ML23156A131

PRM-02-024 61FR31874 - University of Cincinnati; Notice of Receipt of Petition for Rulemaking

ML23156A131
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Issue date:	06/21/1996
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PRM-020-024, 61FR31874
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ADAMS Template: SECY-067 06/21/1996 PRM-020-024 - 61FR31874 - UNIVERSITY OF CINCINNATI; NOTICE OF RECEIPT OF PETITION FOR RULEMAKING PRM-020-024 61FR31874 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PRM-020-024 (61FR31874)

In the Matter of UNIVERSITY OF CINCINNATI; NOTICE OF RECEIPT OF PETITION FOR RULEMAKING DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 04/11/96 04/07/96 06/17/96 06/17 /96 09/03/96 09/02/96 09/03/96 09/28/96 09/03/96 08/27/96 09/09/96 08/22/96 e 01/09/97 12/27/96 12/15/97 11/20/97 LETTER FROM VICTORIA MORRIS, RADIATION SAFETY OFFICER, UNIVERSITY OF CINCINNATI, CONSTITUTING PETITION FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING COMMENT OF PETER G. CRANE (

1)

COMMENT OF RAD PHYSICS, INC. (KEN LOVINS) (

2)

COMMENT OF HOSPITAL PAVIA, DEPARTAMENTO DE MEDICINA NUCLEAR (JOSE 0. MORALES) (

3)

COMMENT OF UCLA, HARBOR MEDICAL CENTER, DEPT OF RADIOLOGY (CAROLS. MARCUS) (

4)

COMMENT OF C. S. NARAYANAN (

5)

COMMENT OF CAROLS. MARCUS, PH.D., M.D. (

6)

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'97 OEC 15 P 1 :36 UCLA SCHOOL OF MEDICINE HARBOR - UCLA MEDICAL CENTER DEPARTMENT OF RADIOLOGY 1000 CARSON STREET TORRANCE, CALIFORNIA 90509 PETITION RULE PRM O - :it./

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MEMOTO:

FROM:

Al Lorman, Bob Carretta, David Nichols, Mark Rotman, Dennis Swanson, Barry Siegel, Jeff Siegel, Jim Ponto, Bill Strauss, Marty Nusynowitz, Jim Fletcher, Ted Silberstein, Ed Bailey, Aubrey Godwin, Rita Aldrich, David Walter, Terry Frazee, Steve Collins, Judith Stitt, Myron Pollycove, Hugh Thompson, Carl Paperiello, Shirley Ann Jackson, Greta Dicus, Nils Dtaz, Ed McGaffigan, Don Cool, Lloyd Bolling, Ed Leidholdt, Joe Felton, Jim Muckerheide

,,,,-a. &

Carol Marcus ~

SUBJECT:

NRC's plan for the Cincinnati Petition DATE:

November 20, 1997 I have recently reviewed the attached document on NRC's plan to handle the Cincinnati petition. After a year and a half of bureaucratic dickering and tinkering at our User Fee expense, NRC is proposing another 0.5 FTE to complete the job, plus $50,000 for contractor support to do the job we already pay NRC to do. We will doubtless end up with another bureaucratic disaster. The whole issue, that of permitting essential support individuals (family members or close friends) to receive up to 500 mrem visiting patients who are hospitalized for radionuclide therapy (or temporary brachytherapy) is a trivial one, and should have been settled in 10 minutes if NRC had handled this correctly. The Visiting Medical Fellow was the only one who needed to be consulted. Instead, this has become an exercise in bureaucratic maximization at NRC, demonstrating the inability of NRC to make (1) an intelligent decision in (2) a timely manner in (3) a cost-effective way while (4) not interfering with medical practice. NRC is failing at all four requirements.

The qualifications for Authorized User status require knowledge of math, physics, and radiation protection science, and Authorized Users are qualified to be Radiation Safety Officers. Those designated as Authorized Users should therefore be assumed to be able to make intelligent radiation protection decisions as part of their medical judgments. NRC should have no further involvement with the decision-making discussed in the Cincinnati

• Petition, because this constitutes a clear interference with medical practice.

Another upsetting aspect ofNRC's *plan is the assumption of harm at 500 mrem, an unfounded acceptance of the linear no-threshold hypothesis (LNT), with refusal to recognize 1997 science. I would recommend to all Appendix K of the Dec., 1995 NAS-NRC'SCINCINNA TPLANI 197.CSM OEC 1 9 1997

U.S. NUa.EAR REGUlATORY COMMISSIOr-4 RULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Docllnent Statistics

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November 20, 1997 Memo Page IOM report on the need for regulatory reform ofNRC's Medical Program. It is a fine summary of the history of the LNT, and I-have appended it here. I am also appending the Health Physics Society (HPS) policy, and wish to add that the ACNP unanimously supported this in Jan., 1997, and the SNM unanimously supported it in June, 1997. The only caveat mentioned by both medical groups was that the HPS didn't go far enough. I am also including a fine article from Science magazine by Prof Marvin Goldman.

The discussion in the attached NRC paper pertaining to "informed consent" is unacceptable, and must be removed. There is no evidence of harm at 100 mrem, or 500 mrem, or 1000 mrem, and for NRC to pretend otherwise is dishonest. "Informed consent" is the property of FDA and OPRR, refers to human experimentation, and NRC has no jurisdiction over these documents or these agencies of DHHS. This appears to be another NRC attempt to dual regulate in this area, as it is trying to do with the proposed rule dealing with C-14 urea capsules (NRC is trying to dual regulate FDA research and FDA manufacturing responsibilities). In any case, the NRC cannot force me or anyone else to lie to patients or to their families, pretending that small quantities of radiation are harmful when we know they are not.

The yearly background radiation dose in Denver is 530 mrem, in ski areas nearby, 600-700 mrem, and in Copper City, CO, it is 890 mrem. Colorado is tied for the third lowest cancer death rate in the United States. If NRC isn't going to evacuate Colorado, it should stop spreading lies about medical radiation.

I encourage abandonment of both the NRC Commission directive and the staff plan, and urge the substitution of an intelligent, risk informed decision that imposes no costs or interference in medical practice.

I further recommend that this responsibility be given to NRC's Visiting Medical Fellow, Myron Pollycove, who can work with members of the ACMUI, NRC medical consultants, and/or the former Visiting Medical Fellow if he is busy and needs some help.

That is what the Visiting Medical Fellow position was designed to do, and it is time the Commission used it. Spending a few hundreds of thousands of our User Fee dollars to enable NRC to create a bad rule, when Dr. Pollycove can handle this whole decision appropriately in minutes, seems to represent mismanagement of financial and personnel resources at NRC.

NRC'SCINCINNA TPLANl 1'7.CSM

. RADIATION IN MEDICINE A NEED FOR REGULATORY

• REFORM Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission Kate-Louise D. Gottfried and Gary Penn, Editors Division of Health Care Services INSlTME OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1996

K The Linear, No-Threshold Model ADOfflON Oll'THE LINEAR, NO-THRESHOLD MODEL A aeries of developmcnla from 1954 lhrougb 1972 marted the transition to adoption of the linear, no-threshold model u a predictive model of radiation injwy in expoacd populations. In 1954, the National Council on Radiation Prolec:tion (NCRP) illued new guidance on ndiation protection in which the tolel'lllee dole WIS replaced by a new concept. the mazinuurt permmibk dose (MPD) (NCRP, 1954). Implicit in the MPD concept WIS rejection of the concept of tolerance dole and catablilbment of the idea of "acceptable risk* at low levels ofapoaure.

DMded Sdllld& Oplalaa, 1951-1"'

ID 1958 the United Natiolll Scientific Committee oa the Effecta of Momic Radiation issued its fint report on the effects of radiation elpOIIIIJ'el in humans (UNSCEAR. 1958). Thia report estimated the risk of adverse effccta of low-level radiation expoaure using both a no-tbreabold and a threshold model of radiation rilk. Tbc report included tbe followins ltalcmcnt:

Plelent knowledge coacemlna loaa-tenn effecll and their CDnlladoll wl1b die amount of radiation received does not permit ua to*evaluate witb any predlion die paaible camequence eo mu of upoaure ID low radiatioa levels. MIily effec:11 of radiation ue delayed; often they cannot be disdapilbcd from other aaea11; many will develop oac:e a tbrabold dme bu beea nceeded; 101De may be cumuJadve

• ocben not; and ladividuala in lup populadoal or particular

APPENDIXK group1 IUCb

• children and felUlea may have special 1e11aidvity. 1bese flda Nllder it very difficult ID accumulate reliable information about the conelatioa between lfflall does and their etfec111 either in lndlvlduala or In large populadona. (UNSCEAR. 1958, p. 42) 28.S With raped to radiation-induced leukemia identified in the Japaese populations cxpoeed to atomic radiation well above the low-dole limit, E

SCEAR concluded that the threshold and no-threshold models of radiation ury had equal validity. Thia c:onclusion was eontcllcd by the Committee on athologic Effcc:ls of Atomic Radiation of the National Academy of ScicnccalNational Raean:b Council (NASINRC). which Slated unequiwc:ally that ** conaidcnble body of experimental evidence" favored nonlinearity and hence presumably a threshold, and urged that nonlinear relationships between dOIC and effect should be given greater attention (NASINRC, 1959). The following year, the short-lived U.S. Federal Radiation Council (PRC, sec Appendix 0) observed that the linear, no-threshold model merely presented an extrapolated upper limit of radiation risk for low exposure levels (PRC, 1960).

In UNSCEAR repor11 in the 1960s, the committee emphaaized that extrapolation of the linear, no-threshold curyc provided an upper limit to the risk of low-level cxpoaurea (UNSCEAR, 1962, 1964). This position was endorsed by the lntcmational Commision on Radiolosical Protection (ICRP, 1966).

Joint Committee on Atomic l'.lleqy Hearblp, 1957-1"°9 Meanwhile, in the late 1950s, the congressional Joint Committee on Atomic a,f,ltergy (JCAE) conducted bearinp that had a major influence on the thinking of Wlx>th -the ICicntific community and the public with regard to radiation huards.

The hearings began in 1957 with an inquiry into the nature of radioactive fallout from weapons testing and ita poaiblc effects on humans (JCAB, 1957).

Tctllimony from ICientific experts addreued but left unresolved the illlle of the fflOlt appropriate modeJ for c:stimating the degree Of hazard at low CllpOIUl'C levels. The JC.AB addresaed this issue again in ita 1959 hearinp (JCAE. 1959) and again left it unresolved. However, the bearing report (p. 59) included teatimony by K.z. Morpn, Director of Health and Human Phyaic:a at the Oak Ridge National Laboratory, claiming that certain bioeffects, including genetic mutations, leukemia induction, and life shoncning. occur without a threshold dole. Also influential was the testimony of E.B. Lewis, professor of biology at the University of California, San Francisco, who atrongly supported the linear, no-threshold hypotheaia u a model for radiation protcc:tion standards. Lewis propoaed the concept of protection called *u low u reuonably achievable"

{ALARA)'(JC.AE, 1960). In subsequent hearinp over the course of the 1960s, tbe JCAJ! moved slowly to the endorsement of the linear, no-threshold model of radiadoa rilk.

I i

286 RADIATION IN MEDICINE

'lbe DEIR Report and the Code or Federal Regulations, 1972 In 1964 the NAS/NRC established an advisory committee on the biological effects of atomic radiation (BEAR) to examine issues related to radiation protection, including the shape of the dose-response curve at low doses. The BEAR committee introduced the concept of regulating doses to the population as a way of limiting the effects of radiation on future generations. The BEAR committee was renamed the Committee on the Biological Effects of Ionizing Radiation (BEIR), which issued its first report in 1972 (NAS/NRC, 1972). The 1972 report did not deal with the iMUe of the shape of the dose-response curve, but it did provide estimates of cancer risk at low doses based on a linear extrapolation from cancer mortality data at high doses in Japanese survivors and other exposed groups. These estimates implied that radiation carcinogenesis docs not exhibit a threshold dose, in spite of the absence of confinnatory experimental data.

Also in 1972, the U.S. Atomic Energy Commission (AEq introduced the AlARA concept (also known as Al.AP, as low as practicable) as Appendix I to Title 10, Part 50, of the Code of Federal Regulations. The implication of AlARA is that no threshold exists for adverse radiation effects and that any dose, no matter how small, is potentially injurious to exposed individuals.

These actions of the NAS/NRC and the AEC completed a major transition in the conceptualization of radiation risk at low doses, and they provided a foundation for the evolution of health physics as a discipline devoted to the protection of workers and the public against small doses of ionizing radiation.

