ML19275A388
| ML19275A388 | |
| Person / Time | |
|---|---|
| Issue date: | 08/31/1979 |
| From: | NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| RTR-REGGD-8.026, TASK-OH-714-4, TASK-OS REGGD-08.XXX, REGGD-8.XXX, NUDOCS 7910040235 | |
| Download: ML19275A388 (9) | |
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U.S. NUCLEAR REGULATORY COMMISSION f
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OFFICE OF STANDARDS DEVELOPMENT August 1979
,c Division 8 1
$,8 DRAFT REGULATORY GUIDE M40 VALUE/ IMPACT STATEMENT Task OH 714-4
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APPLICATIONS OF BI0 ASSAY FOR FISSION AND ACTIVATION PRODUCTS A.
INTRODUCTION Section 20.108, " Orders Requiring Furnishing of Bioassay Services," of 10 CFR Part 20, " Standards for Protection Against Radiation," states that the Nuclear Regulatory Commission may incorporate in any license provisions requir-ing bioassay measurements as necessary or desirable to aid in determining the extent of an individual's exposure to concentrations of radioactive material.
As used by the Commission, the term bioassay includes in vivo measurements as well as measurements of radioactive material in excreta.
This guide identifies the bases tihat will be used by the NRC staff in evalua-ting the need for incorporating in licenses provisions to require bicassay pro-grams in installations where employees may be subject to intetrnal radiation expo-sure from the inhalation or ingestion of fission or neutron activation products.
The guide also describes methods acceptable to the NRC staff for determining the persons to be included in a bioassay program, sampling and measurement tech-niques, the frequency of bioassay measurements, actions based on designated levels of internal radioactivity, estimations of internal dose calculated from bioassay measurements, and record systems appropriate to such bioassay programs.
B.
DISCUSSION Working Group N343, a subcommittee of the Health Physics Society (HPS) Stand-ards Committee, of the American National Standards Institute (ANSI) developed a standard
- presenting requirements and recommended practices for the surveillance
- Copies of ANSI N343-1978, " Internal Dosimetry for Mixed Fission and Activation Products," are available from American National Standards Institute, 345 East 47th Street, New York, N.Y. 10017.
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This regulatory guide and the associated value/ impact statement are being issued in draft fann to involve the public in the early stages of the development of a regulatory position in this area. They have not received complete staff review and do rot represent an official NRC staff position.
Public corr *ents are being solicited on both drafts, the guide (including any implementation schedule) and the value/ impact statement. Convents on the value/ impact statement should be accompanied by supporting dat'
- 0ments on both drif ts should be sent to the Secretary of the Comission U.S. Nuclear Regulatory C oc..
- ion. Washington, D.E 20555. Attention
- Docketing and Serv'ce Cranch, by0CT 2 s 1]B Recuests for single copies of issued guides and draf t guides (which may be reproduced) or for placement on an automatic distribution list for single copies of future guides and drift guides in specific Jivisions should be made i i writing to the 'J.S. *1uclear Regulatory Comission Washington, D.C. 20555, Attention:
Director. Division of Technical Information and Cocument Control, s v $v1 v e s
and protection of employees of licensee installations where fission or activa-tion products may be processed or handled in unencapsulated form.
This standard was approved by ANSI in January 1979, and NRC staff review has indicated that the standard's provisions in these areas are adequate.
C.
REGULATORY POSITION Bioassay programs that meet the requirements and recommendations of ANSI Standard N343 are acceptable for complying with license provisions pursuant to 10 CFR @ 20.108 that may require bioassay for any fission or activation product radionuclides listed in this standard.
However, for compliance with NRC require-ments, paragraph 6.2.2 dealing with the selection of individuals to be included in the bioassay program should be interpreted as follows:
"All facility personnel who routinely enter bioassay areas for routine operations, or for maintenance work, are to be scheduled for in vivo measurements in accordance with the minimum bioassay program.
For non-routine entries, the health physicist shall determine the need on a case basis."
The ANSI standard recommends in Sections 11 and 12 that "As more repre-sentative morphological and metabolic parameters become available, these should be substituted for the ones suggested here" and that "The organ burdens, reten-tion functions, dose rates, and dose commitments shall be based on ICRP models when specific data are unavailable." Since the International Commission on Radiological Protection (ICRP)* methods presented in the ANSI standard were devel-oped, more recent data and methods of calculation (Refs. 1-13) have been pub-lished by the scientists involved in the continued development of methods of e
internal dosimetry, including some new calculations for the ICRP and the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.*
In cases where any direct or indirect bioassay measurements indicate that an individual may receive more than 10 percent of any permissible internal dose
- Publications of the International Commission on Radiological Drotection (ICRP) listed in this guide, in the ANSI standard, or to be published in the future, may be ordered from Pergamon Press, Inc., Maxwell House, Elmsford, N.Y. 10523, or through bookstores in the USA.
