ML20043C035
| ML20043C035 | |
| Person / Time | |
|---|---|
| Issue date: | 03/13/1990 |
| From: | Major R NRC ADVISORY COMMITTEE ON NUCLEAR WASTE (ACNW) |
| To: | Bates A NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NACNUCLE, NUDOCS 9006010226 | |
| Download: ML20043C035 (58) | |
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UNITED STATES Uh /#M <
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- NUCLEAR REGULATORY COMMISSION c
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t ADVISORY COMMITTEE oN NUCLEAR WASTE '
g
,'J WASHINGTON D.C. MAI6 T.z
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n,s. 4,
March 13, 1990 i
MEMORANDUM FOR:
Andrew L. Bates, Chief, Oper.7.tions Branch, SECY c
FROM:
Richa
. Major, Chief, Nuclear Waste Branch, ACNW
SUBJECT:
COMMENTS AND/OR SUGGESTIONS RELATIVE TO POLICY STATEMENT ON
" EXEMPTIONS FROM REGULATORY CONTROL" During the meeting between Dade Moeller, Chairman, ACNW and the J
Commissioners' Technical Assistants on the Morning of March 5,
l~
1990, Dr. Moeller was asked by the technical assistants to suggest changes in the Policy Statement that would alleviate concerns he had.with the current version.
He agreed to provide his comments and they are enclosed.
Also enclosed is a copy of the text of the Policy Statement. with indications where each of the suggested j
comments apply.
It is my understanding that you will make the actual distribution to the appropriate technical assistants [M. Federline, M. Weber, M. Lopez-Otin, J. Kotra, K. Dragonette,.S. Billhorn, R. MacDougall, etc.)
If appropriate, Dr. Moeller would have no objection to p
distribution of a copy of his comments to the NRC staff (e.g. Don Cool, RES).
-Thank you for your help.
l-
Enclosures:
l1.
Comments and/or Suggestions Relative to Policy Statement on " Exemptions From Regulatory Control"
- D.W. Moeller, March 9,-1990 2.
Text of the Policy Statement with Indications Where Each of the Suggested Comments Apply cc:
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h00&226851130 CHPJ 3.3FR g886 %
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I D.
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Moeller LET13 - Mar. 9, 1990
.COMMENTSAND/OR-S'JGGESTIONSRdLATIVETOPOLICY STATEMENT ON " EXEMPTIONS FROM REGULATORY CONTROL" i
1.
Page 1, 1st paragraph, line 12 -- suggest the following a
-be inserted just after the words, "... the release of ef fluent s f rom licensed facilities."
r As dc+ctibed in this policy statement, there are two grounds for exempting a source, practice or product f ree regulet or y c ontrol.
One is that the source, practice or product given rise to small individual doses and small collective doses in both normal and eccident situations.
The second is that the available
[,,
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centrel proc edur es e annot achieve reductions in 8
y' o'f "h' de *p,MI'
- ndividual and collective doses compatible with the s
r esour c es., bot h r egulatory and operat ional, ~ needed tc; j
apply them.
2.
Page 1,- 1 st par agr aph -- suggest you change the last 6 lines on this page and the first two lines on page 2 to read as f ol l ows:
l As guidance in implementing these criteria, the policy statement establishes individual dose rate criteria of L
1 and 10 mrem per year C0.01 and 0.1 mSv per year 3 and a collective dose rate criterion of 1000 person-rem per li -
year [10 person-Sv per year 3.
These criteria, coupled
.].
L
rr i.
t ept with other considerations enumerated below, will serve p$'
~
as major f actors _ in the Commission's determination on whether exemptions will be' granted.
i 3.
Page 3, line 11 -- immediately following the words, for a number of years (10 CFR Part 20)" -- insert the following wordus In terms of exemption criteria, however, the evaluation go 7
of whether a given source,-practice or product meets t he AL ARA c r i t er 2 on wil l be determined prior to consideration of exempting it f rom regulatory control.
Onl y sourcen, practices and products that have been designed, developed and are planned to be implemented a n eccordance w2 th t he ALAPA criterion and the tenets of good radietion protection principles will be considered for esemption.
o JF A$*,'*h, yl'9
- P As previously stated, a major provision of this 4g3 eg av p la c y involves the definition of criteria that would fd go o
delineate conditions under which additional CContinue as in line 14 on page 33.
4..
Page 5, line 4 -- suggest the following wording:
In the mean, Federal and state agencies involved in such exemptic.ns have based them on an evaluation of the 4
1 84 *
$b r
get f ps rish associated with the proposed practice.
The Food and Drug Administration (FDA), for example, (Continue with the esisting text, line 63.
D.
Pago 5, last line -- suggest the following be inserted immedi at ely f ollowing the words, "... f rom reput atory c ont r ol. "
Tou t pol i c y s.t at ement is also being used as a basis for M
reevaluating all ev,isting NRC exemptions to assure that p
(.
they are consistent with the criteria defined herein.
y C C ont i nue: wit h the sentence, "Because this policy
..."3.
6.
Pape 6, l at.t paragraph, line 8 -- suggest the fo11owir4 new wording:
The Commi ssi on beli everJ t hat States will benefit f r om ph the application of a well defined, uniform, national policy on exemptions......"
7.
Page 7, line 3, middle full paragraph -- suggest the following wording:
1
'} pre
- 5*
\\00 onl y pr evi des guidangn individual As such, it not end collective dose rete eriteria, but also discusses
?
1 1
s I
j O.
Page 9, line 4, definition of "Below Regulatory Concern"
-- suggest the following wording j
y*
0 p
quantities of radionuclides that their release v#
'i W
into the general environment would represent such a pk e
'small r i ci: to public health and safety that they may be exempted f rom regulation by the Nuclear Regulatory Commi t si on.
9.
Page 9.
definition of "C 011 ec t i ve dose" -- suggest you j
insert the following sentence just be f or e the " Notes "
f reir pur por et: of evolunting the associated health rists, tho Commiusion recommends that the data reperted in< 1ude bot h the coll ec t i ve dose ei.d the number of peopic being exposed within several dose rate ranges.
The provision of data on the si:e of, and dose rates to, the critical population group, and the si:e of, and dowe rates t o, the general populat ion out side the critical group is one example of an acceptable approach.
l i
l I
10.
Page 10, line 6 -- suggest the f olloQing statement be added to the end of this paragraph Esemptions will also be based on assuring that the b
yrh;sof given souree, preduet, or practice, where appitcable,
/
MTpf 4.
'ti g
e 4
l has been carefully reviewed to confirm that it has been designed, developed and will be implemented in accordanc e wit h the ALARA criterion and $ cod radiation protection principles.
- 11. Page 11, linu 10, definition of " rem" -- suggest you
/
g delete the word, " effective."
Following this approach, the definition would read:
"h m" it t ht-special unat of dc.ne equiva!ent
- 10. Fage 11, definit ion of "Risl:" -- suggest that the wording beginning a n line 6 be changed to read as follows:
For the purpose t o which this policy is directed, the 1.
fete) cencer ra st-a s considerec to be controlling, that O f-15, that cancer in either more lilely to occur or more l'
lil ely t o havc a more severe outcome than the potential l
genetic l
13.
Fage 12, definit ion of "Tetal effective dose j
1 L
equi val ent " -- suggest the following changes:
[4#M
" Total e f f ecti ve dose equivalent," for purposes of this policy st atement, means the sum from all exempted productu and practices of the deep whole body
- sourees, dote equivalent (from esternal sources] and the c omn.1 t t ed whol e bc.dy dose equi velent [from al1 internel l
5
l 4
sources 3.
The total effective dose equivalent is expressed in unith of the rem or sievert.
14.
Page 13, Part A.
Principles of Exemption -- suggest,. p gr 9eu delete "or not" in the second line.
Also, suggest that line 5 be rew rded as follows:
determi ne i f exempti cin i s appropr i ate, from this standpoint, the Commi ssion must determine i f one of the f ol l owing c ondi ti ons, i s mat NOTE:
The phrase, " f r om t hi s st andpoi nt, "
will mal:e et Il clear that t his a u but one of several considerations on which exemptions will be based.
Additional considerat ione are given immediately at the top of page 14 15.
Page 14 jubt after line 6 (item #2) on this page --
suggest t he f ollowing int roduc tory material be added i
l l
t
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L in addition to these two f actors, a second major consideration is the dose that ndividual memberpl Ob A
o f t he publ i c 6441 receive as a result of the introduction of the source, product or practice being c on si der ed for exemption.
For purposes of implementing i t s poli cy, i
l l
ICont inue es wi th the existing text ).
6-1
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L
.c.
16.