WIDENING APPLICATIONS AND CONTINUING DEBATE Risk-Balled Standards for Radiation Protection In 1977 the ICRP announced its risk-based approach to the establishment of standards for radiation protection (ICRP, 1977). This approach was a highly significant departure from traditional dose-based standards, and it defined the concept of acceptable risk from nM;liation exposure of workers in terms of the fatal accident rate in ~led safe industries. In taking this approach, the ICRP used extrapolation based on the linear, no-threshold model to estimate hypothetical death rates from radiation-induced cancers among workers exposed to low-dose radiation and compared these hypothetical. deaths with real and measurable fatalities in other ("safej industries. The ICRP also introduced a number of factors to express the risk of partial-body irradiation in terms of the equivalent risk of whole-body exposure. This risk-based approach to standards of radiation protection was refined and expanded not only by the ICRP (ICRP, 1978-1980, 1990, 1991), but also by the NCRP (NCRP, 1987) and by several U.S. regulatory agencies, including the Environmental Protection Agency (EPA,

APPENDIXK 287 1987), the Department of Energy (DOE, 1988). and the Nuclear Regulatory Commission (NRC. 1991).

BEIR Reports, 1979-1990 In 1980 the NASINRC BEJR committee released a new report (the "BEIR III" report) on the risks of exposure to ionizing radiation. In the report a majority of the committee endorsed a linear-quadratic1 model of radiation-induced cancer.

The report included two "minority opinions," in which one committee member supported a straightforward linear model of cancer induction and another member endorsed a purely quadratic model. This division among the committee members exemplified more general disagreement within the scientific community about the most appropriate way to characterize radiation risk at low doses. It also reflected concern over the growing practice of using dose-response models to estimate hypothetical cancer risks at doses substantially below levels where epidemiological studies have confirmed injury. 2 Two additional BEIR reports were issued after the 1980 report of the BEIR m committee. The BEIR IV report, which addressed the health risks of radon and other internally deposited radionuclidcs (NAS/NRC, 1988), offered several suggestions for further research that, collectively, called for intensified experimental efforts to characterize the shape of the dose-response curve for long-term health effects at low levels of exposure. The BBIR V report again considered the broad topic of adverse health effects from exposure to low levels of ionizing radiation (NASINRC. 1990). Ar. in previous reports, the committee noted the failure of A. epidemiological studies to demonstrate hereditary effects in humans exposed to W

low radiation levels. Nevertheless, the committee confirmed previous estimates of radiation-induced genetic risk in humans, and computed a mutation-doubling dose of 1 Sv in agreement with the range of 0.2-2.0 Sv of BEIR I and 0.5-2.5 Sv of BBIR Ill. There was, however, a significant change in the BEIR V estimates of c:anccr risk from radiation compared with earlier BEJR reports. The new 1 'Ibe llncar-quadradc model predicts that the risks of radiation injury at low-level npo1111a are lea than thole predicted from a linear extrapolation of risks IIIIOcil!ed with high doec cxpoaure leYcla.

1 The BEIR m (NASINRC, 1980) rq,ort offered several important specific observations. The report noted that it was unknown and probably not determinable whether dose rates on the order of 1 mSv (millisicvcrt) per year, on the order of dose rates from background radiation, were detrimental to people. The report concluded that data pracnted by Stcmglau (1968) and others that purported to show an increased incidcnq, of c:anccr In populations expoacd to low doses were the result of flawed ltudiCL The BEIR m committee recognized that different human genotypes may con&r different degrees of cancer risk for a specific dose of radiation, and that dcvelopmcotal effccta from radiation exposure in utcro may exhibit a threshold dole. Finally, the report 1111F9ted that the linear, no-threshold model of radiation risk provided the best estimate of petic risk.

288 RADIATION IN MEDICINE estimates were determined with the linear, no-threshold model, yielding a threefold increase in the risk of solid tumors and a fourfold increase for leukemia. Although the committee did not consider the rate of dose delivery in its estimates of cancer risk, it proposed a Dose Rate Effectiveness Factor (DREF) which, if applied, would reduce the lifetime cancer risk by a factor of two or more if the radiation were delivered over a protracted period.

• Scientific Studies, 1992-1994 Recently published articles addressing the linear, no-threshold model include those of land (1993) and Peterson (1993). land offers a critique of the model's foundation in epidemiological data. Peterson (1993) presents a tabular representation of the evolution of the linear, no-threshold extrapolation to establish an upper limit of radiation risk. He traces the evolution from the postulate that every dose, no matter how small, has an associated risk of ill health, through various steps until the final unequivocal statements are reached that radiation follows a linear, no-threshold dose-response relationship, and that all radiation exposure is unsafe.

Other recent reports that bear on the ~e of extrapolating risks from high-dose to low;Jose exposure are several reports that directly address mechanisms of response to low;Jose exposures. For example, one-third of the most recent UNSCEAR report is devoted to adaptive responses to radiation in cells and or-ganisms (UNSCEAR, 1994). Finally, a recent international meeting in Kyoto was devoted to examining evidence for biological defense mechanisms in re-sponse to low-dose exposures to ionizjng radiation (Sugahara, et al., 1992).

REFERENCES DOE (U.S. Department of Energy). Radiation Protection for Occupational Workers Or-der 5480.11. Washington, DC: U.S. Department of Energy, December 21, 1988.

FRC (Federal Radiation Council). Background Malerial for the DeveloptMlll of Radia-tion Prot<<tion Slllnd4rds: Report No. I. Washington, DC: Federal Radiatioo Council, 1960.

ICRP (International Commission on Radiological Protection). 'Ibe Evaluation of Riska from Radiation. ICRP Publication 8. Oxford, England: Pergamon Press, 1966.

ICRP. Recommendations of the International Commission on Radiological Protection.

Annal& of the ICRP 1(3). Oxford, England: Pergamon Presa, 1m.

ICRP. Limits for Intakes of Radionuclide& by Workers. ICRP Publication 30. Oxford, England: Pcrpmoa Presa, 197S-1980.

ICRP. Individual Monitoring for Intakes of Radionuclidcs by Workers: Design and In-terpretation. ICRP Publication 54. Oxford, England: Pergamon Press, 1990.

ICRP. 1990 Recommendations of the International Commission on Radiological Protec-tion. Annol.s of the ICRP 21(1-3):1-201, 1991.

JCAE (Joint Committee on Alomic Energy) of the Congress of the United States. Hear-ings on the NallUe of Radioactive Fallolll and Its Effects on Man, May 27-29 and J,u,e 3--7 (2 vols.). Washington, DC: Government Printing Office, 1957.

APPEND/XX 289 JCAE. H.,,,,.,. o,a Follotd jroM Nw:lar Wupo,u Tats, May s-8, 1959 (2 vola. plus IUIIUIW)'). Wllbinatm, DC: Goverameat Prindn1 Office, 1959.

JCAB. s.J<<IM M"'6ntlb o,a RHl4do-Proleclloll Crilerll, twl S""""""6: TheJr 11am 1111d u-. Wabha811Ja, DC: Gcwenuneat Printina Offlcc, 1960.

NAS,INJlC (Nadoaal Academy of Scieace&'Nltioul Jlwarcb Council), Committee OD Patbc)lop:al Effim of AIDmk Redi*lioD. A ~

M 1M lwport of 1M Ullilal N""°"11 Sdali/k eo..a-"" 1M S,- of Aliotllk ""'°""°"* NASINRC PnbHt.adcm 647. Wllbin.,., DC: Nadoaal Academy of Science&INadoaal Re-lllldl Council, 1959.

NASJNRC. n. EJ!et:u*Pop,,ldo,uof &po.,,,.1o£owUNb of lOIUZlll6.'lotl!tstio-.

WIiia.... DC: Nadaaal Academy Pllll, lffl.

NASINRC. n. Elftm o,a Pop11i.dot&r of E1lpoan IO Law uwlr of IOIUZlll6 RMIJI,*

doll: BBIR JlI. Wllbinafon, DC: Nadaaal Acldomy P1111, 1980.

NA&ffltC. HMlllt Rlda of a-- 11M 0tJwr l......U,, Dq,o,lr. Alp/11,*&tutlul:

BEIR IV. Wllbinp,a. DC: Nllioaal Academy Preu. 1988.

NAS/NIC. HMlllt Ejfeda of E,poa,,, to Law uwlr of Ionizing Ralltldo,s: BEIR V.

Wllblngton, DC: Nadonal Academy Prell. 1990.

NCRP (Nadoaal Council oa Redl*tion Protection end Meaalrcmcata). Permiuiblo Doee from External Sowma of Jooizina lladiadoa. NCRP Rq,ort No 11. Wllbingtoa, DC: U.S. Depu1ment of Commenle, National Bureau of Standardl Handbook.SO, SeplDmber 24, 1954.

NCRP. Recommeadaticu on Umitl fer Expoluro IO Ionizing Radiation. NCRP Rq,ort No. 93. Betheeda, MD: Nadoaal Council OD Radiation Procecdon end Meuuro-menll. 1987.

NllC (U.S. Nuclear Replalory Commillioa). Standards for PIOtec:tion ApiDlt Radia-doa: Pinal Rule. In: F..,_,....., Vol. 56. Wllbin&ton, DC: National An:bivea end llcordl Adnualecradoa, pp. ~2347.., 1991 *

....._, H.T., Ir. Public Avemioa IO l!nvbonmenlal Reloalea of Small Quutitiea of Redlolcdve Maaerial. JD: LL ICalbJea, D.R. Denham, wl IC. Salmoa, eda. E,_,.,.,., H""'11, Pl,yaa. Pmceedinp of die Tweaty-slalb Midyear Topicel MeotiDa of Ibo Hulda Pbysica Society, Jeauary ~28, 1993. Rlcbl*ncf, WA:. Re-eean:11 BDIDrprilll Pllbli*bin1 Sopllld, pp. 255-262, 1993.

Supbara, T., Sapn. LA.. end Aoylllll. T. (edl.). Law Dtw.*mrffotfote 1lltl Bloloflt:t,l 0.,.,,.. M'°"""611u. Pmceedfnp of Ibo lnlerDldonal C.0.fellace OD law Dole lr-nidladaa 111d INolop:II o.tm. MedlenlPN. New York. NY: Bmlrpta Medici, 1992.

UNSCIAll (UDitld Natioaa Scientific Committee oa tbe Bffec:11 of AIIJlnic lledl*don).

lepcxl of Ibo Unillld Nedoal Scioadftc Committee OD tbe Effec:11 of Aaomic Radla-doD. G...., ~

0//#,dlll BM:onla: ~

SaalOII ~

No. 11 (M838). New York, NY: United Nadoat. 1958.

UNSCBAIL lepcxl of die Unillld Nadolla Sdclldftc Cammiaee OD die l!ffeda of N.omic Rectiedoe. G..,,,J Arr -+ 0/f#,dl,l R<<ortb: ~

SaalOII ~

No. 16 (A/5216). Now York, NY: United Nedoat, 1962.

1JNSC$AR. lepmt of tbo United Nadoat Sc:ioatiftc Commiaee OD tbo Bffecta of N.omic Reclledaa. c;...,...4.-bly 0/f#,dl,l R<<ortb: Nlll,,.,ndt SariOII S,,,,....,, No.

14 (A/581"). New York, NY: United Nadaaa, 1964.

UNSCBAIL Report of die United Nadaal Scientiftc o.nminco oa tbe Bffec:11 of Atomic lecti*daa. G...,.J ~

0/lfdlll RM:ltlrfb: Porty-NINI, s..lM S,,,,,,.,,.MI No. 46 (NW/"6). New York, NY: United Nadont, 1994.

• • .l HPS Newsletter, Volume XXIV Number 3, March 1996 Editorial Starr Editor: Genevieve S. Roeaaler Managiq Editor: Sharon R. Hehl Rt. 1, Box 139H Ely1i1n, MN 56018 Phone: 507-362-8958 PAX: 507-362-4513 e-mail: hp1newa@1ol.com Auoclate Editor: Andrew P. Hull S&BP Diviaion Brookhaven National Laboratory Upton, NY 11973 Pbone:516-282-4210 Auoclate Editor: SIIIVen M. Oarry Florida Power Corporation MAC-NAlH 15760 W. Power Lino St.

Cryllll Rlvor, PL 34'428-6708 Pbono:352-563"'4ffl Coatributiq Eclitor: Marvin Roaenatein 9433 Bethany Place Oithenbur,, MD 20879 Phone: 301-594-4753 Coatributiq Editor: Greaory D. Smith Mayo Foundation 100 Flnt St. SW Rochester, MN 55905 Pbono:507-284-6369 Coatribut1q Editor: KAlnncth W, Skrable Depanmont of Phy1lc1 Univenity of Lowell Lowoll, MA 01854 Phone: 508-934-3287 Offlcen of tbe Society William A. Milla, Pn1id1nt Richard J. Vetter, Pre1ident-Elect Raymond A. Guilmette, Secretary K&lth H. Din1er, Treaaurer Raymond H. Johmoa, Jr.

