ML20245D538

Responds to Re Public Health Risks Associated W/ Exemption from Regulation of Radwaste of Low Concentrations to Be Below Regulatory Concern Per Low-Level Radwaste Policy Amend Act of 1985

ML20245D538
Person / Time
Issue date:	04/06/1989
From:	Zech L NRC COMMISSION (OCM)
To:	Hochbrueckner HOUSE OF REP.
References
NUDOCS 8905010037
Download: ML20245D538 (10)

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April 6, 1989 CHAIRMAN The Honorable George J. Hochbrueckner United States House of Representatives Washington, D.C.

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Dear Congressman Hochbrueckner:

I am responding to your letter of February 10, 1989, in which you expressed concern regarding the public health risks associated with the exemption from regulation of radioactive wastes of sufficiently low concentrations to be below regulatory concern (BRC) as authorized under the Low-Level Radioactive Waste Policy Amendments Act of 1985 (P.L.99-240).

The Commission recognizes that there are complex technical issues related to public health and safety, including those that you have raised, that must be resolved before final action is taken to implement the provisions of P.L.99-240 with respect to BRC waste disposal.

Accordingly, our approach to.the development of agency policy and procedures on this important matter has been designed to encourage and provide ample opportunity for the public to participate in the process.

To date, the Commission has not published any proposed regulations concerning the disposal of low-It:yel waste under the BRC provi-sions of P.L.99-240.

In 1986, in compliance with the Act, the Commission adopted a final policy that established the standards and procedures that will permit us to act on any BRC rulemaking petitions that we might receive.

On December 2, 1986, we pub-lished an Advance Notice of Proposed Rulemaking that solicited public comment on the issue of BRC waste disposal.

More recently, the Nuclear Regulatory Commission (NRC) staff has been in the process of developing a policy that would establish the principles and criteria that would govern all Commission decisions related to the exemption of radioactive materials from regulatory control.

As a key step in this initiative, the Commission issued for public comment the enclosed Advance Notice on December 12, 1988.

Thus far, we have received almost 200 comment letters on this notice.

With respect to the specific issues you raised, the cumulative risk from a combination of waste disposal practices that indivi-dually would not pose a significant risk to public health was one of the issues addressed in this Advance Notice.

As stated in the enclosure (page 49889 of the Federal Register, Volume 53, No. 238, December 12, 1988), "The Commission believes that a key considera-tior in establishing a policy for exemptions, and subsequently in 8905020037 e9o406 f [b#

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. specific rulemaking or licensing decisions, is the question of whether individuals may experience radiation exposure approaching 4

the limiting values through the cumulative effects of more than one practice, even though the exposures from each practice are only small fractions of the limit.

The Commission specifically seeks comment on the issue."

The Advance Notice also contains the Commission's position re,crding the possibility of noncompliance with exemption regula-tions (p. 49890 of the enclosed Federal Register Notice).

It provides for suitable monitoring and verification to ensure that the basic considerations under which an exemption is granted remain valid.

I want to assure you that public comments on these and other issues associated with BRC waste disposal will be carefully con-sidered by the Commission.

In that connection, I have forwarded your letter to the appropriate NRC staff so that your views may be further considered in the development of Commission policy on this matter.

Sincerely, r

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Lando W. Ze c h, J r. [J

Enclosure:

Federal Register Advance Notice cc:

William Reilly, EPA Administrator l

49886 Federal Register / Vol. 53. No. 238 / Monday. December 12, 1988 / Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Ch.1 Polley Statement on Exemptions From Regulatory Control AGENCY: Nuclear Regulatory Commission.

ACTIONS: Advance notica of proposed statement and meeting.

SUMMARY

The NRC is in the process of developing a broad policy on exemptions from regulatory control for practices whose health and safety impacts could be considered below regulatory concern.This policy statement would provide for more eflicient and consistent regulatory actions in connection with exemptions from various specific Commission requirements.The Commission. in formulating this Advance Notice.is seeking public input on some specific

Federal Register / Vol. 53, No. 238 / Monday, December 12,1988/ Proposed Rules 49887 questions which are key considerations country's border. It la hoped that Commission may initiate the in developing such a policy.The NRC exchanges ofideas and information development of appropriate regulations staff will conduct a meeting to inform such as occurred at the intemational or make licensing decisions to exempt the public of its intentions, specifically workshop will, besides providing one from regulatory control persons who to clarify and answer questions avenue ofinput to the Commission's receive, possess, use, transfer own, or concerning the advance notice, and to actions, lead toward a greater degree of acquire certain radioactive material.

hear preliminary views conceming a consistency in such exemptions world-This policy is directed principally policy for exemptions with emphasis on wide. At the international workshop, the toward rulemaking activities but may j

the specific questions raised by the

" Advance Notice of the Development of be applied to license amendments or 1

Commission.

a Commission Policy on Exemptions license applications involving the

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DATES: Meeting to be held on January from Regulatory Control for Practices release of licensed radioactive material 12,1989. Written comments should be Whose Public Health and Safety either to the environment or to persons submitted by January 30,1989.

Impacts are ""~ D*gulatory Concem". who would be exempt from Commission Comments received after this date will presented in this notice, was made be considered if it is practical to do so, available for discussion. The transcript regulations. It is important to emphasize that this polciy does not assert an I

but assurance of consideration can only of the intemational workshop which absence or threshcid of risk but rather be given as to comments received on or includes all the papers presented at the establishes a baseline where further before this date, meeting may be examined and copied AOOnesses: Meeting will be held at the for a fee at the NRC Public Document government regulations to reduce risks is unwananted.

