ML20043B911
| ML20043B911 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1988 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Lahs B NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9006010020 | |
| Download: ML20043B911 (73) | |
Text
's ~c c23
' + ' /o s#g UNITED STATES s
NUCLEAR REGULATORY COMMISSION l
- M' I
wAsmwovow.0 c. sones r
~$
k*****
June 16, 1988 i
NOTE TO: Bill Lahs, RES FROM:
Richard E. Cunningham, NMSS After thinking about the debate we had toward the end of the meeting in Baltimore regarding exclusions to the policy statement on BRC. I propose that we give the Commission an option. The rational for exclusions is in the enclosed draft. Some proposed candidates for exclusion have been added.
They are not intended to be all inclusive and will bear some discussion.
b Richard E. Cunningham i
cc:
R. Bernero, NMSS B. Morris, RES (J. Austin,NMSS
. Cool, NMSS K. Dragonette, NMSS j
l l
l l
l l
9006010020 891130 PDR FR CHP1 53FR49886 FDC
..w.4
-c,_
w1
'o.
i, PRINCIPAL JUST 1
t The principle of justification, within the system of dose limitation, states that no practice shall be adopted unless from that practice can be established Benefit can involve many quantitative and qualitative factors, a net benefit.
In most of which can be encompassed by the broad terms social and economic.
the policy statement regarding exemptions from regulatory control, the degree As of justification required is roughly proportional to the expected dose.
doses approach the trivial level, the staff believes, an'd the policy statement reflects, that justification will likely be based on an economic benefit to someone, however, not necessarily to the person receiving the radiation dose.
This is likely to be acceptable in view of very small doses or risks involved.
The staff further believes, however, that there are some practices which are, prima facie, socially unacceptable regardless of how trivial the dose might be.
An example would be radioluminous eyes on dolls susceptible to chewing by Therefore, the staff proposes, ks an option, that certain exclusions babies.
be added to the policy statement. The proposed exclusions are the intentional introduction of radionuclides in:
a)
Childrens toys, b)
Products intended for ingestion, inhalation or direct application to the skin.
c)
Completely frivolous applications of radioactive material such as radioluminous neckties, product containers or packages, and posters for enjoyment, and; d)
Cases where there are clear, economical alternatives to the use of radionuclides.
~
b M
Q @(,- L I *tt DRAFT Proposed Commission Policy on Rules for Exemption from Regulatory control
- Criteria for Approving Exemption for Practices'Whose Public Health and Safety Impacts'are Below Regulatory Concern.
I,
. INTRODUCTION AND PURPOSE L
Over the last several years, the Commission has become increasingly aware of
/e A a meet the need to provide.aer, explicit policy ^; :ffr::: th:.:.;;. t. :..;S: on the M
C., ntwa e l c.k. c+.o mdeas..'
-subjectofwhet-wreappropriater;./;.;t,sitycent01;teadards, y
i In particular, h:r.....:..:,,, O,;,J.... vi..J:.;; tic;..t;c g the Commission has noted the varying, but often large, expenditures of resources which are nf ;;.id b; directed at protecting the public from man-made sources of radiation that represent small or even negligible health risks.
To address this concern, the Commission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10, Code of Federal Regulations) and policy statements (30 FR'3462, dated March 16, 1965; 47 FR 57446, dated December 27, 1982; and 51 FR 30839, dated August 29,1986).
The purpose of this policy statement is to clearly establish the regulatory basis upon which the Commission may initiate the development of appropriate regulations ~ to exempt from regalatory control certain radioactive material and This persons who receive, posses, use, transfer, own or acquire this material.
policy is directed specifically toward petitions for rulemaking, license
amendments and license applications involving the release or distribution of licensed radioactive material either to persons not subject to Commission
[Attif 64fNa' regulation as currently defined in 10 CTR ".cu 20,kyo
-.nd 7CF, or to the environment.
is u+ uw.
e.. m et e4 ti p l*4.r> s
- s m e b t For example, in 1970, tables N exempt quantities and concentrations for 3
radioactive material were defined which a person could receive, possess, use, enw s transfer, own, or acquire without a requirement for a license, gxemptions
.. e W u. 4 e.a i.
- ci.. * *l allowing distribution of consumer products.or other devices,have been embodied in Commission regulations for some time and occasionally have been included in 4-mt - w.
More license conditions.
N
P
' :;;& t:,, -vamn+ hn e recently, in the Low Level Waste Policy Amendments Act of 1985, the Congress directed the Nuclear Regulatory Commission to develop standards and procedures I
for expeditious handling of petitions to exempt from NRC regulation disposal of slightly contaminated radioactive waste material that the Commission determined
'to be below regulatory concern.
The Commission responded to this legislation by issuing a policy statement in August 1986 (51 FR 30839). That statement contained criteria which, if satisfactorily add.ressed in a petition for l
rulemaking, would allow the Commission to act expeditiously in proposing l
L appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.
The Commission believes that these " practice-specific" exemptions should be J3 e6veloped within a broader NRC policy which will define levels of radiation y
risk, including individual dose benchmarks for radiation exposure, below which i-specified practices would not require NRC regulation based on public health and safety interests.
Below these levels, the public radiation protection benefits I
2
o t
6#
from further application of "s:-1 --me rautonably achievable"-Utt1WQ l
principle t ! :;:;i'i;d ;l;;; ;f ;;ti-N - v - ^ k' is not justified, and the extent of regulatory involvement can be essentially limited to i mectica nA J.or4.4~.An
,4,- c ~.,.h c4 4
anh.,'iince activitiesg The inspection and compliance involvement would
/
/
i generally be directed at licensee jetivities, including potentially imposed
/
/
s,st recordkeepingandreportingregr/irementsOassociatedwiththetraisfer'ofthe
/
/
/
,/
radioactive material from a controlled to an exempt s'tatus.
II.
A
SUMMARY
OF THE PRINCIPLES OF THE EXISTING DOSE LIMITATION SYSTEM i
l' The Commission's overall system for limiting public exposure to radiation g,,
e
%,,4 consists of three basic elements.
(1) justification of, practice or activity, o s,r. y h t-i.e. h there is some net benefit to be gained from the use or disposition of, radioactive material, (2) regulatory dose limits, which establish maximum permissible doses for individual members of the pubite and (3) the ALARA L
m concept, which assures reduction and acceptable distribution of individual 1
doses beneath these limits taking into account economic and societal 44.d F
factors.
For purposes of establishing radiation protection regulations, the Commission accepts a linear hypothesis to calculate potential health effects as a function of the magnitude of radiation dose.
In doing so, the Commission recognizes that this functional model is based upon data collected at SA relatively high dose leve s which is extrapolated to the low dose and low dose rate region where there is no statistically significant experimental data.
' cL..
..,, the functional model provides results which r; preset.;;pr;pri;t; er.ly As s. r a el&
N the radiation effects u 5;
......w.J are stochastic in nature (i.e.,
1P w.s.r mh.. d cancer induction).
Within e 44 dose limitation system, as the dose from a practice or decreases, the controls necessary to limit radiation 3
f exposure can be reduced while maintaining an assurance that the resulting risk remains acceptable.
At the lower end of the ALARA region of dose, below existing dose limits, the concept of below regulatory concern (BRC) comes into play.
This concept can be and has been used to justify exemptions from regulatory control.
BRC connotes a level of risk or dose that either may be justified in relation to some societal benefit achieved or may be considered trivial from a regulatory standpoint, in terms of public health and safety significance.
n6..ig The definition of existing exer:ptions for a particular eewee or practice has been viewed by the Commission as a step-wise process in which consideration is first given to whether or not the
'orpracticeisjustified.
If justified, the individual and collective doses or risks attendant to the exemption are evaluated to determine if a reduction or elimination in l
regulatory controls is warranted.
In W existing regulations, the Commission-believes that its actions have reflected a direct correlation between the risks of radiation exposure that could be delivered by a' or practice, and the l
L necessity for regulatory controls on that ;;.ca$or practice.
.4..
III. THE BASIC ELEMENTS OF A BROAD-BASED REGULATORY EXEMPTION POLICY l
t The Commission,in this policy statement,is expanding upon its existing policy to specifically incorporate a feature which, to date, has been applied in a piecemeal fashion.
That feature is the establishment of levels of radiation risk below which the need for NRC regulation to further control or reduce the distribution or release of radioactive materials is a function of the magnitude 4
I I
of the risk and the benefit of the exempted practice.
A request for exemption for ; g.D :;,,;... vi activity or practice could receive favorable consideration if adequate protection of public health and safety is being maintained and either (1) the costs of regulatory controls are not balanced by the benefits achieve {d in the reduction of risk,er (2) the use of additional v it& ~~7**
_,J.
X
)
controls ori a source of radiation exposure does not result in ainet risk eey)w d espM4 n, e 4 m ra k eesssssM wo% s e n~pM pest 4*ss n he'd j
j
[L,. 9...e reduction, The bases for such requests for exemption must include, and may be largely justified by, the magnitude of the maximum dose which could potentially j
i evdy be received hemmer individually or collected by members of the public.
r The broad-based regulatory exemption policy is made up of three basic elements:
-(1) the currently established dose limits for individuals in unrestricted areas M the limits associated with generally applicable environmental standards as set forth in 10 CFR Part 20, (2) a finding that, based on current and expected near-term practices, individual exposures from multip'le sources of radiation I
from licensed activities, including exempt pract' ices, are not likely to cause the upper-bound individual dose limits in 10 CFR 20 to be exceeded, and (3.) an I
identification of levels of radiation risk, including individual dose l
l benchmarks, below which the need for NRC regulation to further control or L
l reduce release or distribution of radioactive materials is a function of the magnitude of the risk and benefit of the exempted practice, e ^"+ :d 'n *"
.m u _
y w1 iv.,
The first element, the 10 CFR Part 20 unrest'icted area and environmental dose 11 Lits, establishes thc boundary between allowable and unacceptable exposures to individual members of the public.
This limit provides a perspective from which the individual dote and risk benchmarks for exemption can be compared.
1 i
5
c The revision of 10 CFR Part 20, currently under preparation, establishes an annual exposure limit for members of the public of 100 millirems / year from any
% nwwn,ao(7 A tb+ Ao ab. adyds im*Hu *apal** W $3614 licensed activity, l
ey.oti~s &. 4k envisimi.+ 4 e te n pea A*.
The finding provided by the second element ensures that the 10 CFR Part 20 limits are unlikely to be exceeded as a result of an individual being exposed to multiple sources or practices involving use or release of radioactive substances.
In actuality this finding is supported by " practice specific" regulatory limits imposed by both the Nuclear Regulatory Commission (NRC) and the Environmenta1 Protection Agency (EPA).
These " source specific"' limits
~
restrict exposures to individual members of the public from specific activities such as the discharge of effluents from nuclear power plants, the disposal of high an'd low level waste at licensed sites, and the operation of nuclear fuel cycle facilities (see e.g., 40 CFR Part 190-191).
These effluent and environ-mental standards have been established, at least in part, on the basis of what dose reductions are achievable for particular practices given the current status of technology, i.e., what constitutes "as low as is reasonably achievable."
The third element involves the establishment of levels of radiation risk, including individual dose benchmarks, below which the Commission believes that
- r%
the need for further NRC regulation is w t justified.
The intent of the individual dose benchmarks is to define a " graded approach" from which the Commission believes that specific exemption decisions (referred to as below regulatory concern or BRC positions) can be developed, formulated and implemented.
These BRC positions would include the definition of reasonable i
l t
6 l
i l
and prudent conditions under which c:di:ti: :: radioactive material may be And 6, authorized for release or distribution with no further NRC regulatory controls, i
The formulation of terrer pr practice specific BRC positions must reflect the following principles:
(1) unacceptable amounts of radioactive material frow {---- -
licensed activities must not be permitted to enter the environment due to unreasonable dilution or fractionalization practices, (2) all licensed practices or sources using radioactivity or radioactive material for which a BRC position is formulated are considered potential sources of exposure and (3) potential misuse or accidents involving exempted radioactive material must be considered in setting the constraints associated with a specific BRC
' position.