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GUEST EDITORIAL The Linear, No-Threshold Model in Radiation Protection:

The HPS Response Kenneth L. Mossman, HPS Scientific and Public Issues Commit-tee I

n this issuo of tho Newsletter, tho Scientific and Public Isauea Commit-too publishos tho long-awaited Society position statement concerning the linear, no-threshold model (LN-T) in radiation protection. In recent months, tho dia-loguo on the appropriateness of tho LN-T model as a basis for establishing radiation protection standards and prac-tices has reached tho international arena.

Tho Society's position should add a fresh perspective to the ongoing debate.

Tho Committoo carefully considered the many viewpoint. on the LN-T model, both pro and con, expressed in tho Newsletter. Several Society mem-bers (David Gooden, Wade Patterson, Jim Tripodes, Al Tschaeche, and Gary Zeman) attended the Committee meet-ing 24 July 1995 in Boston during the HPS annual meeting and added signifi-cantly to the Committee'* deliberations.

Although* many Committee members have been thinking about the LN-T problem for some time, Wado Patterson really got the ball rolling with a presen-tation to the HPS Board in January 199S at the Charleston midyoar meeting

• Based on Wado'a presentation, the Board charpd tho Scientific and Public Issues *Committee with developing the position statement.

This position statement is based on the premise that there is substantial and convincing evidence for health risks at high dose; however, below 10 rem, risks of health effects either are too sman to be observed or are no~xistent.

Accordingly, the Committee concluded that quantitative risk usessment below individual doses of S rem y*1 or 10 rem lifetime (above background) should be avoided because of insufficient epidemi-ological data to say anything about health risk. It became clear after several drafts, and after reading many letters in tho Newsletter on the LN-T model, that tho appropriateness of the LN-T model to predict risk at low doses is not the major question. The major question is:

Should we be using any dose-response model to predict health risks at low dose? In the absence of epidemiological data in the low-dose region, and the need to extrapolate 2-3 orders of magni-tude in dose (e.g., from direct observa-tions of cancer at 30 rem to predicted numbers of cancers at an exposure limit for the pneral public of 100 mrem y*'),

is it appropriate to quantify risk?

The position statement recommends the use of qualitative expressions of risk below S rem in one year or 10 rem in a lifetime (above background). Clearly, there are many ways in which risk can be expressed qualitatively. For example, assume an individual receives a whole body dose of 10 mrem. The following is an appropriate qualitative expression of the risk:

The amount of radiation received is about JO tima lower than the allowable dose to individual members of the gen-eral public irt OM year. A radiation dose of this magnitude has not been associ-ated with any adverse health effects and the risk is generally considered to be negligible.

Although tho position statement docs not specifically address the appropriate-ness of the LN-T model at low doses, national and international bodies such as NCRP and ICRP should be encouraged to further examine the issue.

• • March 1996 HPS N11w8/etter Health Physics Society*

Position Statement

• RADIATION RISK IN PERSPECTIVE*

Kenneth L. Mossman, Marvin Goldman, Frank Massi, WIiiiam A. Mills, Keith J. Schiager, Richard J. Vetter Tn accordance wit/a curnnl knowledg* of radiation health

.1 risks, tJae Health Physics Society recommends against quantitative estimation of health risk below an individual dose cf$ rem1 in one year or a lifetimt1 dose of 10 rem in addition to background radiation. Risk estimation in this dose range should be strictly qualitative accen.tualing a T011ge cf Jrn,cthetical h<<uth outcomu with an emphasis on the lihly possibility of iero adverse health.Jfects. Tne aunnt philosophy of radiation protection is based on the assumption that any radiatlon dose, no matter how small, may result in human health effects, such as cancer and hereditary genetic damage. Then is substantial and con-vincing scientific evitknce for health risks al high dose.

Below IO mn (which includes occupational and environ-mental exposures), risks of health effects are either too small to be observed or are non-existent.

Current radiation protection standards and practices are based on the premise that any radiation dose, no matter how small, can result in detrimental health effects, such as cancer and genetic damage. Further, it is assumed that these effects are produced in direct proportion to the dose received, i.e., doubiing the radiation dose results in a doubling of the effect. These two assumptions lead to a dose-response relationship, often referred to u the linear, no-threshold model, for estimating health effects at -radia-tion dose levels of interest. There is, however, aubstantial scientific evidence that this model is an oversimplification of tho dose-responso relationship and results in an overesti-mation of health risb in the low dose range. Biological mechanisms includina cellular repair of radiation injury, which are not accounted for by tho linear, no-threshold model, reduce Ibo liblihood of canc:en and genetic effects.

Radlogenlc Health Effects Have Not Been Observed Below 10 Rem Radiogenic health effects (primarily cancer) are observed in humans only at doses in excess of 10 rem delivered at hiah dose rates. Below this dose, estimation of adverse health effects is speculative. Risk estimates that are used to predict health effects in exposed individuals or popula-tions are bued on epidemiological studies of well-defined populations (e.g., tho Japanese survivon of the atomic bombings in 1945 and medical patients) exposed to rela-tively high doses delivered at high dose ratea. Epidemiolog-ical studies have not demonstrated adverse health effects 3

in individuals exposed to small doses (less than 10 rem) delivered in a period of many years.

Limit Quantitative Risk Assessment to Doses at or Above 5 Rem per Year or 10 Rem Lifetime In view of the above, the Society has concluded that cstimatea of risk should be limited to individuals receiving a dose of at least S rem in one yea, or a lifetime doae of at least 10 rem in addition to natural background. Below these doses, risk estimates should not be used; expressions of risk should only be qualitative emphasizing the inability to detect any increased health detriment (i.e., zero health effects is the most likely outcome).

Impact On Radiation Protection Limiting tho use of quantitative risk assessment, as descn'bed above, has tho following implications for radia-tion protection:

(a) The possibility that health effecta might occur at small doses should not be entirely discounted. Conse-quently, risk usessment at low doses should focus on*

establishing a range of health outcomes in the dose range of interest including tho possibility of zero health effects.

(b) Collective doso (the sum of individual doses in an exposed population expressed as person".'rem) remains a useful index for quantifying dose in large populations and in comparina tho magnitude of exposures from different radiation sources. However, for a population in which all individuals receive lifetime doses of lcsa than 10 rem above background, collective dose is a highly speculative and uncertain measure of risk and should not be quantified for tho purposes of estimatina population health risks.

1Tho rem ia tho unit of effective do1e. In international unit.I, 1 rem*0.0l 1MJVort (Sv).

"Tho Health Physic* Society ii a non-profit acientific oraanization dedicated oxcmively to tho protection of JMIOPlo and tho environment mxn ndiation. Since its fonnation in 1956, tho Society hu p,wn to more than 6,800 acicntiat.l, phy1ician1, cnpneon, lawyen, and other profCllionab rcpreacntin1 academia, indumy, aovemment, national laboratoriea, tndo union, and other oraanizationa. Tho Society'*

objective i tho protection of pooplo and tho environment from

~

upoaure to radiation, and ita concern i undentandin1, evaluadna, and oont:rollin1 tho rib from radiation upoaurc relative to tho benef"Jt.1 derived from tho activitie that produce the expoaure1.

Off'icial Poition Statomontl are prepared and adopted in accordance with ltAndard policies and procedures of tho Society. The Society may bo contacted 11: 1313 Dolley Madiaon Blvd., Suite 40'l, McLean, VA 22101; Telephone: 703-790-1745; FAX: 703-790-2672; e-mail: hplburkmgt@aol.com.

. in the absence of significant greenhouse wanning, a major challenge will be to an-ticipate future climate surprises of the type recorded in the paleoclimatic record of the last 10,000 years. This period included sig-nificant shifts in climate forcing, warmer Northern Hemisphere summer tempera-tures, and perhaps our best observational record of significant climatic change ( 17}.

If the climate system turns out to be highly sensitive to elevated atmospheric trace gas concentrations, then we may be confronted with modes of climate variability without precedent. This possibility further high-lighta the need to expand our testing of pre-dictive models against the varied patterns of significant paleoenvironmental change, just

• as we now exercise our modeling ability against the relatively small variability of the 20th century. Major warm climate surprises of the type apparent in the Holocene inter-glacial paleoclimatic record may be our big-gest worry in the years to come.

References

1. W. S. Broecker, Nature 328, 123 (1987).

2. K. Taylor at al., ibid. 388, 549 (1993); P. M.

Grootes, M. Stuiver, J. W. C. White, S. Johnsen, J.

Jouzel, ibid., p. 552; R. B. Alley el al., ibid. 373, 393 (1995)

3. -G. Bond el al., ibid. 385, 143 (1993).

-4. S. Manabe and R. J. Stouffer, Ibid. 378, 165 (1995).

5. F. A. Street-Perrott and R. A. Perrott, Ibid. 343, 607 (1990); F. Gasse and E. Van Campo, Earth Planet. Sci. Lett. 129, 435 (1994).

8. K. A. Hughen, J. T. Overpeck, L. C. Peterson, S.

Trumbore, Nature 378, 51 (1995).

7. W. Dansgaard eta/., ibid. 384,218 (1993).

8. S. L. Forman, A. F. H. Goetz, R. H. Yuhas, Geol-ogy 20, 145 (1992); S. L. Forman, R. Ogle~y, V.

!ancer Risk of Low-Level Exposure Marvin Goldman It is time to scientifically challenge the old tenet stating that cancer risk is always pro-portional to dose, no matter how small.

This seemingly blasphemous statement is based on new approaches that allow test-ing of the hypothesis that cancer risk is linearly proportional to dose with no threshold, the basis of much regulatory and assessment documentation. We hear much th days about the need for all assess-and regulations for risk to be based o

und and solid science. This has not been the case for physical and chemical cancer risks to humans.

For both physical and chemical exposure to agents that are thought to increase cancer risk, it has been traditional to state that responsible evaluations and recom-mendations should assume that all expo-sures, no matter what the amount, carry an associated cancer risk. This assumption al-lows estimation, for example, of the lifetime cancer risk of a single ionization or the risk from intake of a single molecule of a puta-tive carcinogen. It further leads to the con-cept of a collective dose, where all the ion-izationa arc* addc4 up in all the people, and the product [for example, person-roentgen equivalent man (rem) or person-sicvcrt (Sv)J is related to (multiplied by) a cancer risk factor to give a potential population body count (I). Such a calculation is the origin of predictions, for example, that so The author Is In the Department of Surgical and Radio-logical Sciences, Unlvenilty of California, Davis, CA 95618-6742, USA.

many persons will die from radon exposure, or so many cancers will result from treating apples with a chemical.

As an extreme extrapolation, consider that everyone on Earth adds a 1-inch lift to their shoes for just 1 year. The resultant very small increase in cosmic ray dose ( it doubles for every 2000 m in altitude}, mul-tiplied by the very large population of the Earth, would yield a collective dose large enough to kill about 1500 people with cancer over the next 50 years. Of course no epidemiological confirmation of this increment could ever be made, and although the math is approxi-mately correct, the underlying as-sumptions should be questioned.

Most of the environmental risks we now face from present or proposed activities probably arc of this magnitude, and many of our policies say that prudence requires us to reduce these small values even further. We do not seem to have a realistic process whereby we can uniformly both protect the public health and avoid seemingly frivolou, prevention schemes.

A large part of the problem is that all cancer risk assessments arc derived from studies of cohoru exposed to very high lev-els of insult ( l, 2). The conservative as-

. sumption is to connect the high-level risk values to the zero intercept and describe the slope of the resulting line as a "risk coeffi-cient," fatal cancers per unit of dose. The radiation risk issue is the most thoroughly studied, but a similar situation also exists for the case of chemical exposures (3). How-SCIENCE

• VOL. 271

• 29 MARCH 1996 Markgraf, T. Stafford, Global Planet. Change 11,.

35 (1995); K. R. Laird, S. C. Fritz, E. Grirrrn, P. G.

Mueller, Limnol. Ocaanogr.; in press.

9. D. A. Hodell, J. H. Curtis, M. Brenner, Natura 375, 391 (1995).

10. L. L. Ely, Y. Enzel, V. R. Baker, D. R. Cayan, Sci-ence 282, 410 (1993); J. C. Knox, Nature 381, 430(1993).

11. M. K. Hughes and P. M. Brown, Clim. Dyn. 8, 161 (1992); L. J. Graumllch, Oust. Ras. 39, 249 (1992); S. Stine, Natura 389,546 (1994).

12. S. R. O'Brien at al., Science 270, 1962 (1995).

13 D. Rind and J. Overpeck, Qual. Sci. Rev. 12,357 (1993); J. Lean, J. Beer, R. Bradley, Gaophys.

Res. Lett. 22, 3195 (1995).

