ML20043B914
Text
Qp = " n.
- ,. _L ' '
[>
UNITED STATES 4
NUCLE AR REGULATORY COMMISSION c;
s
. [-
WASHINGTON, o. C. 20$66 JUl.!5 1986 MEMORANDUM FOR:
Robert'Bernero HMSS/DD Bill Morris, RES/DRA
-Frank Congel, NRR/DREP John Austin, NMSS/IMAB M tty Dragonnette, NMSS/RB William Lahs, RF.5/RPHEB John Buchanan, NRR/PRPB-Donald Cool, NMSS/IM0B FROM:-
-Richarri E. Cunningham, Director-Division of Industrial and Medica ~1 Nuclear Safety, NHSS
SUBJECT:
REVISION OF DRAFT "BELOW REGULATORY CONCERN" POLICY
- During the ACNW review of the draft policy statement, the Comittee raisad several conceptual and practical problems associated with the draft. This.
has caused NMSS staff to reevaluate this approach to the application'of collective dose and several other issues.
' Enclosed is a first cut on a revision which is aimed at making the statement more practical and consistent with radiation protection concepts'.- I-request that you review this draft and be prepared to coment.on it. Research is
. requested to set a meeting to discuss it, as well as the recommendations,
from ACNW (not yet received as of this date).
-Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated i
4-900601o026 891130 b.$1'$FR49886 PDC
1 n au A".
~
" J
- i sf
_y
.i 1
DRAFT Proposed Comission Policy on Exemptions from Regulatory Control for
- Practices Whose Public Health 'and Safety Impacts are Below Regulatory Concern.
I.
INTRODUCTION AND PURPOSE Over the last several years, the Conrnission 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 Commission is expanding upon its existing policy for protection of the public
-from radiation, currently expressed in existing regulations (Title 10 Code of
,FederalRegulations)andpolicystatements(30FR3462,datedMarch 16, 1965; 47 FR 57446, dated December 27,1982; and 51 FR 30839; dated August 29,1986) by providing an explicit policy on the exemption from regulatory control of practices where public health and safety impacts are below regulatory concern.
The purpose of this policy statement is to establish the basis upon which the Commission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control certain radioactive material and persons who receive, possess, use, transfer, own, or acquire this material. This policy is directed specifically toward petitions for
.rulemaking, license amendments, and license applications involving the release of. licensed radioactive material either to persons not subject to Commission regulations or to the environment.
The concept of regulatory exemptions is not new.
For example, tables of exempt quantities and concentrations for radioattive material were defined in 1965 and 1970 which a person could receive, possess, use, transfer, own, or acquire without a requirement for a license (30 FR 8185 and 35 FR 6427). Other 2xemptions allowing distribution of consumer products or other devices, or releases of radioactive material, have been embodied in Commission's regulations for some time. More recently, the Low Level Waste Policy
~1 J
o?
t 2
I Amendments Act of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Comission determined to be below regulatory concern. The Comission responded i
to this legislation by issuing a policy statement in August 1986(51FR30839).
]
That statement contained criteria which, if satisfactorily addressed in a
-petition for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.
l The Comission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy 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 L
of the radioactive material from a controlled to an exempt status.
The Connission 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 regulatory concern and the Comission believes that L
States will support an expansion of these views to all practices involving distribution or release of radioactive material. The Comnission 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.
II.
RADIATIONPROTECTIONPRINCIptEj The Connission subscribes to three fundamental principles of radiation protection in formulating its policies and regulations to protect workers and the public from the harmful effects of radiation. They are (1) justificatfor of the practice, which requires that there be some net benefit resulting fr:c
__y.
~
L
. 1:
!E J
a 3-the use of radiation or radioactive materials, (2) dose limits, which define the upper boundary of dose which must not be exceeded in the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account.
The term. ALARA, is an acronym for As Low As is Reasonably Achievable.
For the purpose of establishing the health risk associated with its regulatory policies, the Comission also subscribes to the linear model for dose and effect. The hypothesis upon which the linear model is based assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose, regardless of the size of the dose.
In subscribing to this model, the Commission recognizes that it is a functional model based upon data collected-at relatively high doses and dose rates which is then extrapolated to the low dose and dose rate region where there are no statistically reliable epidemio-logical data available.
It is generally believed that the use of the linear
- model for low linear energy transfer (LET) radiation provides a conservative basis for planning purposes.
Although not a principle of radiation protection, collective dose provides a useful way to express the impact of a nuclear activity on the health of the population subject to radiation exposure. Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure.
By assigning collective dose a monetary value, it can be used in cost benefit and other quantitative analysis techniques.
It is often an important factor to consider in balancing benefits and consequences for practice justification and ALARA deterininations.,
III. APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS FROM REGULATORY CONTROL The following sets forth guidelines about how the Comission will apply the fundamental principles of radiation protection in consideration of exemptions from regulatety control, s.
fe.
f J
o' Justification - Exposures resulting from any practice should be justified; thus, even at trivial levels of dose, the_ practice considered for exemption should continue to be justified. However, as lower levels of radiation exposure are projected, the lower levels of benefit needed for justification open the possibility of simpler, less rigorous evaluation.
at suitably low levels of radiation exposure. This reduction in rigor of justification..in due proportion to the lower level of exposure envisioned, is consistant with reliance on the linear non-threshold hypothesis.
o Dose Limits - Individual doses from all practices must not be allowed to exceed the dose limits for members of the public specified in 10 CFR Part 20, Standards for Protection Against Radiation. The dose limits in 10 CFR Part 20 include all sources of radiation exposure under a licensee's control exclusive of natural background and medical exposures. Although it is possible to reasonably project what the dose will be from a practice, and
'then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some degree of loss of control. Therefore, in order to provide reasonable assurance that regulatory decisions regarding exemptions, combined with other sources of radiation, will'not cause members of the public to exceed the dose limits, candidates for exemptions should typically not result in dose, on the average, to members of the critical group (the group defined as the individuals expected to receive the greatest exposure from the practice) in excess of a small fraction of the dose limit.
The Commission has concluded that, for currently licensed activities and those activities which may be licensed in the near future,100 mrem effective whole body dose equivalent (mrem) for the public is not likely to be exceeded as a result of individual exposures to multiple sources or practices involving use or release of radioactive material.
