ML20042D086
| ML20042D086 | |
| Person / Time | |
|---|---|
| Issue date: | 10/17/1988 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20042C963 | List:
|
| References | |
| FRN-53FR49886, RULE-PR-CHP1 NUDOCS 8810280291 | |
| Download: ML20042D086 (7) | |
Text
^^~
~~
~ ~ ^ " ' ^ ~
~ ^^
~
~~~
wa_,
V.,,
x 9
4(
WORKSHOP ON RULES.FOR EXEMPTION FROM REGULATORY CONTROL What Do We.Mean By Below Regulatory Concern?
Donald A. Cool, Ph.D.
Office of Nuclear Material. Safety and Safeguards U.S. Nuclear Regulatory Commission I.
INTRODUCTION One of the problems associated with treating the difficult technical and policy issues of exemption of radioactive materials from regulatory control is the usage and meaning of the terms used to describe the issues. A number of terms have been used in discussions of regulatory controls for activities involving low levels of dose. Of ten, terms such as exemption-levels, below regulatory concern, negligible individual risk level, and de minimis have been used interchangeably to mean both the general region of low dose levels which an-individual would consider to be trivial and the larger region of low dose levels in which regulation to further control dose and risk may be unwarranted.
Thus when we use a term, it may be interpreted by different people as meaning totally different things.
The purpose of this paper is to briefly describe some of the terms which have_
typically been employed when discussing exemptions from regulatory control, so 4
that we can have a common understanding of what is intended by our statements.
I also hope to describe some of the different ways in which an exemption could L
be granted.using the current philosophies, and identify some of the problems j
associated with certain definitions and concepts.
l' II. DEFINITION OF TERMS l
Regulatory Control The phrase regulatory control has been traditionally used to mean the'-
administrative system of notification, registration, and licensing i
employed by a competent or government authority to control radioactive material. This system is described in the Basic Safety Standards adopted o
by the IAEA, ILO, NEA, and WHO, and is based upon the recommendations of' the ICRP.
In the United States these controls take the form of federal guidance and generally applicable environmental radiation standards issued by the Environmental Protection Agency under various legislative authorities, and the regulations issued by agencies such as the Nuclear Regulatory Commission and the Department of Energy which impose specific requirements for possession, control, use, and disposal of radioactive materials.
2 YS
- p. ]5'
wm-4;%
~
j
+
c.
2
- +
Exemptions In international terms, exemption refers to situations in which the full system of regulatory controls envisioned by the Basic Safety Standards is not required for_ a given practice or source of radioactive materials.
The' Basic Safety Standards provide criteria for the exemption of radioactive substances, apparatuses and sources from the requirements of notification, registration, and licensing. National regulations, such as those of the Nuclear Regulatory Comission, also provide ~that the full system of controls is not required for specific situations, such as the use of certain devices, or the possession of specified small quantities of-radioactive material.
Likewise, the release of facilities that were formerly used for the processing, use, or storage of radioactive materials constitutes an exemption from further regulatory controls.
The implicit assumption in an exemption is that the regulatory controls are not required for the protection of the public's health and safety.
Exemption Rules Exemption rules are the fundamental criteria by which a competent authority can determine if radioactive materials can be exempted from some or all regulatory controls. -These criteria may be based upon a number of factors,-some of which may be related to the level of risk or dose implied t
by the use of the radioactive material, and some of which may be related to the effectiveness of regulatory controls to meaningfully reduce the 4
l-risk or dose.
l Exemption rules are often expressed in terms of radiation levels,.
concentrations of radionuclides, quantities of radionuclides, or some combination of these units.
In many cases, the exemption will include a specification on the types and quantities of material that can be released, such as the exemption for smoke detectors containing small quantities of americium.
The exemption may also include the measurements that must be performed, and the quality assurance requirements to be exercised prior to release to ensure compliance with the terms of the exemption.
l Justification L
The term justification refers to one of-the three principal tenets of radiation protection identified by the ICRP and incorporated into the Basic Safety Standards of the IAEA. The principle of justification.
l-
- states that there should be some net benefit to be gained from the use of L
radioactive material, and that the benefit derived should outweigh the L
detriment associated with the radiation exposure.
l Although the justification requirement is frequently dismissed in regula-tory agencies where most practices, such as nuclear power generation, have
. already been justified through national legislation and other means, the l
10 3:
m-g
^
~~
^
^
~
.p_.
}
i e
3 1
concept is still of great importance when considering exemption from regulatory controls. The tendency of many people is to assume that if the j
doses are likely to.be low, then this is de facto proof that the practice 1
causing the exposure is justified. However, a strict interpretation of the justification requirement implies that this principle be considered, irrespective of the size of the potential doses. Thus, there is a question as to the extent to which exposures should be justified when only very small levels of exposure will result from the practice.