14. R. B. Dunbar, G. M. Wellington, M. W. Colgan, P.

W. Glynn, Paleocesnography9, 291 (1994); K. E.

Trenberth and T. J. Hoer, Geophys. Res. Lett. 23, 57 (1996).

15. P. CoHnvaux, Nature 240, 17 (1972).

16. L. D. Keigwin, Eos 78, F282 (1995); J. F. Adkins and E. A. Boyle, ibid., p. F282.

17. J. T. Overpeck, Rev. Geophys. 33, 863 (1995).

ever, it is now possible to evaluate the re-sults of low levels of exposure and to apply newly developed analytical and biological tools and thereby test whether this type of extrapolation is warranted.

Historically, the stochastic or probabilis-tic radiation linearity issue began some seven decades ago when Nobel laureate H.

J. Muller demonstrated that mutations in fruit flies increased linearly with exposure dose (4). (It was not actually linear; he said that "... the number of recessive lethals does not vary directly with x-ray energy ab-sorbed, but more nearly with the square root of the latter... we should have to con-clude that these mutations are not caused directly by a single quanta of x-ray energy absorbed at some critical spot."} The small-est doses, about 0.25 gray (1 gray.. 100 rad), were quite high by today's standards.

Linearity was later related to radia-tion cancer risk during the era of at-mospheric weapons testing (5).

This concept was expanded to ap-ply to chemicals in the Delany Amendment of 1958, where any compound found carcinogenic in any test system at any level of exposure could not be added to foods sold to the public. We have since learned that some natural products and many normal foods (nitrosoamines and smoked or charred meat, peanut buttet, and aflatoxin) contain compounds that arc car-cinogenic at high concentrations.

Radiation exposure is ubiquitous throughout the planet and is higher in some areas than in others ( 1 ). Interestingly, when cancer mortality in populations in higher natural background regions is compared with that of comparable populations living in low-background regions, there is no can-cer incidence increase in the higher back-ground areas ( 6). In fact, most of the studies show the opposite, giving support to a con-cept of honnesis, a beneficial effect of a 1821

low-level exposure to an agent that Is harm-ful at high levels (7, 8).

For radiation risks, the keystone data are derived from the elegant and careful study of the survivors of the atomic bombings of Hiroshima and Nagasaki 50 years ago {1-6). In addition, cohorts of medically or oc-cupationally exposed persons and some ac-cidental ~ures add to the database (1-o).

Some 500 cancer fatalities more than would normally be expected have now been re-ported in the Japanese A-bomb-exposed populations (1 ). Most of these were in per-sons who received an acute radiation dose of more than 1 Sv (100 rem); the lowest ex-posed dose cohort is set at 0.2 Sv (20 rem)

( 1 ). Much attention has been paid to deter-mining the lowest level for study. The com-parison control group consists of all those with zero to 0.1 Sv of exposure; thus, not all A,ed "no dose." There is another "not in c'11f' group that abo served as a parallel control population; the two control groups seem identical. The 0.2-Sv group is actually a cohort from 0.2 to 0.49 Sv, with a median of about 0.3 Sv. A discussion of whether this might be considered a threshold for ef-fects is beyond the purpose of this discussion, especially because the uncertainties about individual radiation sensitivity, of dose, and of the possible effect of neutrons have not yet been rP.SOlved. Although a fetus is much more 9C!l5itive to radiation than an adult, the exact nature of age dependency for radia-tion risks is not clear, nor whether dose-rate amelioration factors are age independent.

In contrast, most people receive a nor-mal, natural lifetime dose of background radiation of about 0.2 Sv from cosmic rays, Athe radiation naturally in the Earth (in-

~

natural radon), and from the small amount of radioactivity in all tissues (1-o).

We now know that continual radiation ex-posure is less carcinogenic than acute expo-sure, all else being equal (1 ). Animal studies further show that as the dose rate is de-creased, the risk per unit dose not only decreases, but the latent period becomes longer (9, 10). If the latent period exceeds the life expectancy, we see in the intersect the equivalent of an effective threshold (11). It also appears that combined expo-sures to both radiation and chemicals at "low" levels exert an additive and not a multiplicative effect (6).

It is true that fetuses and children are about twice as r,;diosensitlve as adults, but not much more than that ( 1). It is also true that a minute fraction of the population may carry a genetic defect that renders them more radiosensitive than the norm; for ex-ample, they may lack certain genes or cellu-lar repair tools (6). But even this sensitivity is less than 10 times the norm.

The evidence now available suggests that cancer induction follows more than 1822 one step (that is, it does not follow first-or-der kinetics), and thus a single ionization and the resultant submolecular lesion is not the whole story of carcinogenesis (12). The intracellular repair mechanisms of mamma-lian cells-the intrinsic quality-assurance systems-are designed to execute amazingly sophisticated repair and removal of such le-sions (8). The few defects that remain may constitute the first step in the carcinogen-esis process (12). Each subsequent step, such as altered cell division rates and supressor gene efficiency (and we do not yet know them all), has its own influence and probability of success. Risk may be the integrated sum of the failure probabilities of all the steps.

Thus, the universal cancer risk curve may later prove to be more of an S or sigmoid curve. Our limited data, shortsightedly, only one order of magnitude wide, are seemingly straight-line segments of that curve.

It is time to update our thinking and policies so that a clear distinction is made between what the science says and what the policy means. The difference between the exposure levels, where almost all the data about effects lie, and the levels to which most people might conceivably be exposed is so great that it is time to seriously con-sider the utility of implementing a concept of an effective or practical threshold for risk, that is, negligible risk. This would be a value below that demonstrated to show harm, but not zero. It is time for us to step back and take a careful vir w of the way we use science to estimate possible risks from low-level exposures, especially delivered at very low dose rates. We should review the molecular biology, the newer models, the available human data, and other pertinent scientific information and decide whether to develop new paradigms for risk that bet-ter relate low levels of exposures to scientifi-cally based determinations of potential harm.

References

1. "Health effects of exposure to low levels of Ioniz-ing radiation [BEIR VJ" (National Research Coun-cil, Washington, DC, 1990).

2. B. L. Cohen, Health Phys. 88, 157 (1995).

3. K. T. Kitchin and L. L. Brown, Toxicology 88, 31 (1994).

4. H.J. MOiier, Science a&, 84 (1927).

5. E. B. Lewis, ibid. 125,965 (1957).

6. "Sources and effects of Ionizing radiation" (United Nations Scientific Committee on Effects of Atomic RadlaUon, United Nations, New York, 1994).

7. S. Kondo, Health Effects of Low-Level Radiation (Kinkl Univ. Press, Osaka, Japan, 1993).

8. S. Wolff, V. Afzal, J. K. Welncke, G. Olivieri, A.

Michaeli, Int. J. Radial. Biol. 53, 39 (1988).

9. M. Goldman, N. W. Hetherington, L. S. Rosen-blatt, L. K. Bustad, Radial. Res. 47,305 (1971).

10. L. S. Rosenblatt, N. W. Hetherington, M. Goldman L. K. Bustad, Health Phys. 21,869 (1971).

11. A. Evans, ibid.17, 497 (1974).

12. B. N. Ames, M. K. Shigenaga, L. Swirsky-Gold, Environ. Health Perspect. 101 (Suppl. 5), 35 (1993).

Notch and Wingless Signals Collide Seth S. Blair During development, the identities of many cells are determined by signals pro-duced by adjacent or distant tissues. Cells often receive several signals simultaneously and must integrate them in order to take on the correct fate. Although genetic experi-ments can provide strong evidence for in-teractions among signaling

pathways, whether such interactions are direct or indi-rect can be difficult to determine by genet-ics alone. In this issue, Axelrod and co-workers use both genetic and molecular techniques used to examine the interaction between the Notch (N) and wingless (Wg) signaling pathways In Drosophila ( 1 ). They show genetically that the two pathways can be mutually inhibitory and suggest that at least some of this inhibition is due to a di-rect physical interaction between Dishev-elled (Dsh), a cytoplasmic protein required The author is in the Department of Zoology, University of Wisconsin, Madison, WI 53706, USA. E-mail:

sblairOmacc.wisc.edu SCIENCE

• VOL. 271

• 29 MARCH 1996 for reception of the Wg signal, and the in-tracellular COOH-terminus of the N pro-tein.

Both N-and Wg-like signaling provide critical patterning information in a variety of developmental contexts and in a number of species. Our understanding of the intracellular mechanisms responsible for transducing these signals is still incomplete. N (like Glp-1, Lin-12, Xotch, and other members of the N family) is a transmembrane protein bearing extracellular epidermal growth factor-like repeats and characteristic intracellular do-mains (2). Although N can function as a re-ceptor (3), it contains no previously charac-terized signal-transduction motifs. Rather, when bound by its ligands Delta or Serrate, N likely activates the Suppressor of Hairless

[Su(H)] protein, which then moves to the nucleus and acts as a transcription factor (4).

A recent study of mammalian homologs of N and Su(H) (mNotch and RBP-Jic) sug-gests that this activation occurs by trunca-tion of the intracellular portion ofN and its

Background:

Revision of Dose Limit for Members of the Public Exposed to Hospitalizing Patients (PRM 20-24) 1e NRC received a petition dated April 7, 1996 from the University of Cincinnati requesting rulemaking to amend §20.1301 11Dose limits for individual members of the public" to authorize *specific visitors" of hospitalized radiation therapy patients, as individual members of the public, to receive up to 500 mrem per year.

2.

A notice of receipt and a request for comment on the Petititon was published in the Federal Register on June 21, 1996 (61 FR 31874).

3.

A draft rulemaking plan was prepared and sent to the Agreement States for review and comment (May 1, 1997).

4.

The revised ruleplan was forwarded to the Commission (SECY-97-177) for approval on e August 1, 1997.

1

Revision of Dose Limit for Members of the Public Exposed to Hospitalizing Patients (PRM 20-24)

Proposed Rulemaking Plan:

1.

Allow authorized user physicians the discretion to permit consenting adult family members to receive up to 0.5 rem (5 mSv) annually from exposure to radiation patients

2.

3.

4.

Amend§§ 35.315 and 35.415 to require licensees to obtain and document voluntary informed consent from family members who may receive > 0.1 rem (1 mSv) TEDE.

Licensees would be required to provide ALARA guidance to these visitors.

Amend § 20.1003 to include a definition of family member 2

ommission Action:

Revision of Dose Limit for Members of the Public Exposed to Ho$pitalizing Patients (PRM 20-24)

The Commission approved the rulemaking plan with the following comments:

1.e Justify, on a public health and safety basis, the requirement for licensee documentation that family members provided informed consent to receive up to 500 mrem TEDE and received ALARA instruction.

2.

Recordkeeping activity associated with licensee documentation should be discussed in the Federal Register notice accompanying the proposed rule and public comment should be requested.

3.

Staff should coordinate with ACMUI to draft a "plain English" informed consent form.

4.

Any public notice of this rule should clearly state that family members admitted to the a

room of a patient with permanent implants, or administered radiopharmaceutical therapy, and subsequently released under 1 o CFR 35. 75, may receive a total dose of 1.0 rem as a result of this rulemaking.

3

Revision of Dose Limit for Members of the Public Exposed to Hospitalizing Patients (PRM 20-24) itl Response:

1.

)..

Staff proposes eliminating the licensee requirement to document informed consent and Al.ARA guidance. Documentation and recordkeeping would impose unnecessary burden and cost upon licensees which cannot be sufficiently justified on the basis of a public health and safety benefit.

Sections 20.1301, 35.315, and 35.415 will be revised.

~-

The Federal Register notice accompanying the proposed rule will clearly state that visitors could receive a total effective dose equivalent up to 1 rem as a consequence of e this proposed rule and the provisions of 1 0 CFR 35.75.

4

PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION 1.ectlon 20.1301 is revised to read as follows:

§20.1301. Dose limits for Individual members of the public.

(a) Each licensee shall conduct operations so that (3) Notwithstanding paragraph (a)(1) above, if the authorized user determines that it is appropriate in accordance with 1 O CFR Part 35, the authorized user may permit a radiation dose limit of 0.5 rem (5 millisievert) in a year for specified adult visitors to individuals

~-inlstered radioactive material.

5

PART 35-MEDICAL USE OF BYPRODUCT MATERIAL

2. Section 35.315 is revised to read as follows:

§35.315 Safety precautions.

(6) authorize on a case-by-case basis, with the approval of the authorized user after consultation with the Radiation Safety Officer, a radiation dose limit of 0.5 rem (5 millisievert) for specified adult visitors in accordance with §20.1301 (a)(3).

