ML20033F858
| ML20033F858 | |
| Person / Time | |
|---|---|
| Issue date: | 08/07/1989 |
| From: | Weber M NRC COMMISSION (OCM) |
| To: | Ader C, Lopezotin M, Marcus G NRC COMMISSION (OCM) |
| Shared Package | |
| ML20033D930 | List: |
| References | |
| NUDOCS 9004030267 | |
| Download: ML20033F858 (8) | |
Text
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f NOTE TO:- Maria Lopez-Otin, OCM/TR Charles Ader,-OCM/TR Gail Marcus, OCM/KR Susan Bilhorn, OCH/KR Janet Kotra, OCM/JC FROM:
Mike Weber, OCM/KC f//f
SUBJECT:
REVISED POSITION ON BRC As a result of our discussions over the last several weeks, Margaret and I have prepared a revised position on BRC (enclosed).
We believe that this position responds to many of your concerns and are circulating it to you prior to discussing it with Chairman Carr.
I intend to discuss the position with staff management starting Wednesday to ensure that we have not overlooked something important.
Please contact me if you have any additional comments on the i
position.
A4 S N 'L cc:
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1.
PRC Policy After_ thorough consideration of the staf f 's proposed policy statement on exemptions f rom regul atory control, I have decided that the policy needs to be revised to ensure that,1t addresses the f ollowing objectives and can be practically implemented.
The policy statement-is sorely needed to provade (1) a threshold for terminating regulatory control when further control does not result in commensurat e i mprovement in the pr otection of human health and the environment and (C) a consistent rlsk basis for the Commission's eMisttog Ard future enemption deci ui ons.
Based on my anclvsic, the r
Commtusion's' policy for exempttons should be composed of the I
f ollowing elements:
b 1.
Below Regulatory Concern The NRC will exempt from further regul atory control a practice that satisfies the criteria listed below.
NRC may conduct research on a periodic basis to ascess the effectiveness of the implementation of the Commi ssi on's exemption policy.
2.
Individual Dose Limit
'The overage i ndi vi dual dove to typical individuals in the critical group should pe less than 10 mrem /yr for individual practices.
An interim 2 r di vi dual dose limit of 1 mrom/yr *cr practices which result in enposures to l arge popul ations se.g.,
consumer products) should be established until the Commission gains more experience wi th the potential for indivicual exposures resulting f rom mul ti pl e practi ces.
Dose will be considered in terms of.ef f ecti ve dose equi val ent.
3.
ALARA Collective doces resul t l oc, f
- om enpocure to a practice shoul d ba as Icw as -easonably achievable (ALARA).
Annual collective doses less than or equal to 1000 per son--r em wi l l be neemed to satisfy the ALARA criterton.
rhe c alculation of collecti vo doar does not need to consider individual doses less than c>r equal w u.1 mrem /yr.
-1 Walvers to Criterla The NRC may exempt practices that do not meet the 2ndividual dose limit on a case-specific basis if the Commi ssion determines that doses to the public are acceptably low and regulatory control is not justified bv iurther reductions in Indlvicual and collec ti ve doces.
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The 10 mrem /vr individuel dose limit would apply to specitic practices with a limited enposed population, such as releasing a decommissionec site for unrestricted use or enempting a low-level
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Although'there is a considerable amount of uncertainty wi th L.
risks' associated with such low coses and dose rates, this dose would=
Increase an individual's risk of fatal cancer by about 7E-7 to 4E-6 annually and SE-5 to 2E-4 over a 70-year lifetime (assuming a risk coefficient of between 7E-5 and 3.5E-4 fatal cancers per rad based.on UNSCEAR 1988).
These risks correspond with levels of risk that peopl e routinely accept voluntarily and involuntarily f rom natural and anthropic sources and activities.
In addition. such low doses represent a small fraction of an individual's annual dose from natura1' background radiation and vari ati on in dosec caused by locational differences in background radiation.
Further. the risk associ ated wi th such a low dose is consistent with risk l evel s attained in other Federal regulatory programs.
Because it is unlikely-that an individual would be exposed to several exempted practices with small exposed popul ations, there is reasonable g
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assurance that an indivi dual's dose f rom all enempted practices will L
not exceed 100 mrem /yr under normal condi ti ons.
NRC's review of applications submitted in response to the Commission's Policy Statement on Below Regulatory Concern should ensure this in assessing individual-doses by caref ully considering anticipated exposure pathways and the characteristics of critical groups.