Page 14, middle paragraph, line 4 -- suggest the f ol l owi ng r ewor di.ng:
fraction of the 100 mrem per year (1 mSv per year) public dose t
l i mi t.
The Commission will consider W
such oractices on a case speci fic basis using the oY general app r o a c h t,,g ( i. e., application of the ALARA principle end coed r edi et i on er ot ec t i on erinciples in develcom$nt end orooosed imolementation'of tha d a *+ 1 o n.
the civen pr oduc t. sour c e or cr ee t i c e, wher e accreoriete. and consideration of the potential for eceidont c and mi susst or ether nonstochastic r adi ol ogi c al impactui outlined in this p611cy s t at ement.
8 NOTE:
I would suggeht that this paragraph end with the 9
above rewerded st atement.
That is to say, the 1est twe p
g EFhtPncer i n t he cur r ent o,4 r p ar ant-shoul d be del et ed.
4/
o 17.
Page 14, last 4 lines -- suggest the f ol l owi ng rewording:
l The Commi ssion (del et e "ther e f or e") believes that indi vi dual and population dose v g,tg criteria should be beste features of it s overall pol i c y, c onsi st ent with k
the limitations prevacu ly described, to defir'e the r e p ori wher e expendi ture of Commission or licensee g
7
~
h resources to bring about a further reduction in dose r ate is no longer warranted.
18.
Page 15, last paragraph, line 4 -- suggest addition of the following words (and/or thought):
further reduce this dose or risk, provided that 1
sound radiation protecticin principles have been applied
~
in the design, development and proposed imp!ementation c'1 the piven practace.
The Commi saion believe the definit 2on of ICont a riue wi th pr esent test].
19.
Page 15, last 9 lanes -- suggest the following r ewor di r ep :
6 Thit. r i sl: level is comparable safety goal policy g
N
(,Y for nucleer power olents (i.e.,
a risk of the sum i
of cencer f at al 2 t y r i sl:L from all other causes).
Using t he no-t hr eshol d hypothesi s, the incremental continuing l
inda v2 dual -dose % having a risk comparable to that of the "saf ety goal" can be. estimated to be 4 mrem per 1
year (0.04 mSv per year).
00.
Page 16, last paragraph, beginning on line 8 on the P
l pege -- suggett the foilow2ng:
-E-1
- L
O In view of the uncer tainties.... the Commission finds a dose rate of to mrem per year (0.1 mSv per year) to be appropriate for use in defining a level of risk that
{
,No#
should be judged to be acceptable to an individual member of the public.* However, until the Commission gains more experience with the potential for individual U
I members of the public receiving exposur,es f rom multiple 3
exempted sour c es, products and/or practices, an interim individual dose rate criterion of 1 mrom per year (0.01 1
mSv per ye at > will be applied to those practices, such au consumer products or recycled material and equapment, that heve the potential.1or widespread di st ri but i on am:ing popul at ion groups.
The Commtasion 3
e ono 2 cler t: thevu valueu under t ahi ng.
The Commission bel t eves thet reasonable assurance can be provided thet exposures to individual me.nber s of the pu'blic from all licensed activities and exempted I
l year (1 mSv L
pr act i cer woul d be well below 100 mrmm n=-
per year), given the Commission's intent (1) to define O
l pr act ic es broadly, (O) t o r equi r e _ - ---1
=nn'!
rt; a
^
h l
c' tSt
^L^^^
- -itr ic-r-d sound r adi ation protect ion _
l principles in the design, development and implementation of each practice, (3) to evaluate l
pot ent i al expc'sur es over the 11 f etime of the practice, l
(4) to monitor and verify how exemptions are 1
implemented under this policy, and (5) to impose 1
associ at ed dose r ete limit s f or individuals and col 1ective dose r ate l i mi t s for pcipulation groups.
9 1
! 3.'
1 I..
f {./I
+ Note:
This is a critical sentence.
I am not sure V
that the suggested wording is acceptable.
21.
Page 17, Part C.,
The Populetion Dose Criterion --
t
.suggest the f ollowing changes in wordings To asuure a limit on the total societal impact, the Commi s>t.i on bel i eves t hat the collective dose rate (i.e.,
the num of the effective dose equivalents reculting irom exposures, received by members of the 1-hD* #gI l
public f rom a single exempted practice) should be less than 1000 person-rem per year (10 person-Sv per year).
The Conimi c31 on not es t hat, at this level of collective dos e. t br> hypot he t i c al annual health affects
.w
( f et el 1 t i er ) estimated to occur en a result of a single j.
ev empt ed pr ac ti c e would be less than one.
/
NOTE:
This is all I would say in this paragraph, that 1
I as to say, I would succest el1 the ether vorde be del et ed.
l 22.
Page 17, last parapraph -- suggest consideratton of the l
following word changes:
i The Commission noten thet..... annual effective dose equivalent is 1 mrem per yeer (0.01 mSv per year) g)/--
or lete.
Tal a ng this r ec or. men d at i on concludes
, p 1
,; a 1
i th in calculating collective doses, individual dose ectuel to 0.1 mrem per year (1 uSv per year) gr -
j 1gy.1*need not be considered.
23.
Page 18, line 4 -- suggest the following statements be added to this paragraph:
l To annure that the data necessary to evaluate the societal impact of a given source, product or practice ate avai1ab1e, the Cornmi terion recommends that the information reported inc1ude both the collective dose and t he number of peopl e wit hin several dose rate ranges.
The provint on of data on the size of, and dose rotes, to, the critical group, and the si:e of, and dose rates tv the gener al population outside the critical group. 15 one exampl c-o f an ac c ept abl e appr oach.
24 Fago 10, 1st full paragraph, beginning at line 5 on the l
papre -- suggent the f ollowing wordings l
l In the sensitivity-of-measure, risk-based guidelines y,'
l g# (
used by...(THAT IS, delete the word, " Fur t her mor e, " )
(II l-
.... insigni fi c anc e.
Using an annual risk coef ficient of would hypothetically incur f rom g continuous li f et irne dose r ete of 0.1 mrem policy.
/
25.
Fape 16, l ett paragraph -- suggest the f ol l owi ng changes. - - -
s 1
The Commission stresses.... collective dose taig Q
(
criteria should not be construed as a decision that dose r et en bel ow these cr i t eria.... can be exempted, i
while de.se rates above the criteria would preclude exemptions.
On the contrary, cost-risk reduction 9
5 G
analyses are not required (DELETE: "or more broadly, AL ARA anal yser.")...... exemption.
Practices not meeting these criteria.... be gained by further reguletory control, that i s, if (1) the potential dose ret en to individual unlikely, (2) the collective
/
(3) both the dos a r e,*gg er e al so su f f i c i ent l y smal l,
I ndi vi dual and collective dose refes have been l
(
c et ef ull y c ont r ol l ed, based on ALAPA considerations, I
and (4) 12ttle. If anything, is to be gained by further l
r egul at s c.n.
en exemption might be granted, l
p 1
p OC.
Page 19, last two linen, and first five lines at the if to;i of pege 20.
I WOULD URGE THAT THIS PARAGRAPH BE DELETED gp#
FFOi. THE POLIC Y STATEMENT.
I FIND IT CONFUSING AND OF LITTLE USE.
1 27.
Page 20, last line -- suggest the f ollowing wording l
(
N#'
must meet t he pol i c y's dose r at'e c r i t er i a be demonEtrated to be ALAPA.
- ~
28.
Page 21, first full paragraph -
suggest the following additionc for c onsi der at i on s locality of Practices must be defined with respect area.
An example would be an exemption for the fb /
disposal of low-level radioactive wastes in a non-ph Wf/
pf licensed facility.
However, many practices will have f
h
>6 accordingly.
Information on.... which individual doce criterion should be applied.
09.
Page 23, section 3, de finit ion of AL ARA -- suggest the f oll owing changen:
As low at is reasonably achievable (ALARA).
The ALARA c ri t er ion re f er red to.... as low as is reasonably ach3evab]n.
Appendix 1 to 10 CFR Part 50 defined what l
1s conutdered to be ALAPA for radicactive material L
r el eauen f rom light water reactors (nuc l ear power-1 plants 1 Under terms of the policy statement outlined of here, an applicant must demonst rat e t hat both the ALARA l
criterion and sound radiation protection principles have been applied in the design, development and 7
implementation of the source, product and/or practice being proposed for e xemp t i on.
(NOTE:
This would conclude thi s i t em -- del et e all other wordina).
i.
e g
COMMENTS ON APPENDIX A -- DOSE AND HEALTH EFFECTS ESTIMATION i
30.
Page 28, line 4 -- suggest:
b
~This concept, which is based on a'coevarison of the o
I risk of death from the delayed effects of ionizing exposures.
