ML20033F837
| ML20033F837 | |
| Person / Time | |
|---|---|
| Issue date: | 09/09/1988 |
| From: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML20033D930 | List: |
| References | |
| NUDOCS 9004030237 | |
| Download: ML20033F837 (58) | |
Text
.
i 2L.
.'t.
I 5
September 9, 1988 i
For:
The Comissioners Victor Stello,ir., Executive Director for Operations From:
PROPOSED C0f911SSION POLICY STATEMENT ON EXEMPTIONS FR
Subject:
i REGULATORY CONTROL FOR PRACTICES WHOSE PUBLIC HEALTH AN SAFETY IMPACTS ARE BELOW REGULATORY CONCERN (BRC)
To provide for Comission consideration, a proposed policy
Purpose:
statement on exemptions from regulatory control for practices whose health and safety impacts are below regulatory concern..
This paper discusses a proposed w1 icy statement whose purpose Sumary:
is to establish the basis upon wiich decisions can be made by the Comission involving exemptions from regulatory control.
The principles, technical considerations and risk basis for :
l the development of this policy are outlined and the constraints and criteria for decision making art presented.
Included among these are numerical criteria which define a range of l
individual and collective doses (below 10 mrem per year and' 100 person-rem per year) which.can be considered ALARA without There has been extensive further cost-benefit analysis.
interoffice coordination in development of the proposed policy, however, there remain some views favoring different L
numerical criteria.
The Staff Requirements Memorandum of March 30, 1988 Discussion:
(Enclosure 1) directed the staff "... to submit for Commission consideration options for a Commission policy which establishes 3
l.l a generic number for exposures which are below regulatory The staff was further directed to "... discuss the concern."
approach for implementing such a number for multiple sources of licensed activities which does not require justification.by individual licensees."
In A proposed policy statement is provided as Enclosure 2.
the proposed policy,f a number of similar sets of coordina set or combination o and continuing activities aimed at a given purpose which could Under this involve the potential for radiation exposure.
Contact:
W. Lahs, RES Ext. 2-3774 N?*$$$3790031s NGPZ PDC
~
I s.
g q
_A _
The Comissioners 2
proposed policy, the definition of " practice" is a critical feature which will assure that-the fomulation of exemptions I
from regulatory control will not allow deliberate dilution of material or fractionation of a practice for the purpose of circumventing controls that would othemise be applicable.
, The policy statement draws upon the basi.cAonsepts-of' i
radiation protection. Theseare(1)juitificationofpractice.
(2) dose limits to define the maximum alTUied~ dose to~an~~
individual, and (3) enhanced safety through achieving doses which are ALARA (as low as reasonably achievable).
In employ-ing these concepts to develop the policy, the possibility that some individuals could experience radiation exposure from more 3
L than one practice has been a key consideration.
To determine if an exemption for a practice is appropriate, the staff believes the Comission must determine whether one of the following conditions is met:
(1)theapplicationor continuation of regulatory controls does not result.in any significant reduction in the individual or collective dose or (2) the costs of the regulatory controls that could be imposed to reduce the individual and collective dose are not balanced by a commensurate risk reduction.
To quantify the residual risks from the low doses associated with exempted practices, the proposed policy subscribes to continued Connission use of a hypothetical linear relationship s
- g between dose and health effects. Based on this relationship,-
D two risk-based criteria are proposed for demonstrating that
- p ALARA has been achieved for pract4ces being considered for For Justified practices 4 involving individual-exemption.
radiation exposures below approxisttely 10 mres per year, and
-collective doses less than approximately 100 person-rem per
- u. W _
year, exemptions may be granted without the necessity of cost benefit analyses to demonstrate that risks are ALARA. Exemp-tion proposals not meeting these criteria may be granted based on appropriate cost benefit analyses.
[
The risks associated with the 10 mres per year individual dose and a 100 person-rem collective dose criteria are believed to be small based on the linear dose-effect model. This model, r
in its simplest form, equates by direct proportion the risk of a statistical health effect-(e.g., random risk of radiation induced cancer or genetic effect)_ from a radiation exposure to the level of that exposure, even down to the smallest exposure.
The use of individual or collective dose to define a threshold for exemption decisions is not based on an assertion that there is no biological damage or risk at these defined dose levels.
Rather, the adoption of these criteria is based on the argument that the risk entailed below these exposure levels is sufficiently low in absolute magnitude and in
~.. --
rO-
_ e y
~
2 The Commissioners
^
1 i
the definition of " practice' is a critical proposed policy,ll assure that the formulation of exemptions-feature wnich w1 from regulatory control will not allow deliberate dilution 1
of material or fractionation of a practice for the pur>ose of
?
circumventing controls that would otherwise be applica)1e.
The policy statement draws upon the basic concepts of-Theseare(1)justificationofpractice,
, radiation protection.
(2) dose limits to define the maximum allowed dose to an individual, and (3) enhanced safety through achieving doses which are ALARA (as low as reasonably achievable).
Ln employ-ing these concepts to develop the policy, the possibility that some individuals could experience radiation exposure from more than one practice has been a key consideration.
To detemine if an exemption for a practice is appropriate.
3 the staff believes the Consiission must detemine whether one (1) the application or of the following conditions is met:
continuation of regulatory controls does not result in any significant reduction in the individual or collective dose or (2) the costs of the regulatory controls that could be imposed to reduce the individua and collective dose are not balanced by a comensurate risk reduction.
a w 1et, associated To quantify the residual risks from thf
. sseribes to with exempted practices, the proposed m e
-or relationship-continued Commission use of a hypothet.ct' between dose and health effects. Based & G relationship, two risk-based criteria are proposed for demonstrating that ALARA has been-achieved for practices.being considered for For justified practices involving individual exemption.
radiation exposures below approximately_10 mram per year, and collective doses-less than approximately 100 person-res per year, exemptions may be granted without the necessity of cost Exemp-benefit analyses to demonstrate that risks are ALARA.
tion proposals not meeting these criteria may be granted based on appropriate cost benefit analyses.
The risks associated with the 10 arem per year individual dose
^ -
and a 100 person-rem collective dose criteria are believed to This model, be small-based on the linear dose-effect model.
in its simplest form, equates by direct proportion the risk of a statistical health effect (e.g., random risk of radiation-induced cancer or genetic effect) from a radiation exposure to the level of that exposure, even down to the smallest exposure.
The use of individual or collective dose to define a thres for exemption decisions is not based on an assertion that there is no biological damage or risk at these defined dose Rather, the adoption of these criteria is based on levels.
the argument that the risk entailed below these exposure levels is sufficiently low in absolute magnitude and in
)
i
- S
+
[..
^
e
'The Comissioners
.j qq veryday risk as to be beneath any reasonable comparison t A radiation exposure of 10 arem threshold of concern.
cormsponds to an incremental annual-individual risk of cancer
+
. fatality which is 0.1 percent of the individual's annual risk In essence, this low level of risk is of a cancer death.
completely consistent with the Comission's Safety Goal Policy Statement for the operation of comercial nuclear For practices involving collective doses m er reactors.
alow 100 person-rem, the risk of fatality would be very unlikely.
The proposed policy also includes Commission guidance, o
g regarding frivolous practices for which regulatory exemption c@/'
nonnally will not be considered. This guidance on frivolous
's ' #c practices, in combination with the criteria for ALARA and the F
p'* /' 4 staff's intention to take into consideration the possibilit of multiple exposures in evaluating exemption proposals,-
- e#
provides assurance that it will be unlikely than any individual d
s g
- g# ]g #
will receive a dose above the limit due to exposure to acre pto
- yes,
,f than one exempted practice.
q The proposed policy statement includes the staf tion decisions on simple-provide the criteria for basing ex Additional demonstrations of justification and This perspective on these values is included in Enclosure 3.
enclosurt 'also discusses-the pros and cons of alternative
- discusses three major policy.
numerical values.
(1) the principle of " justification considerations including:
of practice", (2) whether certain practices _ should be excluded from the exemption policy, and (3) approaches for the calcu-lation and use of collective dose assessments. Enclosu contains responses to the Commission's request for an explicit identification of the assumptions and projected risk estimates used to establish certain BRC limits currently included in NRC This enclosure also discusses the uncertainties regulations.in the data base regarding the coefficients relating radia I
dose to health risk.
A sumary of the staff's recomendations on the major policy considerations, discussed in enclosure 4 is as follows:
Justification:
" Justification of practice" is a basic element of-existing radiation protection policy currently applied The staff both nationally and internationally.
recommends that " justification of practice" should be The required before any regulatory exemption recomendation.
i
-*~-r
- a-
-e
j t-1 4-The Connissioners e./
%'$. d # N*,
4 Exclusions:
- $"#., b The policy identifies specific practices which should be Ac"/
excluded from the exemption policy. This exclusion
. ' h#N P provision reflects the staff's concerns regarding the l
- [g q(6,
$p.f.ye% o 9, e small radiological risks associated with frivolous or social and ethical questions about the acceptance of,
J f
t f
.,< e unjustified practices. The ACW agreed with this staff b e # e ' N o"'
5 position but emphasized that care must be exercised in cM.' " 4 # cp >
defining frivolous practices.
. c *%of
'. p-Calculation and Use of Collective Dose Assessments
- r The collective dose associated with an exempted practice can serve as both a measure of the impact on the exposed population ar;d a mechanism for assessing the benefits ^
regulatory constraints on tho' practice being exempted '%
from regulatory control. The staff's vjew-is'tfiat an Mr active dose igc assessment of the compon must be made to satisfy NEPA requirements. However, in o ve lys41._savaiePf1ternative wt.
performing cost-benefit approaches can allow truncations in collective dose or weighting factors for the monetary value of averted dose i
to be applied.
Truncations in time and space have been used in the past and could continue to be used in situations where a choice between alternatives is 'not further clarified by unbounded collective dose assessments. An individual.e7 dose cutoff could-also be considered on the basis that
'"M small individual doses (e.g., less than 0.1 mrom per W year)representaninsignificantriskandthatthe collective impact from the summation of-these individual Finally, varying monetary exposures will be very small.
l values could be assigned to components of collective dose, e.g., $1000 per person-rem for collective dose composed of individual doses in excess of.1 mrem per year and $100 per person-rem for individual doses less than this value. At this time, the staff believes that the use of any or combinations of the above approaches could be appropriate depending on the practice under l
consideration for exemption'. The ACW supports the concept of a graduated monetary weighting of the individual dose contributions to collective dose.
In developing the proposed policy statement, the staff (30 FR 3692), (2) the gemstone decision, and (3) considered (1) the existing policy on consumer the general statement of policy and procedures concerning petitions submitted pursuant to i 2.802 for disposal of radioactive waste streams below regulatory concern.