Holiday Inn. 8120 Wisconsin Avenue, Room at 2120 L Strert NW Bethesda, MD 20814 (4 blocks north of Washington. DC.

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the Bethesda Metro Station). Telephone: Advance Notice of the Developcaent of a 1970, the Commission promulgated (301) 652-2000,1-800-465-4329. Mail Commission Policy tables of exempt quanuties and N ear Re la o

i Introduction andPurpose concentrations for radioactive material Washington,DC,20555. Attention:

Over the last several years, the e

t n es e d reci ve possess' Docketing and Service Branch.

Commission has become increasingly use, transfer, own, or acquire without a Comments may be delivered to 11555 aware of the need to provide a general Rockville Pike. Rockville, MD between policy on the appropriate entens for requirement for a license (25 FR 7875:

7:30 a.m. and 4:15 p.m. weekdays.

nicase of radioacuve materials from August 17,1960 and 35 FR 6426: April 22, Copies of the comments received may regulatory control.To address this need, 1970). Other exemptions a11owing be examined and copied for a fee at the the Commission is expanding upon its n

n c m e er ucts or NRC Public Document Room at 2120 L existing policy for protection of the ther devices to the general public, or Street, NW., Washington, DC.

public from radiation. curnntly all wing releases of radioactive FOR PURTHER INFORMATION CONTACT:

expressed in existing regulations (Title g

C mm s on s Catherine R. Mattsen. telephone (301)

Ith Code of Federal Regulations) and 492-3638, or William R. Labs, telephone policy statements (30 FR 3462, Use of nguladons for some MmeMore (301) 492-3774 Office of Nuclear Byproduct Material and Source ncendy,de L w el Radioacu,ve Regulatory R esearch. U.S. Nuclear Material, dated March lo,1965: 47 FR Waste Policy Amendments Act of1985 Regulatory Commission. Washington, 57446, Licensing Requirements for Land directed the Ccmmission to develop stand s dp d" '

DC,20555.

Disposal of Radioactive Waste, dated suret.rusNTARY INFORMATION:

December 27.1982: and 51 FR 30839, xpe u band g of pe tons to exempt from regulation the disposal of International Workshop proced es ne rni P ne slightly contaminated radioactive waste material that the Commission In addition to conducting this public Pursuant to i 2.802 for Disposal of meeting, the Commission has sought Radioactive Waste Streams Below determined to be below regulatory input from the international regulatory Regulatory Concern, dated August 29, concern.* Die Commission responded to community through an international 1986).The expansion includes the this legislation by issuing a policy 8 eme o August 291 51 y3gI-workshop on exemptions from development of an explicit policy on the i

regulatory control which was held exemption from regulatory control of October 17-19,1988 in Washington, DC.

practices whose public health and which,if satisfactorily addressed in a The importance of such interaction safety impacts are below regulatory petition for rulemaking, wo,uld allow the stems from the fact that many existing concern. A practice is defined in this Commission to act expedibously in cnd potential exemptions involve policy as an activity or a set or proposing appropriate regula tory relief radioactive materials purposefully used combination of a number of similar sets on a " practice. specific basis consistent in consumer products or introduced into ' of coordinated and continuing activities with the merits of the petition.

various products or materials through aimed at a given purpose which involve The Commission believes that these the recycling of contaminated scrap, the potential for radiation exposure,

" practice. specific" exemptions should either of which may enter international Under this policy, the definition of be encompassed within a broader NRC trade. Even effluents and waste disposal " practice"is a critical feature which will policy which defines levels of radiation can involve exposures to people in assure that the formulation of risk below which specified practices countries other than those from which exemptions from regulatory control will would not require NRC regulation based the effluent or waste originated.This not allow deliber d-*n of meterial on public health and safety interests.

e aspect is a significant issue in the or fractionation of a practice for the For such exemption practices, the European community.Thus, some purpose of circumventing controls that Commission's regulatory involvement degree of consistency internationally is would otherwise be applicable, could therefore be essentially limited to desirable, since exemption decisions The purpose of this policy statement licensing inspection, and compliance can affect populations outside each is to e tablish the ba is s upon which the activities associated with the transfer of s

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4988g Federal Register / Vol 53. No. 238 / Monday. Decetaber 12. 1968 / Proposed Roles the radioative material from a contrdled intemationalcommunity.h values Alternative hypotheses have been undu ennua tion in this policy proposed and reevaluations of the data ra to an exempt status.

The Commission recognizes that,if a Statament do not cacessarily agree with bese at higher doses continne. W national poficy on exemptions from those selected or under cocaideration by Commission believes that use of the regulatory contro!is to be ettective, other countnes.m Commission has lineas non-thresheld bypothesis allows Agreement States will pay an important carefuny reviewed thoea alternate the thearAral establishment of upper implementation role. In the past. Stater cnteria. and does not find significant liraits on b nurnber of beatih effects have been encouraging findings that scientdic evideece that would dictate that adght xcur at very low dosee certain wastes are below regulatory prefarmti.at selection of any of those which are the subject of the exemption l

concerrr and the Commission believes views over what is proposed in the

policy, that States will strpport an expansion of policy stat-mL

& risk of M to anindividad,as calculated using the linear modelis these views to all practices involving M

