisio n t o refrai n fro mapplyin g control s ma

y b e th e appropriate outcome o

f a n ALAR A determination
. Suc

h afinding fo

r a n individua

l practice , o r fo r agrou p o

f practice s meetin g specifie d requirements , ma y b e use d a s on e criterio n for exemptio n fro

mregulator

y control
. However , i n additio n t o afinding tha t th e total healt

h detriment in population s i s no t

larg e enoug h t o justif

y control , i t

i s als o necessar

y t o ensur e tha t individua l exposure s are sufficientl

y small , i n view of th e stipulation s of Recommendatio n 4 , not

to warrant

regulation. Exemption s tha t satisf y each of thes e criteri a woul d b e consistent

wit h thes e propose d recommendations
. Althoug h th e ALAR

A principl e i s relevant

to awid e variet

y o f radiatio n protectio n activities , thes e ten d to fall into tw o genera l categories
. Th e firs t

i s tha t emphasize d above , th e establishment , o

f regulatory level s o

f contro l over

individua l source s o r

categorie s o

f source s b y Federal (o r

State ) agencies
. Th e second , and equally important , i s makin g managemen

t decision s i

n day-to-da

y operation s a

t facilitie s wher

e ionizin g radiatio n o rP.1 2

2 1 dos e limi t base d o n th e critical orga n approach
. Th e 1960 limit for dos e to th e gonad s wa s base d o n a

n entirel y differen

t consideration , tha

t of limitin g th e incrementa

l rate of mutatio n i n th e entire geneti c poo l o f th e U.S
. population
. Th e incrementa l leve l o f mutatio n deemed unacceptabl e wa s o n th e orde r of afe w pe r cent . Thes e recommendations woul d replac e th e syste mdescribe d abov e witi i th e risk-weighted dos e limitatio n syste mintroduce d b y th e ICR P i n 197 7 6

. Th e ICR P syste

m take s into account

th e individua

l contributio n of

eac h expose d par

t of th e bod y t o total risk. I t doe s s o by assignin g to eac h orga n o r tissue of th e bod y aweightin g factor

tha t i s proportional t

b th e risk pe r uni t dos e o f inducin g cancer

or , for th e reproductiv e organs , to th e risk pe r uni t dos e of inducin g hereditar

y effects i n offspring
. Th e risk

limi t i s the n - expresse d i n term s of

th e su mo f weighte d dos e equivalent s to al l part s of th e body , a quantit y calle d th e "effectiv e dos e equivalent " (EDE). 2 0 A limi t in term s of

th e ED E therefore reflects bot

h th e distributio n of

dose s amon g th e variou s organ s an d tissue s and thei r assume d relative sensitivitie s t o cancer and hereditar

y effects
. Further , th e ED E doe s no t differentiat

e exposure s fro

mexterna l an d interna

l sources ; i t

include s both
. Th e effectiv e dos e equivalent i s define d formally in footnot e (b ) t o Recommendatio n 3 an d propose d weightin g factor s are liste d in Note s 5 and 6 , i n th e forma l statemen t o f propose d recommendation s a t th e en d of

thi s notice
. Thes e factor s reflect th e organ-specifi c risks o f letha l cancer , and , for

th e reproductive organs , th e risk o f seriou s hereditar

y effects i n th e first tw o generation s o f

offspring
. They ar e th e sam e weightin g factor s a s thos e adopte d in Federal guidanc e o n radiation protectio n fo r worker s in 1987
. Althoug h ou r curren t bes t estimate s for

thes e effect s o n healt

h woul d lea

d t o somewha

t differen t values , th e difference s ar e sufficientl

y smal l tha

t ne w weightin g factor s are not propose d a s par

t o f thes e recommendations
. Th e Agenc y ha s mad e thi s choic e for

severa l reasons . First , i t

shoul d b e note d tha t change s in th e weightin g factors , base d o n ne w estimate s fo

r mortality , woul d hav e no effect

o n th e leve l of

ris k represented by agiven dos e to th e whole body , sinc e th e su mo f th e weightin g factor s is , by definition , normalize d to unity
. (I f thes e factor s wer

e

Th e weightin g factor

s ar e normalized s o tha

tthe ris k associate d wit

h a give n ED

E i s equa l t o tha tfro m a unifor

m dos e o f the sam e magnitud

e t o th e whol e body .P.1 3

2 3 effectiv e dos e equivalent

i n ayear . I n s o doing , i t woul d create asingl e limit fo r combine d dos e fro mexterna l an d interna

l radiation. Certai n radionuclides, if

inhale d o r

ingested , ma

y remain in an d continu e t o irradiate th e bod y fo r man y years . Thi s propose d recommendatio n incorporate s th e us e o f "committed " dos e into guidanc e for th e genera

l publi c (thi s concep t

wa s introduce d int

o Federal radiation protectio n guidanc e fo r worker s in 1987)
. I t

provide s tha

t Federal agencie s shoul d bas e contro l o f

annua l intak e o f suc h radionuclides upo n th e futur e dos e tha t ma y result ove r time (tha t is , th e committe d dose) , no t jus t th e "annual " dos e accrue d durin g th e first yea r followin g intake
. Thi s woul d assur e that , in regulating annua l intak e of such material s by member s o

f th e public , accoun

t i s take n of

th e additiona

l risks committe d fro

m dose s tha t wil l b e delivere d i n futur

e years . Th e standar

d perio d fo r

which committe d dos e i s calculate d i s propose d t o b e taken a s 5 0 years , a s in th e Agency' s previou s i recommendations for

