ML20043B905

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Forwards Draft Commission Paper Re Exemption from Regulatory Control,For Comments & Recommendations
ML20043B905
Person / Time
Issue date: 11/30/1989
From: Cool D
NRC
To: Congel F, Cunningham R, Fonner R
NRC
Shared Package
ML20042C963 List: ... further results
References
FRN-53FR49886, REF-10CFR9.7, RTR-REGGD-01.086, RTR-REGGD-1.086, RULE-PR-CHP1 ACRS-GENERAL, NACNUCLE, SECY-89-360, NUDOCS 9006010010
Download: ML20043B905 (26)
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For:

The Commissioners -

l From:

James M. Taylor, Acting Executive Director for Operations

Subject:

COMMISSION POLICY STATEMENT ON. EXEMPTIONS FROM REGULATORY-

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CONTROL

Purpose:

To provide for Commission consideration'a final policy l

statement on exemptions from regulatory control.

I Summary:

This paper transmits a final policy statement on exemptions f rom regulatory control which incorporates the elements of, and is consistent with, the directions include.d in the Commission's Staff Requirements Memorandum of October 13, 1989 (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 (SEGY 88-69, SECY 88-227, and SECY-89-184), the staff has provided information l:

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 n.ay be released f rom a licensee's control. These practices could include "below regulatory concern" (BRC) 1 waste disposals as characterized in Pub. L.99-240, the

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l Low-Level Radioactive Waste Policy Amendments Act of.1985.

ic of discussion The elements of this policy were a major top (NUREG/CP-0101)

L at an NRC-sponsored international workshop and were the subject of an advance notice of policy develop-ment issued on December 12, 1988 (53 FR 49886). A public meeting addressing the subject policy also took place on January 12, 1989. Following staff analysis of the public comments on the advance notice of policy development, a proposed policy statement was forwarded to the Comission o

L on Juno 16,1989(SECY-89-184).

A Comission meeting was held on July 11, 1989, at which the proposals in SECY 89-184 were discussed.

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Contact:

Dr. Donald A. Cool, RES Ext. 23785 i

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F Discussion:

In a Staff Requirements Memorandum dated October 13, 1989, the j

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.Comission disapproved the proposed policy statement in-SECY-89-184 and issued directions with regard to the content =

i and format for.a final policy statement on Exemptions from' Regulatory Control. The policy statement attached as responds to this direction.-

-l The enclosed policy statement contains five sections and an.

appendix. An introductory section contains a description of l:

the policy's purpose and need, cites existing exemptions which are already codified in Commission-regulations,_ makes' l.

references to " exemption". policies of other Federal agencies,-

and provides an overview of the content of the policy statement.!

This'section also provides notice that this policy statement '

a supersedes the Commission's previous _ policy statement on-the y

use of byproduct and source material in consumer products (30FR3462).

Section 11 defines key terms and concepts used throughout i

L In this section the definition of the: policy. statement.

l collectivedoseincludestheindividualdosecutoffof l

0.1 mrem per year recomended by the Commission. The definitions are consistent with those in the~ revision of 10 CFR Part 20 (SECY-88-315).

-Section III presents a discussion of the major elements of

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l the exemption policy including:

(1) the dual individual dose criteria of 10 mrem per year and 1 mrem 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.

L The risk basis for-the individual dose criterion and the l-policy bases for the collective dose criteria are described.

Section IV is a new section which, in general terms, discusses how the provisions of the policy statement will L

L be practically implemented. This section also describes the opportunities for public inputs into Commission rulemaking or licensing actions involving exemption decisions.

Section V, also a new section, defines the information needs which would be necessary for evaluation of an i

exemption application. The information in this section is a generalized version of the information requirements contained in the staff implementation plan which was developed to support the " General Statement of-Policy and Procedures Concerning Petitions Pursuant to 92.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern," 10 CFR Part 2, Appendix B. Depending upon the type of practice under

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consideration, not all of the information in this section say be relevant.

However, the general types of information should be appropriate for most rulemaking and licensing

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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.

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i is a sumary of the policy's provisions and rationale for use by. the Consnission in discussions with members of the public.

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During-the preparation of the policy statement, an issue of jurisdiction with respect to licensing by the Agreement

'I States was noted. The'Comission retains the authority for the regulation of distribution of consumer products under i-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 Comission in the area of recycle has not l

L been as clearly defined in the Comission's regulations as.it l

has with consumer products. This issue will be resolved i

during specific rulemakings to implement the policy statement.

