ML20206J312

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Transcript of 881019 Proceedings of 881017-19 Workshop on Rules for Exemption from Regulatory Control in Washington,D.C.Pp 414-489
ML20206J312
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Issue date: 10/19/1988
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l UNITED STATES

[C NUCLEAR REGULATORY COMMISSION emmem================mmmmm............. ,,,,,,,,,,,______

In the matter oft )  ;

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i WORKSHOP ON RULES FOR )

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i l' ages 413 through 489 '

Place: Washington, D.C.

Date: October 19, 1988 l

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Ut3ITED STATES fiUCLEAR REGULATORY COMMISSIOli flUCLEAR EllERGY GEllCY WORKSHOP Oil RULES FOR EXEMPTICll FROM REGULATORY CONTROL Wednesday, Octobr>r 19, 1988 i

PAllO Conference Facilities 525 23rd Street, ta.4 r Washington, D.C.

The above-entitled matter came on for hearing, pursuant to notice, at 9:00 a.m. >

ATTEtIDEES CHARLES E. ADER  !

Tech. Asst. To Commissioner Thomas M. Roberts U.S. IIRC 11555 Rockville Pike Itoc kv ill e , MO 20852 ROBERT C. ALEXA!! DER f Special Asst. to the Director i Offico of Governmental and Public Affairr U.S tlRC 11555 Rockville Pike i Rockville. MD 20852 '

. t JOliti AUSTIri Special Asat. to the Director  !

Office of fluc lear Material Safety and Seieguards  !

U.S. IIRC 11's55 Rockville Pike Rockville, MD 20852 lier i t ago iteporting Corporotion .

(202) 620-40HO  !

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414 ATTE!1 DEES: (Cont'd)

ERIC S. DECKJOF D Director i Office of Nuclear Regulatory Research U.S. NRC 5650 Nicholson Lane Rockville, MD 20852

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CURT BEPsdAN National Institute of Radiation Protection Box 60204 S-10401 Stockholm Sweden RODURT M. BERilCRO Deputy Director Office of Nuclear Material Safety & Safeguards U.S. NRC 11555 Rockville Pike Rochville, MD 20052 TERRY M. CABAUATAtt Executive Secretary Oak Ridge Associated Universities 1019 19th Street, NW

. Washington, D.C. 20036 BREllDA J. CAMPBELL i Technical Secretary Oak Ridge Associated Universities 1019 19th Street, flw Washington, D.C. 20036 PEDRO CARB0!1 ERAS Safet.v and Licensing Manager i

Et3RESA Paseo de la Castellana, 135-15 20046 Madrid

Spain K E !1!1 E Til M . CARR Commissioner U.S. tIRC 11555 Rockville Pike Rockville, MD 20852 4

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415 ATTEllDEES: (Cont'd)

A-M CHAPUIS Chef de la Section d' Etudes de Protection pour les Dechets Commissariat a l'Energie Atomique Institute de Protection et de Surele Nucleaire B. Pn6 92265 Fontenay-Aux-Roses France l t

FRANK CO!! GEL Director, Division of Radiation Protection l

& Emergency Preparedness U.S. !JRC '

11555 Rockville Pike Rockville, MD 20852  :

DO!!ALD A. COOL '

i j Section Leader l Programmatic Safety Section Operations Branch ,

l Division of Industrial & Medical fluclear Safety, 1 11 MSS, flRC U.S. 11RC .

11555 Rockville Pike '

Rockville, MD 20852 EDWARD E. COUR Senior Administrative Officer Oak Ridge Associated Universities l

1019 19th Street, NW washington, D.C. 20036 l 6

LEMOINE J. CUtiNIl1GilAM j Branch Chief Radiation Protection Branch. .

U . S '. 11RC i 11555 Rockvi.lle Pike  !

Rockv1 Ale, MD 2005' l

RICHARD E. CUtit1INGHAM Director Division cf fuel Cycle, Medical, Academic ,

& Commercial Use Safety U.S. 11RC  !

11555 Rockville Pike l Roch- lle, MD 20852 Iler.1tage Reporting Corporation (202) 620-4000

416 ATTENDEESr (Cont'd)

ELAI!1E L. DOGGETT Secretary  :

Oak hidge Associated Universities 1019 19th Street, tiW Washington, D.C. 20036 KITTY S. DRAG 0t1ETTE Senior llealth Physicist U.S. 11RC '

11555 Rockville Pike Rockville, MD 20052 A. G. DUNCAN Deputy Chief Inspector (RS) i

, it . M . Inspectorate of Pollution l

Department of Environment .

Room A516, Romney House  !

43 Marsham Street London SW1 United Kingdom -

JAllICE G. DUf3N-LEE Special Aost. For Safeguards & Intel.

Programs to Chairman Lando W. Zech, Jr.

U.S. t4RC 12555 Rockville Pike [

Rockville, MD 20852  !

TliottAS C. ELSASSER Tech. Asst, to Commissioner Kenneth M. Carr U.S. tiRC '

11555 Rockville Pike Rockville, MD 20852 i A!1Tl!O!!Y 11. EMIT 1G '

Director, Washington Office.

Oak Ridge Associated Universities I_

1019 19th Street, tiW Washington, D.C. 20036 MARGARET FEDERLINE Tech. Asst. To Commissioner Kenneth M. Carr U.S. NRC 11555 Rockville Pike ,

Pockville, MD 20852 i

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4 417 l ATTEt3 DEES: (Cont'd) l DIAllE S. FLACK Technical Specialist Oak Ridge Associated Universities l 1019 19th Street., tiW Washington, D.C. 20036 -

ROBERT FO!111ER Office of General Counsel U.S. t1RC  ;

11555 Rockville Pike  :

Rockville, tid 2005' FLOYD L. G ALPIll Chief, Waste tianagement Standards Branch U.S. Environmental Protection Agency i Office of Radiation Programs ( A!1R-4 6 0 )

4 01 14 Street, SW ,

Washington, D.C. 20460 P. 11. GARDt1ER

Health and Safety Executive 1 Chepstow Place 4 London W2 4TF '

United Kingdom I

ABEL GO!1ZALEZ Section llead l Radiation Protection Section (

Division of fluclear Safety

International Atomic Cr.ergy Agency [

i P.O. Box 100 '

l A-1400 Vienna  !

Ai. stria  :

i . JAt1CT GOHti s, International Relations Officer r

- U.S. !1RC i 11555 Rockville Pike l Rockville, 14D 20852 RICilARD J. GUI!4011D Director, Office of Radiation Programs ( At1R-4 58) (

U.S. Environmental Protection Agency  ;

401 !! Street , SW l j Washington, D.C. 20460 l I

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J. WILLIAM GUllTER Director, Criteria and Standards Division U.S. Environmental Protection Agency 401 M Street, SW Washington, D.C. 20460 11 . J. IIARDT MinisteriL] rat Bundesministerium fur Umwelt 11aturschutz und Reaktorsicherheit

!!usarenstraBe 30 5300 Bonn 1 Federal Republic of Germany MO!1IQUE llARWAY Interpreter 6800 Fleetwood Road, flo . 717 McLean, VA 22101 W. P. IlOLCO!1B Staff Engineer Office of Radiation Programs (A!1R-460)

U.S. Environmental Protection Agency 401 M Street, SW Washington, D.C. 20460 SHIRLEY HUDSO!1 s Administrative Assistant Office of fluclear Regulatory Research U.S. IIRC 11555 Rockville Pike Rockville, MD 20852 DEt1JAMI!1 ilUltt11 CUTT Court Reporter Heritage Reporting Corp.

1220 L Str9et, 11W Washington, D.C. 20005 OSVALDO ILAR7 Deputy th ad of Division Division of Radiation Protection and Waste Management OECD tluclear dnergy Agency 38 Boulevard Suchet 75016 Paris France lloritaqe Reporting Corporatinn (202) 678-4RHn

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. I 419 ATTENDEES: (Cont'd)

GEORGE C. JACK Manager, Waste Management Division Atomic Energy Control Board P.O. Box 1046, Station D Ottawa K1P SS9 ,

Canada ,

H. A. KAHLOS Head of Inspection Office Finnish Centre for Radiation and Nuclear Safety P.O. Box 268 SF-00101 llelsinki

  • Finland

! STEVEN KOPP

, Programmer  ;

l Oak RI.go Associated Universities  ;

1019 1.tth Street, itW Washington, D.C. 20036 WILLIAM R. LAHS [

, Acting Chief, Regu.'.atory Development Branch t

Division of Regulatory Applications t U.S. NRC j

! 5650 Nicholson Lane i i

Rockville, MD 20852 i

l JOHN T. LARKINS '

i Special Asst, for Research and Waste ,

Management to Chairman Lando W. Zech, Jr. >

j U.S. NRC ,

11535 Rockville Pike Rockville, MD 20852 l

! JULI A LOPEZ de la !!IGUERA 1

Radioactive Waste Branch

{ Consejo de Seguridad Nuclear (CSN) Espana i Sor Angela de la Cruz - 3

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28020 Madrid Spain l i

MARIA E. LOPEZ-0 TIN Special Asst. To Commissioner Thomas M. Roberts  ;

U.S. NRC  !

11555 Rockville Pike  ;

Rockville, MD 20852 Ileritago Reporting Corporation [

(202) 620-4000 '

O' 420 ATTEt1 DEES: (Cont'd)

FELIX LUYKX Commission of the European Communities (CEC)

Jean Monnet Building "

2920 1.uxembourg GAIL MARCUS Tech. Asst. To Commissioner Kenneth Rogers U.S. lIRC 11555 hockville Pike' Rockville, MD 20852 C A T iiE D I ll E R . MATTSEll liealth Physicist U.S. 11RC 5650 tilcholson Lane Rockville, MD 20852 RUTl! McBURilEY Administrator, Standards Branch '

Bureau of Radiation Control Texas Department of liealth 1100 W. 49th Street Austin, TX 78756

, CMARLES B. MEIll}l0LD flational Council on Radiation Protection and Measurements Safety and Environmental Protection Division Building 535A Brookhaven flational Laboratory Associated Universities, Inc.

Upton, 11Y 11973 WILLIAM A. MILLS Senior Tect.nical Advisor Oak Ridge Associated Universities

  • 1019 19th Stteet, 11W Nashington, D.C. 20036 D. W. MOELLER Chairman, Advisory Committee on 11uclear Waste Associate Dean Harvard School of Public Health 677 lluntington Avenue Boston, MA 02115 lioritage Itoporting Corporation (202) 628-4888
  • I 4e 421 1 ATTENDEES: (Cont'd)

BILI. M. MORRIS ,

Director, Division of Regulatory Appl 1:ations U.S. NRC 5650 Nicholson Lane Rockville, MD 20852  ;

GIOVANNI HASCl!I Director of Directorate for Nuclear Safety L and Radiation Protection i ENEA - Directorate for Nuclear Safety and Radiation Protection r Via Vitaliano Drancati N 40 00144 Roma Italy  ;

t R. J. A. NEIDER ,

Professor .

Federal Institute for Materials Research

and Testing (BAM)

Unter den Eichen 87 D-1000 Berlin 45  ;

1 . Federal Hepublic of Germany  ;

SANDRA J. NESSFL Office Assistant .

! Oak Ridge Associated Universities l 1019 19th Street, in Washington, D.C. 10036 f r

I STANLEY M. NEUDER  :

f Project Manager l l U.S. NRC l i 5650 Nicholson Lano  !

Roc);ville, MD 20052 .

SOREN NORRBY '.

. Swedish Nuclear Power Inspectorate ,

l Box 27106 i S-102 52 Stockholm Sweden l MASAO OSHINO

Deputy Director, Dept. of Ilealth Physics

Japan Atomic Energy Research Institute (

Toka-mura, Ibaraki-ken, 319-11 j i Japan l

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ATTEllDEES : (Cont'd)

HAROLD T. PETERSOll, JR.

U.S. FIRC 5650 tilcholson Lane Rockville, MD 20052 SILVAllA PIERHATTEI Director of Environmental Radioactivity Division EllEA - Directorate f or fluclear Safety and Radiation Protection Via Brancati 48 00144 Roma Italy Cl!RIS T. G. POMROY Senior Health Physicist Radiation Protection Division Atomic Energy Control Board 270 Albert Street ottawa, Ontario K1P SS9 Canada S. PRETRE llead, Division of Radiation Protection Swiss 11uclear Safety Inspectorate Cil-5303 wurenlingen Switzerland LATICIA RICE Interpreter 808 Burdette Road Rockvillo, 11D 20051 ALLAtl C. B. RICilARDSOld Chief, Guides and Criteria Dranch U.S. Ensironmental Protection Agency 401 M Street, SW ( AtJR-4 60)

Washington, D.C. 20460 T110 MAS M. ROBERTS Commissioner .

U.S. 11RC 11555 Rockville Pike Rockville, MD 20852 licritago Reporting Corporation (202) 628-4000

i 423 I

ATTE N DE E_S_ t (Cont'd)

KENNETil ROGERS Commissioner U.S. NRP i 11555 Rockville Pike l Rockville, MD 20052 l

THJMAS A. RUSSELL J Senior Engineer Roy F. Weston  :

20030 Centt'ry Boulevard i Gern Tntown, MD 20874 JACK SCARDOROUGli Tech. Asst. to Commissioner Kenneth Rogers l

U.S. NRC ,

11555 Rcekville Pike

) Rockville, MD 20852 K. !! . SCilALLER j Commission of the European Communities [

l Directorate-General XII 200, rue de la Loi 4

D-1049 Brussels i

Belgium t

j WARREN K. SINCLAIR L President National Council on Radiatiois Protectic ,

and Measurements 7910 Woodmont Avenue, Suite 800 i Dethesda, MD 20814 .

DAVID S. SMITl!

, Technical Analyst

. Oak Ridge Associated Universities 1019 19th Street, NW Washington, D.C. 20036 THEMIS P. SPEIS Deputy Director for Generic Issues Office of Nuclear Regulatory Research U.S. NRC

! 5650 Nicholson Lan(

Rockville, MD 20852

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424 ATTEllDEES: (Cont'i)

VICTOR STELLO Executive Director for Operations U.S. FIRC 11555 Rockville Pike Rockville, MD 20852 A. F. SUSAll!!A Director of Environmental and Radiation Protection Department EllPA - Directorate for Fluclear Safety and Radiation Protection Via Drancati 48 Roma Italy IDETTE SWETYR Interpreter 6704 Wemberley Way McLean, VA 22101 DARLEllE T110MPSO!!

, Program Assistant Oak Ridge Associated Universities i 1019 19th Street, ilW Washington, D.C. 20036 l HUGli T110MPSO!!

Director i Office of tiuclear Material Safety & Safeguards i U.S. tiRC

! 11555 Roc!.ville Pike Rockville, MD 20052 At1 DREW WALLO III Site Designation and CertAfication Manager 4

U.S. Department of Energy Office of Remedial Action and Weste Technology U.S. dol' NE-23 Washington, D.C. 20545 G. A. M. WEDD i flational Radiological Prote; tion Board Chilton, Didcot Oxfordshire OX11 ORO

'Jnited Kingdom I

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L 425 ATTENDEES: (Cont'd)

CARL G. WELTY Physical Scientist i U.S. DOE ,

EH-231  :

Washington, D.C. 20585  ;

JAMES WILLIAMS Messenger i Heritage Repo: ting Corp. i 122') L Street, NW r Wc.shingtos., D.C. 20005 I t

YOSli!KAZU YOS!!IDA , j Scientific Adviser  :

Japan Atomic Energy Research Institute [

Tokai-mura, ibaraki-ken, 319-11 [

Japan l i

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lilDEX SPEAKER PAGE ROBEliT BERt1ERO Summary of Areas of Consensus - Identification of Outstanding Issues 429 YOS!!IKAZU YOSilIDA Additional Views f rom Session on riational Approaches 458 GEORGE JACK 1

Additional Views from Session on Existing Issues 475 OSVALDO ILARI Additional Views from Session on International

Guidelines 476 l

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427 1 PROCEEDINGS 2  !

3 9:0S a.m.

4 MR. e PEIS: Good morning. This is the last day.

5 All the wisdom and knowledge of the last two days will 1 6 summarized and presented to us, and hopefully we'll have a l 7 very interesting and lively di scussion. l i

I 8 Before I turn over the chair of this last session to i

9 Mr. C2nningham I would like to welcome to this last seasien f

10 our Commissioners Carr and Rogers, and their presence as I li saio earlier Monday morning is another indication of the 12 importance that the Commission attaches to this important i 13 subject that has been discussed for the last few days.

14 So without any additional comments I would like to 15 turn over the microphone to Mr. Cunningham.

16 MR. CUNNING!!AM: Good morning, Ladies and Gentlemen, j 17 Thic is the last session and in a sense perhaps the more 18 important session of our mooting.

I 19 In the past two days we've heard what national 20 authorities are doing and what international authorities are 21 doing in the area of exemptions from regulatory control. We 1

1 22 have emerging I believe in the discussions somu areas c1

) 23 consensus, in fact a large number of areas of consensus and 24 torne where there is not consensus or doesn't appear to be a j

25 consensus.

26 In today's session I hope we will b3 able to clear 1)*

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428 1 draw the lines on where we have consensus on the important 2 issues, and if we don't have consensus to identify what the 3 issues are and lack of consensus. And finally perhaps 4 identify some areas where more international work might be 5 helpful in resolving issues.

6 The agenda as it's stated here calls for me to 7 discuss accomplishments and then for Mr. Bernero to talk about 8 areas of consen1us and so on and so forth. I believe it would 9 be more appropriate for me to discuss accomplishmants after 10 these other discussions take place, i

j 11 Also, I am going to change the timing of the agenda J

12 here so that rather than have the three panel chairmen say 13 something after Bob Bernero speaks, I will allow more time for f 14 discussion after each speaker, spilling past the coffee brc:h, a

15 so that we can discust issues when thoy*re fresh in our mind 16 rather than have one large general discussion after the four i 17 presentations after the coffee break,

! 18 So without further discussion on these points I will 19 call for Bob Bernero to come forward. As each speaker came l .

20 forward in the past a short curriculum vitae was given. I l

21 con't know that one was given for Bob, but he's been speaking 22 quite extensively at this meeting. Dob is Deputy Director of 23 the Office of Nuclear Material Safety and Safeguards. He i

24 probably has more broad experience in the nuclear field than 25 anybedy I know. When he came to government he had a lot of l

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429 1 experience in nuclear and the space program. He's an engineer f 2 by training. He has had various responsibilities for reactor 3 safety, fuel cycle safety, material safety, waste disposal, 4 and I guess was one of the early pioneers in probabilistic  !

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5 risk assessment, to add to other accomplishments.  !

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6 Bob.

L i 7 MR. BERNERO: Thank you, Dick.

p 8 ,

9

SUMMARY

OF AREAS OF CONSENSUS - IDENTIFICATION OF  ;

F 10 OUTSTANDING ISSUES  !

l 11 by ROBER" DERNERO  !

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j 13 MR. BERNERO: My purpose here this morning is to l i

t 14 identify what consensus we have. If I can discern consensus.

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15 If I can discover consensus from what was said in the past two d  ;

j 16 days I will encourage such consensus, I will welcome it, but I .

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17 do not try to force it. So please, as I go through I would i l

i 10 ask you to listen to my words for those things where I believe  !

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j 19 . there is an apparent consensus in the group as distinguished l i

20 from those other areas where I think there is definite l

21 contrm ersy or definite disagreement. I 4

l 22 (Slide) r l

23 The first area I would like to treat is that t i 24 concerning terminology. We started with Don Cool's address I

i 25 about how to define terms. The use of the term "below i

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430 1 regulatory concern" I sense caused difficulty with many people 2 here because the words in English imply that something is 3 negligible without any constraints put on it. It is almost a 4 synonym for what we usually call a de minimums level.

5 Most people are using the, term "exdmpt" or 6 "exemption" and it typically means that the matter is still of 7 concern. It means that typically we envision a practice as 8 being handled with some constraints such as low level waste 9 disposal in a landfill, not merely scattered on a field, and 10 that further regulation is not warranted. Further formal 11 regulation is not warranted, but the constraints are indeed 12 warranted.

13 So I deduce from that a consensus that exempt or 14 exemption is an acceptable or okay term, as I say on the 1$ slide. But BRC is not a good term, that it is somewhat 16 confusing.

17 flow de minimis is indeed a different term. I think 18 there is a consensus that it means something else. It means 19 something is negligible without constraint. If I could 20 digress into another color for a short tutorial on the Latin 21 language, in deference to our learned colleague from Vienna

  • 2 and Argentina, he suggested yesterday in his tutorial on Latin 23 that there was a grammatical error committed by some unknown 24 lawyer, and ht stinguished the term de minimis non curat 25 lex--the law does not dual with trifles, or rio minimis non lieritage Iteporting Corporation (202) 620-4800

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i 431 I curate praetor. The prosecutor or the regulator does not deal '

2 with trifles.

i 3 There is nothing wrong with that Latin. The use of l i

4 that ablative phrase is found in the well known term de  ;

5 gustibus non est disputandum. There should be no argument 6~ about personal tastes. The ablative is a peculiar form in 7 Latin. No, the problem is conceptual. There is a conceptual  !

8 error possibly found here, and I,do not say this is consensus. l i

j 9 If one says that the sum of a large number of trivial, 10 individual exposures is itself trivial, it is a denial of the [

'l 11 linear relationship. If you honor the linear relationship I

12 between dose and consequence at low levels then what you're  !

i i 13 saying is there is in our pool, our populat!on pool of the  !

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14 earth, an accumulation of risk.  !

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) 15 Now t he context in which you might judge the i i t 16 acceptability of that risk, if indeed it is two billion people l l

17 accumulating risk at micro microrem or sieverts, then judge it

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1R that way, but call it what it is. If you have a summation  !

] i i 19 that declares a sum of trivial individuo1 doses is itself 1

1 20 trivial, yop are indeed denying the linear hypothesis, and we 5 i 21 should be clear to identify what our position is there. And I ;

t l 22 detect not a consensus on that.  !

) 23 1 do detect in the words that I have hee *d f or the i

24 last two days, consensus on the three principles of radiation

) 25 protection: justitication, dose limits, and optimization. I l

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4 432 1 think there is general agreement in all parties that those 2 principles prevail, however there are scme differences 3 , apparent in how they are interpreted or how they are 4 quantitatively put down.

5 (Slide) 6 Ju s t i f ica t.lon , the first principle, has been 7 identified in some of the speeches in the past two days as the 8 first consideration, tiot a subsequent cae, not looked at

9 after the fact, but the first consideration.

4 10 There 10 obviously some recognition that national J

11 authorities have flexibility in what they consider socially l

j 12 acceptable in their scciety. We heard from our Canadian l 13 colleague that he would rather do his night time cross country

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14 skiing,in the dark, and not with tritium trailblazers.

15 As you know, the United States has recently wrestled 1 16 with the gemstone question and has made a choice that that aan I

17 be juJtified in the context of extremely low dose rates for 18 the individual and very low population doses. But,1 come back

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i j 19 to what I perceive and that it that there is indeed consensus 20 that social consideration of whether the radiation exposure is l 21 justified, whether the practice is justified, is a first and 22 nocessary consideration.

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23 As far as the second principle, I just found it so 24 simple and clearly of consensus that I put it on the samo 25 slide here. I've detected no disagreement that one l

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4 1 millislevert per annum or 100 millirem per year is recognized 3 2 as the dose limit. That seemed to be incurring no question at 3 all from anyone in the group.

4 Now that is the dose limit. To go into the 5 optimization process involves selection er utilization of many 6 other numbers which are not limits. I think that terminology j 7 was not quite clear. Sometimes people will speak of the lower j 8 values as limits, when indeed they are not.

l 9 The origin of proper, quantitative values to use in

10 the subsequent work, in the optimization, is not clear.

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i 11 Speakers said they did not know where they came from. I 12 suggest that whatever the source might be, maybe Moses did l 13 bring them down from the mountain and he may have been spoken j 14 to up there in the cloud by the member states. But whatever 1 !. the sourco of the numbers might be, they should bi tested, 16 logically tested, by comparisor. to background, by comparison 17 to known risk coefficients and extrapolations from them. They

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18 should be tested logically by whatever means are available, 19 and they should be consistent. And there is some growing 20 consensus internationally on what a code of optimization might 21 be, i

j 22 Yesterday we had an excellent logic diagram put on 23 the screen and Mr. Gonzalez departed, in .y view, from the i

24 Safety Series Number 89. I studied it last night and I l

25 couldn't find the little green circles justified. The logic i

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1 434 1 is excellent when you reach the middle left box where I have a 2 circle with an.S. I interpret, or intend thut to represent 3 what '

find in Safety Series 89, a few tens or a not 10 4 microsieverts explicitly, but 10 or 20 or 30. That's what it 5 99ers to say in Safety Series 89. Perhaps in the older units 6 ..aere ti.at becones one millirem per year it is a little easier 7 to deal with. It's a few millirem to understand that.

8 If one is tempted in all of this, plerse recall we 9 are dealing with risk analysis. We do not know risks so 10 precisely that we can sharply distingu2,h a two from a three, 11 or a one from a three. So we are speaking first in orders of 12 magnitude, one, ten, one hundred, or one thousand. Then if we

.3 feel so very precise we might speak in half orders of 14 magnitude, one, three, ten, thirty, one hundreel and so on.

15 So I think the international consensus that I 16 perceive is that there is a plural associated with the ten, 17 and that the no adjacent to it, I have circ ed it with a  ;

18 question mark, that it's not necessarily no. It is still 2

19 possible. And this I don't see that, I have tn distingsiah.

20 If you make it plural, some would say it is a limit and 4. t 21 should be no. Others vould say even if it is a plural tens g 22 there chould be the option of a dashed transfe'r to av. the 23 question is it still an optimal solution. Is it still 24 possible to have exemption in a region abovt that level?

25 (Slide)

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i 435 l 1 I think it's easier to see in a chart similar to the 2 one Bill Lahs used. Starting at the top of the chart, d

3 remember this is the dose limit. I think we have a clear ,

4 perception that above that level which is 100 millirem per

} 5 year or 1,000 microsieverts per year, above that level it is 6 clearly not exemptible. The perspective now, that we should  :

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7 maintain, in looking at the other numbers, is a lool downward  :

8 as we enter the regime belour the limit. Somewhere in the i

9 regime between the limit and what I have drawn as a dashed

10 line at ten microslaverts por annum, somewhere there we have t i i

, 11 at issue upon which I detect no consensus that some say you (

12 might have exemption in that regime with proper justification.

13 Others seem to say no, one should not exempt in that regime, f I  !

4 14 Then at ten microsieverts per annum or one millirem i j 15 per annum, I h yr - <trawn the dashed line with arrows pointing 1

l 16 upward to repr- 'nt its plurality or uncertainty.  !

17 I think you all heard,that the draft t1RC position f f

drew the line at ten n.1111 rem or ona hundred microsieverts, 18 (

) 19 . and our Canadian colleagues drew it at five. Perhaps that 20 proves that pioneers can still be found in florth America. [

! i

?1 (Laughter) ,

i t I

J2 On the other hand, there are moralists among us, I s i (

23 shall name no namas, who would say that ten microsieverte or

)

j 24 one millirem is the index of interest and is indeed something f 25 of a limit. One does not exempt abovo it.

11eritage Reporting Corporation i (202) 62P. 48F10

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1 I think it is clearly understood though, and a .

2 matter of consensus, that below the fuzzy line, below the ten l 3 microsievert line, that in the little box to the left where 4 one person alevert collective dose is a measure, and ten I

{

5 microsieverts por annum is a measure, that the practice is  :

6 clearly or evidently exemptible. And that beyond that

7 collective dose it can be considered, it can be optimized, and

.i j 8 is possibly exemptible. I think the lower two judgments in t 9 green are a matter of consensus.  !

, 10 In this chart it sums up that the practice is 11 understood. There is consensus that the logic by which we e l 12 approach it should be by the logic diagram from the Gonzalez l 13 paper, or in some iramework such as this, that the logic is [

]

t 14 understood and agreed upen, and it is the quantitative

' i 15 interpretation of practice and exemptfan thereof, where we j i

l '

16

  • still have controversy. f i

17 l'd like to stop at this point.

18 HR. CU11til!! Gila!!: Thank you, Dob. I'm eure we will 19 have some lively discussion out of this. What wo will plan to j i

1 20 do, I hope, is after we have comments, agree on what Bob [

21 summed up as consensus or identify those things in which we l l l

]

22 don't have consensus.

23 I'll start with Abel Gonzalez.

24 MR. GOtJZALE : Thank you, Mr. Chairman, First of 25 all let me say something that really all of us share. This is l

, lieritage Reporting Corteration j (202) 628-4HHH l

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l 437 i

1 an excellent summary of a very complicated meaning. Clearly, 2 I congratulate Dr. Bernero because this is really a short ano 3 excellent summary of a very complicated meeting.

4 I was reflecting like him yesterday night of our i 5 agreements and disagreements, and I arrived practically to the 6 same conclusion with a slight difference. My feeling is this 7 has been produced by a difference between two concepts that we -

8 have not explored deeply. The concept of exemption and the l l 9 concept of exclusion. i

! 10 And probably here there is a grammatical problem 11 again. For me these are two different concepts, and perhaps l

12 some of t he speal ers have put the two concepts together under l

13 the same name.

i

(

14 I have prepared two slides also, and if you will j i

15 allow me, Mr. Chairman, I will show the slides. {

i 16 MR. CUNNI'lGHAM: It's an important point so I think i i 17 we might as well take a little time on this.

! 18 (Slide)

I 19 MR. GONZALES: Something that I showed yesterday i 20 when I said.what I was going to talk about. We said we were  !

21 not going to talk about things that were rejected from 22 regulatory control and I fully agree with Dr. Bernero that [

23 this is not a priority step. To check whether wa comply with ,

4 24 indiviaual dose limits, whether protection is or in not j r

I 25 optimum, and whether the practice is or le not justified, if

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438 1 the answer to that is not the source or the practice is 2 rejected.

3 ,

Tnen we said of course we were not going to talk on 4 the area of regulatory control. We were not going to address S the problem of exclusion. We said we were going only to talk 6 of the problem of exemption. Of course there are sources that

! 7 will be just excluded from the regulations. They cannot be a

l 8 exempted, they are excluded from the regulation. It is c

9 different concept.

10 I said there are others in which control is no 11 feasible. I am convinced that you cannot exercise control in 12 the human body, This source human oody produces a dose which i

13 is much higher than this level that we are talking about.

J 14 ,

But there are other sources that you cannot control 15 in practical terms. I assume that you heve excluded from your

)

i 16 control the granite in Centra) Station on 42nd Street. Doses 17 there can be very high. There is a lot of granite in that i

{ 18 station in 42nd Street in flew York . But you are not exempting l

19 that from the regulation, the regulatory control there is not 20 feasible. The problem that I use there is exclusion.

3

. 21 (Slide)

. 22 Therefore, my summary, Dr. Bernero, is exactly the I

i 23 same as yours with a very small modification. As you said, j 24 about one mil 11 sievert, I said above the dose limit, that is

)

j 25 probably lower than one mil 11 sievert is -- for each source.

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439 1 You reject and in that we agree.

i 2 He agree that in the region below some tens of 3 microsieverts, and you are right, in that drawings there is a l 4 typographical mistake. One sign of approximation is missing.

5 It's around that level, below that, and around ono 6 mil 11 sievert exemption is automatic. Above one mil 11 sievert 7 exemption is possible, assuming that exemption is the optimum 8 .olution. In that area above some tons of microsieverts and 9 below the dose limit, some system of notification, i

10 registration, or licensing should apply. This can be just

11 general notification.

12 This is crude sources which are not included. The 13 exclusion principle, we are not discussing that here We are

, 14 only talking on exemption from regulatory control. But as you 15 see, my thinking is practically the same as ynurs.

16 Thank you.

17 MR. CUtitilflGHAM: Thank you, Dr. Gonzaler. I would

{

J 10 ask Bob to come back up because I'm sure that others have i

! 19 comments. I have a comment on Abel's,' but Bob'should respond i . 20 to that first.

1 21 MR. BER!iERO: Yes indeed, I would like to comment.

22 I think that Abel and I are saying essentially the same thing f 23 about that regime below the dose limit and above the threshold

! 24 of individual dose that one has chosen to use, and where 1 25 speak of it as possibly exemptible, in U.S. practice i i

Heritage Reporting Curporation i (202) 628-4001 l

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440 1 typically associate that with something like a single facility 2 decommissioning where it is not feasible to shovel away half a j 3 hillside in order to further reduce the dose from say 35 1 4 millisleverts per year to a few people, even to some

5 hypothetical person. And whether one calls that an exemption i

6 or a licer. sing control is a matter of national practice, but

! 7 the principle is the same. That it is not the same sort of

! 8 treatment as exempting a consumer product which is found l 9 generally in a much lower regime. So I agree with that 10 distinction.

i l 11 I'm not sure, though, whether that represents a i 12 consensus within this body.

! 13 MR. Cull!!!?iGil AM Let's try to find out if it does.

14 1 think we have agreement between Mr. Dernero and Mr. Gonzalez i

4 15 and I know I certainly agree with this. Does anybody want to 1

16 comment on that point?

i 17 Mr. Jack?

4

! 18 MR. JACKt Thank you, Mr. Chairman. I have two i

f 19 comments on Mr. Gonzalez's slide. I don't agree with that j .

20 intermediate band of registration notification. That may suit j 21 some regulatory authorities in some countries. In some 22 countries, however, it does not. It is not appropriate. An

I 23 millislevert. In that area you say well there must be a j a

24 margin for some particular forms of exemption from the  !

25 national authorities in certain situatione. I would like to j l' (

! t 1

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O 447 1 reminc, perhaps, that it is said in our document, perhaps not 2 so well, not so explicitly, one is to find along the lines of 3 the concept. But it was largely discussed durina the work to 4 prepare this thing. The concept is included of partial 5 exemptions. In other words, when we talk about this famous 6 area between ten microsieverts, one manslevert, etcetera, 7 there we are talking about at total exemption from any sort of 8 regulatory control including notification, registration, 9 licensing and so on, inspection, eteatera. But it le very 10 well possible that certain exemptions are granted with 11 constraints.

12 In other words, you can exempt a certain thing from 13 being licensed, but you can still impose conditions on 14 notification, for example, or registration or these sort of 15 things. This could perhaps take account of your concern for 16 something above these famous values of above ten 17 microsieverts. ,

18 Thank you.

19 . MR. BER!1ERO: I'd like to speak to two things. One, 20 this last point that Mr. Ilari makes I think is a good one 21 because in that regime the idea that I was trying to express 22 was that it was found in a specific cace, not a wide practice 23 but a specific case, to be no longer feasible or practical to 24 go lower. It was optimized for that specific case and 25 typically that would be in a decommissioning er some other floritage Hoporting Corporation (202) 628-4000

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- I 448 i i r<, medial action.

1 And whatever the national authority does, l 2 whether it's called a possession I tcense or a partial l 3 exemption or a registration la not a matter of principle, it's  !

1

,4 a matter of administrative framework.

l 5 I would also like to welcoma the other point he made I

6 about the few tens or a single ten and recognition of multiple j 7 exposure. That was an omission in my summary last night when l {

8 I was going over my notes. I did recognize that the Safety  !

1  !

! 9 Series 89 publication had thet as a basis and in fact one cf l 1 l

10 our speakers from Switzerland in constructing the, started at [

f 11 10 millirem or 100 microsieverts per annum and divided by 5 as 4 12 I recall, in order to get the few tens, the value of 20, for

13 an individual practice allocation. Then there was someone j

j 14 else, I can't recall whom, who commented on the ll.S. NHC paper ,

i I

, 15 that 10 might be neceptable for the total of exposures, but L i '

i 16 not for an individual practice exemption. So I think I sensed i

I; 17 a wide view of that regard, that for the routine exemption of  ;.

I 18 mv practicos there was a sentiment not to use so high a [

, l l l' 19 number for individu.sl practice exeeption because that sum is 20 more appropriate to the total, or totality of exemptions.

21 MR. CUNNINGil AM: I'd just like to comment further en  !

22 this of what Dr. Ilari characterized as partial exemption. 1 23 think if you read Safety Series 89 on the latter part, not .

24 just the dose criteria, but where it discusses hnw you pass [

25 from regulatory control to exemptions, it deals with that hind floritage Reporting Corporation (202) 628-4000 l

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449 .

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I 1 of problem and I think it's important to understand that  !

q 2 process.

L

3 1 believe Dr. asanna is next. ,

4 HR. SUSANilA t Thank you, Mr. Chairman.  !

5 Listen to the discussion of this morning. My  ;

I 6 thought went to the past year. We had exemption, Mr.  ;

2 i 7 Chairman, Turkey -- And now it seems to me that we are trying i 8 to justify or to have a rationale to what we have done, maybe j i i

9 witnout rationale. For instance, I would like to ask Mr. i t

i l 10 Gonzalez, if the Safety Serius Number 9 that has an exemption l L

1 I

, 11 is consistent with the Safety Series 89 that probably not.

1 i So this discussion seems to me something that can  !

12 I

13 not progress too much because it is just too - . My l

i .

I l 14 impression is that we are looking to a rationale or something i I

, 1

! 15 that we have done. I was expecting something more in thie [

i L

{ 16 rerpect. For instance, yesterday I listen on the necessity of f j 17 an international agreement because a lot of these things aro 18 not of national concern nr international concern. This f l

L

{

19 morning not a word has been said on this matter, for instance. j l* 20 Thank you.

1 I

21 MR. CUlJ11IliGHAM: I was planning to address just ' hat . j i  !

' point, out I'll first turn to Abel since the question was 22 1

! 23 raised of consistency between Safety Series 9 and 89. Can you t I 24 address that point? ,

1 I 25 MR. GO!17.ALF.7.t Well, t'w proper way t o build a house i

l lloritago Reporting Corporation (202) 628-4000 1,

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, 450 1

j 1 is to build the basement if,rst and the roof at the end. I 2 have the feeling that in this subject of exemption in the past l 3 (we were producing the roof without having a clear idea of what

?

! 4 was the basement. Safety Seriem 9 was not an exception in i

5 that respect, e

6 We have to recognize; however, that at the time 7 Safety Series 9 was written, and I'm talking in the year, in 8 '82 it was published, but really it was produced in *79 and 9 '80. Really we did not have at that time the problems that we 13 have today. The recycling of meterial was not a problem at 11 the time. The problems were extremely more simple. There was 12 . .o t the rationale, but we have to say that in Safety Series 9 13 we said that some criteria would be -- in the future. What we 14 are doing now is just implemen*.ing that otatement.

15 i don't shara your negat1* ism, Dr. Susanna. I 16 believe that we should rot try to find international consensus 17 the details. What we need is international consensus on 18 the principles, even not in the numbers as Dr. Bernero said, 19 on the principles, for me, it is surprising 1/ good. I am 20 extremely happy of how much we have advanced in this meeting 21 in achieving a big consensus on the orinc;ple. It was very 22 well summarized by Dr. Bernero. I have just the opposite 23 attitude, a very very positive attitude.

24 MR. CUtit11t1GHAM: Let me add to what Abel said. I 25 think it's an area whore I sense there was con =enaua. Gootf Iloritage Reportina Corporation (202) 678-4HRH

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l l i L

i 451 [

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, 1. Nebb brought it up yesterday I believe for the first time when 1

' 2 he asked the question why are we discussing this now when we i

s 3 have had exemptiona for 20 or 30 years?

t I l 4 Exemptions heretofore havv had largely to do with I  !

5 consumer products. tiow we are entering a new era where we are {

]

6 considering exemptions, and in fact have given exemptions, for l i

l l 7 waste disposal, and in some countries I've learned this  !

1 I

j 6 session for recycle of materials. [

t >

9 So we are entering an era where there is going to be d

3 10 more international trade and more opportunity for rLalizing i

j 11 the impact of one nation's exemptions on peoples in other  !

i

{:

12 countries. Therefore, I believe Geoff said it, that the

! 13 reason we are discussing tl.is is to have some international

14 harmonization on the principles to be approached in granting 1

15 exemptions. I think that's what was said yesterday. As far f 16 as I know there was large consensus on that point. And that's f

. t 17 one of the important issues that we etert with, that there in l

l 18 need to understand, have a common language, and have some j i ,

19 consensus on the principles by which we approach granting 20 exemptions.  ;

21 Dr. Meinhold?

. l 22 MR. MEI!HIOLD: Geoff said moFt of the things 1 was I

] i

! 23 going to say with regard to what ICnP would look at the whole [

24 question, and I think he summed it very wall I can't, t l

25 however, avoid discussing Mr. Bernero's statement em de l I

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4 452 4 1 minimis and its implication for collective dost.

2 h' hen the 14CRP came up with this recommendation of 3 not summing doses below one millirem or for collectivo dose j 4 consideration, it did it with an assumption of linearity. I 1

5 take you through tha following scenario, that if you take a i 6 city of a million people and you assume from linearity that j 7 you're going to have two people in that population eventually 0 have cancer because of this one millirem that they've all

! 9 received, that will have no society effect. There will be no 4

i 10 additional police, there will be no additional doctors, there i

11 will ba no additional hospitals, there will be no additional 1

) 12 health care facilitics required. tio family group in that city i

i 13 will be harmed, no group of neighborhoods wi.11 be harmed,

)

l 14 because in that city of a million people two additional cancer i

15 deaths will not have an impact.

16 If you want to extend it to its country of 100 3

l 17 million people, the same concept is true. You can't simply i

la add up bodies, you've got to look at the societal impact which j 19 has to do with what suelcty's resources and needs are applied.

i -

20 That was the basis for eaying that there is no sense in adding i

1 21 up trivial individual risks in a summation.

I 22 I think that's probably enough for t' hat anyhow, t

! 23 MR. CUtittltJGilAMt Dr. Gonzaler.

f 24 MR. G0ll: ALES: Just for clarification, I would like I

j 25 to say that the statement of charlie Meinhold which i believe l

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.i 453 1

i i reflects the position of the flCRP, is not in line with the i  ?

2 basic safety standards for regulation protection of 3 international atomic energy. It is not, I repeat, in line.  ;

f 4 I would like to provoke Dr. Webb and say wh9ther or f

5 not it is in line with the ICRP recommendations. l, 1

l 6 Thank you, Mr. Chairman. [

i 7 MR. CUlitilllGitAM: Geoff, do you want to take that on? j

8 MR FEBB
I don't think I can resist.  ;

l i i 9 You will, of course, all realize that Charlie is a [

! I j 10 member of the main commission of ICRP and I'm only a member of j 11 committee four of 'CRP. But since no one speaks on behalf ( f a

f 12 the Commission -- l 13 (Laughter) [

I

! 14 MR. WEDDt It is not a trivial problem because there [

t l

l 15 are two quite sensible views on thlm and they are both f 1

16 sensible views. The one that Charlie expressed it a very 17 robust view that sinco you cannot, and I agren with him, you I i l 18 will not be able to detect this harm in society because it is

{

19 . a diluted probability of harm that we are predicting with our l

t j

20 assumptions of linearity and additivity of risk, but to me j I

21 that doesn't mean that it won't happen. You may not find it, j i

4 22 but not being able to find it doesn't necessarily mean it i j 23 doesn't occur. k l

l 24 So it seems from a radiological protection and a

}

25 prudent approach to protecting people, better t o accort the l

! Ileritage Reporting Corporation (202) 628-4060

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4 454 I entire logical framework which ICRP has set out as a system of f l 2 radiological protection carries within that logical framework l 1

3 the assumption that if you add up a number of small [

t j 4 probabilities of harm you will get a probability of harm. l 1 ,

5 Just accommodate that within the system.  !

l i 6 I don't think this gives us any practical

(

7 difficulties because it does not prevent us from exempting h 1

8 from control the sources that we think are sensible to exempt f i i

9 from control. We can accept *.he implications and work with t 1

10 them without having to taFe on the one hand a complete logical f l

11 construct and then say well that's all very well, but for 12 common sense reasoas I'in going to ignore this bit of it. I l l

j 13 don't think we have to do it. I don't think we have to get

] 14 into the argumen in order to carry out the practical measures

{ 35 that I think we all recogn!.ze are sensible.

s I 16 I believo if you take the ICRP view from the 1

17 documents of ICRP, from the recommendations, it it quite clear

! 18 that in setting out the concept of collective dose, and i 19 collective dose commitment, the ICRP intend all o .' tha doses, i

j. 20 however small they are individually, to be included.

i j 21 MR. DERl1ERO: I would lihe to Lpeak to it now that 22 we have had the full rango.

j 23 A. someone partially, or at least substantially 24 outside the community of ICRP and 11CRP, 1 think wieden may lie 25 with those who say to display all integrated doses but to lleritage Reporting Corporation (202) 620-4000

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455 i i

I

~

l I carry a cutoff to illuminate the decielon. Because it appears i 2 to me that what Charlie Meinhold is saying is that generically i  !

3 every time you do some trivial doses you will find if they are j l

4 accrued at very low dose rates that it takes millions of -

I 5 people to calculate one or two or three health offects, and  !

i 6 that necessarily these are lost in a very large population and 7 you will always reach the same conclusion,

{

i 0 tut our decisisas every day, ard perhaps the uranium  ;

l

\

1 9 mill tailings disposal is the one that most intensely l 4 i i

10 111t ainates the problem, is our decisions are mixed. We are j 11 facing radionuclides that give their populatien dose to a i L

12 clore in small group and they are necessarily treated l 13 differently than these very dilute ones. And perhaps the i

! 14 sensible thing is, and the 11RC dratt position if you siw the ,

i 15 whole document was trying to deal with this, in saying that in I f

j 16 doing optimization one might elect to integrate over the  ;

i (

j 17 entire range, use a cutoff where appropriate, or even use dual 18 valuation where th+, monetized value of persnn sloverts or 19 person rem Je different for those which are accumulated at *.he {

i

,10 extremely low dose levels, low dose rates, and those which .ste f

) .

t i

i 21 accumulated high. f l l 22 And actually I don't think there is, I tecognize the l

' r 23 tiRC position that Charlie was espousing does net explicitly 24 deny the linear hypotheris. What it really does say is we've 25 done enough optimizations thic way t o kn"w t ha t the answer for lieritago Poporting Corporation ,

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9 456 1 these sets always comes out the same way, that it's two in a 2 million or two in a hundred million.

3 MR. CurirliflGHAM: Dr. Ilari wants to address the same i

4 point. t 5 DR. ILARI: I think there are fortunately another 6 couple et pisces to be added to this pus:le of collective doso 7 and its uss. There are two main reasons which are used to 8 suggest the introduction of practical cutoff in . individual 9 doses in the calculation of collective doac, and there are two 10 counter reasons which suggest not to make this cutoff.

11 Charlie Meinhold has used the reasoning of the 12 societal irnpact which wou'.d not be significantly affected, 13 changing the collective dose, because he looks at the site of 14 impact, duo to collective dose in purely re;ulative terms. .

15 Sma11 town, sma11 collective dose, sma11 socintal impacL. lii g 16 town, big collective dose, but in proportion the societal 17 J rrpac t remains small. It's a relative way of saoing things.

18 You might decide to look at things in an abselote way.

19 Dut apc-t from that the other reasoning t hat 's used 2f somo which is also extremely valid to deny the possibility 2 calculati.ig collective dose to the extremes is the questien ,

6 22 i t.ac e r t a i n t ie s in calculation. In effect rm r e and more an1 l

73 more you go towards large distances, long times, very cms 11 24 individual contributions and perhap.s mete and omre and mute 1

25 you are -- in t hes" calculat ione , in your sronarioc a nd m :de r ,  :

I lieritano HeporLinq Corporation  !

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l 457 j I so you can have any sort of result you want.

2 So this is two reasonings in one direction. But in l i

3 the other direction, and I would be very much tempted 4 personally to like these sort of things and accept the idea 5 that one should cut off at some point. Unfortunately,.7 am of l

6 those on the other side. These are two, in fact.

[

7 One is the one that Geoff Webb has procented as ICRP i 8 which is the co.icoptual approach. If you are of a certain j hypothesis you must be consequentially yourself, consequent, f 9

10 so you can't cut off voaes. - I 11 But there is another consideration which is  ;

i 12 extremely practical instead if you accept that the j 13 uncertainties are controllable within decent limits. It is j 14 the fact that if you cut off collective doses on the casis of f t

15 a cutoff of individual dose, low or trivial individual doses, [

t 16 you, as it has been said yesterday by somo, just have put on j 17 the table a mechaniem for exporting collective doses from one  !

I ib country to another. And because we have said before that t 19 certain practices more and more have an international impact 20 in terms of trade and these sort of things, or in terms ,f 21 environmental impact. Look at sea dumping, fcc example, which 22 has a sort of international impact. Censumer products, other 23 things.

24 If you adjust properly this system of cuttino off 25 certain doses and Lecause the distributien et individual deres lloritage Reporting Corporation (202) 620-4000

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I j

1 i

l 450 l 1

4

! I what it is, you risk to say I exempt the practice or sven 1 i

i 2 license an activity with certain conditions on the basis of an f i

t j 3 assessment of colicetive dose which is only referred to my own [

I 4 country or my own region or my own town or whatever you like, i

)

5 disregarding the impact outside. In this way in some cases t i

6 you might create situations which are not at all acceptable j i

7 from a pure, a largely seen radiation psotection point of I

i 8 view.

I i 9 And J add a last word, Mr. thairman, in these sort l 10 of decisions it is not purely calculations and ICRP principles a

i 11 we count, I would imagine. llaving be n a regulator myself for l t

j 12 many years I can tell you that there are many other reasons  !

) I j 13 which can suggest the national authority not to go too far in i 14 doing these sort of things because of problems of i

15 acceptability, for example, for certain decisions.

16 MR. CUNNING!iAM: Tnank you. Moro discussion on this  !

I j 17 point, Dr. Yoshida is next.

i j 18 i

l 19 ADDITIONAL VIEWS FROM SESSION ON NATIONAL APPROACilES r 20 by YOSilII;A"U YOS!!IDA 1 l l 21 (

1 '

22 MR. YOS}lIDA: Thank you, Mr. Chairmdn.

l 23 (Slide) 24 Although th" international consensu* is obtainmi i

j 25 concerning the principle viewpoint of radiatien protection and 1

i lleritage lleportinq Corgw3 rat inn (202) 628-4000 i

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1 459 i 1

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1 also practical po.nt, that -- dose is essentially necessary. ,

, 2 I believe it is Dr. Meinhold's comment. la my feeling some j t ,

, 3 people thought -- practice such as estimation, some value f 1  !

i 4 between ten microsievert per year would be appropriate j 5 concerning this, f 1 i

! 6 I think the bottom equation is that explained by the  !

i i

! 7 -. Mathematically one in 10,000 persons is exposed to one 0 m1111 sievert is equal, I'm sorry. -- is exposed to one v 9 mil 11 sievert is equal to 10,000 peopla cyposed to ona

! I j 10 microsievert is equal in the basis of mathemacies. Dut in 11 the practJ. cal viewpoint it may not be equal because very low 12 dose estimation has much uncertainties and also due to other l l 13 reasens. I cannot eyolain in English, but my opinion is very 1  !

l 14 similar to Mr. Meinhold s exolanation. }

l 15 Concerning this point may I explain.  !

l 16 (Slido) [

i i 17 Concerning the corrective dose of one nicrosievert l f

j 18 below which optimitation procedure is not necessary is stated j r

i l 19 . in Safety Standard 89, uut from the practical viewpoint this f l l J

20 value should be regianol or global. -- integration timo [

'l should be established. These two, not onl y t wo, but these two j 22 optimums concerning the two items we must have international l consensus because they are principally the same, tiut in order 23  ;

I 24 to drive the actual centro 111ng values we must havo remo l 25 consensus.

2 lieritage Ittporting Corporntion t (202) 620-400n (

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1 Tharik you very much. That is my comment. I 2 MR. CUNNINGHAM: Thank you very enuch. Are there any 3 comments on what Dr. Yoshida just presented before we .vove on? [

a l ,

4 I have other speakers listed, but on Dr. Yoshida's point, Dr. f 5 Gonzalez.

t  !

1 6 MR. GONZALEtt There is ene positive point there and l 1  !

7 that is obviously that international consensus is needed. I l 8 believe that no one would disagree with that. The point is to i

j 9 define what ic international consensus. This is more l 1 i 10 difficult. I 4 i 5

11 \s I montioned yesterday, tha recomniendations of 12 internacional agencies like the World Health Organization, the f

q 13 two agencies that are here represented, and the International j 14 Labor Organization, are not a product of the organization f 15 itself. It's a product of the member state of that i

16 organi:ation. [

i  !

4 17 The basic safety standard for radiation protection  ;

18 has been approved not by the Secretariat but by tha Board of f 19 Governors of our agencico, particularly of my agency, where i

I i

20 all the countries are represented because that t. card l

i

! 21 represents the til members of the agency. In particular, the a

l J

! 22 Japanese governtnent hae a permanent seat in that Board of L l I 23 Governors. That standards clearly specify how the collective  !

h

! 24 dose should be assessel. What is the quantitative collective? '

j 25 They define the quantity. The quantity as a definition does

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f 461 4

i s 1 not include any cutoff, neither in space nor in time.

t 2 Then what do you do with that quantity? It's a 3 different discussion. How you take decisions on the basir of 4 that quantity is a different discussion. But let me tell you J

5 that even in that lerel, at the level of decisions, not just

< 6 at the levol of quantity. At the level of decision and not I

7 quantity is very compi.icated, the issue of whether your

, 8 decision will be different if the dosu is outside your country 2

2 9 or inside your country because the other countries can take 10 tnen the same decision. The international atmosphere will be 11 extremely rare in that case.

I 12 Thank you, j 13 MR. CUNNINGHAR: I will take one more comment on 14 this, and that's from Mr. Jack.

15 MR. JACKt Thank you, Mr. Chr .rman. I was going to 16 come back to what Mr. Ilari said bef ore Dr . Yoshi la who.e he 17 said I think at the beginning of his intervention that the 18 main r9ason t'or objecting to integrating -- dore was the 19 uncsrtainty in the analycis, the uncertainty in the

- 20 calculation,s. That's the scientist talking, and I agree with 21 that. T.at is a very important reason.

22 But it le not the o 11y reason, and for many of us 23 around this table toda) there is another very important reason 24 and this is how tho public hears that result. 1f the result 25 is expressed in absolute terms like tw or three cancer lieritage Heporting Corporation (202) 628-4888

i o ,

462 1 deaths, it is very difficult to get anybody to accept that 2 that is a negligible consequence. If it, on the other hand, 3 ,is expressed es an increase of .01 percent on the natural 4 occurrence or something, it is much more convincing.

5 I just throw this out as a thought, that I think 6 we're shooting ourselves in the foot, to use that expression, 7 when we keep talking in these absolute consequence terms 8 because that is what creates this blockage in terms of public 9 acceptability. llence, the reluctance of regulatory 10 authorities to use this concept, I suspect.

11 Thank you.

12 MR. CUNNINGHAM: That's a real problem, but somewhat 13 different thtn the one we've been discussing. The perception 14 of what the significance of the collective dose is is quite 15 different than doing the collective dose itself.

16 MR. GONLALEZ: It's a very important point.

! 17 MR. CUNNINGHAM: It is a very important point. I'll l

18 let Dr. Gonzalez comment on Mr. Jack's comment, and then Mr.

19 Protre is the final commenter.

20 MR. GONZALCZ: I believe this is a crucial and 21 important point. The linear hypothesis of ICHP has been i

22 suggestod or applied for planning radiation protection, not 23 for making assessmenta of dead bodies. And tho fact that many 24 national authorities have made that mistahe doesn't mean that 25 t. hat is correct. -- has been use of collectiv" dose and has lloritage lloporting Corporation (202) 620-4000 l

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463 1 compared collective dose versus collective dose and never has 2 transferred that collective dose to number of dead bodies. We 3 should not do that. That is wrong. It is wrong. It can be 4 challenged from a technical point of view.

5 The linear hypothesis for planning radiation, for ,

6 planning purposes is like the linear hypothesis in the 7 municipal court, the hypothesis of linearity of string. You 8 use that hypothesis. You can calculate what is the 9 probability that one -- but you will not use the municipal 10 court to count the bodies that in a given city will die 11 because the buildings are falling down. It's a different - .

. 12 Thank you.

13 MR. CUNNINGHAM: That's a very good point, and it's 14 one that's been discussed particularly and extensively after 15 Chernobyl and how collective dose was used. I think there are ,

16 examples of how this counting of dead bodies has been avoided, i 17 and examples of how it's been misused. ,

18 Serge Prette, the lost comment on this point.

19 MR.'PRETRE: Thank you, Mr."Chairman'. I would like 20 to come back to the presentation of Dr. Bernero and I would 21 like to tell him that I liked very much the summary that Le 22 made and I would like to come back on jast one point where he I

. 23 said that those who want to introduce a cutoff of denying the 24 principal of linearity, and I would like to comment on that, j First I would like to say that 1 accopt completely  ;

25 t i

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464 4

I and respect the principle of linearity, and that on one side 2 you have principles, that's okay. And on the other side you 3 have reality, you have to stay realistic. I agree that very ,

4 4 small doses do not exist. They are just increments on the top 5 of other doses, of the usual doses. This increment represents 6 an incremental risk. That's okay.

7 But the sum of all these usual doses in a 8 population, this sum is fluctuating, is changing, is 9 fluctuating ferm-year to year. And what I was s,iying 10 yesterday and I am still saying now is when in this 11 fluctuation you introduce a very little thing which is just a 12 part of that fluctuation, you do not change anything. That 13 was the point where to me it is de minimis and the point where 14 we can begin to speak of a cutoff even respecting the 15 principle of linearity.

16 I would like to give just a very small example. You l'

l 17 probably all of you have calculated that example. If I have 18 the choice for my two weeks holiday to spend two weeks in the 19 mountains in a granitic area, with this option i tako on the 20 top of my usual dose maybe another five millirem. If I choose 21 another option for my two weeks holiday, to spend my two weeks 22 on a houseboat, in a houseboat you get very lo'w dose. You get 23 no radon, very low doso, so you might diminish your dose by 24 another five millirem. So just the decision on what you do as 25 a vacation is for my dose and the dose of my children is a Ileritage Hnporting Corporntion (202) 628-4000

a 465 1 difference of ten millirem.

2 So what I said yesterday is in that field of the 3 fluctuation of normal doses, or usual doses, it doesn't make 4 any difference and it is maybe, there is maybe some where low 5 down there a point where we should not push the principle 6 further down to zero. That is what I was trying to say 7 yesterday.

8 MR. CUti!!I!1GHAM: We're approaching the time for a 9 coffee break. As chairman, I think I have the last word on 10 this subject.

11 Go back to the idea that harmonization in important.

12 Serge Pretro very quickly yeaterday in his talk I believe 13 responding to a question, mentioned harmonization as the 14 fourth principle of radiation protection. He went by that 15 very quickly. He tried it last week at a meeting of the 16 committee in radiation protection of public health with 11EA l 17 and it was roundly rejected. But when you speak of 18 exemptions, I think harmonization becomes more important. I 19 . sense that there is a consensus on harmonization and the need 20 for harmonization.

21 If so, the mechanism by which we harmonize is 22 through agreement of international guidelines, adhesion to 23 international guidelines where you have consensun documents l

24 made up of ogreed to by member nations, one mechanism or 25 another.

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466 1 Turning that to collective dose, there are two 2 schools of thought on collective dose barteolly some 3 variation in this. Both arguments have merit. At this time

,4 the international organisations from ICRP, llE A , IAEA follow 3 the collective doso, the use of the collective dose in making 6 assessments for optimization with no cutoff.

7 If we want to change that and retain harmonization 8 internationally, then we should work this problem through the 9 appropriate international agencies. Otherwise we can result 10 in significant differences or some differences, I don't know 11 that they would necessarily be significant, and certainly 12 differences in concepts of what one nation's decisions might

. 13 be doing to another nation. This is a problem that I think we 14 should strive to avoid.

15 With that, I would like to close this session, take 16 a 15 minute coffee break. As you see, I've adjusted the 17 schedule so we have had long discussion on the summary of 18 these points, and then I will ack the other previous chairmen 19 if they want to bring up further points. So let's take a 20 coffoo break for 15 minutes.

21 Thank you.

22 (Whoreupon, a brief recess was taken) 23 MR. Cull!!IllGilAM: We have a number of issues we want 24 to finish which have been discussen!. I'm not nure how much 25 more time will be necessary for the other three persons listed lieritage Reporting Corpot:ntion (202) 620-4H00

467

1 on the agenda. I will ask each if they want to say anything 2 more starting with Dr. Yoshida.

3 Dr. Yoshida? And I think Dr. Yoshida has some 4 overheads.

5 Mit . YOSilIDA: Thank you, Mr. Chairman.

6 A more practical point on the radiation exemption --

7 such as radioactive concentration in a country, guidelines 0 are necessary based on international agreement. -- and

's parameters should be used. It is practical that exempt 10 quantity be given for several groups of nuclides. In some 11 cases exempt quantities are given depending on form or waste 12 and disposal methods.

13 This is -- IAEA Technical Document 401, but any 14 exemption quantity can be given, but it may be d.fficult or 15 not practical because this value will be very small compared 16 with routine detection limits. So at this point is not --

f 17 from that Technical 401.

18 Also -- system and evaluation system such as an 19 element of collective samples and -- methods for better --

20 based on thp - . From that viewpoint, Technical 401 should be 21 reviewed, and it la hope 21 to be published as IAEA guideline.

22 On the other hand, in transition pr riod for setting 23 exempt quantities in each country or group of countries such 24 as EC, the existing exenpt bodies in spite of practical 25 exemption may not be ignored from the publtc acceptance lieritage Hoport.ing Corporation (202) 620-4000 l

468 1 viewpoint. That is my comment.

2 But just one word again on one man sievert 3 icollective dose. If -- method is not, concerning this 4 consensus is 1.ot obtained -- concept deduced, because one man 5 sievert is estimating, -- that calculation method should be 6 agreed internationally.

7 Thank you very much.

8 MR. CUtit1I11GHAM: Thank you, Dr. Yoshida. Are there 9 any comments on Dr. Yoshida's further statement?

10 Professcr fielder.

11 MR. IlEIDER: Thank you very much, Mr. Chairman.

12 Mr. Yoshida, I agree completely what you have said 13 and I think it is very important that we are not only 14 discus;ing one side of the coin which we have done before the 15 coffee break, that means the ideas and principles. The more 16 important things I think are the derivation of quantities 17 which can be measured. And I remember to my paper where I 18 showed the statistical evaluation, evaluation of for instance 19 the recycling of steel and said one gets a distribution of 20 doses and one has to decide at what level, at what point one 21 cuts off and does not count even if the doses are above that 22 microsievert per year.

23 Another point I would like to point out is the 24 question of real measurements measuring the surface 25 activition. If it is measurable, and last but not least, the lioritage Reporting Corporation (202) 628-4000

e 469 1 averaging. But what mass are you allowed to average? I think 2 here are the very severe difficulties and points which may 3 influence finally the doses some people might receive.

4 Thank you.

5 MR. CUNNINGHAM: These are very important points, 6 Professor Neider. Some of them are going to be very difficult 7 to address. The problem is made more complex because one type 8 of thing you might exempt requires one kind of analysis and 9 another type requires an entirely different kind of analysis 10 so there is no uniform way to come to grips with this problem 11 that I see.

12 I don't know if internationally the work that is 13 being done to further develop the exemptions, I know some work 14 is going on there in various things, I don't know if that will 15 cove: some of this. I do have a couple of points I want to 16 raise for further work later on. It doesn't cover this point 17 exactly, but Abel Gonzalez wants to comment on it.

18 MR. GONZALEZ: Thank you, Mr. Chairman, yes.

19 First of all, I fully agree with Dr.'Neider that wo 20 have an enormous challenge for the future now. That is how to 21 implement these basic principles and to try to reach come 22 consensus in that implementation. People sometimes are afraid 23 of this consensus on methodologies, but in the radiation 24 protection community we were able even to make a otandard --

25 for reaching an international consensus. Therefore, we have lieritage Iteporting Corporation (202) 620-4000

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1 1

470 i some experience in this. I am sure this will not be so 2 complicated.

3 Our agency, as you said, has a problem. It is l 4 included in our progra- of work. We have been working in 5 disposal of low level radioactive waste in relation to 6 exemptions. We have covered a meeting already on consumer l 7 products and there will be a publication on that applying 8 these principles we were discussing before, and also there are e

9 some activities planned for recycling.

i 10 I have a few copies of our program here, and whoever 11 is interested, we probably can get copies of it. Thank you.

12 MR. CUNNINGIIAM: Thank you, Dr. Gonzalet. ,

13 Any more comments on this point? Mr. Luykx?

14 MR. LUYKX: Yes, Mr. Chairman. 4 would like to 15 support what Professor Neider said with respect to these 16 difficulties in practice, and especially with regard to the 17 individual exemption limits. We have said this morning that i P

18 there was general agreement on an exemption limit which would 1

19 be on the order of ten microsieverts, but what we still do not 20 know is if this is a value which is applied, the maximum value 21 applied to ono particular person, to a critical group, or is

22 it an average value, or do we have to do a cal'eulation of a i

23 probability distribution and calculate a median value or a 95 24 percent value or whatever. So I think also on this we still i

l 25 have to reach a consensus.

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e 471 1 Thank you.

2 MR. CUNNINGIIAM: I'd like to address this point. I 3 was going to come to this at the end of the meeting but it's 4 come up a couple of times now. I've tried to identify in my 5 I wrap-up, I was going to identify two areas where further work 6 is needed on the practical application of the principles with 7 which we are trying to come to grips today.

8 Two of those are first, how to calculate the 9 individual dose. Do we take a maximum, an averc ;e to the 10 critical group, or'what have you. I think that is an 11 important work that could be undertaken by an international 12 organization, most likely the IAEA.

13 The second part of the work is to deal with, the 14 issue that came up when I believe it was Abel Gonzalez 15 discussed inherently safe exemptions. What is meant by that?

16 When we look at dose to individuals we assume the i 17 dose occurs with the probability of one. Now tho question ,

\

i 18 comes up how do we deal with the perhaps expected or ,

t 19 -

anticipated but events that have a probability of less than r

20 one? I think Geoff Webb used the example of abuse of a smoke 21 detector where somebody takes a hammer to it and pounds on the L 22 source. That can happen, but certainly not everybody is going 23 to do that. A fire in a warehouse where exempt consumer 24 products are stored. Ilow do we take thos" kinds of doses into 25 account? Do wo use done limits, do we use limita approaching k

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472 1 the non-stochastic region? How do we apply the general 2 concepts that are being developed now that are flowing out of 3 IAEA and perhaps ICRP on dealing with probabilistic events 4 within the overall system of dose limitation, and how do we 5 apply that in a very practical way to our evhluation of 6 exemptions? Those are two areas of work, the one how to 7 calculate individual dose and how to deal with the 8 probabilistic events that I think is further needed for IAEA 9 to undertake.

10 Dr. Bergman is next.

11 MR. BERGMAN: Thank you, Mr. Chairman. I am, as you 12 know, a regulator and -- of the -- triangle, and speaking out 13 of that. I want to give gratitudes to the IAEA and the NEA 14 who have managed to reach agreement on the principles. That 15 is, of course, a very important starting point for the 16 -

regulators to try and have something to work out of. But it's 17 important to continue that work in a way which you give some 18 examples of, but you must do it in all areas where you would 19 interpret the principles to derive different kinds of 20 practical acceptance criteria. I know that type of work is 71 going on within the agency. It's important that it is done 22 within international organizations of that type.

23 I also was very satisfied when I heard Dr. Bernero s 24 presentation of the importance of the juctification as a first 25 step. But when I've been listening about the national lieritage Roporting Corporation (202) 620-4000

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473 1 applications, I'm a little bit worried. It is very important 2 that those who are making exemption rules of different kinds 3 are recognizing that before, for instance a consumer product 4 is introduced, it must be justified. So you must not make a 5 short circuit of the justification step. So that a product is 6 automatically exempted if it is below certain limits. In 7 that case I support the comments made by Dr. Jack.

8 My last comment is, which is also within the work 9 which would be done by the agency. If we should have 10 something of a trivial collective dose in the sense which the 11 one man sievert represents, I think it is necessary to have 12 some international agreements along the line which was 13 indicated by Dr. Yoshida, that you must, you cannot make the 14 theoretical calculation of collective dose commitment without l

15 -- in time. You should try to get some agreement. Because if 16 you don't do that, it is not a limit, but that value, that 17 concept of trivial collective dose will be of no use for the 10 regulators because they can never calculate reasonable value.

19 They muct in reality make some type of limitation of the 20 calculations.

21 Thank you.

22 MR. CUllf1Il1GilAM: On the last point, i. t won't solve 23 the problem entirely, but the ICRP is about to come out with 24 mcthods of optimization and it does deal with hnw you une the 25 collectivo dose to somo oxtent and how far it should bo lieritano Reportino Corporation (202) 6 211-4 H H H

e 474 1 carried out. It doesn't answer all the issues that you 2 pointed out, but I think it's a step in the right direction.

3 ,0f course Geoff Webb has been I guess the principal author of 4 this. So I think some progress is being made there.

5 I believe I had Mr. Susanna next.

6 HR. SUS AN!iA: Thank you, Mr. Chairman. I agree 7 completely with what you have said on the work the agency had 0 to do.

9 I would like to remind that a lot of these problems 10 have been discussed in a field that nobody mentionea in this 11 meeting, and I remember when I started in my career in -- I 12 started with transportation. The problem with transportation 13 is a problem that -- very similar. Think to the fact that in 14 transp?rtation has been fixed the limits for the package, what 15 you can -- and this package is going around the world on the 16 airplane and the train and so on. Even we discussed the 17 problem of accident in this field, and the problem of 18 exemption. There is a lot of exemption in the f t o i r.1 of 19 transportation. A lot of those things have been solved in 20 IAEA. Then I left this field. But I don't know now, but I 21 remember many years ago we discussed a lot of the things that 22 now we are discunning.

23 Thank you.

24 MR. Cull!1IllGilAM Your analogy is very good, Dr.

25 Susanna because transportation is an area wher" you're lieritage Reporting Corporation (202) 6 2 H- 4110 0

I 475 1 introducing radioactive materials, radiation exposure into a 2 broad public sector. We have a similar situation with 3 exemptions, more so t'lan licensing facilities where some 4 members of the public may be exposed, but not the broad 5 application # this.

6 And incidentally, talking about transportation, as I 7 recall the first appearance of that 74 becquerels per gram or 8 twe nannocuries per gram came in the transportation ,

9 regulations. I think people just picked it up from there. ,

10 I would turn now to Mr. Jack, next on my list.

11 George, do you want to add anything to what has already been 12 said?

13 '

i 14 ADDITIO!!AL VIEWS FROM SESSION 011 EXISTIllG ISFUES i 15 by GEORGE JACK i

16 i

17 MR. JACK: Thank you, Mr. Chairman.

f 18 I think adding anything on the subject of existing 19 issues is almost superfluous. Existing issues'as a matter of I -

20 principle have been discussed before the coffee break thanks ,

21 to Mr. Bernero's introduction this morning. I think the 22 discussion is evidence of the completeness of that.  ;

! t 23 The other set of existing issues is what we've just i 24 recently been talking about, how to practically implement ,

f 25 those principles. So no, I don't havo anythinri additional ,

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476 1 that I want to raise at this time. I'd just be prolonging it 2 if I were to create some.

3 Thank you, Mr. Chairman.

4 MR. CtJN!!INGHAM: Dr. Ilari?

5 6 ADDITIOt1AL VIEWS FROM SESSION ON INTERNATIONAL 7 GUIDELINES 8 by OSVALDO ILARI 9

10 DR. ILARI: Mr. Chairman, if you allow me, I would 11 like t'. addrecs two questions. One is concerning one of the 12 points of the discussion this morning and one is a more i

13 general sort cf statement. I 14 The first one concerns, I would like to come back to l

15 this question of collective dose for one minute, and it is in 4

16 the following way. The debate this morning had some heated l l

17 accents for some time. I would like to put some water now on  ;

L 3 18 this fire saying that if we stay in a group of experts and we  ;

)

! 19 discuss conceptur.11y, we will continue perhaps for a long time l l

20 to have disagreement and to have clear cut views, not 21 necessarily similar on this matter. [

22 But let'n look for a moment at the practical aspects j t

23 of the use of the collective dose and see if really the '

24 problem is so grave, so bad as it looks like when wo discuss 25 it conceptually. l

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.. l 477 1 Collective does, the primary utilization or use of 2 collective duse is for the coinparison of options in the 3 process of optimization protection. There are accessory uses 4 of course, to assess the general impact of our practice or a 5 general impact of an accident as we did for Chernobyl, but 6 that is another type of use which is not the primary one and 7 perhaps is the least controversial.

8 If we stay in the optimization and we use collective 9 dose os a tool for comparing options, we must remember that 10 really several options for a certain problem may well be i

11 collectivized by distributions of individual doses which are 12 roughly similar in shape and the only difference would be that 13 they have a different sort of value as a global collective 14 dose and a different prolongation in time and so on. It may 4

l 15 well be -- in practice that let's say they call the tails of 16 these calculations of collective dose, for instance in 17 distance or in time, are at some point, from some point on, 18 are very similar, these days began to be blurred with each 19 . other partly becauco of uncertaintios associated with the i

20 calculation. So at that point even if conceptually we want to 21 say we calculate collective doses out to infinity in time and i

22 in space, in reality we can easily cut out all -- from the 23 actual work of decision making which implies comparing the 24 options because the -- are not relevant. They, in other 25 words, are not relovant for deciding which option is better lieritago Heporting Corporation (202) G20-4000

i 478 i

1 than another one.

2 And in fact I must say that this particular question 3 was recognized by at NEA group of experts which a few years 4 ago issued some recommendations on the so-called long term 5 radiation projection objectives for radioactive waste 6 disposal. The conclusions of this group F3ve been largely 7 used then by the ICRP in publication 46. That group i

8 recognized thic difficulty, and what did they suggest? They 9 suggested that it is in practice possible to adopt a  ;

i 10 truncation in time as Dr. Yoshida suggested, when exactly 11 details of the values collective dose calculations along the 12 long number of years begin to be merging into a blurred sort

13 of thing. So this, for example, for long term waste disposal, 14 is a problem which could be solved in practice. And this is 15 true for other cases.

16 The only difficulty, unfortunately, I suspect 17 remains when the distribution of individual doses is the other 18 way around. In other words, when you have a small part of the 19 collective dose assessment at short distance or short time,

- 20 and a large part of it at long distance, as it could happen 21 for certain cases. In the case of export, for example, of 22 materials to other countries. That is the only point which r

23 really remains ao a difficult issue.