Pdodples showninTable 1 forvarious defined exen pt distribution or release of The Commission recognizes that three levels ciindividual dose. A radiation radioactiveinsterial.The Commission intends that rolemakings codifying fundamental principles of radiation exposure d to mrera per yeas (al mSv regulatory control exemptions will be protection have histoncally guided the per year)for a lifetime corresponds made a matter of compatibihty for formulation of a system of dose theoretically to an increase of a1% of Agreernent States. Consequently, any limitation to protect workers and the the individsal's annual risk d cances rulemakings that evolve from this pohey public from the potentially harmful death.h lifetime risk is based upaa will be coordinated with the States.

effects of radiation.hy are:(1) th further assumption ht tk exposure Advisory and scientdic bodies have Justification of the practice, which levelis the same for each year of a70 offered div erse views to the Commission regeres that there be some oct benefit y,,, ggia, in anticipation of this Policy Statement.

resulting from the use of radiatzon ce in estimating the dose ratesto There is not clear consensue based on radioactive materials.(2) dose limits, members of the public that might axisa existing scientific evidence or research which define the upper boundary of through the use of vanous practices for regarding the selection of numerical adequate protection for a rnember of the which exemptions are being considered.

criteria for use in this Policy Statement public whrch should not be exceeded in the Comndssi n bas decid, ed to app 1y Further, the Commission is aware that the conduct of nuclear retivities, and (3) there are ddfering views within the NRC ALARA. which reqmres that radation t."

c ep luch is staff on the selection of numerical dose be as low as is reasonably bh parism M h delayed achievable. economic and social factors mortality effects of Lordzing radiation criterial for BRC.

in the absence of a scientific bems taken anto account.The term.

consensus. It is the Commission's task to ALARA.is an acronym for As law As is

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j, assess the diversity of views in Reasonably Achievable.N Ma d u @ al d W establishing a responsible BRC policy.

Commissionla interestedin assessing body exposures. Thia appreach waa The authonty and responsibility to make how these pnncrples abouO be applied nriginaDy developed by the the final selection of critena rests with in establishing appropriate criteria for Co a on the Commission. Criteria selected must release of radioactive materials in>m 8

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(1) Provide reasonable assurance that regnfatory control.

expressed in its Publication 26 issued in Because of the abeence of observed 1m. Since that time. the concept has public health and safety will be health effects below $ rem / year (50 been reviewed and evaluated by protected. and (2) consistent with such assurance, permit practices in the public mSv/ year), scientific experts including radiation protection organizations domain which involve the use of the International Commission on throughout the world and has gamed radioisotopes for which society Radiological Protection (ICRp) and the wide acceptance.

National Council on Radiation perceives a demand.

It is recognized that thereis a delicate Protection and Measurement (NCRP)

TAntd 8 botance here. Criterie can be set make the assumption that the frequency sufficiently restrictive such that there is of occurrence of health effects per unit L8a"* a'"

absolute assurance that health and does at low dose lavels is the same as at safety will always be pMeeted.no high doses (10 RAD (al Cy)) where cM

'.Emind en=ad use matter what events might transpire.

health effects have been observed and However, in doing so, the regulator may studied in humans and animals.This 100 wom '

ama m o-'

then place undue and unnecessary linear non-threshold hypothesis assumes restnctions on practices which should that the risk o! radiation induced effects l

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be permitted because of otherwise (principally cancer)islinearly 0.1 sue ano-*

me reasonable social, economic,or proportiorial to dose, no matter bow

' ask coemem os 2no" per== (2no-' per industital considerations.There is small the dose might be. The coefficient always the danger of over-regulation used in the model as a basis for 8QQ,"fc"l'c*y.'fd'$,s..

which results in effects that are felt in estimating statistical health risk is on nnomouse ce gom canew wom areas where the NRC does not have the order of 1x10-* risk of fatal cances gsg gy m

ena authority and responsibility.Moreover, per person-rem of radiation does m.m m mse : e one ne a uness omerese coana m opremon or the Atomic Energy Act does not require (1x10-8 per SV).h Comraission f,"L"E" "U [$*.j'M",M U $

absolute assurances of safety in the use recognizes that it la a conservative oo of radioactive material and licensed model based upon data collected at eomam ser nowces enwnei to m booy ano rw

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relatively high doses and dose rates facilities.

l "Ite moerica! cnteria ultimately which is then extrapolated to the lew l

selected will have significantimpact on dose and dose rate region whera there The Commission recognizes thatit is nuclear regulation bere in the United are no statistically reliable impossible to measure nsk to States and potentially in the epidemiological data available.

individuals or populations directly, and.

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Fedtr:1 R gistzr / Vol. 53, No. 238 / Monday, D cember 12, 1988 / Proposed Rules 49889 th2t in most situations, it is impraedeal licensee's control (natural background

1. The application or continuation of to measure annual doses to individuals and medical exposures are neluded).

regulatory controls on the practice does at the low levels implied by exemption Because of the small risks involved, a to not result in any significant reduction in d reisions. Typically, radioisotope mrem (0.1 mSv) individual dose criterion the dose received by individuals within concentrations or radiation levels from is proposed as the basis for exemption the critical group and by the exposed the material to be exempted are the decisions based on simple analysis and population or:

ectual measurements that can be made, judgements. The Commission 2.The costs of the regulatory controls end doses are then estimated by specifically seeks comment on the need that could be imposed for dose exposure pathway analysis combined for establishing a collective dose limit in reduction are not balanced by the with other types of assumptions related addition to an individual dose criterion.