IV.
PRINCIPLES AND CRITERIA FOR THE DEFINITION OF INDIVIDUAL DOSE BENCHMARKS APPLICABLE TO SPECIFIC BRC DETERMINATIONS l
The underlying principles of radiation protection applicable to exemption policy include the recognition that all deliberate radiation exposures should bejustified.
Recognizing the existence of the 10 CFR Part 20 upper bound limit for individual exposure, it is evident that exposures which fall below this bound should be justified in proportion to their value or societal l
benefit.
As a basis for proportional justification for any exemption-related exposure, the Commission believes that continued acceptance of the linear non-threshold hypothesis is a prudent regulatory posture.
But as lower levels of radiation exposure are projected, the lower levels of degrees of justification open the possibility of simpler, less rigorous evaluation, and even the possibility of summary judgements on simple bases at suitably low 7
h levels of radiation exposure.
This reduction in rigor of justification, in due proportion to the lower level of exposure envisioned, is entirely cons nant with reliance on the linear non-threshold hypothesis.
The concept.of a risk or radiation exposure cutoff or threshold may also be consistent with regulation based on the linear hypothesis.
The linear hypothesis simply equates the risk of a stochastic affects to radiation exposure in some proportion to the level of that exposure, even down to the 6
smallest exposure.
The use of risk or exposure cutoffs doe 5/not have to be based on an assertion that there is no biological damage or no risk at exposure levels below that cutoff.
It can be based on the argument that the admitted risk entailed at exposure levels below the cutoff is so low in comparison to every day risk as to be beneath any reasonable threshold of concern.
Coupled with these underlying principles, the following two criteria must also be met:
(1) [ndividualdosesfrommultipleexposurestosimilarpracticeswithinan 4
exempt class of practices must not be allowed to significantly exceed benchmark values.
The Commission has found that, for currently licensed activities and those activities which may be licensed in the near future, the 10 CFR Part 20 individual dose limits for members of the public are not l'ikely to be exceeded as a result of individual exposures to multiple sources or practices involving use or release of radioactive material.
This finding is supported by the existence of current EPA and NRC effluent and environmental regulations which impose " secondary" limits that are fractions of 10 CFR 20 unrestricted area individual dose limit.
- However, 3
l 8
1
)
the Commission recognizes that regulatory programs must be developed and,
-a' perhaps, additional " secondary" limits may need to be imposed to ensure that this finding remains valid.
I (2) Since af ter exemption, it may no longer be possible to precisely assess or wedsig dq4 *ikvW limittheradiologicalimpactofexempt.c:::M*E$ftMr,the J
3 individual dose benchmarks associated with ; :;;;"hMs sf
+4sen i
i; exemption)should.,
s.
s&
with few exceptions, be e, epp ;prict: fraction of the 10 CFR Part 20 s
limits.
V.
DEFINITION OF INDIVIOUAL DOSE BENCHMARKS APPLICABLE TO BRC POSITIONS P
The Commission believes that projections of individual and collective dose can be used, within a graded approach,to determine if a specific 4eveee-or practice should be exempted from regulatory control.
The Commission believes that the graded approach can be characterized by three ranges of individual. annual i
effective dose equivalent:
(1) the range from applicable upper-bound limits fortheyecificsourceorpracticedownto10mremperyear,(2)therange L
below to mrem per year, and (3) the range below abend,1 mrem per year.
Each range of individual dose must be associated with a specific c.ollective dose consideration.
The Commission considers it appropriate, in this context, to use a maximum or limiting basis for calculating individual dose and a realistic average basis for calculating collective dose.
In both cases, the lifetime ree ru se 4=*
- ne te m
==
dose commitment of annual exposure to the, practice,should be use.
l The first two of these ranges of interest; name (1) upper-bound limits down to 10 mrem per year, and (2) below 10 mrem per year, cover those practices where 9
2 the justification of projected exposure associated with the practice to be 9
exempted must be proportionally considered against t_he societal costs including the impacts of both individual and collective dose.
The third range, below 1 i
aren, per year, enters a regime where summary disposition or acceptance of the practice can be possible based on the simplest considerations of justification i
for both individual and collective dose.
g l
i 1.
Greater than 10 mrem per year but less than applicable upper bound limits t
l, Individual exposures greater than 10 mrem effective dose equivalent per year from a defined source or practice may be justified within a specific below
@ % e n d~4 ken ersulaver, e om.1e.h regulatory concern position, hn ::_
gm t y ~ n -.-....... C n :
f;epr**hLUinvolvingindividualdosesinthisrang()
it must be demonstrated that 3
optimization of protection has been achieved for the specific soweee-ee A4 a p <t.4 t his.pf.
.phs p.ters, t., u.41 e f a svesO f practice gndert: g g i g { Collective dose must be evaluated and the cost of imposition of additional regulatory requirements prior to the transfer of the radioactive material from regulatory control to exempt status must be I#*
_ ".... ". ".. "..* $* * * + = "
r-rd.,Jw mnW. a wd.
^
l In collective dose calculations, individual doses less than 0.1 mrem per year may be neglected.
The 0.1 mrem individual dose cutoff for collective dose assessments was selected on the basis that, if risk coefficients derived for higher dose levels (Inm/yt*$ are conservatively extrapolated downward to this i
I
.s dose, an individual's lifetime risk would approach 10 This level of lifetime risk serves as a target level used by other Federal agencies (i.e., the EPA and the Food and Drug Administration) in the control of chemical 10
carcinogens.
Typically no actions are taken to reduce lifetime risk below this level.
2.
Less than 10 mrem per year Individual exposures less than 10 mrem effective dose equivalent per year, t
or sisat of re+Au resulting from a defined-summm:mer practice, can be considered small and, if the practice 0 s subject to minimal constraints, a strong argument i
arm p+.m 6 r y t 4.ry ;e n A,ot 2. r:fr.;t S could still be made.
The upper for : L i., y.1 ;te., w nm.,
bound of this range represents a value which is 1/10 of the dose limit recom-l mended for members of the public in 10 CFR Part 20.
Based on risk coefficients i
estimated fur annual dose rates 50 times greater (I rem / year), the corresponding risk of inducing lethal cancer would be somewhat greater than 10 per year.
Individual doses in this range, if they are the result of exposures received through the direct or inhalation pathways, would not be ii sW inconsistent with existing regulations (e.g., 40 CFR 190, aan Air Act),
Exemption positions involving individual doses in this range should be o
supported by assessments which provide reasonable assurance that:
(1) the V
individual dose goal (40 mrem / year) will not be exceeded and (2) the societal benefit of the practice justifies the applicable collective dose.
As in the l
upper range, the 0.1 mrem individual dose cutoff for collective dose assessments can be utilized.
looo psesu-rs= /yeo 3.
Below I mrem per year with specific collective dose constraint The Commission believes that from an individual risk standpoint, individual doses which do not exceed a few millirems per year can reasonably be candidates 11
i he
]
,p for exempting,from regulatory control.
Any number within the general range of a few millirem per year could be selected as the lowest of the specific benchmarks to be considered within the graded approach.
The Commission,
)
however, is cognizant of other authorities and regulations which impact on exemption policies; specifically, the individual dose limit of 4 mrems ptr year included in the Environmental Protection Agency's Safe Drinking Water Act and being considered as a below regulatory concern level (applicable to waste stream disposal at other than low level waste facilities) in proposed 40 CFR 193.
The Commission believes that a oewwgr practice should be a strong candidate for exemption from regulatory control if individual exposures resulting from the source or practice are limited to an annual dose of less than 1 mrem effective dose equivalent.
If risk coefficients, derived for exposures greater than 1 rem / year, have validity at this low level of dose, the corresponding risk of inducing lethal cancer would be less than 10' per year -
a risk considered trivial by many regulatory bodies and one which is held to be
(
of no concern to the individual, Within the context of the graded approach in this policy, as d'.scussed in Section.IV, the Commission believes a collective dose constraint of 1,000 person-rem can be applied to this lowest individual dose benchmark.
This constraint also serves two other purposes:
(1) to emphasize that this policy is not defining a level of de minimis or negligible individual risk but is directed toward BRC determinations and (2) to provide reasonable assurance, given current and expected near-term practices, that, when coupled with 1 mrem per year individual dose benchmark, individual doses are very unlikely to approach any existing public protection dose limit as a result of multiple exposures to distributed radioactive material (e.g., consumer products).
The 12
u.
l
'se?ietud-collective dose value of 1,000 person-rem per year is applicable to each source or practice applying for exemption in this lowest range within the-graded approach. The 1,000 person-rem value, is chosen to constrain the number of potential exposures at the 1 mrem individual dose value to a small fraction (0.4%)'of the total U.S. population.
If risk coefficients are prewmed to be valid at low levels of dose, the collective dose would constrain the stochastic prediction of latent cancer fatalities to less than unity for any specific.
r g
source or. practice.
The Commission believes, however,' that even with this graded approach there are some pract. ices which would be prime facie, socially acceptable only if the
! justification for the practice was overwhelming. These practices or uses of i
radioactive material would not likely be exempted from regulatory control, if.
ellowed at all.
Examples of such practices involve, but are not limited to, radionuclide introduction into:
a) childrens toys, b) products intended for ingestion, inhalation or direct application to the skin, and c) widespread applications'_of radioactive material in consumer products for purposes of f
attaining luminosity or product identification.
VI.
PREPARATION OF BRC POSITIONS AND ADMINISTRATION OF EXEMPTIONS In general, the methodologies to develop BRC positions will be based on assessments of individual and collective doses that may arise from the specific practice. These assessments should be appropriate to the practice under consideration and must address the applicable constraints.
\\'
13
If a simple assessment indicates that the likely consequences of exemption are individual and collective doses within the lowest range in the grade:I approach, there would be.high likelihood that the BRC determination would be accepted by the Comer.ission.
There may be cases, however, where simplified assessments will 4
indicate the potential for higher individual or collective doses.
In these cases more detailed cost / benefit assessments and the imposition of constraints on the licensee will be required before transfer of radioactive material from a controlled to an exempt status.
In situations involving potential individual doses greater than 10 mrem / year, a thorough evaluation of available options will, most likely, be required.
In both. situations, the assessment must be carried out using calculational models which take acrount of:
the characteristics of the practice to be e,xempted; the characteristics of the sources involved in the practice.
Models to accomplish the required assessments can be deterministic, covering in detail a sufficient number of exposure scenarios, and/or probabilistic designed to provide a measure of the uncertainty inherent in the modeling and the database use.
The-choice of scenarios should cover reasonable pathways and exposure situations that may arise as a result of the decision to exempt the practice in question. Inclusion of low probability of occurrence events will, of necessity, require regulatory judgements.
The radiological consequence of these events should be subjected to reasonable limits in terms of maximum individual dose.
14
't
_,-.1 1:
lThe annualized dose:from low probability events should not result in values
[.
exceeding the applicable dose benchmark.
Judgements on choice of scenarios and criteria for acceptability within a BRC position should also apply to cases of misuse of the radioactivity involved in 3
_the practice proposed for exemption.
In the calculation of individual and collective doses, particular attention should be paid to:
type of materials involved, physical and chemical characteristics, isotopic composition, surface and mass activity concentrations; total mass (es) and activities involved.
Radiation, sources involved in an exemption will pass from a regulated to an exempt status.
The exemption must be clearly defined to enhance a common understanding about what is exempted.
Restrictions on exemptions will rarely, if.ever, be expressed in terms of individual or collective dose since these parameters are not practical to measure at the operational level.
- Rather, exemptions should be expressed in quantities that are measurable at the point of_ transfer so that compliance with the provisions of the exemption can be determined.