Regarding the existing consumer product policy, the proposed o t gexemption policy is generally consistent with the 1966 policy p 6
- ~$o statement on "Use of Byproduct Material and Source Material -
,%y..et Products Intended for Use by the General Public (Consumer p o9
J M' j
.c 5
The Commissioners On the gemstone issue, the Commission decision
-Products)."
that the practice was justified could, under this policy,- be
-l
. based on a determination of. marginal benefit and on a simple demonstration that individual and collective' doses involved-L with gemstone distribution and use are small. Based on the:
. anticipated ability of the defined practice (f.e., radioactive gemstone distribution to and use by the general:public) to meet the 10 arem per year total effective dose equivalent and
~
l the collective dose criteria, the exemption would be allowed under this policy.
The Comission's statement on policy and procedures concerning petitions for disposal of radioactive waste below regulatory
-concern provided fourteen decision criteria which, if~
f satisfactorily met, would demonstrate that the utition should be suitable for expedited Commission action.. Tie staff believes that the emphasis placed on definition of " practice" and the individual and collective within the proposed policyIteria below which ALARA dose values selected as cr cost-benefit ~ analysis may be waived, envelop the applicable issues addressed by the fourteen criteria. With regard to other exemption regulations, the proposed policy states that.
the Commission will evaluate whether there are existing exemption criteria for which modifications would be beneficial.
The staff has evaluated the proposed policy with regard to
' emerging national and international guidance on the subject.
- It should be noted that the 10 area individual dose criterion for. simple demonstration of justification of practice and p
'l,,g ALARA is somewhat higher than values being considered outside
"'p/
The IAEA has recoseended a value of
+ " d
- Y* i..d the United States.1 mrom. The Atomic Energy Con cp$#% V ing a 5 aren value under certain conditions, and the National s
-" # /
Radiological Protection Board has recommended a 0.5 arem It is expected that the U.S. Environmental Protection Q # v, #
-4sp*p value.
Agency will propose 4 mres as a BRC level for land disposal of low level radioactive waste. Furthermore, in assessing e.
+d*' gd*
collective dose for cost-benefit analysis, the use of an dividual dose cutoff has not been adopted internationally or o
e These issues will be highlighted at the NRC-nationally.
organized international meeting on exemptions scheduled for October 1988.
9.x Q cf*p The staff has, as indicated previously, identified policy
- +#g.
areas in which consensus with the ACNW has been reached.
e
- provides the staff's response to other ACNW coments.
The Comission should note that the proposed policy recognizes that, if a national policy on exemptions from regulatory
.N The Comisstoners_
T[
6
- ff', -
x<
control is to be effective, Agreement States will play an important implementation role. Accordingly, the proposed i
3 policy calls for coordination with the States to expedite the p9 process by which the rulemakings codifying exemption policy g + 40*
can be made matters of.compatability with the States, f +g #
- g#.
Coordination:
The Office of General Counsel has reviewed the proposed policy 4
- statement and has no legal objection.
Recommendations: That the Comission:
1.-
Approve' discussion of the proposed policy statement and options at the NRC-organized, October 17-19, 1988 Workshop on Rules for Exemption from Regulatory Control.
2.
Approve staff efforts to subsequently finalize the-
. proposed ' policy statement for publication in the -
Federal Register. The FRN would include a request for public coment on the basic foundations and key elements of the proposed. policy.
tor St Executive Di ctor for Operations
Enclosures:
1.
Staff-Requirements Memo 2.
Draf t Policy Statement 3.
Options for Numerical Values 4.
Major Policy Alternatives S.
Response to Specific Comission l
Questions Li 6.
Response to ACNW Coments
'.I w
c..-
I
~
2N RESPONSE, PLEASE,
'Nf'8M I
REFER 70:
M880314-j/n p,',%".; *.
NUCLE AR REGULATORY COMMIS$10N 6
u samotone.o.c.p666 ACTION - Beckjord, RES t' 7 March 30, 1988 Cys:
$tello-l
- 4....
Taylor
- ones o, we Rehm
$Neuder..RES MEMORANDUM FOR:. Victor Stello, Jr.
Executive Director for O tions H
FROM:
Samuel J. Chilk, Secreta
SUBJECT:
STAFF REQUIREMENTS - BRI CFLFG ON THE STATUS OF EFFORTS TO DEVELOP A DE<dIlf1HIS POLICY, 2:00 P.M., MONDAY, HARCH I4, 1988, COMMISSIONERS' i:
CONFERENCE'ROOH, D.C. OFFICE (OPEN TO PUBLIC ATTENDANCE) h The Commission was briefed by the staff on the status of efforts to develop a Commission policy statement identifying a level of radiation risk or dose below which government regu-F.
'lation would be limited or unwarranted.
The Commission requested and the staff agreed to submit for Commission consideration options for e Commission policy which establishes.a generic eumber for exposures that are below The pap'er should disen=d' sha'isticereadMimit
~
~
' regulatory concern.
Lin our data base regarding radiation risk and. should include 3
the. supporting scientific and legal rationale for all proposals.
Consideration should be given.to the assumptions made-in M establishing de fact'o BRC*1evels that appear in current NRC regulations.
The staff should also discuss the approach for implementing sucn a nummer ius suasapas sources or licensed actavatzes wnacn coes not require iustification by individual licensees.
This Uptions paper is to be actea upon by the commission prior to the staff meeting with international-groups (T [.g r)j#7 K4W #//
on this subject.
WpW (RES)
-tSECat-Suspenser--9/+/861 us
.o uo Commissioner Bernthal requested the staff to provide him the bases 'and analytical techniques used by other agencies (e.g.,
EPA and FDA) in developing a de minimis policy / regulation on toxic waste (e.g., did they use a linear hypothesis?).
-5ED04 (RES)
(SECY Suspense:
4/29/88)
R e d Off. D 0g, g v V, \\, _
D:te _
..u.
- -l C.W d
'S 4
/.
n creguested:that the staff's options paper should exp l
identify the undergirding. assumptions.and. projected risk estimates, both societal and individual, used in the es'tablish-L Specific ment of such BRC limits appearing in NRC regulations.
L L
points staff:should-address include:
20 to permit disposal In 1981,;the Commission revised Partl ********* * "t**"i"'
1 ofscintillationcocktai}4and a5 "*without regard for their L
C or H
trace concentrations ofAlso,.specifded curie amounts of both radioactivity.
isotopes may be released annually into.the sewerageSome re keeping and limitation on use of contaminated carcasses) system.
but. in ef fect, once released to the environment NRC exerts no further control, thereby setting a floor to ALARA for What calcu-
,=
l these specific isotopes and applications.lations of. societal a Were the in determination.of these exempted levels?
l i
t
-models and assumptions the same as those used to arr ve a in NRC regs?
' tables of exempt quantities elsewhere L
.whether a definition of " radioactive" can be usefullyS p
Not mentioned in Enclosure 2 is the fact (49 CFR 173.403).
established.
that DOT regulatione do precisely that For purposes of' transportation, a radioactive material is L
defined; as a material having a specific.-activity of 2This defin
- )
regulations (10 CFR,71.10) not as a definition per nci/glor greater.
~
Given that a What'is the origin of'this 2 nci/g limit?
limit on total specific activity limit applies to any and all isotopes,what assumptions were made regarding chemical form, pathways to the environment, critical organs, etc.?
e" For purposes of enforcing the many de facto BRC limits which exist in NRC-regulation what explicit allowance is l
(Recall, wade for instrument and measurement uncertainties?
ments for some measure of QA for dosimetry pro I
Acceptable levels of residual surface contamination are Facilities with surface l
designed in Reg. Guide 1.86. contamination levels below those sp L
How many and what types of licensee L
for unrestricted use. facilities have been decommissioned using these
[
L
=
.c 3-The commission was recently made aware of some of the history _behind_the licensing of 3M static eliminator.
devices.
The general license for these devices allowed up to 5 nci of removal activity without any' action'being Do similar required on the-part of the general licenseas.
What is the_ origin of e provisions exist in other licenses?
the 5 nci allowable leakage rate?
What assumptions.cf risk were made'to justify _this number?
cc:
Chaiman tech Commissioner Roberts commissioner Bernthal commissioner Carr Commissioner Rogers OGC (H Street)
GPA
'PDR - Advance DCS - 016_Phillips t.
e,
e e
e T
2 9
e i
l
_____._.m
1,-
DRAFT Proposed Comission Policy on Exemptions from Regulatory Control for Practices Wtiore Public Health and Safety Impacts are Below Regulatory Concern F
1.
INTRODUCTION AND PURPOSE Over the last several years, the Comission has become increasingly aware of the need to provide a general policy on the appropriate criteria' for release of radioactive materials from regulatory control. To address this need, the Connission is expanding upon its existing policy for protecticn of the public l
d'inexistingregulations(Title 10,Codeof from radiation,. current y expresse Federal Regulations) and policy statements (30 FR 3462, Use ef Byproduct Material and Source Material, dated March 16, 1965; 47 FR 57446, Licensing 27,1982; Requirements for Land Disposal of Radioactive Waste, dated December and 51 FR 30839, General Statement of Policy and Procedures Concerning Petitions Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the provision of an explicit policy on the exemption from regulatory control of L
- practices whose public health and safety impacts are below reg.latory concern.
A practice is defined in this policy as an activity or a set or combination of a number of similar sets of coordinated and continuing activities aimed at a l
Under this given purpose which involve the potential for radiation exposure.
j policy, the definition of " practice" is a critical-feature which will assure l
that the formulation of exemptions from regulatory control will not allow l_
deliberate dilution of material or fractionation of a practice for the purpose-of circumventing controls that would otherwise be applicable.
The purpose of this policy statement is to establish the basis upon which the Connission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control persons who receive, 1
- l
~
l possess, use, transfer, own, or acquire certain radioactive material.
This policy is directed principally toward rulemaking activities, but may be applied to license amendments or license applications involving the release of licensed radioactive material either to the environment or to persons who would be
)
a exempt from Comission regulations, The concept of regulatory exemptions is not new. For example, in 1960 and 1970, the Comis'sion promulgated tables of exempt quantities and concentrations -
for radioactive material which a person, under certain circumstances, could receive, possess, use, transfer, own, or acquire without a requirement for a-license (25FR7875and35FR6427). Other exemptions allowing distribution of j
L consumer products or other devices to the general public, or allowing releases r -
of radioactive material to the environment, have been esbodied in the Commission's regulations for some time. More recently, the Low Level Radioactive Waste Policy Amendments Act of 1985 directed the Comission to develop standards and -
r procedures for expeditious handling of petitions to exempt from regulation the m - $,
e disposal of slightly contaminated radioactive waste material that the Commis 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 addressed in a petition for rulemaking, would allow the Cosmission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific" basis consistent with
~
the merits of the petition.
l The Commission believes that these " practice-specific' exemptions should be l
encompassed within a broader NRC poli n which defines levels of radiation risk below which specified practices would not require NRC regulation based on public health and safety interests. For such exempted practices, the Comission's regulatory involvement could therefore be essentially limited to licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt status.
t The Comission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an important
/ implementation role.
