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    #p        oq'o                          UNITED STATES e
    !'                            NUCLEAR REGULATORY COMMISSION
    $ . 3.,,qf[,,g
        "#f.      E          ADVISORY COMMITTEE ON REACTOR SAFEGUARDS W ASHINGTON, D. C. 20555 o            g May 11, 1988 Mr. Victor Stello, Jr.
Executive Director for Operations U.S. Nuclear Regulatory Comission Washington, D.C. 20555
 
==Dear Mr. Stello:==
 
==SUBJECT:==
      "BELOW REGULATORY CONCERN" AND "DE MINIMIS" CONCEPTS Enclosed is a report of the ACRS Subcomittee on Waste Management relative to the NRC Staff's position paper on the applicability of "below regulatory concern" and "de minimis" concepts to Comission policies. This report was provided to the ACRS during its 337th meeting, May 5-7, 1988.
These comments are based en a review of your memorandum (SECY-88-69) of March 8,1988, as well as a meeting held by the Subcomittee with the NRC Staff on May 4, 1988. Since the information it contains may be of interest, we are also enclosing a memorandum from M. Steindler to D.
Moeller dated May 6, 1988.
The ACRS Members hope you will find this material useful.
Sincerely, N
Raymond F. Fraley Executive Director
 
==Enclosures:==
: 1. Report dated May 5, 1988 of the Meeting of the ACRS Subcomittee on Waste Management on May 4, 1988
: 2. Memorandum from M. Steindler to D. Moeller dated May 6, 1988 cc, w/ encis.
S. Chilk, SECY H. L, Thompson, NMSS                                                                    i R. Bernero, NMSS                                                                        !
G. Lear, NMSS E. S. Beckjord, RES                                                                    ,
J. Larkins. OCM                                                                        1 M. Lopez-Otin, OCM                                                                      l J. Scarborough, OCM                                                                    l J. Kotra, OCM                                                                          i
                          , OCM                                  DESIC HTED ORIGIXAL y yse                                            c ,--          ,,    sm                    l
 
Dated: May 5, 1988 REPORT OF MEETING 0F THE THE ACRS SUBCOMMITTEE ON WASTE MANAGEMENT MAY 4, 1988
: 1. Introduction During a meeting on May 4,1988, the Waste Management Subcomittee of the Advisory Committee on Reactor Safeguards met with the NRC Staff to discuss the applicability of de minimis and Below Regulatory Concern (BRC) concepts to Comission policies. Members of the Subcomittee participating in this meeting were Dade W. Moeller, Chairman, Forrest J.
Remick and Martin J. Steindler, members.        Serving as consultants and expert advisors to the Subcomittee were Melvin W. Carter, Richard F.
Foster, and Frank L. Parker. Sumarized below are the observations and suggestions made on this subject by the Subcomittee as a result of discussions that took place during this meeting.
II. Responses to Questions in SECY-88-69 As part of its deliberations, the Subcomittee addressed each of the six issues enumerated in the memorandum of March 8,1988, from the EDO to the Commissioners. These issues and the coments of the Subcomittee on each are given below.
Issue #1:    "What benefit would be realized in establishing a generic BRC level as opposed to source specific levels        (e.g., low-level waste streams, decomissioned lands and structures, recycled materials and equipment, consumer products, etc.)?"
Response:    The Subcomittee strongly recomends addressing this matter on a generic basis. Advantages of this approach include:
(a)  It would enable the NRC to set down relevant basic criteria and ap-proaches.
(b)  It has the potential      for providing a mechanism for bringing consistency to the establishment of a BRC level for each of the multitude of sources and practices being addressed, i.e., it would enable the BRC level for each s.ource or practice to be part of a systematic pattern.
(c) It would avoid the necessity of holding rulemaking hearings on the establishment of a BRC level for each source or practice.
Issue #2: "Of the possible ways to express BRC levels (e.g., cancer risk,    individual dose, collective dose, exempted quantities or concentrations), which are appropriate for the various sources or practices licensed by NRC?"
ENCLOSURE 1
 