-In addition to the basic parameters for the exemption, constraints on the exemption may ensure that the assumptions made in individual and collective dose assessments will not be invalidated and may minimize the likelihood or 15
<f..
N
,,.: ny w
consequence of accidents or incidents of mis'use.
These additional provisions
- may' include constraints on:
a)
-the total activity which may be released in a year from a regulated activity; b): the chemical and, physical form of the exempted material or its origin; c) the design of the exempted source; d) quality assurance requirements; e) the disposition of-the exempted material.
VII.' VERIFICATION THAT PUBLIC HEALTH AND SAFETY CONTINUES TO BE PROTECTED AS BELOW REGULATORY CONCERN POLICIES ARE IMPLEMENTED The Commission believes that'the implementation of any BRC determinatica made
.under this broad policy guidance must be accompanied n/ a suitable monitoring and verification program.
This program, through luitable recordkeeping and-sampling, must be capable of providing appropriate assurance that no individual member of the public is likely to exceed the individual dose benchmark justified;for the specific source or practice being exempted and that compliance is. achieved with the other constraints imposed within a specific below regulatory concern determination.
The Commission intends to develop and 16 i
w
"; ; q.
. p 2
4
.g _.
c: t :
g
[. [ [') '-
pc, -
propose for public. comment a suitable traceability and compliance program prior to' finalization of this policy statement.
s
't k
6
?
(
Ir 9
4 t
I-1, 1
l t
1 s
e i
17
.i.
.- - - - ^ - - - '. "
_______m,___
{
- 4 -,,
~
- K '
Document Name:
BRC POLICY STATEMENT
- Requestor'sEID:
COOL
= Author's'Name:
Cool',; Donald A.
Document Coments:
Policy Statement on BRC and De minimis - NMSS draft e
e 4
[
]
f,).idoM*l*Al' Y
I.
INTRODUCTION AND FURPOSE Over the past several years, the Commission has become increasingly aware of the need to Obe a general policy on the app priate r:hi,;( mb*'
ryerb c seToaddressthisneed, centr;l :"a@rds-for release of radioactive mate the Commission is expanding upon its existing policy for protection of the public from radiation,. currently expressed in existing regulations (Title 10 Code of Federal Regulations) and policy statements (30 FR 3462, dated March 16, 1965; 47 FR 57446, dated December 27, 1982; and 51 FR 30839, dated August 29,1986) by providing an explicit policy on the exemption from regulatory control of practices whose public health and safety impacts are below regulatory concerrySNRP),
The purpose of. this policy statement is to clearly establish the regulatory basis upon which the Commission may initiate the deve,lopment of appropriate regulations to exempt from regulatory control certain radioactive material and persons who receive, possess, use, transfer, own, or acquire this material.
This policy is directed specifically toward petitions for rulemaking, license amendments, and license applications involving the release or distribution licensed radioactive material either to persons not subject to Comission regulation as currently defined in 10 CFR Parts 30, 40 and 70, or to the environment.
The concept of exemption from regulatory requirements is not new. For example, tables of exempt quantities anc concentrations for radioactive material were defined in 1970 which a person could receive, possess, use, transfer, own, or acquire without a requirement for a license. Other exemptions allowing distribution of consumer products or other devices, or releases of radioactive material, have been embodied in the Commission's regulations for some time. More recently, the Low Level Waste Policy Amendments Act of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the DRAFT 06/23/88 BRC POLICY STATEMENT
9 4
2
. disposal of slightly contaminated radioactive waste material that the Comission determined to be/
ulatory concer) The Comission responded to this-legislation by issuing a policy statement in August,1986 (51FR30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Commission to act expeditiously in proposing appropriate regulatory relief on a
" practice-specific" basis consistent with th'e merits of the petition.
The' Comission believes that these " practice-specific" exemptions should be TS5TkNhin a broader NRC policy which defines levels of radiation risk, incluaing individual dose benchmarks for radiation exposure, below which specified practices would not require NRC regulation based on public health and safety interests.
For such exempted practices, the Commissions regulatory involvement could therefore be essentially limited to the inspection and compliance activities associated with the transfer of the radioactive material from a regulated to an exempt status.
II.
RADIATION PROTECTION PRINCIPLES The Commission subscribes to three fundamental principles of radiation protection in formulating its policies and regulations to protect workers and the public from the harmful effects of radiation. They are 1) justification of the practice, which requires that there be some net benefit resulting from the use of radiation or radioactive materials, 2) dose limits, which define the pg./ederAsb^beb upper boundary of dose which must not be exceeded in the conduct of : pr::; ice, and 3) ALAGA,Nrequires that radiation dose below the limits be as low as d it G asonably achievable [
b Mb h W~ b
- h
/
-2 J%g dQ.l% 5L W===% )
policies, theg{ssgagsubges to the linearbe,:.f::gregula For the purpose of establishing the health risk associated w1 it r4
- hy p:th.. n.
dhypoThekis assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose, regardless of the size of the dose.
In subscribing to this hypothesis, the Comission recognizes that it is a functional model based upon data collected at relatively high doses and dose l
DRAFT 06/23/88 BRC POLICY STATEMENT
s
't 3-7 rates geh isyhen eglated to the low dose and dose rate region where y
there J5 no dpG im6i.al data available.
It is generally believed that the use of the linear model provides a conservative basis for planning purposes.
Collective dose is the sum of the individual doses resulting from a practice or source of radiat,1 n exposure.
By assigning collective dose a monetary
- I value.the col M L M e can be used in cost benefit analysis and other Quantitative analysis techniqueMhough not a principle of radiation protection,#$$foNesausefulwaytoexpresstheimpactofanuclear activity on health of the population subject to radiation exposure, t is also an important factor to coiisider in balancing benefits and consequences for justification of a practice and determining if radiation doses are ALARA.
III. APPLICATION OF RADIATION PRINCIPLES TO EXEMPTION FROM REGULATORY CONTROL The'following sets forth guidelines about how the staff will apply the fundamental principles of radiation protection in con, sideration of exemptions from regulatory control.
o Justification - Consistent with the linear model for dose and effect, the extent to which a candidate for exemption must be demonstrat as justified is roughly proportional to the dose involved. At ver.y smeril levels of dose (see below), any effort to petition or apply to the Comission for an exemption implies that there is at least some marginal benefit to the practice.
o Dose limits - The dose limit for members of the public specified in 10 CFR Part 20 is 100 mrem per year from all sources of radiation exclusive of natural background radiation and medical exposure.
Although it is possible through analysis to reasonably project what the dose will be from a practice and to take this into account in controlling regulated practices so that dose limits are not exceeded, exemptions imply some degree of loss of control. Therefore, in order DRAFT 06/23/88 BRC POLICY STATEMENT l
~
w-n e
[
4 to provide reasonable' assurance that regulatory decisions regarding exemptions, combined with other sources of radiation, will not cause members of the public to the exceed dose limits, candidates for exemptions should ordinarily not result in an average dose to members of the critical group (the group defined as the indivicalls expected toreceivethegreatestexposurefromthepractice) exceeding 25 mrem per_ year ALARA. The ALARA principle applies to exemptions in the same manner o
at it is applied to other practices which-are subject to regulation.
However, as in the case with justification, the level of effort to-achieve, or to demonstrate achieving ALARA, be_ proportional to the individual and collective dose.
For.v m a ll dose [, Y y effort to achieve or analyze the benefit of further dose reduction is assumed not to be cost-effective.
IV. CATEGORIES OF EXEMPTIONS Given that a_ practice is justified, i.e., there is a-positUre net benefit to the introduction or use of radioactive material, the decision of whether or not-the practice is a candidate for exemption from regulatory controls hinges on the general. question of whether or not such regulatory controls are
-necessary and cost effective in reducing dose. To determine if exemption is appropriate, the Commission must determine if the following conditions are met.
-- / h The imposition of regulatory controls on the practice does not
. result in any reduction in the individual or collective dose received by the critical group and exposed populationg 2, MThe costs of the regulatory controls that could be imposed to reduce the individual and collective dose are not balanced by the benefits of dose reduction that could be realized, s.
DRAFT 06/23/88 BRC POLICY STATEMENT
'yA
)
x f
i
' ' ?
g The Comission believes that a graded approach to exemptions is appropriate in which two_ specific categories of exemptions can be identified, based upon the individual and collective doses that result from the practice. The first
. category encompasses the range of individual dose bylow 25 mrem per year, and
' ~ '
[ -is: termed the range of Below Regulatory Concer[The second category 4 encompasses the range of_ individual dose below I mrem per year, with the-
_ collective dose limited to ~1000 person-rem, and is termed the range of trivial dose.
f In addition to the abov,e categories of exemptions, the Comission recognizes
! ?
g.that there may_ beTircumstances in which practices or certain discrete sources 9]l A
s s-L of radiation exposure could produce doses in excess of Wmrem per year and yet
- T.
M(h" L be a candidate for exemption from regulatory control.N conside
'{
L.
The Commission will h
principles outlined in-this policy statement.
~
SRC i
M
- Establishment of an exemption for a particular practi.ce in the Belm, Nui wry
[ [
Oce-rn range would not necessarily imply that the individual and collective
,. doses would'be considered as trivial by individuals and population involved.
[
However, if the conditions given above are met, then promulgation of an I*
i
~
E exemption is appropriate from a regulatory standpoint because either the A
the degree of risk is too small to justify the burden of additional regulatory t'
( controls, or because there would be little, gain in risk reduction by the additional controls.
In this range, a Wof collective dose is not specified f
[
j3 i
because the collective dose is one of the principle factors in determining if L
' Condition'2 above has been achieved. J~
- 444kM*
N bh;k.
y & M A W C M *~ W
~$
f L h-
- TTela'ngeoftrivialdosehasbeenestablishedonthebasisoflevelsofrisk
[ @ ~ at which individuals are unlikely to take any actions to further reduce their risk. This range of risk has been taken as being on the order of 10-6 to 10~7 ar. The collective dose limitation results from the Comission's belief M
'that trivial levels of risk should imply that the practice will not contribute significantly to the overall risk of death in the exposed population.
L jQv>&s
- W s h lh g
DRAFT 06/23/88
'h' C
MENT g
L{S t
} 72.,. w A / Q = Aje p f J') J.,;
i n
m tr e n fJtg l l1 6-y e
V.-
APPLICATIONS'FOR EXEMPTION An application for exemption,?either as a petition for rulemaking or as a-license application or amendment..must provide a basis upon which the p
q ' Comission can determine if the basic conditions described above have been satisfied..In generai this means that the application should-address the' -
.{( = individual and collective' doses resulting from the expect the exemption, including the uses of the radioactive materials, the pathways gc of exposures, the levels of activity, and the methods and constraints for i
N f k assuring that the assumptions used remain appropriate as the radioactive I materials move from regulatory control to an exempt status.
W
(,
k If a simple assessment indicates that the likely consequences of an exemption O
are individual and collective doses within the trivial dose range, there would gldbgacgptedbythe pa be a high likelihoghgt tJe agagiong'where simplified assessments will
{
Comission[Ne may be cises, howeVer, g
7 k, j indicate the potential for higher individual or collective doses.
In these g yQ cases,_ a more detailed analysis will be required to make a determination on b
for exemption have been met.
J. p] whether the basic conditions 3
b In addition to considerations of expected activities and pathways, the Comission recognizes-that consideration must also-be given to the potential for accidents and misuse of the radioactive materials involved.in the practice.
<%jt
~
~
., An application for exemption must therefore also address the potentials for y
accidents or misuse, and the consequences of these exceptional conditions in
- k.. I
- terms of individual and collective ' dose.
