ML20043C208
Text
Y[^
gg 50 y
Y f%',
UNITED STATES l.>'
NUCLEAR REGULATORY COMMISSION.
k;)1 omos e sevemmeness and pubes Assehe#.
WasMngton, D.C. WWE i
No.
5-5-88 Tel. 301/492-0240 Remarks by Harold R. Denton, Director
-i Office of Governmental and Public Affairs U.S. Nuclear Regulatory Commission Presented at the Rene Dubos Forum at the New York Academy of Medicine l
Only.One Earth Forum on Managing Hazardous Materials 1
New York, New York May 25, 1988 i
REGULATORY APPROACHES TO THE SETTING OF EXPOSURE STANDARDS FOR, AND THE CONTROL OF, HEALTH HAZARDS FROM NUCLEAR RADIATION-1 The Nuclear Regulatory Comission is constantly confronted by the need to make judgments about the acceptability of risks from the use of radioactive r
materials, from microspheres to power reactors, and I welcome the opportunity to participate in this important symposium.
It has been said that there is no number so small that a regulatory agency cannot divide it by a factor of 10. This reference to our conservative tendencies'is probably well deserved, but well deserved also are the plaudits that our government has received for the foresight which required special protection against the harmful effects of radiation and the avoidance of environmental contamination, such as containment structures to prevent the release of radioactivity in the event of accidents at nuclear power plants.
These. regulatory constraints, among many others, have spared our citizens from harm that might otherwise have been inevitable.- For example, consider the striking contrast between the quantity of radioactivity released at TMI and at Chernobyl (15 curies versus 50 megacuries of Iodine 131).
l
.One must recognize, however, that governmental restrictions can do more harm than good if the restrictions are not actually necessary.
In some cases, L
one's conservatism can result in diverting national resources from some of the more hazardous aspects of our environment to less hazardous ones. Our l-Comission is particularly interested in assuring that all of its regulations are comensurate with actual risks, and we are now in the process of developing a new policy regarding radiation risks that are below regulatory concern.
My role today is to examine several important questions that are receiving a great deal of attention throughout the world. The questions are concerned with new risks to the public that have arisen in connection with technological advancements, how the risks should be dealt with by those who have
-. resocnsibilities for_public protection, and how to communicate with members of g60g230891130
'CHP1 53FR49886' PDC
.x
.a
- ,, w k
^
2 I
, wp,
$ h
i the public who must accept these risks involuntarily without necessarily G
understanding their highly technical nature.
I will share ey personal views with you on these. issues.
'g The first question concerns research - the research needed for dealing with' hazardous materials. Health protection research funded by the NRC is limited to ionizing radiation.
In the area of health effects, one of our l
principal research objectives is to contribute technical information to those advisory (These advisory organizations are the National Council on Radiat based.
i Protection and Measurements (NCRPD) the International Connission on Radiological Protection (ICRP), and the National Acadeny of Sciences (NAS).)
1 For radiation protection,- (NRC's) research projects are intended-,to answer questions of a practical nature, such as those involving radiation measurements of the many kinds required in NRC-licensed activities.
I believe one of the most important research neeos at this time lies in the estimation of health effects of exposure to low levels of radiation.
Although these estimates can be highly influential on future policy decisions, the way they are presently made and reported often leaves the wrong impression.
For example, a recent report estimated the number of cancer deaths from the Chernobyl accident to be between zero and 28,000, an extremely wide range, but probably the best that can be done with present methodology. Subsequent
}-
summaries of the report usually omitted any indication that the number.of health effects could be less than 28,000.
It seems obvious to me that research is needed to reduce the uncertainty in such estimates. Prospects for uncertainty reduction through epidemiological studies are not encouraging; the L
sample sizes required are prohibitively large and the time period for study l:
extremely long.
However, it appears that research on basic cancer-induction mechanisms at the molecular and cellular level could lead at least to a narrowing of estimates and perhaps provide additional knowledge about-threshold reactions,:1f they exist.
Another avenue of research of interest to the NRC involves conservatism in radiation protection standards. When the organizations which recommend such nandards-begin a new standard-development project, they invariably encounter deficiencies in the existing data base.
They usually overcome this problem by adopting conservative assumptions. Thus, while.the resulting standards provide for safe operations,'they may be more costly than necessary.
In many cases, research can provide actual data to be used rather than assumptions, thus providing for the modification of existing standards as well as the development L
of more realistic standards for the future. The NRC is working with the NCRP to identify research possibilities of this nature, and we plan to fund as much of.the indicated research as budget limitations will allow. This. kind of research can lead to more realistic regulatory requirements and be cost i
effective.
A second question concerns institutional and legislative changes that are needed to deal with hazardous materials.
I think that the greatest need for change is in the realm of consistency.
The Congress and the Federal agencies control some hazards very stringently; at one extreme is the well-known Delaney clause, which prohibits the deliberate use of any food additive that is found to be carcinogenic in any animal species.
Some other statutes, such as j
the Toxic Substance Control Act call for a balancing of costs and benefits.
l
7 7
k Y
i.
g nt.
es.
w' And, at the other extreme, governmental controls on tobacco products are JW, limited to certain restriction on advertising, isolation of smoking areas, and
~
warning labels.. Paradoxically, scientific data indicate considerably som risk from smoking than from the ingestion of very small quantities of some substances believed to be carcinogenic. Within these extremes, various agencies impose restrictions to protect the public from the particular hazardous agents assigned to them by Congress.
We do not have an all-encompassing governmental oversight organization for public protection, with responsibilities, including consistency, which cut across all agency mandates. Enomous resources are being expended in some cases for protection against risks that are only suspected and statistically determined, whereas expenditures to protect against hazards whose risks are known-with virtual certainty are sometimes inadequate. As an example, the United States is spending approximately one billion dollars on stabilizing uranium mill tailings. (The action-level for radium concentration is set at a level about equivalent to the radium concentrations in Brazil nuts.) These resources are being spent to avert estimated stochastic effects.to the-public; the most recent estimate being about six health effects per year to the population of the continental United States. On the other hand -haturally occurring radon in dwellings may oe causing an estimated 5,000 to 20,000 deaths per year. This raises the questions of whether the nation's resources for stabilizing uranium mill tailings might be better spent on tax breaks to e
citizens whose homes have high concentrations of radon in order to reduce those levels.
I must say in passing, the Federal government gave tax breaks for i
L sealing up homes for energy conservation purposes which exacerbated the radon problem.
Perhaps an authoritative and respected organization, such at the i
National Research Council, with oversight responsibility for all' hazardous agents could help effect redirection of resources toward the areas of greatest I
need.
I.see this possibility as the most important and promising opportunity for change of an institutional or legislative nature.
A second, and related, opportunity for change of this type can be found-in the increasingly popular concept of Below Regulatory Concern (BRC). According to this concept, for a given hazardous agent a degree of risk exists which, while not trivial to every person who is exposed. -is nevertheless too small generally to justify governmental intervention. Attention is now being given to this concept because it is generally recognized as a reasonable way to avoid costly requirements for protection which are not justified by the law.
For r
example, the EPA is developing BRC 1evels for radioactive waste disposal; for radioactivity levels below BRC, the waste could be disposed of at sanitary land l
fills, greatly reducing costs in a. safe manner.
The Comissioners of the NRC have expressed interest in establishing a generic BRC radiation dose level below which regulation controls licensed ectivities are not required. The NRC staff has been instructed to reconnend expeditiously a dose level for this purpose.
L The third question may be stated as follows: What does the public need L
(and want) to know about these risks, and how do they get effectively involved l
in the risk dialogue? In an attempt to characterize members of the general public for the narrow purposes of this discussion, we should probably think of a
them ts busy people with usually little interest in mathematical and physical details. The public seems to prefer to make personal decisions on the basis of
c a.
3 4
'm s
4 i
)
o
!\\
rapidly-acquired feelings and impressions, as opposed to the time-consuming assimilation and-analysis of data and facts.
If we want to connunicate with f
them successfully, we probably~ need to recognize also that matters which appear.
to be of the greatest interest and importance to us may not be of sufficient significance for most members of the public even to justify reading about or listening to. Without doubt, there will always be strong competition for the public interest and time. And, finally, we have to acknowledge that successful
)
public education ~ programs nomally cost much more money than is available to-j 1
scientific organizations of any kind.
With these thoughts-in mind, we can examine the question of what the public needs and wants to know about the strange new risks to which they are
'now subjected as a result of high technology.
In all-likelihood, almost everyone wants to enjoy the benefits of technological advancements, while almost no.one wants to accept the risks that often accompany these benefits.
What people need and want to know is that their government ~ is carefully watching the scientists.as they embark on one project after another, that the L
governmental watchers are competent and independent, that nothing is being hidden from them, and that there is really nothing to worry about. They m
undoubtedly want.to acquire a sense of security equivalent to the worry-free experience of shopping for safe food in the supemarket. Their tolerance level for-risk is very high if it comes from a familiar source such as automobile travel which provides immediate personal benefits that they can accept or s
reject through individual decisions.
For such hazards, demands for less governmental interference are connon.
Contrast,- for example, the much greater public concern and apprehension
~
over Chernobyl with the lesser concern over radon, in homes despite the-exposure estimates of up to 5,000-20,000 cancer deaths ~each year from radon in homes as. compared-with the estimate of up to 28,000 total health effects over the next 70 years (Chernobyl, of course, did also produce major economic and societal impacts, as well as 31 immediate fatalities). Where unfamiliar risks are essentially forced upon. them, and the perceived benefits are diffuse in nature, tolerance levels tend to be very low indeed.
For these hazards,.
demands for more governmental controls are heard, as would be expected.
It should be-noted that governmental decision makers, responsive to public i
opinion, have tended to provide increasingly greater protection against the new risks and progressively less for those that are old and familiar, L
'One of the primry tools used by the NRC to assure that the risks from L
nuclear power plant operation are acceptably small is the defence-in-depth approach. This concept requires first, a conservative design, built to high quality standards, with proven engineering practices. Secondly, automatic features are required so as to cope in a straight'-forward way with anticipated abnomal occurrences, such as equipinent malfunctions, human errors, pipe breaks, electrical failures, and other safety challenges. A third layer of protection is provided by features and procedures, such as containment L
structures, filters, sprays and emergency plans to mitigate the consequences of any release of radioactive materials from the fuel.
Probably the most important lesson from the few accidents that have occurred has been the increased recognition that people are just as important, if not more important, than the specific plant hardware.
This has lead to increased emphasis on personnel training and qualifications, the use of simulators, better emergency procedures, diagnostic aids, preventative maintenance, and related activities
.,q l'.
5 4:.
ih to improve operational safety. With these and other important changes, the
{..
likelihood of. accidents and consequent harm to the sublic has been reduced.
Thus, while nuclear power and coal seem the most li(ely options for the
+
production of electricity in the near future, to guarantee America s Energy Security, a higher level of safety is being demanded of and achieved in-nuclear plants.
i Just as it is in the stock market, public confidence is the determining factor.
If the public is to be content with the risks that come with advancing
. technology, they must feel confident that their health and safety is in good hands -- and they have nowhere to turn but to their governmental institutions.
! am attempting here to characterize the general pub'ic, while fully j
recognizing that all people do not think along the same lines. But I believe 1
that public confidence in the ability of the government to provide adequate i
protection from hazardous agents depends primarily upon general perceptions that:
The government has the power, the will, and the resources to control these hazards.
That government personnel are technically competent, they have access to the best scientific expertise available, they understand the risks, and they know how to control them.
That governmental decisions are made openly, impartially, and without i
conflict of interest, following full consideration of public Concerns.
That government will not allow chronically unsafe conditions to exist and.
That in the event of an accident, advance preparations required by the government are adequate to cope with anticipated conditions.
Technical details may be of little interest to the public, but these concepts undoubtedly are.
When people feel this way, confidence in their personal safety and in the safety of their family is high, and signs of unrest are few.
It is evident that most of us have such confidence with respect'to air travel, medications, drinking water, food supplies, and many other regulated activities.
that have a very high potential for wi.despread health effects and extensive loss of life if proper controls are not implemented. But for unfamiliar hazards associated with benefits not immediately apparent, confidence can easily be displaced by suspicion with consequences which can in some cases ultimately work to the disadvantage of the public.
For these reasons it seems important to me that the government itself L
should make a conscious and deliberate effort to instill confidence of this l
nature in the minds of its citizens.
If the Federal agencies would undertake risk assessment and management programs, institute effective regulatory l'
regimes, and develop public information programs which dissiminate factual.
[
unbiased information, I believe the advantages to our nation would be enormous.
The debate on radiation risk assessment and management is highly visible today in all the advanced nations as we try to cope with the two-edged sword of h
p
. m q..,
e 6
~~*
- modern technol Some would have us turn back the. technological clock to
'5 4
simpler times.
would propose that we endeavor to improve decisionmaking regarding public risks. No one can predict what the final answers will be.
e The very existence of this conference is encouraging. Authority and resources for public safety can be-better used to extend life expectancy and quality and to provide a healthy, safe environment in which all Americans can. live and--
- work. Whether. they will be used for.these purposes is up to all of us. -
r i
\\'-
e
..j
{
q 4
.t
?
i 4
i
c;,
~y g;,,
L
.-l u,
p'4
- s il
^ UNITED STATES
- i NUCLEAR REOULATORY COMMISSION i'e WASHINGTON, D.C. 20555 usans -
4 t
scenen n..em -
,;P.
OFFICIAL SUSINESS PENALTY FOR PRtVATE V5E,4300 8
0 e
.h
-[
r Y
' i 4
,\\1 j-i r.-
ll
-},
f-
i
- h.,
}
a
.i i
i 4
..c, e.
.?
g
(, '
y.
C q g 329tt Federal Regisler / Vol M. No.16" / Mond:v. August 29. 1968 / Proposed Rules s
}
proJs.ced b L:me ck 2. Mr Lewis is l'etitioner's Propossi consideration can only be sacn to 4-
.ihn ennertned :%:.t the mans costr commen's received on or beforir tl.is mieute i w e. hr 4th risks. rate hiken.
PART g-[ AMENDED) date.
.md o.ber um nown potent;ol problems.
The petitioner regiarsts that Part 2 he ao0messas: Mail written commnts tu:
Grounds for the Petition -
art *J tu n mr il 2 4.61. 2.104,r Ji41 Srcretary. U.S. Nuclear Rwulutory
.o d paragraph Vltibl'41 of Appen4 A Commission. Washmrton DC 20.55.
Mr. Ltu n. citos ses eral long.standmc i,,,ederi the languace prior to issuant e Attention: Docketmp and Seruce operatm p*rAlems at Limeru k 1 end 2 of the final rule pubhshed September 12.