3. Section 35.415 is revised to read as follows:

§35.415 Safety precautions.

(4) authorize on a case-by-case basis, with the approval of the authorized user after

~D~Yltati.on_with. tbe.RadiationSafety...O.fficer, a radiation dose limit of 0.5 rem (5 millisievert) for. specified adult visitors in accordance with §20.1301 {a){3).

Final Rulemaking Plan 10 CFR Parts 20, 35 REVISION OF DOSE LIMIT FOR MEMBERS OF THE PUBLIC EXPOSED TO HOSPITALIZED PATIENTS (PRM 20-24)

Regulatory Issue The NRC received a Petition for Rulemaking (PRM-20-24) dated April 7, 1996, from the University of Cincinnati. The petitioner requested that the NRC amend 10 CFR 20.1301, "Dose limits for individual members of the public,* to authorize specified visitors of hospitalized radiation therapy patients, as individual members of the public, to receive up to 0.5 rem (5 mSv) per year.

The amendment proposed by the petitioner would provide medical licensees the discretion to permit those visitors determined by the physician to be necessary for the emotional or physical support of the patient {e.g., parents of very young radiation therapy patients, close family members of elderly patients, or other persons who could provide emotional support to the patient) to receive up to 0.5 rem (5 mSv).

Furthermore, the petitioner proposes excluding pregnant women and individuals younger than 18 years of age from receiving a dose in excess of 0.1 rem (1 mSv).

Finally, the petitioner suggests that compliance could be documented by issuing radiation dose monitoring devices (i.e., pocket dosimater, film badge, TLC or electronic dosimeter) to each specified visitor...

On June 21, 1996 {61 FR 31874), the NRC published a notice of receipt and a request for comment on the petition. Comments were received from four members of the general public. All commenters agreed with the petition. One of the commenters suggested that the previous 0.5 rem (5 mSv) dose limit for the general public be reinstated for family members and, under unusual circumstances, also permit the attending physician to authorize even higher dose limits provided the latter does not exceed the occupational dose limit.

Existing Regulatory Framework It is acknowledged in Part 20 that there may be instances that warrant individual members of the public receiving a dose in excess of the 0.1 rem {1 mSv) limit Specifically, under the provisions of§ 20.1301{c), licensees may request NRC authorization to operate up to an annual dose limit for individual members of the public of 0.5 rem {5 mSv). However, the Statements of Consideration for the 1991 revision of Part 20 clearly indicate that this provision was intended for temporary situations to allevlate an immediate need to redesign a facility (56 FR 23375).

"The 0.5 rem limit is intended to be applied primarily to temporary situations where operation of a facility, or the person's exposure to radiation and radioactive emissions, is not expected to result in doses above 0.1 rem over long periods of time. For design of new installations, the 0.1 rem limit should be used. However, existing facilities may apply for NRC approval to use the 0.5 rem limit while more complete evaluation of the need for any additional modifications is performed. Such facilities may include, for example, hospitals with existing teletherapy machines that were designed, constructed, and installed to comply with a 0.5 rem annual dose limit.*

The NRC has received few requests to allow family members of radiation patients to exceed the 0.1 rem (1 mSv) public dose limit. In light of the above, it is possible that licensees generally are reluctant to request such authorization, either because they do not believe the provision would apply or because of the administrative or financial burden associated with such a request. (Section 20.1301 (c) requires fairly complete documentation of the circumstances of the request and the licensee's proposal to make changes so the dose limit will not be exceeded in the future). Therefore, denying this petition would restrict and possibly prohibit close contact between family members and patients at a time when the physical and emotional support provided by such individuals is of great perceived benefit to both the patient and the family.

How the Regulatory Problem Will be Addressed By Rulemaking An appropriate change in the Commission's regulations would permit authorized user physicians the discretion to permit family members to receive doses in excess of the 0.1 rem (1 mSv) public dose limit in the course of providing physical and emotional support to patients.

Rulemaking Options

1. Deny the Petition. The petition could be denied on the basis that there are sufficient provisions within§ 20.1301(c) to allow case-by-case use of the 0.5 rem (5 mSv) annual dose limit for visitors of radiation patients. In fact, the NRC recently granted an amendment request to the University of Cincinnati to apply the 0.5 rem (5 mSv) dose limit to visitors of radiation patients as specified by the authorized user physician.

The advantage of option 1 Is that it does not require govemment resources for rulemaking.

The disadvantage of this option is that access to radiation patients by family members would be constrained by the 0.1 rem (1 mSv) dose limit of § 20.1301 unless prior authorization were requested by the licensee and granted by the NRC. The process to obtain authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv) can be time consuming and impose a financial burden on the licensee. It would also require expenditure of NRC resources to review each request.

2. Grant the Petition as Requested. Amend § 20.1301 to allow authorized user physicians the discretion to permit consenting adult, nonpregnant visitors to receive up to 0.5 rem (5 mSv) annually from exposure to radiation therapy patients and to direct the authorized user to provide instructions to the visitors to minimize their doses while visiting the patient, e.g., guidance on keeping visitor doses as low as is reasonably achievable (ALARA). In addition, licensees would be required to badge those visitors whose total effective dose equivalent would exceed 0.1 rem (1 mSv).

The advantage of option 2 is that it would relieve the licensee of the administrative burden and expense of requesting, on a case-by-case basis, NRC authorization to exceed the 0.1 rem (1 mSv} dose limit. Records of individual exposures and documentation of instructions to minimize radiation exposure would enable the NRC to verify that licensees are complying with the new provision. The radiation therapy patient would benefit from the less restrictive visits and additional physical and emotional support provided by the visitor.

There are disadvantages with option 2. First, owing to the fact that no application for a license amendment need be made, a greater number of visitors may be permitted to be in close proximity to radiation therapy patients. Consequently, these visitors would be subject to Increased radiation exposure and an increased, albeit small, health risk.

Second, the licensee would be burdened with implementing and enforcing a provision whereby the authorized user physician would need to determine the pregnancy status of each visitor. Third, the licensee would be burdened by the requirements to badge those visitors who might exceed the 0.1 rem (1 mSv) dose limit, maintain exposure records for each badged visitor, and document that ALARA guidance was provided.

Finally, the NRC also would be burdened with the requirement to inspect licensee records documenting visitor badging, exposure, and ALARA instruction.

3. Grant the Petition with modification. Amend § 20.1301 to allow authorized user physicians the discretion to permit consenting adult family members to receive up to 0.5 rem (5 mSv} annually from exposure to radiation patients or human research subjects.

Amend§§ 35.315 and 35.415 to require licensees to obtain and document voluntary Informed consent from family members who may receive a total effective dose equivalent greater than 0.1 rem (1 mSv}. Licensees would be required to provide instructions (e.g., ALARA guidance) to these visitors to minimize their dose while visiting the patient or human research subject and to document that each visitor received the instruction. Section 20.1003 would be amended to include a definition of family member.

This option differs from the petition on four points. First, the licensee would not be required to issue radiation monitoring devices to visitors nor record (or report) the total effective dose equivalent for each visitor. The total effective dose equivalent

• anticipated for virtually all visitors of radiation patients or human research subjects will be significantly less than 0.5 rem (5 mSv}, especially if the visitor follows the ALARA guidance provided by the licensee. Consequently, it does not appear that the petitioner's suggested measures, beyond basic ALARA instruction, warrant the administrative burdens associated with badging visitors. Second, visitor access would be limited to adult family members. Family member is defined as any person who

• spends a substantial amount of time in the company of the patient or human research subject on a regular basis, providing support and comfort, and who the patient or

human research subject considers a member of their "family," whether by birth, by marriage, or by virtue of a close, caring relationship. Third, this option would not be restricted to family members of radiation therapy patients hospitalized under 10 CFR 35.75 or patients receiving temporary brachytherapy implants under 10 CFR 35.400.

Rather, the authorized user physician retains the discretion to permit a consenting adult family member to visit human research subjects or patients to whom radioactive byproduct materials have been administered for either diagnostic or therapeutic purposes. Finally, at the discretion of the authorized user physician, consenting pregnant family members would be permitted to receive up to 0.5 rem (5 mSv) annually from exposure to radiation patients or human research subjects.

The advantages of this option are similar to those described for option 2 except that licensees would not be burdened with monitoring and recording individual external exposures or with associated reporting requirements. Licensees already demonstrate compliance with the public dose limit by maintaining records of dose rates in unrestricted areas; they are required to post a "Radioactive Materials" sign on the patient's door and note, either on the door or in the patient's chart, where and how long visitors may stay in the patient's room. Responsibility for not exceeding the 0.5 rem (5 mSv) exposure limit ultimately rests with the licensee even though the licensee is reliant upon the visitor to adhere to ALARA guidance and time-distance restrictions, if any.

Although badging and area surveys could be used to document that the 0.5 rem (5 mSv) limit was not exceeded, it is unlikely that badging itself would prevent an overexposure, and therefore badging would not be required. Another advantage of option 3 is that the licensee is not required to ascertain the pregnancy status of a visitor, a provision that could be difficult to implement and enforce.

4. Use a Modified Approach to Granting the Petition. Amend § 20.1301 to allow the medical licensee to permit an adult member of the public to decide for themselves, if they consent, to possibly receive up to 0.5 rem (5 mSv) while visiting a radiation patient.

Amend§§ 35.315 (a)(2) and 35.415 (a)(2) to require the licensee to post on the door of the patient's room a "Radioactive Materials" sign that contains the following information:

(1) where and how long an adult visitor may stay in the patient's room, (2) where and how long visitors under the age of 18 may stay In the patient's room, and (3) a list of guidelines visitors should follow to keep exposures ALARA. Licensees would have the option to not specify the location of the visitor within the room but to adjust the stay-time calculation accordingly. No dosimetry badging of visitors would be required under this option.

The principle advantage of option 4 is that this alternative would alleviate the authorized user physician of the burden of determining which members of the public constitute adult, non-pregnant family members, because responsibility for determining who can visit a radiation patient would be left entirely to the visitor. Entering the patient's room after reading the "Radioactive Materials" sign would constiMe Informed consent, receipt of ALARA guidance, and acceptance of time-distance restrictions.

This would relieve the licensee of the burden of documenting consent to potentially receive a radiation exposure that exceeds the 0.1 rem (1 mSv) public dose limit and providing ALARA instruction and exposure restrictions to each visitor. This option also would reduce the number of inspection requirements and eliminate the need for licensees to collect information from visitors to radiation patients. Although badging would be useful to document that the 0.5 rem (5 mSv) limit was not exceeded, it is

unlikely that badging itself would prevent an overexposure, and therefore would not be required.

The disadvantage of option 4 is that there would be no way to either ensure or document that the visitor read or understood the potential consequences of being in close proximity to the patient, or understood the ALARA instruction. Hence, there is a possibility that individuals could "involuntarily" receive doses in excess of 0.1 rem (1 mSv}.

Agreement State Comments on Draft Rulemaking Plan Comments were received from seven States (Arkansas, Colorado, Florida, Illinois, Iowa, Maine, and Washington). Five States (Arkansas, Colorado, Florida, Illinois, and Maine) support the staff's recommendation to grant the petition as requested by the petitioner. but without a requirement that licensees monitor radiation exposure of family

• members. Two States (Iowa, Washington) agreed with granting the petition as suggested by the petitioner thus requiring the licensee to monitor each visitor (preferably using a direct reading dosimeter only) to allow more direct control of radiation exposure and provide a way for the visitor to monitor their exposure.

In the draft rulemaking plan, family members and specified visitors were described as "care givers: Three States (Iowa, Colorado, Florida) expressed concern that the definition for care giver was too broad and these states interpreted the definition to include professional health care givers (e.g., nurses) and other hospital support staff (e.g., clergy and house keeping staff). One State (Florida) stated that there are too may definitions already. In the draft rulemaking plan, reference was made to both radiation diagnostic and therapy patients. Two States (Iowa, Illinois) suggested that the diagnostic use of radioactive material should not be considered in this rulemaking because these procedures require very little patient/visitor control, and posting a radioactive materials sign on the patients' door is not required.

One state (Colorado) expressed concern that the staff's preferred option does not specifically address pregnancy and that special consideration should be given to women who could be pregnant so that an ample margin of safety is afforded the fetus.

One State (Illinois) recommended a more prescriptive revision of Part 35. Illinois proposed revising§§ 35.310, 35.315, 35.410, and 35.415 to include authorized user guidelines to determine the suitability of visitation of certain patients; guidance regarding who will provide the ALARA instruction, how cumulative exposure will be tracked, when radiation surveys should be performed on the patient's room, and when materials removed from the patient's room should be surveyed; and methods.to control the spread of radioactive material contamination (to include the potential dislodgment and loss of brachytherapy sources} in and out of the patient's room.