V I '. EXCLUSIONS FROM EXEMPTION,
-[
.i
- ( g As the individual and collective dose from a practice becomes trivial, the Comission expects the justification for the practice will be increasingly based
{
s upon an economic benefit to some individuals. However, these individuals are not necessarily the individuals receiving the radiation exposure. The Comission believes that this is reasonable and acceptable in view of the very DRAFT 06/23/88 BRC POLICY STATEMENT 3
41d. "OAW=
77w.g_- % nF#7,5MY 4-lg A
.c A
--At.,4 % a
- . -s~ = = e T. $ JidFr~u'"9
-=
j _p
. {' l lll
~;)[
uJAd'W l
small levels of dose and risk involved. However, there are some types of practices involving radiation or radioactive materials which are, prima facie, y
socially unacceptable regardless of how trivial the resulting dose might be.
(
These practices would not be candidates for exemption, and would, for example, include radioactive material introduction into children's toys, products intended for ingestion, inhalation or direct application to the skin, and
%g ud.,,M~&er products for 6c pm pA Mey.fMM P,'0' prci.;t--
gonsum ef etteinir-h-i"^d t" 1-,....m-..y In a dition, the pa...... frivolous in6oduction of
}
m eg. A.
= ' = = -..
c-r radioactive material when there are clear, economical alternatives to the use N
of radionuclides is generally not justified because there is no unique benefit from using the radioactive materials.
VII. APPLICATION OF COLLECTIVE DOSE ASSESSMENT 2
9 As noted above, a monetary value can be assigned to the collective dose so that quantitative assessments can be made of the costs and benefits of l
l regulatory controls.
In assigning values to collectiye dose, a value of $ 1,000 p
5 gthe Comission,'e de5.1;;;is sa j
perperson-remhasbeenusedpre o
tha orde" of 5 rer per jar essenei.ed wd10 CFR Part 50, Appendix INore recently, the International Atomic Energy Agency has published guidelines on the valuation of collective dose on an international level. These guidelines y
contain a value $ 35 per person-rem. The Comission believes that an appropriate valuation of collective dose can be obtained through t,he~g K
application of different valugny for different levels of dos { consistent o
i withthelineardose-effecthgethdis.ETherefore,collectivedoseassessments I
J s
))
for exemption may be assigned a monetary cost as follows:
t o
$ 1,000 per person-rem for collective dose composed of individual y
doses in excess of 1 mrem.
Q[f o
$ 35 per person-rem for collective dose composed of Individual doses D
' 'j in the range of 1 mrem to 0.1 mrem.
M
- z. -n o
4-O per person-rem for collective dose composed of individual doses J
below 0.1 mrem per year.
)I
. DRAFT 06/23/88 BRC POLICY STATEMENT
^
+
i.
ill r
Y
/W 6
The valuation of $ 0 per person-rem for individual doses b low 0.1 mrem per.
year reflects the risk associated with these very small leve of dose. At.
this level, anl individual's lifetime risk would approach 10-6
,j,y,),g which no actions are typically taken by Federal Agencies to further reduce or M"M" control the lifetime risk. N '.5/=* V "~ F VA ^ = =. " #
14 n-
. y. = m ='J4 -
!. ' pm.. m, y m (III.-
VERIFICATION OF EXEMPTION' CONDITIONS The Commission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic conditions under which an exemption was issued remain valid.
In most cases, the products or materials comprising an exempted practice will movo from regulatory control to the exempt status under a defined set of conditions and criteria. The monitoring and verification program must, therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being complied with during routine activities.; Th; Ow..niaaivii'
..............,71= waceaoi nty una inter.0; te develop ana propose r.
compi1...;; prere pMer -ts Ti..lizatier, of J.ie i I statement.
' ' ' " WW h h,_ _, :, _ _ &(-
r A%g4. A,y * ~ - ~ - A '-
Q. it -n JL =, MK-mz i.-enx s a, 4&g&~ : y. gik C m.v==
&&9' ypp~w rA DRAFT 06/23/88 BRC POLICY STATEMENT
U a
4 o
L Draft 11 6/24/88-Policy Statement Exemption of. Radioactive Materials from Regulatory Control I.
INTRODUCTION AND PURPOSE Over the past several years, the Comission has become increasingly aware of the need to provide a' general policy on the appropriate criteria for release a
of radioactive materials from regulatory control.
To address this need, the Commission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10, Code of-Federal Regulations)'and policy statements (30 FR 3462, dated March 16,1965; 47 FR 57446, dated December 27, 1982; and 51 FR 30839, dated August 29,1986) by providing an explicit policy on the exemption from regulatory control of practices.whose public health and safety impacts are below regulatory concern.
- The purpose of'this policy statement is to clearly establish the regulatory basis upon which the Comission may initiate the development of appropriate
. regulations.to exempt from regulatory control certain radioactive material and persons who: receive, possess, use, transfer, own, or acquire this material.
This policy is directed specifically toward petitions for rulemaking, license amendments, and license applications involving the release or distribution licensed radioactive material either to persons not subject to Comission regulation as currently defined in 10 CFR Parts 30, 40 and 70, or to 'the
- environmen' t.
The concept of exemption from regulatory requirements is not new.
For
-example, tab es of exempt quantities and concentrations for radioactive l
material-were d rined in 1970 which a person could receive, possess, use, transfer, own, or acquire without a requirement for a license. Other exemptions allowing distribution of consumer products or other devices, or releases of radioactive material, have been embodied in the Commission's regulat. ions for some time. More recently, the Low Level Waste Policy Amendments Act of 1985 directed the Commission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the CRAFT 06/23/88 BRC POLICY STATEMENT
.t
. disposal of slightly contaminated radioactive waste material that the Commission determined to be below regulatory concern.- The Comission responded to this legislation by issuing a policy statement in August,1986 (51FR30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow-the Commission to act expeditiously in proposing appropriate regulatory relief on a
" practice-specific" Lasis consistent with.the merits of the petition.
The Commission believes that these " practice-specific" exemptions should be L
encompassed within a broader'NRC policy which defines levels of radiation L
risk, including individual dose benchmarks for radiation exposure, below which specified practices would not require NRC regulation based on public health and safety' interests.
For such exempted practices, the Comissions regulatory involvement could therefore be essentially limited to the inspection and compliance activities associated with the transfer of the radioactive material from a regulated to an exempt status.
L II.
RADIATION PROTECTION PRINCIPLES
.The Commission subscribes to three fundamental principles of radiation protection in. formulating its policies and regulations to protect workers and the public from the harmful effects of radiation.
They are 1) justification of the practice, which requires that there be some net benefit resulting from the use of radiation or radioactive materials, 2) dose limits, which define the
~
upper boundary of dose which must not be exceeded in the conduct of nuclear activities, and -3) ALARA, which requires that radiation dose below the limits be as low as reasonably achievable, economic and social factors being taken p
into account. The term, ALARA, is an acronym for As Low As Reasonably Achievable.
For the purpose of establishing the health risk associated with its regulatory policies, the Consnission also subscribes to the linear model for dose and effect.
The hypotheses upon which the linear model is based assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose.
regardless of the size of the dose.
In subscribing to this hypothesis, the Commission recognizes that it is a functional model based upon data collected at relatively high doses and dose rates which is then extrapolated to the low DRAFT 06/23/88 BRC POLICY STATEMENT
r,.
.4a 1
- Document'Name:l BRC POLICY STATEMENT:
9-Requestor's ID:.
ESTEP
' Author's Name:
in Cool, Donald A.
~ Document Cements:-
Policy Statement on BRC and De minimis - NMSS. draft psolm.n.
r-kT
dose and dose rate region where there are no statistically reliable data available.
It is generally believed that the use of the linear model provides a conservative basis for planning purposes.
Although not a principle of radiation protection, collective dose provides a useful way to express the impact of a nuclear activity on health of the population subject to radiation exposure.
Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure.
By assigning collective' dose a monetary value, it can be use,d in cost benefit analysis and other quantitative analysis techniques.
It isN important factor to consider in balancing benefits and consequences for justification of a practice and determining if radiation doses are ALARA.
III. APPLICATION OF RADIATION ~ PRINCIPLES TO EXEMPTION FROM REGULATORY CONTROL The following sets forth guidelines about how the staff will apply the fundamental principles of radiation protection in consideration of. exemptions from regulatory control.
o Justification - Consistent with the linear model for dose and effect, the extent to which a candidate for exemption must be demonstrated as justified is roughly proportional to the dose involved. At trivial levels of dose (see below), any effort to petition or apply to the Conunission for an exemption implies that there is at least some marginal benefit to the practice, o
Dose limits - The dose limit for members of the public specified in 10 CFR Part 20 is 100 mrem per year from all sources of radiation exclusive of natural background radiation and medical exposure.
Although it is possible through analysis to reasonably project what the dose will be from a practice and to take this into account in controlling regulated practices so that dose limits are not exceeded, exemptions imply some degree of loss of control. Therefore, in order DRAFT 06/23/88 BRC POLICY STATEMENT
y
-l to provide reasonable assurance that regulatory decisions regarding exempti.ons, combined with other sources of radiation, will not cause members of the public to the-exceed dose limits, candidates for-exemptions should ordinarily not result in an average dose to members of the critical group (the group defined as the individuals expected to receive the greatest exposure from.the practice) exceeding-25 mrem per year ALARA - The ALARA principle applies to exemptions in the same manner o
at it is applied to-other practices which are subject to regulation.
However, as in the case with justification, the level'of effort to achieve, or to demonstrate achieving ALARA, will be proportional to the-individual and collective dose.
For trivial doses (see below) any effort to achieve or analyze the benefit of further dose reduction
~
is assumed not to be cost-effective.
IV. CATEGORIES OF EXEMPTIONS est L /dela s
. cn a Edven-.tAat a practice is justified, i.e., there is a positive net benefit to -
j the introduction or use of radioactive material, the decision of whether or not the practice is a candidate for exemption from regulatory controls hinges on the general question of whether or not'such regulatory controls are nueshiry and ccst effective in reducing dese; To rietemine if exemption is appropriate, the Commission must determine if the following conditions are met.
1.
The imposition of regulatory controls on the practice does not result in any reduction-in the individual-or collective dose received by the critical group and exposed population or; 2.
The costs of the regulatory controls that could be imposed to reduce the individual and collective dose are not balanced by the benefits of dose reduction that could be realized.
DRAFT 06/23/88 BRC POLICY STATEMENT
N.
Y
' i x
.]
The Commission believes that a graded approach to exemptions is appropriate in l
which two specific categories of exemptions can be identified, based upon the
-individual.and collective doses that result from the practice. The first category encompasses the range of individual dose below 25 mrem per year, and is temed the range of Below Regulatory Concern (BRC). The second category encompasses the range of individual dose below I mrem per year, with the
. collective dose limited to 1000 person-rem, and is termed the range of
. trivial dose.
In addition to the above categories of exemptions, the Consnission recognizes-that there may be unusual circumstances in which practices or certain discrete sources of radiation exposure could produce doses in excess of 25 mrem per year and yet be a candidate for exemption from regulatory control. The L
Commission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement.
Establishment of an exemption for a particular practice in the BRC range would not necessarily imply that the individual and collective doses would be considered as trivial by individuals and population involved. However, if the conditions given above are met, then promulgation of an exemption is appropriate from a regulatory standpoint because either the the degree of risk is too small L
to justify the burden of additional regulatory controls, or because there would l
be little gain in risk reduction by the additional controls.
In this range, a l
limit of collective dose is not specified because the collective dose is one of the principle factors in determining if Condition 2 above has been achieved.
l In many instances, the collective dose will be proportional to both the extent to which an exempt practice to utilized and the resulting benefits.
For example, the use of smoke detectors containing radioactive sources in houses is known to save lives.
Both the number of lives saved and the collective dose will increase proportionally to the number of smoke detectors used.
The range of trivial dose has been established on the basis of levels of risk at which individuals are unlikely to take any actions to further reduce their This range of risk has been taken as being on the order of 1Y risk.
- 7 to 10 per year. The 1 mrem per year trivial dose represents a risk at the lower ended of this range.
DRAFT 06/23/88 BRC POLICY STATEMENT
k 4
I
. ~..
