ML20043B932
Text
w.s2. a 6O h
JAN 9 4 im 1
MEMORANDUM FOR:
Eric S. Beckjord, Director Office of Nuclear Regulatory Research i
FROM:
Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards i
SUBJECT:
PUBLIC MEETING ON POLICY DEVELOPMENT FOR EXEMPTIONS FROM REGULATORY CONTROL j
i In response to your memorandum of December 27, 1988 on the above subject.
Dr. Donald A. Cool is designated as the HMSS representative to attend the meeting and serve on the panel.
(Signad) etugfL L Thompso4 A i
e Hugh L. Thompson, Jr., Director Office of Nuclear Material L
'3afety and Safeguards cc:
B. Morris, RES W. Lahs, RES T. Murley, NRR F. Congel, NRR DISTRIBUTION:
IMN5 central File NMSS r/f IMDB r/f Director's Office r/f JFunches 61 JHickey GSjoblom RECunningham s
, bl i fL a
OFC: I
[ Mil IM 5
g 55 ims MANE /0 11 Jgy 65 pm RCunningham R5 nero pson DATE:it/p/88 @t/88
//h)/88 #//vJ/y
/
88
/ /] /
OFFICIAL RECORD COPY h8600064891339
,CHP1,53pg49886 PDC e
E p,...
4/
(oS 7
t NRC/ EPA MEETING JANUARY 25, 198g DISCU$$10N OF EPA ComENTS ON THE C0W.1$$!0N'S ADVANCE NOTICE OF PROPOSED POLICY ON EXEMPTIONS FROM REGULATORY CONTROL (For Practices with Public Health and Safety Impacts Below Regulatory Concern) l MMA
' Concept of 'telow Regulatory Concern'
' Definition of Practice 1
l
' Policy vs Rule - Implementation'ef Exemption Decisions l
' Impact of E?A Regulations
' Criteria For Establishing a ' Floor' for Optimization of Protection Efforts
- 10 prem/yr/ practice Individual Dose Criterion
' Individual dose limitation for exemption decisions?
- Measure of societal impact
' Truncations of collective dose
' Risk comparisons to other environmental contaminants i
' Risk Factors
'8ases For Exemption Decisions
' Justification
'$nall Individual Impacts vis-a-vis Existing Limits
- !AEA Safety Series '8g
- 1986 Commission Policy
' Interagency Coordination
' Exemption policy
' Clean air act i
i v-uw
--n--
-n,
,,, - - + -. - -
wg-w
._a-.._
e
.O 9 9 r
i
^e
/
+
- g.
\\
i bis /CH 2-n 7
~'
4 I
1 i
hQ
^^^
" " " ^ ^
. -@ mu4a.u @.d ? :=
- - >3
= <- '- e n..
es
, r
- s.. s_
e D'A puswu At. kec 4 %%a 4O w
V N M4 A f$
W
$^^-
Am wUlf M & &,
. 9/ 4 arr Ant. 3A 4 &.44e'd i_'- %*
j
[H h.d 4*rf
@4 Nf $&
A p l ':
,.k.1 &
j
!"cX'N' & %& WW y1(.s/ w &
I m
& S&1 it, 4
w a
saasu
.4 & af.tA& % ---. ---.
eaw
-aee p_-e *b dy.'~ '*?
@ & Mue-d
. -. ~ - -,
l
. g4 '
so.6fi%?iW6'SX W T
~"
a e
z.w.g e
e a
a u+
.e.e.
e e
e e,e.gs em~r r
occ.
ce oc e
<> > c c m
.cc a o.e. c c ::: a c a a 0a0000000 beGla.<.e //Q,
, L Ma v.M us
(
a v ; a e a
- : ;.2;;.a mua a.a...
c.ccoc:
o o.o
. <.u >. =
e
.w
- - w 4o eee cooc.
o.e.m..,_. u, a
a v>
c, m..