Preferred Option Option 3 is the preferred option. Option 3 is consistent with ICRP, IAEA, and NCRP

• guidance in that it would allow voluntarily exceeding the public dose limits to assist in the medical care of family members. The licensee would be required to provide

sufficient instruction to family members to permit willing and informed consent to the exposure as well as to provide guidance in keeping doses ALARA. In addition, the licensee would be required to document that the visitor provided informed consent about potentially receiving an exposure greater than 0.1 rem (1 mSv) and receipt of ALARA instruction. However, individual monitoring of external radiation exposure by the licensee would not be required.

By increasing the individual dose limit for visitors to 0.5 rem (5 mSv), options 2, 3, and 4 theoretically may result in an increased risk of cancer, but this increase would be negligible. The number of visitors who may exceed the 0.1 rem (1 mSv) limit would certainly be very small and the emotional support provided to the radiation patient or human research subject may be significant. There is a small cost to NRC and the Agreement States associated with proceeding with rulemaking that could be construed as being offset by the benefit to the patient or human research subject. Further, licensees would have the option to refuse to allow visitors to receive the additional dose.

Option 1 Is unacceptable because it does not allow physicians to fully employ their medical judgment in the treatment of their patients. Option 1 unnecessarily restricts family member access to radiation patients unless the licensee requests a license amendment to exceed the current 0.1 rem (1 mSv) public dose limit. Exercising this option requires time to obtain NRC approval and places a financial burden on the license just to request the license amendment. The time required to obtain authorization to exceed the public dose limit occurs when both the patient and family members are likely to receive the greatest benefit from such access.

Option 2 is an acceptable option. It permits closer contact between family members and patients if the individual and the treating physician agree that the potential Increase In risk is justifiable. However, it imposes an additional burden of badging, ALARA instruction, and record keeping on the licensee and imposes an increased inspection burden on the NRC.

Finally, option 4 is not preferred because it lacks any means to ensure or document that family members are truly giving informed consent to receiving doses in excess of the 0.1 rem (1 mSv) dose limit. Further, because this option, unlike options 2 and 3, would remove the licensee's active control to permit access by members of the public to radiation, it is inconsistent with current practice that reflects the NRC's position that the fundamental dose limit for individual members of the public is 0.1 rem (1 mSv), and that higher doses, while appropriate in some circumstances, are not to be permitted routinely.

Office of General Counsel Legal Analysis

'The proposed rulemaking revisions would address the problem identified by the petition for rulemaking. These revisions are consistent with ICRP, IAEA, and NCRP guidance.

OGC has not identified any basis for a legal objection to the rulemaking. The rule does not affect reactors, therefore the rule does not constitute a backfit under 1 O CFR

• 50.109. An environmental assessment must be prepared for this rule in compliance with 10 CFR 51.21. There are new information collection requirements in this proposed

rule, therefore, to comply with the Paperwork Reduction Act of 1980, an analysis must be prepared and the information collection requirements must be submitted to the Office of Management and Budget for approval. The final rule must be evaluated for compliance with the Small Business Regulatory Enforcement Fairness Act of 1996.

Since the proposed rulemaking plan would address resolution of PRM-20-24, the staff will need to assure that the appropriate procedural actions are taken to close the actions associated with that petition. These actions include specifically granting or denying the petition for rulemaking, either in the Federal Register notice associated with the rulemaking or in a separate Federal Register notice, and informing the petitioner of the NRC's decision. The detailed procedures for responding to the rulemaking petition are contained in Part 11 of the Regulations Handbook {NUREG/BR-0053, Rev.3).

e Backfit Analysis This amendment does not affect nuclear reactors, and a backfit analysis is not required.

Agreement State Implementation Issues This amendment would be proposed as a Division 3 matter of compatibility. As such, Agreement States have the option to develop a similar rule if they wish. An Agreement State may decide that licensees should issue radiation dose monitoring devices (e.g.,

ionization chambers or TLDs) to each visitor. Similarly, Agreement States would not necessarily have to adopt the 0.5 rem (5 mSv) annual dose limit in their regulations.

Therefore, Agreement States would not necessarily have to make any changes to their regulations.

e Major Rule This rulemaking does not constitute a major rule.

Supporting Documents Needed A Regulatory Impact Analysis, Environmental Assessment, and an Office of Management and Budget clearance package will need to be developed in support of this rulemaking.

Issuance by Executive Director for Operations or Commission This rulemaklng would not fall within the authority delegated to the EDO to issue this rule In accordance with paragraph 0213 of Management Directive 9.17. It, therefore, will be forwarded to the Commission for approval.

Resources Needed to Complete Rulemaking

The estimated resources to complete- *tiis:n.tie:11'foKir:,i;: wti:Juid: be about 0.5 staff years.

Approximately 60 percent of this efftl~ *w~_\\J;ci-cor-:r:w :-ir:om RES and about 40 percent divided among NMSS, OSP, OE. and Ct'>C.

In addition, contractor support fund1n"~ 't:fi J::m,/JG_;)~; 'M'O'dio trli'l l:-sed to assist in developing the Regulatory Impact Analysis. The~t* ifHuli.1m,d.~ cs:r1? Lm:'J.uded in the current budget.

No additional resources are anticip~~ to 1inp/t>1 rl'&'M t,he n.:J.e.

Staff Level Working Group E. Vincent Holahan ( 415-627.2)

Catherine Haney Kathryn Winsberg Lance Rakovan Herbert Parcover Management Steering Groufi)

A~hok "iihadani Cati \\Paperiello Sv-iar.t. 'f reby 1Rk:fi"t3tlld !3angart Ja-me1 ~e?.eberman No steering group will be used tin~$ ~.1le.maldr.: J. 7l'H; t~~Mnical contacts are identified above.

Public Participation Enhanced public participation is na r.~"~.tmd rbr

• thi~; r~.ma..~ing as affected individuals would be permitted to participate in 'ihh'tet;.'$icn l\\o *,.'l'\\:tt,,r;asi9 their own exposure.

Licensees will not be required to o/.feri tltris:f:ltxib;,\\~t\\y, a-,"~ tmarefore will have adequate opportunity to provide training, doomflti'!oi.::;,1th\\< *aep Pi:i::o~-s. The petition for rulemaking was published in the F,~t11bf.eaj,st.,r~~- f~c0n1ments were received, and all were in support of granting fue.r;e,-Jiti.ffi; A *t}r1 *Jptesse-J ruft't! will be published in the Federal Register and all public com-i<tetmlii~v:;.;,,Jrn co.r.~siti,e.ied. The final rulemaking plan and the rulemaking documents w.'i.ft ~

1r,ooad /)!i;) bo>'.n n,e,I\\JRC electronic rulemaking bulletin board and the interactive ~J.Al1rrrat'ifn£1 \\N~tea, S.t.

Supporting documents will be avaw-ati~ 1tt.,tha pi,i>l!:)i.r.: ttr.,~ug.h the Public Document Room, local Public Document Roor.r.11,, 'if ectliiorc~i1..._ thta ~Re Rulemaking Web site, and through direct contact with the RES 1lir-:a1!a1,1rfr~;:. r,,Jil~M!ikf<'l1g. These mechanisms permit adequate public involvemem ir!i ttm -re ooh.mcwi ~ ~

issues.

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J.S. NUCLEAR REGULATORY OMMISSlO,.

DOCKETING & SERVICE SECTION OFFICE oi= THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _!_E_/. 30 I qt:,.. 1'1iklc.~r s-et1f ~DYii~

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UNIVERSITY OF CALIFORNIA, LOS ANGELES DOCKETED IJ~NR C:

(

)

UCLA BERKELEY

• DAVIS

• IRVINE

• LOS ANGELES

• RIVERSIDE

• SAN DIEGO

• SAN FRANCISCO SANTA BARBARA

• SANTA CRUZ

'96 SEP -9 A August 22, 1996 UCLA SCHOOL OF MEDICINE HARBOR - UCLA MEDICAL CENTER DEPARTMENT OF RADIOLOGY 1000 CARSON STREET TORRANCE, CALIFORNIA 90509 PHONE:

(310) 222-2845 FAX:

(310) 533-7159 U.S. Nuclear Regulatory Commission EMAIL:MARCUS@AFP76.HUMC.EDU Attention: Docketing and Service Branch

@)

Office of the secretary DOCKET NUMBER 4*

Washington, D.c.

20555-001 PETJTIO~

ULE PAM 20-24 Re:

Petition for PRM-20-24.

Dear Sir:

Rulemaking; University of Cin:~:~t~i!o~t2t no.

This is the third petition on this subject that I know of that has been submitted to the NRC since January, 1991. No action has been taken on the previous two except for a written statement by Patricia Holahan that NRC intends to retain the 500 mrem limit for persons who share households with patients who have had radionuclide therapy or permanent brachytherapy sources, and a disastrous proposed rule published over two years ago indicating that NRC did not understand the mathematics, physics, pathophysiology, or radiopharmacokinetics involved. Chairman Selin apologized for the bad job on Aug. 31, 1994, stating that "NRC did not do its homework". I replied that NRC did not know how to do its homework. He vowed to get it fixed. He never did, and neither has Chairman Jackson.

The problem of basic NRC inability is compounded by the very real spectre of a subset of NRC staff and management wishing to turn a simple request using the 10 CFR 20.1301(c} petition mechanism into an opportunity to concoct a vicious, prescriptive rule, with intent to abuse physicians, the same way they did with the "Quality Management" rule. This is unacceptable in its entirety.

The Commissioners should be aware that for several years before the new Part 20 was approved, individuals on the ACMUI asked to review it to evaluate potential impact on medical licensees. This request was denied each and every time, and it is no wonder that Part 20 presents many problems to medical licensees. It was never reviewed by anyone who understood medicine, and certainly Hal Peterson and Don Cool, who did major work on Part 20, have no knowledge of the subject. When I pointed out a couple of problems to Chairman Carr and Dr. Cool at a Calrad Forum meeting in Nov.,

JQC06.CIM SEP 1 3 1996 4cknowleC1g8d by cara................................

l.S. NUCLEAR REGULATORY COMMISSIOh DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Docunent Statisb Postmark Date 2 j 31 / ':J lo Co~es Received _

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(,a)\\a8bec, t1' i..esac '

August 22, 1996 Nuclear Regulatory Commission Page 1990, because I had been given a final version to discuss at a session during the meeting, the EPA problem was fixed before the Commission vote in December, but the medical problems were not.

When I spoke with Hal Peterson in December, 1990, he told me that it was too late to fix it before sign-off, because that had already occurred, and he asked me to write a petition to fix it.

The petition was written Christmas Eve, and received at NRC the first week in January, 1991. There have been numerous follow-up letters and descriptions of NRC problems and an addendum to the petition. They are all in the public record, and I request that copies of those letters be placed in this file. I have just been informed by Norman McElroy that NRC has published a regulatory guide on how to write a petition. When is NRC going to write an internal guide on how to answer a petition?

I wish to now reconcile all three petitions in a manner that makes sense, would avoid further regulatory dysfunctionality and physician abuse, and would, I expect, be acceptable to the regulated community. I recommend that Chairman Jackson remove this issue from the staff and management "working" on it, and settle it as follows. Add:

"§20.130l{f} Those members of the public who share households with patients, or who are involved in their care, or are supportive of their general well-being, mentally or physically, are not considered members of the general public in the context of the 0.1 rem dose limit. The previous 0.5 rem limit will continue to apply to these members of a "specific" public. In unusual situations an Authorized User Physician may determine that the care of a specific patient justifies even higher exposure, but in such circumstances the member of this "specific" public cannot receive more radiation than a radiation worker. The Authorized User Physician is responsible for obtaining agreement from such an individual and appropriately instructing this individual in applicable radiation protection behavior."

Given the fact that there is no evidence that any harm occurs at 0.1 rem, 0.5 rem, or 5 rem, this differentiation may appear foolish. Given the fact that there is more evidence showing hormesis at 5 rem than there is evidence supporting the linear, no-threshold hypothesis (there is none), this differentiation may seem absurd. Nevertheless, it would be consistent with the illogical basis of Part 20, and would permit us to practice medicine safely, sensibly, and cost-effectively. As this activity would be a medical practice issue, NRC must not interpose itself KaCIN.CSM

August 22, 1996 Nuclear Regulatory Commission Page here, with any license conditions, regulatory guides, or inspection. The idea is to deprive NRC of fertile ground for new regulatory mischief.

We may therefore end 10 CFR 35.75 in its entirety.

The basic methodology of NCRP no. 37 applies to the dosimetry, with patient-specific information used as available. The calculations are the responsibility of the Authorized User Physician, and a review will be provided by me, or ACNP, or SNM, or probably a number of qualified professional groups, as needed.