workers
. Althoug h there ar e afe w radionuclide s fro

mwhic h dose s ca

n accru e fo r longer periods , th e risk

associate d wit

h intak e of such radionuclides wil l b e conservativel y estimated , compare d t o th e risk fro macomparabl e externa

l dose , becaus e o

f th e combine d effect

o f th e distributio n over

tim e o f committe d dos e and th e latenc y perio d fo r expressio n o

f cancer . Th e propose d RP G i s expresse d i n term s of bot h th e ne w specia l S I uni t "sievert " an

d th e historically-use d specia l uni t "rem. " I t

i s no t th e intent of thes e recommendation s t o expres s apreferenc e for

eithe r syste mof units , bu t merely to recognize th e existenc e and acceptabilit

y o f both
. Federal agencie s woul d b e free t o "us e eithe r uni t under thes e recommendations , but

shoul d specif

y conversio n factor s between th e tw o system s in ne w regulations
. Th e second part

of Recommendatio n 3 reads: Th e Radiatio n Protectio n Guide ma y no t b e reasonably achievabl e in som e unusua l situations
. I t

ma y b e exceede d temporaril y i n situation s tha t ar e no t anticipate d t o recur chronicall y an d whe

n Recommendation s 1 and 2 are satisfied , provide d tha t th e radiation dos e incurre d in an y yea r doe s no t excee d 5 mS v (50 0 mrem ) effectiv e dos e equivalent
.P.1 4

2 5 Basi s fo r th e Radiatio n Protectio n Guide I n th e latte r

par t of th e twentiet

h century , societ

y ha s becom

e increasingly unwillin g t o accep t risks impose d b y activitie s tha t produc e environmenta

l pollutants
. Man

y o f th e benefit s of

industrialize d society , however , are brought about by activitie s tha

t carr y wit h themsom e unavoidabl e element s of risk. Thi s i s especially th e cas e fo r so-calle d "non-threshold " pollutant s like radiation, for which i t i s assume d tha

t ther e ar e n o risk-free levels
. Th e ris k

t o a n individua

l fro mexposur

e t o ionizin g radiation, a s discusse d above , i s assume d t o depen d linearl y upo n th e radiation dose , without athreshold
. Under

curren t guidanc e th e averag e membe r o f th e publi c no

w receives , fro

mal l th e source s to which tha t guidanc e ha s consistently bee n applied , onl

y aver y small dos e - les s tha

n 0.0 1 mS v ( 1 mrem) in ayear 22

. Th e averag e ris k

o f fata l cancer incurre d fro

msuc h a n exposure i s estimate d to b e somewha

t les s tha n 5 in ten million
. Th e cumulativ e risk

t o societ y associate d wit

h th e variet

y o f curren t use s o f radiatio n i s no w governe d by th e dua

l requirements tha

t each us e b e justifie d an d tha t it s effec t o n publi c exposure minimize d b y optimizin g radiation protection
. Thes e requirement s would b e continue d an d strengthene d unde r propose d Recommendation s 1 and 2
. Typically , thi s woul d result i n adistributio n of

annua l dose s fro meac h sourc e of

radiatio n exposur

e ranging fro

m zer o fo r mos t member s o f

th e populatio n t o amaximu mvalu e (establishe d under Recommendatio n 4 ) accruin g t o asmal l numbe r of individuals
. Th e RP

G serve s a s a

n uppe r bound o n th e highes t

dose s resulting fro

mth e sum of

al l suc h distributions
. A s such , i t act s a s alimi t o n th e annua

l increment

o f risk, now an d i n th e future , t o th e theoreticall y mos t expose d individua

l wit h typica l consumptio n and othe r

relevant behavio r habits
. I n selectin g th e propose d valu e fo r th e RPG th e Agency ha s ha d to consider

anumbe r o f judgmental factors : th e relation between alimi t o n annua l dos e an d th e implie d lifetim

e risk; th e degre e of

protectio n achieve d throug h th e application , b y regulator

y authorities , o

f

2 2 Durin g th e period 196 0 t

o th e present, the curren

tRP G ha s no tconsistently bee

n applied t

o exposur e du e t o natura l sources . The primar

y example s ar

e building materials an

d rado n i n domestic groundwate

r supplies ; thes e contribut e additional

averag e effectiv e dos e equivalent s t o the U.S . populatio

n of 0.03 5 mS

v (3. 5 mrem

) an d 0.01 - 0.0 6 mS v (1- 6 mrem) , per year , respectively . Tobacc o smok e contributes a further

, a tpresen tincompletely characterized , dose . (Thes e estimates ar e derive d from Ionizing Radiation Exposure of the Population of

the United States, Nationa

l Council o

n Radiatio

n Protection an

d Measurement

s Repor t93 . Bethesda, M

D (1993). )P.1 5

2 7 number o f wester n states . Unde r

th e curren t

RPGs , annua

l dose s du e t o externa

l -vposiir e up t o 5 mS v (50 0 mrem

) ar e permitted , in additio n t o orga n dose s fro

minterna l e posur e u p t o 1 5 mS v (150 0 mrem) , dependin g o n th e orga n and th e radionuclide. Suc h dos ( impl

y lifetim e risks up t o 25 0 i

n on e millio n fo

r eac h yea r of externa l exposure , and u

p . 4 0 in on e millio n fo

r each yea r of interna l exposure . Th e propose d RP G of 1 mS v eff

e 'iv e dos e equivalent woul d limi t

th e incrementa

l lifetim e risk associate d wit

h eac h yea

r of c r.bine d external an d internal exposur e t o 5 0 in on e million , asignifican t reductio n in risk. Finally , th e Agenc y note s tha t th e propose d RP