L.ha-3 y
l
's
.s.
I This conclusion is supported by the existence of current EPA and NRC effluent and environmental regulations which impose secondary" limits on classes of activities or practices that are fractions of the limit; information supplied concerning annual releases from certain classes of licensed facilities; and independent environmental survey. data collected in recent years for certain classes of byproduct material users.
The Commission believes that, in addition to these licensed activities.
.the dose limits for members of the public will not be exceeded if the dose to a member of the critical group as a result of most exempted practices does not exceed a few millirem effective dose equivalent per year.
ALARA - The ALARA principle applies to exemptions in the same manner
.- o as it is applied to other practices which are subject to regulation.
However, as in the case with justification, the level of effort to achieve, or to demonstrate achievement of ALARA, will be proportional to the individual and collective dose.
IV. PRINCIPLES OF EXEMPTION Once a practice is established as justified, i.e., there is a positive net benefit to the introduction or use of radioactive material, the decision of whether or not the practice is a candidate for exemption from regulatory controls hinges on the general question of whether or not such regulatory controls are necessary and cost effective in reducing dose. To determine if exemption is appropriate, the Commission must determine if one of the following conditions are 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 exposed population or; 2.
The costs of the regulatory controls that could be imposed to reduce the individual and collective dose are not balanced by the benefits of dose reduction that could be realized.
w ae m-
.x 6-t For purposes'of implementing its policy, the Comission recognizes that only under unusual circumstances would practices which cause radiation exposures The approaching existing limits be considered as candidates for exemption.
Comission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement.
However, as the doses to members of the critical group decrease, the need for regulatory controls decreases and the analysis needed to support a proposal for exemption can become less rigorous.
In essence, complexity of the basis for decision making for exemptions is a continuum ranging down from the established limits of acceptability, namely the dose limits.
Within the continuum of decision making on the applicability of regulatory controls and the risks of radiation exposure received, the ConJnission believes that there is a range of risk at which individuals are unlikely to take any actions to further reduce their risk. This range of risk is taken as being in 0
the range of 10-6 to 10 per year, and is represented by an annual dose on the order of 1 mrem. This order of magnitude of risk or dose has been tevined by the National Council on Radiation Protection and Measurements (NCRP) as the Negligible Individual Risk Level (NIRL) and is taken by the Comission to represent a reasonable threshold of regulatory concern below which decisions about the acceptability of an exemption can be based on simple demonstrations of justification and ALARA.
The establishment of a threshold on the order of 1 mrem per year should not be construed as a decision that doses below this level are acceptable while doses above the level are not. On the contrary, this order of magnitude simply represents the range in which the Comission believes that a closer analysis may not be required in order to make a decision regarding the acceptability of an exemption.
Further, the threshold does not represent a strict line of demarcation, but rather a range of risk represented by an order of magnitude of dose. This approach has been taken in recognition of the Comission's belief that it is reasonable and prudent to allow some flexibility in implementing this policy.
.nu m vw
~ ~ ~ -
-?
- r
,=
7
'The Commission believes that an exemption embodies the conclusion that the practice being exempted will not contribute significantly to the overall-risk to the exposed individual or the general population, and is unlikely to have a significant impact on the environment.
In this regard, the collective dose is one of the principle factors in determining the scope of the practice under consideration, and the potential impact of that practice on the general l
population and the environment.
It is the Comission's expectation that, in most cases, an exemption would not be approved if either the individual or collective dose from a proposed practice were unacceptably or unnecessarily large. A test of significance of collective dose, which assists in defining the scope of practices involving individual dose on the order of 1 mrom and thus requiring simple demonstrations of justification and ALARA, is taken to t
be on the order of 100 person-rem. However, in some instances, the collective dose will be proportional to both the extent to which an exempt practice is l
l utilized and the resulting benefits.
For example, the use of smoke detectors containing radioactive sources in houses is known to save lives. Both the number of lives saved and the collective dose will increase proportionally to the number of smoke detectors used. Thus the Commission does not believe that an 1 priori-limitation on the collective dose is appropriate for this l
e.umption policy.
Establishment of an exemption for a particular practice does not necessarily imply that the individual and collective doses would-be perceived as trivial by the individuals and population involved, even if the individual dose to members of the critical group were within or below the range of 1 mrem per However, the Comission believes that promulgation of an exemption year.
L would still be appropriate, from a regulatory standpoint, because either the degree of risk does not require the burden of regulatory controls, or because there would be little gain in risk reduction by additional controls.
l
n a -.-. ~
'v 4
p
. y' f
V.
EXCLUSIONS FROM EXEMPTIONS As the indt idual and collective doses from a pra dice become sufficiently small, the Comission expects the justification for the practice will still be based upon an economic benefit. However, the individuals who receive the benefit are not necessarily the individuals receiving the radiation exposure.
Such justification may be reasonable and acceptable in view of the very small levels of dose and risk involved. However, there are some types of practices involving radiation or radioactive materials which are, prima facie, socially unacceptable regardless of how trivial the resulting dose might be and, therefore, should be excluded from exemption. Excluded practices would include, but not be limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the skin (suchascosmetics). Exclusions would also include the purposeful gnd frivolous distribution or release of radioactive materials where there are clear, economical alternatives to the use of radionuclides and the practice is not justified because there are no unique benefits from using the radioactive materials.
VI. PROPOSALS FOR EXEMPTION An proposal for exemption, either as a petition for rulemaking or as a license application or amendment, must provide a basis upon which the Comission can detemine if the basic conditions described above have been satisfied.
In general, this means that the application should address the individual and collective doses resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways of exposures, the levels of attivity, ar.d 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 petition 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 Commission decision on such applications will be based on the applicant or licensee's meeting the conditions specified in the
LJ
,.;w i
f.-
hj 9
rule. The 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.
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 threshold of regulatory concern, there would be high likelihood that the application would be accepted by the Commission.
There may be cases, however, where simplified assessments, which typically use conservative assumptions for bounding conditions, will indicate the potential 1
for higher individual or collective doses.