,e; r
=
4
[-
. d.
a. -vr. :. s,~.I 'le
... i; t w
-~
e-w A
e * * ' ** 15 Yl l'
- ~
- g5 [J
,*,. 4 ise f _' f s '
- f. '. *!~*!
E*
~
,,,n.,, r,., e
- 42.,
- '.(
/t:. (.
t r.,,
TL ll. c a < <.'y
- < t
//
Il<
. t ' < I' O'r l,. -
~!... '.. <t.'ll?
YS' f a * *+
.'+
2,u r o
,: c: t et o..e la r.eu,
. t's L e r s't
- l' o
p i s dte r i;
f a t. ** lu. * *
- e.
//r <*
Al.At.'A Jcr.*<'OT':.4 Or t "
c ! '
$t er $.1 it'* ll Y***C'_, ** lCf l t. 4
.ft l f + f f I 4 f.
'I' Y
.l'
- i
?
5' E*
'f gla f rat svt..It, C ' letts.le'
. p' Y K:i
- il f
f s CE.' i J
Yb G sr.o.s. : r.It it'Cr <to nl
.tueA ti f f' 'l U I<lt. s it't ( '
' f! ; * * * '
'?A '
'.(c ;t,. w..
w Tro c,
.ZG
.< c *. cit. Yc te t aft <<(<NJ Ab
\\ 7 LNe
'Yf
/'*Y
/<M Ui'l
' 1..
l ' I " '
~~
a pp t e., e i is.c n.< u h !
ie'o Ad(C4 41 iC C f (;
l'tt s f IC.
k f
.m
['
g f >,7
[ The lower end of the.rangmis chosen to compensate for the possibility that.
an individual might receive dose from multiple practices exempted on the basis that each represents a trivial dose. The collective dose limitation
- rasults from the Commission's belief that trivial levels of risk should imply
. that the practice will not contribute significantly to'the overall risk of.
death in the exposed population.
.V.'
APPLICATIONS FOR EXEMPTION-An application for exemption, either as a petition for-rulemaking or as a license application or amendment, must provide a basis upon which the Commission can determine if the basic conditions described above have been.
""~
satisfied. 'In general this means that the application should address the g
. individual and collective doses resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways
'of exposures, the levels of activity, and the methods and constraints for assuring that the assumptions used renain appropriate as the radioactive materials move from regulatory control-to an exempt status.
If a petition for an exempt practice results in the promulgation of.a rule
- y, Y which specifies the conditions under which the exemption is authorized,
' 'I j persons-applying for licenses to utilize the exemptions do not need to J
address justification or ALARA. The Comission decision on such applications will be based on meeting the specificatiofin the rule.
This is consistent t-
' yJj, past-practice; e.g..' consumer product rules in 10 CFR 30.
If a simple assessment indicates that the likely consequences of an exemption are individual and collective doses within the trivial dose range, there would be a high likelihood that the application would be accepted by the Comission without detailed analysis related to justification or ALARA. There may be cases,- however, where simplified assessmentsjwhich typically use
' conservative assumptions for bounding condition 3 will indicate the potential for higher individual or collective doses.
In these cases, a more detailed analysis will be required to make a determination on whether the basic conditions for a trivial dose exemption have been met.
DRAFT 06/23/88 BRC POLICY STATEMENT
- - ' - = - - - -'
.e
.x
,y,
'In addition to considerations of expected activities and ' pathways, the Comission recognizes that consideration must also-be given to_ the potential for accidents and misuse of the. radioactive materials involved in the practice.
'An application for exemption must therefore also address the potentials for accidents or misuse, and the consequences'of these exceptional conditions in terms of individual and collective dose.
'VI. EXCLUSIONS FROM-EXEMPTION-As'the individualiand collective dose from a practice becomes trivial, the Commission expects the justification for the practice will be increasingly based upon an economic benefit to some individuals. However, these individuals are
. not'necessarily the individuals receiving the radiation exposure. The
- Comission believes that this is reasonable and acceptable in view of the very small levels of dose and risk involved. However, there are some types of practices involving radiation or radioactive materials which are, prima facie, socially unacceptable regardless of how trivial the resulting dose might be.
These: practices would not be candidates for exemption,' and would, for example, include radioactive material introduction into children's toys, products intended for ingestion, inhalation or direct application to the skin, and consumer products for certain identification purpose e.g., the use of radio-active labels to prevent theft or shoplifting.
In addition, the purposeful orL frivolous introduction of radioactive material when there are clear, economical alternatives to the use of radionuclides is generally not justified because there is no unique benefit from using the radioactive materials.
VII. APPLICATION OF COLLECTIVE DOSE ASSESSMENT As noted above, a monetary value can be assigned to the collective dose so that quantitative assessments can be made of the costs and benefits of regulatory controls.
In assigning values to collective dose, a value of $ 1,000 per person-rem has been used previously by the Comission.
It was first used in 10 CFR Part 50, Appendix I for determination of ALARA below Smrem per year.
DRAFT 06/23/88 BRC POLICY STATEMENT II l
llia aie
t 8-i.
The Commission recognizes, however, that the more universal application of the
$1000 per person rem, when applied to summation of doses consisting trivial individual risk for purposes of determining ALARA, can in some instances result in undue expenditure of resources which might better be applied to other uses.
~
More recently, the International Atomic Energy Agency has published guidelines on-the valuation of, collective dose on an international level. These guidelines contain a value $ 35 per person-rem. The Comission believes that an appropriate valuation of collective dose can be obtained through the application of different valuations for different levels of dose or individual risk', consistent with the linear dose-effect model. This is also consistent with the " economic and social factors being taken into account" portion of the ALARA principle. Therefore, collective dose assessments for exemption may be assigned a monetary cost as follows:
$ 1,000 per person-rem for collective dose composed of individual o
doses in excess of 1 mrem.
$ 35 per person-rem for collective dose composed of individual doses o
in the range of 1 mrem to 0.1 mrem, Zero dollars per person-rem for collective dose composed of individual o
doses below 0.1 mrem per year.
The valuation of $ 0 per person-rem for individual doses below 0.1 mrem per year reflects the[rk5'k Nsociated with these very small levels of dose. At this level, an individual's lifetime risk would approach 10-6 if exposed at this level throughout an entire lifetime; a level at which no actions are typically taken by Federal Agencies to further reduce or control the lifetime risk. The 0.1 mrem per year dose is well within the variation of background radiation persons living in any given community would receive due to personal routines or living conditions.
DRAFT 06/23/88 BRC POLICY STATEMENT
9 VIII.
VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implenentation of an exemption under this broad policy guidance must be accompanieo by a suitable program to monitor and-
_g verity that the basic' conditions under which an exemption was issued remain valid.
In most cases, the products or materials comprising an exempted practice will move from regulatory control to the exempt status under a defined set of conditions and criteria. The monitoring and verification program must, therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being complied with during routine activities. The Commission will determine complitnte with the specific conditions of an exemption through its established licensing and inspection program and will, from time to time, conduct, studies as appropriate to assess the impact of an exempted practice or combinations of exempted practices.
?
I DRAFT 06/23/88 BRC POLICY STATEMENT
, +-.
+
~
4.,
fa pc
~
9 '_
T-w% '
M 5
y Y
, 7L,=- N-Ik & WMfQ &
Q
-f t & ~ w 4. x s ; r s n+ s A -
2 u
y
[-
w M d4; J
^ '
p xW~% +5 *
,W-qv A,&sw r,.4 es r
L l
& A % n r,7 a d 4 r f f M A A
& 6.f & W :-X tag 4 f t49 9 94 1958
{^
te gigilkI'j}30Il0E lh $l 0 e
\\$se: '- " &
,f Y
h*
7 l
W,Y7 W&y =,4 n d ny-s 7G. MQm-A.A ~ pn G~ 4 J y
x-an=, ass 4a,u~,. +n :
A f4 -SQ P Y %L 2
e
% a.ta, s p na 2 M A & & f J W., K
$p!Av=$
1, Magd= D. y - - C, J
p p
n a.
.s a
s
'4('
r.
(
.q
., e r
g
. );
- ~, -
- 4
' 's.
' l I
N
^
~
e
}
aj._
^
M k
Ay '
F
-i j.
~ [ [
't 1
A6c. /~
Mm M-h M
i I
t 0
9 4
9 58s t (.64 %d 4 49 8446l t e sti tlt 41I' g sli tite ly lg p i. l l
l
'l 4
1 l
l I.
i l
l t
i c
ll' I
i
0W y'
f)
(p. l.sAA
'a gM 6-l.7 4 l'sio n STATEMENT OF POLICY G ** w n s
- se Mpadw yew d wh p gdw 4
wan,6 is e.wpestm, dere Asd spees.r, se r= 4=s/cd de dearly e v ~ ~P *
- 0,a.
- ' #*N g I.5.,fuating requI.i. s..p 6094 9..,dA Yht G***'J! '* **** '.*s*
si t h. r,ese he e o ~ ~.- ~..
.- ~ ~
+.
stafor,,exemptionf of practices from regulatory control, the
<* M.
e n eva
- 4. gpf w t
Commission will =cw.aws int:i
- M u r d the basic principles of radiation protection
justification of a practice, optimization of protection and 3
limitation of individual risk. The Commission will also cor.tinue to assume, for the purpose of radiation protection, that the, health detriment 3[m..W s'A a.3......doa e-d ses W c'$ ' O
- W
.. A.. 4.J A
proportional to the, collective dose comitment ***4f* Ad'h -
f The smaller the projected doses for a given practice, the less the need for regulatory controls.
For practices where the projected doses are extreme'.y small, even the cost of rigorous analysis on which to base an exemption decision may not be warranted. Thus, a lessening in the degree to which justification and optimization must be shown can be allowed for practices involving lower individual and collective doses.
Demonstration of projected doses is always important. However, the degree of rigor necessary in a dose analysis and the degree of conservatism may vary depending on the magnitude of the doses and the uncertainty inherent in the analysis. Other than balancing conservatism with the degree of uncertainty, consistency in the degree of conservatism is important to consistency in the application of cost-benefit analysis. - ven though a rigorous cost-benefit
< e s.~g
,q analysis normally involves use of a persun-rem [vaIue,,thereareoften
~
<h p4, ~
factors involved in weh-e decisionsthat are difficult or impossible to quantify,whichmustn$$e-the-lessbeconsidered.
06/23/88 1
STATEMENT OF POLICY
m
\\,:r g
o t
- V v
1
,;q.
p-For practices proposed for exemption from regulatory control for which j
individual dotus to the public are likely to exceed 10 mrem / year, a detail.J cost-beneMt analysis will always be required which must show that the practice t
J is justified and the exemption as proposed will ensure that exposures are as i
low as is reasonably achievable. This would also be the case for any' proposed i
action for which a findin0 of no significant impact to the envirotisent cannot ~
t.
.,.,w h.t n..y is as. A., s e, be made, since NEPA, =>'r: ::t; would necessitate an Els.
In performing any cost-benefit analysis, individual doses below 0.1 mrem / year l
nay be omitted from collective dose calculation, as such doses are considered trivial to the individual.
L l
l-l 6
k h
06/23/88 2
STATEMENT OF POLICY
.. y
mux
~..,
(k;. .
l i
,3.lf individual doses to members of the public from a practice proposed for j
w g
1 pexemption are.unlikely to exceed 10mrem / year, a cost-benefit analysis is required but may be.less rigorous depending on how clearcut the justification or appropriate criteria for optimitations' appear. An analysis of a)ternatives m o.
)
to the proposed practice will not be required. However, any. reduction of c'
effort in showing justification or optimization can only be allowed if a finding of no significant impact to the environment can be made; otherwise, s i
j
. 4.'s full Els would be required by kERA.
P l
I 9
9 h
?
A s
06/23/88 3
STATEMENT OF POLICY
1 :.
l
[ :,
l,.