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During the preparation of the policy stacement, several issues '.

were identified by the staff regarding the content of the statement. The staff believes that if the changes suggested l

below are adopted, the policy statement will be more readily

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understood and accepted by other Federal agencies, Congress, 7

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The first issue cNters on the staff's belief that there are l

certain practices; such as the introduction of radioactive A,.y'> 'a -,_j materials ir.to products to be consumed or used by children 2

L N/uW (e.g., baby food or toys), tMt evoid not ce appru% even if G.,4/6< A the radiation doses are very small,or where there are practical alternatives to use of fadioactive materials. The Qq

& g policy statement is silent on this subject, and the elimination M @%,.I of the 1965 policy statement on consumer products could be I

construed as implying that such activities would be considered L

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for exemption. One alternative would be to not rescind the I

l 1965 policy statement as directed in the SRM of October 13, 1989. A second alternative, however, would be to add a statement to the definition of " Practice" on page 11 of the 4

policy statement (Enclosure 2). Such a statement could read:

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J "The Comission may~ determine that certain practiced '

such as the introduction of radios tive materials into products to be consumed or used hildren, m = 0

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where ther are practical-alternatives to the use of radioactive materials 3 h; F;.;L... P ^i:Ex Y

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The staff recommends that such a statement be added to the policy statement to avoid potential-unwarranted criticisms of 4

i the exemption policy, and to make clear the Commission'sMA

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position in this. area.

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A second' issue which was raised during the development of the 3

po-licy statement was the consistency of regulation between the

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co11 active dose criteria of the policy statement and previous nW#

ALARA actions taken by the NRC.

In many cases, ALARA efforts I

have been pursued to levels well below those represented by 1000 person-rem. The staff believes that a value of 100-

h. 1 person-rem is a more appropriate generic criterion for this Jjfj'_.,/u)?g g4 purpose and represents' an order of magnitude reduction in the years per exempted practice.f1n addnion%one fatalitv in tw hypothetical societal health effects of lA cutof'f of

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collective dose calculations at 0.1 mrem may result, due to t

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i the limited. difference between this cutoff and the individual dose criterior, in the collective dote criteria serving no useful purpose-in the evaluation of potential exemptions.

1 This cutoff results in the possibility of collective doses on

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the order of LO,000 person-rem being ignored while the policy l

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as thatrcollective doses be less than 1000 person-rem, 9

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gr The third issue which was raised during the development of the.

policy statement was the potential for a. lack of finality with many of the decisions which may be made under the 10 mrem,he individual dose criterion. This issue was highlighted by t 1

questioning of Chairman Carr by. Congressman Synar during a hearing on decomissioning on August 3,1989.

Use of a 10 mrem value, in light of the lower values under consideration l.

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by the Environmental Protection Agency (EPA) may result in the NRC having to reopen decommissioning actions at a later date -

unless grandfathering is allowed. Values of 1 or a few millirem have a much lower potential for this problem.

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.3-Implementation: One of the initial actions involved in' implementing the.

Exemption Policy will be the development of criteria for l

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. residual levels of radioactivity for decommissioning. During a hearing on decomissioning before the Subcomittee 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 accomodate the schedule. The staff, with contractor support i

from Pacific Northwest Laboratories (PNL), has prepared a draft NUREG/CR technical basis report that describes the dose _

rate conversion factors, pathways, and scenarios for exposure.

of individuals at decommissioned sites. The draft technical-report is the product of several. iterations and extensive 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.

L Tables in the draf t report provide, for approximately 200 o

nuclides, dose rate conversion factors for unit concentration (e.g., pCi/g), for each pathway and for several scenarios,.

each of which represents a combination of pathways associated with the use of structures or land.-

L During the November 15, 1989, staff review meeting, several technical coments requiring resolution were identified.

l These included the need to elaborate.the methods and rationale L

used to derive the drinking water model and scenario and the l

need to clearly describe the method for handling decay chains l

and daughters of nuclides. The comparison of the generic L

scenarios with those of other organizations, such as the NCRP, needs to be described. An aeditional and more significant issue is the possibility that the demolition and onsite l

. b disposal of released structures could affect the drinking l

water pathway. This last concern envisions a scenario that 3

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ad would add contaminated structural debris to already P[\\

contaminated soil. This situation could significantly

\\ resfrD t tha_use of_ generic scenarios for unrestricted release

' of structures because tWtotal inventory of structurally bound radionuclides could be ingested through the drinking water pathway.