G i s consisten

t wit h level s i un

d acceptabl e and in us e b y th e internationa l community
. A valu e of 1 mS v pe r

ye ai s recommende d a s th e upper boun d o n dose s t o member s o f th e publi c b y bot

h th e j TR

P an d th e International Atomi c Energ y Agency , and i s in common us e throughou t th e w < *!d
. T o provid e aperspective o n th e abov e level s of risk, i t ma y b e note d tha

t t e averag e America n i s expose d annually t o a n effectiv e dos e equivalen

t of about 3 mS v (30
. mrem

) fro mnatural backgroun d radiation, includin g a n averag e contributio n of

about 2 n >*
. (20 0 mrem

) fro mradon in homes
. Thi s exposur e i s thre e time s th e propose d RP ( , an d each year' s exposure correspond s t o a n incrementa

l lifetim e risk of 15 0 in on e million
. Although th e averag e leve l o

f exposur e t o natura

l background-provide s perspective , i t doe s • )t
. however , provid e ajustificatio n fo r th e RPG , sinc e i t

represent s a

n uncontrollabl e ourc e o

f risk, an d th e RP G applie s t o controllabl e sources . Th e level s of

risk assume d t o b e associate d wit h radiation exposur

e ma y a l > b e compare d t o involuntar

y an d voluntar

y risks actually incurre d i n common activiti e Fo r example , th e essentially involuntar y ris k o f dyin g of ahousehol d acciden

t averag e abou

t 11 0 i n amillio n pe r

year , between 198 0 and 1990 , and th e averag e probabilit y o f dyi r o f a n automobil e accident

in th e sam

e decade , avoluntar

y risk, wa s 24 0 in amillio n p e \ ear . W e emphasiz e tha

t al l of thes e example s are provide d for perspectiv e only , and tha t t h existenc e of othe r risks, voluntar

y o r involuntary , i s not

ajustificatio n for

an y particula

r incf t nenta l radiation risk. EP A recognize s tha

t som e o f th e assumption s tha

t underli e th e propose d RJ I are no t readily quantified , o r

ar e base d o n experienc e tha t ma y not accurately predic t

th e I ae . W

e wil l continu e t o review exposur e of th e genera

l public , wit

h avie w to initiatin gP.1 6

2 9 instead o f bein g higher , i s lower
. Th e risk o f cancer i n thi s populatio n approache s bein g a n orde r of magnitude smalle

r tha n th e risk t o a n averag e membe

r o f th e population, ' an d th e risk of geneti c consequence s i s normally no longer present . EP

A ha s not propose d ahigher RPG for thi s papulatio n because , a s note d for th e cas e o

f th e unborn , thes e recommendations ar e base d o n limitin g th e risk s tha t accru e over

alifetime, , not

o n ayearly basis
. Th e RP G i s expresse d a s a

n annua l limi t simpl y for eas e o f implementation
. W e als o not e tha t alimit tha t wa s differen

t for differen t age s of member s o

f th e publi c woul d pos e sever e implementatio n difficulties
. Implementatio n of

measure s fo

r assessmen

t an d contro l o f

internal exposure t o radionuclides commonl

y make s us e of

intake-to-dos e convenio n factors
. EP A ha s previously tabulate d such value s for

us e i n implementin g th e Federal Guidanc e fo r Protectio n o f Workers , in Federal Guidanc e Repor t No
. 11 , Limitin g Value s o f Radionuclide Intake and Ai r Concentration , an d Dos e Conversio n Factor s fo r Inhalation
. Submersion , and Ingestio n (EPA-520/1-88-020)
. Th e dos e conversio n factor s in thi s report an d it s subsequen

t edition s als o appl y t o intak e o f radionuclides b y member s o f th e genera

l public
. Fo r

externa l sources , exposure-to-dos e conversio n factor s ar e tabulate d i n Federal Guidanc e Repor t No
. 12 , External Exposur e t o Radionuclide s in Air
. Water , and Soi l (EP A 402-R-93-081)
. Thes e dos e conversio n factor s are appropriate fo r applicatio n t o an

y populatio n adequately characterize d b y th e set o f value s fo r

physiologica

l parameter s develope d b y th e ICRP and collectivel y know n a s "Referenc e Man." 2 3 Th e actua l dos e t o aparticula

r individua l fro magiven intak

e i s dependen

t upo n ag e an d sex , a s wel l a s othe r characteristics
. A s note d earlier , implementin g limit s for th e genera

l publi c expresse d a s ag e and se x dependen

t quantitie s woul d b e difficult
. (Clearly , i t woul d b e impracticabl e to conduc t a n annua l survey of

ag e an d sex a

t ever y locatio n o f

apotential sourc e of

publi c exposure. ) More importantly , th e variabilit y i n dos e du e to thes e factor s i s comparabl e i n magnitude to th e uncertaint y in ou r estimate s of

