ML20137R761
| ML20137R761 | |
| Person / Time | |
|---|---|
| Issue date: | 01/18/1985 |
| From: | NRC |
| To: | NRC |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230643 | |
| Download: ML20137R761 (13) | |
Text
/?A73-/
0/N
/6.26 January 18, 1985 Note to: REC -
Thru: VLM From: nlm f re: Part 35 Briefing held January 10, 1985 Summary: Most individuals are interested in completely eliminating misadminis-trations; there did not appear to be significant interest in current medical policy or the changes proposed in the paper. Comments from each individual follow.
Peter Crane (OGC lead on Part 35; Marty Malsch will assist): All he said in two hours was "I like this. You can read it and know what you have to do."
He appeared to buy my "Let's look at the relative hazard in the hospital" argument for lessening our control of licensees.
Bill Parler (Zech).has had bad dealings with S. Carolina medical industry.
Do not invoke '.' mature industry" thesis. Very interested in misadministrations.
Maria Lopez Ortin (Roberts) was mainly interested in misadministraticns; she thought doctors should be required to inform patients. I said roughly 20% do based on my review of each report. Aron interrupted to say misadministration wording was carefully developed.
Joan Aron (OPE for intergovernmental affairs and some medical issues): "This paper should address more issues. Why aren't we regulating x-rays and NARM7' Don't tell me we don't have staff. What will you do with saved man-hours?"
My response: Moreissuesinonepaperwoulddloudandconfuse. Concerning x-rays and NARM, this is not a "new frontiers" paper, but a consolidation of current requirements with n_oc change in day-to-day operations. We don't have expert medical staff, and from what I hear we aren't getting any in the next fca years; furthermore, FDA is the logical federal agency to regulate medical care. The saved man-hours calculation is tenuous 'and vociferously disputed by the Agreement State experts.
Clyde Jupiter (OPE lead on Part 35): The package is well written. Can we certify physician training programs? My response: We could, but it would be a whole new policy direction for the agency that should be dealt with separately.
I also stressed as frequently as possible: 1. Misadministrations are 0.01%,
compared to 10% for physiologically active drugs. 2. Hospitals are dangerous to work in, and radiation is a minor hazard compared to chemicals, equipment, viruses, and emotional stress there. 3. This will not change a hospital's day-to-day operations. 4. This provides a uniform, nationwide standard.
8509230643 850906 PDR PR 35 50FR30616 PDR
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- 5. This is not an item of compatibility, but the Agreement States think they may be pressured into the flexibility clause. 6. Everyone likes the regulatory text except for the dispute over the flexibility clause.
Briefing for DrogQitis (Asselstine) is scheduled for Friday, January 25.
Stoloff (Bernthal) and Polk (Palladino) wanted a briefing after they read the paper. Nothing scheduled as yet, nlm l
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POLICY STATEMENTS PM alon products (crud as the principal source potential effect of itooling tower operation I. STATEMe.fT or GUERAL POLICY of worker exposu'es at nuclear pos er for a wide variety ofdesigns and site-specific plants. Man-rem exliosure. plant doswtime. conditions which if not exceeded, would be This NRC policy statement is in.
and operating and maintenance costs may deemed to be incomequential to societal in. tended to inform NRC licensees, other be substantially incicased without appropri- terests. If these th eshold limits were ex. Federal and State agencies and the ate exposure conttiil of these depositional ceeded. then mor t detailed assessment public of the Commission's general in-processes. The industry has been exploring would be required f>r the individual licens- tention regarding the regulation of methods of reducin i occupational radiation 6ng action in lieu of itenerte disposition-the medical uses of radioisotoxs.
i exposures due to .hese sources. At such time in the future is information becomes It is expected that future NRC activ-sufficient to justLf] specific regulatory re. Ities in the medical area such as pro-quirements in this area, rulemakins could mulgation of new regulations and de-achieve a specific asnual radiation exposure 44 FR 8242 velopment of cooperative relationships destsu objective for control of occupational Published 2/9/79* Mth other Federal agencies, will
, radiation expesures from crud buildup, iffective 2/9/79 follow this statement of NRC pcIlcy.
- g. analogous to St..Ms for effluent control Based on past experience and the i More immediately. It would appear desir- comments and advice of the public,
. , able to cenduct rulemakins aurrounding the Reguleh.en of the Medical Uses of other Federal ageneles, the States, and f, n'b o P "
vo w pa a e Radielsetepes; Statement of Gener. NRC's Advisory Committee on the Medical Uses of Isot: pes, the Commis-considernuons- (t) Crud formation. solution, el Pelley and deposition inctadins destsn criteria for sien has devel: ped the f llowing state-the primary coolan; system for decontami. AGENCY: Nuclear Regulatory Com- ment of general policy to guide its reg.
nation of crud; ard (11) aspects of plant mission. ' ulation of the medical uses of radioiso-layout and design td. reduce occupational rm- topess
@ation exposure fr>m this source in keep- ACIION: Final Policy Statament. 1. The NRC will continue to regulate
" ing Wh,ALARA criteria in RegulatorF
SUMMARY
- The Nuclear Regulatory the medical uses of radioisotopes as OuideFA Commission (NRC) has the following necessary to prcvide for the radiation safety of workers and the general Lbt ro o refe n'adioYo policy staternent regarding NRC's future role in regulating the medical public.
impact estimates 6re currently prepared through an enstnePrins evaluation of the uses of radiolsotopes.This NRC policy 2. The NRC will regulate the radt-radioactive waste treatment system that statement is intended to infottn NRC ation safety of patient.s where justified produces an invent >ry of radionuclides re- licensees. other Federal and State by the risk to patients and where vol-leased to the enytritrunent, a crlculation of and the publ!C of t'le Com- untary standards, or t-cmpliance with the available atmomiherte and hydroloste di. agencies.s general intention regarding
,g3,g,3 these standards, are Inadequate.
d p i i ate it7e the regulation of the medien! uses nf 3. The NRC will Ininimize intrusion rons and to the poliulation within 50 miles radioisotopes. It is expected that into medical judgments affecting pa-of the site and the tptal(Inited States. A so- future NRC activities in the medkal tients and into other areas traditional-nerte treatment of these radiolosteal im- gren, such as promulgation of new reg. ly considered to be a part of the prac-pacts sould be swipropriate because: tt) tice of medicine, ulations and development of coopers-onct! tNn in calcNateIdo[
tive relationships with other Federal agencies, will follow this statement af II. RAT!oN At2 within 10 CFR Par 50. Appendix I. destsn The NRC and its predecessor the N.- objective values, an I (2) technical specifica. NRC policy.
EFFECTIVE DATE: February 9.1979. fate th m e us s f rad o otopes No@th m to r bele 1 [ since 1946. AEC recognized that phys!-
sults in operating c iteria that always limit FOR FURTRER INFORMATION the impact to a ialue below a specified CONTACn clans have the primary responsibility value. The proposea rulemaking arould be for the protection ,of their patients based. En part, on a survey of the calculated Mr. Edward Podolak. Of!!ce of and designed its regulations according-Impacts in enviromnental statements to de- Standards Develcpment. U.S. Nucle. ly. The physicians were required to be termine appresrtate ranses of doses for cal- ar Regulatory Commission. Wash- licensed by the State, and their appil-esortzins radiolostesIimpacts from radionu- Ington. D.C. 20555 tPhone: 301-443- cable training and experience were clide releases. The 'ipper end of this ranse of doses would be tr e Appendix ! desten ob. 5860). evaluated in consultation with the Ad-Jective values. An elmpirical study of the re- BUPPLEMENTAL INFORMATION; visory Committee on the Medical Uses lation between obsarved and calculated im- he NRC has developed the following of Isotopes. This regulation has been pacts would establish a more reliable lower bound for radiolosca! tmpacts than that three part policy statement regarding NRC's future role in regulating the presently enleulated and would obviate the need for calculatina radjolestcal impacts of snedical uses of radWsotopea. On normal radienuc!!de releases for each indb March 17.1978 the three part poIIcy viduallicensins case statement was published in the Futa-e nreAotd limita for penarte disposition at. Rr.ctstra 143 FR 11208) for public ' "
c/ cooling toicer e/Aets-The potential envt- comment. Copies of the policy state
- so efb duct. a an spec n el oo na eopeN on a e als e ten mentaere seM to allERC medical 11- at matertat.The Nitc does not regulate nat.
tions at a substantic,1 number of case hear.
censees. the States and 25 professional urally occurrins or accelerator produced ra.
Ings. These issues tri:lude senther modifica, societies. Federal agencies, and indl. diotsoccpes. The term tryproduct matertal tion fineressed rali , snow fos, tornadoes viduals. The comment period expired means any radioactive matertal texcept spe-and floods), depositian. Interactions of cool- May 16.1978. Twenty-two comments ctal nuetear matertall yielded in or made ra-d1 acme by uposun to the radfauen p
,( , Ins toner operatiol i sith other plant ef* 4ere received. Nine commenters fa- * "
stye vored all three parts of the policy fp' flal o clear m rt term o a tr.ea e trac \ ion f statement, four commenters opposed mot,,te2 means ti) uranium, tnortum or an, these cases a detalhd examination of these issues in supplemen at testimonlea supports one part of the polley statement and combinauon thereof, in any physical or the conclusion that he impacts are of nestt- nine commenters addressed specific chemteal forrn or (2) crea shleh contain by stble societal Impnrtance. Accordingly, a issues discussed in the March 17,1978 serght one. twentieth of one percent (0.05%:
r te a of d) urantum, nu thorium or mi) useful objeettre of iulemakins would be to F or_ art. Recastra notice. The com- " '*
seek to establish ttireshold limits for each ments are discussed in Section IL Copies of the comments may be exam-T*
e 3 no etude pc
'o I ar mate spces22 nuclear motsrul means (1) pluton &-
Ined in the NRC Public Document um, urentum 233. uranium enriched in the Room at 1717 It Street N.W., Wash. Isotope 233 or in the tsotope 235 or (23 any matertal artificta!!y enriched by any of the
( ington, D.C. foregotns, but do*J not include source mate-rtal.
PS-19 September 1,1982 ri
l POLICY STATEMENTS l
generally oriented tow ard assisting to human uses of byproduct material. The NAS-BE!It 8 report discuases
[
! qualified ph> siclans in discharging yDA's statutory authority (Federal limiting the exposure of the popula-their rtsponsibilities to patients, llow* Food, Drug, and Cosmetic Act, as tion to med! cal applications of lonizing (
ever, regulation by AEC/NRC has at amended. 21 U.S.C. 301 ef sed does radiation That report, s h!ch includes cne time or another encornpassed not diminish NRC's authority. Where all med! cal uses of ion! zing radiation, nearly every aspect of the deihery of NRC's and FDA's authorities overlap.radiopharmaceuticalsshows an average of dose rate /from 1 mrem year radioisotope medleal sersices to pa- the respective authorttles can be har- and an average dose rate from diag-tients. The broadest regulation oc- monized by interagency agreement.
curred between 1962 and 1975, when The central question is a question of nostic radiology of 72 mrem / year in 1970.
the Food and Drug Administration policy not authortly, namely-i l To what extent should the protec. The following quotation is from the (FDA) exempted from its require- all tion of the patlent be cons!dered in NAS-BEIR report; ments for new drugs in the foreseeable future, the n.alor com radiopharmaceuticals regulated by NRC's regulation of the medical use of tributors to radiation exposure of the popu.