In these cases, a more detailed i
analysis will be required to make a determination on whether the basic conditions for an exemption have been met.
s In addition to considerations of expected activities and pathways, the
'Comission recognizes that consideration must also be given to the potential
.for accidents and misuse of the radioactive materials involved in the practice.
t An application for exemption must therefore also address the potentials for u
accidents or misuse, and the consequences of these exceptional conditions in i
terms of individual and collective dose.
VII._ APPLICATION OF COLLECTIVE DOSE ASSESSMENT As noted above, the collective dose can serve as both a measure of the impact L
of a practice on the exposed population and a mechanism for assessing the benefits of regulatory controls.
In the later case, a monetary value can be assigned to the collective dose so that quantitative assessments can be made of the benefits of regulatory controls for comparison with the costs of those controls.
L
~-
g ji' c'
l-pp 10 -
8 In assigning values to collective dose, a value of $1,000 per person-rom has been used previously by the Comission.
It was first used in 10 CFR Part 50, Appendix 1 for determination of ALARA. The Commission recognizes, however, that the more universal application of the $1000 per person-rem. when applied-to sumation of doses consisting of trivial individual risk for purposes of determining ALARA, can in some instances result in undue expenditure of resources which might better be applied to other uses.
The Commission has determined that a dose on the order of 1 mrem per year represents a range of risk in which individuals are unlikely to take any actions to further reduce their risk. This level serves as a threshold for -
determining if a simple analysis is required for approval of an exemption, or if a more detailed analysis is necessary before approval. The Commission believes that this level is also an appropriate value at which to reduce the
^ valuation applied to collective doses for purposes of ALARA and cost-benefit analysis. Therefore, collective dose assessments-for purposes of this exemption policy may be assigned a monetary cost as follows:
$1,000 per person-rem for collective dose composed of individual o
doses in excess of 1 mrem per year.
$100 per person-rem for collective dose composed of individual doses o
below 1 mrem per year.
The valuation of collective dose at $100 per person-rem for individual doses below 1 mrem per year reflects the Commission's belief that tt/. individual risk associated with these small levels of dose do 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 linear hypothesis for radiation protection planning, these small levels of dose should be considered when examining the overall impact of the practice.
1
--s. -~ w n m -
l.
e^
11 -
1 E VERIFICATION OF EXEMPTION CONDITIONS VIII.
The Comission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suitable program to monitor an verify that the basic conditions 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 The monitoring and verification program must set of conditions and criteria.
l therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being The Commission will determine complied with curing routine activities.
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.
i
~
p,
--m
...ml
LNkm.
3.3 r x, DRAFT Proposed Commission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety Impacts are Below Regulatory Concern.
I.
INTRODUCTION AND PURPOSE Over the last several years, the Commission 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 Commission is expanding upon its existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10, Code of
. Federal. Regulations) and policy statements (30 FR.3462, dated March 16, 1965; 47 FR 57446, dated December 27, 1982; and 51 FR 30839, dated August 29,1986) by providing an explicit policy on the exemption from regulatory control of practices where public health and safety impacts are,below regulatory concern.
The purpost of this policy statement is to establish the basis upon which the Commission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control certain radioactive material and persons who receive, possess, use, transfer, own, or acquire this material.
This policy is directed specifically toward petitions for rulemaking, license amendments, and license applications involving the release of licensed radioactive material either to persons not subject to Commission regulations or to the environment.
The concept of regulatory exemptions is not new.
For example, tables of exempt quantities and concentrations for radioactive material were defined in 1965 and 1970 which a person could received, possess, use, transfer, own, or acquire without a requirement for a license (30 FR 8185 and 35 FR 6427). Other exemptions allowing distribution of consumer products or other devices, or releases of radioactive material, have been embodied in Commission's regulations for some time.
More recently, the Low Level Waste Policy
.s
.s g y4)
DRAFT 08/24/88 NM55 BRC POLICY 8/23
w ~. _
t Amendments Act of 1985 directed the Commission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Commission determine 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 the Commission to act expeditiously in proposing-appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.
The Commission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy 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 Commission's regulatory involvement could therefore be essentially limited to the inspection and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt sitatus.
11.
RADIATION PROTECTION PRINCIPLES The Commission subscribes to three fundamental principles of radiation protection in formulating its policies and regulations te protect workers and the public from the harmful effects of radiation. They are (1) justification i
of the practice, which requires that there be some net benefit resulting from the use of radiation or radioactive materials, (2) dose limits, which define the upper boundary of dose which must not be exceeded in the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose below the limits be as low as reasonably achievable, economic and social factors being taken into account. The term, ALARA, is an acronym for As Low As is Reasonably Achievable.
For the purpose of establishing the health risk associated with its regulatory policies, the Commission also subscribes to the linear model for dose and effect. The hypothesis upon which the linear model is based assumes that the l
DRAFT 08/24/88 NMSS BRC POLICY 8/23 N.,
U... -
7 L
-3 E
risk of radiation induced effects (principally cancer) is linearly proportional to dose, regardless of the size of the dose.
In subscribing to this model, the Commission recognizes that it is a functional model based upon data collected at relatively high doses and dose rates which is then extrapo-h lated to the low dose and dose rate region where there are no statistically reliable epidemiological data available.
The coefficient generally used in the model is on the order of 1 x 10'4 risk of death per rem of radiation dose received by an individual.
It is generally believed that the use of the linear q
model provides a conservative basis for planning purposes.
The risk of death to an individual, as calculated using the linear mortel, is s!,own in Table 1 for various levels of individual dose.
The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70 year lifetime.
F E
Table 1 g
Annual Dose Annual Risk Lifetime Risk 1x10,f 7 x 10',4
[
l
~
100 mrem 1 x 10,7 7 x 10 3 10 mrem 1 x 10-8 7 x 10.6 E
1 mrem 7
E 0.1 mrem 1 x 10 7 x 10 Unlessotherwiseindicated,theexpressionofdoseif 1
mrom refers E
to the Total Effective Dose Equivalent.
This term is the sum of the deep dose equivalent for sourcet external to the body and the com-mitted effective dose equivalent for sources internal to the body.
The Commission recognizes that it is impossible to measure risk to individuals E
or populations directly, and that in most situations it is very impractical to E
' 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 g
doses are then estimated by exposure pathway analysis combined with other types of assumptions related to the ways in which people might become C
exposed.
