ML20137Q538
| ML20137Q538 | |
| Person / Time | |
|---|---|
| Issue date: | 08/18/1983 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, PR-830818, NUDOCS 8509230040 | |
| Download: ML20137Q538 (109) | |
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, [7590-01]g,4 f // /3 NUCLEAR REGULATORY COMMISSION y 10 CFR Parts 30, 31, 32, 35, anf40y ed 7/
HUMAN USES OF BYPRODUCT MATERIAL AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modify the process for licensing medical users of radioactive byproduct material. The proposed revision would primarily affect future NRC licensing actions for hospitals, clinics, and individual
! physicians. jgg l By clarifying and consolidating all essential f safetysneeds now contained inf &u$,'s.~,ditions,regulatoryguidepandstaffpositions, li nse con l the pl'n rop.osed regulation l a :" o'n provides a single source' requirements for human use, This-would reducg' the administrative burden on the licensee. The
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proposed regulation also provides. the basis foria more efficient-Heense-
//r s o s il< = y m Na,naes uphn .sq k Mat JM - 4 a% pr,gaftistS applicatien and review preceis that kould c;onserve licensee and NRC a;x resources. The proposed revision to the regulations " a^^ w -to provide uv orw a more efficient method for licensin,g-the medical uses of byproduct material.
DATE: Comment period expires (insert 60 days af ter FRPL --for-purposes-of-Federal-Registerpublication -the-date-computation r formula _is removed. This-language-should-be-included-in-the-cover-memo-that-accompanies the document-when it-is-submitted for pubitcationnSECY will-insert the_. actual-date-based-on-the-FR pub.--date). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments filed on or before this date. I l ADDRESSES: Submit written comments and suggestions to the Secretary of i the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Service Branch. hg2gR 1 Enclosure 1 35 50FR30616 PDR j
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,&%' air Lf nd !" O Copies of the preliminary value/ impact analysis and the comments received may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, D.C. Single copies of the preliminary
[ (value/impactstatementareavailablefromNormanL.McElroy,Officeof l NucleaD:;;;htery 9erearch, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Telephone: (301)443-7970. p%w /. AfTlej-FOR FURTHER INFORMATION CONTACT: Pn . Wiiiiam Walker, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, es2 Washington, D.C. 20555, Telephone: (301)427-4NH!. SUPPLEMENTARY INFORMATION: Uses of Byproduct Material in Medicine Radioactivematerialsareusedindrugsand-seeled-source 8inthe field of nuclear medicine. Drugs labeled with radioisotopes are known 4 w,w n. ,m /ur es . , , as radiopharmaceuticals.g Pat'ients receive these materials by injection, s s .+.. ~ inhalation, or oral administration. Physicians use speci:li cd detectip,g % equipment to visualize the distribution of a radioactive drug within an /6 /A' - 4cgan-system-im the body, Using this technology, it is possible to
.% 0:a a locate tumors and blood clots, measur ~ sielegical. function, and-n
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n w aue/.a nw , r. monitor the effectiveness off treatment. fy Large,r quantities of radio-pharmaceuticals are administ5 red ther:peutic+14y to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 15 to 20 million nuclear medicine procedures are performed in this country annually.
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+./w Sealed sy su radioactive a w sources that produce hi h radiation n e; Sam fields /are n.,w auaw,iLu n used in g therapy units to treat cancer. jieletherapy unit gprovider shielding =d ' ^" 4-" ion-tejdirecti the radiation beam to the af4estedmw" part of the patient's body. An estimated 2 million teletherapy treat-tu. rah: list ments are performed annually by NRC licensees. Much _ smaller; pealed sourcesaredesignedtobeimplanteddirectlyintoatumor7Erappliedon the surface of an area to be treated. Thisprocedurekknownasbrachy- e therapyp limits-the-radiation field-to the-affected-area.and. spares l heal thy-ti s s ue-f rom-ra d i a t i on-damage . NRC licensees perform approximately
, 10,000 brachytherapy treatments annually. l }x./ u.fh /* ,wau n ~ n> N . A a"J u ~ sd uJJ h I .s , > J:' j. ;;;is w W 1 a.t y r ri.u$N.'t sf J 'i ' ' ' - + *U l' j ' 5 " h k.i m J .uda 2- s K v " + 5"''" Inclosure 1
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[7590-01] NRC's Ro1e $ _; ,, u ;; j uj , f ,L , Twenty-six states,}have . . .assumed w ,u - responsibility
.in - for regulating certain radioactive materials *6y agre,ement d; u s,th the NRC. They issue licenses forhumanusefofbyproductmaterial.g' The NRC issues licenses to medical facilitiesnii,na and individual w %
physiciansfinanon-Agreement Statesp These licensesgdstine h use!of radioactive materials for diagnostic and therapeutic medical procedures in humans. -Duning-the-past-three-decades , the-medical-use-of-radioactive: material-has-grown-about-15 percent-per ows zw 7 yean, kNRC currently has 2fal- medical licensees. In 1981,NRC staff ' , aQ received 73 "dpplications for @[. <:,v.icenses, 244 license renewal applica- \ f
- s. m u j tions, and 1,303 license amendment f appf4eationsr for a total of M (1,6k w
licensing actions. f4 NN nahd /en e; d[ y >a/ />4-C m .
. _ . . _ _ _ . _ - - - - .~ ' ~
NRC's Current Licensing Practices The current regulations in 10 CFR Part 35, " Human Uses of Byproduct \ Material," provi,de for general and specific licenses for human use. The $ generallicensefS35.31)"authorizesphysicianstousesmallquantities of prepackaged individual doses of radioactive materials. Physicians !
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simply submit a registration form to NPC and a validated copy with an ; assigned registration number is returned to the applicant. A Most medical institutions and physicians en:ga. aged-in-nucleaMicine peQmofelbyproduct materialj than can be safely permitted by a general license. A specific license, which authorizes a larger inventory of
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byproduct material and a wider variety of uses, may be issued for one 1 rp - O ,, \ current'**jf,... n ,,, or moredhof S 35.100)." s'e six license geoupt applicatio~nNof human ' U N eYiew'eduse[(go_up_s iN N iduaEl I-Med N' in the Eachgroup'i6sthi'isTelateddiagnosticortherapeuticprocedures. A eu k
.f) separate specific license /is- also / issued for use ofiteletherapy units. N,i,,tU /
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/NRC has published many NUREG reports'ande r,gulatory guides that con-au.w w. . w .
tain radiation pfotection-procedures-applicable to-specific licenseesr These publications address three general areas: radiological health and safety, personnel training and experience, and facilities and equip.- 4 .. , ..a n v. f. - - - ment. Experience has shown that if licensees follow thepe(procedurer, the human uses of byproduct material generally do-not- poses j% a, hazard to workers and the public. 3 Enclosure 1
[7590-01] Problems with Current Practice The General License. Issuing a general license for all in-vivo , medical use of radioisotopes to qualified applicants would be the simplest w a.a ~ ,.tu , ns approach forJNRC and licensees. /It'would not/a,,c,,,hieve-th n bjective of-maintaining- an acceptable level of safety 'for- the regulated industry. s.n . . ,, u .a ~ -h ,'.w The concept-of-a general licenseCatsumes that the" quantities and forms
...o .:a e7 w _,.s of the licensed material present such a Alow _leve-1-ofdazard. that &. . _ .
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case-by-case review of applications, on-site inspections, and periodic i (license renewals.are recessary_ ,The eenceptyf-a specific)licensep
- e. 3 U, ,a 'i he-ether-ha41 ncb,rp, orates -+1-4 three of thds. v ,,~e,9 f ehtures g forg these h reason g gaterials that are now specifically, licensed could not be .
i adequately, regulated.nHeiunder- a general license.m '
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/It is no longerfnecessary to,h=c cn in vive-medical general license <
The tests authorized under S 35.31 have been superseded by new in-vitro procedures with more specificity and greater diagnostic accuracy. These developments have been reflected by a significant decrease in the-medical community i
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s-use-ofj the w. - bvivo general license.) C&AItIloudh NRC has 'on file 650 in-vivo general licenses under S 35.31, { only five new applications were received by NRC in 1981.W To determine the status of general license use, sa tthe staff performed a telephone
,,, survey. ,a byuattempting to contact / 10 percent of the current registrants.
a u , . t.1 w x o ' Less than 9 percent of the current registrants still use material under
- . , . . .. . . m s o ...: s u .a a. c . .a d n't a general licensy Many have moved,-are-deceased-or-otherwise could-not-be--located, b ~ hidf~,% "'"lI ' 's 'A'h'N '
l f The-staff 9has concluded that the neneral license-no longer serves a l j useful role in licensing the human use of byproduct material. q -_ - The Specific License. %A major problem with, current licensing / - ~ procedures-is that radiation , w .w protection requirements are not located in in ? i, one document. C-urrentJy-guidance is scattered amo,ng-several regulations, Inspection and Enforcement (IE) orders that modify a license or group of licensesk@_regulatoryguidesNechnicalreports(NUREG)),)andasconditions ! attached to individual licenses. , m.<.,p,
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'-5Eggestions for good practice', contained in Negulatory Guide 10.8, f
" Guide for the Preparation of Applications for Medical Programs," and t
l 4 Enclosure 1 l
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.. : y uu, .a its-16-appen a n a 4 the- bul l e ti ns -i s s ued- by-the - NRC-- O f f i ce-o f- JL#f4Mf" F~*AM, #
i aa 4 yasi wa,. kspection -and-Enforcement have 'come-to-be-incorrectly-perceived-as , , m m u n m,; . . , v,.s m. regulations The revision of Part 35.would correct the pieceme..is ~al fashion 4 in which the regulations have been amended over the years to address specific problems. When preparing a specific license application for review under the m ,.v current licensing #peocedure, the applicant must include sufficient , jysw ... x,.J a v .w 6 information for NRC reviewers to conclude that aH-safety-requirements # for-human-use wH1-be-met. In-addi tion, -the-appH eant-1wst-deseeibe4he procedures-that-will-be-used-to-meet the-rec,uirementsof-the-regulationsr--
, , w m: ~ Ju&wm Therefore, applicants includejcopie's o,f their %-ocg$dures.with their (a}@iEEMinDlGig In many cases, the procedures are edited versions of procedures described in Regulatory Guide 10.8.
When NRC receives the application, a licensing reviewer evaluates w:. . g, -t the applicant'sfexperience, facility, equipme,nt, and procedures in i,.: y ~ a.u 2. .n detail. If the application is found to beadeficient,3a " deficiency letter" is sent to the applicant explaining what spccific additional asd information isfr.cquired. Review of the application is not resumed until 4
-ttm written response from the applicant has been received. Staff studies indicate that about 40 percent of all applicants receive either a defi-
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ciency letter',or phone call for additional information.r However, irr 4 w.uJ Ja 4 fu . , :m a n a. - 9 /,2 . x uhha - meny c% because of the conservativ,e licensing and'; review practicesp . the--lettert -f requently- reque s t- cl a ri f i c a t i on -o f-i n fo rma t i o n -tha t- doe s' not-i nvol ve-s i gn i f i ca nt - matte rs-o f-s a f e ty- Deficiency letters greatly increase the time required to complete licensing actions. uja :m When the application, including any additional ainformation, is approved, the NRC issues a specific license that grants the authority . for human use of byproduct material
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f.sv w:uirements w2.v in addition to those contained in the regulations may-bef indor'porated in the license as conditions of use. Since the licensee must o'ra with conditions -a
,m s s ; .; ._ s . ~ , . . . . /~ o-specified in the license, the license,Take serves to regulate radiation safety in the day-to-day use of byproduct material. .
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The specific license is valid for five years. 3Beforejusep_narcnnne.1,
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L__ _or procedures may be change Q he license must be amended. Amendments to a specific license involve an application, review, and approval n f d.n W . , a L ?,: J i ' 5 Enclosure 1
[7590-01] process similar to that for new licenses. Renewals are treated in the same manner as new license applications. g ;, aj M,. b, y ,da ' ' ?&qw 7 Proposed Peocedural-Appdoach-and-Support-ing-Rat-ionale-
/ NRC intends to modify its regulation of the medical use of byproduct f material. The Commission hat 2 tue ddp plan' Q-)- revise the regulations l to provide a single source of the requirements specifically related to humanuseofbyproductmaterials,andk'2)nevise-themedicallicense~ 1 w .: .- r. g a .. ...<.,.,s.a., , - . . . . ~.,,s- ...s , ~ , a c . . J - ' 7 ,,
revim gi vuss --The-latter ~ step 'wsuld allow use~of an~ automated ,s < o e ' w.> e.,,,..., t tus, management ~information; system-(MIS)t
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' NRCis--current-Heenhe-review process was appropriate -f-oe--the-eaHy-13 ' ' "
( iy .,,+~an. . . s~ : n .
-stageafitechnological-devehpment in nuc-lear medicine. At-that-timay
.1 radiation safety problems were not well defined, regulatory requirements }s
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hadnotcaughtupwithdevelopingtechnology,andItrainingcurriculahad l i not been established. Therefore, it was necessary to review each w a ... 3.1 ( individualaprogram to' ensure that the applicant had adequate personnel,
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x facilities, and equipment.[ ;The current review process -is now becoming
\ Onnecessarily burdsiisome'-fof both licensees and NRC. In'd$cidhg on-the
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k 1-p)roposed action, the staff recognized,that -- past m NRC policy has been to ij issue general licenses for materials *in forms or quantities that present; I t lpttleornohazardtotheuserorpublic. Specific licenses are issuedi n When there is a need for continuing regulatory surveillance. The pro-I posed revision of the licensing process also takes into consideration ! [thefollowing: (1) the safety technology is now more fully developed, I f(2) safety requirements are well defined and (3) several professional boards, which require extensive academic and clinical experience prior
/ 'to certif.ication, have become established. -- _
l Q "gThe proposed revision of 10 CFR Part 35 is consistent with the Commission's general policy on human use of byproduct material issued February 9, 1979 (44 FR 8242), which states "NRC will continue to regu-late the medical uses of radioisotopes, as necessary, to provide for the radiationsafetyofworkersandthegeneralpublic."hn-proposing-this revision;-NRC seeks to ensure that the degree of regulation is commensu-
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rate with the risk posed to health and safety by the various medical uses of byproduct material. k 6 Enclosure 1
[7590-01] Theproceduralrevisionsprimarilyaddressproblemsthatcomplicate} the licensing process. Theydonotdirectlyaddressradiationprotection( issues. NRC believes that the health and safety of people involved in { human use of byproduct material are being adequately protected at present.5 Since most radiation protection practices will be unaffected by the %- -- revision, NRC fully expects the current level of health and safety protection required of medical licensees to be maintained under the revised regulations. , , , -
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yet.o
- m 4 NRC proposes to simplify, the-licensing-process-for medical licensees
,,., ser , m.:, , r by transferring.all human use requirements tos10 CFR Part 35. These regulations would become the primary source of requirements for the
., . .e ny human use of byproduct material and would serve to regulate the daily-e o,w e w.
uses of radioisotopes at : dica!-facilitiec 9 r; N licensees would
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not face new regulatory burdens because, in most cases, these require , , ments currently appear as license conditions which must be met. d 8'T I In conjunction with this effort the staff will revise Regulatory Guide 10.8, " Guide for the Preparation of Applications for Medical Programs." The revised guide will contain I' mode b pro ~cedures that g the applicant can use to develop d ite-specific plar. ; rocedures to meet the requirements in the proposed regulations.'b r hb r.' Ne'.' ? l NRC further proposes to simplify current licensing practice by x"- eliminatingtherequirementthatapplicantssubmitforreviewdetailed l
. proceduresjdescrib'inghowtheyintendtomeetrequirementsintheregu-lations. (Licensees will still be required by-the regulet-ions, hcwevery to establish and implement these written procedures and. have copies available for NRC inspections.) Instead,[Applicanthouldsubmit'descrip-tions of their radiation safet'y pland. The detailed procedures would e
{havetoreflectcommitmentsmadeintheplan,andwouldalsocontain whatever additional requirements the applicant believes necessary to ensure that byproduct material will be used safely. Since procedures would no longer be submitted to NRC for review, l [the practice of including these procedures as conditions of use on the i I license would be eliminated. This simplification would permit licensees 1 to modify procedures to meet NRC requirements without obtaining a license e r a. , m < u m ..r . si .a"w.- .,.. . . -c, n a -,M ~~ , amendment. IJ n its inspection and enforcement role, NRC kould be concerned .s. with whether the requirements in the regulationsYare being met, not with
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e - ( 7 Enclosure 1 i L 2
[7590-01] the details of the procedures used to meet them. A license amendment
) would still be required for changes in types of medical use or $ny change in professional staff. Overall, the number of amendment requests is expected to decrease substantially as a result of this simplification.