AEC. During this perlod AEC regulat. byproduct material?
From the standpoint of cu!Aority, it tation st!! continue to be natural back-ed the radiation safety of sorkers and is clear that NRC can regulate the ground sith an asersge shote body dose of the general public and the safety and medical uses of byproduct material to about 100 mrem / year. and medast app Ica-efficacy of radioactive drugs and de. protect the health and safety of users cons shich nos cor.tr'bute comparatde ex-Vices sith respect to patients. AEC of this material, for instance, patienta. posures to various tissues of the body. Medi-regulation included production of the In !! censing the possession and use of ca! esposures are not under ecntrol or su!d-ance by regulation or law at present. The
,adiolsotope* manufacture of the final byproduct material. NRC establishes use of loninns radiation in medicine ts of radioacth e drug product or desice, dis- within which physicians exer- tremendous value but it is essenttal to tribution use and di:posalof the prod- cIse professional discretion. From the reduce exposures since this esa be accom-ucts. In 1975, the FDA terminated the standpoint of policy, these I!mits ptished 31thout loss of benefit and at rela-exempt!on for radiopharmaceuticals, depend upon how NRC views the po- uvelr low cost. The aim is not only to stating that it sould now regulate the tential hazard to the patient s health reduce the radiation exposure to the indi-safety and efficacy o! radioactive and safety in the uses of the byprod- etdual but also to bare procedures carried drugs with respect to patients. (As uct material.The greater the potential out with mattmum eff;ctency so that there can be a continuing increase in med. cal noted later in this statement FDA hazard to a patient from the byprod. benefits accompanied by a minimum rs,11-does not regulate the physician's rou- uct material or its use by a physician, tlne use of radlopharmaceuticals.) At the more NRC may elect to circum, suon exposure.
the same time. NRC sithdrew from scribe areas that m!aht otherwise be NRC stil act to help ensure that ra-regulating radioactive drug safety and regarded as within the discretion of diation exposure to patients Ls as low efficacy, stating that it would regulate the physician, as is reasonably achievable, consistent the radiation safety of the workers The first part of NRC's po11cy state- with competent medical care and with and the public. The 1976 Medical ment indicates that NRC will continue minima! intrusion into medica! judg-ments. NRC will not exercise regula-Device Amendments to the Food, Drug to. regulate the medical uses of radiol-y and Costnetic Act extended FDA's au- actopes as necessary to provide for the tory control trt those areas where, thority over medical devices (including radiation safety of workers and the upon careful exarnination, it deter-O devices conta!n!ng radioactive materi- general public.* This is the traditional mines alsfin a may simihr to its authority regulatory functicn of NRC for all uses of byproduct, source and special that there are adequate regula-tions by other Federal or State agen-cles or well adtninistered professional
[3 over drugs. standards. Wherever 'possible, NRC NRC's authority to regulate domes- nuclear material. It is a regulatory will work closely with Federal and tically the medical uses of byproduct role that was not questioned by any of State agencies and professional groups material is found in the Atomic the commenters but, rather, it was in design!nt new voluntary guidance Energy Act of 1954, as amended. For consistently recognized as a necessary for practitioners to limit unnecessary example, section 81 of that Act autho- role in the Enedical uses of radioiso- patient rad!ation expomre.
rizes NRC "to issue general or specific topes. NRC's regulation of the radiation The third part of NRC's po!!cy state-licenses to applicants seeking to use safety of workers and the general ment Indicates that NRC sill mini-byproduct matertal for * *
- medical public In the medical taes of radioiso- mize its intrus!on into medical judg-therapy * * *," Section 81 directs NRC topes is relinquished by NRC to Agree- ments affecting the patient and into to regulate the manufacture, produc, ment States; does not oserlap with other areas traditionally cons!dered to tion, transfer, receipt in interstate FDA's activities; 1s in harmony with be a part of the practice of rned!c!ne.
commerce, acquisition, ownership, pos. regulation by the Departrnent of The Commission recogn!zes that phy-session, import and export of b> pro 3 Tramportation, Soc!al Security Ad- slefans base the primary respons:bCity uct material. Finally, Section 81 also ministration and the Joint Commis- for the protect!on of the!r patients.
directs that: sion on Accreditation of IIospitals; and The Commission belletes that basic decisions concerning the diagnosis and The Commtaton shall not permit the d> dovetails with Occupational Safety treatment of disease are a part of the tribution of any byproduct matenal to any and Health Administration regulation physician patient relationship and are licensee and shall recall or order the recall of the work place for the use of natu. traditionally considered to be a part of of any distributed material frorn any Lcens. rally-occurring and acce!erator pro.
' the practice of medicine. NRC regula-duced radiosetive materia!s. tions are predicated on the ass':rnption n such eYs d to otect The second part of NRC's pclicy health as may be estabitshed by the Corn. that properly trained and adequately statement ind! cates that NRC will reg. Lnformed physicians C*1 make dect-mission or sho uses such rnaterialin viola.
con of law or regulauon of the Commission ulate the radiation safety of patlents sions in the best interest of their pa-or in a manner other than as disclosed in where justified by the risk to patients tier.ls.
the apptgation therefor or approved by the and where Volunttry standards, or Comnuon. compliance with these standards, are Commission regulations, for the inadequate. As noted before NRC has rnost part set forth in 10 CFR Parts 30 the authority to regulate the radiation through 35. sere promu' gated to carry safety of patients.
out the broad regulatory scheme en-sisaged by section 81. For exa nple* ' National Ac2&my of Sdences Admory Part 35 establishes regulations specific Comm:ttee on the B.otocical Errects et ton.
barc Rais'. ions (N AS-EEMO report. The Q Effects on Pop:,!ations of Exposure to Low /
Lerels c/ loni.Ptp Radiation. #ctio nal Tg
'The term eeneral public in this state- Acade nv of Sciences-Natagal Resea rch mer.t specifkaily extbJes pa!!cr.!s- Counct!, Waahbston, D C. (1972L September 1,1982 PS 20
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I POLICY STATEMENTS The regulations try to find a balance The Commlalon does not consider Two commenters objected to NRC's between adequate controts and avold- equipment calibration, qualifications regulation of patient radiation safety anee of undue interference in medical of paramedical personnel or reporting because they believe that NRC does i judgments. A consequence of too to NHC misadministrations of radioac- not have the authority to regulate pa. ;
much regulation could be poorer Live material to be exclushely the tient safety. They note that NRC's en-health care dellvery to patients. A con' practice of medicine or a part of physt- abling legislation does not specifically sequence of leaving to physicians the clan-patient relationships. The Com- mention the radiation safety of pa-majority of the dectstons concerning mission intends to regulate these areas tients. They believe that patient !
their patients is that the physicians of patient radiation safety shere fusti, safety is the responsibility of the phy-will make mistakes. The tightest regu* fled by the risk to patients and where sician, a responsibility that cannot be ,
lation of physicians' decisions by Fed- voluntary standards or compliance shared. They be!! eve that the Commis-eral, State and professional groups will with these standards, are inadequate. slon is In error to equate patients with
- siot be able to prevent future incidents !!I. DisccsstoN or Pcatic CostatsTs the public and to consider patients as in the med! cal uses of radlo!sotopes. users Tather than reciplents of radio-The Commiss!on recognl:es that a.comtexts oN THE roLICY sTATDtDT active material.
FDA regulates the manufacture and One cornmenter opposed the use of As noted in the analysis of the sim!-
interstate distribution of drugs,includ. the general term " radioisotopes" in lar comment above, the NRC's overrid-ing. those that are radioactive. FDA the first part of the policy statement. Ing congressional roandate is to pro-also regulates the investigational and This commenter was concerned that, tect the health and safety of the research uses of drugs as weII as the if taken out of the context of the foot
- public.The patient is a member of the specific guidance on doses and proce, note, it could be interpreted to include public, notwithstanding the Commis-dures found in the product labeling. naturally occurring and accelerator ston's recognition of physicians
- prima-However. FDA does not have the au- produced radioisotopes. ry responsibility for protection of thority to restrict the routine use of The Commission believes that the their patients. The policy statement drugs to procedures (described in the general term radioisotopes ** !s plain and, indeed, all of the Commission's product labeling) FDA has spproved English and easily recognized by the actions in regulating the medical uses as safe and effective. Indeed. NRC ls public. It was properly footnoted in of radioisotopes. acknowledge the sec-the only Federal Agency that is cur- the policy staternent to include the encary but necessary role of NRC In tently author! zed to regulate the rou- regulating the radiation safety of pa-Line use of radioactive drugs from the edumbersome but specifie n ' tjents. The Commission also considers standpoint of reducing unnecessary ra- material and to exclude naturally oc- patients to be both users and recipl.
diation exposure to patients. g md I d *d ents of radioactive material. However,
/ The Commfulon believes that the $ gve materi the dist!nction between receipt and diagnostic use of radioactive drugs is. One commenter. In opposition to use of radioactive materials is not in most cases, clearly an area of low NRC's regulation of patient radiation meaningful in this case because NRC radiation risk to patients. Therefore, safety, suggested that NRC limit its regulates, among other things. receipt, NitC will not control physician's pre- role to the radiation safety of the hos. possession, use and transfer of byprod-rogatives on patient selection, instru- pital staff and the general patient uct. source and special nuclear materi-ment selection. procedure selection. population. He believes that patient al in protecting the health and safety drug selection and dose level for most dosimetry is a responsibility of the in.
diagnostic uses of radioisotopes. For dividual institution and not NRC. This of the public.
all therapeutic uses of radioactive commenter feels that NRC should s.co m e e s e eIss m drugs, and in certaIn diagnostic use" first require adequate staffing. Includ-
! for example. the use of phosphorus-32 Ing a board certified physician or ra- There were six comments on the
' for localization of eye tumors-the diopharmacist and a radiation safety question of reporting misadministra-risk to patients is not low. The risk of officer. and then essentially leave the tions of radioactive material. Three tissue or organ damage (or even der.th) institution alone regarding dosimetry. commenters opposed any misadminis-la inherent in the use of therapeutic instrumentation, cailbration, drug pro- tration reporting and three com-levels of radionetive drugs. NRC will curement or any other function con- menters offered suggestions on how continue to restrict the uses of thera- sidered to be the practice of medicine. they should be reported. All of the peutic and certa!n diagnostic radioac- NRC does require the licensee to comments will be considered in dealing tive drugs to the Indicated procedures staff its operation with a radiation with NRC's newly proposed misadmin-that have been approved by FDA. The, safety officer and a physician (not Istration reporting requirement that NRC will not control the physicians necessarily board certified) trained to was published in the FEDrRAL Rectstra prerogatives on patient selection and administer radioactive rnaterial or rs* for public comment on July 7.1978 H3 instrumen) selection for therapy pro- diation to patients. However, the Com* FRThere 292971.
were six comments on the spe-cedures, because these procedures are mission cannot limit its regulatory role so specia!! zed and patient specific. to protecting the hospital staff ar.d elfic issue of paramedical training.