In order to generically bound the range of structures for which decomissioning could be needed, the volumetric and surface contamination which could be allowed might be so low that their utility woulo be diminished. To address these issues, a revised draft will be prepared and submitted for staff review in December 1989.

L The staff believes that the NUREG/CR should be published first for coment to benefit from a greater range of review on the modeling approaches used to derive residual contamination criteria for unrestricted release. The NRC staff plans to prepare a foreword to the report that would caution users that

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.the tables and scenari should not be applied beyond the -

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scope originally intend. A separate report, published with the draft NUREG/CR, will rovide tables of release-criteria e

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n for soils-and structures ich, based on the models in the technical basis, would res it in a 10 mram/ year total-effective dose equivalent. Following publication of the draft' l

NUREG/CR and draft criteria,- snd receipt c' comments, the-t final report and' interim criteria tables g a :d be prepared.-

The-staff anticipates that the interim rnuval radioactivity:

criteria would be incorporated into.a regulatory. guide, which would also contain information on the use and limitations of-the' criteria tables and the technical basis report. _The staff 1

envisions that the dose criteria for decomissioning, upon-

-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 draft technical basis report, and the tables of release criteria for soils and structures, for-Comission review and publication for public comment in January 1990. Publication of the final technical document and draf t 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 developpent of interim residual!

radioactivity standards, while at.the same time allowing for appropriate public a_ o scientific input.

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Coordination:

The Office of General Counsel has reviewed this Comission paper and has no legal objection.

Recomendations: That the Comission:

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Approve publication of the final policy statement on Exemptions From Regulatory Control, incorporating the l

changes suggested in the discussion. The staff believes that if these suggested changes are adopted, the policy will be more readily understood and accepted by other Federal agencies, Congress, and members of the public.

i 2.

Note that the Biological Effects of Ionizing Radiation Report (BEIR V) is expected to be published in mid-December.

The Appendix discussing the risk bases of the policy L

statement includes a discussion of the UNSCEAR report which was published in 1988. Because the UNSCEAR and l

BEIR V reports have been based on the same database. it is likely that their findings will' be similar.fThe N

l Comission may wish o consider the findings in the BEIR

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' report.and make appropriate notations that this report has been examined and that the risk estimates. n the policy i

statement'are consistent with its findings.

'3.

Note that the staff and OGC believe that a clearance of ThTs policy statement by.0MB may be required prior to publication. This requirement is based upon the wording of S CFR 1320.7(c) Collection of information", and stems i

.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.-

James M. Taylor Acting Executive Director for Operations

Enclosure:

11.

Staff Requirements Memorandum 2.

Statement of Policy 3.

Summary of Policy Statement

. DISTRIBUTION:,[ EXEMPTIONS FRM REG CONTROL /CP)

RPHEB R/F-Dcool JTaylor ZRosztoczy Subj. File ~

EBeckjord-DCool Circ./Chron.

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. RECORD NOTE 1: ~1 concur that this policy statement represents the direction provided in the SRM dated-10/13/89. My concurrence does not represent agreement with all of the positions taken by the Consnission in-this action.

Donald A. Cool I

I

~ RECORD NOTE 2:

NRR, ADM, GPA, and NMSS have concurred on the policy statenant.

RETYPED FOR MINOR CHANGES -- SEE PREVIOUS CONCURRENCES.

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NUCLEAR REGULATORY COMMISSION UNITED STATES.

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May 30, 1990

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-For:

The Commissioners From:-

James M. Taylor, Acting Executive Director for Operations

Subject:

COMMISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL

Purpose:

To provide for Commission consideration a final policy statement' on exemptions from regulatory control.

Summary:

This paper transmits a final policy statement on exemptions-from regulatory control which incorporates the elements of, and is consistent with, the oirections included in the Commission's l'

Staff Requirements Memorandum of October 13, 1989 L

(Enclosure 1).

It also provides the status and proposed plans

~for development of residual radioactivity criteria for deconcissioning.