24 The second point is the following. I am sure we are

25 all convinced that radiation protection in these difficult

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479 1 times in which nuclear energy and all the radiation 2 applications are under challenge by averybody or almost 3 everybody, radiation protect 1<a in these difficult times [

i 4 continues to enjoy some sort of Jonsideration in acceptance, 5 partly because of its substantial degree of homogeneity across  !

6 che world.

7 One cf the fundamental strengths of radiation

, i 8 protection is that it is essentially made in the same way and ,

't u 9 thought in the same way in all countries. So the message is 10 to reinforce the things that have been said already this 11 morning and yesterde.y, that although we may continte to debate <

i 12 in a heated way in our circles about principles and concepto 13 and -- and calculations and so on, an effort should be made as  :

i 14 much as possible by regulatory authorities to try to keep as i i

15 much as possible a harmonized sort of view on the way they  ;

16 consider these principles and perhaps on the way they apply

) 17 them in their countries. Of course taking into account I 18 national specificities and so on, this is clear. But I think 1

19 this is a fundamental message that should remain, Mr.

i i . 20 Chairman. , l 21 MR. Cull!11!1Gl!MD Thank you very much, Dr. Ilari. i 22 If there are no comments on thes9 points, I would 23 ask if anybody else has comments that they want to make at i 1

24 this time. Any other comments to be brought up?

I 25 Dr. liardt? j

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480 1 MR. IIARDT Thank you, Mr. Chairman. I would like 2 to point out that I certainly want to join Mr. Susanna, 3 , Professor Yoshida with his statement that there are different 4 areas of concern which we have to consider. One is the dose 1

5 level of exemption. The second is the area of modeling which 6 would be much more difficult. 'And the third, the area of 7 derived limits which has been addressed by most of the i'

8 speakers which presented their national solutions.

9 What I var.t9d to express at the end is that I have l 10 two questions to this workshop. The one is it the system that 11 we have introduced in Germany that means to consider two 1

1 12 leveis of derived limits below the international agreed 74 13 becquerel per gram for different applications, the limits by a 14 factor,oi 1000 -- one million below that. The other is i 15 dependence of the toxicity of cl.fferent nuclides. We consider 16 several systems independent from toxicity or depending after 17 the IAEA system of -- toxicity or dependent from the annual 18 limit of intake. So these are different wayn to come to i

j 19 derived limits for special nuclides. Maybe that the work that 20 was done by our colleagues in transportation gives certain l

21 advice te come to a harmonized world-wide solution.

22 Thank you.

I 23 MR. CUtillI t1GH AM : I think Mr. Hardt, that the derived i 24 limits have to address specific types of practices because you i 25 must always go thivogh the pathway analysis to fin <l out how i

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1 the exposure occurs. Some derived limits will mean one thing  !

2 in one case and another thing in another case, so I think the  :

3 derived limits as you described them, as I understand them,  !

4 p.- obably need to be put in terms of specific kinds of [

t 5 practices such as recycled steel.

6 Any comments on Mr. Hardt's? Mr. Duncan is next. [

7 MR. DUNCAli: Thank you, Mr. Chairman. First of all, 8 I'd like to support the point you made about addressing the  ;

9 issue of inherently safe sources or practices. As for as the accumulation of things lixe smoke detectors is concerned, I l 10 11 explained yesterday that we attach limitations and conditions 12 to exemption orders and in the case of smoke detectors, for 13 example, we limit the number that can be held in a store under 14 exemptim to 100. As it happens we are revising that.

15 But I think it's well worthwhile looking to see how  !

16 the exemption principle can be extended co.mpletely because T 17 can assure you that although it exempts part of the 18 administration of the regulatory prccedure, we still have to

. r 19 police the operation of these things. So it's perhaps not as [

l

. 20 much relief as you might think from the regulatory aide, t i

21 But cetually why I wanted the floor was because I've  !

22 been trying t o distill the sense of the meet ing for my own 23 benefit, and I wonder if I can test it on the meetiag. I j 24 think it follows Mr. Ilari's last point. [

t 25 It seems to me that we actually > wo general l

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f 482 1 agreement as between ICRP, 11EA, IAEA, and others on the 2 general st.ucture of rationale for addressing exemption. But 3 I've also had the uncomfortable forling that the practitioners 4 in individual countries have expressed fairly substantial 5 reservations or qualifications about the role of collective 6 dose. I wonder if actually the only thing that prevents 7 complete agreement on this point is the uncertainties that we [

8 have probably all experienced, the difficulties that we have 9 experienced associated with the uncertainties in its 10 calculation. And if we are saying well we've calculated this, 11 but we can almost get any number we like. I wonder if in 12 addition to recommending the international agencies to look at 13 the question of inherently safe devices, I wonder if we had 14 actually concluded yesterday that effort needed to go into 15 this question of the practicalities of calculating the 16 collective doses for the whole range of IAEA consumer devices, 17 as I think Dr. Gonzalez suggested yesterday.

la Thank you.

19 MR. CUllflIllGil AM : On your f.rst point, Dr. Duncan, I i f

20 think that it's important to read IAca Safety Series 89 on how  ;

21 control is transferred, well how material is transforred from t

22 regulatory control to exemption because there'it does identify [

23 conditions, how you apply conditions and so on and so forth. I 24 So that is somethinq not to lose slaht of. I agree with you j 25 entirely on that point. It's a very practical kind of issue. i lieritage Reportino Corporation -

(202) 628-4000

t 483 1 I think we could recommend in this group that IAEA 2 in the consideration of other twe points also consider how to 3 apply collective dose in a practical sort of way to this kind 4 of problem.

5 Abel wants to comment on that.

6 MR. GONZALEZ: May I comment on the two different 7 problems. On the question of this inherently safe, I would 8 like to repeat that the agency is working on that issue, haa i

9 been working it in the past years, and that an advisory group 10 meeting has been convened for November 2nd. Some people 11 around the table will participate in that group certainly.

12 In fact, thc original intention was to discuss and 13 to reach some agreements on the general problem of i

14 probabilistic exposuto, but after the discussion in this 15 meeting, for me it is evident that that advisory group should 16 discuss in particular the problem of probabilistic exposure in 17 relation to exemptions as well as the particular problem, and f

10 I will convey that message to the advisory group. This is in 1 19 . relation to the first problem.

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- 20 In relation to the second problem, already now a 21 problem that has been approved by the general conference of 22 the agency in September, last September, we forecast to 23 produce a technical document giving guidance on the 24 application of the agency models for individual and collective 25 dose assessments for a spe<:i f ic problem. The voar of l

Ileritage Reporting Corporation j (202) 620-400n l

1 0

r 404 1 completion has been estimated at the end of '90, beginning of j l

2 '91, but this can be accelerated, and really I can convey the  !

3 message that this should be accelerated.

4 Thank you.  !

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5 MR. CUNNINGHAM
Thanh you, Dr. Go6zalez. l 6 I believe Mrs. Piermattei is next.

7 MS. PIORMATTEI: Thank you, Mr. Chairman. I support i 8 what Dr. Hardt said about the derived limits. I think from a

, 9 regulatory point of view it's very important to obtain a f L

10 general consensus of how to obtain derived limits for safety i 11 and practice in the field of exemption becauce it is necessary j t

12 to reach agreements otherwise one nation can use for the same l l

j 13 practice one limit, one derived limit, and the other can use i r

l 14 another one, and this can create confusion at the f i t 15 international level. For instance, when we are dealing with 16 steel recycling of material, with material which are going ,

i  ;

! 17 outside one country. l

! 18 I have another problem, and this in the problem of  :

i I 19 collective doses. I think that an agreement from the  !

t

' i j - 20 conceptual point of ~'ow has been perhaps reached at the 1 21 international level, t.ut at the national lovel the problem t

! 22 remains open. I agree that a definition of collectivo doses (

23 appears in basic safety ct.andard, but the problem ic what ic  ;

24 the meaning of collective coses when I sum up a number of .

j 25 quantitles which are affected by no larae uncertaintion? It j i

i j llo r lt n ytt ltf tport ing Corporatirin l l (*02) 2 f,2 ll = 4 ll N Il f E

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485 1 seems to me

  • hat this is more an intellectual exercise than a 2 practical use would think. I would ask someone to help me in 3 solving this problem. ,

4 Thank you Mr. Chairman.

5 MR. CUtitlIf1GilAM: You've brought up again the 6 problems of collective dose which I think is recognized, and I 7 think Abel addressed part of that problem on how you interpret -

O its meaning .nd significance. There are a number of decuments  !

9 out on this, but I think some further work might be needed as l; 10 it applies to consumer products.  !

11 I don't want to dwell any more on that, I think 12 we've said about everything we can say aSout collective dose 13 and it will be recorded in the minutes of this meeting. [

14 Are there any other comments?

15 Mr. Welty?

16 MR. WELTY: I would like t, take this opportunity to 17 commend tho llRC and the f1EA for this effort, for addressing f

l 18 this major international and national need, and to underscore i

19 in the name of the Department of Energy the nead for the j' 20 critoria and guidance that hopofully will come out of this t f

i l 21 kir.d of effort will bo the final product of this kind of ,

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i 22 deliberation.  !

i 23 As most of you are aware, the Department of Energy  !

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24 is a major operator in terms of cleanup of equipment, -

25 facilities, sitas. W" under mandato from the Congr+rse of the  !

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re n ) can_ anon ,

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I - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - - - - - _ - .

L 486 1 United States are carrying out a major cleanup ot' mill 2 tailings, for example. We have underway major p rograms for 3 , cleaning up other pri/ ate sites, and we face mapor, what wo 4 call D&D, decontamination and decommissioning programs in cur 5 own facilities.

6 So I do want to underscore the tremendous need for ,

7 this kind of criteria and guidance and encourage this effort 8 to continue to fruition.  !

9 I was particularly interested in hearing the 10 comments that we need to address modeling, and I see this

! 11 perhaps as a more ma'jor effort than simply coming to agreement 12 on the principles of exemption a.id the establishment of j

13 guiding principles and guiding numbers. I think in particular 14 there is a need on the national level in this country to come  ;

i 15 to agreement on the development and the application or models L 16 so that we can move forward in cleaning vp the facili. ties, ,

I 17 recycling, and not suffering the consequence then of having to j

! 18 go back and recoup recycled equipment and materials or do l l

1 19 repetitive cleanups as we have in the past.

i

. 20 su I thank you very much for this opportunity to sit I 21 in and listen. l l 22 MR. CUNNINGilAM
Thank you, Carl. l; 4

23 I think I'll sum up this session, at least, the f 24 final session, and than turn it over to Dr. Spoio.

I 25 I bellove we have agreed that international l l

1 i

lieritogo Iteporting Corporation (202) 620-4000 l.

1

487 1

1 harmonization of the approach to exemptions is important and I

2 that there were large areas of consensus which I won't try to 3 cover again, on the principles for exemptions. That we need l t

4 more guidance on the impleinentation of the principles for  ;

5 exemptions, and the implementation is an important part of  !

6 harmonization because the principles are broad. And unless we 7 have internatione) agreement on some importat.t. aspects of [

i' 8 implementation, we really won't have true harmonization.

9 So further work is needed in certain areas of e 10 implementation. That could be useful to us both on an [

11 international basis and on a national basis. There are L 12 important issues that prevail on both counts. So we have i

13 defined further work that the agency might undertake.

14 With that, I believe it sums up where we stand on i 15 this cession, which I believe culminates the work of thesa 16 past two or three dayc.

I 17 With that., I'll turn it back to Dr. Spels.

18 MR. SPEIS: Thank you, Dick. .

19 I d6n't think I can add anything of substance. Dick '

I 20 and Bernero and the other speakers this morning very lucidly I r

21 summarized the issuen, the areas of consensus and the arcos -

t i

22 that ve have to pursuo farther in this area.

i 23 In closing this workshop I would like to thank all l 24 of you who attended. On behalf of thr Commission I wouhl l t

25 oxpress our special .sppreciation to alm the speahors and the  ;

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  • lleporti ng Cor porn t lott f (202) 6 2 H - 4 H il f t  !

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488 l

I 1 session chairmen. I believe that at least from our viewpoint, ,

l 2 from flRC's viewpoint, we havu made considerable progress in 3 our task to formulate a proposed Commission exemption policy. ,

1 4 For as many of you have said theoe last few days, to 5 be successful we must first speak a common language on this <

6 issue. Second, we must understand the various concepts 7 involved. And third, we must air and understand the reasons 8 for any diversity of use amonc regulators and I think we 9 addressed all this very appropriately the last few days.

10 Lastly, I would say that we intend to publish the 11 proceedings from this workshop as an NRC conference report.

12 The report, in addition to the papers, will in: 'ude a summary.

13 of the questions and answers that have been discussed the last 14 two and a half days as also the comments and the summaries and 15 all the other things that were discussed this morning. We 16 hope to make it available in the next two months or so.

17 I would like to ask if any of you have any last 10 minute changes to your formal papera. If you do, for any 19 reason whatsoever, I want you to see Ms. Diano rlack back 20 there and she can mako arrangements to make suro we got your 21 revised papers ar soon as possible.

22 Before I close this workshop I would like to thank 23 the stoff of the Oak Ridge Associated Universities who have

?4 helped us in orrpn'.tinq and in paying the attention to all the 25 details which ha"e made this worht.liot a ruceesn. I would like Horitauo Hororting Corporation (202) 6 7 ll- 4 H il f t

489 1 to thank the translators. And last but not least I would like 2 to thank the young lady whr has helped us so much with the 3 viewgraphs and eim slides.

4 With that, I would like again to thank all of you, 5 and to have a good day. And those of you from Europe or other 6 places, have a good trip back.

7 Thank you.

8 (Whereupon, at 11:35 a.m. the workshop wa 9 concluded.)

.'. 0 11 12 13 14 15 16 17 10 19 .

20 21 22 23 24 25 lloritaqo Itaporting Corpornt ion (202) 6 2 f t-4 nit ti

o 1 CERTIFICATE 2

3 This is to certify that the att n hed proceedings before the 4 United States Nuclear Regulatory Commission in the matter 5 of:

6 , Nama WORKSHOP ON RULES FOL EXEMPTION REGULATORY CONTROL 7

8 Decket Number:

9 Placet Washincton, D.C.

10 Date: October 19, 1988 11 were held as herein appears, and that this is the original 12 transcript thereof for the file of the United States Nuclear 13 Regulatory Commission taken etenographically by me and, 14 thereafter reduced to typewriting by me or under the 15 direction of the court reporting company, and that the >

16 transcript is a true and accurate recors of the foregoing 17 proceedings, y w t

b\_ s. ~mN 18 /s/ __

19 (Signatur$ .yped) : B.K, HUNNICUTT, JR.

20 Official Reporter .

21 Heritage Reporting Corporation 22

23 24 r

25 Heritage Reporting Corpotstion (202) fi28-48 88

Wednesday. October 19, 1988 SESSION 5 - PRESENTATION AND DISCUSSION OF THE CONCLUSIONS OF THE WORKSHOP Chairman: Richard E. Cunningham, office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 9:00 Statement of AccomrLishments Richard Cunningham Office of Nuclear Material Safety and Safeguards U.S. Nuclaar Regulatory Commission 9:15 Succary of Areas of Consensu.* - Identification of  ;

Outstanding Issues .

Robert Bernero Office of Nuclear Material Safety and [

Safeguards  !

U.S. Nuclear Regulatory Commission 9:35 Additional Views from Session on National Approaches Yoshikazu Yoshida Atomic Energy Research Institute Japan l 9:50 Additional Views from Session on Existing Issues George Jack Atomic Energy Control Board ,

Canada 10:05 Additional Views from Session on International Guidelines ,

r Osvaldo Ilari Radiation Protection and Waste i Management Division i Nuclear Energy Agency  :

I 10:20 Broak j 10:40 Floor Discussior.  ;

l 11:45 Workshop Closing  :

Themis Speis office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission

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h ADVANCE NOTICE OF THE DEVELOPMENT  ;

i 0F A COMMISSION POLICY ON t BELOW REGULATORY CONCERN ,

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U..S. NUCLEAR REGULATORY COMMISSION [

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4 ORAFT Advance Notice of the Development of a Comission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety Impacts are Below Regulatory Concern I. INTRODUCTION AND PURPOSE Over the last several years, the Commission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of radioactive materials from regulatory control. To address this need, the Comission is expanding upon its existing policy for protection of the public  ;

from radiation, currently expressed in existing regulations (Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, Use of Byproduct Material and Source Material, dated March 16, 1965; 47 FR 57446, Licensieg Requirements for Land Disposal of Radioactive Waste, dated December 27, 1982; and 51 FR 30839, General Statement of Policy and Procedures Concerning Petitinns Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the development of an explicit policy on the exemption from regulatory control of practices whose public health and safety impacts are below

'( regulatcry concern. A practice is defined in this policy as an activity or a set or combination of a number of similar sets of coordinated ar,d continuing activities aimed at a given purpose which involve the potential for radiation

exposure. Under this policy, the definition of "practice" is a critical ,

i feature which will assure that the formulation of exemptions from regulatory  ;

control will not allow deliberate dilution of material or fractionation of a practice for the purpose of circumventing controls that would otherwise be applicable.

The purpose of this policy statement is to establish the basis upon which the i Comission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control persons who receive, possess, use, transfer, own or acquire certain radioactive material. This policy is directed principally toward rulemaking activities, but may be applied  !

I to license amendments or license applications in olving the release of licensed radioactive material either to the environment or to persons who would be exempt from Comission regulations, it is important to emphasize that this  !

policy does not assert an absence or threshold of risk but rather establishes a 7 baseline where further government regulation to reduce risks is unwarranted.

Tne concept of regulatory exemptions is not new. For example, in 1960 and  !

1970, the Cemission promulgated tables of exempt quantities and concentrations  !

for radioactive material which a persen, under certain circumstances, could

.' receive,(possess, license 25 FR 7875 and use, transfer, 35 FR 6425). own, or acquire without a requireroent for aO

( consumer products or other devices to the general public, or allowing releases

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of radioactive material to the environment, have been embodied in the Comission's regulations for some time. More recently, the Low Level Radioactive Waste Policy Amendments Act of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radioactive waste material that the Comission determined to be below regulatory concern. The Comission responded to this i legislation by issuing a policy statement in August 1986 (51 FR 30839). That statement coctained criteria which, if satisfactorily addressed in a petition 3

for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief on a "practice-specific" basis consistent with the merits of the petition. ,

J j The Comission believes that these "practice-specific" exemptions should be 1 encompassed within a broader NRC policy which defines levels of radiation risk

! below which spe;ified practices would not require NRC regulation based on i public health .nd sa M y interests. For such exempted practices the Comission's regulatory involvement could therefore be essentially limited to -

licensing, inspection, and compliance activities associated with the transfer  ;

of the radioactive material from a controlled to an exempt status.

I The Comission recognizes that, if a national policy on exemptions from

] regulatory control is to be effective, Agreement States will play an important j implementation role. In the past, States have been encouraging findings that

. certain wastes are below regulatory concern and the Comission believes that t States will support an expansion of these views to all practices involving  ;

exempt distribution or release of radioactive material. The Comission intends i

i that rulemakings codifying regulatory control exemptions will be made a matter >

j of compatibility for Agreement States. Consequently, any rulemakings that evolve from this policy will be coordinated with the States, r

! Advisory and scientific bodin have offered diverse views to the Comission in i anticipation of this Policy Statement. There is no clear consensus based on l

existing scientific evidence or research regarding the selection of numerical criteria for use in this Policy Statement. Further, the Comission is aware that there are differing views within the NRC staff on the selection of I numerical criteria for BRC.  ;

In the absence of a scientific consensus, it is the Comission's task to assess  !

the diversity of views in establishing a responsible BRC policy. The authority  ;

i

, and responsibility to make the final selection of criteria rests with the '

Comission. Criteria selected must: 1) provide reasonable assurance that public health and. safety will be protected, and 2) consistent with such  ;

assurance, permit practices in the public domain which involve the use of '

radioisotopes for which society perceives a demand, i

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! It is recognized that there is a delicate balance here. Criteria can be set  !

! sufficiently restrictive such that there is absolute assurance that health

ar.d safety will always be protected, no matter what events might transpire.

I However, in doing so, the regulator may then place undue and unnecessary  ;

! restrictions on practices which should be pennitted becaus2 of otherwise ,

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L I reasonable social, economic, or industrial considerations. There is always the danger of over-regulation which results in effects that are felt in areas where the NRC does no.t have authority and responsibility. Moreover, the Atomic Energy Act does not require absolute assurances of safety in the use of radioactive material and licensed facilities.

The numerical criteria ultimately selected will have significant impact on nuclear regulation here in the United States and potentially in the international community. The value: under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries. The Commission has carefully reviewed those alternate

  • criteria, and does not find significant scientific evidence that would dictate l

preferential selection of any of those views over what is proposed in this Policy Statement.

l i

i  !!. RADIATION PROTECTION PRINCIPLES The Co=is:fon rece;nizes that three fundamental principles of radiation protection have historically guided the formulation of a system of dose limitation to protect workers and the public from the potentially harmful effects of radiation. They are (1) justification of the practice, which requires that there be some net benefit resulting from the use of rrdiation or radioactive materials, (2) dose limits, which define the upper boandary of adequate protection for a menter of the public which should not be exceeded in

( the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account. The term, ALARA, is an acronym for As low As is Reasonably Achievable. The Comission is interested in assessing how these principles should be applied in establishing appropriate criteria for release of radioactive materials from regulatory control.

Because of the absence of observed health effects below 5 rem / year (50 mSv/ year), scientific experts including the International Comission on Radiological Protection (ICRP) and the National Council on Radiatior.

Protection and Mtasurements (NCRP) make the assumption that the frequency of occurrence of health effects per unit dose at low dose levels is the same as at high doses (10 Rad (0.1 Gy)) where health effects have been observed and studied in humans and animals. This linear non threshold hypothesis assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose, no matter how small the dose might be. The evefficient usedinthemogelasabasisforestimatingstatisticalhealthriskisonthe risk of fatal cancer per person-rem of radiation dose ordergf2x10'per (2x10' Sv). The Comission recognizes ti,at it is a conservative model based upon data collected at relatively high doses and dose rates which is then extrapolated to the low dose and dose rate region where there are no statistically reliible epidemiological dati available. Alternative hypotheses have been proposed and reevaluations of the data base at higher doses continue. The Comission belikves that use of the linear non-threshold hypothesis allows the theoretical establishment of upper limits on the nutter of health effects

( that might occur at very low doses which are the subject of the exemption policy, 3

1 The risk of death to an individual, as calculated using the linear model, is

, shown in Table 1 for various defined levels of individual dose. A radiation

exposure of 10 mrem per year (0.1 mSv per year) for a lifetime corresponds '

1 theoretically to an increase of 0.1% of the individual's annual risk of cancer death. The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70-year lifetime. >

l In estimating the dose rates to members of the public that might arise through

the use of various practices for which exemptions are being considered, the Comission has decided to apply the concept of the "effective dose 4

equivalent." This concept, which is based on a comparison of the delayed

  • mortality effects of ionizing radiation exposures, permits through use of weighting factors, the calculation of the whole body dose equivalent of partial body exposures. This approach was o icinally developed by the j International Comission on Radiological Prot 1ction and was first expressed in I its Publication 26 issued in 1977. Since that time, the concept has been i reviewed and evaluated by radiation protection organizations throughout the  ;

I world and has gained wide acceptance.  !

j Table 1*

1 incremental Incremental Lifetime Risk from

Annual Dose Annual Risk Continuing Annual Dose 100 mrem *" 2 x 10 0 4 i ~1 x 10 ' .

) 10 mrem" 2 x 10-6 -1 I 1 mrem 2 x 10*7 ~1 xx 10'5 10- -

! 0.1 mrem 2 x 10-8 ~1 x 10-6

  • Risk coefficient of 2 x 10'4 per rem (2x10'2 perSv)basedupon l

1 publications of the ICRP.

1 1

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" For purposes of comparison, the annual risk to an individual of dying *

! from cancer from all sources in the U.S. is 1 in 500. The additional risk to an individual of dying from cancer when exposed to 10 mrem (0.1 mSv) is 2 in one million.

1

) "* Unless otherwise indicated, the expression of dose in mrem refers to ,

i the Total Effective Dose Equivalent. This terin is the sum of the t 4

deep dose equivalent for sources external to the body and the' (

j corrritted effective dose equivalent for sources internal to the body. j i

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The Comission recognizes that it is impossible to measure risk to individuals {

or populations directly, and, that in most situations, it is impractical to ,

reasure annual doses to individuals at the low levels implied by exemption decisions. Typically, radioisotope concentrations or radiation levels from the <

material to be exempted are the actual measurements that can be made, and doses are then estimated by expot,ure pathway analysis combined with other types of assumptions related to the ways in which people might hecome exposed. Under l such conditions, conservative assumptions are frequently used in modeling so .

that the actual dose is on the low side of the calculated dose. The Comission l y

believes that this is the appropriate approach to be taken when deter.fdning if l

^

an exemption from regulatory controls is warranted. ,

Collective dose is the sum of the individual doses resuming from t.  ;

i practice er source of radiation exposure. By assigning collectivt dose a j

! monetary value, it can be used in cost benefit and other quantiticive analysis ,

techniques. It is a factor to consider in balancing benefits and societal  ;

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impact.  !

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!!!. CONSIDERATIONS IN GRANTING EXEMPTIONS FROM REGULATORY CONTROL

' The following elements are being considered by the Cemission as a basis for ,

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evaluating practices which are proposed to be exempt from regulatory control.  ;

These practices, if approved, would result in products containing low levels of radioact.ve material being distributed to the general public and radioactive J

i I effluents and solid waste being released to areas of the publicly-accessible .

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l environment. t o Justification - The Comission seeks comment on the extent to which l exposures resulting from any practice should be justified. As lower levels of radiation exposure are projected, should lower levels l of benefit be required for practice justification? In establishing its  ;

J i exemption policy, should the Comission exclude certain In practices considering for  !

which there appears to be no reasonable justification? i

{ proposals for exemptions, should the Comission evaluate the social

) acceptability of practices? Should the Comission determine a practice l j  ;

to be unjustified if nonradioactive economical alternatives exist?

l Dose 1.imits and Criterion - Individual doses from practices exempted f o i under this policy should not be allowed tu exceed 100 mrem per year '

(1 mSv per year). This is the dose limit for merters of the public specified I in the final revision of 10 CFR part 20, Standards for Protection Against Radiation. The dose limits in the final revision of 10 CFR Part 20 apply I' to all sources of radiation exposure under a licensee's control (natural background and medical exposures are excluded). Because of the small

! risks involved, a 10 mrem (0.1 mSv) individual dose criterion is proposed j

as the basis for exemption decisions based on simple analysis and judgements.

1 The Comission specifically seekt coment on the need for establishing j a collective dose limit in addition to an individual dose criterion.

I If such a collective dose criterion is needed, what is the basis for this need? If the Comission decides that a collective dose criterion lI l

is needed, what approaches allowing truncation of individual dose in calculation of collective dose or weighting factors for components of collective dose would be appropriate? What J.lternatives should be considered for assessing societal impact?

o ALAPA - The ALARA principle generally applies to determining dose levels below which exerptions may be granted on a cost-benefft basis. However, I it is the purpose of this policy to establish criteria which would in effect, delineate acdievement of ALARA withcut cost-benefit analysis.

Although it is possible to rersonably project what the dose will be from a practice, and then take this informatinn into account in controlling regulated practices so that the dose lih"1s are t exceeded, exemptions imply some degree of loss of control. The *ommi% ion believes that a key coasideration in establishing a policy for exemptient, and subsequently in specific rulemaking or licensing decisions, is the cucstion of whether individuals may experience radiation exposure approaching *..e limiting values through the cumulative effects of more than one practice, even though the exposures from each practica are only small fractions of the limit. The Comission specifically seek:

coment on the issue. By appropriate choices of exemption criteria and througn its evaluations of specific exemption proposals in implementing the policy, the individual will Comission intends towhich experience exposures assure thatthe exceed it is100 unlikely thatyear mrem por any(1 mSv per year) limit.

IV. PRINCIPLES OF EXEMPTION A major consideration in exempting any practice fcom regulatory control hinges on the general Question of whether or not application or continuation of regulatory controls are necessary and cost effective in reducing dose. To determine if exemption is appropriate, the Comission must determine if cne of the following conditions is met:

1. The application or continuation of regulatory r.ontrols on the practice does not result in any significant reduction in the dose received b) individuals within the critical group and by the exposed population or;
2. The costs of the regulatory controls that could be imposed i v dose reduction are not balanced by the comensurate reductiot, in risk l that could be realized.

For purposes of implementing its policy, the Comission recognizes that only under unusual circumstances would practices which cause radlation exposures approaching the 100 mrem per year (1 mSv per year) limit ke considered as candidates for exerption. The Comission will consider such circumstances on a case specific basis using the general principles outlined in this policy statement. However, as the doses and attendant risks to merters of the exposed population decrease, the need fnr regulatory controls decreases and the analysis needed to suppert a proposal for exemption can reasenably be somewhat simplified.

I The Comission is evaluating the use of two numerical criteria in dnfining the i region where ALARA has been achieved. They are (a) a criterion for the maxirum l

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O I individual annual dose reasonably expected to be received as a result of the practice and (b) a measure of societal impact to the exposed population. These criteria are being considered to assure that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact.

If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared with other societal risks. The Co ission believes that annual individual fatality risks belowapproximately10"p(onein 100,000) are of little concern to most members of society. Providin Comission proposes 10 mrem (g for 0.1 mSv) assome margin the level below of annual this level, individual the exposure.

The incremental annual individual cancer fatality risk associated wigh an, exposure level of 10 mrem per year (0.1 mSv per year) is about 2x10" (two in one million) as indicated in Table 1 and of the order of 0.1 percent (one in one thousand) of the overall risk of cancer death.

In evaluating the need for a collective dose criterion, the Comission recognizes

' that this criterion could be the limiting consideration for practices involving

! very small individual doses to very large nunters of people. It is also recognized i that in such cases the collective dose criterion would, in effect, apply the Al. ARA concept to individual doses less than the below regulatory concern level of 10 mrem per year to the individual. Conversely, where the collectise dose criterion would not be limiting, it would serve no purpose. The Comission requests coments on this issue, including corrents on what the magnitude

( of the colltctive dMe criterion, if any, should be.

]

If the dose is less than the below regulatory concern criteria, then the risk from a practice would be considered to be ALARA without further analysis. The Commission stresses that adoption of the criteria should not be construed as a l

decision that smaller doses are necessary beforJ a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary, the

! criteria simply represent a range of risk which the Comission believes is

sufficiently small compared to other individual and societal risks that a cost I benefit analysis is not required in order to make a decision regarding the acceptability of an exemption. Practices not meeting these criteria may be granted exemptions on a case-by case basis in accordance with the principles
ertodied within this policy. To further emphasize the Comission's recognition that a rigid limitation on collective dose would be inappropriate, it r.etes that for some practices, such as use of smoke detectors, appreciable j benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose.

The Comission is aware that existing regulations of the Environmental Protection Agency establish criteria more restrictive than exemptions which

could otherwise be granted under this proposed policy. With regard to its own
regulations, the Cemission will evaluate whether there are exemption criteria j embodied therein for which modification, according to the principles of this policy, would be beneficial.

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V. EXCLUSIONSFROMEXEMOONS The Commission't March 16, 1965, notice on the Use of Byproduct Material and Source Material-products Intended for use by General Public (Consumer products)

(30 FR 3tf2) provides the basis for the Commission's approval of the use of these materials in consumer products without regulatory control on the consumer-user. This is accomplished by case-by-case exemption of the possession and use of approved items from applicable licensing requirements.

Approval of a proposed consumer product depends upon an assessment of exposures of persons to radiation as well as an evaluation of the usefulness of the product.

Certain practices involving radiation or radie, active materials have been judged by N9C to be socially unacceptable regardless of how trivial the resulting dose might be and, therefore, nave been excluded from exemption.

Excluded practices include, but are not limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inha?ation or direct application to the skin (such as cosmetics).

In addition to socially unacceptable uses of radioactive raterials, a question

' also arises regarding uses where there are clear economical alternatives, and no unique cenefits exist from using radioactive material. Where risks are trivial, the regulatory prohibition of such uses could pose an unnecessary regulatory burden by interfering with the conduct of business.

The Comission seeks coments on whether practices should be categorically excluded based on the Comission's judgement regarding social acceptability or the existance of alternatives. An alternative to categorical exclusion could be case specific determination based on a safety analysis.

VI, PROPOSALS FOR EXEMPTION A proposal for exetrption must provide a basis upon which the Comission can determine if the basic conditions described above have been satisfied. In j I general, this means that the proposal should address the individual dose and societal impact resulting from the expected activities under the exemption, including the uses of the radioactive materials, the pathways of exposure, the levels of activity, and the methods and constraints for assuring that the assumptions used to define a practice remain appropriate as the radioactive materials move from regulatory control to an exempt status.

If a proposal for exemption results in a rule containing generic requirements, ,

a person applying to utilize the exemption would not need to address I justification or ALARA. The Comission decision on such proposals will be based on the licensee's meeting the conditions specified in the rule. The promulgation of the rule would, under these circumstances, constitute a finding that the exempted practice is justified, and that ALARA considerations have been dealt with. This approach is consistent with past practice, e.g.,

consumer product rules in 10 CFR dart 30.

In evaluating proposals for exemption under this policy, the projected exposures to different components of the exposed population will be considered with regard to the potential that some individuals may receive doses near the 100 mrem per 8

d o

a I year (1 mSv per year) limit when doses from othet i,ioctices are also taken into  !

i consideration. if exposures from moltiple practices can occur which are significantly beyond the individual dose criterion (10 mrem per year (0.1 mSv per year)), the exemption will not be granted without further analysis. As <

experience is gained, this policy and its implementation will be reevaluated  !

with regard to this issue to assure that the exposures to the public remain well below 100 mrem per year (1 mSv per year).

In addition to considerations of expected activities and pathways, the Comission recognizes that consideration must also be given to the potential for accidents and misuse of the radicactive materials involved in the practice.  ;

1 A proposal fer exemption of a defined practice must theref' ore also address the -

l potentials for accidents or misuse, and the consequences of these exceptional l conditions in terms of individual and cellective dose. ,

l VII. VERIFICATION OF EXEMPTION CONDITIONS l

The Cennission believes that the implementation of an exemption under this  :

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! broad policy guidsnce must be accompanied by a suitable program to monitor and verify that the basic considerations under which an exemption was issued remain .

valid. In most cases, the products or materials comprising an exempted I practice will move from regulatory control to the exempt status under a defined

set of conditions and criteria. The monitoring and verification program must (

therefore be capable of providing the Comission whh the appropriate assurance j] that the conditions for the exemption remain valid, and that they are being observed. The Comission will determine compliance with the specific l(

conditions of an exemption through its established licensing and inspection  !

i program and will, from time to time, conduct studies as appropriate to assess i the impact of an exempted practice or combinations of exempted practices, i

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U.S. N clos R ulatory Nuclear Energy l Wor < shop on Rules for Exemption i from Regulatory Control l

Sponsored by the ,

U.S. Nuclear Regulatory Commission 1 in Cooperation with the ,

Nuclear Energy Agency, OECD l I

r October 17-19,1988 Washington, D.C., U.S.A. .

.o Oak Ridge h Associated Universities a

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NRC/NEA WORKSHOP CN RULES FOR

'-. EXEMPTION FROM REGULATORY CONTROL j Agenda ,

Monday. Ogigbar 17. 1988 i

8:30 Registration SESSION 1 - INTRODUCTION AND IDENTIFICATION OF ISSUES Chairman: Themis Speis U.S. Nuc), ear Regulatory Commission 9:30 Welcoming Addresses c Themis Speis Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission  ;

Victor Stallo officer of Executive Director for i i

Operations  !

' U.S. Iluclear Regulatory Commission Osvaldo Ilari Radia": ion Prctaction and Wa9te Management Division I Nuclear Energy Agency 10t00 Overview of Major' Regulatory Exemption Activities Underway ac che U.S. Nuclear Regulatory Commission l

Eric Beckjord Office of Nuclear Regulatory Research j i

U.S. Nuclear Regulatory Commission j f

i 10115 What Do We Mean by Belav Regulacory Concern? [

Donald Cool Office of Nuclear Material Safety and (

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) Safeguards  !

U.S. Nuclear Regulatory Commission  ;

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, 10:40 Break  :

. I i 11100 The Concept of "PraccJ.ce" in Radiacion Proteccion j Osvaldo Ilari Radiation Protection and Waste [

i Management Division OECD, Nuclear Energy Agency 11t30 The' Concepc of Negligit'le Risk l Geoff Webb National Radiological Protection Board

- United Kingdom l

_, 12
00 Lunch '

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SESSION 2 - MhTIONAL SITUATIONS AND APPROACHES TO THE i ESTABLTSHMENT AND DEVEIAPMENT OF EYEMPTION RULES Chairmant Yoshikazu Yoshida Atomic Energy Research Institute Japan .

j 1130 EPA's Views on Regulatory Cucoffs for Radiation Exposure Richard Guinend, Office of Radiation Programs J. William Gunter, U.S. Environmental Protection Floyd Galpin Agency 2t00 Report on National Situation and Approaches in Canada George Jack Atomic Energy Contrcl Board ,

i Canada

} 2t20 Exemption Rules Appiled in Tiniand H.A. Kahlos, 71nnian Centre for Radiation and E. Ruokola Nuclear Safety 1

  • Finland
2t40 Approche Francaise En Ce Qui Concerne L* Exemption De Materlaux De Tres Talbie Radio ActLvice (The French Approach for ExemptinE Materials with Very Low Level l RadioactivLcy)

Anne-Narie Chapuis Commissariat & l'Energie Atomique 3

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Institut de Protection et de I SQrete Nucidaire

! France i 3 00 Break 3t20 Department of Energy Gu i tie 1 L n e s for Residual Radioactive 1 Material at TUSRAP and STMP Sites and the ALARA Process Andrew Wallo Office of Remedial Action and Waste Technology

U.S. Department of Energy i

NOTEt Where the papers have multiple authors, the individual presenting the paper is underlined. .

Monday,__Qctober 17. IgjLg 3t50 Report of Nacional S L cuacion and Approaches in the Federal Republic of Germany R. Neider Federal Institute for Materials Research H-J. Hardt and Testir.g Federal Republic of Germany 4t10 Criteria Governing the 2xemption Rules of Radioacctve statorials from Regulatory Control in Italy S. Benassai,* *ENEA-DISP S. Frullani,** **Instituto Superiore Sanita G. Naschi,* Italy S. Piermattei,*

A. Susanna*

4t30 Report of Nacional Situation and Approaches in Japan Masao Oshina Atomic Energy Research Institute Japan i

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Tuesday. October 18. 1988 s

SESSION 2 (cont.) - NATIONAL SITUATIONS AND APPROACHES TO THE ESTABLISHMENT AND DEVEIIDMENT OF ext:1PPION Bil.LKE J

9t00 Rules on ExempcLon from Regulatory Control - A Preposed Broad Poiicy Scacement by the U.S. Nuclear Regulatory Commission Bill Morris, Office cf Nuclear Regulatory Research William Lahs U.S. Nuclear Regulatory Commission ,

9t30 Spanish Situacion and Approaches to che Escab1Lshment and i Development of Exemption Rules

. Julia L6pez Consejo de Seguiridad Nuclear Espana -

de la Higuera Spain 9t50 Establishment and Implementacion of Exemption Leve.s in Sweden C. Baraman,*

  • National Institute of Radiation G. Hellstr6m,* Protection S. Norrby** ** Nuclear Power Inspectorate Sweden Posicion of Switzerland i 10.10 Serge Pretro Swiss Nuclear Safety Inspectorate r Switzerland t

lot 30 Break 10t50 R:; ort on'Nacional Situation and Approaches in che United Kingdom j Alan Duncan Her Majesty's Inspectorate of Pollution

- England ,

11t10 The R e g u i s t o ry Provisions of the European Community  ?

Concerning the Reporting and Authorization of Activities Involving Radioactive Substances I

i G. Gouvras, Connission of the European Corununities FeliY Luvkx Luxembourg ,

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I Tuesday. October 18.. 1988

-s SESCION 2 (cont.) -

}iATI.ONAL JJTUATIONS AND APPROACHES TO THE EAUBLISHMENT J),@ DEVE LOPMENT OF EXEMPTION RULLS 11:30 Txeupcions from R'gulacory e Control in Australia

  • J. E. Cock, Australian Nuclear Science and A. Murray Technology Organization Australia
  • To be presented by Osvaldo Ilari 12100 Lunch .

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Tuesdavu october 18. 198R SESSION 3 - DISCUSSION OF EXISTING ISSUES Chairmant George Jack Atom:.c Energy Control Board  ;

Canada 1t30 Review of Existing Issues Geoff Webb National Radiological Protection Board United Kingdom -

1855 A Compromis* Regarding the Three Different Cultural l Responses to che *De Minials' Question l Serge Pretre Swiss Nuclear safety Inspectorate Switzerland 3t20 Principe De DecoralnacLon De LLaicos Derivees Pour i L' Exemption D'Objets Ou Do Macerlaux (Principle for Decoraining Derived Liales for the Exemption of Objects i and Ma;erials)

Anne-Marie Chapuis Coma!ssariat & l'Energie Atomique

Instivat de Protection et de SQrate Nucidaire 2

Frarce i

3t45 Currenc Status of Risk Estimates for Assessing Health

Consequences of Low Doses l National Council on Radiation Protection
Whrren Sinclair l

and Measurements .

0 United States i

j 3110 Break I

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. t Tggadav. October 18. 1988 cm t

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, SESSION 4 - STATUS OF INTERNATIONAL GUIDELINES ON EXEMPfION RULES chairmant

osvaldo Ilari i Ndclear Energy Agency h 3t30 ZCRP Guide!Lnes

) Geoff Webb National Radiological Protection Board i United Kingdoa 4t00 Research at the European Conaission Related to the

) Development and the Use of Exemption Rules 1

Karl schaller commission of the European communities

Belgium i . 4t30 Princigles for Exemption of RadLation Sources and

} Practices from Radiation Protection Standards l Abel GonzAlan, Radiation Protection Section 2 Osvaldo Ilari International Atomic Energy Agency 1

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t Wednesday. October 19. 1988 SESSION 5 - PRESENTATION AND DISCUSSION OF THE CONCLUSIONS OF THE WORKSHOP Chairmans Richard E.,Cunningham, Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commissio*.

9t00 Scacement of Accomplishments Richard Cunningham Of[iceofNuclearMaterisiSafetyand Safeguards U.S. Nuclear Regulatory Commission 9115 Summary of Areas of Consensus . Identificacion of Oucscanding Issues Robert Bernero Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 9135 Additional Views from Session on Nacional Approaches Yoshikazu Yoshida Atomic Energy Research Institute Japan 9150 Additional VLews from Session on Existing Issues George Jack Atomic Energy Control Board  :

Canada 10105 Additional Views from Session on Internacional Guidelines Osvaldo Ilari Radiation Protection and Waste Management Division Nuclear Energy Agency 10120 Break l

10:40 Floor Discussion 11:45 Workshop Closing

Themis Speis Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commi tion l

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, ,' NRC/NEA gnoramnp og 3 plug y0R EXEMPFION FRON REGUIATORY CONTROL ,

Pan American Realth Organisation (PANO) Conference Facilities '

i -- 525 - 23rd Street, NW j Washington, DC, United States i  !

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i EUIIAING USE l The Pan American Health organisation will be open Monday through i 1 Wednesday from 8:00 a.m. to 5:00 p.m. seminar participante must  !

i wear an identification badge at all times while in the building.  !

Smoking is not allowed anywhere in the build.ing, and food and l

beverages are not allowed on the second floor of the building. l 4

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aremnann DESK  !

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- The telephone number for the message desk is (202) 861-4351.  !

, Messages may he left for participants at the conference from 8:30

! a.m. to 5:00 p.m. Monday and Tuesday, and from 8:30 a.m. to 12:00 f

noon on Wednesday. If you are expecting a call, please remember i

! to check the message desk during the breaks.  ;

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i BA.tX i 1

First American Bank of Washington, 502 - 23rd Street, NW (located i;

!' in Columbia Plaza) . Hours are Monday through Thursday 9:00 a.m. i d

to 2:00 p.m., Friday 9:00 a.m. to 2:00 p.m. and 4:00 p.m. to 5:30  :

l p.m. Exchange of foreign currency available. Telephona

637-2506. i

! f j masTAumANTs l Aun Beaum Champs Charlie Chiang,

French Cuisine Chinese cuising l 2800 Pennsylvania Avenue, NW 1912 I Street, NW ,

) Telephone 342-0810 Telephone: 273-6000 j t  !

} Bombay Palace Columbia Flass Gourmet Deli  :

Indian Cuisine Deli and Bakery  ;

1834 K street, NW 538 - 23rd Street, NW  !

Telephone 331-0111 Telephore: 847-8240 l

'the Bristol Orill Devon Bar and Grill (

i American cuisine steak and Seafood I i 2430 Pennsylvania Avenue, NW 2000 Pennsylvania Avenue, NW l l Telephone 955-6400 Telephones 833-5660 1

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RESTAURANTS (con't) .S l I

Dominique Restaurant Joe & Mo's French Cuisine American Cuisine l 1900 Pennsylvania Avenue, NW 1211 Connecticut Avenue, NW  ;

Telephone 452-1126 Telephone 659-1211 The Dubliner Res W rant & Pub Ia Maree Irish Cuisine French Cuisine l 520 N. Capital Street, NW 1919 I Street, NW j Telephone 737-3773 Telephone 659-4e47 t i

Enriqueta's Restaurant IARuche French Cafe .  ;

Mexican Cuisine French Cuisine t 2811 M Street, NW 1039 - 31st Street, NW i Telephone 338-7772 Telephone 965-2684 f t

F Scott 8s Im Chauniore i American cuisine French cuisine 1232 - 34th Street, NW 2:13 M Street, NW ,

telephone 965-17s9 Telephone 33s-17s4 j i

Filomena Restaurant Le Gaulois i Italian Cuisine French Cuisine i 1063 Wisconsin Avenue, NW 2133 Pennsylvnia Avenue, NW i Telephone: 33s-es00 Telephone 465-3232 [

Nouse of Nunan Le Jardin Chinese cuisine French Cuisine  ;

1900 K Street, NW 1113 - 23rd Street, NW .

Telephone: 293-9111 Telephone 457-0057 (

Iron Gate Inn Im Eteak [

Middle Eastern cuisine French cuisine l 1734 N Street, NW 3060 M Street, NW  !

Telephone: 737-1370 Telephone 965-1627 Japan Inn Ime Champs Japanese cuisine French cuisine 1715 Wisconsin Avenue, WW 600 New Hampshire Avenue, NW Telephone: 337-3400 Telephone: 238-4477 Jean Imuis at Watergate Imigi's Pisseria French cuisine Pissa 2650 Virginia Avenue, NW 1132 - 19th Street, NW Telephone: 298-4488 Telephone 331-7574 .

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RESTAURANT 3 (con't)

Magic Gourd 1789 Restaurant Chinese Cuisine American Cuisine 528 - 23rd Street, NW 1226 - 36th Street, NW (located in Columbia Plaza) Telephonet 965-1789 Telephonet 466-3995 Sichuan Pavilion Morton's of Chicago Chinese cuisine American Cuisine 1820 K Street, NW 3251 Prospect Street, NW Telephone 466-7790 Telephone 342-6258 Swensens Ice Cream Parlor Mr. K's Sandwiches, Salade, and Chinese cuisine Ice cream 212' K Street, NW 1990 K Streat, NW T' phone J31-8868 Telephonal 833-1140 Nathan's Thai Taste of Georgetown Italian Cuisine Thai cuisine 3150 M Street, NW 3287 1/2 M Street, NW Talephone 338 2000 Telephonet 965-7988 Old Europe Tiberio Rinkorante German Cuisine Italian Cuisine 2434 Wisconsin Avenue, NW 1915 K Street, NW Telephone 333-7600 Telephonet 452-1915 Palm Restaurant Vie de France American cuisine French Cafe and Bakery 1225 - 19th Street, NW 1990 K Street, NW Telephone: 293-9091 Telephone 659-0055 Potowmack Ianding Seafood George Washington Parkway (Alexandria, VA)

Telephone 548-0001 Powerscourt Restauratnt -

Irish cuisine 520 N. Capitol Street, NW Telephone 737-3776 Primo Rib .

American Cuisine 2020 K Street, NW Telephonet 466-8811 .

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. NRC/NEA WORESNOP ON RULES FOR EXEMPTION FROM REGUIATORY CONTROL Pan American Health Organisation (PANO) Conference Facilities l 525 - 23rd Street, NW .

i Washington, DC, United States l October 17-19, 1988 i

ATTENDEES I

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Charles E. Ader  !

1 Tech. Asst. to ConkAssioner Thomas M. Roberts -

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U.S. NRC l 11555 Rockville Pike l Rockville, MD 20852 I United Stateu l

. Telephones 301-492-1800 l Robert E. Alexander Special Asst. to the Director Office of Governmental and Public Affaira l U.S. NRC  ;

11555 kockville Pike )

Rockville, MD 20852 - r Telephone 301-492-1786 -

I John Austin F 1

Special Asst. to the Director i

Office of Nuclear Naterial Safety and Safeguards [

U.S. NRC f l 11555 Rockville Pike i l Rockville, ND 20852

! United States  !

Telephone: 301 492-0689 Eric 5. Beckjord j Director i Office of Nuclear Regulatory Research U.S. NRC l 5650 Nicholson Lane Rockville, MD 20852

. United States Telephone 301-492-3714 Curt Bergman National Institute of Radiation Protection

! Sox 60204 3

S-10401 Stockholm *

Sweden L_. . Telephone 8-7927100 b

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i Robert M. Barnero '

Deputy Director office of Nuclear Material Safety and Safeguards

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U.S. NRC  ;

11555 Rockville Pike Rockville, MD 20852 l United States Telephone 301-492-3326 [

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Pedro carboneras Safety and Licensing Manager i ENRESA Paseo de la Castellana, 135-158 i 28046 Madrid l Spain  :

7 Telephone: 1-571-49 "O Kenneth M. Carr Commissioner l U.S. NRC ,

11555 Rockville Pike  ;

Rockville, MD 20852 United States Telephonet 301-492-1820 f

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Anne-Marie Chapuis L Chef de la Section d' Etudes i de Protection pour les Dechets Commissariat & l'Energie Atomique i

, Institut de Protection et de sureld Nucidaire  ;

B. P n' 6 l

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, 92265 Fontenay-Aux-Roses France ,

. Telephone 1-46-54-72-33 .

I Frank csngel

- Director, Division of Radiation Protectior.  !

- and Energency Preparedness j U.S. NRC i 11555 Rockville Pike Rockville, MD 20u52 f l

United States Telephones 301-492-1088 l I

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, Donald 4.. Cool Section Leader .

Programmatic Safety Section Operations Branch Divasion of Industrial and Medical Nuclear Safety, NMSS, NRC U.S. NRC

.\1555 Rockville Pike Rockville, MD 20852 United States Teleph0 net 301-492 *422 s

Edward E. Cour Senior Administrative Officer Oak Ridge Associated UniversitioG 1019 19th Streat, NW Washington, DC 20036 United States Telephona 203-053-5505 .

Lemoine J. Cunningham -

, Branch Chief l Radiation Protection Branch U.S. NRC 11555 Rockville Pike Rockville, MD 2F)52 United States Telephone 301-492-1111 Richard E. Cunningham . s 3

Director Division of ruel Cycle, Medical, Academic and Commercial Use Safety U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States Telephonet 301-492-3426 Kitty C. Dragor.etta Senior Health Physicist U.S. NRC 11555 Rockville. Pike Rockville, MD 20852 United States Telephone 301-492-3437

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A. G. Duncan Depu?,y Chief Inspector-(RS) -

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H.M. Inspectorate of Pollution Department of Environment Room A516,, Romney House 43 Marsham Street London SW1 United Kingdom Telephonw: 01-276-0129 Janice G. Dunn-Lee Special Asst. for Safeguards and Intl.

Programs to Chairman Lando W. Zech, Jr.

U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States Telephone: 301-492-1750 .

Thomas C. Elsasser Tech. Asst. to Commissioner Kenneth M. Carz U.S. NRC 11555 Rockville Pike Rockville,'MD 20852 United States Telephone: 301-492-1820 Anthony H. Ewing -

Director, Washington Offico Oak Ridge Associated Universities 1019 19th Street, ITW Kahhington, DC 20036 U.r',ted States Telephone: 202-653-5505 Margaret Federline Tech. Asst, to Commissioner Kenneth M. Carr l U.S. NRC l 11555 Rockville Pike l Rockville, MD 20852

! United States Telephone: 301-492-1820 Diane S. Flack

! Technical Specialist I

Oak Ridge Associated Universities l 1019 19th Street, NW .

Washington, DC 20036 United States .

l Telephone: 202-653-5505 N

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--s.. .. . _ _ _ _ _ - - - _ ___ _- - -

e Robert Fonner

- Office of General Counsel U.S. NRC .

11555 Rockville Pike Rockville, MD 20852 United States Telephone: 301-492-1643 Floyd L. Galpin Chief, Waste Management Standards Branch U.S. Environmental Protection Agency Office of R&diation Programs (ANR-460) 401 M Street, SW Washington, DC 20460 United States Telephone: 202-475-9633 P. H. Gardner Health and Safety Executive 1 Chepstow Place London W2 4TF United Kingdom Telephone: 01-243-0837 Abel Gonzdlez Section Head Radiation Protection Section Division of Nuclear Safety International Atomic Energy Agency P.O. Box 100 A-1400 Vianna Austria Telephone: 43-222-2360-2716 Janet Gorn International Relations Officer -

U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States Telephone: 301-492-1783 Richard J. Guimond Director, Office of Radiation Programa (ANR-458)

U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 United States Telephone: 202-475-9600 ,

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J. William Gunter

Director, Criteria and Standards Division -}

I U.S. Environmental Protection Agency 1

401 M Street, SW Washington,'DC 20460 United States Telephone: 202-475-9603 )

i H. J. Hardt Ministerialrat Bundesministerium fQr Umwelt Naturschutz und Reaktorsicherheit HusarenstraBe 30 5300 Bonn 1 Federal Republic of Germany Telephone: 0228-305-2920 W. F. Holcomb Staff Engineer Office of Radiation Programs (ANR-460) .

~U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 United States Telephone: 202-475-9633 i

Osvaldo Ilari

  • Deputy Head of Division Division of Radiation Protection and Waste Managemont OECD Nuclear Energy Agency 38 Boulevard Suchet 75016 Paris France Telephone: 33-1-45240687 t

George C. Jack [

! Manager, Waste Management Division Atomic Energy Control Board j P.O. Box 1046, Station B Ottawa K1P SS9 [

Canada  ;

Telephone: 613-995-4055 ,

H. A. Kahlos Head of Inspection Office Finnish Centre for Radiation ,

and Nuclear Safety P.O. Box 268 l SF-00101 Helsinki Finland Telephone: 3580-70821 .

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.ms William R. Lahs-Acting Chief, Regulatory Development Branch Division of Regulatory Applications U.S. NRC 5650 Nicholson Lane Rockville, MD 20852 United States Telephone: 301-492-3774 John T. Larkins Special Asst. for Research and Waste Management to Chairman Lando W. Zech, Jr.

U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States ,

Telephone: 301-492-1750 Julia Lopez de la Higuera Radioactive Waste Branch .

Consejo de Seguridad Nuclear (CSN) Espa6a Sor Angela de la Cruz - 3 28020 Madrid Spain Telephone: 4561812 Maria E. Lopez-Otin Specia'. Asst.' to Commissioner Thomas M. Roberts U.S. NRC 11555 Rockville Pike i Rockville, MD 20852 l United States l

Telephone: 301-492-1800 Felix Luykx Commission of the European Communities (CEC)

Jean Monnet Building

, 2920 Luxembourg Telephone: 4301-2718 Gail Marcus Tech. Asst, to Commissioner Kenneth Rogers U.S. NRC 11555 Rockvillo Pike Rockville, MD 20852 ,

United States Telephone: 301-492-1850 l

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Catherine R. Mattsen j Health Physicist ]

l U.S. NRC 5650 Nicholson Lane l l

Rockville, MD 20852 United States  !

Telephone: 301-492-3638 Ruth McBurney Administrator, Standards Branch Bureau of Radiation Control Texas Department of Health 1100 W. 49th Street Austin, TX 78756 Telephone: 512-835-7000 Charles B. Meinhold Nationel Council on Radiation Protection and Measurements Safety and Environmental Protection Division Building 535A Brookhaven National Laboratory Associated Universities, Inc.

Upton, NY 11973 United States Telephone: 516-282-4209 William A. Mills Senior Technical Advisor .

Oak Ridge Associated Universities 1019 19th Street, NW Washington, DC 20036 United States  ;

Telephone: 202-653-5505 Dade W. Moeller Chairman, Advisory Committee on Nuclear Wasto Associate Dean Harvard School of Public Health 677 Huntington Avenue  ;

Boston, MA 02115 United States Telephone 617-732-0793 Bill M. Morris '

Director, Division of Regulatory Applications  ;

U.S. NRC 5650 Nicholson Lane Rockville, MD 20852 United Status Telephone: 301-492-3750 ,

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Giovanni Naschi

,I ) Director of Directorate for Nuclear Safety

/ and Radiation Protection ENEA - Directorate for Nuclear Safety and r

Radiation Protection Via Vitaliano Brancati N* 48 00144 Roma Italy Telephone 0039-6-85282051 R. J. A. Neider .

Professor Federal Institute for Materials Research .

and Testing (BAM)

Unter den Eichen 87 D-1000 Berlin 45 Federal Republic of Germany Telephone: 030-81046300 Stanley M. Neuder Froject Manager U.S. NRO 5650 Nicholson Lane Rockville, MD 20852 United States Telephone: 301-492-3737 S6ren Norrby Swedish Nuclear Power Inspectorate -

Box 27106 S-102 52 Stockholm Sweden Telephone: 8-6635560 Masao Oshino Deputy Director, Dept. of Health Physicts Japan Atomic Energy Research Institute Toka-mura, Ibaraki-ken, 319-11 Japan Telephone: 0292-82-5191 Harold T. Peterson, Jr. .

U.S. NRC 5650 Nicholson Lane

- Rockville, MD 20852 United States Telephone: 301-492-3640 l

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Silvana Pieraattei Director of Environmental Radioactivity Division . '\

ENEA - Directorate for Nuclear Safety and Radiation Protection Via Brancati 48 00144 Roma Italy j Telephone: 0039-6-85282862 Chris T. G. Poaroy Senior Health Physicist

. Radiation Protdction Division Atomic Energy Control Board .

270 Albert Street Ottawa, Ontario KlP 5S9 ,

Canada Telephone: 613-996-2106 Serge Pretre Head, Division of Radiation Protection Swiss Nuclear Safety Inspectorate -

CH-5303 WQrenlingen

! Switzerland l Telephone: 56-99-39-35 Allan C. B. Richardson Chief, Guides and Criteria Branch U.S. Environmental Protection. Agency 401 M Street. SW (ANR-460) .

Washington, DC 20460 United States Telephone: 202-475-9620-Thomas M. Roberts Commissioner '

U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States Telephone: 301-492-1800 l

Kenneth Rogers , l Commissione: i U.S. NRC 11555 Rockville Pike Rockville, MD 20852 '

United States .

Telephones 301-492-1855 3

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q Thomas A. Russell Senior Engineer

- Roy F. Weston 20030 Century Boulevard Germantown, MD 20874 ,

United States Telephone 301-353-1281 Jack Scarborough Tech. Asst. to Commissioner Kenneth Rogers U.S. NRC 11555 Rockville Pike Rockville, MD 20852 l United States Telephone: 301-492-1850 K. H. Schaller commission of the European Communities '

Directorate-General XII I

200, rue de la Loi B-1049 Brussels Belgium Telephone: .32-2-235-83-21 Warren K. Sinclair President National Council on Radistion Protection and Measurements 7910 Woodmont Avenue, Suite 800 Bethesda, MD 20814 United Statas Telephone: 301-657-2652 David S. Smith Technical Analyst Oak Ridga Associated Universities 1019 19th Street, NW Washington, DC 20036 United States Telephone: 202-653-5505 Themis P. Speis Deputy Director for Generic Issues office of Nuclear Regulatory Research U.S. NRC 5650 Nicholson Lane Rockville, MD 20852 United States Telephone: 301-492-3710

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Victor Stallo Executive Director for Operations '}

U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States Telephone: 301-402-1700 A. F. Susanna Director of Environmental and Radiation Protection Department ENEA - Directorate for Nuclear Safety and Radiation Protection Via Brancati 48 Roma Italy Telephone: 0039-6-85282860 Hugh Thompson Director Office of Nuclear Material Safety and Shfeguards U.S. NRC 11555 Rockville Pike Rockville, MD 20852 United States Telephone: 301-492-3352 Andrew Wallo III Site Designation and Certification Manager U.S.. Department of Energy Office of Remedial Action and Waste Technology U.S. DOE, NE-23 Washington, DC 20545 ,,

United States Telephone 301-363-5439 G.A.M. Webb National Radiological Protection Board Chilton, Didcot Oxfordshire OX11 ORQ United Kingdom Telephone: 0235-831600 Carl G. Welty l Physical Scientist l U.S. DOE EH-231 Washington, DC 20585 United States Telephone: 202-586-2417 l

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Yoshikazu Yoshida O Scientific Adviser Japan Atocic Energy Research Institute Tokai-mura, Ibaraki-ken, 319-11 Japan Telephone: 02,2-82-5913 P

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!  ; WORKSHOP ON RULES

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OPENING REMARKS BY THE WORKSHOP CHAIRMAN by THEMIS P. SPEIS Office of Nuclear Regu.latory Research U.S. Nuclear Regulatory Commission l

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WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL Opening Remarks By The Workshop Chairman Themis P. Speis, Deputy Director Office of Nuclear Regulatory Research U. S. Nuclear Regulatory Comission ,

My name is Themis Speis. I am Deputy Director for Generic and Regulatory Issues in the Office of Nuclear Regulatory Research at the United States Nuclear Regulatory Comission (NRC). Over the next 21 days I.have been given th' honor of serving as your ovorall Workshop Chairman. The intent of the Workshop is to focus international regulatory attention and enhance international regulatory cooperation on the broad subject of exemption policies. From a more parochial point of view, we would direct your attention and invite your coments on the Comission's advance notice regarding a draft broad exemption policy which can be found at the back of your Workshop notebook.

The Workshop on Rules for Exemption from Regulatory Control has been organized by the United States NRC in cooperation with the Nuclear Energy Agency of the Organization for Economic Cooperation and Development. The words, "in cooperation with", do not do justice to the efforts of Dr. Osvaldo Ilari of the Nuclear Energy Agency who, sit' ting to my imediate right, has been largely responsible for inviting and arranging for speakers and session chairmen from the international comunity. Dr. Ilari will be chairing the session on Tuesday afternoon which I will describe the status of international guidelines on exemption rules. For l

his efforts as liaison with Dr. Ilari and the international comunity, I would l

also like to acknowledge Mr. Richard Cunningham, seated to eqy imediate left, j who many of you know through his extensive participation over the years in the radiation protection activities of both the Nuclear Energy Agency and the International Atomic Energy Agency. Mr. Cunningham will be chairman of our final session on Wednesday morning. On any far left, Dr. Yoshikazu Yoshida will chair our longest session which will descritM the national situations and approaches to the establishment and development of exemption rules. Finally, on rny far right is Mr. George Jack who, on short notice, agreed to chair the I session which will discuss the major existing issues in establishing exemption policies.

I I believe we have gathered at this workshop a distinguished group of

) international regulatory authorities, and others, who have very important responsibil.ities related to the establishment of criteria for activities associated with the release of radioactive material.to the environment and the l use of radioactive material by members of the public. At last count, we are honored to have representatives at this workshop from eleven countries, the Comission of the European Communities, the International Atomic Energy Agency, the Nuclear Energy Agency, and the International Comission on Radiological Protection. From the United States, we have representatives from the National

- Council on Radiation Protection and Measurements, the Environmental Protection

, Agency, and the Department of Energy. I hope I haven't forgotten anyone.

I

Many of you will recognize a number of f amiliar faces because of your intimate involvement with the issues which will be addressed at this workshop. Others, like.myself and several of my colleagues from the United States, know many of you through your contributions to the fields of radiation protection and waste management. To indicate the importance that the U.S. NRC attaches to the subject of this workshop, I would note that several of our Commissioners are expected to attend and that Mr. Victor Stello, the Executive Director for Operations for the NRC, will shortly be welcoming you to this workshop. j The scope of our discussions is fairly broad. We have terminology barriers to  !

overcome, there are value judgements to be made', and there is a spirit of cooperation and consensus to achieve, if the decisions we make on exceptions from regulatory control are to be accepted by political authorities and members of the public.

Before starting on these important tasks, I would like to briefly mention the workshop structure which we hope will encourage an open exchange of views following each of tne presentations. There is a card in your notebook which describes the process by which I will be able to recognize you when you wish to make a statement or comment. In making statements or comments, please speak at no faster then a moderate pace so that the translators and recorders can accomplish their tasks. Our intention is to allow for a period of questions and answers after each paper, beginning with the papers this morning after the telcoming and introductory presentations. But since we do have a full schedule, and we must leave this. facility by 5:30 p.m. each day, my intent is to work with the individual session chairman to maintain a reasonable schedule.

If we begin to run behind, questions may be deferred to the end of the particular session. I would also point out that on Wednesday morning, we have scheduled a discussion and conclusion sestion which provides for a lengthy paried for floor discussion.

If any of you have questions en the arrangements of the workshop, your accommodations, or have any other related problems, I would encourage you to speak to Ms. Diane Flack or Mr. Edward Cour of the Oak Ridge Associated Universities. Together with Mr. William Lahs of the NRC, these three individuals have put in long hours and have been largely responsible for performing the secretariat functions of the workshop.

If the preliminaries are now taken care of, I would like to introduce Mr.

Victor Stello, the Executive Director for Operations of the U.S. huclear Regulatory Commission, who will officially wcicome you to the workshop and provide his opening remarks.

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WELCOMING ADDRESS by VICTOR STELLO, JR.

Office of the Executive Director for Operations U.S. Nuclear Regulatory Commission i

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WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL ,

4 Welcoming Address i

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Victor Stello, Jr.

Executive Director for Operations U.S. Nuclear Regulatory Comission  !

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! It is certainly iny pleasure to welcome all of you on behalf of the United i States Nuclear Regulatory Comission  !

Comissioners Carr, Rogers, and Roberts.and specifically Chairman Zech, '

i The subject of exemptions from regulatory control is not a new issue but one which the Comission has typically dealt with over the yea decisions.

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The exemptions which exist in NRC's regulations include specified i

quantities and concentrations of radioactive materials, some of which are l and in certain waste forms such as liquid scintillation media an!

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I acarcasses containing very low levels of tritium and carbon 14. just to mention few examples.  ;

j These exemptions were issued by the Comission following  ;

evaluations which included qualitative or quantitative cost benefit analyses.

j The exemptions appearing in NRC regulations are issued by the NRC through what  !

is referred to.as a rulemaking proceeding.

public coments are adequately considered. These proceedings assure that ,

But many believe as our  ;

j L Comissioners do, that the highly visible needs of today in w,aste disposal, l i

! dec*missioning decisions. and recycling cannot continue to be served by narrowly deffned

( overdue. A broad policy with an underlying logical consistency is long i l

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In the past the Comission has attempted to address the exemption issue on a broader fron,t but to date with only limited success. About five to seven

years ago, con,siderable effort was expended to incorporate a generic dose limit into our radiation protection standards to avoid extending regulatory actions  !

beyond what is needed to protect public health.  !

j as a part of a rulemaking proceeding involving a revision of NRC's StandardsIn fac .

' for Protection Against Radiation, the concept was publicly discussed and such a  !

generic dose lim <t was proposed. l Over the intervening years, the attempt to promulgate this limit into the basic standards has fallen by the wayside. i j Concurrently, in early 1986, the generic exemption issue was also addrested in i a different context by our United States Congress through passage of the Low Level Radioactive Waste Policy Amendments Act of 1985. )

i In this legislation the i

! term "below regulatory concern" was used to address disposal of certain radio-active wastes. These wastes would not need to be subject to regulatory control.  !

to assure adequate radioactivity protection of the public health because of their small content.  !

So, over the last few years, new term: hav V have evolved. But, over these same years,e been intru dollars, :ced and new concepts ti acs and other currencies continue to flow out in substantial am,ounts to controlpounds, marks, yen I

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disposal sites; to decontaminate sites, materialuranium mill tailings; to d activities; and to control radioactivity in consu,mer and equipment used in nuclear products.

time we are asking ourselves whether the resources that And are all the being expended to protect the public from overly not best be expended in protecting the publi:: conservative estimated risk calculations would from real risks. The fundamental such small risks if indeed they are in reality risks! issue is the socie associated with these practices:On calculated the other side of the coin, we have the indi but as yet scientifically unproved latent cancerindividual death per risks, year.which may involve,a 1 in a million chance of a As regulators, I believe we must seek some rational balance between these societal risks and the cost of industry and regulatory efforts needed for their control.

The Nuclear Regulatory Comission is searching as many of you are for a solution based on a logical, solid scientific basis.

field are not alone. In fact We in the radiation l

i a similar and perhaps more com, plex issue.I believe the control of chemical carcinogens is Environmental Protection Agency is struggling with the issue of definingHe acceptable example, levels benzene. of risk for widely used and beneficial chemicals, as for public coment four proposals for alterna':ive approaches for con benzene emissions.

risk approaches and Three include:of these alternatives are singh, parameter acceptable first, an approach which would tolerate one cancer to benzene;persecond yeargto the millions in the United States population who are exposed individual to a 10 an approach which would limit the maximum exposed lifetime aspect of this value.risk of death. And I want to emphasize the lifetime but 10~6where the risk is lowered, yes lowered, by two orders of magnitude to lifetime risk.

react By way of comparison, our safety goal for nuclear power 2x10~grs includes annual risk or aabout societal a 1x10 co'pognt wn~ ich has been expressed in terms of a lifetime risk.

be considered too small by some and too large by others, but they must beThese valu rationallyisaddressed resources achieved. so that a reasonable and proper expenditure of national I understand that considerable pro auspices in addressing this issue.gress has been made under IAEA and NEA tell you, as others will at this meetingI have seen several recent reports and can considered in the formulation of a propos,ed Comission policy.that In fact, our your ideas art b hosting of this workshop reflects the importance that we afford to your views Butthis on toissue.

be successful in formulating a policy, we must speak a comon languag We must understand the various concepts involved We m st air charged with protectingand understand the reasons .for any lators whodiversity are of views amon must be able :o convey, public health or the environment. Most importantly, we to the political authorities and the general public,

the prudence and reasonableness of the risk-benefit or other rationale used to

( justify radiation protection policies in general, and exemption policies in particular.

associated with Weradiation must do all this at low dose in the face et uncertainties in risk with the inherent potential uncertainties or conservatisms of many, models by which we calculate effects on people, and with an open airing of the regulatory-value judgements which must 2

be made in balancing costs against ben ~efits. Only in this way can decisions be made which are in the common natio.7=1 and international interest. The goal must be to weave logical approaches, reasonably conserv?tive models, and sound judgement into a regulatory fabric whose value and usefulness can be widely comprehended. The Commission recognizes that one of its major tasks in establishing a responsible exemption policy is to assess existing diversities in views. To clearly focus on those issues where differences in opinion may exist or specific comments are sought, the Commission has directed that the aforementioned draft Advance Notice of the Development of a Commission Policy on Exemptions from Regulatory Control be made available to you. You will find that the issues pertaining to "justification of practice," and "value of or alternatives to use of collective dose criterion" are uppermost in the Commission's mind. These issues will be discussed in more detail in our presentation tomorrow morning, in closing, I,have reviewed the agenda of this workshop and believe it is one in which the many facets of regulatory exemption issues, including the ones I have already mentioned, can be fruitfully discussed. I would encourage all of you to freely express your views. I can attest to the fact that within the NRC, over the last severa? months, wide ranges of opinions have been brought forward, just on the single issue regarding the foundation on which an exemption policy should be based. I would surmise that when a policy is established, implementation issues will bring out a far wider range of opinions and alternatives. If we in this industry are allowed one fulfilled dream, let it be a logical exemption policy based on a sound dose response relationship. I would express the Commission's special thanks to Mr.Ilari and to the speakers and Session Chairmen who have put in the effort to make this Workshop a success.

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OVERVIEW 0F MAJOR REGULATORY EXEMPTION ACTIVITIES UNDERWAY AT THE U.S. NUCLEAR REGULATORY COMMISSION t ',' s

. by ERIC 5. BECKJORD l s 0ffice of Nuclear Regulatory Research U.S.. Nuclear Regulatory Commission .

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! i h WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL i

Overview of Major Regulatory Exemption Activities l Underway at the U.S. Nuclear Regulatory Commission i

i Eric S. Beckjord, Director r l Office of Nuclear' Regulatory Research  !

j U.S. Nuclear Regulatory Cosmission  !

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! First of all, I would like to add my welcome to those already given and to

] personally thank all of you for your interest in atter.uing this workshop. I ,

j believe we all recognize both the importance and the sensitivity of the issuvs involved. In attempting to define rules for exemption from regulatory control, t

Victor Stello made reference to the magnitude of the resources involved and ,

pointed out that a responsible regulatory approach requires not only a sound i

, technical basis, but one which can be described to and generally understood by }

our national political leaders and the general public. Since the individual I national approaches can be expected to have a degree of variance comensurate  !

with the legitimate range of national value judgements, we, as nationel i i

regulators, must understand and be able to explain these differences in a ,

comprehensive fashion.  !

l As a starting point to the workshop this norning, I woul,d like to present t.n  ;

i overview of some of the major regulatory exemption activities now underway  !

within the U.S. Nuclear Regulatory Comission. Other agencies in the U.S. with i relevant activities are the Ensironmental Protection Agency, with the .

responsibility for generally applicable environantal standards, and the i l

Department ssfety of the of Energy,from the operation of DOE facilities as well as forwith the respo public t i remedial action programs involving the cleanup of formerly utilized sites and ,

the control of uranium mill tailin A number of the ongoing relevant l activities concern waste disposal,gs.where there is the greatest need for -

1 regulatory exemption criteria. This need has become particularly urgent l because of the large nuder of waste generators in the U.S. and the relatively f scall nud er of licensed radioactive waste disposal sites. When the NRC  ;

) published its regulations on "Licensing Requirements For Land Disposal of (

Radioactive Waste' in Deced er 1982, it e'xpressed its view that the l l establishment of standards for waste for which there is no regulatory concern i would be beneficial and would, among other things, reduce disposal and  ;

long-tem disposal site maintenance costs, help preserve the limited capacity

of the licensed waste disposal sites for the disposal of wastes with higher

! levels of activity, and enhance overall disposal site stability. This att i

! benefit is a result of reducing the volume of the least radioactive waste sent i to the radioactive waste buria ground. The typical waste fom of this i

! eventually resulting in structural degradation. l material affectinghas very low overall densityf stability o the site through slumping, collapse, or other failure of the disposal unit and thereby leading to water infiltration which  :

affects ground water migration impacts.