REPORT ON WASTE MAN'AGEMENT              2 Response: The Subcomittee believes that the BRC level should be expressed in terms of the health risks to an individual. Such an ap-proach would have several advantages:
(a)  It would permit all sources and practices to be treated on a comparable basis.
(b)  It would permit comparisons to be made bctween the BRC level for radioactive and other toxic (nonradioactive) substances.
(c)    It would avoid the necessity of changing the BRC level as new data are developed on the quantitative relationship between radiation doses and their associated health effects.
Tc implement this approach, it would be necessary for the NRC Staff to develop a hierarchical system of supplementary guidance, similar to that recommended by the ACRS in the development and implementation of the Safety Goals for nuclear power plants. This hierarchical system would include secondary or tertiary guidance in the form of dose limits, radionuclide concentration limits, limits for surface contamination, etc. In this regard, we applaud the adoption by the NRC Staff of the effective dose equivalent as a means for expressing both single organ and whole body exposures.
Issue #3: "Given the complexity of some licensed activities, some of which may involve multiple contribution to public dose, what are the most useful definitions of ' sources' and ' practices' for which BRC dose limits would be developed?"
Response: We believe that the draft report of the Nuclear Energy Agency / International Atomic Energy Agency (NEA/IAEA) Expert Group on "Exemption of Radiation Sources and Practices from Regulatory Control" offers a useful      beginning for the development of definitions of "sources" and "practices." The Expert Group defined a "practice" as:
                  "a set of co-ordinated and continuing activities involving radiation exposure which are aimed at a given purpose, or the combination of a number of similar such sets."                ,
i And the Expert Group stated that a "source":
                  "is simply the radioactive material, the equipment emitting    :
radiation    or  containing  radioactive  material  or  the i installation (or group of installations) producing or using    i radioactive material..."
Following this approach, the Subcommittee believes that a "source" might be defined as:
                  "a  physical    entity that can be separately regulated or controlled."
 
i REPORT ON WASTE MANAGEMENT            3                                                  l i
Issue #4: "If cost vs. risk reduction analyses are to be performed to establish BRC levels, what cost-averted / risk ratio (or ratios) should be used for the various licensed sources or practices?"
Response:    Although  we  foresee    the        need to      apply  optimization evaluations (cost vs. risk reduction analyses) in the initial efforts to establish an appropriate BRC level for a range of cicsses of sources and practices that involve radioactive materials, once this effort is completed on a generic basis there should be no need to repeat it for the subsequent evaluations of individual sources and practices. In particular, we see no need to apply optimization techniques to sources or practices whose associated risks fall at or below the applicable BRC level. To establish the cost-averted / risk ratio (or ratios) that should be used in such analyses, we recomend the use of rulemaking hearings.
The documents supporting the establishment of Title 10, CFR Part 50, Appendix ! indicated that such hearings were to be held. So far as we know, this has never been done.
Issue #5:    "What approach should be taken to translate operational BRC levels (such as individual or collective dose or exempt quantities and concentrations) into fatality or cancer risks given the absence of data correlating such levels with risk (i.e., do we use the linear non-threshold dcse-response relationship at very low doses)?"
Response:    Although we realize that the assumption and application of a Tinear relationship has limitations, at the present time we know of no approach that is demonstrably superior. To assure that the risk coefficient applied in the associated calculations is acceptable, the Comission might consider requesting the support and assistance of an independent group such as the National Council on Radiation Protection and Measurements, or the Comittee on Interagency Radiation Research and Policy Coordination (CIRRPC).
Issue #6:    "Can a dose or risk be set at which radioactivity can be ignored    (i.e.,  can  a  definition of radioactivity be usefully established)?"
Response _:_ The Subcomittee strongly recomends that the NRC concentrate its efforts on the establishment of a BRC level, leaving the matter of the establishment of a de minimis level to other groups such as the U.S.
Environmental Protection Agency or an interagency comittee (such as CIRRPC). So far as we know, the NRC does not need to define at this time the conditions under which a material or substance needs to be considered "radioactive." Should special circumstances show that such a definition would be useful, we would recomend that the concentration (2 nCi/g) specified by the Department of Transportation (and cited in 10 CFR Part 71) be used.
III. Additional Coments In the way of additional coments, the Subcomittee offers the follow-ing:
 