If individual doses, f rom a practice proposed for exetption are unlikely to j
exceed 1 mrem / year and the collective dose commitment is unlikely to exceed a
1000 person rem / year, it is not necessary to perform a rigorous cost-benefit analysis. Justification may be shown through a relatively cursory non-qualitative evaluation of general benefits. Even at this very low level of risk, however, it is not possible to give a blanket approval to any
. practice which meets the criteria. Factors other than projected doses to the public will be considered in determining whether a practice is acceptable far exemption. Although it would generally be assumed that a de facto benefit exists for practices which are proposed for exemption, the benefit from the useofradioactifematerialusedintoys, novelties,andadornmentsis generally considered marginal. Approval of such items would require a closer look at the cost / benefit and specifically the degree of usefulness of the proposed product.
9 4
STATEMENT OF POLICY 06/23/88
hg 4kh $$
l' q w.c a gn 6 t / &
t.!s5 f.
DRAFT Proposed Comission Po" " on Regulatory Control Exemptions for Practices Whose Public Health.ad Sa#,y Impacts are Below Regulatory Concern.
, 1.
PROPOSED
SUMMARY
STATEMENT OF POLICY
- 11. POLICY STATEMENT RATIONALE A.
Introduction and Purpose
' Over the last several years, the Comission has become' increasingly aware of the need to provide a more explicit policy on the subject of appropriate radioactivity control standards for release or distribution of radioactive materials.
In particular, the Comission has noted the varying, but often large, expenditures of resources which are directed at protecting the public from man-made sources of radiation that represent small or even negligible health risks. To address this concern, the Comission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10. Code of Federal Regulations) and policy statements (30 FR 3462, dated March 16, 1965; 47 FR 57446, dated December 27, 1982) and 51 FR 30839, dated August 29, 19B6).
8 The purpose of this policy statement is to clearly estaWish the er'".:7
. basis upon which the Comission may initiate the development of appropriate 06/27/88 1
BRO O POLICY STATEMENT
a regulations to exempt from regulatory control certain radioactive materit h and persons who receive, posses, use, trentfer,-own or acquire this material. This policy is directed specifically toward petitions for rulemaking, license amendments and license applications involving the release er. distribution of licensed radioactive material either to persons not subject to Commission regulation as currently defined in 10 CFR Parts 30, 40, 50, and 70, or to the environment.
~* '
The concept of regulatory exemptions is not new. For example, in 1965 end 1970, tables of exempt quantities and concentrations for radioactive material were defined which a person could receive, possess, use, transfer, own, or acquire without a requirement for a license (30 FR 8185 and 35 FR 6427). Other exemptions allowing distribution of consumer products or other devices and releases of radioactive material have been embodied in. Commission regulations for some time and occasionally have been included in license conditions. More recently, in the Low Level Waste Policy Amendments Act of 1985, the Congress directed the Nuclear Regulatory Commission to develop standards and procedures for expeditious handling of petitions to exempt from NRC regulation disposal of slightly contaminated radioactive waste material that the Commission determined to be below regulatory concern. The Commission responded to this legislation by issuing a policy statement in August 1986(51FR30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Commission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific
- basis consistent with the merits of the petition.
]
06/27/88 2
BROAD POLICY STATEMENT f
_=-__
i k
The Comission believes that these " practice specific" exemptions should be enveloped within a broader NRC policy which will define levels of radiation risk, including individuel dose benchmarks of radiation exposure, below which specified practices would not reouire NRC regulation based on public health and safety interests.
Below these levels, the public radiation protection benefit from further application of the "as-low-as reasonably achievable" (ALARA) principle is not justified, and the extent of regulatory involvement can be essentially limited to inspection and compliance activities. The inspection 5.
and compliance involvement would generally be directed at licensee activities.
l including potentially imposed recordkeeping and reporting requirements, associated with the transfer of the radioactive material from a controlled to an exempt status.
B.
A Sumery of the Principles of the Existing Dese l. imitation System The Commission's overall system for limiting public exposure to radiation consists of three basic elements:
(1) justification of the practice or activity, i.e. assuring that there is some net benefit to be gained from the i
proposed use or disposition of the radioactive material. (2) regulatory dose limits, which establish maximum permissible doses for individual members of the l
public and (3) the ALARA concept, which assures reduction and acceptable l
I distribution of individual doses beneath these limits taking into account i
economic and societal impact factors.
The 10 CFR Part 20 unrestricted area and environmental dose limits, establish the boundary between allowable and unacceptable exposures to individual members of the public. This limit provides a perspective from which the individual 06/27/88 3
BROAD POLICY STATEPENT
p.
l dose and risk benchmarks for exemption can be compared. The revision of 10 CFR Part 20, currently under preparation, establishes an annual exposure limit for members of the public of 100 millirems / year from any licensed activity.. By. reference, 10 CFR Part 20 also subjects licensees engaged in fuel cycle operations to the more restrictive provisions of 40 CFR Part 190.
As the dose from a practice or activity decreases, the controls necessary to limit radiation exposure can be reduced while maintaining an assurance that the resulting risk remains acceptable.
For purposes of establishing radiatior,.
-u protection regulations, the Comission accepts the linear hypothesis as a prudent planning basis for estimating the bounding potential health effects as i
a function of the magnitude of radiation dose.
In doing so, the Commission recognizes that this functional model is based upon data collected at relatively high dose levels which is extrapolated to the low dose and low dose rate region where there is no directly-supporting statistically significant experimental or epidemiological data. This functional model is applicable only ce u.4 *S A 8
to radiation effects, stochastic in nature (i.e., cancer induction).
At the lower and of the ALARA region of dose, below the existing upper-bound dose limits for individual exposure, the concept of below regulatory concern (BRC)comesintoplay. This concept can be and has been used to justify exemptions from regulatory control. BRC connotes a level of risk or dose that
' either may be justified in relation to some societal benefit achieved or may be considered trivial from a regulatory standpoint, in tems of public health and safety significance.
- 06/27/88 4
BROAD POLICY STATEMENT
L i
i L.
i
'The definition of existing exemptions for a particular activity or practice has l
4 been viewed by the Comission as a step-wise process in which consideration is first given to whether or not the activity or practice is justified.
If justified, the individual and collective doses or risks attendant to,the exemption are evaluated to determine if a reduction or eliminatiun in regulatory controls is warranted.
For the exemptions contained in existing i
regulations, the Comission believes that its actions have reflected an ad hoc j
correlation between.the risks of radiation exposure that could be delivered by an activity or practice, and the necessity for regulatory controls on that j
4 activity or practice.
t C.
The Basic Approach to a Broad-Based Reculatory Exemption Policy l
The Comission, in this policy statement, is expanding upon its existing system l
of radiation protection to specifically incorporate a feature which, to date, g
L has been applied in a piecemeal fashion.
l feature involves the establishment of regions of radiation risk, including-individual dose benchmarks, below which the Comission believes that the need for further NRC regulation is a function of the magnitude of the risk and the l
L benefit of the exempted practice. The intent of the individual dose benchmarks is to define a " graded approach" from which the Commission believes that specific exemptions (referred to as below regulatory concern or BRC positions) can be developed, formulated and implemented. These BRC positions would include the definition of reasonable and prudent conditions under which the radioactive material may be authorized for release or distribution with no further need for NRC regulatory controls.
06/27/88 5
BROAD POLICY STATEMENT
lllal
....l
- e,,
for the Definition of Individual Dese Benchmarks x
D.
Principles Applicable to $0ecific BRC Deteminations The underlying principles of radiation protection applicable to exemption policy include the recognition that all deliberate radiation exposures should bejustified. Recogniring the existence of the 10 CFR Part 20 upper bound limit for individual exposure, it is evident that exposures which fall below this bound should be justified in proportion to their value or societal As a basis for proportional justification for any exemption-related benefit.
exposure, the Comission believes that continued acceptance.of the linear But as lower levels non-threshold hypothesis is a prudent regulatory posture.
of radiation exposure are projected, the lower levels of degrees of justification open the possibility of simpler, less rigorous evaluation, and even the possibility of sumary judgements on simple beses at suitably low This reduction in rigor of justification, in due levels of radiation exposure.
proportion to the lower level of exposure envisioned, is entirely consonant with reliance on the linear non-threshold hypothesis.
The concept of a risk or radiation exposure cutoff or threshold may also be consistent with regulation based on the linear hypothesis. The linear hypothesis simply equates the risk of a stochastic effect to radiation exposure in some proportion to the level of that exposure, even down to the smallest The use of risk or exposure cutoffs does not have to be based on an exposure.
t.ssertion that there is no biological damage or no risk at exposure levels below that cutoff. Rather, a cutoff can be based on the argument that the admitted risk entailed at exposure levels below the cutoff is so low in 6
BROAD POLICY STATEME14T
'06/27/88 i
n 1
.[
I comparison to every day risk as to be beneath any reasonable threshold of concarn.
E.
Def'inition of Individual Dose Benchmarks Applicable to BRC Positions The Comission believes that projections of individual and collective dose can be used, within a graded approach, to determine if a specific practice should be exempted from regulatory control. The Commission believes that the graded 4
. approach can be characterized through use of three regiodofradiationrisk l-including individual dose benchmarks. The benchmarks define ranges of individual dose as follows:
i (1) The range from the applicable upper-bound limit for the specific practice down to 10 mrem per year, (2) the range below 10 mrem per year, and, as a subset of this second
- range, 1
(3) the range below I mrem per year.
Each range of individual dose is associated with'a specific collective dose consideration. The Commission considers it appropriate, in this context, to use a maximum or limiting basis for calculating individual dose and a realistic i
average basis for calculatir.g collective dose.. In both cases, the lifetime dose comitment of annual exposure to the practice proposed for exemption y
should be used.
7 BROAD POLICY STATEMENT 06/27/88-w
- w
.m y
se- - - -
e.e-
.=,
e.m.
- m a
---u.
l i
i The first two of these ranges of interesti namely, (1) upper-bound limits down to 10 mrem per year, and (2) below 10 mrem per year, cover those practices J
where the justification of projected exposure associated with the practice to be exempted must be proportionally considered against the societal costs including the impacts of both individual and collective dose. The third range, l
below 1 mrem per year, enters a regime where sumary disposition or acceptance of the practice can be possible based on the simplest considerations of justification for both individual and collective dose.
h.
1.
Greater than 10 mrem per year but less than applicable upper bound limits i
Individual exposures greater than 10 mrem effective dose equivalent per year i
from a defined practice or class of practice may be justified within a specific I
below regulatory concern position. For practices invo1ving individual doses in f'
this range to be exempt from regulatory control, it must be demonstrated that I
optimization of protection has been achieved for the specific practice or class of practice under consideration. As a part of this optimization process, co11cetive dose must be evaluated and the cost of imposition of additional regulatory requirements prior to the transfer of the radioactive material from regulatory control to exempt status must be balanced against achieved V
reductions in risks. Theflower bound of this range represents a value which t
is 1/10 of the dose limit recommended for members of the public in 10 CFR Part
- 20. Based on risk coefficients estimated for annual dose rates 50 times greater (1000 mrem / year), the corresponding risk of inducing lethal cancer l
would be somewhat greater than 10-6 per year.
06/27/88 8
BROAD POLICY STATEMENT
i e
In collective dose calculations, individual doses less than 0.1 prem per year j
I may be neglected. The 0.1 mrem individual dose cutoff for collective dose i
assessments was selected on the basis that, if risk coefficients derived for j
sooneem V
higher dose levels (4-eem/ year) are conservatively extrapolated downward to this dose, en individua 's lifetime risk woule approach 10-6, 2.
Less than 10 mrem per year Individual exposures less than 10 mrem effective dose equivalent per year, resulting from a defined practice or class of practice, can be considered small and, if.the practice is subject to minimal constraints, a strong argument for exemption from regulatory control could be made. The upper bound value of this range has been previously characterized.