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Subsequently, the Low Level Radioactive Waste Policy Amendments Act of 1985  ;

required the NRC to develop a policy statement on "below regulatory concern d '

00, what is comonly referred to as, BRC waste. That policy statement was issued in August 1986. It defines the policy and procedures for expedited action on petitions for rulemaking to exempt specific waste streams from regulatory control. It contains det.ision criteria which, if adequately addressed by a petition for rulemaking, would allow the NRC to act  ;

expeditiously to grant an exemption to radioactive waste disposal requir vents.

The NRC also published an advance notice of proposed rulemaking, in DeNmber 1986, soliciting coment on ,the possibility of a generic BRC rulemak' .g. A generic rulemaking might provide a more efficient and effective mr.ns of dealing with disposal of wastes which are below regulatory concern and could potentially reduce the burdens associated with disposal of radioactive waste by all NRC licensees. Some of the 50 states within the Uniteo States are developing their own generic criteria which would allow the disposal of shorter half-life materials in unlicensed sanitary landfills. In the meantime industry has been developing a petition for rulemaking for disposal of, specific -

taste streams which it intends to submit under the BRC waste policy statement, which I mentioned previously. Our understanding is that these waste streams, all associated wit 1 nuclear power reactors, will include dry active waste, waste oil, sand and soil, secondary side ion exchange resins from pressurized cater reactors, and sandblasting grit from boiling water reactors.

One petition for a BRC rulemaking had been previously submitted in response to '

the NRC views expressed when the regulations on land disposal of radioactive taste were first published in 1982. It sought an exemptiun from mgulatory

, control for reactor-generated waste oil and' proposed several alternative disposal methods. Although the NRC concluded dhat the petition did not provide  !

enough information on which to base BRC r,riteria for waste oil, the NRC did propose a rule in August of this year which would allow onsite incineration of waste oil at nuclear power plants under existing effluent limits.

In addition to waste disposal, the other ares mst in need of a regulatory exemption policy is the definition of residual radioactivity limits for the release of land, structures, equipment, and materials for unrestricted public use. Currently, criteria exist only in the form of various NRC guidance documents. The most pertinent of these is referred to as Regulatory Guide 1.86, which is entitled "Termination of Operatwig Licenses for Nuclear Reactors". The existing guidance primarily consists of acceptable levels of surface contaminatioi:. Although the NRC has recognized the need for more comprehensive criteria in this area for a long time, such as the need for l volumetric contamination limits, it has been a difficult issue to resolve and a number of problems have delayed NRC action. Priority has now been placed on establishing a complete set of criteria for lands and structures since this is that is most needed for decommissioning. Development of such criteria is being actively pursued at this time and the NRC expects to publish first an interim '

policy statement consolidating existing guidance and current licensing practices. This interim policy would be followed by a more comprehensive set of criteria for the release of lands and structures for unrestricted use which i is also being developed. It is projected that these new criteria will be ,

l provided in the form of volumetric concentrations, surface concentrations, and i

external exposure rates and will be directly related, isotope-by-isotope, to an i annual effective dose equivalent. A long range goal is to also provide similar criteria for the recycle of contaminated materials and equipment.

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All of these activities I've mentioned involve "practice specific" criteria.

In making each of these "practice-specific" exemption decisions, we believe the primary objective must be to prevent undue risk to public health but that, once adequate protection is assured, the basis for establishing specific exemption or release criteria can be based on cost-benefit considerations. In considering the primary objective, we recognize that total exposures of people from all of the various exempt and licensed practices must be kept within acceptable limits. This has been one of the primary considerations in the NRC's development of an "Advance Notice of the Development of a Comission Policy on Exemptions from Regulatory Control" which has been prepared for discussion at this meeting and which will be the subject of the opening paper tomorrow morning. It was the desire to develop this broad policy, in fact, that prorpted us to plan this workshop to discuss the similarities and diversity of views among national and international regulaAcry agencies and advisory groups. Ultimately, our hope is to contribute to the development of a reasonable degree of consistency internationally. As we see it, this broad policy would not replace the "practice specific" approach, but cather would provide a framework under which a practice specific exemption decision may be more easily made depending on the magnitude of the individual, and oossibly the collective risk, associated with the given practice. The policy specifically proposes a numerical criterion - 10 millirem per year (or 100 microsievcets per year) as an individual exposure level below which an exempt practice may be cen;idered to meet the as low as reasonably achievable or ALARA principle withoet the need for further quantitative cost-benefit analysis. The policy questiens the need far a companion collective dose criterion, the policy also discusser the potential use of the concept of justificatica of practice, the appitcation of which could preclude nme practices from consideratlon for exemption from regulatory control, no matter how small the associated risks.

This proposed broad polic) on rules for exemption from regulatory control has polved from a presentation made to our Cottnissioners just last month. I would enphasize that the policy is still in the formative stage and will be forwarded again for Comission approval after the NRC staff reflects on the views expressed at tnis workshup and considers feedback from other interested parties including industry, the Department of Energy, and, of course, our Environmental Protection Agency.

In developing this policy, we are concerned with reducing regulation and its associated costs where the health cnd safety considerations do not warrant continued regulatory control. But we are also aware that if we allow an increasing nuder of exemptions from regulatory control it may become more important to reassess our findings with respect to multiple exposures. We must also assure that the basis upon which these exemptions are grant M sW valid and, as a result, that public health and saf=ty continues to be adequately protected. Currently, the NRC is aware of potential problems with reconcentration of radioactivity from.licuid effluents in sewage sludge and is analyzing potential population and worker exposures from such contamination through sludge incineration, soil application, and other potential pathways to These analyses may show the need to reconsider exemption the environment.

limits for these types of waste streams. As more enmptions are granted, particularly for BRC waste streams, an increasing level of effort is envisioned in monitoring the total impacts to the environment. In conclusion, I hope that this workshop turns out to be valuable to all of you attending in formulating criteria for exetiotions and that it will contribute to a better understanding of the various reguintery concepts, approaches, and terminologies involved.

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WHAT 00 WE MEAN BY BELOW REGULATORY CONTROL?

1 by DONALD A. COOL d

Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission l

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WORKSHOP ON RULES F0P EXEMPTION FROM REGULATORY CONTROL What Do We Mm n By Below Regulato's doncern?

Donald A. ;ool, Ph.D.

Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commissicn I. INTRODUCTION One of the problems associated with treating the difficult technical and policy issues of exemption of radioactive materials from regulatory control is the usage and meaning of the terms used to describe the issues. A number of terms a have been used in discussions of regulatory controls for activities involving

, low levels of dose. Often, terms such as exemption levels, below regulatory

concern, negligible individual risk level, and de minimis have been used interchangeably to mean both the general region of low dose levels which an individual would consider to be trivial and the larger region of low dose levels in which regulation to further control dose and risk may be unn rranted.

4 Thus when we use a term, it may be interpreted by different ,)eople as meaning

- totally different things.

l The purpose of this paper is to briefly describe some of the terms which have l typically been employed when c cussing exemstions froin regulatory control, so

that we can have a comon understancing of w1at is intended by our statements.

I also hope to describe some of the different ways in which an exemption could be granted using the current philosophies, and identify some of the problems associated with certain definitions and concepts.

!!. DEFINITION OF TERFt l Regulatory Control

! The phrase regulatory control has been traditionally used to mean the administrative system of notification, regis',tation, and licensing employed by a competent or government authority to control radioactive material. This system is described in the Basic Safety Standards adopted by the IAEA, ILO, NEA, and WHO, and is based upon the recomendations of the ICRP. In the United States these controls take the form of federal guidance and generally applicable environmental radiation standards issued by the Environmental Protection Agency under various legislative

authorities, and the regulations issued by agencies such as the Nuclear Regulatory Comission and the Department of Energy which impose specific requirements for possession, control, use, and disposal of radioactive materials.

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2 Eramptions In international terms, exemption refers to situations in which the full system of regulatory controls envisioned by the Basic Safety Standards is not required for a given practice or source of radioactive materials.

The Basic Safety Standards provide criteria for the exemption of radioactive substances, apparat'uses and sources from the requirements of notification, registration, and licensing. National regulations, such as those of the Nuclear Regulatory Connission, also provide that the full system of controls is not required for specific. situations, such as the use of certain devices, or the possession of specified small quantities of radioactive material. Likewise, the release of facilities that were formerly used for the processing, use, or storage of radioactive materials constitutes an exemption from further regulatory controls.

The implicit assumption la an exemption is that the regulatory controls are not required for the protection of the public's health and safety.

Exemption Rules Exemption rules are the fundamental criteria by which a competent authority can determine if radioactive materials can be exemoted from some or all regulstnry controls. These criteria may be based upon a number of factors, some of which may be related to the level of risk or dose implied by the use cf the radioactive material, and some of which may be related to the effectiveness of regulatory controls to meaningfully reduce the risk.or dose, l

l Exemption rules are often expressed in terms of radiation levels, concentrations of radionuclides, quantities of radionuclides or some corrbination of these units. In many cases, the exemption will include a l specification on the types and quantities of material that can be released, such as the exemption for sMake detectors containing small quantities of neericium. The exemption may also include the measurements that must be performed, and the quality essurance requirements to be exercised prior to release to ensure compliance with the terms of the uemption.

Justi#ication )

The tera justification refers to one of the three principal tenets of radiation protection identified by the I.CRP and incorporated into the Basic Safety Standards of the IAEA. The principle of justification states that there $hould be some net benefit to be gained from the use of radioactive material, and that the benefit derived should outweigh the detriment associated with the radiation exposure.

Although tne justification requirement is frequently dismissed in regula-tory agencies where most practices, such as nuclear powar generation, have  ; .

already been justified through national legislation and other means, the  !

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concept is still of great impr.rtance when considering exemption from regulatory controls. The tendency of many people is to assume that if the dnses are likely to be low, then this is de facto proof that the practice causing the exposure is justified. However, a strict interpretation of the justification requirement implies that this principle be considered, irrespective of the size of the potentici doses. Thus, there is a question as to the extent to which exposures sh uld be justified when only very small levels of exposure will result from the practice.

Practice The definition of "practice" is a critical feature for exemption policy that outlines the extent and applicability of a given exemption. Properly defined, a practice should assure that the formulation of exemptions from regulatory control will rot allow deliberate dilution or fractionation of radioactive material for the purpose of circumventing controls that would otherwise be applicable. In the recent draf t "Principles for the Exemption of Radiation Sources and Practices from Regulatory Control",

l IAEA and NEA noted that any identified specific practice should include the following characteristics:

1 the activities are ained at a comon objective; 1{ the sources should be clearly identified; I 5} it should be possible to identify the cr.itical group or groups l

! uniquely linked to the practice; (4) the dose to the critical group anu the exposed population should not be significantly affected by other similar or identical practices; ind I

(5) the activities constituting the practice are sufficiently l l well identified and defined to allow analysis.  !

l l Several difficulties arise when these characteristics are applied to real exemption situations. For example, should all types of waste from a nuclear reactor which could be disposed of in a landfill be considereo as a single practice, or could each unique type of material such as dry activated waste, secondary resins, and contaminated soils be considered as separate pra'ctices. Furthermore, should these wastes be considered a aractice on a national or international scale, such as was proposed by the NRC's policy stat. ment on waste disposal published in 1986, or on a more localized level. These questions are of particular concern at this time as the NRC attempts to formulate its broad policy regarding exempt.uns, ano I look forward to Dr. Ilari's thoughts on this matter in a few minutes.

Negligibleind3Mdualrisklevel This term t siers to a level of risk or dose that would likely be taken by most individuals as not warranting further actions or the expenditure of their resources to reduce risk. The phrases "de minimis level" and

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"trivial level" have also been used to express this same concept. There has been a great deal of effort devoted to determining such a level, and, althoughspeculative,aconsensusisemergingamongthoseJhathavg i studied the issue that a risk of death on the order of 10' to 10- would be considered as negligible by most people. This level of risk currently translates to doses on the order of 10 to 100 uSv (1 to 10 mrem). Mr.

Webu will be discussing this topic in greater detail.

De minimis 1 The term "de minimis" is an abbreviation of the phrase "de minimis non curat lex", and can be translated as "the law is .1ot concerned with trivialities." The initial use of the term was in a general sense of reference to very low radiation exposure situations where the level of risk to any member of the public would be considered as trivial. In this context, the term does not reflect any basis for a decision other than the risk to an individual as a result of radiation dose. For the purposes of these discussions, the phrase "de minimis" will be used to refer to the exemption concept in which the exemption rules are based upon 7 "trivial" or "negitgible individue.1 risk" level.

Below regulatory conceg The phrase "below regulatory concern" has come into use in the last couple of years, especiall) in t;ie Unitid States, as a reference to a situttion in which the promulgation of an exemption is appropriate from a regulatory standpoint, usually because there would be little gain in risk reduct,f on oy the addition of regulatory controls. The concept of "belw replatory co~cer n" was intended to differentiate between "de mininis",

which implies the e3tablishrent of a trivial risk without the need for aoditional regulatory considerations, and those situations in which other regulatory considerations, such as ALARA, enter into an exemption decision. Thus, in these discussions, the phrsse "below regulatory concern" will be used to refer to the exemption concept in which the exemption is based upon, at least in part, fM tors other than "trivial" or "negligible individual risk" levch.

A decision that a practice is "below regulatory concern" is not intended to imply that any generically applicable level of risk has been achieved for the critical group, or for the exposed population as a whole.

Instead, the phrase is simply intended to implv that further regulatory action is inappropriate, i.e. an exemption sh6uld be granted.

The "below regulatory concern" concept and the "de minimis" concept, while resulting in nurerically equivalent levels for certain situations, are distinct from each other bLeause of the basis for the decision. Further, a "below regulatory concern" criterion may be established for both individual dose and collective dose, based upon the efforts necessary to reduce these quantities. This is not, however, generally the case for a

5 "de minimis" duision, which applies to the individual's perception, but has no direct counterpart fo. society as a whole. The collective dose criterion which is often discussed in reference to exemption policies has its origins in economic considerations, in particular, the cost implied by a simple optimization analysis. While tie literature is now replete with references to "negligiole individual risk" or "de minimis" levels for individuals, no such values for societal im>cct have been prop sed. Thus, a reduction in societal or collective dose iss, up until tiis point at least, always it. plied some type of optimization consideration.

III. BRC EXEMPTIONS -

In the preceding discussion, I have attempted to outline the meaning for some I of the terms which have been used when discussing exemptions from regulatory l control. I would now like to return briefly to the more g neral discussion of j exemption from the viupoint of the "below regulatory conc rn" concept.

Exemption from regulatory controls such as licensing, registration, and notification, using a below regulatory concern concept, connotes levels of risk or dose that may be considered acceptable from a regulatory standpoint, i.e.,

individuO er.d collective doses that warrant limited government attentie ,

taking irto account the cost of further regulation and the likelihood t it such regulation would'significantly alter the resulting dose. A practice could be considered as a candidate for reduced regulatory requirements if it could be demonstrated that certain specific corditions are met. The conditions for considering exemption might include esquirements such as:

(1) the use of additional controls on the practice or source of e posure does not result in an additional reduction in the' dose received; or (2) the costs of the regulatory controls are not balanced by the benefits of dose reduction that could be achieved.

Thus, the authoritation of an exemption for a prectice can generally be made only after an optimization analysis.

Establishment, of an exemption for a particular practice or source of exposure ,

on these bases does not imply that the dose would necessarily be considered as negligible or trivial by individuals. Becaust decisions on triviality are based upon each individual's subjective personal judgements, some individuals migh'. wish to take some further action to reduce or avoid the risk associated with a low level of radiation dose.

Etaptions based upon a "below regulatory concern" philosophy can be estegorized into two general types. First, the decision can be made with respect to a specific practice, or in some cases, even specific, discrete sources. An example of this type of exemption would be the release for unrestricted use of a facility that formerly used radio'ictive material. In

, this example, the release would be based upon a canscioes decision that costs sf further decontaination would outweigh the benefiu that could be achieved

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l 6 'b through further reductions in potential doses. Such 'a decision would therefore be unique to that particular situation, and would not necessarily carry any implications for the next decision which could involve an antirely different set of circumstances.

The second general type of exemption is based upon a generic decision about what constitutes "below regulatory concern" for the decision-maker. In this case, a level of risk or dose is selected that represents the point where it is unnecessary to perform any type of cost-benefit analysis, irrespective of the source or practice under consideration. It is this type of BRC exemption which is often blurred with a "de minimis" type of exemption finding. T11s is particularly the case when an individual risk or dose level, selected on the i basis of trivial risks, is combined with a collective level selected on some tylei of cost-benefit basis.

In some rituations, case specific determinations of what is "below regulatory concern" for the decision-maker could result in doses which are above the level selected on a more generic basis. However, depending upon how the generic level is set, it is also possible that a case specific determination could restth in a dose which is less than the generic level derived from broader considerations.

I mentioned briefly that the decision regarding a "below regulatory concern" exemptions encompasses both individual and collective (societal) conside -

ations. The impact of an exemption upon the exposed population could be of i crucial importance for two reasons. The first is that while an exemption could result in lov individual risks to any single member of society, a broad dpplication of the exemption Could result in potentially unacceptable Conse-quences to the society as a whole. An exampl6 of such a situation is the wide distribution of an exempted product. The second reason for societal considerations is the possibility of multiple exposures 2.1 individuals or population groups as a result of exempted practices.

A limitation on the collective dose, which has been proposed in a nunter of situations, may not be sufficient to deal with concerns described above. In particular, the collective dose does not usually provide an adequate mechan um fer assuring that multiple exposures of the same critical group will no' -

as a result of a broad exemption policy. As a result, the NRC is requ '

comment on alternatives to the use of a collective dose criterion in d <

mining the impact of exemptions on the exposed population, and specific subgroups witiin that population. Whatever the outcome on the use of a col'ective dose criterion, the NRC exemption policy will require that the potential for multiple exposures be specifically addressed as part of the analysis and findings necessary before en exemption could be granted.

Within the context of an exemption policy, the NRC considers the "below regulatory concern" corcept to be indicative of a level at which a fundamental change in the decisionmaking approach can be made. The proposed broad exemption policy, which Mr. Lahs will be discussing in greater detail tomorrow

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morning, provides criteria which, if satisfied by the practice under analysis, would allow for a simplified decision regarding the acceptability of the '

practice for exemption. These criteria constitute a generic type of "below regulatory concern" finding. However, if a practice would result in doses greater than the proposed criteria, the practice could still be considered for exemption from some or all regulatory controls on the basis of further ALARA analyses. This second stage recognizes the application of case specific .

findings of "below regulatory concern". In either case, the granting of the exemption would be based upon a finding that further regulatory cor.trols are not appropriate, either because the degree of risk is toc small to justify the burden of additional regulatory requirements, or because there would be little i 4

gain in risk reduction by the addition of regulatory controls.

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THE CONCEPT OF "PRACTICE" IN RADIATION PROTECTION by OSVALDO ILARI OECD/ Nuclear Energy Agency Paris G

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j THE CONCEPT OF "PRACTICE" IN RADIATION PROTECTION

1. INTRODUCTION The term "practice", often associated with such terms as "operation" and "source", has been used very frequently in the last few years in radiation l

protection recommendations and regulations ts characterise the object of specific guidance or assessment. Examples of this are the definition of i "justificat*on of an operation or a practice", the concept of "collective dose per unit practice", the "exemption of sources and practices from regulatory control", etc.

'Jnfortunately, the concept of "practice", which was initially l introduced by the ICRP and then largely used in the guidance of the other l 4 international organisations, was never accompanied by a clear definition of '

the corresponding terminology. This has created uncertainty and confusion in interpretation on several occasions.

For example, the ICRP principle of justification has been invoked, interpreted and used in various ways, depending on whether the practice to which it was applied was meant to be a single action or operation or a whole  !

set of activities, a single facility or a group of facilities, a whole 3

industrial process or a part of it. The same kind of problems apply to the .

] principle of optimisation of protection. [

A specific area where uncertainties and the potential for developing I ambiguous guidance exist is the 'elinition of criteria for the exemption of i sources or practices from regulatory control. This ambiguity is further  :

! enhanced by the loose use of the terms "source" ai.:' "practice" which is made f l in various international recommendations and do.__.a u. In some of these ,

i documents the two terms "source" and "practice" are used at times in conjunction (as if they referred to different things) and at times in  !

j alternation (as if they were synominous or had a similar meaning). More guidance is, therefore, required to define what constitutes a source or .

i practice in the concrete situations for which exemption from regulatory I j control is considered.

J l The recent international guidance on exemption principles recommends

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that exemption should apply to a source or practice as a whole and, when thi: l j

is not feasible (e.g., in defining exempt quantities of vaste from one of many F

institutions), that the national authority should take into consideration the i implications of an exemption across the whole practice or source. This is intended as a varning against the possible misuse of the exet
ption principles, f j for example, by deliberate tractionation of radioactive vaste so as to achieve
compliance with the exemption criteria. t i

j On the other hand, these principles may be expected to find use in a

! variety of applications, including, for example,'the exemption from control of i

the disposal of certain types of lov-level radioactive vastes in terrestrial (

! v, and marine environments and the recycle of slightly contaminated materials Also, in some applications the practice being j from the nuclear industry.  !

considered for e.xemption may involve the whole period of use of a source, including disposal. In other cases, it may be a;pr'opriate to consider the disposal process itself as a separate practice. .

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It is clear, therefore, that the sources or practices may be very different in nature, which makes it difficult to establish a general definition of the terms "source" and "practice", for exceple in relation to exemptien. During the activities carried out by the IAFA and the NEA be'veen 1985 and 1988 to develop principles and criteria for exemption from regolatory control, the lack of such a definition was seen as a major obstacle to the achievement of a clear cut and unequivocal guidance. In effect, without this definition, any recommendations in terms of individual and collective dose criteria for exemption appeared ambiguous and of difficult application.

As a contribution to overcome this difficulty, a possible scheme for defining practJcos and sources was developed at the NEA. This scheme vas successively adopted, in Mnrch 1988, by the IAEA/NEA Advisory Group on Principles for Exemption from Regulatory Control, and is part of the guidance issued by the IAEA and NEA in~the recently published IAEA Safety Series Report No. 89 "Principles for Exemption of Radiation Sources and Practices from '

Regulatory Control".

2. Definition of Practice and Source Vhen one thinks of a practice involving radiation exposure, the nearest description of it that can be drawn from dictionaries is that of a repeated professional work. This implies a co-ordination of the elementary actions composing the practice towards a unique objective and a degree of repetition of these actions. A unified definition of practice that can, therefore, be drawn from this is the folloving:

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

The size, scope and time duration of a practice for radiation protection purposes can be different, depending on the purpose and the intended impact of the radiation protection assessment or regulatory action addressing the practice. In particular, these three features may be taken as different in the case of justification of the practice, or optimisation of protection, or licensing or exemption of a given activity, respectively. A few examples are given in the following: -

for justification of a practice such as nuclear energy production, the "practice" includes all stages of the nuclear fuel cycle (all reactors and fuel cycle facilities in all phases of operation, decommissioning and vaste disposal) in a country during all the period in which nuclear energy is produced and the resulting vastes are disposed of.

for licensing of consumer goeds, the "practice" is the sale and distribution, use and disposal of all items of a given type of consumer product in a country, or even internationally.

for optimisation of the discharge of radioactive effluents, the j "practice" is the treatment and discharge of these effluents from

'a given facility provided that the dose to the corresponding critical group of population and the collective dose resulting from the discharge are not significantly affected (by no more than 1/10 or 1/57) by contributions due to effluent discharges from other f acilities of the same kind. If these contributions are .

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larger than the stated fraction, the definition of the practice should be enlarged to include these other facilities.

- for licensing of a vaste disposal facility, the "practice" is the operation and the further existence (after closure) of that repository. ree'ided that the dose to the corresponding critical group and "t> :n11ective dose associated with the repository are not signifiGw -)y af fected (by no more than 1/10 or 1/57) by contributiour 'e e to cther 1%cilities of the same kind. If these contribution > N4 1 3 CF that the stated fraction, the definition of the pract:c.~ 1' Oe aclarged to include these other repositories.

Vith the definitior "'eractice" given above, the definition of "source" can be considerahl 'd..hia.- "J narrowed in scope. It is, in fact, proposed to define ac xce* t>.,

"physical entity vhose ee, car gulation, operation, decosnissioning and/or disposal, constitu.Js vne co-ordinated set of activities defined above as "practice".

In other vords, the "sou:ce" is not equivalent to the "practice", but is simply the radioactive material, or the equipment containing radioactive material or the installation (or group of installations) producing or using radioactive material, which is the object of the oract.ce.

3. Distinctive Features of Practice and Source A definition, even detailed, of a concept such as that of practice may not be sufficient to identify and characterise unequivocally an industrial or other activity for the purposes of exeuption. It is, therefore, appropriate to establish a set of conditions, or features which should characterise any identified "practice". These are the followingt (a) the activitie; compostag the practice should be co-ordinated and aimed at a common objectives (b) tha c;urces which are the object of the practice should be clearly identified (c) it should be possible to identify a specific c.ritical group (or groups) uniquely linked to the practices (d) the dose to the individuals of the critical group (s) and the collective dcse resulting from the practice should not be significantly affected by ccatributions due to other similar (or identical) practicea (e.g., several vaste disposal sites in the same region):

(e) the activit'les composing the practice should be easy to identify and describe, both in spatial and temporal terms., and be sufficiently vell defined to facilitate impact analysis and regulatory assessments and to minimize the complexity of the procedures required for regulatory control or exemption from it.

4 As far as the "source" is concerned, specific features to be used to  !

characterise it include its possibility to be distinguished from other sources not only in terms of its physical characteristics and location, but also in terms of different environmental impact pathways, critical groups, etc.

The verification of compliance with the above conditions should be of help in applying the general definition of practice and source to the identification of a practice.

4. Application to Specific Practices The application of the above definitions to exemption from regulatory control is liable to be different for different practices. A few major cases are currently or primary interest. They include the use of consumer products, the disposal of very lov level solid radioactive vastes, the recycle and reuse of materials resulting from decommissioning of nuclear facilities, and the discharge of very small quantities of radioactive effluents. Examples of definition of "practice" and "source" for these cases are discussed in the following. It is to be noted that it is the exemption of "prettices" which is normally being considered. However, this does not exclude the possibility of applying the exemption principles to a singla "source", in some cases.

4.1 Consumer products The term "consumer products" covers a large variety of items of general use that emit radiation or contain radioactive substances. They include, for example, smoke detectors, time-pieces, stat,ic eliminators, optical lenses, glassvare, electronic tubes, etc.

The sale and distribution of a number of consumer products are subject in most countries to notification, registration and, often, licensing. There may bs, however, some types of consumer products whose associated radiation risk and detriment are so small that their sale and distribution could be exempted from licensing and, perhaps, even from notification and registration.

The general definitions given in Section 2 are expressed in the following vay for consumer products:

The "practice" is defined as the sale, distribution, use and disposal of a gisen type of consumer product on a national scale (the production of these items is considered as a separate practics, which is usually subject to regulatory control).

The "source" is defined as the total of individual radioactive sources represented by the single items of the coasumer product being considered.

As far as the correspondence to the features indicated in Section 3 is concerned, the situation is the following:

- conditions (a) and (b) are obviously satisfied by the definition '

given here for the practice; ,

- condition (c) can be ful' filled (the identified critical group can be a specific group of usecs, a group of transport and distribution vorkers, or other):

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- condition (d) can generally be fulfilled. The other "similar oractices" to be considered for the assessment of their fractional contribution to the doses associated with the p;actice under consideration are the sala and distribution of other types of consumer productsi

- condition (e) can be fu1(111ed without significant difficulties if the practice covers one type of consumer product. This vould be core difficult from the technical vievpeint and complicated from the administrative viewpoint if the definition of the practice, in order tc comply with condition (d), had to cover several different types of consumer products.

4.2 Lov level solid radioactive vastes

In princinle, the activity being considered for exemption is the disposal of very lov 1cvel solid radioactive vastes to municipal landfill or incineration facilities, or into the sea at coastal disposal sites. However, it is appropriate, for practical reasons, to deal with exemption from each site at which these operations are carried out.

Therefore, in this case, the "practice" is defined as the disposal of very lov level solid radioactive vastes at a given municipal landfill or incineration facility, er coas:sl disposal site. This includes the operation of the site and the period of its remaining in existence after discontinuation of disposal. However, if two or more disposal sites vere located at a short

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distance from each other and gave ecmparable contributions to the dose cf a same critical group, the practice should be defined to cover the combination of these disposal sites in order to satisfy condition (d).

The "source" is defined as the rudioactive vastes disposed of in the considered site (or grana of sites).

As far as the correspondence to the features indicated in Section 3 is concerned, the situation is the following: .

- condition (a) is obviously satisfied by the definition given here for the practice

- condition (b) may be less easy to fulfil. Infact, although the definition proposed above for the source refers to the entirety of the vaste streams terminating in the disposal site, the regulatory authority could find it more practical to consider as the "soure.'

the installation (or group of installations) from which the vastes are generated

- condition (c) can be fulfilled (the identified critical group can be the workers at the disposal site or a specific population group);

- condition (d) can be satisfied by a judicious choice of the site or sites to be included in a given practice and the installations f rom which t he relevant vastes are generated:

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- condition (e) may be less easy to fulfil due to the potential complexity and the variability of the set of installations and .

vaste streams composing the source. l j

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i It is to be noted that a practice as defined in this case could cover 'i one disposal facility or a small group of such facilities out of a greater - -

total number of potential disposal facilities existing in a country. In this case, therefore, the national authority should take due account of the potential impact of the totality of disposal facilities in the country when

deciding on its exemption policy.

According to another proposal which suggests that, as in Section 1, I exemptions should apply to a practice as a whole, the "practice" to be considered for exemption should encompass the whole of low level solid vaste  ;

disposal activities across a country. In this case, the "source" should be defined as the totality of radioactive vastes disposed of in all sites in the .

country.

i This definition of practice vou,1d certainly better comply with the

, above-mentioned recommendation of Section 1. However, its correspondence with the features' indicated in Section 3 vould be incomplete and the practical <

application of the regulatory assessment and procedures for exemption vould be difficult.

In fact, as far as the above mentioned features are concerned:

conditions (a) and (b) would continue to be fulfilled:

- condition (c) vould be very difficult to apply in practice. It is, in fact, unlikely that a unified critical group could be ldentified for the complex of dispoaal sites in the country:

I

- condition (d) vould not be relevant any furthers  :

- condition (e) would be very difficult to fulfil in practice.

4.3 Recycle or reuse of materials Activated or contaminated materials (steel, aluminium, concrete, etc.)  !

resulting, for example, from decommissioning of nuclear facilities could be  !

recycled or reused without radiological restrictions if a regime of exemption i vere applicable to them.

In this case, the "practice" is defined as the set of activities  ;

starting from the release of the material (or materials) out of the boundary i vithin which regulatory control applies (for example, the boundary of a nuclear site) and including all the operations, manipulations and uses which lead to exposure of a critical group (or groups). j t

The "source" can be defined as the radioactive material (s) to be t recycled or reused or as the nuclear facility (ies) releasing the material for f

, recycle or reuse, ,

i The scope of the defined practice and the definition of source depend .

on the features of r.hese activities with reference to Section 3 and on the '

particular exemption policy preferred by a national authority. }

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If it is preferred, for practical reasons, to deal vith exemption from each site producing material for recycle or reuse (e.g., an exemption for each  :

nuclear power station to be decommissioned), then the "practice" would be - '

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y' defined to cover only the material released from a given site and it should be 1

3 made sure that the critic.i group and population doses relative to that  !

! practice are not significantly affected by the contribution of materials released (for the same kind of uses) from other nuclear sites in! .

t on the other hand, it could be considered that, i l because different different ways and expose different groups ofeyworkers!  !

be sensible to define each material as a different "source".pulation, it may the recycle and reuse of each separate stream of materials In this case.

could b .

a separate practice, because it vould have a different purpose and would e defined as

! involve different exposure pathways and critical groups.

Moreover, some material add to the exposure of the same g(e.g. steel) released in one year could voll in another year from a same site or group of sites, so the "source"!

of its production and release, and the "practice" de l the recycle and rea e of all that material irrespective of the tim e of its i production stations). (e.g., all the steel frca decommissioning of one or more pl i

1 in the following way:The correspondence to the features indicated een in Sectio 3 1 J

possible definitions of the source and practicescon! l 3 -  !

j condition (b) c% be mca or less easy to fulfil  !

choice adoptu for the definition of the source a,nd practicetdepenl i

condition (c) can be fulfilled with different degrees of i 1

difficulty the sourceand specificity depending on the definition adopted for and practice i 1

i condition (d) can be fulfilled by a judicious choice of the  !

material (s) and site (s) comprising a practicet  !

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condition (e) can be more or less easy and complex to satisfy l

depending on the choice of the material (s) and site (s) comp[

a practice.

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3 consider as the "practice" to be exempted the whole materials going an in a country.

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4.4 Other practices 1

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be applied to other practices which may have on.

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j discharge of very small quantities of airborne into the environment from certain types of facilities or liquid ra effluent the exemption from registration of doses to vorkers which are belov recor, ding levels

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5. Conclusion Authorities and experts who have tried in the past to establish criteria for exemption from regulatory control often experienced severe difficulties when they tried to apply these concepts to real situations. This was partly due to the lack of clear definitions of the domains of application of the exemption criteria. It is hoped that the newly achieved consensus on the definitions of "practice" and "source" may contribute to facilitate the concrete application of the principles of exemption.

References

1. OECD Nuclear Energy Agency, "The Concept of Practice in Radiation Protection", SAN / DOC (86)4 (restricted distribution), 1988
2. Ir.ternational Atomic Energy Agency, Safety Series No. 89, "Principles l for the Exemption of Radiation Sources and Practices from Regulatory Control", IAEA, Vienna, 1988.

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1 THE CONCEPT OF NEGLIGIBLE RISK l

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Introductica When I accepted the invitation to Negligible Risk my first reaction was oh' no, prepare a paper not again'. Thison thelargely was Concept of prompted by memory of a paper that I co-authored with Andrew McLean in 1977 (Vebb and McLean, 1977) which was entitled Insignificant Levels of Dose. In particular, when re-reading this report I found in the section entitled ' Negligible Levels of Risk' the following statements:

'It is apparent that there are high levels of risk which the individual will accept in exchange for the benefits. These annual risk rates commonly range as high as 10.a for certain occupations or voluntary activities,

  1. including cigarette smoking. At lower levels of risk are most occupations which are not normally regarded as ' hazardous' with an average annual risk rate ranging from 10** - 10**. The annual risk of death from natural causes (excluding accidents) for people in the prime of life is also about 10** and et no time does it drop belov 10**. The risks from events over which people feel they have little control (involuntary risks) tend in general to be lower than risks from voluntary activities. The concept of a level of risk which is not taken into account by the individual when making decisions is the concept of a ' negligible' level of risk.

! It is suggested that the lowest level of annual risk which people do take into account in making decisions is probably in the region of

  • 10** - 10*' and that at some point below this the risks cease to be seriously considered and are therefore ' negligible'. Quantitative levels for

' negligible' risk have been suggested by several authors...

Ve propose that an annual risk rate of 10*' is one which is not taken into account by individuals in arriving at decisions as to their actions and which is therefore ' negligible', ie, it can be neglected.'

This annual risk rate was then converted to a dose using a risk coefficient of 10** per rad to give a dose of 10 mrad. As a further justification for the trivi'al level, the dose was compared with variations in natural background and the dose incurred in conventional jet flying. It was recognised hat this negligible level applied to the total dose from a number of sources or pecctices so allowance was made for these. The net result of this was to propose an insignificant level of annual individual dose of 0.1 to 1.0 mrad from a defined source,or practice.

When I compared this with the latest draft resulting from the joint IAEA/NEA meeting on exemption from regulatory control held in March of this year (IAEA, 1988) I found a section headed ' Individual Related Trivial Risk'. This says

'For the individual there are two main considsrations to deciding upon a trivial level of dose: firstly, choosing a level of risk which is of no significance to individuals thence a level of dose; secondly, to use the existence of the natural background of radiation exposure, to the extent that it is normal and difficult to avoid, as a relevant reference level.

There is a,widely held, although speculative, view that few people sould commit their own resources to reduce an annual risk of death of 10* and that even fewer would take action at an annual level of 10**. Most authors proposing values of trivial individual dose have set the level of annual risk of death which is held to be of no concern to the individual at 10*' - 10*'.

_, Taking a rounded risk factor of 10*8 Sv for whole body exposure as a broad average over age and sex, the level of trivial individual effective dose equivalent would be in the range 10-100 pSv per year.'

b:ckgrcund cad to ccaciude that: l

'A lovel of individual redictica dese, rogordicas of its scurco, is likely to be regard d es trivial if it is of the order of some tons of microsievert in a year.' ,

The similarity of these two statements leads ne to conclude that there must be more probless than are immediately apparent associated with the concept of negli2ible risk otherwise it would have been adopted and readily put into practice over the last decade. The fact that we are having this meeting today is a recognition that there are difficulties. What I would like to do in this paper is to examine whether it is a fundsmental difficulty with the concept of negligible risk or rather a technical difficulty in moving from the concept into a practical system of exewptions. In order to do so, I will work within the frastaork established many ye4rs ago and which has persisted throughout all the discussions on this topic, namely to deal separately with ' individual' risk and ' societal' risk. .

What do we mean by risk?

Risk is the chancs that something adverse vill' happen. When people think about risk in an everyday context, they are usually considering both the probability of an undesired event occurring and the consequence, were it to occur, and implicitly weighing these two against the benefits associated with the course of action leading to the risk. Thus, we see that even in its simplest form risk has a number of aspects, whereas, when we commandeer the concept and use in radiological protection, we often ignore one or more of these aspects. -

When we put on our radiological blinkers we tend to define risk in a very much narrower form. To quote from an ICRP report for which I was the Chairman of the Task Group (ICRP, 1986) risk is defined as:

'The probability that a serious detrimental health effect will occur in a potentially exposed individual or his descendants.'

The definition includes the probability of the initiating event giving rise to the dose and the probabilit" .' harm from the resultant dese. It excludes, however, any overt consideration as to whether the risk is voluntary or involuntary (Wilson and Crouch, 1982; Wilson, 1984) and it excludes any consideration of the associated benefit. It also uses the concept of a serious detrimental health effect. This can be cancer, an immediate acute effect of radiation, or a genetic effect in subsequent generations. People's willingness to accept risks are a function of their attitude to the consequence as well as their attitude to the probability of its occurrence. This aspect is also hidden in our classical definition.

. A further point which may or say not be important is the time distribution of tne risk rate. A cooperison is of ten saae with being struck by lightening and we are told that be about 10*' perpeuple are year. not concerned From my personal with thisoflevel point of sitting view, risk, generally taken in this room atto

,the moment or even when I was preparing this paper in my office. I had not the slightest concern over being struck by lightening. However, on the golf course, in the siddle of a thunder storm with if ghtening flashing around me, I would think seriously about ratsing my six iron above my head. The point is that perhaps we are being 'a little too simplistic in our statements of acceptability or triviality on behalf of members of the public.

When we ccee to societal risk, the position gets even more complex because ve '

4; 5.few overtly considering the magnitude of consequences from events. It is very vc n.st society's reaction to consequences is strongly non-linear depending on

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well cs wh:th:r tho initicting ev:nt is natural er man ccused (Clarks, 1985).

Against ths b:ckgrsund of thinking of this type, I wsuld nou liks to censider furth3r the dsfiniticas of negligiblo individual risk and negligible societal risk

. that are being proposed in the context of exemption froe regulatory control.

Individual nemlisible risk criteria This crAterion is normally approached from two points of view. The subjective viewpoint attributed to individual members of society that there !s a level of risk below which they would no longer be concerned and the objectise -

viewpoint that certain levels of risk.or their consequences cannot be distinguished from unavoidable fluctuations in risk.

Examining first the subjective viewpoint, the arguments for this generally rer.t on people's supposed disinterest in risks below particular levels, either in terms of sodifying their own actions to reduce the risk or in terms of requiring society to devote more resources to reducing the risks. As I have tried to illustrate with my lightening example, people's attitudes to risk levels are not necessarily as simple as the statistics normally quoted would imply and there is at least a point of view that 'no risk is worth taking if there is no benefit' (Spangler, 1987(a)). As to people's lack of action er lack of willingness to take decisions to avert very small risks, this, even if it is a correct view of society, may reflect more complex decision processes than purely the magnitude of the risk level.' It is very likely to include the consideration of personal benefit as in the acceptance of risks of flying or it may simply be due to ignorance of the risk level and what could be done to improve it. This has*almost certainly been the case until recently in terms of risks from various components of diet.

Considering the more objective definition of a negligible level of risk we can observe that the risk to people from everyday causes of death, including disease, is about 10** per year and rarely falls below 10** per year (HSE,1988; Royal Society of London,1983). It is than a plausible argument that ar imposed additional risk so small that it does not significantly affect the pre-existing risk should not be of concern to the individual. This argument is probably true in broad terms but can also fail when the time distribution of the risk is taken into account under some circumstances.

A possibly more robust argument, and one which does not rely so heavily on attitude to risk, is to examine fluctuations in dose, particularly dose from na'tural radiation. It is well known that there are extreme fluctuations in the dose from radon daughters but since these are subject to control at the upper end, they do not form a particularly useful comparison for this purpose. Probably better are the totally unavoidable fluctuations in the doses from cosmic radiation and terrestrial samma rays. Here again, we must be careful over the argument that people do not move from the mountain states to the coastal states in order to save a small amount of radiation dose. The reason that they do not move is totally unconnected with the radiation dose, even if they knew about it, and is connected with other overwhelming inputs to the decision on where to live. Nonetheless, there are fluctuations in natural radiation dose that, even if the individual was aware of then, would be totally outside his control. Minor changes within the range of that fluctuation could legitimately be regarded as also outside any wish for control.

If we take this latter argument we must note that it only works in regard to radia. tion dose and is not necessarily transferable back into risk terms, because in making the comparison we have implicitly taken out of the discussion the time variation both of the delivery of *he dose and of the occurrence of the consequences, and we have taken out any consideration of the magnitude of the consequences or of the benefits of the practice.

wr vewmwr, samunnrucw,wuvw,vmusum.mv uvumy = sw -vm of an undetectable dose or e statistically insignificant dose addition to the unavoidable natural background, rather than dealing primarily with the much more .

subjective concept of negligible risk.

Nonetheless the risk concept has to be faced squarely in dealing with .

installations that have a potential for accidents or in a more general sense "probabilistic events". Indeed the idea of an negligible risk is implicit in the US standards for reactors which can be translated (Spangler 1987(b)) into a level of no special concern of 4 10*' per year for prompt fatality in individuals. The UK safety assessment principles of the Nuclear Installations Inspectorate alsa imply (HSE 1988) similar levels of risk that are tolerable in the sense that no further efforts would be put in to reduce them, even though they may not be strictly ' negligible'. In both of these cases there is recognition of the benefit from the practice giving rise to the dose and it may be that we should take more

. credit for this, given that all practices must fulfil the first requirement of the ICRP system of dose limitation ie, justification. In dealing with some aspects of solid waste disposal, we may also be forced to work in terms of rish rather than dese.

In coming to a numerical value the very broadest of rounding is appropriate and all of the numerical considerations lead to overall figures of negligible individual dose of the order of 1 - 10 pSv per year. Allowance for multiple sources of exposure is then generally taken to reduce these by about a factor of 10 to.0.1 - 1 pSv per year. Using current ICRP rounded risk factors this corresponds to a range of negligible individual risk, with all the caveats I have indicated, of 10*' - 10*' per year (NRPB, 1985; A B Fleishman, 1985; K Shaiger et al, 1986; Spangler, 1988; IAEA, 1987). These are probably defensible figure's, but I believe they need a more coherently annunciated defence.

Societal negligible risk criteria In examining societal risk in the context of exemption from regulatory control, I have becoce convinced that in this case we are unable to deal simply with risk itself since this must include consideration of both the probability of an event and the size of the consequence of the event together with its other charceteristics. All these aspects have to be considered separately rather than combining them in some way to give a single figure. If the potential consequences are large enough, then it is arguable that however low the probability estimate, the practice is not a candidate for exemption frem regulatory control.

It may, however, be that in the situation of relatively s=all magnitude consequences and moderately high probabilities of occurrence, that the expectation value of the outcome is a sufficiently good indication 'f the actual outcome that it can be used in a comparative sense to assess whether the societal risk is negligible. One possible approach along these lines (IAEA.1987) is to propose that a negligible level of societal risk would correspond to a most likely outecce of zero health effects. This is the "most likely" in the sense that the probability of the outcome being no health effect rather than 1, 2, 3 ... is greater than 50%. It does not of course cean that the expected value of the i outcoce is 0.00 health effecta. l If we side step this risk-based approach then the best alternative is the application of optimisation of radiological prote: tion, to the doses that would result from the uncontrolled use of the practice or source. This is a simplified application of optimisation on which I will not dwell further here except to note that because of the constraint on individual doses, we are likely to be working in an area where unmodified cost-benefit analysis is applicable. This is the approach which has been used by the I AEA group to define a collective dose of negligible significance of one can Sv. (I AEA , 1983 ; I AEA , 1987 ; I AEA , 1988) on the grounds that the cost of carrying an optimisation study will be at least a few thousand dollars. This collective dose also has a very high probability of no

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first critorica as wall.

Codelusiens for ex*sptien purposes

, Despite the difficulties I have noted above in the definition of risk and the many attributes associated with it such as the associated benefit and the type of consequences, I feel that there are a sufficient number of convergent approaches, both in the individual and societal context, that the essential concept of a negligible individual and collective risk can be substantiated. For reguictory purposes in exemption, given that we do not wish to exempt practices having a substantial accident potential, I suggest that it is easier to work in terms of negligible individual dose and negligible collective dose explicitly, relating these quantities first to their dose comparisons in the terms of the individual quantity and to the optimisation concept in terms of the collective quantity and using risk comparisons as a secondary supporting argument. If this is done then I

believe that the numerical values which result are a sensible basis fcr exemption of practices from regulatory control, so that the major implementation problem then becomes the practical definition of the practice. I note that a very workable definition has been provided by the recent IAIA advisory group (IAEA, 1988) but this is the subject of another presentation.

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g u m. .m R H C1crke, Raditicgicci Prct:cticn Aspects of Ex mpticn Levols in tho Nucicar , ,

Fu21 Cyclo, Pag:s 234-245. IN Interfcco Qu:stiens in Nuc1cer H:cith and S:fety.

NEA, P ris, 1985.

A B Fleishman, The Significance of Small Doses of Radiation to Members of the '

Public, NRPB - R175, 1985.

Health and Safety Executive, The Tolerability of Risk from Nuclear Power Stations.

London, HMSO, 1988.

IAEA, De Minimis Concepts in Radioactive Waste Disposal. IAEA-TICDOC - 282, 1983.

IAEA, Exemption of Radiation Sources and Practices frem Regulatory Control Interim Report. I AEA-TECDOC - 401, 1987.

IAEA, Principles for the Exemption of Radiation Sources and Practices from the Basic Safety Standards for Radiation Protection. Draft Report of an Advisory Group Meeting, March, 1988.

ICRP, Radiation Protection Principles for the Disposal of Solid Radioactive Vaste, ICRT Publication 46. Annals of the ICRP Volume 15 No. 4 Pergamon Press, 1985.

NRPB, Small Radiation Doses to Members of the Public ASP 7,1985.

Royal Society of London, Risk Assessment: A Study Group Report by the Royal' Society, London, 1983.

I K Schiager, V J Bair, M V Carter, A P Hull and J E Till, De Minimis Environmental l Radiation Levels: Concepts and Consequences. Health Physics Volume 50, No. 5, Page 569-579, 1986.

1 M B Spangler, De Minimis Risk Concepts in the US Nuclear Regulatory Commission, I Part 1: As Low As Reasonably Achievable. Project Appraisal, Volume 2, No. 4, Page l 231-242, 1987(a).

M B Spangler, A Summary Perspective on NRC's Implicit and Explicit Use of De Minimis Risk Concepts in Regulating for Radiological Protection in the Nuclear Fuel Cycle. IN De Minimis Risk, Edited by C Vhipple. Cleanham Press, New York i and London, 1987(b). j G A M Vebb and A S McLean, Insignificant Levels of Dose: A Practical suggestion  ;

for Decision Making. NRPB - R62, 1977. I R Vilson and E Crouch, Risk / Benefit Analysis, Ba11enger Publishing Company, Cambridge Mass, 1982.

R Vilson, Commentary: Risks - their acceptability. Science Technology ead Human Values, Volume 9. No. 2. Page 11-22, 1984.

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EPA's VIEWS ON REGULATORY CUTOFFS FOR RADIATION EXPOSURE 4 . ,

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Introduction The Environmental Protection Agency develops basic radiation l protection standards and guides under a number of legal authorities.

t As part of our program, we consider the development of criteria for exemption of certain practices as an essential part of this process.

It is my intent today to present where EPA stands in this proce=s, the importance of terminology, and a challenge for future success.

Why Have Any Cutoff?

The first question we have to ask ourselves is why have any regulatory cutoffs? There is a school of thought that we should not, that the only acceptable risk is zero risk. However, there are some good reasons to pursue developing some form of lower limit for regula-tion.

The primary reason for establishing regulatory cutoffs is economic, that is, to benefit both the regulator and regulated.

Theoretically, the public will benefit too. Implementation of standards is expencive and exclusion of even a part of the spectrum of very low-level radioactive material may have large benefits. A regulatory program should direct its resources where they are most needed. Formulating a regulatory cutoff has the potential of improving environmental radiation protection by focusing resources on the most significant health risks. Hopefully resources saved by not requiring controls that provide little health benefit can be used to I reduce risk in situations where the resources will be more effective, i Unfortunately, this is often not true in the real world, one million dollars saved from less control over radioactive vaste does not .

necessarily mean one million more for rat control, AID's research, or i radon mitigation.

1 A second reason for cutoffs is improved credibility. Since we realize that reducing all radiation exposure to zero is not only i

impractical but impossible, then the public should recognize that -

certain levels of risks are very small in comparison with other

' everyday risks and that regulating these risks does not provide much j added health protection. A stated policy on how to deal with such small risks is much better than simply ignoring them.

l In the United States, support for developing a regulatory cutoff I i approach has been enhanced by actions of the Congress. The Low-Level Radioactive Waste Policy Amendments Act of 1985 calls for a regulatory  ;

cutoff practice to be initiated. Within EPA, it is clear that we i

i should determine the risk related context within which those decisi,ons l l

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Impiteat'an of Dose Effect Relationship The question arises as to whether there is a threshold dose level below which no effects occur. If there were such a threshold I for radiation, it would be very simple to set a lower cutoff for I regulation. However, the radiation advisory bodies, both National and International, indicate that one should assume that all exposure carries some risk, and that this is the prudent course for regulators to follow. Therefore, there is no scientific health effect basis for a lower exposure limit.

There is one additional implication of the dose-effect relationship that should be discussed before we leave it. Some have advocated setting some dollar value on person-rems as a part of their regulatory evaluation. In EPA we have avoided that, as in the end it necessitates placing a dollar value en human life, a matter for which judgment we have been unable even to tind the proper forum, much less to answer the question. An offspring of this idea has further suggested that a person-rem made up of lesser individual doses be given a lesser dollar value than one made up of higher individual doses. This conflicts with two precepts on dose effect.

First, it commingles and confuses considerations of collective dose (detriment) and individual risk. We believe that both should be evaluated separately. Secondly, it dismisses the linearity policy without specifically acknowledging the action.

Generic cutoff Some people and organi:ations advocate a generic or universal Also, cutoff. Without doubt, this approach has tremendous allure.

the higher the generic cutoff the better for the regulator and the regulated. Life would be so much more simplified with a generic cutoff of 100 mrems per year, 25 mrems per year, or even 10 mrems per year. The regulator could wave its handa at most things that involvo radiation exposure. The regulator would no longer have to feet over analyses, rationalos, and explanations of their decisions to permit some things and not others, clearly, the cutoff would automatically do it for them. Also the regulated would not have to worry about the vagaries and pressures on the regulators, the generic cutoff would decide things without the fickleness of human decisions.

But before we all become too jubilant over the potential benefits to the regulator and regulated from the kind of gene:ic cutoff I just described, let's look at what it means in a broader context. Many of us in the radiation protection business have long believed that our radiation standards and other radiation protection actions have resulted in the best protection to the public from just about all environmental contaminants and occupations 1 insults.

However, if we closely examine the standards and actions involving chemical pollutants, hazardous waste disposal, contaminated sitec, and water protection, we quickly see that ir. many cases the radiatio, C

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protection community has not even come close to the level of protection provided for these other activities.

Consequently, if a generic cutoff is what we want for radiation l protection, then to be compatible with other actions of our society, the cutoff probably would have to be established in the neighborhood l

of the kinds of cutoffs that are frequently used for various I

nonradiation problem areas. Also, the rationale could be all or partially based on the much talked about "de minimis" principle. ,

By finding the risk level that is trivial from a purely health ,

I protection point of reference, we could readily dianiss anything that presents lower risks. A universal cutoff considering these approaches I would probably be set at a lifetime cancer risk level of about 1 in one million or less, which would translate to an effective dose equivalent of substantially less than one mrem per year. Needless to ,

say, a generic cutoff at such a risk level practically would not i solve many of the problems that the proponents of the universalokay, i

cutoff for radiation protection would like to see it handle, l lets say we abandon the "du minimis" ratie, ale and the comparisons to >

i the standards and guidelines used for the .hemicals and otaer 1 pollutants and stick to a much high universal cutoff based on other l rationales. The serious downside to this "damn the torpedoes, full speed ahead approach" is that the rationale for the universal cutoff loses credibility and its critics have lots of ammunition to under-mine it. Further, and perhaps the most serious, we might find that the public continues to "misunderstand" the actions of the officials j charged to provide ar7topriate protection from radiation exposure.

l Backaround Based Cutoff l

Before 1 complete my discussion of rationales for universal ,

' cutoffs, there is one more that merits discussion. The generic background

! cutoff could be chosen based on some fraction of normaDafortunately, I

! exposure or the variability in background exposure. t this rationale does not get us out of most of the problems I have previously discussed, t for example, if we were to use radiation background itself as a basis, the first question is background where? The natural radiation background exposure of the U.S. population, excluding indoor radon, generally varies with location from 50 to 150 millirem per year.

Equitability would certainly be questioned in using either end of  ;

this spectrum.

Suggestions for establishing a cutoff related to backgroand have included using a quantity equal to background down to some small percentage of background. The reasoning seems to be;

  • Mother Nature gives people this much, why can't we give them as much as some percent of it." When wo looked at this, we asked the question in a little diffetent way. We said: "What right does tho insult from

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Mother Nature give us to insult anyone further?" We have been unable to answer that question.

The added argument that some make for using background is that people do noh consider their change in radiation risk It when they is questionable choose to reside near the ocean or in the Rockies.

whether most people are aware of the risks involved. In any event, whatever radiar. ion or other risks people incur by moving about or taking trips, they are taking these risks voluntarily. Risk taken voluntarily by segments of the population have little to offer in serving as a basis for risks to be imposed on other segments of the population without their consent, and without consideration of the related costs and benefits.

Nonetheless, one very important consideration presented by.

background variability is that it does affectInour ability to detect exposures associated with specific sources. this way, it puts ,

limitations on our abilities to measure the impacts of sources and This aspect determine whether some control actions are effective.

has also been a continuing problem in some of our environmental assessments, particularly where these have daalt with radon and its progeny.

Consequently, neither risk alone nor relationships to background appear to give us a clear basis for selecting cut-off values. How-ever, they do provius at valuable perspective for developing criteria i that any cutoff should achieve.

Below Regulatory Concern (LRC)

We hase now arrived at a point where we have to add other considerations in our attempt to develop a lower regulatory cutoff.

The most important of these 1.s economics, i.e., There the costs are two of important implementing a standard versun no control. i consequences of this: first, there is no single number applicable to all practices and there may be a separate and distinct number Second, such a cutoff associated wit,h each activity or "practice.'

by the nature of its determina. tion, s9tves as a floor to "as low as We have chosen to reasonably achievable" (ALARA) for the practice.

use the term "Below Pegulatory Concern (BRC)" as most descriptive of our intentions. This is intended to convey that ye have done a careful analysis and thoughtfally deliberated before deciding on a i level below which regulation is not warranted.

The first practice fo: which we have undertaken to develop a BRC has been the disposal of low-level radioactive waste. I will briefly discuss the technical analysis later, but what is most important in this forum is the generalited criteria that we found to be necessary to justify any BRC. We certainly did not have all of these criteria in mind when we started on this venture, and since the process is still ongoing, with public comment and hearings ahead, we will claim

.. 5 However, I neither their universal validity or all inclusiveness. ,

believe they are worthwhile passing on for discussion in this forum. .

They are seven in number.

A BRC decision should t I

1. Exempt a relatively small collective dose which does not significantly change with individual dose in the area of the BRC ,

decision. We have no magic number for this collective dose, but its si=e should be considered relative to the total collective dose if the whole of the practice were unregulated.

2. Represent an individual dose that is well below the overall This is so that it can be readily regulatory limit for the practice.

differentiated from the regulatory limit, which is presumed to repre-sent an acceptable risk. In serving as a floor to ALARA for the practice, it represents a significantly lesser risk. If there are j substrata established for the overall regulatory limit, as for particular media, the BRC should not exceed any of those substrata

limits.
3. B2 formulated so that it does not increase other environmental impacts.

. 4. Be compatible with legal authorities and other control i actions dealing with nonradioactive pollutants.

5. Be able to be practically implemented using available i management systems, analytical techniques, end instruments.  ;

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6. Result in the possibility of some resource savings for th6 l

regulator and the practice. It can be anticipated that, as with anything new, the initial implementation of a BRC for a practice might actually require some increase in effort. However, if it holds little hope for ultimately saving resources it would negate one of our prime teasons for considering a BRC in the first place (i.e.,

allocatlon of resources to the more significant risks).

7. Be supported by an analysis that provides a reasonable and sufficient basis for the decision-makers to arrive at a judgment.

Details of our BRC analysis for low-level radioactive waste 3

disposal standards havu been described in several papers The presented detailsby our rtaff and these are available to you upon request.

are also laid out in the technical . pport documents that support our proposed standard for the management and disposal of low-level i radioactive waste.

We performed our analyses by evaluating the possible increase in population and indisidual risks, and the associated estimate of cost savings that would occur by sequentially deregulating waste streams i

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of increasing risk potential. It was not our intent, nor is it our role under the authorities we have, to deregulate specific waste streams. It was our intention to provide support for the cence e that aBRClevelchosenbytheAgencywouldallowusingavailab$t resources to reduce the most significant related risks.

Implementation I leave you with one final challenge. The future success of any regulatory cutoff approach in radiation protection will depend on the prudence with which we implement our first steps. A key factor in this will be the assurance we are able to give that things are going as we predicted, i.e., the collective impact (detriment) is low.

Each additional step must be taken with a cognizance of the ones before, and how they might interact. We must make periodic reviews l

of tne validity of our assumptions. We must show ourselves worthy of the responsibility entrusted to us.

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, SESSION 2 - M*nday, 2:00

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CURRENT SITUATIO!. IN CANADA WITH RESPECT TO DE MINIMIS by GEORGE JACK Atomic Energy Control Board Canada 9

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l . CTdtENT SITUATIOM,JN CANADA WITH RESPECT TO DE MINIMIS j Introduction  ;

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{ In Canada thi nuclear indur'ry and users of radioactive material are refulated by l 1 the federal govewnt. The federal agency charged with *.iis responsibliity is  ;

4 the Atomic Energy Control Board (AECB). Although nuclear facilities are regulated  !

I by the federal government, some of the activities at these facilities impinge on  !

l areas which are regulated by cne of the ten provincial gtvernments. A noteworthy l cxample is the transfer of waste to taunicipal landfill sites. As a result, the ,

! AECB has developed a system of regulating in which it collaborates closely with j J the various provincial agencies in an attempt to deliver one package to the  ;

licensee in which all the regulatory requirements and restrf:tions are present, j J

This multi-agency nature of regulation in Canada is important in the de minimis  !

j issue because in some instances, even if a certain parameter was below the j regulatory interest of the AECB, it would not necessarily be unregulated unless '

the relevant. provincial agency also agreed.

It appears there is now concensus appearing that there is not a singla de minimis i l 1evel that is applicable and useful across the complete tsnge of activities. This  !

is because any such universal level must take into account extreme cases. In  !

i doing that, and in order to avoid being overpermissive in these extreme cases, it l l would be so restrictive for most cases that it would cease to be a useful l

) quantity. In Canada, as in arny other countries, a lot of time was wested trying [

l to derive one universally applicable quantity before it was realized that this was  !

i probably unattainable. The main thrust for that realization in Canada came in the  !

l area of wasts management. '[

t i De Minimis Applied to Waste I f

j It came about be.caase there were specific instances where generators of extremely }

low concentration radioactive waste wished to use municipal landfill as their t saste disposal route. This was prohibited by provincial law in some provinces i j without first holding public hearings, since radioactive waste, with no threshold i j quantity specified, was included in the general definition of hazardous waste.  !

The potential level of hazard from these slightly radioactive wastes was so small j

! that it was obvious that public hearings would not be warranted. One therefore v l had the choice of either blocking an eminantly sensible proposal or attempting to l l' change the law to introduce some threshold of radioactivity for waste going to landfill sites. As a result of this, the AECB started looking at the derivation of a de minimis level for the specific, narrow, application of waste which would be allowed to go to unlicensed facilities. Despite narrowing the problem down f like this and the passage of some considerable time since starting addressing the  ;

probles, no regulatory position has yet been formally adopted. One is in a fair?.y  !

advanced state of drafting, however, and it will be of great interest to us to j determine whether other countries are moving in t?1 same general direction as Canada.

The AECB staff recommendation that has been drafted reads as follows: "The AECB ,

reccanfzes that persons accepting certain radioactive materials for disposal  ;

should be exempted from AECB licensing control. The AECB will use k de mininjs ,  ;

)

dose of radiation to individuals of 0.05 millisieverts in a. year for deciding such

" exemptions on a case-by-case basis, provided that the radiological impa:t will be i localized and tre potential for exposure of large populations is small. Approval  ;

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for' exemption fram furtner. licensing will be given in such instances if it is satisfactori;y demonstrated that these criteris are met, using methods and procedures no dif.' retit from thosa that would be applied to the corresponding uncontaminated m' f N. . " A few parts of that statement bear further discussicn.

1. "Certain ra; .g gaterials": As I have already mentiored, the intent of this policy st , to restrict it to certain radioactive wastes only. It would not inc! o , or aqueous effluents, and would be aimed primarily at two categorier .. The first was the waste generated by users of unsealed radioisotopes - , such as hospitals, universities, biochemistry labs, etc.

The second was pectfic accumulations of waste generated by a few licensees. An cxample in this latter group is a uranium refinery which generates wasta that is mainly calcium fluoride, strongly alkaline in nature, and contaminated with uranium to the extent of a few hundred parts per million. At one poin. the genarstor of this waste was exploring the possibility of shipping his waste material to a company which specializes in handling similar non-radioactive ,

s matc.ials. That company's te hnique is to solidify them in a concrete-type matrix. The proposal that came to the AECB was whether this uranium-contaminated waste could go to that handier without the recipient being licensed to receive it. ,

It should be noted that the idea of de minimis in this case is not one where there is no further interest, but rather one where licensing the recipient would not be warranted provided he handles the material in a pre-agreed fashion. If, for example, he were to cease mixing the waste with a concrete matrix and start dumping it into a landfill, that .uld not be acceptable.

2. "Individual Dose of 0.05 mSv/ year":

-6 This individual dose was derived from a fatality risk of 10 . That risk in turn was regarded as the risk which would generally be disregarded by most people, and t hence could be called insignificant. Many other jurisdictions believe there is a need for an arbitrary reduction from such a level, by a factor of five or ten, to allow for the potential of an individual being exposed to more t.han one exempt practice, but this is an approach which AECB staff currently believe is not required in Can-ada for the two categories of waste discussed above. In the first category, it has been determined that the resulting dose to individuals is several  ;

, orders of magnitude below .05 mSv per year and therefore it would not matter if an individual was 4xposed to more than one such practica. In the second category, it is expected that there will be sufficiently few individual cases that it will be '

relatively easy to keep track of each and allow for the consequences arising from

' previous approvals in each new approval. This means that if a proponent were to  !

make a submission which would result in a previous critical group being again i exposed, this time to the consequences of h,s de minimis waste, the permissible dose for that new proponent's submission would be reduced belye .05 mSv by the amount already taken up by the previously approved practice. It is also intended  !

that the approved practices will be periodically reviewed to ensure that they are

continuing unchanged. It is recognized, however, that this approach may not be cpplicable in countries whose geography and demographics are significantly different from Canada's. [

3."Localized Impact": (

1 .

The complete phrase in our proposed policy statement is: "Provided that tho '  !

radiological impact will be localized and the potential for exposure of large l

populations is sm
11". This rather vague phrase was incorporated in order to 0 .

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allow the regulator to limit the overall detriment from a practice without l actually specifying in advance a parameter such as a collective dose limit. It was also intended to preclude any attempt to meet the individual dose constraint by dilution and dispersal.

De Minimis in Other Applications The wastes which are affected by the de minimis policy statement which I have been discussing are only one example of a category of radioactive material that has been exempted from licensing control in Can&da. Exemptions from licensing have been granted for several consumer products over the years on a case-by-case basis and we have studied them to see if the logic that was used in approving the exemptions would be consistent with our proposed de minimis waste policy. It seems that it is not.

The major point of divergence occurs with the individual dose. For some of the devices whose distribution has been exempted from licensing, inviddal radiation -

doses in excess of .05 mSv in a year are feasible.For example, the dose that could result from breakage of a baci-lit tritium watch was estimated to be approximately 0.25 mSv. The Atomic Energy Control Re5ulations themselves exempt from licensing sources of up to one scheduled quantity, and allow the possession of ten of these in one year. The scheduled quantities are such that it is feasible that a person in possession of such sources could receive a radiation dose up to the regulatory limit of 5.0 mSv for non-atomic radiation workers if the source was sufficiently maltreated.

Ionizrtion smoke detectors are at the other und of the scale, the 'easible doses from these being several orders of magnitude lower. The desigr standards which must be met by smoke detectors in order to be approved by the AEC8 for licence-exempt use in Canada are strict, and relaxation of some of these would certainly not result in the doses even approaching values commonly mentioned as de minimis doses.

Thus there are exempt devices whose radiological consequences to individuals range from being truly trivial up to a level where they approach the dose limits. This means that ALARA is still applied below de minimis doses in some cases, and exemption from licensing allowed above de minimis doses in other cases. The rationale for this ar .sntly paradoxical situation is based,on several factors.

One of these is wheti. .ie doso results from chronic exposure or a single act of abuse. The probability of occurrence of the latter is' low, and the probability of reoccurrence even lower. Another factor is the type of source, and hence the type of person possessing it. For example, calibration sources ars not likely to fall into the hands of people who would be inclined to deliberately abuse them. A third factor is the availability of practical alternatives. If the source is in a device that will be distributed very widely, licensing individual possessors is not a viable option. In this case, only two alternatives exist - ban or exempt. 1 Thus the magnitude of the dose is not the only important parameter in datermining whether a source should be licensed or exempt - and so it seems rather futile to specify a de minimis dose that would be used for that purpose. That is not sufficient reason.to drop the concept entirely, however, for it could be very useful when applied to discreet portions of the industry. The only portion so far identified in Canada as being in need of this ic waste management, but others may develop in the future.

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4-e De Minimis Risk s

Many scientists dislike ad hoc solutions, and prefer to scek the general solution, whatever the problem. In the case of de minimis, it appears that any such general colution would have to be in terms of rivk, rather than dose. Even then, there ere two cajor impediments to the usefulness of such a quantity. The first is that it does not address the question of justification. There are several uses of radioactive material where the risk is miniscule, but the benefit has been judged to be so low that the use has been banned. Thus the lack of justification has an overriding effect over de minimis risk, which is of questionable logic if the risk is really trivial. The second impediment appears when one attempts to assign the values of probability that one needs in calculating the risk resulting from some scenarios. When dealing with the probability of failure of a piece of equipment for which there is extensive operational data, this is not a problem, but in many

. real ceses of radioisotope use, the limiting accidents are more due to what can only be described as irrational human behaviour. Assigning meaningful probabilities in that type of case seems to be impossible.

Coming back to the turren: !!!uetion in Can:4:: ev:n the value for de minimic that AECB staff are recommending for certain types of radioactive wastes will to a large extent be useless unless other tegulatory agencies in Canada accept them.

As I mentioned earlier, the Atomic Energy Control Board regulates the nuclear industry in Canada but the provincial Ministries of Environment sfor example, prohibit certain materials from being deposited in landfill sites. For the de minimis concepts to be really useful for waste disposal, those provincial ministries must be persuaded to call up the de minimis level in their regulations.

To date that has not happened, but once the AECB has published its own recommendations on this subject, some of those other agencies might then be willing to follow.

AECB October, 1988 9 e 4

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. I EXEMPTION RULES APPLIED IN FINLAND by H. KAHLOS and E. RUOKOLA 1

Finnish Centre for Radiatiott and Nuclear Safety O

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- EXEMPTION RULES APPLIED IN FINLAND H. Kahlos and E. Ruokola Finnish Centre for Radiation and Nuclear Safety P.O. BOX 268' SF-00101 Helsinki, Finland  ;

l CONTENTS

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1. Exemption of non-nuclear radiation sources and practices l 1.1 Reguintory bases for exemption

. 1.2 Development or regulations l 1.3 Role and use of consumer products 1.4 Other relevant practices and sources 1.5 Non-nuclear radioactive waste .

2. Exemption of nuclear waste 2.1 Exemption principles 2.2 Practical examples of exemption
3. References

) 1. Exemption of non-nuclear radiation sources and practices 1.1 Regulatory bases for exemption

i. The principles for exemption policy of non-nuclear radiation sources and prpctices are given in the Finnish radiation protection legisla-tion. The basis of supervision is the safety license which is required for the manufacture, use, import and export, possession '

of e,nd trade with radioactive materials as well as the use of appara-i tuses and installations producing radiation. By legislation, some radiation sources and practices have been excluded from regulatory control. The competent authority, the Finnish Centre for Radiation and Nuclear Safety- (STUK), which grants the safety licanoes has also been authorized to exempt, on certain conditions, a specific source or practice from licensing and other control. In legislation, the following regulations and criteria concerning exemption are

. given:

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(a) Apparatuses excluded from control -

Legislation does not concern apparatuses and installations producing X-rays, if the voltage used is lower than 5 kV. I l

(b) Radioactive substances excluded from control No safety license shall be required for the manufacture, use, import or export, holding or placing on sale of a radioactive substance provided that (1) its activity is below the following limits:4 108 Dq (101 C1) group 1 (very high radiotoxicity) group 2 (high radiotoxicity) 4 104 Bq (10-5 C1) group 3 (moderate radiotoxicity) 4 10' Bq (105 C1) group 4 (low radiotoxicity) 4*108 Bq (104 Ci)

Examples group 1: Ra-226, Am-241 group 3: C-14, Pm-147 group 2: Cs-137, Co-60 group 4: H-3, Kr-85 (2) its concentrstion in material is less than 74 Bq/g (2 10" C1/g,; or (3) the concent. ration of naturally occurring radioactive substances in a solid material is less than 370 Bq/g (108 C1/g).

1 The license shal?. nevertheless be necesr,ary for the manufacture and use of any .adioactive substance !.f it is used for medical purposes .or as an additive in foodstuffs. In practice, the adding of radioactive substancen into foodstuf fs is not allowed.

(c) Criteria for exemption of special source or practice The competent authority has been authorized to exempt from t

l safety license any installation and the use of an X-ray unit or other apparatus producing radiation or containing a radioac-tive source, if by the prototype inspection the apparatus has been shown to emit so little radiation that its use is not considered to have "any harmful effects on health".

This requirement for exemption will be met by an apparatus or a sealed radiation source, (1) cmfor which the dose rate, measured at the distance of 10 from the outer surface, does not exceed 1 ySv/h.(0.1 mrem /h); or (2) for which the dose rate exceeds 1 Sv/h, but the shielding is so good that the radiation does'not cause "danger to health".

In a decision concerning the exemption it can be ordered that a notification shall be made to the authority. A notification has not been required as a rule, because the manufacture, import and trade of exempted sources already are being supervised.

)

3 1.2 Development of regulations The radiaticn protection legislation is under revision in Finland.  ;

The proposal for a new radiation act was prepared by an ad-hoc i committee in 1987-88. The legislation in force concerns the use of ,

I ionizing radiation sources in medicine, industry, research and teaching, as well as the import, export, trade and manufacture of radioactive materials. Recently, legislation was expanded to concern also non-ionizing radiation. By the new radiation act supervision is intended to be expanded to concern also natural radiation exposure occuring in amounts harmful to health.

The law proposal contains general stipulations concerning the exemp-tion of some specific ionizing radiation sources and practices from safety license or from control. The practices to which natural radiation exposure is related are exempted from safety license but the employer shall be responsible, when necessary for providing a study of tha exoosure and for undertaking the radiation protec-tion nessures.

According to the law proposal, a safety license would not be needed 1.a.

(a) for the use of a radiation apparatus which has been approved as a consumer product. (A radiation apparatus is defined as an apparatus containing a radioactive source or being capable of producing radiation);

(b) for the use of a radiation apparatus which has been exempted from license on the basis of prototype testing; (c) for thn use of a radiation source (e.g. radioactive material or radiation apparatus) which has been exempted from prototype testing because of a very low radiation exposure rate; (d) for the manufacture and trade of a consumer product in which parasitic radiation is produced electrically.