th e risks which provid e th e basi s for ou r choic e o f th e RPG
. Fo r

thi s reaso n EP

A believe s that , fo

r th e purpos e o

f providin g radiation protectio n unde r

th e condition s addresse d by thes e recommendations , th e assumption s

2 3 ICR P No . 23 , Repor

to f th e Tas k Grou p o n Referenc

e Man . 1974 .P.1 7

3 1 guidanc e wit

h respeat o limitatio n o f

dose s wil l b e satisfied
. Implementatio n o f th e ALAR

A requirement

(Recommendatio n 2 ) wil l involv e consideratio n o f collectiv e dose s to populations 24 , o f

contro l mechanisms , an d of othe r factor s tha

t wil l diffe r for eac h categor

y of sources , an d wil l usually lea d to contro l level s tha

t result in dose s t o individual s les s tha n th e RPG (Recommendatio n 3)
. However , there are man y differen t categorie s of

activitie s usin g radiation tha

t ca n lea d t o exposure of

member s of

th e public
. Thes e currentl y include medica l use s of radiation an d thei r

supportin g activities ; nuclea r electri c power

facilitie s and thei r supportin g fue

l cycl e facilities ; research an d industria l users ; weapon s production , storage , and disposa

l facilities ; technologically-enhance d exposur e t o natura

l radiation sources ; consume

r products ; spac e applications ; disposa l site s fo r radioactive wastes ; an d decommissione d site s a

t which radioactive material s wer e formerly used
. I t

i s therefore als o necessar y t o ensure tha

t total dose s t o individuals , who ma y b e expose d no t

only to more tha n on e sourc e in agive n categor y in afe w cases , but

mor e ofte n t o anumbe

r o f differen t categorie s of

source s a t on e time , ar e no t

likely t o excee d th e RPG
. I t i s no t intende d tha

t thi s objectiv e b e implemente d throug h apportionment of th e RP G amon g categorie s of sources ; thi s woul d b e impracticable
. Rather , thi s consideration , which mus t encompas s th e potential for

dose s t o th e general publi c bot h no w an d in th e future , wil l necessarily b e a broad judgment , base d o n general observation s o f th e characteristic s of

existin g activities , projection s fo r

thei r us e in th e future , an d th e potential fo r presentl y unidentifie d futur e uses . T o implemen

t thes e objectives , authoritie s responsibl e for limitin g exposur

e o f th e publi c shoul d gover

n source s throug h us e of

"authorize d limits " establishe d eithe r fo r categorie s of

simila r source s o r

fo r specifi c sources . I n establishin g thes e authorize d limits , sinc e th e ALAR

A proces s consider s actua

l cost s and capabilitie s of

controls , i t

i s importan

t tha t assessment s o f

dose s t o individual s an d population s b e carrie d out realisticall y an d comprehensively
. Such assessment s shoul d contai n neither unnecessarily unrealisti c

Thes e recommendation

s ar e notintende

d t o requir e numerica

l limit s fo r collectiv e dose . Althoug h the determinatio

n o f ALAR A level s necessaril y involve s optimization o f th e collectiv e dose , th

e regulations tha

t implemen tthes e level s can b e expresse d i n terms o f individua l o r collectiv e dose , tota

l o r concentratio n o f

activit y released , installation an

d us e o f specifie d controls , o r an y other specificatio n tha

tth e regulator

y authorit y find s appropriate .P.1 8

33 operation s of

aspecifi c source . Thes e requirement s thu s serv e t o avoi d th e nee d t o perfor m detailed , an d in som

e case s ver

y difficul t to validate , evaluation s o f th e combine d incrementa

l dose s fro mothe r source s a t individua l sites
. Conversely , if

thes e requirement s ar e exceede d (o r

ar e absent) , the n suc

h evaluation s ma

y b e necessar

y t o assure conformanc e t o th e RPG (Recommendatio n 3)
. Th e second par

t of Recommendatio n 4 reads : Source s shoul d b e designe d no t t o excee d authorize d limits , and shoul d b e operate d s o a s t o maintai n dose s t o member s o f th e genera

l publi c a s low a s reasonably achievabl e withi n suc h limits
. Th e ALAR

A principl e applie s no t

only t o th e establishmen

t of authorize d limits , bu t als o to detaile d managemen t o f facilitie s wher

e source s o

f radiatio n are prepared , employed , stored , o r transported
. Thi s i s necessar y and appropriate becaus e authorize d limit s mus t usually provid e flexibilit

y fo r anticipate d deviation s fro

mdesig n performance , an d control s usually ca n perfor mbette r tha n thei r desig n limits
. Thus , exposure of th e genera

l public , even if asourc e conform s to authorize d limits , wil l no t b e ALAR

A whe n lower exposure s are reasonably achievable
. A s exemplifie d by th e performanc e of man y facilitie s over

th e pas t tw o decades , dose s t o th e publi c usually ca n b e maintaine d fa

r belo w authorize d limit s throug h responsible an d skillful contro l of

radiation sources . Thi s ha s required careful managemen t and supervisio n of

radiation protectio n activities , includin g th e choic e an d implementatio n o f radiatio n contro l measure s for source s of

exposur e of member s o

f th e public , trainin g i

n procedure s t o contro l such exposure , an d monitoring , assessment , and reportin g of exposur e level s an d dose s a

t appropriate on-site an d off-sit e locations
. Th e routine managemen t o f a facilit y an d decision s o n how , o r whether , particula

r action s shoul d b e carrie d out can , i n the aggregate , b e a s (o r

more ) significan

t for radiation protectio n of

th e publi c a s th e desig n o f th e facilit y an d choic e of

it s authorize d limit
. Th e selectio n of

authorize d limit s an d th e applicatio n of th e ALAR

A principl e to operation s requires technicall y informe d judgments
. Thus , th e practic e of ALAR A must b e th e responsibilit