' Congress recently gave FDA authort- the general patient population and at Three commenters believe that it is ty to regulate medical devices, similar the same time fulflu its congressional unnecessary for NRC to become in-to FDA's authority to regulate drugs. mandate to protect the health and volved in paramedical tratning because but with additional authority to re- safety of the pubtle as regards source' several organizations are already pro-strict the routine use of medical de- byproduct and special nuclear materi- viding or deseloping minimum stand-1 rices as tnay be necessary to provide al. The patient being treated or diag- ards. guidelines or certification. One nosed with radioactive material, as commenter believed that NRC should reasonable assurance of their safety well as the general public who may be k Wolved in this area because the and had effectiveness.
suffic!cnt time FDA has not yet to implement its exposed to radiation as a result of that technologist, not the physician, does full authority to regulate medical de- treatment, are all members of the most of the work with radioisotopes.
vices conta!n!ng byproduct, source or public to be protected by NRC. Two commenters believe that radiolog-special nuc: ear material. Therefore. leal physicists should be separated out NRC will continue to restrict phys!- from other paramedical personnel and elan's uses of these medical devices' one of these commenters offered a both for d:agnosts and therapy, to definition of radiological physicist.
those procedures that NRC has deter-mined (in consultation with its Adviso-ry Committee on the Medical Uses of Isotopes) to be safe and effective.
September 1,1982 PS-21
POLICY STATEMENTS As noted in the proposed policy 44pggg7g 44 FR 59686 statement. NRC is studying the var- pm O tous allied health certification pro-grams currently in effect or being drafted by other Federal. State and jggg comment period entended to 3/ tens Putdished l0/16n9 C'***"' Piod eipires tohene A
j 1
professional groups. If the coverage i l
provided by these programs is not ade- '
quate to protect the patient from un. GENIR6C RutEMAKING TO RMPROVE NUCilAt necessary radiation exposure. NRC POWER PLANT UCIN5ING {
will sork with these groups to develop i ,,,;. per;sy sievemene, tatenst.e se Proposed Agone @v5cy and a new NRC proposed rule for the Co ent Peried Procedures for C ltfering Profeselonal '
training of allied health personnel. Opinions; Requent for Comments
- There were five tomments on the AGENCY: U.S. Nuclear Regulatory specific subject of nuclear ' pharmacies Commission. The Nuclear Regulatory Commission (radiopharmacles). (NRC) has develaped a statement of ACTION: Extension of comment e One commenter urged NRC to dis- period. Pohey on differina professional opinions tinguish between radiopharmacista and the general p scedures for
SUMMARY
- The Nuclear Regulatory implementing this policy within the working in a hospital setting and thost Co " he working in a retail environment (com- ,omm o f nterirn agency.The NRCrequests comments merelal nuclear pharmacy). This com. Statement regarding Generic Rule. Upon the proposeil policy and the making to Improve Nuclear Power Procedures, and aIso any additional fh Drob m of e ilYn th Plant Licensing for an additional 30 recommendations or experiences days. The Interim Policy Statement tegarding policy cbjectives, procedures.
ides radio harmse u I als to ot was published on December 14. 1978 or other provisiums that the Commission hospitals and practituners in its area. H3 FR 58377). The original comment should consider before proceeding to As noted in the proposed policy "
statement, the NRC will defer to the (#Igg79 ,"r]nfo ad pt the proposed policy and on ega -
- Food and Drug Administration (FDA) 1ets generic rulemaking issues and staff E# #'
regarding a determination of those ac- The proposed s atement of policy delibe.
tivities of nuclear pharmacies that will gggg, rations is Statement
. Preliminary found in NUREO.
on Gen- clarifies the responsibilities of both NRC be considered manufacture and those eral Polley for Rulemaking to improve employees and MtC management acth-ities that will be considered the : Nuclear Power Plant Licensing"*. Sup- regarding the exp ession and resolution ordinary practice of pharmacy (com* iglement No. I to NUREO-0499 con. of differing professional opinions.
pounding and dispensing). Moreover, the policy assures all
'.tains information Four commenters objected to NRC's erations and Issues onof" Significance General Consid-on employes the opp artunity to have licensing nuclear pharmacies to dis- the Evaluation of Alternative Sites for differing professic nal opinions heerd tribute only those products that theF Nuclear Generating Stations Under and considered b r NRC mana8ement have prepared frorn FDA. approved NEPA". Copics of these documents are v
O radiopharmaceuticals or reagent kita. available by *Titing to the Distribu-One commenter cited the practice of tion Servlees Branch. Division of yTee m ahah>an b any fonn.
The proposed estem for implmenting thn,spolicy on differing nuclear pharmacies supplying radio. Technical Information and Document chemteals to researchers sho use Control. U.S. Nuclear Regulatory Professional opinions within the agency thern on humans under their ouT1 Commission. Washington D.C. 20555. is described in a aet of thirteen detailed FDA " Notice of Claimed Investigation. procedures. Thera procedures provide, ew e al Exemption for a New Drug" (IND). A] yg,omment period expiret for example, alterlate channels for the One commenter noted that FDA per-
- g submission of diflering professional mits nuclear pharmacies to operate in ADDRESSES: Written comments or opinions, account ibility for all actions the absence of a final determination of suggestions for considerat!on in con- taken on a differirg professional their status, providing they meet all nection with the proposed Interim State and local pharmaceutical regula- Statement on Rulemaking Policy opinion, resolutio!i of all differing tions. The two other commenters should be submitted to the Secretary Professional opmions submitted in characterized the NRC's restrictions of the Commiss!on. UA Nuclear Res. accordance whh these promdures, and on the distribution of ulatory Commission. Washington, D.C. assurance against retaliation for the radiopharmaceuticals by nuclear phar. 20555. Attention: Docketing and Serv- submission of a diflcring professional macies as an unwarranted intrusion Ice Brarich. opinion. Alsoincluded are provisions for into the practice of pharmacy shich is FOR FURTHER INFORMATION follow.up and evalustion of these regulated by the States. CONTACm procedures to ens se that
' hama Dr. Muler B. Spangler. Office of Nu. implementation ancornplishes the stated dis bute r d oac e dr g, a a objectives and to 'ecommend changes, been approved by FDA. This includes clear Reactor Regulation. Dh-tston of radioactive drugs subject to an FDA. Site Safety and Environmental Anal, as appropriate, approved "New Drug Appheation" ysis. U.S. Nuclear Regulatory Com. Single copies of the proposed policy (NDA), or " Notice of Claimed Investi. mission. Washington. D.C. 20555, and procedures cma be obtained by gational Exernption for a New Drug" telephone 301/1924305. writing to the U.S. Nuclear Regulatory (IND). NRC relles on FDA approval of Commission. Office of Management and radioactive drugs because NRC has Program Analysis Washington, D.C.
not regulated the safety and effective
- 20555. In addition. a single copy of the ness of radioactive drugs since 1975. proposed policy a id procedures is Also, there are not many States that available, and ma r be inspected and are equipped to regulate radioactive Copied, in the Cor- mission's Public drug safety and effectiseness.
Dated at Washington, D.C. this 1st cument hom C y H Street. W.
Wa shington. D.C. Copies of comments day of February 1979. received are also ovailable for O, nnspection at the Washington. D.C.
(
September 1,1982 ps.22
l 11108 PROPOSED RULES For the NuclIar Regulatory Com- regulating the medical uses of radio!. Daaed on past experience and the l mission. sotopes and to provide a basis for pos- comments and advice of the public.
Saunut J. CnIt.x, alble future rulemaking. The notice re- other Federal agencies, the States and s Secrefery q/fAe Commission quested comments on specific issues as NRC's Advisory Committee on the [
foHows: Medical Uses of Isotopes the Commis- r Doc. 78-7187 Filed 3-1s-18; S:15 aml To what extent should the protec- alon has developed the foUowing I l
tion of the patient be considered in poucy statement to guide its regula- , L l
[7590-G1] NRC's regulation of the medical use of Lion of the medical uses of radioiso- m l
[10 CyR Pod 35] byproduct material? Areas of possible topes: ' . S
! regulatory involvement by NRCin 1.The NRC wiu continue to regulate fl stE2ULATION OF THE MEDICAL U535 this the medical uses of radloisotopes as . !<
I 1.area include:of physician's clinical necessary to provide for the radlation Evaluation i l OF RADIOL 50 TOPES qualifications, safety of workers and the general Proposeal Polley Statemen, 2. Selection of patients for diagnos- public. f tic or therapeutic procedures. 2. The NRC will regulate the radl- 1 AOENCY: Nuclear Regulatory Com- 3, . Selection of instruments to be ation safety of patients where justified 213'lIn- used in performing diagnostic or by the risk to patients and where vol-ACTION: Advanced notice of proposed therapeutte procedures, untary standards, or compliance with at rulem aktnr. 4. Selection of radioactive drugs or these standards. are inadequate. i CUMMARY: The Nuclear Regulatory devices to be used. 3. The NRC will minimtw intrusion l
- 5. Selection of procedures to be per- Into medical judgmenta affecting pa- l C:mmtulon (NRC) has under consid. " '
trati:n the fonowing proposed policy 6 Se ection of doselevel(quantity of cons!! to art of e rac -
statem:nt regarding NRC s future role radioactive material or radiation dose) Lice of medicine
- in regulating the medical uses of re- to be used.
di: Isotopes. This NRC policy state. 7. Proper measurements of the dose _ II. RAT 1oNa12 m;nt is intended to inform NRC H- the patient receives, The NRC and its predecessor the censees, other Federal and State agen- 8. Calibration of diagnostic equip- Atomic Energy Commtalon have regu.
cies and the pubuc of the Commis- ment and dose-measuring instrumen- lated the medical uses of radioisotopes siin's general intention regarding the tation, since 1946. AEC recognized that physt.
regul: Lion of the medical uses of ra- 9. Qualifications of paramedical per, clans have the primary responsibility dioisotopes. It is expected that future sonnel, such as technologista, nurses, for the protectjon of their patients NRC activities in the medical area, radiopharmacista and radiological and designed its regulations according-such as promulgation of new regula* physicista, and tions and development of cooperative 10. Reporting to NRC, the patient ly. The physlef ans were required to be relationships with other Federal agen- and/or the patient's physician, misma. licensed by the State, and their appu-ties, wiu follow this statement of NRC ministration of radioactive material or cable training and experience were poucy, radiation from devices incorporating evaluated in consultation with the Ad-
'N radioactive material. visory Committee on the Medical Uses (Lore TE: Comments t May 16.1978.
are due on or In addition to the FEDERAI.Rootstra of Isotopes. This regulation has been notice and other pubHe announce. generally oriented toward assisting ADDRESSES: Send commenta and ments. NRC directly contacted more quallfled physicians in discharging suggestions to: Secretary of the Com- than 30 physician groups, professional their responsibilifies to patients. How.
missi:n, U.S. Nuclear Regulatory societies, public interest groups, and ever, regulation by AEC/NRC has at Commiuton. Washington, D.C. 20555, Federal agencies, the 25 NRC Agree- one time or another encompassed Attrntion: Docketing and Service ment States and several non-Agree- nearly every aspect of the delivery of Branch. Copies of comments may be ment States. radioisotope medical services to pa.