Under such conditions, conservative assumptions are frequently used in modeling so that the actual dose is on the low side of the calculated DRAFT 08/24/88 NMSS BRC POLICY 8/23 m &-
L na.-.s;.
~
^
F u
J c
4 dose.
The Commission believes that this is the appropriate approach to be taken when _ determining if an exemption from regulatory controls is warranted.
t In the application of the fundamental principles of radiation ptotection, collective dose provides a useful way to express the impact of a nuclear activity on health of the population subject to radiation exposure.
Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure.
By assigning collective dose a monetary value, it can be used in cost benefit analysis and other quantitative analysis techniques.
- Thus, l
it is an important factor to consider in balancing benefits and consequences i
for justification of a practice and determining if radiation doses are ALARA.
l III. APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS FROM REGULATORY CONTROL The following sets forth guidelines about how the staff will apply the fundamental principles of radiation protection in cor) sideration of exemptions from regulatory control.
o Justification - Exposures resulting from any practice should be justified; thus, even at trivial levels of dose, the practice considered for exemption should continue to be justified,
- However, as lower levels of radiation exposure are projected, the lower levels of benefit needed for justification open the possibility of simpler, less rigorous evaluation.
This reduction in the rigor of the analysis for justification, in due proportion to the lower level of exposure envisioned, is entirely consonant with reliance on the linear non-threshold hypothesis.
o Dose Limits - The sum of individual doses from all practices exposing that individual should not be allowed to exceed the dose limits.
The limit for members of the public; as specified in proposed 10 CFR Part 20, is 100 mrem, and is applicable to all sources of exposuro under a licensee's control exclusive of natural background M"
k o huv6%
.s.
and medical exposures.
Although it is possible to reasonably project what the dose will be from a practice, and then tak6 this information into account in controlling regulated practices so that the dose limits are not exceeded, exemptions imply some degree of loss of control.
Therefore, in order to provide reasonable assurance that regulatory decisions regarding exemptions, combined with other sources of radiation, will not cause members of the public to exceed the dose limits, candidates for exemptions should ordinarily not result in an average dose to members of the critical group (the group
)
{
defined as the individuals expected to received the greatest exp'osure l
from the practice) in excess of small fraction of the dose limits.
i The Commission has concluded that, for currently licensed activities and those activities which may be licensed in the near future, 100 j
mrem per year for members of the public is not likely to be exceeded as a result of individual exposures to multiple sources or practices L
involving use or release of radioactive material.
This finding is l
supported by current EPA and NRC effluent and environmental l
regulations which impose " secondary" limits on classes of activities or practices that are fractions of the limit; information supplied concerning annual releases from certain classes of licensed facilities; and independent environmental survey data collected in l
\\
recent years for certain classes of byproduct material users.
The Commission believes that, in addition to these licensed activities, the dose limits for members of the public will not be exceeded if the l
dose to the critical group as a result of most exempted practices does not exceed a few millirem per year.
l c
ALARA - The ALARA principle applies to exemptions in the same manner L
as it is applied to other practices which are subject to regulation.
However, as in the case with justification, the level of effort to achieve, or to demonstrate achieving ALARA, will be proportional to the individual and collective dose,
(
DRAFT' 08/24/88 NMSS BRC POLICY 3/23
+
w 6-IV.
PRINCIPLES OF EXEMPTIONS Once a practice is established as justified, i.e., there is a positive net benefit to the introduction or use of radioactive material, the decision of whether or not the practice is a candidate for exemption from regulatory controls hinges on the general question of whether or not such regulatory controls are necessary and cost effective in reducing dose.
To determine if exemption is appropriate, the Commission must determine if'one ofihe following conditions are 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 exposed population or; 2.
The costs of the regulatory controls that could be imposed to reduce the individual and collective dose are not, balanced by the benefits of dose reduction that could be realized.
For purposes of implementing its policy, the Commission recognizes that only l
under unusual circumstances would practices which cause radiation exposures l
approaching existing limits be considered as candidates for exemption.
The Commission will consider such circumstances on a case specific basis using the I
general principles outlined in this policy statement.
However, as the doses to members of the critical group decrease, the need for regulatory controls decreases and the analysis needed to support an application for exemption can become less rigorous.
In essence, the complexity of the basis for decision making on exemptions is a continuum ranging down from the established limits i
of acceptability, namely the dose limits.
Within the continuum of decision making on the applicability of regulatory controls and the risks of radiation exposure received, the Commission believes
[
that there is a range of risk of death at which individuals are unlikely to spend resources or otherwise take any actions to further reduce their risk.
DRAFT 08/24/88 NMSS BRC POLICY 8/23
- - ---_~._ _
L
)
5 l*
\\
.y.
~
l
-6
~7 This range of risk is taken as being on the order of 10 to 10 per year, and 15 represented by an annual dose on the order of 1 mrem.
This order of magnitude of risk or dose has been teraad by the National Council on Radiation q
Protection and Measurements (NCRP) as the Negligible Individual Risk Level (NIRL) and is taken by the Commission to represent a reasonable threshold of j
regulatory concern below which decisions about the acceptability of an y
exemption can be based on simple demonstrations of justification and ALARA.
The establishment of a threshold on the order of 1 mrem per year should not be cunstrued as a decision that doses below this level are acceptable while doses above the level are not.
On the contrary, as was shown in Table 1, a dose of 10 mrom also corresponds to an annual risk on the order of 10-6 However, the Commission believes that doses on the order of 1 mrem represent the range above which a closer analysis may be required in order to make a decision regarding the acceptability of an exemption, particularly when the potential exists for an individual to be exposed to multiple exempted sources of radiation, such as consumer products.
Further, the threshold does not represent a strict line of l
demarcation, but rather a range of risk represented by an order of magnitude i
of dose.
This approach has been taken in recognition of the Commission's belief that it is reasonable and prudent to allow some flexibility in implementing this policy as it applies to the 1 mrem dose.
l The Commission believes that an exemption embodies the conclusion that the practice being exempted will not contribute significantly to the overall risk to the exposed individual or the general population, and is unlikely to have a significant impact on the environment.