commensurate reduction in sisk that to the ways m which people might If such a collective dose criterion is could be realized.

become exposed. Under such conditions, needed. what is the basis for this need?

c:nservative assumptions are frequently If the Commission decides that a For purposes ofimplementing its usId in modeling so that the actual dose, collective dose criterion is needed, what policy, the Commission recognizes that only under unusual circumstances is on the low aide of the calculated dose. approaches allowing tmncation of would practices which cause radiation The Commission believes that this is the individual dose in calculation of exposures approaching the 100 mrem per appropriate approach to be taken when collective dose or weighting factors for year (i mSv per year)lunit be determining if an exemption from components of collective dose would be considered as candidates for exemption.

regulatory controls is warranted.

appropriate? What altematives should The Commission will consider such Collective dose is the sum of the be considered for assessing societal individual doses resulting from a impact?

circumstances on a case specific basis using the general principles outlined in practice or source of radiation exposure.

• ALARA-The ALARA principle this policy statement. However, as the By assigning collective dose a monetary generally applies to determining dose doses and attendant risks to members of value. it can be used in cost benefit and levels below which exemptions may be the exposed population decrease, the oth5r quantitative analysis techniques. It granted on a cost benefit basis.

is a factor w consider in balancing However,it is the purpose of this policy need for regulatory controls decreases benents and societalimpact.

to establish criteria which would, in and the analysis needed to support a Considemtions in Cmnting Exemptions effect, delineate achievement of ALARA proposal for exemption can reasonably be somewhat simplified.

Emm Regulofory Contml ghi ls possfble o easonably The Commission is evaluating the use th The following elements are being project what the dose will be from a

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" d fining the considered by the Commission as a practice, and then take this information be basis Ibr evaluating practices which are into account in controlling regulated schieved. They are:(s) A criterion for proposed to be exempt from regulatory practices so that the dose limits are not the maximum individual annual dose control.These practices.if approved.

exceeded, exemptions imply some reasonably expected to be received as a w:uld result in products containing low degree ofloss of control.The muit of the pradce and N a measum levels of radioactive material being Commission believes that a key of a cietalimpact to the exposed distributed to the general public and consideration in establishing a policy for po t.fo a giv!n radioactive effluents and solid waste exemptions, and subsequently in dere ssure t being released to aress of the publicly-specific rulemaking or licensing exempted practice. no individual will be c:ccessible environment.

decisions,is the question of whether exposed to a significant risk and that the

• Justification-The Commission individuals may experience radiation population as a whole does not suffer a sIeks comment on the extent to which osure approaching the limiting signWcant impact.

exposures resulting from any practice exfues through the cumulative effects ofIf the individual doses from a practice va should be justified. As lower levels of more than one practice, even though the under consideration for exemption are rad;ation exposure are projected, should exposures from each practice are only sufficiently small, the attendant risks lower levels of benefit be required for smallfractions of thelimit.The willbe small compared with other practice justification? In establishing its Commission specifically seeks comment societal risks. The Commission believes exemption policy, should the on the issue. By appropriate choices of that annual individial fatality risks -

Commission exclude certain practices exemption criteria and through its below approximately 10-'(one in for which there appears to be no evaluations of specific exemption 100.000) are oflittle concem to most reasonable justification? In considering proposals in implementing the policy, members of society. Providing for some proposals for exemptions, should the the Commission intends to assure that it margin below this level, the Commission Commission evaluate the social is unlikely that any individual will Proposes 10 mrem (0.1 mSv) as the level l

acceptability of practices? Should the experience exposures which exceed the of annualindividual exposure. The Commission determine a praeice to be 100 mrem per year (1 mSv per year) incremental annual individual cancer unjustified if nonradioactive economical limit.

fatality nsk associated with an exposure alternatives exist?

level of 10 mrem per year (0.1 mSv per

• Dose 1.iroits and Criterion -

Pn.nciples ofExemptw.n year)is about 2x10-'(two in one Individual doses from practices A malor consideration in exempting million) as indicated in Table 1 and of exempted under this policy should not any practice from regulatory control the order of 0.1 percent (one in one be allowed to exceed 100 mrem per year hinges on the general question of thousand) of the overall risk of cancer (1 mSv per year). This is the dose limit whether or not application or

death, for members of the public specified in continuation of regulatory controls are In evaluating the need for a collective the final revision of to Cm Part 20.

necessary and cost effective in reducing dose criterion, the Commission Standards for Protection Against dose. To determine if exemption is recognizes that this criterion could be Radiation.The dose limits in the final appropriate, the Commission must the limiting consideration for practices revision of 10 CR Part 20 apply to all determine if one of the following involving very smallindividual doses to sources of radiation exposure under a conditions is met:

very large numbers of people. it is also

49890 E';derd Register / Vol 53. No. ma / Monday. December 12. 1988 / Proposed Rules recognized that in such cases the from apphcable licensing requirements.

that ALARA coraiderations have been coIIective dose criterion would,in effect. Approvalof a proposed consumer dealt with.This approach is consistent apply the ALAPA concept to Individual product dependa upon an assessment of with past practice, e g., consumez doses less than the below regulatory exposures of pessons to radiation as product rules in to CFR Part 30s concern level of 10 mrem per year to the well as an evaluation of the usefulnesa in evaluating proposals im exempt on individual. Conversely where the of the product.