There is no need for any further involvement of NRC, and no more of our User Fees should be wasted pretending that a helpful NRC response will emerge.

That has not happened in nearly six years, and that is long enough to convince any sensible person to give up hope.

Thank you for your attention and consideration.

Carols. Marcus, Ph.D., M.D.

Director, Nuclear Med. Outpt. Clinic and Professor of Radiological Sciences, UCLA cc:

Chairman Shirley Ann Jackson Commissioner Greta Dicus Commissioner Kenneth Rodgers Hugh Thompson, Deputy EDO James Taylor, EDO Carl Paperiello, NMSS

HOSPITAL PAVIA DOCKETED UStJRC

• 96 SEP -3 A10 :26 L

r

!-4, DEPARTAMENTO DE MEDICINA NUCL~RtiKETlr-Jq _:_ SER VIC[

BR,..i,NC H Jose 0. Morales, M.D. FACNP DIRECTOR DOCKET NUMBER Q)

PETITION RULE PRM 29-24

( to I I= R 31 '8'74-)

Office of the Secretary Nuclear Regulatory Corrnnission Attn. Docketing and Service Branch Washington, DC 20555-0001

Dear Sir:

August 27, 1996 Re: Docket No.

PRM 24 I am writing to express my support for the above proposed rule. It has been my experience that t he presence and support of a friend or relative is a very important component in the care of patients.

Since it would be possible to have the authorized visitor remain at least one meter away in most circumstances, the exposure would certainly be below the 500 mrem limit.

In addition since more than one visitor would be used,

the individual exposures would then be even less.

Sincerely, 0-~ ~~ ~

Jose 0. Morales,MD FACNP SEP 1 3 *18~6

-'\\cknowleclged by cara..............................

APART ADO 19523

• San Juan, PR

• 00910-1523 Tel. (809) 727-6060 Ext. 487

• Fax 727-6060 Ext. 346

J.S. NUCLEAR REGULATORY COMMISSIOt-.

DOCKETING & SERVICE SECTK'lN OFFICE Of THE SECRETARY OF THE COMMISSION DoQJnent StatidCS Postmark Date ~~µh=-7.l--____

..,,=

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28 August 1996 United States Nuclear Regulatory Commission Attn: Docketing and Service Branch Office of the Secretary Washington, DC 20555-0001 Re: Docket No. PRM-20-24

Dear Ma'am/Sir:

vCKET l'W~.,:SER PETITION RULE PRM 2Q-24

{to I ~R..sl i74) -

DOCKETED USNRC

'96 SEP -3 A10 :28 @

OFFICE OF SECRt: TARY OOCKET ll~G -3: SER VICE BRANCH Since exposures to family members of radiopharmaceutical therapy patients are infrequent and the benefit to a patient of having certain family members present can be great, members of the patient's family (and/or those with a significant personal relationship to the patient) should be permitted to receive up to 5 millisievert (0.5 rem) from exposure to patients treated with radiopharmaceutical therapy. It should not matter if this dose is received while the patient is hospitalized for the therapy procedure, after the patient is released from the hospital, or some combination of both.

The current petition poses a valid argument, however, two things should be considered before ruling on this petition:

1.)

If a member (or members) of the patient's family are permitted to receive up to 5 millisievert (0.5 rem) while the patient is hospitalized, that family member will not be permitted to receive any more radiation exposure from the patient once he/she has been released from the hospital [unless the 5 millisievert (0.5 rem) limit can be added to the current limit of 1 millisievert (0.1 rem), which would give an overall limit of 6 millisievert (0.6 rem)].

2.)

The NRC is still acting on two petitions for rulemaking that, among other things, address dose limits for family members after the patient is released from the hospital (see 59FR114 pp. 30724-30732). The requested dose limits in both of these petitions are 5 mSv (0.5 rem). These petitions led to two other NRC publications: NUREG-1492, 'Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material', and Draft Regulatory Guide DG-8015, 'Release of Patients Administered Radioactive Materials'.

It should also be noted that NCRP Commentary No. 11 (Dose Limits for Individuals who Receive Exposure From Radionuclide Therapy Patients) recommends keeping the I mSv (0.1 rem) dose limit for members of the general public, except family members. For these persons, the NCRP recommends a dose limit of 5 mSv (0.5 rem) annually, with provisions to receive up to 50 mSv (5 rem) with physician recommendation, training and individual monitoring.

Perhaps it would be best for the NRC to combine the current petition with the two previous petitions mentioned above and promulgate a regulation that will allow family members (and significant others) to receive up to 5 mSv (0.5 rem) annually from radiopharmaceutical therapy patients, independent of the time of exposure (i.e. whether the patient is in or out of the hospital).

~ ~

Ken Lovins, M.S.

Health Physicist Rad Physics, Inc.

400 Oak Street Suite Q-1 Cincinnati, OH 45219 513-751-6288 (phone & fax)

SEP 1 3 1996 "cknowlooged by cara".~_........ N........,~

J.S. NUCLEAR REGULATORY COMMISSIOJI.

DOCKETING & SERVICE SECTION OFFICE Of THE SECRET ARY OF THE COMMISSlON DoQrnent Statistics Postmark Dall _i:.1-t...,?.J-:) ___

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sP/58J)R0QS lc5:'i,:; G,alk'/Jber, I

Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 DOCKETED USNRC 4809 Drummond Avenue Chevy Chase, MD 20..81 5sEP _3 A9.41 September 2, 1996-~b OFFICE OF sccqETARY OOCKETlr~G c. '....ERV ICE BR'NCH Re:

PRM-20-4 DOCKET NUMBER (jJ

Dear Mr. Hoyle:

PETITION RULE PRM 20 -2 4 (IL>Jf:R31'?71)

I would like to offer my comments on the petition for rulEfmaking filed by the University of Cincinnati Medical Center, which proposes a rule change to allow friends and family members to visit persons hospitalized for treatment with radiopharmaceuticals.

I do so in my private capacity as a member of the public, not in my role as Counsel for Special Projects in the NRC Office of the General Counsel.

These comments are, of course, written at home, on my own time.

The University of Cincinnati petition reasons that if a person, properly informed as to the risks involved, wishes to visit a patient in radiological isolation, he or she should be allowed to do so.

I believe that this is a humane and sensible idea, one that shows sensitivity both to the needs of patients and their loved ones and to the interests of the public at large.

It means, for example, that if your child or your spouse is in radiological isolation, you can decide for yourself whether the benefits of such a visit outweigh the risks to yourself.

My reason for favoring this proposal is quite personal.

Between 1988 and 1991, I was an in-patient at the National Institutes of Health five times, receiving radioiodine treatments for a recurrence of thyroid cancer.

I don't think I'm unique in finding radiological isolation a singularly demoralizing experience.

Unlike the usual hospital stay, in which nurses and orderlies come and go, the patient in isolation for treatment with radioiodine has the sense of being in solitary confinement.

Given that one is already coping with the knowledge of having cancer, and may be experiencing nausea and other kinds of discomfort from the radioiodine, the depressing effect is all the greater.

On one occasion only, I had a visit while in isolation, from an office colleague who, ignoring the prohibitions against visits, appeared in my doorway to say hello.

To my concerns about her 4 k SEP 1 3 1996 c nowl8dged by card...............................

r J.S. NUCLEAR REGULATORY COUMISSIO~

DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSK:>N Doa.ment Stddcl Postmark Date baadde!JVeced Co~esReceived._1-I _ _ ___ _

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2 well-being, she said cheerfully, "It can't hurt me, I don't have a thyroid to lose."

This was true; she was a former thyroid patient herself, who had undergone radioiodine treatment, and for that reason, she knew exactly what radiological isolation felt like.

There are two possible ways of alleviating the demoralizing effects of radiological isolation.

One is to allow the patient to receive visits, as proposed by the University of Cincinnati.

The other is to treat patients -- even those with large amounts of radioactive iodine in their systems -- on an out-patient basis.

This is the approach advocated by Dr. Carol Marcus in a petition for rulemaking now pending before the NRC.

If this proposal were adopted, patients would be instructed how to minimize the radiation exposure to others and would be trusted to obey those instructions.

It would be nice to be able to believe that all thyroid cancer patients are equally conscientious about following such instructions and ensuring that family members and others are not needlessly exposed to radiation.

It seems, from the comments filed by NIH on Dr. Marcus's petition, that this is not the case.

NIH reported, for example, that despite cautions to the contrary, some patients from foreign countries, upon release, go directly to the airport and board planes for home, which means that they are in close proximity to others for many hours.

(Bear in mind that under current regulations, these patients cannot be released from isolation until no more than 30 millicuries of radioiodine remain in their systems.)

If the Marcus proposal is adopted, the protection afforded to the public will be only as good as the conscience of the individual patient.

Then as now, patients will have the option of disregarding instructions and going directly to the airport to board a flight for home.

The difference is that instead of having a maximum of 30 millicuries of I-131 in his or her system, the patient may recently have received 150 or 200 millicuries of 1-131, and the person sitting beside the patient may receive a sizable dose of radiation without knowing it. It is small wonder, therefore, that the International Basic Safety Standards, to which the United States is a signatory, call for keeping patients in radioactive isolation when they have received more

3 than 30 millicuries of I-131.

1 In sum, the Commission should act quickly to approve the University of Cincinnati's petition, and should keep this sensible and modest alternative in mind when it considers the unnecessarily drastic proposal put forward by Dr. Marcus.

I would like to ask that copies of this comment letter also be placed in the dockets of PRM-35-10, PRM-35-11, and PRM-20-20.

Sincerely, Peter G. Crane 1 So that there will be no misunderstanding, my position on the patient release criteria proposal was that I-131 was a special

case, and that whatever the NRC did with respect to other radiopharmaceuticals, it should not allow patients with large amounts of I-131 in their systems to be released from isolation, because of the risk to family members and the public at large.

My position was consistent with the comments of a number of states (on the notice of the receipt of the petition for rulemaking) and the Basic Safety Standards.

Dr.

Marcus herself apparently recognized the special risks of I-131, because her original petition would have left the 30-millicurie limit in place for that radiopharmaceutical.

Later, she amended her petition to eliminate the exception for radioiodine.

DOC, ETED US R'

'96 JUN 17 P 4 :5 3

[7590-(Q_F.:fi... ~ Of ~f.ClETAi"f(

DOC f:. TitH; * ~. \\11 CE NUCLEAR REGULATORY COMMISSION BRAl~C:; 1 10 CFR Part 20

[Docket No. PRM-20-24]

University of Cincinnati AGENCY:

Nuclear Regulatory Commission.

DOCKET NUMBER PETITION RULE PRM ol-0-ci+

( {o\\ FR--3\\9, 1 +)

ACTION : Notice of receipt of petition for rulemaking.

SUMMARY

The Nuclear Regulatory Commission (NRC) is docketing. as a petition for rulemaking. a document dated April 7. 1996. and filed with the Commission by the University of Cincinnati.

The petition was assigned Docket No. PRM 24 on April 15. 1996. The petitioner requests that the Commission amend its regulations to authorize specified visitors of radiation patients. as members of the public, to receive up to 500 mrem per year. In this document. the NRC is announcing the receipt of the petition and requesting public comment on the suggested amendment.

~

4) 19'1~

DATES: Submit comments by ~75 days after publication in the Federal Register).

Comments received after this date will be considered if it is practical to do so.

Hv#ever. assurance of considera~ion cannot be given except as to comments received on or before this date.

1

ADDRESSES:

Submit comments to the Nu~1ear Regulatory Commission. Attention:

Docketing and Service Branch. Office of the Secretary. Washing~on. DC 20555-001.

For a copy of the petition. write to the Rules Review Section. Rules Review and Directives Branch. Division of Freedom of Information and Publications Services. Office of Administration. U.S. Nuclear Regulatory Commission. Washington. DC 20555.

Deliver comments to 11555 Rockville Pike. Rockville. Maryland. between 7:30 a.m. and 4:15 p.m. on Federal workdays.

For information on submitting comments electronically. see "Electronic Access" under the Supplementary Information section of this notice.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar. Chief. Rules Review Section. at the same address as above or by telephone. 301-415-7163. or toll free. 1-800-368-5642. or E-mail. MTL@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Background

In §20.130l(a)(l). each licensee is required to conduct operations so that the total effective radiation dose limit for members of the public does not exceed 0.1 rem (1 millisievert) in a year.

The dose equivalent must be exclusive of the dose contributions fro[ 1ackground radiation. any medical administration the individual has received. voluntary participation in medical research programs. and the licensee*s disposal of radioactive material into 2

sanitary sewerage in accordance with §20.2003.

The current regulations state in §20.130l(c) that a licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv).