e.o ec
... u --
m
. e.o co ce e
..., e er w : m t les0GGGOCCCCCOOOOOOOGOOOaS9
.secc= cec==a-L
.e i
l t
l l
1
i
\\
umiso sTATss
[
r NUCLE AR REGULATORY COMMISSION f
up46HowoTON,p C.se666 y
\\....+,
j MEMORANDUM FOR:
Victor Stello Jr., Executive Director for Operations FROM:
Eric 5. Beckjord, Director Office of Nuclear Regulatory l
Research
{
$UBJECT:
RES PLANS FOR DEVELOPING PROPOSED EXEMPTION POLICY STATEMENT AND FOR RESPONDING TO EPA'S LETTER 70 CHILK/8ECKJORD i
)
At the public setting on January'12,iew that, as proposed, the regulatory 1989 and in follow up causent letters (enclosure),theEPAexpressedthev i
exemption policy publisied in the December 12 1988 advance notice would not
" adequately protect public health and the quality of son's environment.' EPA also stated their belief that it is presature to establish generic numbers fcr defining below regulatory concern (BRC) criteria. They invited the NRC thMugh the EPA /NRC Interface Council, to work jointly with EPA to develop a j
framework for a ragulatory exemption policy that would be in the ' mainstream i
of other national and international concepts.' In order to attempt to seet the Cosnission's schedule for developing a proposed exemption policy and to respond to EPA's coments, the following plan is proposed:
On the matter of interaction between the two agencies, we plan,f6iis'with as we l
a.
develop the proposed nolicy statesent, to continue our interact i
EPA w W on an 'as needede and m,.;,et informal basis. Specifically:
l (1) copies of revised drafts of the proposea polisy.1,.tement being developed by the staff and other pertinent information will be sent to EPA for comunent, as has been done to date and (21 settings with EPA staff l
will be held monthly or on an 'as needed' huisjour last meeting was held I
on January 25 1989). A proposal for a more formal interactive process l
will be high1Ighted in the Cossnission paper transmitting the staff's L
revision of tht neanated policy. We are currently pumMng that thTs more formal interaction would cossnence following publication of the proposed policy statement in the Federal Register. The implementation of a romal interactive process would provide a means for EPA to express their views in the development of the final policy statement but would not slow down staff efforts to get the revised policy before the Comission on schedule. The Comission paper is currently scheduled to go to the iL Cosnission on April 28, 1989.
i l
H,.
't-
{*
^
Victor Stello, Jr.
2 l
b.
RES plans, for the record, to develop and send to EPA a written response to their coments - specifically addressing those coments where apparent misunderstanding exists.
c.
The aforementioned response will also be included in the analysis of public cosmients which will be included in the Commission paper containing the staff's recomendation for a proposed exemption policy.
Unless we hear from you to the contrary, we propose to follow the plan described above.
l Eric S. Beckjord, Director Office of Nuclear Regulatory Research 1
Enclosure:
Comment letters I
l l
l E
i
. n-UNITS 0 sTATss
[
- a NUCLE AR REGULATORY COMMISSION s
wasm woTow.o.c.ne m
\\,...../
i Mr. Richard E. Sanderson, Director OfficeofFederalActivities(A-100AE)
United States Environmental Protection Agency Washington, DC 20460
Dear Mr. Sanderson:
Your letter of February 2,1989 and a follow-up letter from Mr. Richard Guimond to Mr. Eric Beckjord dated February 17, 1989, transmitted the U.S. Environmental Protection Agency')s (EPA) views and concerns regarding the U.S. Nuclear Regulatory r
Comission's (NRC Advance Notice of a Proposed Policy Statement on Exemptions from Regulatory Control.