undes this pobcy, the projected collective dose criterion would not be Certain practices involving radiation exposures to diflerent components of limiting,it would serve no purpose. %e or radioactive materials have been the exposed populanon will be Commission requests commerrts on this judged by NRC to be socia!Iy canodered with regard to the potential issue,ineleding comments on what the unacceptable regardless of how trivial that some individuals may receive doses magnitude of the collective dose the resulting dose might be and.

neae the 100 mrm per year O mSv per-criterion. if anr. should be.

therefore.have been mtW from year) limit when doses from other if the dose is less than the bekrw exemption. Excluded practices include.

prahs are also tahn m. to regulatory concern enterie, then the risk but are notlimited ta.the intentional conh8tm U exposures from from a practice would be considered to introduction of radioactive material into multiple practices can occur which are be ALARA without further analysis.He toys and products intended fos significantly beyond the individoal dose Commission stresses that adoption of ingestian. Inhalation or direct the enteria should not be construed es e application to the skin (such as enterion 00 mrem per year (0.1 mSv per yearn the exemption will not be granted decision that smaller doses are cosmetical.

necessary before a practice can be in addition to sociaIIy unacceptahIe without further analysis. As experience exempted, while doses above the uses of radioactive raaterials, a question is gained.this policy and its criteria wonld preclude exetnptions. On also arises regarding uses where there implementation will be reevaluated with the contrary, the critena simply are clear economical alternatives, and regard to this issue to assure that the represent a range of risk which the no unique beneSts exist from using exposures to the public remain well Commissionbebeves is sufficiently radioactive rnaterialWhere riska are below 100 mrtu. per year (1 mSv per 1

small compared to other individual and trivial, the reguIntory prohibition of such year).

societai nska that a cost benefit analysis uses could pose an unnecessary in addition to considerations of is not required in order to make a regulatory burden by irderfering with the expected activities and pathways, the decision regarding the acceptahihty of conduct of businesa.

Commission recognizes that an exemption. Practices not meeting he Commission seeks commmfs on consideration must also be given to the these entena may be granted whether practices should be potential for accidents and misuse of the exemptions on a case-by. case bas,s m, categoncally excluded based on the radioactive materials involved in the c

cecordance with the pnnciples Commission's Judgement regarding practice. A proposal for exemption of a embodied within this policy.To further social acceptability or the existance of defined practice must therefore also emphasize the Commission's recognition alternatives. An alternative to that a rigid limitation on collective dose categorical exclusica could be a case address the potentials for accidents or would be inappropriate,it notes that foe specific determination based on a safety misuse, and the consequences of these some practices, such as use of srnoke analysis.

exceptionalconditions in terms of individuals and collective dose.

detectors, appreciable benefits can only be attained through extensive utilization ProposolsforExemptiarr and, hence, with a commensurate A proposal for exemption mmt The Commission believes that the collective dose.

em provide a basis upon which the q3,

Commission can determine if the basic implementation of an exemption under The Commission is aware that existing regulatic.is of the conditions described above have been this broad policy guidance must be EnvironmentalProtection Agency satisfied.In general, this means that the accompanied by a suitable program to catablish criteria more restnctive than proposal should address the individual monitor and verify that the basic exemptions whic,h could otherwise be

' dose and societal impact resulting from considerations under which an granted under this proposed pohey.

the expected activities under the exemption was issued remain valid. In With regard to its own regulations, the exemption, including the use of the most cases the products oc materials Commission will evaluate whether there radioactive materials, the pathways of comprising an exempted practice will cre exemption criteria ernbodied therein exposure. the levels of activity, and the move from regulatory control to the for which modification according to the methods and constraints for assuring exempt status under a defined set of nntiples of this policy.would be that the assumptions coed to define a conditions and criteria.The monitoring eneficial practice remain appropriate as the and verification program must therefore radioactive materials move from be capable of provichng the Commission Exclusions from Exemptions regulatory control to an exempt status.

with the appropriate assurance that the The Commission's March M1965, If a proposal for exemption results in conditions for the exemption remain notice on the Use of Byproduct Material a rule contammg genene requirements, a valid and that they are being observed.

and Source Material Products Intended person applyicg to utilize the exemption The Commission will deteraune for use by General Public(Consumee would not need to address justification compliance with the specific conditions Products)(30 FR 342) provides the or ALARA. The Commission decision on of an exemption through its established j

basis for the Commission's approval af such proposals will be based on the licensing and inspection program and the use of these rnaterials in consumer licensee's meeting the conditions will, frorn time to time, conduct studies

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products without regulatory control on specified in the rule.The promulgation the consumer-user.This is accompbsbed of the rule would, under these as appropriate to assess the impact of g

by case-by. case exemptm of the circumstances, constitute a fmding that an exempted practice or combinations i

possession and use of approved items, the exempted practice is justified, and of exempted practices.

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7-Federal Register / Vol. 53. No. 238 / Monday, December 12, 1988 / Proposed Rules 49891 Tintotive Meethrg Agendo prsence to a fracten of the emell

1. Introduction and Summary-NRC Staff 2 A thoug mo exempted sources 11 Discussion of SpecMc Questions-Brief NRC Staff summary and presentations or would be expected to involve indmd.

mal doses whach are a emell fracnon rivestions from scheduled participants.

of the overall limit, should flexibility A. Application of principle of justification be maintained by considering exemp-including the questions:

tions on a cost benefit basis above 10

1. As low er levels of radiation exposures mrem /yearf are projected. should lower levels of

3. Is the evaluation of collective dose benefit be required for lushficanon of importans in considarms the multiple a practice which is a candidate for exposure tesuet exeunpuont t Whil the appbcation of lastification of 2.

la establishing eumption policy, practice help to mamtain a smaller should the Commission exclude cer, number of sources makmg it easier to sala practices for which there appears control overall exposurest to be no reasonable justification

5. How important is monitorms to main.

3. In considenng proposals for exemp.

taining assurance that individual ex-tion, should the Commission evaluate pomm do not exceed to the overall social acceptability of the practicey limit?