Petitioner's Request The pe*c it i oner states that. as recoinmended in a report from the National Committee on Radiation Protection (NCRP 91). the proposed amendment would permit a small population of the general public to be infrequently exposed to an annual exposure limit of 500 mrem total effective dose equivalent.

The petitioner presents the following specific recommendations concerning the requested amendment:

1. The individuals to whom the 500 mrem annual limit applies would be specified visitors of radiation therapy patients hospitalized under 10 CFR 35.75 or specified visitors of radiation therapy patients receiving temporary brachytherapy implants under 10 CFR 35.400.

2. The dose limit is not requested for all visitors of all radiation therapy patients hospitalized under 10 CFR 35.75 or receiving a temporary implant under 10 CFR 35.400.

The dose limit would apply only to specified visitors determined by the physician to be necessary for the emotional and/or physical support of the patient (e.g.. parents of children. eldjr7y patients who need support from a familiar individual. etc.).

3. The specified visitors would be limited to adult (18 or older) non-3

pregnant individuals who are members of the family or are individuals with a significant personal relationship to the patient.

4. The specified visitors would be instructed by the licensee or authorized user to maintain their exposure as low as reasonable achievable (ALARA).

The instruction would emphasize the radiation safety precautions of time. distance and shielding.

5. The dose limit would apply only to dose received while the patient is hospitalized under 10 CFR 35.75 and/or receiving a temporary brachytherapy implant under 10 CFR 35.400. A personnel monitor (pocket dosimeter. film badge. TLD or electronic dosimeter) would document compliance.

The Petitioner's Proposed Amendment The petitioner proposes that§ 20.1301 be amended to permit specified visitors of radiation patients to be exposed to an exposure limit of 500 mrem total effective dose per year.

Electronic Access Comments may be submitted electronically. in either ASCII text or WordPerfect format (version 5.1 or later). by calling the NRC Electronic Bulletin Board (BBS) on FedWorld. The bulletin board may be accessed using a personal computer. a modem. and one of the commonly available communications software packages. or directly via Internet.

Background documents on this petition a7so are available for downloaring and viewing on the bulletin board.

If using a personal computer and modem. the NRC rulemaking subsystem on FedWorld can be accessed directly by dialing the toll-free number 800-4

303-9672.

Set communication software parameters as follows:

parity to none.

data bits to 8. and stop bits to 1 (N.8.1). Using the ANSI or VT-100 terminal emulation. the NRC rulemaking subsystem can then be accessed by selecting the "rules menu" option from the "NRC main menu." Users will flnd the "FedWorld On-line User's Guides" particularly helpful. Many NRC subsystems and data bases also have a "Help/Information Center" option that is tallored to the particular subsystem.

The NRC subsystem on FedWorld also can be accessed by a direct-dial e

telephone number for the main FedWorld BBS. (703)321-3339. or by using Telnet via Internet: fedworld.gov.

If using (703)321-3339 to contact FedWorld. the NRC subsystem will be accessed from the FedWorld main menu by selecting the "Regulatory, Government Administration and State Systems." then selecting "Regulatory Information Mall."

At that point. a menu will be displayed that has an optlon "U.S. Nuclear Regulatory Commission" that will take you to the NRC on-line main menu.

The NRC on-line area also can be accessed directly by typing "/go nrc" at a FedWorld command line. If NRC is accessed from FedWorld's main menu. the user may return to FedWorld by selecting the "Return to FedWorld" option from the NRC on-line main menu.

However. if NRC at FedWorld is accessed by using NRC's toll-free number. the user will have full access to all NRC systems but not to the main FedWorld system.

If FedWorld is contacted using Telnet. the user will see the NRC area and menus. including the rules menu.

Although the user will be able to download documents and leave messages. he or she will not be able to write comments or upload files (comments). If FedWorld is contacted using File Transfer Program (FTP). all files can be accessed and downloaded but uploading files is not allowed--the user will see only a list of files without 5

descriptions (normal gopher look). An index file is available that lists all files within a subdirectory. with descriptions of those files.

There is a 15-minute time limit for FTP access.

Although FedWorld also can be ac~essed through the Worldwide Web. like FTP. that mode only provides access for downloading files and does not display the NRC rules menu.

For more information on NRC bulletin boards call Mr. Arthur Davis.

Systems Integration and Development Branch. NRC. Washington. DC 20555-0001.

telephone (301)415-5780 : E-mail AXD3@nrc.gov.

Single copies of this petition may be obtained by written request or telefax ((301)415-5144) from the Rules Review Section. Rules Review and Directives Branch. Division of Freedom of Information and Publications Services. Office of Administration. Mail Stop T6-D59. U.S. Nuclear Regulatory Commission. Washington. DC 20555-0001. Certain documents related to this petition. including comments received. may be examined at the NRC Public Document Room. 2120 L Street NW. (Lower Level). Washington. DC. These same documents also may be viewed and downloaded electronically via the Electronic Bulletin Board established by NRC for this petition as indicated above.

/1 1/,

I Dated at Rockville. Maryland. the aay of..J{.,u,,._,(_. 1996.

For the Nuclear Regulatory Commission.

John c'. Hoyle.

t Secretary of the Commission.

6

University of Cincinnati April 7, 1996 Secretary United States Nuclear Regulatory Commission Washington, DC 20555 Attn: Chief Docketing Re:

Petition Radiation Safety Office Radiation Safety Lab University of Cincinnati PO Box 670591 Cincinnati OH 45267-0591 Phone (513) 558-411 O Fax (513) 558-9905 DOCKET NUMBER PETITION RULE PRM

--,-=

i:....::::a.

( {o\\f~~\\~,~

and Service Branch.

In accordance with 10 CFR 2.802, the University of Cincinnati submits this petition to the Nuclear Regulatory Commission. The University of Cincinnati petitions the Nuclear Regulatory Commission to amend 10 CFR 20.1301 to authorize specified visitors of radiation patients, as members of the public, to receive up to 500 mrem per year.

As recommended in NCRP 91 (copy attached) the requested amendment would permit a small population of the general public to be infrequently exposed to an annual exposure limit of 500 mrem total effective dose equivalent. Specifically, a)

The individuals to whom the 500 mrem annual limit would apply would be specified visitors of radiation therapy patients hospitalized under 10 CFR 35.75 or specified visitors of radiation therapy patients receiving temporary brachytherapy implants under 10 CFR 35.400.

b)

The dose limit is not requested for all visitors of all radiation therapy patients hospitalized under 10 CFR 35.75 or receiving a temporary implant under 10 CFR 35.400. The dose limit would only apply to specified visitors determined by the physician to be necessary for the emotional and/or physical support of the patient (e.g., parents of children, elderly patients who need support from a familiar individual, etc.).

c)

The specified visitors would be limited to adult (18 or older) non-pregnant individuals who are members of the family or are individuals with a significant personal relationship to the patient.

d)

The specified visitors would be instructed by the licensee or authorized user to maintain their exposure ALARA. The An affirmative action/equal opportunity institution

IJ.S. NUCLEAR f.c,,Jt.}\\TORY COMMISSl()t,.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ~~~~---

Co~s Aeceived-..L _____ _

.\\dd'l Copes Reprodoced ---1-----

Speclal Distrltxstion J:ir:e??,~

of.

instruction would emphasize the basic radiation safety precautions of time, distance and shielding.

e)

The dose limit would only apply to dose received while the patient is hospitalized under 10 CFR 35.75 and/or receiving a temporary brachytherapy implant under 10 CFR 35.400.

Compliance would be documented by use of a personnel monitor (pocket dosimeter, film badge, TLD or electronic dosimeter).

If you have any questions do not hesitate to call.

v

• ctoria Morris, M.S., CHP Radiation Safety Officer c:

C. Kupferberg R. Millard, Ph.D.

18.

Remedial Action Levels for l\\1embers of the Public If the recommendations of the previous Section are observed, i_nan*

made radiation sources will not expose members of the pubhc _ to annual effective dose equivnlents greater than 1 mSv (Q.l rem) conlm-uously, or 5 mSv {0.5 rem) infrequently. Exposur_e~ ~hould al':"~}:s be less than the limits and, indeed, on the average, ubhzmg the prmc1ples of ALARA, they should be much less.

However, natural background is exduded from th~e hm1ts and there are circumstances in which natural background itself, ~r more especially, natural radiation sourc~ en_hanced Io~ally by_ ma_n s oper*

ations for selected purposes, can give nse (sometimes qmte madvert-ent!v) to annual exposures above the level of 1 mSv (0.1 rem).

It~ then becomes necessary to consjder at what e.x~osure. level re-medial action, which may be possible on?y at substantial societal c~st, h

Id be undertaken. Remedial action levels involve a balance of risk S OU f

and many other socioeconomic factors. In gene~al, the atm ~ setting a remedial action Ievel is to reduce the greatest nsks_ from~ gzven ty~

of radiation source. It is clear that once a remedial act100 lew*el 1s established for given circumstances, action is mandatory wh~n _a Je-.*el above it is found. Actions to reduce exposure should not be l11~1te? by or to the remedial action level and, following the ALARA pn~c1ple, levels substantiaIIy lrelow the remedial action le\\-*e? may be obtamab1e and appropriate.

For external sources, the NCRP considers that the nsks to the public from exposure to nll sources except medical, should not exeffd ahoul fi,.*e times the totnl of other risks faced by members of :he puli!ic. Thus, an annual remedial action level is specified at an effccLive dose equivalent of 5 ms,., (0.5 rem) for alt extern.a( _SfJurres other than medical. External ~mres are specified hecau!'C 1_nt~?nat _ exposures from radionuclides other than radon are rarely lumhng m present circumstances (NCHP, 198-fa).

The l"('C'()mmendcd remedial action le,..*el'. 5 mSv (O.? rem), rs 10 times greater than t.he average annual effective dose equn,~lcnt due ~o external exposure from natural background 0.5 m~v (OJ)i> rc1~)- It LS l

I I.,,*1th the annual effective dose eqmvalent received by a so compara, e ~

many raruat.ion *workers.

40 I

J8. REMEDIAL ACTION LEVEL...~

/

41 The NCRP has given special attention to the problems occasioned hy exposure to indoor radon (NCRP, 1984a, 1984h) and notes that this is potentially tlut most important public radiation exposure problem that currently exists. As a result. a remedial action level of0.007,Jhm-l v-1 (2 WL'.\\1 y-1

) was recommended in NCRP Report No. 77 (NCRP, J9Bfa). Elements of feasibility enter the considerations here since jt is c*,ident from NCRP Report No.,7 (NCRP, W84a) th.it in a

!'-ulistanti(ll number of homes the radon levels are estimated t.o exceed the average by amounts up to 5 or IO times or more. It is certainly

<legirahle that such levels be reduced and the risks as.sociated with them dccr<'ased. A remedial action le11el must, therefore, be chosen for which the societal impacts are not ex~ssi\\*e, but the greatest risks are avoided. The NCRP recognires that an annual inhalation level for radon that corresponds to 5 mSv (0.5 rem) effective dose equivalent would be about 0.00175 Jbm-~ (0.5 WLM). see ICRP Publicati,)": 32

{ICRP, 1981). However, this is only two and one-halftimes the present estimated average annual indoor radon background exposure of 0.0007

.Jhm-3 (0.2 \\\\o'Ll\\-1) and imposition of a remedial action leve] at this value could im*olve a very large number of homes. Therefore, the NCRP proposed a remedial action level whicb was ha!-ed on excess lifetime risk being no more than 10 times the present average annual background le,rel, or 0.007 Jhm-3 y-1 (2 \\\\'LM y-1) (NCRP, 1984a).

The annual risk of lung cancer associated with this level is 4 X 10- 4, and NCRP considers risks of this magnitude undesirable. However, it is anticipated that remedial actions. once taken, will, together with ALARA, establish new annual radon exposures in a given home much below 0.007 Jhm-s (2 WLM).

It is a]so anticipated, over time, and assuming that the problem of indoor radon is addressed by taking the worst situations first, that radon levels in existing homes will be reduced Furthermore. the Council believes that for new homes. suitable comt.raints should be developed so that -they will have radon levels helow those of many present structures.

For the present. it is recommended that reme~al action be under-taken:

( l) When lhe at,--erag<' annua( ef{el'liff dose equfra!.cnl from external c-,:posurc 12 (excluding medical, but including naturally occurring 5,11u*ccs) continuow1ly exceeds 5 mSv (0.5 n*m).

(2) When tire total exposure to rodrm and its df'rn_v prrxfurts /r}r cm indit)idtml exnxds nn anmwl rm*m,i::<' of O.OIJ'"i Jlrrn-' (2 WLM}.

"In the unlikely event. that internal exJ>o~ur~ other th:in rn,lr,n could makt> a s.ignifKant ccmlrihution. it should be included in th(. a:s~,:;ment of PXJ)(l!l~ne.

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