Because lengthy procedural descriptions are presently affixed to licenses as conditions of use, applications can be 50 pages or more in length. Under the proposed approach, the licensee would operate the facility according to the requirements for human use in the regulations and the commitments made in the radiation safety plan submitted with the application. Day-to-day practices would be essentially unchanged under this scheme, but the volume of paperwork transferred between NRC and its medical licensees and the volume of the license itself would be greatly reduced. Institutions that have broad licenses authorizing research and development of human uses of byproduct material in addition to medical uses that are generally recognized as safe will still have to submit appropriate procedures for review. Each will be exempted by license condition from those sections of Part 35 that would unduly inhibit its I medical research program. Broad license applicants who wish to be authorized for in-vitro and animal research under the authorization of the Radiation Safety Committee and for human use as described in Part 35 will also continue to be required to submit appropriate descriptions of procedures for review in accordance with 10 CFR Part 33. To summarize, placing all_ hum.an use requirements in the regulations andeliminatingsubmittal[of'specificprocedureswouldexpeditethe licensing review process. NRC estimates that eliminating staff review of procedures would decrease the necessary review time by about 50 percent. I NRC estimates that the proposed simplifications would decrease the rate of deficiency letters for medical applicants by greater than 95 percent. This would result in a reduced process burden for NRC and faster turn-around time for licensees. Since the NRC processing time would be reduced, NRC staff would have time to conduct postlicensing inspections of medical applicants shortly after the start of operations. NRC plans to modify an existing MIS to further increase the y efficiency of the review process. The MIS would be designed to decrease delays in the licensing process caused by paperwork processing. It would aid the staff in their review of applications. Furthermore, the J 8 Enclosure 1
3 "The-Connissio h ecided-to cc MIIe flie pre-n censing review m y ( * ,, ,lin.u i g '.st J p c i;a , ,.g c [y of-applicant-s -operating-proceduresTr . '" The staff will i nn : centinue-to review procedures subnitted;in _ 6 p. , .p e " O '-an-- E
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. appl 4ect+cn in order to determine whether they are sqficient ,a
- ~ j. x n ;, ~y- r,y s wili , issue a "
g to neet the requirenents of the regtiationsp) ~ .. deficiencyletteri-fpcccedurcs-a%p,y.wincomplete or inadequate,g k, ,m . . o
} Consistent with current practice, applicants will30e' allowed to ,
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sinply certify that they will folloa the nodel procedure gsupplied in Regul atory Guide 10.8g on-they-wi+1-be--eWwed-to-submit.-tbeir own-atternatTve procedures for review.) (Tlicensee will be citb)
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rfbailure to have\/the written procedures required by the _, ,. , 1 f .w ' u , regulations, failure to follow those",procedurey, failure to have the records required by the regulations, failure to follow technically valid prucedures, or failure to neet the requirements of the regulations or license conditions (which would list, for example, authorized users, locations of use, authorized methods
; of use, authorized byproduct naterial and inventory limits, and y other site-specific limitations). ' However, to allow each licensee
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to nake pronpt use of new safety nethods and to adjust procedures to neet new needs caused by changes in need for patient care services or patient load, licensee'7 s will be free to nodify their procedures without NRC review or approval. At an institution, the Radiation Safety Connittee nust review and approve a modified procedure before it nay be inglenented. At non-institution facilities, the RSO and nanagement nust review and approve f W'I "* a, e; .;..
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nodi fi cations. '4 v I j QW
RAFT PLAN FOR REVISING'PART 35
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The Conai sioners unaninously d octed the staff to revise-S'ECY-83-62 in ccordance ith four directives.
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The directives a,nd'the planned responses
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follow.
- 1. "Thef danission approves the consolidation of the essentia /
SIetyelements. . , nto a Part 35 rule." Except as noted sta lbelow,g the regu on the staff will only naker elitorial and other non-su tantive changes such as addi~ng recently approved drugs n recently approved seale rce device, addin e' initions for podiatrists an entists, and updati the regionalization information.
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) 2. *The CUmi3'slttrhas detitied-tomnti E the pVEniMnTiiig
- -reviga of physietensa_quaHfica ens . .
".G. . proposed regulations w+M-require specific training and experience for
>d the use of material in,>any-particulai3'use group. 'hc regulaMorr and-liccasing ueusi will- h^ re'ficed to-rcqu re-ead proposed i authorized user (AU) physiciani and Radiation Safety Officer '
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-% ' + ' ' s (RS0) and Qualified Teletherapy Calibration Experts (0TCEJ/
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,to subnit sunnaries of their training and experience.eJi.
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form , - A f, i.!' a n/[:. O '; h sini];r *e
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u n %pp onante a nna rt .The staff
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J fwill : ~1 reviewc i' tnose t 'w
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individuals' training and exherience before authorizing then k as an AU, RSO, or h' Use, or supervision of use, j w .- r of naterial without tha-sper#4ed-tenning-end-experience would be a violation of the regulations which would subject the user
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to an enforcement action. /^ ~ 'W / " ' (f
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I-r "The- staff-should-cTari-fy itow-it wi-H-ii.ipl eneat-the gi vp'used-m ' a x s . , ci.< E . < <.J 'a ll, fw, , d ) _i. . , , ,:, .y _ _ 3m , L, miuirenenb mgardtmFlicense-amendments . . ." - ThNff-
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for4saas four types-of-ew,en esets u' a , ,5 6 / a aua ,au ?c y upw Q v d a ~~~'-.d""'~~ 56 -- - s .- > t w i y :. :a Uc * . V*'% ' *% N *' W p.; r . > ra; , Ar , a . ya ,a >> 4 > & a m ta in d' - - d .. a.m.t nu ab w , ; F 't de .a pu tt & ^ f a. ilew users. The)%atf-will review the training and experience NilC -- of each proposed AU, RSO, and QTCE as described " iter 2.- . above. i.b> i .< o p*, .u w,3 , .u'Dj/u v w '{ S !^'My S ' O '- ' '
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/ ty. New type of us'. e Amead-a* requests to add a type of use T ,6 ,, n c e ~, 0c /, a ,w
\
will be handled as a new application. The AU's training and experience will be reviewed for adequacy with respect to the new type of use, and procedures which must be submitted in support of the request will be reviewed for completeness I and adequacy with respect to the new type of use before the anendnent is issued. fc. New nethod of use. Twotypesofamendment%ay-beneeded: y A. If a new radioactiva naterial (RAM) becomes available, and the procedures needed for its safe use are identical to the procedures already established for an already established and authorized use (for example, a new imaging ok, .< agent administered byfi njection), the new RA'i will be added by rulemaking to the list of materials in the appropriate use group specified in the regulations. l The NRC will mail to licensees who are authorized to use m/ke I material in that use group a letter,,that says they may l a begin using the new RAM on the ef fective date of the fip1on Ho individual licensing ac rule that adds the new RAM # m 11 be taken. p /c ,7,6 7c
A M. If a new RAM becomes available but its safe use depends on following a new procedure that current licensees have not submitted and MRC has not reviewed, two actions will ) be taken. t J'. The new RA'i will be added by rulemaking to the appropriate use group in the regulations but authorization to use it will be limited to persons licensed after it was added to the use group. These persons, when na uJ applying for rendaents woul dosubnit the new RAM procedure for reviewq, e/m c/// a d & fuhys. L, ' is /ic 6
- g. NRC will nail to current licensees a let+= that says they nay apply for authority to use the new RAM.
rda e a I:s With thataktier, NRC will supply a nodel procedure, ed <h 4 3 ,,w.p;.;eReX y /p } for the new RAM. -(-T4njs ifould becone a4--a44itica tg
, - - - ~
(Regulatory Guide 10.8A, Those licensees who want to use the new RAM will have to submit a request for
&' 'G "W!222%uk'u hWU
/
amendmenYthat will be reviewed,for completeness and adequacy. This review wm-irlude--ravis efgrocedures for the new 6 1.
- f. New location of use. A request to leave one location of use and begin working in a new location will have to be supported by a complete new application package. A request to add a satellite location will only have to identify the new location. -
,Jo .tay,wI Jo' . .
ca(3 xww (
&'k 4L hi a ; , .ja c , u- / cpu,~ ~ W 0 ' ~' Y ' b ' A 'Y fM t
l[ pm.f.2u , ,4 A!d[ ixa w' .an FMn oc, bWWW N P' "*'
,Nuaf N & ) : d O l b. /sc a l: m J. ( mH *So .'+*;*W'l$
L 7.&
) p ropc s ;d c e il i e r wi l l -eet be a u r.. b 6. 4 ^>'f'"" g H.d /kwu ,mit a>:.tair.)I n La s unr'a xi eu ry
- :c,: , the % a,,,.:.x regu lda/ t'$ry + ~.t ::, .Ju%J.
eM t aeivaly odi Fied (er:cpt for s'J hsenuertLrula h.g A.:o.a gas 4aWve-been
,,o2c, e.m / i u t Is
_.a. <--___--n., ,, g.,, D ^ " ' t and usos)- The G eff willjreview user training and experience,and issue deficicacy letter; if necessary. The M[6 M will review site-specific procedures for congleteness and adequacy aika and issue deficiency letters if necessary, but willgot 7: quire licensees to nud / feHee-the ;pecifir procedures that were submitted in support of the a ' .s v1 i v
^
j' L w.. .u.4 . T, v, x i: n.;o -
- u. ..4* - Q ui, a ppl i cat i on'.
Anendment's will generally be handled just as new applications
,/
)
are handled. "
'{ } ,f - ! Ag e,h s' g h I
h 9
- Ye
[7590-01] 1 MIS can be used to compare application oata with licensees of similar ) type and size. Unusual variations will automatically be brought to thc attention of the reviewer. This prelicensing audit capability would identify conditions that may warrant further evaluation of the applicant's program by the reviewer. The MIS would provide for: (1) automated screening of applications for completeness and (2) an automated data base management system that would permit preparation of descriptive statistics and evaluation of trends. These are impractical with the current manual processing and hard copy filing systems. The MIS would also benefit licensees by reducing delays in the review process. Although the MIS would enhance the improvements of the proposed revisions, definite gains in efficiency would be made in the licensing review process without modifying the existing MIS. However, it is estimated that review time could be reduced by an additional 10 days per applicationbyusingtheMIScombinedwiththeotherprocessingrevisionb. I The time gained by NRC staff through the proposed simplifications would be focused on reducing the backlog of medical licensing actions and o evaluation of other safety issues. . r @Under the proposed revisiont', the license would authorize medical use of byproduct materials. Licensees would be regulated by the require-/ ments for use specified in the regulations. This would simplify h [I t ~,P C ' '
- t7 tions for NRC inspectors because they would only need to be familiar 4 &J.//
with one set of regulations rather than a different set of license iconditions and procedures at each faci.lity. _ N Scope of Revision of Human Use Regulations (10 CFR Part 35) -- , NRC is proposing a revision of the human use regulations to (1) provide the necessary changes to clarify and simplify the medical licensing process and (2) include staff resolutions of recent issues and of a petition for rulenaking that pertains to medical licensees (PRM-35-2). Most of the changes involve a transfer of a recommended practice or requirement from another NRC document to the regulations without modifi-cation of the requirement itself. 9 Enclosure 1
i.n < s, m rm *
-/ e 4 ~ wn,u,. s.
> .M s'" w hi d d.m ' ""I -.
~?
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~n' ' ' v
{ Jf t j /j) w. ?:y, , ;s c < g,g d me. m.h u a v a 9e y' u e /^6 A - *d [7590-01] e g n; ,, >r. mi k:ai , i ,v , i
, '~
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+ : it : w . ;
/i,rk & at . sa,/,4,x , ;'_3 _,,;c,,;;; J'lm',.4 4 a <,:, w f,3n N 4v
;rs;H<:l 0 ,w w,a.i /& % 0 :i; / y iimwi.Discussion mh of-Proposed-Regulat7ons >
) e. .,, ,
..f. ~ f.)
The primary purpose in initiatinTf.fiis~irevision to the regulations is to simplify the regulatory process by providing licensees with a single source of requirements for the human use of byproduct material. Radiationprotectionfr'oNresnowcontainedinseveralexistingregu-lations, Inspection and Enforcement orders that modify a single license or group of licenses, technical reports (NUREGs), standard conditions
; of licenses, and regulatory guices would be consolidated into a concise f set of regulations. The requirements that apply to all licensees appear L rst, fi followed m by the specific requirements for each of the six basic
. , n J < n. u r
types of use.YgThe-previsier, for general licenses has been eliminated from the proposed regulations, and all human use will be specifically 1.icensed. (Current general licensg*s will be incorporated in the specific license-system. Gencrci licen:cc ;jw,ll wi be limited to the i I ta . u k.. , .
-methods of use described in the current S 35.31, and relieved, rom
/
those provisions of the proposed Part 35 that,; aresaxW,w unnecessarill b urde % someforthoseauthorizedamountsandmethodsofuse.)(TheproposeD isp'ecific license,~# .differ from the current licenses because they would n e a . m y x .im w c r ut.n, w (- not speci y additionaTyrequirenients y except in unusual cases. Items of general information, general administrative requirements, l and general technical requirements are addressed first,,-- These-are-found- j inSubpartsAthroughC,respectivelyjoftheprupuseu reyui a i. i uns. Subparts D through I contain the additional technical requirements that apply to licensees for each of the six types of human use. Subpart J lists the training and experience requirements for cccb type sf d and Subpart K lists the penalties for violations of the regulations. In order to maintain consistency among the various parts of NRC's regulations, conforming amendments have been made to the affected sections en sit . of Parts 30, 31, 32,.and-40f These conforming amendments can be found immediately after the revised Part 35. A s,ection-by-section discussion Su 's - (of th_e g //a w :i proposed a m i lw . u k.revision b g n >l Eof Part m. 35 follows@ $' % u'a && A ", ' I' ny eM m,o nAcQ 4 A autm ,L / .J ,; i:,. w .. ! b e., /,,uz, 4 /s ,a a kt Jw , a . \ Subpart-A,--General Information-q q ,j . ,, 3.ug j o s., , ,, . ,. , , 4 n S 35.1 Purpose and scope. 6 a u N /m 4 - o 'E " A "i " " #*' M ^ #
< e. .j . x1 a. -
The regulations in this part apply-to all pers'nso li , censed by the ! Commission to intentionally administer byproduct material or the h s
&/,,, 4 10 Enclosure 1
, .k @ % m ila d a s a 5 >!il .
~h % , ui.,'c.z,u s.y wa n c n ..s
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; 6a uH .q is') '%a
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, a ,,,m p u~10 4 es / m nid?
,. % q wat u th m*JJ u m b as c . /Glo,
[7590-01] radiation from byproduct material to humans, and to individuals working under their supervision. S 35.2 License required. g,., / __ This section requires that persons,whoI h'andle' byproduct material M N"'* w_-
' have a license issued by the Commission or an Agreement Statet The Commission uses the specific licensing process to limit the use of byproductmaterialtoONlNentswhohavetheequipment, facilities, training, and experience needed to ensure its safe use. Individuals who are working under the supervision of an authorized user do not need a y
licensef This does not relieve them of the requirement to conduct their work in accordance with requirements of the license and the regulations of this chapter. The licensee remains responsible for the noncompliance e of such agents or employees, and may be subject to sanctions for j failure to comply. S 35.8 Reporting, recordkeeping, and application requirements: OMB Approval. This section certifies that the Office of Management and Budget has } reviewed and approved the information collection requirements contained in this part. S 35.15 Definitions. The term " Agreement State" was included to identify those states that have agreed to assure the safe use of byproduct material within their borders. The word "ALARA" was added to identify the acronym for the phrase "as low as reasonably achievable." The term " authorized user" was added to identify individuals who are identified by name on a license and who are authorized by the Commission or an Agreement State to administer byproduct material, or
' " y _, :/ s w.
the radiation therefrom, to humans for medical care, ' The term " dentist" was added to identify a group of practitioners who might use byproduct materials in their practice. The term " human use" was included to help identify the scope of this part. The word " intentional" was added to the current definition of the I 11 Enclosure 1
[7590-01] cur. rent-definition-of-the term human use to make it clear that occupational
)
and nonaccupational exposures under the regulations of Part 20, accidental exposures, and unwanted exposures from other sources of radiation (e.g., nuclear powered cardiac pacemakers, smoke detectors, and radioactive waste) are not considered human use. The word " institution" was added to identify organizations with medical byproduct material programs in which the safe use of byproduct material depends on the cooperation of individuals from several different departments. The word " management" was added to identify the individual responsible for defining the licensee's polic; wand allocating personnel, budget, and space resources. The word " misadministration" was included to define those instances in which a mistake has been made in the human use of byproduct material. The definitions are consistent with the current 9 35.41. The term " mobile service" was added to describe the transport of byproduct material for the purpose of offering diagnostic nuclear medicine } services at addresses other than the principal business address of the ( licensee. The word " output" was added to describe the amount of radiation in a teletherapy beam. The word " physician" was included to identify individuals licensed to practice medicine and therefore eligible to apply for a license to use byproduct material in the practice of medicine. The term " podiatrist" was added to identify a group of practitioners who might use byproduct materials in their practice. The term " qualified teletherapy calibration expert" was included to replace the term " qualified expert" which is used in the current 9 35.24. The new y, term better reflects the training, experiences and responsibilities is s. u .- l of.that individua1 j i > y's 'i- /' S'/dy erk5 - +;. a"d The term " Radiation Safety Officer" was added to identify the individual ident4f4ed-by name>1 on a license and who is responsible for managing the licensee's radiation safety program. The term " sealed source" was included to identify byproduct material that is specially encapsulated to prevent leakage or escape during use and storage. It is the same definition as used in 6 30.4. 12 Enclosure 1 i
/ ..
S
~
,- [7590-01]
t
,. "/ .
, ,[
The term " visiting authorized user" was added to identify authorized users who, while working for a licensee on a temporary or occasional basis, use byproduct material under the restrictions of the temporary employer's k license, which does not identify the visitor as an authorized user.
-SM5:16- Application ~for license,'and S'35.17 ~~ License ~ aine~ndme~nts.