4. Should the Commission determine a IU. General Discussion / Question period-preence to be unjustified if non-radio-Comments or questions by scheduled par-logical economical ahernatives existr tacipanta. Open to the floor as tune per.

EL Individual dose entenon for determuung achievement of the

• as low as reason. Those enembers of the public who wish to chly achievable" (ALARA) pnnciple in participate by speakmg at the sneetmg cxemption decision makmg:

should notafy one of the contacts listed

1. la the to mrem / year criterion pro-th a posed by the Commission appropnate?

2. Is the appropriateness of this number Dated in Rockvilla Maryland. this 24 day affected by the decision regarding of Dacember 1988.

whether a collective dose entenon abould be used with the indsvidual g,5,,,, ggd'"

doee cnteriony Executive Dissctorfor Operations.

3. Should the indmdual dose critenon [TR Doc 88-24491 Taled 124 48,8.45 am) be chosen on the basis of neshgible asussa coca reso.ews eisk as is done intemationally (i.e.

1AEA Safety Series No. 80) or can a somewhat higher number be used based on a Commission policy deci-slon regardmg a level of individual risk for which expenditure of re-sources is not warranted?

4. How important is international con-sistency in choosing an individual dose enterion?

C. Use of a collective dose critarion for determining achievement of the ALARA p;inciple in exemption decision-making-

1. Is a co!!ective dose criterion needed in addition to an individual dose cnta-rion?

2. If so, what is the basis of that need?

3. If the Commission decides a collective dose entenon should be used, what should its magnitude be?

4. What altemauve to a collective dose criterion should be considered for as-aessing societalimpact?

5. In calculating collective dose. what approaches allowing truncation of in-dividual doses or the use of weighting factors for components of collective done are appropriate?

D. Approaches for assuring total expo-sures of Individuals from mutiple preo-ticas will not exceed the too snremf year limit.

1. Is the approach of generally limiting individuals doses imm each source se

PART 61 o PROPOSED RULE MAKING

.specifically id1ntifus drift QA guidInce Advance Notice of Prop;s:d of avaibbl2 technicalinformatun for the dIsign, construction, cnd Rulemaking (ANPRM)(51FR 5992) relat:d to waste ci:ssihcatnin cnd operation of those structures, systems, announcmg its intent to revise the

" intermedia te" disposal facilities, and and components as well as for site definition of the term "high-level review of relevant statutory proposes.

charactenzation activities.

ra6osetive waste"(EW) that appears the Comnussion has deternuned that it in to CFR Part 60. In the ANFRM. the would be best to proceed quite 8

Commission reviewed the previous differendy from its original suggestion da of ce r.

7 statutory and regulatory uses of the term put forth in the AhTRM.

For the Nuclear Regulatory Commsssion-

"high-levelradioactive waste." the I

n cheels. k riey.

NRC's current regulations related to AePmeessing Wastes Chief. Argulordry Bror ch. pirision of t.on waste classihcation and disposal and lere/ Waste Aronagement gnd the pertinent provisions of the Nuclear The NWPA first labels as HLW under Decommissioning, ogice o/ Nuclear Aforerial Waste Policy Act of 1982. Pub. L 97-.425.

Clusse (A), the " highly radioactive Sofetr andSofeguoMs.

42 U.S.C.10101 et seg. (NWTA). As material" resulting from the indicated in the ANPRM. the NWTA reprocessing of spent, fuel, including not includes,a specific definition of "high-only the bquid wastes but also any solid R 7709 level radioactive waste and the material derived from such liquid wasta that contains fission products "in comment expres 7/18/88.

t rul e oo eW

"" * "[

'h"r 10 CFR Part 61 In the NPRM the Commission purp ses iNWPA since the Federal Government was already responsible Disposalof Radioactive Westes fb t "f,(t,*

g r wou a p y th er ActNev: Nuclear Regulatory high-level radioar*ve waste" to Commission.

materials in amoul and passed. (The only commercially-acviow: Proposed rule.

cm.entrawns emA ume&al generated reprocessing wastes were made a Federal Government values that would be stated explicidy in suesatany:'fhe NRC is publishing th form of a table. Thus. HLW would responsibility in 1980 pursuant to the proposed amendments which require be characterized by the kind of hazard West Valley Demonstration Project Act, 6sposal of " greater than. Class-C" low.

that could only be guarded against by Pub. L 96-308,42 U.S.C. 2021e note.) In level radioactive wastes in a deep isposalin a geologic repository or light of this fact. the Commission geologic repository unless d sposal equivalent facility. Those westes that beheves that the preferable construction elsewhere has been approved by the could be disposed of safely in an of th sh is to confonn to th traditional definition. Under this Commission. The proposed amendments intermediate disposal facility would obviate the need for altenna existing contmue to be classified as low-level approach, materials that are H W for classifications of radioactive wastes as radioactive waste rather than as HL%,.

purposes of thelicensing. jurisdiction high-level or low-level.

provtsions of the Energy Reorganization Comments cate Comment period expires luly 18.