This radietion exposures, permits, approach was proposed by the International Commission on Radiological Pr ot ec t i on (ICRP) in its Publication 2 6., 1suuod in 1977.
This approach will be revised and upcInt ed a ti a report r.c h edul ed for publication by the g (~
ICFF in 1990.
The concept has been reviewed, evalusted, and adopt ed by r adiation protection or g an t :: a t l on throughout the worId must be taten 2 nto acc ount.
L 31.
Page 29, beas nning with line 2 on the page -- suggest the f ollowing changes:
The NPC focuses on the risi. of fatal cancer development principally because (1.1 the mortality rist represents a more severe outcome than the nonf atal cancer risk, and
( 2.) the mortality risk is thought to be higher N'
(NOTE:
I am succest2no del et i on ci f what i s the curr ent ll item 88 1.
I found it c on f usi no and unnecessarv),
ji r#
22.
Page 30, beginning about line 4 on this page -- suggest
- 5' that some mention be made here of the BEIR-V report.
You might say something along the following lines:..
The PEIR-V report, recently issued by the National Research Council, appears to support the statements in 4
this policy and, although the BEIR Committee concluded that the health ef fects of ionizing radiation were I
higher than previously estimated, the newer risk coef ficients they recommend are comparable with the values proposed in this policy statement.
33.
Pepe 30, line 5 -- suggest t hat the words, "In
,f addition," be deleted as an antroduction to this parapraph.
31.
N ge 33, line 6 --- suggest you consider saying nomething along the following lines:
t he r ) 11. f ect or et low doses r eflect s the s t ai gh t -l i ne (linear) doso-effect relatienship.
h St. Page 32, line 2 -- suggest this say:
".... dose rlt e of to mrem per year..."
\\
36.
Page 22, first footnote -- suggest the following possible changes
+ The e>.pression of dose refers to the Total Effective Dose Equi val ent.
This term is the sum of the deep (whol e body 3 ~ dose equival ent for sourc es external to
l i
the body, and the committed effective (whole body 3 dose cQuavalent for sources internal to the body.
i NOTE:
There may be a better way to say this -- but the objective should be to clearly point out that it is the ef f ective (whole body) dose equivalent that you are
'summi ng fsr both e>.ternal and internal exposures.
1 37.
Page 33, Part B,
first four lines -- suggest pr ot ec t i on, the collective In the 6ppl a e at ion of dono provides a useful way....
radiation exposure.
The ccillect i ve dose is the sum..."
NOTE:
The vord, "c ommi t t ed, "
appears to confuse the p
i s t.ue.
The dose equiva)ent is a commi t ted dose only PS f
f or ~ r adionuc li den deposited inside the body.
38.
Paps 33. lest thr ee lines -- suggest Typically, radionuclide concentration or radiation dose rate measurementu can be made only while a source, j
product or practice is still under regulator y control.
Estimates of the dose rates to the public that occur as V
tl s
a result of the release of a material into the envaronment or for general public use must be based on the input of these data into exposure pathway models, us 2 ng M sumpt ) c.nt rel ated to the ways in which people
p-1 might become exposed.
These assumptions incorporate eufficient conservatisms in......
NOTE:
This is one suggestion f or an improved approach 88 in presenting this inf ormation.
Hopefully, it will help in developing somthing suitable.
COMMENTS ON SUMMAF:Y OF POLICY STATEMENT 29.
F a p t+
1, 11ne 3.-- suppent that "redicactive meterial" tursy be a better wor d ihan "r adi cac t i vi t y. "
P 40.
Page 1,
second paragraph, line 7 -- suggest that this sentence uay:
"In general, es 1J2e_ level of the residual 1
r i si. bec omen vraall,...."
41.
Page J, bec orid par apr aph, s1x 1ines up f r o.m the bot t om l
l of the page
- suggest that t he word, "r adi onuc l i des, "
be used rather than "rediofcotopes."
40.
Page 0, upper portion -- suggest this be reworded as follows:
One of the purposes of the policy statement is to l
inform the public of the Commission's judgment regarding the level of residual risi that should be considered to be acceptable from licensed ac t i vi t i es.
E~
Qs V.
For certain sources and products, such as materials and equipment that have been used in nuclear facilities etnd have become contaminat ed, the policy statement defines a level where further ef forts to control or reduce exposures to' radi ation and/or radioactive materials are 4
unuarranted.
The Commission has selected its criteria everyday la ves.
The Commission believes that use of resources for the 1 in 200 thousand.
This a ndi vi duel r i ul. l evel or approsimately one-tenth of the everane netural rediat1on bacLground dose yate radon.
l f r on c os >tia c rays and naturally occurring 1
Feople encounter than frame houses.
40.
fage 2, last paragraph -- two suggest ions e.
In the second line, reword as f ol l ows:
could r ec ei ve t oret. f r on, sever al di f f erent exempted aGtivltieb."
b.
Cc nsi deration might be given to having the last sentence in this paragraph (the last 5 lines on page 2) be the beginning of a new paragraph.
This seems l
l ogi c al since the thought in this sentence has little to do with the magnitude of the collective dose (the material that was discussed in preceding portions of the exiutang parapreph).
I f
-18
o 44.
Page 3, last paragraph -- suggest adding the following
,~
l new metc 1sla Based on in f ormation cur rently available....
unrestricted public use.
Other applications of the new policy will include a review of existing exemptions (such as consumer products and the management and control of low level radionuclide releases) to assure that they are consistent with the criteria and guides prciposed here.
Et111 ot her applications of the new policy may evolve from petitions for rulemal.ing or 11 cenne oppli c et i ons, but these cannot be reliably predictec et this time.
t h
4 f
-19
_~ _
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[7690-01) i NUCLEAR REGUt.ATORY COMMIS$10N Exemptions from Regulatory Control Policy Statement j
AGENCY: Nuclear Regulatory Comission.
1 ACTION: Policy statement.
' i i
SUMMARY
- This policy statement establishes the framework within which the Comission will make decisions to o w certain products and activities involving radioactive material frta i ee or all regulatory controls. The l
[
exemptions may involve the release of licensee controlled radioactive material l
either to the generally accessible environment or to persons who would be exempt l
from Comission regulations. Activities for which exemptions may be granted include but are not limited to (1) the disposal of very low-level radioactive waste at other than licensed disposal sites, (2) the distribution of consumer products containing.small' amounts of racioactive material, (3) the release for l
unrestricted public use of lands and structures containing residual radioactivity, (4) the recycling of slightly contaminated equipment and materials, and (5) the release of effluents from licensed facilities.[The policy statement defines i
/ l i
the dose criteria and other considerations that will be most important in making (Z
decisions regarding exemptions. The policy establishes individual dose criteria 1
. [1 and 10 mram per year (0.01 to 0.1 mSv per year)] and a collective dose L
/.
criterion [1000 person-rem per year (10 person-Sv per year)] that will be major, factors in the Commission's detenninetion on whether further efforts would be a-m.
)-
w
-+w
- - - -is.i
--t.
e t wry
_~
e necessary to reduce doses free a defined activity to values which are as low as 7
is reasonably achievable (ALARA).
EFFECTIVE DATE:
(InsertPublicationDate.)
i FOR FURTHER INFORMATION CONTACT: Dr. Donald A. Cool, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Courission. Washington, DC 20555, telephone:
(301)4g2-3785.
SUPPLEPENTARY INFORPATION:
Statement of Policy 1.
Introduction.
The purpose of this policy statement is to establish the framework within which the Comission will make decisions to exempt certain practices from regulatory control. This policy defines the risks and other considerations attendant to the Comission's decisionmaking framework. The exemptions from regulatory control addressed by this policy will typically involve the release of small quantities or low concentrations of radioactive material to the public or to environments accessible to the public. However, this policy, in and of itself, does not grant an exemption from regulatory control for any radioactive materials.
Implementation will be accomplished by regulations developed through Comission rulemaking activities or by the Commission's approval of license amendments or license applications involving the releas'e of radioactive material from a licensee's control.
2
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-m-v---s
.m e
i
'I-Under the regulatory approach used by the U.S. Nuclear Regulatory l
Commission (NRC),licensedpracticesaresubjecttolimitsandconditionsthat ensure the protection of the health and safety of both workers and members of the general public, and the environment. For example, radioactive u terial is controlled by Comission and Agreement State licensees to ensure that dose limits are not exceeded. In addition, it is necessary to design, use, and dispose of f
sources of radiation in a manner that ensures that exposures to radiation or radioactive material are as low as is reasonably achievable (ALARA), economic and social factors being taken into account. This position, that doses be ALARA, has been a part of NRC regulatory practice for a number of years (10 CFR Parte).