Examined in the: Nuclear Regulatory The meetings of NRC staff with the tienta. The broadest regulation oc-Commission Public Document Room, public and the Advisory Cotamittee on curred between 1962 and 1975, when 1717 H Street NW., Washington, D.C. Medical Uses of Isotopes were held on the Food and Drug Administration May 6,1977, in Silver Spring. Mary- (FDA) exempted from its require-l FOR FURTHER INFORMATION land. The meeting record was held ments for new drugs all CONTACI: open for 70 days foHowing the meeting radiopharmaceuticals regulated by Mr. Edward Podolak. Office of Stan- for the receipt of written commenta.
I dards Development. U.S. Nuclear over 90 people participated in the .The NRC licenses rad!olaotopes in three 8 i Regulatory Commtalon. Washing- pubuc meetings and 33 comments were categories: byproduct. nource and special nu.
I ton D.C. 20555,301-443-6910. received for the record. Transcripts of clear matertal ne NRC doce not regulate ,
the meetings and copies of the ccm- naturally occurrina or screlerator produced um .
SUPPLEMENTAL INFORMATION: ments may be examined in the NRC radiotsotopes. The term byproduct material ' d In 1976. NRC, with a view to possible PubUc Document Room at 1717 H means any radioactive material (except spe. [/
cial nuclear material) ytelded in or made rm. L changes. began reviewing Ita regula. Street NW., Washington, D.C. di metive by expceure to the radlauon ines- r tions regsrding the medical uses of ra- dent to the process of producina or utilizing g dioisotopes, originauy promulgated by I. Paoroszn Por.tc7 STATEME!Tr .
special nuclear materlat he term source the Atomic Energy Commtulon This NRC polley statement is in- material tocans (D uranium. thortum, or
( AEC). On April 21, 1977 NRC pub- tended to inform NRC lleensees, other Ty combinmuon thereof. in any physteal or ', '
lished a meeting notice in the FEDERAL Federal and State agencies and the chemical form, or (2) ores which contain by RectsTER (42 FR 20691) inviting the public of the Commlulon's general in- welsht one-twentieth of one percent (0.05 pubuc to comment on NRC's regula. tention regarding the regulation of percent) or more of (1) uranium. (u) thor. J tions concerning medical practices. the medical uses of radioisotopes. It is tum, or (IH) any combination thereof.
s urce material does not include special nu- .~
The FEDERAr. RzctSTER not!Ce and re- expected that future NRC acitivites in clear mawal. Wal nuclear rasterial lated public annodncementa stated the medical area. auch as promulga- "
that the purpose of the public meet- tion of new regulations and develop- $" in t ings was to receive written and oral ment of cooperative relationships with . 235, or (2) anr rnaterial artancially enriched pe t$e $
"omments that the Commission could other Federal agencies. will follow this by any of the foresoins. but does not en-k in deciding future NRC policy in statement of NRC policy. caude sourte matertat
.o FIDitAt RIOllTit, Vot. 43, HO. 53--finDAY, f4AsCH 1r,1973 I
u - . _ - _ _ _ _ _ _ _ .
I Mto?OSED 20125 11209 AEC. During this period AEC regulst- NRC's regulation of the medical use of shows an average dote rate from ed the radiation safety of workers and byproduct matertal? radiopharmaceuticals of 1 mrem / year
- the general public and the safety and From the standpoint of authority, it and an average dose rate from diag-Efficacy of radioactive drugs and de- is clear that NRC can regulate the nostic radiology of 72 mrem / year in >
medical uses of byproduct material to 1970.
regulation O vices included production with respect to patients.of the AECprotect the health and safety of users The following quotation is from the ,
radioisotope, manufacture of the final of this material, for instance. patients. NAS-BCR report: >
radioactive drug product or device, dis. In licensing the possesalon and use of !
In the foreseeable future, the major con. y
- tribution, use and disposal of the prod- byproduct material, NRC establfshes ucts. In 1975, the FDA terminated the limits within which physicians exer- yy[Ty*
" Q7,,0 g Pg0, Gxemption for radiopharmaceuticals, cise professionti discretton. From the ground with an averase whole bodt dose of f1 stating that it would now regulate the standpoint of poucy, these limits about 100 mrem /yest, and medical appuca-a safety and efficacy of radioactive , depend upon how NRC views the po- tions which now contrt5ute comparable es. 1 drugs with respect to patients. (As tential hazard to the patient's health posures to various tissues of the body. Medt. r Isoted later in this statement, PDA and safety in the uses of the byprod- cal exposures are not under controt or guld. ,
does not regulate the physician's rou- uct material. The greater the potential anee by regulation or tse et present. 'Ibe tine use of radiopharmaceuticals.) At hamd to a patient from the byprod- use of tonizins rad!suon in medicine is of the same time, NRC withdrew from uct material or its use by a physician, tremendous value but it is essenual to the more NRC may elect to circum. reduce exposures since this can be accom-j regulating radioactive drug safety and scribe areas that might otherwise be plished without loss of benefit and at rela, i efflency, stating that it would regulate regarded as within the discretion of tively low cost. The aim is not only to the radiat6en safety of the workers the physician. reduce the radiation exposure to the inds.
vidual but also to have procedures carried and the public. The 1976 Medical .
Dodes Amendments to the Food. Drug The first part of NRC's policy state- out with maximum efficiency so that there I and Cosmetic act extended FDA's au. ment indicates that NRC will continue can be a continuins increase in medical !
thortty over medical devices (including to reguiste the medical uses of radlo- benef!ta secompanied by a mint =um radi. -
devices containing radioactive materg. Isotopes as necessary to provide for ation exposure.
als) in a way simliar to its authority 08 e,ty of workers and NRC will act to help ensure that ra-
. om druss- diation exposure to patients is as low NRC's authority to regulate domes. This is the traditional regulatory as is reasonably achievable, consistent tiemlly the medical uses of byproduct function of NRC for all uses of by- with competent medical care and with material is found in the Atomic product, source and special nuclear minimal intrusion into medical judg.
Energy Act of 1954, as amended. For material. It is a regulatory role =that ments. NRC will not exercise regula-szample, section 81 of that Act autho. was not questioned by any of the com- tory control in those areas where' rtsse NRC "to issue general or specific menters but, rather, it was consistent- u it d licenses to appUcants seeking to use ly recognized as a necessary role in the [nescareful examinati that there are ad u' ate re byproduct material for * *
- medical medical uses of radlotsotopes. tions by other Federal or State agen-therapy * * *." Section 81 directs NRC NRC's regulation of the radiation cles or wen admin!stered professional to regulate the manufacture, produc- safety of workers and the general standards. Wherever possible, NRC tion, transfer, receipt in interstate pubuc in the medical uses of radioiso- will work closely with Federal and commerte, acquisttlon, ownership, pos. topes is relinquished by NRC to Agree- State agencies and professional groups seeston, import and export of byprod. ment States; does not overlap with in design!ng new voluntary guidance uct material Finally, Section 81 also FDA's activities; la in harmony with for pracWoners to Emit unnecessary l(
directs that:
'N Commtmaton shall not permit the dis-regulation by the Department of Transportation. Social Security Ad-ministration and the Joint Commts-patient radiation exposure. However, there are specific areas discussed in tribution of any byproduct material to any alon on Accreditation of Hospitals; and Section IU of this policy statement licensee, and shall recall or order the recall dovetans with Occupational Safety where NRC will regulate the radiation i
ee, o eq ipped o fa to and Health Administration regulation safety of patienta to help minimtw un-o observe such safety standards to proteeg of the work place for the use of natu. necessary patient exposure.
bealth as may be estabushed by the Com. Fally occurring and accelerator-pro. The third part of NRC's poucy state-i mission or who uses such material in viola, duced radioactive materials. meut indicates that NRC will mini.
taon of law or resulation of the Commf uton The second part of NRC's poucy mlze its intrusion into medical judg-ce in a m-=r other than as disclosed in statement indicates that NRC will reg, menta affecting the patient and into the application therefor or approved by the ulate the radiation safety of patienta other areas traditionally musidered to *i Commt =h where justLfled by the risk to patients be a part of the practice of medleine.
Commission regulations, for the and where voluntary standards, or The Commhaton recognizes that phy.
most part set forth in 10 CFR Parts 30 compuance with these standards. are s!cians have the primary responsibluty through 36, were promulgated to carry inadequate. As noted before. NRC has for the protection of their patients.
cut the broad regulatory scheme en- the authority to regulate the radiation The Commisalon believes that basic
. visaged by section 81. For example, safety of patients. decisions concerning the diagnosis a:nd 9' Fart 35 estabushes regulations specifle The NAS-BEIR* report discusses' treatment of disease are a part of the I' to human uses of byproduct material limiting the exposure of the popula. physician patient relationship and are 'l FDA's statutory authority (Federal tion to medical applications of ioril7tnz traditionally considered to be a part of
, Food, Drug and Cosmetic Act, as radiation. That report, which includes the practice of medicine. NRC regula-amended. 21 U.S.C. 301 et seq.) does all medical use.s of ionizing radiation, tions are predicated on the assumption i not diminish NRC's authority, Where that properly trained and adequately k-NRC's and FDA's authorttles overlap, ,
informed physicians will make dect-the respective authorttles can be har- ** b in Ws sWe. s!ons in the best interest of their pa- f
,[, g"[jj[, tients.
monized by intengency agreement.
