ML20214R504

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Value Impact Statement for Proposed Reg Guide 8.XX, Info Relevent to Assuring That Occupational Radiation Exposures at Medical Institutions Will Be Alara. No Adverse Impact of Guide on Any Medical Institutions Predicted
ML20214R504
Person / Time
Issue date: 02/02/1977
From:
NRC OFFICE OF STANDARDS DEVELOPMENT
To:
Shared Package
ML20214R475 List:
References
REGGD-08.018, REGGD-8.018, NUDOCS 8609290194
Download: ML20214R504 (9)


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VALUE II:?ACT STnicm..a r0u FEDFOSED REGULATORY GUIDE 8.XX, I ;F0?J'.ATIO: RELEVAi!T TO A35:.!RI!!G TFAT OCCUPATICI AL RADIATI0ft EXPOSURES As MEDICAL INSTITUTI0 tis WILL BE AS LCW AS IS REA50::A5LY ACHIEVABLE f I. VALUE_ ,

This Regulatory Guide has been prepared to provide medical institutions ...

that have not already developed adequate programs for. achieving ALARA occupa- ,

tional exposures with ready access to the core imdortant safety procedt$'res for various types of activities in hospitals us-hng licensed radioaciiive .

materials. In addition to a su=ary of the 5cre important things to do 'a ,

. :chieve ALARA exposures, a list is provided of tha more important reco=enda-tiens .and guides, rnd addresses of where to obtain them.' This information -

l' provides the licensee with the necessary data and information to establish adequate radiation safety proc 5dures for it.eeting ALARA exposures and ,

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satisfying regulatory and licensing requirements. - - -

~The values of this guide include all of the geneial,' values that ,

constitute the aim of the regulatory guide series: ,

a) Appropriate guidance is very helpful in the,. selection of optimum ,

radiation safety procedures and in the reduction of overdesign or l

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inefficient desi5n of fa'cilities and equipment; , ,

b) Codification and standardization of procedural and equipment b

- reco=endations reduces misunderstanding of licensing requirements . j .? ~

s and results in less waste of effort by both the applicant and the l i

f NRC licensing staff; -

c) Ready reference to the dore important ALARA exposure efforts pertinent to respective facilities, and listed separately for each

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l t;9e of facility, makes it easier for the licensee to satisfy ALARA exposure and licensing requirements to reduce employee (and other) .

radiation ex;:osures. -

d) The issuance of a Regulatory Guide on this topic provides the much needed NRC staff position as to what is meant, in the ca'se of medical, licensees, by 520.1(c) of 10 C.R Part 20, which states that licensees ,

should maintain occupational exposures as icw as is reasonably .

achievable. .

e) The staff believes that issuance of this Suida will effect.a ,

substantial reduc' tion in occupational expcsure's at certain medical -

i licensee facilitie's. t There is evidence that, despite past NRC and state, regulatory efforts and

  • NCRP recommendations, there is still,a wide variation in the degree to which individual nuclear medicine departments,(1) and individual medical institu-

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tiens in general,(2,3,4) adhere to ALARA philosophy. The fact biat scme . -

. medical licensees are performing their work with lower radiation doses than  ;.

others clearly indicates that improvement is achievable. -  !

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- Using an average exposure for nuclear medicine employees of 0.5 Rem / year,(1'c' -

an average of more than 7 employees working with NRC-licensed radioactive (

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.. materials al'oneII) per licensed medical institution, and about 3,000 NRC-licensed institutions, we may estimate on the order of 10,000 man-rems j occupational exposure from nuclear medicine procedures alone. (Exposure from l

additional licensed and non-licensed radiation sources in all medical .

institutions in the United States may be an order of magnitude higher.)

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Exposure per mci of Tc-99m administered.has been shown to vary by a factor of more than 60 betaeen 47 nuclear medicine departments surve

, 1968-73 period, and Average exposures per employee increased about 25% over the the integrated population (man-rem) dose increased 60% over the same .

Pariod.(I) The use of licensed radionuclides in medical institutions is

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increasingatarapidrate.(1)

While the unnecessary dose is increasing, the average exposure oer mci _ '

infected has actualiy decreased from 0:47 mR/ mci to 0.11 mR/ mci,U) and l

estimated further reduction in Tc-5'9.m exposures from 0.11 to 0.05 mR/ mci should be possible through the use of good radiation protection practice and l

properly planned facilities.U '0) This indicates that a factor of 2 reduction Other authors have is probably achievable in the administration of Tc-99m.

also discussed the possibilities for reducing exposures from other radiation

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sources in hospitals, as well as from Tc-99m.(7-12) s Thus, it would seem reasonable i:o expect that expo'ure reductions ,of several thousand man-rems may result from the publication of this ALARh

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. regulatory guide, which condenses into compact sections of one document t e '

major recom:.endations of good radiation safety practice from over 50 literature sources and standards, as well as staff licensing and he' spital