Individual doses in this range, if they are the result of exposures received through the direct or inhalation pathways,_would not be inconsistent with existing regulations (e.g., 40 CFR 190 and 191, and the Clear Air Act). Exemption positions involving individual doses in this range should be supported by assessments which provide reasonable i
assurance that:
(1) the individual dose goal (10 mrem per year) will not be exceeded and (2) the societal benefit of the practice justifies the applicable collective dose. As in the upper range, the 0.1 mrem individual dose cutoff for collective dose assessments can be utilized.
Below 1 mrem per year with a specific 1.000 person-rem / year collective 3.
dose constraint The Comission believes that from an individual risk standpoint, individual doses which do not exceed a few millirems per year can reasonably be candidates
=06/27/88 9
BROAD POLICY STATEMENT
.,.a
k for exempting a practice from regulatory control. Any number within the general range of a'few millirem per year could be selected as the lowest of the specific benchmarks to be considered within the graded approach. The Commission, however, is cognizant of other authorities and regulatians which impact on exemption policies; specifically, the individual dose limit of 4 mrems per year included in the Environmental Protection Agency's safe Drinking Water Act and being considered as a below regulatory concern level (applicable to waste stream disposal at other than low level waste facilities) in proposed 40 CFR 193. The Comission believes that a practice should be a strong candidate for exemption from regulatory control if individual exposures resulting from the source or practice are limited to an annual dose of less than 1 mrem effective dose equivalent.
If risk coefficients, derived for exposures greater than 2000 mrem / year, have validity at this low level of dose, 4
the corresponding risk of inducing lethal cancer would be less than 10 per year - a risk considered trivial by many regulatory bodies and one which is held to be of no concern to the individual.
Within the context of the graded approach # tH: r"ty, as discussed in 4
Section h, the Comission believes a collective dose constraint of 1,000 person rem can be applied to this lowest individual dose benchmark. This constraint also serves two other purposes:
(1) to emphasize that this policy is not defining a level of de minimis or negligible individual risk but is directed toward BRC determinations and (2) to provide reasonable assurance, given current and expected near-term practices, that, when coupled with 1 mrem per year individual dose benchmark, individual doses are very unlikely to approach any existing public protection dose limit as a result of multiple exposures to distributed radioactive material (e.g., consumer products). The l
06/27/88 10 BROAD POLICY STATEMENT
,7 y
q i
j selected collective dose value of 1,000 person-rem per year is applicable to J
each source or practice applying for exemption in this lowest range within the graded approach.
If risk' coefficients are presumed to be valid at low levels j
of-dose, the collective dose constraint would limit the stochastic prediction of latent cancer fatalities to less than unity for any specific practice. The Comission believes that this 1,000 person-rem value represents an j
insignificant collective risk.
5.
The Comission believes, however, that even with this graded approach, there are certain practices which are prima facia socially unacceptable and, therefore, unacceptable candidates for exemption from regulatory control.
These practices would be disallowed, not only on the basis of their lack of benefit vis-a-vis their small public health and safety significance, but also I
on the principle that the unjustified widespread dispersal of radioactive i
material can have potential economic or other impacts. Examples of unacceptable practices involve, but are not limited to, radionuclide introduction into: a) childrens toys, b) products intended for ingestion, inhalation or direct application to the skin, and c) Jer radioluminous M_peaav e
.y O,
A i
l
.L.,,,c e m.t
- m.== =p e Pw r ea.
product containers or packages, and posters den enjoyment / The exemption L
policies defined in this statement will not be applied to these or similar
' frivolous practices, i
F.
Preparation of BRC Positions and Administration of Exemotions In' general, the methodologies to develop BRC positions will be based on assessments of individual and collective doses that may arise from a specific n4..: %
practice or class of practice. The ht:-5th of practice must assure that:
06/27/88 11 BROAD POLICY STATEMENT
l (1) unacceptable amounts of radioactive material from licensed activities are not permitted to enter the environment due to unreasonable dilution or
?
fractionalizationpractices,(2)alllicensedpracticesorsourcesusing radioactivity or radioactive material for which a BRC position is formulated are' considered potential sources of exposure and (3) potential misuse or.
accidents involving exempted radioactive material are considered in setting the constraints associated with a specific BRC position. These individual and s
collective dose assessments should be appropriate to the practice under consideration and must address any applicable constraints imposed through the g,
L licensee before the radioactive material is transferred from a controlled to an A
exemptstath.
4 If a simple assessment indicates that the likely consequences of exemption are
[
individual and collective doses within the lowest region in the graded L
approach, there would be high likelihood that the BRC determination would be accepted by the Comission.
If the practice proposed for exemption falls outside the lowest region in the graded approach but individual doses to members of the public are unlikely to
-exceed 10 mrem / year, a cost-benefit analysis is required. The rigor of this analysis would depend on how clearcut the justification for ;=td exemption can be demonstrated. An analysis of alternatives to the proposed practice will not be required. However, any reduction of effort in showing justification or optimization can only be allowed if a finding of no significant impact to the environment can be made; otherwise, a full Environmental Impact Statement would be required by the National Environmental Policy Act as implemented in 10 CFR Part 51.
06/27/88' 12 BROAD POLICY STATEMENT
J s
y m. -
i For practices proposed for exemption from regulatory control for which j
individual doses to the public are likely to exceed 10 mrem / year, a detailed cost-benefit analysis will always be required which must show that the practice is justified and the exemption as proposed will ensure that exposure,s are as low as is reasonably achievable. This would also be the case for any proposed
)
action for which a finding of no significant impact to the environment cannot be made, since NEPA, as implemented through 10 CFR Part 51, would necessitate an EIS.
In perfoming any cost-benefit analysis within the upper two regions of the graded approach, individual doses below 0.1 mrem / year may be omitted from collective dose calculation, as such does are considered trivial to the individual. In all situations, the assessment must be carried out using calculational models which take account of:
the characteristics of the practice to be exempted; the characteristics of the sources involved in the practice.
l L
Models to accomplish the required assessments can be deteministic, covering in detail a sufficient number of exposure scenarios, and/or probabilistic designed to provide a measure of the uncertainty inherent in the modeling and the database use.
The choice of scenarios should cover reasonable pathways and exposure situations that may arise as a result of the decision to exempt the practice in question. Inclusion of low probability of occurrence events will, of necessity, require regolatory judgements. The radiological consequence of these events 06/27/88 13 BROAD POLICY STATEMENT
E i
<=
j should be subjected to reasonable limits in tems of maximum individual dose.
The annualized dose from low probability events should not result in values exceeding the applicable dose benchmark.
Judg nts on choice of scen'arios and criteria for acceptability within a BRC position should.also apply to cases of misuse of the radioactivity involved in p
.the practice proposed for exemption.
I
(
In the calculation of individual and collective doses, particular attention should be paid to:
type of materials involved, physical and chemical characteristics,
)
isotopic composition, surface and mass activity concentrations; totalmass(es)andactivitiesinvolved.
l~
L Radiation sources involved in an exemption will pass from a regulated to en exempt status. The exemption must be clearly defined to enhance a comon understanding about what is exempted. Restrictions on exemptions will rarely, if ever, be expressed in terms of individual or collective dose'since these parameters are not practical to measure at the operational level. Rather.
l-exemptions should be expressed in quantith: that are measurable at the point of transfer so that compliance with the provisions of the exemption can be detemined.
I In addition to the basic parameters for the exemption, constraints on the exemption may ensure that the assumptions made in individual and collective 06/27/88 14 BROAD POLICY STATEMENT
t-i dose assessments will not be invalidated and may minimize the likelihood or
' consequence of accidents or incidents of misuse. These additional provisions l
may include constraints on:
a) the total activity which may be released in a year from a regulated activity; b) the chemical and physical form of the exempted material or its 3,
origin; L
c) the design of the exempted $ource; P
I q
d) quality assurance requirements; e) the disposition of the exempted material.
p.
t G.
Verification that Public Health and Safety Continues to be Protected as Below Regulatory Concern Policies are implemented J
Je)W " W su Jfnplementation of any BRC detemination made under this broad policy guidance mustbeaccompaniedbyasuitableinspection,traceabilityandcompliance[
This program, through suitable recordkeeping and sampling, must be program.
capable of providing appropriate assurance that no individual member of the public.is likely to exceed the individual dose benchmark justified for the specific practice being exempted and that compliance is achieved with the other constraints imposed within a specific below regulatory concern detemination.
06/27/88' 15 BROAD POLICY STATEMENT
=-. - -... -.
l 1The Commission intends to develop a inspection, traceability and compliance j
program suitable for the regulatory exemptions granted under this policy.
)
)
The Commission believes that individus1 doses from multiple exposures to
)
similar practices within an exempt class of practices must not be allowed to j
,,gygt significantly exceed benchmark values. The Commission-has found that, for y*6d currently licensed activities and those activities which way be licensed in the j
.g 9Nd near future, the 10 CFR Part 20 individual dose limits for members of the l
public are not likely to be exceeded as a result of individual exposures to
- g multiple sources or practices involving use or release of radioactive material.
This finding.is supported by the existence of current EPA and NRC effluent and environmental regulations which impose " secondary" limitu that are fractions of 10 CFR 20 unrestricted area individual dose limit. However, the Commission recognizes that, to ensure that this finding remains valid, i
r l
k l
. 06/27/88 16 BROAD POLICY STATEMENT I -
E i
r,
sh}/ 441sd 6(c. W $$
,a ac 6.< T tt V t'5ft ENCLOSURE 3 Options Pertinent to Proposed Exemption Policy and Discussion of the Uncertainties in the Data Base Regarding Radiation Risk I.
Options Pertinent to Proposed Exemption Policy A.
Numerical Values Selected for Individual and Collective Dose Values Within the Graded Approach (1) Individual Dose Benchmarks The numerical values within the graded approach were associated with three regions of radiological risk:
(1) maximum individual dose greater than 10 mrems per year but less than the applicable upper bound limit, combined with a justified collective dose, (2) maximum individual dose less than 10 mrem per year combined with a justified collective dose, and (3) maximum individual dose less than 1 mrem per year with a collective dose per practice of 1,000 person-rem per year or less. Within the upper two risk regions of the graded approach, an individual dose cutoff of 0.1' mrem per year is applied to collective dose assessments.
1 1
(a) The 10 mrem per year individual dose benchmark value.
l Selection of the 10 mrem per year value as described in the policy statement as representing a value which is 1/10 of l-[las 88 g
i i
the dose limit recommended for me w ers of the public in 3
Based on risk coefficients estimated for annual dose rates 50 rimes greater (1 rem / year), the corresponding risk of including lethal cancer would be j
somewhat greater than 10 per year.
Internationally, this i
risk value is often referred to as being a trivial risk j
which is at no concern to the individual.
This risk value is approximately equal to the societal mortality risk established as a design objective within the Commission's i
safety goal policy.
l The 10 mrems/ year value corresponds to an exposure level which is (1) about 10% of the annual effective dose i
equivalent from natural background (excluding radon),
(2) representative of about one-half (1/2) the variation in y
dose from natural exposure to cosmic radiation across the r
United States (i.e., Washington, DC vs Denver, Colorado),
l (3) less than 1/4 the variation in dose from natural I
I terrestrial gamma radiation between the Atlantic / Gulf coastal plain and regions on the eastern slope of the l
Rockies and approximately equal to the variation between I
the Atlantic / Gulf coastal plain and the remainder of the country excluding the eastern slope of the Rockies.
The 10 l
mrem per year value is currently below and is likely to remain below limits set in generally applicable environmental standards established by the U.S.
Environmental Protection Agency.
The order of magnitude of 2
1
,_____-.__..--.___n
~
a j-l L.,
the numerical value is also consistent with the nature of i
i the value judgements being expressed in the proposed policy statement and reflects the infused maximum individual dose associated with past guidance applied to decontamination t
activities preceding license terminations of research t
reactors.
i f
Alternative values below this individual dose benchmark would add little to supporting arguments on value l
justificationotherthanincreasingtheinternational consensus on what level of, individual dose constitutes a de minimis risk (e.g., the Canadians are considering a
<j 5 stem per year value).