Publications of the MIRD Committee may be obtained from Medical Internal Radiation Dose (MIRD) Committee, Society of Nuclear Medicine, 475 Park Avenue South, New York, N.Y. 10016.
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I limit, the additional references listed in this guide, as well as the methods and references of the ANSI standard, should be consulted to determine the most accurate methods of internal dose assessment for the radionuclide(s) and condi-tions of exposure involved.
In some cases, more than one method of evaluation may be required to properly assess internal exposures.
All methods of internal dose assessment, as well as all data used in the assessments, should be clearly referenced and recorded as part of the records systems recommended in Section 16 of the ANSI standard.
D.
IMPLEMENTATION The purpose of this section is to provide informaticn to applicants regard-ing the NRC staf f's plans for using this regulatory guide.
This proposeu guide has been released to encourage public participation in its development.
Except in those cases in which an applicant proposes an accept-able alternative method for complying with specified portions of the Commission's regulations, if' method to be described in the active guide reflecting public D
comments will tm used in the evaluation of license applications on licensee bio-assay programs after the implementation date to be specified in the active guide.
Implementation by the staff will in no case be earlier than February 28, 1980.
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REFERENCES 1.
L. T. Dillman, and F. C. von der lage, Radionuclide Decay Schemes and Nuclear Parameters for Use in Radiation Dose Estimation, NM/MIRD Pamphlet No. 10, Society of Nuclear Medicine, New York, September 1975.
2.
M. J. Martin, Nuclear Decay Data for Selected Radionuclides, ORNL-5114, Oak Ridge National Laboratory, Oak Ridge, Tennessee 37830, March 1976.
3.
D. C. Kocher, Nuclear Decay Data for Radionuclides Occurring in Routine Releases from Nuclear Fuel Cycle Facilities, ORNL/NUREG/TM-102, Oak Ridge National Laboratory, Oak Ridge, Tennessee 37830, August 1977.
4.
M. R. Ford, S. R. Bernard, L. T. Dillman, and S. B. Watson, Internal Dosimetry and Methods of ICRP - Part I, ORNL/NUREG/TM-315, Oak Ridge National Laboratory, Oak Ridge, Tennessee 37830, June 1979.
5.
W. S. Snyder, M. R. Ford, G. G. Warner, and S. B. Watson, A Tabulation of Dose Equivalent per Microcurie-Day for Source and Target Organs of an Adult for Various Radionuclides:
Part I, ORNL-5000, Oak Ridge National Labora-tory, Oak Ridge, Tennessee 37830, 1974.
6.
S. Snyder, M. R. Ford, G. G. Warner, and S. B. Watson, A Tabulation nf Dose Equivalent per Microcurie-Day for Source and Target Organs of an Adult for Various Radionuclides:
Part II, ORNL-5000, Oak Ridge National Labora-tory, Oak Ridge, Tennessee 37830, 1975.
7.
S. B. Watson, W. S. Snyder, and M. R. Ford, TIMED:
A Computer Program for Calculating Activity of a Radionuclide in the Organs of the Human Body at a Given Time, t, Af ter Depositig, ORNL/CSD/Til-17, Oak Ridge National Laboratory, Oak Ridge, Tennessee 37830, 1976.
8.
W. S. Snyder, M. R. Ford, G. G. Warner, and S. 8. Watson, "S", Absorbed Dose per Cumulated Activity for Selected Radionuclides ar-Organs, NM/MIRD Pamphlet No. 11, Society of Nuclear Medicine, New York, 1975.
9.
N. Adams, B. W. Hunt, and J. A. Reissland, Annual Limits of Intake of Radionuclides for Jorkers, NRPB-R82, National Radiological Protection Board, Harwell, Didcut., Oxon, OX11 ORQ, England, October 1978.
10.
G. G. Killough, D. E. Dunning, Jr., S. R. Bernard, and J. C. Pleasant, Estimates of Internal Dose Equivalent to 22 Target Organs for Radionuclides Occurring in Routine Releases from Nuclear Fuel-Cycle Facilities, Vol.
1, ORNL/NUREG/TM-190, Oak Ridge National Laboratory, Cak Pidge, Tenneasee 37830, June 1978.
11.
G. G. Killough, D. E. Dunning, Jr., and J. C. Pleasant, INREM II:
A Computer Implementation of Recent Models for Estimating the Dose Equivalent to Organs of Man from an Inhaled or Ingested Radionuclide, ORNL/NUREG/TM-84, Oak Ridge National Laboratory, Oak Ridge, Tennessee 37830, 1978.