REPORTONWASTEMANAGEMENT                4
: 1. Although the Subcommittee fully endorses the undertaking by the NRC of an effort to establish a BRC level, we believe it is important to recognize the complexity of this task. In essence, this effort is designed to answer the question, "How Safe is Safe Enough?"
Whereas the establishment of Safety Goals for nuclear power plants answered this question for that portion of NRC's licensing respon-sibilities, the current effort is designed to answer the same ques-tion for a host of other sources and practices, some of which will apply to individual sources and practices at nuclear power plants.
Since the Safety Goals for nuclear power plants appear to have gained wide acceptance, we would urge that the BRC level, under consideration here, reflect a health risk comparable to these Goals. Such an appreach would constitute a first step for bringing consistency to the regulation of a multitude of sources and prac-tices currently being addressed on an individual (and sometimes unecordinated) basis. Further, we believe that attaining general consister.cy among the various public risk goals being established by the NRC would represent a major contribution towards improved national regulation and towards increased respect for the regula--
tory process.
: 2. We recommend that the Comission concentrate on the establishment of a BRC level that places a limit on the health risks to individ-ual members of the public. Such an approach, in our opinion, will assure that the associated collective doses are acceptable.
: 3. In the draft NEA/IAEA report, the suggestion was made that varia-tions in the doses from natural background radiation could be used as a basis for the establishment of a BRC level. As stated above, we believe that consideration of the associated health risks to individuals can serve as a better basis for the establishment of such a level.
Should the NRC decide, however, to use variations in natural background as one of several bases for setting a BRC level, we believe it is important to restrict these considerations to vari-ations in the ambient (outdoor) natural background radiation. In our opinion, the consideration of variations in radiation dose rates inside buildings, which include "technologically enhanced" sources such as radon, would be inappropriate.
: 4. Regardless of the level ultimately considered to be BRC, it should be recognized from the onset that it will be impossible (with current technology) to measure the associated doses. Major re-liance will have to be placed on mathematical models for estimating impacts individually and collectively on members of the public that arise as a result of the movement of radionuclides through a
          ' variety of environmental pathways under a range of scenarios. For this reason, it is important that such models, and the associated computer codes, be evaluated and validated. Included in such evaluations should be a determination of the uncertainties associ-ated with the final dose estimates.
 
REPORT ON l.'ASTE MANAGEMENT              5
: 5. One characteristic of sources or practices that we believe should be included among the considerations taken into account in the establishment of secondary or tertiary guidance, is the matter of the half-lives of the radionuclides involved.        Whereas radionu-clides, such as 6%o, once released into the environment can be expected                                            nviro eat within a matter oftodecades, decay and  thus and    be "removed" radionuclides  from such asthegSr and 3/ Cs will decay wignPu,  a matter  of several represent        centuries, what must          long-lived be considered      materials, as "pennanent" such as contamination. Although evaluating the associated risk of ex-tremely long-lived radionuclides on the basis of their lifetime dose coninitment tends to compensate for this concern, it may well be that guidance for the control of these radienuclides should be more restrictive than that for sources and practices involving shorter-lived materials. Once released, long-lived materials represent a dose commitment to existing as well as to future generations.
: 6. It should also be recognized that the establishment of a BRC level, and the declaration that a given source or practice falls into this category, is not an action that is to be taken once and for all.
The NRC Staff should be asked periodically during subsequent years to reexamine given sources and practices to assure that the antici-pated characteristics and behavior of these sources and practices continue to be as originally assumed. Where changes and/or defi-ciencies are found, suitable adjustments should be made.
: 7. On the basis of our review, it would appear that, depending on the source or practice, health (fatal cancer) risks that would be representative of an acceptable BRC level would be less than 10 6 per year. Correspo thus be less than 10-gding acceptable lifetime health risks would i
                                    ,}}