It should be noted that internationally the judgement on de minimis is always made r
for activities for which justification of practiceu has been demonstrated.
If the'three-region graded approach is used in defining exemption policy, alternative values greater than the baseline 10 mrom per year individual dose benchmark could be selected which approach limits defined l
l-in generally applicable environmental standards (i.e.,
25 mrem per year).
Argument against dose of higher values include (1) the proximity of a exemption related dose value to an upper-bound environmental standard and (2) the fact that the risk associated with higher dose values fails i
outside the range of values generally assumed to be trivial to individuals.
I 3
i;
(*[v
+
'd L.-
(b) The 1 mrem per year individual dose benchmark value.
l Selection of the 1 mrem per year value is described in the l
policy statement as corresponding to a lethal cancer risk
~
of less than 10 8 per year - a risk considered trivial by many regulatory bodies and one which is held to be of no concern to the individual.
This individual dose benchmark is one-hundreth (1/100) of the dose limit recommended for members of the public in the proposed 10 CFR Part 20.
This l
t value also corresponds'to an exposure level which is (1) approximately one-fourth (1/4) the estimated national average individual exposure received'through use of L
domestic drinking water supplies, (2) approximately one-fourth (1/4) the exposure received by a large fraction of the population from radioacti've material in building l
materials, (3) about 1% of the annual effective dose equivalent from natural background radiation er,cluding radon, (4) less than one-twentieth (1/20) of the variation in dose from natural exposure to cosmic radiation across L
l the Unites States, and (5) less than one-twenty-fifth (1/25) of the variation in dose from natural terrestrial l
gamma radiation.
l Alternative values below this individual dose benchmark would add little to supporting arguments.on value justification although 0.5 mrem per year would translate into a risk on the low end of the range of values commonly d
T m -
. u m
e.-
r
..--m-y
-y...
~
e i
identified as being trivial to individuals.
Alternative greater than 1 arem per year could be selected.
The most l
reasonable alternative would be 4 mrem per year - a limiting value used by the EPA in drinking water standards, ard being proposed as a BRC level for land disposal of low level waste streams.
The 4 mrom per year value was discarded principally because its selection could imply a degree of precision inconsistent with the value-judgement aspects of the proposed policy.
The 4 mrem per year value would also exceed the 3 mrem design objective guide for liquid effluent release proposed in 10 CFR Part 50, Appendix 1.
i t
(c) The 1,000 person-rem per practice per year collective dose
{
constraint within the lowest ran'ge of the graded approach.
The selection of this collective dose value constrains the l-number of potential individual exposures at 1 mrem per year (i.e., the upper bound of the lowest range within the graded approach) to one million or
- 0.4% of the U.S.
population.
For widely distributed (U.S. population) consumer products, the effect of this value is to restrict individual doses to a few micro tem per year.
Many consumer products currently licensed for distribution to persons exempt from requirements for a license have been evaluated to cause collective doses less than 1,000
+
person-rem.
5 e
w.
e-
-m e
s.;, _
~
[
4' An alternative collective dose value below 1,000 person-rem i
i i
t could be selected at 100 person-rem. The 100 person-rem i
value_has been used internationally to represent a de minimis collective dose on the bases that their would be_
no potential for reducing collective dose below this value at reasonable cost.
Furthermore, the value is low enough I
that the total collective dose from all exempted sources would not be excessive.- The disadvantage of this value is that most evaluations of consumer products indicate l
collective doses in excess of 100 person-rem.
)
An alternative collective dose value greater than 1,000 person-rem could be selected at 2,000 person rem.
This-value would retain the advantages of the 1,000 person-rem value (with the exception that a non-order-of' magnitude value could imply a certainty of knowledge not commensurate with the value judgements incorporated in the proposed policy). The 2,000 person-rem value would be consistent with application of the Commission's societal risk safety j
goal if applied to the average 1.7 million people estimated with 1979 data to be within 50 miles of nuclear power
- plants, t
l 6
y(,)@YN
. so
?
b j
For:-
The Commissioners 9
From:
Victor Stello, Jr.
Executive Director for Operations
Subject:
PROPOSED COMMISSION POLICY STATEMENT ON REGULATORY CONTROL EXEMPTIONS FOR PRACTICES WHOSE PUBLIC HEALTH AND SAFETY.lMPACTS ARE BELOW REGULATORY CONCERN (BRC)
Purpose:
To provide for Commiss on consideration, a proposed 3
policy statement'olf egN d h ontroi ;;.; p ions with several implementa[ ion options and to obtain Comission approval to publish a proposed policy statement for public comment.
Discussion:
The Staff Requirements Memorandum of March 30, 1968 (Enclosure 1) directed the staff "... to submit for Commission consideratiun options for a Commiss' ion policy which establishes a general number for exposure; which are below regulatory concern." The staff was further directed to "... discuss the approach for implementing such a number for multiple sources of licensed activities which does not require justification by individual licensees."
Contact:
W. Lahs, RES Ext. 2-377S p
4 T* '
[
The Commissioners 2
A proposed policy statement is provided as Enclosure 2.
The proposed policy includes a " graded approach" to exemption decisions - an approach which identifies three levels of radiation risk, including individual dose benchmarks, below which the need for NRC regulations to further control or reduce release or distribution of radioactive material is a function of the magnitude of the risk and the benefit of exempting specific practices.
The three levels are identified as follows:
(1) maximum individual dose greater than 10 mrem per year but less than the proposed 10 CFR Part 20 unrestricted area limit J
(i.e.,100 mrem per year) or k limit imposed by a generally applicable environmental standards, (2) maximum
[ /
<1 individual dose less than 10 mrem per year, and
//
f less a
gk (3)maximumindividualdose17;;;g';j;=;^..o y
fp.fj M than 1 mrem per year coupled wit a, collective dose per 7 practice of 1,000 person-rem per year or less. / At the lowest level of risk,' the proposed policy provides a basis for exempting practices involving use or t . distribution of radioactive, material which may be of only marginal F a+=1 benefit IJf,"the' radiological risk 4 M detriment is so low that the practice p= t'; @;tM;.y /'"- ~. w s.ac c . by ev;, : :-91 nr;ini L;...iirto the potilic. Coupled with this provision, the proposed policy also includes Comission guidance regarding practiceser d.i:5 're;p.>h tery : =..A ion poi;;ie;,,ili yni 6-entertained if overwnsiming justiii m ion is prov;?;d et4 / M M k 4 l4: h, Wf '"Y"" [ Within the two upper levels of radiation risk, decisions j'j on exemption from regulatory control for a specific class / ^^ Lea;ftc anniysis. These (+ of practice will involve analyses will be reqeir to be increasingly more %s-e c %, ov&dN h-' c-~c 7
1 [i L p.wyJ, .~.4~-$ / &,' " " 7 u A & 9 aw G % ~ * " " D y [i _ r, i 3 ,,.#.ne. - y 9=+ l The Comissioners ("*%, g &g j, g s a m % m '* A \\ [ '( b 'I4( _p rigorous as the level of risk from the exempted practice i increases and will include an evaluation of individual l and collective dose associated with exemption of the ) specific practice or class.of practice from regulatory i I' control. The assessment of collective dose within the i two upper ranges in the " graded approach" includes an i individual dose cutoff of 0.1 mrem per year
- -r;""
[#"#'p 1 3 Although the proposed policy statement provides, bases for %s gd the selection of individual and collective dose values.. m gne 4u i additional perspective on these values and a discussion of the uncertainties in the data base regarding radiation risk are included in Enclosure 3. This enclosure also discusses the pros and cons of several options including the selection of <ernative values to define levels of radiation risk. contains responses to the Comission's request for an explicit identification of L the undergirding assumptions and projected risk estimates used to establish the BRC limits currently included in l-NRC regulations. l i In developing the proposed policy statement wide range,s = o of F i r
- "s options were[ g b nd hi A&b l
r-5: M -the staff. -MMffering positions most 4r frequently evolved from "value" judgments inherent in defining a regulatory exemption policy. Three issues elicited the most serious consideration. The first I involved the role to be played by " justification of practice," a basic element of existing radiation protection policy applied both nationally and internationally. Although there was no variance in staff opinion that some " justification of practice" should be required, there were differences in how justification should be applied in the lowest range of the graded a. _,.~...
k'h s. y i ' g.G. f 'k Mll w The Commissioners-4 7 .i[ ff, 1 ~ approach. The proposed policy statement in Enclosure 2 [;1 provides the possibility of regulatory exemption for practices of marginal benefit but includes Commission ggncepnsppcificJracticesforwhicQxemptionwould b 1'" M... -..... i vn .or,b $NaNdaN 4i i. orovide_d. This y ry ch reflects concerns not only: regarding the ptH44eal and ethical health and safety acceptability of certain uses of radioactive material but 9 i alsothepossibilityof" contamination"ofmattMaisusedlf.M < A-in " clean" industrial applications. -p#.) {. NN'k The second issue.h ted to the first, involved the d- 'Mb appropriateness of including an individual dose cutoff in j hp coIlective dose calculation D The dose cutoff, E [f.,gCZ-
- P originally considered in the proposed revision to 10 CFR part 20, has been included as'a component in the upper g"g%d M[p.>
e M< two ranges within the " graded approach" of the proposed ,.y cpe w g/d M. exemption policy. It has purposefully been excluded from c-5 5 jfsM the lowest range. This'non-universal application 4 bf"~ i presents an apparent dichotomy. However, the exclusion ' g'M 5 of the dose cutoff concept from the lowest of the'" graded 46'. MM ,4 [ approach" ranges, when combined with a collective dose [ restriction, assures that the average' individual dose , NW associated with potentially widely-distributed ( h~ *, p_,,y/ M radioactive material (e.g., in consumer products) would ki UW"' -be negligibly small. This level of individual dose could 4 m jf g,y be.%Jged to be " acceptable" even for practices having marginal societal benefit. y cfL ', [/bP/ M# Finally, the third issue involved the possibility of
- o+. assigning weighting factors to the monetary values 7' l M, g g [
& A, g, assigned to individual doses (e.g., a 0.1 mrem per year -s M I,,,., dose could be assigned a lower value ($1/ person-rem) than 610 mrem per year dose ($1,000/ person-rem)). The d: e...s
,1
- ,,~
The Commissioners 5 j + ~ weighting would be based on the assumption that 4 increasing individual dose proportionally. reduces acceptability to the individual. This approach could serve as an alternative to,the'use of the individual doso cutoff-for collective-dose calculations. As proposed, the enclosed policy statement is not inconsistent with (1) the existing policy on consumer products (30FR3692)..(2)thegemstonedecision,and(3) the general statement of policy and procedures concerning petitions pursuant to 62.802 for disposal of radioactive waste streams below regulatory concern. Recommendatiens: S l / l,/ ).f g . C./ d' A f' 6w ,6 ,.Li, M ' -v b m / swr
- r"=
k ,/ i / e" T/ ~ 7h iy, u; YAM ,p g[,y m) j J...- y- .y a-, yl_aT a,,M b eg J h.{i AWM / ? 'Ju a n, % f' . &b. ,JJW ~ k
Ti~( c T H W ! R 6 E l -' .. " Te oo .c e oo. ,e .. e eesceeee .. :...,e e.> e c cooecc ec a: n.~a c a a a a a a a a a o a sse ac
- g.,_ ~ z ai. m ud pY so g / p/ ggt <.
ma c. e ect o cc o e.e c c c a ew een <eace ..ee, s e e. w _~uaaaoaosees _ _. _ _ _. _ _ _ _ - _ - _ _ _ -.. _ - - _ _ _ _ _ _ _ _ _ _. _. _ _ _ _, _, _ _,., _,, _ _ _ _,,}}