~
The criteria ~ that"will be used-bf the stafFt6 evaluate-requests for-ti' enses, c amendments, and exemptTons ire ~ identified-in-9-35.-28,- L-icense-issuance 7 0f this discussion of' proposed regulations. i S 35.16 Application for license, n , U, n a . :u d A physician,in private practice may apply for a license. An indi-i vidual physician may not apply for a license if his use of material is >
}in-connection-with-the provisions -of -nuclear-medicine services-by lii
institution,-i.e.$ [an organization dictr provides various medical services'. At an institution, only management may apply for a license) > J The individual physicians would be listed as authorized users. This requirement reflects the need for coordination with other employees who may not be under the administrative control of the authorized user. W
/ An application must be filed on Form NRC-313MH'because it elicits informa- ; .,-- - i I
tion in an orderlyf-ceedettle'mannerj -It ,/ will .also allow for uniformity
\y in Commission information handling systems.
This section also reflects the Commission's decision to delegate to Regional Administrators some of-+he- licensing functions which, until recently, were conducted in the headquarters. This program was described in a Federal Register notice published April 14, 1983 (48 FR 16030). . S 35.17 License amendments.
- q. .-
The Commission-believes that si ync e-e x po s u re s-s hou ld-be-kep t-as -l u w as--reasonably-achievable-(ALARAh the licensee must obtain an amendment for any changes dthe,14 cense that might increase the potential .for radiation,to workers and the general public /The Commission has deter- 7 mined that certain changes are potentially significant for the following reasons and thus will require an amendment: '
+1 r ut*d ' L (1) A change in3 t ypejof human use orireceipt'of byproduct material /
may increase radiation exposure.' ' ' ' ' '
' ' ~
/ s .
t (s ,, .6 , , , e fa !
~
_/
,/,, ;/ 1 cc 13 ' Enclosure 1 _
,~
an. . . . . ,
y ,'n p p .w ~ A' : p:!, & fu a " 'm ' y - } .) L/A.q . C /CDM/f, "c "f ,** ' v * **
~d u, .b d , a a . L: , ,: ^
[)7590-01]
*t J, "
(2) The use of byproduct material at an address not identified on the T e.,w (Jm b d e , .c- < ll; & < . . - 0 . . . .d c u a wu n > t d m n n '. Y
} l i cen s e may-al4ew-en-inc. . .;is.rease-irr unmonitored-radiation-exposure-levels: i 3 A change itt-Mthee--the-individual--listed-as-the iEadiatio~n (Safety _0f ficerf,36-en authorized user, or-as-the' qualified teletherapy
' , calibration
, s t, .. . experthequiras an amerdment-request-so-thathheCommission -
may-determine'that the training and experience of'Thi,-k,e indindual-n-bsufficienttoensuresafeuseofbyproductmaterial. (4) Any other program changes that might result in an increase of j w m. - 1 radiation exposureato workers or the public requires an amendment. S 35.18 Notifications. A notification requirement was added to require the licensee to , notify the Commission if an authorized user, Radiation Safety Officer 1 (RS0), or qualified teletherapy calibration expert is no longer affiliated { with the licensee's byproduct material program. The NRC would no longer ' be assured that the collective training and experience of the licensee's remaining personnel is adequate to assure the safe use of byproduct mate-rial for all the types of use authorized by the license. (For the pur-=-
-pose of-ttTts 3Latement7r consideratRn7thTrerm-" type of use" refers' l
to-titles of_ Subparts _D_ through_1.- For example, tiptakei dilution, and- l excretion is a-type of use-Imaging'is'~a' type of~'Use. ) The Commission has made a judgment that notification within 30 days is sufficient. Technicians who have worked under the supervision of the authorized user can adequately assure the safe receipt and proper storage of byproduct material for a few weeks ( This parallels the Commission's judgment that common carriers who handle byproduct material packages neednotbelicensed.)However,overalongerperiodoftime, r absence of an individual to oversee,p' ogram r 4ssponsibi44 ties may increase the probability of an accumulation of unused byproduct material or unauthor-ized use of; restricted areas. This presents an unacceptable potential hazard.
- .1 ,:. i;~, J
, i
' n cyt > '
S 35.28 License issuance. The Commission has selected a license term of five years. A shorter term would not benefit the public health and safety because" , medical programs do not generally change significantly over that period of time. 14 Enclosure 1 l - - - - - _ _ _ _ . - _
, 1
- Jpvo ,a., , , ,
- p ' _' ~ / s. , pe, ;.
[- y .f [7590-01] l
/
A shorter term may unduly interfere in patient care because the licensee would spend an inordinate amount of time requesting renewals. Overk longer term, the-descriptive-information7 i,.~.x submitted Wthe appMration' j,..1 m 1. , a, .i , . . .c s / n .o . + . may no-longer, accurately-describe-thefs. cope _of the byproduct-material ~ progc2= and rascurces-availabler-- i h .~The applicant must use Form NRC-313 M-because-it-wasm pecificaHy-f , ;.a s, , a . , >w,
.dasigned-to-eli eirte-the-i n f o rm a ti o,.n-t he- C omm i s si o n -need s-to- c omp l e t e-
-e safety review of the applicant'.* The' Commission will apply certain goaun en standards when reviewing an application to-asjure that the safety of i workers and the public will not be compromised if the license is granted.
The staff must be assured that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property (S 30.33(a)(2)), and that the authorized users are qualified by training and experience to use the material for the purposes listed in the application in such a manner as to protect health and minimize f danger to life or property ($ 30.33(a)(3)), and that the applicant has I l established procedures adequate to assure the safe use of byproduct t ; material. It is the sense of Congress that fees may be necessary to
! recover operating costs. The Commission's discussion of this topic is f femd in 36 FR 145, published January 6, 1971.
l I ! S 35.29 Specific exemptions. The Commission may allow"6xemptions .w* from-thie fequirement$c of this n ,e ---- - _p@if the applicant can show the-exemption <will not compromise the health and safety of .theworker' and public.
)
j Subpart B--General Administrative Requirements S35.30 ALARA program. An ALARA program is a management tool needed to assure that all I reasonable efforts are made to assure the safe use of byproduct material in institutions. (See ' Management Organization and Administration for ALARA' by Kathren, Health Physics, Vol. 42, No. 2, February 1982,
- p. 119-131, and ' Radiation Safety in a Nuclear Medicine Department,'
by Gandsman et al., Health Physics, Vol. 38, No. 3, March 1980, p. 399-408.) Many workers from different departments within an institution 15 Enclosure 1
f,b t.:uS b .. ka ,,u(la N.Tckc.lYNNfIhlf a,,.a G M' wn NY AYA5h '"[ l pjtd. ! 7w 'L s **~ :M I/mmM r ,%
'[7590-01]
n tw.e,:.Ms Cw g:,' 4't ;sa u uJ i '- A hJ 9 .x Ali
- ;,, j u ij.a ,J ew an w i .u .
'up r4 ' m ~ dN.) x might be occasionally exposed to byproduct material. The Commission has made a judgment that a formal ALARA program is the only management
, pw4 m o . ,+c : f tool that canpassurp that sources of radiation and work procedures,are us .w regularly reviewed for safety. Specificidet4ee usually considered part of an ALARA pro '~ / - " ~ H ,x. n m :.y. gram w care required by .a kpad-cc SS 35.31 and 35.32.1w ,.n 3 , f ,siu n h a.3 l La a a d.1!,pd a p .7,, a , , , ,t ,a.x) u .k A up. w 9 , t, n ..q# w . .: v &D 6 y'7 'S 35.31. Radiation Safety Committee. ' a w w "a, v> 7,n" W.n w'F, o w""w. ~'"#'# g n a u nw . The proposed Part 35 requires institutional licensees to establish a Radiation Safety Committee to oversee the use of byproduct material. Under this proposal, committee membership must include a physician identified on the institution's license as an authorized user of byproduct material for each type of use permitted by the license, the institution's Radiation Safety Officer, a representative of the institution's management and a representative of the nursing service. A similar requirement was s ~. published as a proposed rule on April 9, 1979 (44 FR 21023). ,.e. _ The NRC is not soliciting comments on the Radiation Safety Committee rule of Part 35 because an opportunity to comment on the rule has already been provided in the recently completed rulemaking on the Radiation Safety Committee. That rulemaking, published as a final rule on September 13, nw~ , . ~ r.1 , 4, 1982 (47 '.
- FR 40149),,jwill-be incorporated in the'41na h ording of Part 35.
Jhe Committee must_reviewdl)_the s,in ,.,a: u s qualifications of each individual i 7 (tobe_listedasanauthorizeduser[+and(2)eachproposedmethodof_used , c !? to assure the_ safety of workers and the public A 4 'In its reviews,
- ,,, im a n in ,r. m ci,oc -
the committee should consider compliance with NRC regulations, special l physical or chemical containment problems, the amount of byproduct I material that will be used, and the relative hazard of the material. ! l The committee must review o.ccupational exposur_es,guarter.19b. A,more
- ~
freqN 5 ( @ Wourd inappropriately emphasize normal ~and' expected statistical variations in exposure data. A less frequent review would allow an unnecessary or unnecessarily high exposure to continue l uncorrected for an unacceptably long period g
$The quarterly review should beA.ased-on f . % .o .. -
two trigger levels for individual exposures. The lower level would be a minimum level below which no action need be taken. Above the minimum level, the A source nn of exposure should be determined and consideration given torreducing the
, exposuref The higher level should trigger immediate intervention by the 16 Enclosure 1
/^ 's [7590-01]
i t ' I Radiation Safety Officer to reduce the exposure. The committee should review the appropriateness and completeness of the intervention, and should develop a permanent solution to maintain exposures at.a lower level.
'- The annual review of the safety program should-inc4ude-the-status-
# 4 . y ., . u
.of- current,,use of all byproduct material. In the Commission's judgment, a review at least once each year is adequate to assure that exposures
,, , o remain ALARA considering the few programfehanges typically made during any single year. More time between reviews might not permit the committee to make timely recommendations for avoiding unnecessary worker or patient exposures. ,,
x ; <ay c. 1 S 35.3s) Radiation Safety Officer. An individual with special expertise is needed to coordinate the safe iise of'\ byproduct y material in accordance with the license and I regulations. T4 lieladiation Safety Of ficer (RS0)'.i.' In ; 35.3fh L_ paragraphs-fabthrougtr(v) spectfy~ttle RSO'rTafety 765ponsibilitiet:- S 35.33 Admin kttatu ., e Requirements / forAuthorityAdd', Responsibilities. c ,, 4 , a To 'a'ssure that proper,-records-are'_kep.t , -responsibili ty -for- record- ' au . o ', ,,sn ~ . .
. . .m. .t , ,! , -
, er< ,'
keeping ~ required -by -this- part -rests with- the RSO and..the committee. > n., . .i. . . . .. ; , < p.p. s a a ..i,,i.,q Recordrthat desc' ribe the . licensee's_ receipt,_use, andIdisposal- of-l byproduct materal',~ equipment checks, and surveys.must be kept. The licensee must also' keep records that show that the RSO, the authorized users, and-qtialified teletherapy calibration expert meet the training and,ex6hriencerequirementsof,SubhartJ. These records may be either
/
topies of certifications.by ' certifying bodies listed in,that subpart, or a transcript of,appropfiate training courses and a narrative of experi-
, a.ae, e . , ,s .<
encej which together meet the appropriate requirements of Subpart J. For R50'sj authorized users, and qualified teletherapy calibration experts x l who do not have a certification, the preceptor's statement ,-form NRC-313M
, /
Supplements A and B which is-appended to Regulatory Guide 10.8, i c6nstitutes an adequate record. S 35.34 Visiting authorized user. In the Commission's judgment, the uninterrupted provision of
-necessary medical., services occasionally requires a visiting authorized 17 Enclosure 1
_ - _ - ---;--, = - - - - - - - -
'fj pia /z knu ruld
- h f , ' " " ' " " ' '"
i in :+b u t' b w k c & f $ "y ~"" (h '
, [7590-013 a s u&,4 .v.lth nNvh'n N * " '" ' ' ' ,
w. k t ,w wn A / w' dak :.s.A n.1 hu d
)
~'O M' S *'% ) fY
- user to work for a licensee for a limited period. The sixty-day limit
) of 6 35.34 will allow licensees to provide uninterrupted service at times when its permanent staff may be unable to do so. Since the visit-l ing authorized user has the required training and experience, public health and safety will not be adversely affected at the visited medical f facility. Visits of more than 60 days in on'e year suggest that the visiting authorized user is an integral part of the institution's health care delivery system, and should be identified as an authorized user on l l the medical facility's license. f I i S 35.35 Mobile service administrative requirements. k--- 4 Mobile service licensees are required to have a letter of permission i e l from the management of each client facility,, -TMs-wQassure that the L. l client management is aware of and in agreement with the human use of byproduct material within the facility. i 8 35.37 Records and reports of misadministrations. r
'o
( The proposed Part 35 maintains the misadministration definitions )' ~~~
'and reporting and recordkeeping requirements of the current Part 35 3 440-changes have-teca = d;-to-these requirr =tt NRC is not soliciting comments on the misadministration requirements of the proposed Part 35 because they are identical to the requirements of the current Part 35.
On October 29, 1982, the Commission in SECY 82-388 disapproved the , staff's recommendation to propose withdrawal of this requirement. l 6 35.38 Supervision, j The authorized user is qualified to use byproduct material in the practice of medicine. Frequently, specific tasks may be delegated b (under 6 35.2(b)) to individuals with less training and experience. nuvw Thw afoe*, it is necessary that a qualified individual instruct them, oversee their work on a frequent basis, and be available to promptly respond in unusual or emergency situations. When using byproduct material, supervised individuals must comply with instructions, procedures, and the regulations.
% ;{ a% , .:t.v ,
% y a m D " '~ $ N N /"^ '
18 Enclosure 1
, !( n# [7590-01]
(}, .Ju A alw\ g;i S 35.49 Supplier g j gJ I.. p " authorized users may use only radiopharmaceuticak-that-have
-been manufactured and distributed under procedures that were reviewed
, for safety by the NRC, the Food and Drug Administration (FDA), or an Agreement State. In certain institutions, the FDA has vested in a Radioactive Drug Research Committee (RDRC) (pursuant to 21 CFR 361.1) the right and responsibility to review for safety certain new radio-pharmaceuticals that are in the research stage. It is the Commission's x , m .. , judgment that the review criteria established by the FDA and,followed by the RDRC arJ Tufficient to assure the health and safety of the public
)
and workers. Subpart C--General Technical Requirements 6 35.50 Possession, use, calibration, and check of dose calibrators. f Acc'uraEp[m~
~
e enithe~ ability'to exactly measure a specified quardify[ M l 1 gearity, means- the ability to exactly measure a range of quantities., ' A dosiblibrator'htis[Ie tested ~foratheqc character 4sMos-to[ssure that J
^^
the#adunt- of material given is thejpresc'ritie~d.[ME [The AiiiirTc7 u. a .<
.u National Standards Institute (ANSI) recommends these; test frequencies to assure the proper operation of dose calibrators. (See ANSI N42.13-1978.,)
The activity levels of the accuracy check sources were chosen because a lower activity would invalidate the accuracy test due to expected statis-
~
f tical fluctuations. To choose a higher activity would present an unnecessary source of radiation exposure to workers. The geometry test f ! ! assures that the shape of the syringe or vial containing the byproduct l' l material does not affect the dosage measurement. The daily constancy I check assures that the dose calibrator has worked consistently since it f was last tested.
! S 35.51 Possenton,-use,. calibrationgd check of survey instruments.
The 1000 mR/hr limit was chosen because that is the highest radiation exposure rate that is likely to be encountered in the medical environment.