In the past, States have been encouraging findings that
^$*[## certain wastes are below rt.gulatory concern and the Commission believes that s..e b y
States will support an expansion of these views to all practices involving exempt distribution or release of radioactive material. The Comission intends that rulemakings codifying regulatory control exemptions will be made a matter.
~
.of compatibility for Agreement States. Consequently, any rulemakings that evolve from this policy will be coordinated with the States.
g L
RADIATION PROTECTION PRINCIPLES
. The Comission subscribes to three fundamental principles of radiation protection-in formulating its policies and regulations to protect workers and p
L the public from the harmful effects of radiation..They are (1) justificationlD ofthepractice,whichrequiresthattherebesomehbenefitresultingfromjfso'w l
the use of radiation or radioactive materials, (2) dose limits, which definejd
[*j,
l the upper boundary of adequate protection for a mes6er of the public which L* Meg should not be exceeded in the conduct of nuclear' activities, and (3) ALARA,,, s b q..
NTMr'
- which requires that radiation dose be as low as is reason economic and social factors being taken into account. The term, ALARA, is an f
l acronym for As Low As is Reasonably Achievable, p ]p 6
es fje
- s Forthepurposeofestablishingthestochastic(i.e., statistical)healthrisk associated with its radiation protection policies, the Comission also subscribes
.to a linear quadratic relationship between dose and effect which is linear over
- o
~
the dose range for which this policy applies. The hypothesis upon which the.
modelisbased.assumesthattheriskofradiationinducedeffects(principally cancer)islinearlyproportionaltodose,nomatterhowsmallthedosemight I
be. The coefficient used in the model is on the order of 2x10 risk of fatal cancer per ren of radiation dose received by an individual.
In subscribing to "*
this model, the Comission recognizes that it is a model based upon data
[p collected at relatively high doses and dose rates which is then extrapolated y*hyo&
[ to the low dose and dose rate region where there are no statistically reliable.
epidemiological data available. Although alternative hypotheses have been
(
o
%# y proposed and reevaluations of the data base at higher doses continue, no fo icant change is anticipated in the generally accepted linear model and fts I'M[A It is therefore the Comission's view that the use of numerical coefficient.
the linear model provides a reasonsble basis for developing exemption policy.
hap \\
4.'
t* g Q*
O L
3
. ~.
-i The' risk of death to an individual, as calculated using the linear model, is shown in Table 1 for various defined levels of individual dose. The'11fetime risk is based upon the fu,rther assumption that the exposure level is the same, l
for'each year of a>70 year 11fetime7 ~ %
f Table 1 Incremental Incremental Lifetime Risk-from Annual Dose Annual Risk Continuina Annual Dose l
l 100 arem 2 x 10
~ 1 x 10 2 x 10,,7
~ 1 x 10-5 10.
aren 2 x 10-8
~ 1 x 10-6 1
arem 0.1 mrem 2 x 10
~ 1 x 10 1 Unless otherwise indicated, the expression of dose in arem refers to the Total Effective Dose Equivalent. This term is the sum of the deep dose equivalent for sources external to the body and the committed effective dose equivalent for sources internal to the body.
2 Risk coefficient of 2 x 10'4 per rem based upon publications of the ICRP.
The Commission recognizes that it is impossible to measure risk to individuals or populations directly, and, that in most situations, it is impractical to measure annual doses to individuals at the low levels implied by exemption decisions.'. Typically, radioisotope concentrations.or. radiation levels from the material to be exempted are the actual measurements that can be made, and dosei are then estimated by exposure pathway analysis combined with other types of assumptions related to.the ways in which people might become exposed. Under such conditions',' conservative assumptions are frequently used in modeling so that the actual dose is on the low side of the calculated dose.
The Commission believes that this is the appropriate approach to be taken when determining if an exemption from regulatory controls is warranted.
.In the application of the fundamental principles of radiation protection, t.e collective dose provides a useful way to express the impact (i.e., detriments) h of a nuclear activity on the health of the population subject to radiation Collective dose is the sum of the individual doses resulting from a exposure.
practice or source of radiation exposure.
By assigning collective dose a monetary value, it can be used in cost-benefit and other quantitative analysis 4
?,
e
^ techniques.
It is therefore an important factor to consider in balancing benefits and societal detriments for practice justification and ALARA determinations.
III. APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS)
REGULATORY CONTROL The following sets forth guidelines about how the Comission will apply the fundamental principles of radiation protection in consideration of practices which are proposed to be exempt from regulatory control. These practices, if approved, would result in products containing low levels of radioactive L
material being distributed to the general public and radioactive effluents and solid waste being released to-areas of the publically-accessible environment.
Justification - Exposures resulting from any practice should be justified; o
thus, even at trivial levels of dose, the practice considered for I
exemption should be justified. As lower levels of radiation exposure are projected, lower levels of benefit will be needed for practice e
However, in establishing its policies the Comission will
@A # j' justification.
l continue to prohibit certain practices for which there is no reasonable %,
-w pu me,n w w m e.,sw uvase?
i co $
L justification, a wu. w% am.,s y u,,wg w
g, _ g,
'a*:m*w% wweo *weewt"am % m +
wwn ucm er, ve-T hy
'.,%o3 td, Q tem'*4 tWl) IM h P S Ah 'A.4, 9 con M et TW<, m e.e7 01e'thtgv ngg L
Dose Limits - Individual doses from practices exempted under this policy 'u~ %w l
no m, -
o This is the dose limit W
should not be allowed to exceed 100 mrom per year.
for members of the public specified in the final revision of 10 CFR Part The dose limits in the 20, Standards for Protection Against Radiation.
final revision of 10 CFR Part 20 apply to all sources of radiation exposure L
under a licensee's control (natural background and medical exposures are excluded).
1 ALARA - The ALARA principle generally applies to determining dose levels o
'below which exemptions may be granted on a cost-benefit basis. However, it is the purpose of this policy to establish criteria for individual and collective dose which would delineate achievement of ALARA without y
cost-benefit analysis.
5
_ ~.
u l
' Althoughlit~1s possible to reas'onably project what the dose _will be from a
. practice, and then take this information into account in controlling regulated j
practices so that the dose limits are not exceeded, exemptions imply some:
. degree of loss of control.. The Comission believes that a key _ consideration in establishing a policy for exemptions, and subsequently in specific rulemaking or. licensing. decisions, is the possibility that individuals any experience-radiation exposur,e approaching the limiting values through the cumulative effects of more than one practice, even though the exposures from each practice are only_small fractions of the limit. By appropriate choices of exemption criteria and through its evaluations of specific exemption proposals in implementing the policy, the Commission intends to assure thatLit is unlikely that any individual will experience exposures which exceed the 100 mrem limit.
L l'
IV. PRINCIPLES OF EXEMPTION V fr m%
m*
- Once a practice is established as justified, i.e., there is a positive ng Qd7 [
benefit to the introduction or use of radioactive material, the decision of h*T -
c w w e.t whether or not the entire practice, or some defined subset of the practice, is a candidate for exemption from regulatory control hinges on the general
-question of whether or not application or continuation of regulatory controls l
are necessary and cost effective in reducing dose. To determine if exemption is appropriate, the Comission must determine if one of the following L
conditions is met:
1.
The application or continuation of regulatory controls on the practice does not result in any significant reduction in the individual or collective dose received by individuals within the critical group and by ther 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 commen-
' surate reduction in risk that could be realized.
For purposes of implementing its policy, the Comission recognizes that only under unusual circumstances would practices which cause radiation exposures The approaching the 100 aren limit be considered as candidates for exemption.
6
Comission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement. However, as the doses and attendant risks to members of the exposed population decrease, the reed for regulatory controls decreases and the analysis needed to support a proposal for
)
exemption can reas'onably be somewhat simplified. At a sufficiently low level
'f of individual risk, decisions regarding exemptions (i.e., whether ALARA has sW' $
been achieved) can be reduced to an evaluation of whether the overall public.
risk is sufficiently small.
The Comission therefore proposes that two numerical criteria should be established in defining the region where ALARA has been achieved. They are (a) a criterion for t'he maximum individual annual dose reasonably expected to be received as a result of the practice and (b) the collective dose to the exposed population.
in con 61 nation, these criteria are chosen to assure that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact.
If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared with other 3mr The Comission believes that annual individual fatality risk ["
societal risks.
'below approximately 10 are of little concern to most mes6ers of society. /
"' T 4
p Providing for some margin below this level, the Comission proposes 10 mrom as the level of annual individus1 exposure below which ALARA can be demonstrated on the basis that collective dose is also sufficiently small. The incremental annual individual cancer fatality risk associated with an exposure level of d*"
10 mram per year is about 2x10 as indicated in Table 1 and of the order of r.STWi 0.1 percent of the overall risk of cancer death.
6en The collective dose criterion proposed is 100 person-rem per year per practice.
Adoptien of this value provides assurance that the number of individual ysco e exposures at or near 10 mrea will be no more than a few thousand people and $$
that for the exempt practices to which it is applied a fatality among the #$, *sr "
- 5 exposed population would be very unlikely.
If the collective dose and individual dose fall below these levels, then the y y '[ g risk from a justified practice is considered to be ALARA without further k w "5'
, co s 7
analysis. The Comission stresses that adoption of the individual and collective dose criteria should not be construed as a decision that doses below these criteria are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary, the criteria sisply represent a range of risk which the Commission believes is sufficiently small compared to other individual and societal risks that a cost-benefit analysis is not required in order to make a decision regarding the acceptability of an exemption.
Practices not meeting these criteria may be granted exemptions on a case-by-case basis in accordance with the principles ~
embodied within this policy. To further emphasize the Commission's recognition t
g # v.
that a rigid limitation on collective base is inappropriate, it notes that for some practices, such as use of smoke detectors, appreciable benefits can only
(.h,,
be attained through extensive utilization and, hence, with a comensurate collective dose.
The Comission is aware that existing regulations of the Environmental
- wt W Protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy. With regard to its ow n
regulations,-the Comission will evaluate whether there are exemption criteri embodied therein for which modification, according to the principles of this i
policy, would be beneficial.
M Ne 690 yobR V.
EXCLUSIONS FROM EXEMPTIONS y mm M. V?%%;vd2i"g
~
~There are some types of practices involving radiation or radioactive materials
'which are, prima facie, socially unacceptable regardless of how tr w"4 resulting dose might be and, therefore, should be excluded from exemption, o
Excluded practices would include, but not be limited to, the intentional 1@%
introduction of radioactive material into toys,and products intended for swrv-wc ingestion, inhalation or direct application to the skin (such as cosmetics). Q [
Exclusions would also include the purposeful and frivolous distribution or w m ro release'of radioactive materials where there are. clear, economical alternatives "
l to such use and the practice is not justified because there are no unique benefits from using the radioactive materials.