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l DRAFT VALUE/ IMPACT STATEMENT 1.
SUMMARY
AND CONCLUSIONS The development of ANSI Standard N343, " Internal Dosimetry For Mixed Fission and Activation Products," has been carried out by the Health Physics Society's Standards Committee (HPSSC) on a high priority basis and was approved by ANSI for publication in 1979.
This guidance is needed to facilitate the licensing process, since differing methods of measurement and interpretation for these nuclides are carried out in different licensee facilities.
NRC staff members have participated in the work performed by the HPSSC working group and have collected NRC staff comments on the draft standards for ANSI.
Staff comments from the Office of Nuclear Reactor Regulation (NRR) indicate that the ANSI standard is satisfactory for adoption as a regulatory guide, with the single interpretation of individuals to be bioassayed, a,s stated in the draft guide.
The adoption of the proposed guide would replace interim informal guidance provided by the staff.
I 2.
DESCRIPTION OF THE PROPOSED ACTION 2.1 The Proposed Action To adopt ANSI Standard N343 on bioassay for fission and activation products as a regulatory guide.
2.2 Need for the Proposed Action
.W To alleviate present uncertainties and conflicts in judgment between various licensees and various professionals in establishing bioassay requirements and interpreting compliance for exposures to different fission and activation product racionuclides as discussed further in Section 4 below.
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I 2.3 Relevant NRC Statutory Authority The Atomic Energy Act.
2.4 Requirement for NEPA Assessment There is no requirement for NEPA assessment; appraisal indicates that the proposed action would not significantly affoct the quality of the human environment.
3.
ALTERNATIVES TO THE PROPOSED ACTION 3.1 No Action This alternative would simply allow present uncertainties and conflicts in judgment between NRC staff and some licensee installations to continue.
Delay at this time in the development of interim guidance would not be likely to I
result in better guidance in the future, since considerable professional research and review is already incorporated into the ANSI standard.
Develop-ment of such guidance at this time would not preclude later revisions to include improvements in bioassay program recommendations, or further precision in dose assessment when more radiobiological data or better methods of measure-ment become available.
3.2 Prepare a Different NRC Version This action would ignore the NRC staff review and participition already incorporated into the ANSI standard, as well as input and information from other experienced professional ANSI subcommittee and committee members, without any prospect of producing more acceptable or safer guidance.
3.3 Alternatives Judged Viable 1099 0P;6 The staff believes that the ANSI Standard N343 should be adopted by publica-tion of the proposed guide for comment, with the minor interpretation paragraph as indicated in Section C of the proposed guide.
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4.
PROBABLE VAltlE/ IMPACT OF THE PROPOSED ACTION AND VIABLE ALTERNATIVES l
4.1 Value The need for a bioassay guide for fission and activation products has been evident for many years fiom the different methods of monitoring and evaluating internal exposures from fission and activation product radionuclides in various licensee radiation safety programs.
The recognition of this need has recently resulted in the development of the ANSI Standard N343 by the HPSSC.
NRC staff members have participated in the meetings of the HPSSC working group and have contributed and received information related to the development of this stand-ard.
Comments from other NRC offices have also been incorporated into the published version of ANSI N343.
The standard includes recommendations regarding the types of activities requiring a bioassay sampling program, what ir.Jividuals should be included in the sampling program, analytical methods and methods of dose evaluation, action levels, recordkeeping requirements, and other data and procedures that need to
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be provided as part of a general program of monitoring internal exposure from the radionuclides included in the scope.
The values of the proposed action also include the value of regulatory guides in providing more efficient regulatory actions and decisions, as well as providing a convenient reference for the licensee or license applicant in designing his program to meet regulatory requirements and standards of good safety practice.
4.2 Impact From the discussion in Section 4.1 above, there are reasons to expect that there would be a net benefit (economic as well as health) from the proposed action to employees, industry, government, and the public.
This is especially true since any of the licensees who may be required to initiate new bioassay programs are likely to already possess equipment, methods, or contractual arrange-ments with bioassay laboratories.
Also, as a result of the standardization of
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acceptable methods of evaluation for regulatory purposes, the licensee will be able to choose an easy, yet safe, method for evaluating, recording, and report-ing results of urinalysis or whole body counting data that will be acceptable to NRC as well as appropriate for regulatory and legal recordkeeping require-ments.
This will in turn provide an easier and more consistent set of records for review by NRC inspectors.
It is expected that the interim guidance and ultimate standard will result in more frequent bioassays for some licensees and less frequent bioassays for others.
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