, Thi libration f requency[c'o'nsistent with ANSI N323-1978.SeeMon-4rbi g
, f~~[ , . /... J n
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r ~v ni r . 9 a .c ,
[7590-01] J S 35.53 MeasurementofgadiopharmaceuticalDosages.me ,
+ I /
). This section requires that the licensee assay each j radionharmaceutical dosage before it is administered to a patient and keep a record of the assay results. This procedure is currently required by ell sp :ific-Meenses-for medical-ttse-of-byproduct aterial to $Uure that the patient receives the intended dose. A similar requirement was published as a proposed rule on September 1, 1981 (46 FR 43840). The comment period on the proposed rule expired November 30, 1981. Eighteen comments were received. The NRC is incorporating the dosage measurement proposal in this revision. The proposed Part 35 dosage measurement requirement differs from the 1981 proposal only in its recordkeeping requirement. The
- Part 35 proposal requires the dosage measurement record to include the l patient's name,and identification numbef." 'ThiIinforha~t' ion is not ,
required by the 1981 proposal. NRC invites comment on the requirement that dosage measurement records include patient information. NRC is not soliciting comment on other portions of the dosage measurement require-ments because they are substantively the same as the 1981 proposal. Comments received in response to the Part 35 revision and the 1981 dosage measurement proposal will be addressed in the statement of consideration published with the final rule revising Part 35. S 35.58 Authorization for calibration and reference sources. n.a ..~ These sources are needed jto test- the preper function-of- radiation afetyinstrumenth&ien,+3They represent
., n wsv ...
a small radiation hazard in rela-tion to the amount of Iadioactivity used in patient care. The activity level was chosen to allow licensees to have a range of sources with several energies and hal f-lives available. te-f*Hy-test-theic-equipment, S 35.59 Requirements for possession of scaled sources. The user must follow the manufacturer's instructions because they have been reviewed for safety considerations by the Commission or an Agreement State. The six-month test interval h in the current rea da-t4 ens-and has been recommended by the National Council on Radiation 20 Enclosure 1
[7590-01] l Protection and Measurements (NCRP)1 inReportNo.57,) Instrumentation and Monitoring Methods for Radiation Protection.', More frequent testing is inconsistent with ALARA considerations governing worker exposure because it would cause occupational exposure with a negligible probability of finding a leaking source. Less frequent testing does not adequately assure safety. The test procedures described maximize the probability of detecting contamination from a leaking source. Report No. 57, Sec- ,
,.n. ..s a a.a w c tion 3.3.5.3 recommends a ==d u permissible-removable-contamination l
,,,,,.. n a s a . c.2. s < s.n u . .-
limit of 0.005 microcuries forfsealed scurces % This level is co ,nsistent ; with the requirements of other parts of the current regulations (see, { for example, SS 31.5 and 34.25), and is only slight".y nigher than the minimum detectable activity exhibited by instrumentation available to f licensees. The Commission has made a judgment that this level provides the most conservative detection level technically achievable at a j reasonable cost. The Commission has made a judgment that records : l retention for 3 years is sufficient to show the existence of a working l sealed source leak test program. To conduct a physical inventory more l frequently is inconsistent with ALARA exposure goals. To inventory less ,
- b. ,n. sp .. , , ~a n . a . ;
/ frequently maygallow an unacceptable radiation exposure to go on for too ; long without detection. The Commission has made a judgment that the f exempted sources do not present a contamination hazard because of the i small amount of radioactivity in the sources, the method in which they are constructed, the short half-life of the byproduct material, or the ! small hazard of the byproduct material. S 35.60 Syringe shields, i e ! Syringes that contain byproduct material f p, a ,it an external radla-I tion hazard and should therefore be shielded at all times. In some cases n an . ;. o . the use of the,shieldjcould interfere significantly with the injection. 1 d t% =terii Since this would Meh patient benefit,ithe higher pr s,p .v u a. , ~ 1The National Council on Radiation Protection and Measurements (NCRP) is a nonprofit corporation chartered by Congress in 1964 % draft pro- ! posed recommendations on protection against radiation andA radiation ; measurements, quantities, and units, particularly those concerned with r radiation protection. l l 21 Enclosure 1
-in 3l %,,,a,s t,s NJ & ,,., u ,, a c,n s , , l uj a .w'-Md nyiw,.an G , , , n , , f ,.
a ,, (s,j6 w%is: gi.94 a.m xw ~ ~ :<w 0 w hpm.
,,v n.
- d. 2 ,.<di.,t, p u
w.
,,n,
. . 7590-01]
[, i ,~. & , , b dd , l l ' ll yi% d,w(Jn. .&%<<, n' ~ A Md , / ,' y ; } , w ,. w ,,. lTll.*d .e ., s ~ pyr', .a y a y : .. J. ; ,( , , *;,,,,, radiation exposure 3 received by the technician /in-the-absence of a shield ag ~___ ) is warranted.(,} m ~ sIhere the harm-from- extravasati_ong forexample,[isgreater than the benefit of reduced worker exposuryQhT~ eld need not be usedQ S 35.61 Vial shields. A vial radiation shield can significantly reduce the radiation exposure to the fingers and hands of an individual handling a vial of byproduct material. SS 35.62 Syringe labels, and 35.63 Vial labels. Some misadministrations have been caused by accidentally transposing
\twovialsorsyringes. The proper labelling of containers will help to avoid this type of mistake.
S 35.70 Surveys for contamination and ambient radiation exposure rate. Since radiopharmaceuticals are frequently handled, it is plausible that a syringe or some radioactive waste may be mislaid. This would result in unnecessary radiation exposure to workers and the public. The m .s. ) usurv. a v,,.. ney will bring this problem to the attention of workers. The weekly
~. a nw
, survey of waste storage areas will ensure that exposure,to-workers in thatareaand-to-uncontrol. led-areaswillbemonitoredand%hatspecial
- c. . ~
steps w Ria be taken if greater than avera.ge use of radiopharmaceuticals
'results in higher than average exposur(IE& -in the waste storage area. The Commission has made a judgment that records retention for one year is sufficient to show the existence of a working survey program.
S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. A patient whose body contains byproduct material is a potentially hazardous source of radiation. While"the Commission proposes to allow
\
release limits based on residual activity in the patient or exposure rate at a specified distance from the patient at the licensce's option. i -. The 30 mci limit is based on a recommendation of-th~e NCRPsand current g7 e .. licensing practice.) For iodine-131, the most common
,o ,,, ,. , o.
therapeutic
, n .
radio-pharmaceuticalk'gthe 6 mR/hr limit'would-result-In a-whole-body-dose. q'ulv'a5AttI-aco-workeror-familymemberof'about-500~ millirem,-assuming s 3, ,% m n, u .;.s , ,s.
.i,_
m,' - < - '
~'y i , .y ( , ;. ;. ;/-
; ,a - m< c .< '
J, , .m aa/ < , 22 ' Enclosure 1
[7590-01] L. . a J. i ?,- ri .u. n i. a iV' . E u, ,,, j h y a n ,a s h , . n ,t ,% l
's that-individual spends eight-hours per-day-at an-average-distance.of-.
Lmeter-from-the patient. The-Commi.ssion-considered.a-lower-limit that , wouldirequire-a longer-period of-patient-confinement. " The Commission # has made a judgment that further reductions in public exposure are not reasonably achievable considering the potential for detrimental effect f ~
-of- an unnecessaril/ long hospital confinement.
S 35.80 Mobile service technical. require,me.nts. , , . .. a - _ . . . - , The Commission has limited $ mobile service licensees to transporting s ,
- n. . ...a > n., . :
-ybyproduct-materiabas unit dosages be.cause,_at' s s.
this-time,, there is
~,r., .
~,w ea.. c . . s ,aa.c m insufficient assurance.that_the facilities,:and_ equipment-needed to-pre-
,, m i . ' -
. pare bulk radiopharmaceuticals' and-pa,rbr. :, .m-quality-control-measurements. 1 can.be-frequently transported and still worLreliably. The mobile service must remove all radioactive waste generated during the use of byproduct material at a client facility because it is unlikely that the client facility has a li, .<-cense to :receive
,. , . u. . . ~ and process
< ,~.i w,~ radioactive waste. x, The mobile service licensee 4must-co'ns4 der client facilities,Ja,s unre-
~ . . ,
stricted areas,beceuse there is no assurance that the licensee can control access to areas of use while working in a facility that is under another person's administrative control. g
-The equipment checks required by r35-80(d)-is-necessary/to assure theproperfunctionofsafetyinstrumentationand,Nguipmentafter,trans-
., uam port and before byproduct material is handled. The survey reg: M d by-T-35-00(e-)-is to assure that all byproduct material has been removed I
from the location of use. The mobile nuclear medicine service must carry a calibrated survey meter to monitor exposure and contamination in caseofa-traffic-or-otherjadcidentthatmayresultinareleaseof byproduct material. The Commission has made a judgment that records retention for one year is sufficient to show the existence of a working exit survey program. 1 SS 35.90 Storage of volatiles and gases, and-35r20E-Control-of-
-aerosols-and_gasesr --
Some radiopharmaceuticals present an inhalation or immersion hazard (e.g., iodine-131 and xenon-133). That hazard can be minimized by 23 Enclosure 1
s .; , , c n ie, . .~. . ~.).. 'u) n A N3" "l ? d?, .< Au
,, .., e ; .e , . J. ~ J.n <., ' , J dA y n,.t.,a n n.s
. , , ,, , w ,,,,'[7590-01]
9 / s ,,. ,f, , <t. . g ,. , a j, .-3 ~ :J i ^
'q storingtheseinafumehoodordoubleairtightbarrier),andbyusing
) them with a collection or ventilation system. l 635.92 Decay-in-storage. , ,,. s . . . ~ t-For most hospital / waste, decay to background levels is essentially complete over a period of days or months. The requirements of 6 20.301, directed primarily at longer, half-lived material, are not necessary for tm a-short half-lived hu , man-use waste. Because the special handling required u. for long half-lived material isj,typicaHy not needed for human-use m 4f & d' * (
,,s~,<ari .. . . . , c waste,pf-3&r92-exempts-thiswaste[ fro,m,ther,equirementsofS20.301. A
( half-life of 65 days was chosen as the decay in storage half-life cutoff limit because storage in excess of 650 days is more appropriately con-f sidered as permanent storage. Ten half-lives was chosen as a decay f period because such a time period will assure that, in most cases, byproduct material will have decayed to levels below those in 6 30.71, s,: - which are quantities that, underispeetfie c'onditions, are exempt from a requirement for a specific license. Waste must be monitored to assure J.J 1 ." f . v a ?? ise: 4, / . e .t. i e a s- cs, f,, ' . , x y .it # ..,w ...*r. st -* that long-lived waste was not accidentally mixed with short-lived waste. When the waste is monitored, neither the waste nor the survey instrument
...e may have any radiation shielding (Shielding-of-the waste ordetector-might hide the presence of long-lived byproduct material in the waste.
+The Commission has made a judgment that records retention for two years is suf ficient to show the existence of a working decay-in-storage program.
SubpartD--fG70upGenerai ptake, dilution,7ex ) S6 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion j studies, and 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studles. Drugs approved for human use by the FDA have a label or package insert that specifies the FDA-approved use, physical form, route of administration, and dosage range. NRC relies primarily on FDA's deter-I mination of a radioactive drug's safety and effectiveness when it is used according to the package insert. By restricting the physician to the FDA-approved physical form, route of administration, and dosage 24 Enclosure 1
($flini y .c nim.hso l
- o. A au LM ~
W 'M JK m
* " I~ '
- e. Aujw
' I' d " '
g : ym , . , . [7590-01]
/ (f ,.,u. x n n. u o tt) n J fc ). a u w '? + 2 Ja - +' i. v .+! .,~, - x. a N. c.., , way. Ak, u ht !/ >> .a k %4 F t " ~ ' ~~' s "- w h ~ '% " n - f M - % ) n tg fe s a d. , ./. a.wsA Asa s i. - n a' 4 U p " !" ' ' '
range, NRC assures the safety of the public while allowing the physician
, flexibility regarding the choice of the clinical procedure. W 4/ JS Manufacturersarecurrentlydistributinggeneralklicense0 radiopharmaceuticals under a license issued pursuant to section 32.70.
If this revision is adopted by the Commission, these manufacturers would have to apply for a license amendment to distribute radiopharmaceuticals pursuant to section 32.72.
].G
.u u O )7 ~ {(_a Subpart E--Group II/III) Umagingh S 35.200 Useofradio}ihdmaceuticals, generators,andreagentkitsfor imaging and localizat' ion studies.
Xenon-133 as a gas or saline solution has been added to this group. Manufacturers are currently distributing the product under a license issued pursuant to Part 30. If this revision is adopted by the Commis-sion, these manufacturers would have to apply for a license amendment . to distribute xenon pursuant to section 32.72. l Through continuing medical research, new uses may be found for existing approved radiopharmaceuticals. These new uses, which may / require a different dosage, route of administration, or physical form, may not appear on the manufacturer's label or package insert instructions. It was such a situation that resulted in a petition filed by Dr. George V. Taplin (Docket No. PRM-35-1) requesting an exemption for Tc-99m pentetate aad aerosolyd-for lung function studies. A proposed rule was published on April 13, 1982 (47 FR 15798). The comment period on this proposed rule expired June 14, 1982, and 35 comments were received. The NRC adopted the rule in final form without change on February 4, 1983 (48 FR 5217). The NRC is incorporating this regulation into this revi-sion of Part 35 without soliciting public comment because there are no substantive changes to the rule as adopted. 6 35.204 Permissible molybdenum-99 concentration. When molybdenum-99 undergoes radioactive decay, clinically useful technetium-99m is produced. Occasionally, unwanted molybdenum appears in the technetium solution. ~
+
25 Enclosure 1
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[7590-01] The permissible concentration of molybdenum-99 was chosen to be ) consistent with the permissible concentration listed in the United States Pharmacopeia (USP), -The USP is the nationwide standard for all pharmaceuticals used in the practice of medicine. It is the judgment of na u;r A,ame av.us a o ~w a u wd at : wn a > J the Commission that3 tovinutroduce
,vp a different standard would,,_in-this-
-case s beconfusingandunproductive.]
GSince diagnostic dosages of technetium-99m are generally 30 milli-curies or less, the maximum permissible level of molybdenum-99 in such a dosage would result in a patient receiving an undesired 4.5 microcuries of molybdenum-99. The molybdenum would be taken up primarily by the liver. The dose to the liver would be about 0.2 rads as a result of the molybdenum concentration. The Commission has made a judgment that this radiation dose is insignificant compared to the radiation dose which would be received by the patient due to the administration of the technetium. S 35.205 Control of aerosols and gases. Add tcxt. M b " ~ 'A ' " " > i //st+:p4m M.d y u ;/a 4, & e%/m + w h '# d
'"f*fO F k
/ 0/lShMSubpart i""# F mGroup d " " P' " " ' ~ D "_ '~IV M adiiiphirmsceuticals for_.therap?)
..u m~
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7 n l M 5.300 Use of radiopharmaceuticals for therapy. l Drugs approved for human use by the FDA have a label or package l l insert that specifies the FDA-approved use, physical form, route of l administration, and dosage range. NRC relies primarily on FDA's deter-l mination of a radioactive drug's safety and effectiveness when used according to the package insert, w " F *# T" # '" I" " ' l a w w ,;/.a ., u . . t m o. s ,a. a . w e ?. 9 ~ & - I tO 9C i 6635.3,04' Safety instruction, and 35.4p5 Safety instruction. In the hospital setting, the use of byproduct material presents special training problems whichy .in-the-judgment of-the-Commissiongare not addressed in Part 19 because they are unique to the medical environ-I ment. For example, visitor control in a hospital cannot be accomplished by physical barriers which might impede the delivery of emergency medical care. Also, after administration, the byproduct material is contained in an ambulatory human. Therefore, the Commission has made a judgment that worker instruction in addition to that required by Part 19 is 26 Enclosure 1 _ _ - _ _ _ _ _ _ _ _ _ _ - - w
[7590-01] l l necessary. (This parallels special instruction required, for example, for radiographers and radiographer's assistants pursuant to S 34.31 of this chapter.) The Commission has also made a judgment that record retention for two years is sufficient to show the existence of a work-ing safety instruction program. g v;. s o /w .. . + sm a k,h~+L. l
<t M @ p , 2 % __
Subpart G tIl dourcesforbrachytherap3) j S 35.400 Use of sources for brachytherapy. This section identifies brachytherapy sources that may be used in
; , td
- human use. The list was taken from the current 6 35.100' khdie A l 4re"? VL Tantalum wire has been added.
i 9 35.404 Release of patients treated with temporary implants. A responsibility of the Commission is to restrict the movement of l byproduct material when the public exposure would be increased. Brachy-therapy sources for temporary implants have high levels of radiation, and remain radioactive for a long period of time. Loss of control of these sources and their release to unrestricted areas may result in potentially lethal radiation exposure to members of the public. The Commission has made a judgment that temporary confinement of the brachytherapy patient is necessary to assure public safety. Section 35.404 requires that the , licensee confine the patient until all temporary brachytherapy sources have been removed. The Commission has made a judgment that records I retention for two years is sufficient to show the existence of a working l
- source control program.
! 6d./p,? W __ _ Qs,,.V-_ % SubpartH-4roup_VII)Odealedsourcesfordiagnosid) y- . _ . _ - S 35.500 Use of sealed sources for diagnosis. This is a new use group established to incorporate the recent development of medical devices which use a sealed source of byproduct material to create a beam of ionizing radiation. These devices
.; c are ,
4, u E ./ <.._t 5.no - currently available to persons licensed under-Group VT nf the enrrent-- Pert Th* Since the devices represent a lower level of hazard than the other sealed sources in that group, the Commission has determined that these devices should comprise a new group. M1,) 70 27 Enclosure 1 l l l
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[7590-01] p-N Subpart I--Group VIII ( eletherapy) C,, O' S 35.600 Use of a sealed source in a teletherapy unit, j: n . This is a wnew use group established to a & celedge a well estab-r.-: lished roedical precedttre. Safety measures that apply to all licensees withinthjgrouphavebeenusedovertheyearsandarereflectedin these proposed regulations. S 35.604 Information to be submitted with application. This requirement identifies the information needed to describe the unique characteristics of a teletherapy installation. The plans, eleva-tions, and shielding are needed to assure that the requirements of S 20.105 will be met. The interlock information is needed to assure k against accidental exposure of workers and members of the general public. - The viewing system is needed to monitor the orientation of the patient oc and the teletherapy unit, thereby assuring 4the safe-exposure-to radiatiorv.,..
- g i ja J ,, ,i su , .c A S 35.605 Maintenance and repair restrictions.
C/ This section provides that only specially licensed persons may , maintain, adjustyor repair teletherapy units./r< .s A-
-: x ,. . Da a . ., a , A qa,. .1 c.~ u.c t +.L ,/
'l/.jg;[ .W F '.
< 6 e a 6 35.606 Amendments.
Amendments are required for items identified in paragraphs (a) through (f) because any change described in these paragraphs could result in an increase in radiation levels in excess of the levels auth-orized in S 20.105. The service of a qualified teletherapy calibration expert is a critical component in assuring the safe use of a teletherapy unit. The Commission has made a judgment that only an individual with proper training and experience can determine the operating characteristics of the licensee's teletherapy unit. fdl S 35.610 4mergency instructions. Emergency instructions r.ust be posted to remind individuals of the Gi~ t, n - proper 4 asks- to be , completed in case of an emergency and to identify individuals to be notified in an emergency. j/ Owc sm xu! b " u na . .3 .y a p ! ,:
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, c. , 28, ., u's<,' e {; Enclosure 1 " ,. ,
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>> . . To
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f'M, Q b ' ~ j'" da A ' *f e s - ( L sLs_i& f / c= *]l s
~
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[7590-01]
/t g $ 35.620 Doors, interlocks, and warning systems.