8
4 4
h VI. PROPOSALS FOR EXEMPTION h
A proposal for exemption must provide a basis upon which the Comission can l
detemine if the basic conditions described above have been satisfied. In general, this means that'the proposal should address the individual and collective doses resulting from the enpected activities under the exemption, L
including the uses of the radioactive materials, the pathways of exposure, the levels of activity, and the methods and constraints for assuring that the assumptions used to define a practice remain appropriate as the radioactive materials move from regulatory control to an exempt status.
If a proposal-for exemption results in a rule containing generic requirements, a person applying to utilize the exemption would not need to address justification or ALARA. The Comission decision on such proposals will be The based on the licensee's meeting the conditions.specified in the rule.
promulgation of the rule would, under these circumstances, constitute a finding that the exempted practice is justified, and that ALARA considerations have been dealt with. This approach is consistent with past practice, e.g.,
consumer product rules in 10 CFR Part 30.
I If, after a practice is determined to be justified and a simple assessment indicates that the likely consequences of exemption are individual and collec-tive doses approximately equal.to or less than the criteria ~ values, there would be high likelihood that the application would be accepted by the Comission.
In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard I
to the potential that some individuals may receive doses near the 100 arem If limit when dose-from other practices are also taken into consideration.
exposures from multiple practices can occur which are significantly beyond the p
individual dose criterion (10 mrem), the exemption will not be granted without further analysis. As expertence is gained, this policy and its implementation will be reevaluated with regard to this issue to assure that the exposures to the public health remain well below 100 mrom.
9 y
w--'-
w.+--+-
+ -. _, _,. _ _ _ _
t
' g -
I 1
In addition to considerations of expected activities and pathways, the' Commission recognizes that consideration must also be given to the potential' for accidents and misuse of the radioactive materials involved in the practice.
A proposal for exemption of a defined practice must therefore also address the potentials for accidents or misuse,-and the consequences of these exceptio j
J conditions in terms of individual and collective doss,
- VII.CALCULATIONANDUSEOFCOLLECTIVEDOSEASSESSMCy The collective dose can serve as both a measure of the impact (i.e., detriment of a practice on the exposed population and a mechanism for assessing the benefits of regulatory constraints on the practice _ being exempted from In the latter case, a monetary value can be assigned to regulatory control.
the collective dose so that cost-benefit assessments can be made with respect to the usefulness of controls or constraints on a practice to further reduce collective dose.
The Consission believes the assessment of the components of total collective
[
dose must be made to satisfy National Environmental Policy Act requirements.
( '
However, when used for cost-benefit analyses or for evaluation against the collective dose criterion proposed in this policy, several alternative For l
-approaches can allow truncatfons or weighting factors to be applied.
example, the collective dose is often used to discriminate between alterna The collec.tive dose in web cases should be calculated to the or options.
Complying with this requirement point where a choice between options is clear.
will often allow the truncation of the collective dose assessment in Also, large uncertainties associated with dose, particularly at and/or space.
very low dose or dose rates may render certain components of the assessm Furthermore, an individual dose non-useful in the comparison of alternatives.
cutoff could also be considered on the basis that the summation individual doses (e.g., less than 0.1 mrom per year) represent an insignificant societal risk or that the collective dose attributed to these sma very small in comparison to the remaining collective dose from the exemp Finally, varying monetary values could be assigned to components o practice.
collective dose, e.g., $1000 per person-rem for collective dose composed of 10 a
4 f.
d lower individual doses in excess'of 1 ares per year and $100 per person-ren for The Comission believes that the use of one or more of the individual doses.
above approaches could be appropriate depending on the practice under consider-1 ation for exemption from regulatory control.
V111.
VERIFICATION OF EXEMPTION CONDITIONS The Comission 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 considerations under which an exemption was issued remain In most cases, the products or materials comprising an exempted valid.
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 Comission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being observed.- The Comission will determine compliance 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.
O e
11
p,
'i
.\\
L,,;,
L l
t, i
ENCLOSURE 3 1
I Options For Numerical Values Within The Proposed Exemption Policy The proposed exemption policy is broadly based on the principle that, if s
adequate public protection is provided, exemptions for a particular practice or b
class.of practices can be based on justification of practice and a supporting cost-benefit analysis or detemination. Numerical values are proposed for individual and collective dose which, because of the small risks involved, h
would allow the merits of' exempting a practice from regulatory control to be based on simple analyses or judgments. These exemptions would involve
' practices in which individual doses to the critical population group would b limited to less than 10 mrem per year and the collective dose would not exceed L
100 person-rem per year.
I (1) The 10 mrem per year individual dose value The 10 mrem per year individual dose value together with the i
100 person-rem collective dose criterion provides the basis for exempt on decisions based on simple' demonstrations of justification of practice and <
I ALARA. Selection of this individual dose value is based on the premise a
per year, for a practice
- w that an individual risk approximating 10 providing some societal benefit, is a level of risk cons many regulatory bodies and one which is widely held to be of little The 10 arem per year value is one-tenth (1/10) concern to the individual.
of the 100 arm per year dose limit applicable to members of the public in This value can also be the draft final major revision to 10 CFR Part 20.
compared to other exposures received by members of the public as ind in Table 1.
1 Dose when used in this enclosure refers to total effective dose 1
equivalent.
1
6g/;&e r#
.+
f* e ff[g ~}~
p f
A \\
The National Council on Radiation Protection and Measurements (NCRP) recommends 1 mres per year as a negligible' individual risk level (NIRL) 3p which, if resulting from a specific practice, could be dismissed from
- p -
regulatory consideration.
However, they recognize that if an individual
,e d would be exposed to as many as ten sources or practices in a year, the use %#
of NIRL could result in the annual dismissal of up to 10 arem per year for c'
F an individual. The International Atomic Energy' Agency (IAEA) and several-national regulatory bodies have made similar (e.g., de minimis) determina-tions at individual dose values ranging from 0.5 to 5 mrom per year.
Alternative values below the 10 mrem per yea be chosen to be combined with the collective dose criterion. A 1 mrem per year value would translate into an individual risk at the low end of the
{#[
p wx range of values commonly identified by several regulatory bodies as being m" " " "
trivial to individuals. Somewhat lower, the National Radiological Protection Board (NRPB) has recommended a 0.5 ares per year-value as a de minimis individual dose rate when associated with exposure from a single practice.
The Atomic Energy Control Board of Canada (AECB) is' considering adopting 5 mrem per year as a de minimis dose rate for exempting specific sources and practices from licensing. This annual value of dose is stated as corresponding to the upper end.of.the range of risks considered insignif-icant by individuals in their personal decision-making. However, the AECB --
states that this value will be used to decide upon exemptions provided that the radiological impact is localized and the potential for exposures of large populations is small.
Further, the AECB will take into account in exempting any new practice, the dose received by individuals within the 1
critical group from all license-exempt practices.
Another alternative to the 10 mrem per year value would be 4 arem per year, a limiting value used by the EPA in drinking water standards, and being proposed by EPA as a BRC level for land disposal of low level radioactive waste. The 4 mrem per year value was discarded principally g because its selection could imply a degree of precision inconsistent with the value-judgment aspects of the proposed policy. Since the existing Commission statement of policy and procedures regarding petitions for BRC 2
.~
W^:
waste disposal refers to a range of doses (i.e., a few millires per year),
]
the significance of choosing between a 10 or 4 mrom per year value is i
diminished from the technical standpoint.
It should be recognized, S ocet however, that. existing Comission regulations and those of the (PA may be f
more restrictive regarding potential exemptions for specific practices.
f per year collective dose value (2) The 100 person-rem t
The 100 person-rem collective dose value together with the individual dose criterion, provides the basis for exemption decisions based on simple' This criterion demonstrations of justification of practice and ALARA.
plays a prominent role by limiting the number of hypothetical individual a 0.004 percent of exposures at 10 mrem per year to' ten thousand people or the U.S. population. As a result, the collective dose criterion serves as a constraint which would reduce the chance of a specific individual being exposed to multiple exempt practices at dose rates approaching the 10 arem Using the linear relationship between dose.and effect, g;
this collective dose criterion would provide high assurance that, for the k per year value.
exempt practices to which it is applied, no statistical fatalities would w
The 100 person-rem value has been usedea 5"'
be predicted per year of practice.
internationally'to represent a.de minimis collective dose on the basis $Nb that there would be no potential for reducing collective dose below this g *
.mbame value at reasonable regulatory cost.
vium bMW An alternative collective dose value of 500 person-rem could be selected.
.[
This value would retain the advantages of the 100 person-ren value (with the exception that a non-order-of-magnitude value could imply a certainty y
of knowledge not comensurate with the value judgments incorporate The 500 person-rem value would be consistent, although
.y.
proposed policy).
not truly comparable, with the Comission's societal risk safety goal if.
the societal risk goal was applied to the average 57 thousand people g
estimated (based on 1979 data) to be within 10 miles of nuclear power w %
s.,
cremco,o plants.
bu_et noe M t.
I 3
I TABLE 1 l
CDMPARISON OF INDIVIDUAL DOSE VALUES TO REFERENCE EXPOSURES R BY MEMBERS OF THE PUBLIC Fraction or Multiple of Reference Value DOSE OF. EQUIVALENT VALUES 10 arem/yr.
1 arem/yr 0.1 arem/yr r
Natural Background (excluding redon) ~ 100 mres/yr 0.1 0.01 0.001 Cosmic Radiation (U.S. Average)
~ 28 arem/yr 0.4 0.D4 0.004 I
U.S. Variation in Cosmic Radiation
- Washington D.C. vs Denver, C0
~ 24 arem/yr (26-50) 0.5 0.05 0.005 t
, Terrestrial Gamma Radiation
~ 28 arem/yr 0.4 0.04 0.004 U.S. Variation in Terrestrial Gamma Radiation - Atlantic / Gulf Coast vs. Rockies East Slope
~ 47 mrem /yr (16-63) 0.25 0.025 0.0025 One Hour of Air Travel at 39,000 feet - Enhanced Cosmic Exposure
~ 0.5 stem 20 2
0.2 4
. m& f"gc%
,9
. f@ / s # f +' % @
ge '$
N 4%
'.+
+
r 8 (3 * / p +,*,e ff*f 4
f 1
& Wp
[F'?;,,~(p+ f'p~o'~
7, g
E
%'(5
'W f'
d
- , d ' f c-* DS p
$ ~b g :'
Y U
F ENCLOSURE 4 f
c(
fh 8
[
1f the individual-exposures to members of the critical population group are less than a value of
%iced Y.y,
%p>*-
about 10 arem per year and the collective dose to the general public is less a
7 than about 100. person-res per year. This decision process recognizes that the,
small individual and collective risks associated with certain practices should require little balancing in terms of compensating benefits.