The-1 mrem /yr individual dose limit for practices with widespread distribution is intended as,an interim limit until NRC gains suf4 1clent experJence in the implementation of the BRC Policy.
Because of the potentiall y large exposed population associateo with such pract:ces (e.g.,
consumer products), an individual could be exposed to.several of these practices (e.g.,
5).
The lower interim dose limi t prnvides reasonable assurance that doses to individuals from all-exempted practices will remain below the 100 mrem /yr limit for members of the general public.
The interim dose limit for practices of widespread distribution also provides greater restriction on euposures resulting from innalation. ingestion. or direct. skin appitcation. which society generally considers less desirable than radiation via other pathways of exposure.
Recognl: 1ng the uncertainty associated with low dose estimates. the individual risk of fatal cancer resul ting f rom a 1 mrom/ fr dose as between 'E -8 and 4E-7 annuall y and SE-6 to 2E-5 over a 70 year lifetime.
The effects of such low doses cannot be'demonstreted in society.
Instead, they are calculational artifacts derived from the conservative assumption of the no-threshold, linear dose-resoonse model.
In NCRP 91, the National Council of Radiation Protection and Measurements concluded that such low doses are trivial because they result in negligible risks to individuals.
Therefore, regulation of practices with wide-Spread distribution resulting in Individual doses less than or equal to i mrem /vr is clearly unwarranted.
Collective doses resultino from exposures to an enempted practice should be as low as reasonably achievable (ALARA).
The 1000 person-rem annual dose tc celectec as a floor to ALARA in reviewing applications for enemptions.
The value of the collective dose threthold precludes the accurence of a stettsticel hecitn e1 4ect 2-
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I resulting from exposure to an exempted practice in the population at large.
Using a high risk coefficient of 0.5E-4 fatal cancers per h
rad. the collective dose' threshold would allow an astimated 0.4' health effects per year.
UNSCEAR 1988. cautions, however, that the product.of the risk coef ficient based on the linear hypothesis and the collective dose limit only provides reasonable estimates of the number of health effects when the collective dose is on the order of at least 10,000 person-rem.
At the low individual doses and collective doses allowed for exempted practices allowed under the BRC Policy, therefore, no' statistical health effects will probably result from exposure of the population at large from an exemoted practice.
The 1000 person-rem thr eshol d value is also based on a balance between the amounr. of effort recuired to prepare and assess an ALARA y
analysis and the potential benefits to be gained by further reductions in collective dose.
Driving ALARA analyses to attain further reductions in collective dose below 1000 person-rem would not reasonably justify the additional resource expenditures by the applicant or the NRC.
The additional benefits gained by the such reductions would be disproportionate to the resources expended for analysis, design, and regulatorv review of the enempted practice.
Therefore, the threshold value denotes a Below Regulatory Concern threshold, below which further reductions in collective dose f rom an exempted practtee are of negligible benefit.
Individual doses l en than O.1 mrem /yr do not need to be considered in the estimation of col lec ti ve doses.
Based on the no-threshold linear hypothesis, some would argue that collective cose assessments should. consider very low doses to individuals (e.g.,
microrem/ year).
However, consideration of such low doses provides a false sense of the significance and certainty of the doseu.
In addition, their consideration may reduce the utility of ALARA analyses if thev
-secount for a large percentage of the total collective cose.
NCRP 91 re commended that collective dcse assecuments for a particular practice eMclude Individual doses less than a 1 mrom/vr Negligible Individual Risk Level (NIFL).
As noted above. the NIRL corresponds to a lifetime risk of fatal cancer of 2E-5.
At v.1 nrem/vr. the
-individual ltietime rist is cn the order et 1Em. which 1 :- c orm i :.t er -
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with risk thresholds used in roguiatory programs tnroughout the
~ Federal government (e.g..
Food and Drug Admtnistration and Environmental Prctection Agencv>.
NRC previousiv proposed the 0.1 mrem /vr value as a de mi ni mi s l evel of risk in the supplementary information in the proposed revi sions to 10 CFR Part 20 (51 FR 1110).
Although I am not proposing to adopt 0.1 mrem /yr as a de minimis dose to individuals. I consider 0.1 mrem /vr to be an appropriate cutoff value for calculating collecti ve doses.
2.
BPC Policv 5 t at_ omen t_
The Commicsien't SRC Policy 5tatement should be rewritten and l'
published as 4 1nal in tne ederal Register in accordance with the elements describee above.
The Statement should be revised to centcrm to the following format:
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l.