Act of 1974 (ERA) will slao be regarded 1988. Comments received after this date The Commission solicited comments as HLW under NWPA.'Dtis would will be considered if it is practical to do on several specified issues and received indude the primary reprocessing wests so. but the Commission is able to assure letters from nearly 100 public agencies, streams at DOE facilities, though not the consideration only for co nments private organizations and individuals.

incidental, wastes produced in received on or before this date.

VirtuaDy au cments on tb ANPRM reprocessmg.

agreed with the Commission on one Other Westes ApoREse: Mall written comn ents to:

Secretary. U.S. Nuclear Regulatory point: use of the term "high-level radioactive waste." at least under in the AhTRM the Commission Commission. Washington. DC 20555.

Clause (B) of the NWPA definition, propos*d to classify wastes as HL% or Attention: Docketmg and Service serves to identify those wastes which non-HLW by examining line desposal Branch.Dehver comments to:1 White require the degree ofisolation afforded espacility of hypothetical.

Flint North.11555 Rockville Pike, Rockville. Md. betwen 7:30 a.m. and 4.15 by a deep geologic repository. However.

" intermediate" disposal facilities less comments differed widely regarding the secure than a deep geologic repository.

p.m. Federal workdays, or to the NRC specific wastes perceived to require that Westes which could not be safely Pubhc Document Room at the address degree ofisolation. Some comments disposed ofin such facilities would be and times below. Copies of the advocated classification of all classified as EW regulatory. analysis and comraents radioactive wastes, other than the most Following pubhcation of the ANPRM.

received may be esamined e the NRC innocuous, es HI.W while other a technical report (Kocher. D. C. and A.

Public Document Room.1717 H Street comrnents would prefer to reclassifiy as C. Croff. A Proposed Classification NW., Washington. DC between 7:30 low.levellarge quantf ties of defense System for High.Levelcod Other s.m. and 4:15 p.m.

reprocessmg wastes long regarded as Rodsooctive Waster. ORNidTM-10:so.

FOR FURTtte.R INFORhlafloM COef7ACT:

HLW. Conspicuously absent from the Oak Ridge Nationallaboratory 1967)

W. Clark Prichard. Division of comments was any compensus regarding was pubbsed which attempted to Engineering. Office of Nuctsar the means to be used by the provide a technical basis for Regulatory Research. U.S. Nuclear Commission to distinguish HLW from classification of wastes as HLW or non-Regulatory Commission. Washington, non.HLW/For example, even the basic HLW.'this repo(t described a number of DC 20555, telephone (301) 492-3884.

concept of a numerical definition of conceptual " intermediate" disposal suces.asstwrAnysweons ATlose HLW as suggested in the ANPRM. was facilities which would use either criticized as an invitation to dilute or engmeered barriers or deeper burial to

Background

fractionate wastes solely to aher their provide a degree of waste isolation On February 27.1987, the Nuclear classificationinlight of the comments intermed ate between that of shallow Regulatory Commission pub!!shed an received, the Commisolon's own review land burial and a deep geologic S1=PM May 31,1988

PART E1 o PROPOSED RULE MAKING repository.The authors attempted an protection standards that might have exceeding the hmits estabhshed in to analysis of the waste isolation been estabbshed by the U.S.

CFR part 61 for Class C radioactive capabshty of such facihties but.

Environmental Protection Agency waste. In view of this development, the emphasizmg the site-specific nature of Technical critena to implement the Commission percenes httle practical such analyses and the very large performance obiectives and importance or sigmficance m proceedmg uncertainties mvolved. concluded that environme'ntal s tandards would be with a precise defimtion of HLW.To do "la)t the present time..leuch developed by tt e Commission after DOE so would not advance the objectives of facihties arej not sufficiently deseloped had completed its conceptual design and N%TA.

to provide a basis for definmg waste selected a site for a specihc type of classes. and disposal of any wastes facihty.

Proposed Amendments usmg (such facihties) must be The Commission considers that the In ime with the foregoing discussion, considered on a case-by case basis."

proposai presented m the notice would therefore, the Commission is proposmg Kocher and Croff then presented an obviate any need to reclassify certain two changes to its existing rules. First.

attemative approach for definmg HLW CTCC wastes as HLW. The proposal by amendmg to CF7 61.55. it would which. m essence. is based solely on the follows the alternative approach alluded henceforth require all greater-than-short-term storage and handhng naks to m the ANFRM. that the Commission Class-C waste to be disposed of in a associated with the heat and external "need not exercise NWPA Clause (B) geologic repository unless an alternative radiation levels Fenerated by a waste.

authonty m order to assure that proposalis approved by the The Commission could not accept this radioactive wastes from heensed Commission. Second. the jurisdictional attemeuve approach smce it bears no activities are disposed of properly"(52 reach of to CFR Part 61 would be correlation to the degree of waste FR 5998). Many comments on the extended to cover all activities of the isolation required followmg d sposal.