Practice The definition of " practice" is a critical feature for exemption policy that outlines the extent and applicability of a given exemption.
Properly defined, a practice should assure that the formulation of exemptions from regulatory control will not allow deliberate dilution or fractionation of L
radioactive material for the purpose of circumventing controls that would L
otherwise be applicable.
In the recent draft " Principles for the Exemption of Radiation Sources and Practices from Regulatory Control".
IAEA and NEA noted that any identified specific practice should include the following characteristics:
the activities are aimed at a common objective; the sources should be clearly identified; it should be possible to identify the critical group or groups uniquely linked to the practice; (4) the dose to the critical group and the exposed population should L
not be significantly affected by other similar or identical practices; and (5) the activities constituting the practice are sufficiently well identified and defined to allow analysis.
L Several offficulties arise when these characteristics are gpplied to real exemption situations.
For example, should all types of w ste from a nuclear reactor which could be disposed of in a landfill be considered as p
a single practice, or could each unique type of material such as dry E
activated waste, secondary: resins, and contaminated soils be considered as separate practices.
Furthermore, should-these wastes be considered a practice on a national or international scale, such as was proposed by the NRC's policy statement on waste disposal published in 1986, or on a more i
localized level. These questions are of particular concern at this time as the NRC attempts -to formulate its broad policy regarding exemptions.
-and I look forward to Dr. Ilari's thoughts on this matter in a few minutes.
Negligible individual risk level This term refers to a level of risk or dose that would likely be taken by most individuals as not warranting further actions or the expenditure of their resources to reouce risk. The phrases "de minimis level" and
L
_.o m
.1 J
" trivial level" have also been used to express this same concept.
There has been a great deal of effort devoted to determining such a level, and, althoughspeculative,aconsensusisemergingamongthoseJhathavg studied the issue that a risk of death on the order of 10~ to 10' wou'Id be considered as negligible by most people. This level of risk currently translates to dosts on the order of 10 to 100 uSv (1 to 10 mrem). Mr.
a Webb will be discussing this topic in greater detail.
De minimis The term "de minimis" is an abbreviation of the phrase "de mihimis non curat lex", and can be translated as "the law is not concerned with trivialities." The initial use of the term was in a general sense of reference to very low radiation exposure situations where the level of risk to any member of the public would be considered as trivial.
In this context, the term does not reflect any basis for a decision other than the risk to an individual as a result of radiation dose. 'For the purposes of these discussions, the phrase "de minimis" will be used to refer to the exemption concept in which the exemption rules are based upon a " trivial" t
or " negligible individual risk" level.
Below regulatory concern The phrase "below regulatory concern" has come into use in the last couple of years, especially in the United States, as a reference to a situation in which the promulgation of an exemption is appropriate from a regulatory standpoint, usually because there would be little gain in risk reduction by the addition of regulatory controls. The concept of "below regulatory concern" was intended to differcntiate between "de minimis",
which implies the establishment of a trivial risk without the need for additional regulatnry considerations, at:d those situations in which other regulatory considerations, such as ALARA, enter into an exemption decision. Thus, in these discussions,.the phrase "below regulatory concern" will be used to refer to the exemption concept in which the exemption is based upon, at least in part, factors other than
" trivial" or " negligible individual risk" levels.
A decision that a practice is "below regulatory concern" is not intended l
to imply that any generically applicable level of risk has been achieved l
for the critical group, or for the exposed population as a whole.
Instead, the phrase is simply intended to imply that further regulatory action is inapp.ropriate, i.e. an exemption should be granted.
The "below regulatory concern" concept and the "de minimis" concept, while resulting in numerically equivalent levels for certain situations, are l
distinct from each other because of the basis for the decision.
- Further, a "below regulatory concern" criterion may be established for both individual dose and collective dose, based upon the efforts necessary to reduce these quantities.
This is not, however, generally the, case for a 1
1
p ww,_
(
5 "de minimis" decision, which applies to the individual's perception, but I
has no direct counterpart for society as a whole.
The collective dose l
criterion which is often discussed in reference to exemption policies has 1
its origins in economic considerations, in ) articular, the cost implied by a simple optimization analysis. While tie literature is now replete with references to " negligible individual risk or "de minimis" levels for individuals,-no such values for societal impact have been proposed. Thus,
)
a reduction in societal or collective dose has, up until this point at least, always implied some type of optimization consideration.
l III. BRC EXEMPTIONS p
In the preceding discussion, I have attempted to outline the meaning for some of the terms which have been used when discussing exemptions from regulatory i
control.