Background:

In a series of Commission 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 i

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 Radioactive 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-ment issued on December 12,1988- (53 FR 49886).. A public meeting addressing the subject policy also took place on January 12, 1989. Following staff analysis of the public comments on the advance notice of policy development, a proposed policy statement was forwarded to the Commission on June 16,1989.(SECY-89-184). A Commission meeting was held on July 11, 1989, at which the proposals in SECY 89-184 were discussed.

Contact:

Dr. Donald A. Cool, RES Ext. 23785

l

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Discussion:-

In a Staff. Requirements Nemorandum' dated October 13, 1989,_the Comission disapproved the proposed policy statement in

.SECY-89-184 and issued directions with regard to the content i

and format for a final policy statement on Exemptfons From Regulatory Control. The policy statement attached as ~

l responds to this direction.

F

The enclosed. policy statement contains five sections. and.an appendix. An introductory section contains a description of-the p611cy's purpose and need, cites existing exemptions

=i which are already codified in Commission regulations, makes references to " exemption

  • policies of other Federal agencies, and provides an overview of the content of the policy statement.

This section also provides notice that this-policy statement-supersedes the Commission's previous policy statement on the use of byproduct and source material in consumer products E

-(30 FR 3462).

Section II defines key terms and. concepts used throughout the' policy statement.

In this section the definition of collectivedoseincludestheindividualdosecutoffof 0.1 mrem per year recomended by' the Comission. The definitions are consistent with-those in the revision of 10CFRPart20(SECY-88-315).

Section III presents a discussion of the major elements of the exemption policy including:

(1)thedualindividual dose criteria of 10 mrem per years and l-erem per year, (2) the collective dose criterion of 1000 person-rem per 2

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 IV is a new section which, _in general terms, discusses how the provisions of the policy statement will be practically implemented. This section also describes the opportunities for public inputs into Comission rulemaking or licensing actions involving exemption decisions.

Section V, also a new section, defines the information needs which would be necessary for evaluation of an exemption application. The information in this section is a generalized version of the information requirements contained in the staff implementation plan which was developed to support j

the " General Statement of Pulicy and Procedures Concerning Petitions Pursuant to 92.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern," 10 CFR Part 2, Appendix B. Depending upon the type of practice under f

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~.c The Commissioners 3

v consideration, not all of the information in this section nay be relevant.

However, the general types of information-s should be-appropriate for most rulemaking and licepsing 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 j

members'of the public.

During the preparation of the policy staterent, an issue of jurisdiction with respect to licensing by the Agreement States was~noted. The Commission retains the authority for the regulation of distribution of consumer products under i

E 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 Commission 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 pol. icy statement.

During the preparation of the policy statement, several issues were identified by the staff regarding the content of the statement. The staff believes that if the changes suggested below are adopted, the policy statement will be more readily understood and accepted by other Federal agencies, Congress, and members of the public.

The first issue centers on the staff's belief that there are e

certain practices, such as the introduction of radioactive materials irito products to be consumed or used by children (e.g., baby food or toys), that should not be approved, 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 woulo be-considered for exemption. One alternative would be to not rescind the 1965 policy statement as directed in the SRM of October 13, 1989. A second alternative, however, would be to add a statement to the definition of " Practice" on page 11 of the policy statement (Enclosure 2). Such a statement could read:

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'"The Commission may determine that certain practices,.

V such as the introduction of radioactive materials into

. products to be consumed or used by children,'are not appropriate, irrespective of.the dose levels. involved or where therGare: practical alternatives to the use of

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radioactive materials. These practices'would therefore not be candidates for exemption."

NU-The' staff recommends that-such a statement be added to the policy statement to avoid potential unwarranted criticisms of the exemption policy, and to make cleer:the Commission's position in this area.

' A second. issue which was raised during the development of the policy statement was the. consistency of regulation between the i,

collective dose criteria of. the policy statement and previous

.ALARA actions taken by the NRC.

In many cases, ALARA efforts J'

have been pursued to levels well below those represented by

'1000 person-rem. The staff believes that a value of 100 person-rem is a.more appropriate generic criterion for this purpose and represents an order of magnitude reduction in the hypothetical societal health effects o_f one fatality in two years p'er exempted practice. In addition, the cutoTT oT collectiiii doie calcii1Rions at 0.1 mrem may result, due to the: limited difference between this cutoff and-the individual dose criterion, in-the cullective dose criteria serving no J

useful purpose in the evaluation of potential exemptions.

yh j,.. ' \\a This cutoff results in-the possibility of collective doses on th4 order of 10,000 person-remsbeing ignored while the policy)

  • requires that collective' doses' be less,than 1000, person-rem '

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{ before the ALARA prot'ess can be curtailed.