NCRP Report No. 57, " Instrumentation and Monitoring Methods for Radiation Protection," on page 42, states that a survey of a new tele-therapy facility must determine that ". . .All entrances into the irradiation room or other high radiation areas are provided with barriers equipped with interlocks that are not dependent on the operation of a single circuit, and that will interrupt radiation production when the barrier is opened." There have been incidents in irradiation facilities in which personnel were unnecessarily exposed to radiation because door interlocks or alarms were intentionally bypassed for convenience. See, for example, cases 19, 21, and 28 in NUREG/8R-0001, " Case Histories of Radiography Events," vol. 1, 1980. If the interlocks and warning systems had not been bypassed, personnel would not have been irradiated. The Commission, however, has made a judgment that the dual warning system of a door interlock and a radiation monitor in the teletherapy room obviates the need for the dual circuit door interlock recommended in the report. , , , 4
.ll< ha ns ar,J Gw i ns . 4 .k ;/ t , s' . jcc. i 4 wL- ^
( 9S435.621
/:a un n Av ,+L Radiation monitoring device.
a > A u % A ~ p' . The radiation monitoring device is needed to indicate radiation levels in the teletherapy room in the event of the failure of the inter-locks or the warning system. There have been a number of documented t instances in which individuals have been unnecessarily exposed following the failure of the source retraction mechanism, coupled with a failure of the primary beam condition indicator system. Section 35.621 requires licensees to install a permanent radiation monitor in each teletherapy room, to check its operation before using the teletherapy unit, and to use a portable survey instrument or personal audible alarm dosimeter if the monitor is inoperable. Identical requirements were published as a proposed rule on April 28, 1982, (47 FR 18131). .These requirements were adopted in a final rule published January 18, 1983 (48 FR 2116). The NRC is incorporating the rulemaking on teletherapy monitoring and servicing in this rulemaking on the revision of Part 35. NRC is not soliciting comment on the new teletherapy requirements of the proposed
. Part 35 because they are identical to the requirements of the earlier 1982 rulemaking.
, y , 29 Enclosure 1
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eY.
- c . -
-Jn g*g i d l*N tisi s! .T b?p , t y ,y,a
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[7590-01]
, S 35.622 Viewing system.
b' Occas4enaHy#apatientmovefduringatherapeuticadministration jhiscouldresultina200raddosetohealthytissue. The viewing ' system is needed to monitor the orientation of the patient and the teletherapy unit, Wereby assuring the,sefe application of radiation.
? pcc.? ue<&
S 35.630 Dosimetry equipment. 15. m 45 1 NM"*? #~' M# [Dosimetryequipmentisneededtoassurethatthedoseprescribedis the dose actually given." The equipment requirements are the same as the
,n,w J current SS 35.22 and 35.23. This section also contains thearesolution of the petition filed by the American Association of Physicists in Medicine, Petition Docket No. PRM 35-2 (see 47 FR 4311; January 29, 1982). Currently, regulations require that primary dosimetry equipment be calibrated every two years. The petitioner requested this two year w yw~ . .:e c .a . . :n requirement be relaxed to four years if, gat-the-two-year-mark, the primary dosimetry system is compared with a system' b was calibrated within the past two years, and the results of the comparison indicate that the calibration factor used to convert an instrument reading to a v dosemeasurementhadnotchangedbymorethantwopercent.[Intercompari-son meetings are occasionally scheduled by several qualified teletherapy calibration experts within a geographic area. Each expert takes a
, ,. L t dosimetry system to the meeting [.x e,E'ach dosimetry system,.is then-exposed to the same radiation dose from a teletherapy unit. The response of each dosimetry system can then be compared to the response of the other systems. If each system measures the same radiation dose in rads, this provides assurance that each system is working properly.) This suggestion has been incorporated into these proposed regulations. The petitioner also asked that the licensee be required to make quarterly constancy checks to assure the consistency of operation of the dosimetry system. ,: int The Commission u
did not incorporate _this suggestion because the
., J exposure s TssJ .
.c:
ratgidfdR ifda byTcT> --nstancy check devicesJmay va:r.iiv.y by as'much as two percent even though the calibration factor for the dosimetery equipment has not changed. V As-a-resuMT-montMy constancy checks would not-m . .'. . 1, s.,,,. ,
...m,c iu u ,,
necessarily provide' increased assurance of proper operation. 1 p 1 0 l l 30 Enclosure 1
[7590-01] n S 35.632 Full calibration measurements. U The required frequency of full calibrations remains unchanged from that of the current Part 35. The test for timer accuracy has been clarified to include on-off error. The accuracy of localization devices which are used to position the teletherapy patient has been added to minimize the risk of unintentionally irradiating healthy tissue. The function of mechanical and electrical interlocks which are used to limit
~.t n , ,,a a n w a n o .w us:x xm thedirectionsinwhichthebeamcanbeaimedfasalsobeenadded.,The licensee need no longer perform all measurements with a calibrated dosimetry system. Instead, the calibrated dosimetry system need only be used for one representative measurement, and then a relative exposure rate system can be used to complete the calibration. N ** %4'" [ * 'I w . g ,a w ay a 1 w.phnna.,-mlowm,- n,w naThe exposure rate from a radioactive source goes down,a s w.1 w ~.
as time progresses due to source radioactive decay. To assure accurate dose delivery, the regulation requires that licensees mathematically take this into account in calculating patient doses. The regulation requires that the licensee use time periods of not longer than one month when making decay calculations. This will assure that the actual dose does not differ from the calculated dose by more than one percent due to this decay error. SS 35.633 Periodic spot-checks, and 35.642 Facility checks following installation of a source. A monthly spot-check is required by S 35.22 of the current l regulations. The following changes have been made. Timer accuracy has been clarified to include on-off error. The accuracy of localization devices has been added. The qualified teletherapy calibration expert
- must review the results of the spot-check measurements within fif teen 1
days, and must notify the licensee in writing of the results of the monthly checkj The-purpose-of-this-notification-requirement-is to i assure the licensee and the Commission that the check results were reviewed by a qualified individual. The Commission has made a judgment
- s. w aqu su that thepa eis to-the public-health-and-safety-over fif teen days 4s en 6< c. c , tu,u6 w uco.
minimab A requirement to check certain safety systems in the teletherapy
- facility has been added. These checks are needed to assure that safety ?)
G systems required by other sections of the regulations are working properly. 31 Enclosure 1
f~ [7590-01]
,-. These checks need not be performed by the qualified teletherapy calibration expert. DevicesNich-arenotworkingmustbepromptlyrepairedin order to assure the safety of the teletherapy facility.
S 35.641 Radiation measurements following installation of a source. The Commission has used these maximum and average permissible source leakage radiation levels for several years as ,/s license conditions. They are consistent with guidance from the NCRP j,,See-NCRP y Report No. 33,
" Medical X-ray and Gamma-ray Protection for Energies up to 10 MeV -
Equipment Design and Use," Section 4.2.2. The Commission has made a judgment that they are sufficiently restrictive to keep exposures as low as reasonably achievable. 4 kf L y rm tp chth, U, wed viawwA. S 35.644 Reports fdlewing-instalfation of-a-source. Given the potential for high d xposure to workers and the public, the radiation survey information required by Section 35.644 is needed to assure that teletherapy sources have been properly installed and are sufficiently shielded to assure compliance with the exposure limits of Part 20. S 35.645 Five year inspection. ~ Many licensees replace teletherapy sources at five year intervals. Requiring a mechanical check at five year intervals helps to laan ace"m suun in n.w . sw ~a u ,m. n w . . r t e. a ,% .,. u , s wn ,,-b ise s ,a x, e,pur.qn i;,w tional exposures, as-tow :: reasonably-achievable. The mechanic who exchanges sources and inspects units can remove the source, inspect the drawer mechanism, and then install the new source. More frequent checks would require greater time near a very radioactive source. Less frequent checks would not be sufficient to assure the continuous proper operation of the exposure mechanism. The identification information in the "ecord is needed to establish which unit was inspected, when, and by whom. The remaining information is needed so the Commission may determine that the I inspection was of sufficient depth to assure the health and safety of workers and the public.
)]QJ$ pi;D/.~/Nul?'<dS M 7 t Yi er 'as ~ d' h h *r &f*
Gidnuni p s .p > ~ . O I % w&>. e m Ad 5 u.f m M Iu war Au ,: .wy r'. c & A
^4 a vywr .; L . n p;gd..au Abi k ca~ld -; w m
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in 4.u/w n m d%ab, 32 Enclosure 1
[7590-01] Subpart J--Training and Experience Requirements A combination of theoretical and practical training and experience' is necessary to assure the safe use of byproduct material. The criteria in this subpart were developed by the staff with the advice of the Advisory Committee on the Medical Use of Isotopes (ACMUI). The require-ments for the Radiation Safety Officer have not been published before. The requirements for authorized users are similar to those published as an amendment to Appendix A of Regulatory Guide 10.8, " Guide for the; Preparation of Applications for Medical Programs," in the Federal, Register on December 2, 1982 (47 FR 54376). The requirements for the Qualified TeletherapyCalibrationExpertaresimilartothoserequiredIfa Qualified Expert pursuant to the current S 35.24. SS 35.900(a), 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.941(a), 35.950(a), 35.960(a), and 35.961(a) concerning certification. The Commission has made a judgment that in some cases, certifica-tion by an appropriate professional board constitutes. proof of ade-A quate training and experience because the criteria which must be met to attain certification are more stringent than the training and experience required by the Commission. > $ 35.900(b) Authorized user as a Radiation Safety Officer. The training and experience required by the Commission includes safety considerations for the byproduct material that the authorized user may use. Therefore an authorized user is qualified to oversee the safe use of byproduct material that he is authorized to use pursuant to l ,' the conditions of the license. l S 35.900(c) Training within the last five years or continuous > involvement. Radiation safety regulations and practices may be expected to change with time. The Commission has made a judgment that training received within the preceding five years is sufficiently up-to-date to assure the safe use of byproduct material. If an individal received training more than five years prior to the application but has had continuing, 33 Enclosure 1
[7590-01] involvement in the field, conformance with Section 19.12, Instructions to Workers, assures that the individual has had continuing instruction in radiation safety. SS 35.900(d) and ( 5.910(b), 35.920(b), 35.930(b), 35.940(b), 35.941(b), 35.950(b), 35.960(b), and 35.961(b) Training and experience. The criteria identified in these sections were developed by the staff with the assistance of the ACMUI over the past several years. The Commission has made a judgment that, for each type of use, the training and experience described is necessary to assure the safe use of byproduct material. SS 35.910(c) and 35.920(c) Integrated programs. The Accreditation Council for Graduate Medical Education (ACGME) reviews and approves training programs for physicians. Approval of these training programs is based, in part, on adequate radiation safety content. The Commission has made a judgment that individuals who have V successfully completed an approved training program have received sufficient training and experience to use byproduct material safely. SS 35.901 and 35.970 Current radiation safety officers and authorized users. The staff has reviewed and found acceptable the training and experience of each individual who is currently listed as a radiation safety officer or an authorized user. Further review of the creden-tials of these individuals is unnecessary. S 35.971 Three month training program. In addition to the ACGME, the American Board of Radiology, the American Board of Osteopathic Radiology, and the American Board of Nuclear Medicine review and approve nuclear medicine training programs for physicians. These three boards independently arrived at the conclu-sion that, while currently acceptable, a three month training program may not allow sufficient time in the future to provide the training and experience needed to develop a satisfactory level of expertise in nuclear 34 Enclosure 1 - n
/ [7590-01]
I w-medicine, including radiation safety. All three boards and the ACGME
; \ ' .-
s_/ are therefore planning to require that, by August 31, 1987, training
, programs be of six months duration. The Commission has made a judgment that, in the meantime, individuals who have successfully completed an approved three month training program have received sufficient training
, and experience to use byproduct material safely.
YYf. o < sq B+f & %~
- u '~ w ' d '"' " !'^Y ' "'" W 'I ceme7 4 ef' m aj " d (ATION TABLE The following derivation table indentifies the origin of each section of the proposed regulations. Sources of the proposed regulations include 10 CFR Parts 19, 30, and 35, Federal Register Notices (FR),
frequently used license conditions, licensing staff policy, regulatory guides (RG), Office of Inspection and Enforcement bulletins, M he United States Pharmacopeia, and new text prepared by staff. 4 6 (a ,, NEW SECTION NUMBER ORIGIN t
" Subpart A--General Information 35.1 Purpose and scope. 35.1 revised 35.2 License required. j d7 35.2 revised 35.8 Reporting, recording,and new text application requirements:
OMB Approval. 35.15 Definitions n -rw.c w h 2,;, 3 ALARA acronym Authorized users term used on licenses Dentist new term Human use 35.3(a) revised Institution new term Management new term Misadministration 35.41 Mobile service new term Output new term p) Physician 35.3(b) revised
Podiatrist new term
$uAlhd A:ARus;r
,_E.,d ed,h /u, c w./
35 Enclosure 1
[7590-01] p Radiation Safety Officer term used on licenses V Sealed source 30.4(r) verbatim Visiting authorized user new term 35.16 Application for license 35.4 revised a,ankamt n u mfs. 35.17 License amendments. new text; compare 30.38 35.18 Notifications. new text
- 35.28 License issuance. new text, compare 30.36 35.29 Specific exemptions. new text; compare 30.11 Subpart B--General Administrative Requirements 35.30 ALARA program. new text; see RG 10.8 Appendix 0 revised 35.31 Radiation Safety Committee. g 35.11(b) revised 35.32 -Responsibilities-of -theC RG 10.8 Radiation Safety Officer.
35.33 ^&inistn% requirements for ~. authorityandjEsifoNibilities. newteU 35.34 Visiting authorized user. license condition O 35.35 Mobile service administrative licensing policy requirements 35.37 Records and reports of 35.42 verbatim misadministrations. 35.38 Supervision. expanded from RG 10.8 p. 3 35.49 Suppliers. 35.14 revised Subpart C--General Technical Requirements 35.50 Possession, use, calibration, RG 10.8 Appendix D2 revised, and check of dose calibrators , and new text 35.51 Pette :hL u s a_, calibra g b RG 10.8 Appendix D1 revised h eck of survey instruments. and new text 35.53 Measurement of radio- proposed rulemaking 35.15 pharmaceutical dosages. (46 FR 43840; September 1, 1981) 35.58 Authorization for calibration 35.14(d) revised and reference sources. J 36 Enclosure 1
[7590-01]
,, 35.59 Requirements for possession 35.14(e)(1)(i), 35.14(f) e i V of sealed sources. revised 35.60 Syringe shields. Inspection and Enforcement letter April 16, 1979 35.61 Vial shields. Inspection and Enforcement letter April 16, 1979 35.62 Syringe labels. new text 35.63 Vial labels. new text 35.70 Surveys for contamination RG 10.8 Appendix I revised and ambient radiation exposure rate.
35.75 Release of patients containing new text radiopharmaceuticals or permanent implants. 35.80 Mobile service technical. licensing policy requirements. 35.90 Storage of volatiles and gases. RG 10.8 Appendix M revised 35.92 Decay-in-storage. license condition O Subpart 0--srouo_ General / ptake, diluton,* w 35.100 Use of radiopharmaceuticals, 35.31 and 35.100 (I) revised for uptake, dilution, and excretion studies. /2c., M 3 21< S 3s. t 2a in s w,n of emny m.,L, rw d. 35.200 Use of radiopharmaceuticals, 35.100 (II) and (III) revised generators, and reagent kits for imaging and localization studies. 35.204 Permissible molybdenum-99 US Pharmacopeia concentration. 35.205 Control of aerosols RG 10.8 Appendix M revised and gases. 36.22o k :cwra y a vy iub v an(:. h; a l'/ag< S Subpart F tGroup IV/. iopharmaceuticals ) 35.300 Use of rad M maceuticals 35.100 (IV) and (V) revised s for therapy. - 35.304' Safety instruction. 19.12 revised a
'5, fe jb n a >uw "
-! wM1 2' 5n!KY. E '0' ' !"9' '
g/gf-- Imaj"'fgj&3gig-<% i c37 n'ud.)
= ' Enclosure 1
[7590-01]
#y N SubpartG-45roup.VDtsources._for_brachythera3)
(s\ V 35.400 Use of sources for 35.100 (VI) revised ! brachytherapy. - 35.404 Release of patients treated 35.14(b)(5)(vii) revised with temporary implants. Safety instruction. 19.12 revised (35'.4$5' 3s un bu/J;4% 2 4 8.li tv a 35420 A mnha slqc.c < uac ,, n ,.kh,. yg ;utan n, J ye ' Subpart H--ttfr~oup VIITeMe~dTsoiircesEforidiagnosis) v 35.500 Use of sealed sources for new text diagnosis. , , 3S.T2o l1 et dt h!/ r} f,' : <Mej> < ~ e n ~ ' A ' ! ," b, r Subpart I-tGroup VII p$eletherap7) d 35.600 UseofaseKTIsourcein new text a teletherapy unit.
-35.Cai Tnfa' mat.icn tebc stebmitted 30d3(a-)'(tWsed-with~appticetten.