You state that in EPA's review of the notice, a number of significant areas of concern have been identified which lead you to
'believe that the criteria, stated in the notice, are not appropriate for i
adoption as a generic policy. The listed areas of concern include:
(a) federal responsibilities and authority; (b) concepts for establishing l
'Below Regulatory Concern" levels; (c) the exemption level for individual dose;-
L (d) implications of the proposal for collective dose; (e) implications for implementation of the proposal and (f) implications for consistency with international and NRC policy. The purpose of this letter is to provide a preliminary response to your coments.
In so doing, my intent is to extend the dialogue on the issues raised so that many, if not all, may be resolved as the Comission's proposed policy statement is developed.
First, I would emphasize that NRC recognizes that the subject of regulatory exemptions is one in which EPA and NRC have been given shared and complementary responsibilities.
In fact, our infomal discussions with EPA staff during NRC's development of a proposed policy for Comission consideration, and the subsequent NRC invitation to EPA to attend the October 1
1988 International Workshop, were intended to achieve a reasonable degree of coordination. This approach apprently needs to be improved; therefcre, I agree with your proposal to establish a coordinating mechanism for developing I intend to recomend that EPA's 1.a common framework for exemption decisions. suggestion (that the issue be pursue l
l l
Interface Council) be adopted,,once the Congiu9 W issued a revised policy
,for public comen.
In the meanu me, as we proceed t Toeveiop a revisec crart. I
'poliqy for su m ssion to the Commission, we will continue to interact with the L Office of Radiat 6n Programs' staff.
I would add that the NRC also supports EPA efforts to &.alop the below regulatory concern concept for the disposal of certain low level radioactive waste at other than licensed waste disposal sites. Our development of a broad-based policy statement, which recognized EPA's authorities, was intended to be complementary to your efforts.
l l
7 L,.
i 4 41 Mr.. Richard E. Sanderson~
2 l
The information provided in the enclosure is inten'ded to respond'to the areas l
of concern reflected in items-(b) through (f) of your letter. Please contact l
-se (492-3750) or Mr. William Lahs (492-3774) if you become aware of a need for l-
- further' clarification or if additional questions arise. Mr. Robert Bernero, NRC's. representative on the EPA /NRC Interface Council, has been made aware of your connents and will propose the~issus for discussion at the next Council 1
l
. meeting.
l
- )
E Bill M. Morris, Director Division of Regulatory Applications Office of Nuclear Regulatory Research i
Enclosure:
As stated' o
l l
?
1 I
L i
)
1 1
1-CONCEPTS FOR ESTABLISHING BRC LEVELS EPA Comment practice that, while beneficial [ justified)y decision to limit regulation of a There are two essential elements of an, can cause radiation exposure to the general public. The first is that the deleterious impact of the practice on health in the exposed population, taken as a whole, is small enough that the effort and expense of regulation of the radioactive hazard is not warranted.
The second is that the risk to any person is small enough that the majority of individuals would not consider it of concern. Neither element is adequately addressedbytheproposedpolicy[advancenoticeofaproposedpolicy statement].
NRC Response On the contrary, we believe the discussion in the advance notice reflected our appreciation of these elements. A major purpose of the proposed policy would be to establish criteria which would, in effect, delineate achievement of ALARA for a justified practice i.e., indicating when a licensee need not expend further resources for cost-benefit (cost risk reduction) efforts. The advance notice stated that the Comission is evaluating the use of two numerical criteria in defining the region where ALARA has been achieved: a) a criterion for the maximum individual annual dose reasonably expected to be received as a An individual dose criteran was proposed (i.e.,10 mrem per year) population.
result of the practice and {5) a measure of societal impact to the but coments were solicited on whether, or in what form, a societal impact criterion should be proposed.
The C
.ission recognized that a collective dose criterion could be used to addres societal impact but questioned whether alternative approaches could be devis-to define a minimal societal impact for a given practice (e.g.
setting different individual dose criterion on the basis of the number of people potentially exposed and the distribution of the expected individual doses). Therefore, although the Commission has questioned how to characterize the societal impact criterion (including consideration of the argument that the societal impact of the total of all trivial or negligible individual risks should be treated as being negligible), conceptually, the need for such a criterion has not been rejected. As a result, we believe both of the two essential elements have been addressed for the purposes you describe.