The third issue which was raised during the development of the policy statement was the potential for a lack of finality with many of the decisions which may be made under,the 10 mrem individual dose criterion. This issue was highlighted by the questioning of Chairman Carr by Congressman Synar during a hearing-on decommissioning on August 3, 1989. Use of a 10 mrem value, in light of the lower values under consideration by the Environmental Protection Agency (EPA)' may result in the NRC having to reopen decommissioning actions at a later date unless grandfathering is allowed. Values of W a few millirem ate. i have a much lower potential for this problem.

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Implementation:

One of the initial actions invo'1ved in implementing the-Exemption Policy will be the development of criteria for.

' residual levels of radioactivity.for decommissioning.: During-a hearing on decomissioning before the Subcomittee 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 accommodate the schedule.. The staff, with contractor support fromPacificNorthwestLaboratories(PNL)',hasprepareda-I draft NUREG/CR technical basis report that describesithe dose.

rate 1 conversion factors, pathways, and scenarios for exposure of-individuals at-decommissioned sites. The draft technical

. report is the product:of several iterations and extensive 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 nuclides, dose; rate conversion factors for unit concentration (e.g., pCi/g), for each pathway and for several scenarios, each of which represents a combination of pathways associated L

with the use of structures or land.

During the November 15, 1989, staf,f review meeting, several technical coments requiring resolution were identified.

These included the need to elaborate the methods and rationale h

L used to derive the drinking. water model and scenario and the

{

need to clearly describe the method for handling decay chains and daughters of nuclides. The comparison.of the generic scenarios with those of other organizations, such as the NCRP, needs.to be described. An aeditional and more significant issue is the possibility that.the demolition and onsite B

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 l

l of structures because the total inventory. of structurally bound radionuclides could be ingested through the drinking

[

water pathway.

In order to generically bound the range of structures for which decomissioning could be needed, the t-volumetric and surface contamination which could be allowed L

might be so-low that their utility woulo be diminished. To address these issues, a revised draft will be prepared and l'

submitted for staff review in December 1989.

L The staff believes that the'NUREG/CR should be published first L

for coment to benefit from a greater range of review on the modeling approaches used to derive residual contamination criteria for unrestricted release. The NRC staff plans to prepare a foreword to the report that would caution users that p

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the-tables and scenarios should not be applied beyond the

--scope originally intended. - A separate report, published with:

the draft NUREG/CR, will provide tables.of release criteria for. soils and structures which, based on the sedels in the technical basis,:would result in a.10 mram/ year total-.

effective dose equivalent. Following publication of the draft NUREG/CR and draft criteria, and receipt of comments, the final report and interim criteria tables would be prepared.

1

.The staff anticipates-that the interim residual radioactivity criteria would be incorporated into a regulatory guide, which would also contain information'on the use and limitations of:

-the criteria tables and the technical basis report. The staff envisions that the dose criteria for decomissioning, upon 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-t E

use.

i Given the new information developed during the review, the staff now plans to provide the draft technical basis report, and the tables of release criteria for soils and structures, for. Comission review and publication for public comment in g

L' r

January 1990. Publication of the final technical document and draf t regulatory guide would-follow the public comment period. The staff believes that this approach meets the intent of the statements made before f

Congress on _the development of interim residual j

radioactivity standards, while at the same time allowing for appropriate public ano scientific input.

Coordination:

The Office of General Counsel has reviewed this Comission paper and has no legal objection, j

l Recommendations: That the;Comission:

1.

Approve publication of the final policy statement on O

Exemptions From Regulatory Control, incorporating the J

changes suggested in the discussion. The staff believes that if these suggested changes are adopted, the policy will be more readily understood and accepted by other Federal agencies, Congress, and members of the public.

i 2.

Note that the Biological Effects of Ionizing Radiation j

t Report (BEIR V) is expected to be published in mid-December.

-1 The Appendix discussing the risk bases of the policy E

statement includes a discussion of the UNSCEAR report which was published in 1988. Because the UNSCEAR and BEIR V reports have been based on the same database, it is likely that their findings will be similar. The Comission may wish to consider the findings in the BEIR

.1

l 7

  • ~The Commissioners <

report and make appropriate notations that this report has U

been examined and that the risk estimates in the policy l

'st6tement are consistent with its findings.