Latest revision as of 02:22, 4 November 2020

Forwards ACRS Subcommittee on Waste Mgt Rept on NRC Position Paper Re Applicability of Below Regulatory Concern & De Minimis Concepts to Commission Policies.M Steindler 880506 Memo to D Moeller Encl
ML20154D700
Person / Time
Issue date: 05/11/1988
From: Fraley R
Advisory Committee on Reactor Safeguards
To: Stello V
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML19306H915 List:
References
REF-WM-1 ACRS-GENERAL, NUDOCS 8805190300
Download: ML20154D700 (6)


Text

__ .

D A S/AW5$

e* "8 c

  1. p oq'o UNITED STATES e

!' NUCLEAR REGULATORY COMMISSION

$ . 3.,,qf[,,g

"#f. E ADVISORY COMMITTEE ON REACTOR SAFEGUARDS W ASHINGTON, D. C. 20555 o g May 11, 1988 Mr. Victor Stello, Jr.

Executive Director for Operations U.S. Nuclear Regulatory Comission Washington, D.C. 20555

Dear Mr. Stello:

SUBJECT:

"BELOW REGULATORY CONCERN" AND "DE MINIMIS" CONCEPTS Enclosed is a report of the ACRS Subcomittee on Waste Management relative to the NRC Staff's position paper on the applicability of "below regulatory concern" and "de minimis" concepts to Comission policies. This report was provided to the ACRS during its 337th meeting, May 5-7, 1988.

These comments are based en a review of your memorandum (SECY-88-69) of March 8,1988, as well as a meeting held by the Subcomittee with the NRC Staff on May 4, 1988. Since the information it contains may be of interest, we are also enclosing a memorandum from M. Steindler to D.

Moeller dated May 6, 1988.

The ACRS Members hope you will find this material useful.

Sincerely, N

Raymond F. Fraley Executive Director

Enclosures:

1. Report dated May 5, 1988 of the Meeting of the ACRS Subcomittee on Waste Management on May 4, 1988
2. Memorandum from M. Steindler to D. Moeller dated May 6, 1988 cc, w/ encis.

S. Chilk, SECY H. L, Thompson, NMSS i R. Bernero, NMSS  !

G. Lear, NMSS E. S. Beckjord, RES ,

J. Larkins. OCM 1 M. Lopez-Otin, OCM l J. Scarborough, OCM l J. Kotra, OCM i

, OCM DESIC HTED ORIGIXAL y yse c ,-- ,, sm l

Dated: May 5, 1988 REPORT OF MEETING 0F THE THE ACRS SUBCOMMITTEE ON WASTE MANAGEMENT MAY 4, 1988

1. Introduction During a meeting on May 4,1988, the Waste Management Subcomittee of the Advisory Committee on Reactor Safeguards met with the NRC Staff to discuss the applicability of de minimis and Below Regulatory Concern (BRC) concepts to Comission policies. Members of the Subcomittee participating in this meeting were Dade W. Moeller, Chairman, Forrest J.

Remick and Martin J. Steindler, members. Serving as consultants and expert advisors to the Subcomittee were Melvin W. Carter, Richard F.

Foster, and Frank L. Parker. Sumarized below are the observations and suggestions made on this subject by the Subcomittee as a result of discussions that took place during this meeting.

II. Responses to Questions in SECY-88-69 As part of its deliberations, the Subcomittee addressed each of the six issues enumerated in the memorandum of March 8,1988, from the EDO to the Commissioners. These issues and the coments of the Subcomittee on each are given below.

Issue #1: "What benefit would be realized in establishing a generic BRC level as opposed to source specific levels (e.g., low-level waste streams, decomissioned lands and structures, recycled materials and equipment, consumer products, etc.)?"

Response: The Subcomittee strongly recomends addressing this matter on a generic basis. Advantages of this approach include:

(a) It would enable the NRC to set down relevant basic criteria and ap-proaches.

(b) It has the potential for providing a mechanism for bringing consistency to the establishment of a BRC level for each of the multitude of sources and practices being addressed, i.e., it would enable the BRC level for each s.ource or practice to be part of a systematic pattern.

(c) It would avoid the necessity of holding rulemaking hearings on the establishment of a BRC level for each source or practice.