Dr nch. Comments may be del.werd tu
.md Peach Lattnm plants that he clairr.s tuh4 (49 Fk 3?i?4;j 11555 Rockville Pike. Rocksille MI) have placed a Im ncial burdet on betw een 7.30 a.m. and 415 p.m.
ITCOJMr. Lewis asserts that PFCO haa PART 50-[ AMENDED) weekdays.
admitted 1o bems under fin.mcial riessure and that the cost of Limerick 1 The petitioner requests that Part 50 be
,;,),(f,*he e iIn tI i'
,n and 2 has plcced the company bilhon, amended to revise il 50.2(x). 50.33(f).
of dollars in deb.t. Mr. Lewis indicates
.o 40(b). and 50.57(al(4) to reflect the assessment and fmding of no significant that the fmancial problems facmg PECO lancune pnor to issuance of the hnal impact may be esamined and copied f or a fee at the NRC Public Document Room willlead to a situatmn such as the rule pubbshed September 12.1964 (49 FR Shutdown of Snoreham nuchar power 3.7 471-at 1717 H Street. NW. Washmpton. DC.
Pon ructTMan nep0RssAft0N 008f7AcT:
- ! ant after 11 became radioactive. Mr.
Dated at Rockvdk. MD this 23d day of Lewin states thet Shoreham we p anted Axue tugg Catherine R. Mattsen. O!hce of Nm.le..
a hcense despde the shaky brand f or tb Nuclear R.Watwr> Commission.
Regulatory Research. U.S Nuclear rwa % Commnssn. % askaton.
t.ondition of the paient utiht.L Long Samu,1 g. cst Island Lightmp Cornpan) (LII.CO;. lie
,, 7, ;s.g.f c,,m,,,,,,,
DC 20555. Telephone:(301) 492-3fna e %ms that LlLCO has admitted that it
'm tiaM9M: Filed 8-:5 46. a 45 el sumausNTARY WF0masAtl0*
does not huse sufficient manies to pas aw=c coos neo ei.es
Background
for dettenm.ssioning of the nuch:.r power plant.
The Edison Electric Institute IEE!) and G:oeral Solution to the Problem 10 CFR Part 20 the Utility Nuclear Waste Management Group (UNW MG) petitioned the The petitioner requests that NRC L posat of Weste Oil by incineration Commission on July 31.19s4 (RPM remstate financial qualihcations as a
- 13) to mitiate rulemaking to defme a requeement for electric utihties and A' tNev: Nuclear Regulatory level of radioactive materials in reactor.
nspend the bcensms proceedmss for
( nmission-generated waste oils which would Limenck 2 un'.il the parent utility. PECO.
A noN: Proposed rule permit disposal of such oils without con demunstrate to the NRC that it is regard to their radioactive material Onancial!y quubf:ed to safely proceed summany: The Nuclear Regulatory r ontent. Currently, the only generically with Limenck 2 and its other nuclear Commission proposes to amend its approved method of disposal forlove ere ations Tr r gtitioner requests that regulatiuns to permit the onsite level radioactively contamined oil from n o Mde em ment period for this inemeration of shghtly contaminated nuclear power plants involves petition ue reed in order to prevent waste oils generated at hcensed nuclear sohdification or immobilization.
further (m mal hardship on PECO.
power plants without the need to packaging. and transportation to and specifically amend existmg Part 50 burial at a licensed disposal site. The Cenclusion operatmg licenses.This proposed action petition was submitted in response to Mr. Lewis bebes es that Limenck 2 is would help ensure that the hmited Commission views expressed in the soiry " critical" i e. will beam to capacity of licensed regional low. level Supplementary information statement wrcrate pmeer. and may be closed waste burial erounds is used more accompanying publication of to CFR lar iif the plant stays open.Mr. Lewis efficiently while maintainmg releases Part 61 " Licensing Requirements for stdies that tne shipment of radioactive from operatmg nuclear power plants at Land Disposal of Radioactive Waste" waste will expose him to radiation levels which are "as low as is (December 27.1982. 47 FR 57446). In that without correspondmg benefit. which he reasonably achievable" as required by statement. the Commission expressed its claims is in violation of the Atomic 10 CFR Part 50. Appendix !. Incineration uews that the establishment of l
Energy Act Mr. Lewis states this Act of this class of v.aste would be carned standards for waste for which there is exhorts the Federal Government to out in full comphance with Commission no regulatory concern would be protect health and safety of the pubbe regulations restrictmg the release of beneficial and would, among other and that the Nuclear Regulatory radioactive matenals to the environment things. reduce disposal and long. term Commission has been charged with that are currently m force at each disposal site maintenance costs, help l
enforcing this mandate.
Operating nuclear power plant. This preserve the limited capacity of the proposed rule. if promulgated. would regionallicensed waste disposal sites 3o ce Regarding Petitioner,s Request to constitute a partial granting of a petition for the deposal of wastes with hieher e ute 30-day Comment Period for rulemakmg (PRM-20-15) submitted levels of activity and enhance oietall l
The staflhas read the petitioner'ti by Edison Electne Institute and Utility site stabihty of disposal facilities by Inter to muive the 30. day comment Nuclear Waste Management Group.
reducing the volume of Class A waste.
period for this nctice of petition int Omer portions of the petition are bems
' That view was further advanced when tulem.. imp and determined that n is
& rued the Commission announctd its mtent p
s ngth no c'e ofrece omment penod expires on (August 29.1986. 51 FR 30839) 'o of pMen for ruicmakmp with !r ber 28. m8 Comments recened expeditiously process petitions in dat
%por unity for 1e pabhc tc commen'.
", a c t ca ill be considered tf it is exempt specific waste streams from the to do so. but assurance of Commission's regulations The
~
1 1
-- ~..
- [
, ptr
.v.
l yound space moet -d. -.
d..e.
.d. _.e
,..e.s;
_ e.b
, p.bheb.d Vi Advance plottee of the limited buria acceptable method bened on
. Rulemaking. ANpRM.
bor 3.
ofRciently. De Commiselon is therefore nonrediologicalconsidwetions.Neither' \\
19ED: 31 FR 43337) soliciting public proposing to amend its regulations.
NUREC/C44730 not the information comments on the broad esacepts of Based on information provided by the submitted by the petitioners addressed defining classes of weste which were petitioners and a Brookhaven National the nonradiological toxic properties of "below regulatory concem" MC).
Laboratory report. " Evaluation of reactor waste oil; thus. this class of The pention, however. predates the Potential Mixed Wastes Containing impacts from other disposal methods Policy Statement and does not include 14sd. Chromium. Used 011. or Organic cannot be adequately considered.
all of the information required for Liquids"(NUREC/CR-4730.8 january
- 3. Concentretions of radionuclides m expedited evaluation and handling 19 7), and exponence with the few the ash from incinwation a.id in the under the Policy Statement.The licensees incinerstma waste oil under petitioners have chosen not to license amendment, the Commission is sludge from recycling may be too high to supplement the petition to follow the conymced that as a class, waste oil exempt an oilsite incmerator et a guidance provided in the policy generally contains such low levels of recycimg center from requirements for a l
Statement.
radioactive contamination that releases radioscuve matenals licenna. As noted in the subject petition, the EE! and the to the general environment from its in Consideration 1. the ash residue may UNWMG suggested that an appropriate incineranon would have an also contain s_ignificant quantities of toxic metala.These issues were twt basis for establishing a cutoff level for
- C'n'"mu.sl radiological impact on determining whether specific weste the health and sefety of the public even evaluated by the petitioners, streams were SRC would be that the in combination with other routine
- 3. An offsite incinerator or recycling direct reisese of the specific wests reactor effluents. Incmeretion is a center might handle weste oil for streams to the environment would not
. demonstrated disposal technology and multiple reactors. his factor has not result in a dose to an individual member one that can be camed out by licensees been adequately incorporated into the of the generel public greater than 1 within already established redistion pettuonus' dou aulysia.
mrem /yr.ne petitioners suggested that protecnon entena set forth in 10 CFR 4, g;j gg,gg,4 using a 1 mrem /yr limit, ettemative Part 50. Appendix 1.Thus, by econosilcal than low. level waste (11Wl disposal methods, including (1) on-or maintsining effluents under established g
,, g,g g,,
n or o ret the processing and handlms and would thus offsite incineration. (2) an. or offsite 5Hin[ con it result in less cost and nok pavuigs than w
burial. (3) road stabilisation (spraying),
doses from effluents that are "as low as incinwouon.
ab e a es lu buri is reasonably achieveble."
Analysis of Comuments gg g,,g g pg The other disposal methods proposed p,,,,,,,,,, g
'he ogfc impacts received on the sobrect peacon (13 from accompanying the Commission's policy statement published on August 29.1986 c,pta bly I redt (51 f1t 30tae) suggested that 1 mremlyr However, sdequate information has not
!ndustry and 1 from a pnvate was low enough to facilitate expedited been supplied to evaluate the individual). The fourteenth comment I'"*' C"I processing of a petition for exemptmg a acceptability of these disposal methods pehuonen,stad of the ongmal specific weste stroom end that higher in additI'"' ' ""*b" f oth" analysis of se een comments received by the Commission l
doses might be acceptable but could h0",'
,',"*v f
and a revised version of the petition. All to t
require more extensive histifiestion.
However, the policy statement and incineration. Some of the more but one of the commenters supported e
implementanon plan dealt with important of these considerations are the idea of exempting slightly additional entens windi have not been the foil c ntaminated weste ou from se 1.Be s f practical considerations. requirements for disposal at an 11W addressed by the petitioners After due consideration of the EPA has recently exempted waste oil disposal site and most supported the pertinent 4suesinvolved the from requirements for hazardous waste petmon in its entirety. Many specificalty Commission has concluded that in disposal however, waste oil does commented on the excessive cost of respondmg to this pettnen at this contam a significant amount of toxic d:sposal a t an LLW disposal site relatn e particular ame,it would not be constituents.Many of these constituents to the health and safety and i
appropriate to attempt to make a generic are combustible and thus are destroyed nuronmutalimpacts of attemative determination se to what level of dunns incineration, but not through disposal methods. One commenter radioactive contamination in waste oil other proposed disposal methods. The provided a detaded estimate of LLW would constitute a 1 remainder of the toxic constituents are disposal costs for waste oil.
regulatory concern.,evel which le "below metals which remain in the ash residues Consideration of thsse comments The petition did not supply either adequate information on from incineration.These residues can be contnbuted to the commission e decision which to base the selection of a dose disposed of in a controlled manner in to proude some relmf through an the case of onsite incmeration.
41terna tive disposal method. However. e enterion for weste oil or an adequate basis for evaluatmg all of the proposed incineration m industrial boilers is few f the commenters raised questions l
disposal attemauves. ne Commission EPA's preferred method of disposal of cucuning some f the specific disposal methods and concentranon hmtts i
believes. however, that action on the proposed by the petitioners. such as (1) i eel /UNWMG petition is warranted in 3j{7,]l,ygj,7gnysYoj [ "
the concentraticn of radionuchdes m the view of the very small radiological rN*ts Offee F O Bm %.* von DC udge produced dur:ng recychng m@t i
doses imposed on any member c! the
- woe: ceci., mwee, v ~
be high enough that the ret.r. ling center j
i pubhc from disposal of waste oil. the
- a W = l e s" % u u3**
w ou!d need a radioacta e nwent.s Polenflal reduCllon m fire and toMC
[,"'*
. W ideratinn sh luld be nsks. the inordmate costs of disposmg C
6, e aw, p m,1.i n 3
,,.t w _
anen to multip;e socces of w.m o 1 of this waste matenalin heensed low
. a w oc
,e:ng *.andled at ene offsce ur.hemed i
i t.
l LW -
/'
Federal Register / Vc?. 53. No.167 / Monda.. Aunust 29. 1988 / Proposed Rules l
I 33ng.
1 p
w.r incinerstor or recycling eenter;111 some that will be used to collee'. store.
been maintaining the contribution hem : -
J' secondary pathways might be more determine the radiological components weste oil at 0.1% of the dose halt. er on i
hmiting than those considered by the of. and incinerste waste oils; and (2) the the order of15 prem/yr.
petitionet (4) road spraying is results of the radiological and other Section 30.306(b)(3) of the proposed prohibited in nome areas because of analyses of each batch of oildischarpad rule is included so that a technical envimnmental considerations of through the disposal system which specification change, conshtuting a petroleum products alone: and (5) burial demonstrate that effluents from the license amendment. will not be at a landfill will save low level waste facihty includmg effluents from this necessary, for exernple,if a rolesse burial space but remams a costly operation, are below existmg plant point other than those identified in the attemetwe.These and other discharge bmits established under Part technical specifications is used. This considerations resulted in the
- 50. Appendix 1. as well as t 50.36a.
orovision will also relieve licensees who
- conclusion that meineration onsite was The hrst part of this information. the have already received a license the only clearly acceptable altemative description of equipment and amendment allowing waste oil at this time. Although the petitioners procedures, would be submitted to the
- incineration from requirements in their addreesed these issues in their comment Commission under 150.71(e) as a license that might be more restnctive snelysis, that analysis was not change to the FSAR since it represents a than is necessary to conform to the sufficient.
change to the information submitted in requirernents of Appendix ! of Part 80.