Second, the staff has provided, in the policy statement, an explicit recognition that rulemakings would constitute a finding by the Commission that the exempted practice was justified. Therefore, a person applying to utilize the exemption would not e,
need to address justification or ALARA.
e c+
gg c.rW.
m v =.4, vc 4 39',TWsthegu V4 W3M W WL, I
uue.n:m.
e.-
On the issue of multiple sources, the staff's recommendation that all practices be justified precludes a plethora of unjustified practices which would f
contribute to the probles of exposures to multiple sources.
If a practice involves limited individual and collective risk as defined, the detemination on whether the specific practice should be exempt from regulatory control would only hings on the proper assessment of.the individual exposures within the critical population group and the collective exposure of the general public.
If the Commission should decide that " justification of practice" is not required for certain activities, based solely on the fact that the consequent.
doses are below certain levels, the staff believes that the Commission is essentially opting for definition of a de minimis or negligible risk policy.
The staff and the ACRS Subcommittee on Nuclear Waste (now the ACNW) are b agreement with the Commission's decision (made in the March 30, 1988 Staff Requirements Memorandum) to focus a proposed Commission exemption policy on below regulatory concern rather than de minimis considerations.
A BRC policy is much more likely to'have a positive impact in assuring reasonable and proper Since a 8RC expenditure of resources to control small radiological risks.
policy implies an acceptable trade-off between benefits and costs of regulatory control, the staff believes that the concept of justification of practice must be retained, although the rigor used to evaluate justification can be reduced, g-,
to allow simple or straight-forward judgments if radiological risks are sufficiently small.
gpn wgv L
W-CONSIDERATION 2 - SPECIFICATION OF PRACTICES EXCLUDED FROM THE u <c.
POLICY The proposed policy includes a section which describes practices which would be excluded from the exemption policy.
Excluded practices would include, but not be limited to, radioactive material introduction into toys and products intended for ingestion, inhalation, or direct application to the skin (such as cosmetics). The staff believes that these classes of practice would be considered socially unacceptable regardless of how trivial the resulting dose
- 19ht be.
e WL Wouu Wc Sotg W
5%t gtebLWN
~3N i
mt (L --
prw WTC l'CuCN (lod (Au C9%M b l e d.t r e Meo
i y
.4 The need to identify practices excluded from exemption policy is closely tied to the role ultimately defined by the Commission for the " justification of practice" principle.
If the Commission should decide to reduce the role played l
by " justification of practice" as currently described in the proposed policy, the staff believes the need for identification of excluded practices would be accentuated.
As currently proposed, the section of the policy describing excluded practices provides guidance on the types of practices for whicle the Cornission believes that use of radioactive material is not justitisd.
CONSIDERATION 3 - CALCULATION AND USE OF COLLECTIVE DOSE ASSESSMENTS The collective dose can serve as both a measure of the impact of a practice on the exposed population and a mechanism for assessing the benefits of any regulatory constraints on the practice being exempted from regulatory control.
The assessment or description of the components of total collective dose must " %e '
be made to satisfy NEPA requirements. However, in performing cost-benefit analyses, several approaches can allow truncation or weighting factors to be applied. Use of these truncations or weighting factors can be supported if the purpose of the collective dose assessment is to discriminate between options or if large uncertainties are associated with dose assessments, particularly at very low doses or dose rates, so that assessment of certain components of collective dose serves little purpose. Three approaches are described below which could be ecceptable for use in decision-making regarding practices which are candidates for exemption from regulatory control.
Individual Dose Cutoff in Collwetive Dose Calculations l
In the background discussion accompanying the publication of the proposed l
10 CFR Part 20 revision ($1 FR 1113) dated January 9, 1986, application of a de minimis individual dose level cutoff was considered which would be applicable to the calculation of collective dose. The proposed application of this de minimis concept was recognized as having an influence on the evaluation of situations where very large numbers of people could be subjected to very low doses.
This provision was excluded frc= tM final Part 20 rule in deference to the formulation of the policy proposed in this statement.
3
~
l l
In essence, the individual dose cutoff approach would disregard extronely low l
annual individual doses (<0.1 ares per year) from the cellective dose impacts 7l],y veo associated with a practice being considered for exemption free regulatory control. The recommended value for the individual dose cutoff in this approac a ou is 0.1 ares per year which represents an individual lifetime risk of about This risk level is used by other Federal and State agencies to make 10 judgements on the risk of chemical carcinogens both in the environment and as residual containinetion in food products.
In these situations, substantial Typically, numbers of people can be exposed at these individual risk levels.
no actions are taken when individual lifetime risk is less than 10'", even whe significant populations could be affected.
Exposures of about 50 million people would have to occur at the 0.1 area per year level before use of the linear hypothesis would predict a societal health effect. Where collective doses to a population are evaluated, the acceptability of the associated potential risks can also be compared to the sum of the potential risks from background radiation experienced by the same population over the same time Consequently, even though some practices could result in very small interval.
but finite doses to very large numbers of people, the comparative collective risk to which these people are routinely subjected is also very substantial and proportional to the number of people considered.
It should be pointed out that, although the NCRP supports the cutoff concept, neither the ICRP not NRPB has accepted the use of an individual dose cuto The NRC's Office of General Counsel has noted collective dose calculations.
7 that use of a collective dose cutoff in the mill tailings decision would have QW reduced the calculated benefits of the regulations.
Assionment of Varying Monetary Values to Collective ' Dose Components In assigning values to collective dose, a value of $1,000 per person-ree has been used previously by the Commission.
It was first used in 10 CFR Part 50, Appendix I for determination of ALARA. However, it has been recognized that the more universal application of the $1,000 per person-ree, when applied to
- to 10 per summation of doses representing individual risks less than 10 year, for purposes of determining ALARA, can in some instances result in undue expenditure of resources which eight better be applied to other uses.
4
II I EIII 8
i Numerous regulatory bodies have determined that a dose an the order of 1-10 ores per year represents a range of risk in which individuals are unlikely to take any actions te further reduce their risk.
This 10 erse per year level serves, in the proposed Commission Policy Statement, as a criterion, together with a collective dose criterion, for determining if a simple analysis or a more detailed analysis is required for approval of an exemption. This level may also be an appropriate value at which to reduce the valuation applied to collective doses for purposes of ALARA or cost-benefit analysis.
For example, collective dose assessments for purposes of exemption policy may be assigned monetary values as follows:
$1,000 per person-tem for collective dose composed of individual doses in excess of 1 mrem per year.
$100 per person-rem for collective dose composed of individual doses at or below 1 mrem per year.
The valuation of collective dose at $100 per person-rem for individual doses at or below I arem per year reflects the belief that the individual risk associated with this small level of dose does not warrant the same level of consideration as larger doses. This is not meant to imply, however, that these doses can be dismissed entirely.
In keeping with the lineae hypothesis for radiation protection planning, these small levels of dose should be considered when establishing that the overall detriment of the practice is adequately balanced by the benefits of the practice.
Truncations of Dose in Time and Space Truncations of collective dose in either time or space have been used in the past. These truncations could continue to be used in situations where a choice between alternatives is not clarified by unbounded r.ollective dose assessments.
For example, collective dose may be truncated to reflect the limitations of an engineering design under consideration (several hundred years) or collective dose from effluents may be limited to populations within a specified distance of the releasing facility.
1 5
1 j
Responses to Commission Questions Regardino Basis for Prior BRC Actions and Discussion of Uncertainty in Oose Resoonse coefficients
)
i Question:
i In 1981, the Commission revised Part 20 to permit disposal of scintillation 14 cocktails and aniwl carcasses containing trace concentrations of C or sH l
without regard for their radioactivity. Also, specified curie amounts of both isotopes may be released annually into the sewerage system.
Some regulatory control remains (e.g. recordkeeping and limitation on use of contaminated carcasses) but in effect, once released to the environment NRC exerts no l
l further control, thereby setting a floor to AL. ARA for these specific isotopes and applications. What calculations of societal and/or individual risk were l
employed in determination of these exempted levels? Were the models and assumptions the same as those used to arrive at tables of exempt quantities elsewhere in NRC regs?
Answer The analysis provided with SECY-81-77, Final Amendments to 10 CFR Part 20 on Disposal of Certain H-3 and C-14 Wastes, included calculations of individual and societal risks associated with the disposal of trace concentrations of H-3 and C-14 without regard to their radioactivity.
In the preamble to that final rule, estimates were provided that total quantities of radioactive material affected by the rule would be 28 Ci of H-3 and 6 Ci of C-14 annually. The unrestricted disposal of these materials (except as to their non-radioactive hazardous properties) could result in a maximum radiation dose t's exposed individuals of less than 1 elllires per year, and less than 1 socistal health effect over the next 1000 generations.
These impacts result Doses from one years practice under the exemption at present levels of use.
were derived using incineration as the disposal method, Regulatory Guide 1
-. ~ --
}
[
1.109 as the basis for breathing rate assumptions and for inhalation dose conversion factors, and ORNL-4992, A Methodology for Calculating Radiation Doses from Radioactivity Released to the Environment, for dose calculational methods and associated conversion factors.
Doses associated with disposal of l
H-3 and C-14 using the sanitary sewage system were calculated to be much 4
lower than doses from incineration.
The exempt quantities rule was issued much earlier, in the 1960's. The modeling and criteria used in that case were much simpler; if an exempt quantity was inhaled or ingested, the critical organ would not receive a dose i
commitment in excess of 500 ares.
e f
(
t y
i 4
2
I
.=
Question:
For purposes of enforcing the many de facto BRC limits, what explicit allowance is made for instrument and measurement uncertainties?
Answer:
There are instrument and measurement uncertainties associated with manufac-turing consumer products, and with NRC activities aimed at assuring compliance with regulatory restrictions placed on the' manufacturer. These uncertainties.
.!'~ as applied to the manufacture of products for exempt distribution, are not so j
different from measurement uncertainties applicable to other activities involving use or release of radioactivity.
Applicants for licenses to manufacture products containing byproduct material for exempt distribution are selectively required to submit " quality control procedures to be followed in the fabrication of production lots of the product and the quality control l
standards that the product will be required to meet" (10CFR32.26(b)(15)).
i With a reasonable quality assurance program, measurement and instrument
~
l inaccuracies are not a major source of uncertainty in t.he dose analyses for exempt products.
For decommissioning and some waste forms, difficulties in fully assessing the contamination present unique problems which must be carefully considered in rulemaking or licensing actions in these areas.
l Assessing residual radioactivity for the purposes of license termination involves the use of historical information to "look for" potential areas of I
significant contamination and application of statistical analyses to estimate doses since it is impractical to sample every inch of a facility or site where there is potential for contamination. The keeping of appropriate records to assist in decommissioning planning and in termination survey design has been addressed in the recently published decommissioning rule (June 27, 1988;
$3FR24018). The verification process is being considered in an ongoing Battelle PNL contract which is providing input to the development of a policy or rulemaking on residual radioactivity criteria for license termination.