In addition, the competent authority (STUK) could exempt Crum safety license an other type of radiation source or practice than those mentioned above, if it can be assured reliably enough that the radiation source or practice will not cause a risk or detriment to i health.

1.3 Role and use of consumer products The concept of the consumer product has not been included in the radiation protection legislation in force. The regulations applied to consumer products are the.e pres w ed above for the exemption of a special source or pr ctice. In making a decision on exemption a

the po Q y and general principles given in international guides are applied where appropriate.

4 The exemption of a consumer product means in practice that the used products should be allowed to be disposed of freely via the public waste treatment systems. However, in approving rsmoke detectors which have a long-lived alpha emitting source, a recom.nendation is given to return the used detector back to the seller (importer) for disposal. Because of a "very small risk", the disposal of a single unit with household wasta should te preferred instead of collecting the used sources in one place.

The manufactura and import of consumer products containing radioac-tive material have not been, with few exceptione, exempted from control but a safety license is required.

1.3.1 Timepieces Although liquid crystal display watches have in recent years become more and more common, there are still a great number of radioluminous timepieces for sale in Finland. In 1983 the estimated current import for timepieces containgng 'radioluminous compounds, tritium or P.n-147, was about 100 000. Ra-226 is no more in use in time-pieces for sale. The exemption limits for tritium and Pm-147 time-pieces are those given above. In spite of the old practice, it should be considered, is there any need at all to use radioluminous com-pounds in timepieces.

1.3.2 Compasses Different types of portable and marine compasses and similar instru-ments, manufactured by two Finnish companies, have been prototype tested and accepted for use without a safety license. The radioac-tive material used is tritium, sealed in gas form in a glass con-tainer (GTLS, gaseous tritium light source) or as a tritium con-taining paint. The amount of tritium depends on the oype of compass, being at highest 1 01' Bq in compasses where GTL-sources are used.

To indicate the presence of a radioactive material, the sign "T" is required in the compass and, in the instructions, the presence of radioactive material shall be stated. The used compasses may be disposed of via a public waste 4 treatment system. In teting and considering the approval OECD/NEA the guidelines and recomtandations were applied where appropriate.

The imported compasses have not been systematically investigated from the point of view of acceptance. Occasional checks have been made. E.g. a small number of old Bendix-compasses, earlier used in aircraf ts, have been imported for private use in boats. Some of them may contain unacceptable amounts of Ra-226.

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5 l.3.3 Smoke detectors Smoke detectors which contain a radioactive source and are intended J to be distributed to the public have been accepted on the basis of prototype testing for use, possession and trade without safety license on the following conditions. The radioactive source is Am-241 and the activity not more than 40 kBq. In the label and instruc-tions of the datector, the radioactive source and its amount shall be stated. Manufacture and import have not been exempted from license and the number of manufactured or imported detectors will be control-led.

1.3.4 Electronic products emitting parasitic X-Isys In recent years, about 180 colour television rectivers and video display terminaJs have been prototype tested and exemp*ed from control. Testing showed that the exposure rates of /-radiation are mostly well below the detection limits obtained with standard instru-ments. A more careful spectrometric examiption of 18 different colour television sets confirmed the results . Except for one recei-ver, the dose rate at 5 cm distance from the surface of the CRT was below the minimum detectablej limit of the spectrometer, 10 ' Gy/h.

According to the standard of IEC 65, the acceptance limit for television receivers and other devices having a CRT as a potential X-ray source is 1.3 10-7 C/(kg h) (0.5 mR/h) at the distance of 5 cm. Recently, before adopting of the international practice, the limit for the dose rate 1 pSv/h at the distance of 10 cm was used, basing on our national regtlations, l

1.4 Other relevant practices and sources In addition to consumer products there are some practices or sources which are partly or totally exempted from safety license or notifi-cation. When considering exemption, the following aspects are taken into account:

(a) The apparatuses to be exempted are special instruments'for medicine, industry or research and their distribution is rest-ricted. The apparatuses are not consumer products.

l (b) The manufacturer, importer or a person or organization autho-l rised by them shall have a safety license for installation and

! service of the apparatuses.

(c) The apparatuses shall be prototype-tested and the instruc-tions accepted by the competent authority (STUK).

(d) The source shall be disposed cf as radioactive waste according to the instructions given.

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(e) The manufacturer or the importer sha.11 keep a record of the '

radioactive sources delivered and they era prescribed also to l

' take back the used sources. I l

(f) The radioactive sources may also be prescribed to be notified

,' to the competent authority for registration l Examples:

The use of teaching instruments, sealed radioactive sources etc.

at schools has been exempted from safety license end notification provided that they are specially designed for demonstration in  ;

physics and chemistry. The instruments and sources shall be proto-type tested, and advice on the disposal of radioactive sources is given in the instructions.

i Sealed radioactive sources used as part of some scientific instru-ments for calibration or ionization, like in liquid scintillation counters, gas chromatographers, etc. are exempted from safety license on the basis of prototype testing. The disposal of the sources is prescribed in tna instructions. The sources are registered by manu-  !

facturer or importer.

Electron microscopes will be exrunpted from safety licanas on the i basis of prototype testing or on-the-spot inspection when being taken into use. According to a survey made in 1986 for different types of microscopes, a very small leak radiation could be detected in the ones having a high voltage over 100 kV. However, this leak radiation was too low to give a quantitative reading. ,

i The use of some "entirely closed" X-ray units have been exempted -

from safety license on the basis of prototype testing. The voltage  ;

. of the exerepted units has been low, not over 30 kV. ,

Portable surface level gauges for checking the content of fire extinguishing systems have been exempted from safety license when

' used in ships. The radioactive source is Co-60 or Cs-137 and activity shall be less than or equal to 40 MBq. The sources are registered ,

and instructions for their use, storage and disposal are needed.

There are miscellaneous radioluminous items contairiing tritium, ,

which have not been exempted. Examples of them are exit signs of f

l aircrafts and gun sights.

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Airport luggaga inspection systems, as well as postal packet inspec- l tion systems consisting of an X-ray cabinet have not been exempted ,

from safety license. Shoe-fitting fluoroscopes are not in use in l l

Finland. Static eliminators containing Po-210 are, because of leakage >

found, for the present taken off use. The user or the lessor shall l 1 have a safety license.

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1.5 Non-nuclear radioactive waste

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The supervision of the use of radioactive material is based on safety license. The general rules on the treatment and disposal of radiogetive waste are given in the radiation protection legisla-In the legislation, detailed orders are given for liquid tion.

and gaseous wastes. If necessary, case by case requirements con-carning the disposal of solid wastes are given in the safety license and the inspection protocols.

in addition to legal provisions, principles followed in the disposal of radioactive wastes are bssed on international reewamendations.

Practical guidelines app ied in the Nordic countries ne published as joint recommendations by the Nordic radiation protection authori-ties in 1986. The following example.) of the disposal of low-activity waste from control are based on these recommandations.

Consumer products contain a very small quantity of radioactive substances and they do not present any disposal problems. In gene-ral, this type of waste can be dealt with.as though it were non-radioactive. Approval as a consumer product also means indirect-ly that a product is no more under control and can be disposed freely.

Solid wastes with a very low activity concentration may be treated and disposed of via the public waste treatment systems. These wastes are usually produced in connection with radiological work in hospi-tals and at research institutes. A separate sealed so' tree with an aciiivity of less than 100 kBq can be disposed of in this way. The content of alpha-emitting radionuclides and radionuclides with long half-lives such as Sr-90 and Cs-137 should be low. The surface dose rate on individual waste packages must not exceed 5 pSv/h.

Each waste package may not contain more than 1 ALI,gn of radioecti-ve material, and the total disposed activity per month may not exceed 10 A L I ,in . ALI, i n value is the minimum value for Annul 1 Limit on I ake given in the ICRP Publication 30 and its Supplements The activity of liquid waste which may be poured into the sewer system is less than or equal to 1 ALI,,, but not more than 100 MBq on each occasion. Not more than a total of 10 ALI,in may be disposed of in one month.

Because of toxic organic solutions the liquid scintillation counting waste constitutes a special problem. Waste which mainly contains tritium or C-14 and has an activity conc 9ntration of less than 100 Bq/ml may be considered as a non-radioactive waste.

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2. Exemption of nuclear waste s

)

2.1 Exemption principles In Finland all wastes originating in the controlled areas of nuclear installations are regarded as nuclear waste and consequently are '

subject to regulatory control. However, on certain conditions they may be exempted from regulatory control for recycling or for The general exa disposal as conventional waste.have been stated in the Nuclear Energy Decree.gtion According to p these rules, the competent authority, the the Finnish Centre for Radiation :.ind Nuclear Safety grants permissions for the transfer of a nuclear wasta quantity from one holder to another, and, in

, general, the receiver of the waste shall have en authorisation requi-red by nuclear energy legislation. The receiver, however, does not need such an authorization, i.e. the waste is exempted from regulato-ry control, provided that ,

(a) the averaga activity concentration in the waste is lower than 10 kBq/kg, and the nuclide content in the waste transferred to one receiver is less than the following limits: 1 GBq for the  !

l total activity and 0.01 GBq for the total alpha activity, and ,

(b) the estimated ef fective dose equivalent commitment to any individual, resulting from the exempted waste, is less than 0.01 mSv and, in addition, the total radiation exposure caused by the exempted waste is as low as reasonably achievable ,

. (ALARA).

More detailed directions are given in a guide issued by the Finnish l

Centre for Radiation and Nuclear Safety. At present, the guide is applied only to exemption for the disposal of waste, but it is inten-ded to be enlarged to cover also exemption for the recycling of ,

waste. The guide includes information on the safety assessments l to be made, monitoring the activity in the waste, wasta quality restrictions, acceptable disposal methods, exemption procedures and supervision performed by the regulatory body.  ;

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When deciding on an application for a transfer and the subsequent  ;

! exemption of a wasta quantity, the Finnish Centre for Radiation l and Nuclear Safety evaluates whether the provisions for exemption are mat. A similar procedure is followed also in case that the l waste producer disposes of the waste itself, though no permission  ;

for the transfer of waste is then needed. P i

2.2 Practical examples of exemption To illustrate the application of the aforemer.tioned exemption prin-ciples, a couple of practical oxamples are given.

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. 2.2.1 Disposal of very low-level trash waste l

Annually about 15 tons of very low-level trash waste from the TVO nuclear power plant has been exempted for burial in a landfill on the NPP site. The nuclide content of the waste sacks is monitored by means of a computerized gamma spectrometric measuring system and limits are set for a number of nuclides (e.g. 2 kBq/kg for Cs-137, 10 kBq/kg for Co-60, 100 kBq/kg for Cr-51).

2.2.2 Recycling of worn-out condenser In 1985 the copper-aluminium condenser units of the TVO II nuclear power plant were replaced by new titanium units. Seven of the eight replaced condenser blocks were exempted after activity measure-ments. The resulting wasta consisted of 150 tons of copper-aluminium (total gamma less than 50 MBq, average specific activity c. 350 Bq/kg) and 30 tons of steel (total gamma below 0.1 MBq). The activi-ty was mainly of Co-60.

The copper-aluminium tubes were sold to a copper producer. The tubes were melted together with other copper concentrate (mixing ratio less than 1/30). The copper was further refined electrolyti-cally to 99,99 % purity. The copper is used for manufacturing copper wire, tubes and sheets. As a by-product, for example silver and nickel sulfide are recovered from the electrolytic sludge.

The validity of the safety assessments was verified by means of a follow-up measurement program: activity in materials was measured at a number of points during the process. The measurements indicated

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that a major part of the Co-60 activity goes with slug while a

' minor fraction accumulates in the nickel sulfide which is separated from the electro. '- As Ag-110m is enriched in the silver separa-tion process, it waJ regarded as a critical nuclide with respect to individual dose. The analyses indicated that activity concentra-tions in the silver products remained far below the derived limits.

3. References 1 Act on protection against radiation (174/57) and its amendments (1/65, 144/73, 431/78, 15/86, 992/87).

Decree on protection against radiation (328/57) and its amend-l ment (545/68).

Decree of Ministry of Social Affairs and Health on radiation l

protection (594/68) and its amendments (872/76, 775/78).

1 2 IAEA/ILO/NEA (OECD)/WHO: Basic Safety Standards for Radiation Protection, IAEA Safety Series No 9, Vienna, 1982.

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l 3 NEA (OECD): A guide for controlling consumer products containing .

radioactive substances, Paris, 1985. ,

4 NEA (OECD) : Radiation protection standards for gaseous tritium J light devices, Paris, 1973.

5 Niemi T: Personal communication, The Finnish Centre for Radia-tion and Nuclear Safety.

6 Servomaa A and Tapiovaara M: Veritelevisioiden sateilyturval-lisuus. Report STUK-B65. Helsinki, Finnish Centre for Radiation and Nuclear Safety, 1986. In Finnish.

7 IEC standard 65 Amendment no. 1 (1978): Safety requirements for main operated electronic and related apparatus for household and similar general use.

8 Application in the Nordic Countries of International Radioactive Waste Recommandaticits. The Radiation Protection Institutes in Denmark, Finland, Iceland, Norway and Sweden, 1986.

9 ICRP: Limits for Intakes of Radionuclides by Workers, Publica-tion 30, Part 1, Ann. ICRP, 2 no 3/4 (1978).

10 Nuclear Energy Decree (161/88), Statutes of Finland, 1988.

11 Wasta Arising from the Controlled Areas of Nuclear Power Plants:

Exemption from Regulatory Control for Disposal, YVL Guide 8.2, 1985.

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CONCERNE L' EXEMPTION DE MATERIAUX' i

DE TRES FAIBLE RADIO-ACTIVITE ,

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- APPROCHE FRANCAISE EN CE QUI CONCERNE L' EXEMPTION DE MATERIAUX DE TRES FAIBLE RADIO-ACTIVITE Anne-Marie CHAPUIS Commissariat & l'Energie Atomique Institut de Protection et de SGret6 Nue16 aire D6partement de Protection Technique Fontenay-aux-Roses. FRANCE I. REGLEMENTATIONS Le decret n*66-450 du 20 juin 1966, modifie par le d6cret n'88-521 du 18 avril 1988, a pour but de fixer les principes g6neraux de protection contre les dangere pouvant resulter des rayonnements ionisants. Il s' applique A toute' activite imp 11anant une exposition A des rayonnements ionisants, et notamment A la production. au traitement, i 1 =enipulation, i l'utilisation. A la detention, au stockage, au transport et A l'411mination des substances radioactives naturelles ou artificielles.

L'exercice de ces activites est soumis A un regime de declaration ou d'autorisation prealable, sauf lorsque ces activitar portent sur des substances radioactives ou appareils entrant dans l'une des catagories suivantes :

. Substances radioactives dont l'activit6 totale est inferieure a 5 kilobecquerels pour les radionuc161 des les plus toxiques (groupe I) ou aux valeurs aquivalentes datermindes dans chaque cas en fonction de la radiotoxicit6 relative ;

. Substances radioactives dont l'activite massique est inferieure A 100 kilobecquerals par kilogramme, ou a 500 kilobecquerels par kilogramme pour les substances radioactives solides naturelles ;

. Appareils 4mettant des rayonnements ionisants, A condition que les matieres radioactives 6ventuellement incluses soient efficacement proteg6es contre tout contact et toute fuite, et que le d6 bit de fluence energ6tique n'entratne pas, dans les conditions normales d'utilisation, en tout point exterieur situa A une distance de 0,1 m&tre de la surface de l'appareil, un d6 bit d'aquivalent de dose de plus de 1 microsievert par heure, et que ces appareils soient d'un type agr66 par les autorit6s ministirin11es competentes.

Toutefois, par derogation aux disposition c i-d e,s su s , une autorisation

. praalable est toujours n6cessaire pour l'utilisation de substances radioactives A des fins medicales.

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De plus sont interdites :

. L' addition de substances radioactives dans la fabrication des denries alimentaires, des produits cosmetiques et dcs produits & usage domestique ;

. L'utilisation de substance radioactives dans la fabrication des jouets.

Les articles 20 et 30 de ce dieret definissent les competences du Ministare de la Sante en mati4re de radioprotection et pr6cisent que le niveau des mesures de radioactivits A prendre en compte sur le plan sanitaire est fixe par le Ministare de la Sante.

Depuis quelques annies des restrictions ont ete apporties 4 l'utilisation de mati4res radioactives, par exemple :

- arrate du 11.10.1983, mis en application & partir du 01.01.1986, sur l' interdiction d'emploi de radio 414ments pour le fabrication de paratonnerres ainsi que de leur commeretalisation et de leur importation !

- conditions particulitren d'emploi des radio 414ments artificiels dans les detecteurs de fumes ou gas de combustion (modifications du 11 mai 1982).

II. DIFFICULTES L' application simple des limites d'activites figurant dans le dacret 66-450 1 1' exemption de materiaux ou d'objets pose un certain nombre de probl4mes pour les raisons suivantes :

- la limite de 100 Bq par gramme qui ne depend pas du radionucidida considere peut se reviler trop 41evie dans le cas de radionucleides de

. forte radiotoxicite si les masses de materiaux exempties sent importantes.

Inversement cette limite semble faible pour les radionuc141 des de faible radiotoxicite comme le tritium ou le carbone 14 3

- les limites portant sus l'activite totale pourraient 8tre ut,111sies pour la remise de dichets dans b domaine public 1 condition de preciser dans quelles conditions et avec que21e periodicite ces activites peuvent 8tre rejeties. Un avis du Ministire de la Sante aux utilisateurs de I radio 414ments soumis au regime d'autorisation prevu par le code de la 1

Sante Publique, publia au Journal Officiel du 6 juin 1970 precise ces conditions. Ces limites ne sont applicables que pour des quantites de dichets relativement faibles.

- les riglementations qui s'appliquent A un certain nombre d'insta11ations clasicies pour la protection de l'environnement precisent que ces installations ne doivent pas recevoir de materiaux radioactifs.

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. 3 III. ETUDES ET PROJETS )

~. l Devant ces difficult 6s les Minist6res interess6s 6tudient la possibilit6 )

de d6finir avec plus de precision les mat 6riaux et les objets qui pourront 6tre '

exempt 6s des contr81es r6glementaires sur les materiaux radioactifs. Parmi les l 6tudes et projete en cours citons les suivants :

- Une instruction est en cours de pr6paration par la Ministare de la Sant6 afin d'exempter les d6chets faiblement criti6s utilis6s par les services de m6decine nuc16 aire. Cette proc 6 dure vise les d6chets constitu6s par les flacons contenant des scintillateurs liquides. Elle repose sur le fait que l'activite totale de tritium distribu6e annuellement en France est de l'ordre de 1 Ci, .

r6partie entre 200 laboratoires, et que le coGt de traitement de ces d6chets en  !

tant que d6chets radioactifs ne se justifie pas sur le plan de la sante publique.

- Il convient que les installations d'61tmination des d6chets (traitement -

et/ou stockage) puissent recevoir des mat 6riaux de tras faible radioactivit6 qui devront etra en accord avec ceux figurant dans les autres reglementations sur les mat 6rtaux radioactifs. Une concertation interministerielle est en cours '

pour d6finir les niveaux d'activit6 4 prendre en consid4 ration.

Des 6tudes sur les principes g6n6raux d' exemption et application &

certains types de mat 6riaux sont effectu6es par l'Institut de Protection et de SGret6 Nac16 aire du Commissariat & l'Energie Atomique. Ces 6tudes montrent les possibilites et les limites des proc 6dures d' exemption ainsi que la n6cessit6 de modifier et d'harmoniser les limites d'activit6 au-dessus desquelles s'appliquent les dif ferentes r6glementations : protection des travailleurs et du public contre les rayonnements ionisants, installations nuc16aires, installations class 6es pour la protection de l'environnement, transport...

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V. PROCEDURE

S ACTUELLES Actuellement la remise de mat 6riaux dans le 'domaine public, , pour recyclage, traitement ou stockage, se pratique apras accord au cas par cas donn6e par le Service Central de Protection contre les Rayonnements Ionisants, ce qui a permis par exemple

- le d6 pat de boues d'une acation de traitement des eaux, contamin6es en m6tsux lourds at tras faiblement radioactives, dans une d6 charge industrielle ;

- le recyclage de ferrailles criti6es. Dans ce cas particulier une d6rogation 1 la r6glementation des transports de mati4res radioactives a 6t6 necessaire ;

- le recyclage de ferrailles provenant du demant61ement d'un reacteur.

Pour celles-ci, la limite d'activit6 utilis6e, de 1 Bq/g, est celle propos6e par un groupe de travail de la CCE et basde sur les travaux de l l'IPSN ;

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1 THE FRENCH APPROACH FOR EXEWTING MATERIALS WI1H YERY LOW-LEVEL RADICACTIVITY Anne-Marie Chapuis Atomic Energy Commission Institute for Nuclear Protxtica and S3fety Technical Protection Department Fontenay-aux-Roses, France I. REGut.ATIONS The purpose of Decroc No.66-450 of June 20, 1966, amended by Decree No.88-521 of April 18, 1988, is to establish the general principles of protection against dangers that can result from ionizing radiation. The decree applies to any activity that involves exposure to ionizing radiation, and in particular, to the productions processing, handling, use, holding, storage, shipment and disposal of natural or artificial radioactive substances.

The implementation of activities is subject to a system of advance permission or disclosure, except when the activities involve radioactive substances or devices that f all into one of the following categories o Radioactive substances with overall activity under 5 kilobecquerels for the most toxic radionuclides (group I), or those that are under equivalent values, determined on a case-by-case basise according to the relative radiotoxicitys o Radioactive substances with mass activity under 100 kilobecquerels per kilogram, or 500 kilubecquerels per kilogram for natural solid radioactive substances; o Devices that emit ionizing radiation, provided that the radioactive materials that may be included are effectively protected against any contacts and any leaks, for which the energy fluence flow, under normal usage conditions-at any external point located 0.1 meter from the surf ace of the device--does not cause & dose equivalent flow of over 1 .

microsievert per hour, and for which the devices are of a type approved by the ministerial authorities in charge of these issues.

However, as an exceptien to the abeve mantioned provisionse advance permission is always required when radioactive substances are used for medical purposes.

-.- Moreover, the following is prohibited o Adding radioactive substances in manufacturing foodstuffse cosmetics, and products for the homes

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2 o Using radioactive substances in manufacturing toys.

Articles 20 and 30 of the decree set forth the authority of the Ministry of Health for protection against radiation and stipulate that the level of radioactivity tests to be taken into account for health-related matters is to be set by the Ministry of Health.

For the last few years restrictions have been placed on the use of radIcactive matorials, for examples

- the order of 10-11-83, which tcok effect on 1-1-86, dealing with the Mn on using ridiM1=+nts for manuf acturing, selling, and importing lightning rods!

- special raquirements for using artificial radioelements in smoke detectors or stack gas (amendments of May 11, 1983).

II. PR00LEMS The implementation alone of limits on activities thst f all under Decree 66-450, M the exemption of materials or objects, causes a cer+.atn number of problems for the following reasons:

- the limit of 100 Bq per gram, which is not based on the radionuclide under consideration, may prove to be too high for radionuclides with high-level radictoxicity, if the masses of the materials that are exse.pted are high. Conversely, the limit seems low for radionuclides with low-level radictoxicity, such as tritium or carbon 14;

- the limits on overall activity could be used for turning waste over to the public domain, as long as the conditions for rejecting these activities and the intervals are specified. A notice from the Ministry of Health to users of radicolements that are subject to the permission system prescribed by the Public Health Code, published in the Official Gazette of June 6,1970, sets forth these conditions. These limits are applicable only to relatively small amounts of waste.

- the regulations that apply to a certain number of facilities for, environmental protection specify that such f acilities are not to receive l radioactive tratorials.

III. $T1)0 ES AND PLANS Confronted with these problems, the Ministries involved are studying the '

l possibility of identifying in greater dotati those materials and objects that might be exeepted from regulatory control of radioactive materials. The following studies and plans will be mentioned among those now undenray

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- The Ministry of Health is now in the process of propi 'ng to investigate l the exemption of low-level tritiated waste used by nucleti ,nedicine personnel. 4 This procedure focuses on vaste created by bottles that contain liquid ,

scintillators. It is based on the f act that the overall yearly activity '

throughout France is about 1 C1, which is distributed among 2001sNoratories, and that the cost for treatir.g this vaste as radioactive waste is not justified in terms of public health. ,

- Waste disposal facilities (tren*oent and/or storages should be allowed to receive materials with very low-level radioactivity. These materials should be ,

consistent with those in the other regulations on radioactivs materials. The ministria: tr: act working together to identify the activity levels to be taken into ceeefderation.

- Studies on the general principles of exemption and application to certain l types of materials are performed by the Institute for Nuclear Protection and Safety of the Atomic Energy Commission. The studies show the possibilities and limits of the exemption procedures and the necessity to c.hange and standardize the activity limits above which the dif ferent regulations apply, i.e.,

protecting workers and the public from ionizing radiation, nuclear f acilitiese f acilities for environmental protection, transportation, etc...

IV. OJRRENT PROCEDURES i

{ At this point the turning over of materials to the public domain for

, recyclinge processing or storage is done after case-by-case approval, given by the Central Department for Protection against Ionizing Radiation. For examples

, this has made it possible to do the following

- deposit mud from a water treatrent plant, where the water was contaminated with heavy metals and very low-level radiatione into an f ndustrial dumping arsas l - recycle tritiated scrap iron. In this particular case, a waiver from the l l

regulation of trentporting radioactive materials was necessary; i

- recycling scrap f ron f rom a reactor being dismantled. For such scrap trene the activity limit used (1 Sq/g) is that suggested by an EEC panel '

' based on the work of the Institute for Nuclear Protection anc Safety; t I

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i DEPARTMENT OF ENERGY GUIDELINES FOR ,

i RESIDUAL RADI0 ACTIVE MATERIAL AT FUSRAP l c

4 'AND SFMP SITES AND THE ALARA PROCESS i  ;

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4 t ANDREW WALLO, III T i 6 4

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Office of Remedial Action and Waste Technology r

U.S. Department of Energy -

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DEPARTMENT OF ENERGY GUIDELINES FOR RESIDUAL RADIOACTIVE MATERIAL AT FUSRAR AND SFMP SITES AND THE ALARA PROCESS

Background

In the late 1970's and early 1980's, the Department of Energy (DOE) began working at several Formerly Utilized Sites Remedial Action Program (FUSRAP) sites and remote Surplus Facilities Management Program (SFMP)* sites.

Criteria for cleanup of these sites w rs proposed on a site by site basis by the field offices responsible for the specific remedial actions. The criteria and even the approaches to development of cleanup criteria varied.

In reviewing the proposed criteria OLE headquarters realized a need for general guidelines for these activities. The major requirement was the need for soil criteria. Several attempts were made by the National Laboratories, at the request of 005 headqisrters, to develop soil limits applicable to remedial tc>.fons. In 1733, the Deasetment began to c.1nsolidate thera cH teria and associated procedures in order to identify generic soil criteria for all DOE remedial actions.

Headquarters established a working group comprised of representatives from the concerned Headquarters Program Offices and the Office of Environment, Safety, and Health, DOE operations offices, and the National Laboratories involved in the development of specific criteria or decontamination efforts. The working group activities were also coordinated with Environmental Protection Agency (EPA) and Nuclear Regulatory Comission (NRC) representatives. These representatives also attended several of the ,

working group meetings in any advisory capacity.

  • Remote SFMP sites are those that are not on A jor DOE installations.

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The initial charter of the group was to develop an acceptable set of generic soil criteria. However, recommendations from the first meeting of the complete working group resulted in DOE expanding the charter to include all aspects of cleanup operations. Also, recognizing that many site specific ,f actors have significant impacts on soil criteria, the working group recommended that rather than developing generic soil concentration limits, a generic procedure for deriving soil criteria should be included in the guidelines. The following is a summary of the working groups findings and recommendations:

1. The guidelines should be consistent with othr:r available standards where they are appropriate. These included the EPA UMTRA standards **

which were in draft during the initial part of the working groups activities; NRC sur/a.ce contamination limits ***; and DOE Orders.

2. The Department should adopt and utilize the recommendations and system of standards and models provided in ICRP-26 and ICRP-30 for their

! residual radioactivity guidelines. This included the use of effective dose aquivalent rather than the ICRP-2 critical organ dose concept for defining dose limits for tho general public and the adoption of the

' lifetime average limit of 100 mrem / year effr.ctive dose equivalent. At i the time, the Department ifmit for the general public was 500 ,

mrem / year.

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    • EPA regulations ia the U.S. Code of Federal Pigulations Title 40 Part 192. t

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      • U.S. NRC Ge;delines for Decontamination of facilities and Cquipment Prior to Release fe,r Unrestrictei Used or Termination of License for Byproduct. Source, l or Specil,1 Nuclear Material. Division of Fuel Cycle and Material Safety, ~'

Washingt.in, D.C., July 1982.

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3. Soil criteria for'nuclides other than those covered under the UMTRA standard (radium and thorium) should be derived for each site on the basis of the dose timit. They should be based on a worst case plausible (realistic) use scenario.
4. The As Low As Reasonably Achievable process (ALARA) should be incorporated into the guidelines for all ph'ases cf the remedial action.
5. No attempt should be made by 00E to define de minimus or Below ,

Regulatory Concern (ERC) levels, This recommendation resulted from l

several concerns. The working group felt that the identification of a de minimus dose for maximum exposed individual might reduce the attention paid to ALARA and negate its use in the low dose regime where

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dose reductions might sti.11 be reasonable to control collective dose. .

In the other extreme, there was concern that a de minimus limit might become a defacto standard for remedial action. Considering the conservatism used in developing soil guidelines, use of a de minimus as the defacto limit could result in very high remedial action costs with no significant environmental or health benefit for certain sites.

Finally, the working group felt that because, at the time, there was no guidance or even general consensus identifying an appropriate de minimus limit, development of such guidance was beyond the scope of the working group charter.

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4 The Department of Energy Guidelines for Residual Radioactive Material were developed in accordance with these recomendations and were first issued in February 1985. The second revision was prepared and issued in March 1987.

The revisions were general'iy procedural in nature and were directed toward resolving implementation problems experienced with the earlier version.

The guidelines are supported by a separate but integral implementation manual that contains:

- Pathway Analysis Methodology for Deriving Soil Criteria based on dose to the maximum exposed individual ,

- Associated Dose Conversion Factors

- Environmental Transport Factors

- Guidance on application of the guid**.Mes including hot spot criteria and ALARA A computer code,.RESRAD, has been developed consistent with the manual and is available. The' manual is presently in draft form but will be published l along with the current version of the code this year (calendar 1988),

l The guidelines are presently being modified for inclusion in the DOE environmental protection order, Order 5400.3, formerly Draft Order 5400.xx.

Sumary of the Guidelines The' guidelines contain several elements including the definition of basic f dose limits (the DOE dose limit), secondary limits for remedial action and

} The 00E' dose,11mit for requiremerits for storage and disposal of residues.

remedial action projects as previously noted is 100 mrem / year effective dose equivalent plus a requirement to implement the ALARA process.

Secondary limits are basically concentration limits or activity limits used J

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to guide remedial actions. They include guidelines and limits in various media that are established or derived for o specific remedial action.

Site specific guidelines for soil are secondary limits. For radium and thorium, they are 5 pCi/g in the first 15 cm and 15 pCf/g in each 15 cm layer below the surface. Other soil limits are derived. These

! concentration limits are generally developed for large areas bet are applied to each 100 square meter area. If several radionuclides occur at a site, the concentration shall be reduced so that (1) the dose from th'e mixtureofradionuclidesdoesnotexceedtheDOEdoselimitor(2)thesum l of the ratios of the soil concentration of each radionuclide to the l

allowablelimitforthatradionuclidewillnotexceed1("unity").

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l In addition to general soil criteria for the 100 square meter areas, 00E l has developed additional "hot spot" criteria for inhomogeneous contamination to ensure that small areas of contamination that might comply with the standard when averaged over 100 square meters, do not pose unacceptable risk of exposure.

. Limits for radon and its decay products in air are equivalent with those l provided in Title 40 Part 192 of the U.S. Code of Federal Regulations.

Retnedial actions shall be conducted to reduce concentrations of radon decay i products resulting from residual radioactive material to concentrations less than 0.02 wl. Concentration limits for other radionuclides are to be established for each site to ensure compliance with EPA requirements and 00E orders. In all cases, remedial actions will be conducted in a manner that will reduce doses as far below the DOE dose linit as is reasonably ,

achievable (theALARAProcess).

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Guidance for concentratiot:s in water is similar; however, the Department is f in the process of formalizing a ground water protection strategy. The J requirements of this policy will be incorporated irato the guidelines. ,

Levels of radiation measured directly ( beta and alpha radiation) or, surfaces must comply with surface contamination limits that are consistent with I4RC requirements ***. Indoor levels of external gama radiation must  !

be less than 20 microR/ hour above background and the direct exposure ,

pathway must be controlled to ensure the DOE dose limit is'not exceeded and the objectives of the ALARA process are attained.  ;

The guidelines also have provisions, supplemental limits or exceptions to cover situations where the general guidelines or limits may not be appropriate. Use of these provisions are generally discouraged. They are to be used only for unique situations where in balance actions required to comply with the general guidelines would not be cost beneficial or environmentally sound or represent a greater risk to health cod safety then they mitigate.

The requirements for disposal or storage of wastes comply with DOE Order 5820.2 and are consistent with the requirements of Title 40 Part 192 of the U.S. Code of Ftderal Regulatioas for those large volurnes of materials that arecatecorizedasbyproductmaterialundersection11e(2)oftheAtomic Energy Act of 1954 as amended.

      • U.S. NRC Guidelir.N for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Used or Termination of Licenses for Byproduct, Source.

- or Special Nuclear Material, Division of IW1 Cycle and Material Safety.

Washington, D.C. , July 1982. .

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7 I, TheALARAProcessandRemedialActM Application of the ALARA process is required in DGC hvironmental Protection and Health and Safety orders and it is required in the DOE residual radioactive materiale p idelines. ALARA is a process that has as its objective, the attainment of duse levels that is as far below applicable limits as is practicable and reasonably achievable considering many factors including econoinics, safety, and environment. There is no set formula for. determining hov: and when ALARA is achieved and, therefore, ,

unlike the below regulatory concern or de minimus concepts which can define a lower limit to how low you should clean before remedial action begin'.

the ALARA process must be applied throughout the project from planning to i field work with each application resulting in some reduction in dose or potential dose. Application of the ALARA prneess to any radiation protection project is difficult and somewhat subjective. Success of the philosophy depends on good judgement of the health physicit.s and managers that a.re responsible for its app 1tcation. Its application to remedial actions is even more corriplex and many cases more qualitative than it is in operating situations. In operating f acilities, one can identify the waste I

streams, pathways, potential exposed individuals and likely time periods for the cperation of the facility. The dose reductions from specif 4

[ control actions, having specific costs, over the expected time period, can ,

ce estimated and compared. In the case of contaminahd facilities requir.ng renedial action, it is more difficult to define all of these elements, particularly if you must project effects many years into the future. *

/ Application of ALARA process through the planning activities occurs both in the generic development of guidelines and the site specific application of 4

8 the guidelines. Conservative models, and scenarios defined by the model

/

will result in reductions of real doses below the established dose limit.

For instance, calculating limits from potential doses on the basis of large areas (thousands of square meters) and then requiring the concentrations be averaged over areas no greater than 100 m and the addition of hot spot criteria to derived soil limit are two examples the application of the ALARA process during the development of the remedial action guidelines.

Other standards such as the VMTRA limits (40 CFR 192) and the NRC surface contamination limits consider technology such as the ability to measure or find the contaminat' ion in establishing limits. It is obviously unreasonable to require cleanup of materials below a level that provides adequate protection for the public, if measurement of the material below those levels is very difficult or impossible. On the other hand, it is reasonable to require control of materials below the dose limit if they can be reasured and controlled with relative ease.

Similarly, in. planning a specific remedial action, limits should be developed giving due consideration to ALARA. Depending on the specific pr:ja:t, the magnitude of dose reduction resulting from ALARA either in planning or the truplementation phases can vary. In some projects the it is clear in the planning activities that specific limits can be lowered well below those derived on the basis of the DOE dose limit with minimal impact on overall project costs. In such cases, soil guidelines, for instance, tay be lowered significantly during planning as part of the ALARA process.

In other instances, however, such reductions may not be warranted and hence, the greater reductions may result during the implementation of the remedial action.

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The impact or dose reducti)n resulting from the ALARA process during l planning activities is easier to document than those that result during l implementation. For example, the calculated soil limit derived from the ,

dose limit for the Colonie, NY, remedial action project was approximately ,

120 pCi/g of depleted uranium in soil. This in itself was conservative, in that, undct actual use conditions, the majority of properties that would .

have been designated under this standard, would not result in doses to the t l

individuals in excest of the dose limit. However, as a result of a review of potential costs of cleanup and discussions with New York State and EPA, remedial action criteria were set at 35 pCi/g average and 100 pCi/g maximum for depleted uranium. In this example, hypothetical potintial doses were I estimated to be near the dose limit for the initial proposed limit and 1/3 that value for the estabi hhed cleanup limit, however, more realistic analyses indicated they were A fraction of the dose limit even before ,

remedial action. In any case, it was estimated that the application of the ALARA process did provide a positive benefit and was worth the cost.

L While the Depwint has no BRC for remedial action, our decisions are ,.

influenced indirectly by levels that are being proposed by other agencies and national and international radiation protection organizations.

Typically, if af ter applying the ALARA process, potential doses are near the dose limit, more documentation would be required to demonstrate that that level attained the objectives of the ALARA process than would be required if doses are only a' small fraction of the DOE dose limit. When cleanup criteria set as part of the ALARA process will cause actual doses in the range of a few mrem / year (levels consistent with proposed BRC levels) little more than a qualitative analysis is necessary to demonstrate ALARA has been achieved.

O

O 10 However, in some caset, it is practicable, reasonable, and we believe, _

justifiable to go below these low levels. For instance, at the Shippingport facility, we determined that potential doses under our base case, upon completion of the project, would be approximately 3.5 mrem / year to the most exposed individual. The Department opted to reduce this potential dose still further to 2.1 mrem / year at a cost of about $30,000.

This is a potential maximum individual dose and the contarination did not  :

offer any potential for significant collective dose. Therefore, on a

  • dollars per dose basis ($350,000/manrem), this action could probably not be Justified as an ALARA action. However, additional fill was required for the project, and this fill was scheduled to be dumped in open areas such as trenches and open roon:s that remained below surface level. The Department felt it made good sense, considering that the incremental cost actually represented less than a few hundredths of one percent of the decomissioning effort, to scrape-up and dump the most contaminated surface residues into these open areas, even though concentrations in these soils werewellbeiowguidelines. Then the clean fill would be spread over the site, i

Sometimes, the ALARA process can not be applied effectively or is not worth l addressing during remedial action planning. In some situations, for  ;

)

instance,'wherelargeuncertaintiesexistwithrEgardto(1)thesite conditions or (2) the impacts of ALARA on costs of an action, it may not be possible to reduce soil criteria during planning, instead, the major impact  !

of the ALARA process will result during field application. Similarly, on

{ small sites where contamination is minimal or spotty in nature and eatlly detected, it is not worth the manpower and time requirements to complete i -- __- ..- - _

e

- 11

- ALARA evaluations. In such cases, ALARA is implemented almost entirely as a field activity.

Application of the ALARA process in the field can materialize in different ways. The field procedures may require that direct measurements used tc, ,

guide the remedial action provide a significant margin of safety to ensure that the derived site limits are never exceeded. This has the impact of reducing the average values to well below the limit established for the site. In other cases, the field manager may decide to remove some slightly l

elevated areas ana bring the site to or nearer to background leyels becaust it involves a relatively minor amount of additional effort. While such l

activities are normal occurrences during remedial action, they are difficult to document and if they are documented it is difficult to assess t

their overall impact. However, it is clear, the success or fatture of ALARA in the field is dependent on the experience and good judgement of the manager and health physicist worf.ing in the field. It is, therefore, very important for program management to consistently emphasize the importance of ALARA to field personnel.

With regard to the application of BRC to remedial actions, we believe that j the development of a BRC or de minimus limit could be useful to help identify an area where ALARA is not of significant importance. However, care must be taken that such numbers do not become defacto limits for i

! remedial action and that they do not restrict the use of ALARA at these

[ lower levels if good health physics suggests that further dose reductions i are beneficial and worthwhile. It is important to remember in considering ALARA and its relaticn to BRC that ALARA is not a limit but a process that requires thought and good judgement.

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USE AND ESTABLISHMENT OF. EXEMPTION RULES CONCERNING THE RECYCLE OF CONTAMINATED MATOMIALS AND 1

THE DISPOSAL OF LOW LEVEL RADIO *.CTIVE WASTE j AS IF IT WERE NON RADIOACTIVE IN THE i

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USE AND ESTABLISHMENT OF EXEMPTION RULES CONCERNING THE RECYCLE OF CONTAMINATED MATERIALS AND THE DISPOSAL OF LOW LEVEL RADI0 ACTIVE WASTE

^

AS IF IT WERE NON RADI0 ACTIVE IN THE FEDERAL REPUBLIC OF GERMANY Rudolf J. A. Neider, Federal Institute f.or Materials Research and Testing (BAM),

Berlin (West), FRG.

1. Recycle of contaminated materials 1.1 Past and present practice.

In the Federal Republic of Germany several nuclear power plants,

,, research reactors and other nuclear installations were shut down during the last 10 years. In the course of decommissioning large amounts of materials with very low level specific or surface ac-tivities arise. These may be handled either as conventional waste, reused and recycled conventionally or treated as radioactive waste.

In the past several different criteria were applied in order to declare these materials to be below regulatory concern and to treat them as if they were non radioactive. One of the first typical cases were the dismantling of the first european marine propulsion reactor of the ship NS Otto Hahn. This reactor was shut down in 1979 after 10 1/2 years in operation. Exemption levels applied for r61 ease of the materials for unrectricted recycling were fixed according to the national Radiation Protection Ordinance (RPO) which requires for the release of materials from controlled areas

- thet the surface activity to less than 0.37 Sq/cm' for usta- and gamraa-emitters and 0.037 Bq/cm 8 for alpha-emitters.

The same condition for release was and is applied for all other decommissioning proJeets. But additionally criteria for the coe-cific activity of the material to be recycled were established.

These are valid not only for activated materials but for surface contaminated materials too. The following criteria were applied by the Authorities of the federal states (BundeslEnder):

- para 4 (4) No. 2 e of the RPO which specifies 10-4 times the activity excompcion limit per gramm for the radionuclides concerned. (This means e.g. for Co 60 3.7 Bq/g) ,

- appendix III No. 3 (RPO) which specifies materials with a spe-cific activity of 74 Sq/g as below regulatory concern as far as they are applied in the professional field.

- para 4 (4) No. 2 e sets for consumer products and plant protec-tives a limit of 0.37 Sq/g below which no licence and.notifica- '

i tion is required.

For the decommissioned nuclear power plant Gundremmingen with the

KRB-A reactor the following criteria was established for the re- 3 latae.of materials: )

The specific activity of the material should satisfy the condition Am An

[ N+q i 0.9 x 10 4 m,n

! Am a specific activities of the radionuclides which were~ identified

[ '

by gamma-spectroscopy in aq/g f

l Fm a the relevant activity excenstion limita according to appendix s IV table,.IV column 4 (RPO)

An a detection limits for the specific activity of non gaseous radionuclides which could not be detected by gamma-spectros-

copy but which are to be supposed to be present in the mate-l rial Fn a the relevant activity excomption limits of non gaseous radio-

, nuclides which could not be detected by gamma-spectroscopy but which are to be supposed to be present in the material In addition the already mentioned surface activity release criteria j was applied.

l By the factor 0.9 those part of radionuclides were taken into i account which emit alpha , beta- or X-rays without detectable

] gamma rays and which are normally present in the material.

i i 1.2 Recentl'y published radiation protection principles

for the safe recycling and reuse of low level j radioactive steel and iron from nuclear power plants.

The Radiation Protection Commission advising the Federal Minister i for Environment, Nature Protection and Reactor Safety has estab-lished a recommendation, which was published in December 1987 as a j guide for the Authorities (1). In this paper it is said that, it

, must berealized that the release of large amounts of very low level

! radioactive materials for unrestricted recycling or reuse will cause the exposure of many people to ionizing radiation even if only with i very low doses. In order to minimize this exposure in the Federal Republic of Germany the first option of these radiation protection

! princ.iples for recycling and reuse of very low level active materi-

als, especially steel scrap, is to restrict the recycling and reuse to the nuclear field as far as possible. How th.is is already being practised has been described by Sappok (2). If recycling in the nu-j clear field is not possible or practicable the following three dis-j tinctione are made

! N i a) Unrestriced release: Completely unrestricted release is possib 1 if the specific overall activity is not higher than 0.1 Sq/g ano#

the surface' contamination does not exceed 0.37 Sq/cm' for beta-

  • gamma emitters and 0.037 Sq/cm' for alpha emitters. Each indi-vidual item has to comply with these limits. The surface con- ,

tamination may be averaged over 100 cm'. i L

b) Release for general melting: The release of scrap material for

' general melting in a normal steel furnace together with other inactive scrap is possible if the specific overall activity of  ;

each individual item is not higher than 1 Sq/g, and at the same i time, the surfaca activity conditions for unrestricted release are complied with. The producer of the scrap just has to prove <

that the scrap material he is going to release is really going l into a furnace. The owner of the furnace does not need any l t licence for handling this material. l c) Controlled recycling: If the specific overall activity of 1 Sq/g is exceeded, or if it is not possible to measure it because the t scrap items are of a too complicated geometrical shape or are too small, a controlled melting is possible - under a special licence according to the Radiation Protection Ordinance. The only condi-  ;

tion is that, if the product material is going to be released  ;

unrestrictedly, the specific activity must not exceed 0.1 Sq/g.

l In any case 'the resulting specific activity of the material must ,

not exceed 1 Sq/g. The competent authority can allow this mate- L rial to be used outside controlled areas if it can be guaranteed  !

that no enhanced exposure to individuals is to be expected.

F.or all three kinds of release a lincence by the competent Authority is required for each case.  !

F

{ For the derivation of these recommendations a new stochastic expo-  ;

sure scenario was developed which is based not only on one or sev-  :

j eral deterministic exposure scenarios but which takes into account '

that the process of recycling has basically a stochastic character

, (3). The pathways of these materials cannot be predicted determin-  ;

{ istically and the quantities which are relevant for the radiological l 1 essessnent fluctuate. Consequently a stochastic simulation of the complete process of scrap release, scrap processing, steel making, l 3

j product manuf acturing and the use of products including the exposure l

) scenario on each of these stages presents an adequate approach. Such [

j a probabilistic model has been developed, some of the important t input parameters of which are listed in Table I. l e

The result of each simulation is a distribution of individual doses. I

) Figure 1 shows the average dose distribution obtained by multipl,e [

{

repetition of the simulation. The distribution of the maximum doses  :

obtained after 200-fold repetition of the simulation process is

! shown in Fig. 2. One sees that the number of cases where 10 pSv/a [

is exceeded is rather limited and the maximum doses remain within i l one order of magnitude above 10 gSv/a. This is the criteria for the  !

Radiation Protection Commission to be fulfilled in order to protect  !

the public sufficiently against stochastic radiation damages.

l I l I l u ,_ ~ . .

The graduation of release limits into cases of unrestricted releas-without any further conditions (0.1 Bq/g) and cases of release for general melting (1 Bq/g) was established on the one-hand to set a lower level of specific activity for release without any further requirements and controls and, on the other hand, to have the pos-sibility to release materials with a specific activity of 1 Bq/g the further use uf which should be subject to some kind of control. The producer of such materials has to ensure that the material conc 6tned actually goes to a steel furnace and is melted together with inac-tive material. By this requirement it should be guaranteed that the material is reused only after some degree of dilution. This was taken into account by the stochastic exposure scenario.

- In most contaminated materials the activity limits for the surface contamination will be the only restricting criteria. In the case of the 0.1 Bq/g limit for the specific activity the surface contamina-tion criteria will be decisive for steel sheet thicknesses of more than 5 mm and for 1 Sq/g the surface contamination criteria will be decisive for thicknesses of more than 0.5 mm.

Studies for the derivation of excemption limits for other materials than iron and steel and for alpha-contaminated materials are in progress but not finished. For this reason corresponding recommen-dations have not yet been given.

2. Activity release limits for the uncontrolled disoosal of very low level radioactive waste Dy incineration and landfill Since 1979 the Authorities used the following criteria for the release of very low level radioactive waste as if it were non radioactive (4):

According to the RPO para. 47, every licensee is obliged to deliver radioactive wastes to a radioactive waste collection centre. Para.

2 (2) of the Atomic Act requires that only those radioactive wastes are to be considered as non radioactive for which, because of their low level radioactivity, no special precautions need to be adminis-tered in order to protect life and health as well as property a-gainst the effects of ionizing radiation. In order to apply these regulations it is necessary to establish activiy release limits below which very low level radioactive waste is to be considered as non-radioactive. This is den = by defining a de minimis dose which

might be received by members of the public but can be considered as negligible because the risk to health which it represents does not warrant the expenditure of the time and effort which wo01d be in-volved in the regulatory process and is comparable to other risks taken by the general population without any benefit. Similar to the cace of the recycling of low level radioactive material, the dose

, of the order of 10 pSv/a is accepted as de minimis on an interna-tional level, which means it can be considered negligible.

One criteria that this condition is met is given by para 4 (4)

- 5-sentence 1 No. 2 e of the RPO which requires for the specific ac-tivity that it must not exceed the level of 10-4 times the activity excemption limits per gramm for the radionuclides concerned. In addition the authority has to take into account the kind, mass and frequency by which the wastes arise before licensing the disposal as conventional waste.

In order to check whether this practice can be applied also in future a generic environmental study was performed to calculate which specific activity wastes may have in order to be disposed of as conventional nonradioactive waste leading to an annual dose of not more than 10 nSv/s for members of the general public (5). This was done separately for a great variety of radionuclides. The expo-

- sure pathways considered are shown in Fig. .. ' The two main pathways of the wastes to be considered were the disposal onto a landfill and delivery to a municipal incineration plant. It was assumed that in the Federal Republic of Germany about 5 000 t/s of very low level radioactive waste would be produced which might comply with the requirements for disposal as conventional waste. Three differ-ent types of landfills were considered namely with 10 000, 75 000 and 500 000 t/a waste disposal. For the municipal incineration plant the annual throughput was assumed to be 75 000 t/a. It turned out that for about 75 % of all radionuclides inhalation and exter-nal irradiation were the most critical exposure pathways. In the other cases, especially for the pure beta emitters, the critical pathway is by water seeping to the groundwate r and, finally, inges-tion in drinking water. The most restricting values were calculated for the landfill with the smallest annual waste disposal, because in this case the dilution factor is also small.

In Table II some typical radionuclides are listed together with the calculated specific activity leading to an exposure of 10 kSv/a, For comparison the values used until now in the Federal Republic of Germany are listed under the heading Para 4 (4) No. 2 e of the Raciation Protection Ordinance.

It can be concluded that the current practice in the Federa.'. Repub-lie of Germany for most of the radionuclides is conservative. Only in the case of iodine-129 and also technatium-99, which is not listed here, the new calculation resulted in lower values. This can be explained by the low absorption which Tc and I undergoe when they are washed into the water seeping through the landfill and afterwards seep into the groundwater. Consequently the present practice was essentially confirmed b, the Radiation Protection Commission. .

The release limits for the recycling of materials from the decom-missioning of nuclear installations of 0.1 and 1 Sq/g for all ra-dionuclides are in most cases also in good agreement or on the safe side with respect to the values in Table II.

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References (1) StrahlenschutzgrundsMtze zur schadlosen Wiedervarwertung und -ver-a wendung von schwachradioaktivem Stahl und Eisen aus Kernkraftwer-

) ken, Bundesanzeiger Nr. 5 (1988), 63.

(2) SAPPOCK, M., "Results of metallic waste treatment by melting",

j Proc. Int. Decommissioning Symp., Pittsburg (1987), Vol. 1, p.

' III-115-127.

I (3) GURTZ, R., "Entwicklung eines Modells zur statistischen Simulation 4 der Individua1dosisverteilung infolge des Rezyklierens von Eisenme-tallen", Seminar Verwertung von Reststoffen aus Reparatur- und Stillegungsma0nahmen bei kerntschnischen Anlagen, KFA J011ch (1987).

(4) RdSchr. d. BMI v. 20.9.1979, GMB1 1979, S. 631.

j (5) MULLER, M.K., KUCHEIDA, D., REGAUER, F., WIRTH, E., "Ableitung von

AktivitMtsgrenzwarten fur schwach radioaktiv kontaminierte Abful-4 le", Abschlu0bericht zum Vorhaben 988, Institut fur Strahlenhygier.e

! des Bundesgesundheitsamtes, Neuberberg (1988).

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Basic parameters for the stechastic si. l s mulation of scenarios for scrap recycling Amount of scrap released 1000 t Contamination release level 0.37 Bq/cm 8 Release level for

' specific total activity"

((surface + bulk activity) / mar.2) 1 Bq/g Radlonuclide present Co 60 Average fraction of activated scrap 0.1 Note: Only exterr.:.1 gamma exposure taken into uccount.

Tab.2 ACTIVITY RELEASE LIMITS FOR THE DISPOSAL OF VERY LOW LEVEL RADIOACTIVE WASTE AS CONVENTIONAL WASTE.

t Radionuclide specific activity para. 4(4)

Sq/g No. 2e Bq/g

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.7

Exemotion Levels in the German Radiaton Protection Law by Heins- Joachim Hardt The German Radiation Protection Ordinance contains in section 4 a system of exemption levels which is grouped there after prac-tical requirements but exists in principle of three stages:

- materials which are used in or on the human body

- materials in the environment of man

- general exemption levels.

The basic values of these 3 stages are, without distinction of different nuclides 0,37 sq/kg for food, cosmetics and medicine, 370 Sq/kg for consumer products and generally 74 resp. 370 kBq/kg for material containing artificial resp. natural nucli-des.

The exemption levels of specific activity differ from stage to stage by a factor of 1000.

For higher specific activities than the values mentioned above, there are additional exemption levels of activity, so called allowances. which are grouped into 4 classes according to the radiotoxicity of the different nuclides.

This regulation as well as the general exemption levels of the specific activity are contained in the Basic Safety Standards of the European Community and are equally applied in all member states.

Additional regulations contained in the German Radiation Pro-taction Ordinance have to be coordinated to the three stages of the system mentioned above.

w*

.9

2- ,

Further' regulations of section 4 have to be attached to the second stages

- ror fertilizers or plant protective agents the same value of i 370 Sq/kg applies as for consumer products with the differen-ce, that it is vaild only for artificial nuclides, not for i natural ones,

- the exemption level for radioactive wastes has been introdu- ,

ced 1976 and is of special interest as f ar as it is related to the toxicity of ditterent nuclides according to the system of allowances in appendix IV. The values differ from 370

] Bq/kg in the class of highest toxicity to 370 kBq/kg in the class of lowest toxicity.

1 The regulations of section 80 of finding and acquisition of actual control of radioactive substances apply among others to drinking water and water of sewage plants and have to be rela- (

]

j ted to the stages one and two respectively. For drinking water

, j applies a value of 20 times the annual limit of intake per l

cubic meter, for we.,er of sewage plants 2000 times. According

! to the annual limits of intake the exemption levels here differ  !

up to nine decades for different nuclides, e.g. for drinking l

! water from 0,4 sq/kg (Ra 226) to 120 kBq/kg (H3).

, Additional regulations for special cases are compiled in the i appendix III. These apply e.g. for radioactive luminous paints, t 1

l for uraniferous ceramic articles, smoke detectors and other technical devices and instruments containing radioactive substances. Appendix II contains those cases, in which no l

license is necessary, but notification to the competent l authorities.  ;

i I

The different requiations are listed in the table attached. The l sections of the radiation protection ordinance, which have been f

mentioned above are added as appendices. 3 ,

i l

f (' ..

Table: Exemption tevels in the German Radiation Protection Ordinance, Exemption level Remarks Application Regulation 0.37 Sq/kg Indepent from toxicity of Food Sec. 4 nuclide Medicine Cossetics Stage e.g.: 0.4 Sq/kg for Ra 226 20 times the annual limit 1 Drinking water Sec. 80 with of intake per cubic meter App. IV col. 6 160 8q/kg for Pu 239 -

1204 Sq/kg for H 3 l .

l 370 8q/kg Indepent from toxicity of nuclide Consumer products Sec. 4 370 Bq/kg In# pent from nuclide but only Fertilizers Sec. 4 for artificial nuclides Stage # times the a!!owance per gram e.g.: 370 Sq/kg for Ra 226 10 Waste:-s ' Sec. 4 with 2 App. IV co. 4 37048q/kg for H 3 e.g.: 40 Sq/kg for Ra 226 2000 times the annual limit of Waste water Sec. 80 with intake per cubic meter app. IV col. -6 16 0 g/kg for Pu 239 12 M Sq/kg for H 3 74 kBq/kg for artificial Ir-fwfM from toxity of nuclide General value Sec. 4 with app. III 370 kBq/kg for natural nuclides Stage 3.7 k3q for Ra 226 Allowance depending from toxicity for higher specific Sec. 4 with .e.g.: ,

class os nuclide activity than above app. !!! and IV 3,7 M g for H 3 I Depending from material, device, Different values of Special application Sec. 4 with declaration and design approval app. 11 and III activity and specific  ;

activity )

k

e

-1i. .

Appendix Section 4 - Handling not requiring a 11cese 61i Anyone ..andling radioactive substances in the manner specified in A;;endix II shall not requtre a itcense under Sees 6, 7 or 9 of The At:ste Energy Act or under sec. 3, para (1) of this Crdinance provided that he gives advance notice of the cemencement of suen handinng to the respenstble authority.

(2) Anyone handling radicactive substances of the kind specified in Appendix III. Nos. 2 to S. 7 to 9. 11 and 12 shall not require a license under Sec. 6. 7 or 9 of the Atomic Energy Act or under Sec. 3, para (1) of this Ordi.sance. Anyone who,' in pursuance of tPis occupation, handles radioactive substances of the ktnd specified in Appendia !!!, Nos. 1, 6,10 and 13, shall not require a license under Secs 4, 7 or 9 of t%e Atcaic Energy Act or under Sec. 3, para. (1) of this ordinar. s.

(3) Paras 1 und 2 shall also apply to those who store, treat, procssa or otherwise use nuclear fuels by reason of a license granted under Sees 6, 7 or 9 of the Atorsic Energy Act, or handle other radioactive l substances by rearan of a license granted under Sec. 3, para. 11) of this Ordinance. ,

(4) Exewption from the licensing, requirement as specified in paras (1) and (3) shall not apply to anyone who 1 treats, with ionising radiation, pharmaceuticals as defined by the Pharzaceuticals Act, foodstuifa as defLned by the Foodstuifs and consusmer Goods Act, or f eedstuff s or feedstuf f additives as defined by the reedstuffs Act, if the specified activity of the products so treated escoeds 0.00037 reciprocal seconds (0.01 picocurie) per gram, -

3. employe radioactive ouhetsacos (a) and uses them on the humaA body if the specifie activity of the materiale exceeds 0.00037 reetprocal seconds (0.01 picoeurtel per gram, except for water as specified La Appendia !!!. No. 11.

(b) and adds them to phazzaceuticals as detined by the Pharmaceuticals Act, to foodstuffs or cossastics as defined by the Foodstuffs and Cor.sumer Foods Act, or to f eedstuf f s or feedstuf f additives as defimet by the Feedstuffs Act, if the specific activity of the products asceeds 0.00037 reciprocal seccada (0.01 picocuriel per gram. _. , _ _ , _

1) "substances which, withou' ame fust emit toniting

.ve materlatta radiatton scontaneousiv i

- - - - - - __.O. _ _ . ____

. l A2 (c) ond uses or adds them in the production of censumer goods as defined by the roodstuff s and Consumer Goods Act, or of products intended for household, non-occupational purposes, if the specific activity of these products exceeds 0.37 reciprocal seconds (10 picoeuriel per gram, (d) and uses them in the manufacture or use of plant protective agents as defined by the Plant Protection Act, other pesticides or fertilisers as defined by the Tertilisers Act.

of other soil-treating agents, in such a manner that the agent produced or prepared contains radioactive substances other than those of natural origin of a specific activity of more than 0.37 reciprocal seconds (10 picocuriel per gram.

(e) and disposes of them in the form of waste substances whose specific activity exceeds 10*4 times the allowances per gram as specified in Appendix IV, Table tv 1, Column 4 so .long as it is not waste produced by the use of radioactive substances for household, non-occupational pur po s e s.

1 The first sentence, subpara. (2) shall not apply to .foodstuf f s and drinking water that conform to the legal requirements for foodstuffs. The first sentence, subpara. (2) shall not apply either to s adioactive substances whose allowances are not restricted in Appe.ndix IV, Table IV 1. Column 4.

(S) The responsible authority may prohibit the handling of radioactive substances which requires a declaration under para.

(1) if

. 1. the person responsible for such declaration or the radiological protection officer appointed by him for directing or controlling such handling does not have adequate knowledge in radiological prot ect ion.

l 2. the required nunker of radiological protection officers for safe handling are not or no longer available, or

3. the person responsible for such declaration or the radiological protection of ficer appointed by him for the direction ir control l

of such handling is not reliable.

f V, .

I I

l

A3- .

section 80 - Finding of radioactive substances and acquisition of actual control (1) Anyone who

1. finds and takes possession of radioactive substances,
2. unintentionally acquires actual control of radioactive substances,
3. acquires actual control of radioactive substances without knowing that these substances are radioactive,
4. acquires actual control of water or waste water containing t radioactive substances in his capacity as proprietor of an l installation for the supply of drinking water or industrial water,
  • shall declare them to the nuclear supervisory authority or the au-thority responsible for pubite safety and order immediately he learns of the activity of these substances or the content of radioactive substances in the water or waste water. This shall not apply in cases where the handling of r6dioactive substances requires no license or declaration or where the activity of radioactive substances in the water of plante for the supply of drinking water or industrial water does not ancoed, in one cubic meter, 20 tLaes the values specified in AppendLa IV, Tables IV 1, or IV 3, Column 4 or, in the water of swwage plante, 2000 times the said values. ,

(21 A license as stipulated La secs 4, 4 or 9 of the Atomic Energy Act or as stipulated in see. 3, para. (1) or see. 8, para. (1) of this ordinance shall not be required by anyone who in the cases of para. (1), first sentence, eabparas 1 to 3, af ter Lamediately submitting the declaration, stores the radioactive substances or transports them for the purpose of securing them, pending the decioton of the responeihie authority.

4 t

l

~

7,,,, ,

'. -A4-EElindix !!

(to Sec. 4 p a r a'. (til 4

Mar.ditro requirine a declaration

1. Handling of radioactive substances whose activity does not exceed ten, tires the allevances specified in Appendix IV.

Table IV 1. Column 4.

2. Use and storage of devices into which sealed radioactive substances have been introduced whose design is approved*

in accordance with Appendix XI!!. Nos.1 or 4.

3. Use and storage of test emitters for checking the readings of radiation monitoring instruments or destmeters, whose design is approved in accordance with Appendix XI!!. No. 2. , ,
4. Use and storage of devices which contain unsealed radioactive ,

substances for exclusive use in schools for teaching purposes.

if the design is approved in accordance with Appendix XI!!.

No. 3 .

S Use and storage of devices which contain sealed radioactive substances, for exclusive use in schools for teaching purposes, if the design of the device is approved in accordance with Appendix XI!!, No. 4.

6. Use and storage of up to two neutron sources for exclusive use in schools for teaching purposes if the design is approved in accordance with Appendix XI!!. No. S.

o 4

+'

G D

0 "

9

-A$

7. Use and stcrag' . 4e watches, whose dials and pointers contaan firml) v car.sactive luminous paints, if the use of radt: active . , .: ces for the tusincus patnts is restricted to trts.am, pre ethium- 147 or radium-226 or, in the case of special watenes in the form of pocket watches, to tritium or premetatum- 147 and the total activity of the radioactive sutstances in respect of each special watch does not exceed the fo11cwing values:

'Trittum 9.25 x 10 8 recipro al seconds (25 millicurie)

Promethium-147 i,g$ x jo? reciprtcal seconds (0.5 millieuriel Radian-226 5.55 x to' reciprocal seconds (1.5 microcuriel and if the special watches are enclosed by a casing whose tranopsrent coter has a surface density of at least 50 mg/cat at each Points the casing and the transparent cover shall be sufficiently strong to withstand conditions occurring in normal use and in minor accidents: the special watches shall be marked as follows:

Radioactive substance Markins Mastmus activity limit 9.25 x 108 s

  • I Tritius *T 25' (25 aci) 7 *I Promethium-147 'Pn o.5* 1.85 x 10 s (0.5 mcal Radium-226 *Ra 1.5* 5.55 x lo' s*I (1.5juC1) d l '

e e

p.

- A6-Appendin III (to sec. 4. para, (J))

Hardline not reeutrint a license or declaration

1. Storage of nuclear fuels cutside rederal custedy, the treatment, processing or other use of nuclear fuels inside or outside installations as specified in Sec. 7 of the Atomic Energy Act, as well as the handling of other radioactive substances which ar,e not classified as substances under !!os, 2 to to and 12, if the activity of the radioactive substtnces does not exceed the allewances indicated in Appendix IV. Table tv 1, Column 4.
2. Handling of radioactive substancos whose specific activity is less than 74 reciprocal seconds (0.002 miere:urie) per gram.
3. Handling of solid subutances whose specific activity of natural radioactive substances is less than 370 reciprocal seconds (0.01 microcurie) per gram
4. Use, storage and disposal of pharmaceuticals which have been marketed under Sec. 2 of the ordinance Relating to the Registration of Pharmaceuticals which have been treated with lonising radiation or which contain radioactive substances, . in the version published on August 8,1967 (rederal Statutes I, p. 893), last amended by the ordinance dated May to. 1971 traderal Atatutes !. p. 449).

9

$. Use, storage and disposal of appliances which contain gauges or indicators containing firmly bonded radioactive luminous y paint if such luminous paints 5.1 are f ree of tedicactive substances whose radiotoxicity ,

allowance in Appendix IV Table IV 1. Column 4 is lower than 3.7 x 105 reciprocal seconds (10 microcuriel, S.2 are usually protected f ree being touched, and the local dose rate of the unprotected radiation at a distance of 0.1 a f rca the tusinous paint does not exceed I microjoule per kilogram and hour (0.1 milliren'per houri, and O

e

i l

_ A7 .

$.3 have been activated with tritium and the individual appliance does not contain more than fifty stres the allowance specified in Appendix IV. Table IV 1, Column 4.

4. Repair of appliances described in No. $ so long as the gauges er indicators are not coated with radioactive luminous paints or these luminous paints are not peeled of f.
7. Use, storage and disposal of uraniterous glazed ceramic articles or porcelain were or of uraniferous glassware, if the glazing of the ceramic articles or porcelain were contains no more than'to 4 by mass, or the glass contains no more than to t by mass of natural uranium or of uranium-225 - and uranium-234 - depleted uranium or if the coat of underglane paint does not contain more than 2 mil 11 grams of uranium per square contaseter or the overglaze paint does not contain more than 0.1 milligrams of bran.um per square centtneter.
8. Use, storage and disposal of optical or electronic components l or of electrical or gas appitances intended for lighting. f excepting toys or ionisation fire detectors if 8.1 the individual ccaponent or appliance contaLas no radioactive substance whose radictoxicity allowance in Appendix IV, Table IV 1. Column 4 is lower than 3.7 x 100 reciprocal seconds (1 microcuriel and whos,e activity exceede the allowances specified in Appendix IV, Table TV 1. Column 4 and 8.3 the local dose rate at a distance of 0.1 a from the touchable surf ace of the component or appliance does not exceed 1 microjoule per kilogram and hour (01 mL11& rom per hourl s if an appliance contains a number of electronic coeponents, then the local dose rate at a distance of 0 1 a from the touchable surf ace of the appliance may not exceed 1 micro-joule per kilogram and hour (0.1 milli, rem per hotr) .
9. Use in aircraf t of counterweights with depleted uranium which are permanently coated with an inactive metal and marked.

D e

-A8-to. Handling of natural thorium up to 100 grams for chemical analyses or preparations.

11. Handling of water from natural sources and whose specific activity of natural origin is not increased.
12. Use and storage of not more than two devices into which sealed radioactive substances have been introduced and whose design has teen approved according to Appendix XIII, No. 6.
13. Use of ionisation smoke detectors whose design has been approved according to Appendim XI!!,, No. 6 if
1. the ionisation smoke detectors are installed in a batiding of the purchaser by the ho1 der of a 11:ense as stipulated in Sec. 3, para, (1),
2. the total activity of the ioniJation fire detectors installed in a building does not exceed, in the case of 4

radium-226, two hundred tLaes the allywances specified in Appendix IV, Table IV 1. Colaan 4, and in a11 other cases one thousand times said allowanese,

3. a repair and maintenance contract has been concluded between' the manuf acturer or dLetributor and the purenaser

,under which the purchaser agrees that repairs and maintenance work shall not be carrie4 out by himself, and

4. the manuf acturst or ' distributor notifies the authcrity having responsibility for the manuf acturer or distributor and the authority having responsibility for the purchaser, of the kind, activity, radienuclide, number and type of installation, the date of deliv'ery and address of the purchaser.

9 e

S

%9

___.___._..___L_______

A9 .