Other comments were worthy of note.
the origmal license appbcation under Since no dose crimnonis being One commenter discussed means of I 50.341b)(2)(i) and (b)(3) and i 50.34a.
chosen and the only releases to the reducmp the generation of and the The second part, the determination of environment bqing allowed by this concentration of contaminants in waste the quantiues released. will be reported action are effluents controlled under oil. Although these methods are likely io under existag semiannual effluent existing operating limits, this rule does be desirable,it is not necessary for the reportmg requirements. In addition, the not st9ctly constitute a BRC regulanons to deal with these specific requirements of ( 50 59 apply. These determination. Rather,it only makes an concepts. lJeansees should have include the writmg of a safety exception to the restriction against flexibihty in handhnF these wastes as evaluation to assure that the changes do long as nsks can be kept acceptably not mvoh e an unreviewed safety incineration without prior approval contained in 5 30.306.'!he decision low, Several commenters favored the question. the submittal of a summary of concept of de mimmis being apphed to the changes and of the safety criteria contained in the BRC policy other waste streams and regulations.
r valuation. and associated statement of August 1988 have not been l
The Commission is currently recordkeepin.
expbcitly addressed.
considenng this issue in the context of a As noted, t e proposed rule does not Becem the proped rule would i
potential pohey statement that would
< sempt these effluents from the allow a licensee to adopt a potentially identify a level of radiation nsk below "perating limits developed under Part more cost and risk effective means of which' government regulation becomes
% Appendix 1.The licensees are disposing of this class of weste while unwo rt anted, required to demonstrate that all maintaining existing limits on plant E
The remaining comments concern effluents, including those resulting from effluents, se not impact of We action
(
details which rehite to specihe matters the inemeration of waste oil meet the should be positive. For each licensee, I
that are irreles ent to the proposed effluent dose limits estabhshed under the onetime cost of preparsag the l
course of echon; thus, a detailed Appendix 1 and are thus "as low as is appropriate documentation to support discussion of these specific comments is reasonably achievable." This would be an incineration operation should be not warranted, done in practice through a limited more than offset by direct first year The Commission is therefore modification of the offsite dose savings in waste disposal costs. For proposing to grant the petitioner's calculation manual (ODCM) and the those licensees who elect to process request orsly with respect to onsite semiannual effluent reports. The ODCM. waste oils in this fashion. monitoring i
inemeration and to deny the other although not specified m the regulations, and maintaining records on waste oil options w#fhout prejudice at this time.
is a document required in the technical disposal activities would be covered by The Proposed Rule specifications estabbshed under current regulatory requirements set forth Appendix 1.Section IV, paragraph B and in Part 50. Appendix 1. which are The proposed rule, which would apply 6 50.36a which contains the analysis implemented pnmarily through technical all operators of nuclear power plants methods to calculate offsite doses from specifications established under licensed under 10.CFR Part 50. would effluents: the additions to the ODCM i 50.36a. Even if a new incinerator is ellow the onnte incineration of slightly would be included in the first installed exclusively for this purpose, contaminated waste lubricating oils and semiennual effluent report following costs could be recovered in a few years, hydrauhc fluids generated onsite initietion ofincineration. This approach in addition, risk asscciated with without the need to apply for a specific for assessing doses from the effluents transportation to the Lt.W burial site are beense amendment as is presently from the incineration of weste oil has eliminated and toxic and fire hasards required under the provisions of been used in the case of licensees who associated with storage would likely be il 20.106 and 23.302. The inemeration have incinerated waste oil under a reduced. It should be noted that any could be carned out either in the bcense amendment.The applicable dose solid radioactive residues produced in hcensee's existmg auxihary boiler or hmit m hmitmg conditions for the incineration process would, for incmerator. if available, or in an onsite operations, consistent with the design purposes of regulation. be treated as any fecihty specifically constructed for this objective in Appendix 1 of Part 50,is other low. level redioactive solid weste.
l purpose. Each heensee would be generally 15 mrem /yr to any organ of an Madang of No Significant Environmental required to prepare and retam the mdividual m an unrestricteo area from 3rnpact:Availabihty l
followine types of records in acccrdance radioactive fodme and radioactive with acphcable NRC record retention matenalin particulate form. t.icensees The Commission has determined requirements h) A complete desenptier with existing heense amendments under the National Environmental Policy of equipment. Idcihties, and procedure allow.ng incineration of waste oil have Act of 1969. as amended. and the l
l
t' Federal Register / Vtl. 53. Ns.167 / Monday. August D. sees / Proposed Rules r'ammklon's regulations in Subpart A Regulatory Research. U.S. Nuclear are leased under sec. mie). es seat. see, sal-
'4
- of10 CPR Part 51 not to prepare en Regulatory Commission. Washington, amended (42 U.S.C.samloll.
environmentalimpact statement for this DC 20555, Telephone (301) 492-3638.
- 1. Section 20.305 is revised to read as ~ s f
proposed amendment to 10 Cf1t 20.305 Regulatory Flexibility CartiAcation follows:
because the Commission has concluded on the basis of an environmental in accordance with the Regulatory Iso.30s Treatmentereieoonaltry assesament that this proposed rule, if F!vubility Act of1960(5 U.S C. 605(bl) eneeneresson 8
adopted. would not be a major Federal the Comm:ssion certifies that this rule (a) No licensee shall treat or dispose action signficantly affecting the quality wdl not, if promu: gated, have a of licensed matenal by incineraton of the human environment.
Significant economic impact on a e scept:.
The proposed rule would allow substantial number of small entit!*
(1) As authorized by paragrnh 'hl rf incineration of waste oil at nuclear This proposed rule affects only nuc! ear this section:
Power plant sites resulting in very small power plan's.The enmpanies that own (2) For materials listed s. rider i :Cyn releases of radionuclides to the these plants do not fall within the scope or environment. Total effluent releases of the definition of "small entities
- set (3) As specifically approved by the from the plants. includmg those resulting forth in the rieguld' ors F:eubihty Act of Commission pursuant to l 20.10tib) 97
. from waste oilincineration. will be the Small Busmess Size S'andards set g :o.3og.
mamtamed at or below existing plant cut m regulathns issued by the Small (b)(1) Waste oils (water immiscible
. discharge limits determined to be,"as Dasiness Adm:mstraticn at 11 CFR Part creanic hydrocarbons used principally low as is reasonably achievable.
121.
Potentially. risks from toxic components as lubricants or hydraulic fluids) that in waste oil, fire hazards from storage of Backfit Analpis has e been radioactively Contaminated oil. and risks inherent in transportat;;n This amendrnent tu the Commission's in the course of the operation of a ragulat ons wculd not impcse any new nuclear power reactor licensed under may be somewhat reduced from those i
associated with the currently as recirements on cr% ction w Part 50 of this chapter may be d;sposal option of butta! at LIM,a!!able utihzation facihties. it only allows meinerated on the site where generated d:sposal sites. Incmeration wid not mcmeration of waste oils onsite without provided that the total tadioactn e require significant quantitics of t..e need for sopcific approval by license effluents from the facility, including the materials, water. or energy and in sorr.e amendment. The amendment to 10 CFR effluents from such incineration. must cases may insolve the recovery of
.0.3M ts therefore not a backfit under 10 conform to the requirements of energy. Thus. no significant impact on CFR 50.109 and a backfit analysis is not pjndix
\\
can repo ny c w
the enuronment would result.
required.
d additions to the information supplied List of Subjects in to CFR Part 20 under il 50.34 and 50.34a of this chapter find g of o s if t pa which this determmation is based are Byproduct manal. Licensed associated with this incineration published as Appendix A to this rms'er: 11. Nudear matenais. Nuclear pursuant to 6 50.71 of this chapter. as document and are asallable for power plants and reactors Occupatier.
lPMam.h knm shau also mspection and copying at the NRC s4fe'v cnd h.@h. Packermit and
.,11 w the procedures of I 50.59 of this Public D ctment Room.1717 H Street centainers P.'nalty. Pad..it.5n chapter with respect to such changes to i
NW., Washmaton. DC. Smgle copies of
- tecct
- on. Reportire and rccordkeepir the facility or procedures.
the enuronme'ntal assessment and reptements. Special nac' ear matenet.
- Solid residues produced in the f:nding of no sinnificant impact are Source matenal. Was:e treatment and m rets of incinerstmg weste oils must asa.:able from Cathenne R. Mattsen, disposal.
be @ posed of as provided by $20.301.
Office of Nue! ear Regulatory Research.
For the reasons set out in the U.S. Nuclear Regulatory Commission,
"**"*U*"
l-tJ011490-3638-preamble and under the whent} of the
.t t*.e terms of this section and l
Atom:c Energy Act cf 1).R a< amended.
s,,,de any provision in an indiudual
(
Paperwoe,. Reduction Act Statement the Er erry Reorgamzam \\.t of 19r4.
..cen<e or techmcal specification l
This proposed rule does not contain a as amended, and 5 !..S C.{3 the NRC my be mconsistent.
d new or amended mfarmatinn railution
'5[# P $
hm m pragraph tblof this d
to l0 i r4 eses the hcensee from l
requirement sub:ect to the Paperwork Reduction Act of 1960 (44 U.S C. 3501 et PART 20-STANDARDS FOR W:...e with other applicab!e i
eet). Existmg requirements were PROTECTION AGAINST RADIATION
. ' N!. State. and local regulations 1
approved by the Office of Management
, n mg any other toxic or hazntdous l*
and Budget approval number 3150-0011. - 1. The authority c:taaen for P art :o
, ; crty of these matenals.
l Regulatory Analysis
,,,.d at Radulle. Maryland this :9th day cWinues t read Js idow s:
L Authontv: Sus *.143 M 11 in3 mi. tn1
\\.. st We The Commission has prepared a draft ce s:,. ao na.M M M M d8 te Lc: ear R cd.itur) Commmien regulatory analysis for thit, proposed amenced 142 L.4 C ;;t1 ; Y 2m3. a n.
i
,,,, $ g,;;,' y
i ru!e.That analysis exammes the costs
- in ;tu
- st:. s. s ;e1 n amend..J. ;al L
. and benefits of the alternative courses 2% Fe 9at !;4;. a m-;ed !;4a 1/6u14; t L ' M# 4e* tors of action that the Commisuon USC.5en5m.wl.
upi ndis A-Environmental considered in respondmg to the si blect F or ., &wn if (PC. 223 Sd hhgl Q og
%mgng gnd {jngjng o{ No petition.The draft analys:s is asatlable M" ' ' 'J '2 U 5 C); n t t..' Nt fu te U.;mlicant Impact 9'd
.3"
" 4 I
for mspection at the NRC Pubhc Os..r.ron. DC. Smpe copes ei +e
?' l; " $j.{ ~
V.*
- M:wh er ' :o J CF3.'2 JW l
Docurent Rocm.1r17 H Swet NW,
- 1
..~
l
' 2' ' " h 1 ' E OrJ 'A n draf t anah sis may be obtumed from
- e a; t s ;..
.t.
h. it Reed.*vy Cc~m:en 1
C.nhenne R. M..itsen. Off.ce of Nude.it
.wi.u
.u, u ;,., m
. y to a.enJ as re,!itmes m l
1
- -~
33ng Federal Reglster / Vol. 53. No.16- / Mcnday. Au.cust 20. 1988 / Proposed Rules
~ llow power reactor licensees to nthe wise be the esse Thys. the ove'all incineeration. (See discussion under d"
a incinerate st*htly contarrunsted waste impacts of such meineration must be
- Altematives to the Proposed Action.") 3 oil onsite without obtaining the specific considerert.
result in reduced storage of waste ofPo approval of the Commission through a Some information on the quantities bcense amendment.
and coacentratior.s of wnte oil onsite thus reducing the associated fire $
1 generated at nuclear power plants was hasard. Also. risks inherent in 4
Environmental Assessment provided in the petition and in a transportation would be reduced frem
/dentvicotion of Proposed At twn.
Brookhaven report " Evaluation of those associated with the currently 1
Present i 20.305 forbids the incmers. tion Potential Mixed Wastes Containing available disposal option of butal at 1
of any licensed material, except that 14ad. Chromium. Used Oil. or Organic 11W disposal sites. Incineration will not specifically exempted by 6 20J06.
Uguids"(NUREG/CR-4730. lanuary require significant quantities of without the specific approval of the 1p67). The amounts and concentrations materials, water. or energy and in some Commission. The proposed action would very considerably from plant to plant casce mayinvolve the focovery of amend i 3D.305 to allow power reactor and even from year to year at a given energy. e.g., when the oil is bumed in en licensees to incinerate shghtly plant. Generally. the volumes produced auxthery boiler.
contaminated waste oil onsi:e without are approximately 1.000 gallyear at a Based on these considerations, this prior approval. lt would not exempt the PWR and up to 5.000 gallyear at a BWR. action will not result in a significant effluents from this process from the in addition, some utiliues have large effect on the quality of the human requirements established under quantities in storage on site, environment.
Appendix ! to Part 50. In particular.
Cocentrations of radioactive Alternatives to the Proposed Action.
1 effluent limits and effluent momtering contammants are typically 10" to 10" As required by Section 102(2)(E) of and reporting.
pCi/ml but can be as high as 10'8pCl/
NEpA (42 U.S.C. 4322t2)(E)). possible Aced for the Proposed Art'on The mlin some cases. Total activity per attematives to the proposed action have Edison Electric institute and the Utility reactnr per year is generally no greater been considered. One attemative Nuclear Weste Management G*oup than 10" Ct. The domment considered was to defer any action until petitioned the Commission (pRM-20-15.
radionuchdes are Mn-54. Co-68, Co-60 decisions are made regardmg the l
dated July 31,1964) to initiate Ce134. and Cs-137. Others reported ongoing genenc BRC rulemaking.
rulemaking to define a level of include St-90. Cd-109 Zn-65 and Zr-05.
However, this alternative would ba radioacurity in power. reactor generated it appears that the bu k of waste oil inconsistent with Commission pohey waste oils which would permit disposal anerated. in terms of solume, could be adopted in 51 FR 30839 (August 23.
of these oils without regard to their meinerated with resultant individual 1986). Since it is apparent that the cost radioactive material content. Currently.
,i.nes of less than 1 mrem /yr. Ucensees to licensees to sohdify or immobilise, the only generically approved methed of mth license amendments permittmg package. transport. and bury i
disposal for low level radioactively
. isite incineration have been able t contammhted weste oil at heensed contammated oil from nuclear power
- spose of most of their waste oils under disposal sites is not justified based on plants involves solidification or a technical specification of 0.1% of the the very limited doses from incineration
. immobihastion. packaging. and total dose limit, which is generally 15 and the fact that other environmental transportation to and bunal at a mrem /yr from radioactive iodme and impacts.if anything,willbe reduced.
heensed disposal site.The cost of this radioactive material in particulate form and since it is more cost. effective to type of disposalis significant. while the (in keepmg with the guidance contained allow the incineration through
,l concentrations of contaminants are in Appendix ! of Part 50), or 15 prem/
quite low.The weste oilis a po,tential year. Although waste oil contaminated rulemaking rather than to continue p,,,,,,,,,ppige,,;,n,go,g;c,,,,
candidate for being declared a below
- dunng res: tor operation might amendment. this action should be taken regulatory concem (BRC) waste.
eventually be declared below Although there is an ongomg action to regulatory concem/ this decision is rather than delay the rehef any further, t
Other alternatives were considered resolve comments on an Advance bemg doit red to the ongoing generic on this suliject or until a which would have granted more of what Notice of Proposed Rulemakms rulemakinbowing the August 1960 the petitioners ongmally requested.