Issue #2: "Of the possible ways to express BRC levels (e.g., cancer risk, individual dose, collective dose, exempted quantities or concentrations), which are appropriate for the various sources or practices licensed by NRC?"

ENCLOSURE 1

REPORT ON WASTE MAN'AGEMENT 2 Response: The Subcomittee believes that the BRC level should be expressed in terms of the health risks to an individual. Such an ap-proach would have several advantages:

(a) It would permit all sources and practices to be treated on a comparable basis.

(b) It would permit comparisons to be made bctween the BRC level for radioactive and other toxic (nonradioactive) substances.

(c) It would avoid the necessity of changing the BRC level as new data are developed on the quantitative relationship between radiation doses and their associated health effects.

Tc implement this approach, it would be necessary for the NRC Staff to develop a hierarchical system of supplementary guidance, similar to that recommended by the ACRS in the development and implementation of the Safety Goals for nuclear power plants. This hierarchical system would include secondary or tertiary guidance in the form of dose limits, radionuclide concentration limits, limits for surface contamination, etc. In this regard, we applaud the adoption by the NRC Staff of the effective dose equivalent as a means for expressing both single organ and whole body exposures.

Issue #3: "Given the complexity of some licensed activities, some of which may involve multiple contribution to public dose, what are the most useful definitions of ' sources' and ' practices' for which BRC dose limits would be developed?"

Response: We believe that the draft report of the Nuclear Energy Agency / International Atomic Energy Agency (NEA/IAEA) Expert Group on "Exemption of Radiation Sources and Practices from Regulatory Control" offers a useful beginning for the development of definitions of "sources" and "practices." The Expert Group defined a "practice" as:

"a set of co-ordinated and continuing activities involving radiation exposure which are aimed at a given purpose, or the combination of a number of similar such sets." ,

i And the Expert Group stated that a "source":

"is simply the radioactive material, the equipment emitting  :

radiation or containing radioactive material or the i installation (or group of installations) producing or using i radioactive material..."

Following this approach, the Subcommittee believes that a "source" might be defined as:

"a physical entity that can be separately regulated or controlled."

i REPORT ON WASTE MANAGEMENT 3 l i

Issue #4: "If cost vs. risk reduction analyses are to be performed to establish BRC levels, what cost-averted / risk ratio (or ratios) should be used for the various licensed sources or practices?"

Response: Although we foresee the need to apply optimization evaluations (cost vs. risk reduction analyses) in the initial efforts to establish an appropriate BRC level for a range of cicsses of sources and practices that involve radioactive materials, once this effort is completed on a generic basis there should be no need to repeat it for the subsequent evaluations of individual sources and practices. In particular, we see no need to apply optimization techniques to sources or practices whose associated risks fall at or below the applicable BRC level. To establish the cost-averted / risk ratio (or ratios) that should be used in such analyses, we recomend the use of rulemaking hearings.

The documents supporting the establishment of Title 10, CFR Part 50, Appendix ! indicated that such hearings were to be held. So far as we know, this has never been done.

Issue #5: "What approach should be taken to translate operational BRC levels (such as individual or collective dose or exempt quantities and concentrations) into fatality or cancer risks given the absence of data correlating such levels with risk (i.e., do we use the linear non-threshold dcse-response relationship at very low doses)?"

Response: Although we realize that the assumption and application of a Tinear relationship has limitations, at the present time we know of no approach that is demonstrably superior. To assure that the risk coefficient applied in the associated calculations is acceptable, the Comission might consider requesting the support and assistance of an independent group such as the National Council on Radiation Protection and Measurements, or the Comittee on Interagency Radiation Research and Policy Coordination (CIRRPC).

Issue #6: "Can a dose or risk be set at which radioactivity can be ignored (i.e., can a definition of radioactivity be usefully established)?"

Response _:_ The Subcomittee strongly recomends that the NRC concentrate its efforts on the establishment of a BRC level, leaving the matter of the establishment of a de minimis level to other groups such as the U.S.