In this regard, the collective dose is one of the principle factors in determining the scope of the practice under j
consideration, and the potential impact of that practice on the general population and the' environment.
It is the Commission's expectation that, in most cases, an exemption would not be approved if either the individual or collective dose from a proposed practice were unacceptably or unnecessarily i
i large.
A test of significance of collective dose, which assists in defining the scope of practices invelving individual dose on the order of 1 mrem and thus requiring simple demonstrations of justification and ALARA, is taken to be 1
DRAFT 08/24/88 NMSS BRC POLICY 8/23
7
. %.w m y s
-8 on the order of 100 person rem.
However, in some instances, the collective dose will be proportional to both the extent to which an exempt practice is utilized and the resulting benefits.
For example, the use of smoke detectors containing radioactive sources in houses is known to save lives.
Both the number of lives saved and the collective dose will increase proportionally to the number of smoke detectors used.
Thus the Commission does not believe that an a priori limitation on the collective dose is appropriate for this exemption policy.
Establishment of an exemption fo'r a particular practice does not necessarily imply that the individual and collective doses would be perceived as trivial by the individuals and population involved, even if the individual dose to members of the critical group were within or below the range of 1 arem per year.
However, the Commission believes that promulgation of an exemption would still be appropriate, from a regulatory standpoint, because either the degree of risk does not require the burden of regulatory controls, or because there would be little gain in risk reduction by addit,ional controls.
V.
IMPLEMENTATION OF EXEMPTION POLICY A.
EXCLUSIONS FROM EXEMPTIONS l
There are some types of practices involving radiation or radioactive materials which are, prima facie, socially unacceptable regardless of how trivial the resulting dose might be.
These practices would not be candidates for exemption.
Excluded practices would include, but not be limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the tkin (such as cosmetics).
Exclusions would also include the purposeful introduction, distribution, or release of radioactive materials when there are clear, economical alternatives to the use of radionuclides and the practice is not justified because there is no unique benefit from using the radioactive materials.
I 08/24/88 NMSS BRC POLICY 8/23 o
DRAFT
v,
. _. i...~ r
~
~
~
^~
^ ^~ 7
' ~ ~ ^ ~
~ ^ ^ " ' ^ ^ ^ ~
B.
PROPOSALS FOR EXEMPTION k
A proposal for exemption, either as a petition for rulemaking or as a
[
license application or amendment, must provide a basis upon which the Commission can deterwine if the basic conditions described above have been satisfied.
In general, this means that the application should address the individual and collective doses resulting from the expected activities under the exemption, including the uses of.the radioactive materials, the pathways of exposures, the levels of activity, and the methods and f
constraints for assuring that the assumptions used remain appropriate as the radioactive materials move from regulatory control to an exempt status.
If a proposal for exemption results in a rule that contains generic requirements, a person applying for a license to utilize the exemption would not need to address justification or ALARA.
The Commission decision on such proposals will be based on the licensee'.s meeting the conditions specified in the rule.
The promulgation of the rule would, under these l
circumstances, constitute a finding that the exempted practice is justified, and that ALARA considerations have been dealt with.
This approach i
' stent with past practice, e.g., consumer product rules in 10 CFR Part If, after a practice is determined to be justified and a simple assessment indicates that the likely consequences of an exemption are individual and collective doses approximately equal to or less than the threshold of regulatory concern, there would be a high likelyhood that the application would be-accepted by the Commission.
l There may be cases, however, where simplified assessments, which typically C
use conservative assumptions for bounding conditions, will indicate the potential for higher individual or collective doses.
In these cases, a more detailed analysis will be required to make a deterwination on whether the basic conditions for an exemption have been met.
ORAFT 08/24/88 NMSS BRC POLICY 8/23
~
[ '
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.
An application for exemption must therefore also address l
the potentials for accidents or misuse, and the consequences of these exceptional conditions in terms of individual and collective dose.
C.
APPLICATION OF COLLECTIVE DOSE ASSESSMENT As noted above, the collective dose can serve as both a measure of the impact of a practice on the exposed population and a mechanism for i
assessing the benefits of regulatory controls.
In the later case, a monetary value can be assigned to the collective dose so that quantitative assessments can be made of the benefits of regulatory controls for I
comparison with the costs of those controls.
9 The Commiss ieves that a base value for collective dose evaluations should be
, in kee y ith the linear hypothesis for ra p4 protection planning, and 4 t: a value of $100 per person-resy he
,A w 4
~
adoption of a base value for collective dose evaluations is consistent with international activities in this area, and the selected value of $100 per person-rem is somewhat greater than the value recently suggested by the International Atomic Energy Agency as the international minimum for transboundary exposures.
However, in assigning values to collective dose in previous situations (i.e., 10 CFR Part 50, Appendix I), a value of
$1,000 per person-rem has been used by the Commission, i
The Commission has determined that a dose on the order of 1 arem per year
' represents a range of risk in which individuals are unlikely to take any actions to further reduce their risk.
This level serves as a threshold for determining if a simple analysis is sufficient for approval of an exemption, or if a more detailed analysis is neces'sary before approval.
The Commission believes that this level is also an appropriate point at which to increase the base valuation applied to collective doses as a DRAFT 08/24/88 NMSS BRC POLICY 8/23
Om_ -..
i e,
i,.
reflection of the increased level of concern.
As the individual dose increases, i.e., above doses on the order of 1 arem, the higher valuation of $1,000 per person-rem is appropriate because of the increased risk posed
)
by that exposure to the individual.
Therefore, collective dose assessments for purposes of ALARA and cost-benefit analysis may be assigned a monetary value as follows:
)
o
$100 per person-rem for collective dose composed of individual doses j
below I mrem per year.
1 o
$1,000 per person-rem for collective dose composed of individual doses in excess of 1 mrem per year.
VI.
VERIFICATION OF EXEMPTION CONDITIONS I
The Commission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suitahle program to monitor and verify that the basic conditions 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 l
program must therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being complied with during routine activities.
The Commission will determine compliance with the specific conditions of an exemption through l'
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.
t 1
DRAFT 08/24/88 NMSS BRC POLICY 8/23
L._.ll..
s 3f o
3a 4'
Document Name:
[
t NMSS BRC POLICY 8/23 Requestor's 1D:
I ESTEP Author's Name Cool, Donald A.