(December 2.1986: 51 FR 43367) for a petition fo potential genenc rule on BRC wastes. a Commission pohey is filed.This action However, methods other than onsite Commission decision on a genene BRC modifies the restriction against mchahnwd $ m m waste rule is not expected in the near incineration without prior approval complete information and analysis for future. Also. EPA is considenng a contained in i 20.305 to make an waste oil. Controlled incinetution onsite t
similar standard.
exception for waste oil et power reactor has been demonstrated to be an l-Several power reactor licensees have sites. however,it does not exempt the acceptable technical alternative for,
l requested and been granted resultmg effluents from the requirements disposal of material. Although there is amendments to their licenses to allow of Appendix ! of part 50. These hmiting not sufficient information available to onsite incineration of shghtly conditions for operation include dose preclude allowing any of the other contaminated waste oil. Others are hmits for effluents and monitoring and alternatives in the future. incineration interested in doing so.
reportirp requiremints. Although this appears to be environmentally Environmental /mports c'th action may shghtly increase actual preferable to the other proposed Proposed Action. The pnmary impact of e[nuents. the radioactivity in these alternatitet Althousth used oilis not this rulemaking is to reduce the effluents must be accounted against hsted as a Federal hazardous waste. it i
admmistrative effort involved in the existme hmits for total dose from does contain a significant amount of apphcation for and issuance nf nuclear power p' ant effluents which touc st.bstances consistmg of vanous amendments to power reactor been3cs has e 6e rietermmed te sa':sh the "as organic compounds and metals.
tyowever eusmg these reallow mcmeration of wasie cd h>w as is reamn..b!) ochmable" Although therr may be some i
l qmrements ct: tenon environmental impact from the touc inc nerated th7n uj * "'e im acts fr m the tow const.tuents of nature of used oil for on) d:sposal r
used od would be m+ninured b,s onote alterna:n c. incincration Ht a controlied i
l
-w
a3 4
Federal R
/ Vol.'83. No.167 / Monday.' A t D. 1300 /
Rules' site minimises these effects and is EPS's suasesAsm The Nuclear Regulatory The the-laa has undersehen 0 breferred method for used oil disposal.-
Commission (Commission)is developing program to develop a regulatoey d 1
E organic components are essentially regulations for extendmg nuclear power framework which meets the need of
. destroyed by the incineration procesa plant licenses bevond 40 years. In order utilities to be informed of license
't n
. and the metals essentially remain in the to inform the public, industry and other renewal requirements sufficiently early ash residue. inemeretion at a controlled. govemment agencies of its activities and so that utilities can either prepare for site assures that the disposal of the ash to solicit timely comments on various residue can be controlled appropriateiy regulatory options and issues developed. license renewal or pursue alte sources of generstmg capacity. A considering both its radiologic and toxic thus far. the Commission is solicitation for comments on seven constituents. Nationally, a ny promul sting this notice and requesting maior issues (21 separate questions) was t
nonradiological environmental effect of comments on NUREG-1317 " Regulatory pubbshed on November 6. Ne4 disposal of todioactively contaminated Options for Nucle r Plant Ucense
" Request for Comments on Developewnt used oil from nuclear power plants Rene wal."
of pol 6cy for Nucles Power Plant 3
would be small compared to that A free copy of NUREG-1317 may be Ucense Renewal." Federal Resister. 51 associated with the total quantity of requested by those considenng public FR 40334 and 40335. A total of 58 written used oil disposed. All power plants in comment by writing to the U.S. Nuclear comments were received from a cross.
i total produce on the order of 15t1000 Regulatory Commission. Washington, section of the United States which l
gallons / year of such used oil: nationally. DC 20555. A copy is also available for included the electnc utility industry.
vehicle maintenance produces about 700 inspection or copytng for a fee in the public interest gropps, pnvate citizens.
million gallons / year of used oil.
NRC Public Document Room.1717 H independent consultants and j
Any other attemative action to this Street NW., Washington. DC.
government agencies.These comments I
proposed rulemaking would take lonaer Oats:The comment period expires 10/
were reviewed and a summary providad to complete. thus delsymg any relief to 24/68. Cumments received after this to the Commission in SECY-47-179, licensees and other benefits such as date will be considered if it is practical
" Status of Staff Activities to Develop a savings in land usage for waste to do so but the Commission is able to Ucense Renewal Policy. Regulations
- disposal, assure consideration only for comments and Woensing Guidance and to Report Agencies and Persons Consulted.
receised on or before this date.
on Public Comments." 8 dated July 21.
Further concultation has been made 1987.
Aoonasses: Mall e mments to:The Subsequently, the Comsnission has with the petitioners (PRM-20-15)
Secretary of the Commission. U.S.
decided to by. pass a policy statement concerning this action as a resulution of Nuclear Regulatory Commission, and go directly to a proposed rule. As the petition.
t
'U l
Consideration has also been Eiven to Dor ga e
eB ncl the Commission begms to focus on the
" I**"*"
- "*Y l
8 ongoms EPA activities. the 14 comment Deliver comments to 11555 Rockville of topics into a proposed rule for license.
letters received on the petition, and the n
tenewel. it !s w rthwhile to provide the -
Brookhaven report. NUREC/CR-4730.
- d '*
P F' ""l *
'Y
opportunity for public comment on the Emding ofNo Significant /mpact The Commission has determmed under'the Examine copies of comments re ved issues and options under consideration.
"8 a ng 37 Regu o 1
as ame ded an the mm ss n's l
regulations in 10 CFR Part St. Ihat this con puntaan imponasAvion cowTac r:
Options for Nuclear Plant Ucense proposed amendment to 10 CFR Part 20 Donald P. Cleary. Office of Nucleo Renewal." svallable for public comment.
t to allow the incineration of slightly Regulatory Research. U.S. Nuclear Comments are solicited on the contammated waste oil by power Regulatory Commission. Washington, following questions concerning the I
1-reactorlicensees onsite,if adopted.
DC 20555. Telephone (301) 492-3556.
content of NUREG-1317.This list of would not have a sigraficant effect on suest.sassNTAnY luponssATeow:
quesuons is not etheustive, therefore.
comments am welcome on any I'
the quahty of the human environment Histoncal Backsmund additional questions rtised in NUREG-anethat an environmental impact statement is not required This In the early part of the twenty first 1317-determination is based on the foregoing century a significant number of the
- 1. Are there any other maior environmental assessment performed in licenses for the eustmg operating resul. story options that should be accordance with the pmcedures and nucient power plants are due to expire, cors;Je ed for heense renewal?
cnteria in Part St. " Environmental Without renewal of these licenses. these
- 2. What are the relative merits of each l
l Protection Regulations for Domestic plants will be shut down and their option with regard to ensuring the Licensing and Related Regulatory generating capacay will be lost. The contmued adequate protection of the i
l Functions."
electric power which would have to be pubhc health and safety?
I supplied from new generating capacity
- 3. What are the benefits of requiring a t
lFR Doc. as-tn345 bled 6-26-48 8 45 ami ts substantial. In response to the brensee to wnfy his or gmal heensing
'"' C C" """
recogn tiun of this situ.ition and the design basis. as subsequently amended.
- necessity to address hcense renewal as a part of the beense renewal process?
10 CFR Part 50 issun wir h unhtice.. industry. or i 4 With regard to each of the the Dapartment uf Ener:y IDOE) are inhnoknin d environment.il and Nuclear Plant Ucense Renewal
<p n cnra programs to study plant i.<n proceduralissues, are there any l
"Wnion :ar bcth n*r and non.
I Commission.
ruriear gnmat ne piar9 The a a
.:m s e e...rt u.....
AceNcy: Nu :lt er Reed.rrors cm.m im u+
er : ma:e k t.
r ' '- * m R-
<r.o ACTION: Ad\\ JP4ed nui:'e of pr,
"U O t
.i r
nilem.ias
' " * " " ' ' " ' ' " "P" ' " 2
^-
4 o*W'v'r?*..r-p IN'k
.(
w, 3.- s
.25 4
- f....g
(,
)
on-ber 1.1989 POLICY ISSUE secy 9-3.o (Affirmation)
]
For:
The Comissioners From:
James M. Taylor, Acting Executive Director for Operations Sub.iect:
COMMIS$10N POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL
Purpose:
To provide for Comission consideration a final policy statement on exemptions from regulatory control.
Sumery:
This paper transmits a final-policy statement on exemptions from regulatory control which incorporates the elements of, and is consistent with, the directions included in the Comission's Staff Requirements Memorandum of October 13, 1989 Y
(Enclosure 1),
it also provides the status and proposed plans for-development of residual radioactivity criteria for decomissioning.
Background:
In a series of Comission papers (SECY 88-69. SECY 88-227,
['
and SECY 89-184), the staff has provided information and proposals for a proposed policy statement on exemptions from regulatory control. The proposed policy would be directed at a broad range of practices in which radioactive material may be released from a licensee's control. These practices.could include "below regulatory concern" (BRC) waste disposals as characterized in Pub. L.99-240, the Low-Level Radioactiva Waste Policy Amendments Act of 1985.
ic of discussion The elements of this policy were a major top (NUREG/CP-0101) at an NRC-sponsored international workshop and were the~ subject of an advance notice of policy develop-l ment issued on December 12,1988 (53 FR 49886). A public meeting addressing the subject policy also took place on January 12, 198,9. Following staff analysis of the public coments on the advance notice of policy development, a l
L Contag Dr. Donald A. Cool, RES Ext. 23785
' $ U EOv0 o g
O 99
@W N
~ *
$$M M
M
,1
)
0 g;
- The Connissioners 2
proposed policy statement was forwarded to the Commission-
- on June 16,1989(SECY-89-184). A Cosmission meeting was-held on July 11,1989, at which the proposals in SECY 89-184 were discussed.
Discussion:
In a Staff Requirements Memorandum dated October 1.3, 1989, the Cosmission disapproved the proposed policy statement in SECY-89-184 and issued directions with regard to the content.
and fonnat for a final policy statement on Exemptions From Regulatory Control. The policy statement attached as responds to this direction.
I The enclosed policy statement contains five sections and an appendix.' An-introductory section contains a description of the policy's purpose and need, cites existing exemptions c
l which are already codified in Cosnission regulations, makes references to " exemption" policies of other Federal agencies, ano provides an overview of the content of the policy statement.
This section also provides notice that this policy statement supersedes the Consission's previous policy statement on the o
use of byproduct and source material in consumer products j
(30 FR 3462).
j c
Section 11 defines key. terms and concepts used throughout the policy statement.
In this section, the definition of collective dose includes the individual dose cutoff of l.-
0.1 mrem per year recommended by the Commission..The definitions are consistent with those in the revision of l
Section III presents a discussion of the major elements of the exemption policy including:
(1) the dual individual dose criteria of 10 mrem per year and 1 arem per year, (2) the collective dose criterion of 1000 person-rem per year per practice, and (3) the provision for possible exemptions for practices not meeting the dose criteria.
--The risk basis for the individual dose criterion and the policy bases for the collective dose criteria are described.
Section !Y is a new section which, in general. terms, discusses how the provisions of the policy statement will be practically implemented. This section also describes 1
l, the opportunities for public inputs into Connission rulemaking or licensing actions involving exemption decisions.
4 i.
e-
7-_
i
.g r-4 a,.
7 4
l e..,
i The Commissioners 3
8 Section V, also a new section, defines the information l
needs which would be necessary for evaluation of an I
exemption application. The information in this section is a poneralized version of the information requirements contained
< n the staff implementation plan which was developed to support the ' General Statement of Policy and Procedures Concerning l
Petitions Pursuant to 12.802 for Disposal of Radioact ue Weste Streams Below Regulatory Concern," 10 CFR Part 2, t
Appendix 8. Depending upon the type of practice under consideration, not ail of the information in this section l
may be relevant. However, the general types of information should be appropriate for most rulemaking and licensing actions.
Finally, an Appendix is provided on the subject of dose and health risk estimates. This material is similar to that included in the staff's policy proposal contained in SECY-89 184
- is a summary of the policy's provisions and rationale for use by the Commission in discussions with members of the public.
During the preparation of the policy statement, an issue of
(
jurisdiction with respect to licensing by the Agreement States was noted. The Coenission retains the authority for the regulation of distribution of consumer products under this policy statement. However, the recycle of radioactive material will also result in the widespread distribution of radioactive materials to the public and the environment. The -
jurisdiction of the Cosnission in the area of recycle has not been as clearly defined in the Commission's regulations as it has with consumer products. This issue will be resolved during specific rulemakings to implement the policy statement.
An issue was also identified regarding the content of the statement. The issue centers on the staff's belief that there are certain practices that should not be approved, such as the introduction of radioactive materials into products to be consumed or used by children (e.g., toys), even if the radiation doses are very small, or where there are practical alternatives to use of radioactive materials. The policy statement is silent on this subject, and the elimination of the 1965 policy statement on consumer products could be construed as implying that such activities would be considered
'k-
+
v wy vm,x
,n--,,,-4
,,+
a
,-.,-_,,,er
4 l
~
Of The Commissioners 4
4 for exemption. One alternative would be to not rescind the 1965 policy statement as directed in the SRM of October 13 L
1989. A second alternative, however, would be to add a statement to the definition of ' practice' on page 11 of the t
policy statement (Enclosure 2). Such a statement could read:
1
'The Cosmission may determine that certain practices J
should not be approved, such as the introduction of I
radioactive materials into products to be consumed or used primarily by children, irrespective of the dose levels involved, or where there are practical alternatives to the use of radioactive materials. These practices would l
therefore not be likely candidates for exemption."
The staff recommends that such a statement be added to the l
i policy statement to avoid potential unwarranted criticisms of the exemption policy, and to make clear the Commission's position in this area. The staff believes that the change suggested would make the policy statement more readily understood and accepted by other Federal agencies, Congress, and members of the public.
)
Iri recent communications with both the Commission and the -
ACRS, the issue of coherence in the regulatory process has been raised, in light of the increased emphasis upon a
-f;-
consistent regulatory approach, the staff is preparing a separate memorandum which will identify and describe any potential areas of inconsistency with prior aMons related to reactors.
Implementation: One of the initial actions involved in implementing the
~
Exemption Policy will be the development of criteria for residual levels of radioactivity for decomissioning.. During i
a hearing on decosmissioning before the Subcommittee on Environment, Energy and Natural Resources on August 3,1989, Chairman Carr indicated his goal to develop these criteria by December 1989. The staff established a high priority for this task. A panel of technical reviewers has met frequently to accocoodate the schedule. The staff, with contractor support from Pacific Northwest Laboratories ()NL), has prepared a draft NUREG/CR technical basis report that describes the dose t
rate conversion f actors, pathways, and scenarios for exposure i
of incividuals at decomissioned sites. The draft technical report is the product of several iterations and extensive l
staff review, and it covers residual radioactivity in structures and soils, in addition, the report includes a model of the effects of soil contamination on drinking water.
Tables in the draft report provide, for approximately 200 4
?
e r
- ~,- -
x-u-.
+*
-,2
L.L
.--...1
- - - ~ -, -
-v
.-r
.. i
.s j
j
~::;ry j
~~'
The Cossisaioners 5
nuclides, dose rate conversion factors for unit concentration i
1 (e.g., pCi/g), for each pathway and for several scenarios.