Aspendix IV s Allowances, derived itsetts U of annual activat, incorperstion )

byinhalationandingestionanddettvedlimits{I of activity concentration in air II Table tv to Allowances and derived 11.intts of annual activisy incorporation by inhalation and inges';1on of intdividual radionuclides Atosto Radio. L&mit of annual activity i.uabe r tienent nuclide Allowance incorporation via

- I air l water and food (inhalation) l (ingestion)

(1/s) (C1) (1/s) (CL) e i . . . e i Hydrogen H 39 3,f tr t s. iea ip ir 92 10-4 so tr , to it-*

f.0 sed 67 108 8.4 19-4 it ig8 3 4 gg-e 4 lery1119e so.1 3,7 108 a Carten C in 19 tr A . t o-* see Table IV 4 8 l# 4 8 ' 'P' C 14 8) 17 108 1.0 it-* t.8 tr 1.39-8

? Mitro9en N t3 3.1.tr t.6 19-*

0 0879tfl 0 18 LF 188 f.4 It-* ,' see fat 19 IV 4 t 3,9 408 L.0 IP8 1.4 IF 14 19-4 14. tyd

- p Fluorine F.tg d.t tr 3C 11tds He 13 1,7 198 lA Ltd 4,7 198 (J IPd ' s.3 tr 3.4. tes it No 34 11 t e* t.o it-* t# ir 3.3 Itd (s ir tJ ie-d 14 $111 con s.-31 17 108 1.e 19-* Ar tr IJ te-4 u tr so ies 3

Phospncrus P 33 11 108 14 10-8 4,4 tr l l IP* U tr 'se 10-8 I 5wipnur 3,7 ir t.s ted t,4 tes la ttd t.1 ir te tre  ;

is s is IT Chlorine Cl 34 11 le t0 t9-4 J LP 14 t4-8 t.4 IF 14 te-4 if 108 t A it 9-8 L.: 108 1,1 iP4 f,1 les t.9 10-4 C3-30 At@ 3,9. ige t.g.Ig-e g le Ar$0n .

ar 41 11 108 t.s ted I see Table IV 4 t.4 itd 14 le lA Itd 16. l.P 9 6 ird eg Potassiw K 43 11 108 K 43 3.1 108 A 10-8 it t08 1,7 + ltd te to' t.1 Itdi -

I K est met limited not ltetted not lietted C41cle Co os 3,7 tr i.e te* iA tr 4.s tr* IA tea (4 ie' 3e Ce of 17 tr t.8 Itd 94 tr LS Itd f.A tr I A 19-* ,

Il reeteegunadLas to t/w el see nomy aee, vet.ee sess6f ted 6e asesed6e s. tenwee 4.

fee the ee6steen ergoe al 46 ente et toneek 4446v6ty teserwese6aa ete 6e teessee of vesse end eth 486t6us eteesen$i enten esse esopos686se66, 6ese gne 6esermed6ery esteest:en saw aisee estemente gene seet est oseees saat of eise

, Il 46a6te et sam.44 est6 6ty 6meerforat6em ese 6e seewet of esteen 46ee66e one meseeo6se s .eeee ett assoso e w e ,e6en rese ease pese met .mepos6fice6 essees thate of sete.4, sete one 4eserumssery metees&6em en 46e466e  ;

si 46e6:e of one.at sein,6i, 6.*ee,w 56ee 6i esse = et esitetes mete estisw .

es.ame e  ;

nalf =66te greetos Lt a t eeve i f

i

F l-LO

- 1 10 -

Table n* 1: continued: Allowances and derived limits U of annual activity incorporation by inhalation and ingestion of individual radionuclides Atomic' L "A" f *^^"*A **"VY Madio- incorporation via N@r Mement nuclide Allowance Z air water and food (inhtlation) (ingestion)

(1/s (CO (1/ss (C1) a e

17 t0* I,0 10-* 1.3 108 16 lip

  • e,7 10* l.s 10-8 21 5eandium sc-es
  • 3,7 108 ,1.0 104 17108 7.2 10-* 1,6 108 4.3 10-*

- Sc.47 Sc 40 3.7*IW lA 10-8 7J ' 108 2.1 10-* 4.9 108 1.3 10-*

Yanadium v 4e 17 lW l.0 10-8 11 108 s.4 ID-8 s.l le 1.4 10d 23 28 Chromium Ct SI 17 108 1.0 10-* l.1 108 3.4 10-8 2.7 17 7.2 10-8 Ma-31 17 10' l.0 10-s p.3 108 2.1 10-* 5.3 108 1.4 10-*

23 Nnganese Hade 3.7 a08 l.0 10-* 1.9 108 S.2 t9-8 2.1 108 S.4 it-*

Me H 3.7 ' 1 08 1.0 10-8 2.3 108 7,8 10-* 1.8 108 4.4 It-*

i 24 Po 33 17 108 1.0 10-8 2.1 108 17 10-4 4.0 108 1.1 10-88)

. Tron 1,4 les is Ie-o re 58 17 108 1.0 IP8 4.7 108 1.3 19-8 Pe se l ' 10' l.0 le 18 108 7A 19-8 9J a les 1S'It-e 27 Cc34 W IF lA le 2.1 IW 17 lH 4A W l.1 M Gobalt Co S7 17 108 1.0 ' It-8 8.f t8' 2.4 It-8 8.7 a 108 l.a t0-8 I Co Sea 17 10' l.0 10-4 4.9 108 1.3 19-8 14 198 SA 10-4

(*e 38 3.7 108 1A led 11 108 8.4 It-8 lA 108 4J t 9-*

3.7 108 l.0 10-* 4.9 108 8.3 It 6,1 198 1.7 19-e Code N 38 M'# IS

  • I' II' # I'I
  • I'"
  • IU 'A * 'D' 20 Nicke1 3.7 10 - 1.0*10-8 8 3.6 ' 1 08 9A IF 4.9'les g,3. gw S 43 N145 3.7 108 1.0 led 2J 1W 7,8'10-* I A 108 4A 10-8 C444 3.7 108 l.0 10-8 18*108 l6 10-8 it IW l.0 10-8 29 Copper 1 1,4s u .108 14 le8 u le ,A le is.W u ,l e 30 ,1,,

Za 40s 17'lW l.0'l0-' 14 108 4.4 10-8 1.l lW 2,9 10-*

17*108 1.0 10-4 4.0 108- 1.1 10-* 11 108 8.4 10-8 Za-se Go 72 3.7 108 1.0 10-8 1.0 108 18*10-8 47 10' lA 10-*

31 G4111um Go 71 17 108 1.0 1P* *3,6 I F s.s 10-4 1 3 ' i48 7.s 10-4 33 G nium A4 73 ' 17 108 1 A It*8 il

  • 108 17 10-* ~ IJ ISS 12 it-8 33 AraeniC 1.9 10-8 9J W 15 IM A474 17 108 l.0'19-8 &f le 17'108 1.0 10-4 55 IP lJ It-8 3J
  • It* SA ' le' As 76 As 77 17 108 1.0 It-4 12 108 8.8al0-* l.4
  • 108 18 It-8 34 Se7$ M lW IA M h# lA M 4J h 1.3- @

g,g,ggu,

17. It' I,0 10-8 I A 108 2A . le-o s,y Ig* l.3 ig-4 33 St43 Breeine Il Cerroepending 44 3/Sco of the ts y deee valves spectited tag Appeedia se Colume 2.

for the eettleen ottaa al Liette of annuet settetty ineetpotettre to respeet of salisted bete emittore heetag e natteltf e greetoe tAae I home e

9 m _ _ _ _ _ _ _ . _ _ _ _ _ _ __ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _

7

- A 11 -

U of Table IV 1s continued. Allowances and derived limitsannual activity incorporation by inhalatio and ingestion of individu 1 radionuclides Limit of the annual activity Atomic Radio- Allowance incorporation via Number Element nuclide air water and food 2 (inhalation) (ingestion)

(C1)

. (1/s) (C1,) ( 1/ i. s 8 l

  • Kr45* 3.7 108 1.0 10-8 J 34 Krypton 11 10 1.0 10-* .see Table IV 4 Kr43 1 Kr 81 3.7 los 1.0 10-8 i 1,0 10-* 4.3 108 1.1 10-*

a > 64 3.7 108 1.0 10 -8 3.4. les 37 Rubtdium not limited ' not limited not limited Rwa 7 13 10** 8.1 10' 11 10-*

17 108 1,0

  • 10-* 1.8 108 34

$trontium - St43*

1.4 10** 1.7 l08 4.4 l0-8

$r.45 3.7 108 1.0 le8 3.8 108 1.0 10-8 IJ 108 4.1*10-8 108 la 10-8 St 40 17 108 3,g.10-4 1,0 10-8 6,e lu8 1.7 10-4 los St.90 3,7 108 3.7 108 1,0 iP8 1.4*108 18 10-* e7 108 13 10-4 St 91 1.0 108 la IP*

l.0 10-4  :,e.108 L4 ' 10-8

$r.93 3.7 108 I S8 I? ",4 10-* 3.4 10' 9.6 10-8 Y# 17 108 1.0 10-8 29 Yttrium 3.4+10-4 4,0 108 1.6 10-*

Y 9t* 17*108 1.0 ' l e-* 94 <

.," 408 4.8 10-8 4,7 108 t.3 lo-*

Y 98 17 108 1.0*10-8 1,0*10-* l.6 108 4,4*10-4 1.0 108 3.4 lo-*

Y 93 17 los (9

  • 10* l.3 lo-* j 1.0 10-a yg.108 *t.1
  • Ied Y 93 \7 108 1.9 + l0d 1.4 108 3.4 10-s It 83 17 108 1.0*10-8 7.1
  • 1 08 40 lirConium 1,7 10* 1,0 10-* 1J
  • 108 (8 10-8 1.1 108 10 10-8 Is43 8.4*10-* 11 108 8,4+10-8 3,7
  • 1 08 1.0'10-8 3.1 108 Zs 97 7,* 108 1.9 10-s Nt saa 17 108 1.0*10-8 of 108 l.s 10-8 N1obium 1.3 10-8 1.7 108 4.6 10-*

41 17*108 1.0 10-8 S.5 Ius Nb.t$ 7.2 *10 8 1.8 ' 1 08 4.4 10-s 17*108 1A 10-8 17 108

!Tb F7 1.1

  • le 14 10-* 6f le 1.9 it-*

Molytdenum Ho M M IP l0 10-8 43 1.8 tv (4 10-* 1.s.108 44 iO-*

Tc Ma 17 108 1.0 10-4 43 . Technetium l.0 10-8 IJ

  • 108 14*1 - 7.4 Its 3 h 10-*

Tc M 17 *108 8,4 10-*

l .

4,4 10* 3.3 10-4 11 108 Te pf* 17 108 1.0 IP*

i 1,0

  • IP8 1,8 108 L4 10-* l.4 108 3J 20 -*

Te47 1 / 108 it

  • 108 1,3 LO-*

17 1# l.a

  • IP* 7 A
  • 108 11
  • led 7,8 10-*

Te 90* 8.4*10-8 3.9 + 108 17 108 i A ' 10-8 3J a 10' Tc M l

44 1e8 14 10-8 42 108 l.7 10-e f.4

  • leo 44 Ruthenium Re 37 17*198 4 7 ' l96 IJ+lP* l.4 10 8 it ' led f Re.lN 17 108 1A O' i 3,9 ' l98 7,8+l0=* l.8 *198 4.4 10**

Realt$ 17'198 th 18-8 8,4

  • lP* 11 108 18 19-8 1 7
  • l 98 .. 9-* 1 3 l ' 1 98 Re lM s*le-* 3J a lF 9.9 lP* %1 lW 18 18"*

Rh l02* 17*108 u ie u ir 43 Rhodium u.a u.ir R..iu u . i, u. ie f 8**e val ee speetfled ta appenets n, Coloma le ti cettedenotag to 3/Sco of tDe bea?

for the efttlest estee

. 3

]

l

- A 12 - l Table IV 1: continued: Allowances and derived limits U of annual activity incorporation by inhalation and ingestion of individual radionuclides Atomic Radio

  • Limit of annual activtty Number Element nuclide Allowance incorporation via 2 air water and food (inhalation) (ingestion)

(1/s) (C1) (1/s) (C1) e"  : i e . .

44 Palladium N iO3 U 108 1.0 10-* 4.2 108 1,8 10-8 4.s . 108 1.3 t0-8 N 100 17 108 l.0 Ipo i,t 108 S.2 10-* 1,2. t08 14 10-*

47 Silver As tes 17 108 1.0 ted 4.4

  • Le 1.2'10-* l 7 ' 108 4.6 iG-*

Ag il0* 3,7 108 1,0*t0-* S.S LF I,4 ' 10-* SJ IP l.4 10-*

Ag lit 3.7*10s 1.0 10-* iJ

  • 108 3.3 10-* 7A le 2.0 10-4 de Cadshe C4100 3.7 ' 1 08 1.0 10-8 1A 108 7 8'10-8 11 108 8.4*10-4 Cd ti3" 17 108 1.0 ' le-* IJ 10' 5.3'10-' 4.4 108 l.2 t 0-*

Cd lI$ 17'108 1.0 t0-8 1.0

  • 1 08 2.8*10-8 Le le 1.6 10-*

In ll3* 3,7

  • 108 1.0 10-* 3J 108 1.0. IP4 2.2 LO8 6.0 LO-s 49 Indium laIl4* 3,7 + le 1.0*l0-8 1.2 ' t98 12 19-8 3,1 108 8.4 80-8 4 tlS* 17 + l08 1.0*tt-8 1.0 ' 198 18 19-8 E.7 + l98 IJ tes ta lls not limited not 11mited not limited Tin Sa'll3 3.?'108 1.0 le* 2.8 ' l98 7A 10-8 1.4 108 3.8'10-4 30 1 7 '98 1.0 tP8 U
  • 108 1.3
  • lt-* 3,8 108 8,4'60-8 Sa 125 Antie0ny 56 122 17 108 1.0 le-4 8# le 2.2 tP* 11 108 l.4 ' te*

St S1pl24 3,7

  • 198 1.0*le-4 1,l a t08 19. le8 4.8 10e g,g.ig-e

$b 123 3.7 ' l0* 1.0'10-8 1.5 tr 4.0'10-8 IA LS8 4,7 IP*

17 t08 7.1 tr 1.s ' 10-* 2,1 ' 108 18 ' te-*

$3 Tellurius Tel23* 1.0 10-4 6.0+10-8 9J a l38 2J'l0-*

Te127" 17'108 li'10-* 12 108 To 127 17'108 1.0 10-* 4 s*108 1.3 tP8 11 108 8.4 10d 42.gg-s 16 10e gg.10-8 Te 1298 17 ' t08 1A 10-8 I A 10e Te 129 3.7 ' t08 1,0 10-* 2.2 tr 6.0'19-8 1.5 108 4.0 10-8 Te l31* 3.7 108 1.0*10-4 1,0 ' 1 08 18 10-* 6,7 108 '.8 10-*

17 108 1.0 ' 10-* SJ ' 106 1.4

  • 10d 3.8
  • 10e 1.0 10-8 To132 J 124 17'108 1.0 10-* 11 108 17 + 10-4 4.0 l@ 1.1 Ie)

53 {pding 2,1 108 17 10-8 4.0 108 1.1 t0-8 ')

Jal25 17*108 1.0 10-*

1 7 ' l04 1.0 10-* 10 108 SJ'IPd IJ e t08 4.1 10-*

J'138 3,3.ig-* 4,4 + 108 1.2 10-* 13 Iga 10'10-*

J 139 17 ' les J 130 17*108 l.0 ttd 2,1 108 17 + tP* 4Aalt8 1.l 'IP 88)

J 131 17*108 1.8*lt-* 14 + 198 SJalt-* 1J.108 4J ' le-*

J lat 3,7 108 l.0+19-8 M ' It8 IJ ' 1P' 18 108 1.4 1P8 J 133 17 + 198 1.0*l0-4 8.0

  • 1 98 14'lP* 4.7 108 IA'10-8 17 108 1.0 104 IJ ' 198 4.0 + 1P4 1,1 108 19*10-8 J 134 J 135 3,7 108 I A les 2.8'l98 7.8 19-8 11 108 SJ le-'

$4 Xenon Nel3t* 17 108 I xe 133 17'ir 1.e '. It-*i see Table IV 4 1.0 ie-*

xe138 17 108 1.0 ' 10 **

11 twat to 3/ loo . 2/1000 fee todine toetsgies = of the eody esse values spectised La Appeedia a. Celes I ta respoet of tae erstatet eggee il k6atte of osunset eettvity sneeepoesttee La teopoet et maltsted eeu t.aatters havtag a helfeltfe greater gaan 1 hgas mi o

e

- - - - . . - . . . _ , . . - - . - . - , . . , - . . . , . , -r--

s

, - A 13 - .

II Table IV 1: continuad Allowances andincorporation derived linitsby inhalation of annus1 activity and ingestion of individual radionuclides '

Atomic Radio- fan 1T of annuai activity Number Element nuclide Allowance incorporation via 2 air water r.nd food (inhalation) (ingestion)

(1/s) (C1) (1/s) (C1)

, e . . s f .

SS Cesium Cs131 3.7 tF l.0.t0-s 1.8 108 4.8 10-8 1.6 108 4.4 10-8 Cs 134" 3.7 108 1.0 10-* 3J l? 8.0 10-8 2.0 l? 5.3 le8 Cs134 3.7

  • 1 08 1.0 10-4 7.1 108 1.9 le* I,5 10e 4, g .10-*

Cst 33 3.7

  • 1 08 '.0 10-s 3,g . g oe g,4. gpa 2.0
  • 1 08 S.3 10-*

Cst 38 17 108 1.0 10-8 9J 108 13 IP* 1.7. 108 11 10-4 Cst 37 3.7 108 1.0 10-8 d,3 108 2.2 1P* 2.7 108 7.2 to-*

$4 Bariu:s Be 131 17 los i,0 te8 t.3 108 5.2 tP* 11 108 8.4 le*

34 140 1.7 10* l.0 10-* 1 & 10' 6.4 10-* 4.4 108 1.2 10-*

1.0 10-s 6f a tte g,g . g g-e 4.2 108 1.1 10-4

$7 L3nthanum La 140 17 10s Co l4t 17 10s 1.0 10-8 8.7 10*' 2.3 1P* 1.6 108 4.1 10-8 54 CerLum Co143 3.7 108 1.0 104 1.2 108 3.1 lP* 7.f 108 l.9*10-e

' Co 144 3.7

  • 1 08 1.0 10-8 3.6 108 9.6 IP* 2.1 108 at le-'

3.7 1F l.0 10-8 0,7 104 2.3 IP* 3.3 10* 1,4 to-*

59 Prassodymium Pr t42 Pr.t 43 3.7

  • 1 08 1.0 10-8 Sp t08 to t0-e g,p . ige 2.3*10-4 80 Neodymium Nd 144 not limited not Italted not listted N4 147 3.7 108 1.0 10-s g,3 108 3.4 10-8 t.1 + 108 2.9 led Nd 149 17 108 1.0 19-8 A0 108 2.2 10-8 4.9 108 1.3 10-s 37 108 10 10-8 la los 9.s.10-8 4.0 108 1.t 10-s

$1 Promethium Pm 147 1,2 108 14 10-8 7.a.30s . 2 1 10-*

Pre let 3.7 108 t0 10-8 Sm 147 not limited not Itatted not limited 62- Samarium 9.6 10-8 f.4 10-8 Sa llt 3.7 10* 1.0 IP4 34 108 4.7 108 Sm l$3 17 108 1.0 t0-8 2.2 t08 0.0*10-4 1.4 108 3.7 t0-4 Europium Eu is2* 17 108 1.0 10-8 . l.s 108 4.s.10-* t.1 108 10 10-*

03 Ca t32 17 108 1.0 10-8 6.9

  • 1 08 1.3*10-* 1.4 108 17*10-8 3,7. ig-* 4.0 IDe 3,g . ges Ew I$4 '3.7 10* 1.0 10-8 2.1
  • Ies 3.7 10* 1.0 10-4 4.0 108 1.1 10-8 3A
  • 108 9.6 10-*

Ee 1S3 3,g gp i,4.gg-4 3 g . os g.e. se4 64 Gadolinium cd 153 3.7 108 1.0 10-s 3.7 t08 1.0 10-8 13 t08 6.0 t0-* 1.4 108 3.7 10-*

C4 t$$

Wto 17 1P t0 10-8 1.4 le 4.8 IP 8 7.0 le, 2.1 le 63 Terbium 1.0 10-8 1.1 108 it 10-8 7.1 108 1.9 10-8 r Dr.163 3.b 108 64 Dyaprosius 17 le 1.0 10-8 1.1 le 2.s 10

  • 6.7 le 1.s le* ,

Dl.tu

- 1.0 10-4 MW 2.3 W U.W 1,3 W 67 Holmium

1) Corresponetne to 3/$o0 of the udy 4eee vetwee spectited La Appeneta I. Cetumn I, tot the ernstest organ n

I l

- A%-  ;

1 II of i Table IV It'continuedl Allowances annual activity andincorporation derived limitsby inhalation and ingestion of individual radioneclides Radio- Limit of annuai activity Atomic Number Element nuclide Allowance incorporation via I

air water and food (inhalation) (ingettion)

(1/s) (ct) (1/s) (cil-i e e i i 40 grgjus Es.189 3.?*108 1.0*10-8 2.1

  • 108 $.7 lee . g,g .108 4 4*10-8 Et.171 3.7 108 1.0*10-4 3J
  • 108 9.0*10-8 2.0 108 $.3 It-*

1.0 lP8 1Aetr S.2. lpe gg . gp 2.2 10-*

84 Thyljya hlM 17 tr h t?! 17 108 1.0 10-8 61 it' t,7 . It'* 3p 108 13 10-8 Wl?$ U 108 IA*10-4 3J 108 9.0a10-8 2.0 108 SJ 10-*

M ygg,rgjye a in u . i.8 i . i- u . i, u.ie. i . iO8 u . it

,i to,,,,,e, Hl itt U Ir IA*lt-* 2Nr U le-* 1,1 108 14 10-4 n Hafnium Tantalue Tele 2 u le 1.0 1e-* l.2. le8 u . l t-* 7.4 108 l.s IP*

73 W.let 17 le8 1.e.10-8 s p ios l A . led sA le8 l.a.ie-*

74 Tegs ter, 2.8'108 SJ 19-8 W. led 17 108 1.0 10-4 8.2 ' 1 98 1.7 19-e W.IW U

  • 108 1.0*10-s l A .1g8 4A . IP4 g,g .108 - it led Re 183 M 108 1 A 10-8 L7 108 13,10-8 4.8 108 lJ 19-6 73 Rhenius 14'10-8 L4 198 2J.IP8 Re let U ' It8 1.0. It-8 IJ ' 108 Re ip not limited not lietted not lietted Re 100 D
  • 108 1.0 10-8 84 108 14 19-* SJ 198 IJ-lP* ,

'3.2 led oeias u i08 1.0 le* ts le 7.2 1t-8 1.2 108 N 0seius 42'108 1.1'19-*

Co 191* 3.1'108 IA le* 11'108 l.4 10-4 Oe 191 U 108 1.0'10-4 2.2 ' 108 4.0 ' led 2.9 108 7A 10-*

oe193 U ' LQ8 1.0 a 10-4 1J ' 108 41 10-* SJ les 2.3 10-8 1.0 It-4 12*108 Le

  • 10-8 3.1 108 8.4 10-8 7 If'idium it L90 17 + 108 ft.198 3,7 a l0e (A.gg-e g,4 808 14 ' IP 8 4.7' tr l A . It-*

131M 17 108 1.0 led 8.7 Ir 2J 1P* S.3 108 l.4 t9-*

I Platinus M.ise 3,7. ica 1.0 10-4 11. iO8 g4 10-4 10 108 13 le-*

to (4*10-8 M 19t* 3.7*IF i A It-8 2A

  • 108 7.8 IP4 1.4
  • 108 M.lIS 17*108 i A 10-8 1.8
  • 108 4.8*19-* 1.7 les 4J 19-8 U ' 158 7,2- it** l A
  • 198 44'19-8 M 19PR 3.7*lt' 1.0*19-4 M lN 3,7 a 108 1 A 10-8 11*108 f.4 1t-* 2A
  • 188 $J
  • ltd u les i.e
  • N d 3J
  • 188 9A
  • 19-* 2.5 188 7.2 led n Gold Aeles As ISB M a lO8 l A
  • le-a gj . gg8 13. gpe $1' l98 2.2
  • tt-*

2A

  • le8 7A ' lP*. I An 190 17 108 l A le-* 4.4 408 1.2 ' l9-*

I 3.7 108 I A

  • lt-8 ( 0 108 t.l lP4 11 108 L4 lP*

Sc MGMW7 He197*

M al08 l.? ' It-* 13 108 1,4 19-8 HelW 1 7 ' l 98 1.0 19-4 U 108 1,0+l0-8 4.8 198 1,l le-* 11 19s, gg . ggd ,

Ht 33 14 Cetteependtag to 3/900 of the buey dose valese spectited la Appendia 3. Coloma 3.

for tao stat 6oet orgea .

e

l '

l - A 15 -

m Table IV 1: continued: Allowances and derived ifiaits U of annual activity incorporation by inhalation and ingestion of individual radionuclides Atomic Radio- Limit of annuai activity Number Element nuclide Allowance incorporation via 1 air water and food (inhalation) (ingestion) *

(1/s) (C: ) (1/s) (C1) i e e e e 01 Thallius n 200 U.tr 1.0 10-8 0.1 ir u le-* u ir 1.1 ie8 n308 U 108 1.0'10-8 4.0 108 1.3 10-8 3.1 te 0.4. it-e TI 303 3.7 + t 08 1 A a le-* l.3 108 3A 10-4 1.2

  • l 08 14 10-4 R204 M
  • l08 1 A
  • tP* If' 808 4A
  • 10-* 1,1
  • l08 2.0'10-*

02 l'8d Pb 203 U 108 1.0*10-4 1.0

  • 108 17 1P4 01+1W 1.b 10-s PO 2it 17*108 1.0*10-8 & 9 108 1.0*19-* 2.9 108 it*10-4 PD 213 U les 1.0 19-8 f 6 108 it ' le"* 3.1*108 0.4 10-8 03 815euth 04 200 M ' 198 1.0 ' led d.0 108 2J le-* 9.7 l@e 3,g.10-8 86207 U 108 l A
  • led 7.f 108 2.0 le-* l.l 808 34 10-*

06 210 U 108 1.0 a it-* 3J 108 0,0a10-* 7J 108 2.0 10-*

04 212 3.7 ' 1 98 IA' led 5.3 108 1.4

  • lP* E3' 808 l.7 LO-8

. 84 P010ntus Pe 310 M ' l08 .l.0 led 1.1 108 3.0 se IJ 108 3.s ' te*

es Astetine Al 3ll 3.7 tW l.0108 2.0 108 s.3 It-* l.5 tW 4.1

  • le*

08 Redon Ra.230 U + 108 1,0

  • IH 1.0 108 4,4 - l9-4 1 Ra 223 U
  • t08 1.0 ' IP4 1.0 108 44 ' IP8 [ not lietted te Aedius Re.223 U ' lW l.0 10-* l.3 tr 3.0'10-* 1.3 te u iG-8 Re 224 U
  • 198 lA*10-4 40 108 1.1
  • 10-* 4.0
  • 1 08
  • 1.1 tP8 Ra 230 M ' 108 14 19-8 1.0 108 4J ' 1P*e 2.1 108 S.0 to..e Re 220 17 = 108 10 IP8 2.1 108 U a IP8 (0 108 IJ 10-4 80 A't d U8 Ar 227 U
  • 108 1.0*10-* 1J 198' 3J*1t*8 3J t08 0.0 104 Ac.220 M
  • 10e 1 A a 10-8 OJ 108 2J*IP* 1.0
  • 1 08 4.2 10-4 to IM U8 4 227 U *108 1.0
  • 19-* 1,0 108 17*IP* 3.1a108 0.4 tP8 4 220 U 108 1.0 ' I P* 3J . ;go g,3 10-88 IJ 108 3.3 t0-8 h 230 U les !A'10-* l.1'IW 3.4
  • 1 0 -88 3.1*108 0,4't0-4 4 231 U
  • 108 1.0'10-4 0.7*108 1.0'19-8 4.0*1g6  :,g . 0-e 4 223 M
  • lge 3,s.gg-a gj . ggs 43.gg-e gy. ggs pj . gre h 234 3,7 108 1 A
  • lP8 1 A
  • 198 4A
  • lP* 3.1 108 0.4 10-8 heet 8) 17 a 108 iA'It-* I A + 108 4A*10-8 13*108 0.0 IP*

01 Prot 0Clinjun Po230 U 108 1.0 ' IP4 4 4'198 IJalP4 L2 + l98 1.l

  • lP8 Pe 231 M e t08 1.0
  • led GA a lt 4 1.F a lys g4. iga 4.3 lP*

Pe 233 U

  • 108 i A
  • lt.a 84. ges gg. se gf . ges 10 10-8 Il seest to 3/'te = 3/1000 for At.Ill . of the tear deoe' votese easetfled La A**peasta 5 Column a in respect at the estatest ergen .

Il Fee naturet taetta the settettles refer to tAe tn.333 eenteet. the altamamee eer.reogasuno to to g of tAe pegeng e eptance. tne eettetty sette of tAe nwettees in=333 and in ale te t : 1.

J e

  • I e

. . . - . . . . _ . . . . m. ]

N

- A 16 -

Table IV It continued: Allowances and derived limits of annual activity incorporation by

  • 2alation and ingestion of individual radionuclides Atomic Radio- Limit og annuai activity Number Element nuclide Allowance incorporation via; 2 air water and food (inhalation) (ingestion)

(1/s) (1/s)

(CL) (C1) e  : I e a e a 92 hiL88 U 2m 3,7 108 IA.It-* 8.1 le8 4 I,7'Itd 9 (2 ' 198 9 1.1 19d i U 23 U . los 1.o .19d 14 199 41 19-'*i 1J 198 9 (0 19-8 9 U tas 17 1e8 t.o . le-* spa nt i l A. Itd 9 ?J .1o8 9 18 19-8 9 U 234 u les i.e . te-* U . tes i t A 19-* i ?# 1989 LeaIt-*i U zas 3,7 to* 1A.19-4 7,falesi lAett-* i U 108 5 l.a.10-8 9 U-238 u Its i.e It-* e,t le8 9 .1.s ' ted i d,e to8912 ledi

, U ase u tc8 1.e tt-* 4.s le8 9 1.t 10-* 9 l.e le89 2A It-di Ule

. + Mp3ae u . lo8 1.o.19-* sA.198 9 2,s. le-4 i to Iri 14.it-di V-eati U + 198 l.0 19d 3J a le8 9 9A a le-se g 34.gges) 13 3 ,4 9 as 76eptmitan NP2sp M

  • tes 1.8
  • 19d u. les sA . it-48 ss les lJ. led Np230 u ' le8 - l A + 19-* 3A
  • le8 IA led 12 108 44 + led M M ' le8 I A
  • ltd 1 I ' le8 13, gg-ee gg. ggs g4. gy e Plutonitsu Pe 23B Pe 230 M
  • le8 lA
  • ted GJ+ le* 18 ' 1Pd8 # Aa te8 2.2 1e8 Pe 3m 17
  • ter I A + led 94 e 10 4 18 19-88 9.0 108 2.2 led Pe 341 M ' 108 i A a led 11 a le8 l.4
  • I9
  • Le 108 1.1
  • ted Pe 34 U
  • 108 I A ' 10-8 I A
  • 108 M a Itd8 0,4
  • 108 2J led .

Po 24 U IP I A ' Itd SA ' le8 2A ' led 8,4'188 1.2*19

  • Pe 344 U
  • 108 lA*te-o gg . gg-* 2J
  • lt-*e 93. gas 2,4
  • le*

es Americius An 241 Ma le8 l A

  • lt-8 3J .108 3,4 + 19-68 U.198 l A e te=8 An 342* U = 108 1.0
  • 19d 3,1 ate 8 8,4
  • 1 9 -88 7A 108 2,1 iled A m 342 M
  • 108 1,0*I9-e gg . ges p. gg a 13. gs 8,8*19-4 Am 343 17 ' t08 I A
  • tt-8 3,latet 8,4 19-*8 7A
  • le8 2latt-*

Am.244 3,7 108 t.0 ' 19-4 12*lf 8,0

  • 19d 8,4
  • 108 2.3 19-*

Co 242 U + l08 lA'!td 47 108 lJett-4 4,2. les 1,1. lt-4 M Cyr{yg Co 243 3.7'198 lA It d 1 6 108 SA*lt-* 3,1 108 2J e ted Cm 344 17 108 l.0*19-8 $4*IF 1,4 10-# 1J + les 3,4. itd Cm MS U a108 1 A

  • 10-8 2J* 198 7.2*10-*8 6,R = 148 1.7. te*

Cm 348 3,7 + 108 l.4 = ltd 2J.108 7,2

  • 1t ** GA let 1.7. Ltd Cm 38 1 7 * ! 98 1.0
  • ted 2,7 108 7.3 a le-** th le8 1,7. led g Ca 348 U a 108 l A
  • led 3J It 4 4A
  • 10-8 7A a tel 2,1
  • Itd Cm 340 U 188 1.0 ' t9-* .41 108 1.7 10-4 (4+19 1,l a te-*
  • 87 Sortelilm m.se U. tr I A. ie 4 s.l . te8 l.4. ltd l A tot 2J.it-4 m 388 M a l08 lA*ted & # 1 08 12+19-+ LO ' le8 1,l a t t-*

11 Cervenemedtog to 3/los et the body p values eyeetited ta Aeosetta s, celan 3, ese the sett&esa erges.

31 with te%:4 es the seesteet testetty of estete seeste tematettee ee.sessegges any est

. eseest 3.8 og and lle og respoettvely toe osy one day, streepeettve et the mustado cesquee & t tse, ,

31 Pet ettote1 steeim iteetuding depteled utesamt the tettettsee 96yee ese le respeet of the emeteet of W330. The etteusese corroopende to 300 g of the seteel euteteese. The settetty rette of 4Ae,avenidos W334. Wile end Wall to 1 e i s 0.06 4

= #

w 1 17 -

II of Table IV 1: continued: Allowances annual activity and derived incorporation limita by inhalation and ingestion of individual radionuclides Limit og annuai a tytty Atomic Radio.- l incorporation via Number Element nuclide Allowance water and food air Z

(inhalation) ,

(ingestion)

(C1' (1/s) (C1) (1/s) l e 8

i i I i a 8.7 10-8 13 19-" 7A'le 2.0

  • lt-*

ge f 4 If0P"hn 1 Cf 24e U ' 108 1.0 30-8 2.2 108 6.4'10-8 Cf.230 17*108 l,0*10-8 17*1F ?.2

  • 10-*8 1,0 10-8 9.3 le** 2.3 10-** 7.5
  • 108 2.0 tOd Cf.2Ji 17 108 Cf.232 17*108 1.0'10-8 34 108 9.4 10"" l.2 108 2J le-8 1,0*10-8 4.2*108 1.1
  • led 2.4 108 4.4 10-*

Cf.233 17*108 17 t# 7.2 a tras gg .108 5.8 10-*

Cf.254 3.7

  • 108 l A 19-8 17 108 1.e le-* 3J 108 u 10-* 4.e.iO8 1.t le-*

de 2as se Einsteinium 3,7

  • 1Os 1,0 ' 10-* 10*IF  ?.0 19-* 3J 108 9.0 10-8 Es.254* 2.4= 108 4,8108 14 254 3.7 ' 1 08 l A
  • 10-8 1A 108 ' 2A
  • 19-**

4,3. gge 3,3 10-*

Es.133 3.7 108 1,0 10-8 2.2 198 u

  • 19-.

3,s gga u . gg-e gg ggs 3,3. ge.4 Fe254 17 108 100 Fereiue 1.0'.10-4 3.0 10-8 4.0

  • 108 . l.a. tW 14 I98 t.6 t0-4 Fe215 17. les 4.2 10
  • 1,0 It-* 9J .108 14 10-8 l.s 108 F e 234 17 108 u.1t i.4 v.4i...ei1... ,

ii.n. .. tit. .. hair.itre it 1 i no.e u ie i.e it-4 t, u. ie u ie-*i Alpha ..Ltters, half.llfe 114 ) I hour 17 108 1,$ . l@=8 '"'" 't-'

sei. ..Lii.re , ..ir.iii. it

  • i ..e u ie i.e ie-* i @ U *I

se te e.htters, half life ti.e p I hewt 3,7. t08 14 10-* ,' 11*I For more than one radionuclide or a mixture of radionuclides of known composition the allowance'and the limit of annual activity incorporation shall be determined as the sum of the nuclide -

proportions. The sua of the ratios of the activity and the allowance, or the annual activity incorporation and the limit I of annual activity incorporation of the various radionuclides l must be 1.

I 13 c er,e,m4tn, s. 2noo et t>e n++7 **** v.tu.e spoet tled La Aavad.ta 8. C*t*e 2. fee sne erseteet er,aa.

m i

I

. 1 II cf annual activity incorporation by inhalation of g Table IV 2: Limits mixtures of radionuclides of an unknown composition I-e Limits II of annual activity y incorporation via air Eind of misture (inhalation)

(1/s) (C1)

-I ~I 3,4.10 9,0.10 Amy mixture ~I I 6.0.10~ 1,7.10 Amy mixture if Car-244 need not be considered Any misture if Pa-231. Pu-239, Pu-240, Pu-242, Fu-244, 0 2,9.10

-II Cm-248, cf-249 and Cf-251 need not be considered 2) 3,3,10 I

I ,

Any mixture if Ac-227, Th-230, Pa-231, Pu-238, Pu-239, I ru-240, Pa-242, Pu-244, On-248, Cf-249 and Cf-251 need 0 6,0.10

-II 2,2.10 not be considered 23 s

- W i

. Any mixture if the alpha emitters as well as 2 Ac-227, 2,1.10 1

5,7.10

-10 An-242" and Cf-254 need not be considered )

t 8

l l

Amy mixture if the alpha emitters as well as Pb-210, 2 -9 I

Ac-277,ang28,Pu-241,Am2428andCf-254neednotbe 2,2.10 6.0.10 ocasidered Any mixture if the alpha emitters as well as Br-90, J-129. Pb-210, Ac-227, Ra-228, Pa-230, ru-241, An-242s, sk-249, cf- 255 and Pm-256 seed not be 3 _g consideredg53,Ci-254,Es- 2,1.10 5,7.10

' 2 1)- Determined by the derived limit of the most toxic nuclide possibly still contained, corresponding to 3/500 of the body dose values specified in Appendix X, Column 2, for .

the critical organ.

~

2) A muclide need not be considered *1f its share of annual activity incorporation is only a megligible fraction of the limit specified in Table IV 1.

6

o

. l l

l 1

,a Table IV 3: Limits II of annual activity incorporation by ingestion of mixtures of radionuclides of an unknoem compositon E

Limits of annual activity incorporation via water and Elad of mixture food (lagestion) I (1/s) (C1)

Any mixture if no information es to its 2,2.i0 I

5,8.10

-10 j composition is available I

Any pinture if Ra-226 and Ra-228 need not 2,2.10 2 5,8.10

-9 he considered 2)

Any mixture if .1-129, Pb-210, Ra 226, 2 7,2.10 2 1,9.10

-8 ,

Ra-228 and Cf-214 need not be crasidered )

Any mixture if Sr-90, J-126, J -129, 0-131, Pty-210, Po-310, At-211, Ra-22'J, Ra-226, Ra-228, Ac-227, %-230, %-732, %-pat, '

Fa-231. D-232, U-238, U-na*_, Cm-248, 2 4,0.10 3 1,1.10

-7

. Cf-254 and re-256 need M t be considered )

1) Determined by the derived limit of the most tonic nuclide possibly still contained, corresponding to 3/500 of the body oose values specified la p e ndix X, Column 2, for the critical organ
2) A muc11de need not be considered if its share of annual activity incorporation is only a megligible fraction of the limit specified in Table IV 1

~ *

~

/

- ~ .

.a E l Table IV 4: Derived limits

1) of activity concentration in air 7 Atomic I Limits of mean annual Ilumber Element Radionuclide Allowance activity cgpcentration .

3, (1/s) (Cil in the air 8 (1/a m3 I (C1/m )

3 4 5 1" 2 .

C-11 3,7.10' 1.0.10'# 1,3.10 2 3,5.10

6 Carbon 3,7.10' 1,0.10'# 1,0.10 2 2,8.10

7 M1trogen Il-13 Oxygen 0-15 3,7.10 1.0.10 9,6.10 2,6.10

S 6,0.10' 18 Argon Ar-37 3,7.10' 1,0.10 2,2.10 2,2.10

$ 1,0.10' 7,8.10 s Ar-41 3,7.10 8,4.10'I

$ 1,0.10' 3,1.10 y 36 Erypton Kr-85" 3,7.10 2 -8 Kr-85 3,7.10' 1,0.10 6,0.10 1,6.10 m O

i Kr-87 3,7.10 1,0.10' 5,1.10 1,4.10 8

54 xenon Xe-131" 3,7.10' 1,0.10' 9,0.10 2.4.10

3,7.10' 1,0.10

~4 7,8.10 2,0.10

xe-133 3,7.10 5 1.0.10

-5 jt,2.10 2 6,0.10

Xe-135 For radionuclides had eixtures of nuclides for which inhalation determines the limit, thelimitsofmeanannualactivityconcentrationareobtainedbydividingthelimitsof annual activity incorporation by the annual inhalation vola.me of 7 300teatricted m . For the access determination of the limits of mean annual activity concentration in areas, not only the higher permissible body doas for occupationally amposed persons but also the reduced exposure time with an annual inhalation volume s,f 2 500 m3 shall ne considered.

ce,see,eemas, se 3/soo of the near dese estese eyeestase se A,,ewte z. cas.ee 3. for the as&taset erges

, J) The estume gueted safer to 3/10C of the meele medy does se eyecified te Appeedte E, celuse 3. sammetes east-toflette o.aessetes espeemse O

e

.q c - ...,..2yc g- 3 c. 4,. 4 g y m , u. m.  ; ., - .r

. ,,, 9 . _ . ,

r.- . .

. . . ,. . ..n. . s f f a

r s. . .

CRITERIA. GOVERNING ThC EXEMPTION RULES ,

OF RADIOACTIVE MATEk!ALS FROM .

REGULATORY CONTROL IN ITALY J

' by S. BENASSAI*- , S. FRULLANI**, G. NASCHI*,

S. PIERMATTEI* and A. SUSANNA*

4 s

  • ENEA - DISP l ** Istituto Superiore Sanita

. Italy <-

u. '

~  %

n * -  % d  %

Criteria governing the exemption rules of radioactive materie,1s from regulatory control in Italy.

S.Benassei (*), S. Fru11ani (**), G. Naschi (*),

S. Piermattei (*), A. Susanna (*)

(*) ENEA-DISP - Roma Italy

(**) Tstituto Superiore Sanita' - Roma Italy

1. BACKGROUND According to the Directive of the European Community on the protection of general public and wor).ers against the canger of ioni:ing radiations 1959(1), the Ita11ar, law f or radiation protection (2), set out the quantities of radioactive substances in terms of activity concentration and total activity exempted from regulatory j control (see table 1). 'The law provides also exemption levels for pcculiar applications of radioactive materials. For instance users of rcdioactive materials, except those involved in nuclear fuel cycle, cro allowed to release without prior application the materials as cffluents or waste, when the total activities and concentrations are bolow the levels indicated in table 2. It has to be underlined that tho Directives of European Community of 1980 and 1984(3) provide also oxcmpt quantities Which are in agreement with those set out in 1960 Cxcept in the_ case of solid natural radioactive sources where the limit han been set at 500 Bq/g (0.014fCi/g); the radictoxicity group of some radionucliden has been also changed in the meantime. These Directives will be introduced in our law in the near future.
2. PRESENT POSITION OF THE ITALIAN REGULATORY AUTHORITY ENEA/ DISP, the Italian Regulatory Authority, considers the setting up of exemption levels as a step in the optimi:ation process.(4)

First of all it wan convened that reference has to be made to a source not to a practtee. Then the first step in the optimization is *o cotablish a nource related upper bound in terms of individual dose tho second one is the adoption of improvements to 1cHer the individual doses below the source upper bound. At this stage it is advisable to 4 cct exwmption levels. Infact it is no useful to expand r egul ato,ry offerts in reducing individual and collective deses already very low.

Tho paramoters to be taken into account in establishing a framework ,

for exemption criteria are individual dose limiti individual riski natural radiation background;

- j apportionment among various sources. l Tho dia unsions carried out on the subject 'at inturnettonal level and

,. in other countries, as well as the proposals and the values suggested or adopted, are important pointo of reference.(5,6) 1

On thoco bccca o figuro for tho offcetivo dono oquivelcnt of to l jk ,/ year has S been preposed as exemption level below which further l efforts in the optimization process are not deemed necessary. The Adviscry Committee for Radiological Protection, consultative body of tho ENEA/ DISP, has approved such figure. At international per level 10 pSv/ year have been .al so suggested in a IAEA Bafety Guide n.=B9 "Principles for Exemption from Regulatory control of Radiation

. Sources" published recently. With reference to the collective dose, tho meaning, in practical terms, of 1 man-Sievert suggested at international level is being investigated.

At present, however, a discussion is going on in our country on the m0cning of collective dose in the context of exempt quantition. There io a tendency to of collective doses.

contider 10fkSv as a cut-off value in the evaluation It has to be underlined that the evaluation of collective doses in ecce of very small individual dosus can be very difficult" per so" and alco because there is no reference to a time scale. The calculation roquires also the use of conservative hypoteses, which in turn cannot bo very simple.

Tho definition of exemption levels in terms of effective dose cquivalent leaves the door open to the problem of setting up derived lovels in terms of activity concentration, surface contamination, etc.

This is really a very dif ficult task as it implies the definition of hypothetical scenarios to evaluate the exposure of the general public.

The assumptions to derive the relevant parameters to be used in the calculations are also critical.

At present derived levels have been evaluated for the exemption from the regulatory control of solid waste and materials arising from dccommissioning of nuclear power plants.

Ao far as consumer goods are concerned, they are exempted according to the provisions of our legislation in accordanCP with t'e requirements of the EC Directives.

Although, at present, tne ICRP principles are not mentioned in the italian law, the Justification principle has been applied in case of cortain types' of consumer goods, whose use was considered l unjustifiable (e.g. lightning rods).

l

3. EXPERIENCE GAINED IN ITALY IN THE APPLICATION OF EXEMPTION LEVELS.
1. Decommissioning To date, in Italy, the relevant experience in the field of. materials CHcmptions from radiological control nas been gained with obsolete inctallations.

! Gince 1985, five small-size research reactors have been completely dienantled and one nuclear power station was authorised to perform activities aimed at safe storage conditions, including partial dicmantling.

8311d materials resulting f rom decommissioning have been monitored for unrestricted release, according to ad hoe Itmits established by the ENEA/ DISP and enforced by the Competent Authorithy.

l Tho rationale to establish such li'mits is outlined in the following.

l In case of low level contaminated solids, owing to the peculiar

! chcracteristics of such materi al s: physical form, chemical l compocition, volumes etc., the transfer models used to simulate the i

- 2

- - 4

-6 ,

l l

l trencport of rcdio:ctivo liquido or of flucnto ecnnot 60 cpplied. When dcoling with liquid or gaseous effluents, in fact, the radioactive concentration is progressively reduced giving rise to the exposure at vary low doses ef large popul tiuo gruups. For low level solids the natural precesses to separate the radionuclides from the matrix where thcy are dispersed, are extremely low and the time scale involved are ucuelly much greater than their radioactive half-lives. As a rule, in this case the number of individuals in the "Theorothical Reference Group" will be limited by the model constraints, mainly areas and volumes of the materials. Hence, it is reasonable to assume that the collective doses will depend on mass concentration and surface contamination rather than on the total activity released.

In other words, the radiological judgement will be determined by the individual deses within the "Theoretical Reference Group", since it is difficult to figure out individual (and collective) doses outside this group.

The limits in terms of individual doses, for unrestricted release of low level activated / contaminated materia's, will be obtained by the cpplication of the principles of radiation protection (optimization end limitattun of individual risk). At present, it is the opinion of tho Italian Regulatory Authority that a limit in the range of 10 to 100pBv por year to be considered as an average value within the "Theoretical . Reference Group", is adequate. Domes within this range cro small enough to be acceptable, while the relevant technology is cvoi l abl e.

Tho derived i t'mi t s in terms of mass concentration and surface contamination can be obtained considecing two "Theoretical Reference Groups" (including any possible irradiation of the general public):

peopic boing in close contact with the holid malwrials resulting from nuclear activitios, on account of their particular jobs, pecple in the general public using products manufactured with the above materiale.

For the first Reference Group (warehouso personnel, truck drivers ote.) an average contact time with the materAals of 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> per year may be assumed. Hay 1ng taken into account the specific radionuclides involved and the chemical-phystett characteristics of the materials, done limits f rom 5 to "O p Sv per year would be correlated to mass concentration / surface contamination values of 1 Bq/g and i Bq/cma recpectively, resulting in dose equivalente rates between 0.01-0.1

, pSv/h at one meter distance. Airborne resuspension over long periods could give rise to some contamination in the air in the vicinity of tho materials. Howevor the annual intake would be much less than the coplicable limit for the general public. The internal irradiation is thurefore not uignificant for this Reference Group.

For alpha-emitters, the cerived limits would be lowered by a factor of tcn 1.e. 0.1 Sq/g and 0.1 Sq/cm".

The swternal irradiation of the second Reference Group can be considerably di f f erent f rom the first one. Irradiation times may be longer, but the concentration / contamination values would be ceders of .

mcgnitude icwor. As a matter of fact, solid materiala released from nuclear installations are usually subjected to industrial dilution with uncontaminated materials in the manufacture process of consumer

. 3

producto. H;nco, cvcroga individual decos within tho occond Reference Group are much lower than thone 'in first one.

Thcroforo the limits of i Bq/g of total beta gamma activity concentration, and 0.1 Bq/g for alpha activity were adopted for solid cubstances resulting from d ecommi ssi oni ng operations. For surface contamination the limit was set at 1 Bq/cm8 for beta gamma emitters cnd 0.1 Bq/cm* for alpha emitters.

An additienal requirement to register the destination and the physical chcracteristics of the rel eased materials is imposed.

In case of the nuclear power plants, additional limits for the fixed surface contamination have been established non according to the IAEA Bafe Transport Regulations. Moreover the dose equivalent rate Chc11notexceedatanypoint1pSv/ hat 10 cm from the surface of the material. '

The advice of thP Advigory Committee for Radiological Protection is to cdopt for solid materials f rom decommissioning the same derived limits adopted for surface contamination by CNCA/ DISP on thw beeis of a case by caue analysis, while a limit of a factor ten lower was for activity concentrati on (B) . suggested These limits should guarantwo the compliance with an exemption level of 10pSv/ year. The movice of the Boced will be reconsidered when a'grewment will be reached at international level.

Solid Wasten According to the most recent position of ENEA/ DISP in the field of radioactive months or wastes (9), first category waste are waste which within few at maximum within few years, decay to a radioactivity concentration lower than that indicated in table 2. When these values have been reached, first category waste can be released freely in the onvironment as their radiological impact can be considered negligible iless than 1-1015Sv per year).

/

4. Reserch Work Roccntly a study has been c'onducted in Italy on re:ycling of stoel and dicpoual of concrete in municipal l and4111 ( 10) . In the study it was accuned an activity concentration of i Bq/g for Co 60, Cs 137, Br 90, cnd 0.1 Bq/g for Pu 'l*7, Am 241. Reference waste quantities are 10,000 t of concrete materials and 12,000 t of steel materials.

Tho results show that whilo the compliance with a target of individual effective dose equivalent of 10k Sv per year can be an j

cchtoved, the collectiva dose of 1 (5m:n-Sv as nrder of magnitude). man-Sv is mere difficult to reach It is obvious that the degroo of conservattom adapted in the picyu a major rela. On this matter it is highly desirable thatmodel an cgreement should be reached at international level on the'modelo to be cdopted, on their degram of conservattvism and reliability.

I A_________

i REFERENCES m 1.

2.

Garretta Ufficiale Comunita' CE, n.11, feb. 1959 D.P.R. 185, feb. 1964

3. Gazzetta Ufficiale Comunita' CE, L. 246, sept.17, 1980; 1 L. 265, oct. 5, 1984
4. Regulatory trends in implementing optimization requirements in Italy, IAEA-SM-285/08, 1986 ,
5. CEA-IPGN-Maximum potential doses from the recycling of steel from dismantled power reactors. Dec. 1985
6. The derivation of exempt quantities for application to 7.

terrestrial waste disposal . IAEA Report, Aug. 1985 IAEA-Safety Guide n. 89, 1988

8. ENEA-DISP-CCPR Rel. L.85/01 Protezione ENEA, 11-12, 1986 Marzo 1986 in Sicurezza e i 9 ENEA-DISP Guida Tecnica n. 26, Gestione dei Rifiuti Radioattivi, 1998
10. SNIA-TECHINT Analisi del rischio radiologico da materiali l risultanti dallo smantellamento di impianti nuclear 1, July 1987 (restricted).

t e l I

i i

, e I

e

l . )

l b ,

l l .

Table i Total activity and activity concentration of radioactive sustances balow which the requirements of the Italian law on radiation prctaction and the administrative controls do not apply.

a) Total activity Radiotexicitv crouc 0,1 pCi I i Ci II 10 Ci III 100 C1 IV .

i b) 8.c t i vi ty concentration Materials ,

C1/g)

O,001 solid natural radioactive substances i

! O,002 all the other radioactive I

substances Both tho two conditionn must be fulfillodi For medical applications and other spe;;ific applications, the law applies irrespective of the activity and concentration.

. ~

\

,1 I

f

, , , Table 2 Exemption levels for radioactive effluents.

1 Annual activity 10* figures given in a) Table 1 if Ts,e < 30 days

,. 108 figures given in a) Table 1 if Tse. >= 30 days 80 figures given in a) Table i for alpha emitters a figures given in a) Table i for U and Th.

activity concentration at the discharoe coin 1 gas # Cut effluent 41 MPC for radiation werkers liquid effluentwa 10 MPC for radiation workurs solid wastes concentration toxicity group pci/kg)

(

10-s= I 10-' II 10-*  !!!

10-v IV e

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- l SESSION 2 - Mondcy, 4:30

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PRESENT STATUS ON EXEMPTION OF RADIOACTIVE ,

WASTE FROM REGULATORY CONTROL IN JAPAN t

j s r bY.

- M. OSHINO and Y. YOSHIDA s

A i 1

a y

l Japan Atomic Energy Research Institute

. JAPAN i

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PRESENT STATUS OM EXEMPTION OF RADIOACTIVE WASTE FROM REGULATORY CONTROL IN JAPAN M. OSHINO and Y. YOSHIDA Japan Atomic Energy Research Institute

1. Introduction j In Japan, exemption of radioactive waste from regulatory control has been invatigated since the middle of 1970's.

l In 1985, the policy on land disposal of radioactive wastes was established

! by the Atomic Energy Cosmission, which clearly pointed out that land disposal of low-level radioactive wastes should be made rationally, depending on the level

' of radioactivity of the waste. The Atomic Energy Coamission also pointed out that it was necessary to develop exemption levels (lower limits of low-level radioactivewaste)inordertoimplementthispolicy.

As to the regulatory aspects of this policy, in 1985, the basic principle of the safety regulation on disposal of low-level radioactive solid waste was established by the Nuclear Safety Consission. This principle refers to the safety regulation of shallow land burial of low-level radioactive solid waste, including the concept of "stepwise management of the disposal". The basis of this principle is that after the end of management period of the disposal the dose to the general public could be regarded as being negligible from the viewpoit of radiation protection.

In 1988, the Radiation Council established the dose to be exempted from regulatory control in the shallow land burial of radioactive waste, as the dose level of 10p5v/y to the general public.

Low-level radioactive wastes are generated from routine operations of nuclear facilities, and are expected to be produced in large amount in the near future, following the decoenissioning of nuclear reactors and so on. It is necessary to establish the exempt quantities of radioactive wastes for disposal, recycle and reuse of these low-level radioactive wastes. The study is now in

2 .

progress by the Nuclear Safety Comission on exempt quantities of radioactive .

waste.

2. Basic principle of the safety regulation on land disposal of low-level radioactive. solid waste i

The basic principle of the safety regulation on land disposal of low-level j radioactive solid waste in Japan can be sumerized as follows:  ;

i The radioactive wastes are kept in the safety manner by means of the stepwise management (see Fig.1). The stepwise management consists of four steps:

1 ist step: The radioactivity in the waste is confined ,

within engineered barriers.

4 2nd step: The migration of radioactivity is retarded I

j by both engineered and natural barriers.

3rd step: Specified activities of the public, such as residence in the site, are prohibited. j 4th step: The disposal is exempted from regulatory I control.

1 After the end of the management period of the disposal (at 4th step), the ,

dose to the general public due to the waste should be so low that the l consequences of the dose do not need to be taken into account from the viewpoint i of the radiation protection, therefore the disposal can be exempted from

! regulatory control. [

l 3. Dose to be exempted from regulatory control in the shallow land burial of l radioactive solid waste  !

3.1 Principle of exemption i

1

! The Radiation Council made the following conclusion on the dose to be j

exempted from regulatory control in the shallow land burial of radioactive solid l waste. j l

j (1) Dose to be exempted from regulatory control  :

J l (1) The doses due to the disposal of radioactive wastes exempted from ,

regulatory control shall be sufficiently low compared with the dose limit for f l

l i

- - - - - - - - . - . - - -- --_ A

3 1

the general public, to ensure that the public will not be exposed to radiation beyond the dose limit, even taking into account the possibility of exposure from other sources and practices at present and in future.

(ii) According to the above-mentioned rationale, it is appropriate that the dose which the exemption to be based on is set as 10pSv/y to the individual members j of the public, in conformity to the individual dose proposed in the ICRP Pub'1 cation 46 and in the Statement by the IAEA group of senior experts on general principles for exemption from the Basic Safety Standards.

(iii)The requirements for exemption should be considered to be satisfied, even if the calculated doses of specific incidents exceed 10pSv/y for certain individuals, provided the resultant individual risks are sufficiently small because of extremely small probabilities of occurrence of such incidents.

l (2) Optimization of exemption The methods.of disposal of radioactive solid wastes exempted from the  ;

regulatory contro, should also be examined from the viewpoint of optimization.

3.2 Discussion on collective dose The exempt quantities will be derived basically from the individual dose to the general public. Collective dose will,be evaluated as a reference for'  !

optimization.

An international consensus should be necessary to assess collective dose l

[

comit$ent by realistic method, for example, the method incorporating l

"truncatiun" and "cut-off dose". Especially, it is required to decide which collective dose should be used, regional or global, in assessing the collective dose of 1 man Sv below which quantitative optimization would ret be necessary, given in the IAEA Safety Guide.

4. Concept for derivation of exempt quantities of radioactive waste According to "The basic principle of the safety regulation on disposal of low level radioactive solid waste" by the Nuclear Safety Comission, exempt quantities of radioactive waste will be estabitshed as follows:

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(1) Exempt quantity, such as radioactive concentration, can be derived for each l disposal method from the exemption dose by setting dosimetric models of radiation exposure from the wastes considering the type (form) of wastes and by selecting appropriate input parameter values (see Fig. 2). The concentration of natural radionuclides could also be used as reference data.

(ii) In principle the exempt quantities will be calculated for representative radionuclides, but it would be practical to set the exempt quantity for each group of radionuclides in practical unit.

S. Conclusion As mentioned above, the exemption dose from regulatory control for radioactive waste in Japan was established as the individual dose of 10pSv/y to the general public.

The exemption dose is the basis of exempt quantities of radioactive waste for land disposal. Establishment of the exempt quantity of radioactive waste is under investigation by the Nuclear Safety Commission.

It is desirable that an international consansus will be reached on the ,

derivation of exempt quantities and an international guideline will be published at an early date.

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' RULES ON EXEMP' TION FROM REGULATORY CONTROL -

A PROPOSED BROAD POLICY STATEMENT BY THE U.S. NUCLEAR REGULATORY COMMISSION

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- by BILL M. MORRIS and WILLIAM R. LAHS

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Office of Nuclear Regulatory.Research U.S. Nuclear Regulatory Commission ,

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WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL Rules on Exemption from Regulatory Control - A Proposed Broad Policy Statement by the U.S. Nuclear Regulatory ComHsion Bill M. Morris William R. Lahs U.S. Nuclear Regulatory Comission The purpose of my presentation today is to discuss the U.3. Nu lear Regulatory Comission's efforts to develop a broad policy statement on the subject of exemptions from regulatory control for practices whose public health and safety -

impacts are described as being below regulatory concern. So that you may understand the context of my presentation, I would like to briefly mention some background events which have highlighted the need to develop this broad policy statement and have led to the diversity in views in its formuhtion.

As both Mr. Stello and Mr. Beckjord have indicated in their remarks, Congressional actions in late 1985 focussed attention toward, and specifically called for Nuclear Regulatory Comission action regarding, the potential disposal of very low-level radioactive waste at o*.her than licensed low-level waste sites. The result was that the Comission issued a policy statement on this specific subject in August of 1986. . That policy statement essentially established Comission procedures for making practical and timely dechions regarding the disposal of radioact he wastes wh:ch were described as being below regulatory concern. In that policy, individual doses of a few millirem per year and small colleative doses were called for, as two of fourteen criteria, which if met, wvuld allow the Comission to act expeditiously on an exemption application. Then, last November, the Comission made another exemption-related policy decision which allowed issuance of interim licenses for distribution of irradiated gemstones. This decision brought out a wide variety of views on the fundamental concepts of exemption decisionmaking. So much so that the Comission directed that a "fresh look" needed to be taken at the de minimis and below regulatory concern concepts and that a broad Comission policy should be developed that would identify a level of radiation risk below which government regulation would not be warranted. Subsequent Comission meetings were held in which exemption policy was discussed in light of the de minimis and below regulatory concern concepts, with specific

. reference to both the Comission's existing and proposed exemption standards.

Finally, last month, a proposed . policy sta*atent with options was presented to the Comission for their consideration. The proposed policy was base.1 on the -

below regulatory concern rather than the de minimis risk concept. That is, the policy proposed that practice-specific, exemption-related, exposures could be set at a level where the effort and expense of further regulation overshadowed any gain in risk reduction.

In anticipation of the ptoposed policy statement, advisory and scientific bodies had offered diverse views to the Comission on a few key policy questions. As a result just two weeks ago, the Comission approved a draf t advanced notice of development of a policy on below regulatory concern and .

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f specifically directed that it should be made available for coment at this workshop. I hope you have had a chance to look at this advance notice which is included at the back of your workshop notebook, In that document, you will i

notice that the Comission specifically seeks coment on two issues: tne need to justify exempt practices that result in potential exposures that are celow regulatory concern and the need for a collective doce criterion which, when coupled with an individua' dose criterion, would delineate achievement of theI "es low as reasonably act avable" or optimization of protection prir.ciple.

till be discussing both . these issues in a few n ments.

With that background, le. . i now attempt to describe the proposed Comission policy. The purpose of th.' policy is to establish a basis for development of regulations and for making individual licensingindecisions which would the rear future, exempt we would expect l

certain practices from regulatory control.

this policy to be applied to exemption decisions regarding the disposal of low-level radioactive waste, the termination of licenses and release for public use of lands and structures with low-levels of residual contamination, and the release of slightly contaminated materials and equipment. New consumer products using radioactive material could also be distrit,uted to unlicensed individuals under provisions of the polir . If the exemption decisions made under this policy are translated into new regulations, individual licensees would only have to demonstrate compliance with defined conditions of exemption (e.g., volumetric contamination levels) in order to take advantage of the policy.

Let me now sumarize the major elements and outstanding questions regarding the proposed policy. First, as I have mentioned, the proposed policy provides for exemptions to be granted for a practice on the basis of a defensible, "as low as reasonably achievable (ALARA)" or optimization of protection position assuming that applicable radiation protection dose limits for individual members of the public are not exceeded. The ALARA analysis required by the policy could involve a cost-risk reduction evaluation; however, if the exempt practice can be shown to retult in sufficiently Twolow levels ofcriteria numerical risk, ALARA are beingwould be demonstrated on this risk basis alone.

evaluated for use in defining this region where ALARA would be achieved. They are (a) a criterion for the maximum individual annual dose reasonably expected to be received as a result of the practice and (b) a measure of societal impact to the exposed population. These criteria are being considered to r.sturc that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact.

If the individual doses from a practice under consideration for exemption are safficiently small, the attendant risks will be small compared with other societal risks. Thedefinitionoftheproperlevelofriskstartswithtgeare presumption that annual individual f atality risks below approximately 10' of little concern to most members of society. Providing for some margin below this level, 10 mrem (0.1 mSv) is proposed as the level of annual individual exposure, which, if not exceeded in exempting a practice, would delineate l cancer fatality risk achievement of ALARA. The tacremental annual indi id associated .ith this exposure level is about 2x10'g and uais of the order of 0.1 in percent of the overall annual risk of cancer death in the United State converting dose to risk, a risk coefficient of 2x10" per rem or 2x10'g,per Sv is being used.

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As a' measure of societal impact to the population, collective dose was initially proposed as a second criterion which would also have to be met by an I

exempt practice to delineate achinvement of ALARA. Adoption of a collective dose criterion would provide assurance that a single exempt practice (e.g.,

widespread distribution of a consumer product, recycled equipment o! cecycled material) would not impose a significant societal risk without the requirement

{ for a supporting cost-benefit analysis. The Comission recognized that this J

criterion would be the limiting consideratioi. for practices involving very small doses to very large numbers of people. Their concern was that this provision, in effect, was applying the ALARA or optimization of protection principle to very small levels of individual dose - doses below what most reasonable people would consider de minimis. For example, a natio distributed product involving annual doses of a few microrem ( 10"pally) uSv would theoretically be subject to an ALARA evaluation. Because of this concern, the advance notice solicits comments on what the magnitude of the collective dose criterion if any, should be or what alternative courses of action are possible.,' Consideration has been given to a collective dose criterion of either 100 or 1000 person-rem (1-10 person Sv) per year per practice.

Selection of either value would assure that a single exempt practice would not impose a societal radiokgical risk greater than one statistically predicted cancer death every 50 years or 5 years, respectively, without the requireunt for a supporting cost-benefit analysis. Without some criterion on societa, impact, as long as individual doses from an exempt practice are less than 10 mrem per year (0.1 mSv per year), collective doses could theoretically approach 2,500,000 person-rem (25,000 person-Sv). This could imply 500 statistic 411y-predicted deaths per year from a practice, whose exemption from regulatory control could be granted without the need for consideration of practical dose reduction efforts.

Alternatives to the use of collective dose as a measure for evaluating societal impact could involve limiting the radioactivity of individual products. Wh:tever the ru ult, it ,hould be clearly understood that the use of the individual, and possibly the collective, dose criterion does not define a bound on exempt practices but only establishes a procedural process for demonstration of ALARA. If the risks associated with an exempt practice fall within the region indicated on the figure, no further cost-risk reduction efforts would be required. As a result, these criteria have only an indirect health and safety significance.

The proposed policy presented to the Comission closely followed the approach being advanced by the IAEA in the latest revision of IAEA-TEC000-401.

Specifically, the three basic elements of the system of dose limitation had been reflected in its development; that is, justification of practice, optimization of radiation protection, and limitation of individual rhk. As you will note in the advanced notice, these principles are acknowledged a d advice is sought on how these principles should be applied in establishir, appropriate control. The cri,teria for release of radioactive material from regulatory role for the "justification of practice" principle, when applied 20 exemption policy, is of specific concern to the Comission. The arg cent made on this point is that, as long as the regulatory agency prudently .v"s the level of protection for the publics' health and safety, the agency ne.. e 't and should may demand. not infringe on societies' right to be allowed possession of p ./

questions:

To resolve this issue, the Commission is seeking response ;9 o they four

1) As lower levels of radiation exposure are projected, would comensurately lower levels of the benefit be required for practhe justification, or at some point, would justification not be required? 2) In 3

establishing its exemption policy, should the Comission exclude certain practices for which there appears to be no reasonable justification?, 3) In considering proposals for exemptions, should the Corwission evaluate the social acceptability of practices?, and 4) Should the Commission determine a practice to be unjustified if nonradioactive economical alternatives exist? The answer to these questions becomes very thought provoking, especially when the individual risks of a practice under consideration for exemption are low, and possibly so low, that they may be below negligible or de minimis risk levels.

1 Skipping for the moment to the third principle, "limitation of individual risk", there is apparently considerable agreement; that is, the proposed policy is strongly tied to existing radiation dose limits. These limits are those expressed in NRC regulations. These regulations, for which publication of a revision is expected very shortly, specify that the maximum allowed annual dose to a memoer of the public from a licensed source is 100 mrem per year (imSv per year). In granting exemptions under the proposed policy a basic objective is i that by no means should an individual be reasonably expec,ted to receive a cumulative dose greater than this value when all licensed and exempt practices, that is multiple exposures, are taken into account. In fact, the goal, that t7ould be intended, is that such doses would be wel' below the 100 mrem per year (ImSv per year) public dose limit.

Finally, going back to the second principle, enhanced margins of protection are expected to be required in defining specific exemption regulations. Under this principle, costs and practicality of dose reduction are considered. This has been one traditional way of defining what is below regulatory concern in making exemption decisions, although, in some cases, it could be argued that anticipated doses have been so small that the exemptions have been approved on de facto negligible risk considerations. In evaluating the value of dose i reduction efforts, a linear non-threshold relationship between dose and risk is i used over the low dose levels to which the policy applies, 4

previously, the risk coefficient used in the policy is 2x10'gs Ilatent mentioned cancer fat.alities per aerson-rem (2x10'2 latent cancer fatalities per person-sievert).

The Comission has proposed that use of the linear non-threshold hypothesis i allows the theoretical establishment of upper limits on the number of health

effects that might occur at very low doses which are the subject of the exemption policy. We believe that in selecting the 10 mrem per year (0.1 per year) individual dose criterion, there will be assurance that the 10'gy '

' acnual individual risk level will be met notwithstanding (1) t;1e uncertainties associated with the linear non-threshold model and (2) the potential change in i risk coefficient resulting from reevaluation of bomb data dosimetry, i

j There is one last point I would like to discuss with you today and that i

involves the provisions of the policy which could add to our confidence that members of the public will not be subjected to unacceptable levels of radiation  :

beca'use of multiple exposure to licensed and exempt sources of radiation.

First, unless the practice meets the criteria for delineationL of achievement of ALARA, there is the requirement for a cost-benefit evaluation to support any i exemption decision. This evaluat 4n would be expected to consider the possibility of multiple exposures from the exempted practice. With regard to' practices meeting the dose criteria which delineate achievement of ALARA, it should be emphasized that the individual dose is described as the maximum dose reasonably expected to be received due to a given practice. Only under very '

unusual circumstances would the majority of those exposed be expected to be 4

..e very near this level. However, if one were to hypothesize such a situaticn, a population dose criterion would limit the number of individuals who could be exposed from a single practice at the 10 mrem per year (100 v5v per year) individual dose level to 10,000, if a 100 person-rem (1 person-Sv) value was used, and 100,000, if the criterion was chosen at 1000 person-rem (10 person-Sv).

Second, if the exemption policy includes the provision that exposures will only be tolerated from justified practices, one would be assured that a largr. number i of unjustified practices would not contribute to the problem of exposures from multiple sources.  ;

Third, the point is made in the policy that as the policy is implemented, an assessment of the potential cumulative doses to various key members of the exposed population will be made, taking into account exposures to multiple practices. The policy statement specifically states that if such exposures appear to be significantly greater than 10 mrem per year (100 MSv per year),

4 further analysis will be necessary before,an exemption could be granted.

Fourth, in the definition of a practice to be considered for exemption, the statement is made that deliberate dilution or fractionation of a practice will not be allowed. That is, where there are similar activities which clearly should be considered for exemption in an integrated way, it would not be

! permissible to artificially break these up to meet the conditions of the ,

exemption policy. And, finally, a comitment is made that as experience is  !

gained on this issue, an integrated reevaluation of the policy and its implementation should take place to assure that exposure to individual members of the public remain well below the allowed limits, i

In conclusion, we believe the development of a Comission policy on rules for  :

exemptions from regulatory control can provide the foundation for rational decisions and regulations which will seek a balance between small individual and societal risks and the costs of regulatory and industry efforts needed for their control. But we recognize that bacause of the value judgements which

! will be involved in any specific exemption decision, the broad policy, by itself, cannot provide all the answers in black and white. Good judgement and comon sense in case-by-case decisions, and in the development of specific regulations, will be required. As lir. Stello stated in his welcoming address, i we can expect policy implementation to bring out a far wider range of opinions l 1 and alternatives.

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m PROPOSED EXEMPTION POLICY SCHEMATIC 100 g- ---- PUBLIC DOSE LIMIT - - - - - -

ALARA C/B REGION 10 _5 " ^E~'~'-'~~-',-'-'-S .

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l SPANISH SITUATION AND APPROACHES TO THE ESTABLISHMENT AND DEVELOPMENT OF EXEMPTION RULES 1

by JULIA LdPEZ DE LA HIGUERA i

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! Consejo de Seguridad Nuclear i Spain l

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1. SPANISH REGULATORY FRAMEWORK _TO BE APPLIED _TO THE_ EXEMPTION OF PRACTICES FROM REGULATORY CONTROL 1.1. Legal Basis, ,

The spanish legal basis for the develop. mar.t and applica-tion of nuclear activities are as follows:

- The Nuclear Energy Law of 1964. This is an outline re-gulation, governing the subsequent development of a ge-neral legislation programmo in the nuclear field (1).

- The Decree on Regulations of Nuclear and Radioactive installations of 1972. This decree stablishes the rules of practice for domestic licencing proceedings (2).

- The Law cf 1980 creating the Nuclear Saf ety . Council (CSN) (3).

- The Royal Decree on Regulation of Protection against ionizing radiation (1982) and aubsequent modification according the directive 84/467/ EURATOM (4).

This regulstions constitute the spanish legal framework in nuclear field and contains several provisions regarding exemption posibilities.

1.2. Responsibilities The Department of Industry and Energy, the Department of Health and the Nuclear Safety Council are responsible of the enforcement ar.d implementation of regulation in their -

own field of domain.

The Nuclear Safety Council is independent of Public Admi-nistration and it is the only competent body in Nuclear Safety and Radiation Protection. Some of its duties aren v - To propose to the Government, regulations and reviews, concerning Nuclear Safety and Radiation Protection.

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'I i - To carry out safety assesment, control and inspection of installations from the point of view of nuclear sa-fety and radiation protection.

- To conduet with the Department of Industry and Energy the licesing procedure. The CSN elaborates the precop-tive and linking report in aspects related to radiation protection and Nuclear Safety.

1.3. Posibilities of exemption according to spanish regulations In Spain, there is not at present specific regulations concerning the exemption of very low level radioactive ma-terials from regulatory control.

Nevertheless, the applicable regulations state "a priori" special situations exempt from general licensing procedu-re.

The Decree on regulations of Nuclear and Radioactive Ins-tallations (2) establishes that all of them are obliged to be below regulatory control and apply for an specific ope-rating license. However, the follow cases are not includes in the regulatory action:

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a. Installations using or storing radioactive material in case the radionuclides activity are below specific va-lues related in the Decree Appendix (Annex 1).

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b. Devices containing a radioactive substance, in case of normal operating conditions cause a dose rate of less than 1 uSv/h at 100 mm from any accesible surf ace and is of a type approved by the Department of Industry and Energy.
c. The quantity of radioactive material does not exceed 0.002 uCi/g, or 0.01 uci/g in case of natural radioac-tive material.

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f d. Devices producing X rays of quantum energy not exceo- i ding 5 kev.

f Furthermore, in accordance with the Royal Decree on Regu-lation of Protection Against Ionizing Radiation, the use of timepieces and instruments containing radioluminiscent paint shall not be required to be under regulatory con-trol. Manufacture is also exempt when the paints contain less than specific quantities of radionuclides. (Annex II).

This installations or practices described above are not required by spanish regulations to be under control. From the point of view of nuclear safety and radiation protec-tion

- The accomplisment of licencing proceeding is not a no-cessary requirement for them.

- They are not under control and inspection actions by the regulatory body.

- The competent authority only requires notification and registration of the total amount of sources or radioac-tive material in the country.

It's necessary to have in mind the scope of this exemp-tions. The regulation only contains special situations exempt from general licencing procedures but this regula- ,

tion is not applicable to the exemption of disposal of va-ry low level radioactive waste from regulatory control.

2. SAFETY AND PROTECTION CRITERIA APPLIED BY CSN IN COMMON PRACTICES EXEMPTION In some cases, the CSN have taken into account special si-tuations of radioactive , material releases, that would not need to be subject to regulatory control because of their low radioactive content.

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l This is the circumstance of hospital facilities with parpo-ses on diagnostic and therapy, using low activities of short life radionuclides and having skilled staff in the Technical Units of Radiation Protection.

The basic criteria applied by CSN is to require petitioners the presentation of all needed information in order to d=-

monstrate compliance with a small fraction (10%) cf the annual limit of intake for the most critical radionuclide.

The documentary information should contain at least

- Activity to be discharged to the sewerage system.

- Flcw discharges to the sewerage system.

- Maxbmun concentration regarding the most restrictive ra-dionuclides.

- Date and person who is responsible of the discharge.

- All relevant information to demortrate compliance with the criteria.

In case of compliance with the criteria, the licencee shall dispose by release into sewerage systam. Sometimes it's not possible for him to comply with radiological criteria be-cause of the non soluble or dispersible material in water.

In this case he must contact the National Company of, Ra-dioactive Wastes (ENRESA).

The CSN requires each licensee, the maintenance of records with all the pertinent information, to demonstrate complian-ce with the procedures during control inspection by the CSN staff.

Licensing of disposal by release into sewerage system, has been considered ,by CSN only in a limited number taking into account radiation protection capabilities of the licensee in '

1 order to grant a optimum development.

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4. ACTIONS TO_ DEVELOP IN RELATION TO EXEMPT.'ON OF RADIOACTIVE MATERIAL r

The exemption of very low level activity radioactive nate-I rial from regulatory control has been authorized by CSN in particular circumstances.

The non-existence of specific regulation and the necessity of carry out a suitable management of very low level radio-active waste, reveal the importance of setting up a exemp-tion policy.

The first steps lead to analyze the international background on the subject. Now, the CSN is considering a work plan in order to carry out the implementation of exemption rules.

The main 2'jetives fall into three fundamental areas

- Criteria definitions ,

- Methodology

- Awareness of international progress Particularly

- To define and propose the basic criteria for the implemen-tation of exemption rules.

- To be aware of international situation and development of exemption rules.

- To study the methodology and it application.

- To identify the potencial uses and fields of application.

- To develop a procedure and specific regulations to be applied to the exemption of a practice.

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5. REFERENCES (1) LAW NBR.25/1964 OF 29.4.1964 (BOE).

(2) DECREE NBR-2669/1972 or 21.7.1972 (BoE).