Environmental Protection Agency or an interagency comittee (such as CIRRPC). So far as we know, the NRC does not need to define at this time the conditions under which a material or substance needs to be considered "radioactive." Should special circumstances show that such a definition would be useful, we would recomend that the concentration (2 nCi/g) specified by the Department of Transportation (and cited in 10 CFR Part 71) be used.

III. Additional Coments In the way of additional coments, the Subcomittee offers the follow-ing:

REPORTONWASTEMANAGEMENT 4

1. Although the Subcommittee fully endorses the undertaking by the NRC of an effort to establish a BRC level, we believe it is important to recognize the complexity of this task. In essence, this effort is designed to answer the question, "How Safe is Safe Enough?"

Whereas the establishment of Safety Goals for nuclear power plants answered this question for that portion of NRC's licensing respon-sibilities, the current effort is designed to answer the same ques-tion for a host of other sources and practices, some of which will apply to individual sources and practices at nuclear power plants.

Since the Safety Goals for nuclear power plants appear to have gained wide acceptance, we would urge that the BRC level, under consideration here, reflect a health risk comparable to these Goals. Such an appreach would constitute a first step for bringing consistency to the regulation of a multitude of sources and prac-tices currently being addressed on an individual (and sometimes unecordinated) basis. Further, we believe that attaining general consister.cy among the various public risk goals being established by the NRC would represent a major contribution towards improved national regulation and towards increased respect for the regula--

tory process.

2. We recommend that the Comission concentrate on the establishment of a BRC level that places a limit on the health risks to individ-ual members of the public. Such an approach, in our opinion, will assure that the associated collective doses are acceptable.
3. In the draft NEA/IAEA report, the suggestion was made that varia-tions in the doses from natural background radiation could be used as a basis for the establishment of a BRC level. As stated above, we believe that consideration of the associated health risks to individuals can serve as a better basis for the establishment of such a level.

Should the NRC decide, however, to use variations in natural background as one of several bases for setting a BRC level, we believe it is important to restrict these considerations to vari-ations in the ambient (outdoor) natural background radiation. In our opinion, the consideration of variations in radiation dose rates inside buildings, which include "technologically enhanced" sources such as radon, would be inappropriate.

4. Regardless of the level ultimately considered to be BRC, it should be recognized from the onset that it will be impossible (with current technology) to measure the associated doses. Major re-liance will have to be placed on mathematical models for estimating impacts individually and collectively on members of the public that arise as a result of the movement of radionuclides through a

' variety of environmental pathways under a range of scenarios. For this reason, it is important that such models, and the associated computer codes, be evaluated and validated. Included in such evaluations should be a determination of the uncertainties associ-ated with the final dose estimates.

REPORT ON l.'ASTE MANAGEMENT 5

5. One characteristic of sources or practices that we believe should be included among the considerations taken into account in the establishment of secondary or tertiary guidance, is the matter of the half-lives of the radionuclides involved. Whereas radionu-clides, such as 6%o, once released into the environment can be expected nviro eat within a matter oftodecades, decay and thus and be "removed" radionuclides from such asthegSr and 3/ Cs will decay wignPu, a matter of several represent centuries, what must long-lived be considered materials, as "pennanent" such as contamination. Although evaluating the associated risk of ex-tremely long-lived radionuclides on the basis of their lifetime dose coninitment tends to compensate for this concern, it may well be that guidance for the control of these radienuclides should be more restrictive than that for sources and practices involving shorter-lived materials. Once released, long-lived materials represent a dose commitment to existing as well as to future generations.
6. It should also be recognized that the establishment of a BRC level, and the declaration that a given source or practice falls into this category, is not an action that is to be taken once and for all.

The NRC Staff should be asked periodically during subsequent years to reexamine given sources and practices to assure that the antici-pated characteristics and behavior of these sources and practices continue to be as originally assumed. Where changes and/or defi-ciencies are found, suitable adjustments should be made.

7. On the basis of our review, it would appear that, depending on the source or practice, health (fatal cancer) risks that would be representative of an acceptable BRC level would be less than 10 6 per year. Correspo thus be less than 10-gding acceptable lifetime health risks would i

,