- . _.. j experience. - )

s II. IMPACT There should be no adverse impact of this guide on any medical institu-

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tien. Those medical institutions which, as indicated in the discussion section of, the gu,ide, have provid[d leadership in determin,ing proper radiation safety procedures will already have established the programs reco::nended by

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. the guide. No new regulatory requirsments 'that should cost money or' extra ,

time are included, since the recomendations can be found in one place or ,

another in the already-established references cited, which basically document hospital experience in those institutions carrying out their sa'fety responsibilities. The new license applicant, or hospital whose program is expanding, will be encouraged by. this guide to provide better facilities, ,

equipment and staffing in order t'o carry out. regulatory requirements, license 7:

$G.i conditiens, and ALARA objectives. Experience has indicatdd that provision .M.

@,s of proper sta'ffing and facilities in the areas of radiation safety (and I .~.

associated medical physics) does not necessarily add to overhead costs, but

=ey instead pr6 vide savings in the economy of operation of equipment and facilities and icwer maintenance and repair costs. Ice (13) has shown in a large university-medical complex that a properly organized and staffed Radiation Safety Office actually reduces costs by providing uniform standards jf;'.

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and procedures, centralized control and processing of orders for radio- '

nuclides, professional consultation on research uses of radionuelides, and other services that would other< rise be paid for by individual investigators or physicians. A net favorable irpact on' health services may also accrue

, from the addition of science and engineering competence in using the many t>

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.. scientific tools in today's hospital.

The attached pagesII4) indicate a medical profession (ACR) opinion of ....

the need and value of additional staffing in medical physics in hospitals.

l In most hospitals, the medical or radiological physics staff also carries at least part of the radiation safety responsibilities, and there is an .

! i l interrelationship between the adequacy of the radiation safety program and I management's recognition of staffing and facility requirements.

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. i REFEREflCES

l. R. C. Barrall, L. H. Lan::1, and J. W. Hilbert, "A Survey of Personnel I Exposure in f;uclear Medicine," a special cc mittee report to the American ,

Association of Physicists in Medicine, August 3,1975. i f

2. S. R. Amtey and M. D. Douglas, " Personnel, Space, and Budget Needs of a University Radiaticn Safety Program," in P. L. Carson, W. R. Hendee, and D. C. Hunt, Eds. , " Operational Health Physics," Proceedings of the Ninth . , ,c Midyear Topical Sy=osium of the Health Physics Society, Feb. 9-17., 1976 ..

9.

- - (available from Central Rocky Mountain Chapter, Health Physics Society, P. O. Box 3229, Boulder, Colorado 80303). This reference also discusses . a medical institution programs in university medical centers. ' ..7;

3. F. C. Watts, "An Analysis of the Roles and Responsibilities of the .

Medical Center Health Physicists," Health Physics 29,, 924, 1975.

4. A. Brodsky, S. Levin, and E. D. Durkosh, " Staff and Facility Rec;uirements

. ~ for Radiation Safety in Hospitals," Health Physics 29,,9 924, December 1975. l .

5. R. P. Specht and A. Brodsky, " Log-Nomal Distributions of Occupational .

Exposure to Medical Personnel," in press, Health Physics,1975. '

6. R. C. Barrall and S. I. Smith, " Personnel Radiation Exposure and Protection .

from Tc-99m Radiation," presented at the annual meeting of the American- I.T.~..

- Association of Physicists in Medicine, San Antonio, Texas,1975 (available -

- from Office of Health Physics, Safety and Health, 67 Encina Hall, Stanford University, Stanford, California 194305). -

7. J. St. Germain, "Ocerational Health Physics in Diagnosis," in DHEW
Publication (FDA) 73-8029, " Health Physics in the Healing Arts," proceedings of the Seventh Midyear Symposium of the Health Physics Society, San Juan, .

Puerto Rico, Dec. 11-14,1972 (available from Bureau of Radiological  !-

Health, FD.f., DHEW, 5600 Fisher's Lane, Rockville, Maryland 20852). .

l E. Watson, " Radiation Doses from Nuclear Medicine

8. R. J. Cloutier and E. p..

Procedures," in DHEH Pub. 73-8029, o.o_. cit., pp 71-78.

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.. 9. F. Dobrowolski, " Health Physics in Radiotherapy," ibid., pp 200-202. .-

10. M. G. Mayes, R. L. Douglas, M. W. Carter, T. h. Grady, and E. van der .

1 Smissen, " Study" of Radiation Exposure from Technetium Generators at Three' Ho,spitals," ibid., pp 222-226. .

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11. M. H. Lombardi, W. L. Beck, and R. J. Cloutier, " Survey of Radiophar-maceutical Use and Safety in Sixty-Nine Hospitals," ibid. , pp 227-226.