However, no criteria have as yet been provided that would establish the basis f r defining the level of residual risk at which continued application of the ALARA principle is no longer warranted. Thus a major provision of this policy involves the definition of criteria that would delineate conditions under which additional l
expenditures of regulatory and licensee resources would not be necessary to further reduce radiation exposures from a given practice. For exempted practices, the Comission's regulatory involvement could be essentially limited to licensing and. inspection activities associated with the transfer of the radioactive material l-from a controlled to an uncontrolled status. That is, the Comission, through o
appropriate rulemaking actions or licensing decisions would define the constraints, requirements, and conditions applicable to an exemption decision, and would verify that these constraints are adhered to by NRC licensees when radioactive materials are to be transferred from a controlled to an uncontrolled or exempt status, l
3
The concept of regulatory exemptions is not new. The Atomic Energy Act of 1954, as amended, authorizes the Commiseion to exempt certain classes, quantities, or uses of radioactive material when it finds that such i
J deregulation will not constitute an unreasonable risk to common defense and security and to the health and safety of the public.
In 1960 and 1970, the Coenission used this authority to promulgate tables of exempt quantities and concentrations for radioactive mat'erial. These exemptions allow a person or a licensee, under certain circumstances, to receive, possess, use, transfer, own, or acquire radioactive material without a requirement for a license (30 FR-8185; June 26, 1985 and 35 FR 6427; 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 environment have been embodied
, in the Commission's regulations f or some time. For example, regulations currently specify the conditions under which licensees are allowed to dispose of radioactive material into a sanitary sewer system (10 CFR 20.303). Thus these existing regulations specify requirements, conditions, and constraints that a licensee must meet if radioactive material is to be " transferred" from a controlled to an uncontrolled status. More recently, Section 10 of the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 directed the Comission to develop standards anc procedures for expeditious handling of petitions "... to exempt specific radioactive waste streams from regulation... due to the presence of radionuclides... in sufficiently low concentrations or quantities to be below regulatory concern." The Comission responded to this legislation by issuing a policy statement on August 29,1986(51FR30839). That policy statement contained criteria that, if satisfactorily addressed in a petition for rulemaking, L
1 1
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would allow the Commission to act expeditiously in proposing appropriate relief in its regulations on a ' practice-specific" basis consistent with the merits of the petition.
j MOther Federal and State agencies have also developed and used risk bases to.
]
ablish a threshold for regulatory agency involvement. The Food and Drug.
Administration (FDA),forexample,hasappliedsensitivity-of-method, risk-based, guidelines in connection with the regulation of animal' drugs, food contaminants, and trace constituents in some food additives. Similarly, the Environeental Protection Agency (EPA) has suggested de minimis incividual lifetime risk levels for small and large populations in the regulation of pesticides and carcinogenic chemicals.
The Commission believes that the need for policies defining thresholds for regulatory action is driven by two basic realizations. The first is the
~
L recognition that, for certain practices involving minimal public health and l
safety concerns, the imposition of undue or unnecessary regulatory controls l
could prohibit a practice that should otherwise be pemitted because of reasonable l
societal (including public health and safety), economic, or industrial benefits.
i The second realization is the necessary national focus on fiscal responsibility and the knowledge that resources expended for regulatory control of practices with minimal health and safety impacts could~ better be used to address more significant radiological and nonradiological health and safety concerns. To address this need, the Commission, in this policy, is expanding on its existing regulations and policies for protection of the public from radiation that currently define a number of longstanding exemptions 'f rom regulatory control ecause this policy (5*
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now pmvides a consistent risk basis for exempting the use of byproduct and source material in consumer products, this policy sepersedes the Commission's March 16, 1965, policystatementonthissubject(30FR3462).
It is isportant to emphasize that, in this policy, the Commission does not assert an absence or threshold of risk at low radiation dose levels but rather establishes a baseline where further government regulation to reduce risks is unwarranted. The presence of natural background radiation and variations in the levels of this, background are used to provide a perspective on which to judge the relative significance of the radiological risks involvec in the exemption decisionmaking process.
The Consnission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an important role in its implementation; specifically, with regard to proposals for disposals of radioactive material at other than licensed low-level racioactive waste sites. Pursuant to the LLRWPAA, States, either alone or in cooperation I
with other States, are responsible for providing for disposal of certain L
low-level radioactive wastes.
In the past, some States have been encouraging findings that certain wastes are below regulatory concern.
- The Cosmission h
believes that States will benefit fmei the application of a n onal policy on exemptions for specific practices involving distribution or release of radioactive material. The Commission therefore expects that rulemakings codifying exemptions for practices under this policy will be made a matter of strict compatibility for Agreement States to the extent that States, under the terms of the Agreements, are responsible for exemptions in their Stctes. Consequently, those rulemakings involving Agreement States that evolve from this policy will continue to be closely 6
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The Cosmission will, however, retain its sole coordinated with the States.
authority for issuing licenses for the manufacture and/or distribution of consumer products using byproduct or source material and its other authorities C
as defined in 10 CFR part 150.
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The policy described in this document is intended to provide the pubite ork that would apply to a wide spectrum of Commission health ano safe exemption 11ecisions. /As such, it not only provides indivieval and collective riteri6 but also ciscusses other important elements of an exemption desa Section !! provides definitions of key terms and decisionmaking process.
concepts used in the policy statement. Section !!! presents the basic elements of the policy while Section IV discusses how the policy will be implemented through rulemakings and licensing actions and describes how the public will be This provided an opportunity to comment' on the Commission's exemption decisions.
section alsu discusses NRC plans to 9 view past exemption decisions to ensure consistency with exemption policy provisions.Section V describes, in general terr.s, the information needed to support the exemption decisionmaking process.
!!. Definitions.
" Activity," when used to describe radioactive material in this policy statement, is the rate of disintegration (transformation) or decay of, 10 radioactive material. The units of activity are the curie (1 Ci = 3.7 x 10 disintegrations per second) and the becquerel (1 Bq = 1 disintegration per second).
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i "ALARA" (acronym for 'es low as is reasonably achievable *) seans making I
every reasonable effort to maintain raciation esposures as far below applicable dose limits as is practical, consistent with the purpose for which the licensed activity is undertaken taking into account the state of technolog, the economics of improvements in relation to benefits to the public health and safe'ty, and other societal and socioeconomic considerations and in relation to ut111 ation of nuclear energy and licensed materials in the public interest.
" Agreement State" means any State with which the Commission has entered into an effective agreement under subsection 274(b) of the Atomic Energy Act of 1954, as amended.
" Byproduct material" means --
(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the raciation incident to the process of producing or utilizing special nuclear material; and (2) The tailings or wastes produced by the extraction or I
concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute " byproduct material" within this definition.
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'Below regulatory concern" is a ters taken from $ection 10 of the Low Level Radioactive Waste Policy Amendments Act of 1986 (Pub.L. 99 240) that refers to waste streams containing sufficiently low concentrations or
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quantities of radionuclides that the waste stream may be esempted fr &
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regulation by the Nuclear Regulatory Comission.
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' Collective dose" is the sum of the i idualdoses(totaleffective 1
dose equivalents) received in a given eriod of time by a specified population fromexposuretoaspecifiedsourceofradiation(orpracticeinvolvingthe use of racioactive material).
ote: The calculated collective dose used to determine compliance with the criterion of this policy need not include individual dose contributions received at a rate of less than 0.1 mrem per year.
4
" Committed effective dose equivalent" is the sum of the products of i
i weighting factors applicable to each of the body organs or tissues that are irradiated and the comitted dose equivalent to those organs or tissues as defined in 10 CFR Part 20.
" Deep dose equivalent" is the dose equivalent at a tissue depth of I cn.
l
" Dose" or " radiation dose" is a generic tem that means absorbed dose, I
dose equivalent, effective dose equivalent, comimitted dose equivalent, f
cosmitted effective dose equivalent, or total effective dose equivalent.
In l
this policy, the tem refers to the total effective dose equivalent.
9 L
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- Exemption from regulatory contro1* refers to a decision process that may allow radioactive material to be transferred from a controlled status to an uncontrolled status. Exemptions will be based upon the ses11 magnitude of I
risk to public and occupational health and safety and the need to direct the resources of regulatory agencies and t regulated community into optimal risk reduction endeavors. M~ / h
" Exposure" means being exposed to ionizing radiation or to radioactive material.
" Licensed material" means source material, special nuclear material, or byproduct material that is received, po.ssessed, used, transferred, or disposed of under a general or specific license issued by the Commission.