y primaril y of

thos e person s who contro l and manag e source s of radiatio nP.1 9

- _**
_ 3 5

I t i s th e purpos e o

f thi s recommendation t o ensure that , whe n Federal agencie s formulat e policies , an d mak

e decision s tha

t influenc e th e exposur

e o f th e general public , informatio n tha

t wil l adequately infor

mth e publi c durin g th e decision-makin g proces s i s mad e availabl e by themin atimely manner . Although i t i s no t intende d t o require genera l disseminatio n o f

informatio n concernin g ongoin g operations , no r t o require major

publi c informatio n distributio n efforts , suc h activitie s are encourage d wheneve r i t i s reasonabl e t c carr y the mout . Recommendatio n 6 : Assessment s an d record s appropriate t o th e origi n and magnitude o f expecte d dose s an d th e expose d populatio n shoul d b e performe d an d maintaine d t o demonstrat e conformanc e wit

h requirements which implemen t thes e recommendations
. Th e type s an d accurac y o f

method s an d procedure s use d in thes e assessment s shoul d b e reviewed periodicall y t o ensure tha t the y are appropriate and are bein g competently applied
. Contro l o f exposure o f

th e publi c i s normally ensure d throug h analysi s o f releases fro msource s an d modelin g of environmenta

l transpor t to hypothetica

l "critica l groups " of

th e genera l publi c assume d t o receive th e greates t exposure . Unlik

e th e situatio n for

worker s expose d occupatlonally , i t i s usuall y neither

appropriate nor

feasibl e t o physically momtor dose s t o individua

l member s of

th e public
. Suc

h dos e rates an d concentration s ma y b e determine d b y measuremen t of radioactive effluents , mathematica l modelin g of

th e dispersa

l of radionuclides i n th e environment , o r both
. Assessment s an d records required t o ensure conformanc e wit h these , recommendation s wil l vary , dependin g upo n th e nature of th e sourc e o

f exposure . Responsibl e authoritie s wil l hav e to determin e wha

t i s neede d t o ensure tha

t exposure s o f

member s o f

th e publi c actually are maintaine d withi n authorize d limit s an d are ALARA
. I n som e cases , comprehensiv e radiatio n assessmen

t program s wil l b e neede d which includ e traine d personnel , facilit y an d environmenta

l measurements , audi t

procedures , an d maintenanc e of records
. I n man

y case s conservativ e assumptions , such a s th e assessmen t o f dose s to ahypothetically mos t exposed3 7

are aware of

n o regulated source s tha

t excee d th e propose d RPG
. Pertjp s th e mos t significan t implicatio n o f

thes e recommendations woul d b e t o promote Federal agencie s b y clarifyin g th e basi c consideration s t o b e taken into development

o f new standard s an d regulations , an d i n thei r implementa recommendations moderniz e th e methodolog y fo r expressin g dose , and relationship o f

th e RP G t o standard s an d regulation s for sources , a s w e application s of

th e principl e tha

t dose s shoul d b e maintaine d "a s low a s achievable, " an d the y provide , for th e firs t tim e a s apar

t of thei r bas i of th e variou s risk s fro

mlow level s of

ionizin g radiation
. Implementatio n of

th e propose d recommendations woul d require change s i n Federal regulations, an d shoul d b e achievabl e over ashor t p o f th e change s calle d fo r

are largel y alread

y wel l under

way , majo

r ex ; revisions recently made b y th e Department of Energ y i n thei r

Order N < recently promulgate d b y th e Nuclea r Regulator y Commissio n i n 1 0 C F expecte d tha

t Federal agencie s wil l hav e littl e difficult y i n identifyin g a remaining proble mareas , an d i n providin g necessar y flexibilit y an d tr a.itio n periods , t o avoi d undu e impact s tha

t might inhibi t promp t implementatio n o f

ne w We note i n passin g tha

t i n som e case s (notably i n th e regulation publi c fromth e transportatio n o f radioactive materials ) conformanc e t o base d upo n th e assumptio n of "reasonably foreseeable " scenario s for t h relationship betwee n radioactive material s an d member s o f th e public , ; thi s assuranc e th e RP G wil l never b e exceede d canno t

b e give n wit

h a t Thes e recommendations d o no t propos e an

y change s in thi s regard, an e such case s th e sam

e approac h t o protectio n woul d continu e t o b e empk conformanc e t o tiies e ne

w recommendations. Th e anticipate d cost s o

f implementin g thes e recommendations a woul d b e incurre d by th e various , agencie s i n modifying thei r ow n regi expecte d t o b e substantial , sinc e mos t of th e necessar

y methodologica

l -insistenc

y between ccoun t i n th e on . Th e larif y th e a s th e variou s reasonabl y numerica l estimate s onl y minima l no d of time
. Man

y nple s bein g th e 5400.5 , an d thos e Par t 20
. I t i s d correctin g an

y ndance
.