In a
mavvm n
s.
addition, some waste streams, such as dry active waste, present a particularly
~
difficult assessment problem which must be considered in any waste stream specific BRC waste rulemaking.
l, S6 99 6
L e
e' n
s S
4 O
4 2
07/13/88
e i
Question:
What is the origin of the DDT value of 2 nanocuries per gram used to define radioactive material for purposes of transportation?
l 1
Answer:
The Department of Transportation regulations in Title 49 of the Code of Federal Regulations contain a definition of " radioactive material" which excludes materials having a specific activity not greater than 0.002 microcuries per gram. This definition was taken from the Transportation Safety Act of 1974 l
(P.L. 93 633), Section 108, where its applicability was limited to l
transportation of radioactive materials by passenger aircraft.
Prior to that,
+
the definition has had broad applicability and for many years has been included in the Regulations for the Safe Transport of Radioactive Material (Safety
~~
Series No. 6) of the International Atomic Energy Agency (IAEA).
i The IAEA explanation (IAEA Safety Series No. 7) of the reason for its definition of " radioactive material" including a lower-cutoff of 70kBq/kg (0.002 pei/g) is "to avoid bringing within the scope of the regulations many substances, often naturally occurring, which contain insignificant amounts of i
radioactivity, and which, if transported, pose no significant hazard."
,e 4
As to the origin of the limit, the French CEA, following its 1968 examination of the IAEA Transport regulations, offered the following explanation to the European Atomic Energy community-Euratom:
Working downwards, there necessarily comes a time when the specific activity of a material is so low that it no longer presents av external or internal radiation hazards; this limit has been fixed conventionally at 0.002 pti/g.
It is a limit relating to each gram of material and not a lia'it relating to the nuclide itself contained in this material. Below and up to this limit, the Regulations do not apply.
This value probably originated as follows: Plutonium 239 was selected as being the most representative nuclide commonly met in transport. The MPC 07/13/88 3
'l
-l (air) was, according to the ICRP recommendations at that time,
~7 3
6 x 10 pCi/m for continuous 168 hour0.00194 days <br />0.0467 hours <br />2.777778e-4 weeks <br />6.3924e-5 months <br /> per week exposure. Taking 0.3 mg/m, i.e. 3 x 10 g/m, N the dust content of polluted air, the 3
- d 3
radioactive concentration of this air which could reach the above MPC was l
a maximum of-6'x 10~7 = 0.002 pCi/g.
~4 3 x 10 i
Today's equivalent of this number, taking the internationally recommended 3
-6 3
derived air concentration (DAC) for Pu-23g of 2x10'I Sq/m (5x10 pci/m ) for occupational exposure at 40 hr/wk and conv'erting for continuous exposure of the
.." general public would be 0.0004 pct /g.
It is not immediately clear if this limit on the definition of radioactive material derived through consideration of the inhalation pathway would have applicability to the wide range of practices for which "below regulatory concern" determinations could justify exemptions from regulatory control.
b i
GW66vTn
~ - -.
4
i i
l Question:
t Acceptable levels of residual surface contamination are designated in Reg.
Guide 1.86.
Facilities with surface contamination levels below those specified may be released for unrestricted use.
How many and what types of licensee facilities have been decommissioned using these criteria?
Answer:
The " Acceptable levels of residual surface contamination" of Regulatory Guide 1.86 have been used since June of 1974 for releases of reactor facilities to unrestricted access followin~g decommissioning. The same set of j
numbers was used in the decommissioning of reactors prior to issuance of Regulatory Guide 1.86 and since at least 1970. At that time these numbers were specified in a draft position from the Division of Materials Licensing dated April 22, 1970 (Attachment 1).
Since April of 1970 NRR has teminated
. reactor licenses for 31 non power reactors (including critical facilities) l under the above surface contamination criteria.
Since 1981, NRR has added a requirement for specific gamma emitting radionuclides (Co-60, Eu-152, and Cs-137) that are not surface contamination. /
These radionuclides must be removed such that the radiation level from them is.-
.less than 5 microroentgens per hour above natural background as measured at one meter from the surface. Alternatively, since 1982, a licensee is pemitted to demonstrate that reasonable occupancy of an area would be such that the potential exposure from these gamma-emitting radionuc1 Ides would be lost tnan 10 area per year.
Examples of these criteria are provided in Attachment 2.
1 e
I f
I i
The following summarizes the status, as of March 8,1988, of reactors f
(including critical facilities) that have been shutdown with continued license l
or decommissioned:
Type of Licensee Facility Number Shutdown or Decommissioned 17
{
Power, Test, and' Nuclear Ship Reactors Research Reactors and Critical Facilities i
with Continued Possession License 8
33 Dismantled Research Reactors 17 Dismantled Critical Facilities Decommissioned Demonstration Nuclear 4
Power Plants (00E Owned) l l
The criteria generally used by HMSS for releasing facilities for unrestricted l
use are contained in two documents. These documents are (1) " Guidelines for i
i Decontamination of Facilities and Equipment Prior to Release for Unrestricted ;-
Material", (Attachment 3) and (2) Disposal or Onsite Storage of Residual Thorium or Uranium (Either as Natural Ores or Without Daughters Present) From Past Operations Provided to the Commission in SECY-81-576 dated October 5, The guidelines have been used to release on the order of 20 facilities 1981.
or buildings that processed natural U or Th, Pu, enriened U or depleted U.
There are also on the order of 10 facilities or buildings where release is The pending the confirmatory survey or the removal of residual contastnation.
criteria in the second document has been used to release land or soil on the order of,10 times.
In addition, over 19 requests for release using those criteria are pending.
Occasionally, site specific criteria are established.
These numbers do not include facilities that may have been released by the regions.
,U,-.~
. _ _ -, ~,
._.....,-..<e
4.*
ATTAcez a s.
.. t-i s.1 l-
.e l
s
. e.
cultcL.1123 FGt ICCOiT/JC13710;i OP FACILITim A':D EQUIFIET FAIOR to RE!X.43E FOR Ui"JCC17.1CT3 USE 1 0F LIC2SES FOR 3'.*FRQD'.*CT, scURCE, *m SPECII.L INCLTAR l'.ATERIL l CR n:;t.31%TIO:
3 t
(
4 U. S. Atomic Energy Ccanission Division o'r l'.sterials Licensing
.. Washington, D. C.
1%b) j l.
l I
i i
8 g.
.f APRIL 22,1970 I
)
t.
e -
2, s.
a.*
3 2*
i
%t e
s.
l l
,e S
g
' :N O.
i
~*
)
1 e.
/,
he instructions in this Cuide in ponjunction with Tables I and II speeify the radioactivity ased* radiation, exposure rate limits which should be used in accomplishiria;, %e decontamination one aunay sf t or release
. sufaces of premises and equip-ant prior to abandonssaDe limits in for unrestricted use.
to premises, eq alpment, or sers.p containing induced radioactivity l considerations pertinent to their use
?
.. for whlek the tsdiolof,1cahe release of such facilities or itcas from
. may be difrerent.
reguintory control will,be con Jde, red on a case-by case basis.
)
De licensee shull make a rgasonable effort to aliminate l
1.
residual contkaination.
Radioactivity on equip =ent or surfaces shall not be covered
't.
- by paint, plating, or oGer coverir.C materica unless con-tanination levele, as detemir,ed by a survey and doeunented, t
are below the limits specified in tables 2 or II prior to A reasonable effer.t must be ande to applying the covering.
sinimite the contamination prior to use of any covering.
.J*
- 3. De radioactivity on the interior surfaces of pipes, drain Oef l
lines, or ductwork shall be deterninto by asking asasurements r.
at au traps, and other appropriate acetas points, provided that contamination at these Icee,ations is likely to be repre-sentat.tve of contaminatten on the interior of the pipes, drain i
Surfaces of praaises, equipment, or scrap
- ~
lines, or duetverk.
1,*
which are likely to be contaminated but are of such site, consthletion, or location as to anhe the surface ir.accest.ible for purposes of measure =ent shall be presumed to be contaminated 4'
/
in execss of thd limits.
3 Upon request, the Cornission may authorite a licensee to relinqu li.
possession or control of premises, equipment, or scrap having surfaces contaminated with mater'lais in excess of th j '
speelfied.
circumstances such as msins of buildings, transfer of premises
.['
to another organisation contipuing work with radioactive asterials, or conversion of facilities to & long term storage or standby status. Such regnests must:
..s **
Provide detailed, specific inferr.ation describing the premises, equipacut or oeray, radioactive contaminants, and ne nature, a.
extent, and degree of residual surface contamine. tion.
Provide a detailed health and safety analysis which reflects b.
that the residual amounts of at.ter'inis on surface areas, together with other considerations such as pros la an unreascoable risk to the hea14 and safety of the public.
C..
c y
O f
j
\\
Prior to release of premises for unrestricted use, %e lieessee shall 5
sake a compreheritive radiation survey which astr.blishes that conte.m.
Anation is wi%1n the limits spec,1fied in Tables I or II. A copy of the survey report shall be filed 41th the. Director, Division of 20%.h and also the'
- Materiels Licensing, US/IC, W.shington, D. C.
Director of the Regional Division of Co::pliance Cffice having The report shv.34 be filed at least 30 days prior to durisdiction.
The survey report shall 2
,the pihnned date of abandescen.
a.
2dentify the preadses.,
Show thkt masomble effort has becu sa6e to elininate resit.uti b.
eenta'aination.
Describe.We unope 90 me survey sued Central procedures followed.
.e.
State %e risullnes of %e survey in units specified in the 9..
d.
o Atratruction.
To11 ovine review of the report, the Atc will consider visiting the
., facilities to confirm the survey.
s s
a.
g S
,8 g
9
.g t
'=
C 9
- ,'s
o g
e-
. Y.4
_searAer chemunanos treeLs.II.,
i e
e e
TA%. E 11_
N ISOT. OPE (
MPTA1,IN RDtffAst.g TUTAL RDIOVABLE TABLE 1 IU I verse.e 2
1,000 dpm e/100 c:s A
2.
set, U-235, 3-230, 10,000 dye e/100 em 1,000 dpa e/100 co 3, coo dys s/100 cm est, Th-232, and i M.ts is e s 2
ecloted decoy predeets
-25,000 Jps 3/200 ao 3,,,,,,,W 2
1 1
ser isotopes whten decay 1,000 dye e/100'em 100 dra e/100 cm -
500 dye s/100 cm 100. dye afl00 01pha estesten er by weteneous fission Mets f-'co 2
_ 2.590 dpa e/100 en W
0.4 seed /hr et 1 es(3) 1,003 dpa5y/100 co#
Ave-eq /hr et 1 en(5)-
1,000 dpa2-1/1002 U.2 etc.d to-gence emitters (iso-
. e.
pes with decay modes ressem III W them alpha amission
, 1.0 r.: d/hr et 1 en spentoneous fissioe)
I For exa:sple, if all bete-geese readie2s were less than 0.4 need/hr et 1 d e: der Table II pre-tither Table 1 er Table 11 may be used.