The central question in the April 21, 1977. Fzouuu. RrcIsTra notice is a c' bo $d 'gjpg The regulattons try to find a balance between adequate controls and avoid-s uh mmm art. m Cuestion of poucy not authority
- Effecta on Populations of Exposure to low ance of undue interference in medical l namely: levels of Ionizing Radation. Natlonal Acad. Judgments. A consequence of too )
To what extent should the protec- e:ny of Sciences-Nations! Research Coup. much regulation could be poorer i health care deUvery to patienta. A con-tion of the patient be considered in ett, Washington. D C. (1972L I HDIRAt anoisitt, vot. 43, No. 53--FroAY. MA1CH 17,17r3 h E
F
l l
11210 PROPOSED RULH Once of leaving to physicians the to NRC =taaAmMistrations of radioac- quirement is (nat the physician's terity of the decisions concerning Live material to be exclusively the training include supervised examina.
their patienta is that the physicians practice of medicine or a part of physi- tion of patients to determine the suit- ,
wiu make mistakes. The tightest regu- clan patient relationships. As de . ability for radiotsotope diagnosis and L litirn of physicians' decisions by Ped- scribed in detail in Section III, the recommendation on dosage to be pre-eral, State and professional groups will Commisalon intends to regulate these scribed."
The Commtmaton recognizes that the j
not be t.ble to prevent future incidents areas of patient radiation safety where .
in the medical uses of radioisotopes. Justified by the risk to patients and selection of patienta for diagnostic or }
The Commission recognizes that where voluntary standards, or comp 11 therapeutic procedures is basicaHy a FDA regulates the manufacture and ance with these standards, are inad. matter of medical judgment. Diagnos tic procedures have a low patient risk inttrstate distribution of drugs,includ- equate. and therapeutic procedures are spe-f ing thost that are radioactive. FDA III. NRC PosmoN oW Srsesric Issess cialized and patient specific. Radioac-also regulates the investigational and k research uses of drugs as weH as the tive drug manufacturers provide guld- .
The foUowing represent the Com- ance on patient selection and contrain-specific guidance on doses and proco- misalon's p sition on the specific dications in the product labeling. Sup.
dures f:und in the product labeling. lasm raised in the April 21,1977 Fun- plemental voluntary guidelines on '
h=svar, FDA does not have the au. mL Rantsysa announcemnt (42 FR limiting patient radiation exposure,in-thirity to restrict the routine use of 20691). . cluding the standpoint of patient se-drugs to procedures (described in the eCtion, are available in the literaturg, product labeling) FDA has approved 1. svALUAT1oM or FNYsICIANs* CLINICAL T Mon to unnecessary pa-as safe and effective. Indeed, NRC is QUAL 1ricATIoNs Ment exposure imm improper selee.
l the cnly Federal Agency that is cur. NRC has always required that 11 tion of patients is believed to be smau.
rently tuthorized to regulate the rou.
tin 2 use of radioactive drugs from the censees be qualified by training and Therefore the Commteaton does not l standpoint of reducing unnecessary rs. experience in the hand 11ag of radioso- anticipate the need to limit, to any dirtion exposure to patients. tive material from the standpoint of major extent, the physician's discro- '
l Thz Commtenton believes that the radiation safety of workers and the tion thein NRCselection does not of evaluate patients.physician Bemuse I diagnostic use of radioactive drugs is, general public, The Commianlon believes that it is qualifications for the general license, in most cases, clearly an area of low the Commisalon wiu conunue l'.a radittiin risk to patienta. Therefore, necessary to continue to evaluate phy, minor restriction in the general medi-NRC will not control physician's pre. sicians' clinical qualifications prf >r to license fl0 CFR 35.31(cM4)) pro-rogatives on patient selection, instru. lasuance of NRC licenass. At thb time biting administrations of radio.
mint selection, procedure selection, there is no alternative method of de- phartanceuticals to a woman with con-drug selection and dose level for most termining if a physician, not certified firmed pregnancy or toDersons under ostic uses of radioisotopes. Pbr by the American Board cf Nuclear erspeutic uses of radioactive Medicine or the American Board of fotaf ec[sp file and in certain diagnostic uses- Radiology, is competent to use byprod-for example, the use of phosphorus.32 uct material. However, the Commta. s.saxacTroW or INoravasswrs To su f r loce.lization of eye tumors-the alon also believes that, as this field of vaso su rsaromaEING DIAGNOSTIC os risk to patienta is not low. The risk of medicine continues to mature, other ygggApggggc yaocEDUmas tissus cr organ damage (or even death) alternsMves will replace the NRC eval- NRC evaluation of a phystelan's is inherent in the use of therapeutic. untion of clinical quaufications.
levels cf radioactive drugs. NRC w111 NRC has for several years accepted qualifiestions includes an evaluauon r continua to restrict the uses of thers, certification by the American Board of ofstrumntadon. training in radiation phyaks and in- j peutic and certain diagnostic radioac. Nuclear Medicine and the American The selection of instruments for per. l tivt drugs to the indicated procedures Board of Radiology as sufficient evt. forming diagnostic or therapeutic pro- l that have been approved by FDA.The dence of clinical competence in the cedures is. Hke padent selecuot best.
NRC wiu not control the physicians
- fields of nuclear medicine and radi- cany a snauer of mdical judgment. I prerogatives on patient selection and stion therapy, respectively. It has re- '
instrumtot selection for therapy pro. cently determined that certifiestion by g11$bl on e a lect calib on cedur s, because these procedures are the American Board of Radiology in and maintenance of instrumentauon.
so specialized and patient specific. Diagnostic Radiology, with Special Again, diagnostic procedures have low Congress recently gave FDA author. Competence in Nuclear Radiology, is patient risk and therapeutic proce. '
ity to regulate medical devices, simnar sufficient evidence of clinical compe- dures are specialized and pauent spe.
to FDA's authority to regulate drugs, tence in nuclear imaging p ocedum. cific. NRC does not currently restrict I but with additional authority tc re. Based on specific assessments in con- selection of instruments and does not 4 strict the routine use of medical de. sultation with its Advisory Committee anticipate the need for doing so in the "
vices as may be necessary to provide . on the Medical Uses of Isotopes NRC future. The Commission recognises '
reasontble assurance of their safety will continue to expand its use of the that FDA will regulate the investiga-and effectiveness. FDA has not yet various board certifications as satisfac- tional and research uses of medical de.
had sufficient time to implement its tory evidence of adequate clinical vlees under its new legislation, the
- i full authority to regulate medical de. training and experience for the medi- Medical Device Amendments of 1976
4 vices containing byproduct, source or cal uses or radioisotopes. NRC will (Pub. L.94-295). The Commission also special nuclear material. Therefore, also work closely with the professional recognizes that these amendments b-NRC wiu continue to restrict physi. societies to assist them in developing give FDA new authority to restrict the l
clan's uses of these medical devices, suitable permanent alternatives to routine use of medical devices under P I both for alagnosis and therapy, to NRC's evaluation of physicians
- clini- such conditions as may be necessary to l those procedures that NRC has deter. cal qualifications. provide reasonable assurance of their mined (in consultation with its Adviso- safety and effectiveness, ommittee on the Medical Uses of mwosms.onsezzemn or FAmm roa MRArEUTIc raoCEDUmas e. sEI.sCTIoM or mADIoACrIVE DaCGs om es) to be safe and effective. mess To as UssD Commission does not consider NRC currently evaluates a physi-equ!pment calibration, qualifications clan's clinical qualifications to use ra- The NRC now restricts a physician's t of pararnedical personnel or reporting dioisotopes on humans. One NRC re- selection of radioactive drugs by limit.
FEDERAL REGl$tet, vol. 43, NO. SS-7RIDAY, MARCH 17, ifFs i
)
PROPOSED RULIS 11211 k
ing the distribution of the radioactive cedures for which there is substantial labeling. NRC regulations are more re-drugs to those products meeting FDA evidence of safety and effectiveness, strictive than FDA regulations. [
regulrements. The physician is thus that is, to those procedures approved at.Elsewhere in this issue of the F*nsa-Rectstra is a proposed rule that g
+
drestricted to using radioactive drugs in the drug labehng. According to would delete the specification of the .
subject to an FDA-approsed " Notice of FDA's statement on drug labeling. clinical procedure from the lists of the i Claimed Investigaticnal Exemption diagnostic radioactive drugs in P for a New Drug" (IND) or an FDA.ap- tha o a 335.100. However, this proposed rule C proved "New Drug Application" not alwars contain all the most current in. would place limitations on a drug's use (NDA). NRC regulates the manufac- formation meallable to physicians relating to ,
' ture and installation of teletherapy the proper use of the drug in good medical for prcedures not speciftfed in the dwices as wen as the integrity testing practice. Advances in medical knowledge package insert. -l As noted in Section II of this policy cf these and other radioactive medical and practice inevitably precede labeling re- statement, the radiation risk' to the
. i drvices during use. However. NRC eston by the manufacturer and formal in- b' approval by the Food and Drug Ad- patient from most diagnostic nuclsar
- does not now require that medical de. belins min 18trSt!00- medicine procedures is low, while the Y'
vices containing radioactive material risk is significant from misuse of I meet FDA requirements. eNus t t fre therapeuticlevels of radioactive druss, The Commlulon beneves that it is use drugs according to their best knowledge Those few diagnostic procedures k ;'
W I necessary to continue its restrictions and judgment. Certainly, when a phyalcan where the risk to the patient is high
- en the availability of radioactive drugs use a drug for a use not in the approved la.
to those that meet FDA requirements. belins. he has the responsibility to be well- are not listed in K 35.100 but are the l NRC will study and assess with FDA informed about the drug and to beae such subject of specific license authortma-thi necessity for a similar NRC re. use on firm adentific rationnie or sound tions and will continue to have the medical evidence, and to maintain adequate clinical procedure specified.
quirement for radioactive medical de- medical records of the drugs use and effects, '
ygces. but such usage in the practice of medicine is s. sELECrloN or DOSE LsTE1 (GUAErrtTY radioph sceu e ave be proved by FDA for the same proce-a a et. [
Basically. NRC issues two types of 11- As noted in Item 2. selection of 36-dure, the Commission does not plan to censes to medical institutions for the Lients, the physician's traintryr asunt estrict a physician's decision regard- human uses of byproduct material, the include supervised experience in ree-
.ng which agent to use. The Commis- medicallicense of broad scope and the ommending proper namaes a for speciac tion considers the basic decision on medical license of limited scope. patients.
drug or device selection to be a tradi. Broad medical licenses authorize The Commlulon recognises the so-tional part of medical practics.