EPA Comment The proposed policy could be considered arbitrary since, without definition of a practice, an optimization assessment can not be performed. Sufficient experience should be gained with individual case from which a trend may emerge permitting generalization to a single set of generic numerical criteria for BRC.
l
e T
NRC Response The NRC believes the approach described in IAEA Safety Series 89, can be followed. This approach would involve the definition of both an appropriate individual risk and a minimal societal-impact. The value of the societal impact would be such that most reasonable people would agree that the broad societal cost of any regulation would be greater than the value chosen, and that regulatory resources would be better spent on the control and regulation of more risk significant radiological activities. As the discussion in the advance notice indicates, the individual criterion could be based on a fatality risk judged to be of little concern to most members of society (e.g., a risk which the individual would not spend resources to avoid). The importance i
attached to optimization assessments was also reflected in our recognition that there co'uld be situations in which the optimization evaluation for a specific practice could indicate that an exemption should be granted even though calculatedindividualandcollectivedosesmayexceedtheaforementionedcriterion values. The discussion in the advance notice, however, does need to be improved since we have received many coments indicating that many readers believed that the Comission was proposing that practices causing potential individual exposures approaching public dose limits would be routinely exempted from regulation. This is not the case and in developing a proposed policy for l
Comission consideration, the NRC staff intends to rewrite and clarify this l
point.
1 THE EXEMPTION LEVEL FOR INDIVIDUAL DOSE EPA Comment At the international workshop in October 1988, there appeared to be virtual unanimity that a 10 mrem / year value was too high as a criterion for establishing when licensees need not expend further resources on ALARA or optimization efforts.
NRC Response On review, we believe your conclusion is somewhat overstated. Our view was that most participants considered individual effective dose equivalents in the range of 1-10 mrem per year to be " trivial." The discussion at the meeting frevolvedaroundtheissueofhowthisnun6ershouldbe" fractionalized"to apply to a single practice.
Our approach was to estat11sh the individual dose criterion on the basis of a risk level which the Comission believes most individuals would not spend their resources to avoid. This represents a slightly different approach than However, the NRC is still actively I_ the trivial risk basis used internationally.considering what individual dose criterion s
\\ should be used to defend the selected value.
Your comments on this issue will l receive serious consideration.
EDA Comment l
Consideration of exemptions involving the possibility of exposures as l
high as 100 mrem per year is totally inappropriate.
l 1.
2
4 k
NRC Response As stated in the advance notice, the intent of the policy is to assure that individuals exposures to the public remain well below 100 mrem per year.
The intent of the discussion in the advance notice was to reflect flexibility in the regulatory decision-making process regarding exemptions. For example, there may be rare instances where exemptions, on the basis of an optimization evaluation, could be granted for practices where a few individuals could receive doses above 10 mrem per year. Our intent is to clarify this point in the proposed policy statement.
EPA Coment The individual risk levels associated with doses in the 10-100 stem / year range are not consistent with many Congressional and regulatory actions being taken relative to other environmental contaminants.
NRC Response The NRC is aware of this issue and is concerned that all of the many factors l
important in establishing acceptable health risk levels be considered for each l
environmental contaminant.
Populations impacted, distribution of individual impacts, uncertainties in health impacts, persistence of the purported hazard, the potential for multiple exposures, and other issues -- all must be addressed i
in establishing ' risk-based" regulatory policy. Our intent is to discuss this issue of consistency further in the development of the proposed policy.
EPA Coment -
The dose to risk conversion factor used in the advance notice is out-of-date.
NRC Response The NRC was aware of the impending recommendations regarding dose-to-risk conversion factors as the proposed policy was being developed.