Tablo 1.could be used; but if the semi:imes reading were 0.0 stad/hr, esteriel could be release
)
viding the everste was less then 0.1 orod/hr.
blished for alpha Whero surface contaminetlea by both alphe and bete-ge=se esittig 1setspes exists, the linits esta
)
est beta-gasus emitting feetepes shell apply 17.'p'ently.
i meteriel es Ao used la this table, dyn (disfategretiene per einste) meene the rete of e
~
for beek-1) greend, effielency, and geometric feeteen esseeleted i.ith the instrumentatten.
l of surface seem ehe11 be deternieed by wiplag that ares, or 2
The ameent of renewable radiometive materiel per 100 es d
, with dry filter er soft abgerbent peper and with the rppliestica of ne erate pressrd i) la detensining reseesbic con-d ta:sinettoa en objects of lesser surface eres, the pertlaent levels eksil.be re uce surface shell be wiped. -
b
. essured through not more than 7 milligress per stearet centimeter of tetel absor er.
5)
For objects of lesser m
M,..n raents of total contaminant. thall not be evers;.ed crer aste than 13 sgeste meters.
e ENCLOSURE 6 Staff Response to AC W Comments On July 21,1988, the Advisory Committee on Nuclear Weste reviewed an eariter draft of the Comission paper with the proposed policy statement and other The Comittee's comments were transmitted to the Commission on enclosures.
August 9, 1988 and several areas of consensus have been identified in the body W" a of the Comission paper.
- c. c ow; w w w k ex.*
The ACW has stated that exemptions 1 ould be granted for practices whose annual and lifetideQndividual risks} 1ess than 10 and 10-5, respectively, 4
and that, under these conditions, any restriction on collective doss is The staff, however, believes that both the 10 arem per year unnecessary.
individual dose (increased from 1 sros per year in the previous draft policy) and the 100 person-rem collective dose are necessary to define a threshold The AC W (and the x M O"de below which ALARA cost-benefit analysis may be waived.
i%,
staff'sproposedpolicy)Supportsthepossibilityofgrantingexemptionsfor eb practices not meeting the aforementioned criteria based on cost-benefit analysis rw w 640T Mt2:
ew (which isplies a role for collective dose). Thus, if a threshold is to be defined below which ALARA cost-benefit analysis may be waived, cutoffs on both individual and collective dose appear logical. The staff would also point out wsu that other Federal and State agency decisions on cle infer a role for collective dose even down to implied de minists risk levels
$p i 4
(10-6 to 10 lifetimerisk).
,wWf 6*
qq udT6 E
p3 sM O,. u.
,g,.
r The ACW has also recomended that the policy statement should require all past NRC exemptions to be reviewed for compatibility with the proposed policy. The staff could support this position and could develop a plan and estimate the e,, c c resources needed for such an undertaking. The staff believes that cosnitting to such an undertaking in the policy statement is premature.
Similarly, the ACW suggests that prior methodologies for performing cost-benefit analyses should be carefully reexamined. Again the staff could support this position but I believes the issue does not need to be resolved prior to issuance of the policy statement or discussion of the issues at the forthcoming international workshop.
Finally, the staff believes that it has logically presented a policy addressing the entire complex issue of exemptions from regulatory control. The staff q recognizes that its recomendation goes somewhat beyond the Comission's desire for a single generic nun 6er for exposures that are below regulatory concern.
However, the staff believes that a policy along the lines proposed (including definition of individual and collective dose criteria for simple demonstration of
- justification of practice' and Al. ARA) will have a more meaningful impact on the granting of exemptions which will assure public health and safety while fostering a more logical expenditure of resources to control levels of risk below basic standards of adequacy.
e 2
=aanuestow.o.s.eesas
? q, SW4.W. /,. I f
man lcW)
APR 211982 Docket No. 50-141 Dr. Roland A. Finston Otractor Health physics and 8tosafety Stanford University 57 Encina Hall (tanford. Callforata g4305
Dear,
Dr.' Finstant 17.1981 we provided radf atton eriterta' forN1 ease By letter dates March
,ef the dismantled stanford Reseirch Reactor to unrestricted access. That Briteria spectfled Reg. Cuide 1.86 for surface contamination and 8 atero
- Rea par, hour at one meter for reactor generated, gaena acttting (sotopes.
' Since March 17, 1981, we have reffned further ove position trith reipect to relgse criteria and have determined that' radiation from samma esittfag isotopes is also acceptable if 'the potential exposure.te individuals is 4,ess than 10 mRea per year.with reasonable occupancy assumptions. If lms wish to justify gamma exposure rates from reactor generated isotopes $44t
. Ore greater than 5 niers Ren'per hour..you should show that reasonable
- occupancy of that area would be sufft.ctently less than 2000 how per. year, ethich would result in exposures of less than 10 mRea per year stacar 1/
Vnj
/
James R..M111 r. Chief Stdndardtaati a and Spec'lal projects tranch Division of Licenst,ng 9
t 4
6 e i
J
- /,l( d *8 * * $
. u=iew.
3 fg....'
- ' NUCLEAR REGULATORY COMW.lssl0N f
3
[
f amiwevow.o.s. mss Ma.rch 17,1981.
.a\\w.w*.
oce s
Socket No. 50-141,.'.
\\
s
, *... ' =....
I
- ^u Dr. Roland A. Fins' ton
- e Director. Health Physics and 5fosafety i,
Stanford University i
57 tacina Hall.
Stanfor11 California 94005
Dear.Dr'. Finston:
J ly letters dated December 9,1977 pad June 3,1980 you pr'evided data on the fasidual activity at the dissantled Stanford Research Reactpr. You "further requested terninstion of reactor License No. R-60.
..ee
..t*,.
As discussed with you, we hsve now determined the levels of r'adiation l
that.would be acceptable for release of the stanford esactor facility
- i to smrestricted acces's. Enclosure No'.1 provides that criteria. Enclosure Do. 2 (Regulatory Guide 1.86) is also provided.for your informati,on.
1hereforei'we, can terminate License No. R-60 when our independent sbrveys
. confirm that you have removed sufficient residual-radioactivity toineet 1
the criteria of Enclosure No.1..
py of.this letter to the NRC Region V Office we request that they.-
~
is,a compliance with.y survey when you notify the s'.
By ett a confirmatot Enclosure No. I criteria.
incerely y&
I J n E. Stols. Chief J 0 rating Reactors Branch d4 I
vision of Licensi,ng
-inclosures:-
- 1. Radiation Levels for Release to Unrestricted Access
- 2. Regulatory Guide.1.86 s
ec w/ enclosure 1 only:
See next page
'g.
.,a--n,--
,_,n,,
' r.... ' >
x....
'd**.
Enc,1osure 1 3
RADIAT10H LEVELS FOR RELEASE OF REACTOR
(
. FACILITY TO UHRESTRICTED.
ACCESS SurfaceContaminthon' j
l Surfaces must be decontam nated to levels. consistent with Table 1 of Rep., Guide 1.85.
Enficact'ive Material Othe'r Than Surface contesination (to 6l t
Co 10. Es 152 and Cs 137't$st my exist.in concrete, couponents.
i stevetures, and soil' gust be removed such that the radiation levt f.am these isotopes is less than ipa /hr above natural backgroundU -
,as estasured at one met. er from surn ce.
g
- seneral Site survey proce,dures acceptable to the NRC avst be used..'
..s I) Radiation from natu' rally.oc'ivrring radioisotopes as measured.i.t a comparabl
'uncontan.inated structure or exterce.r soil surface.
s O
e g
e
i Arreeu w 3 I
I GUIDELINES FOR DECONTAMINATION OF FACILITIES AND EQUIPMENT PRIOR TO RELEASE FOR UNRESTRICTED USE OR TERMINATION OF LICEN5El FOR BYPRODUCT. SOURCE.
1 l
l U.S. Nuclear Regulatory Comission Utvision of Industrial and Medical Nuclear Safety Washington, DC 20555 August 1987 e
e e
4 r -,,, -.. - ~,,, _,,.,...... _. _
f The instructions in this guide, in conjunction with Table ! specify the decentamination and survey of surfaces or promises and equipment prior to abandonment or release for unrestricted use. The Ifmits in Table 1 do not apply to premises, equipment, or scrap containing induced radioactivity for which the radiological considerations pertinent to their use may be different.
The release of such facilities or items from regulatory control is considered on a case by-case basis.
The licensee shall make a reasonable effort to altainate residual 1.
contamination.
Radioactivity on equipment or surfaces shall not be covered by paint, 2.
plating, or other covering material unless contamination levels, as determined by a survey and documented are below the limits specified in Table 1 prior to the application of the covering. A reasonable effort must be made to minimite the contamination prior te use of any covering.
The radioactivity on the interior surfaces of pipes, drain lines, or 3.
ductwork shall be determined by making measurements at all traps, and other appropriate access points, prov' ded that contamination at these locations is likely to be representative of contamination on the interior of the pipes, drain lines, or ductwork. Surfaces of premises, equipment, or scrap which are likely to be contaminated but are of such site.
construction, or location as to make the surface inaccessible for purposes of measurement shall be presumed to be contaminated in excess of tw limits.
Upon request, the Commission may authorite a Itcensee to relinquish 4.
or scrap having surfaces possession or control of premises, equipment, limits specified. This may contaminated with materials in excess of the include, but would not be limited to, special circumstances such as rating of buildings, transfer of premises to another organisation continuing work with radioactive materials, or conversion of fachlities to a long ters storage or standby status. Such requests must:
Provide detailed, specific infotsation describing the premises, equipment or scrap, radioactive contaminants, and the nature, extent, a.
and degree of residual surface contamination, Provide a detailed health and safety analysis which reflects that the b.
residual amounts of materials on surface areas, together with other considerations such as prospective use of the premises, equipment, or scrap, are unlikely to result in en unreasonable risk to the health and safety of the public.
I I
j i
5.
prior to release of premises for unrestricted use, the licensee shall make a comprehensive radiattor, survey which establishes that contamination 1s within the limits specified ih Table 1. A copy of the survey report shall be filed with the Division of Industrial and Medical Nuclear Safety.
U. 5. Nuclear Regulatory Comission. Washington, DC 20555. and also the Administrator of the NRC Regional Office having jurisdiction. The report should be filed at least 30 days prior to.the planned date of abandonment.
The survey report shall:
a.
Identify the premises.
b.
Show that reasonPble effort has been made to eliminate residual l
contamination.
Describe the scope of the survey and general procedures followed.
l c.
i d.
State the findings of the survey in units specified in the instruction.