(3) LAW NBR-15/1980 0F 22.4.1980 (BCE 25.4.80)

(4) ROYAL DECREE NBR-2519/1982 OF 12.8.1982 (Bot 8.10.82)

AND ROYAL DECREE N9 1755/1987 or 25.11.87 (BOE 15.1.87). .

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  • 1 l

4 i 9 i ESTABLISHMENT A!!D IMPLEMENTATION 1, OF EXEMPTION LEVELS IN SWEDEN 4 l i - I a 1-by

C. BERGMAN,
  • i G. HELLSTROM,
  • 4 and S. NORRBY **

.i , . I i l ! x . I i { l l . i i l

  • National Institute of Radiation Protection f
                           **      Nuclear Power Inspectorate i

I

  • I i

rs I l l ' I - t

l ESTABLISHMENT AND IMPLEMENTATION OF EXEMPTION LEVELS IN SWEDEN

            .                  C. Bergman end a He11strom National Institute of Radiation Protection Box 60204 S-104 01 Stockholm                                                                         !

Sweden S. Norrby Nuclear Power Ir.sp ctorate Box 2S106 . 5-102 52 stockhoin Sweden

1. Legal situation In Sweden radioactive material is regulated primarily by three  :

laws:

1) Act on Financing of Future Expenses for Spent Nuclear Fuel etc (SFS 19812669), effected on 1st July 1981)
2) Act on Nuclear Activities (SFS 1984:3), effected on 1st February 1984 (replacing the Atomic Energy Act from 1956)
3) Act on Radiation Protection (SFS 1988:293) effected on 1st July 1988 (replacing the old Radiation Protection Act from ,

1958). . L L the Act on financing regulates primarily financing of future costs for radioactive wastes frca nuclear activities and decomunissioning of nuclear installations. Exemption levels are l however not considered.  !

The Act on Nuclear Activities regulates all nuclear safety
aspects of nuclear installations as well as of fissile material i

and nuclear wastes. The latter is defined in the law as l I a) spent nuclear fuel that has been placed in a final

repository b) any radioactive substance that has been generated in a a nuclear plant or material or any other substance, that has ,

beccme radioactivly contaminated in such a plant, and

,                                 c) radioactive parts of a nuclear plant that is                                        l
deccumtissioned. [

Licence is needed a>; cording to the law for among other things operation of nucle 4r installations and all handling jx - transportation an9 importation into Sweden of nuclear wastes. The Act on Radi'4 tion Protection covers all practices where -

ionizing radiation is generated. Licence is needed for all i j

t l handling, sale, transportation and importation into Sweden of 5 l radioactive material. The two Acts, the Act on Nuclear Activities and the Act on Radiation Protection, are parallell acts in the sense they regulate different aspects of the same practice although the Act on Radiation Protection is covering all radioactive material while the Act on nuclear activities is concerned with radioactive material in the nuclear fuel cycle. In the ordinance on Nuclear Activities there is a general licence i according to the Act on Nuclear Activities for everyone to acquire, possess, handle, transport and import small quantities of nuclear waste to be used for the purpose of instruction er research or for medical, agriculture, industrial or ceamercial a purposes provided that licence according to the Act on Radiation 4 Protection is granted. The competent authority for nuclear  ! safety, the Nuclear Power Inspectorate (SKI), has however also a I supervision responsibility according to the Act for this type of nuclear wastes.

 !                          The ordinance on Radiation Protection authorite the National                                                l Institute of Radiation Protection (S$1) to exempt radioactive                                               !

material from licencing requirements. There is also a general j exemption given in the ordinance which is further discussed in chapter 3. l

 ?                          In th6 terminology used in the Swedish laws' nuclear waste' is a part of the more general term ' radioactive waste'. That reflect the political intention of having a stronger regulatory control of radioactive wastes originating from nuclear fuel cycle activities.
2. Authorities and Responsibilitites I i

According to the Act on Radiation Protection the SSI is the competent authority in the field of radiation protection and the SKI is competent authority for nuclear safety according to the Act on ?'uclear Activities. Within the two laws, Ordinances and I } Instructions given by the Government, the authorities act I i independently of political organisations. 1 The SSI and SKI are authorised to licence all ditforent activities, except sosie najor ones, such as construction and operation of nuclear power plants which is licenced by the

 ;                          Goverrunent, to inspect installations and to give binding 1

instructions to licenceholders.  !

 \                                                                                                                                      '

i' Since there is a general licence according.ta ;he Act on Nuclear Activities for small quantities of nuclear wastes and there are ! no or small nuclear safety problems with very small quantities of . j radioactive material the exemption of radioacti've raterial frca l j regulatory control is regulated by S$1 according te the Act on Radiation Protection it must however be recognised that although ! the radioactive material, if it also is nuclear waate in the ' I legal definition, is exempted frca further regulatory control based on radiation protection consideration it is still under 1

T 3 supervision by SKI as nuclear waste. There is ni formal way by > which nuclear wastes can be either reclassified or exempted according to the Act on Nuclear Activities. The SK1 has howeve no intention to exercise real supervision of exempted material.  ! For nuclear substances, mainly fissile material, also safeguard  ! aspects have to be considered when exempting material from i regulatory control. It is possible to withdraw batches of r.Jelear i substances from further safeguard control after individual application but not as a general exemption. Such decissions are made by the SKI. One provision is that the coetanteation of fissile material is sufficiently low. [ t

3. Exemption according to ordinance on Radiation Protection f i

By specification in an ordinance the Government has exerpted some

        ,_ _ amutena andraetkelties asse ths.ameemorte=waseeMed" the Act on Radiation Protection. 'l'he most important sources and practices are:                                                            l
1) radioactive material with a specific activity nct exceeding 100 kBq/kg
l
                                                                                      ~

1

2) substances existing in nature with highet activity l, concentrations than in point 1 above which hkve not been l l treated with the purpose of increasing the activity  ;

j concentration  ; 1 i 3) uranium, thorium and their ccupounds which are used for j chemical analyses of other elements in laboratories or used  ; for the purpose of demonstration, research or education at L universities or research at universities or research 1 laboratories. l { 4) thorium in some electrodes or incandecent gas mantles l t I

5) single sealed sources with activity content not exceeding 50 kSq -

! The SSI may prescribe that license according to the Act on Radiation Protection is needed even for material with specific activity less than 100 ksq/kg. In 'act $3I has prescribed that the paragraph is not applica.ble for instance for nuclear wastes, j tven if the ordiaance exempts radiation sources which naturally j exist in the nature frcui licensing the 33! can exercise supervision of the sources and the envirornment in which the sources exist especially if that is a working area. Also it can, according to the new law, take. actions agairst such sources. l Since that possibility did not exist in the c,la law no prazia l have yet been established on how to use that possibility. It may l be.used in the future for setting limits for concentration of radionuclides in building material and for releases of radionuclides from coal and peat fired power plants as well as for disposal of ashea from such plants. .

                                                                             ~
4. Principles for etemption The first discussion in the Board of the SSI regk ..

principles for exempting material free regulatory s .o1 held in 1902. It was related to the reuse and recirt 'ie scrap material from nuclear power plants. The meaning Board was that it was acceeptable to reuse and circulat. contaminated material but decision should be based on as6 of both individual and collective doses and decision shoul, taken on a case-by-case basis. At that time it existed no internationally accepted principles for reuse of contaminated material, but the SSI had closly followed the international discussions going on. No values was given for individual dose except that it should be a fraction of 1 msv per year. The collective dose should be below 0.1 manSv per batch of recycled material. These values are in good agreement with the general principles accepted by the experts at the IAEA-meeting in april 1988 which are a) the annual individual dose to the critical group shall be less than 10 uSv from each practice ' "' b) the collective dose shall be less than 1 manSv per year of practice (higher values may be acceptable if exemption is j shown to be in accordance with the ALAR). principle) . l SSI will follow this principle but will have the intention of having the individual doses well below the stipulated value of 10 uSv per year. In some cases, especially whsn discussing constuner products, SSI also consider the JUSTITICATION of the use of the source before j deciding upon exemption. In Sweden it is at prssent no plans to introduce a 'de minimis*, concept meaning that a geneial exemptinn level will be introdu-ced. The g licy is and will be to exempt those specified scurces and practices which fullfill the general principles for exemption and alto for other reasons are acceptable. It is in Sweden possible to give a general licence for sources and in the general licence incluoe conditions and prescribtions. Such sources are not in a strict sense exempted sources. There are some general licences issued by the SSI for instance for smoke detectors connected tc fire alarm rystems where each detector has stronger radiation sources than the smoke detectors products used in private houses. Such detectors included it. clarm systems are cnly permitted in industries, hotels, hospitt.ls and sMlar placas. Those types of licenced sotress and practices are not further discussed. In the following t!.e situation in Sweden in the different areas for exe=pting sources and practices are discussed. -

5 i

5. Exemption of consumer products and small sources for consumer products only the individual use of single items by the general public is exempted and not the production, whole sale

, and 5 rtation. Before new consumer products is introduced to the market the product must be approved by SSI (the source, construction etc) . ' i One example of an approved consumer product is smoke detectors. The conditions for approval are among other things

                  - The radioactive source shall be classified as sealed source according to international standards (ISO)                                                          "
                  - The activity of the source shall not exceed 40 kBq An-241 (Also other. radionuclides may in principle be accepted. Tor those cases the SSI will have to specify the maximum acceptable activity content. So far no such smoke detector is approved)
                  - Absorbed dose 0.1 m from the surface of the smoke detectors must not exceed 1 uGy/h.

Disposal of single smoke detectors can be licenced together with l ordinary domestic waste. from 1974 to 1987 3 380 000 smoke detectors were imported to Sweden. No manufacturing is made in Sweden.

Compasses containing tritium in form of GTLS (Gaseous Tritium
;                 Light Sources) and luminious paint containing tritium are also exempted for individual use. The activity content of tritium must not exceed 15 GBq. About 5 000 compasses are sold per year.

i Also other types of ordinary consumer products which have existed on the market for a long time, such as watches and clocks with luminious paint activated by incorporated radionuclides, are ! accepted without any specific decision by SSI. The introduction l l' of watches with gaseous tritium light sources was however not accepted in Sweden since it was not deemed to be a justified use. ' Also the importation of topames which have been irradiated with { neutrons to improve their blue colour and by that become slightly L i contaminated with radionuclides is not accepted. It was however l not possible to forbid irradiation in Sweden of topazes intended i for export according to the old radiation protection law. It is not yet evaluated if the new law will give legal possibility to  : stop such irradiation. The question will be escussed soon. 1 1

6. Disposal of radioactive waste from outside the nuclear fuel ,

cycle ' t Unsealed radier.uclides are used in medicin, research and industry in more than 1000 different working places. In total 30 TBq of different radionuclides are used, malnly Ho-99/Tc-99 and Xe-133 (20 TBq) but also significant quantities of tritium, C-14, I-125 and I-131. '

6 Most of the waste generated at those places can be discharged into the ordinary sewer system, onto a municipal landfill or incinerated in a municipal incinerator (in Sweden roughly 50 %'of the ordinary household waste is incinerated) according to a ro7ulation issued by SSI (SSI TS 1983:7). According to this regulation vaste can be released into the sewer system if the activity do not exceed 10 ALInin (ALImin is the lowest of the two ALI values,.for ingestion and inhalation) per month from each laboratory or 1 ALImin at each occasion. There is also a limit of 100 MBq per occasion. No limitation is applicable for urine and faeces from patients. Liquid scintillator solutions do not have to be treated as radioactive waste if it does not contain alpha essaitting radionuclides and less than 10 Sq per milliliter of other radionuclides. For tritium and C-14 the limit is 100 Bq per milliliter. For solid waste to be disposed of a municipal landfill or in incinerator the limit is 10 ALImin per laboratory per month and 1 ALImin per package. The surface doserate must not excesd 5 uGy/h. The regulation is not applicable to waste frca the nucloar fuel cycle. The full text is given in annex 1.

7. Exe@ tion of radioactive waste frcm the nuclear fuel cycle There is a regulation (SSI TS 1988:3) exempting contaminated oil frca nuclear power plants from further. control of incinerated in oil destruction plants or large incinerator provided that:
             - the oil has been treated to remove water and particulates
             - the activit.y concentration is less than 5 000 Bq/kg of beta /gaassa emitting radionuclides and 50 Sq/kg of alpha enetitting radionuclides.

The nuclear power plants shall unnually report to SSI the quantities released and the total activity content of that type of waste. During 1987 approximately 80 m3 contaminated oil containing in total 8 MBq (mainly cebolt-60) have been incinerated. Annex 2 gives the full text of the regulation. Sludge frca the sanitory sever systems in controlled areas of nuclear installations may be used as fertil!'er on the fields or disposed of on municipal landfills if the total activity content. l 1s less than 20 kBq/kg (dry weight) .1000 tons containing 60 MBq l have been disposed of during 1987. l l Ringnals nuclear power plant (PWR) have teen licenced to dispose j ion exchange resins from the condenser clean up system and the  ; bottom blow system with activity concentration not exceeding 1 kBq/kg (dry weight) on a local landfill on the site and the total volume not exceeding 100 cubic meter. The resins can be disposed ' of as if they were not radioactive. l l e 4

7 Contaminated scrap metal can be reused (sent to a melter) after a case by case decision frem SSI. In the application the applicant shall present estimates of the activity concentration as well as the total activity of the most important radionuclides. The estimates shall te based on measuraments, but credit can be given to a known history of the batch and by thet restricting the measurements to certain radionuclides. The intention of SSI is that the material shall be melted before reuse and that the products produced should not be consumer products although it is not a mandatary demand, for that reason the applicant shall in his application informe SSI to whose the material shall be sold. The highest acceptable activity concentration levels are in the region of 400-800 3q/kg. In total more than 1 500 tons have been melted and used as inactive material. Most of the material, which was a copper / aluminum alloy, have been used for production of ship-propellers. In 1987 Studsvik As hare installed a melter on controlled area in which scrap can be melted before an accurate activity determina-tin has been made. The advantage with this arrangement is that it is easy to detersine tha activity concentration in the melted material since it is hemogenous. Also a small decontamination effect can be reached because some radionuclides will go to the slag which is a idnor quantity that can be disposed of as radioactive wastes at reasonable costs. Since the melter started operation last autumn roughly 300 tons have been melted, 90 % , carbone steel and 10 % stainless steel.

8. Future developtment Sweden will closely follow the international development in the field and will also try to influence the outcome of the discussions. We will show a restrictive attitude to new consumer products containing radionuclides.

Large quantities of contaminated scrap metal will be introduced on the national and international scrap market. It is necessary to establish internationally accepted criteria and application principles for exempting such material from control. Awaiting such criteria and principles we will continue to treat applications for recycle and reuse on a case by case bases. It is however necessary to have a better national system based on a formal regulation before irrge scale decommisloning takes place. The use of a molter to homogenise the activity distribution in scrap metal in order to facilitate accurate activity detonaination and to reduce surface contamination is an interesting option which will be further studied. 9

i l84-03

                                        \

i r.u s , c... w..ss -,i.. Statens 8o 60204 Karoi nsha siukhuset os 244080 i stralskydds.institut to4oi stocxsotu soina 1 I I

           ,                                                                  information                     ,

i ,- l l f REGULATIONS ISSUED BY THE NATIONAL INSTITUTE OF RADIATION PROTEC D l l ON RAD 10ACT!YE WASTE NOT ASSOCIATED WITH NUCLEAR ENEReiY t l This is an English trans1arion of the Swedi:.h regulation (SSI FS 1983:7) f I on radioactive vaste not associated with nuclear energy, issued in r December 20th 1983 by the National Swedish Institute of Radiation f Protection. The translation has no legal status on its own. In all l I , .; i i matters of juridical significance the Svedish original text shall be \ J Valid, l . i I l l l l l l l !, ~ - - _ _ .

r r > (. NATIONAL SWEDISH INSTITUTE OF RADIATION PROTECTION ISSN 0347-5468 REGULATIONS ISSUED BY THE NATIONA.L INSTITUTE OF RADIATION PROTECTION ON RADI0 ACTIVE WASTE NOT ASSOCIATED WITH NUCLEAR ENERCY SSI FS 1983 7 Issued December 20th 1983 Category 18 Printed March 23rd 1984 The National Institute of Radiation Protection hereby issues the following regulations with the authority of $ 5 af the Radiation Protection Act (Swedish Code of Statutes 1958:110).1 ( Thase regulations are appilcable to the handling of solid and

                           ~

5 1. liquid wastes not associated with nuclear power. The activity limitations specified in $$ 3 and 8 for vastes apply to each of the laboratories (or corresponding entities) covered by licences issued by the National Institute of Radiation Protection for work with radioactive substances and at which the work results in the production of radiactive wastes. Note. The handling of the waste may be controlled by reasons other than radiation protection, for example because of its toxicity or risks for infection or fire. In such cases, these regulations fora a coeptement to such other rules or regulations. I 2. If the conditions laid down in $$ 3 - 11 are compised with, the radiactive waste may be disposed of locally without specific permission from the National Institute of Radiation Protection. Local deposition means either release into the municipal sewage system or delivery to a municipal refuse disposal plant. Liguid vaste

   ,./                                .
                   . I 3. The total activity released into the sewage system must not exceed 10 ALI     per month per laboratory (or corresponding entity). On each min
               -       t - L w m u nm - w o u, s adtortrenutacions.

2 .

                                                                                                                                           }  ,

occasion on which a release is made, the activity must not exceed 1 ALi g and must not exceed 100 megabecquerel. On e ch release occasion flushing ,, shall be carried f.,ut with considerable quantities of water. The values for ALI min which shall be applied are shown in Table 1 in Appendix 1. If the waste contains more than one radionuclide, the maximum permitted activity shall be calculated in accordance. with' Appendix 1. {

                                                           $ 4. Release of radioactive waste should be confined to one release point for each laboratory.
                            $ 5. At each release point there shall be a visible sign stating that                                                   u radioactive wasta may be released into the sewage system.

t i 5 6. Urine and fasces fror, patients who have been administered radio-

                                                                                                                                                    $s nuclides in connection with diagnosis of treatment may be released to                                                    y the sewage system without the activity being included in the maximum                                                   i permitted activity in accordance with 5 3.

I 7. Liquid scintillation solutions need not be treated as radimactiva on wastes provided that:

1. the solution does not contain alpha-emitting radionuclides,
2. the activity does not exceed 10 becqueret per taillilitre or, if the solution only contains H or C, 100 becqueret per millilitre.

Solid wastes l 8. The total activity supplied to a municipal refitu disposal plant must not exceed 10 ALI dn per month per laboratory ker curresponding entity). The maximum activity per vaste package must ner. uceed 1 ALidn

  • The 31ues for ALI min which shall be applied are chew te Tabic 1 in Appendix 1. If the vaste contains more than one t.A couclido, t%n
                                  ;iighest permitted activity shall be calculated in accurdance with Appendix 1.                                                                                                     .

1 5 9. The dose rate at the surface of a package supplied to a municipal refuse disposal plant unist not exceed 5 microgray per hour.

3

                 $ 10. Radiosceive waste in solid form shall be packed in such a way that there is no risk of leakage. When a package is sent to a municipal waste disposal plant it shall carry the following markings
1. the warning sign for 'onizing radiation, *
2. information as to the sender,
3. information as to the dominant radionuclide and its activity,
4. a statement that the surface dose rate does not exceed 5 microgray per hour.

Note. The design of the warning symbol for ionizing radiation is specified in Swedish Standard Specification SIS 03 12 10. Special rules apply to the transportation of radioactive material.

                  $ 11. Packages sent to a municipal refuse disposal plant must not contain any sealed radioactive source with an activity exceeding 50 kilobecquerel.

Note. The term "sealed rad! .itive source" is defined in the Swedish Standard Sps aication SS-ISO 1677. e 5 12. While waiting for disposal radioactive waste shall be stored in a satisf actory manner. Storage' of waste which is subject to change due to fermentation, rotting or similar processes shall be given special consideration. I 13. At the place of storage there shall be a conspicuous sign stating that radioactive vaste is stored there. These regulations come into force on January 1st 1985 On behalf of the Board of the National Institute of Radiation Proeection

   \

CUNNAR BENGTSSON Ingemar MalmstrBm

A Appendix 1 > SS! FS 1983:7  ; f I The concept ALImin ALI (Annual Limit on Intake) is defined in ICRP Publication 30, l "Limits for intakes of Radionuclides by Workers" and it constitutes limits for intakes of radioactive substances by persons employed in radiological work. The limits have been set paying regard to the ICRP annual dose limit (50 asv). There are different ALI values for oral intake as opposed to inhalation. ALImin for each nuclide means the lesser of these two values.

    '           Table 1 shows the values for ALImin for the most common radionuclides.

For nuclides.not included in the table, the National Institute of Radiation Protection specifies applicable values. l- Wasteswh_ichcontainmorethanoneradionuclig

  • 1 For vastes released into the sewage system or sent .o a municipal )

I refuse visposal plant the following shall apply to the total activity during one month: w

                                                                             ^y            4                                                                           '

{k ~ 10. ALImin k For the activity in one individual package the following shall apply:

                                                                             ^k

[ ALIm in k

  • 1*

k [ l For each occasion on which a release is made to the municipal sewage system the following shall apply: 7 A

                                                                         /LIain k I 1.
              .                k The total activity, howaver, must not exceed 100 megabecquerels.

I A is the the activity f radi nuclide k and ALImin k is the ALImin k value in the table for radionuclide k.

                                                                                                                                                                                          }

4 6 6

O App;ndix 1. e . [ SSI FS 1983:7 k' '" ~ , y , Table ?.. ALIsin values for some cosanon radionuclides Nuclide ALImin (Bq) . idclide ALImin (89) lit water 3 10' 85mSr 8 10' ' C 3 10' '5Sr 6 10' l ley 2 10' "Sr 1 10' l 88 Ha 2 10' Sr 5 10'

                     Na               1 10"                        "Sr            1   10

l r iti t 1.to' 94y 2 30'

                     '1p                i.1ot                        H mTc          3 10' 155              8 10'                         " Mo            2 10 8 1'Cl              9 106 '                     t11 min           2 10'

( 38C1 6 10 8 18'Sb 1 10'

                     *2 K               2 10 8                     183 1             1 10' 6Ig                2.t0 8                     125 I             1 10 6 65 Ca              3 10 7                     18'I              2*10 5
                     Ca               3 10'                      13'I               1 10' t 10' 51Cr              7 10'                       181 I s2 Hn             3 10'                       **8 1             1 10 8 s tingn            g.io s                     1 ' Cd            1 10' u                  16Hn-              3 10 7                     115Cd             3 10' 5'Mn               2 1O'                      111 1n            2 10' s2p,               3.jof                      it'Cs             9 10' 55Fe               7 10 7                     18'Cs             2 10' 181 Cs            8 10' 5'Fe               1 10 7 5'Co               7 10'                      18'Cs              3 10' 5'Co               2 10 7                      136mCs            4 10' seCo               3 10'                       1"Cs              4 10'
                      Co               1 10'                       181 Ba            1 10'
                      '8Ni               1 10  8                     1838Ba      . 9 10'
                      Cu               4 10'                       188"Ba            1 10 8
                      Cu               2 10 8                      1"'La             2 10' 6 : zn            5 10 7                      lYh             2 to' 45Zn               1 10'                       198 tr           8 10'
                       aZa             2 10  8                      1 " Au           4 10'
                       Ca               3 10 7                      1"Hg             2 10 8
                       Ca              6 10'                        8'8 Hg            2 10 7
                       '8 As             8 108                  -     881T1             6 10'
                       As               8 10 7                      8Tl             7 10'
                        '5Se              6 10 7                      sta rb            9 10 8
                        Rt              1 10'                       218 Pb            t 10'
                        'Br               6 10'                        81'Po            2 10' 888 Ra           2 10" saBr              1 10' 888 Th           4 101 eimRb             9 10'
   %/
                        'I Rb             i 10'                        83'u              2 10 8'1 hu           2 10 8
             ,-         Rb              2 10' e s ith          7'10'
                                            -                           8Cm            4 108 858 Cf           1 10 3
                         Rb              1 10' e

l NATIONAL SWEDISH INSTITUTE OF RADIATION PROTECTION ISSN 0347-5468 The regulations of the National Swedish Institute of Radiation Protection concerning contaminated oil from nuclear power stations (Issued 29 November 1982) The National Institute of Radiation Protection hereby issues the following regulations with the authority of S 5 ) of the Radiation Protection Act (Swedish code of Statutes 1958:110): 51 These regulations apply to contaminated oil which originates as waste from a nuclear power station. Note. Other regulations also apply to the handling of oil, e.g. the Enviroment Protection Act (Swedish Code of Statutes 1969:387) and the Ordinance on Environmentally Dangerous Wastes (Swedish Code of

                           . Statutes 1975:346) These regulation constitute a complement to such regulations.

S2 If the requirements specified in SS 3-6 are satisfied, oil may, without special permission from the National Institute of Radiation Protection, be burned in a g, furnace which is specially intended for the destruction of chemicals or in an oil-fired boiler with a power exceeding 10 megawatts. S. 3 Contaminated oil shall be separated from solid particles and water at the nuclear power station. S4 After separation the ,ectivity of the remaining radioactive substances shall be determined using a method which also provides information on the radionuclides present. If in some other way it is evident that the activity of the alpha-active radionuclides does not exceed the applicable limiting value, measurennent of the alpha sctivity need not be carried out. The method used for the sampling and measurement of

 -               the   radioactivity             shall  be   approved                by  the   National                             !

Institute of Radiation Protection. S5 After separation, the activity of the remaining radioactive substances must not exceed

1. 50 becquerels per litre for alpha-active i radionuclides, l
2. 5000 becquerels per litre for beta-active and

. gamma-active radionuclides. - S6 The volume of the oil dispatched for destruction must not exceed 100 cubic metres per reactor block per annum.

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S7 Each nuclear power station shall, during the month of January, supply a report to the National Institute of Radiation Protection concerning the oil which was dispatched for destruction during the previous calender year. The report shall include information on each dispatch and comprise

1. The volume of the dispatched oil,
2. The radionuclides contained in the oil and their activities,
3. The date of the dispatch,
4. The recipient of the dispatch, The reporting of the activities shall include error estimations.

These regulations come into force on 1st January 1983. On behalf of the Board of the National Institute of Radiation Protection GUNNAR BENGTSSON Curt Bergman - w

  '- '                      Important notes _ This translation corresponds closely to the Swedish text but is intended only for information purposes. Only the original version in Swedish is legally                                                                              *
         ,-                 valid.                    ,

l . - ! i o ( POSITION OF SWITZERLAND by SERGE PR$TRE Swiss Nuc' lear Safety Inspectorate Switzerland G e 4 k. 9 u = 4 m.____.__.__________..__._.__._.m_ _ - _ . _ _ _ _ . _ a __ __ _ ___ - _- - - --_- -_

WORKSHOP ON RULG FOR EXENPTION FROM REGULATORY CONTROL USNRC / OECD-NEA. WASHINGTON 0.C. 17 - 19 OCT. 1988 POSITION OF SWITZERLAND (note by S. Pretre) A new radiation protection law is now in the c'ocess of being discussed in our parliament. It is a general law with approxim tiy 50 articles regulating the general principles of radiation protection, the responsibilities, the authori-zations, the controls and juridical questions. It is planned that this law will come irao force in 1990. It must be added that there are no numerical dose nor activity values in the law. All numerical values will appear in the ordinance on radiation protection (one level below the law). The present ordinance is ratner old (last revision in 1976) and it must now be totally revised in order to be adapted to the new law. We have started the revision in several working groups. For the time being, nothing is official, but we can present some of the trends which have emerged. We intend to have in the revised ordinance some references regarding "exemption levels" and/or "de minimis doses" and/or "cut-off doses".

1. Dosimetry of workers The personal dosemeters are usually read monthly and for official registration the results will be rounded to the next 0.X mSv. For example:

I 64 mrem + 0,6 mSv l 287 mrem -., 2,9 mSv 1 I This mis" basket

                'gives ajust firstbyfeeling rounding.             of about how much dose can fall into some "de mini-   -
2. Definition of collective dose *)

It is the sum of all individual contributions larger than 0,01 mSv/ year (> 1 mrem /a). We intend to introduce such a cut-off in the sense mentioned in NCRP-91.

3. Ootimisation Individual contributions of less than 0,01 mSv/ year (1 mrem /a) need not be con-sidered in the optimisation process.

Or: Below 0,01 mSv/ year optimisation is not required.

4. Exemotion of a oractice from reaulatory control The criterion will probably be: 4 doses *) above 0,01 mSv/ year. We do not in-tend to introduce a rubsidiary requirement on the collective dose.

For checking the compliance with this criterion, the calculation will have to be made on the basis of realistic (or at most reasonably conservative) assumptions. Finally I want to recall, that the points mentioned above are just trends or intentions. Our revised ordinance on radiation procection will come into force probably in 1991. Therefore we will have the opportunity of taking the new basic s

     /   recomandations of the ICRP into consideration.
         *) "dose" means: "effective dose equivalent"
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SESSION 2.- Tuesday, 10:50 l l ( EXEMPTION OF RADIATION SOURCES AND ,

                                                             . PRACTICES FROM REGULATORY CONTROL:

THE UK POSITION - t i I c a I 4 . L i by r ALLAN DUNCAN *

                                          \                                                          PETER GARDNER **

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  • Her Majesty's Inspectorate of Pollution  :
                     .       **           Health and Safety Nuclear Institute Inspectorate                                                                                                                                           i UNITED KINGDOM                                                                                                                  i i

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NRC/NEA WORKSHOP ON RULES FOR EXEMPTION TROM REGULATORY CONTROL EXEMPTION OF RADIATION SOURCES AND PRACTICES FROM REGULATORY CONTROL : THE UK POSITION

1. Introduction The main regulatory instruments for centrol of radioactive substances and radiation-sources are; I - The Radioactive Substances Act, 1960(1) and
                      -           The Ionising Radi~ation Regulations, 1985(2).

l l There are also regulations for the safe transport of radioactive j These adopt the relevant IAEA recommendations, materials. l f including those relating to exemptions, with the only significant difference being an additional, partial exemption from some regulations for professional users who are experienced in handling radioactive materialc. In view of the widespread acceptance and understanding of these IAEA recommendations the matter of transport is not considered further..

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2. The Ionising Radiation Regulations, 1985.

~ Occupational exposure to ionising radiations in the UK is regulated mainly by the Ionising Radiations Regulations 1985. ' These implement requirements of.the European Council set out in Euratom Directives (3,4) which are based on the same principles as i the recommendations of the International Commission on Radiological Protection (5). Because of the Directives' requirements, great care has to be taken to ensure that any l . I general exemption from regulatory control does not permit a few untypical - but nevertheless possibly hazardous - activities to become to-regulated. Thus, there are no general de minimis dose or radioactivity levels in the regulations below which all , regulatory control disappears. Nonetheless, where radiation l hazards are negligible, and it is judged that to regulate them presents an unwarranted burden on employers and an ineffective t use of enforcement resources, two main means of exemption exist. The first is to limit the definition of ' radioactive substance' in l l the regulations for the purpose of regulatory control. This is:- l l 1 (1) a substance with a specific activity exceeding 100 Bq I . gm"1 and l l + t I e 2 , 1* - . . _ - - - _ _ . - _ .' _ _ __ }

t (ii) any other substance where the activity cannot be disregarded for radiation protection purposes. The latter category, for example, would include 232 Th and 238 U in dusty operations. In similar fashion, some of the regulatory requirements specifically exclude radiation generators such as X-ray machines operating below 5 kV, and cathode ray tubes where the dose rate does not exceed 5 pSvh~1 at 50 mm. The second is tnat certain types of work with lonising radiations do not have to be notified to the regulatory authority: also, these types of work do not require the'amployer to have available the services of a radiation protection expert. It is emphasised that, in these circumstances, the employer is not exempted from other requirements of the regulations. It does mean, however, that the regulatory authority does not give special priority to checking radiation safety in such workplacas. The occupational activities that do not have to be notified are based on lists in the Euratom Directives and include for example:- - (1) work where the total activity on the premises - presents a very low potential hazard (eg less than 5 x 10 3 Bq of 239 Pu), ms 3

(ii) the storage and use of luminous instruments and /

                                                                            )

also. gas mantles containing Th, (iii) the repair of luminous instruments which contain less than 2 GBq of 3-H or 100 MBq of 147 Pm is present, and (iv) the use of apparatus which is type-approved by the regulatory authority, and where the dose rate does not exceed 1 pSvh-1 at 100 mm. In practice, criteria for type-approval follow recognised national or international standards, og NEA standard for ionisation chamber smoke ~ detectors (6). In the UK there has not yet been a demand from amployers to have equipment type-approved where there is no existing recognised standard. If shch a demand was forthcoming, detailed criteria would be set around basic principles which include: (1) the dose rate to be less than 1 pSvh-1 at 100 mm, (ii) the user to have no need to obtain access to,any part of the apparatus which would be a controlled area (for external radiation this would equate to a dose rate exceeding 7.5 ySvh"1), 4

5- _ (iii) robustness and fire resistance to ensure that in the event of an accident no. person would receive a dose exceeding 5 mSv, (iv) and the radioactive source should be encapsulated to form a sealed source. In summary no de minimis dose or radioactivity levels exist or are planned in the area of occupational exposure which would give complete exemption from statutory control. In all cases the basic safety standards relating to optimisation and dose limits apply.

3. The Radi~oactive Substance's Act, 1960

3.1 Background

The main objective of the Radioactive Substances Act is to control the disposal of radioactive waste and the release of radioactive substances into the environment. This is achieved by

          ' controlling not only disposals but also the uses and accumulation of radioactive substances. The Act prohibits the keeping and use of* radioactive materials except by registered users and prohibits the accumulation and disposal of radioactive waste except by those authorised to do so.

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An important principle underlying the operation of the Act is that all uses and disposals should be subject to the provisions ') of the Act unless specifically excluded. Exemption from some of its provisions is provided for cases where equivalent control exists under other legislation. Further provision is made for exempting certain uses and disposals from the respective requirements for registration and au'thorisation. For these purposes, the Act has precise definitions of "radioactive material" and "radioactive waste" and incorporates a schedule which specifies concentrations of certain naturally occurring radioactive elements below which they are not regarded as radioactive for the purposes of control. Thase values are based on concentrations in which the elements occur in nature. The Act also provides for introduction of Exemption Orders. These have been introduced for certain uses or'practicas which are widespread and from which the radiological hazards are negligible or can be made so by specification of limitations and conditions. This approach is beneficial in that, as new uses or practices involving radioactivity arise, they fall automatically within the control system and only then may be considered as candidates for examption. t a 6 i . e __.__r __ _, _ _ . __ . . , . _ _ , . _ - . _ , _ . , _ . _ . , , _ -. , . - . . , , , . _ , _ _ . _ , _ _ _ _ _ _ . , , _ _ _ _ . _ . _ _ _ _ _ _ , . _

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         ,,           3.2     Radiological Protection Criteria As stated above, the Euratom Directives of 1980 and 1984, on Basic Safety Standards for Radiation Protection, are given effect 4

in the UK by the Ionising Radiation Regulations of 1985 in regard to practices and radioactive substances used in the workplace, i For the purposes of radioactive waste management, the UK complies with advice given by the National Radiological Protection Board j on the interpretation of the recommendations of ICRP, (eg (7)). This advice not only applies to the waste arising from substan-4 tial uses of radioactive substances (as in the nuclear fuel i cycle) but provide guidance for exemption from regulation of small uses where waste disposal is typically with domestic wastes. In general, the criterion against which a practice is now considered for exemption is that doses to individuals arising from normal use, mis-use, accidents and waste disposal should not I be more than a few pSv/ year. Although collective dose is assessed, it is not applied as a criterion since we would wish to ensure that, where there is a benefit to be gained from exemption, the machinery of regulation is not applied for its own sake, thereby releasing resources of both users and enforcers towards more important uses of radioactive substances.

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As stated, examption orders frequently include limitations and ' I conditions so as to constrain the application of the exemption to  ! particular methods of disposal for example. This has the effect of reducing individual and collective dose, l 3.3 The Current Position A list of current Exemption Orders, with dates of introduction, is presented in Table 1. Some of these give unconditional exemption from the requirements for registration and/or authorisation, and others have limitations or conditions attached. Some Orders are now quite old and there have-been some important developments since their introduction. For example, the CEC introduced the Euratom Directives setting down basic safety standards and, in that context, is now studying the exemption of non-nuclear radioactive waste from regulatory control. Also detailed work is now being undertaken by NEA and iAEA on exemption criteria and this includes development of a Code of Practice for Control of Consumer Products. For these reasons it was considered timely to review the radiological consequences of these Exemption Orders. The work is now complete (8) and consideration is being given to whether or how they should be revised. . 8

3.4 Review of Current Exemption Orders This review concentrated primarily on assessing the radiation doses to workers and members of the public arising from exempted disposal practices. In the case of phosphatic fertilisers, doses from normal use in agriculture were calculated. For the purposes of assessment, standard disposal scenarios were used and the disposal routes for solid and liquid wastes are shown schematically in Figures 1 and 2. A substantial amount of information had to be obtained on matters such as,

                               -                       distribution of wastes between disposal / treatment routes, f
                               -                        location of disposal facilities and local populations,
                               -                        numbers of workers involved in disposal operations, contact-time with waste, radioactive dust concentrations, etc l

l and assumptions had to be made about matters such as eventuc.1 use j of disposal sites, etc. In all cases the values used are thought to be very conservative. 1 9 . __

Examples of results are shown in Table 2. These demonstrate the i general finding that individual and collective doses are low except for the case of phosphatic fertilisers where the collective dose is considerably higher than the criterion for automatic exemption limit of 1 man Sv/ year of operation currently proposed by the NEA/IAEA(9) but the maximum individual dose is low. This would seem to be a case, however, where the detriment is more than balanced by the wider benefits to food production and nothing would be gained by regulatory control. 3.5 _.e Next Steps So far, examination of the results of this review confirms that there is no urgency to revise these Examption Orders for reasons of radiological protection against the background of currently available guidance. They will be examined again in the light of the final IAEA, NEA and CEC guidance, codes and standards, and then maybe revised. It may also be appropriate to introduce, then, new Exemption Orders for practices which are currently subject to the full regulatory requirements. S l 10 .

        ~.,                                                                                                                                   -

0 The results and methodology of the review are now being used in a more detailed study of the Smoke Detector Exemption Order which is being carried out with a view to increasing the limit on the number of loose detectors (ie, not affixed to e building or structure) which may be kept on any premises (eg a retail store) without being registered. This is because of the greatly increased demand for smoke detectors following advice on safety l in the home in the event of fire and the consequent need for large holdings in an increasing number of stores. O t l . 11 -

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References ,

1. The Radioactive Substances Act 1960, HMSO, London 1960.
2. The Ionising Radiations Regulations 1985, Statutory Instrument 1985 No. 1333. HMSO, London 1985.  ;
3. Directive 80/836/ Euratom of 15 July 1980, Official Journal of the European Communities, L246, Vol. 23 (17 September 1980).
4. Directive 84/467/ Euratom of 3 September 1984, Official Journal of the European Communities, L265, Vol. 27 (5 October 1984).
5. ICRP Publication 26, Recommendations of the International Commission on Radiological Protection. Annals of the ICRP 1, No. 3. Pergamon Press, Oxford 1977.
6. OECD Nuclear Energy Agency: Recommendations for Ionisation Chamber Smoke Detectors in implementation of radiation protection standards, NEA/OECD, Paris 1977.
7. Small Radiation Doses to Members of the Public. NRPB Publication ASP 7, NRPB, Chilton, 1985
8. A Review of the Justification for Exemption Orders and for other Low Level Radioactive Waste Disposal Practices. DOT Report DOE /RW/87.069, Dept of Environment, London, July 1987 and August 1988.
9. IAEA Advisory Group on Exsmption Rules, Vienna, 21-25 March 1988.

e l _ ___ ____ _ _ _. . _ ll _

TABLE 1 '\ RADIOACTIVE SUBST^NCES ACT 1960 EXEMPTION ORDERS IN OPERATION I Date of Title .. Number issue St NO.26 45 1962

1. EXHIBITIONS St NO.2646 1962
2. STORAGE IN TRANSIT
3. PHOSPHATIC SUBSTANCES, RARE EARTHS ETC St NO.2648 1962 SI NO.2649 1962
4. LEAD St NO.2710 1962
5. URANIUM AND THORIUM St NO.2711 1962
6. PREPARED URANIUM AND THORIUM COMPOUNDS St NO.2712 1G62
7. GEOLOGICAL SPECIMENS St NO.1831 1963
8. WASTE CLOSED SOURCES St NO.1832 1363
9. SCHOOLS ETC Si NO.1833 7963
10. HOSPITALS ~ WASTE St NO.501 1974
11. HOSPITALS
  • WASTE - AMENDMENT 1963 Si NO.1836
12. PRECIPITATED PHOSPHATE 1967
                                                  .      St NO.1797
13. ELECTRONIC VALVES 1980 Si NO.953
14. SMOKE DETECTORS 1985 St NO.1047
15. GASE'OUS TRITIUM LIGHT DEVICES 1985 St NO.1048
16. LUMINOUS ARTICLES 1985 St NO.1049
17. TESTING INSTRPIMENTS 1986 St NO.1002
18. SUBSTANCES OF LOW ACTIVITY i
                                                                                                      }
   ' 001 HMIP CSI 1088 TABLE 1

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                        . . ,   ,-                                                                                                         k EXAMPLES OF ANNUAL INDIVIDUAL AND COLLECTIVE DOSE USE OF EXEMPTION ORDERS IN THE UK I

Collective Dose Max. Individual Dose (manSv.y") (pSv.y) Exemption Order Disposal General Disposal General Public Workers Public '

                                        -                               Workers negligible             1.2*

negligible 50.O* Gaseous Tritium Light Devices 0.2 0.00001 0.006 0.1 Omoke Detectors 0.1 0.00002 0.001 0.6 Uranium and Thorium 0.1 0.002 0.21 Hospital Wastes 14.0 O.9 N/A 14.0

                               ' Phosphatic Substances                     N/A (Fertilizer)
  • Note:- It is assumed that these devices remain intact in transit and the initial processes of landfill, but are subsequently destroyed; the tritium is then released and converted within the landfill, or at incineration, to tritiated water. This assumption is conservative.

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SCHEMATIC PLAN OF DISPOSAL OF LIQUID DOMESTIC AND COMMERCIAL WASTES 1 SEWER SEWAGE , TREATMENT PLANT i l LIQUID SOLID El-FLUENT EFFLUENT I e G LANDFILL AGRIOULTURE 004 HMIP 001 1088 FIG 2

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g.s . w . s THE REGULATORY PROVISIONS OF THE EUROPEAN COMMUNITY CONCERNING THE REPORTING AND AUTHORIZATION OF A'CTIVITIES INVOLVING RADIOACTIVE SUBSTANCES h by' G. G0UVRAS and F. LUYKX t 4 Commission of the European Communi ti es + Belgium

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                           .ON RtA.ES FOR EXEMPTION FROM REGULATORY CONTROL The regulatory provisions of the European Community
                     ~

concerning the reporting and authorization of activities involving radioactive substances G. GOUVRAS and F. LUYKX Directorate of Nuclear Safety, Waste Management, Prevention and Control of Pollutior. Commission of the European Communities Luxembourg I. INTRODUCTION The European Atomic Energy Community (Euratou) was established in 1957 with the cbjective of creating the conditions for the establishment and rapid growth of the nuclear industry, thus providing for an increase in Living standards of the peoples of the Community, and the development of trade with non-Mtaber States. For the attainment of its aims, the Community resolved (Article 2 of the Euratom Treaty) that uniform saf ety standards to protect the health of workers and of the general public be established and their application be ensured. These standarus are laid down in directives pursuant to Article 30, Chapter III, Title II of the Euratom Treaty ; they comprise :

        - maximum permissible doses compatible with adequate safety ;
        - maximum permissible levels of exposure and contamination :

principles Coverning the health surveillance of workers. The basic standards were first established in 1959. As they are an ongoing responsibility of Euratos, these standards need to be continuously adapted to take account of technical and scientific developments in the field of nuclear energy and experience with their practical application. Article 32 of the Treaty thus providee for these standards to be revised and this has oeen dons repeatedly. The standards are drawn up by the Commission of the Europe an Communities af ter obtaining the ady'ce of a group (the so-called Art. 31 Group) of Member State experts in the fields of public health care, radiation protection and physics. The Commission and the group of experts take publications by the ICRP as a basis in order to ensure that radiation protection in the European Community is in line with radiation protection in non-Member States. In addition the European Community's Economic and Social Committee is consvlted, a body comprising representativos of employers end workers, who are jointly concerned with the application of basic

,     ,  c6W : 4        "- e-O af Mnisters establishea the definitive basic standards i          (Article 31) af te'    <;hin; the actaine at ine European F.rilament.

This was Last oone in the Directives (1) of 15 July 1980 (80/d36) and 3 September 1984 (84/466) aeonding earlier directives laying down the basic safety standards (BSS) for the health protection of the general public and workers against the dangers of ionizing radiation. These directives were strongly influenced by ICRP Publications ra 26 and no 10. , j

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Directives in general are bir. ding the Member States as to the results to be a:hivved while Leaving to national authorities a competence as to form and means ; . it is therefore mandatory upon *5e Member States to transpose in the prescribed  ; time the BSS onto national statutes and to ensure their integral application. ' II. SCCPE OF THE BASIC SAFETY STANDARDS DIRECTIVE Article 2 of the current 'BSS directive states that it "shall apply to the ' production e processing, handling, use, holding, storage, transport and disposal of natural and artificial radioactive substances and to any other activity wh:ch involves a honrd arising f rom ionizing radi.ition" As a minimum requirement,.the activities referred to in Article 2 must be reported. However, the Member States of the *ommunity may go further and require prior authorization in cases decided upon by each Member State, account taken of the dangers involved and other relevant considerations (Article 3). Nevertheless, a system of prior authorizatiori must be applied, besides the prohibitions provided for by national law and irrespective of the degree of danger involved, in respect of : (i) the ac Hnistration of radioactive substances to perso(s for purposes of diagnosis, treatment or research; (ii) the use of radioactive substances in toys and the importation of toys containing radioactive substances ; (iii) the addition of radioactive substances in the production and manuf acture of foodstuffs, medicinal products, cosmetics and products for household use and the importation for commercial purposes of such goods if they contain radioactive substances. Em2mption f rom the requirements for reporting and prior authorization is provided in Article 4 of the Directive for activities involving : (a) radioactive substances where the quantities involved do not exceed in total the values given in Annex I ; i (b) rgyioactive substances of a c'oncentration of (0.014 les}3 than pCi g100 for sq g"I3)(0.0027 p g ), this L:ait Leiag increased to 500 sq g solid natural radioactive substances ; (c) the use of navigation instruments or timepieces containing radioluminescent paint, but nor their manufacture er repa'r except as provided for in (a) ; (d) apparatus esitting ionizing radiation and containing radioactive substances in . quantities exceeding the values specified in (a), provided that :  !

1. it is of a type approved by the competent aut:iority ;
2. it possesses advantages in relation to the potential hazard 'that, in the opinion of the competent authority, justify its use ;
3. it is const ructed in the form of sealed socrees ensuring effective protection 6 gainst any contact with the radioactive substances and against ,

any leakage of then ; and I r -

4. it does not cause, at any point sitosted at a distance of 0.1 o f rco the accessible surface of the apparatus and under normal operating conditions, a dose rats exceeding 1 pSv h~l (0.1 aren h~l);

(e) apparatus other than that referred to in (f) emitting ionizing radiaticn but not containing any radioactive substances, provided that :

1. it is of a type approved by the ccupetent authority ;
                /. it possesses advantages in reletion to the potential hazard that,                                     in the opinion of the competent authority, justify its use; and
3. it does not cause, at any point situated at a distance of 0.1 m f rom the accessible surf ace of the apparatus and under normal operating conditions, a dose rate exceeding 1 pSv h~l (0.1 mrem h"I);

(f) cathsde ray tubes intended for the display of visual images which do not cause, at an/ point situated at a dstance of 0.05 m from the accessible surface of the apparatus, a dose rate exceeding 5 p3v h~l (0.5 mren h"I) ; Exemption is not granted for the activities (i), (ii) and (iii) above irrespective of the radiation sources or radioactive substances involved except for the navigation instruments and timepieces containing radioluminescent paint. III. PR,08LEMS ENCOUNTERED IN PRACTICE It is evident from the above that a stric* systes of regulatory control sust be instituted in each Member State by virtue of the BSS directive. Exemption f rom the requirements of re por ting and authorization is narrowly defined for certain activities but insufficiently to for others ; the problem centers on the meaning and interpretation of the statement (iii) above, i.e. "the addition of radioactive substances in the production and manuf acture of foodstufis etc." Clearly, a lot depends on the attributes of the word "addition" : "intentional" or "unintentional", "accidental" or "in normal circumstances", "avoidable" or "unavoidable", "voluntary" or "involuntary". This interpretation problem was recognized by the Commission before the advent of Chernobyl and its consequences for foodstuf f s trade ; at issue was the Legitimacy or not of euenotion f rom reporting and authorization o' mater')Ls of very low activity from the dismantling of nuclear installations, given that the eventual use of such materials, for example in the na7uf acture of household appliances, is not known a priori. The Commission was, at the came time, aware of the efforts, at the international level, to develop a coherent philosophy concerning the "de minimis" Levels of activity and of dose, concepts made obsolete by the advances made in clarifying the framework of ex e mpt i ons. The Article 31 Group was kept constantly informed on oevelopments in this field  ; indeed some af its members participated in the joint WH0/I AEA/0 ECD-NEA programme aiming at establihing a roseon basis for exemption of s./ sources and practices f rom regulatory control. It goes without saying that the Group and the Commission gave their unqualified support to these efforts. Whilst attentive to trogress made as regarus the basis for ex e mpt i on, the Consission was forced to tackle with urgency the probles of unrestricted release and recycling of materials from the dissantling of nuclear installations, not least

4 b cause of its obligatiun to give an opinion, und2r Article 37 of the Euratoa Treaty, on the radiological impact of planc to dispose radioactive waste from such . installations. The Commission sought to fill the vacuum by undertaking appropriate action through its vaste management research programme and, or' the regulatory level, through the powers conferred upon it by the Euratom Treaty. IV. PROPOSED RADIOLOGICAL PROTECTION FOR RECYCLING I As it is well known, a considerable fraction of the materials used in the construction of nuclear installations will, on decommissioning and dismantling , be f only lightly active or contaminated. These materials could have high economic value and this provides an incentive for recycling or reuse ; their recycling either as scrap or as discrete items, would require them to follow conventional processing and marketing procedures which do not provides for further radiological control. Since many installations are reaching the erd of their working life, and since large quantities of s rap and items circulate between the various countries, the l radiologi:al problest of recycling would have to be resolved on an international scale. To put things into perspective, it should be noted that several studies of pcwr reactor decommissioning in the US (2,3,4) and Europe '.5) have shown that the tocol quantity of steel ir the active areas of a large (1000 MWe) pressurized sater

reactor or boiling water reactor is sporoximately 10,000 tonnes, of which about I half has a potential for recycling with currently available techniques. An advanced gas cooled reactor of the 600 MW(e) class would also contain in its active areas about 10,000 tonnes of steel with a similar potential for recycling (6), whereas the quantity of steel f rom active areas resulting from the decommissioning of a typical. stees pressure vesset Magnox reactor would be about 13,000 tonnes, of which about a third may be suitable vor recycling (7,8).

On the initiative of the Commission the Article 31 Group set up a Working Party to look into the problem of recycling and propose appropriate criteria. The Working Party first reviewed the situation regarding existing exemption criteria and limits (1,9) ; it was concluded that a suitable basis for establishing criteria for recycling was not available. Two approaches to the eroblem were explored, one based on defining acceptable individual and collective dese levels, the other based on setting "clearance" levels for the activity concentration of the materials concerned, such that the potential individual and collective doses resulting from recycling would be insirnificant. An analysis of current regulatory practice showed that the stipulation of dose limits for the practice of recycl.ing poses practical, and sometimes intractable, problems for both regulators en cperators. The requisite critaria were consequently formulated based on activity concentration levels. They are directly applicable to steel scrap and equipemt f rom nuclear power plants, but the methods by which they were derived can bt applied for the development of criteria for other valuable metals, such as copper and aluminium, end other nuclear installations. The clearance levels oroposed in the report of the Working Party are :

          - For p / [ radiation 1 Sq.g' averaged over a maximum sass of 1000 kg ; to avoid the inclusion o f, highly active items within the average gmass there is an additional requirement that no single iten may exceed 10 Bq.g
          - To comply with IAEA regulations (10) for the safe transport of radioactive materials q the surf ace activity for p // radiation would have to be limited to 0.4 Sq2 cm   for non-fixed contamination on accessib          surfaces,   everaged over 300 cm or over the surface area if less than 300 cm}e        ; fo- fixed contamination themassactivityconcentrationclearancelevelisassume,ptoapply.                The surface activity for o( radiation is to be limited to 0.04 Bq.ca        measured over any area

5-of 300 co2 of any part of the surf ace. For b3th p / T ar.d cA cencentraticns, if

        -     doubt exists for non-accessible surf aces, the activity must be assumed to be higher than the respective clearance level.

The recommended clearance levels are intended to apply to the total activity cencentration of all nuclides, i.e. not only those due to residence in a nuclear installation, but also those present in the raw materials that were used in the canufacture of the steels and equipment involved, and those added during the manufacturing process (such as Co-60 used to indicate the wear of furnace liners). Examination of the question of the boundary at which the criteria Mould be applied led to the conclusion that it is not necessarily, in every case, either the boundary of the licensed site or processing plant or of the state concerned. The relevant boundary is that at which all control ia in fact relinquished, and as such may vary from case to case. A generic assessment of radiation exposures resulting from the recycling of caterials was performed, in which individual and collective doses to workers and the public were evaluated corresponding to various activity levels, in order to appreciate the relative impact of each radionuclide and to identify the most limiting cases. At the clearance levels recommended, the maxj,9al individual dose to torkers or members of the public would be less than 10 pSv.a . The collective dose from the recycling of 10000 tonnes of steel in a year, arising for example from the In exceptional dismantling of two large PWRs, would bc about 1 man Sv. circumstances, associated with very low probabilities of occurrence, the dose to the most exposed individual f rom the direct reuse of scrap or equipeent having an activyy concentration equal to the level recommended might be greater than 10 pSv.a , but the individual risk is not expected to increase significantly (11). Similarly, the recycling of amounts of materials greater than 10000 tonnes per year uilt result in a linear increase in the collective dose but will have no significant effect on the magriitude of individual doses. It was also estimated that the ultimate disposal of recycled materials will not add significantly to exposure, and that the small reduction in detriment by burial in shallow land sites would y have to be achieved by disproportionate costs. . For materials with levels of activity concentration above the proposed clearance Lesels, a case-by-case assessment, of the kind currently performed by the competent authorities in accordance with national regulations, may be required for a particular recycling application. As materials will pass f rom the domain of regulatory control to that of exemption from reporting and authorization, certain "transfer" conditions will have to be set by the national concetent authorities and met by those carrying out thw transfer, such as constraints on the total mass or activity of materials to be transferred, and the identification of the person or organization to whom the materials are seld. Above all, the competent authorities must review in advance and approve the methods and procedures for transfers of materials out of the sphere of regulatory control, and wit} have to ensure that the stipulated clearance levels are cc9 plied with. Appropriate techniques to ascertain compliance already exist, fo this end, a - monitoring programme should be designed and applied, once all significant parameters relevant to the components or metals being released have been identified. This programme should include survey plans for surface contamination _- measurements, sampling techniques and analyses for sctivation products, selection of appropriate portable field ins t rument s and fixed ano mobile laboratory equipeent, and quality assurance methods for the documentation and control of measuring and sampling procedures, instructions, processes and eat.ipment.

It should be noted, h cever, that practical prcble s of measurement cay tell arise in the case of the very low mass activity concentration for alpha emitters derived , from the above clearance level for surface contamination. In addition, the experience gained to date with materials having a potenti&L for recycling shows that the alpha activity, if present, is in the form of surface contamination. For these reasons a clearance level for the mass activity concentration of alpha taitters, has not been recommended. The report of the Working Party wss submitted to the Article 31 Group and revised to take account of remarks made by its members. Considerable delays in the c$nsultation process arose as a consequence of Chernobyl-imposed priorities. It is now expected that the report and the relevant recommendations wiLL be adopted at the next meeting of the Group in October 1988 and published shortly afterwards. 1 i I l O e e

REFERENCES (1) - Council Directive of 15.7.80 amending the Directives laying down the Basic Saf ety Standards for the health protection of the general public and workers against the dangers of ionizing radiation (Of ficial Journal of the European Communities, L 246 of 17.8.1960) EUR 7330, Luxembourg

               -    Council Directive of 3.9.1984 amending Directive 80/836 Euratom as regards the basic saf ety standards for the health protection of the general public and workers against the dangers of ionizing radiation (Of ficial Journal of the Europ2an Communities L 265 of 5.10.1964), EUR 9728, Lux embourg (2)      H.O. 0AK, G.M. HOLTER, W.E. KENNEDY and Jr. G. KONZEK Technology, Safety and costs of decommissioning a            reference boiling water reactor power station                                                                    '

NUREG/CR - 0672, vol 1 & 2, June 1980 (3) R.I. SMITH and L.M. POLENTZ Technology, safety and costs of decommissioning a reference pressurized wate'r reactor power station NUREG/CR - 0130, August 1979 (4) Proposed rulemaking exemption f rom Licensing requirements for smelted alloys containing residual technecium-99 and low enriched uranium NUREG 0518, 158 p , 1980 . (5) K.H. SCHALLER and B. HUBER, Eds Decommissioning of nuclear power plants Proceedings of a European Conference held in Luxembourg ' 22-24 May 1934, EUR 9474 (6) J.D. REGAN, S.J. CRIPPS, 8.R. Kell,Y, 8. HAMBLETON and J.R. NICHOLSON Design features facilitating the decommissioning of advanced gas cooled reactors CEC Report EUR 92070, Luxembourg,1984 (7) CEG8 Generation Development and Construction Division : Proposals for decommissioning of Magnox nuclear power stations. CEGB Report DCM 1-4, Barnwood, Gloucester, U.K.,1982 (8) P.B. WOOLAN and I.G. PUGH The radioactive inventory of a decommissioned Magnon power station structure CEGB Report R0/8/R 4350, Berkeley Nuclear Laboratories,1978 (9) International Atomic Energy Agency, I AEA Safety Series no 9 - Basic safety standardt for radiation protection,1982, vienna (10) International Atomic Energy Agency IAEA Safety Series no 6 - Regulations for the Safe Transport of Radioactive , material, 1985, Vienna (11) R. GOERTZ et al. .

                      "Statistical    evaluation  of recycling      radioactive matal waste",          in Unt e rsuc hung zur Stillegung kerntechnischer Anlagen-Bundesministerium fur Umwelt                                                                              '

Schriftenreihe Reaktorsicherheit und Strahlenschutz (1987) v - r -

No L 265/6 Offical Joumal of the E:ropean Communifes 5.10.84 ANNEXl

1. Values of acovmes not to be excaded,in compliance with Arnde 4 (a), for raeonud. des (i):

nudades of very hgh rs&otomary: J to' Sq: 1,4 *10-7 O (poup I); auchdes of high raeotoxicityt .b 10* Sq; 1,4

  • 10-4 O (poup 2);

auchdee of moderate taamoucary 3

  • 108 Sq; 1,4 10-8 Q (poup 3);

nudades of low raemoucity: $

  • 10' Sq; 1,4
  • 10-* O (poup 4).
2. The panopal rs&oecnve auchda are due 6ad u foDows, according to ther r.lative radaotoA Qryn (a) v.ey be r.e . icier (you, ih gg, gg, i:'Gd altrb 2ggpa *j$na $Ra $Ac 4W 2En Wn gn 2h 2itra stu mu mu 9tu 4tNr (i.i5 10' r) 2iiNe *itru 4tru 21:Pu ytru 'tiru mh mAm yl=Am sjAm TCm 4}Cm Ncm y:cm Ncm ylc. ';?cm Mcm 8;;n 8;tcr
                                      %ct       4tes        met         met       auct       *>            tym       titud (b) High r.dm miciry (youp 2h
                                      '!k       i1Al        lisi        tiri      e          >             >         W 14Y       :)Zr        ifNb        '!!h      8PRh Tu                  '!)=4     '11 4 med       i!Pcd       i! Ped 4 -i.          'A 'Iti                  mr        'lti mi        Tca         'N          'ilce     ' fr=      ' tra         ':15=     %5=

yfEu(34.ar) mEm 'litu TEu yin 8 t-Ho 9tLu m-tu mar yt-Hi mar tos 4 Pit 4;-tr 't:Hg 4 Tr6 Trb 211 m 'Its 811Ai 81.% WAc %As

                                                 $n           ,,n not             yira       Tre           Tra       sjra sac 9tu       MN,(22.s h)            2its,     4:Pu       nam           TCm       TBk
                                       'itcf     *Wct        *W         24 ta      19Fm      }{Ma          (($m       }jPm tilw rei u.d.e ee.&       .a ey(you,ab
                                        'ic      ffwa        itNa        ilus      lie        tie           tki       !W
                 .                     ik        ik          uca         Sc.       It-se      itse          fisc      !?sc itse      !!v         itcr        Hua       tua        IP.           UFe       QFe
                                        >        >           >           >         18m        ENi           ((Ni      j$Ni I                                        Scu      >           >           t.'-za    >          ttca          fic.      Ilc.                            ,

tice > IW IN IN W ItAs IW ' W W W Ith lik kn En En 1:n tmb  !;u hu > tist > > ' W tty 1;Y tty RY itY llY itY

                                        >         >          gz,         gz,        Cz,        :iss         :t-m      :In                             '
!-m itNs !uo
Juo  !!uo :fr.  !;-T. Unu t mnu it!nu  :;n tu ill u mu mn, Trd Ted $!:rd '!(Ag 41-Ag 'llAg QAg QCd ,TCd I
                                         'W       4%.         '18         ig-s. it; s.     % s.          'is. Ts.                          1 (9 ne erhaha.cai un a
  • rs appears a the end d thaa Anan. ,

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Official Joumal of the C ropean Communifes Na L 263/7 5.10,84 mn(sndi mn 'I;sb illsb 'itsb 'lisd ms. ma(9,0iL) 8jish 'j}Te m-Te lij*Te m*Te 'li Te T-T, mie m-Te TT. m Te '111 mi mi m mi mi 'l!xe mxe 'l!x, WC. mi ytC. yic. ills. ms. yrs. ms. T s. in . T-Ce 8jjCe 8jjCe mL. 'jiL. mLa 8ljCe WCe 1llCe 8l(Pr 8jlPr 1llPr 81$Nd TNd mPm 8llPm

                     '!!Pm       ':t Pm ' tP=                ':!P=        'llP=                   ' 15=                                                            '!!sm                                            '!!s=

8lfEu (12,62 h) 8(j Eu mEu mEu 81}Eu '!!Eu 3liEu 8l}Eu 'j!cd 80Cd 8NCd 8!!Gd TCd ll:Gd 3l)Eu i:in itin mn yin yin 41-rbn4,4h) 'Itn ' TTb i:tTb 81}Tb TDy 'gDy lithe 8l[Er TE: TEr TTm 8ltrm 3llTm 8llTm TTm ')$Yb 8)$Yb li!Yb ')ILu 8i!Lu mLu mLu mLu lit *Lu liilu m*Hf 'llHf 8)iHf 9fTa yiTo , lifHf THf THf mis 'llis ' lit. mW TT 'f!T 8l}Re mRe (64 h) 1)jke 8l ire TOs TOs mos, 1)j-Re I)}Re mRe mi, ip ik ip mi, 'Hi, mi, mO. mPt 8ll-Pt m-Pt 8EP: 3l$Pt 3)$Au I){Au WP: 9lAu lj$Au 8)$Au 8PAu 88*Hg m-Hg 87Hg 87,Hg mHg 3lfD mn 3lin 3lfPb TN mN TN mm mm mm mm mm. mm 'Its m^i 1((n  % 2llPa 3l fps 3llRa mFr mFr mTb 1l}U 8;tU mNP SjNp 1((NP 1lINP 9:Pu 1l1U 9;Pu 2;;Pu 9 tam mAm m Am mAm 9lCm m&k mik mDk 8)lCf 1l$Es Ides (d) W . 2 -W (youp 4): (H ik 'lc ilF ' llsi ljs {jc3 [1C fW fW * *

  • 1&c. i!sc its<

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                        %           ttc.           lice         Ilce         lice                           %                                                                !>                                        IW IN          Its.           D se        !!se          >                              >                                                                W                                        line lik         >              !Por        >          elin<                             >                                                                I:x,                                     itKr Ex,         1Pxe           H Ke        Ure           Mb                              ll-n                                                             lin                                     !Pn Wb          Mb             Pb          >             >                               !Ps,                                                             1Pse                                    PY WY          1:v            Hy          ttNb          !;Nbi66 = >                                                                                      !!ab o n = )
                         !!Nb         ltNb          :fW mW                    !PTc                             llTc                                                             IPTc                                    IITc
t-Tc l ire :tT. :PTc :tre mie ittT4  ::Ru
t n $!Pu i:t-n i!;n itPd 'CPd iN '!N itt As i!N PA4 '!N 'tted , iGcd med T-cd
                          %            'ista (69,i mm)           % (4 h)                                         %                                                               81 Pia                                 '!Pl.
                          %           yt-t.          yPia        %             i!Pt.                             msa                                                              yes.                                  ms.
 --'                      ik           ma            i};-sb       ita          yin                               mm                                                               y;n                                   ma ns,as m.)

ilt-n ilt-n ma no,4 ==) msb Min 4tte 4tTe ii;T. ytre mTe ytTe T-i mi mi mi .

No L 263/8 Official Joumal cf the European Commundes 3.10.84 8ljl 8l?Xe $Xe 8){Xe 8llXe 8]I*Xe  %"Xe ;jj*Xe 8l}Xe 8l}"Xe TXe 8llCs 8l}Cs 8jjCs @^s 8llCs 8lj"Cs 8ljCs @*Cs 8llCs 3){Ba 8l!"St 8llBa 8jjBa 8jjBa 8l}La $ta 8j$La 8jlLa $La , 8jice 8ltPr 8l?Pr 8ll*Pr 8l$Pr 8j}"Pr 8f;Pr 8jPr 8lyJd 8lj"Nd h 8!!Nd 81&4d 8llNd $Nd TPm 8lfPm  %*5m 8l}5m 8ll5m T5m T5m TEu 81}Gd TGd 80Tb 8lfTb

                        @*Tb ($ h)                                                  TDy          TDy     81lDy      $Ho        8SHo         THo 88Ho         $*Ho THo                                                    85*Ho THo          88Ho       TEr          8SEr 88 Tan       litTm                                          QTm          %Yb     NW         8QYb       QYb          Q"Lu
                        @Lu          9"Lu                                           QLu          liilu   q*Hf       8lf"Hf     %"Hf         THf 8ijTa        8JITs                                          8lfTa        @Ta     $Ta        9Ta        8l1*Ta       8lfTo
                        @*Ta         WTa                                            8lfTa        9W      8i!T       @T         8i!T         %W mne          gne                                            mne (iz,7 6)         8tt ne     mne        8lt ne       Tos mos          if -os                                         m-os         mi,     mit        mit        P it         mu mit          %ei                                            ma           wn      m ri       Sri        %            %
                        %Au          'h                                             'h           1"Hg 8Ef*n         8iTD       Tn           Tn
                        'It-n        'itn                                           irtn         Tn      m rb       mrb        trb          tes T-rb         Tr6                                            ' firs       'ffm    %m         Tm         Tro          Tro
                        'Cro         21:na                                          2Gna         Mu      Mu         Tu           ,a u ai saU dspined (*)                                                         aggy,   affNp      TPu        $Pu          tam MAm          %Am                                            M"Am MAm             ajlCm
3. la the case of the nuclides 8881a,8**Nd,"nh,8"Re and 8"Se the roquarement for repornas and obtasmang pnor euthernacos may be waived, irrespecove .af the quamones used.
4. la the case of a snur.are of r a a- d A= onher than Tb-est and U-aat belcasing to ddferent re&osomary youps, 6e roquarumsma for repnrnas and abu:nant poor authoruseon may be werved only if the ousa ed the renos beeween the acemey of each of the reeon i A= and the have land down en peregraph I for 6e youp so wkh it belongs is Isas thaa or equal to 1.
3. For th penet, the requersmanes for reporees and obe... mag pnar authorusace need not be if the overau wowwy in resoacave A- dose not encsed 210' Sq of ennem (3,410p- Q),1+10s Sq of ?"rui(2,710-8 Q) or 3108 Jeg, Sq of gt,4.to.s Q) and where this paant is kept or used for the ----% or repeir of the -_ - ; and asmepieces relemd to in Arnde 4 (c).
6. nh see M A 8 in this Annes shad, where necsenary, be asagned to a tomary group by the compnent authonry.
7. la the caan of gas mandes % " wnh thonuse the regereneect for reporung and obtairdng b, r av6 n.. .eed be e,,hed e e,e i. - of *e., me une<m,e.

t e n (') ne esoo breween the acenty of MU and MU must not exceed 1.

Of6cial Journal of the European CommunEes No L 365/9 3.10.84 L Alphabetical list of the elements Asoma Anwng Nomte Number NW Ac 89 Actinium N 7 Nitrogen Ag 47 50ver Na 11 Sodium Al 13 Alumirdum Nb 41 Niobium Am 95 Americium Nd 60 Neodymium Ar 18 Argon Ne 10 Neon As

  • 33 Arsenic Ni 28 Nickel At 83 Astatine No 102 Nobelium Au 79 Gold Np 93 Nepeunium E 3 E" Ozynea O 8 Ba 56 Barium Os 76 Osmium Be 4 Beryllium Bi 83 Bismurh p g g ,

Bk 97 Berkelium p, ,g pyg,, , Br 33 Broraine Pb 82 W C 6 Carbon Pd 46 Palladeon Ca 20 Calcium Pm 61 Promethium Cd 48 Cadmium Po 84 Polonium Cerium Pr 59 Preaeodymiens Ce 38 Cf 98 Caldornium Pt 78 Platinum C1 17 Chlorine Pu 94 Pluroaism Cm 96 Curium Co 27 Cobal Ra 88 Radiues Cr 24 Chromium Rb 37 Rubidium Cs 33 CassiunvCesium Re 73 Rhenium Cu 29 Copper Rh 43 Rhodium

  • Ra 86 Radoa Dy 66 Dysprosium Ru 44 Ruthenium Er 64 Erbium Ea 99 Unstemium 5 16 Suhaut Eu 63 Europium Sb $1 A mi-y
                                                                                                .4          21    Scandma F           9      luorme                       5e          34    Selenium Fe         26     fron                           si          14    Silicoe Fm      100      Fermium                        $m          62    Sassariana Fr        87     Franaum                        sn          30    Tim
                                                                                                  '         38                                        !

Ga 31 Gallium

                                                          '"     U*         ""

Ta 73 Tantaluen Ce Germanium 32 n 63 Th H 1 Hydrogen Tc 43 Technetsum He 2 Helium Te 32 Tellunum Hf 72 Hafnium Th 90 Thorma Hg 80r Mercury Ti 22 Titanium Ho 67 Holmium T1 81 nallium Tm 69 Thulium I 33 lodans la 49 Indma U 92 Ursaiam le 77 tridma v V 23 Vanadium , 19 Potasa um , M N T 74 Tumentes La $7 lanthanum Xe 34 Xenon u 3 Uthium I "" Y 39 Yttrium ' Md 101 Mendelenum Yb 70 Ytterbium Mg 12 Magnesium

  • Mo 15 Mansamese Zn 30 Zinc '

Mo 42 Molybdenum Zr 40 Zirconium O t

u 3 Np. c ,v . , ,< a l t EXEMPTIONS FROM REGULATORY CONTROL 4

   -            -                                 by J.E. COOK      and A. MURRAY Australian Nuclear Science and Technology Organisation Australia 9

i \ . 9 l . { .

i 4 EXEMPTIONS FRON REGULATORY CONTROL IN AUSTRALIA Introduction Under the Australian Constitution responsibility for safety, including radiation safety, rests with the individual States and Territories. Each State and Territory theref ore has its own Acts and Regulations for the control within its borders of exposure to ionising radiation. The Commonwealth Government provides recommendations on control of exposure to ioni' sing radiation,  ; particularly with regard to the mining and milling of radioactive , ores and on radioactive waste management and disposal, which'may be adopted in States' legislation. With regard to the transport of radioactive materials, all States and. Territories, and the Commonwealth, adopt the IAEA Transport Regulations, including their exemption provisions.  ; Current Loaislation Most States have legislation which includes clauses that allow I for exemptions under specific circumstances and usually at the ! discretion of the State regulatory authority. These clauses have ! generally been applied te exempt individuals working under the I supervision of a licensed person from licensing and/or i registration requirements, rather than for the exemption of specific sources or pr actices. l However, examples of cases where exemption of specific sources

                                                                         ~

have been provided for in regulations include: j . radioactive substances if the total quantities are less j than 0.0004, 0.004, 0.04, 0.4 or 4 megabecquereis, ( depending on the radionuclides concerned:

                .                    timekeeping and other app' roved devices containing
  . ,                                radioactive self-luminous elements with radioactivities                                                               7 not exceeding specific quar. cities; E

I~ c i I l 2 .

                                                                      .       l r
       . radioactive substances in cardiac pacemakers, except for          I identification and notification.                                  i
       . television receivers which emit radiation, which when measured at a distance of 5 centimetres from any part on the external surface and averaged over a 10 square centimetre area does not exceed 5 microgray per hourg           ,
       . ionisation chamber smoke detectors where the radioactive material is in the f orm of a sealed americium-241 source and which meet specific labelling requirements:

l

       . gaseous tritium light devices under particular circumstances.