J each of which represents a combination of pathways associated with the use of structures or land.
several During the November 15,198g, staff review meetingIfied.
technical comments requiring resolution were ident These included the need to elaborate the methods and rationale used to derive the drinking water model and scenario and the need to clearly describe the method for handling decay chains The comparison of the. generic and daughters of nuclides.
scenarios with those of other organizations, such as the NCRP, f
needs to be described. An additional and more significant issue is the possibility that the demolition and onsite disposal of released structures could affect the drinking.
water pathway. This last concern envisions a scenario that would add contaminated structural debris to already
)
contaminated soil. This situation could significantly restrict the use of generic scenarios for unrestricted release of structures because a large fraction of the total inventory 7
of structurally bound radioruclides could be ingested through the drinking water pathway.
In order to generically bound the range of structures for which decommissioning could be needtd.
i the volumetric and surface contamination which could be allowed To might be so low that their utility would be diminished.
(
address these issues, a revised draft will-be prepared and I \\
submitted for staff review in December 1989..
The staff believes that the NUREG/CR should be published first for comment to benefit f rom a greater range of review on the modeling approaches used to derive residual contamination criteria for unrestrit.ted release. The NRC staff plans to prepare a foreword to the report that would caution users that the tables and scenarios should not be applied beyond the scope originally intenced. A separate report, published with the draft NUREG/CR, will provide tables of release criteria i
l -
for soils and structures which, based on the models in the l-technical basis, would result in a 10 mrom/ year total effective dose equivalent. Following publication of the draft NUREG/CR and draft criteria, and receipt of comunents, the L
final report and interim criteria tables would be prepared.
The staff anticipates that the interim residual radioactivity criteria would be incorporated int ~o a regulatory fluide, which would also contain information on the use and 11m'tations of I
the criteria tables and the technical basis report. The staff envisions that the dose criteria for decoenissioning, upon
(
t s_,,--
- ~
^*
s.
m, The Commissioners 6
which the release criteria are founded, would be the subject of a rulemaking action to amend 10 CFR Part 20 to codify the acceptable conditions for release of sites for unrestricted use.
Given the new information developed during the review, the staff now plans to provide the craft technical basis report, and the tables of release criteria for soils and structures, for Commission review and publication for public comment in January 1990. Publication of the final technical document and j
draft regulatory guide would follow the public comment period.
The staff believes that this approach meets the intent of the statements made before Congress on the development of interim residual radioactivity standards, while at the same time allowing for appropriate public and scientific input.
Coordination:
The Office of General Counsel has reviewed this Comission paper and has no legal objection.
Recomendations: That the Commission:
1 1.
Acorove publication of the final policy statement on Exemptions From Regulatory Control, incorporating the' change suggested in the discussion. The staff believes
, - [,
that if this change is adopted, the policy will be more 4
readily understood and accepted by other Federal agencies, Congress, and members of the public.
2.
Note that the Biological Effects of lonizing Radiation Te%rt(BEIRV)isexpectedtobepublishedinmid-December.
l The Appendix discussing the risk bases of the policy statement includes a discussion of the UNSCEAR report which was published in 1988. Because the UNSCEAR and BEIR Y reports have been based on the same database, it is likely that their scientific findings will be similar.
However, the meaning and significance of the findings might be characterited in a somewhat different manner.
The Comission may wish to consider the findings in the BEIR report and make appropriate notations that this report has been examined and that the risk estimates in the policy statement are consistent with its findings.
4 3.
Note that the staff and OGC believe that a clearance of TFi policy statement by OMB may be required prior to publication. This requirement is based upon the wording i
of 5 CFR 1320.7(c) " Collection of information', and stems 0
---m.
4
-., - - - -~ _ _ - -
Jr.i c;
The Commissioners 7
1 from the fact that Section V of the policy statement defines the information needs which would be necessary for evaluation of an exemption application. Clearance by OMB would require a minimum of about 90 days.. The staff will provide further information 19 the Commission on this question.
4.
A separate memorandum will be provided by December 13, 1989, which identifies and discusses any potential areas of inconsistency with prior actions related to reactors.
/
- - W mes M. Ta r
t cting Executive Director for Operations
Enclosure:
1.
Staff Requirements Memorandum 2.
Statement of Policy 3.
Sunnary of Policy Statement
//
Commissioners' comments or consent should be provided directly
(
to the Office of the Secretary by COB Monday, December 18, 1989.
Commission Staff office comments, if any, should be submitted to the Commissioners NLT Monday, December 11, 1989, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected, l
This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of December 18, 1989.
Plea.se refer to the appropriate Weekly Commission Schedule, when published, for a' specific date end time.
DISTRIBUTION:
Commissioners OGC.
OIG LSS GPA REGIONAL OFFICES EDO ACRS ACNW ASLBP ASLAP SECY
4 c.
.s 2,.
4,,
4~.
i M. >-
.,7,
l t
t e
b I
ENCLOSURE 1 5TAFF REQUIREMENTS MEMORANDUM DATED OCTOBER 13. 1989 SECY-89-184 P
L e
s e
1 4
+. -
- e, a.
. +.
..-.4
+ -.
g.
gna. gecyord. RE5
^".
UNIT 8087AT88 f#st Taylor i
NUCLEAR RECULATORY COMMISBNNd g
s j,'
)
nam mestem.sa.snus
~
pernero.19855 4
Murley. IstR der....
Sc] gins.E o
ase vue ascene October 13. 1989 James M. Taylor MENORANDUM FOR:
Acting Executive Director for Operations William C. Parler, General Counsel Barold R. Denton, Director, GPA FRON:
[
1 J. Chilk, secretary
. STAFF REQUIREMENTS - SECY-89-184 - PROPOSED sus: RECT:
COMMISSION POLICY STATENENT ON EXEMPTIONS FROM REGULATORY CONTROL This is to advise you the the Commission, with all Commissioners agreeing, has disapproved your recommendation on a proposed Commission Policy Statement on Exemption from Regulatory Control.
The Commission requested the staff to submit for Commission approval a final policy statement which incorporates the
(
following elements:
A.
BEicW REGUIATORY CONTROL The NRC will exempt from further regulatory control a
-practice that' satisfies the criteria listed below.
3.
INDIVIDUAL DOSE CRITERION The average individual dose to typical individuals in
~ he critical group should be less than 10 area / year t
An interia individual dose for individual practicos.
limit of 1 ares /yr for exposures resulting from asterials and products used by the general public should be established until the Commission gains more experience with the potential for individual The exposures resulting from multiple practices.
staff should be clear, arid precise in defining en approach to distinguish which practices are subject Dose will be to each of these dose limits.
considered in terms of effective dose equivalent.
f!e:'dDu.u.,
Date
/o - t y - g* 9
~~
. ~ -
9@g m.W...,
~.
c.'
azARA collective doses resulting.from exposure to e practice should be as low as rsasonably achievableAnn
,,to 1000 person-res will be deemed to satisfy theThe calculation (ALARA).
i A1 ARA criterion.does not need to cionsider individual do
]
or. equal to 0.1 area /yr.
)
OTHER BRC EXEMPTIONS D.
The NRC may exempt practices that do not meet the individual dose criterion on a case-specific basis if the commission determines that doses to the public
^
are AIARA and regulatory control is not justified by
~
l further reductions in individual and collective l
doses.
The final policy statement should be. written in terms understood by the, average lay person and the discussions of the above criteria should be explained in the context of the risks l
that the ordinary individual faces in his or her everyday life.
o The' policy statement should also be consist,ent with the I
l 4
following format:
[
1.
INTRODUCTION Describe the purpose of the RRC Policy; cite existing exemptions.already, codified in NRC's regulations and those of other Federal agencies; overview the content of'the Policy Statement.
2.
TERMS AND CONCEPTS Define key terms and concepts used in the Policy Statement (e.g., practice, dose, risk, linear hypothesis, AIARA).
3.
POLICY Describe and justify the RRC criteria listed above
' (BRC, individual dose criterion, AIARA with theco The rationale should exemptions at higher doses). clearly describe the unifying ri establishing the critaria.
O 4
u-,,,+,,,-a-.---
r.
,n- -.,
a,.
-c,,-
,-a-----,,,----
i
+
.p.
i
.13 4.
IMPI.ENENTATION l
Describe how the 3RC Policy will be implemented t
through rulemakings and licensing actions; describe
}
opportunities for public comment through subsequent actionst identify the potential need, if any, for environmental impacts provide assessment'of guidance on how the NRC will consider applications
'for exemptions (e.g., would NRC develop a general rule for exempting consumer products or for specific
' ' products such as trying pans, jewelry, gas santles,e practices to ensure that the assumptions j
exempted made were appropriate.
STANDARD FORMAT AND CONTENT 9
5,,
Describe, in general terms, the format and content of exemption applications that the NRC staff would find I
l acceptable.
Additional comments are provided in the Commissioners' vote sheets.
The BRC Policy Statement should supersede the Commission's policy statement on consumer products dated March 8,
exempting practicestusing radioactive materials from regulat'ory
(
control.
2700s19
-f300> (RES)
(SECY Suspense:
11/30/89)
The General Counsel should examine the treatment of the iss of Agressent State compatibility under the Policy Statement, focusing on.the question of whether we have the authority to require Agreement States to adopt criteria that are identical to those set forth.in the Policy. statement (i.e., Agreement state SRC criteria can be neither less stringent nor more stringent than the criteria established by the Commission).
(SECY Suspense:
11/30/89)
(oGC)
- schedule, TheCommissionrequestedthestafftosubmitaplanless and resource requi, resents for the following activit Initiation of a. systematic assessment of existing exemptions for radioactive' materials in NRC's.As the a.
i regulations.
staff should identify existing exemptions and prepare a plan for evaluating them for conformance with the BRC policy.
9 9
--,_._-.,-.-,-~..,...,~.._,-,,_---m...--.;
' 1 t
t 3
Rulemaking activities, as appropriate, to ensure that b.
tions are consistent with the ERC codified exemp policy.
4 Development of a regulatory guidance to ensure that the SRC Policy is, implemented consistently in c.
licensing actions and future exemptions.
.Proactive program for disseminating information onthe d.
i local authorities,. Indian Tribal organisations, This' program should include l
sedia, and the public.
publication of an: informative pamphlet on the SRC policy for widespread distribution to the general public in terms understood by the lay person.
Program for assuring that staff remains cognisant of ongoing health effects research about the nature and e.,
' significance of riska at low doses and dose
' rates', as well as working with other responsible agencies to ensure that necessary research is being L
conducted and wi11' provide useful results.
' Consideration should be given for the need to conduct on a periodic eppropriate health effects research
' basis,ontheeffactiver,eseofthekaplementationof the Commission's exemption policy.
01/30/90) f 900 /Q
- p RES
-(990/GPA))
(SECY Suspense:
(EDOSuspense: 01/16/90) cc Chairman Carr commissioner Roberts Commissioner Rogers Commissioner Curtiss ACRS ACNW 2G l
I,.
_...,im,,,.
,,. _, - _......, _ _ _,,,, ~ - - -. -. -
vy
%yM g
e g,
4I
- e a
g',;, '.
?}
o
..'s e
- .Q t
a,y,s,-.
_{
. 4 17' I
e
'. +. -
l 1
I 6
5
(
)
1 1
k 9
[
t s
p t
rI F
ENCLOSURE 2 t
rs t
FINAL. POLICY STATEMENT 1
4 k
r L
4[
L
' ?
k i-t t
?
e f'
?
L-e p
t g
- 6 e
V h
y h
!=
j t.
h e
E g
F>
c 5
Y 9
b k
'g,3A,,w,,-.
.**"***".ymo.g,.
e
[
b.
,,,,..mmsmmm,,,m.,e,m.,.
m,..
.c,.m
~
,m.
V+%,ho......
,.m
,,,,,,n e e w n wwwm.m.~_,, rs,._,.
,;p l
[7590-01]
g L.
p p
e 3
NUCLEAR REGULATORY C0fM15$10N Exemptions from Regulatory Control; Policy Statement 1
- AGENCY:. Nuclear Regulatory Comunission.
' ACTION:' Policy statement..
j
?
j
SUMMARY
- This policy statement estab'11shes the framework within which the
- Comission will make decisions to exempt certain products and activities involving radioactive material from some or all regulatory controis. The exemptions may involve the release of licensee-controlled radioactive material either to the generally accessible environment or to persons who would be exempt-from Comission regulations. Activities for which exemptions may be granted include but are not limited to (1) the disposal of very low-level radioactive waste at other than licensed disposal sites, (2) the distribution of consumer productscontainingsmallamountsofradioactivematerial,(3)thereleasefor unrestricted public use of lands and strue.tures containing residual radioactivity, (4) the recycling of slightly contaminated equipment and materials, and (S) the release of effluents from licensed facilities. The policy statement defines the dose criteria and other considerations that will be most important in making decisions regarding exemptions. The policy establishes individual dose criteria
[1 and 10 arem per year (0.01 to 0.1 mSv per year)] and a collective dose criterion [1000 person-rem per year (10 person-Sv per year)] that will be major
- factors in the Commission's determination on whether further efforts would be s
0
-7
c gy necessary to reduce doses from a defined a'ctivity to values which are as low as l
1sreasonablyachievable(ALARA).
9 i
EFFECTIVE DATE:
(InsertPublicationDate.)
2 FOR FURTHER INFORMATION CONTACT: Dr. Donald A. Cool, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Cosnission Washington, DC 20555, telephone:
(301)492-3785.
l L
SUPPLEMENTARY INFORMATION:
5m -
Statement of Policy I.
Introduction.
The purpose of this policy statement is to establish the framework within which the Comission will make decisions to exempt certain practices from regulatory control. This policy defines the risks and other considerations attendant to the Comission's decisionmaking framework. The exemptions from regulatory control addressed by this policy will typically involve the release of small quantities or low concentrations of radioactive material to the public or to environments accessible to the public. However, this policy, in and of itself, does not grant an exemption from regulatory control for any radioactive materials.
Implementation will be accomplished by regulations developed through Comission rulemaking activities or by the Comission's approval of license amendments or license applications involving the release of radioactive material from a licensee's control.
2
4=
- e
.Se.
r W
- s. :
Under the regulatory approach used by the U.S. Nuclear Regulatory Commission (NRC), licensed practices are subject to limits and conditions that ensure the protection of the health and safety of both workers and members of the general public, and the environment. For example, radioactive anatorial is controlled by Commission and Agreement State licensee's to ensure that dose limits are not exceeded.
In addition, it is necessary to design, use, and dispose of l
sources of radiation in a manner that ensures that exposures to radiation or radioactive material are as low as is reasonably achievable (ALARA), economic and social factors being taken into account. This position, that doses be ALARA, has been a part of NRC regulatory practice for a number of years (10 CFR Part 20).