, ANpRM adocated classification of all Department of Energy that may be The Commission's review of Kocher CTCC wastes as HLW in order to subject to the hcensmg and regolatory and Croff's study leads it to the same ensure availabihty of a safe disposal authority of the Commission. This is conclusion regardmg the "home" for those wastes. but this intended to reflect the pohey of the Low-inspracticability of waste classification proposal achieves the same purpose Level Radioactive Waste Policy based on analyses of the performance of while leaving open the prospect that an Amendments Act, which provides that intermediate disposal facihties. If waoe mtermediate disposal facihty may prove all commercially-generated weste with classification is to be at all reahstic.

attractive at nome time in the future, concentrations exceedmg Class C limits additional disposal facility development (Since the possibility of using such a shall be disposed ofin a facihty bcensed must be completed which will provide a facihty is left open. the Commission is by the Commission that the Commission supportable basis for such classification.

not now determming that the wastes, determines is adequate to protect the Such disposal facility development is even if highly radioactive, do in fact pubhc health and safety.This change more properly the responsibihty of DOE

• require permanent isolation"1 would take the form o. ehminatmg the rather than NRC. Ilowever, the very accordmgly, the NWPA definition of more restnctive lanFuage regardmg the small volume (about 2.000 m8 throueh HLW does not apply). Moreover, this Deparatment of Energy that a;. pears in the year 2020) of commercially-proposal avoids the problem of trying to the defmition of the term " Person"in genera ted. greater-than-Cla ss-C (GTCCI distmguish HLW from non-HLW without i 6L2.

wastes may make an intermediate en adequate techmcal basis for doms so-msposal facihty economically And the legal and admin strative Environmentalhnpact: Coteponcol unattractive. Because no such facihty comphcations identified in the ANPRM.

g,,jy# #

now exista for disposal of commercially-as well as questions as to the retroactive The NRC has determmed that this generated wastes and because there is apphcstion of any new classification, proposed regulation is the type of action no assurane that one will ever be would be avoided or reduced. However, described in categoncal exclusion to constructed, the Commission beheves additionallegislation may be needed by CFR 51.22(c)(2).Therefore neither an that an alernative. technically DOE to provide for payment of disposal enviornmentalimpact statement nor en conservative approach should be taken costs for above Class C waste's. or to environmental assessment has been The Commission proposes to require authonze recipt of such wastes for prepared for this proposed regulation.

disposal of all CTCC wastes in a deep disposal at a repository.

geologic repository unless disposal De hrst change.pertainmg to the The Commission also observes that defirution of " person."is corrective in elsewhere has been exphcitly approved by the Commission. %is proposal the satutory framework for nuclear that it merely reflects the broader reflects the Comnussion's view that waste raatters has changed Freatly smce junsdiction of the Commission under the enactment of NWPA. When that law Low-Level Radioactive Waste Policy intermediate disposal facihties may was passed,it placed a responsibihty on Amendments Act.The modifications never be avallable,in which case a the Federal govemment to receive.

not substantial.

repository would be the only type of manage, and disposal of certam wastes facihty generally capable of providmF (HLW as well as spent nuclear fuel)in The second change, pertaining to the safe disposal for CTCC wastes. At the Feologic repositones. In that context. the disposal of greater than-Class-C same time, the Commission wishes to definition of the term"high4evel radioactive wastes in a geological avoid forec!osingpossible use of radioactive waste" assumed importance repository,is minor.The existmg intermediate disposal facilities by the because it provided a basis for regulations in to CFR Part et already reclude disposal of GTCC in a Part et Department of Energy (DOE). lf DOE differentiating between State and ficensed disposal facility without further chooses to develop one or more Tederal responsibilities.This concern review and approval This amendinent intermediate disposal facilities, the was subsequently mooted by adoption does no more thau state the Comrnission anticiples that the of the Low LevelRadioactive Weste Commission's conclusion that,in the acceptabihty of such facilities would be Pohey Amendments Act of 1985. Pub. L absence of such an approved evaluaicd in the light of the particular 99-240,42 U.S.C. 2021b et seq. This later alternative, a geologic repository is the circumstances, considenng for example statute established a Federal only currently authorized facility the existing performance objectives of Government responsibility for the acceptable for CTCC disposal without 10 CFR Part 61 and any generally disposal of commercially generated further review by the Commission. nus, applicable environment radiation wastes with radionuclides concentrations it is a minor change to specify that the May 31,1988 61 PR-8

GEDRGE J. HOCNBRUECKNER

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100s toxnwoeva n2use omca evnoso ist Di.tasci, Ngo vors e

a Wagnetston DC 20316

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(202)226-3826 AR D R CES MERCHANT MARlNE 4

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s Sg 4 IWITE III ECIENCE. SPACE. AND TECHNOLOGY 6 689 676?

Congress of tfje Eniteb 6tates

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Rwsawaac NY 19901

%0Hgt of Mtpresentatibtg

• * '252'52 iMastjington, DC 20515 Admiral Lando Zech February 10, 1989 Chairman Nuclear Regulatory Commission Washington, D.C.

20555

Dear Admiral Zech:

I have recently become aware of the proposed declassification of "Below Regulatory Concern" (BRC) low-level radioactive waste authorized under the Low-Level Waste Policy Amendment Act of 1985.

I am writing to register my concern that such action may put the public health at considerable risk.

While I am aware of the claim that individual sources of BRC waste may not pose significant risks to the public health, I am concerned about the combination of many different sources of unregulated waste creating a level of radiation that is above acceptable limits.

In addition, deregulation of any type of radioactive waste, no matter how low the level of radiation, opens up the possibility of noncompliance with guidelines, which could result in unmonitored dangers to the general public.

In your deliberation on this matter, I hope you will consider this concern.

Sincerely, i

George Hochbrueckner Member of Congress GJH:mh cc: William Reilly, EPA Administrator O6n kL n n M l b 1 r

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