There are no exemptions in place with respect to the disposal of l radioactive wastes, although there are regulations f or the controlled dispssal of l ow-l ev el airborne and water-borne activity and recommendations f or the disposal of low-level solic wastes by the user. Commonwealth Codes In the Commonwealth of Australia's "Code of Practice on Radiation i Protection in the Mining and Mil?ing of Radioactive Ores, 1987", made under the Environment Protec tion (Nuclear Codes) Act 1978, i there is provision f or the appropriate authority to grant f exemptions from all or some of the provisions of the Code where ] the authority is satisfied that no employee is likely to receive an effective cose in excess of 5 mSv per year and members of the public could not receive ef f ective doses in excess of 1 mSv per year, and neither receive tissue (skin, lens of eye) doses in excess of 50 mSv per year. Also the authority must be satisfied that facilities and procedures used would ensure that radiation exposure is and will remain as low as reasonably achieveable. )

3 . The Establisheent and Develcoment of Exemotion Rut es Currently there are no specific proposals under consideration by the Commonwealth, States or Territory Governments within Australia for the development of rules for the exemption of practices or sources from regulatory control. There is however the recognition of a need for a consistent approach to the provision of exemptions, both across States and across different practices. The record of the present meeting is awaited with considerable interest. t t l t t I ~ _ .) b G I

p. r f REVIEW OF EXISTING ISSUES by G. A. M. WEBB National Radiological Protection Board United Kingdom e [

 \.                                                                                  1 4

is

                       /                                                                                          G A M thbb
                       . Introduction The purpose of this paper is to offer brief personal comments on a number of specific topics related .o exemption from regulatory control.

The need for justification of a practice under exemption ruly For the reasons I have already noted in the paper on a definition of negligible risk, I believe that the benefit associa.ted with a practice is a very imporLant aspect of the acceptance by members of the public of the risk associated with the practics. Since justification is the process of determining whether a practice has an associated not benefit, it seems to me essential that this process is retained as a pre-requisite for exseption under whatever system is devised. Having said that, I recognise the difficulties in carrying cat a justification evaluation, both in circumstances where the benefit, and indeed the detriment, may be difficult to quantify, and in circumstances where they are both extremely small. This is very of ten the case in dealing with, for example, con:;umer products but nonetheless, I believe that a qualitative assessment of benefit is required. This would avoid what could be known as frivolous uses of radiacion being exempted from regulatory control, just on the grounds that the doses associated with them were very small. We must recall that the concept of exemption from control does not apply only in the context of vaste disposal but could apply to all practices involved with ionising radiation. Another time when justification is a difficult concept is when the sourcs being considered for exemption is not a complete practice in the ICRP terms. This is the general situation for waste disposal but here again, it is necessary to show that there is a demonstrable net benefit in the entire practice of which vaste disposal is an indispensible part, even though the vaste disposal component, looked at in isolation, may have an overall net detr! ment. Despite the suggestions of the ICRP, I do not personally believe that cost-benefit analysis is an adequate tool for assessing justification. It may be that more flexible decision aiding procedures such as multi-attribute utility analysis would be better for this purpose since they can secommodate inputs to the justification decision that are difficult to quantify in cost terms, The role of individual and collective dose assessments in establishing exceptions f It is quite clear to me that the quantitative basis for exemption rests ou an assessment of both the individual and the collectivo doses from the source or practice being considered for exemption. As I said in my earlier paper. I believe that we are correctly dealing with doso rather than risk when we consider sources for exemption so that I do not stray here inta the realm of probability, at least not of low probability. In assessing the maximum individual dose un the proposed practice, the procedure is a normal one involving the defini' n of a critical group, the l selection of the appropriate pathways and radionuclides and the calculation of the maximum annual individual dose. It is apparent from thic description that I do l not believe one can exempt a piece of radioactive material without sees idea of where it is goiag to go and now it is scing to be treated. If there is no control over this then the pathways and scenarios must be set up on a very broad basis to ence= pass all reasonable use and even ' reasonable abuse' of the material. This raises a rather fine distinction between total exemption from control and exemption from control under certain conditions, for exa=ple, it may be a condition of exe=ption that caterial is disposed of as vaste rather than sold to l the nearest second-hand' dealer. If such a condition cannot be imposed then the L secn: ries fcr essescoent cf maximum individual d:so nted to take acccunt of the possibility of re-use of the satorial in various veys. These points have been N recognised by th3 IAEA Advisory Groun. In assessing the collective dose, there are rather more divergent views . available as to the summation of individual doses to make up the collective dose, the time scale over which the collective dose commitment is irtegrated, and the period of practice for which the collective dose commitment is calculated. Although there is a strong lobby, which carries a great deal of common sense with it, to ignore in the collective dose assessment individual doses which are themselves negligible, this would reduce the procedure of exemption to simply an examination of the maximum individual dose and a determination whether or not this was below a ' negligible level'. Since I believe that it is logically inescapable, given the ICRP system of dose limitation, that the' addition of very small individual doses provides a collective dose which has an implied health censequence, then it is only sensible to assess the collective dose by integration over all individual doses for the purpose of judging exemption. Integration of collective dose rates over time is more problematic because in some cases we will be dealing with extremely long lived radionuclidas and the reliability of integrals over a thousand, ten thousand or even a million years becomes highly suspect. I would personally tend to truncate the integral at the point when we can no longer sensibly rely on the answer, ie, at perhaps ten thousand years. In assessing the duration of practice to be included, this needs to be commensurate with the time scales of regulatory control and the duration of the practice concerned. It is not in my view helpful to establish a firm rule on this aspect but to assess the practice so that the collective dose commitment is a reasonable fraction of either the total collective dose commitment from the practice being considered or a reasonab'; fraction of the total duration of a regulatory system. In line with general requirements connected with optimisation, the collective dose assessment should be a best estimate; also in this case, since we are seeking the optimum treatment, the individual dose assesseent should be a best estimate. The basis for derivation of individual dose exemption levels As I have noted in my earlier paper, there are two points of view from which these levels can be approached. The subjective approach,' making judgements as to the view of risk levels by individuals in society and the points at which individuals would regard these risk levels as negligible. This approach is the traditional method for obtaining an exemption dose level but the concentration has perhaps been too great on the numerical value of 10** or 10*' per year at which the individual was judged to , regard the dose risk as negligible without sufficient recognition of the other attributes of the risk. The objective approach relies more heavily on the unavoidability of doses frem radiation, particularly natural radiation, and the unavoidability of fluctuations in these doses. It uses the argument that a change which is small compared with the unavoidable fluctuation cannot significantly affect the well being or risk status of the exposed individual, given that all of the other parameters of the risk, apart from the anthropogenic nature of the source are the same. Probably the optimum result is to use both approaches, but it might be more sensible to start with the second objective approach and use the subjective argument in a supporting role rather than the other way round. It is important in argu=ents concerned with exemption levels to distinguish , fairly clearly that the risks being discussed are those of a totally negligible and inconsequential nature and not those which are tolerable. The latter is appropriate to discussion of the dose limits rather than exemption levels. . O

i The rain cf opti-is-tion el protectirn in estr.b1Bshina rnd applyina extrpGurn

 . rules           .

At the extreme, exorptien could be rescrdsd es seroly a specici ecso of

 . optimisation. Thus, optimisation is a crucial component of the e.nemption procedure, although the way in which optimisation is carried out, in generating a collective dose figure for automatic exemption, is slightly different from the normal procedure. The essential argument, which has already been stated, is that if the detriment from the practice being considered is so small that the associated resources which would be available, using an appropriate figure for the cost of unit collective dose derived from cost benefit considerations, is very small, then clearly the practice is not susceptible to further practical measures.

Thus, the optimum solution for this practice is to exempt it from further regulatory examination and control. It is important to recognise however, that exemption from contrci may well be the appropriate course of action, even though the practice does not satisfy the criteria for automatic exesption on the grounds described above. It may well be that of the courses of action open to the regulatory authority, exemption provides the greatest overall benefit or the minimum overall detriment among the available options. It is then the optimum procedure. This view could be arrived at either on a case by case basis with particular practices, or in a generic sense by carrying out studies on classes of practice with a view to developing general guidelines for their regulation. . In carrying out optimisation studies on sources which are candidates for exemption, it will generally be adequate to use cost-benfit analysis because the individual dose criterion will ensure that all doses are extremely small and, in general, only the objective health detriment will need to be considered. Thus, in ICRP terms we only need to work with the alpha term and can ignore for practical purposes the beta terms.

                                                      ~

Basis and need for collective dose lower bounds I assume that by the phrase collective dose lower bound is meant the criterion of a commitment 1 man Sv per year of practice. If so, then I see this as a criterion for automatic exemption without further thought or investigation by the regulatory authority. It should not, however, be seen as a criterion above j which it is not possible for the regulatory authority to exempt from control. As I have stated already, I believe that under some circumstances exemption may be the optimum choice, even though the collective dose might be above the criterion. If this is explicitly recognised then'I see no problem with a collective lose lower bound of this form, but if thsre is a possibiltty that it turns into a de faero limit then we might be better to do without it and treat the optimisation for each practice as an exercise in its own right. Method for establishing derived exempted quantities This is not an aspect to vnich I have devoted great thought but I do not find any significant difiiculties with the procedures used in, for example, the Annex to the most recent IAEA advisory group report. However I recognise that it is possibly when we get to level of achieving international agreement as the assumptions to be made that the most intractable practical problems over implementation could occur. 9 4

       . , -   ;v .- ,
                 .     . .-      w         , ,             ,
   ~                                                              .

A COMPROMISE REGARDING THE THREE DIFFERENT CULTURAL RESPONSES TO THE "DE MINIMIS" QUESTION by SERGE PRETRE L t i Swiss Nuclear Safety Inspectorate i Switzerland l I 9 e I l l lu I

  ~

1 6

( r t Workshop on rules for exemption from regulatory control i USNRC / OECD NEA Washington D.C. 17-19 october 1988  ;

i 4 .

A COMPROMISE REGARDING THE THREE DIFFERENT s. CULTURAL RESPONSES TO THE "DE MINIMIS" QUESTION l 3 i I I i S. Pritre  ! l [ Swiss Nuclear Safety inspectorate l 3 Division of Radiation Protection , CH 5303 Wuerenlingen, Switzerland 4 J f L,.' i' l l

         = _ . _ - - - - __ - _ - . . - - _ .           . .- -__-..- - , -- ...         - - _ , . . _ , . , . . . . . ,

A Comoromise Recardina the Three Different Cultural Resoonses to the "de minimis" Question i S. Pritre Swiss Nuclear Safety Inspectorate l I 1. Introdvetion in the documents preparing for the present NRC/NEA Workshop on Exemption Rules there is a stimulating list of 6 issues for Session 4. I have chosen the following three as a starting point for my paper:

    - Basis for Derivation of Individual Dose Exemption Levels.
    - Need for Collective Dose Lower Bounds, o Methods for Establishing Derived Exempted Quantities.

Another part of the ideas developped in,this paper comes from the book "Risk and Culture" by Mary Douglas and Aaron Wildavsky. In this book it is shown quite clearly that the perception of risk is much more a social rather than a techni-cal problem. This is evident when questions such as the following are formula-ted: o How safe is safe enough?, or

     -   How small should a risk be to be considered as negligible?

The answer to these questions is a matter of culture or perhaps of-psychological profile.

2. A soectral analysis of the society Imagine that there exists a parameter which describes the different responses of persons to risks. If we ask a large number of persons how they would react to several dangers or risks we obtain, according to sociologists and
   , anthropologists, 3 main groups of reactions.

Response of modern society to risks (a spectral analysis) o _

                                                                                                       ' ~i          .
                                                                                       ,     'M ~' f r I
                                                                                          ~~

freed 6m g c . . . . . . ;. ' V g : lg, o - order

                                                        .t1111i,                                                           .

purity I 11 , , Parameter describing the type of response to risks

0 3e l f For the first group the key word is FREEDOM. For the second group it is ORDER l and for the third it is PURITY. These 3 tendencies are not just of theoretical or intellectual nature; they are I an observed reality which has been thoroughly studied among primitive societies. (1,2). Anthropologists have observed the reactiuns of primitive people to several problems connected with danger or impurity. They discovered these 3 tendencies, which among primitive people are more pronounced, less nuanced than in modern society. In modern man, the 3 tendencies should to certain degrees be simultaneously present in the same person. A mixture of the 3 groups forms the whole society, and a society where these 3 groups are represented in a well balanced way and where the extreme views are not too strong, will react soundly to dangers or risks. I.et us now look closer at these 3 groups.

3. The Dioneerina society The sociologists call it the "heroic" society but I prefer to use the label "pioneering society". The individuals of this society are initiative, optimis-tic, pragmatic; they consider freedom as being the most important thing. They are individualists, and the extreme exponents of this group will tend towards ruthless seeking of power.

These people have little relation to risk and are rather stimulated by dangers; they consider dangers as being interesting challenges. The pioneering society does not really consider our "de minimis" problem as being a problem. When you ask them what the "de minimis" dose, or the dose of no significance could be, they answer: Of course, this "de minimis" dose must be distinctly below the lowest threshold for non stochastic effects; if it seems mandatory to have a figure, choose for exanple a value around natural background. But we don't see the need for setting a value.

4. The reculatina 30cietY The sociologists call it the "bureaucratic" society. Because of th'e negative political flavor of this word I prefer to use the more neutral term of "regulating society". The individuals of this society prefer method, structure, rulis and laws. The most important thing for them is order. They have a strong tei.ency towards introducing hierarchy everywhere. In extreme cases this group will tend towards caste distinction.

in this society, dangers are used to reinforce the rules or the laws. For the "regulating society", the "de minimis" problem is a.n important one, and it must be solved quantitatively for the sake of ORDER. For them it is important to clearly set 3 value, but which value is less important. Nevertheless, the chosen value must be compatible with existing laws in order not to threaten the inter-nal coharence of the structure of rules. . G

                                           . _ _     _ _ _ _ _ _ _ _ _ _ _ _ _ - _ - _ _ _ - _ _ _____---___-__--_-----------___--_--__a

4

5. The moralisina society The sociologists call it the "sectarian" society. Once more, I want to avoid this term because it is too negatively loaded, and I propose to use the label of "moralising society'. The individuals of this society are t*.rongly motivated by health aspects, cleanliness and protection. Their key word is curity because purification is most important to them. They are usually rather pessimistic, and tneir views tend to become sectarian. At the extreme, this group could tend towards self-destruction.

In this society, the dangers will be used to reinforce the cobeston of the group which wants to protect itself. This society will therefore show the tendency to encapsulate itself. With regard to the "de minimis" question, the moralising society reacts as follows: Even the smallest dose can have a lethal consequence, therefore, there is in principle no "de minimis* dose other than zero. If a value other than zero is to be chosen by international bodies, we insist that this value be very small, and furthermore it should be connected with a limitation of the collective dose. l 6. A sound or well balanced society l All 3 above mentioned tendencies play useful roles in modern society, but within l every tendency, the extremes views 7.re not constructive. The whole situation can l be represented in a triangle where it is important that the center of gravity of our modern society remains near the center of the triangle. l regulating # moralising (bureaucratic) 4 ' (sectarian) society e - - *' --------------- - -- 7, society s

                                                                                                              /~
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                                                   \(freedom)//
                                                     \

IndMduausm power seeking ' s / 3 basic cultural

                                                           \/                                              responses to risk
                 -                                           %/

pioneering (herolc) society ,

  -                                                        o     5o All three tendencies by themselves                                                                        ,

I have limited usefulness, but together they correspond to necessary fur.c- I steering brakes I tions, like the engine, the steering gerir and the brakes of a car. l regulating l rnoralising l If we look back at the evolution of l society society our society within the last 40 years, l we observe the following trend which is worthwhile mentioning: The earlier e---- -------- -----v ( society strongly believed in techr.o- \ h  %. / l logy cnd the FREEDOM Group (Pioneering \/ ~ group) alone represented the majority. With time a shifting occured from the , pioneers to the regulators, and later i / on from the regulators to the mora- \ '

                                                                                                             /

lists. 'N\ j

                                                                                                         /

Some 10,to 20 years ago, the pioneers and regulaturs together had such a (II'*dOf") '09 I"O comfortable majority that they did not We need i / listen to the warnings expressed by all three \,v,/ the moral;sts. As a consequence, the groups! majority of that time failed to see pioneering the limits of growth, society Trends in our industrial society 1950 ---+ 1988 k-NNI5h-l!)bb e X-: -:-:-:-:~-:-:-Z-: , 5555$?5$555: h.kNN555Nkh E -F_-5 ___'__.

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                               . . - >        q.                      .y               c- .  .-3 5 pioneering               regulating                                rnoraising society                 society                                   socloty Today, the moralists are becoming an important and strong group, and we are now observing a dramatic change which has already taken place in sor.e countries: a new majority of regulators and moralists is appearing.

This new majority could possibly rule out the groh of the pwoeers, and would - therefore destroy the ' engine" of our society. That would be the beginning of decadence. _ _ _ _ _ _

6-I am not trying to moralise, but what I would like to show is, that all three tendencies have e positive role - to play in a modern society. The other ' important fact is that the regulating group is always the winner, because it , has a steering role and because its s / views are felt to be less extreme than the views of both other groups. old

                                                                ** 4 w]               gg Therefore, the regulating group might in the future receive more responsabi-Y       .
                                                                                                     ,,,m,
                                                                                                              \ ***

lity than the other two groups. What about our own tendency? 7. l We radiation protection people have the responsability to set up standards s h l for the protection of the workers and *<% the protection of the public. In this ' tay, we decide for them. Therefore, po m ' The new mawity the society has the right to require " h*mers) from us, that we protect it according coud oestroy ma}ority \ v'< me 'engne' and to its views. In other words, our twig decaoence. protection standards should avoid l extreme tendencies, and should be a compromise not too far from the center of the triangle. . Thus, each one of us should know about his (her) conscious and also subconscious tendancies, coming from our education, our religion, the structure of our language, and our culture. All these influences have created a computer software in our head that we have to live with. This computer software might be called "psychological profile" if you prefer. And this profile has influenced the choice of our profession. Why do we deal with protection? Why do we feel res-ponsible to protect other people? All radiation protection people probably have some sort of common bias towards the regulating (ORDERI) or the moralising (PURITYl) society. We should be conscious of that Mas and should try to com-pensate it by avoiding too extreme positions. Once a group is nut of balance, i.e. when a large majority of the group thinks and feels along the same lines, this tendency will tend to reinforce itself, util glide towards exageration and will become contagious. The minority will be swallowed and the collective bias will become more and more extreme. This group dynamic process is called ' psychological epidemy" by C.G. Juni, (3,4) and can even reach collective psychosis. It seems important to me, that the group of radiation protection people will become conscious of its bias which is not pathologic yet and will restore the balance by trying to reach the center of the triangle.

8. National biases There are also national biases:

let me recall the chaos of diverging reactions to the Chernobyl fallout. It is interesting to observe that there were'very marked cultural differences: Which countries reacted excessively as

      - a pioneering societp?                a regulating society?_ _ _ _ - _ a moralising society?

l i i Countries like France, Germany, Italy, Sweden, Norway and Austria reacted in J l very different ways, which are perhaps predictible when you study the dominating cultural and religious background of these societies. ' l Thus, arriving at a harmonised radiation protection all around the world seems to be a difficult challenge, because the differences are deep within the soul. Nevertheless, if you and I are participating in international bodios who pretend , to set up international protection standards, we should at least be aware of the i t question: where is the real problem located? And we should at least try not to impose upon others our own psychological and cultural tendencies. International harmonization is perhaps a good remedy because it forces every country to leave l its national bias. L.et us hope thtt international htmonisation will also be usefull in moderating our professional bias. , i  ! i

9. Acolication to our "de minimis" oroblem At a first glance, it seems that the 3 positions to the "de minimis" question (as described above) are so far from each other, that a compromise is impossible. But it has also been seen that the regulating group is the key group for several reasons. In addition, the positions of the pioneering and moralising groups tend to neutralise one another. Therefore it seems to us, that i

the only way out of this impossible situation is to ask a moderate regulating group to propose a compromise. In the following pages, I will try to represent this group and to propose such a compromise.

10. Facts about f atalitY rates in modern Society l

1.et us take as a basis the overall risk of death in our society. Fatality Rate Depending on Age and Cause I (Switzerland, Mean of 1979-1983) i [ l 5 l - l g. 10-1 l ,' <]

                                                                            -                                                     10-2 j                        s
  • I 5

1

                                                                                    . . . . nma, . i o . . '
                         ',                                                                                                       10 ~3 i

u*c 6d e / H om6c ed f 1 Qth.r Ac cidents 5 l l Traffic Accdents f , e . . . . ,,- .3 ,., .- .. .. .. - l J I I ' I I I I 20 30 40 Age 60 70 80  !

8 During childhood it ligs arond 310 4 per year, between 20 and 40 years of age it is approximatly 10-3 per year, and at 60 years of age it is already 10-2 per year. Let us propose the following idea as being the basis for an international agreement on what could be called a neg'igible additional risk: During childhood, when the overall risk of death is N310 4 per year, an additional leukemia risk of $10-6 per year is negligible. Otherwise, most cancers occur at ages when the overall risk of death is N 10 2 per year. An additional cancer risk of $10 5 per year is therefore negligible.

11. The "de minimis" dose .

Even if we use pessimistic risk coefficients, we see that at all ages, an additional individual dose of less than 0,1 mSv/a (< 10 mrem /a) is to be regarded as a negligible dose. Therefore we finally come to the following proposal: ! 1. For any individual, an additional annual dose of < 0,1 mSv i (< 10 mrem) is negligible.

2. The annual sum of all "de minimis" doses for each individual should be lower than 0,1 mSv (10 mrem).

3, The 'de minimis" upper bound for any single source could be s 1/5 of that value. 4 The "de minimis" dose from any single source could be 0,02 mSv/a (= 2 mrem /a). This value corresponds to less than 1 % of natural background. It is also smaller than the yearly fluctuation of the natural background at the same location, or for the same person. At this trivial level of individual dose, the

   ' regulating society" feels that collective dose considerations are not neces-sary.

References:

(1) Mary Douglas and Aaron Wildavsky "RISK AND CULTURE' An Essay on the Selection of Technological and Environmental Dangers. University of California Press,1983 [2] Mary Douglas ' PURITY AND DANGER" Routledge and Kegan Ltd., London 1967 (3) C.G. Jung "PRESENT ET AVENIR" Buchet-Chastel 1962/1970 [4] C.G. Jung ' ASPECTS DU DRAME CONTEMPORAIN' Buchet Chastel 1983

 ,       *e PRINCIP" DE DETERMINATION DE LIMITES                    :

DERIVEES POUR L' EXEMPTION D'0BJETS , OU DE MATERIAUX

                                                                    ?

by  ! ANNE-MARIE CHAPUIS I f i Commissariat a' l'Energie Atomiqut [ France I i l'

                                                                     ]

S h s

PRINCIPE DE DETERMINATION DE LiMITES DERIVE.?S POUR L' EXEMPTION D'0BJETS OU DE NATERIAUX 7-

     -'                                                                                            Anne-Marie CHAPUIS Commissariat a l'Energie Atomique Institut de Protection et de SGret6 Nue16 aire D6partement de Protection Technique Fontenay-aux-Roces, FRANCE Pour que des mat 6riaux ou des objets puissent Stre exempt 6s de la r6glementation sur la protection contre les rayonnements ionisants deux critares doivent Stre pris en consideration :
                         - le risque individuel doit 8tre suffisamment faible ;
                         - la protection, incluant des consid6 rations sur le coGt du contr61e reglemenzaire, doit Stre optimis6e.                                                  .

La limite th6orique an dessous de laquelle il est possible d'exempter ces produits est donc d6termin6e entre autre par la valeur du risque consid6:6 comme acceptable par lo public. Una valgur du risqui mortel consid6rd comme acceptableagt66valu6eaenviron10 par an. Compte teau d'un facteur de

                                   ~

g risque de 10 pour une dose de un sievert on en d&duit qu'une dosa inf&rieure a 100 pSv par an peut 8tre considarse comme n4gligeable. Ccnstatons toutefois qu'aucun individu ne prend en consid6 ration des variations du bruit de food-naturel de l'ordre de 1 mSv par an. Afin de tenir compte de la possibilit6 qu'un individu recoive des expositions en provenancs de plusieurs sources, ia dose limite pour chaque source ne devrait 8tre qu'une fraction de la valeur de 100 pSv. Dans ce but une dose de r6f6rence de 10 pSv par an a 6t6 sugg6r6e. Ce niveau d' exemption, exprim6 en dose annuelle, n'est pas utilisable pratiquement, il est donc necessaire de definir des limites derivaes qui puissent stre appliquaes par les personnes en possession des mat 6riaux destin6s A Stre exempt 6s. l Une m6thodologie a d6j A at6 propos6e pour d6finir des limites d6riv6es a par <c; dos limites de base. Quelques applications en ont at6 faites. Cette m6thodologie comprend les 6 tapes suivantes :

                         - choix d'un terme source et caractarisation de cette source du
                            *p oint de vue physique, chimique et radiocctif ;
                         - description du devenir des mat 6riaux : ensemble des operations                                  -

subies par le mat 6riau lui-mime ou par les sous-produits des op& rations prac6 dentes ;

                          - description des scenarios qui, au cours de ces op6 rations, peuvent conduire A l' exposition des personnes ;
                          - choix des valeurs des parametres caract6ristiques de ces

( sc6narios ; t W

2

             - calcul des doses individuelles annuelles ;                                                                    .     .

I

             - comparaison de ces doses avec le niveau de ref6rence de 10 pSv par an ;
             - pr? position de limites d6riv6es.

Ce document ne traite que de l'4tablissement de limites d6riv6es. Cependant il ne faut pas oublier que d'autres 6 tapes sont Egalement propos6es avec de prendre la d6 cision d' exemption ; ce sont les suivantes :

             - Evaluation de la dose collective correspondant au flux de d6 chat attendu et aux limites d6rivies prac6 dentes ;
             - Comparaison avec le niveau de rafarance de 1 homme.aicvert ;.
                 ;i la dose collective est sup&rieure A 1 homme.siesert. 6tude d'optimisation ;
             - D6 cision d'exempter ou non les mat 6riaux ou les cbjets.

Le projat de document de l' AIEA sur les principes d'exemptiot. qui fait suite A la reunion ds mars 1988 donne quelques guidee et quelques conseils pour l' application de cette methodologie :

             - d&finition de la "pratique" ;
             - d6finition de la "source" ;
             - utilisation du concept de groupe critique, constitu6 d'individus recevant les do;2s les plus Glev6es, ce groupe 6 tant relativement homog6ne vis-A-vis des facteuzs qui affectent les doses ;
             - 6 valuation de la dose individuelle moyenne de ce groupe critique ;
             - 6 valuation des doses au moment ou celles-ci sont maximales ;
             - les sc6narios doivent comprendre toutes les situations vraisemblables d' exposition ou de transfert ;
             - les expositions normales et accidentelles doivent 8tre examindes ;
             - le prot 16me des expositions de faible probabilit4 mais pouvant conduire A des doses sup6rieures aux limites doit 8tre examine par les autorites nationales.

Ce texte donne agalement quelques exemples de dispositions qui peuvent 8tre prises pour s' assurer que la limite de dose ne sera pas d6passae et pour diminuer la probabilita d' accidents. Nous avons appliqu6 cette machodologie & differentes sources, nous en avons discut4 au niveau international, nous avons recu des critiques et des obj ections. Nous avons 43alement remis des mat 6riaux dans le domaine public, apr6s autorisation au cas par cas, mais en utilisant comme limite d'activitt une limite d6riv6e calcul6e selon la methodologie pr6c6d.nte. ! i Tout ceci nous permet de f aire ressortir les difficultas de la methode, de souligner les points d611 cats, d'apporter quelques modifications et de suggerer le schema de la figure 1. ] I f

3 La dif ference essentielle entre ce schama et celui expose pr6c6demmant concerne d'une part l'examen critique des doses calcul6es, d' autre part la comparaison. des doses avec les diff6rentes doses de r6f6rence, enfin le passage des niveaux d6riv6s th6oriques aux limites deriv 6es pratiques. Nous ne parlerons pas de l' exemption d'une "pratique". Il nous semble en effet que ce n'est pas la pratique qui peut 8tre exemptse de la r6glementation sur la protection contre les rayonnements mais seulement la source qui sera doumist A cette pratique. - Celle-ci ne Rett qu'l d6finir le devenir des taat6riaux et les scenarios correspondants. d e 0 9 e _ _ _ _ _ _ - . - _ _ _ - _ - - - -- . - - ~

4 4 Caract6ristique de'la source . Description du devenir des mat 6riaux

                                                                                  ~

4-- k DescriptiondesscEnariosl 1 Choix des valeurs des param&tres

                                                    .                          L
          ,                                                        Calcul des doses Examen critique des risultats     ;

I L

            ^

Comparaison avec les doses de (. r6fJronce - t IP Niveaux d6rivas th6eriques Limites d6riv6es pratiques ! Figure 1 - Mathode pour d6finir les limites d6riv6es t t i A e 0

                                                                                                                      ~

0

                                                                                                                   .)

I t

                       .                                                                                                                                                      l 5

l

                       . 1. CARACTERISTIQUES DE LA SOURCE                                                                                                                    !

l Les operations, et les scanarios qui leur sont associ6s, d6 pendent 6troitement des caract6ristiques physico-chimiques du mat 6riau qui contient les produits radioactifs. De ce fait la source est g6n6ralement constitude de mat 6riaux ou d'objets dont les devenirs sont semblables. Outre ses propri6t6s physico-chimiques la source est caract6ris6e par ses propri6t6s radioactives : activites massiques, surfaciques, totales..., et par la quantit6 produite annuellement. Les doses dependant de deux param4tres ind6 pendants : l'activit6 par unit 6 de masse ou d2 surface (ou l'activit6 par objet) et le flux annuel exempte. Les doces acnt proportionnelles A l'activit6 de la source, les limites d6rivdes sont ind6pendantes de cette activita. Par contre is relation entre la dose maximale et le flux de mat 1&re est une fonction diserate. En effet la dose maximale peut provenir de sc6nat'.os

diff6 rents selon le flux consid6r6.

Nous verrons plus loin dans l' analyse critique quelle est l' influence de ce paramatre sur les resultats. . II. DESCRIPTION DU DEVENIR DES MATERIAL'X i La figure 2 repr6sente le sch6ma g6n6ral du devenir des mat 6riaux. L' ensemble des operations ne figure pas necessairement pour chaque type de matdriau. III. DESCRIPTION DES SCENARIOS i Las scenarios doivent decrire, pour toutes les op6 rations, les conditions vraisemblables d' exposition de l'hommo : exposition externe, exposition interne par inhalation et par ingestion, sventuellement incorporation cutan6e par le i tritium ou par une blessure.  ! Les conditions d' exposition sont tres nombreuses et cras variees et 11'est  ; absolument impossible de les d6crire toutes. On s41ectionne donc les plus representatives en veillant toutefois A retenir les scenarios pour lesquels les doses d6 pendent de paramatres diff6 tents. Il est possible par exemple [ d'611 miner les sc6narios donnant les debito de dose A des distances diff6rentes j d'un meme type de source et en ne gardant que celui, ou ceux, donnant las doses les plus 61ev6es. Le choix des scanarios doit couvrir toutes les expositions vraisemblables,  ! celles-ci peuvent donc corresrondre a des conditions normales ou a des j conditions accidentelles (ma *.s vraisemblables). Parmi les conditions i accidentelles vraisemblables ci:.ons par example les accidents de transport et les chutes d ' obj e t pendant les manutentions. Certains' sc6narios sont vraisemblables dans certains pays, peu probables dans d'autres : par etemple la t r6cuparation d'objets sur une d6 charge. L I h i

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        %     i'WGIC4DlI2C                                                                    .

EIT 046 L'DNDD000T 11 FIEIGHK.DGATIGl 4 (g k' t L J[ i 6s@ I  ; llIlllSAilm QJ MIRISj 1 E701 10 l g E70K ES M19t!M 5 i FIGURE 2 SCHEMA D'UNE PRATT.QUE

  , IV. CHOIX DES VALEURS DES PARAMETRES Il ne faut pas oublier que la.s mat 6riaux ou les objets qui sont exempt 6s vont Etre traites de maniare conventionnelle. Rien ne les diff6rencie des autres mat 6riaux auxquels il vont rapidement 8tre m61ang6s. Les valeurs des paramatres sont donc celles qui peuvent 8tre constat6es dans l'industrie classique ou dans la vie quotidienne. Il faut se m6fier des resultats de mesures effectu6es sur des installations pilote 3 6chelle r6duite ou des prototypes de laboratoire.

Il est d' usage dans les 6tudes de radioprotection de choisir les valeurs des paramstres de maniare p6nalisani.e afin de s' assurer que les limites de dose ne seront pas depassees. Dans le cas de l' exemption la valeur de 10 pSv par an n'est pas une limite mais une valeur de r6f6rence, les valeurs des param&tres doivent donc Etre choisies de maniare r6aliste. V. CALCUL DES DOSEC Deux m6thodes de calcul peuvent Etre utilis6es : un calcul d6terministe ou un calcul probabiliste. Dans le pra.mier cas une valeur est attribu6e A chaque paramatre et les doses sont calcul6es avec des modales plus ou moins simples selon le type de sc6nario. Dans le second cas chaque paramatre peut prendre plusieurs valeurs et les calculs sont ef fectu6s un grand nombre de fois avec differents jeux de valeurs des paramatres. On obtient ainsi la distribution des doces. La valeur la plus probable est g6n6ralement proche de la valeur calcul6e par la methode d6terministe lorsqu'on utilise les valeurs les plus probables des paramatres. Mais la m6thode probabiliste est surtout utilis6e pour connaltre l' incertitude due aux erreurs ou aux fluctuations des paramatres. Elle ne permet pas de connaltre celle inh 6rente au module lui-m8me. En theorie cette m6thode est tras s6duisante, elle pe rme t entre autre de connaitre la probabilits pour que la dose d6 passe une valeur donn6e. En r6 alit 6 cette probabilite, comme la forme g4n6 rale de la courbe de distribution de la dcse d6 pend 6troitement des lois de distribution des paramatres et de.leurs domaines de variation. Or les uns et les autras ne sont presque jamais connus ; on suppose alore que les paramitres suivent une des lois de distribution rencontr6es habituellement : constanle, normale, log-normale etc. Il est alors tras dif ficile de juger de la pertinence du ,resultat. La methode probabiliste doit tenir compte, dans les jeux de valeurs des param4tres, de la d6pendance 6ventuelle entre certains param&tres ou s' assurer que les paramatres sont ind6 pendants. 1 4 0 4

7 Par exemple la dose due A 1' inhalation de pouss16res pendant des op6ratfons de traiten ant est- souvent calcul6e A l' aide du produit de la ' concentration de pouss1&res dras l' air par le facteur de concentration du radionuc161de entre les pouse dres et le materiau trait 6. Or ce facteur de concentration d6 pend de la quantit6 de pouss16res 6mises et nous avons pu constater que le produit de ces deux nombres est relativement constant, alors que les deux facteurs varient consid6rablement. Les doses recues par un individu ne sont gen 6ralement pas constantes dans le temps. Ceci pour plusieurs raisons :

       - le flux de mater'au exempt 6 vers une installation donn6e peut Gere limit 6 dans le   mps.
       - la dose recue par un individu en possession d'un objet r6utilis6 ou recycid decroft pendant la durde de son utilisation en raison de la d6croissance radioactive.

La radioprotection vise A 11mitel le risque annual et donc A limiter ir dose annuelle (dose annuelle due A l' exposition externe et engagement de dose dG A l' incorporation annuelle). Elle conduit done A 6 valuer ces doses l' ann 6e ou elles sont maximales. C'est 6galement ce qui est propos6 pour d6finir l' exemption de mat 6riaux ou d ' obj e t s . Ceci introduit un facteur de s6curit6 implicite pour le risque sur la vie. VI. EXAMEN CRITIQUE DES RESULTATS C'est le point essentiel de la m6thode et nous allons pr6ciser quelques unes des questions qui doivent Etre pos6es. VI. l . Con: ment la dose varie-t-elle en fonction des caracteristiques de la source ? La figure 3 repr6sence les formes g6narales de variation des doses en fonction de la masse totale exempt 6e pour deux valeurs a et b de l'activit6 cassique. Pour certains sc6narios la dose ne d6 pend que de l'activit6 massique (ou de l'activit6 surfacique), c'est le cas par exemple de la dose due A la r6utilisation des objets ou de celle due A l'utilisation du mat 6riau recycle (courbes la et Ib). Pour d'autres sc6narios la dose est fonction de la masse exempt 6e. Pour les f aibles masses la dose est proportionnelle A la masse exempt 6e mais on atteint une saturation car la masse concern 6e par un sc6nario est toujours limitee (courbes II et III). Au dela de cette masse limite et quel que soit le flux de mat 6ria~~ exempt 6 la dose reste constante, seul change le nombre de personnes expos 6es. e

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L r i i FIGURE 3  ! i t l EVOLUTION DES DOSES EN FONCTION DE LA MASSE l r V - r TOTALE EXEMPTEE POUR DEUX VALEURS DE L'ACTIVITE MASSSIQUE. i i l

o . 8 I cette limitation est due en partie & la limitation de la duree annuelle - d' exposition. De plus dans un grand nombre d' installations, pour des raisons de 1 politique industrielle et pour des imperatifs techniquen, la masse de materiau exempte qui y est traitee est limitee & une fraction de la capacite de l' installation. i-Ces courbes II et III sont representatives des dosas recues pendant le

      $ransport, dans les installations de tra'.t ement , au cours de la mise en dicharge ou celles dues aux rejets dans l'environnement.
 '            Les limites derivies sont fixies par les doses los plus 41evees, elles dependent donc de la position respective des courbes qui varie avec la masse de dechets exemptie.

Dans le cas represente sur la figure 3 les doses II sont inferieures aux doses I, quelle que soit la masse concernie, et n'interviennent pas dans la d4 termination des limites d4rivies. Au desscus de la masse M, les limites derivdes sont fixies par les doses I, au dessue par les doses III. Au dell de la masse M 2 les limites fixies par les doses III sont ind4pendantes de la masse. Il y a donc lieu d'examinwr si la masse retenue pour le terme source est repr4sentative de la masse exemptie attendue et comment elle se situe vis-i-vis de Mg et de M2 ' Dans le cas de sources les doses dependent de l'activite par source et du nombre de sources exempties selon le aime schas.a que celui de la figure 3. VI.2. Les doses dependent-elles de la pratique realisde les annies anterieures ? Les doses sont calculdes J' annie ob elles sont maximales. Trois cas peuvent'se presenter :- a) la dose est recue dans l'annSe qui suit la procedure d' exemption, les doses stant nulles les annies suivantes. C'est le cas par exemple des doses aux ouvriers assurant le transport, la manutention ou la mise en dicharge directe,

    , Il n'y a alors pas d' influence d'une annie d' operation sur une autre annie.

b) Le delai entre la mise dans le domaine public et l' exposition du public conduit & une dispersion temporelle des expositions. La dose doic 8t: 3 calcul6e pour une operation continue, pendant une durie compatible avec cette operation, au moment ob la dose est maximale. C'est le cas de l' exposition du public due au transfert par l' eau ou par le sol apr4s la mise en dicharge des matariaux, c) Le schema general des operations presente 'dans la figure 2 montre la presence de boucles correspondant au recyclage des produits et des sous-produits. Apras utilisation', les materials peuvent 8tre recycles ce qui conduit & une nouvelle exposition du public. Ces doses successives sont de plus en plus faibles en raison de la periode radioactive, de la fraction non recyclie rejet4e dans l'environnement et de la .lispersion des objets entre les diverses installations de recuperation. a wr -

9

   . VI.3 Quelles sont les caracetristiques des groupes concern 6s ?

Les individris peuvent-ils 8tre expos 6s A des op6 rations dif ferentes sur un m8me mat 6riau exempts ou a des op6 rations sur d'autres materiaux ? Cette  : question est importante puisque le niveau de r6ference de 10 pSv par an a sta propos6 pour tenir compte de la possibilits d' exposition d'un m8me individu A plusieurt pratiques d' exemption Dans le sch6ma de la figure 2 les op6 rations repr6sentnes sur la gauche concernent les travailleurs et chaque individu n'est soumis qu'A une seule des operations . Les op6 rations represent 6es sur la droite concernent le public en gen 6ral qui peut 8tre soumis A differentes expositions. Il faut n6anmoins remarquer que les doses au public snt 6valuees pour les groupes les plus expos 4s de chaque op6 ration. Ce sont qeelquefois des groupes restreints dont la probabilite d' exposition aux doses maxin.d eq des autres op6 rations est faible (par exemple personnes vivant sur une ancienne d6 charge ou dans la zone ,de retomb6e maximale d'une cheminne d'incin6rateur). VI.4. Les doses calcul6es peuvent-elle 8tre depass6es ? a Deux cas doivent 8tre distinguan,. On bien il s'agit de la dose moyenne du groupe en raison de la m6connaissance de la valeur d'un (ou plusieurs) parametre ou d'une erreur dans le choix de cette valeur. Ou bien il s'agit de l la dose recue par quelques individus du groupe en raison de la fluctuation des param6tres d'un individu A l' autre du mime graupe. C'est a cette derniste question que se proposent de r6pondre les calculs probabilistes. L'importance du d6passement, la probabilita de ce d6passement et le' nombre de personnes impliqu6es doivent Stre examinss, ils d6 pendent du scenario, de la connaissance des paramstres et du choix des valeurs. Il n'y a aucune raison, compte tenu de la m6thodologie adopt 6e pour que les doses ne depassent pas le niveau de r6ference de 10 pSv par an. Il faut cependant noter qu'il existe un facteur de secur. de 100 pour une exposition prolong 6e (ou 500 pout une exposition occasit. 4elle) entre le niveau de r6ference et la limite de dose pour le public qui doit 8tre respect 6e pour ' chaque individu. VI.S.'Quelles sont les doses en cas d'secident ? On peut distinguer deux types d' accidents. Il s'agit soit d'un accident au l sens classique du terme, soit d'une situation ne correspondant pas aux i scenarios normaux d' exposition. Dans le premier cas, qui correspond par exemple i aux accidents de transport, aux chutes de nsnutention, aux blessures, la i probabilite de l' accident peut 8tre connue : c'est celle constat6e dans l' l'industrie classique ou la vie quotidiene '.. Les caracteristiques moyennes de ces 4ccidents peuvent agalement Stre estim6es et permettre de calculer les i . doses correspondantes. Dans la second cas, qui correspond par exemple A la reutilisation d'une source comme bijou, la probabilit6 est dif ficile 16 valuer. Les doses, si elles sont trop 61evdes, peuvent conduire A ne pas exempter. ' Hais il n'existe pas & l'heure actuelle de niveaux de reference en ce qui  ! concerne les expositions accidentelles, ces niveaux pourraient Stre fonction de ' I la probabilit6 de l' ac c id er.t (c'est alors le risque qui est limit 6 et non la dose). l 1

10 VI.6. Existe-t-il des sc6narios conduisant A une concentration d'activit6 7 Il faut s' assurer que ce type de sc6nario a bien 6t6 pris en consid6 ration nr il peut conduire & des doses 6 levees pour certains radionuc!61 des. Ces

   %ncentrations se produisent gan6ralement au mouent des traitements physico-chimiques.

III. CCMPARAISON AVEC LES DOSES DE REFERENCE Selon le type de scenario il y a lieu de so r6f 6ter A dif f& rents niveaux de dose. Pour les groupes susceptibles de recevoir des doses en provenance de plusieurs materiaux ou en provenance de plusieurs op6 rations, le niveau de ref6rence par op6 ration et par mat 6riau est de 10 pSv par an. Aucun groupe ne doit recevoir, de l' ensemble des operations, de dose sup6rieure A 100 pSv par an. Certains groupes ne recoivent de dose que d'un nombre tras restreint "operations, l'une d' entre elle 6 tant pr6dominante. Il est alors possible d'envisager pour celle-ci un niveau de r6f 6rence de quelques dizaines de pSv par an. VIII. NIVEAUX THEORIQUES ET LIMITES DERIVEES PRATIQUES La comparaison des doses calcul6es avec les niveaux de r6f6rence permet de calculer pour chaque scenario un niveau d'activita, le niveau d6riva th6orique est le plus faible de ces niveaux d'activits. (En realit6 il y a autant de niveain d6riv6s th6oriques qu'il y a de grandeurs utilis6es : activit6 massique, activit6 surfacique totale, activite surfacique non fix6e...). Le niveau d6riva theorique est una valeur moyenne sur la quantit6 de mati&re envisag6e par le scenario. Il peut s'agir de l' activit6 "toyenne de l' ensemble des materiaux trait 6s annucllement dans une installation ou de l'activits moyenne par op& ration de traitement (par exemple : four de fusion) ou de l'activit6 moyenne par objet, etc. Pour les lots de masse inf6rieure A celle du scenario d6finissant le niveau d6riv6 th6orique il faudrait alors examiner les scenarios correspondants et d6finir un autre niveau d6riv6

 . th6orique 6 gal & la plus faible des activit6s et ainsi de suite jusqu'au lot de masse la plus faible.

En fait ceci ne peut pas Etre appliqu6 pour les raisons suivantes : a) Le principe d' exemption ne doit pas conduire A imposer une comptabilit6 des matieres exempt 6es. La moyenne doit donc 8tre 6valu4e sur chaque lot remis dans le domaine public qui correspond, suivant le type de materiau, & une poubelle, un fGt, un conteneur, une benne de camion. La masse d'un lot ne d6 passe donc pas quelques connes. b) Les sc6narios les plus contraignants, dont la taille des lots consideris, ne sont pas les mimes pour tous les radionuc161 des en raison des dif f 6rences dans leurs caract6ristiques physico-chimiques et radioactives. Il ne peut Stre question de proposer des lots dont la taille ne soit pas la mime pour tcus les radionuc161 des, on choisira donc le lot le plus petit. s 0 0

11 - c) La formulation des timites d6riv6es ne doit pas permettre au producteur d'utiliser la dilution volontaire pour atteindre ces valeurs. Or habituellement, au cours d'une production ou d'un traitement, l'activite moyenne des lots est g6n6ralement comprise entre le tiers e r. le dix 14me de l'activit6 maximale du lot. C'est ce que nous avons pu constater sur un lot de 20 tonnes de ferrailles qui ont 6t6 recyc16es ; la valeur maximale de l'activit6 par 914ce avait 6t6 fix6e A 1 Bq/g, l'activit6 moyenne deg 20 tonnes 6 tait de 0,25 Bq/g. C'est 6galement ce qu'on constate pour les c6chets de faible cetivit6 stock 6s en centre de surface. Il semble donc raisonnable de proposer que l'activit6 per objet ne d6 passe pas 10 fois la valeur moyenne. L'importance du lot sur lequel cette moyenne doit Scre 6valu6e doit 8tre la plus faible des deux valeurs cu.'.vantes, soit la masse correspondant au scenario le plus contraignant, soit la masse contenue dans le conteneur de mise au rebut ou de transport. On obtient ainsi pour chaque radionuc1&ide, une limite pratique par objet par lot. Si le sednario le plus contraignant est celui d'un objet il n'y a plus qu'un niveau d6riv6 celui correspondant A l'objet. Dans la pratique on peut souhaiter regrouper les radionuc161 dss par classe et ne fixer qu'une valear par classe. Les classes doivent Etre caract&ris6es sans ambiguit6. La limite d6riv6e caracteristique d'une classe est la plus faible des limites deriv 6es des radionuclaides de cette classe. Cette methode conduit a p6naliser les radionuc161 des dont les niveaux d4 rives th6oriques sont superieurs A la limite deriv 6e pratique de la classe correspondante. Cependant ceci peut se justifier lorsque leur contribution est faible. Enfin il est possible de d6finir des limites d6riv6.s pratiques qui tiennent compte du spectre de radionue161 des attendu. L' exemption s'applicue alors aux materiaux issus d'un type d' installation donn6. On peut ainsi d6finir des limites d'activit6 en 6metteurs y pour les mat 6riaux provenant du demantalement de r6acteurs A eau 16gare ou des limites d'activit6 en emetteurs a pour les materiaux issus d'usines d'enrichissement de l' uranium. IX. COMPARAISON AVEC D'AUTRES LIMITES Ces limites d6tiv6es 6 tant d6finies il est int &ressant de les comparer aux limites figurant dans d'autres reglementations. Un materiau exempt 6 doit pouvoir 8tre transport 6 dans les mimes conditions qu'un mat 6riau "classique" et ne pas Etre soumis A la r6glementation sur le transport des mati4res radioactives. Un materiau exempte doit pouvoir'8tre trait 6 coc:=e un materiau "classique". Il faut donc que les autorigations de fonctionnement et de rejet d' effluents des installations de traitement ou de stockage soient compatibles avec les limites d' exemption. X. CONCLUSION Nous avons pr6sente une methode pour d6finir les limites deriv 6es pratiques permettant l' exemption de materiaux ou d'objets et contra les dif ficult6s /* cette d6finition. Nous avons insiste sur l' analyse crit /.que du resultat du cr.cul des doses qui permet de v6rifier le bien-fonde du cho.x des scenarios et des valours des param4tres. Certainu probl4mes ne sont pas encore resolus, il s'agit en particulier des doses reques en conditions accidentelles, et de celles ayant une faible probabilite d' occurrence. 4 O S

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PRINCIPLE FOR DETERMINING DERIVED LIMITS FOR THE EXEMPTION OF OBJECTS AND MATERIALS Anne-Marie Chapuls French Atomic Energy Commission Institute of Nuclear Protection and Safety Technical Protection Department Fontenay-aux-Roses, France in order for material and objects to be exempted from regulatory controls for the protection against lonizing radiation, two criteria must be %en into consideration:

               - the indMdual risk must be sufficiently low; the protection, h ecluding cost and regulatory conW considerations, must be optimized.

The theoretical limit below which it is possible to exempt these products is therefore determined, amongst others, by the value of the risk considered acceptable by the ' public. A mortal risk value considered acceptable was evaluated at about 104 per year. Based on a risk factor of 102 for a dose of one sievert, it was deduced that a dose of less than 100 microSv per year can be considered negiigible. Let us point out, however, that ilo indMdual takes into account the variations in the natural background noise wilich are on the order of 1 mSv per year. In order to take into account the possibility 91at an individual may be exposed to radiation from several sources, the dose limit for each source should only be a fraction of the 100 microSv value. For this purpose a reference dose of 10 microSv per year was suggested. l In p edw,this revel of exernption, expressed as an annual exemption, is not  ; usable; we must therefore define derived limits that can be applied by those in possession of materials that are to be ex'e mpted. A methodology has already been proposed to define derived limits starting with fundamental limits, it has already been used in some applications. l .. . 4

                                                           - - , , - , - . - - - ~ .

This methodology consitis of the following stages:

     - Choice of a source term and characterization of this source from the physical, chemical, and radioactive point of view;
     - Description of the processing of the materia!s: the entire set of operations that ths l

material itself undergoes or that the by products of the preceding . operations are l I subjected to; Description of the scenarios which, in the course of these operations, can result in exposure to people; Choice of values for the characteristic parameters of these scenarios; Calculation of the annualindividual doses; Comparison of these doses with the reference level of 10 microSv per year; Proposal of derived limits. l This document only deals with the setting up of derived limits. Nevertheless, we must not forget that other stages are also proposed in conjunction to make an exemption decision; they are as follows:

     - Evaluation of the collective dose corresponding to the expected waste flow and the foregoing derived limits; Comparison with the reference level of 1 man. sievert; if the collective dose is greater than 1 man. sievert, an optimization study; Dech. .a to exempt or not exempt materials or objects.
    .The draft document of the IAEA concoming the exemption principles which accounts for the meeting of March 1988 gives a few guides and some recommendations for applying this methode*vy/:
     - Definition of the "practice";

Definition of the "source"; Use of the concept of a critical group consisting of Individuals receMng the highest dosas, with this group being relatively homogeneous with respect to the factors affecting dose levels;

     - Determination of the average individual dose from the critical group; Determination of the doses at times when they are at their peaks; 1

1

 ,._                - The scenarios must include all the likely exposure or transfer situations; Both normal and accidental exposures must be examined; The problem of low probability exposures that may lead to doses in excess of the                 .

limits must be examined by the national authorities. l This text also gives a few examples of measures that can be taken to ensure that the dose limit is not exceeded and to decrease the likelihood of accidents. We have applied tNs methodology to different sources, have discussed it on an internationellevel, and have received criticism and objections. We have also placed materials la the public domain after authorizations granted case by case, but based on a derived limit determined according to the preceding methodology. l All this enables us to highlight the difficulties of the method, to emphasse the  : delicate points, to make some modifications, and to suggest the diagram presented in l Figure 1,  ! J  ; The essential difference between this diagram and the one presented previously 4 l concerns both a critical examination of the calculated doses and a comparison of the

doses with the various reference doses, and finally a transition from the theoret! cal denved levels to the practical derived limits.

We shall not concern ourseas with the exemption of a "practice." Indeed, we do  ; not feel that a practice can be exempted from regulatory control on radbtion protection, l but only the source that is to be subjected to the practice. The purpose of the practics is j only to define the processing of the materials and the corresponding scenarios. j l l I i 1 I 1 . j l  ! 4 i l ) . 3 i

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4 l Characteristic of the burce bescription of the processing of the materials *~ - A Description of the scenarios 1 Choice of parameter values  : L Calculation of deses b Critical examination of the results - 4 Comparisonwith the references doses v Theoreticalderived limits 4 Practical derived limits Figure 1 Method for defining derived limits. k 4 4 e

        ~                                     - - - - - - . _ _ _ - - _ _ _ . _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _     __
l. CHARACTERISTICS OF THE SOURCE The operations and their associated scenarios are closely dopendent upon the  ;

physical and chemical properties of the material containing the radioactive produ::ts. For this reason, the source is generalty composed of materials or objects whose processing ' is similar, , in addition to its physical and chemical properties, the source is also characterized by its radioactive prope: ties: specific actMty, surface activity, tott.) activity, etc., and by the quantity produced annually. The doses are dependent upon two independent I parameters: the activity per unit of mass or surface area (or the actMty per object) and the annual flow exempted. The doses are proportional to the actMty of the source and the derived limits are independent of this actMty. However, the relationship between the maximum dose and the substance flow is a discrete function. Indeed, the maximum dose can come from different scenarios depending on the flow considered. We shall see later in this critical analysis how this parameter influences the results. II. DESCRIPTION OF THE PROCESSING OF THE MATERIALS Figure 2 shows the general diagram of the processing of the materials. Allthe  ; operations for each type of material me not necessarily shown. i ill. DESCRIPTION OF SCENARIOS

            'The scenarios must describe the probable human exposure conditions for all the operations: external exposure, internal exposure through inhalation and by ingestion, and possible irsaigativu intothe body by means of tritium or injuries.

l The exposure conditions are very numerous and highly varied and it is therefore absolutely impossible to describe them all. We shall consequently choose the most representative ones,while stillensuring that scenarios, for which the deses &.rcrd en i different pararneters,are chosen. For example, it is possible to eliminate smnarios which yield varying doses at different distances from the same type of souice and only retain those which result in :he highest doses.

                                                                                                       . i 6

i

The choice of scenarios must cover all the likely types of exposure, meaning both those associated with normal conditions and those brought about by accidents (provided they a*e conceivable). Among the conceivable accident conditions we wish to point out transport and falling objects during handling as possible examples. Certain scenarios are conceivable in certain countries, but not in others: for example, salvaging of objects from a dump. l l I

                                                                                         \

l i l 1 Nuclear facay d Transport u

      -a  MAnnnw a        2           ) Reuse of objects 9 u

Mechanical o grocessing cutting, 3 Dumping disassembly, y shredding-h 4By products l Physi j and -

                                                                      ,n          ,e "chemical processing                                         ! Release into the
             . Smetting     i                                     [environhrent
          / incineration         (gWaste]            ?
                                                                      ?

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Use of recycled material

__ Recycling of ' , materfinis Figure 2 Diagram of a Practice

l IV. CHolCE OF VALUES FOR PARAMETERS ' We must bear in mind that the materials or objects that are exempted will be treated Iri a conventional manner. Nothing will differentiate them from the other materials with which they will be quickly mixed. The values of the parameters are therefore those which can be found in conventionalindustries or in daily life. One must be wary of the results of measurements taken in small scale pilot facilities or in prototype laboratcries, in radiation protection studies it is customary to choose conservative parameter values in order to ensure that the dose limit values will not be exceeded. In the case of exempGon the value of 10 microSv per year is not a limit but a reference value the parameter vaiues must therefore be chosen realistically. V. CALCULATION OF DOSES Two calculation methods can be used: deterministic calculation or probabilistic calculation. In the first method a value is atsigned to each parameter and the' doses e.te calculated with more or less simple models depending on the type of scenario. In the second method each parameter may take on several valuco and the calculations a.e performed many times with different. sets of parameter values. We thus obtr.in a dose distribution. The most probable value is generally close to the value calculated according to the deterministic method when the most probable values are used for the parameters. De probabilistic method, however, is mcstly used to find the uncertainty caused by errors or fluctuations in the parameters. It does not enable us to find the uncertainty inherent in the modelitself. In theory thismathod is very attractive; amongst others, it enables us to know the likelihood of a dose exceeding a given value, in reality, this probability, represented as the general shape of the distribution curve of the dose,is closely dependent upon the distribution laws of the parameters and their variation ranges. But these two items are almost never known; we consequently assume that the parameters follow one of the distribution laws commonly encountered: constant, normal, log normal, etc. It is thus very difficult to judge the validity of the results.

y _ ~ ~. . . I in the sets of parameter values the probabilistic method must take into account the possbie interdependence between certain parameters, or insure that the parameters are independentof each other. L For example, the dose due to inhalation of dust during the treatment operations is often calculated using the product of the dust concentration in the air times the concentration factor of the radionuclide between the dust and the trcated material. . However, this concentration factor depends upon the quantity of dust released and we f

have been able to observe that the product c
t these two numbers is relatively constant, whereas the two factors vary considerabW.

l The doses received by an individual are generally not observed in time. There are

several reasons for this
!
- The flow of exempted material toward a given facility can be limited in time.

4 The dose received by an individual in possession of an reused or recycled object decreases throughout the duration of its use due to the decreasing radioactivity. i

The aim of radiation protection is to limit the annual risk and therefore limit tho' annualdose (annualdose due to external exposure and takirry of doses due to annual

! incorporation). This therefore results in evaluation of these doses in the year in which

they are maximal. This is also what is proposed for defining the exemption of material or objects. This introduces an implicit safety factor for the risk to human life.

! VI. CRITICAL EXAMINATION OF THE RESULTS l This is the essential point of the method and we shali now point out some of the i questions that must be asked. l VI.1. 16 does the dose vary in relation to the cource properties? l Figure 3 shows the general varbtion shapes of the doses as a function of the total l weight exempted for two values of the specific activity, a and b. , J For certain scenarios the dose depends only on the specific activity (or surface i

   ../   utivity); for exa'mple, this is the case of doses due to the reusing of objects or doses cauJed by the use of recycled meterial (curves la and Ib).

) -

'I In the case of other scenarios the dose is a function of the exempted weight. For smail amounts the dose is proportional to the weight exempted, but a saturation level is reached because the weight concerned by one scenario is always limited (curves 11 and 111). Bevond this weight limit, and regardless of the flow of exempted material, the doso l remains constant, with only the number of persons exposed varying.

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M1 M2 Weight Figure 3 Variation in doses according to the total exempted weight for two values of the specific 4

l ' This limitation is partly due to the limitation in the annual duration of exposure. Ir. addition, in a very largrs number of facilities the amount of exempted material treated in them is limited to a fraction of their capacities for reasons of industrial policy and technical requirements.  : i Curves ll and ill are representative of doses rceelved during tranmort, in treatnnnt i facilities, at the time of dumping, or those due to releases into the environment. , The derived limits are set by the highest doses PM therefore depend on the respective positions of the curves which vary with the amount of exempted waste. In the case portrayed by Figure 3, doses lia and lib are less than doses la and Ib . regardless of the amount involved, and do not come into play in the determination of the derived limits. Below weight M, the derived limits ars set by doses la and Ib, v.tille above that limit they are set by doses Illa and lilb. Beyond weight M, the limits set by doses lila and lilb are independent of the weight. There is consequently raason to examine  ; whether the weight selected as the source term is representatiw of the expected exempted weight and how it stands in relation to M, and M,.  ! In the case of sources, the doses depend on the activity for each source and the number of sources exempted, following the same diagram as that in Figure 3. VI.2. Do tne dosee depend on the practices implemented in previous years? The doses are calculated in the year in which they are greatest. Three different . cases can arise: a) The dose is received in the year following the exemption procedure, with the , doses in the following years being zero. This, for example, is the case of workers involved in the transporting, handling or direct dumping. In this case one year of operation does not affect any other year. b) The time lapse between the time of becoming part of the public domain and the l time of exposure to the public leads to a time dispersion of the exposure. The dose must  ! be c'alculated for a contirNous operation for a duration that is compatible with this  ! operation, at the time when the dose is at its peak. This is the case of exposure to the public caused by transfer through water or the soil after dumping the materials.

                                                                                                                       'I i

I

I c) The general diagram of the operations shown in Figure 2 reveals the presence of loops corresponding to the recycling of products and by products. After being used the materials can be recycled, thus leading to another exposure to the public. These successive doces grow smaller and smaller on account of the radcactive half life, the non recyc:ad portion that is released into the environment, and the distribution of the objects among the various salvaging facilities. VI.3. What are the characteristics of the groups concerned? Can indMduals be exposed to different operations on the ame 3xempted material or to operations on other materials? This is an important question since the reference level of 10 microSv per year was propnsed to take into account the possibility of the same indMdual being exposed to several e :emption practices. In the diagram of Figure 2 the operations shown on the left concern workers and each indMdualis only subjected to one of the operations. The operations shown on the right concem the general public which can be subjected to different exposures. One must nevertheless note that the doses of the public are evaluated for the niost exposed groups of each operation. These are sometimes limited groups whose probability of exposure to maximum doses from the othe. operations it low (for example, people living I on a former dump or in the zone of maximum fallout from an incinerator smoke stack). VI.4. CLn the calculated doses be exceeded? A distinction needs to be made between two case, Either we are dealing with the average dose of the group because the value of one (or several) parameters is not known or an error was made in the choice of this value, or thc dose received by a few IndMduals in thesroup due to the fluctuation of the parameters from one indMduallo another in the same group. It is this last question that the probabilistic calculations are intended to answer. The amount in excess, the probability of this excess, aM the number of persons invoNed must be examined; they depend on the scenario, the knowledge of the parameters, and the choice of the values. In light of the adopted methodology, there is nothing preventing the doses from exceeding the reference level of 10 microSv per year. One must nete, however, that there is a safety factor of 100 for a prolonged exposure (or 500 for an occasional

exposure) between the reference level and the dose limit for the public which must be complied with for eachir(Jvidual. 1 VI.5. What are the doses in the event c'f an accident

  • Two types of accidents can be considered. Either an accident occurs in the traditional sense of the term, or there arises a situation not correaponding to the normal exposure scenarios, in the first instance __which, for example, might occur in a transportaten accident, handling mishaps, or injuries __the probability of the accident can be known and is that observed in traditional industries or in daily life.* 1he average characteristics of these accidents can also be estimated and allow us to calculate . the i corresponding doses, in the second case _'.yhich would arise, say, from the reuse of a
source as a a piece of jewelry __the probability is difficult to determine.  ;

if the doses are too high they can prevent exemption. However, to this day there are no referenos levels for accidental exposures; these levels could depend on the j l probability of the accident (in thit case the risk is limited and not the dose).  : i , I VI.8. Are there scenarios which lead to a concentration of actMty? It must be ensured that this type of scenario has indeed been taken into  ; consideration, for it can lead 't o high doses of certain radionuclides. These l concentrations generally occur at the time of physical and chemical treatments. l Vll. COMPARISON WITH REFERENCE DOSES 7 l Depending on the type of scenario different dose lev 6:s need to be referred to. In

the case of groups likely to receive doses coming from several materials or from several
operations theTeforence levelfor each operation and each materialis 10 mictoSv per  ;

i year. No indMdual shall receive a dose of more than 100 mictoSv per year for all the 9 I operations combined. . ! Certain groupo receive doses from only a very limited number of operations, with l

one of the operations being predominant. It is consequently possible to conceive a  !
reference level of a few tens of microSv per year for the predominant operation, i I '

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Vill. THTORETICAL LEVELS AND PRACTICAL DER ' 'O L6'ITS A comparison of the calculated doses with the reference byels enables us to cajeulate an activity level for each scenario, wi0, the thooredcal derived level being the smallest of the these actMty lovels. (In rea!!!y there are as many theoretical derived limps as thers are units: specific activity, total surface actmty, non fixed surface activ;ty, etc.). The theoretical derived level is an average value for the qusntity of material planned on by the scenario, it crm be the average actMty of all the materials treated annually irt a facility or the average actMty per treatment operation (for example, smelting furnace) or the average actMty per object, etc. For batches whose weight is less than that of the scenario defining the theoretical derived limit the corresponding scenarios would have to be examined and another theoretical derived limit set to the lowest activity level, and so on right down to the smallest batch. Actually, tNs cannot be applied for the following reasons: a) The principle of exemption must not end up requiring an accounting for the exempted materials. The average must therefore be determined for each batch released into the public domain which, depending on the type of material, means a wastebasket, a barrel, a container, or a truck bin. The weight of a batch therefore does not exceed a few , metric tons, b) The most restricting scenarios, in which the sizes of the batches considered are not the same for all the racionucildes due to the differences in their phyelcal, chemical, and radioactive properties. It is unacceptable to p couse batches whose size is not the same for all the radionuclides; for this reason the smallest batch shall be chosen. c) The wwnig of derived limits must not enable a producer to use voluntary dilution to satisfy these values. However, generalty during a product!an or trea' ment process the average actMty of the batches is usualty between one third and one tenth of ~ I the maximum actMty of the batch. This is what we were able to observe in a batch of 20 mettk: tons of scro,. Iron th6t was recycled; the maximum value of the actMty for each , part had been set at 1 Bq/g while the averago actmty of the 20 metric tons was 0.25 BQg. This is also what is observed in the case of low actMty waste stored in surface j v' centers.

                                                                                                       . l

It therefore seems reasonabie to propose that the activity per object not exceed 10 times the average value. The size of the batch from which this average must be taken must ba the smaller of the fol' awing two values: either the weight corresponding to the most restricting scenal!o, or the weight contained in the disposal or shipping container. t We thus obtain for each radionuclide a practical limit k sr object per batch, if the most . g restricting scenario is that of a s!ngle object, then there is just one derived level, that of the object. In practice we can hope to group radionueddes by classification and only set a value for the classification. Thr., classifications must be characterized without ambiguity. The characteristic derived limit of a chssi5 cation is the smallest of the derived

   !!mits of the radionuclid M belonging to the classification. This method penalizes k  radionuclides whose thwretical derived levels are greater than the practical derived limit of the corresponding classification. Nevertheless, this can be justified when their contribution is small.

Finally, it is possib!0 to define practical derived limits which take into account the spectrum of expected radionuclides. The exemption would then apply to materials coming from a given type of inctallation. We can thus define activity limits and gamma E emitters for the mPterials Corning from the dismantling of light water reactors or alpha-emitter activmf iin4 - or materials coming from uranium enrichment facilities. IX. COMPARISON WITH OTHER LIMITS r ' Having defined these derived limits it is interesting to compare them with those contained in ether regulations. An exempted material must be able to be transported under the same conditions as a "conventional" material and not be subject to the regulations goveming the transport of radioactive substances. An exemptod matarial must be able to be traaled as a "conventional" material. The operation and waste-disposal authorizations for treatment or storage facilities must therefore be compatible with the exemption limits X. CONCLUSION ([ Wa have presortva a u~ ,; the practical derived limits enabling the oxemption of material or oq.sb . . : 9 - imenst ated the difficuttles of such a definitice We N.V: thasized the om si analy? of the results of the dose calculations S E

' -~ which allows us to ascertain the basis for a choice of scenarios arv.1 parameter values. Certain problems are still not solved, particularly these inv0Mng received doses under accident conditions and those having a low probability of occurrence. 5 9 h t ) l r 4 t l 1 t [ I i i l l l i

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                                                         -Current Status of Risk Estinates for Assessing Health Consequences of Low Doses v

4 Warren K. Sinclair N National Council on Radiation Protection and Measurements

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o s Current Status of Risk Estimates for Assessing Health Consecuences of Low Doses NRC/NEA Vorkshop on Rules for Exemption from Regulatory Control i PA90, Washington i l Warren K. Sinclair October 18, 1988 In radiation protection at low cosaa the primary biological ef fects of concern a*e stochastic in nature, i.e., they are more probable the higher the dose but their severity is independent of the dose. Thn principal effects are the risk of cancer induction in the irradiated individuals or the risk of genetic effects in their offspring. The risk of genetic ef fects per unit dose I has been widely evaluated by various sources including UNSCEAR and BEIR2 and is now well documented for the most common genetic changes. However, an important unknown component concerns multif actorial diseases of genetic origin which are now known ;o be more prevalent than previously thought. Their susceptibility to radiation induction is not at all well known however. Except for this uncertain cooponent other estimates of genetic risk tend not to be larger, than they were a decade ago. The primary estimates of the risk of cancer upon which we have until recently relied in radiation protection are those of UNSCEAR Iin 1977 and BEIR (111)2 in 1980. While all human sources of information are considered in each report, both evaluations depended heavily on the experience of the Japanese survivors of the A-bombs. At that time, data from this experience were , available only through 1974. Separate estimates by radiation protection bodies, ICRP3 and NChP did not dif fer substantially from the UN5CEAR and BEIR ovaluations. The risk of cancer was estimated at about 1.25%/Sv, often rounded to 1%/Sv for radiation protection purposes. In the decade since then much new epidemiological information on radiation induced cancer in humt..s has become available. In the Japanese survivors three new four-year cycles of data have accumulated and a completely tevised dosimetry system (DS86) has been f.ntroduced. The new dosimetry is importent. The changes. f rom the old dosimetry are modest for the Nagasaki weapon but extensive for the Hiroshima weapon. These include changes in both s_ , the yield and the output, revised calculations of neutron and gansa ray transport through moist air over ground, new allowances for structural

4 shielding of the survivors and for the shielding of organs by overlying tissues. Most important of all, direct experimental confirmation of the dosimetry calculations has been p ovided within the survivor range of doses by the rmoluminescent studies of bricks and tiles. The overall result is that the neutron dortu at Hiroshima are much lower than previously thought and the 5 gamma ray doses are higher . Many of the changes made in the dosimetry tend to cancel so that the net effect of the dosimetry on the risk estimates for cancer is te increase them by a 'accor of between 1 and 2 depending on the location of the organ in the sody. Another important factor is the method of projection of the cancer risks within the period of observation to the lifetime of the popalation concerned (i.e., the Japanese survivors). Two models have been used for this purpose, cdditive and multiplicative, leading to rather different results, the cultiplicative model giving higher risks. Workers at the Radiation Effects Research Foundation (RERF) in Japan have tended to prefet the multiplicative model which is favored 'oy many today because it tends to fit better the time course observed for most age groups in the Japanese survivors. However, some ovaluation groups may give results for both modele. The new Japaness data extend now up to 1985, an important addition of cleven years which has increased the .iata base very substantially. The new data has been evaluated by Preston and Pierev6 using the multiplicative codel. The principal resalts indicate substantially increased risk estimates at high dose and high dose rate, especially for younger persons and ranging up to 12%/Sv li'etime for a population of all ages. (Leukemia is increased to cbout 1% per Sievert and solid tuners to about 11% per Sievert.) Preston and Pierce then used a dose reduction factor of 2.5 to obtain 5%/Sv for low doses sad all ages and about 3 /Sv foe low doses and adult ages only. Re-evaluation of the risk of cancer f rom all human sources is being undertaken by both UNSCEAR and by BSIR. These include not only the Japaness but mora extensive information in other human populations such as those treated for ankylosing spondylitis and a worldwide group treated for cancer o' the cervix. Results from UNSCEAR give a range, for high doses and dese rates of 3-11%/Sv f'or all ages. 4-8%/Sv for adult ages, with a dose rate reduction f actor of 2 to 10 recommended for low doses and dose rates. The cedaction factor for low doses depends almnat entirely on

i experimental studies in the laboratory using animal and cellular systems. Data in human beings are scant. When high dose rate and low dose rate ef fects are compared in humans, ratios between the two are more of ten found in the lower end of the range of reduction f actors. UNSCEAR has also evaluated the cancer risk for each organ and provides a table of some nine organs for which significant risks are given. Some of these differ substantially from earlier estimates for individual organ risks. So f ar BEIR V has not completed their evaluation but preliminary indications are that their evaluations will not differ greatly from those of UNSC EAR. For radiation protection purposes (low doses, adult populations mainly) nominal values of ri;k since the 1977-80 period have been about 11/Sv as noted above. This value will need to be re-evaluated upwards by ICRP and national radiation protection bodies in the light of the new estimates. Also risk estimarts for various tissues must be reconsidered and weighting factors used in the ICRP system of 1977 will need to be comple tely re-examined. Specification of exemption, de minimis or negligible risk quantities must also take these new risk estiaster into account. Re f erenc es

1. UNSCEAR (1977). United Nations Scientific Comnittee on the Ef fects of Atomic Radiation, So,urces and Flfects of Ionizing Radiation. United Nations Sales Publication E.77.IX.1, New York.
2. 3EIR III (1980). Committee on the Biological Ef fects of Ionizing Radia. tion, Ef fects on Populations of Exposure to Low Levels of Ionizing Rad ia tio n. National Academy of Sciences / National Research Council.

Nation al Academy P. ass, Washington, D.C.

3. ICRP (1977). International Consission on 9adiologica! Protection, N. Recomm dations of the International Commission on Radiologie,a1 Protection, ICRP Publication 26 Annals of the ICRP, Vol. 1, No. 3, Pergamon Press, New York.

e .! l 4o NCRP (1983). National Council on Radiation Protection and Measurements,  !