Document Comments:
BRC Policy Statement 8/23/88 NMSS alternative t
qrno e e <v re W
i e
f 4
4 g
a L
u l
P b
- 4,_
s-
C C _. _ _
i a
4 DRAFT Proposed Commission Policy on Exemptions from Regulatory Control for i
Practices Whose Public Health and Safety Impacts are Below Regulatory Concern.
1 1
1.
INTRODUCTION AND PURPOSE Over the last several years, the Commission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of radioactive m&terials from regulatory control.
To address this need the Commission is expanding upon its existing policy for protection of the public from radiation, currently expresced in existing regulations (Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, dated March 16, 1965; 47 FR 57446, dated December 27, 1982; and 51 FR 30'839, dated August 29,1986) by providing an explicit policy on the exemption from regulatory control of practices where public health and safety impacts are below regulatory concern.
The purpose of this policy statement is to establish the basis upon which the Commission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control certain radioactive material and persons who receive, possess, use, transfer, own, or acquire this material.
This policy is directed specifically toward petitions for rulemaking, license amendments, and license applications involving the release of licensed radioactive material either to persons not subject to Commission regulations or to the environment.
The concept of regulatory exemptions is not new.
For example, tables of exempt quantities and concentrations for radioactive material were defined in 1965 and 1970 which a person could received, possess, use, transfer, own, or acquire without requirement for a license (30 FR 8185 and 35 FR 6427).
Other exemptions allowing distribution of consumer products or other devices, or releases of radioactive material, have been embodied in Commission's regulations for some time.
More recently, the Low Level Waste Policy DRAFT 08/24/88 NMSS BRC POLICY 8/23
(
1-l b
i O
1,
l Amendments Act of 1985 directed the Commission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the j
disposal of slightly contaminated radioactive waste material that the Commission determine to be below regulatory concern.
The Commission responded I
to this legislation by 4 suing a policy statement in August 1986 ($1 FR 30839).
That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would the Commission to act expeditiously in proposing j
appropriate regulatory relief on a " practice-specific" basis consistent with the merits of the petition.
1 The Commission believes that these " practice-specific" exemptions should be encompassed within a broader NRC policy 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 Commission's regulatory involvemant could therefore be essentially limited to the inspection and compliance activities associated with the transfer of the radioactive material from a controlled to an exempt status.
II.
RADIATION PROTECTION PRINCIPLES The Commission subscribes to three fundamental principles of radiation protection in formulating its policies and regulations to protect workers and the public from the harmful effects of radiation.
They are (1) justification of the practice, which iequires that there be some net benefit resulting from the use of radiation or radioactive materials, (2) dose limits, which define the upper boundary of dose which must not be exceeded in the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose below the limits be as low as reasonably achievable, economic and social factors being taken into account.
The term, ALARA, is an acronym for As Low As is Reasonably Achievable.
For the purpose of establishing the health risk associated with its regulatory policies, the Commission also subscribes to the linear model for dose and effect.
The hypothesis upon which the linear model is based assumes that the DRAFT 08/24/88 NMSS BRC POLICY 8/23
risk of radiation induced effects (principally cancer) is linearly proportional to dose, regardless of the size of the dose, in subscribing to this model, the Commission recognizes that it is a functional model based upon data collected at relatively high doses and dose rates which is then extrapo-lated to the low dose and dose rate region where there are no statistically reliable epidemiological data available.
The coefficient generally used in the model is on the order of I x 10'4 risk of death per rem of radiation dose received by an individual.
It is generally believed that tne use of the linear model provides a conservative basis for planning purposes.
The risk of death to an individual, as calculated using the linear model, is shown in Table 1 for various levels of individual dose.
The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70 year 1* fetime.
Table 1 Annual Dose Annual Risk Lifetime Risk l
100 mrem 1 x 10 7 x 10 10 mrem 1 x 10 7 x 10-1 x 10,7 7 x 10,6 1
mrem g
7 0.1 mrem 1 x 10 7 x 10 I
1 Unless otherwise indicated, the expression of dose in.erem refers to ths Total Effective Dose Equivalent.
This term 1: the sum of the deep dose equivalent for sources external to the body and the com-mitted effective dose equivalent for sources internal to the body.
l The Commission recognizes that it is impossible to measure risk to individuals i
or populations directly, and that in most situations it is very 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 doses are then estimated by exposure pathway analysis combined with other k
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 DRAFT 08/24/88 NMSS BRC POLICY 8/23
C 3
o 4
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, collective dose provides a useful way to express the impact of a nuclear activity on health of the population subject to radiation exposure.
Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure.
By assigning collective dose a monetary value, it can be used in cost benefit analysis and other quantitative analysis techniques.
- Thus, it is an important factor to consider in balancing benefits and consequences for justification of a practice and determining if radiation doses are ALARA.
III. APPLICATION OF RADIATION PROTECTION PRINCIPLES TO EXEMPTIONS FROM REGULATORY CONTROL The following sets forth guidelines about how the staff will apply the fundamental principles of radiation protection in consideration of exemptions from regulatory control.
o Justification - Exposures resulting from any practice should be justified; thus, even at trivial levels of dose, the practice considered for exemption should continue td be justified.
- However, as lower levels of radiation exposure are projected, the lower levels L
of benefit needed for justification open the possibility of simpler, l
1ess rigorous evaluation.
This reduction in the rigor of the analysis l
for justification, in due proportion to the lower level of exposure envisioned, is entirely consonant with reliance on the linear non-threshold hypothesis.
o Dose Limits - The sum of individual doses from all practices exposing that individual should not be allowed to exceed the dose limits.
The limit for members of the pt611c, as specified in proposed 10 CFR Part 20, is 100 mrem, and is applicable to all sources of exposure under a licensee's control exclusive of natural background
' DRAFT 08/24/88 NMSS BRC POLICY 8/23
Ir..nu
~~
~
~
^~
~
p+
i t..
,3,
?
s and medical exposures.
Although it is possible to reasonably project what the dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose f
limits are not exceeded, exemptions imply some degree of loss of control.