However, no criteria have as yet been provided that would establish the basis for defining the level of residual risk at which. continued application of the ALARA principle is no longer warranted. Thus a major provision of this policy involves the definition of criteria that would delineate conditions under which additional f
expenditures of regulatory and licensee resources would not be necessary to further reduce radiation exposures from a given practice. For exempted practices, the Commission's regulatory involvement could be essentially limited to licensing i
and inspection activities associated with the transfer of the radioactive material from a controlled to an uncontrolled status. That is, the Cornission, through L
appropriate rulemaking actions or licensing decisions would define the constraints, requirements, and conditions applicable to an exemption decision, and would verify that these constraints are adhered to by NRC licensees when L
radioactive materials are to 6e transferred from a controlled to an uncontrolled or exempt status.
o l
3 l
l
- .. A.
b The concept of regulatory exemptions is not new. The Atomic Energy Act of l
i 1954, as amended, authorizes the Commission to exempt certain classes, quantities, or uses of radioa'ctive material when it finds that such deregulation will not constitute an unreasonable risk to comen defense and security and to the heal'th and safety of the public. In 1960 and 1970, the Cosmission used this authority to prosas1 gate tables of exempt quantities and concentrations for radioactive material. These exemptions allow a person or a licensee, under certain circumstances, to receive, possess, use, transfer, own, or acquire radioactive material without a requirement for a license (30 FR 8185; June 26,1985and35FR6427; April 22,1970). Other exemptions allowing distribution of consumer products or other devices to the general public or allowing releases of radioactive material to the environment have been embodied in the Commission's regulations for some time.
For example, regulations currently specify the conditions under which licensees are allowed to cispose of radioactive material into a sanitary sewer system (10 CFR 20.303). Thus these existing i
regulations specify requirements, conditions, and constraints that a licensee must meet if radioactive material is to be " transferred" from a controlled to an uncontrolled status. More recently, Section 10 of the Low-Level Radioective Waste Policy Amendments Act (LLRWPAA) of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions "... to exempt l
specific radioactive waste streams from regulation... due to the presence of radionuclides... in sufficiently low concentrations or quantities to be below regulatory concern." The Comission responded to this legislation by issuing a policy statement on August 29,1986(51FR30839). That policy statement contained criteria that, if satisfactorily addressed in a petition for rulemaking, 4
l l
- l. L -.
l R
4, e
l M ::
i would allow the Commission to act expeditiously in proposing appropriate relief l
in its regulations on a
- practice specific" basis consistent with the merits of l
(
the petition.
Other Federal and State agencies have also developed and used risk bases to establish a threshold for regulatory agency involvement. The Food and Drug Administration (FDA),forexample,hasappliedsensitivity-of-method, risk-based, l
J guidelines in connection with the regulation of animal drugs, food contaminants, and trace constituents in some food additives. Similarly, the Environmental.
Protection Agency (EPA) has suggested de minimis incividual lifetime risk levels for small and large populations in the regulation of pesticides and carcinogenic chemicals.
i The Commission believes that the need for policies defining thresholds for regulatory action is driven by two basic realizations. The first is the recognition that, for certain practices involving minimal public health and safety concerns, the imposition of undue or unnecessary regulatory controls could prohibit a practice that should otherwise be permitted because of reasonable societal (including public health and safety), economic, or industrial benefits.
The second realization is the necessary national focus on fiscal responsibility and the knowledge that resources expended for regulatory control of practices with minimal health and safety impacts could better be used to address more significant radiological and nonradiological health and safety concerns.
To address this need, the Commission, in this policy, is expanding on its existing regulations and policies for protection of the public from radiation that currently define a number of longstanding exemptions from regulatory control. Because this policy 5
i
.s*.
-E 7
^ '
.?'F i
now provides a consistent risk basis for exempting the use of byproduct and source material in consumer products, this policy supersedes the Comission's l
March 16, 1965, policystatementonthissubject(30FR342).
It is igortant to emphasize that, in this policy, the Comission does i
not assert an absence or threshold of risk at low radiation dose levels but rather establishes a baseline where further government regulation to reduce risks is unwarranted. The presence of natural background radiation and variations in the levels of this. background are used to provide.a perspsetive on which to judge the relative significance of the radiological risks involveo in the exemption decisionmaking process.
l The Comission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an important
(-
role in its implementation; specifically, with regard to proposals for disposals of radioactive material at other than licensed low-level racioactive waste. sites. Pursuant to the LLRWPAA, States, either alone or in cooperation with other States, are responsible for providing for disposal of certain i
low-level radioactive wastes.
In the past, some States have been encouragihg findings that certain wastes are below regulatory concern. The Comission believes that States will benefit from the application of a national policy on exemptions for specific practices involving distribution or release of radioactive material.. The. Commission therefore expects that rulemakings codifying exemptions for practices under this policy will be made a matter of strict compatibility for Agreement States to the extent that States, under the terms of the Agreements, are responsible for exemptions in their States. Consequently, those rulemakings involving Agreement States that evolve from this policy will continue to be closely 6
l
l'g'-
, +.
coordinated with the States. The Coemission wil1. however, retain its sole
, authority for issuing licenses for the manufacture and/or distribution of consumer products using byproduct or source material and its other authorities as defined in 10 CFR part 150.
The policy described in this document is intended to provide the public health ano safety ' framework that would apply to a wide spectrum of Commission exemption decisions. As such, it not only provides indivieval and collective dose criteria but also ciscusses other important elements of an exemption decisionmaking process.
Section l'I provides definitions *of key terms 6nd concepts used in the policy statement. Section !!! presents the basic elements of the policy while Section !Y discusses how the policy will be implemented through rulemakings and licensing actions and describes how the public will be This provided an opportunity to comment on the Commission's exemption decisions.
f section also discusses NRC plans to review past exemption decisions to ensure consistency with exemption policy provisions.Section V describes, in general terms, the information needed to support the exemption decisionmaking process.
V
- 11. Definitions.
' Activity," when used to describe radioactivt material in this policy statement, is the rate of disintegration (transformation) or decay of 10 radioactive material. The units of activity are the curie (1 Ci = 3.7 x 10 disintegrations per second) and the becquerel (1 Sq = 1 disintegration per second).
t 7
.. ~
~
.g
[
M
$N:
ALARA" (acronym for "as low as is reasonably achievable') means making every reasonable effort to maintain raciation exposures as far below appliceble dose limits as is practical, consistent with the purpose for which the licensed activity is undertaken taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations and in relation to utilization of nuclear energy and licensed materials in the public interest.
Agreement State" means any State with which the Commission has entered into an effective agreement under subsection 274(b) of the Atomic Energy Act of 1954, as amended.
Byproduct material" means -
(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; and (2) The tailings or wastes produced by the extraction or
^
concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes.
Underground ore bodies depleted by t
these solution extraction operations do not constitute ' byproduct material" within this definition.
4 8
p n-
,,w.
~.
m-
-a.-
,. mew n
-,y..,,,,,
6%
2 "Below regule 'ory concern" is a term taken from Section 10 of the Low level Radioactive Waste Policy Amendments Act of 1985 (Pub.L.99-240) that refers to waste streams containing sufficiently low concentrations.or quantities of radionuclides that the waste stream may be exempted from regulation by the Nuclear Regulatory Comission.
" Collective dose" is the sum of the individual doses (total effective dose equivalents) received in a given period of time by a specified population from exposure to a specified source of radiation (or practice involving the useofracioactivematerial). Note: The calculated collective dose used to determine compliance with the criterion of this policy need not include individual dose contributions received at a rate of less than 0.1 mrem per year.
l l
" Committed effective dose equivalent" is the sum of the products of weighting factors applicable to each of the body organs or tissues that are irradiated and the comitted dose equivalent to those organs or tissues as defined in 10 CFR Part 20.
- Deep dose equivalent" is the dose equivalent at a tissue depth of I cm.
" Dose" or " radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, L
l-comitted effective dose equivalent, or total effective dose equivalent.
In l
this policy, the term refers to the total effective dose equivalent.
9
\\
c.
t q.
O k%".
j
'R
' Exemption from regulatory control' refers to a decision pmcess that may allow radioactive material to be transformd from a controlled status to en uncontrolled status. Exemptions will be based upon the small magnitude of risk to public and occupational health sad safety and the need to direct the resources of regulatory agencies and the regulated community into optimal risk reduction endeavors.
)
J
" Exposure" means being exposed to ionizing radiation or to radioactive j
material.
- Licensed material" means source material, special nuclear material, or 1
l byproduct material that is received, possessed, used, transferred, or disposed of under a general or specific license issued by the Commission.
" Licensee" means the holder of an NRC or Agreement State license.
- Natural background dose" means the dose received from naturally occurring cosmic and terrestrial radiation and radioactive material but not including source, byproouct, or special nuclear material (as defined in 10 CFR Part 20).
'No-threshold hypothesis" refers to the theory that, at the small dose levels considered in this policy, there continues to be a risk without threshold for exposure to radiation and that there is a relationship between dose and the statistical probability of the occurrence of a health effect (such as latent cancersandgeneticeffects).
b i
10
c T
l y.
g-
Practice" is a broadly defined activity or a set or combination of a number of similar coordinated and continuing activities aimed at a. given purpose that involves the potential for radiation exposure. Disposal of very low level radioactive waste; the release for unrestricted public use of lands and structures with residual levels of radioactivity; the distribution, use, and disposal of specific consumer products containing small amounts of radioactive material; and the recycle and reuse of residua 11y contaminated materials and equipment are examples of practices for which this policy will have potential applicability.
' Rem" is the special unit of effective dose equivalent (1 rem = 0.01 sievert).
i
- Risk," for purposes of this policy, means the annual or lifetime probability of the developme'nt of fatal cancer from exposure to ionizing radiation and is taken as the product of the dose received by an exposed l
individual and a conversion factor based upon the linear, no-threshold d
hypothesis. The conversion factor for dose to risk is taken to be S x 10 I
fatal cancer per rem of radiation dose.
For the purpose to which this policy is directed, the fatal cancer risk is considered to be either more likely or have a more severe outcome than the potential genetic and nonfatal cancer risks and the potential risk of developmental anomalies in fetuses.
" Source material" means --
(1) Uranium or thorium, or any combination of uranium and thorium in any physical or chemical form; or 1.
L 11 m
7
t i
j g
(2) Ores which contain, by weight, one-twentieth of one percent 1
(0.05 percent), or more, or uranium, thorium, or any combination of uranium and l
thorium. Source material does not include special nuclear material, "Special nuclear material" means.
i (1) Plutonium, uranium-233, uranigm enriched in the isotope 233 or in the isotope 235, and any other material which the Commission, pursuant to the provisions of Section 51 of the Act, determines to be special nuclear material, but does not include source material; or (2) Any material artificially enriched by any of the foregoing but does not include source material.
" Total effective dose equivalent" means the sum of the deep dose equivalent (for external exposures) and the committed effective dose equivalent (forinternalexposures)expressedinremorsieverts, r
111. Policy Elements.
The purpose of this policy. statement is to establish the basis upon which the Commission will initiate the development of appropriate regulations or make licensing decisions to exempt certain practices from some or all regulatory controls. This policy is directed principally toward rulemaking activities but may be applieo to license amendments or license applications involving the release of licensed radioactive inaterial either to the environment or to persons who would be exempt from Comission regulations.
12
.m----
--,,e
3 It is the Comission's intent to broadly define specific practices so that the effect of an exemption decision on any individual or population will be
]
evaluated in its entirety and not in a piecemeal fash. ion. At the same time, the practice must be identified and described in terms that will facilitate reasonable impact analyses and allow imposition of appropriate constraints, requirements, and conditions as the radioactive material passes from a controlled to an uncontrolled status (i.e., the material is no longer under the i
control of a licensee). Under this policy, the definition of a ' practice" in t
any specific decision (rulemaking or licensing action) is a critical feature L
that will be used to ensure that formulation of exemptions from regulatory l
control will not allow deliberate dilution of material or fractionation of the radiation or radioactive material for the purpose of circumventing controls l
that would otherwise be applicable. The definition of the practice in any specific exemption decision will also provide the framework for taking into
~
account the possible consequences of accidents or misuse or the potential for other nonstochastic radiological impacts associated with the exemption, i
A.
Principles of Exemption, o
A major consideration in exempting any practice from some or all regulatory controls hinges on the general question of whether or not the application or continuation of regulatory controls is necessary and cost effective in reducing a small risk (i.e., a commensurate small dose). To determine if exemption is appropriate, the Comission must determine if one of the following conditions is met:
l 13 i
-,,-ics--www------
--a.g-e
<s-
+e----
w r-*-t
=9M'.
iL;
[
M i
W.
1.
The application or continuation of regulatory controls on the practice does not result in any significant reduction in dose received by individuals within a critical group (i.e... the group expected to receive the highest exposure) and by the exposed population or; 2.
The costs of the controls that could be imposed for dose reduction are not balanced by the comensurate reduction in risk that could be realized.
For purposes of implementing its policy, the Comission intends that only under unusual circumstances would exemptions be considered for practices that could cause continuing raciation exposure to incividuals exceeding a small fraction of the 100 mrem per year (1 mSv per year) public dose limit. 'The Comission will consider such circumstances on a case specific basis using the generalapproach(i.e.,applicationoftheALARAprincipleandconsiderationof f
the potential for accidents or misuse or other nonstochastic radiological
' impacts) outlined in this policy statement. However, as the doses and attendant risks to members of the exposed population decrease below the public cose limit, the need for regulatory control decreases. At a sufficiently low l-level of risk, the Comission believes the decisionmaking process for granting specific exemptions from some or all regulatory controls can be essentially reduced to an evaluation of whether the overall individual and collective risks are sufficiently small.
The Comission therefore believes that individual and population dose criteria should be basic features of its overall policy to define the region
^
where the expenditure of Comission or licensee resources to bring about a l-further incremental compliance with the ALARA principle is no longer warranted.
14
i
-.n3 l
o y..
Thesespecificcriteriainclude(1)valuesfortheindividualannualdose l
reasonably expected to be received as a result of the practice (e.g., an f
everage dose to individuals in a critical group) and (2) a measure of t
i radiological impact to the exposed population.
In combination, these criteria are chosen to ensure that, for a given exesyted practice, no individual will be esposed to a significant radiological risk and that the population as a whole does not suffer a significant radiological impact.
B.