In lieu of l
speculating on the implication of unpublished data, the discussion in the advance notice indicated that the Comission included a margin-of-safety in establishing an appropriate individual dose value. However, with the iminent I
publication of the BEIR V report and the recent publication of the 1988 report by the United Nations Scientific Comittee on the Effects of Atomic Radiation, the NRC staff will include consideration of these developments in its recomended proposed policy.
j COLLECTIVE DOSE EPA Comment Any decision to exempt a practice from regulatory control needs to include an evaluation of the total impact of the exemption on public health.
3
i NRC Response As mentioned previously, the discussion in the advance notice recognized that the total impact of any exemption decision on public health and the environment needs to be considered. The NRC staff is currently evaluating the efficacy of using collective dose, or some other alternative, to address total social impacts.
EPA Comment There is no valid scientific basis for truncations in the assessment of i
collective dose in the exemption decision-making process.
NRC Response l
Although the Comission asked for conenents on this subject, I would emphasize that neither the advance notice nor the staff's original draft proposed policy included a decision regarding truncations. On this point, I would further note that an assessment of the total societal impact of an exemption decision does not necessarily preclude the usefulness of a truncation l
provision in the numerical process of evaluating collective dose.
IMPLEMENTATION EPA Coment l
_ Upper limits for doses to populations can not be assured if exemptions l
_ were permitted to cause potential exposures approachin'g 100 mram/ year.
NRC Response This would be true if such exemptions involved were widespread individual 1
exposures at this elevated level or routinely granted. However, as discussed
'l previously, this is not the intent of the policy. While it may be possible to grant an exemption involving doses above 10 mrem in some cases, these would be rare and would involve special measures to assure that the individual doses for the limited population involved would not exceed 100 mrem per year.
l EPA Coment.
How would there be assurance that some source-specific limits are not
,exceeded as a result of exemption decisions?
NRC Response i
j-The advance notice made reference, and we are aware, that certain existing or proposed regulations may impose additional restrictions on exemption decisions.
If this is the case, the effect of compliance with these more restrictive regulations would be to further assure that no individual member of the public is likely to approach an annual exposure of 100 mrem per year from i
all sources.
l 4
.[
i.
CONSISTENCY WITH INTERNATIONAL AND NRC POLICY EPA Coment Theproposedpolicy[advancenoticediscussion)isnotconsistentwith I-international recomendations.
NRC Response The NRC staff is familiar with IAEA Safety Series 89, " Principles for the l
Exemption of Radiation Sources and Practices from Regulatory Control" and its in many cases to use this document forerunner drafts and, in fact, attempted,ft proposed policy originally i
as a model for certain sections of the dra L
presented to the Comission. As you correctly point out, a major difference involves the selection of the individual dose criterion which, when coupled with other requirements, would delineate when a licensee need not expend further resources to minimize radiological impacts. The international approach uses the concept of trivial (or negligible) individual risk while the Comissions' proposal is tied to a Comission policy judgement on the level of risk below which an individual would not expend resources to avoid. Although the NRC staff believes this is a significant distinction, we are reevaluating all our--
alternatives for establishing criteria for defining a " floor" for ALARA evaluations.
EPA Coment The discussion in the advance notice is inconsistent with the Comission's own policy on BRC for low level waste issued in August,1986.
NRC Response The NRC does not believe there is an inconsistency. The 1986 policy involved the achievement of regulatory expediency; that is, the policy provided,
the criteria which must be met, if a petition for rulemaking on BRC disposals" was to be treated by NRC in an expeditious manner. The implication of expeditious treatment was that the NRC could publish a proposed rule within 6 or 7 months of receipt of the petition, but does not imply that exemptions would be granted only if the criteria of the policy were met. As stated in the advance notice, the Comission will evaluate whether there are exemption criteria embodied [within its own regulations) for which modifications according to the principles of this policy, would be beneficial.
1 l
5 1
e s
E
~_