" Licensee" means the holder of an NRC or Agreement State license, l
" Natural background dose" means the dose received from naturally occurring cosmic and terrestrial radiation and radioactive material but not including t
source, byprocuct, or special nuclear material (as defined in 10 CFR Part 20).
l:
'No threshold hypothesis" refers to the theory that, at the small dose levels considered in this policy, there continues to be a risk without threshold for exposure to radiatioh and that there is a relationship between dose and the statistical probability of the occurrence of a health effect (such as latent cancers and genetic effects).
f 10 L.
' Practice' is a broadly defined activity or a set or combination of a number of similar coorcinated and continuing activities aimed at a given purpose that involves the potential for radiation exposure. Disposal of very low level radioactive waste; the release for unrestricted public use of lands and structures with residual levels of radioactivity; the distribution, use, and disposal.cf specific consumer products containing small amounts of radioactive material; and the recycle and reuse of residue 11y contaminated materials and equipment are examples of practices for which this policy will I
have potential applicability.
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" Rem" is the special unit of eff, ve dose equivalent (1 rem = 0.01 sievert).
" Risk,' for purposes of this policy, means the annual or lifetime probability of the development of fatal cancer from exposure to ionizing r
radiation and is taken as the product of the dose received by an exposed g
individual and a conversion factor based upon the linear, no-thresh 0 d
hypothesis. The conversion factor for dose to risk 4s'fa' n to be 5 x 10 I
fatal cancer per rem of radiation dose. Fo purpose to which this policy I
is directed, the fatal cancer risk is considered to be either more likely or have a more severe outcome than the potential genetic and nonfatal cancer risks and the potential risk of' developmental anomalies in fetuses.
l
" Source material" means --
l (1) Uranium or thorium, or any combination of uranium and thorium in any physical or chemical form; or l
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I (2) ' Ores which contain, by weight, one-twentieth of one percent (0.05 percent), or more, or uranium, thorium, or any combination of uranium and thorium. Source material does not include special nuclear material.
"Special nuclear material" means --
(1) Plutonium, uranium-233, uranium enriched in th.e isotope 233 or in the isotope 235, and any other material which the Commission, pursuant to the provisions of S'ection 51 of the Act, determines to be special nuclear material,butdoesnotincludesbrcematerial;or (2) Any material artificially enriched by any of the foregoing but does not include source material.
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" Total effective dose equivalent" means the sum of the deep dose a,
knu ihe committed effective dose equivalent equivalent (for external expot (for internal exposures) exf S u N ir v e sieverts.
111. Policy Elements.
The purpose of this policy statement is to establish the basis upon which the Commission will initiate the development of appropriate regulations or make licensing decisions to exempt certain practices from some or all regulatory controls. 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.
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lt is the Comissiott's intent to broadly define specific practices so that the effect of.an exemption decision on any individual or population will be evaluated in its entirety and not in a piecemeal fashts.t. At the same time, the practice must be identifien an< (ascribed in terms that will facilitate reasonable impact analyses ac4 d'apw (mposition of appropriate constraints, requirements, and conditions as the radioactive mat 6Hai casses from a controlled to an uncontrolled status (i.e., the material is no longer under tha control of a licensee). Under this policy, the definition of a " practice" in any specific decision (rulemaking or licensing action) is a critical feature that will be used to ensure that formulation of exemptions from regulatory control will not allow deliberate dilution of material or fractionation of the radiation or radioactive material for the purpose of circumventing controls
.that would otherwise be applicable. The definition of the practice in any specific exemption decision will also provide the framework for taking into account the possible consequences of accidents or misuse or the potential fo'r other nonstochastic radiological impacts associated with the exemption.
A.
Principles of Exemption.
A major consideration in exempting any practice from some or all regulatory controls hinges on the general question of whether the appTication or continuation of regulatory controls is necessary and_ cost effective in reducing a small risk (i.e., a commensurate small dose). To determine if exemption is appropriate, the Cosmission must determine if one of N
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1.
The application or continuation:of regulatory controls on the practice does not result in any significant reduction in dose received by individuals within a critical group (i.e.. the group expected to receive the highest exposure) and by the exposed population or; 2.,
The costs of the controls that could be imposed for dose reduction are not balanced by e comensurate reduction in risk that could be realized..
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+7or purposes of, implementing its policy, the.Comission intends that onl
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under unusual circumstances would exemptions be considered for practices that could cause continuing raciation exposure to incividuals exceeding a small fraction of the 100 mram per year (1 mSv per year) public dose. limit.
e
.Comission will consider such circumstances on a case specific basis using the general approach (i.e., application of the ALARA principle and consideration of L-the potential for accidents or misuse or other nonstochastic radiological L
impacts)outlinedinthispolicystatement./However,asthedosesand attendant risks to members of the exposed population decrease below the public cose. limit, the need for regulatory control decreases. At a sufficiently low level of risk, the Comission believes the decisionmaking process for granting O'
L specific exemptions from some or all regulatory controls can be essentially l
reduced to an evaluation of whether the overall individual and collective risks are sufficiently smal L,,_.
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lY The Commission th believes that individual and population dose criteria should be basic features of its overall policy to define the region where.the expenditure of Comission or licensee resourc's to bring about a e
further incremental compliance with the ALARA principle is no longer warranted, t
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These specific criteria 1:aclude (1) values for the individual annual dose reasonably expected to be received as a result of the practice (e.g., an averagedosetoindividualsinacriticalgroup)and(2)ameasureof radiological impact to the exposed population.
In combination, these criteria t
are chosen to ensure that, for a given exempted practice, no individual will be.
exposed to a significant radiological risk and that the population as a whole does not suffer a significant radiological impact.
B.
The Individual Dose Criterion, f
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If the doses to indiviouals from a pr ice unoer consideration for exemption are sufficiently small, the at'tendant risks will be small compared to
.other societal risks, and there wou be little merit in expending resources to further reduce this cose or risk. The Comission' believes the definition of this risk or dose level can be developed from two perspectives. The fir.at of these is related to quantitative risk levels. The Comission believes that most members of society will not expend resources to reduce an annual individual fatality risk below approximately 10-5 (i.e.,1 changin 100,000).
This~ risk level is comparable to that (i.e., 2x10-6) selected byNe Comission in the development of its safety goal policy for nuclear power coactors (i.e.,
a risk level equal to 0.1% (1/1000) of the sum of cancer fatality risk from all other causes). Using the no-threshold hypothesis, ~ the incremental continuing annual individual exposure level comparable to the " safety goal" risk level can be estimated as 4 mrem per year (0.04 mSv per year). The second perspective is based on those variations in dose, and hence risks, knowingly or unknowingly tolerated by individuals because of factors such as their lifestyle or place of residence. The Commission notes that resources are not expended to reduce 15 4
A
4 differential exposures associated with variations in natural background f
radiation (e.g., the 60-70 mrom per year difference between annual doses received in Denver, Colorado, vs. Washington, DC.). Nor are, resources spent to l
reduce (1) the-difference in doses between living in a brick vs. a frase house, (2)the5mremdosethatanindividualwouldreceiveduringasingleroundtrip L
coast-to-coastaircraftflight,or(3)thedosefromotheractivitiesthat involve a small fra tio of background radiation.
T.~.
In view of the uncertai,nties involved in risk assessment at low doses and g
taking into account the aforementioned risk and dose perspectives, the Commission finds an individual dose of 10 mrem per year (0.1 mSv per year) to L
be appropriate for use as an individual dose criterion that would define l
whether,or not additional resources need to be spent to comply further with the-ALARA principle. -However, until the Consnission gains more experience with the potential for individual exposures from multiple practices, an interim l
individual dose criterion of 1 mrem per year (0.01 mSv per year) will be applied to those practices involving widespread distribution of materials D
containing radioactive material such as consumer products or recycled material and equipment. The Commission considers these values to be appropriate given the unce'rtainties involved and notes that, with these values, implementation of this policy in future rulemakings or licensing decisions should be a practical p
underta king. The Cossnission believes that reasonable. assurance can be provided 7
that individual exposures to the public from all licensed activities and to E
p exempted practices would not exceed 100 mrem per year (1 mSv per year) given o
the Commission's intent (1) to define practices broadly, (2) to evaluate potential exposures over the lifetime of the practice, (3) to monitor and
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verify how exemptions are implemented under this policy, and (4) to impose a 16 i
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-companion population or collective dose criterion in defining when further application of the ALARA principle is unwarranted.
C.
The Population Dose Criterion.
(7 r Cosmiss on lieves that the collective dose (i.e., the sum of s
individual total effective dose equivalents) resulting frow exposure to an Q-N exempt practice should be ALARA. However, the Commission believes that, if the h collective dose resulting from an exempted practice is less than an expected value of 1000 person-rem per year, the resources of the Comission _and its licensees are better expended to address more significant health and safety issues. The Comission notes that, at this level of collective exposure, the O'
7 hypothetical' health effects calculsted for the e,xempted practice on an annual L
basis are less than one fatality.