The Individual Dose Criterion.
i If the doses to individuals from a practice under consideration for l
exemption are sufficiently smil, the attendant risks will be small compared to t
other societal risks, and there would be little merit in expending resources to further reduce this cose or risk. The Comission believes the definition of
\\
this risk or dose level can be developed from two perspectives.. The first of these is related to cuantitative risk levels. The Commission believes that most members of society will not expend resources to reduce an annual l
individual f atality risk below approximately 10-5 (i.e.,1 chance in 100,000).
l This risk level is comparable to that, (i.e., 2x10-6) selected by the Comission in the development of its safety goal policy for nuclear power reactors (i.e.,
a risk level equal-to 0.11(1/1000) of the sum of cancer fatality risk from all othercauses). Using the no-threshold hypothesis, the incremental continuing annual individual exposure level comparable to the ' safety goal" risk level can be estimated as 4 mrom per year (0.04 mSv per year). The second perspective is based on those variations in dose, and hence risks, knowingly or unknowingly tolerated by individuals because of factors such as their lifestyle or place of
?
residence. The Comission notes that resources are not expendee to reduce 15 w
-w.,
..m.---.+-
- + - -
,,-....v.----
-.--,,--.w.n,
p-4 w
&l s
kI differential exposures associated with variations in natural background f
radiation (e.g., the 6040 mram per year difference between annual doses received in Denver, Colorado, vs. Washington, DC.). Nor are resources spent to L
reduce (1) the difference in doses between living in a brick vs. a frame house.
)
(2)the5mromdosethatanindividualwouldreceiveduringasingleroundtrip
'f coast-to-coast aircraft flight, or (3) the dose from other activities that J
1 inyolve a small fraction of background radiation.
L In view of the uncertainties involved in risk assessment at low doses and taking into account the aforementioned risk and dose perspectives, the Comission finds an individual dose of 10 mrom per year (0.1 mSv per year) to
{
be appropriate for use as an individual dose criterion that would define s
whether or not additional resources need to be sp,ent to comply further with the ALARA principle. However, until the Comission gains more experience with the potential for individual exposures from multiple practices, an interim individual dose criterion of 1 mrem per year (0.01 m5v per year) will be applied to those practices involving widespread distribution of materials containing radioactive material such as consumer products or recycled material and equipment. The Comission considers these values to be appropriate given the uncertainties involved and notes that, with these values, implementation of this policy in future rulemakings or licensing decisions should be a practical underta king. The Comission believes that reasonable assurance can be provided i
that individual exposures to the public from all licensed activities and exempted practices would not exceed 100 mrom per year (1 mSv per year) given I
the Commission's intent (1) to define practices broadly, (2) to evaluate potential exposures over the lifetime of the practice (3) to monitor and verify how exemptiens are implemented under this policy, and (4) to impose a 16
- C 4..
companion population or collective dose criterion in defining when further epplication of the ALARA principle is unwarranted.
i C..
The population Dose Criterion, i
The Commission believes that the collective dose (i.e., the sum of
. individual total effective dose equivalents) resulting from exposure to en exempt practice should be ALARA. However, the Comission believes that, if the collective dose resulting from an exempted practice is less than an expected value of 2000 person-rem per year, the resources of the Comission and its licensees are better expended to address more significant health and safety issues. The Commission notes that, at this level of collective exposure, the hypothetical health effects calculated for the exempted practice on an annual basis are less than one fatality.
l The Comission notes that the National Council of Radiation Protection and 1
Measurements recomends in its Report No. 91, recommends that collective dose assessments for a particular practice should exclude those individuals whose annual effective dose equivalent is 1 mrem per year (0.01 mSv per year).
Taking this recomunendation into account and considering the uncertainties l
l associated with the potential for exposure to multiple practices, the Comission concludes that, in calculating collective dose, individual doses I. Recommencations on Limits for Exposure to lonizing Radiation, NCRP Report No. 91, National Council on Rediation Protection and Measurements, June 1, 1967. Available for purchase from NCRP Publications, 7910 Woodmont Ave., Suite 1016, Bethesda, MD 20814 17
~
,. : y,;
A s
. 4..
~
- less than 0.1 mrem par year (1 pSv per year) need not be considered. The Commission believes that inclusion of individual doses below this range L
L
- introduces an unnecessary complexitv into collective dose assessments and could
[
provide a false sense of the significance and certainty of such dose levels.
i Furthermore, in the sensitivity-of-measure, risk-based guidelines used by EPA and FDA,'a 10-6' lifetime risk of cancer has been used as a quantitative criterion of insignificance. Using an annua'l risk coefficient of 5x10'4 per
+
rem (5x10-2 persievert)asdiscussedinAppendixA,the10-6 lifetime risk
'value would approximate the risk that an individual would hypothetically incur from continuous lifetime exposures of 0.1 mrem (0.001 mSv) per year. As a t
result, the Comission believes this value is an appropriate truncation value j-p to be applied in the assesspent of collective. doses for the purposes of this policy.
The Comission stresses that adoption of the individual and collective.
. dose criteria should not be construed as a decision that doses below these criteria are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary, the criteria simply represent a range-of risk that the Commission believes is.sufficiently small compared to other individual and societal risks that further cost-risk reduction analyses (or more broadly, ALARA analyses) are not required in order to make a decision regarding the acceptability of an exemption. Practices not meeting these criteria may be granted exemptions on a case-by-case basis in accordance with the principles embodied within this policy, since little would a
be gained.by further regulatory control, that is, if (1) the potential doses to t
individual members of the public are sufficiently small or unlikely, (2) the collective dose from the exempted practice has been minimized based on ALARA p
18
g
.i 1.
i
['
)
- 's considerations, and (3)'little, if anything, is to be gained by further Eregulation, an exemption might be granted, n.
IV.
Implementation, i
The Commission's intent is that the provisions of its exemption policy will be implemented principally through its rulemaking processes; however, exemption decisions could also be associated with specific licensing actions.
In the first case, a proposal for exemption, whether initiated by the NRC I
or requested by outside parties in a petition for rulemaking, must provide a h
L basis upon which the Commission can detemine if the basic policy conditions i
have been satisfied.
In general, this means that the proposal should address the individual and societal impacts resulting from the expected activities that l
could result if the exemption were to be granted. As a result, the proposal 1
must consider the use:. A the radi active materials, the pathways of exposure, the levels of radioat W 'is. *N M wth'ods and constraints for ensuring that L
l the assumpti,ons used ;) $81re A pre:tice remain appropriate as the radioactive-materials move from a "nmTlen to an uncontrolles status. Any such o
I rulemaking action would follow the Administrative Procedure Act, which requires publication of a proposed rule in order to solicit public connant on the i
rulemaking action under consideration. The rulemaking action would include an appropriate level of environmental review under the National Environmental L
]
p Policy Act.
]
L If a proposal for exemption results in a Comission regulat1on containing a
specific requirements for a particular exemption, a person using the exemption 19 u
o
y.-
Wj e
.would no longer need to further apply the ALARA principle. The Cosmission's exempiion decision would be based on the licensee meeting the conditions specified in the regulation. The promulgatica of the regulation would, under these circumstances, co%titsM; a finding that the exempted practice is j
authorized and that st#A trinsiderations heve been addressed, e
The second means of policy implementation could involve exemptions that-would be granted through licensing actions. These licensing actions may be subject to a public hearing process and, depending on the specific action taken, may be required to be noticed in the Federal Register.
In defining its exemption policy, the Commission believes it must ensure that the assumptions and criteria used to justify past exemption decisions remain appropriate. As a result, the NRC will undertake a systematic I
assessment of exemptions currently existing in NRC's regulations. The NRC will', on a, periodic basis, review the exemptions granted under this policy to ensure that the public health and safety continue to be adequately protected.
i V.
Information To Support Exemption Decisions.
.A.
General.
The information required to support an exemption decision in a rulemaking or licensing action must address the bases for exemption described in Section n
III of this policy.
In addressing the radiological health and safety impacts, indivicual and collective doses attributed to the pract' ice under consideration l
must either meet the policy's dose criteria or otherwise be demonstrated to be 20 i
m
't u,..
+.,.
4 o
y ALARA.
In adoition to the impacts of routine exposures, the impacts resulting from potential misuse or accident scenarios must also be evaluated and
~
demonstrated to be not significant.
Practices must be defined with respect to the geographic and demographic areas to which the exemption will apply.
In some cases, an exemption will be limited to one particular locality or area. However, many practices will have i
national applicability and must be characterized accordingly._ Information on these issues will be necessary for determinations regarding which individual dose criterion should be applied. The Comission believes that the implementation guidance provided with its " General Statement of Policy and Procedures Concerning Petitions Pursuant to 62.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern," published August 29,,1986, 51 FR 30839, generally defines the types of information needed to support an exemption decision.
However, not all of the information may be applicable to the broader range of practices considered for exemption under this policy.
Applicants should examine all applicable guidance and provide the information which is relevant to the particular type of exemption decision being requested.
B.
Characterization.
p I
1.
Radiological properties. The radiological properties of the
-materials to be exempted should be described, including, as appropriate, the concentration or contamination levels and the half-lives, total quantities, and identities of the radionuclides associated with the exempted practice. The chemical and physical form of the radionuclides should be specified. All radionuclides present or potentially present should be specified. The 21 l
l E
Y,
- i Q
NM distribution of the radionuclides should be noted (e.g., surface or volume sistribution). Mass and. volume averaged concentrations should also be presented..The variability of radionuclide concentration, distribution, or type as a function of process variation or variations among licensees should be
-addressed and bounded, as appropriate.
2.
Nonradiological properties. An understanding of the nonradiological properties of the materials to be exempted may be needed to assure that they have been properly addressed. An NRC exemption, baseo on radiological impacts, would not relieve licensees from the applicable rules of other agencies which cover nonradiological properties. A description of the materials, including their origin, chemical composition, physical state, volume, and mass should be provided..The variability and potential changes in the radioactive material form as a function of process variation should be addressed. The variation among licensees should be described and bounded, as applicable.
C.
Practice Characterization 1.
Total impact. A regulatory action taken under this exemption policy is likely to be generic, and the exemption may be nationwide in scale.
Therefore, to the extent possible, an estimate of the number of NRC and Agreement State licensees that possess the radioactive material considered for exemption, the annual volumes and masses, and the total quantities of each*
radionuclide that would be a part of the exempted practice should be given.
The estimates should include the current situation and the likely variability over the reasonably foreseeable future. A concentration distribution would be a helpful tool in characterizing the radioactive material involved in the 1
22
t
-~
- [
4's exemption' decision. Such distribution would permit more realistic assessment
- of impacts in addition to conservative bounding estimates using maximum values.
- In any case, the typical quantities produced per practice and an estimate of 4
the geographic distribution of the practice should be described. The potential for recycle should also be addressed as applicable. Both the resource value (e.g., salvageable metals) and the functional usefulness (e.g.; usable tools) o s
should be examined. Both short-and long-term potentials for recycle are of significant concern to the Copenission and should be addressed.
l 2.
Basis for assessment. The basis for the material characterizations should be provided. Monitoring, analytical data, and calculations should be specified. Actual measurements or values that can be related to measurements to confirm calculations are important and should be provided. The description of the bases should include quality assurance aspects of data collection and f
analysis.
If any surveys were conducted, they should be described. Market information may be useful in characterizing a practice on a national basis.
3.
As low as is reasonably achievable (ALARA). The ALARA principle referred to in 10 CFR Part 20 applies to efforts by licensees to maintain radiation exposures and releases of radioactive materials in effluents to unrestricted areas as low as is reasonably achievable. Appendix I to 10 CFR Part 50 described ALARA for radioactive materials in light water reactor effluents. Licensee compliance with the ALARA principle must remain in effect unless the dose criteria and other conditions contained in this policy are met.
23 T
1 m
4 L,.. M.-
l m
g p
er D.
Impact Analyses.
To support and justify a request for exemption, each petitioner or licensee shoula assess the radiological and nonradiological impacts of the exempted practice. The analyses should be based on the characterizations described previously and should cover all aspects of the proposed exempt i-practice, including possession, use, transfer, ownership, and disposal of'the material. Consideration of the exemption and any environmental assessments and regulatory analyses required will be based on the impact analyses and l
l supporting characterizations.
l 1.
Radiological impacts. The evaluation of radiological impa, cts should clearly address the policy's criteria for demonstrating compliance with the ALARA principle or provide a self-supporting ALARA evaluation supporting the exemption.
In either case, the following impacts should be assessed:
The maximum individual exposures; The critical group exposures; Thecumulativeorcollectivepopulationexposures(underconditions defined in Section III);
The potential for nonstochastic radiological impacts; and The potential for reconcentration of radionuclides.
The total population exposure should be estimated and summed in two parts. One part is the critical group, where the exposures are likely to be the greatest and for whom the assessment of doses is likely to be the most accurate. The critical group should be the segment of the population most 24 v
w a,..
g 3p.
highly exposed exclusive of radiation workers. The second part of'the
- population exposure is the general population. For this group. the individual exposures should.be smaller, and the assessment will often be less precise.
In-1 situations where truncation of the collective dose is done under the provisions of the policy, the basis for applying the truncation provision and the uncertainty in dose estimates should be provided.
The evaluation of radiological impacts should distinguish between expected and potential exposures.and events. The analysis of potential.
exposures or accidents should include all of the assumptions, data, and results-used in the analysis in order to facilitate review. The potential for
. reasonable interactions between the exempted radioactive material and the public should be assessed.
L 1
(
- 2.
Other impacts. The analysis of other impacts such as those from transportation, handling, processing, and disposal of exempted materials should be evaluated. The impacts from nonradiological properties should also be l
E adoressed since they must be considered under 10 CFR Part 51. Any NRC action L
l to exempt a practice from further regulatory control would not relieve persons
. using, handling, processing, owning, or disposing of the radioactive material
- from the requirements applicable to the nonradiological properties of the material.
E.
Cost-Benefit Considerations (as required).
l 4
l 1
A cost / benefit discussion is an essential part of both environmental and regulatory impact considerations. The discussion should focus on expected 25 4
w e-
,+w---
- -w w
y-w
-we m
. 7 W.
1 exposures and realistic concentrations or quantities of radionuclides. The cost / benefit discussion should compare the exposures and economic costs v
associated with exemption and nonexemption decisions.
It may also. include 1
qualitative benefits. Costs of surveys and verifying compliance discussed under Item V.G. should also be covered. Any legal or ringulatory constraints
- that might affect any exemption decision should be identified. For example, one such constraint might stem from Department of Transportation (D0T)-
labeling, placarding, and manifesting requirements for radioactive materials in 49 CFR Part 173.
I F.
Constraints, Requirements, or Conditions on Exemptions.
In most cases, the characterizations of the material and the assessment of-impacts will be based on either explicit or implicit constraints.
In order for an exemption based on these Characteri2ations and assessments, the constraints must be incorpurated into the exemption decision. Therefore, the relationship between the proposed. materials to be exempted and the constraints to be applied as part of the exemption such as quantity limits, concentration limits, and physical form must be addressed. The bases on which these constraints are to be t
l-ensured must also be discussed.
In general, constraints must be inspectable and verifiable in order to be included in an exemption decision.
G.
Recordkeeping and Reporting.
i 1.
Quality assurance / quality control. The program to ensure compliance with specific exemption constraints, requirements, or conditions must be defined. The records of tests, surveys, calculations, etc. used to demonstrate 26
o
< w'.
- ffg
~'
3A compliance should be maintained for inspection.