The Food. Drug and Cosmetic Act multiple quantitles and types of by- lection of dose level is hantemuy p differentiates between pharmacy and product material for unspectfled uses matter of medical judgment- The and are issued to institutions that (1) package inserta for radioactive drup manufacture. However no clean line have had previous experience operat- include the recommended usual does has been establi.shed to determine ing under a limited medical Ucense and usual dosage ranse. Because of and (2) are engaged in medical re- the many variables that determine the O uhen beyond a nuclear the ordinary pharmacy has search practice of phar. gone as well as routine diagnosis and most effective dosage for both the di-macy (compounding and dispensing) therapy using radioisotopes. The pro- agnostic and therapeutic use of radiol-and has become a manufacturer. The grams under the broad medical license sotopes, the NRC does not now regu-FDA is drafting guidelines that will Operate under the supervision of a late, nor does it anticipate the necessi-define au of those operations (of .nu. medical isotopes committee. No phys!- ty of restricting in the future, the phy-cl:ar pharmacies) connected with the clans are named as individual users on sician's selection of doselevel.
preparation of radioactive drugs which the license. nor are radioisotopes 11 mite will be regarded as manufacture (and, ed to specific c!!nical procedurcs. 7. PRorIR Mr.ASUREMENT or THE DOSE l therefore, subject to FDA new drug re- laimited medical licenses specify the THE MENT RENTEs Quirements) and not part of the prac- radioisotopes and the clinical proce- The Commluton beUeve that tice FDAof pharmacy.
guidelines. theInNRC the licenses absencenu, of dures that may be performed by phy- proper measurement of tige radloso.
sicians named on the license. Under tive drug dosage, or radiation dose in clear pharmaci:s to distribute only limited medical licenses the institu- the case of therapy. helps to ensurs those products that they have pre- tional licensee must have a medical that the patient receives what the pared from or maceuticals FDA-approved reagent kita. radio- phar- Isotopes committee and the physicians physician has presedbed and thus I
. named on the institution a 11 cense con- helps mtnfmim unneermanry radiataea [
- s. sELECrloN or FRoCEDUREs To BE duct their programs with the approval exposure to patienta. NRC now re- -
PERroaMED of that committee. Under limited culres most licensees. particularly a medical license the authorized diag- those who prepare radioactive druss iI NRC evaluates a physician's clinical I *
- i
. tu s. d ap tr f e ist in h '
tories to establish the most appropri- tion 10 CFR { 35100. " Schedule A-8 P n NR auy crits l ures imi lo e ntra cato m eYa1
- The authorized clinical procedu:'s- amending its regulations to require
, and so forth, measurernent of all diagnostle and i The Commission recognizes that the listed in the groups are procedures ap- therapeutie doses cf radio- pharma- 7i selection of procedures is basicaHy a proved by FDA in the drug labeling, ceuticals, regardless of origin. -
matter of medical judgment. The Since FDA does not restrict the physi-1 to clinical procedures usted in the ,The risk to a patient from a false postuve 7 eed i t, t or e te t. or a false nesee dinan sta throush the t physician's discretion in the selection ' Radioactive materials la i35.100 are d!- use of a drug for a purpose not fully investi- r of clinical procedures. vided into six groups. each aroup havins gated and specified on the label would be i The Commission recognizes that similst requirements for user training and expected to be srester than it ts for a ta.
FDA does not restrict the routine use expertence. fact 11 tics and equiprnent, and rs- beled use but this risk La difficult to quanth of NDA-approved drugs to those pro- diation safety procedures- fF.
b nomt umsm, vot. c. m n-mon mAnn ir, im ;
f r
I
11212 PROPOHD RULES NRC currently has under consider- State, Federal and private agencies in- any other drug or physicians in any l tion a proposed rule (42 FR 25743) cluding". the Health Services Arimtnta- other field of med! cine.
)t would require anngal calibration tration (Medicare and Medicaid The purpose of a mt=Amintatration Jd monthly checks of teletherapy DHEW), the Bureau of Radiological reporting requirement is to anow NRC units. This rule has reesived many Health (FDA/DHEW), the Joint Co:n. to investigate the incident, evaluste public comments; the anmments will mission on Accreditation of Hospitals the corrective action taken by the 11- L be ans1rsed and the rule modified, if (JCAH), the American Registry of Ra- censee to minimt= the chance for re- m warrantad. BasM on the disposition of diological Technologists (ARRT), the currence, and, if other licensees could j this propeeed ru2e on teletherapy call- Registry of Medical Technologists make the same errors, begin generic .
1, brstion, NRC may propose a esmn" (RMT) and the new certification corrective action which would, as s ?:
rule fer the periodic calibration of bre- board by the Technologist 4 Section of minimum,' inform other licensees of chytherapy sources, the Society of Nuclear Medicine. the potential problem. h The Commtulon also recoamium that As also noted in Item 9. In the near j l s#anmmw omacaceric the majority of paramedical (allied future NRC plans to publish, in the t J sammr m noss mzasvamo health) personnel using radioactive FroznAI. Raotsrzm a new proposed rule !<
8 8N7"T**8 material are not covered by these pro- for m'andmtntatration reporting. The ,
The Commt== ion believes that the grams. Rather they are trained on .new NRC proposal will address:(1) the 41 1 cabbration of diagnostic equipment the-job, are not certified; and many do types of =wmintatrations to be re- L '
l and dosage measuring devices helps not have their trefninr documented. ported, (3) the substance and timins of
! casure that the patient receives what However, the introduction of a rela- the reports, and (3) the recipients of the physician prescribes and thus tively less comprehensive NRC pro- mhdm'ntatration reports, for exam-htlps minimim unnecessary radiation gram, such as that in the 1973 AEC ple, the referring physician and possi-exp=ure to patients. NRC presently proposal, could undermine the efforts bly the patient or a responsible rela-
- requires Ucensees who prepare radio. of voluntary organizations or those tive, as wen as NRC.
&ctive drugs from radioisotope gener. Federal or State agencies relying on Mmeamn Anver ComTm ctors and reagent kits to describe in more cornprehensive guidelines. CoxxxnTs l
the Ucense applications a method for In the near future NRC will pubush caubration of their dose measuring de. a FsounAI. RactsTra announcement The NRC staff met with the publir vices. NRC also provides an acceptable withdrawing the 1973 AEC proposal on the morning of May 6,1977, ar' method for calibrating dose calibra- and substituting an NRC proposed with its Advisory Committee on the tors in "A Oulde for Preparation of m'==dministration reporting require. Medical Uses of Isotopes in an after- ,
.Appilcations for Medical Programs" ment. That future announcement will noon pubUc meeting on the same day.
(NUREO-0338 Rev.1 November 1977) discuss more thoroughly the reasons The members of the Advisory Com-that can be obtained by writing to the for withdrawal of the AEC proposal mittee were the chairman Mr. Rich-Radi isotopes Licensing Branch, Divi. and substitution of the NRC proposal. ard E. Cunningham Deputy Director 6 sfon of Fuel Cycle and Material NRC is studying the various allied of the Division of Fuel Cycle and Ms.
Sftty, Nuclear Regulatory Commis. beslth artification programs current- terial Safety of NRC's Office of Nucle-E I ly in effect or being drafted by other ar Material Safety and Safeguards; Dr. '
l O'n. Washington, RC presently D.C. not have any re- Federal. State and professional James Quinn from Northwestern Me-does 20555.
quirements concerning the calibration groups. If the coverage provided by morial Hospital: Dr. Joseph Workman cf diagncstic equipment. Because of these programs is not adequate to pro. from Duke University Medical Center; the extensive experience of FDA's tect the patient from unnecessary ra- Dr. David Kuhl from the University of Bureau of Radiological Health and the diation exposure, NRC will work with California Ims Angeles; Dr. Henry new cuthority of FDA's Bureau of these groups to develop a new NRC Wagner from John Hopkins Medical Medical Devices. NRC will collaborate proposed rule for the tretntnr of allied Institution; Dr. Edward Webster from
- trith them in their development of vol. health personnel Massachusetts General Hospital; and untary guideunes for the routine call- Dr. Frank Deland from the University 8**""" UI * **"#'#**" of Kentucky.Two consultants to NRC, bration of diagnostic equipment. At the same time. NRC will study the or mAnmAm mmtar. on maDI. Captain Willlam Briner from Duke merits of propnetna mandatory re-am mm exs mcomPonAM Univeralty Hospital and Dr. Peter "A"" *C" "T**** Almond from the M. D. Anderson Hos-quirements. )
, As describe in Item 9, in 1973 AEC pital, also attended.
- s. QUALITICATIoNs or PAmmanICAI. PER. published a proposed rule that would The comments from members of the '
soWEL. BUCH as TsCHNotcoteTs, require lleensees to report m'amAminA public can be classified broadly in two l mSES. RAMMARMClaTs AND mADio- trations of radiopharmaceuticals or ra- categories. In the first category, the '
tocicAI. MMC 1sTs distion from byprcduct material to physicians, physicians
- groups, p"nar.
l 1 On March 9.1973, AEC published the CommW and to the patient or macists' groups and industry com. U, (33 FR 6399) a proposed amendment a responsible relative whenever the menta range from statements that t to its regulations in 10 CFR Part 35 mi==Amf=ltrstion could cause a "de- *present regulations are sufficient ** to
. that would (1) define the activities monstrably adverse effect on the pa- the "the NRC should not regulate the that may be delegated by physicians tient." Ninety-eight comment letters use of radioisotopes in medicine at ,
and those that may not, (2) require were received. most objecting to the all." Msny of the commenta in this ,
physicians to determine that para- proposal for reporting to the patient.. categor. stated that FDA regulates
- d madical personnel have been properly Reasons given for objection to the re- the aaft y and efficacy of drugs and (
trained, red (3) require medical licens. quirement for reporting m!amAminN that NRC should withdraw from this r ,
ecs to report to the Commisalon and to trations to the patient were: (1) such area and regulate only the radiation J; the patient misadministrations of rs- reports would constitute self.incrim!- safety of workers and the general .
thacthe material. nation, (2) such reports would invite public. f The Commluton recognizes that or increase unwarranted malpractice In the second category, NRC Agree- ;
i there are several organizations cur- suits, (3) this would place the govern- ment and non. Agreement State radt- >
rently involved in developing or pro- ment as a third party in the physician. ation control agencies' commenta 06 Wrumum standards. guidelina.s patient relationship. (1) this is a range from statements that "present i
- dention for technician training. matter of medical ethics, and (5) there regulations are sufficient" to "much ;
~ ~' tirWrams are administered by are no comparable requirements for stronger regulation is necessary." i flotRAL R1041TIR, VOt. 43, HO. 534t! DAY, MARCH 1r,19rs {
PROPOSED RULES 11213 $
Many of the comments in this catego- should not restrict the physician to requirements. The pharmacy, radio- g ry note that FDA does not regulate those diagnostic procedures that have pharmactst and technologtst groups t been approved by FDA in the labeling. are particularly agalnst NRC granting a
O theand, toroutine therefore, uses ensure that NRC of should drugs the patient regulate One member believes that NRC credentials to paramedical personnel and devices is protected ahould continue this restriction or citing the numerous certifications and ,
frorn unnecessary radiation exposure. that some arrangement should be activities of other Federal and State r
+
In the area of NRC's evaluation of a made similar to the in house institu- agencies, as well as Natmfng lack of
- physician's clinical qualifications, both tion committee review under an hMC NRC authority to regulate in this ce,tegories of commenters recommend Broad Medical License. area. The physician groups cite the greater use by NRC of board certifica. Regarding proper measurement of fear that the number of certified tech-tions. Physicians and the industry in the dose the patient receives, the nologists will fall far abort of the need !
general appear to be interested in States urge NRC to expand the pre- ~ forThe these personnel sense of the Advisory Commit-maintatnine NRC evaluation as a sent licensing requirement for mes-means of entry into the field. They surement of doses of radioactive drugs tee is that extsting certifications cover feel that if NRC withdrew from evalu- prepared from radionuclide gener- paramedical qualifications and hospi-ating physician's clinical qualifica- ators, to cover all doses of radioactive tals look rather carefully at these. -
tions. the institutions or States would drugs regardless of how they are pre- They feel that, in the final analysis, 1 require specialty board certification. pared. On the related question of the physicians are responsible for their pa- .