Therefore, in order to provide reasonable assurance that regulatory decisions regarding exemptions, combined with other sources of radiation, will not cause members of.the public to exceed the dose limits, candidates for exemptions should ordinarily not result in an average dose to members of the critical group (the group defined as the individuals expected to received the greatest exposure I
from the practice) in excess of small fraction of the dose limits.
The Commission has concluded that, for currently licensed activities and those activities which may be licensed in the near future, 100 mrem per, year for members of the public'is net likely to be exceeded l
as a result of individual exposures to multiple sources or practices involving use or release of radioactive material.
This finding is supported by current EPA and NRC effluent s'nd environmental regulations which impose " secondary" limits on classes of activities or practices that are fractions of the limit; information supplied concerning annual releases from certain classes of licensed facilities; and independent environmental survey data collected in recent' years for certain classes of byproduct material users.
The Commission believes that, in addition to these licensed activities,
'the dose limits for members of the public will not be exceeded if the dose to the critical group as a result of most exempted practices does not exceed a few millirem per year.
o ALARA - The ALARA principle applies to exemptions in the same manner as it is applied to other practices which are subject to regulation.
However, as in the case with justification, the level of effort to achieve, or to demonstrate achieving ALARA, will be proportional to the individual and collective dose.
,,. +
DRAFT 08/24/88 NMIS BRC POLICY 8/23
J-.-
~
6-IV.
PRINCIPLES OF EXEMPTIONS Once a practice is established as justified, i.e., there is a positive net benefit to the introduction or use of radioactive material, the decision of whether or not the practice is a candidate for exemption from regulatory controls hinges on the general question of whether or not such regulatory controls are necessary and cost effective in reducing dose.
To determine if exemption is appropriate, the Commission must determine if one of the following crmditions are met:
I l
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 exposed population or; 2.
The costs of the regulatory controls that could he imposed to reduce the individual and collective dose are not balanced by the benefits of dose reduction that could be realized.
For purposes of implementing its policy, the Commission recognizes that only under unusual circumstances would practices which cause radiation exposures approaching existing limits be considered as candidates for exemption.
The l
Commission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement.
However, as the doses to members of the critical group decrease, the need for regulatory controls decreases and the analysis needed to support an application for exemption can become less rigorous.
In essence, the complexity of the basis for decision making on exemptions is a continuum ranging down from the established limits L
of acceptability, namely the dose limits.
Within the continuum of decision making on the applicability of regulatory controls and the risks of radiation exposure received, -the Commission believes that there is a range of risk of death at which individuals are unlikely to spend resources or otherwise take any actions to further reduce their risk.
DRAFT 08/24/88 NMSS BRC POLICY 8/23
p rgfdd d $r O = M l
7 l
t
-6 to 10'I per year, and This range of risk is taken as being on the order of 10 is represented by an annual dose on the order of I mrem.
This order of magnitude of risk or dose has been termed by the National Council on Radiation Protection and Measurements (NCRP) as the Negligible Individual Risk Level (NIRL) and is taken by the Commission to represent a reasonable threshold of i
regulatory concern below which decisions about the acceptability of an exemption can be based on simple demonstrations of justification and ALARA.
The establishment of a threshold on the order of 1 mrem per year should not be construed as a decision that doses below this level are acceptable while doses above the level are not.
On the contrary, as was shown in Table 1, a dose of
-6 10 mrem also corresponds to an annual risk on the order of 10 However, the Commission believes that doses on the order of 1 mrem represent the range above which a closer analysis may be required in order to make a decision regarding the acceptability of an exemption, particularly when the potential exists for an individual to be exposed to multiple exempted sources of radiation, such as consumer products.
Further, the threshold does not represent a strict line of demarcation, but rather a range of risk repr6sented by an order of magnitude This approach has been taken in recognition of the Commission's of dose.
l belief that it is reasonable and prudent to allow some flexibility in implementing this policy as it applies to the I mrem dose.
The Commission believes that an exemption embodies the conclusion that the practice being exempted will not contribute significantly to the overall risk to the exposed individual or the general population, and is unlikely to have a significant impact on the environment.
In this regard, the collective dose is one of the principle factors in determining the scope of the practice under consideration, and the potential impact of that practice on the general population and the environment.
It is the Commission's expectation that, in most cases, an exemption would not be approved if either the individual or collective dose from a proposed practice were unacceptably or unnecessarily large.
A test of significance of collective dose, which assists in defining the scope of practices involving individual dose on the order of 1 mrem and thus requiring simple demonstrations of justification and ALARA, is taken to be DRAFT 08/24/88 NMSS BRC POLICY 8/23
l C
t
- 4 on the order of 100 person-rem. However, in some instances, the collective dose will be proportional to both the extent to which an exempt practice is utilized and the resulting benefits.
For example, the use of smoke detectors containing radioactive sources in houses is known to save lives.
Both the number of lives saved and the collective dose will increase proportionally to the number of smoke de+ actors used.
Thus the Commission does not believe that an a priori limitation on the collective dose is appropriate for this exemption policy.
Establishment of an exemption for a particular practice does not necessarily imply that the individual and collective doses would be perceived as trivial by the individuals and population involved, even if the individual dose to members of the critical group were within or below the range of 1 mrem per year.
However, the Commission believes that promulgation of an exemption would still be appropriate, from a regulatory standpoint, because either the degree of risk does not require the burden of regulatory controls, or because there would be little gain in risk reduction by additional controls.
1 V.
IMPLEMENTATION OF EXEMPTION POLICY A.
E_XCLUSIONS FROM EXEMPTIONS There are some types of practices involving radiation or radioactive materials which are, prima facie, socially unacceptable regardless of how trivial the resulting dose might be.
These practices would not be i
candidates for exemption.
Excluded practices would include, but not be limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the skin (such as cosmetics).
Exclusions would also include the purposeful introduction, distribution, or release of radioactive materials when there are clear, economical alternatives to the use of radionuclides and the practice is not justified because there is no unique benefit from using the radioactive materials.
DRAFT 08/24/88 NMSS BRC POLICY 8/23
~
'~
~'
~
I
.L l*
.g.
B.