35.605 Maintenance and repair license condition restrictions. 35.606 Amendments,.y new text 35.610 us E-^ 5 r: instructions. license condition ard ^"" M 35.620 Doors, interlocks, license condition and warning systems. n a rc A s uu , .s .4 w w n e ~:~..unt. 35.621 Radiation monitoring 35.25 (48 FR 2115; device. January 18, 1983) 35.622 Viewing system. license condition 35.630 Dosimetry equipment. 35.22, 35.23 revised 35.632 Full calibration 35.21 revised measurements. 35.633 Periodic spot-checks. 35.22 revised and license condition 35.641 Radiation measurements license condition following installation cf a source. 35.642 Facility checks following license condition p installation of a source. d 38 Enclosure 1
[7590-01] 35.643 Modification of teletherapy ,ra DL '1., N unit or room before beginning a treatment program.
/A 35.644 Reports of teletherapy surveys,4 # license condition
,ad- tests, u.4 maamou n%-
35.645 Five year inspection. license condition Subpart J--Training and experience requirements 35.900 Radiation Safety Officer. new text 35.901 Radiation Safety Officer new text
, Training Exception.
35.910 Training for uptake, Revision of Federal Register dilution, and excretion Notice (47 FR 53476; December 2, studies. 1982) 35.920 Training for imaging ad- Revision of Federal Register
-ledizatica studies. Notice (47 FR 53476; December 2, 1982) 35.930 Training for therapeutic use Revision of Federal Register d of radiopharmaceuticals. Notice (47 FR 53476; December 2, 1982) 35.940 Training for therapeutic Revision of Federal Register use of brachytherapy sources. Notice (47 FR 53476; December 2, 1982) 35.941 Training for ophthalmic Revision of Federal Register use of strontium-90. Notice (47 FR 53476; December 2,
~ ~ '
/
p [ ,
,1, 1982) 35.950 ' Training for diagnostdo A-- new text S,ealed sources 35.960 Training for teletherapy. Revision of Federal Register Notice (47 FR 53476 December 2, 1982) 35.961 Training for qualified 35.24 revised teletherapy calibration expert.
35.970 Experienced physician training new text O' exception. 39 Enclosure 1
/
[7590-013 g 35.971 New physician training new text V exception. Subpart S--Enforcement 35.990 Violations. new text Environmental Impact - Negative Declaration The proposed rule, if adopted, would not result in any activity that significantly affects the quality of the human environment. The Commis-sion has determined that under the National Environmental Policy Act, and the criteria in 10 CFR Part 51, an environmental impact statement is not required for this proposed rule. The environmental impact appraisal forming the basis for this deter-mination is available for inspection at the NRC Public Document Room, 1717 H St, NW., Washington, D.C. Paperwork Reduction Act Statement The Nuclear Regulatory Commission will submit this proposed rule to V the Office of Management and Budget (OMB) for any review that may be necessary under the Paperwork Reduction Act, Public L. 96-511. The SF-83
" Request for Clearance," the Supporting Statement, and any other docu-mentation submitted to OMB, have been placed in the NRC Public Document Room at 1717 H Street NW., Washington, D.C. 20555, for inspection, and copying for a fee.
Regulatory Flexibility Certification Based on the information available at this stage of the rulemaking proceeding, in accordance with Section 605(b) of the Regulatory Flexi-bility Act of 1980, the Commission certifies that this proposed rule, if promulgated, will not have a significant adverse economic impact on a substantial number of small entities. The NRC has issued approximately 2600 medical licenses under 10 CFR Part 35. Of these, approximately 2200 are held by institutions, and approximately 300 by individual physicians. Most of the institutional licensees are community hospitals that range in size from 75 bed facilities to 750 bed facilities. The V Small Business Administration size standards, 13 CFR Part 121, classify 40 Enclosure 1
.= . -
[7590-01] , i g a hospital as a small entity if its capacity is less than 150 beds or if V its gross annual receipts do not exceed $1.5 million. Under these size standards, a substantial number of NRC medical licensees could be considered "small entities" for purposes of the Regulatory Flexibility Act. Although the number of medical licensees that would fall into the small entity category constitutes a substantial number for purposes of the Regulatory Flexibility Act, there should not be a negative economic impact on these small entities. The Commission believes that the proposed rule would result in cost savings to almost all licensees. The primary l objective of the proposed rule is to eliminate unnecessary administrative paperwork burdens on medical licensees by simplifying the licensing process without lessening the protection necessary to preserve public , health and safety. This will be accomplished through incorporation of ens mu a ~ ~ w., m existing lidengng-amendmentsjinto the regulations, the elimination or modification of requirements that are not essential to the protection of public health and safety, by simplification of the licensing application form, and by establishment of a computerized licensing information
- (v~.) system. These steps will not only make it easier for a licensee to determine what is required to obtain a license but should also substan-tially reduce the economic burden on medical licensees that is associated l
with the present licensing system. ! The Commission has prepared a preliminary value/ impact statement for this proposed regulation. The preliminary value/ impact statement contains information concerning the anticipated economic effect of this t regulation on licensees and presents the basis for the Commission's belief that the proposed regulation would result in cost savings to all licensees. The preliminary value/ impact statement is available for i public inspection in the NRC Public Document Room at 1717 H Street NW., Washington, DC. Single copies of the preliminary value/, impact statement o,,,,,a.o. m % w u.tw ~. n .. : ~ are available from Maureer Meetert!y, Office of Nuclear M5teri:1 Safety-and S= 4 ;":rt , U.S. Nuclear Regulatory Commission, Washington, D.C. al 3 747# Telephone: (301)427-423&. Because of the widely differing conditions under which licensees e covered by this proposed regulation operate, the Commission specifically k seeks public comment from small entities. Any small entity subject to 41 Enclosure 1
[7590-01] p this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates: (1) The licensee's size in terms of annual income or revenue, number of employees and, if the licensee is a treatment center, the number of beds and patients treated annually; (2) How the proposed regulation would result in a significant economic burden on the licensee as compared to that on a larger licensee; (3) How the proposed regulations could be modified to take into account the licensee's differing needs or capabilities; (4) The benefits that would be gained or the detriments that would be avoided to the licensee, if the proposed regulations were modified as
~
suggested by the commenter; and (5) Hcw the regulation, : =cdified, would still adequetely protect public health and safety. 34 List of Subjects in 10 CFR Parts 30,A32, 35- 40t od Y-
,r] Rules of General Applicability to Domestic Licensing of Byproduct Material V Part 30 - Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting requirements.
General Domestic Licenses for Byproduct Material Part 31 - & v4d inuk.st, .6 % , gM., v . n s % & oy , - 4 m A m,
.x ,,w is Au ,,/jh L>d.} , ,aa. %yJA, spay 7, > w t'.
Specific Domestic License to Manufacture or Transfer Certain Items Containing Byproduct Materials Part 32 - Byproduct materials, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting requirements. Human use Of Byproduct Material Part 35 - Byproduct material, Drugs, Health devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements. l l 42 Enclosure 1 l g, . . . . . .
)afy,ip <j ,01 m 6:jfd - Ea va T s ha'w w' W ~' < ' 0 m fA
/ Ik & /'av.bv G & Ovaw w [ys90 013
(~~ ? tof_71- p h .i:~ , a.26 -L'.re ,e? 6 k , Aldn> '; h i , /i -is , . . ,
.t
[lw /a< au, k; & , &pr &; s y w s C. f Domestic Licensing of Source Material
+
V Part 40 - Government contracts, Hazardous materials - transportation, Nuclear materials, Penalty, Reporting requirements, Source material, Uranium. Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and section 553 of title 5 of the United States Code, notice is hereby given that adoption of the following revision of 10 CFR Part 35 and the following amendments to vJ 7/ 10 CFR Parts 30, 32,and 40,ji s contemplated.
- 1. 10 CFR Part 35 is revised to read as follows:
PART 35--HUMAN USE OF BYPRODUCT MATERIAL Sec. Subpart A--General Information 35.1 Purpose and scope. 35.2 License required. 35.8 Reporting, recordkeeping, and application requirements: b OMB approval. 35.15 Definitions. 35.16 Application for license, amendment, or renewal. 35.17 License amendments. 35.18 Notifications. 35.28 License issuance. 35.29 Specific exemptions. l Subpart B--General Administrative Requirements 35.30 ALARA program. 35.31
- Radiation Safety Committee.
35.32 Radiation Safety Officer. g f 35.33 A & " h tr:the requirements c for authority and responsibilities. A s 35.34 Visiting authorized user. 35.35 Mobile service administrative requirements. 35.37 Records and reports of misadministrations.
,s 35.38 Supervision.
( ) v 35.49 Suppliers. 43 Enclosure 1
[7590-01]
\
Subpart C--General Technical Requirements O 35.50 35.51 Possession, use, calibration, and check of dose calibrators. MPossession;,-usew galibration,dnd check of survey instruments. j 35.53 Measurement of radiopharmaceutical dosages. 35.58 Authorization for calibration and reference sources. aa paapp ,, ud 35.59 Requirements for possession of sealed sourceg. v i 35.60 Syringe shields. 35.61 Vial shields. 35.62 Syringe labels. 4 35.63 Vial labels. 35.70 Surveys for contamination and ambient radiation exposure rate. i 35.75 Release of patients containing radiopharmaceuticals or permanent implants. I 35.80 Mobile service technical requirements. 35.90 Storage of volatiles and gases. 35.92 Decay-in storage. SubpartD--froupGeneral/D ution,"exc ) 35.100 Use of radiopharmaceuticals for uptake, dilution, and excretion studies. 3t/CC t h;mhw } w',' I'd jh p SubpartE--QroupII/ iip ][ 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. 35.204 Permissible molybdenum-99 concentration. 35.205 Control of aerosols and gases.
- n. n o t< . n &n ej swwg, ',Jiwu >vra .
*-O_ _
Subpart F- @ p_IV/ %Vadiopharmaceuticals for therapFj)
%v -
35.300 Use of radiopharmaceuticals for therapy. Safety instruction. 35.3[ja w ' ,.n y c. ~ q&
~~c-~
' u-gg.32o Subpart G-fd M ygources for brachytheraph 35.400 Use of sources for brachytherapy.
3,5.404 Release of patients' treated with temporary implants. 35.4dh Safety instruction. O 35.406 M.ho Brachytherapy source' inventory. j? . i w. c. .- ,
-Ju n A.
44 Enclosure 1
[7590-01]
., Subpart H-gp VID Qeal_ed sources _fon diagnoliii) \ 35.500 Use.of sealed sources for diagnosis.
S S. %'a a m b si4} 9' way ;i . w a t
~c Subpart I--Gjp VIIIdgetherap3) 35.600 Use of a sealed source in a teletherapy unit.
G5.004 L fe..m i.-;en tc S: c'h-itted-with 'rplicatier - 35.605 Maintenance and repair restrictions. 35.606 Amendments, p.5.4 35.610 b erg ^ncyeinstructions.
- 35. Q20'/$
a .. . ,, i o r .. Doors, w a .. ninterlocks,andwarnin0. w ,. a um .w , systems. 35.621 Radi ation' moni to'yring device. 35.622 Viewing system. 35.630 Dosimetry equipment. 35.632 Full calibration measurements. 35.633 Periodic spot-checks. 35.641 Radiation measurements following installation of a source. 35.642 Facility checks following installation of a source. 35.643 Modification of teletherapy unit or room before beginning d
"'"f ?509'.? .w v , kl4 (A a-r 2 "M !" ~b '
35.644 Reports fell wini; instellation-of-a-source. 35.645 Five year inspection. Subpart J--Training and experience requirements 35.900 Radiation Safety Officer. 35.901 Radiation safety officer training exception. 35.910 Training for uptake, dilution, and excretion studies. 35.920 Training for imaging =d localizetion[ studies. 35.930 Training for therapeutic use of radiopharmaceuticals. 35.940 Training for therapeutic use of brachytherapy sources. 35.941 Training for ophthalmic use of strontium-90. a e,.11 - 35.950 Training for,(alno{ 1eaKdTourles 35.960 Training for teletherapy. 35.961 Training for qualified teletherapy calibration expert, wt.ru yJaan 35.970 Experienced php ;;isit training exception. 35.971 New physician training exception. O 45 Enclosure 1
[7590-01] g Subpart K--Enforcement U 35.990 Violations. Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). For the purposes of sec. 223 ca..' 2273);6635.2,35.17,35.30(a))s,68
/ / .
i (c), 35.31(a)Stat.958,asamended(42U.S.C p)-{+)( d 35.31gb) 35.32, 35.33, 35.34(a), 35.38 d E .30( & (c A 35.49, 35.50(a)-( ), p 35.51(a)-(d), 35.53(a) and (b), 35.59(a)-(c), (e)(1),}a'nd (h), 35.60, 't 35.61,3,56fh$.70(a)-(f)#, 35.75', 35.80(a)-(e)', pg, 3g.,9,2(a)fl-)M4N 35.100Ig 35.200I 35.204(a) and, (b)I 35.205,j35.I00,n35.400, 35.404(a), " # 'A ' nmo s u. u, v a o s, 35.500,/35.600, 35.605, 35.606,"135.620, 35.621(a)-(d), 35.621(f) and &] \ (g)',35.622l35.630(a)and(b),'35.632(a)-(f),35.633(a)-(i)',35.641(a),}. sum vam, and (b),, 35.642(a) and (b); 35.645(a) and (b), 35.900, 35.910, 35.920,- " 35.930,35.940,35.941,['960,and35.961areissuedundersec.161b['
/ d 68 Stat. 948, as amended.(42 U.S.C. 2201(b)); and 66 35.18, 35.30(d),
p v 3e s r.n e ), - 35.31(ir)f4) =d (a)(5h 35 3/(f) M 35.34(c),A35.37(a)-(d), 35.50(d), 35.51(e), 35.53(c), 35.59(d) and (e[n.5.59(g) 3 uun and (i)', 35.70(d)
, man Dom, 35.80(f),35.92(b)(35.204(c)',35.304,735.464(b),35.405,435-fr14 q 35.621(e)$35.630(c)",35.632(g),35.633(j)',35.641(c)$35.642(c)",/35.644, and 35.645(c)'are issued under sec. 1610, 68 Stat. 950 as amended (42 U.S.C. 2201(o)). bCM """"'I j'S Subpart A -- General Information 6 35.1 Purpose and scope.
This part prescribes requirements for issuance of specific licenses authorizing the human use of byproduct material. This part also pre-scribes requirements for the human use of byproduct material in order to provide for the protection of the public health and safety. The provi-sions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. The requirements and provisions of Parts 19, 20, 21, 30, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted. 46 Enclosure 1
[7590-01] 6 35.2 License required. (a) No person shall manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for human use except in accordance with a specific license issued by the Commission or an Agreement State and as allowed in paragraph (b) of this section. An individual (b) , ,um. may receive, possess , use, or transfer byproduct mig g, n.cA, .w, m m material;g,under the supervision of an aufhorized user as provided in S 35.38, unless prohibited by license condition. 6 35.8 Reporting, recordkeeping, and application requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget for approval as required by the Paperwork Reduction Act (Pub. L. 96-511). OMB approved the information collection requirements on (1) The OMB control number is . (2) OMB approval expires . l (b)- The approved information collection requirements include the l application, recordkeeping, and reporting requirements contained in um, e s ar-SS 35.16,A35.18, 35.30( d 35.31(p), 35.32(f), &;) =d (if 35.33(b), l 35.34(c), 35.35 b), 35.37(a)-(d), 35.50( k 35.51(e), 35.53(c), 35.50(d), 35.59(dfdNh}f(), 35.70(),35.80(f),35.92(b),35.204,"35.3kbf n u e s, c c 35.404(b),35.40f,,35 5.610, 35.621(d), 35.630(c), 35.632(g), l 35.633(e) and (j), 35.641(c), 35.642(c),935.644, and 35.645(c). s eascq 9 35.15 Definitions.
" Agreement State" means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.
"ALARA" means as low as reasonably achievable, u.s. a .m t
" Authorized user" means a physician,sut who fs n[dentified as an g
authorized user on a Commission or Agreement State license that authorizes the human use of byproduct material. O 47 Enclosure 1
[7590-01] p " Dentist" means an individual licensed by a State or Territory of d the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice the art of dentistry on humans.
" Human use" means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human beings in the practice of medicine in accordance with a license issued by a State u
orTerritory'n}theUnitedStates,theDistrictofColumbia,orthe )( Commonwealth of Puerto Rico in the art of medicine.
" Institution" means an organization in which several medical disciplines are practiced.
,5ve
" Management" means the chief . administrative officer,af a licemce? -
" Misadministration" means the administration of:
(1) A radiopharmaceutical or radiation from a sealed source other . than the one intended; (2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; p (4) A diagnostic dosd of a radiopharmaceutical differing from the O prescribeddofbymorethan50 percent; (5) Atherapeuticdos'$ofaradiopharmaceuticaldifferingfromthe
/
prescribed dos)ae by more than 10 percent; or (6) A therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent.
" Mobile service" means the transportation and use of byproduct material for human use and for checks and tests of equipment used in conjunction with human use by the licensee.
" Output" means the exposure rate,, dose rate,, or a quantity related in
~a a ,w n cn..r aknownmannertotheseratespforaspecifi'edsetofexposureconditions.
" Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
O 48 Enclosure 1
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" Podiatrist" means an individual licensed by a State or Territory }
" of the United States, the District of Columbia, or the Commonwealth of ) Puerto Rico to practice the art of podiatry on humans. f
" Qualified teletherapy calibration expert" means the individual identified as the qualified teletherapy calibration expert on a Commission i
license.