/
zv The Comission notes that the National Council'of Radiation Protection and I
Measurements recomencs in its Report No. 91, recomends that collective dose
~'
assessments for a particular practice should exclude those-individuals whose annual effective dose equivalent is 1 mrem per year (0.01 mSv per year).
Taking this recomendation into account and considering the uncertainties associated with the potential for exposure to multiple practices, the Commission concludes that, in calculating collective dose, individual doses l
p
- 1. Recommencations on Limits for Exposure to Ionizing Radiation, NCRP Report No. 91, National Council on Radiation Protection and Measurements, June 1, 1987. Available for purchase from NCRP Publications, 7910 Woodmont Ave., Suite L
1016, Bethesda, MD 20814 17
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less than 0.1 mrom per year- (1 pSv per year) need not be considered. The Commission believes that inclusion of individual doses below this range
-introduces an unnecessary complexity into collective dose assessments.and could provide a false sense of the significance and certainty of su dosg levels. J g ll g/h Furthermore, in he sensitivity-of-measure, risk-based guidelines used by EPAandFDA,a50-6 lifetime risk of cancer has been used as a quantitative 4
criterion of insignificance. Using an annual risk coefficient of 5x10 per rem (5z10-2 per sievert) as discussed-in Appendix A, the 10-6 lifetime risk value would approximate the risk that an individual would hypothetically incur from continuous lifetime exposures of 0.1 mrem (0.001 mSv) per year. As a L
result, the Commission believes this value is an appropriate truncation value l
to be applied in the assessment of collective doses for the purposes of this L
- policy, h
7 I
The Comission stresses that adoption of the individual and collective 1
dose criteria should;not be construed as a decision that doses below these criteria are necessary before a practice can be exempted, while doses above the r
l' criteria would preclude exemptions. On the contrary, the criteria simply represent a range of risk that the Commission believes is sufficiently-small compared to other individual and societal risks that further cost-risk l
reduction analyses (or more broadly. ALARA analyses) are 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, since little would be gained by further regulatory control, that is, if (1) the potential doses to individual members of the public are sufficiently small or unlikely, (2) the collective dose from the exempted practice has been minimized based on ALARA 18 9
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considerations, and (3) little, if anything, is to be gained by further
. regulation, an exemption might be granted.
.,IV.-
Implementation.
The Commission's intent is that the, provisions of its exemption policy will be implemented principally through its rulemaking processes; however, exemption' decisions could also be associated with specific licensing actions.
~
In the first case, a proposal for exemption, whether initiated by the NRC i'
or requested by outside parties in a petition for rulemaking, must provide a l:
basis upon which the Commission can determine if the' basic policy conditions have been satisfied.
In general, this means that the proposal should address the individual and societal impacts resulting from the expected activities that could result if the exemption were to be granted. As a result, the proposal must consider the uses of the radioactive materials, the pathways of exposure, the levels of radioactivity, and the methods and constraints for ensuring that the assumptions used to define a practice remain appropriate as the racioactive materials move from a controlled to an uncontrollet status. Any such rulemaking action would follow the Administrative Procedure Act, which requires l
. publication of a proposed rule in order to solicit public coment on the rulemaking action under consideration. The rulemaking action would include an appropriate level of environmental review under the National Environmental e
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Policy Act.
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If a proposal for exemptio res in a Comission r lation containing q% exemption,apje using the exemption specific requirements for a par f
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would no longer need further aply the ALARA principle. The Coeurssion's exemption decision wou14 be. based on the licensee meeting the conditions k
.specified in the regulat on. The promulgation of the regulation would, under i
these circumstances, consti te a finding that the exempted practice is authorizea and p at ALARA cons erations have been addressed.
The' second means of policy implementation could involve exemptions that would be granted through licensing actions. These licensing actions may be subject to a public hearing process and, depending'on the specific action taken, may be required to be noticed in the Federal Register.
In defining its exemption policy, the Comission believes it must ensure
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that the assumptions and criteria used to justify past exemption decisions L
remain appropriate. As a result, the NRC will undertake a systematic-
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assessment of exemptions currently existing in NRC's regulations. The NRC will, on a periodic basis, review the exemptions granted under this policy to ensure that'the public health and safety continue to be adequately protected.
V.
Information To Support Exemption Decisions.
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.A.
General.
The information required to support an exempfion decision in a rulemaking
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. or licensing action must address the bases r exemption described in Section E
III of this policy.
In addressing the r diological health and safety impacts, individual and collective doses att"1 uted to the practice under consideration must either meet the policy's dose).riteria or otherwise be demonstrated to be 20
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In addition to the impacts of routine exposures, the impacts resulting i
from potential misuse or accident scenarios muit also be evaluated and I
demonstrated to be not significant.
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Practices must be defined with respect to e geographic and demographic i
areas to which the exemption will apply.
In cases, an exemption will be L
limited to one particular locality or area.i However, many practices will have national applicability and must be characterized accordingly.
Information on these. issues will be necessary for determinations regarding which individual dose criterion should be applied. The Consission believes that the i
L implementation guidance provided with its " General Statement of Policy and i:-
Procedures Concerning Petitions Pursuant to 12.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern," published August 29, 1986, 51 FR y
30839, generally defines the types of information needed to support an L
exemption decision. However, not all of the information may be applicable to the broader range of practices considered for exemption under this policy.
Applicants:should examine all applicable guidance and provide the information which is relevant to the particular type of exemption decision being requested.
B.
Characterization.
1.
Radiological properties. The radiological properties of the materials to be exempted should be described, including, as appropriate, the 4
concentration or contamination levels and the half-lives.. total quantities, and identitiu of the radionuclides associated with the exempted practice. The chemical and physical form of the radionuclides should be specified. All radionuclides present or potentially present should be specified. The 21
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distribution of the radionuclides should be noted (e.g., surface or volume distribution). Mass and volume' averaged concentrations should also be presented. The variability'of radionuclide concentration, distribution, or type as a function of process variation or variations among licensees should be
-addressed and bounded, as appropriate.
2.
Nonradiological properties. An understanding of the nonradiological properties of the materials to be exempted may be needed to assure that they have been properly addressed. 'An NRC exemption, basec on radiological impacts, would not relieve licensees from the applicable rules of other agencies which cover nonradiological properties. A description of the materials,. including their origin. chemical composition, physical state, volume, and mass should be provided. The variability and potential changes in the radioactive material.
p form as a function of process variation should be addressed. The variation L
among licensees should be described and bounded, as applicable.
1 C.
Practice Characterization L
1.
Total impact. A regulatory action taken under this exemption policy is likely to be generic, and the exemption may be nationwide in scale.
Therefore, to the extent possible, an estimate of the number of NRC and Agreement State licensees that possess the radioactive material considered for exemption, the annual volumes and masses, and the total quantities of each radionuclide that would be a part of the exempted practice should be given.
The estimates should include the current situation and the likely variability over the reasonably foreseeable future. A concentration distribution would be a helpful tool in characterizing the radioactive material involved in the 22 t
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exemption decision. Such distribution would_ permit more realistic assessment i
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In any case, the typical quantities produced per practice and an estimate of q
1e the geographic distribution of the practice should be described. The potential for recycle should also be addressed as applicable. Both the resource value (e.g., salvageable metals) and the functional usefulnes (e.g., usable tools).
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should be examined. Both=short-and long-term potentials for recycle are of q
significant concern to the Comission and should be addressed.
2.
Basis for assessment. The basis for the mat'erial characterizations should be provided. Monitoring, analytical data, and calculations should be specified. Actual measurements or values that can be related to measurements l
to confirm calculations are important and.should be provided. The description of the bases should include quality assurance aspects of data collection and analysis.
If any surveys were conducted, they should be described. Market information may be useful in characterizing a practice on a nati nal sis.
8 2) o 3.
As low as is reasonably achievable (ALARA). T e ALARA principle
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l referred to in 10 CFR P.trt 20 applies to efforts by lic nsees to maintain l
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radiation exposures and releases of radioactive materia ls in effluents to unrestricted areas as low as is reasonably achievable.f Appendix I to 10 CFR Part 50 described ALARA for radioactive materials in light water reactor effluents. Licensee compliance with the ALARA principle must remain in effect unless the dose criteria and other conditions contained in this policy are met.
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L D.
Impact Analyses.
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l To support and justify a request for exemption, each petitioner or l-
. licensee shoula assess the. radiological and nonradiological impacts of the exempted practice. The analyses should be based on the characterizations described previously and should cover all aspects of the proposed exempt 1
practice, including possession, use, transfer, ownership, and disposal of.the material. Consideration of the exemption and any environmental assessments and regulatory analyses required will be based on the impact analyses and a
supporting characterizations.