L 3.

Note that the staff and OGC believe that a c1earance of 4

ThTi policy statement by OMB may be required prior to publication.- This requirement-is based upon the wording of 5 CFR 1320.7(c) " Collection of information", and stems from the fact that Section Y of the policy statement defines the information needs which would belnecessary

.i for evaluation of an exemption application. Clearance by I

OMB would require a minimum of about 90 days.

James M. Taylor Acting Executive Director for Ope ntions

Enclosure:

y 1.

Staff Requirements Memorandum i

J 2.- Statement of Policy.

3.

Summary of Policy Statement DISTRIBUTION: '[ EXEMPTIONS FRM REG. CONTROL /CP) ~

RPHEB R/F-DCool JTaylor.

ZRosztoczy Subj. File EBeckjord DCool Circ./Chron.

TSpeis WLahs i'

-RECORD-NOTE 1:. I concur that this policy statement represents the direction.

provided in'the SRM dated 10/13/89. My concurrence does not represent agreement with all.of the positions taken by the Commission in this action.

Donald A. Cool 4

RECORD NOTE 2: NRR, ADM, GPA, and HMSS have concurred on the policy statenent.

RETYPED FOR MINOR CHANGES -- SEE PREVIOUS CONCURRENCES.

l DFFC:NPHED:DRA :DD:DRA

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.NAME:DACool

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For:-

The Comissioners From:

James M. Taylor, Acting Executive Director for Operations I

Subject:

COMMISSION POLICY STATEMENT ON EXEMPTIONS FROM REGULATORY CONTROL

Purpose:

=To provide for Commission.consideratior, a final policy statement on exemptions from regulatory co.ntrol..

Sumary:

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 Commission's Staff Requirements Memorandum of October 13, 1989 (Enclosure 1),

it also provides the status and proposed plans for development of residual radioactivity criteria for decommissioning.-

s

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 l'

Low-Level Radioactive Waste Policy ' Amendments Act of 1985.

1 The elements of this policy were a major' topic of discussion at an NRC-sponsored international workshop (NUREG/CP-0101) and were the subject of an advance notice of policy develop-ment issued on December 12, 1988 (53 FR 49886). A public meeting addressing the subject policy also took place on January 12, 1989. Following staff analysis of the public comments on the advance notice of policy development, a proposed policy statement was forwarded to the Comission l

on June 16,1989(SECY-89-184). A Comission meeting was held on July 11, 1989, at which the proposals in SECY 89-184 o

were discussed.

-Contacti Dr. Donald A. Cool, RES Ext. 23785

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' l Discussion:

. In~a Staff Requirements Memorandum dated October 13, 1989, the'.

Commission disapproved the proposed policy statement in 3

SECY-89-184 and. issued directions with regard to the content

and format for a final policy statement on Exemptions From-y Regulatory Control. The policy statement attached as-Enclosure.2 responds to'this~ direction.

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 which are already codified in Commission regulations, makes references to " exemption" policies of other Federal agencies.

and provides an overview of the content of the policy statement.

This section also provides notice that this policy statement supersedes the Commission's previous policy statement on the use of-byproduct and source material in consumer products-(30 FR 3462).

Section II defines key terms and concepts used.throughout the policy statement.

In this section, the definition of collective dose includes the individual dose cutoff of O.1 mrem per year recommended by the Commission. The definitions are consistent with those in the revision of 10 CFR Part 20 (SECY-88-315).

Section III presents a discussion of'the major elements of the exemption policy inc uding:

(1)the'dualindividual l

dose criteria of 10 mrem per year and 1 mrem 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 IV is a new section which, in general terms..

discusses how the provisions of the policy statement will be practically implemented. This section also describes the opportunities for public inputs into Commission rulemaking or licensing actions involving exemption decisions.

Section V, also a new section, defines the information i

needs which woulo be necessary for evaluation of an exemption application. The information in this section is a generalized version of the information requirements' contained in the staff implementation plan which was developed to support the " General Statement of Policy and Procedures Concerning Petitions Pursuant to $2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern," 10 CFR Pa,rt 2, Appendix B. Depending upon the type of practice under

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' consideration, not all of the.information in this section may be relevant. However, the general types of information l

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

]y is a sunirary of the policy's provisions and.

j rationale for use by the Comission in discussions with members of the public.

j During the preparation of the policy statement, an issue of 1

jurisdiction with respect to licensing by the Agreement L.