. f exposure o

f th e xistin g guidanc e i s spatia l an d tempora

l i d tha t becaus e of clut e certainty
. EP A expect s tha

t in e d t o achiev e

. rimaril y thos e tha

t ions
. Thes e are no t iige s hav e alread

y bee n implemente d i n connectio n wit h th e revised Federa

l guidanc e fo

r ft*, cupationa

l exposur e issue d i n 1987
. Unlike th e situatio n for occupationa

l exposure , wher

e I
_nee d t o reduce th eP.2 1

3 9 protectio n polic y int o conformanc e wit h tha t in general internationa

l use . EP A expect s thes e change s woul d strengthe n th e overal l syste mfo r radiation protectio n o f

th e member s o

f th e publi c i n th e Unite d States
. Thes e recommendation s woul d replac e thos e portion s o f curren t Federal Radiatio n Protectio n Guidanc e (2 5 F R 4402 ) tha t apply t o protectio n of

th e general publi c fro

m ionizin g radiation. I t

i s expecte d tha

t individua l Federal agencies , o n th e basi s o f thei r knowledg e o f

specifi c source s o f

exposure o f

th e general public , woul d us e thi s ne w guidanc e a s th e basi s upo n which t o revis e o r develo p detaile d standard s o r regulations, t o th e extent tha t they hav e regulatory o r

administrativ e jurisdiction
. Pursuant t o m y responsibilities under

Executiv e Orde r

10831 , th e Atomi c Energ y Act o f 1954 , a s amended , and Reorganizatio n Pla

n No
. 3 o f

1970, 1 woul d propos e t o keep informe d o f Federal agenc y action s t o implemen

t thi s guidanc e an d t o interpre t an d clarif y thes e recommendations, and , in consultatio n wit

h affected Federal agencies , fro mtime t o tim e amend di e clarifyin g note s t o reflect ne w technica

l information , a s necessar

y t o promote aconsistent

an d effectiv e Federal programof

protectio n o f

th e publi c fro

mradiation
. Reques t fo r Comment s EPA requests comment s o n an y an d al l aspect s o f

thes e propose d recommendations. W e would , fo r

example , appreciate commen t o n th e overal l approac h t o protectio n o f th e publi c embodie d b y thes e proposals , whic h woul d continu e an d expan d upo n th e approac h recommended for

protectio n agains t

th e effect s of

exposur e t o radiation b y nationa

l an d international professiona

l advisor y bodies , an d whic h ha s forme d th e basi s fo r previou s guidanc e to Federal agencies
. I n additio n t o genera l comments , w e ar e als o particularl y . intereste d i n commenter' s view s o n th e followin g specifi c matters : 1
. Shoul d EP A consider

alower o r highe r valu e for th e Radiatio n Protectio n Guide (RPG) ; e.g. , 0.3 , 0.5 , o r

1. 5 mS v (30 , 50 , o r

15 0 mrem) ? Wha

t woul d b e th e rationale for suc h avalue ? I f

alowe r valu e i s adopte d woul d i t b e necessar

y t o modif

y Recommendatio n 4 , and , i f so , how coul d i t

b e modifie d t o retain flexibility t o provid e for possibl e futur

e beneficia l uses ?P.2 2

\ FEDERA L REGISTE RNOTIC E - FEDfiRAfcTtADIATIO N FR O GUIDANC E FO REXPQSVftBXSFTHE GENERA L PUBI_l£*£*pag e 4 1 o f 4 7

EP A wj l carefull y conside r al l writte n responses t o thi s reques tfo r comments , an d w e encourag e intereste d partie s t o presen tthei r view s atth e publi c hearin g tha twil l b e hel d o n thes e proposals . Followin g thes e hearing s w e will , afte r consultin g with affecte d Federa l agencies , formulate an

d transmi tfinal recommendations t o th e Presiden tfo r revisions t o Federal radiatio n protectio n guidanc e fo r exposur e o f th e general public . 

### Dated : DE C 1 A 199 4 ^

Caro l M . Browne r Administrato r
^SSK^^lfJ^-''^ - • • ' <*z -y ^*y, . •••* • '*"""'>-S22J#s|gg

f

4 3 Protectio n Guid e o f

1 mS v (10 0 mrem ) effectiv e dos e equivalen tto a n individual/ 4 Th e Radiatio n Protectio n Guid e applie s t o th e su m o f th e effectiv e dos e equivalen tresulting fro m exposur e t o external source s o f radiation durin g a yea r and th e committe d effectiv e dos e equivalen tincurre d fro m th e intak e o f radionuclide s durin g tha tyear . (Se e Note s 4 throug h 7. ) Th e Radiatio n Protectio n Guid e ma y no tb e reasonably achievabl e i n som e unusua l situations . I tmay b e exceede d temporaril y i n situation s tha tare no tanticipate d t o recur chronicall y and whe n Recommendation s 1 and 2 are satisfied , provide d tha tth e radiation dos e incurre d i n any yea r doe s no texcee d 5 mS v (50 0 mrem ) effectiv e dos e equivalent . Continue d exposur e o f

a n individual ove r substantia l portion s o f

a lifetim e a

to r near th e leve l o f

th e Radiatio n Protectio n Guid e shoul d b e avoided . Thi s wil l normall y b e achieve d through conformanc e o f individual source s t o Recommendation s 2 an d 4 . 4 . Authorize d limits (d > fo r source s shoul d b e establishe d t o ensur e tha tindividual and collectiv e dose s i n currentand future population s satisf y th e objective s o f

thi s guidance .