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12. 3. C. Fasiska, " Radiation Safety Procedures and Centcmination Centrol
  • P:::tices Incalved in High Level I-131 Therapy Cases," in P. L. Carson, W. R. Hendee, and D. C. Hunt, Eds. , co_. n cit. , pp 227-291. . .
13. R. Ice, " Establishment of a University Radiation Safety Office," Health -

Physics 20, 444-446, 1971. (Tni's paper also discusses a program enco: passing a large university medical center c:= plex.)

14. DHEW Publication No. (FDA) 74-8014, l' Status and Futum Manpower Needs of Physicists in Medicine in the' United States," Preface by William S. Cole,-

M.D., 1973. . . .

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DI!EW Publicatien No. (FDA17?S014 l

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STATUS and FUiURE 7 .5 E .. } -

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MANPOWER NEEDS ' gggj-l of PHYSICISTS in MEDICINE l ..

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in the UNITED STATES

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.l-by The Joint Cc-4: tee on Hanpower Needs in Medical Physics ,

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. The A=erican Collece of ?.adieleer and  !

The A=erican Associatien of ?hysicists in Medicine j

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Division of ?.adioactive Materials and Nuclear Medicine ..

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.NOVEF=R. 1973 . .

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U.S. DEPARTMENT OF llEALTi!. EDUCATION, AND WELFARE  :.

Public IIesith Servie.e .

FOOD AND DRUG ADMINISTRATION . l*

. Bureau of Radiolo5i cal lieulth -

Rockville, Eryland 00352 .

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PREFACE -

' This publication contains-the final report of the American College , l of Radic1c y in ecepcration with the Amerienn Association of Physicists  !

in Medicine on the Sta:us The andwork Pu:ure for SisManpowerpublication Needs was con- of Physicists [in i .

ledicine in ducted asthe United part of the States. continuing rndiological heal $ education project ofj ,

21e American College of Radiology and supported The primary by the Bureau of t l.

Radiological IIealth through contract PH 86-6'T-202. p' purpose of this study was to provide a basis for describ .

Included in the report is an estimate of the manpower needs for l physicistsThis and the influence of these needs on medical physics} training r

estimate, based on the ratio of physicists to patient r programs.

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radiologic procedures at the responding If.Se recommendation institutions, reflects the present_

of the~'Eport , ' bjip . .f under-utilication of the crofession.

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'(onc mecical physicist for each 300-bed hospital) is generally f adopted,  : 4 a doubling of this ratio may be considered However, the_ conservative..;in <

g av .ilable capacity for training medical physicists. d -

potential cf staff chysicis:s to increase cuality of calien: cars re uce j j

"c5 ec, cT.C IOCreE5d eli1Cidncv of COeration canno; be b racla!10 l reanned - r-rui thi succort c: nospnal ac=inistra: ors, Also

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anc secrec" .. 2 -ancies. l j ...

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oTEdicie r~ decar:=en:s. anc it~~ - 2neeccc. are cot.acera::ve worr.mg i rela:

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! 'ogists and radiologic engineeis in both hospitals and industry.

This report is a continuation of supportive manpower activities in  ?. c medical physics initiated by the Screau of Radiological Health i l with publicatien of the 1965 "ResearchI hope Report this on thewill Training of Radiolog@ca report be l

Physicists," prepared by E. M. Parker.useful -, - ~

in furter prc=cting the

.I rol f - medical radiation. . '

. :a Mr. William C. Stronach (ACR), Mr. William K. Melton (ACR),' ' :lN Dr. Peter Almond (President, AAPM), and Dr, Robert D. Moseley *

(University encouragement.

of Chicago) deserve special thanks for their supp ,

vided valuable advice on questionnaire layout and workup of computer  ;

data.

Dr. William Van de Riet, Postdoctoral Fellow in Radiation [j Physics at the University of Cincinnati. The efforts ofprovided all AAPM valuable aid in data ,

analysis and graphic presentation. ed themembers question-l- and Regional Medical Program Directors who com naires are appreciated. ,

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i Acting Director . '

Division of Radioactive Materials and Nuclear Medicine

, Bureau of Radiological Health I

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SlNMARY ANALYSIS OF PilllLIC C0fMENTS ""

REG GUIDE 8.18 NUREG-0267 i TOTALS 30 27 I. FAVORABLE

a. Includes Suggestions for Changes 26 21
b. No Suggestions Given 4 6 II. NEUTRAL TOTALS 25 18
a. Includes Suggestions for Changes 23 16
b. No Suggestions Given 2 2 i III. UNFAVORABLE TOTALS 7 6
a. Includes Suggestions for Changes 3 3
b. No Suggestions Given 4 3
  • Favorable - generally feel document is helpful; Unfavorable - document generally detrimental (value < impact)
    • Inc1 tales letters of comment received from the public between January and July,19'/8. ,

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