L 1.
Radiological impacts. The evaluation of radiological impacts should 1
clearly address the policy's criteria for demonstrating compliance with the ALARA principle or provide a self-supporting ALARA evaluation supporting the exemption.
In either case, the following impacts should be assessed:
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The maximum individual exposures; L
- The critical group exposures; The cumulative or collective population exposures (under conditions l
definedinSectionIll);
The potential for nonstochastic radiological impacts; and The potential for reconcentration of radionuclides.
The total population exposure should be estimated and sunened in two pa rts. One part is the critical group, where the exposures are likely to be L
the greatest and for whom the assessment of doses is likely to be the most accurate. The critical group should be the segment of the population most l
l 24 L
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highly exposed exclusive of radiation workers. The second part of the population exposure is the general population. For this group, the individual.
exposures sh'ould be smaller, and the assessment will often be less precise. In-situations where truncation of.the collective dose is done under the provisions j
of the policy, the basis for applying the truncation provision and the uncertainty in dose estinates should,be provided.
The evaluation of radiological impacts should distinguish between expected and potential exposures and events. -The analysis of potential exposures or accidents should include all of the assumptions, data, and results used in the analysis in order to facilitate review. The potential for reasonable interactions between the exempted radioactive material and the public should be assessed.
2.
Other impacts. The analysis of other impacts such as those from L
transportation, handling, processing, and disposal of. exempted materials should
-be evaluated.- The impacts from nonradiological properties should also be adoressed since they must be considered under 10 CFR Part 51. Any NRC action to exempt a practice from further regulatory control would not relieve persons using, handling, processing, owning, or disposing of the radioactive material from the requirements applicable to the nonradiological properties of the material.
1.
E.
Cost-BenefitConsiderations(asrequired).
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A cost / benefit discussion is an essential part of both environmental and regulatory impact considerations. The discussion should focus on expected 25
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- exposures'and realistic concentrations or quantities of radionuclides. The cost / benefit discussion should compare the exposures and economic costs associated with exemption and nonexemption decisions, it aey also include qualitative benefits. Costs of surveys and verifyin's compliance discussed under item V.G. should also be covered. Any legal or regulatory constraints that might affect any exemption decision should be identified. For example, one such constraint might stem from Department of Transportation (DOT) labeling, placarding, and manifesting requirements for radioactive materials in 49 CFR Part'173.
F.
Constraints, Requirements, or Conditions on Exemptions.
In most cases, the characterizations of the material and the assessment of impacts will be based on either explicit or implicit constraints.
In order for an exemption based on these characterizations and assessments, the constraints must.be incorpurated into the exemption decision. Therefore, the relationship
. between the proposed materials to be exempted and the constraints to be applied as part of the exemption such as quantity limits, concentration limits, and physical form must be addressed. The bases on which these. constraints are to be ensured must also be discussed.
In general, constraints must be inspectable and verifiable in order to be included in an exemption decision.
G.
Recordkeeping and Reporting.
1.
Quality assurance / quality control. The program to ensure compliance with specific exemption constraints, requirements, or condit* ions must be defined. The records of tests, surveys, calculations, etc. used to demonstrate 26
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.s cospliance should be maintained for inspection.
2;.
Reports. Annual reports will be required from licensees who, by rule d
or-license, are pemitted to release materials exempted from regulatory
. I l
control, and' associated recordkeeping to generate the reports will be imposed.
.l
.4 Minimum information in the annual reports could include volume and curie content. More detailed recordkeeping and reporting requirements may be imposed to andress uncertainties in projecting future volumes or amounts of exempted materials and NRC's responsibility.to consider the cumulative impacts of
- multiple exemptions, q
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APPENDIX A - DOSE AND HEALTH EFFECTS ESTIMATION I.
Dose Estimation g'
In estimating the dose rates to members of the public that might arise through the use of various practices for which exemptions are being considered,-
I the Connission has, decided to apply' the concept of the " total effective dose equivalent." This concept, which is based on a comparison of the delayed i
health effects of ionizing radiation exposures, permits, through use of' weighting factors, the calcul6 tion of the whole body dose equivalent of partial bocy and organ exposures. This approach was proposed by the International l
l Comission on Radiological Protection in its Publication 26, issued in 1977.
Since that time, the concept has been reviewed, evaluated, and adopted by l
raciation protection organizations throughout the world and has gained wide acceptance. The " total effective dose equivalent" concept is incorporated in
" Radiation Protection Guidance to Federal Agencies for Occupational Exposure -
' Recommendations Approved by the President," that was signed by the President and published in the Federal Register on January 27,1987(52FR2822). The Comission recognizes that, in considering specific exemption proposals, the 1
total effective dose equivalent must be taken into account.
- 11. Estimating Health Effects from Radiation Exposure A.
Individual Risks.
In the establishment of its radiation protection policies, the Commission has considered the three major types of health effects that can be caused by f
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relatively low doses of r 14 tion:
cancer, genetic effects, and developmental anos.alies in fetuses.
he NRC focuses on the risk of fatal cancer development 3
l principally because,/at relativel 10@&as Mws swappeeMurts I
m exis%3344fffythe tisTo%rtalW (2)themortality L
risk represents a more severe outcome than the nonfatal cancer risk, and (3) the
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. mortality risk is thought to be higher than the risk associated with genetic and
' developmental effects on fetuses.I However, even though radiation has been shown I
to be carcinogenic, the development of a risk factor applicable to continuing 2
radiation exposures at levels equal to natural background requires a significant extrapolation from the observed effects at much higher doses ano dose rates.3 The result is a significant uncertainty reflected by the views of experts in the field. For example, the Comittee on the Biological Effects of Ionizing Radiation of the National Academy of Science has cautioned that the risk values l
are "... based on incomplete data and involve a large degree of uncertainty, especially in the low dose region." This Comittee also stated that it
"...does not know whether dose rates of gama or x-rays (low LET) (low linear i
- Further discussion on these topics is provided in " Sources, Effects and Risks of Ionizing Radiation," United Nations Scientific Comittee on the Effects of Atomic Radiation (UNSCEAR),1988 Report to the General Assembly with Annexes.
2 Natural background radiation can vary with time and a person's location.
In Washington, D.C., natural background radiation (excluding radon) results in individual doses of about 90 mram per year (0.9 mSv/ year), while in Denver, Colorado, the value is about 160 mrem per year (1.6 mSv/yr), including, in both cases, a contribution of about 40 mrem per year (0.4 mSv/ year) from naturally
- occurring radioactive material contained in the human bocy (NCRP Report No. 93,
" Ionizing Radiation Exposure of the Population of the United States").
3 The health effects clearly attributable to radiation have occurred principally L
among early radiation workers, survivors of the atomic bomb explosions at Hiroshima and Nagasaki, individuals exposed for medical purposes, and laboratory animals. - Natural background causes a dose over a one-year period that is at least two orders of magnitude less than the dose received by human populations from which the cancer risks are derived. However, there are indications of cancer risk at lower doses _ from experiments at the cellular level.
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e energy transfer radiation) of about 100 erads/ year (1 ediy/ year) are detrimental to man." The Commission understands that the Committee's statement is a reflection of the' uncertainties involved and does not imply either the absence nce of detrimental effects at this dose level.[
or pre 4asambd444ee,
- he Commission is aware that the United Nat ons Scientific i
Comiittee on the Effects of Atomic Radiation (UNSCEAR), in their 1988 Report to the General Assembly, has stated that "...there was'a need for a reduction factor to modify the risks (derived at high doses and dose rates)...for low doses and-dose rates '..an appropriate range (for this factor) to be applied to total risk for low cose and dose rate should be between 2 and 10."
(Thisfactorwouldlead to a risk coefficient value between 7x10-5 and 3.5x10'4 perrad(7x10-3 and 3.5x10*2 per Gy) based on an UNSCEAR risk coefficient of 7.1x10'# per rad
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' (7.17. per gray) for 1 gray (100 rad) organ absorbed doses at high dose rates).
The report also stated, "The product of the risk coefficient appropriate for individual risk and the relevant collective dose will give the expected number of cancer deaths in the exposed population, provided that the collective dose is at least of the order of 100 man-Sv (10,000 person-rem).