They state that there are not enough calibration of diagnostic equipment tients and, therefore, are responsible board certified physicians to fill the and dose measuring instrumentation, fof the qualifications of paramedical demand for services and that board the States favor NRC activity aimed at personnel working under their direc-certtfication is not necessary for many limiting patients exposures but recom. tion in caring for patients. With the i cf the radioisotope procedures. The mend that NRC coordinate its activt. exception of physicist's qualifications State radiation control agencies be- ties with FDA's Bureau of Radiologi- for calibration of radiation therapy, ;
lleve that NRC's evaluation of phys!. cal Health and other professional and the Advisory Committee does not rec. ;
clan clinical qualifications is necessary scientific groups. ommend that NRC become involved in :
to protect the patient. They feel that The category of physicians, physi- regulating the qualifications of para-if NRC withdraws there will be a regu. clan groups, and so on, varies in its medical personnel 1 story gap. Some States suggest that a commenta regarding measurement of The States consider m'=A=fnistra-physician's qualifications should be re- dose and calibration of diagnostic in- limit tion reporting necessary in order to unnamanary radiation exposure viewed periodically, for example, every strumentation and dose-measuring in-five years, to determine that he is strumentation. Several commenters to patients. They point out that with keeping abreast of this rapidly chang. state emphatically-that NRC has no reports of mtwiministrations of by.
ing field. business regulating in this area. Many product material or radiat!on from by-The general sense of NRC's Advisory of them state as their reason the new product material. NRC will be able to Committee on the Medical Uses of Iso- authority of FDA's Bureau of Medical investigate the incident, determine if topes was that NRC should continue, Devices and the recent activities of the corrective action is adequate and, i g ct least graminefor the immediate physicians future.qualifica-
- clinical to FDA'sinBureau of Radiological developing Health voluntary quality if the con- problem stitutions could notify occur at other in-otherifcensees.
g tions and should make greater use of trol guidelines. Several other com- Physicians and physician groups are, the various type of board certification menters state that NRC activities in in general, opposed to NRC requiring c'r registration. as evidence of ade- this area are both welcome and neces- reports of mL=dminf=trations. They quate qualifications to practice in the sary to 11mit~ unnecessary patient expo- cite the low number of mismetministra-areas of nuclear medicine and radi. sures. Similar to the States' comments, tions of radiometive material to date r, tion therapy. some of these latter commenters ree- combined with the fear of malpractice On the question of selection of pa- ommend NRC cooperation with FDA's suits and the already h!gh insurance tients, instruments, radioactive drugs Bureau of Radiological Health and premiums as the principal reasons for or devices, procedures and dose level, other professional and scientific opposina mf=dministration report;ng.
the State radiation control agencies groups active in developing guidelines They point out that most mMAminta-believes that NRC should not regulate for dose measurement and instrument trations of diagnostic levels of the selection of patients or instru- calibration. _
radiopharmaceuticals do not harm the ments. However, the States believe The consensus of the Advisory Com- patient and are similar to midstmtnta. I l
that 11eenses should specify the per. mittee on the Medical Uses of Isotopes trations of other drugs. They state mitted radioactive materials and pro- is that NRC would do well to concen- that medical institutions and the .
cedures and should require adherence trate its activities on assurances that medical profession have pro dures [
to instructions and dose schedules in the patient receives the proper dose for dealing with mMdminfatrations. L FDA approved package inserts. The prescribed by the physician.The Advi- Several commenters question NRC's
9 physicians and the industry believe sory Committee can see no reason why authority to require such reports, stat- '
that decisions on selection of patients, radioactive drug doses should not be ing that this is within the traditional
- Instruments, radioactive drugs or de- measured by well-calibrated instru- practice of medicine and such a report-vices, procedures and dose levels are mentation prior to administration bs ing requirement would be unique in all ,l medical decisions and traditionally a the patient. On the other hand, the of medical practice. Several com- /
part of the practice of medicine. They Advisory Committee is not enthusD- menters do not object to keeping re- a-e commented that NRC should not reg- tic about the idea of NRC requiring cords of mMAminfitrations for on-site ulate these areas. Some argued that the calibration of diagnostic instru- examinat!on by NRC inspectors, but NRC has no suthority to regulate in mentation.The existence of guidelines these commenters feel that more these areas since Congress gave FDA in this area and the market pressures harm than good would result from -
the authority to regulate the safety on manufacturers to provide quality making such reports directly to NRC, -
and efficacy of all drugs and medical instrumentation are two examples where they would become a part of devices. that it discussed. the public record.
The Advisory Committee on the On the question of the qualifications The Advisory Committee on the i Medical Uses of Isotopes does not have of paramedical personnel, the phys!- Medical Uses of Isotopes does not have A a consensus on this issue. The major- clan industry category is virtually a consensus on the issue of misadmin-Ity of the committee feels that NRC unanimous in its opposition to NRC istration reporting. The members who FEDERAL RECI5TER, VOL. 43 PO. 53-FMAY, MM".M 11, 1978 l
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t
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11214 commented are against requiring re- 'r L
ports of those mh*Aministrations having no demonstrable health effects i i
on the patient, k One general comment occurred sev-eral times, during the ' morning and F afternoon meetings and in manY of
- l
{ the public comments. It concerns the {
j need for uniformity in Pederal, State j and private regulation of the medical =
uses of radioisotopes. Several com-1 menters call for uniformity between I
NRC and State regulations, but most
( focus on the discrepancy between the f,
regulation of byproduct material and a the regulation of naturally-occurring and accelerator-produced radianctive materials and accelerator therapy.
l One commenter discusses this discrep.
ancy with regard to therapy. This commenter expresses his concern that L regulatory considerations have come to play an important part in decialon making, particularly in matters where the d=4= ion is for a choice among near equals. Specif!cally, he is concerned that the competition between cobalt-60 and electron accelerator telether-apy may be influenced, not from dif-ferences in hazards, but because NRC regulates cobalt-60 teletherapy units
, and does not regulate electron accel-( erstor units. He feels that physicians may choose the least regulated alter-native in order to have more time avnDahle for the patient oriented de-mands of their practice. He suggests that NRC should cooperate with those agencies that can regulate accelerator teletherapy, so that these competing alternatives receive more uniform res-ulation. He further suggests that any increase,in the regulation of one altar-native would be counterproductive to pubtle health and safety.
V.ConcLusrow -
This proposed policy statement on b NRC's regulation of the medical uses f of radioisotopes is published with the czpectation that public comment will
improve the ultimate Commission de- ,
cision. To that end, it would be helpful ;
if responses include the reasons for a ..
J particular point of view or recommen- b dation. I Dated at Washington, D.C., this $.
13th day of March 1978.
~
For the Nuclear Regulatory Com- '
mission.
SAMUEL J. CRU.K. p O. Secretary of the Commission.
IFTt Doc. 78 'l168 FUed 3-16-78; 8 45 mm1 l
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/M 73-/
Mpno%p UNITED STATES M[ j j -
e 4 NUCLEAR REGULATORY COMMISSION E S WASHINGTON, D, C. 20555 h3 "E
[V \. ... ./
June 25, 1980 TO ALL MEDICAL AND ACADEMIC LICENSEES There are a number of steps licensees engaged in nuclear medicine practice and biomedical research can take under NRC rules to substantially reduce, and in some cases eliminate, the need to send radioactive waste to commercial low-level waste disposal facilities. By taking advantage of these alternatives and following good waste management practices, licensees can often reduce the risk of having their programs impacted through further curtailment of commercial waste disposal facilities. Some of the more important steps that can be taken are to:
c' 1 Segregate radioactive waste from non-radioactive waste to reduce unnecessary volume. This simply requires a little time and discipline in the laboratory.
V 2. Hold waste with short-lived radionuclides in storage for decay to background levels, then dispose of it in the ordinary trash. This procedure requires a license amendment. (See Enclosure 1 for information to be submitted with the amendment request).
- 3. Release certain materials into the sanitary sewage system in accordance with 10 CFR Part 20.303. No license amendment is required but 10 CFR Part 20.303 should be carefully reviewed to stay within limits.
Judicious use of these three steps can substantially reduce the volume of waste shipped to burial grounds. Some nuclear medicine laboratories using only short-lived radionuclides can eliminate waste shipments.
Waste from biomedical research is generally somcwhat more difficult to manage. Two of the most common problems are disposal of liquid scintillation counting waste (LSCW) and animal carcasses. The most frequently used-radioisotopes in both are tritium and carbon-14.
LSCW presents a particularly troublesome problem due to the flammability and toxicity of the solvents. Disposal of LSCW has been given special consideration by NRC. The staff has investigated alternatives to managing these wastes and the results have been published in NUREG-0656.
[
G ypp ymwn- C) f T l ^'4 I I ( ,
Consideration should be given to disposal by incineration for LSCW and laboratory animals containing small amounts of tritium and carbon-14.
This method requires a license amendment; 10 CFR Part 20.305 contains the provisions for incineration. Enclosure 2 identifies the information to be submitted with an amendment request for incineration.
There are other provisions in the regulations that cover waste disposal.
We have mentioned only the few that are most easily and commonly used.
Other regulatory provisions include:
- 1. Disposal by burial in soil in accordance wich 10 CFR 20.304
( A proposed rule change is under consideration to delete this provision. It will likely be replaced by a provision which requires specific approval by license amendment for burial).
- 2. Release as effluents to unrestricted areas pursuant to 10 CFR Part 20.106. In keeping with the ALARA concept, this method should normally be used only for releases incident to the procedures involved.
We suggest that you review and consider alternatives to commerical land burial for the management of your low-level radicactive waste.
Implementation of some of these alternatives may require an amendment to your license. Amendment requests should be submitted to the Material Licensing Branch through the use of normal channels. Specific licensing questions concerning NUREG-0656 should be directed to the Material Licensing Branch (301) 427-4232. Copies of the NUREG-0656 may be obtained from the Division of Technical Information and Document Control, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
Sincerely,
' ndy
.h lillbr, Ch eT N riateri Licensing Branch Division of Fuel Cycle and Material Safety l
Enclosures:
1
- 1. Information to be submitted When Requesting Amendment to Dispose of Radioactive Waste by Decay-In-Storage.