          'The Risk Systes for Radiation Protection. Scientific Committee 1 draft report on basic radiation protection criteria, National Council on                                                                            !

l Radiation Protection and Measuremente, Bethesda, Maryland.  ; i l L 50 Roesch, 9.C., Ed. (1987). Final Report on Reassessment of Atomic Bomb [ t j , Radiation Dosimetry in Riroshima and Nagasaki, Radiation Ef fects Research Foundation, Hiroshima. j

  ,                                                                                                                                                       l l

! 60 Preston, D.L. ard Pierce, D. A. (1988). "The effect of changes in  ; dosimetry on cancer nortality risk estimates in the atomic boah [ l survivors", Rad. Res. 114, 437-466. . i i i l 70 UNSCEAR (1988). United National Scientific Committee on the Effects of l i l Atomic Radiation. Sources. Effects and Riska of Ionising Radiation, i l United Nations, New York (in press). I t I I i ! l } I

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r RESEARCH AT THE EUROPEAN COMMISSION RELATED TO THE' DEVELOPMENT AND THE USE OF EXEMPTION RULES by KARL H. SCHALLER Commission of the European Communities Brussels l i i i o e 4 4

1 , i RESEARCH AT THE EUROPEAN COMMISSION RELATED TO TH_E, DEVELOPMENT AND THE USE OF EXEMPTION RULES K.H. Schaller Commission of the European Consunities Rue de la Loi 200, B-1049 Brussels BACKCROUND Research and development related to exemption of very low level radioactive vaste from regula';ory control is performed and supported by the European Commission's Directorate General for Science, Research and Development. [ The Directorate's action in thik area is determined by the "Plan of Action in the Field of Radioactive Waste" (1980-1992), with item 3 calling for "Consultation on practices concerning the management of wnste r the quality and properties of condi-  ! tioned waste and the conditions governing the disposal of waste"; recommendations concerning the satisfactory execution of vasts management operations should be made, and regular consultations should make it possible to "assess the feasibility of , harmonizing waste management practices". Funding for ressarch is available through the wost-sharing programmes "Radioactive i Waste Management and Storage" (3rd prograsuse 1985-1989 with a budget of 62 millions ECU*) and "Decommissioning of Nucitar Installations" (2nd programme 1984-1988 with a ' budget.of 12.1 millions ECU). METHODOLOGY F0R EVALUATING RADIOLOGICAL CONSEQUENCES OF RELEASE Or VERY LOV-LEVEL i l RADIOACTIVE WASTE [ 4 Back in 1983, the Commission placed a contract jointly with the UK National Radio-logical Protection Board and the French Coussissariat A l'Energie Atomique, to ! develop a methodology for evaluating radiological consequences of the management of  !

                     "ery low-level vaste, particularly solid waste from dismantling of nuclear power plants (ref. /1/).

The analysis of waste categorJes has shown that quantities of practical importance

crone for contaminated steel, and activated and contaminated concrete. The disposal

. routas taken into account were: l

                      -                recycling of scrap, with ass'ssment of the exposure arising from melting of                                                                                                                                                        L steel, utilisation of slag, working of the steel product, and from steel reuse;
                     -                 shallow land disposal, either at a municipal refuse tip or at the reactor site,                                                                                                                                                    !

t::kina, into account river and ocean sites for the latter,.  !

                     -                 disposal on the seabed, considering coastal waters and the deep sea.                                                                                                                                                               .

A tange of activity values and scenarios for unrestricted releaea and decay-times up to 100 years before disposal have been assumed, and radiological consequences were found to be rather small; it has been demonstrated that ott.or factors than radiolo-  ! gical consequences, such a s cocts for tranrport, treatment and measurements, and regulatory and social factors, for exemple acceptanca by the public, may well be  ! more important in sanagement decisions. The methodology developed here has been enlarged to establish draft recommendations on scrap recycling.  !

  • 1 ECU = 1.11 US $ in September 1988. ,
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2 TECHNOLOGY FOR MEASURING AND CONTROLLYNG VERY LOW-LEVEL RADIOACTIVITY In the EC-Member States, exemption limits under certain conditions have been set by the European Community directive on Basic Safety Standards; the assimilation of this directive in national legislation takes various foms, but all Member States have oither global regulations for exempt values and quantities, or values given in licences for specific installations. It has been argued that limit values are of ten so lov, that measurement to show compliance is impossible. A contractual study by the French Commissariat A l'Energie Atomique and the German GKSS-Forschungszentrum has analysed the state-of-the-art of technology for measuring very low levels of activity (ref. /2/). It has been shown that for regular surfaces and low background radiation levels, cven the lowest threshold values envisaged for unrestricted release could reliably bo measured. Problems ~ arise for measurements on circular surfaces, cracks, inside cmall-diameter tubing, etc.; for some of these particular situations, spedal dotectors are under development. Lov values will nevertheless lead to higher costs: the time for a, measurement will be longer and shielding against background radiation c y be required. The roport gives also a number of examples of measurements perfomed for release of Icrge equipments; the most spectacular example is probably the meas"rement programme citer dismantling of the nuclear reactor of the N.V. "0TTO HAHN", with a total of 1,440,000 measurements requiring approximate 1r 13,000 hours cf work. RELEASE AND RECYCLE OF CONTAMINATED STEEL During normal operation of a nuclear installation, between 10 and 40 tons a year of l scrap f rom repair and backfitting are produced. Some very large backfitting opera-tions on four Geman BVR-reactors in 1982 gave rise to 700 to 900 tons of scrap per reactor. Dismantling of large installations will be the largest source of contaminated scrap in the future, with several thousands of tons suitable for decontamination and , release or recycling. The "Decommissioning" programme supports experimental work related to unrestricted release in a number of fields (ref. /3/ and /4/):

  -    decontamination of steel surfaces by chemical, electrochemical and mechanical methods: tests have shown that even primary loop material from BWRs may be
>      decontaminated to unrestricted release, but at a price;
  -    melting for unrestricted recycling in UK and FRG-facilitics;
  -    melting for restricted release, mainly in order to ast shielding or containers for radioactive vaste;
  -    melting for decontamination, confiming that Co-60 is distributed homogeneously mainly in the veld, and that Cs-137 is transferred to slag and filters;
  -    supercompaction or -melting as a conditioning method and for vaste volume minimi-sation.

The decision on a particular disposal route in a given regulatory framework is governed by the availability ef dispossi facilities and cost. The upper limit for cny releame or recycle route is too price for disposal as low-active radioactive veste. One of the large FRG vaste-treatment coepanies, GNS-Essen, has calculated this threshold to be about 4,400 ECU/ ton (ref. /5/) in the frame of a CEC-contract;

3 this valua is based on 500 kg raw scrap, the cost of a 200 1 drum, cutting  : cperations, suw r-compaction, handling, transport, 5 year interim storage and deep i geological dirposal in the KONRAD mine. For the iK and France, where almost no interim storage time is required and near-surface d',sposal is much less expensive, the equivalent threshold values would be 2,700 ECU/un for drummed disposal at Drigg in the UK, and 3,000 ECU/ ton for the

Centre de 1. Manche in France.
The "classic" unrestricted release-route for scrap includes
            -        first rough measurements of the contamination levell
           -         pre-cutting of items if requiredt
           -         decontamination by mache.;ical, chemical, or electrochemical methods;
           -         muasurements as required by authorities for unrestricted release 3
           -         transport to melting facility;
           -         melting together with scrap from other sources (c. minimum dilution of 10 is normally assumed).

Tests with significant quantities of scrap have shown that typically about 10% of $ the total quantity may not be released (hot spots, surfaces unsuitable for measure- ! cent); as a consequence of the decontamination process, secondary waste is produced j (the quantity varies widely). In total, the costs for this procedure range between l 1,440 ECU/ ton and 4.400 ECU/ ton, the lowest costs beias reached for larga quantities (thousands of ton at the KRB-A Gundrammingen A plant) of relatively thick-walled ,

low-contaminated components. These values suppose an unrestricted release limit l corresponding to 3.7 Bq/g for beta / gamma activities.

Lower limits for unrestricted release would push up costs for decontamination and censurements disproportionally and might well favour another management route, direct celting. Direct melting is nerformed at a large scale only in the FRG, where furnaces may , celt items with specific activities up to 74 Bq/g under a special licence. Scrap is

cut to auttable volume, pre-sorted and melted to ingots. Samples taken from the I homogenecus melt decide on the future utilisations
- ingots below the unrestricted release limit are sold as scrap; j - ingots between the limit and the 74 Bq/g value are used to produce items for the j nuclear industry, mainly shielding and waste containers.

a l RELEASE AND RECYCLE OF CONCRETE , Huge quantities of c merete are present in nuclear installations reaching more than i 150,000 tons in a large nuclear power plant but less than 10% of this quantity is ! radioactive waste or suspected to be contamined at the and of life-time, yor activa-l ted concrete, experimental and theoretical work has shown that the "borderline" j between radioactive and non-radioactive vaste is easily defined as a function of the release-limit: for a 0.37 Bq/g limit, there are 400 additions 1 tons to be managed as radioactive waste as compared to a 37 Bq/g limit. The amount of contaminated waste depends on penetration of contaminatien in valls and floors and the quantity may reach 15,000 tons under bad conditions. ] 4V The CEC programme has supported research on separation of active and non-active l_ concrete, recycling of concrete by producing waste r:ontainers, and decontamination. j Some limited work on release of contaminated or activated concrete is available in ref. /1/, which draws attention to the fact that the natural setivity level in - I concrete is to be expected at levels ranging betwesn 0.4 and 1.0 Bq/g. i.

4 GRAPHITE s M:nagement medes for graphite arising in Magnox, AGP. and other ge9-graphite reactors at decommissioning have been clorely assessed (ref. /6/). From this and other work, it may be deduced that such graphite, due to the presence of Co-60 and C-14, is not sv! table for unrestricted release under the radiological condition that the collective dose equivalert comitmenc from such a practice be of the order of one manSv or less. Release will have to be subject to an optimisation procedure. RELEASE AND RECYCLE OF ALUMINIUM AND COPPER In a contract with the French Comissariat A l'Energie Atomique, a radiological evaluation of releasing very low-level radioactive copper and alur'.inium is presently in progress. Data on arisingr and contamination degree have been assembled and first fusion tests in an induction furnace of 700 kg capacity have been performed. EXD(PTION OF RADIOACTIVE VASTE NOT LINKED TO THE NUCLLAR FUEL CYCLE One of the tasks of the Comission's "Radioactive Waste Management Programe" is the joint elaboration of radioactive vaste management policies. The working group for this task tacklet the analyris of the exemption practice for vaste outside the nuclear fuel cycle. The level of radioactivity involved is rather lov and of ten radionuclides with a short half-life are used, but there is a multitude of small producers, and heavy costs are involved in collecting and conditioning the vaste. The aims of the acti- . vity are:

                 -   to assess the present situation, as rega.d5 exemption in practice;
                 -   to review the most recently applicable radi. tion protection criteria;
                 -   to analyse the radiological consequences of different exemption practices.

I I The types of vaste under consideration are her .c.1 waste, research institute vaste. industrial vaste, smoke detectors and luminous ;ticles, demolition vaste and other l l items, as long as they are handled in a controlled manner. The quantities involved I are about one thousand cubic meters annually for the larger EC-Member States, with l about half of that amount being short-lived so-called "decay" waste. l l The group presently gathers data from Member States; four contracts have been concluded in order to collect more information on the present situation in a number of Member States, and to help the group in evaluating radiological consequences and developing recommendations for exemption practices:

                 -   e UK company collects information on such vastes and the current practice in ecllecting, conditioning and disposal in the UK; future arisings and consequences of changes in policy and procedures are also evaluated; in a second part, problem areas are aingled out, and procedures for improvement and optimisation are proposed; i                 -   a German contractor studies the FRG situation and particularly pin-points crite-l ria for management decisions and the regulatory background;
                 -   a French contractor analyses particularly management practice of the "small producers"; the main body of the work is dedicated to the calculation of the
;                    radiological consequences of possible release and disposal scenarios; easy-to-
;                    follow routes for management of this type of vaste vill be proposed;
                  -  a Belgian company collects information on the Belgian situctir'n, with a particu-                                          .

lar attention to management practice in industrial application.

5 RELEASE OF LAND AFTER REMEDIAL ACTION Af ter clean-up of a site, the land will be available for industrial, residential or cgricultural use. Clearly, such a site has to be monitored carefully before the change in use to determine whether resid'tal activity is present on the site or in the soil. Standard sampling techniques make use of core samples, but this method is expansive for large surf aces and survey techniques using portable equipment may be used to detect localised sources. In a contract in the frame of the "Decommissioning" programme, the UK Imperial College of Science and Technology develops a survey technique to detect local gama snitters, making use of an adaptive moving array detector system. REFERENCES -

                      /1/   G.M. Smith et al.t "Methodology for evaluating radiological consequences of the management of very low-level solid waste arising from decocunis sioning of nucicar power plants", EUR-10058 (1985), Euroffice, Luxembourg.
                      /2/   M. Hulot et al.t "State-of-the-art review on te chus'.ogy for measuring and controlling very low-level radioactivity in relation to the decommissioning of nuclear power plants", EUR-10643 (1986), Euroffice, Luxembourg.
                      /3/   K.H. Schaller, B. Hubert "Decommissioning of nuclear power plants", EUR-9474 (1984), Graham & Trotman, Londan.
                      /4/ CEC: 'The Community's research and development programme on decommissioning of                          '

nuclear installations - 3rd annual progress report (1987)", EUR-11715 (1988), Euroffice, Luxembourg. 1

                      /5/   K. Jantstgt "Economic comparison of management modes for contaminated metal
scrap", EUR-11149 (1987). Euroffice, Luxembourg.
                      /6/   I.T. White et al.    "Assessment of management modes for graphite from reactor decommissioning". EUR-9232 (1984), Euroffice Luxembourg.

L

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a ,7 i SESSION 4 - Tuccday, 4:30

  ; /S              ,

EXEMPTION OF RADIATION SOURCES AND PRACTICES FROM RADIATION PROTECTION STANDARDS by A. J. GONZALEZ and G. LINSLEY . International Atomic Energy Agency Vienna, Austria 4 and i I l 0. ILARI i OECD/ Nuclear Energy Agency* l Paris, France i i i l I , I ) j . -  ; i t

6

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                      ~                                  .

NRC/NEA WORKSHOP ON RULES FOR EXEMPTION FROM REGULATORY CONTROL i i EXEMPTION OF RADIATION SOURCES AND PRACTICES FROM RADIATION PROTECT.'ON STANDARDS I A.J. GONIALEZ

                                              =2 4                                                               %l and i

G. LINSLEY International Atomic Energy ).gency Viennn. Austria i and i

0. ILARI t OECD/ Nuclear Energy Agency . ,.

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CONTENTS INTRODUCTION CONCEPTS OF EXCLUSION AND EEEMPTION FROM RADIATION PROTECTION STANDARDS , BASIC RADIATION PROTECTION CONCEPTS IN RELATION TO EEEMPTIONS Aims and Principles Individual-related r3quirement Source-rsisted regairement Basic Assumptions in Relation to Low Doses i Risk and Quantities Rolsted to R:uk Detriment and Quantities Related to Detriment i , Limits Optimization of Protecton Cost-benefit analysis AssigninE a value to the health detriment Distributional pcoblema Transboundary sspects EXEMPTION FROM RECULATORY CONTROL AND THE CONCEPT OF 'DE MINIMIS* t EXEMPTIONS AND THE BSS PRINCIPLES TOR EXEMPTION , i Individual-Risk Constder tions .  !

'               Insignific' ant risk i

. Natural back Eround Trivial Andividual dose l I Individual-, dose exemption criteria l l Optimization of Protection Considerations l i EXEMPTION IN PRACTICE i t t CONCLUSI0,NS , OUTLOOK i REFERENCES

INTRODUCTION The Basic Safety Standards for Radiation Protection (BSS) [1] are an international set of radiation protection requirements, developed and adopted by the International Atomic Energy Agency (IAEA), the World Health Organizatio1 (WHO), the International Labour organization (ILO) and the Wuclear Energy Agency of the otCD (WEA) on the basis of the recomendstions of the International Commission on Radiological Protection (ICRP) (2). The DSS were publisned as IAEA Safety Series No.9 in 1982. The radiation protection regulations and regulatory systems in many countries are consistent with this body of standacds. The BSS establirhed a system of dose limitation intended tc restrain human exposure to ionizing radiation delivered by radiation sources and by practices in which such radiations are used. The Section III of the BSS require, intar alia, that radiation sources and practices be. controlled by a system of notification, registration and licensing, to be established by the competent authority. According to this requirement "no source or practice involving exposure of man to ionizing radiation shall be Luthorized unless it As subject to control" (by the system of notification, registration and licensing). The objective of this paper is to present principles for exempting radiation. sources and practie,es from the 'BSS's system of notification, registration and licensing. The paper includes a summary of what - in the opinion of the authors - are the essential features of an international concensus on exemption principles recently achieved under the convaon sponsorship of IAEA and WEA [31 CONCEPTS OF EXCLUSION AND Ex IION FROM RADIATION PROTICTION nANDanDR All people are exposed to ionizing radiation de1Liered by both natural and man-made sources. Moreover, virtually all materials are radioactive, either because they contain natural radionuclides or because t ey are contaminated with artificial radionuclides usually at very lo. levolc. Many radioactive sources cannot be subject to regulatory ecntrol because such control is not feasible. Examples of radiation sources for whith regulatory control is not feasible are cosmic rays, radionuclides that are constituents of the human body (e.g., petassium-40), and radionuclides in nonnal building materials; such uncontrollable sources are by their nature excluded from radiation protection standards (*). On the other hand, there are sources and practices which, although theoretically covered by the system of dose limitation, deliver such small radiation expoauras that the application of the system of h) However, there are practices for which exposures f rom naturally vecorring radionucli. des have been enhanced by concentrat!cn or inadvertent mobilization, resulting in doses sufficiently high as to warrant regulatory control. 9

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                                                                               -4 4

notification', registration, and licensing may not be warranted. These sources and practices are candidates f or exemption f rom the relevant radiation protection standards. The principal arees where practices are usually considered for exemption are public distribution and use of consumer products containing small amounts of radioactive materials, the disposal of very low level solid esdioactive wastes, thc recycling and reuse of slightly contaminated materials from decommissioned tuelear facilities, and the discharge into the environment of very small amounto of radioactive materials. BASIC RADIATION PROTICTION CONCEPTP.IV_REI.ATION TO EXEMPTIONS Alms and Principles Radiaticn protection is concerned with the prot.ction of man, while still allowing justified activities involving radiation exposures. One of the basic objectives of radiation pcote tion is to Ilmit the likelihood of the induction of radiation health effects to levels deamed to be acceptable. In schle.dng these aims, the BSS system of does lijaitation provides the guiding principles. Such principi.es are (1,21: (a) no practice shall be adopted unless its introduction produces a positive not benefit, or justification of the practice; (b) all exposures s h a l '. be kept as low as reasonably achievable, economic and social factors being taken into account, or optimization of protection; and (c) the dose equivalent to individuals shall not exceed the limits recorreended for the appropriate circumstances by the ICRP, or individual dose limitation. The system of dose limication is generally viewed as a set of interrelated requirements applying to the individual, on the one hand, and to the radiation source, on the other hand. Individual-related requirement The BSS establish primary dose limits in order to identifv a forbidden range of individual doses. Secondary limits - related to the primary dose limits - are also specified, e.g., in t= nns of limits on the intake of radioactive materials into the body. Keeping doses below dose limits ensures that the risk to individuals from all controllable sources of ionizing radiation is appropriately low. However, an individual may be exposed to several different sources and sa the whole of the dose limit cannot be used for limiting the dose delivered to an individual from a single source. Instead the dose limit must be partitioned amongst the difforent sources of exposure. These so called "source upper bounds" should be established f ov each source in order that the sum of the doses from all sources cannot reach the individual dose limit (Fis.ure la). 4 4 4

i

 .                                                                                                                                                           I l

Source-related reou t remen_ts : The requirement for justification , of a practice establishes that in order to prevent unnecessary ' exposure, no practice involving exposure to ionizing radiation shall be authorized by the competent authorities unless the introduction of the practice produces a positive not benefit. The requirement for optimization of radiation protection establishes that planning, designing, using or operating sources and practices shall be performed in such a manner that exposures are as low as reasonably achievable, economic and social factors being taken into account ( U ruce 1(b)). Although justification appears to be an obvious requirement, regulators have sometimes authorized the introduction of practh es without questioning whether the societal benefit outweighs the detrimental impact. Thus, before deciding to approve the introduction of a practics; involving exposure to ionizing radiation, it is important to consider the potential radiological harm to society f rom the practice. Optimization appliac to all situations where radiation exposures Fcom a source can be controlled by protective measures. Optimization requires that the optimum level of protection to be used should be determined by appropriatsly balancing the protective ef forts and the benefits of reduced radiation harm. The BSS introduce cost-benefit analysis techniques se practical guidance for optimizing radistion protection. Firure 1 provides a simplified illustration of these interrelated principles. Basic Assumptions in Relation to Low Dose,11 Detrimental effects are assumed to occur in man f ollowing radiatirn exposure even at the low levels of radiation dose expected to occur from practices and sources that are candidates for exemption. At such low-level doses, radiation effects are of a stochastic nature. Stochastic effects are enaracterized by the probability of their occurrence being a function of the dose, while their severity is independent of the dose. The main

-ochastic effects are malignancies and hereditary effects. A fundamental assumption in international radiation protection reconnendations is that the dose-response relationship for the dose range where only stochastic effects may occur is linear and without any threshold. Response, in this context. means the probability that the exposed individual will suf fer a serious health ef f ect as a result

Firut'e 1 trulleidual - rotated requits monts mal mal Source Source upper bound upperbound ! N / Dose limit (a) The Dame 5aftfy Standards for Ita6ermen Proisenom e*isure an edeqsate need of indMdeal proteethe through aa 46 enfwletated regw&emer which estabashes that no aMtridwl shan be esposed, es a result of contro5ed sources and pretteces,in eseses of the dose Amirs set forth by the Standards The totalindMdual does escted6ng nervril background and snedical enposurm of pecens must be considered, if esposure from several sources is poemble, soester+pm 6ewMs shound be estabhahed; those are fractsons of the does hmitA mangned to partwelar soortes of esposaret Soutes - teleted requiremente

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lg,/ -e . ()) The Standards pamde seditional protecnon thsowgh source reisted regure==ect which eeubhah the twin!!cerua of the preente . for nach the source a eseded - and the oprtauJaram of redwrun protection to be app 4ed to the source. These take less accomet the ese of as diums - bevor sened - daievered by the seetco sugardless of hacemos and tune of the en peanse. .

        -~ ,-        . . _ _ - - . _ _                 , _ - _ . _ _ _              . . - _ . _ , . . . _ , . . . _ . _ _ , _ - . . . - -

I l of the incurred radiation dose; internationally, this probability is called ' risk' [4). The i doss-risk relationship used for radiation purposes is illustrated in Fiaure 2. one-me resteam, woes tw twiet+a peent a pwepeies implication of the assumption of linearity is that at any . - - - - - - dose increaent, no matter how small, will correspond to a go " j proportional risk increment. - - - , Consequently, doses are / additive in the sense that  ; 10 __ j - equal dose increments l increase equally the risk or 80 probability of a deleterious g -- effect, by a value which is independent of the previously i accumulated dose. A j consequence of this is that the total expectation of harm *,, in a population, i.e. the sum of all population, risks is in that proportional 10 8 to to t M' 10 to the sum of all doses two n,we awarcee me wa reetmann weee tw incurred by the population .,,,, ,,,eo ,,,eece gn,,0 ,e,,tae n ee ,ee ,. however small such doses now: put e e. m,we owe. e trutea et eae 44reet, easy might be. #want* e *1* w. ** s'""""Y "'"" **** eweetty ere.oruoam to tm one wve. Tweee meiwee vote unem in me ewuine,vwww eae sevm e*** tic eaects Tne assumption of m ee owc.eeen e.rww.eae e nuenuate et tu cww 1ineae responsa without mee**ve xtweeaseamnewmes taet. tow- as ear produced, **""**'d**'""**""****"**'a**

      ' threshold             has                                prea+ty e en e ns. e Yn.e i am aweteerg en nect s

during the last decades, an ,,,eeent,,0. g , e eio,,,, 0ceu reww w ee., se increasing pressure to apply a eaew pewt4W eseemete weae e tw p=aa.as ow-

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controls to all radiation e""pramme,eowii to m ' sourees and peaetiees ,e,,we seew,,,ee w as e,ew in ,,e ,en,.. ,e, , 1st.a involving radiation exposure, prewtion ewe ees, me *** * = eae o e. me am tes*w irrespective of the level of ***'**1""""""""'h'"" m: . :: : mm wwmmea ea memw eeme eer.wre 4, the resulting radiological see,e w i.e '. e n. ,wtw ,n.,at coa,e m me Mwre, ni sw eme et e etwasm *.ctaea e ww newt. detriments. sothreroe m a chest pense et tame, nea etwheets eMeow sney escur, The seeevies rWetieneNo seereswnetoe te e ea,mese reet.oneNe, As m ee stesmeets tea,e. the esem pope seeease en e ave %.e es ruin, owen se im eeen ree, wheth etww M relevent 4r pe6mw ner steaeaee et esteewre. FW e Sete et esereaimete#y 3 S, me yeeesdtty et eeeth 4 esewtSS.Q)Fm48v.40leteewmee tP et fed soeee hyaet then seewt $ 10 $t, eteverse M e ened pe**ee 6.' time. pecyte4y es wresisted kwwe. ele wie awf%e en ecwte red etion eyaste84 ene eveatweIPy e4 w e 4.a 44wertte et tae trencia. theA Therefers, the teLHeneNp to teewmee le secre=M wymetetweet a 5##e.*4ay of Wuty ter seeee negaer then esows big 30, l

l Risk and b tities Related to Risk: The term righ is usad in the context of radiation protection to mean the probability that a given , individual will incur a severe stochastic deleterious effect as the result of a radiation dose. Under the assumption of linearity, the risk to an individual is proportional to the effective dose equivalent incurred by that individual. i The effective dose equivalent. Hg. is defined as Hg = E T "T H' T where Hr is the mean dose equivalent in tissue T and wt is a weighting factor for tissue T expres sing the radiosusceptibility of such tissue. The BSS established the appropriate weighting factors, wT. for particular tissues. T [2]. 1 The effective dose equivalent is based on the concept that, at a given level of protection, the risk should be equal whether the whole body is irradiated unifomly or whether there is non-uniform or partial irradiation. In this paper, except when specifically indicated, the tem dose and the notation H mean effective dose i equivalent and Ng respectively. The BSS also established the quantity rosualtted dose, which is defined as the sum of doses that would be recoived by an individual over a specified period of time following the intake of a radioactive substance. This quantity is needed in order to implement,a basic BSS criterion for individual dose limitation, which is to limit the lifetime risk ::ossaitted in a year. rather than the dose delivered in a year. The comitted dose following intake is a conservative measure of risk when compared with the risk associated with an equal dose f rom extet'nal exposure. This is because there is a delay before all of the dose is delivered. The quantity that reflects the risk comitted in any one year is the sum of the external dose received in

  • that year and the comitted dose from intakes in that same year; hereinalter, the tem annual dose will be used to express this  ;

quantity. Detri- t a Quantities Related to Detrimentt The individual i.e., riJk to radiation (R) is assumed to be proportional to the dose (H). the risk is given by f R=rH where, e is a proportionality constant called risk factor. It follows, therefore, that if all individuals in a group of W receive a dose H. the expectation of the number of severe stochastic effects. G. wh'ch is called radiation health detriment, is G = r H W. 9

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. g  ! When several groups i composed of Ng individuals receive doses H, L the detriment C, is given by 1 0 = r I NtN t. 1 The sum 3 = { Mt NL is called collective effective dose equivslent, hereinafter referred to as collective dose. It follows that the detrimen6 is proportional to the collective dose. The  ! collective dose, S, is an extensive quantity so that if there are components of collective dose, St, the total collective dose is  ; given by S = [St. Sometimes there is a continuous distribution of doses over the ' exposed population. In such cases, the defining suaumation. S, of the collective dose can be expressed as ar. integral S =,l " H N(H) dH where N(H) dH is the num* .'r of individuals incurring a dose in the range H to H + dH.  ; Usually, the dose to the population f rom a source is delivered [ at a varying rate over time. Therefore, it is convenient to define a l collective dose este at time t, 4(t), as the weighted product of the dose rate due to the source and number of individuals in the population (see Flaure 3a): i S = l A N(A) dA. { The total collective dose Sc. due to a given decision, event  ! or defined amount of practice, is the infinite time integral of the [ collective dose rate. S'( t ) , caused by that decision, practice or amount of practice (see Flaure 3b)1  ; i Oo . SC = of S(t) dt i This total collective dose is usually called collective dose cossaitment; it is a measure of the total detriment to health f rom the  ! exposure to a source. [ l

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sy detinition, the collective dose includes all the doses to all the individuals who are expo sed as a result of the source or practice under consideration. Hence, it is not permissible, a priori, t to truncate collective dose calculations in space, in time. or at a a given level of individual dose. Howevet for some putyoses it is ! useful to separate the parts of the total collective dose which are received by particular populations, at particular levels of individual dose, over particular periods, or at different degrees of uncertainty. Limits: The primary dose limits for individuals, given in the, BSS (2). are those recommended by the ICRP (1). The value currently recommended by the ICRP for the limit of the annual dose for members i of the public is 1 mSv. The ICRP also states that it is permissible to use a subsidiary dose limit of 5 mSv in a year for some years, provided that the average annual effective dose equivalent over a lifetime does not exceed the principal limit of 1 mSv in a year (51 Since the primary dose limita cannot be applied in full to limit the dose contribution to a r. individual from a particular source, they l serve only as bases for deterdning source-related uppte bounds. The , upper bound, to be imposed oy che competent authority, should be so selected that the envisaged total of sources, present and future, will not cause doses above the primary limits. Optimization of Protectiont Ootim,sa6.lon 8 of protection requires that protection be improved to reduce doses below limits and below upper bounds to levels such that further dose reductions do not warrant the efforts needed to achieve such reduction.

!                         Cost-Benefit Analysis: One of the techniques f or implementing 4

optimization is the use of dif ferential cost-benefit analysis. (6]In differential cost-benefit analysis, the value assigned to the j radiation health detriaient saved by reducing the doses is compared with the cost of increasing the level of protection in order to i 3 achieve such reduction. The optimum level of protection is obtained j when the next level spent on protection exceeds the value of health j q detriment thereby averted. Cost-benefit analysis for perfoming , l quantitative optimization is by no means exclusive. Other approaches - I 1 some quantitative, some more qualitative - can also be used for  ! j optimizing radiation protection. However, cost-benefit analysis is a l l simple technique to demonstrate that a balance has been reached J between the achieved benefits, in terms of radiation detriment i reduction, and the protective of forts. This is the case if the sum of i the values anduned to the ef forts made for further improvement of the E ( c f l 1 l . ! I

  - -,_   - _ _ _     _,      ___.___ _ _..._,,_.,-.._._         .,._                              , , ,__ _. _ -. - -_ _             _..-.m. . - , _ _ _ _ _ _ _ _ _ _ , _ _ _ , _ ,

protection and the resulting decrease in the detriment is at a minimum (Fiaure 4). While protective ef forts can easily be quantified in tems of the cost of protection, the assignment of a value to the l detriment Firure 4 to obtain the so-called  ; i cost of the detriment is a particularly difficult problem. s.y Assir.nina a value to the health detriment: The BSS require that all doses , I delivered by a source I should be included when l l determining the health ' detriment, without discrimination as to dose distribution. The RSS recorinend use of a . J constant, alpha, to be l , I applied to the collective l dose cv.enitment for  ! obtaining the value of the u health detriment. Since for a comparative purposes the cost of the detriment D h*W" W should be presented in the aame units ps the cost of N" " 1 0' '"" ** "* * # '"'* *

  • P* ** ** * "'

ptoteetion, alpha is P"'*""***'***'*"*"A'"'""*"""I" the case,24 asa e to God the protocoon legt at usually et.p re s s ed in .a,ch ee ,e g i.x roer o/rornriosi, x. pl.: ee monetary units per cost e/dernmeer. Y e si e minimen . la som com l collective dose unit. This *e maimissooa procas a retet"W7 ** pie - u r

                                                                    **** ta se neum - becava to* o i premtion and haa produced a wideJpread                                       eetnswai coeu are coenn.o.e rmte as d one                                      ;

misunderstanding regarding ,,om,,o. ,,,,aem, w. The e1 be the sau sf me t the phLlosophieal and promoo pu mem in, roe u wen me e.cknew or ethical consequences of shwediM os me no.nie et a wouli m ayiam. Ia i such an approach because **"***8T'h"**""P'*****"****

                                                                     **"""*****"****O**d**8"'"""**

the intrinsic connotation m endab6e; *e opumem ces one he echwod is that a monetary value aroup aa 6tmiso pese, s. by .hch inenusary , would be assigned to a ben w,ets or pmeceo. m i nod to unn si the r human life. However, the poiai

  • ash asistas the coa *uee et ===== toul ,,, l BSS clearly state that they do not place a monetary value on human life and ,

that there is no limit on the cost of the protection needed to keep individual i exposures within recomended limits. Optimization requires that, if there is any further reduction of exposure, economic and social h f actors should be taken into account so as to cnsure that there is an optimum use of the resources available in achieving that ' reduction. The ICRP recomendations on cost-benefit analysis in 'the optimization  ! of radiation protection su5 gest that, although cost-benefit analysis i techniques require the valuation of the change in life expectancy of - i

unknown indiviuuals, no value is being assigned to identified individuals. In fact, the f actor alpha represent the amount allocated by society to avoid a unit of collective dose, and its magnitude determines the attainable level of radiation protection. It has nothing to do with a valuetion of human life but is a rational device for conserving lives. It contributes to society's acceptance of a level of radiation protection which is the highest possible that can be aM;ained without conflicting with other legitimate needs and duties of soalet/. Distributional croblems: An interesting question is whether or not detriments occurring at different places or dif ferent times should N valued on an equal basis. The basic ethical principle that ef forts u imp:nve life expectancy should not be discriminatory regardless of where end when the life is expected te be lived, appears to be the only rational approach. In the DSS there is no discrimination in the assignment of valce to different spatial and temporal components of a detriment. However, it has been suggested that the valuing of components from different times might justify applying different i weighting factors to the respective costs. Some advocates have suggesteo use of n?gative factors for futu*e cost on economic grounds, using the account N cencept of discounting future costs to bring them to present time; others have recomended positive weighting factors, on the ethical grounds that future generations who will experience the detriment cannot participate in establishing the costing procedure. In this connection, the IAEA's Principles for Establishing Limits for the Release of Radioactive Materials into the Environment eJtablish that I the assignment of present values to future costs is a matter for careful judgement by regulatory authorities, who trast decide whether it is reasonable to attach less weight to doses far n the future than i to doses in the near future. A report of a group ot experts convened by the Holy See's Pontifical Academy of Sciences recomends that future doses that can be avoided by protec;!.a measures should always be given the same weight as present doses. The controversy may, in the end, prove to have no practical implicat!ons since for many i optimization assessments only detriments to be incurred in the relatively near future have to be considered. Trans-boundary aspects: Since radiation detriments originating from a source in one country can be incurred by people its soother . country, it appears obvious that international agreements will be necessary to assign values to the trans-bound.ry components of such detriments. ICRP suggested that the relevance of this problem could be reduced if some internationally acceptable minimum limit for the value of alpha could be established and that, in any case, the v tNe applied to other countries should not be lower than the Value apy34ed within ] , the source country. In imp'ementing the BSS, the IAEA has already promoted such an international agreement (7). , n--i!ON FROM REGULATORY CONTROL AND THE CONCEP'r OF 'DF )gNIMIS' A variety of approaches have been pror ., sed to implement exemptions from regulatory control. They apply to different aspects of the system of dose limitation and use dif ferent terminologies. Terms such as "trivial" dose, "non-radioactive" waste, "de minimis" values, values "below regulatory concern", "regulatory cut-o &*, have been i proposed. ,

A popular expression, "de minimis", sometimes used as an adjective to qualify individual dose levels which supposedly should not provoke regulatory concern; it implies that small dose increments have to be entirely noglected, e.g., introducing a dose cat-off. Reference is made to the jurists' concept of de minimis non curat lex, or the law is not conce rned with trivialities, but also de minimis non cure praetor, or the prosecuter is not concerned with trivialities (a slightly different concept). Both these concepts are ablative expressions which refer to a cause of no concern either for the law (or regulation) or for the pttsecutor (or regulator). The jurists do net intend to use the concept of de minimis to qualify one of the components of a cause of no-concern, such as the individual dose, but rather to characterize such causo. The confusion in the discussion on de minimis doses .s partly cesated by the lack of distinction between source-related and individual-related assessments. The expression has been largely misinterpreted and misused, in the sense that individual doses lowar than a "de minimis" level, corresponding to a trivial individual risk, could be disregarded in radiation protection assessments and, particularly, could be excluded from the sumation of invidiual doses for the calculation of the collective dose commitment to the exposed pop.lation groep. Thl p, interpretation is not in line with the concept and the use of collective dose as one the primary parameters of the process of optinization of protection. In effect, while the linear, dose-response relationship, with no threshold, rcmains the fundamental assumption behind the system of dose limitation and the BSS, very small individual doses may well be of no concern to individuals, but their accu.tulation wJthin an exposed population can still give rise to a collective de t riroent of conce rn to society and the regulators (or prosecutors). T" zummary, even though there are undoubtedly levels of risk incremet i ; hh would not significantly change the overall radiation risk fu 'he exposed individuals, this is not a sufficient basis to say th a t. such exposures would not be of regulatory concern. It is also riecessary to xnow that the collective dose from such practices or such a set of sources is suf ficiently small, even though the collective dose may be comprised of small doses to a large number of individuals. There is no doubt that it is appropriate to disregard trivial doses in a purely individual-related assessasnt: very sr.all doses and the corresponding minute riskf should not be of any concern, neither legally nor from the indiviaual's point of view. However, the . situatior. is different in the source-related assessment, where the total detriment, on the postulated assumptions, would be the same f rom a small LMividual dose to each member of a large population as from a l a r g *. r dose to eve:yone in a small population. In addition, in exempting individual sources, the possible build-up of a global contamination from many small sources must also be considered. The relevant quantity in the source-related assessment is the collective dose commitment rather than its individual compenents. Fi s.u re 5 illustrates how similar collectiva doses, and therefore detriments, from' two different situations producing different distributions of individual dose rates, would be judged to be very different if a 'de minimis' cut-off dose were introduced.

                   ~

Figure 5 i 4 a NiH) SITUATION A (e.g. population f ar away from the source) f f Ih i 6hA i TT ,_, . r,me,, fig i HL ' gmaxA l i  ! l a M(A) . SITUATION B i (e.g. population near l thesourceL M  !

                                                       "(Wh  s 5            ."
  • k i nrnrn mn N k i h I i -

f A

                                                                                        ,maxA    -

A DE MINIMIS ?

In sunenary , a competent authority may exempt a particular practice or ca,tegory of sources f rom defined regulatory requirements because individual and collective doses received from it are both so low that they may be reasonably be ignored. The ef forts involved in an optimization analysis itself (e.g. the cost of the analysis) may re taken into account 1, the competent authority in determining wnat level of collective dose might be ignored. Also, a justifiable practice that leads to negligible individual doses might be exempted l if an optimization analysis indicated that extra protective measures I would not be warranted by any reduction in collective doses that could be achieved. EXIMPTIONS AND THE BSS The basis for exemptiens already exists in the BSS. The Standards include, in fact, a clause providing for the exemption of i specific sources or practices from the requirements of notification. I registration and licensing. Exemption may be granted if, based on an l 2nalysis of the health hasseds involved, the competent authority is assured that the detriment associated with these sources or practices will be so small as not to warrant the application of these requirements (1). The radiological criteria for exemption are, however, not specified in thr BSS and, therefore, the IAEA started in the last few years an ef fort to develop such criteria at the conceptual level and l to study their application to specific situations. The development of a consistent set of conceptual principles for exemption turned out to be more difficult than expected and many discussions among experts l were needed to reach consensus on a number of issues. Eventually, a l joint ef fort by the IAEA and the OECD Nuclear Energy Agency (NEA), in l 1988, was successful in achieving such a consensus and the IAEA has I just published a Jocument on Principles for Exemption of Radiation l Sou,ces and Practices from Regulatory control (3), which recommends a widely agreed policy for exemption that Member States are now expected to consider and, hopefully, to adopt. The system of dose limitation is applied in the BSS to the regulation of practices which are nonnally subject to control. Therefore, the~ exemption of a practice or source from the requirements of notification, registration and licensing must be seen in the context of this system and the application of its basic principles must be considered when granting an exemption. It is recalled here ! that these basic principles are the Justification of a practice, osti=l tation of protection and limitation of individual risk. Decisions on the justification of a practice usually derive from considerationtt which are much broader that those based on radiation protection alone. Therefcre, these decisions may well be made outside the context cl regulatory control (or exemption from such control). For these reasons, the guidance on exemption refers to sources or practtees that are justified and, therefore, the principle of justification, is not evoked any further. The principles for exemption theretore will be governed by the limitation of the individual risk and the optimization of.ptotection.

17 PRIMcIPLES FOR EXEMPTION It is apparent that there are three L;teues to conalder in deelding on exemption of a given source or picactice. The first is the purely individuul-reacted issue of what is a trivial radiation risk and dose to an individual regardlear of where the risk comes from. The second is the individual- and source-related issue of risk build-up for individuals f rom multiple sources of exposure. The third is the purely source-related issue of the societal impact associated with the l detriment produced by a given source or practice and its implications for optimizing radiation protection. In order to be consistent with the criteria of risk limitation and optimization, therefore, the principles for determining whether nr not a practice can be a candidate for an exemption from the system of notification, registration, and licensing ara as follows: (1) individual doses must be :suf ficiently low a. to be of no concern for the exposed individuals and not to warrant regulatory action, taken in*o account that the build-up of many low doses may produce a dose of concernt and, (2) further dose reductions by regulatory control must be shown not to be justified in terms of the regulatory effort needed to achieve such reductions. The firs *; aspect is addressed by defining a level of individual risk and consequently of dose that can be assumed to be "trivial" for the indiviCuals. The second aspect is usually addressed by using optimization criteria, either intuitively or through formal techniques, such as cost-benefit analysis. Individual-nisk considerationi If exemption of a source (r practice is considered from a purely individual-related point of view, there appears to be broad i agreement that very small doses and the corres,londing minute risks should not be of any concern for the individual or for the regulator, i For the individual, the two main approaches to deciding upon a trivial level of risk or dose can be used: (1) to choose 'a level of risk ano the corresponding dose which is of no significance to individuals; and, (11) to use the natural background exposure and its variability, to the extent that they are nomal and unavoidable, as a relevant reference level. , Instanificant Risk: It is widely ecognized that levels of individual risk which can be treated as insignificant by the decision-maker ' correspond to a level at which individuals who are aware of the risks they run would not comit significant resources of their own to reduce such levels. This is a difficult questien to judge, because few individuals are conscious of the magnitude of small risks and people have little opportunity to demonstrate their preferences in this field. There is likely to be a wide range of individual views on this subject and any decision may leave people

     -  feeling that they are exposed to risks calling for further control.

_. _ _ _. _ ___.. - _ . _ ~ _ . . __ _ _ _ ___ _ __

However, there is a large convergence of expert opinions on the view that few people would commit their own resources to reduce an annual risk of death of the order of 10-5 (one in a hundred thousand) and that an annual risk of death of 10-6 (one in a million) is not taken into account by individuals in arriving at I decisions regarding their actions. The IAEA/NgA Advisory Group, in accordance with most authors, has therefore suggested that the level of annual risk of death which is held to be of no concern to individuals should be in the range 10-6 (one in a million) to 10-7 (one in ten millions). If this risk range is converted into a range of doses by us'ing a rounded value of 10-2 per sievert for the risk factor (eee Figure 1), the level of trivial individual dose is in the ange of 10-100 microsieverts per year, i.e. between one tenth and one hundredth of the current dose limits for members of the public. Watural Backaround Natural background radiation has been

estimated to give, as an average, an individual dose of about 2.4 millisleverts per year. t. bout half of this dose is due to radon ,

exposues, especially in Uwellings, a source for which controls are -

suggested. The other half comes from exposure to cosmic rays, terrestrial samma rays and radionuclides in the body, for which control is not feasible.

Individual members of the public do not generally take account ! of the variation in exposure to natural background radiation when considering residing in one part of a country or in another, or when going on holiday. It can, therefore, be judged that a le'el v of dose which is small in comparison with the variatione in natural background radiation can be regarded as trivial. A figure of dose of the order of one to a few per cent of natural background, i.e. 20-100 microsieverts , per year, has been suggested. This is within the range of 10-100 j; microsieverts previously identified as being of no concern to ' 4 individuals. Finure 6 shows the various contributors to natural background radiation and their variability. Trivial Individual Dosg: It follows, therefore, that an individual dose is likely to be regarded es trivial if it is of the l' order of some tens of microsieverts per year. It is to be restated that this level of dose corresponds to a few per cent of the annual i dose limit for members of the public reconumended by the BSS and is I smaller than author ,sd limits set by competent authorities for i practices subject to regulatory control. Individual-Dose gxemption Criteria: An individual may, however, 4 l be exposed to radiation doses f rom several sources or practices that l are c,andidates for exemption and his total dose might, therefore, rise . above the trivial individual dose criterion. To avoid this, each l exempt practice should only utilize a part of the criterion. In other l words, the individual dose defined as "trivial" for a sinale source or i practice needs to be lower than that regarded as trivial for a_l1 , sources taken together. On this basis, it is suggested by the IAEA/NEA

4 . Finure 6 e Cd 3n enternel p _ Internet h Terrestfiel 440 , e xternel . . . internel "K  ; t 1100 10p 888 Mn-e88 *Po i 27 _ sig tioPo 120 , 82' 8"T1 $ t 0 100 200 300 400 500 000 700 800 900 1000 1100 1200 micraievert Advisory Group that national authorities should apportion a fraction of the individual trivial dose criterion to each exempted source or practice. This fractionation should lead to an exemption criterion of individual dose for one source or practice of the order of 10 microsieverts per year. Optimization of Protection Considerations The trivial individual risk level is most helpful in putting

           . radiation risks to individuals intu perspective. In most practical situations, however, the regulatory need for an exemption arises in the consideration of           source-related assessments,                               where the total detriment, expressed by the collective dose to the population group exposed from a source or practice,                                 is the primary parameter of interest.

This leads to the application of the second of the general principles for exesption, i.e., that radiation protection must be optimized. When considering exem).tlon, the concept of optimization of protection must be seen in a broad sense. It is, in fact, not merely the search for the technient solution which, amo'ns dif f erent options, corresponds to the optieum level of protection, but, rather, the

r comparison of the regulatory efforts and resources of various possible options for regulstory control, from full licensing down to total exemption.. versus the benefits - in terms of radiation detriment avoided - achieved as a result of such efforts. The source or practice under consideration should be regarded as a suitable candidate for exemption if the result of this assessment shows that, among the different regulatory options, exemption is the option that optimizes protection. As was mentioned before, it was felt useful if, as for the individual dose, guidance were given on a value of collective dose commonly considered as trivial and which could be used as a basis for exemption without a need for an in-depth analysis. For this purpose, the IAEA/NEA Advisory Group developed guidance along the following lines. The undertaking of a fomal optimization assessment involves some cost and commitment of regulatory resources. It can, therefore, be argued that where, in the absence of further protection measures, the individual doses are "trivial" and the collective dose is sufficiently small, the cost of performing the optimization analysis may in itself outweigh further potential reduction in health detriment. In such situations, the rigorous use of cost-benefit or other method of optimization analysis would not be justified and the initial assessment of levels of exposure may be sufficient for a decision to exempt the source or practice under consideration. This is not becaus* the levels of dose and health detriment are of no concern per se, but because protection is optimal. Practical experience suggests that the cost of femal optimization procedures will be at least in the order of some thousands of dollars. This cost can be converted into a value of collective dose, for instance by using, as a reference, the alpha value - or the monetary cost assigned to the unit collective dose - suggested by ths IAEA for international use in cptimization of protection in relation to transboundary releases of cadioactive material, namely a minimum value of 3000 US$ (1983) per mansievert (7). This would lead to a practice-related ' trivial' collective dose for exemption purposes of the order of a few mansieverts. For continuing practices this may be interpreted as a collective dose comitment of about one mansievert per year of practice. In conclusion, each practice should initially be assessed as if it were to be subjected to a fomal optimization procedure. A generic study of the available options (including various kinds of regulatory action) should be made by the regulatory authority and the conclusion reached that exemption is the option that optimizes radiation protection. However, if this generic study. in its early stages, indicates that the collective dose committed by one year of the unregulated practice will be less than about one mansievert, it may be concluded that the total detriment is low enough to pemit exemption without more detailed examination of other options. IIEMPTION TV PRACTICE The procedure for the practical application of the exemption policy described above is summarized in,the scheme of Figure 7.

                                                                                   -   21 -

Fizure 7 Radiation protection PRACTICE OR SOURCE IS so CWSON FROM REGMTCN CON L BLE? \ 1 y YES IS so N U  : NO EXEMPTON FROM REGULATCN E O 1 a y YES t$ iS NO NO COLLECTIVE DOSE LESS THAN

                                 -1 mansvty?

EX E MPTCN OPT 1uAL OPTCN7 YES. YES v v . l

                                       -               EXEMPTCN FMOW REGULATCN Sweget te the c<eeire.no of N eene weoor-bevne neognes ey the seiones reewwery esonry tar ed esongsene pew tone of mcreeeven per year)

A flee sheet may hotp to twtune the preseewre let mohang esteenene en Wie esempeen of gew e ses ene precuses As eheen, the meth88eh7) to serWe en esempteen le neced en yte senseement of pte inetytewel and sedesteve Geese that may artee from the prestese weisen le e genetgees ter estenphen, W e gemene seeseement. et Me earty e449ee, Pte644444 thet the 166e87 seneegwences of the esempeen,in terme of reenete especure, are behoe the thesen tr4ene, the authermee mey wen i l Gothee te grant the esemppen, in teses where euSA e campefted preseewre ineesetee What the sehective sees le not metes Ute trMenen more estease seeeeemente,4petwe6ag semporteene egh echer puedemo openene, well ne regwared. (The flee sheet *** Gevoteped by the )sent LARAMA escretenet of en oevisory group moeung et Wie (ASA le leerse.1944 ) i 4

When considering a source or practice, the regulatory authority must respond, first of all, to the basic question of whether or not it is feasible to apply a regulatory system to the source or practice in order to exercise restraint on the doses it delivers. As indicated earlier, the nature of some sources is such that control by competent authorities is not practicable or even not possible. Such sources are by their nature excluded from regulatory control. If rtgulatory contest on the source or practice is feasible, tha first aasessment to be made concerns the fulfillment of the condition that the annual individual dose to the members .f the critical group, namely the group receiving the highest exposure from the source or practice, does not exceed ten microsieverts per year. If this condition is fulfilled, then an assessment of the collective dose should be made. If the collective dose satisfies the condition of not exceeding about one mansievert pe= year of practice, then the practice can be exempted. However, even if , the collective dose exceeds this criterion, it is still possible to consider exemption by applying the process of optimization of protection and demonstrating that exemption is the optimum opt!.on f rom the radiation protection viewpoint. There is a further constraint to be censidered in practice before granting an exemptions the condition that. the accumulation of doses to the same individuals from several exempted cueces or practices must not exceed the individual-related "trivial" doss level of a few tens of microsieverts. An additional condition - not specifically indicated in the scheme of Figure 7 - is that exemption is intended f or sources and practices which are inherently safe. Therefore, the regulator needs to take account of the probability and severity of possible consequences of accidents and misuse, and exemptions should not be granted if there is a possibility of accident or stisuse scenarios leading to exposures in excess of those resulting from the general criteria described above. CONCLUS105 A major contribution towards reducing the difficulties in keeping under regulatory control radiation sources and practices involving minute risk and detriments has been made by the issuance of the Principles for Ramption of Radiatian Sources and Practices from Regulatory Control by IAEA and WEA( M D). As the "de minimis" dose issue has produced controversies ascr.g experts, uncertainties in regulatory practices and disorientation in the regulated industry, the new principles are expected to help resolving these problems. It is now for national authorities to convert these principles into actual regulatory terms. The application of the recocunended exemption policy requires care f rom the authorities and f airness f rom the operators in order to avoid the use of exemption to circumvent controls that would otherwise be applicable, by -interalia- deliberate dilution of material or fractionation of a practice. For this purpose a clear and unequivocal definition of the sources and practices is eusential (8).

23 -

                                                                                                                                                                                                                                        )

E The international agreement on exemption principles is expected to lead to a more unified worldwide approach to exempting radiation I sources and practices from regulatory control. perhaps the most important feature is that a logical procedure for establishing  ! exemption criteria has been agreed upon internationally. Thus, although it is possible that the actual dose values used could change. [ because of dif f erent levels of ambition or because of changes in the i risk factors, the framework for arriving at the criteria should remain l the same. The IAEA and the NEA are continuing to provide guidance to their Member states on how to use the owes 9 tion principles in ' some  ! sain application areas, cuidance on a methodology for deriving exempt [ concentrations of radionuclides in low-level wastes for disposal in i municipal landfills or by incineration has already been prepared (91. l Work is under way on the appliestion of the principles to the use of j consumer products. in the recycling and reuse of slightly contaminated materials f rom decomunissioning nuclear f acilities, and in the disposal [ of very low-level radioactive materials in the marine environment (10) - (11). ( i i t i h r i t f l L 1 l I I

     .                                                                                                                                                                                                                                  t ul e

l REFEREE,II, (1) INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for Radiation Protection. 1982 kdition. Safdy Series No. 9 IAEA. Vienna (1982). I (2) INTERNATIONAL COMMISSICW ON RADIOLOGICAL PROTECTION.  ! Reconnendations of the International r9maission on Radiological Protection. ICRP Publication No.26 Pergamon Press. Oxford and , New York (1977). (3) . INTERNATIONAL ATOMIC ENERGY AGENCY. Principles for the Exemption of Radiation Sources and Practices from Regulatory Control. Safety Series No. 89 (jointly sponsored by IAEA and OECD/NEA), Vienna (1988). (4) INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTkCTION, A  ; Compilation of the Major Concepts and Quantities in Use by i ICRP. ICRP Publication No.42 Pergamon Press, Oxford and New ' York (1985). (5) IWTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION. Statement from the 1985 Paris Meeting of the ICRP, Ann. ICRP 15 3 Pergamon Press. Oxford and New York (1985). RADIOLOGICAL PROTECTION, [6] INTERNATIONAL COMMISSION ON Cost-Benefit Analysis in the Optimization of Radiation

Protection. ICRP Publication No.37 Pergamon Press. Oxf ord and New York (1983). ,

(7) INTERNATIONAL ATOMIC ENERGY AGENCY. Assigning a Valus *o Transboundary Radiation Exposure. Safety Series No.67 IAEA, j Vienna (1985). * (8) ILARI, O. , Tre Concept of Prt,ctices in Radiation Protection. in the NRC/NEA Workshop on Rules for Exemption from Regulatory i Control, Washington October 17, 1988 (in preparation). l

,                   [9]    INTERMATIONAL ATOMIC ENERGY AGENCY.                                                                                                                                                                   Exemption of radia"Lion                                                      f sources and practices from regulatory controlt Interim report.

IAEA-TECDOC-401. Vienna (1987). [10] INTERNATIONAL ATOMIC ENERGY AGEhCY, Code of practice on regulating the use of consumer products containing radioactive i materials. Safety Series, IAEA. Vienna (in preparation). (11) INTERNATIONAL ATOMIC ENERGY AGENCY. Exemption principles j applied to ths recycling of materials from nuclear f acilities, i Safety Series, IAEA Vienna (in preparation). ( I ! L 1

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DRAFT Advance Notice of the Development of a Comission Policy on Exemptions from Regulatory Control for Practices Whose Public Health and Safety Impacts are Below Regulatory Concern

1. INTRODUCTION AND PURPOSE Over the last several years, the Comission has become increasingly aware of the need to provide a general policy on the appropriate criteria for release of radioactive materials from re ulatory control. To address this need, the Comission is expanding upon ts existing policy for protection of the public from radiation, currently expressed in existing regulations (Title 10, Code of Federal Regulations) and policy statements (30 FR 3462, Use. of Byproduct Material and Source Material, uated March 16, 1965; 47 FR 57446, Licensing Requirements for Land Disposal of Radioactive Waste, dated Decenter 27, 1982; and 51 FR 30839, General Statement of Policy and Procedures Conce.ning Petittor.t Pursuant to i 2.802 for Disposal of Radioactive Waste Streams Below Regulatory Concern, dated August 29,1986). The expansion includes the development of an explicit policy on the exemption from regulatory control of practices whose public health and safety impacts are below regulatory concern. A practice is defiaed in this policy as an activity or a set or combination of a number of similar sets of coordinated and continuing activities aimed at a given purpose which involve the potential for radiation-exposure. Under this policy, the definition of "practice" is a critical feature which will assure that the formulation of exemptions from regulatory control will nut allow deliberate dilution of material or fractionation of a practice for the purpose of circumventing controls that would otherwise be applicable.

The purpose of this policy statement is to establish the basis upon which the Comission may initiate the development of appropriate regulations or make licensing decisions to exempt from regulatory control persons who receive, passess use, transfer, own or acquire certain radioactive material. This policy Is directed principally toward rulemaking activities, but may be applied to license amendments or Itcense applications involving the release of licensed radioactive material either to the environment or to persons who would be exempt from Comission regulations. It is important to emphasize that this policy does not assert an absence or threshold of risk but rather establishes a ' baseline where further government regulation to reduce risks is unwarranted. The concept of regulatory exemptions is not new. For example, in 1960 and 1970, the Comission promulgated tables of exempt quantities and concentrations for radioactive material which a' person, under certain circumstances, could receive,(possess, license 25 FR 7875 anduse, transfer, 35 FR 6425). own, or acquire allowing Other exemptions withoutdistribution a requirement of for a consumer products or other devices to the general public, or allowing releases

of radioactive material to the environment, have been em6odied in the Comission's regulations for some time. More recently, the Low Level Radioactive Waste policy Amendments Act of 1985 directed the Comission to develop standards and procedures for expeditious handling of petitions to exempt from regulation the disposal of slightly contaminated radin.ctive waste material that the Comission determined to be below regulatory con' ern. The Comission responded to this legislation by issuing a policy statement in August 1936 ($1 FR 30839). That statement contained criteria which, if satisfactorily addressed in a petition for rulemaking, would allow the Comission to act expeditiously in proposing appropriate regulatory relief on a "practice-specific" basis consistent with the merits of the petition. The Comission believes that these "practice-specific" exemptions should be encompassed within a broader NRC policy which defines levels of radiation risk below which specified practices would not require NRC regulation based on public health and safety interests. For Jch exempted practices the Comission's regulatory involvement could therefore be essentially limited to licensing, inspection, and compliance activities associated with the transfer of the radioactive material from a controlled to'an exempt status. The Comission recognizes that, if a national policy on exemptions from regulatory control is to be effective, Agreement States will play an important implementation role. In the past, States have been encouraging findings that certain wastes are below regulatory concern and the Comission believes that States will support an expansion of these views to all practices involving exempt distribution or release of radioactive material. The Comission intends that rulemakings codifying regulatory control exemptions will be made a matter of compatibility for Agreement States. Consequently, any rulemakings that evolve from this policy will be coordinated with the States. Advisory and scientific bodies have offered diverse views to the Comission in anticipation of this policy Statement. There is no clear consensus based on existing scientific evidence or research regarding the selection of numerical , criteria for use in this Policy Statement. Further, the Comission is aware that there are differing views within the NRC staff on the selection of numerical criteria for BRC. In the absence of a scientific consensus, it is the Comission's task to assess the diversity of views in establishing a responsible BRC policy. The authority ' and responsibility to make the final selection of criteria rests with the Comission. Criteria selected must: 1) provide reasonable assu:ance that public health and safety will be protected, and 2) consistent with such assurance, permit practices in the public domain which involve the use of . I radioisotopes for which society perceives a demand. It is recognized that there is a delicate balance here. Criteria can be set sufficiently restrictive such that there is absolute assurance that health and safety will always be protected, no matter what events might transpire. ' However, in doing so, the regulator may then place undue and unnecessary restrictions on practices which should be permitted because of otherwise 2

reasonable social, economic, or industrial considerations. There is always the danger of over-regulation which results in effects that are f.lt in areas where the NRC does not have authority and responsibility. Moreover, the Atumic Energy Act does not require absolute assurances of safety in the use of radioactive material and licensed facilities. The numerical criteria ultimate Q selected will have significant impact on nuclear regulation here in the United States and potentially in the international comunity. The values under consideration in this Policy Statement do not necessarily agree with those selected or under consideration by other countries. The Comission has carefully reviewed those alternate criteria, and des not find significant scientific evidence that would dictate preferential selection of any of those views over what is proposed in this Policy Statement. II. RADIATION PROTCCTION PRINCIPLES The Comission recognizes that three fundamental principles of radiation protection have historically guided the formulation of a system of dose limitation to protect workers and the public from the potentially hurmful effects of radiation. They are (1) justification of the practice, which requires th6t there be some net benefit resulting from the use of radiation or radioactive materials, (2) dose limits, which define the upper boundary of adequate protection for a menter of the public which should not be exceeded in the conduct of nuclear activities, and (3) ALARA, which requires that radiation dose be as low as is reasonably achievable, economic and social factors being taken into account. The term ALARA, is an acronym for As Low As is Reasonably Achievable. The Comission is interested in assessing how these principles should be applied in establishing appropriate criteria for release of radioactive materials from regulatory control. Because of the absence of observed health effects below 5 rem / year (50 mSv/ year), scientific experts including the International Comission on Radiological Protection (ICRP) and the National Council on Radiation Protection and Measurements (NCRP) make the assumption that the frequency of occurrence of health effects per unit dose at low dose levels is the same as at high doses (10 Rad (0.1 Gy)) where health effects have been observed and studied in humans and animals. This linear non-threshold hypothesis assumes that the risk of radiation induced effects (principally cancer) is linearly proportional to dose, no matter how small the dose might be. The coefficient usedinthemogelasabasisforestimatingstatisticalhealthriskisanthe < ordergf2x10' risk of fr.i:a1 cancer per person rem of radiation dose (2x10' per Sv). The Comission recognizes that it is a conservative model based upon data collected at relatively high doses and dose rates which is then extrapolated to the low dose and dose rate region where there are no statistically reliable epidemiological data available. Alternative hypotheses have been proposed and reevaluations of the data base at higher doses continue. The Comission believes that use of the linear non-threshold hypothesis allows the theoretical establishment of upper 1.mits on the nunter of health effects

  • that might occur at very low doses which are the subject of the , exemption policy.

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The risk of death to an individual, as calculated using the linear model, is shown in Table 1 for various defined levels of individual dose. A radiation exposure of 10 mrem per year (0.1 mSv per year) for a lifetime corresponds theoretically to an increase of 0.1% of the individual's annual risk of cancer death. The lifetime risk is based upon the further assumption that the exposure level is the same for each year of a 70-year lifetime. l In estimating the dose rates to menters of the public that might aris2 through the use of various practices for which exemptions are being considered, the l Comission has decided to apply the concept of the "effect've dose i equivalent." This concept, which is hesed on a comparison of the delayed mortality effects of ionizing radiation exposures, permits through use of teighting factors, the calculation of the whole body dose equivalent of partial body exposures. This approach was originally developed by the International Comission on Radiological Protection and was first expressed in its Publication 26 issued in 1977. Since that time, the concept has been i reviewed and evaluated by radiation protection organizations throughout the corld and has gained wide acceptance. l Table 1* Incremental Inc.emental Lifetime Risk from Annual Dose Annual 9ig Continuing At3ual Dose 3 100 mrem"r 2 x 10-5 ~ 1 x 10~4 2 x 10-67 ,3 x 10'5 10 mrem" 1 mrem 2 ~1 x 10-0,1 mrem 2 xx 10 10-8 -1 x 10-6

  • Risk coefficient of 2 x 10'# per rem (2x10 2 perSv)basedupon jublications of the ICRp.
       **     For purposes of comparison, the annual risk to an individual of dying
              'from cancer from all sources in tr.e U.S. is 1 in 500. The additional risk to an individual of dying from cancer when exposed to 10 mrem (0.1 mSv) is 2 in one million.
       "* Unless otherwise indicated, the expression of dose in mrem refers to the Total Effective Oose Equivalent. This term is the sum of the deep dose equivalent for sources external to the body and the l

comitted effective dose equivalent for sources internal to the body. 1 t l 4

f ( l J The Comission recognizes that it is impossible to measure risk to individuals 1 or populations directly, and, that in most situations, it is impractical to  ;

measure annual doses to individuals at the low levels implied by exemption decisions. Typically, radioisotope concentrations or radiation levels from the
material to be exempted are the actual measurements that can be made, and doses

, are then estimated by exposure pathway analysis combined with other types of assumptions related to the ways in which people might become exposed. Under . such conditions, conserv&tive assumptions are frequently used in modeling so l ] that the actual dose is on the low side of the calculated dose. The Comission believes that this is the appropriate approach to be taken when determining if an exemption from regulatory controls is warranted. 1 Collective dose is the sum of the individual doses resulting from a practice or source of radiation exposure. By assigning collective dose a monetary value, it can be used in cost benefit and other quantitative analysis techniques. It is a factor to consider in balancing benefits and societal impact.

         !!!. CONSIDERATIONS IN GRANTING EXEMPTIONS FROM REGULAT,0RY CONTROL The following elements are being considered by the Comission as a basis for evaluating practices which are proposed to be exempt from regulatory control.

These practices, if approved, would result in products conta<ning low levels of radioactive material being distributed to the general public and r3dioactive effluents and solid waste being released to areas of the publicly a ccessible environment.. o Justification - The Comission seeks comment on the extent to which exposures rcsulting from any practice should be justified. As lower levels of radiation exposure are projected, should lower levels of benefit be required for practice justification? In establishing its exemption policy, should the Comiaien exelude certain practices for which there appears to be no reasonable justification? In considering proposals for exemptions, should the Comission evaluate the social acceptability of practices? Should the Comission determine a practice to be ur. justified if nonradioactive economical alternatives exist? o Dose Limits and Criterion - Individual dosas from practices exempted under this policy should not be allowed to uteed 100 mrem per year (1 mSv per year). This is the dose limit for menters of the public spe:ified in the final revision of 10 CFR Part 20 Standards for Protection Against Radiation. Thedoselimitsinthefinalrevisionof10CFRPart20 apply to all sources of radiation exposure under a licensee's control (natural background and medical exposures are excluded). Because of the small risks involved, a 10 mrem (0.1 mSv) individual dose criterion is proposed as the basis for exemption decisions based on simple analysis and judgements. The Comission specifically seeks coment on the need for establishing a collective dose limit in addition to an individual dose criterion. If such a collective dose criterion is needed, what is the basis for this need? If the Comission decides that a collective dose criterion s-5

is needea, what approaches allowing' truncation of individual dose in calculation of collective dose or weighting factors for components of collective dose would be appropriate? What alternatives should be considered for assessing societal impact? o ALARA - The ALARA principle generally applies to determining dose levels below which exemptions may be granted on a cost benefit basis. However it is the purpose of this policy to esteblish criteria which would in effect, delineate achievement of ALARA without cost-benefit analysis. Although it is possible to reasonably project what the dose will be from a practice, and then take this information into account in controlling regulated practices so that the dose limits are not exceeded, exen.ptions imply some degree of loss of control. The Comission believes that a key consideration in establishing a policy for exemptions, and subsequently in specific rulemaking or licensing decisions, is the question of whether individuals may experience radiation exposure approaching the limiting values through the cumulative effects of more than one practice even though the exposures from each practice are only sniall fractions of the IImit. The Comission specifically seeks coment on the issue. By appropriate choices of exemption criteria and through its evaluations of specific exemption oroposals in implenienting the policy, the individual will Comission intends towhich experience exposures assure thatthe exceed it is100 unlikely mrem that any(1 mSv per year) limit. per year IV, PRINCIPLES OF EXEMPTION A major consideration in exempting any practice from regulatory control hinges on the general question of whether or not application or continuation of regulatory controls are necessary and cost effective in reducing dose. To determine if exemption is appropriate, the Comission must determine if one of the following conditions is met:

1. The application or continuation of regulatory controls on the practice does not result in any significant reriuction in the dose received by individuals within the critical group and by the exposed population or;
2. The costs of the regulatory controls that could be imposed for dose reduction are not balanced by the comensurate reduction in risk that could be realized.

For purposes of implementing its policy the Comission recogni:es that only under unusual circumstances would practices which cause radiation s posures approaching the 100 mrem per year (1 mSv per year) limit be considered as candidates for exemption. TL4 Comission will consider such circumstances on a case specific basis using the general principles outlined in this pelicy statement. However, as the doses and attendant risks to merters of the exposed population decrease, the need for regulatory controls decreases and the analysis needed to support a proposal for exemption can reasonably be somewhat simplified. The Comission is evaluating the use of two numerical criteria in defining the region where ALARA has been achieved. The/ are (a) a criterion for the maFiFUm 6

individual annual dose reasonably expected to be received as a result of the practice and (b) a measure of societal impMt to the exposed population. These criteria are being considered to assure that, for a given exempted practice, no individual will be exposed to a significant risk and that the population as a whole does not suffer a significant impact. If the individual doses from a practice under consideration for exemption are sufficiently small, the attendant risks will be small compared with other societal risks. The Co ission believes that annual individual fatality risks belowapproximately10'p(onein 100,000) are of little concern to most merbers of society. Providing for some margin below this level, the Comission proposes 10 mrem (0.1 mSv) as the level of annual individual exposure. The incremental annual indisidual cancer fatality risk associated wigh an exposure level of 10 mrem per year (0.1 mSv per year) is about 2x10' two in one million) as indicated in Table 1 and of the order of 0.1 percent one in one thousandi of the overall risk of cancer death. In evaluating the need for a collective dose criterion, the Comission recognizes that this criterion could be the limiting consideration for practices involving very small individual doses to very large numbers of people. It is aisc recognized that in such esses the collective dose criterion woul.I, in effect, apply the ALARA concept tu individual doses less than the below regulatory concern level of 10 mrem per year to the individual. Conversely, where the collective dose criterion would not be limiting, it would serve no purpose. The Comission requests coments on this issJe, including coments on what the magnitude of the collective dose criterion, if any, shculd be. If the dose is lest than the below regulatory concern criteria, then the risk from a practice would be considered to be ALARA without further analysis. The Comission stresses that adoption of the criteria should not be construed as a decision that smaller doses are necessary before a practice can be exempted, while doses above the criteria would preclude exemptions. On the contrary, the criteria siinply represent a range of risk which the Comission believes is sufficiently small compared to other individual and societal risks that a cost I t,enefit analysis is ne required in order to make a decision regarding the acceptab Mity of an exemption. Practices not meeting these criteria may be granted exemptions on a case-by-case basis in accordance with the principles embodied within this policy. To further emphasize the Comission's recognition that a rigid lir.itation on collective dose would be inappropriate, it notes that for some practices, such as use of smoke detectors, appreciable benefits can only be attained through extensive utilization and, hence, with a comensurate collective dose. The Comission is aware that existing regulations of the Environmental Protection Agency establish criteria more restrictive than exemptions which could otherwise be granted under this proposed policy. With regard to its own regulations, the Comission will evaluate whether there are exemption criteria embodied therein for which modification, according to the principles of this policy, would be beneficial. 7

Y. EXCLUSIONSFROMEXEMPTI@S The Commission's March 16, 1965, notice on the Use of Byproduct Material and Source Material-Products Intended for use by General Public (Consumer Products) (30 FR 3462) provides the basis for the Comission's approval of the use of l these materials in consumer products without regulatory control on the consumer-user. This is accomplished by case-by-case exemption of the possession and use of approved items from applicable licensing requirements. l Approval of a proposed consumer product depends upon an assessment of exposures of persons to radiation as well as an evaluation of the usefulness l of the product. Certain practices involvin radiation or radioactive materials have been judged by NRC to be social y unacceptable regardless of how trivial the resulting dose might be and, therefore, have been excluded from exemption. Excluded practices include, but are not limited to, the intentional introduction of radioactive material into toys and products intended for ingestion, inhalation or direct application to the skin (such as cosmetics). n addition to socially unacceptable uses of radioactive materials, a question 1so arises regarding uses whero there are clear economical alternatives, and unique benefits exist from using radioactive material. Where risks are

          ' vial, the regulatory prohibition of such uses could pose an unnecessary                      ,

slatory burden by interfering with the conduct of business.

             ' omission seeks coments on whether practices should be categorically 1ed based on the Commission's judgement regarding social acceptability or istance of a'iterr.atives. An alternative to categorical exclusion could
                 $   specific determination based on a safety analysis.
                    'POSALS FOR EXEMPTION 1 for exemption must provide a basis upon which the f. omission can if the basic conditions described above have been s6tisfied. In his means that the proposal should address the individual dose and pact resulting from the expected activities under the exemption, ie uses of the radioactive materitis, the pathway? of exposure, i

f activity, and the methods and constraints for assuring that the 1 ' sed to define a practice remsin appropriate as the radioactive j t from regulatory control to an exempt status. I 'or exemption results in a rule containing generic requirements, ig to utilize the exemption would not need to address

  • ALARA. The Comission decision on such proposals will be
         \                       insee's meeting the conditions specified in the rule. The he rule would, under these circumstancec, constitute a finding f*                     practice is justified, and that ALARA considerations have This approach is consistent with past practice, e.g.,

les in 10 CFR Part 30. sls for exemption under this policy, the projected exposures

                                      'ts of the exposed population will be considered with regard some individuals may receive doses near the 100 mrem per e

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year (1 mSv per year) limit when doses from other practices are also tabn into l consideration. If exposures from multiple practices can occur which are i significantly beyond the individual dose criterion (10 mrom per year (0.1 m$v  ! per year)), the exemption will not be eranted without further analysis. As  ! experience is gained this policy and its implementation will be reevaluated l with regard to this Issue to assure that the exposures to the public remain . well be 'ow 100 mrom per year (1 m$v per year). ( L In addition to considerations of expected activities and pathways, the l Comission recognizes that consideration must also be given to the potential - , for accidents and misuse of the radioactive materials Involved in the practice. l A proposal for exemption of a defined practice must therefore also a6 dress the j potentials for accidents or misuse, and the consequeeces of these exceptional j conditions in terms of individual and collective dose.  ; l j VII. VERIFICATION OF EXD.17!0N CONDITIONS The C antission believes that the implemet.tation of an exemption under this i broad policy guidance must be accompanied by a suitable program to monitor and verify that the basic considerations under which an exemption was issued remain valid. In most cases, the products or materials comprising an exempted practice will move from regulatory control to the exempt status under a defined l set of conditions and criteria. The monitoring and verification program must  : there* ore be capable of providing the Comission with the appropriate assurance  ! that the conditions for the exemption remain valid, and that they are being i

    .       observed. The Consiission will determine compliance with the specific                        '

conditions of an exemption through its established licensing and inspection program and will, from time to time, conduct st9 dies as appropriate to assess , the impact of an exempted practice or cos61 nations of exempted practices. l r f 1 I I q i e l 1 i } i 9 <}}