" Radiation Safety Officer" means the individual identified as the
,,,,)f /,,u 4 u gyy radiation , safety officer on a Commission license. j
" Sealed source" means any byproduct material that is encased in a i i
capsule designed to prevent leakage or escape of the byproduct material. 4
" Visiting authorized user" means an authorized user who participates in the human use of byproduct material at a location other than that j identified on the license that identifies the physician as an authorized
. . , , r C L.s.<<A7"1T'~ w~~w - , .
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3, l ,i i e /j f r a; M1b : 5 9l' '# U"' E' S 35.16 Application for license, amendment, or renewal. \ ' An application for a license, a license amendment, or the renewal
.u w .a , ;~.e n . s .w, v. w, u . a w :i _.; .
/ jl of a license for human use of byproduct material as,ptwided-by"this
(] V part must be made by filing Form NRC-313)('Revis-ion-1[" Application for/ / ! Materials Licenseb}luman-%"Nor ~u'se by[in~ institution, only manage - ment may apply. For use outside an institution, an physician, l su n ,. ,.,~ <$may app y. The applicant shall mail the completed application orm as directed below. (4) If the applicant is a Federal agency, if the applicant is an T agency of the District of Columbia,'/ if the> applicant f uso. . ., za. .s i e is located s inc a Statp that is n,ot mentioned in paragraph (p), (p), (#), (g), or (<O of this section, -or-if-the epplicaLiun is mryfor g teletherapy unit (the pplicant shall: (1) Mail the completed application form to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, or (2) Deliver the completed application form to the Commission offices at: (i) 1717 H Street, N.W., Washington, D.C., or L (ii) 7915 Eastern Avenue, Willste Building, Silver Spring, Maryland. M:nt b:,), TJ v 49 Enclosure 1
[7590-01] A ()l) If the applicant is not a Federal agency and is located in O, Connecticut, Delaware, Maine, Massachusetts, New Jersey, Pennsylvania, or Vermont, and--th spplication is net-oMy for a teletherapy uMt the applicant shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region I, Material Program Section No. 2, 631 Park Avenue, King of Prussia, Pennsylvania 19406. (h If the applicant is not a Federal agency and is located in Virginia or West Virginia, and the epp % Lien is net eMy-for-a-tele therapy-uni-ty- the applicant shall mail or deliver the completed appli-cation form to U.S. Nuclear Regulatory Commission, Region II, Material Licensing Section 101 Marietta Street, Suite 3100, Atlanta, Georgia 30303. (k) If the applicant is not a Federal agency and is located in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wisconsin =d+" 1
-- " -- Me-k mt
.. h. fc.c takthanm. r,mit. tha applicant shall mail or deliver the completed application form to U.S. N Nuclear Regulatory Commission, Region III, Material Licensing Section, 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
d (4) If the applicant is not a Federal agency and is located in O' Montana, South Dakota, Utah, or Wyoming, 2 M th: 2pplicatien is uvi-oMy-for a teletherapy unity applicant shall mail or deliver the completed application form to U. 5. Nuclear Regulatory Commission, Region IV, Material Licensing Section, 611 Ryan Plaza Drive, Suite 1000, Arlington, Texas 76011. e (f) If the applicant is not a Federal agency and is located in Alaska, Hawaii, or a U.S. territory or possession in the Pacific, the applicant shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region V, Material Licensing Section, 94596.
@p6 1450U_ariaLane, Suite 210,WalnutCreek, California 6 35.17 License amendments.
A licensee shall apply for and must receive a license amendment: e ,s (a) Before using byproduct material for a method of g human use not permitted by the license issued under this part; O l 50 Enclosure 1 t_
[7590-01]
,_3 (b) Before the licensee permits a physician, other than a visiting b authorized user described in S 35.34, to work as an authorized user under the license; (c) Before the licensee permits an individual not listed
;y m < g.v p, E license to perform the duties of the Radiation Safetym r;
j Office,. ,on th (d) Before receiving byproduct material in excess of the amount authorized on the 1 cense; g,, j g jm e,, , ,4 (e) Before supplying -^5ile Tcle r ;.edicinc service te 2-locaMon. not- identified on the license; and (f) Before making any changes in the licensed program. 6 35.18 Notifications. g The licensee shall notify the Commission (ir. -iti v en ruim
-NRC -312" R 'fici:r 1 within thirty days when an authorized user, Radiation Safety Officer, or qualified teletherapy calibration expert, permanently discontinues performance of duties under the license. The licensee shall mail the form to the appropriate address identified in 6 35.16.
6 35.28 License issuance. The Commission shall issue a license for the human use of byproduct material for a term of five years if: (a) The applicant has filed Form NRC-313,k-Aevmmr- " Application
- a u n ia w a s m u s e n s .n 53rr for Materials Licensel-fkesten- Use'P, 4
(b) The applicant has paid any applicable fee as provided in Part 170 of this chapter; (c) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission for the protection of the public health and safety; and
- (d) The applicant meets the requirements of Part 30 of this chapter.
6 35.29 Specific exemptions. The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. 51 Enclosure 1
[7590-01] Subpart B--General Administrative Requirements O_ 6 35.30 ALARA program. (a) Each institutional licensee shall establish a program to maintain individual and collective dose equivalents as low as reasonably achievable. (b) To satisfy the requirement of paragraph (a) of this section: (1) Management, the Radiation Safety Officer, and all authorized users must participate in the establishment, implementation, and operation of the program. ,. g n,,/y, w g jc ,? 3 _ , , , , , , (2) The program must include a periodic review of byproduct material use, and continuing education and training for all personnel who work with or in the vicinity of byproduct material. The review an& education # - must assure that individuals make every reasonable effort to maintain individual and collective occupational dose qsickat as low as reason-ably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits. - (c) The licensee shall keep a written description of the ALARA (V program for the duration of the license. The written description must include: 4,g (1) A commitment by management to keep individual and collective / dose aa" M 1 ante as low as reasonably achievable; (2) A requirement that the Radiation Safety Officer brief management once each year on the byproduct material program; (3) Personnel exposure investigational levels that, when exceeded, will initiate an investigation of the cause of the exposure by the Radiation Safety Officer; and (4) Personnel exposure investigational levels that;when ex.ceeded, 5, ew gn v-will initiate a prompt investigation of the cause of the exposure and ga consideration of actions that might be taken to reduce the probability of recurrence. hyyCb W S f Of b Sk S/c 6 35.31 Radiation Safety Committee. Each institutional licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material. Management may establish more than one committee to meet these responsibilities, but 52 Enclosure 1
[7590-01] each committee that is established shall meet the administrative (../ requirements. To satisfy this requirement: (a) The committee must meet the following administrative requirements: (1) Membership must consist of at least three individuals and must include an authorized user for each type of use permitted by the license, itmuuav theRadiationSafetyOfficer,arepresentativeofthenursingservicg and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate. (2) The committee must meet at least quarterly. (3) To establish a quorum and to conduct business, one-half of the committee's membership must be present, including the Radiation Safety Officer and the mananoment ronresentative. (4) The minutes of each Radiation Safety Committee meeting must include: (i) The date of the meeting; i m (ii) Members present; (iii) Members absent; (iv) Summary of deliberations; (v) Recommended actions and the numerical results of all ballots; and g (vi) ALARA program reviewst i (5) The Committee must provide each member with a copy of the meeting minutes, and maintain one copy for the duration of the license. (b) To oversee the use of licensed material, the Committee must: (1) Be responsible for monitoring the institutional program to maintain individual and collective doses as low as reasonably achievable; ( (2) Review on the basis of safety and approve or disapprove any individual who is to be vlisted as an authorized user or the Radiation Safety Officer pMor-to'the license application or application for amendment; h*5"' ' " ^' Y (3) Review #and approve or disappro % n the basis of sa M l D considersticas each proposed method of use of byproduct material; U) Ama .m A l.m .3l ay; a ~c sjff n .4 9 q&Ja.K #f en daca jn n .ej o.,
.; yj.u t ,na*J; p,,,s,, ,3 l
i ! 53 Enclosure 1 l i L
[7590-01] s n (4') Review quarterly, with the assistance of the Radiation Safety b Officer, occupational radiation exposure records of all personnel working with byproduct material; (d) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; (6) Review annually, with the assistance of the Radiation Safety t, Of ficer, the Oga.at=H<.sw,ic=fety aa program; and 4 (7) Establish a table of investigational levels for occupational , dose :4 Welents that,when exceeded, will initiate investigations and considerations of action by the Radiation Safety Officer. fe 32-q 6 35.32 Radiation Safety Officer. ($Eocii licensee shall appoint a Radiation Safety Officer who is g responsible for implementing the radiation safety pi7.m anr. qhe Radiatier-Safety-Officer-must-be-a-member-of-the-RadiatimT-Safety-Caittee32nd be-
.5 iu a s a sw sm w n fresponsible to the licensee's management for ensuring that radiation
- a. amnae : : + .9 wan o a.w a
,A safety activities are being correctly performedg in the daily operation q") a a sme -
ofthelicensee's?_gticasafetyprogram. including: p /o / > k (a) Investigating known instances of deviation from good practice and implementing corrective action as necessary; (b) Investigating, and in an institution reporting to the Radiation 7p
}SafetyCommittee,thefindingsandactionstakenininstancesinwhich occupationally exposed individuals have exceeded investigational levels; and (c) Assisting, and in an institution advising the Radiation Safety i Committee, in performing those functions specified in 6 35.31(b).
p Y JAmed of 6 35.33 A &inistrative requirements for authority anditresponsibilities.
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(a) The licensee shall provide t, iation Safety Co mitt p 6diation Safety Officer /siffricient authority an,d organizational freedom to: (1) identify radiation safety problems; (6)~ initiate, recommendj or provide solutions; and (3) verity implementation of solutions. D (b) The licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Efdiation Safety Committe and Radiation Safety Office 3 3r nti:fy th:-r w irements,.of l,) b c anh/ 54 Enclosure 1
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[7590-01] g C this section, in addition to the functions specified in SS 35.31 and 35.32, \ the Radiation Safety Committee or Radiation Safety Officer must perform or ensure performance of the following functions: (1) duthorizing the purchase or' receipt of byproduct material and its distribution; (2) Establishing written ' policy and procedures for disposal of all byproduct material; (3) Establishing and ensuring implementation of writteri procedures for: / (i) Emergency actions; ,
,/
(ii Periodic radiation surveys; / (iii) Periodic inventory of byproduct material; (iv) Safety during use of byproduct material; (v) Perfer=.ance check: cf sfety equip:::ent nd curvey ' instrumentation; and (vi) Training of personnel./ (4) Establishing and implementing a radiation safety education /
- program for personnel working in or frequenting areas where byproduct
, materia,1 is used and stored; (5) Maintaining records to show compliance with the training and experience requirements of Subpart J of this part, which includes: (i) For the Radiation Safety Officer, a photocopy of that indivi-dual's certificate as listed in S 35.900 or a completed Form NRC-313M Revision 1 Supplement A; (ii) For the Qualified Teletherapy Calibration Expert, a photocopy l 7 M} q.{} of that individual's certification as listed in S 35.961 or a completed Form NRC-313M Revion upplement A; and g l (iii) For each authorized u,ser, a photocopy of that individual's license to practice medicine, and either a photocopy of a certification that is listed as appropriate for the types of use in which the authorized user is engaged, a completed Form NRC-313M Revision 1 Supplements A and B, or a photocopy of an NRC or Agreement State license issued by (** insert , effective date of final rule **) that identifies the individual as an , authorized user for the types of use in which the authorized user is agaged; and p- ~ N 55 Enclosure 1 l 1
[7590-01] (4--Establishing'aWdTaT6t'a'fHilifs'tecordkeeping system'for recordsmthfr>A' renuired by abpectf"f ;ch; ding-the-minutes-of -c= Linus u T -- Lhe Redi at-ion-
~
Safety-Committee reqlif red ~0ndsF6 35~31(a)'T6d'Ficords~bf'the' Committee's' av.iew-and-deliberations-required undeTS 35 31ttri-6 35.34 Visiting authorized user. (a) A licensee may permit any yisiting authorized user to use licensed material for human use under the terms of the licensee's wk 4 license for sixty 4days in any calendar year if: (1) The yisiting authorized user has the prior written permission of , the licensee's management and, if such use occurs on behalf of an institu-tion, the institution's Radiation Safety Committee; (2) The licensee has a copy of a Commission or Agreement State licer.;c that lists the visiting authorized uses as aii ouliiorized user for human use; and (3) The visiting authorized user performs only those procedures for which the visiting authorized user is specifically authorized by a
- Commission or Agreement State license.
(b) The licensee need not apply for a license amendment authorizing the short-term use described in paragraph (a) of this section. (c) The licensee shall NOetain for two years copies of the critte,. wuu p- i:r.jspecified in paragraph (a)(1) of this section and of the license.specified in paragraph (a)(2) of this section. l 9 35.35 Mobile service administrative requirements. (a) The Commission will only license mobile service in accordance with Subparts D, E and H of this part and S 31.11 of this chaoter. w p m .uah (b) Mobile service licensees shall maintainaa letteruthori ,a &z+ng-- w n ,,W useofbyproductmaterialfsignedbythemanagementofeachlocath hereservicesarerenderekNat) 6 35.37 Records and reports of misadministrations. (a) When a misadministration involves any therapy procedure, the i licensee shall notify, by telephone only, the appropriate NRC Regional l Office listed in Appendix 0 of Part 20 of this chapter. The licensee j shall also notify the referring physician of the affected patient and j 56 Enclosure 1 , 1
; I l l
[7590-01] the patient or a responsible relative (or guardian), unless the referring physician personally informs the licensee either that he will inform the patient or that, in his medical judgment, telling the patient or the patient's responsible relative (or guardian) would be harmful to one or the other, respectively. These notifications shall be made within 24 hours after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the , patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient because of this. (b) Within 15 days after an initial therapy misadministration report to NRC, the licensee siiall repurL, in writing, Lu Liie NRC Regionai Office initially telephoned and to the referring physician, and furnish a copy of the report to the patient or the patient's responsible relative (or guardian) if either was previously notified by the licensee under paragraph (a) of this section. The written report shall include the licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recur-rence; whether the licensee informed the patient or the patient's responsible relative (or guardian), and if not, why not. The report must not include the patient's name or other information that could lead to identification of the patient. (c) When a misadministration involves a diagnostic procedure, the licensee shall notify, in writing, the referring physician and the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. Licensee reports of diagnostic misadministrations are due within 10 days after the end of the calendar quarters (defined by March, June, September and December) in which they occui. These written reports must include the licensee's name; the referring physician's name; a description of the event; the effect on the patient; and the action taken to prevent recurrence. The report should not include the patient's name or other information that could lead to identification of the patient. 57 Enclosure 1
[7590-01] (d) Each licensee shall. maintain for Commission inspection a (q' record of each misadministration. The record must contain the names of all individuals involved in the event (including the physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number, a brief description of the event, the effect on the patient, and the action taken to prevent recurrence. The licensee shall preserve misadministration records until the Commission authorizes their disposition. (e) Aside from the notification requirement, nothing in this section shall affect any rights or duties of licensees and physicians in relation to each other, patients, or responsible relatives (or guardians). S 35.38 Supervision. The licensee who permits the receipt, possession, use, or transfer of byproduct material authe-iz d by an individual under the supervision of an authorized user as authorized by S 35.2(b) shall: (a)(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct O- material; (2) Review the supervised individual's use of byproduct material and the records kept to reflect such use; (3) Require the authorized user to be immediately available by telephone to the supervised individual; and nu,. 4 g-(4) Require the authorized user to be gphysically present and available to the supervised individual on one hour's notice. The supervising authorized user need not be present for each use of byproduct material. (b) Require the supervised individual receiving, possessing, using or transferring byproduct material under S 35.2(b) to: (1) Follow the instructions of the supervising authorized user; (2) Follow the procedures established by the Radiation Safety Officer,pursuntteS35.3[and ,,g g ,2 ,,..,,gAi (3) Complywiththeregulationsofthispartgwithrespecttothe use of byproduct material. O 58 Enclosure 1
e [7590-01]
^ S 35.49 Suppliers.
The licensee may use for human use only: (a) Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regula-tions in Part 30 and SS 32.72, 32.73, or 32.74 of this chapter or equivalent regulations of an Agreement State; (b) Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with an approval by the Commission pursuant to S 32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for human use; and (c) Radiopharmaceuticals authorized by a Radioactive Drug Research Committee that has been approved by the Food and Drug Administration pursuant to 21 CFR 361.1. i Subpart C--General Technical Requirements S 35.50 Possession, use, calibration, and check of dose calibrators. (a) Each human use licensee who is authorized to administer radiopharmaceuticals shall have in his possession a dose calibrator and use it to measure the amount of activity administered to each patient. (b) The licensee shall: g, ,g,,,, ,j u d /9f (1) Checkeachdosecalibratorforconstancydcilypri5 rte (use. To satisfy the requirement of this paragraph, the check must be done on a frequently used setting with a sealed source of not less than 10 micro- i curies of radium-226 or 50 microcuries of any other gamma-emitting radionuclide; (2) Test each dose calibrator for accuracy upon installation and i at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, and whose activity is at least 10 microcuries for radium-226, and 50 microcuries for any other gamma-emitting radionuclide; (3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the highest l a'dmInstredand10microcuries;and 59 Enclosure 1 1
[7590-01]
- (4) Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which i ormanywill j
usey. The licensee shall keep a record of this test for the duration of the use of the dose calibrator. (c) The licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator. (d) The licensee shall mathematically correct readings for any errorinexcessof10percentifthedofisgreaterthan10microcuries. and the radiopharmaceut-ical-emit::, a pheten with-an-energy-greater than
) The licensee shall % r or .the$hck nd test required by this sectica for two years unless directed otherwise.