I would now like to return briefly to the more general discussion of exemption from the viewpoint of the "below regulatory concern" concept.
1 l
Exemption from regulatory controls such as licensing, registration, and notification, using a below regulatory concern concept, connotes levels of risk L
or dose that may be considered acceptable from a regulatory standpoint, i.e.,
3 I
individual and collective doses that warrant limited government attention, taking into account the cost of further regulation and the likelihood that such regulation would significantly alter the resulting dose. A practice could be considered as a candidate for reduced regulatory requirements if it could be demonstrated that certain specific conditions are met.
The conditions for considering exemption might include requirements such'as:
1 (1) the use of additional controls on the practice or source of exposure does not result in an additional reduction in the dose received; or (2) the costs of the regulatory controls are not balanced by the benefits of dose reduction that could be achieved.
Thus, the authorization of an exemption for a practice can generally be made L
only af ter an optimization analysis.
Establishment of an exemption for a particular practice or source of exposure j
on these bases does not imply that the dose would necessarily be considered as negligible or trivial by individuals.
Because decisions on triviality are based upon each individual's subjective personal judgements, some individuals
-might wish to take some further action to reduce or avoid the risk associated with a low level of radiation dose.
g l
L Exemptions based upon a "below regulatory concern" philosophy can be categorized into two general types.
First, the decision can be made with respect to a specific practice, or in some cases, even specific, discrete l.
sources. An example of this type of exemption would be the release for unrestricted use of a facility that formerly used radioactive meterial.
In this example, the release would be based upon a conscious decision that costs of further decontamination would outweigh the benefits that could be achieved
- : s,w C
~
^ ~'
~ ~~
~
~ ~
~ ' ^ ~
^
^
~
~
^
6 e
through further reductions in potential doses.
Such a decision would.
therefore be unique to that particular~ situation, and would not necessarily carry any implications for the next decision which could involve an entirely different set of circumstances.
The second genera 11 type of exemption is based upon a generic decision about what constitutes "below regulatory concern" for the decision-maker.
In this case, a level of risk or dose is selected that represents the point where it is unnecessary to perform any type of cost-benefit analysis, irrespective of the source or practice under consideration.
It is this type of BRC exemption which is often blurred with a "de minimis" type of exemption finding. This is particularly the case when an individual risk or dose level, selected on the basis of trivial risks, is combined with a collective level selected on some 3
l type of cost-benefit basis.
l In some situations, case specific determinations of what is "below regulatory concern" for the decision-maker could result in doses which are above the level selected on a more generic basis.
However, depending upon how the generic.
level is set, it is also possible that a case specific determination could result in.a dose which is less than the generic level derived from broader considerations.
I mentioned briefly that the decision regarding a "below regulatory concern" exemptionsencompassesbothindividualandcollective(societal) consider-ations. The~ impact of an exemption upon the exposed population could be of crucial importance for two reasons. The first is that while an exemption could result in low individual risks to any single member of society, a broad application of the exemption could result in potentially unacceptable conse-quences to the society as a whole. An example of such a situation is the wide distribution of an exempted product. The second reason for societal considerations is the possibility of multiple exposures to individuals or population groups as a result of exempted practices.
A limitation on the collective dose, which has been proposed 'in a number of situations, may not be sufficient to deal with concerns described above.
In particular, the collective dose does not usually provide an adequate mechanism for assuring that multiple exposures of the same critical group will not occur as a result of a broad exemption policy. As a result, the NRC is requesting comment-on alternatives to the use of a collective dose criterion in deter-mining the impact of exemptions on the exposed population, and specific subgroups within that population.
Whatever the outcome on the use of a collective dose criterion, the NRC exemption policy will require that the potential for multiple exposures be specifically addressed as part of the analysis and findings necessary before an exemption could be granted.
Within the context of an exemption policy, the HRC considers the "below regulatory concern" concept to be indicative of a level at which a fundamental change in the decisionmaking approach can be made.
The proposed broad exemption policy, which Mr. Lahs will be discussing in greater detail tomorrow a
nam :aw.
l
,LI-7 morning, provides criteria which, if satisfied by the practice under analysis, would allow for a simplified decision regarding the acceptability of the practice for exemption.
These criteria constitute a generic type of "below regulatory concern" finding.
However, if a practice would result in doses greater than the proposed criteria, the practice could still be considered for exemption from some or all regulatory controls on the basis of further ALARA analyses. This second stage recognizes the application of case specific-findings of "below regulatory concern"'
In either case, the granting of the exemption would be based upon a finding that further regulatoty controls are H
not appropriate, either because the degree of risk is too small to justify the burden of additional regulatory requirements, or because there would be little gain in risk reduction by the addition of regulatory controls.
4 0
.