- 2. Information Required for Commission Approval of Treatment or l Disposal by Incineration.
Enclosure 1 '
l Information to be Submitted When Requesting Amendment to Dispose l of Radioactive Waste by Decay-In-Storage Method l This is in reference to your request for information concerning authorization to dispose of radioactive waste via decay-in-storage. In order to approve such an amendment request, we need the following information:
- 1. Please submit a diagram of the area where the waste will be decayed-in-sto, rage. Show the type, location, and thickness of shielding that you will i have available in this area on your diagram. Your storage area should be large enough to handle an accumulation of used Tc-99m generators as well as other solid waste.
Identify adjacent unrestricted areas located across the walls from the storage area and show that adequate steps have been taken to assure that radiation levels do not exceed the limits specified in 10 CFR 20.105 (enclosed).
- 2. Describe your security measures for the decay-in-storage area.
- 3. Confirm that radiation levels in this area will be surveyed and recorded at least weekly.
O 4. Describe your procedures for monitoring the waste to assure that it has decayed to backgrcund levels prior to disposal. As a minimum, your de-scription should include these points:
- a. Monitor the waste in a low background area.
i
- b. Monitor with a low level GM type survey meter as appropriate for !
contamination surveys. Use the most sensitive scale.
I
- c. Remove all shielding prior to monitoring.
[ d. Maintain records of these surveys as required under 10 CFR 20.
- 5. Note that decay-in-storage may not be a practical method of disposal for >
Tc-99m generators. These generators may contain long-lived radioisotopic contaminants. If you intend to dispose of generators by this method, you
- should include procedures for segregating the generator columns so that they may be monitored separately.
Be certain to submit your amendment request in duplicate. Unless your institution ;
is fee exempt, your request should be accompanied by the appropriate amendment fee. Refer to 10 CFR 170.
i t
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1 5
Enclosure 2 (
INFORMATION REQUIRED FOR COMMISSION APPROVAL OF TREATMENT OR DISPOSAL BY INCINERATION Revised October 3, 1979
- 1. State specifically the isotopes you wish to incinerate. For each isotope listed, you should submit calculations demonstrating that air concentrations of the effluents at the stack are in accordance with the requirements of Section 20.106 of 10 CFR Part 20.
- 2. Submit the characteristics of the incinerator such as height of the stack, height of and distance to buildings in the surrounding areas, rated airflow of the incinerator in cubic feet per hour or similar units and its proximity to any air intake ducts.
- 3. The gaseous effluent from the incinerator stack should not exceed the limits specified for air in Appendix B, Table II,10 CFR Part 20, when averaged over a twenty-four (24) hour period.
- 4. In order to be in compliance with the ALARA philosophy stated in Section 20.1(c) of 10 CFR Part 20, the gaseous effluent from the incinerator stack should be a fraction (approximately 10%) of the limits specified for air in Appendix B, Table II,10 CFR Part 20, when averaged over a one year period.
, 5. Describe the method of measurement or estimation of the concentration of radioactive material appearing in ash residue.
- 6. Describe the procedures for handling and disposing of ash from the incinerator.
- 7. Describe procedures to be follcwed to prevent overexposure of personnel during all . phases of the operation, including instruction given to personnel handling the combustibles and the ash.
- 8. Submit evidence that all State and local regulations concerning incineration of radioactive naterial have been met by your institution.
- 9. State the maximum number of barns to be performed in any one week and the maximum number of burr.s per year.
1
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3 ff ,,
o UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 gy r,, e j
- ....,+ ,Rpi 0 41981 TO ALL MEDICAL LICENSEES:
On June 23, 1980 all medical and academic licensees were sent a letter describing steps that they could take to substantially reduce or eliminate radioactive waste _sent to commercial low-level waste disposal facilities.
One of these: steps was to hold radioactive waste in storage for decay
~ ..to-background levels before disposal in ordinary trash. For those licensees who do not have decay-in-storage as a method for disposal of radioactive waste in their NRC license, this requires a license amendment.
In order to ease the burden of applying for an amendment to your license for decay-in-storage of radioactive waste, we have decided that we will place a condition on all medical and academic licenses which states:
"The licensee is authorized to hold radioactive material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash provided:
[m) a. Effected radioactive waste shall be held for decay a minimum of ten
\.j (10) half-lives.
- b. Prior to disposal as normal waste, radioactive waste shall be monitored to determine that its radioactivity cannot be distinguished from background with typical low-level laboratory survey instruments.
All radiation labels will be removed or obliterated.
- c. Generator columns shall be segregated so that they may be monitored separately to ensure decay to background levels prior to disposal."
There are two ways that the above condition can be incorporated into your license:
- 1. Without your prior request, we will automatically place this condition on all. medical byproduct material licenses as they are issued in response to new or renewal applications and amendment requests; or
- 2. If you desire to have this condition placed on your present license right away, you should submit a request for amendment referencing this document. This type of amendment request will be fee exempt.
b d
i (
gg ~7i L J
1 i
To All Medical Licensees l 1
You are reminded of the requirements contained in 10 CFR 20.105 and l 10 CFR 20.207, which address established limits for radiation levels in unrestricted areas and storing or securing radioative material respectively. ;
l h 4 ndy L. Ailler, Chief L - -
Material Licensing Branch Division of Fuel Cycle and Material Safety, NMSS O:
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UNITED ST ATES NUCLE AR REGULATORY CO M M IS$10 N W ASHINGTON. O. C. 20555 I
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- Ant / 8./3 p MEDICAL APPLICATIONS CHECK LIST
\
.x
. Name - (note any changes)
. Address-(comparetoprevious)
. Proper signature - (Hospital Administrator or Management representative) 5
.. . User a)' Items 8 and 9 . . . .
No. 8 - training experience (200 hrs)
No. 9 - actual use of isotopes (500 hrs) .
b) Preceptor s,tatement or certification . .
- 1) All procedures .
ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> - institutional training V
1.11 ) . Signature ,
~
c) License to practice medicine ,
. Private User (Physician) .
~
O a) b)
HoeP i tei end eddrees for Patieats Agreement letter from hospital c) Procedures and equipment for management of patients RadiationProtectionOfficer-(Ifotherthannameduser) '
O .
a) Training ,
b Duties .
c Availability - (In house vs. consultant)
' ~
Instruments - Listing ,
High level survey meter - to 1 R/hr a) b) Low level survey meter - Down to .1 mR/hr ,
c) Dose calibrator d) Diagnostic instruments Calibration Procedures - (Check file if private consultant) 3 a) Survey meters - (Check for backup if needed) i) Frequency (annually) ii) Adequate standards (energy and activity NBS)
- Check for accuracy and manufacturer fIs iii) Two points on each scale
- + 10%
- ~
+ 20% with chart or graph
3 (G
b) Dose calibrator
- 1) Daily checks - Constancy + 5%
ii)
, Proper standards (1) H. M L if needed .
(2) Activity (3) NBS '
iii) Linearity check - quarterly + 5% ~'
- 1st elution - highest activity _
- iv) Accuracy - yearly + 5% ..
- 8. FacilitiesandEq'uipment(DiagramNeeded) -
a) Fume hoods '
b) Shielding around generator c) Storage areas
- waste shielding ~
d) Preparation areas ;-
e) Long-term storage - ".
- 9. Medical Isotopes Comittee
-]
a) Membership b) Responsibilities and authority - Check to ensure Regulation Guideline.
c) Meeting frequency (quarterly) ,,
d '-
- 10. Personnel Dosimetry ,',.
a) Whole body ,
b) Extremeties - finger badge c) Dosimeters - Procedures and frequency of calibration P-
-~
4_+.
- 11. Bioassays e
- Iodine
- Tritium , ._
- 12. Receipt and notification ,
a) Working hours
- b) Receipt procedures for off duty hours
. c) Storage location for off duty hours d) Instructions for personnel receiving during off duty hours
- Phone No. for RSO e
-4
L 3 l\ -
l
. 13. Opening procedures -
a) Monitor outsida
- 200 mR/hr at surface ~
t - 10 mR/hr at 1 meter b) Wear gloves while opening Appendix F
, c) Check packing material after opening d) Report leakage ~.
e) Incorrect exemption of packages
- 14. Training l (-
c) Technicians - initially and yearly. Must cover 10 CFR 19.12 including pertinent NRC regulations, etc.
b) Others - initially and yearly. ,
- 15. Laboratory Instructions ,
a) Lab coats -
c b) Gloves t '
c) Use of fume hoods or glove boxes '
d) Monitor hands and clothing Appendix G e) Syringe shields f) Eating, drinking, smoking g) Mouth pipetting '
h) Assay of individual doses i)
Disposal j) ,
Instruction for use of personnel monitors
- 16. Emergency Instructions - Contact RSO immediately
[
- a) Immediate steps < -
b) Notification ,
Appendix H ,
c) Clean-up ,
- 17. Animal Use - must specifically request ,
~
a) Housing facilities b) Handling and clean-up procedures
, , c) Haste disposal
- 18. Area Surveys ,
a) Daily - elution and preparation areas b) Weekly - All areas Appendix I c) Wipe Testing -
d) Removed areas
---Y-, -.-
1 1
4 O
V ,
- 19. Therapy (unsealed) a) Instruction ~s to nurses b) Room assignment i
c) ' Disposable items Appendix K l
- Patient trash saved and monitored
' d)- Linens '
e) Dismissal survey f) Volatile iodine handling -
(fumehoodandbioassays)
- 20. Brachytherapy -
a) Storage
- Precautions for handling sources Refer to Item 20 Reg Guide 10.8
.b) Transportation c) Inventory procedures Appendix L
- Source Accountability
- Quarterly required
- Before patient discharge -
d) Measurement of extremity dose '
- Wrist or ring badge .
e) Instructions to nurses
- Save linen in marked hamper until marked f) Room assignment g) Room surveys
'i) ASAP after implant ii) After patient leaves ,
- 21. Waste Disposal a) Liquid
- Must include copy of Appen' dix -
J in application b) Solid c) Generator -
d) Surveys -
e) Survey long-term storage area Appendix J -
- 22. Xenon a) Storage location b) Ventilation in use area
- Recirculation
- Periodic checks of ventilation system f'
- flegative pressure assured
- Diagram of intake and outflow vents
. c) Procedures d) Emergency procedures
5 e) Disposal .
- 1) Fume hood ii) Gas trap
+
- Manufacturer and Model No.
iii) Other
- Monitoring saturated filters
- How filters disposed f) 20.103 (1 x 10 s g) 20.106 (3 x 10 7 pCi (ML.)
pCi/ML.) (Restricted))
(unrestricted -
h) Calculations -
~
i) Xenon checklist
~
h e e"e=
0 .
D f . , .
fg e
4 e k
e e
_ _ _ _ _ _ _ _ _ _ _ _ _ _