Introduction - Describe the purpose of.the BRCEPolicy cite existing. exemptions already codified in NRC's regul ations and those of other Federal agencies over vi ew the content of the Policy Statement.
O.
Policy - Describe the policy elements listed above (BRC.
individual dose limits. ALARA. and limit waivers).-
O.
Terms and Concepts - De+ine key terms and concepts used.in.
the Policy Statement (e.g.,
practice, dose, risk. ALARA).
4._
flmpl ement at i on - Describe-hov the BRC Folicy will be L
implemented through rulemakings and licensing ' actions describe opportunities for public comment through subsecuent actions identify the need for assessment of environmental impacts for each_ practices and provide guidance on how tne NRC will consider applications for exemptions (e.g..
would NRC develop a general j
rule f or exempting consumer products or for specific' products-i such as frying pans, jewelry, gas mantles).
l 5.
Standard Format and Content - describe. in general terms, the f ormat and content of _ exemotion applications that the NRC staff would find accaptable.
The revised BRC Policy Statpment should be prepared in-the form of a cederal Register notice and resubmi tted to the Commi ssion within 45 i
days.
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1 3.
Exi stino Exemptions j
i Once the BRC Policy is established. NRC should initiate a systematic assessment of existing exemotions for radioactive material in NRC's regulations.
As a product of the assessment. NRC -should develop
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rul emaki ng s, as appropriate, to ensure that codified exempticns.are
-l consistent with the BRC Policy.
NRC should also develoo'regulatorv j
-quidance to ensure that the DRC Policy is implemented consistently in l
licensino actions and future-exemptions.
i 4
Outreach Procram l
NRC should develop and implement a proactive program for disseminating information.on the BRC Policy to other Feaeral agencies. State and local authorities. Indian Tribal organizations, media, and the public.
As a minimum, this program should include publication of an informative pamphlet on the ERC colicy for widespread distribution to the general public.
5.
Fjese ar c h Needs In light of the areat deal of uncertaintv occcciacea with.ery low doses and dose rates. NRC anculd assess the need for additional research to clarify the nature of risks at sucn low coser and ccse estes and work with other respons t ie agencies tc on2ure that f
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The rational f or selecting a BFC numoer'and a truncation number L
should be benea on health and safety concer.7s not on whetner it-wi11 al1ow or prevent _a particuler practice.
The recommendetion ta use e trunestten lev 41 of 1 nram t5 not bssed on any prectice toet may or men not be e.l l owed.
It is'a judgement cell (in othe.s judgement it could be 0.1,
+s you suggest, 10. as one commenter suggested, O.01, G.001, or any ether number).
The reescns for recommending Imrem are a6 f ollows(not in any order of i nportance) :
1.
The Commission will be t al:i ng a bold step in issuing a BFC policy and will t+Le some hear. regardless-of the level-selected.
Thcrefore, the Commission should select as large a-number as it can J u g t.i_ { v _gn _a _g ub lig _ beg l,th _t ad _ s gig tv hi g ig..
(In suggesting Imrem as the level for widespreso practices, we have already made thi s heal th and safety judgement.)
2.
The NCRP recommends it as negligible individual risk level that is trivial in compariscn to other risks and can, therefore, be di smi s-ed from consideration.
Accordingly, they recommend it as a level for. truncation.
s 3.
The Commission. in the Prooosed 10 CFR Part 20,, selected' imrem for truncation.
4.
It is 1/10 the ERC l evel (as'the proposed BRC level of 10 mrem is 1/10 of the 100 mrem limit.
5.
It is appronimately equivalent to a risk of 1 in 100,000 persons in a' lifetime (about 70 years).
If 0.1 is selected, it is appronimately equivalent to 1 in 1 million.
- Again, a Judgement call.
Why not 1 in'LO,000 or 1 in 10 million.
6.
Net as the basis. but to put it in perspective, it is 1% of the natural background level, 4% of that from our own bodies, 20% of that recei ved f rom one round trip coast-to-coast flight.
Hooef ul l y, this is sui tabl e to respond to the Chairman's questions as I understand them.
I am available to discuss this further.
Charlie
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l JUSTI
, Justification Because of the trivial' nature of the risks embodied in the BRC the application.of ALARA, the Comission will not normally consider the justification of this practice, i.e., demonstration of a positive net benefit in its implementing rulemaking process. - However, as is the case for all proposed rulemakings, the Consnission will carefully ti p
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address public comments on proposed BRC rulemakings..It would therefore I
helpful to decision making, if petitioners for rulemaking address benefits to I
the extent pricticable.
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