States was noted. The Commission retains the authority for pe the regulation of distribution of.' consumer products under this policy statement. However, the recycle of radioactive H

material will-also result in the widespread distribution of L

radioactive materials to the public and the environment. The L

jurisdiction of the Commission 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.

During the preparation of the policy statement, several issues L

were identified by the staff regarding the content of the p

statement. The staff believes that if the changes suggested f 'W',g,,.i ;below are adopted, the policy statement will be more readily El ' '.## 6

Junderstood and accepted by other Federal agencies, Congress, g.,.r y w Tu. net # land members of the public.,

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Lr ;r The first issue centers cn the staff's belief that there are certain practices /, such as the introduction of radioactive 7

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<. < J materials.into products-to be consumed or used by. children L

16 i - (< o, (e'.g., baby food or toys), tht NW =t h :;;rn;d, even if

, the radiation doses are very small, or where there are L

.b.,^"#.

practical alternatives to use of radioactive materials. The l

policy statement is silent on this subject, and the elimination of the 1965 policy statement on consumer products could be l

L construed as implying that such activities would be considered H

for exemption. One alternative would be to not rescind the i

1965 policy statement as directed in the SRM of October 13, i

1989.

A second alternative, however, would be to add a l

statement to the definition of " Practice" on page 11 of the L

policy statement (Enclosure 2).

Such a statement could read:

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"The Commission may determine tt/at certain practices',

suchastheintroductionofradjoactivematerialsinto L

products _to be consumed or used by children,;;n nt

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"j 1rrespective of the dose levels ~ involved,'or:

w1ere there are-practical alternatives to.the use of.

radioactive materials. These practices would therefore-not be(candidates for exemption."

t< % -

The staff reconnends that such a statement be added to the

! policy statement to avoidfotential-~ unwarranted criticisms of the exemption policy, and to make clear the Commission's-position.in this area.

-Q g

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  • .s-A second-issue which was raised during the development of the policy statement was the consistency of regulation between the collective dose criteria of the policy statement and previous ALARA actions taken by the'NRC.

In many cases, ALARA efforts have been pursued to-levels well below those represented by i

1000 person-rem. The staff believes that a value of-100 or 500-

-person-rem is a more appropriate generic criterion for this L,

purpose, and represents a reduction from the potentially L

. unacceptable hypothetical societal health-effects level of one y

fatality in two years per exempted practice isplied by the j

1000 person-rem value.

In addition, due to the limited difference between the cutoff of collmetive dose calculations l

at 0.1 mrem, and the 1 mrem individual dose criterion, the L

collective dose criteria may serve no useful-purpose in the I

evaluation of potential-exemptions.

It should be noted that t

l-the cutoff results in the possibility of collective doses on the order of 10,000 person-rem being ignored, while the policy L(

l 4eams to require that collective doses be less than 1000 person-rem before the ALARA process can be curtailed.

The third issue which was noted during the development of the policy statement was the potential for a lack of finality with many of the decisions which may be made under the 10 mrem individual dose criterion.- This issue was highlighted by the questioning of Chairman Carr by Congressman Synar during a l'

hearing on decommissioning on August 3, 1989. Use of a 10 mrem value, in light of the-lower values under consideration by the Environmental Protection Agency (EPA)-may result in the NRC having to reopen deconnissioning actions at a later date, unless grandfathering is allowed. Values of I or a few millirem have a much lower potential for this problem, i

y4 W

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1 q

.i

'The Comissioners' 5

.m Implementation: One of the initial actions involved in implementing the Exemption Policy will be the development of criteria for residual levels of radioactivity for' decommissioning. _ During a hearing on decommissioning before the Subcomittee 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-l accommodate the schedule. The staff, with contractor support-1 from Pacific Northwest Laboratories (PNL), has prepared a draft NUREG/CR technical basis report that describes the dose-1 rate conversion factors, pathways, and scenarios for exposure of individuals at decommissioned sites. The draft technical

. report is the product of several iterations and extensive 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 nuclides, dose rate conversion' factors for unit concentration (e.g., pCi/g), for each pathway and for several scenarios, each of which represents a combination of pathways associated i

with the use of structures or land.