Fo110wieg review of the report, the NRC will consider visiting the l
L facilities to confim the survey.
l G
9 9
I 6
1
H I
mi l ll i
e taatt t acotevant seuract comessantsen trvtts aggotsgb c f seu1W d f arseBynathaf entists*
r r
1.cos eps./tes ca
.eto 5-235. s.tje,and 5.seo dos ertoo ed 15.ese ape oftes o sectates decer products ossereales. 9e-226. Re-Ite, les estfee est see 4ettes est te dem(tes car i 23e, i:5220. po-231
~
- -227o I-125. 1-129 wasto in-232. Se-98 19eO.4e(100.en!
3000 dpa#100 eel tes dearles cul
>t23o Re-tre. 5-232. 1-126, 131o I-133 ete-geurs cettters (ast19 des
~
Sees 4 e ey/100 aof 15.988 dre er/tes coI lege beer /1esest Ith dEteF asses other then Igen eatssten er spontaesses Isslee) encept Sr-9e and thers seted stove.
dettag sectedes entsts, tse itetts esta61tshed for alphe-and Nets-gesme-emettley surface contanlastles by teth alphe-and R _
escisdes shee N opply Sedependently.
na esed to this te61e. dem (destategrettoms per mensee) asens tse rete er emessson er redsesettee seteriet
- tten, cesets per senete etterved by se appesprSete detector for nachgeseed, efficiency. and geometric factort essecte For e6)ects of less surface aree, the everage leesserements of everage contentaset sheen aet to everaged over more tems i sgssee seter.
sheeM he dertved for each such e6 ject.
% menisse contesteettee levet appI9es to se eMe of met more 98ee les emI.
%e asemat of venove61e vedtoective metectet per DOS emI of serfw sees sheen be detevetoed by wip0eg th fth as appropreete testrement of abeertent posee, appfylag moderete pressere, and essenstag the assent of endteectlee setectal se 18e taous efftctency.
propertteme11p amo the sottre surface shesM te artped.
d The avevege see sestase vedtetten levels essee$sted w0th surtees centesteettee resettfay prem tots-games settte f
0.2 aredthe at I en and 1.0 ared/hr et 1 ce, respect 9 eely. seesered Stenegh met more tBee 7 ellitgrams per egeere teette
~
tetet eerserter.
ovestion:
The Commission was recently made aware of some of the history behind the licensing of 3M static eliminator devices. The general license for these devices allowed up to 5 nCi of removal activity without any action being required on the pan of the general licensees. Do similar provisions exist in other licenses? What is the origin of. the 5 nCi allowable leakage rate? What assumptions of risk were made to justify this numbert Answer:
,; The 3M ststic eliminator devices are used under a general license provided in 531.5 of 10 CFR part 31 ' General Domestic Licenses for Byproduct Material.'
Users of devices under that general license are required, with certain exceptions (set out in $31.5(c) (2)), to test the device for leakage of radioactive material at intervals no longer than six months or at sveh other intervals as are specified in the label on the device. Section 32.51(b) of 10 CFR part 32. ' Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material.' states the infomation which a manufacturer must :vbmit in an application for approval of a label which provides a test interval greater than six sonths.
If the test for leakage results in detection of 0.005 microcurie (5 act) er more removable radioactive material, the general licensee is eequired to immediately suspend operation of the device until it has been repaired or, shall dispose of the device by transfer to a specific licensee. The general licensee also sust submit to the NRC a report containing a description of the event and the remedial action taken.
Similar provisions for " leak testing.' suspension of operations, remedial action. and reporting are routinely set out in specific licenses which authertae the use of licensed material in the form of a sealed source.
i
,e e
L 4
a Radiation safety programs for the use of licensed material as a sealed source are structured on the presumption that'the radioactive material will not leak from the sealed source pand contaminate the environment or expose individuals to radiation. The leak test is a check on the validity of that presumption.
j p
The 5 nCi quantity.is not an allowable leakage rate. It is a point at which certain regulatory actions are to be taken. The detection of 5 nC1 or more is
]
l considered as a flag or signal that safety problems may exist.
]
The 5 nC1 quantity has been used for about 30 to 35 years in the NRC (AEC) regulatory program and in industry standards. During early use, the 5 nCi quantity applied to alpha emitting radionuclides and a 50 nC1 quantity applied
,;.to beta-penna emitters. A primary consideration in early use of these quantities was the general availability and use of instruments which could sessure the quantities.
In about 1960, for ackninistrative convenience in th
%'f j
regulatory program and with better instruments available, use of the 50 nC1 pg quantity was largely discontinued and a single quantity. 5 nC1. has since been e*o
~
used.
l The 5 nCi quantity, which serves as an initiator for further actions.
l-historically has not been justified on specific assumptions of risk. It has l
generally been considered a sufficiently small quantity that, by itself.
presents very low levels of radiation but is readily measured. It is not used
?
in the regulatory program or by industry as an allowable leakage rate.
l Further, although termed a " leak test.' the usual test performed by users of sealed sources and devices containing sealed sources is 's ' contamination test" and a positive indication does not always indicate leakage. A positive indication does show a need for further evaluation.
...m
_-._.,....._-.sm.m.,._
i Question: What are the uncertainties in the estimates of the biological effects-of ionizing radiation?
Answer:
The principal reference used by NRC to estimate the biological 4
effects of low-level ionizing radiation is the 1980 Report of the Consnittee on the Biological Effects of ionizing Radiation of the National Acadeny of $ciences entitled, 'The Effects on Populations of Exposure to Low Levels of Ionizing Radiation' (BEIR 111). BEIR.111, however, did not provide a precise set of health risk estimators for-low levels of ionizing radiation, but rather presented a range of 4
acceptablehealthriskestimatorsforbothsomatic(cancer)and l
genetic health effects. The range of values for radiation-induced cancer was based on available data from high' doses to human populations.
Various mathematical methods of extrapolation from this i
high dose data were then used to estimate the probable health effects ;
l at low doses. The BEIR !!! Constittee cautioned that the values from the models were ' based on incomplete data and involve a large degree of encertainty, especially in the low-dose region." It also stated 7
that ' estimates of risk at low doses depend more on what is assumed about the mathematical form of the dose-response function than on the I
data themselves* and that 'the Committee does not know whether dose 3
rates of gasus or x rays (low LET) of about 100 mrads/yr are detrimental to man."
l In estimating the somatic health effects, the BEIR !!! report utilized epidemiological data obtained from studies of survivors of i
~
_~
j Hiroshima and Nagasaki and, to a lesser extent, other irradiated populations. The variations in risk estimates were due to factors l
other than just uncertainties in the Japanese and other epidemiological data bases. As noted above, most excess cancers have been observed following relatively large doses delivered at high dose I
rates. ' Moreover, the observation time of the exposed populations does not yet extend through the lifetimes of the irradiated individuals. Therefore, assumptions must be made about how observations at high doses should be applied at low doses and low dose rates for radiation of a given type (LET) and how risks from radiation might vary long after the time of exposure.
l
~
l l
l The BEIR Ill report examined three dose response functions in detail:
1 (1) linear, in which effects are directly proportional to dose at all doses; (2) linear-quadratic, in which effects are very nearly proportional to dose at very low doses and proportional to the square
{
ofthedoseathighdoses;and(3) quadratic,inwhichtherisk 4
varies as the square of the dose at all dose levels. However, in view of the results of preliminary analyses based on dose assessment of Hiroshima and Nagasaki survivors, the quadratic model is not being considered as viable at this time. All mathematical functions assume that there is no threshold dose below which there is no excess health risk. For low levels of low LET radiations, the BEIR !!! recomended
, the use of a linear-quadratic dose response function.
To estimate the risk of radiation exposure beyond the years of observations, either a relative risk or an absolute risk projection 2
[,} I s
- Q;
. model(orsuitablevariations)mustbeused. The relative risk projection model projects the currently observed percentage increase i
a
.in cancer risk, per unit dose into future years. An absolute risk O'
model projects the average observed number of excess cancers per unit l
dose into the future years at risk.
Because the baseline rate of e
cancer incidence rises dramatically with age, the relative risk projection model predicts a larger number of radiation induced cancers in an aging population for years beyond the periods of cbservation; consequently, the average lifetime risk calculated according to the relative risk model is higher.
The BEIR Comittee did not specify which projection model is the appropriate choice for most radiogenic cancers.
Based on sensitivity I '
studies regarding this choice risk estimates derived using different models could differ by a factor of about 3.
When such variations are combined with the effect of different choices for the dose response function (i.e., linear vs. linear 4
l quadratic) the risk estimates as indicated in BEIR !!! range over a factor of-about 6.
Because of a smaller data base, even greater uncertainties exist regarding risk estimates for individual body L
organs, in utero exposure, and high LET radiation, such as fission neutrons and alpha particles from radon decay products. There is also the question of describing the health risk in terms of morbidity R
or mortality.
lI E
3
A, r
.d.
Since publication of BEIR III, the assess, ment of doses received by Hiroshima and Nagasaki survivors has been revised, It'.D al analyses-comparing results based or, the old dosimetry systen (T650) and on the revised dosimetry system (D586) have been reported.I These analyses make it clear that the effect on risk estimates will be strongly dependent on'the assumed RBE for neutrons, which cannot be reliably estimated with the revised dosimetry, and on the shielding provided by the body for specific organs of interest.
Complete assessment of these recent data has not yet been reported and evaluated; however, based on preliminary evaluation by Preston and Pierce, it appears unlikely that the modified dosimetry will.
increase risk estimates by more than a factor or two.
Risk estimates for genetic effects are based on experimental animal data, since no suitable human data is available. BEIR 111 estimates 5 to 75 additional serious genetic disorders per million live births in the first generation following parental dose of 1 rem. Such a parental dose will, according to BEIR 111 estimates, result over all time (i.e.,overmanyfuturegenerations)inatotalincreaseof60 to 1,100 serious genetic disorders per million liveborn offsprings.
The ranges of risk estimates underscore the limited understanding of genetic effects of radiation on human populations.
1 Preston,D.t...andPierce,D.A.(1987): The Effect of Changes in Dosimetry on Cancer Mortality Risk Estimates in the Atomic Bomb Survivors.
RERF Technical Report 9-87 (Hiroshima City 730 Japan:
Radiation Effects ResearchFoundation).
4
. = = =
p
/.
l To summarize, the prit.cipal sources of uncertainty in estimates of risk from low levels of ionizing radiation are:
1.
Assumption of deleterious effects at any dose, no matter how low 1.'e., no-threshold.
2.
Selection of mathematical model for extrapolation from high dose /doserates(whereeffectshavebeenstatisticallyobserved) to low dose / dose rates.
3.
Selection of temporal pro.iection model beyond period of observation (absolutevsrelative).
4.
Variability (geographical and temporal) in " normal" cancer rates upon which the relative risk estimates are based.
5.
Uncertainties in doses received by populations included in-epidemiologic studies.
Currently the NAS has a revision of BEIR III (BEIR V) underway which is expected in early 1989.
De
=
5