* ' Effectiv e dos e equivalenti s a derive d quantit y defined a s th e risk-weighte d su m o f dos e equivalent

s t o specifie d Organ s an d tissues. Dos e equivalenti s th e produc to f th e absorbe

d dos e an d a qualit y facto r whic

h varie s wit

h the energy an

d typ e o f radiation . I

n th e syste m o f

quantities o f

ionizin g radiatio

n historicall y i n us e i n the Unite d States , th e uni to f dos e equivalenti s th e "rem. " I n th e internationa

l system (S.L) , th e corresponding uni ti s th e "sievert " (Sv) . On e sievert equal s 10 0 rem . Th e effectiv e dos e equivalent , Hg , incurred i n a give n perio d o f tim e i s th e su

m o f th e effectiv e dos e equivalent , Hg^ , receive d from externa l exposure i n tha

tperio d an

d th e committed effectiv e dos e equivalent , ___.», incurre d from th e intak

e o f radionuclide * durin

g tha tperiod . Tha

tis , H

_= Hg^ s + H^ o = L WT^HT^, , + H TS) ) , wher e wT i s a weightin g facto r fo r orga n o r tissue t ; H T _, n i s th e dos e equivalen

tfro m externa

l irradiatio

n averaged ove r orga n o r tissue T ; an

d H-^ , th e committed dos e equivalent , i s th e su m o f al l dos e equivalents , averaged ove r orga n o r tissu e T , tha

tma y accumulat

e ove r a n individual' s anticipated remainin g lifetim e (take

n as S O years ) fro

m radionuclide s retained within di e body . Th e weightin g factor s satisf y th e conditio n 2 . w T = 1 . Th e wor d "dose" , when use d alon e i n dies e recommendations , i s intende d t o carr y th e specifi c dos e uni

timplied b y th e surroundin

g text . (e ) The ter

m "individual " means a typical member o f an y critica l group o f mosthighly expose d member s o f the genera l public ; itrefers t o persons wit h typical consumption an d othe r relevan

tbehavio r habits . ( * Authorized limit

s ar e standards , regulations , o r other requirement s establishe d b

y a responsibl e authorit

y for categorie s o f

source s o r fo r a specifi c source .- s (*?•'52^-* ' •--'.: ' ~-.

__ . _-v_SBtJs_3J|!^gS^ ^



### 4 5
NOTE S
Th e followin g note s are provide d t o clarif y applicatio n o f

th e abov e recommendations:
1 . Backgroun d radiation include s natura l source s o f

backgroun d radiation, such a s cosmi c radiation and radiation fro m nsutuially-occunin g radionuclides undisturbe d b y huma n activities , a s wel l a s radiatio n fro m certai n othe r source s o f exposur e beyon d Federal regulatory control , such a s residual fallou tfro m pas tnuclea r accident s and weapon s tests . 2 . Peopl e may , b y technologica l means , enhanc e thei r exposur e t o natura l radiatio n source s thatmigh totherwis e b e considere d source s o f backgroun d radiation . Technologically-enhance d exposure s t o natura l radiation ar e usuall y controllable , i n tha tthe y may b e avoide d o r reduce d b y takin g reasonabl e actions . Unles s specificall y noted , thes e recommendations appl y t o controllabl e technologically-enhance d exposur e t o suc h natura l radiatio n sources . 3 . Th e admonitio n t o maintai n dose s "a s lo w a s reasonably achievable " include s consideratio n o f

economi c an d societa l factors , an d applie s t o radiatio n exposur e tha tmay occu r no w o r i n th e foreseeabl e future . I n makin g thi s judgmen tfo r dose s t o populations , an y incrementa l dose s t o individual s tha tar e avoidabl e an d whic h mak e a significan t contributio n t o collectiv e dos e shoul d b e considered . 4 . Althoug h indoo r rado n fro m proximate natura l source s i s considere d technologically-enhance d exposur e t o natura l radiation , Recommendation s 3 an d 4 o f thi s guidanc e do no tappl y t o suc h exposure . Specifi c advic e fo r protectio n agains texposur e t o indoo r rado n i s provide d i n A Citizen' s Guid e T o Rado n (EP A documen t402-K92-00 1 an d subsequen teditions ) an d i n othe r EP A technica l publications .P.2 5

4 7 8
. T o ensure tha

t specifi c source s o r

categorie s of

sources , includin g thei r

installe d contro l capability , ar e designe d an d operate d to achiev e a s low a s reasonably achievabl e level s of exposure , avariet

y of quantitativ e an d qualitativ e analysi s an d decisio n method s ma y b e use d t o determin e authorize d limits
. These , i n additio n to considerin g radiatio n detriment an d risk , an d direc t

costs , ma y als o tak e into accoun

t societa l an d othe r

economi c factors
. Statutor

y requirement s ma

y impos e additiona

l constraint s o n th e selectio n of authorize d limits
.

,J *3 fP.2 6

Att a c'-r-.er. t
DOCKE T
Th e .-ockeT^shoul d includ e bot h th e informatic

- considere d b y th e Agenc y mirin g rulemakin g (section s II , II Aan d IV ) an d th e officia l Statement s of th e Administrator' s positio n o n variou s issue s relevan t t o th e rulemakin g (section s I , III , an d V ) . Section s II , II Aan d I V shoul d consis t o f al l informatio n receive d fro m