If the-tal'atetive dose is only a few person-Sv (100 person-rem), the most likely eutcome is zero deaths."
i In view of this type of information, the NRC, the Environmental Protection Agency, and other national and international radiation protection authorities have established radiation protection standards defining reconnended dose limits 30
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l for radiation workers and individual members of the public. As a matter of
- regulatory prudence, all these bodies have derived the value presumed to apply at lower dose and dose rates associated with the radiation protection standards by extrapolation f rom values derived at higher doses and cose rates. The I
extrapolation is frequently referred to as'the no-threshold hypothesis, in which-refl { T lope of the b ffect relationship, the risk factor at 1 s
hy )"
The Commission, in the development of an exemption policy, is again faced with the issue of how to characterize the individual and population risks associated with low doses and dose rates. Although the uncertainties are large, useful perspective on the bounding risk associated with very low levels of radiation can be provided by continued use of the no-threshold hypothesis.
Consequently, such risk estimates have been a f actor in establishing individual.
and collective dose criteria associated with this policy. The estimations of the low risk from potentially exempted practices can be compared to the relatively nigher potential risks associated with other activities or decisions over which the NRC has-regulatory responsibility. Through such comparisons, the Consnission can ensure that its raciation protection resources and those of its licensees
. are expended in an optimal manner to accomplish its public health and safety mission.
In this context, the. risk to an individual as calculated using the no-threshold model is shown in Table 1 for various defined levels of annual individual dose. The values in the hypothesized lifetime risk column are based I
on the further assumption that the annual dose is continuously received during I
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each eaf of a 70-year lifetime. To provide further perspective, a radiation-dose 86'f 10 mrem'per year (0.1 mSv'per year) received continuously over a lifetime -
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corresponds to a hypothesized increase of about 0.25% in an individual's lifetime-l risk of. cancer death. -Ten milliram per year (0.1 mSv per year) is also a dose
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rate that. is a small fraction of naturally occurring background raciation and
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'not much larger'than the temporal variations -in natural background radiation due to fluctuations that occur at any specific location.
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Table 1 L-1 Hypothesized Hypothesized Incremental Incremental Lifetime Risk From Annual Dose
- Annual Risk **
Continuino Annual Dose **
100 mrem (1 mSv) 5 x 10-5 3.5x10j~
5 x 10-6 3.5 x 10 0.1 mSv))5 x 10-7 3.5 x 10-5 10> mrem 4
0.01 mSv I
arem 0.1 mrem -
0.001 mSv) 5 x 10-8 3.5 x 10-6.
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- The expression of dose refers-he Total Effective Dose Equivalent. This term is the sum of the deep dose vivalent for sources external to the body and the comitted effective dose equivalent for sources internal to the body.
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- Risk coefficient of 5 x 10'# per rem (5x10~2 p6r Sv) for low linear energy transfer raciation has been based on results reported in UNSCEAR 1988 (Footnote 1). Also,refertoNUREG/CR-4214(Rev.1).
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Collective or Population Risk.
o In the application of the fundamsntal principles of radiation protection,
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. (camittedjbilective dose provides a useful way to express t e radiological h
impact (i.e., potential detriments) of a nuclear activity on the' health of the population subject to radiation exposure.
ollective dose is the sum of the individual tot 61 effective dose equivalents resulting from a practice or source of raciation exposure.
It is used in comparative cost-benefit and other quantitative analysis techniques and therefore an important factor to consider in balancing benefits ano societal detriments in applying the ALARA principle. For purposes of this policy, individual total effective dose L
ecuivalents less than 0.1 mrem per year (1 mSv per year) do not need to be I
L considered in the estimation of collective doses. The Commission believes p
l consideration of such doses provides a false sense of their significance and certainty. The NRC has used collective dose, including rationales for its truncation, in a number of rulemaking decisions and decisions involving l
resolution of a variety of generic safety issues.
III. Derivation of Measurable Quantities From Dose / Risk Estimates ~
The Commission recognizes that it is frequently not possible to measure risk-l
'to individuals or populations directly and, in most situations, it is impractical to measure annual doses to individuals at the low levels potentially associated with its exemption decisions. Typically, radionuclide concentrations or l
radiation levels from the material to be released from regulatory control are L
the actual measurements that can be made, and doses are then estimated by y
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exposure pathway analysis using assumptions related to the ways in which people might become exposed. ~These assumptions' incorporate sufficient conservatism in modeling to account for uncertainties so that any actual dose would be expectedI
- to be lower than the calculated dose. The Cosmission believes that this is the appropriate. approach to be taken when determining if an exemption from some or all regulatory. controls is warrantec.-
. Dated at Rockville, Maryland, this day of 1989.
For the Nuclear Regulatory Commission..
l Samuel J. Chilk Secretary of the Consission.
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ENCLOSURE 3
SUMMARY
OF POLICY STATEMENT i
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St# WARY OF POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL
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The Nuclear Regulatory Commission (NRC) issued a pol statement-(FRN
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ations and licensing decisions which establishes the bases for future agency
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which would exempt small quantities @adioact1vityMe regulatory control.
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The concept of exemptions is not new. The NRC's current regulations and the l
licenses it has issued already include a number of such exemptions. Examples of these past decisions, which were made over a nusber of years on a case-by-case basis, include release of consumer products such as smoke detectors, waste and effluents from medical use of radioactive material at hospitals and e uent from nuclear power plants.
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-In-its new policy, as in its past actions, the primary goal of the Commission is to fulfill its mandate under the Atomic Energy Act to protect the health and safety of the public and the environment. However, like many of the activities society engages in, the use of radiation or radioactive material cannot be undertaken without some small risks. Thus, the Commission has traditionally requir d that the radiation dose tc individuals and to society be reduced to levels, that are as low as reasonably achievable (ALARA).
In general, as the level o residual risk becomes small, the resources necessary to further incrementally l
reduce the risks become larger, and the expenditure of such resources reaches a-point where the cost of such efforts are far outweighed by the small benefits l
that result. Taken to the extreme, such measures could preclude or impose unwarranted expense on the use of {adibisoto h medical or industrial applications, or the' production of nuclear power. Th Commission believes that this would be unwise and unnecessary in view of the benefits to be achieved by society and that its radiation protection reso rces and those of its licensees would be l
better directed to other activities w ich would promote the health and safety i
of the public.
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The Consission has iss its new policy statement to inform the public of the Commission's judgment regarding the level of residual risk from licensed
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activities where further efforts to control or reduce exposures to radioactivity are unwarranted. The Comission has selected its criteria on the basis that the attendant individual and collective societal risks are sufficiently small, both in the' absolute sense and in comparison to other risks which people encounte
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- in their everyday lives. The Cosmission believes that use of resources for the further reduction of risks is unwarranted if the annual risks of cancer fatality to individuals are below 1 in 200 thousand. This individual risk level is less than one-half of 1 percent of the real risk from cancer fatality from all other causes of cancer, and corresponds to a radiation dose of 10 millires per year, i
]
or approximately one-tenth of the natural radiation background from cosmic rays I
and naturally occurring radioactive material in the earth, excluding radon, L
People encounter radiation doses and associated risks of similar magnitude when taking cross-country airplane flights' or h n (hey choose to-live in brick rather than frame houses.
}
The Commission recogndaaedhat some situations could develop where an individual couldreceive[easure,fromseveraldifferentexemptedactivities.
desef As an.added conservative m activities (such as consumer products) that are likely to expose large numbers of people will be subject to a lower individual risk
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criterion of 1 in 2 million. This risk level corresponds to an annual dose of L
1 millirem per year.- The Comission has also established a criterion for the collective dose (the sum of all of the individual doses) from an activity at 1000 person-rems per year (equivalent to 100,000 incividuals receiving 10 L
millirem). The magnitude of this collective criterion has been chosen so that a (hypothetical) cancer fatality would not be expected on an annual basis from the exempted practice.
In estimating the collective dose from an exempted activity, calcula individual doses of less than 0.1 millirem per year need not be considere. for these reasons, the Commission believes that activities
.having such small ri ks and doses can be considered as candid 6tes for exemption from the usual requi ments contained in regulations and licenses, and that national resources can e better directed and more sensibly used in other risk-reduction efforts, u
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.. The policy statement is not a regulation and does not constitute a decision on any specific exemption from regulatory control.
It is, instead, a general s
cuideline for such actions. Before any changes to NRC regulations are made or
.]
ere any generic regulatory guidance is issued, there will be announcements
~
n the Federal Register which will clearly explain the details and particular circumstances associated with the proposed exemption. The'public will have an opportunity to connent on these proposals, and these comannts will be considered
]
before f,inal decisions are made.
Based on information currently available to the Comission, exemption decisions within the next few years are most likely to involve disposal of very low level radioactive waste from medical and research institutions and nuclear power g
plants and the release of residua 11y contaminated f acilities, and materials for unrestricted public use, Other applications of the new policy may evolve from petitions for rulemaking or license applications, but these cannot be reliably i
predicted at this time.
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