PROPOSALS FOR EXEMPTION A proposal for exemption, either as a petition for rulemaking or as a license application or amendment, must provide a basis upon which the Commission can determine if the basic conditions described above have been satisfied.
In general, this means that the application should address the individual and collective doses resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways of exposures, the levels of activity, and the methods and constraints for assuring that the assumptions used remain appropriate'as the radioactive materials move from regulatory control to an exempt status.
If a proposal for exemption results in a rule that contains generic requirements, a person applying for a license to utilize the exemption would not need to address justification or ALARA.
The Commission decision on such proposals will be based on the licensee's meeting the conditions specified in the rule. The 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.
If, af ter a practice is determined to be justiMed and a simple assessment indicates that the likely consequences of an exemption are individual and collective doses approximately equal to or less than the threshold of regulatory concern, there would be a high likelyhood that the application would be accepted by the Commission.
^
There may be cases, however, where simplified assessments which typically use conservative assumptions for bounding conditions, will indicate the potential for higher individual or collective doses.
In these cases, a more detailed analysis will be required to make a determination on whether the basic conditions for an exemption have been met.
DRAFT 08/24/88 NMSS BRC POLICY 8/23
w_.,
10
)
i In addition to considerations of expected activities and pathways, the j
Commission recognizes that consideration must also be given to the potential for accidents and misuse of the radioactive e.aterials involved in the practice.
An application for exemption must therefore also address
)
3 the potentials for accidents or misuse, and the consequences of these exceptional conditions in terms of individual and collective dose.
C.
APPLICAT10N OF COLLECTIVE DOSE ASSESSMENT As noted above, 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 regulatory controls.
In the later case, a monetary value can be assigned to the collective dose so that quantitative assessments can be made of the benefits of regulatory controls for comparison with the costs of those controls.
The Commission believes that a base value for collective dose evaluations should be identified, in keeping with the linear
- hypothesis for radiation protection planning, and considers a value of $100 per person-rem as a suitable choice for this base value.
The adoption of a base value for collective dose evaluations is consistent with international activities in this area, and the selected value of $100 per person-rem is somewhat greater than the value recently suggested by the International Atomic Energy Agency as the international minimum for transboundary exposures.
However, in assigning values to collective dose in previous situations (i.e.,10 CFR Part 50, Appendix I), a value of $1,000 per person-res has l
been used by the Commission.
The Commission has determined that a dose on the order of 1 prem per year represents a range of risk in which individuals are unlikely to take any actions to further reduce their risk.
This level serves as a threshold for determining if a simple analysis is sufficient for approval of an I
exemption, or_if a more detailed analysis is necessary before approval.
The Commission believes that this level is also an appropriate point at DRAFT 08/23/88 NMSS BRC POLICY 8/23
f
..-~~-
~ ~. -. -
.s 13 e
which to increase the base valuation applied to collective doses as a reflection of the increased level of concern.
As the individual dose increases, i.e., above doses on the order of 1 mrem, the higher valuation of $1,000 per person-rem is appropriate because of the increased risk posed l
by that exposure to the individual.
Therefore, collective dose assessments for purposes of ALARA and cost-benefit analysis may be
. assigned a monetary value as follows:
D o
$100 per person-rem for collective dose composed of individual doses l
below 1 mrem per year.
o
$1,000 per person-rem for cellective dose composed of individual doses in excess of 1 mrem per year.
VI.
VERIFICATION OF EXEMPTION CONDITIONS The Commission believes that the implementation of an exemption under this broad policy guidance must be accompanied by a suit
nrogram to monitor and verify that the basic conditions under which an exempt, eas issued remain valid.
In most cases, the products or materials compristi.g an exempted practice will move from regulatory control to the exempt status under a defined set of conditions and criteria.
The monitoring and verification program must therefore be capable of providing the Commission with the appropriate assurance that the conditions for the exemption remain valid, and that they are being complied with during routine activities.
The Commission will determine 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.
5.
DRAFT 08/23/88 NMSS BRC POLICY 8/23
p.
- t-4NaTw b
w.
3f
{
p
~
k The Comission believes it likely that few people would consnit resources or otherwise take action to avoid an annual risk of death of 10-5 and that even fewer would take action to avoid a similar risk of 10-6 This translates to a dose of 10 mrem and 1 mrem respectively. The Comission also recognizes that it is very impractical, if at all possible, to reasure annual doses to people at these levels.
Typically, radioisotopes concentrations or radiation levels from the material to be exempted are measured and doses are estimated by exposure pathway analysis combined with other types of assumptions related to how people might come in contact with the exempted material. At very low doses, such modeling may differ from the actual dose by a factor of 10.
Under 1
such conditions, conservative assumptions are frequently used in modeling so that the actus1 dose is on the low side of the calculated dose. Conversely, a simple value assigned to individual dose is normally assigned to the larger l
segment of the population, which are the end users'of products or larger popula-tions exposed exempt releases.
Very small segments of the population, e.g.,
persons handling large quantities of irradiated gems in retail stores or landfill workers disposing of exempt waste, may be subject to somewhat higher doses.
Taking these considerations into account, the Comission believes that l
the range of dose constituting a trivial individual risk falls within the approximate range of 10 mrem to 1 mrem, with the individual dose for the bulk of the population at risk being on the order of 1 mrem. This order of magnitute of risk or dose (1 mrem) has been terined by the National Council on Radiation Protection and Measurenents (NCRP) as the Negligible Individual Risk Level (NIRL).
On the basis that the individual dose from an exempted practice will be on the order of 1 mrem for most of the pcpulation comprising the bulk of the collective dose, simple demonstrations of justification and ALARA for a specific practice is warranted.
It recognizes and allows for some individual doses to range up to 10 mrem within the scope of this provision. Also, in defining the scope of practices to which the test for individual trivial dose applies, a test of significance of collective dose on the order of 100 person rem is established.
If the collective dose falls below this level. - - - - - -
a f
_ _.._ ~-,
p, 9
~
i A 8 Q
e g4./:,v4 s
4 E-4 i'
aN
,,w=,,
cC.:
Y
- 4..,
MZG a u. v.
4 p
.,e, b
g e
e t
\\
i 4
l l
l I
r e
l
~
... ~
e l
..