outsid e person s and al l relevan t factua l informatio n considere d b y th e Agency . Thi s doe s no t includ e an y interna l polic y recommendations , optio n memoranda , actio n memos , etc . Section s 1 , III , an d V ar e t o consis t p f th e officia l statement s o f th e Administrator' s position , represente d by th e publishe d rulemakin g document s an d an y supplementar y materia l (suc h a s technica l suppor t documents ) tha t for ma n additiona l par t o f th e officia l explanatio n o f th e Administrator' s position . Document s shoul d b e entere d int o th e docke t i n th e apppropriat e categor y an d give n a sequentia l docke t numbe r a s the y becom e available . (Fo r example , writte n publi c comment s woul d b e numbere d IV-D-1 , IV-D-2 * etc. ) I f a documen t doe s no t hav e internal pag e numbers , page s shoul d b e numbere d a t thi s time . Th e docke t itsel f i s t o consis t of , a fil e containin g a serie s o f fil e folder s fo r eac h categor y o f documents , a s wel l a s a n inde x i n th e fron t o f eac h fil e folde r listin g th e document s containe d i n th e folde r wit h thei r docke t numbers . Sometime s a reconsideratio n o f th e rulemakin g take s place' , etihe r unde r cour t orde r o r upo n petitio n fo r consideration . I n suc h a case , a n additiona l docke t sectio n o r section s woul d •becom e relevant . See . Docke t V I and not e 3 . • * CATEGORIE S I . NOTIC E O F INTEN T O R ANPRM , I F AN Y II . ITEMS^SbKSUlERE D I NDEVELOPIN G PROPOSA L 1 / A . EP A

studie s o r contracto r report s B . EP A

factua l memorand a (includin g technica l tri p reports , data , advisor y committe e minutes )

T 7 Thi s sectio n o f th e docke t shoul d b e close d t o furthe r .materia l o n th e dat e o f signin g o f th e proposa l (o r soone r i f th e Agenc y stoppe d considerin g materia l sooner) .P.2 7

y . ' -2

-

C . EP Acorrespondenc e _ o person s outside'th e Agenc y (includin g draft s oT~ regulations circulate d t o outsid e persons ) D . Correspondenc e receive d fro mperson s outsid e th e Agenc y - E.
- EP Ar.c.?orand

a o f meeting s wit h outsid e person s an d o f telephon e conversation s wit h outsid e person s F . Interagenc y Revie w Materials : draft s sen t t o othe r Governmen t agencie s fo r comment , a cop y o f eac h documen t accompanyin g suc h drafts , al l comment s b y suc h agencies , an d EPA' s writte n respons e 

### these^corflmen^s , i f

any ^ -- CAr A k ^ o eac h o f
IIA . CRITERI ADOCUMEN T DOCKE T (in^h e cas e o f tfAAQS unde r §§108 , 109 ) A . Al l publi c notice s relatin g t o developmen t o f a criteri a documen t B . EP Astudie s o r contracto r report s use d i n developin g criteri a documen t C . EP Afactua l memorand a (se e ite mII.B . above ) use d i n developin g criteri a documen t D . EP Acorrespondenc e t o person s outsid e th e Agenc y (includin g draft s o f criteri a documen t circulate d t o outsid e persons ) E . . Correspondenc e receive d fro mperson s outsid e th e Agenc y F . Minute s o f SA B meetings , and al l writte n comment s b y SA B member s o r other s submitte d a t SA B meeting s G . EP Amemorand a o f meeting s an d telephon e conversation s witfcApiitsid

e person s E . Fina l Criteri a Documen t I . EP Arespons e t o comment s receive d durin g developmen t o f criteri a documen t III . PROPOSA L A . Notic e o f Propose d Rulemakin g E . Propose d Suppor t Documen tIV . ADDITIONA L ITEM S CONSIDERE D AfTE R PROPOSA L

FINA L RUL E 2 / A . Additiona l EP Astudies.o r contracto r report s B . Ad*_tT5B__. l EP Afactua l memorand a (se e it.e mII.B . above^ r
* C . Additiona l EP Acorrespondenc e t £ person s outsid e

th e Agenc y D . Additiona l comment s receive d (includin g any correspondenc e fro moutsiders , whethe r o r no t labele d a s a publi c comment ) E . EP Amemorand a o f meeting s wit h outsid e person s an d o f telephon e conversation s wit h outsid e persons . F . Transcrip t o f hearings , i f an y G . Post-hearin g comment s receive d H . Interagenc y Revie w Material s (se e II.F . above ) V . FINA L ACTIO N A . Notic e o f Rulemakin g B . Fina l Suppor t Documen t C . Respons e t o Comment s Documen t VI . RECONSIDERATION , I F AN Y

. A . ' Rebues t o r Order.seekin g o r directin g reconsideratio n B . Ne w factual.materials , correspondence , comments , memorand a o f meeting s o f converations , etc. , relevan t t o reconsideratio n C . Agency.jdecisio n grantin g o r denyin g recons-ideratio n 2_/ VII . REPROPOSAL^ ' " VIII . ADDITIONA L ITEM S CONSIDERE D ix . FINA L ACTIO N T/ This sectio n (Docke t IV ) i s t o b e opened , a s soo n a s Docke t I I i s closed . I t i s t b b e close d o n th e dat e o f signin g o f th e fina l rule . 2/ I f reconsideratio n i s granted , ne w section s VII , VII I an d I X woul d b e sequentiall y added , an d woul d correspon d t o section s III , I V

an d V o f th e origina l rulemakin g docket .P.2 9

DOCKET : CATEGORY :

• - - — DAT E SEN T DAT E O F NUMBE R T O DOCKE T COMMENTE R OR ADDRESSEE . TITLE . DESCRIPTION . ETC . DOCUMEN T