I During the November 15, 1989, staff review meeting, several technical comments requiring resoluti.on were identified.

These included the need to elaborate the methods and rationale used to derive the' drinking water model and scenario and the l

need to clearly describe the method for handling decay chains-(L 4 and daughters of nuclides. The comparison of the generic scenarios with those of other organizations, such as the NCRP, needs'to be described. An additional and more significant issue is the possibility that the demolition and onsite y

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 b,

restrict the use of generic scenarios for unrestricted release L

of structures because the total inventory of structurally L

bound radionuclides could be ingested through=the drinking L

water pathway.

In order to generically bound the range of structures for which decommissioning could be needed, the.

volumetric and surface contamination which could be allowed might be so low that their utility would be diminished. To 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 L

for comment to benefit f rom a greater range of review on the modeling approaches used to derive residual contamination criteria for unrestricted release. The NRC staff plans to prepare a foreword to the report that would caution users that l-

5 w

i

+

1

'The. Commissioners l V

the' tables and scenarios-should not be applied beyond the -

scope originally intended. A separate report, published with

{

the draft NUREG/CR, will provide tables of release criteria i

for soils and structures which, based on the models in the-

. 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. comments, the-.

i final report and interim criteria tables would be prepared.

i 4

The staff anticipates that the interim residual radioactivity criteria would be incorporated into a regulatory guioe, which would also contain information on the use and limitations of the criteria-tables and the technical basis report. The staff i

envisions that the dose criteria for decommissioning. upon 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 pla.ns to provide the draft technical basis report, and the tables of release criteria for soils and structures, for-Commission review and publication for public coment in

. January 1990. Publication of the final technical document and t

craf t regulatory' guide would follow the public coment period, The staff believes that-this approach meets the intent of the statements made before Congress on the' development of interim c

residual radioactivity standards, while at' the same time

~

U allowing for appropriate public and scientific input.

-C_ ordination:

The Office of General Counsel has reviewed this Commission o

paper and has no legal objection.

7 Recommendations: That the Commission:

l L

1.

Approve publication of the final policy statement on P

Exemptions From Regulatory Control, incorporating the L

changes suggested in the discussion. The staff believes l

that if these suggested changes are adopted, the policy L

will be more readily understood and accepted by 'other Federal agencies, Congress, and members of the public.

2.

Note that the Biological Effects of Ionizing Radiation

?

Efort(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 l

BEIR V reports have been based on the same database, it is likely that their findings will be similar. The l.

Commission may wish to consider the findings in the BEIR l

1

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j;; -

p,sg, k

Th'e Commissioners 7

l a,

t report and make appropriate notations that this report has been examined and that the. risk estimates in-the policy statement are.cohsistent with its. findings.

t 3.-

Note that the staff and OGC believe that a clearance of TEE policy statement by 0MB may be required prior to publication. This requirement is based upon the wording of 5 CFR 1320.7(c) " Collection of.information", and stems from the fact that Section V of the policy statement-

1. -

' defines the information needs which would be necessary l

for evaluation of an exemption application. Cherence by

^

OMB-would require a minimum of about 90 days.

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James M. Taylor Acting Executive Director for Operations

Enclosure:

1.

Staff Requirements Memorandum

-2.

Statement of Policy 3.

Sumary of Policy Statement

' DISTRIBUTION:- [ EXEMPT FROM REG C011TROLS]

RPHEB R/F-DCool JTaylor-ZRosztoczy Subj.-File EBeckjord DCool

-Circ./Chron.

TSpeis WLahs RECORD' NOTE 1:

I concur that this policy statement represents the direction provided in the SRM. dated 10/13/89.- My concurrence does not represent-agreement with all of the positions taken by the Comission in,this action.

Donald A. Cool RECORD NOTE 2:

NRR, ADM, GPA,.and NMSS have concurred on the policy statement.

RETYPED FOR MINOR CHANGES -- SEE PREVIOUS CONCURRENCES.

r 0FFC:RPHEB:DRA :DD:DRA

D:DRA
RE5:DD
RE5:D
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T5peis
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n,roaner

-DATE: -/- /89

/ /89 :

/

/89 :

/ /89

/ /89

/ /89

/

/t9 :

OFFICIAL RECORD COPY

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Document Name:-

'4 EXEMPT FROM: REG CONTROLS b

' Requestor's'10:'

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-PETERSON I

Author's Name:

I Document - Coments: '

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