2.
Reports. Annual reports will be required from licensees who, by rule or license, are pemitted to release materials exempted fmm regulatory
-control. and' associated.recordkeeping to generate the reports will be imposed.
Minimum information in the annual reports could include volume and curie content. More detailed recordkeeping and reporting requirements may be imposed
.to address uncertainties in projecting future volumes or amounts of exempted materials and NRC's responsibility to consider the cumulative impacts of l
l multiple exemptions.
l
~.
l l
G i
l-l'-
1 l
27
+ : ' * -'
4
. a:.
g APPENDIX A - DOSE AND HEALTH EFFECTS ESTIMATION 1.
Dose Estimation In estimating the dose rates'to members of the public that might ari.se through the use of various practices for which exemptions _are being considered, '
i the Commission has decided to apply the concept of the " total effective dose equivalent." This concept, which is based on a comparison of the delayed health effects of ionizing radiation exposures, permits, through use of.
weighting factors, the calculation of the whole body dose equivalent of partial l'
body and organ' exposures. This approach was proposed by the, International l
Comission on Radiologica.1 Protection in its Publication 26, issued in 1977.
Since that time, the concept has been reviewed, evaluated; and adopted by raoiation protection organizations throughout the world and has gained wide I,,.
acceptance. The " total effective dose equivalent" concept is incorporated in
" Radiation Protection Guidance to Federal Agencies for Occupational Exposure -
[
Recommendations Approved by the President," that was signed by the President and published in the Federal Register on January 27, 1987 (52 FR 2822). Tht!
l Commission recognizes that, in considering specific exemption proposals, the total effective dose equivalent must be taken into account.
i II.
Estimating He31th Effects From Radiation Exposure A.
Individual Risks.
In the establishment of its radiation protection policies, the Commission has considered the three major types of health effects that can be caused by 28
l
~
~
dtkf n
relatively low doses of radiation: cancer, genetic effects, and developmental
-anomalies in fetuses. The NRC focuses on the risk of fatal cancer development
~
principally because, at relatively high radiation doses (1) the strongest basis L
exists for quantifying the risk of cancer mortality in humans, (2) the mortality risk represents a more severe outcome than the nonfatal cancer risk, and (3) the mortality-risk is thought to be higher than the risk associated with genetic and s
developmental effects on fetuses.I However, even though radiation has been shown to be carcinogenic, the development of a risk factor applicable to continuing 2
radiation exposures at levels equal to natural background requires a significant extrapolation from the observed effects at much higher doses ano dose rates.3 The result is a significant uncertainty reflected by the views of experts in the field.
For example, the Comittee on the Biological Effects of Ionizing L
Radiation of the National Academy of Science has cautioned that the risk values.
are "... based on incomplete data and involve a large degree of uncertainty, especially in the low dose region." This Comittee also stated that it
"...does not know whether dose rates of gasna or x-rays (low LET) (low linear I Further discussion on these topics is provided in " Sources, Effects and Risks of Ionizing Radiation," United Nations Scientific Cosmittee on the
-Effects of Atomic Radiation (UNSCEAR), 1988 Report to the General Assembly with Annexes.
2 Natural background radiation can vary with time and a person's location.
In Washington, D.C., natural background radiation (excluding. radon) results-in individual doses of about 90 mrem per year (0.9 mSv/ year), while in Denver, Colorado, the value is about 160 mrem per year (1.6 mSv/yr), including, in both
. cases, a contribution of about 40 mrem per year (0.4 mSv/ year) from naturally occurring radioactive material contained in the human body (NCRP Report No. 93,
" Ionizing Radiation Exposure of the Population of the United States").
3 The health effects clearly attributable to radiation have occurred principally among early radiation workers, survivors of the atomic bomb explosions at Hiroshima and Nagasaki, individuals exposed for medical purposes, and laboratory l
animals. Natural' background causes a dose over a one-year period that is at least two orders of magnitude less than the dose received by human populations i
from which the cancer risks are derived. However, there are indications of cancer risk at lower doses-from experiments at the cellular level.
l 29 l:
s[.
4.
a
~ W 5t* _
,~
I energy transfer radiation) of about 100 mrads/ year (1 mGy/ year) are detrimental to. man." The Comission understands that the Comittee's statement is a l' '
. reflection'of the uncertainties involved and does not imply either the absence or presence of detrimental effects at this dose level, In addition, the Commission is aware that the United Nations Scientific Comittee on the Effects of Atomic Radiation (UNSCEAR), in their 1988 Report to the General Assembly, has stated that "...there was a need for a reduction factor to modify the risks (derived at high doses and dose rates,)...for low-doses and I
dosie rates...an appropriate range (for this factor) to be applied to total risk for low dose and dose rate should be between 2 and 10."
(Thisfactorwould-lead 5 and 3.5x10'# per rad (7x10-3 and to e risk coefficient value between-7x1 3.5x10'2 per Gy) based on an UNSCEAR. risk coefficient of 7.1x10~4 per rad (7.1% per gray) for:1 gray (100 rad). organ absorbed doses at high dose rates).
The report also stated, "The product of the risk coefficient appropriate 'for individual risk and the relevant collective dose will give the expected number of cancer deaths in the exposed population, provided that the collective dose isatleastoftheorderof100 man-Sv(10,000 person-res).
If the collective dose is only a few person-Sv (100 person-rem), the most likely r
outcotae is zero deaths."
In view of this type of information, the NRC, the Environmental Protection
' Agency, and other national and international radiation protection authorities have established radiation protection standards defining reconnended dose limits 30 w
n
~.-w
[
jg,{
]p for radiation workers and individual members of the public. As a matter of
' *
- regulatory prudence, all these bodies have derived the value presumed to apply at lower dose and dose rates associated with the radiation protection standards by extrapolation from values derived at higher doses and oose rates. The a
extrapolation is frequently referred to as the no-threshold hypothesis, in which the risk factor at low doses reflects the slope of the dose-effect relationship.
+
The Commission, in the development of an exemption policy, is'again faced with the issue of how to characterize the individual and population risks associated with low doses and dose rates. Although the uncertainties are large.
-useful perspective on the bounding risk associated with very low levels of radiation can be provided by continued use of the no-threshold hypothesis.
Consequently, such risk estimates have been a factor in establishing individual and collective dose criteria associated with this policy. The estimations of
.b the low risk from potentially exempted practices can be compared to the relatively I
nigher potential risks associated with other activities or decisions over which the NRC has regulatory responsibility. Through such comparisons, the Comission can ensure that its radiation protection resources and those of its licensees are expended in an optimal manner to accomplish its public health and.
L safety mission.
In this' context, the risk to an individual as calculatad using the no-threshold model is shown in Table 1 for various defined levels of annual l
individual dose. The values in the hypothesized lifetime risk column are based l
l:
on the further assumption that the annual dose is continuously received during L
1 31
,['
j
- y..
each year of a 70-year lifetime. To provide further perspective, a radiation
- dose of 10 arem per year (0.1 mSv per year) recafved continuously over a Iffetime
~
corresponds to a hypothesized increase of about 0.255 in an individual's lifetime
. risk of cancer death., Ten millirem per year-(0.1 mSv per year);is also a dose
~
rate that is a small fractiot, of naturally. occurring background raciation end not much larger than the temporal variations in natural background radiation due
'l to fluctuations that occur at any specific location.
e Table 1 t-Hypothesized Hypothesized Incremental Incremental Lifetime Risk From
. Annual Dose
- Annual-Risk **
Continuing Annual Dose **
l' 100 mrem (1 mSv) 5 x 10-5 3.5 x 10-3 10 mrem (0.1 mSv) 5 x 10-6
'3.5 x 10'4 I-1 mrem (0.01 mSv) 5 x 10 8 3.5 x 10-5 7
0.1 mrem (0.001 mSv) 5 x 10 3.5 x 10-6
- The expression of dose refers to the Total Effective Dose Equivalent. This term is the sum of the deep dose equivalent for sources external to the body and the conunitted effective dose equivalent for sources internal to the body.
- Risk coefficient of 5 x 10~4 perrem(5x10-2 perSv)forlowlinearenergy
. transfer radiation has been based on results reported in UNSCEAR-1988 (Footnote 1). Also,refertoNUREG/CR-4214(Rev.1).
~
{
L p
l 32 y
l
4
+4 c
u l/
b, 2..
~
B.
Collective or Population Risk.
In the application of the fundamental principles of radiation protection, committed collective dose provides a useful way to express the radiological impact (i.e., potential detriments) of a nuclear activity on the health of the population subject to radiation exposure. Committed collective dose is the sum of the individual total effective dose equivalents resulting from a practice or source of radiation exposure.
It is used in comparative cost-benefit and other quantitative analysis techniques and therefore an important factor to consider in balancing benefits and societal detriments in applying the ALARA principle.
For purposes of this policy, individual total effective dose equivalents less than 0.1 mrem per year (1 mSv per year) do not need to be considered in the estimation of collective doses. The Commission believes consideration of such doses provides a false sense of their significance and
'h certainty. The NRC has used. collective ' dose, including rationales for its truncation, in a number of rulemaking decisions and decisions involving resolution of a variety of generic safety issues.
III. Derivation of Measurable Quantities From Dose / Risk Estimates The Commission recognizes that it is frequently not possible to measure risk to individuals or populations directly and, in most situations, it is impractical to measure annual doses to individuals at the low levels potentially associated with its exemption decisions. Typically, radionuclide concentrations or radiation levels from the material to be released from regulatory control are the actual measurements that can be made, and doses are' then estimated by 33
~~.
+
~,
,s....
s.
.. w ~
,g
. --. y.
' kk.
(exposure pathway analysis using assumptions related to the ways in which people might become exposed. These assumptions incorporate sufficient conservatism in e
modeling to account for uncertainties so that any actual dose would be expected -
u to be lower than the calculated dose. The Consiission believes that this is the approprf, ate approach to be.taken when determining if an exemption from some or all regulatory controls is warranted.
I Dated at Rockville, Maryland, this day of
,1989.
For the Nuclear Regulatory Commission.
.O Samuel J. Chilk Secretary of the Commission.
t L
e I
O I
34 1
+
a 6
9
'k g'g
},'h 44'
/&[,
wo
(
= I _g se 4
e 7
l'
' ?
- 4 '
I
^!
2 4
t k
f i
k l
L 4
9 ENCLOSURE 3
SUMMARY
OF POLICY STATEMENT e
9 r*.
l i-l t -
i 1
- t i
1 '
i
. j l
4
+
=
t w
r
" C, g.,,
h wi
~ &
c
" Tat L
L
SUMMARY
OF POLICY STATEMENT ON EXEMPTION FROM REGULATORY CONTROL j
The Nuclear Regulatory Consnission (NRC) issued a policy statement (FRN
)
which establishes the bases for future agency regulations and licensing decisions which would exempt small quantities of radioactivity from regulatory control.
The concept of exemptions is not new. The NRC's current regulations and the licenses it has issued already include a number of such exemptions. Examples of these past decisions, which we're made over a nus6er of years on a case-by-case basis, include release of consumer products such as smoke detectors, waste and effluents from medical use of radioactive material at hospitals and effluents from nuclear power plants.
In its new policy, as in its past actions, the primary goal of the Commission is to fulfill its mandate under the Atomic Energy Act to protect the health and
' [.-
safety of the public and the environment. However, like many of the activities society engages in, the use of radiation or radioactive material cannot be undertaken without some small risks. Thus, the Commission has traditionally required that the radiation dose to individuals and to' society be reduced to levels that are as low as reasonably achievable (ALARA).
In general, as the level of this residual risk beccmes small, the resources necessary to further incrementally -
reduce the risks become larger, and the expenditure of such resources reaches a point where the cost of such efforts are far outweighed by the small benefits that result. Taken to the extreme, such measures could preclude or impose unwarranted expense on the use of radioisotopes, medical or industrial applications, or the production of nuclear power. The Commission believes that this would be unwise.and unnecessary in view of the net benefits to be achieved by society and that its radiation protection resources and those of its licensees would be better directed to other activities which would promote the health and safety of the public.
1
- c y,
4
' 9E%
The Cosmission has issued its new policy statement to inform the public of the j
Commission's judgment regarding the level of residual' risk from licensed
~
j
.w activities where further efforts to control or reduce exposures to radioactivity i
are unwarranted. The Comission has selected its criteria on the basis that the attendant individual and collective societal risks are sufficiently small, both in the absolute sense and in comparison to other risks which people encounter in their everyday lives. The Cosmission believes that use of resources for the 1
L further reduction of risks is unwarranted if the annual risks of cancer fatality to indiviouals are below 1 in 200 thousand. This individual risk level is less l
th'an one-half of 1 percent of the real risk from cancer fatality from all other causes of cancer, and corresponds to a radiation dose of 10 millirem per year, 1
or approximately one-tenth of the natural radiation background from cosmic rays and naturally occurring radioactive material in the earth, excluding radon.
People encounter radiation doses and associated risks of similar magnitude when taking cross-country airplane flights or when they choose to live in brick l
rather than frame houses.
The Comission recognizes that some situations could develop where an individual
_could receive e dose from several different exempted activities. As an added conservative measure, activities (such as consumer products) that are likely to expose large numbers of people will be subject to a lower individual risk criterion of 1 in 2 million. This risk level corresponds to an annual dose of 1 millirem per year. The Comission has also established a criterion for the collective dose (the sum of all of the individual-doses) from an activity at 1000 person-rems per year (equivalent to 100,000 incividuals receiving 10 millirem)..The magnitude of this collective criterion has been chosen so that a (hypothetical) cancer fatality would not be expected on an annual basis from the exempted practice.
In estimating the col.lective dose from an exempted
. activity, calculated individual doses of less than 0.1 millirem per year need not be considered. For these reasons, the Commission believes that activities having such small risks and doses can be considered as candidates for exemption from the usual requirements contained in regulations-and licenses, and that national resources can be better directed and more sensibly used in other risk reduction efforts.
l 2
y,,.
~
~f'
(....
s
- o The policy statement is not a regulation and does not constitute a decision on
-any specific exemption from regulatory contro.
It is, instead, 4 general l
guideline for such actions. Before any changes to NRC regulations are made or before any generic regulatory guidance is issued, there will be announcements
. in the Federal Register which will clearly explain the details and particular circumstances associated with the proposed exemption. The public will have an opportunity to connent on these proposals, and these cossents will be considered before final decisions are made.
Based on information currently available to the Cosmission, exemption decisions within the next few years are most likely to involve disposal of very low level radioactive waste from medical and research institutions and nuclear power plants and the release of residua 11y contaminated f acilities and materials for unrestricted public use. Other applications of the new policy may evolve from petitions for rulemaking or license applications, but these cannot be reliably predicted at this time.
lb p
\\
o
^
l L
l 3
-