(1) The record required in paragraph (b)(1) of this section must include the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the check, the activity measured, and the initials of the individual who performed the check. d (2) The record required in paragraph (b)(2) of this section must include the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide f contained in the source and its activity, the date of the test, the results of the test, and the signature of the Radiation Safety Officer. (3) The record required in paragraph (b)(3) of this section must include the model and serial number of the dose calibrator, the calcu-lated activities, the measured activities, the date of the test, and the signature of the Radiation Safety Officer. (4) The record required in paragraph (b)(4) of this section must ! include the model and serial number of the dose calibrator, the configu-ration of the source measured, the activity measured for each volume l l measured, the date of the test, and the signature of the Radiation Safety Officer. 60 Enclosure 1
[7590-01] y 6 35.51 Possessrionruse alibration and check of survey instruments. V% g (-a)-Each-human-usedicensee-shall-have-in his_possaniona K ,. 7jj 3 g a portable low Yevel radiation survey instrument whose most 9 sensitive scale has a full-scale deflection of not more than 1 milli-j p '( 4 roent en er hoy g -- R. }{-2)fa portable high levelara#diation survey instrument that has a , hcale with a full scale deflection of 1 roentgen per hou, 9 g(6) The licensee shall calibrate survey instruments before first use, annually, and following repair; g b(,c) To satisfy the requirements of paragraph (b') of this section, the licensee shall: (1) Calibrate all scale readings up to 1000 milliroentgens per hour; and - 52 (2) Calibrate two readings on each scale that must be calibrated; and (3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of c calibrationjand the date of calibration. [ k/) To satisfy the requirements of paragraph (b) of this section, the licensee may: (1) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 10 percent; and (2) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent if a correction chart or graph is conspicuously attached to the instrument. puav epaa dg. d(/) The licensee shall check each survey instrument forg fdaction with the dedicated check source before and after each use. The licensee is not required to keep records of these function checks. Nfin gj(/) The licegsee.shall keepga record of each calibration required inparagraphh)a ff[r$t dd6 U57use of the imtrcment. To satisfy the requirements of this paragraph, the record must include: (1) A description of the calibration procedure; and i 61 Enclosure 1
[7590-01] 1 >
\
q (2) A description of the source radionuclide used and its esti-b.) mated activity, the calculated or measured exposure rates from the source, M the rates indicated by the instrument being calibrated 6 oud'h2 84b difauAfsom Mu eduraGr. 44., aj Mr*ah una' e + oj ndad cahs twt / m>ug, w c.8 /t.t A N S 35.53 Measurement of radiopharmaceutical dosages. 1 The licensee shall: (a) Assay before human use the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a radionuclide that
,"~, " emits electromagnetic radiation in the form of gamma rays or x-raysg I
_\ (b) Assay before human use the activity of each radiopharmaceutical
, dosage with a desired activity of 10 microcuries or less of a radionuclide
, , that emits electromagnetic radiation in the form of gamma rays or x-rays
/4 d.ota4c to verify that 4& does not exceed 10 microcuries.
AiEw i' (c) Keep a record of the measurements required by this section for {4 two years. To satisfy this requirement, the record must contain the:
/ (1) Generic name of the radiopharmaceutical, its lot number, and
^^
expiration date; y fu,y a; (2). Patient'snameandidentificationnumbe(gud ; (3) Total activity of the dosage at the time of measurement, or a notation that the total activity is less than 10 microcuries; and (4) Date and time of the measurement. 9 35.58 . Authorization for calibration and reference sources. Any person authorized by 9 35.2 for human use of byproduct material u; n tu ~ ) may receive, possess, and use byproduct material /- -
$ led sources O i Ws~n'u"6ctured nu R distributed by a person licensed pursuant to_S_32_74 of ,_)
this chapter or equivalent Aareement State re ulation b heck, cali-
! bration, and reference use if such searc(not exceed 6 millicuries,j adCl / OW I ', 9,,JgE -/[ "
6 35.59 Requirementsforpossessionofsealedsourch?. .w w Wre/f , w (a).Alicenseeinpossessionof[ edsourceko uman-use d shall use the source in accordance with the instructions supplied by the manufacturer, and shall maintain such instructions in a legible form
, convenient to users of the source.
V 62 Enclosure 1
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$/ 4,wA //s u,uw s', av e r:1.r u <>h.r.uc $ M y or d na,u , s Le w oh <>l** ++o4 [7590-01]
'(b) A licensee in possession of a sealed source shall:
(^)T
' J
; (1) Test the source for leakage before its first use unless the licensee has a certificate from a licensed transferor indicating that the source was tested within six months prior to transfer to the licensee; and
-(2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State and described in the supplier's label or brochure that accompanies the~ source. 4 (c) To satisfy the leak test requirements of this section, the licensee must: ,
-(1) Take the tc:t- sample from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate; (2) Take the test sample from a teletherapy source with the source in the "off" position; and g (3) Measure the sample so that theAtest can detect the presence of A 0.005 microcuries of radioactive nr.aa, material O & on the sample./w (d) The licensee shall Aeep- leak > test records for years.
The records must contain the model number and serial number of each source tested, and the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries, a description of the method used to measure each test sample, the date of the test, and the signature of the Radiation Safety Officer. dc (e) If the leak / test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall: (1) Immediately withdraw the sealed source from use and ' store, decontaminate, repair, or dispose of the source in accordance with Parts 20 and 30 of this chapter; and g (2) File a report within five days of the leak Itest with the appropriate Nuclear Regulatory Commission Regional Office listed in Appendix D of Part 20 of this chapter, with a copy to Director of Inspec-tion and Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, describing the equipment involved, the test results, and the (~)S \', corrective action taken. 63 Enclosure 1
[7590-01] (f) The licensee need not perform a leak > test on the following O sources: (1) Sources containing only byproduct material with a half-life of less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage prior to any use or transfer unless it F 1 tested within six months prior to the date of use or has been leak transfer; (5) Seeds of iridium-192 encased in nylon ribbon; (6) Sources containing only hydrogen-3; (7) Wires of iridium-192; and (8) Wires of tantalum-182. g,4 v w ou (g) Any licensee in possession of a sealed source /shall conduct a sa quarterly physical inventory of all tar= '.cd sources in the licensee's
,, possession. ThelicenseeshallZeepo.asinventory recordi'for two years.
I s m V The inventory records must contain the model,,6ild A s wial numberlof_ parh g J source, the identity of each source radionuclide and its estimaG M~d-% 4u ~ 4ax activity, the location of each source, and the signature of the Radiation Safety Officer. g4 soggcc 34 (h) Any licensee in possession of a sealed sourcegshall survey with a low range survey meter quarterly all areas where sealedjsources are stored. (i) The licensee shall keep a record of the vey required in paragraph (h) of this section for-two years. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area expressed in millirem per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the Radiation Safety Officer. 6 35.60 Syringe shields. (a) The licensee shall keep syringes that contain byproduct mate-U rial to be administered in a radiation shield. 64 Enclosure 1
[7590-01]
,q (b) The licensee shall require each individual who administers a O radiopharmaceutical by injection to use a syringe radiation shield unless the use of the shield is contraindicated for that injection.
6 35.61 Vial shields. The licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial-radiation shield. 6 35.62 Syringe labels. The licensee shall conspicuously label each syringe radiation shield that contains a syringe with a radiopharmaceutical to be admini-stered with the radiopharmaceutical abbreviation or type of diagnostic study or therapy procedure to be performed. 6 35.63 Vial labels. The licensee shall conspicuously label each vial radiation shield
,q that contains a vial of a radiopharmaceutical to be administered with 'v' the chemical name or its abbreviation.
6 35.70 Surveys for contamination and ambient radiation exposure rate. (a) The licensee shall survey with a low range survey meter at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered. (b) The licensee shall survey with a low range survey meter at least once each week all areas where radiopharmaceuticals or radio-pharmaceutical waste is stored. (c) The licensee shall conduct the surveys required by paragraphs (a) and (b) of this section so as to be able to measure exposure rates that are greater than 0.1 milliroentgen per hour. (d) The licensee shall establish radiation exposure rate action levels for the surveys required by paragraphs (a) and (b) of this section andshallrequirethattheindjvidualwhoisperformingthesurveyimme-diately notify the radiaton 6Nlcer if an exposure rate exceeds an , q action level. v 65 Enclosure 1 l l
[7590-01] (e) The licensee shall survey for removable contamination once each week all areai where radiopharmaceuticals are routinely prepared for use, administered, or stored. (f) The licensee shall establish removable contamination action levels for the surveys required by paragraph (e) of this section and shall require that the individual who is performing the survey immedi-ately notify the Radiation Safety Officer if contamination exceeds the action level. - l (g) The licensee shall a record of survey one year. The record must include the date of the survey, a plan of each area that thac tim fxvd teCd.tasu fn sacn mm was surveyed,7the measured exposure rate at several points in each area expressed in millirem per hour or disintegrations per minute, the model number of the instrument used to make the surve analyze the samples, and the initials of the individual who performed the survey. 6 35.75 Release of patients containing radiopharmaceuticals or permanent implants. (a) The licensee shall not authorize release from confinement for medical care of any patient administered a radiopharmaceutical until either: (1) The exposure rate from the patient is less than 6 milliroentgens per hour at a distance of one,,. or meter;md m (2) The reddval activity 41 s fess than 30 millicuries. (b) The licensee shall not authorize release from confinement for medical care of any patient administered a permanent brachytherapy implant until the exposure rate from the patient is less than 6 milli-roentgens per hour at a distance of one meter. 6 35.80 Mobile service technical requirements. A licensee providing mobile service shall:
.(a) Transport to each location of use only syringes or vials containing unit dos'es of prepared radiopharmaceuticals; (b) Bring into each location of use all byproduct material to be used and, before leaving, remove all unused byproduct material and all associated waste; D
66 Enclosure 1
'} }
'r # 'y V' [7590-01]
. ~ , <,
y 7 U y;JY 3 (~3 (c) Secure or keep under constant surveillance and immediate control all byproduct material (d) Check survey instruments and dose calibrators as described in SS 35.50 and 35.51, and check all other equipment as recommended by the manufacturer or as prescribed by the licensee before administering byproductmaterialtohumansgM dd4 I"d N f G (e) Carry a calibrated survey meter in each vehicle that is being used to transport byproduct material, and survey for ambient radiation exposure rate with a low range survey meter prior to departure from_the
^
location of hr$0uct-mateMakwusetoensurethatallbhrEdust4aterihl
,e andallassociatedwasteha(beenremoved;and , jd #
p-au t- P %^*/'4 2 (f) A ctah-keep a record of Wepurvey;urrequired in s&cction (e)g)for one year. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area expressed in millirem per hour, the model number of the instrument used to make the survey, and the initials of the individual who performed the survey. n (V) 6 35.90 Storage of volatiles and gases. The licensee shall store volatile radiopharmaceuticals and radioactive gases in a fume hood or in a container with two airtight barriers against release. 6 35.92 Decay-in-storage. (a) The licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of S 20.301 of this chapter if the licensee: (1) Holds byproduct material for decay a minimum of ten (10) half-lives; , j g gm ., a j (2) Monitors byproduct material j prior to disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a low range survey meter set on its most sensitive scale and unshielded; p (3) Removes or obliterates all radiation labels; and O 1 67 Enclosure 1 l l
[7590-01]
,m (4) Separates and monitors each generatord column individually
( ) //w / M fd s a without any shielding to ensurejfecay /'o t background radiation level prior to disposal. ' j (b) For paragraph (a) of this section, the licensee shall Seep a record of each disposal for two years. The record must include the date of the disposal, the date on which the byproduct material w/sstor A e s .,k,,the modelnumberofthesurveyinstrumentused,thebackgroundrb1iationA$vid, ox.. a s.s the radiationjlevel-measured at the surface of each waste containejandthe name of the individual who performed the disposal. Subpart D--E d General /) 0ptake, dilution -) n 9 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies. . (a) The licensee shall use the following prepared radiophar-maceuticals for diagnostic studies involving the measurement of uptake, dilution, or excretion in accordance with the product labeling or pack-age insert instructions for use supplied by the radiopharmaceutical b, 7 manufacturer, except as provided in paragraph (b) of this section: (1) Iodine-131 as sodium iodide, iodinated human serum albumin (IHSA), labeled rose bengal, or sodium iodohippurate; (2) Iodine-125 as sodium iodide or iodinated human serum albumin (IHSA); (3) Cobalt-58 as labeled cyanocobalamin; (4) Cobalt-60 as labeled cyanocobalamin; (5) Chromium-51 as sodium chromate or labeled human serum albumin; (6) Iron-59 as citrate; (7) Technetium-99m as pertechnetate; (8) Any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion authorized by the Food and Drug Administration (FDA), or by[the i kem,ee's Radioactive Drug Research Committee that has been approved by the FDA , pursuant to 21 CFR 361.1. (b) The licensee using a radiopharmaceutical listed in paragraph (a) ' , ,i of this section for a clinical procedure other than one specified in the t V product labeling or package insert instructions for use shall comply with 68 Enclosure 1
rj ~L e,f, / _, , L, m~ >.w y y v,7- ;[7590-01]-
},
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; a y,
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~
the product labeling or package insert instructions regarding physical >au;i_ y ' O form, route of administration and dosage range. Subpart E- g p_II/IID , magi j _ G 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. (a) The licensee shall use the following radiopharmaceuticals, generators, and reagent kits for imaging and localization studies in accordance with the product labeling or package insert or other manu-facturer's instructions for use, except as provided in paragraphs (b) and (c) of this section: (1) Molybdenum-99/ technetium-99m generators for the elution or extraction of technetium-99m as pertechnetate; (2) Technetium-99m as pertechnetate; (3) Prepared radiopharmaceuticals and reagent kits for the preparation of the following technetium-99m labeled radiopharmaceuticals: (i) Sulfur colloid; (ii) Pentetate sodium; (iii) Human serum albumin microspheres; (iv) Polyphosphate; (v) Macroaggregated human serum albumin; (vi) Etidronate sodium; (vii) Stannous pyrophosphate; (viii) Human serum albumin; (ix) Medronate sodium; (x) Gluceptate sodium; (xi) 0xidronate sodium; (xii) Dissfenin; and (xiii) Succimer. i (4) Tin-113/ indium-113m generators for the elution of indium-113m as choride; O 69 Enclosure 1
[7590-01] t g (5) Iodine-131 as sodium iodide, iodinated human serum albumin, l V- macroaggregated iodinated human serum albumin, colloidal (microaggregated) l iodinated human serum albumin, rose bengal, or sodium iodohippurate; j (6) Iodine-125 as sodium iodide or fibrinogen; l (7) Chromium-51 as human serum albumin; j (8) Gold-198 in colloidal form; (9) Mercury-197 as chlormerodrin;
- (10) Selenium-75 as selenomethionine;
! (11). Strontium-85 as nitrate; (12) Ytterbium-169 as pentetate sodium; (13) Indium-113m as chloride; (14) Xenon-133 as a gas or saline solution; (15) Any byproduct material in a radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing byproduct material authorized by the Food and Drug Administra-u tion or by th: lice. wee's Radioactive Drug Research Committee that has l been approved by the FDA pursuant to 21 CFR 361.1. (b) The licensee using the radiopharmaceuticals listed in , paragraph (a) of this section for clinical procedures other than those specified in the product labeling or package insert shall comply with the product labeling or package insert regarding: (1) Physical form; 1 (2) Route of administration; and (3) Dosage range. (c) The following radiopharmaceuticals, when used for the listed clinical procedures, are not subject to the restrictions in paragraphs (a) and (b) of this section: (1) Technetium-99m pentetate as an aerosol for lung function studies. 6 35.204 Permissible molybdenum-99 concentration. (a) The licensee shall not administer to humans a radiopharmaceuti-cal containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m'; , ap (b) Thelicensee,prepari technetium-99m radiopharmaceuticals ower nu-from molybdenum-99/ technetium-99m generators shall test :::h ;;c=raton-(eTuate or extract) molybdenum-99 ( _. _ _ . . , . - concentration.*_J"
- Ny{,
m __ 70 Enclosure 1
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h;,gg,((f590-01]
\w cw; , - v.
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(c) The lic,ensee,'shall;,mmaintain a record of, molybdenum concentration a_. ~ .s a n s yw ..u. + . . . j (__ test rewl-tgor two years. The record must include, for each elution j I or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries, the measured activity of the molybdenum expressed ! m to n niso a,,uw.1 a> <a w~,,.. -r.. 7 < . i r . t .~, in microcuries,' g the date of the test, and the initials of the individual who performed the test. [ f,,,4 4 ,,, o ,.- 6 35.205 Control of aerosols and gases. The licensee who administers radioactive aerosols or gases shall do so with a system that will prevent the unintended dispersal of the
/
byproduct material. The system must either be directly vented to the f , atmosphere through an air exhaust or provide for collection and decay or / disposal of the aerosol or gas in a shielded container. 4/' Subpart F- h up_IV/ opharmaceuticals for t N apy') t ;- _ 6 35.300 Use of radiopharmaceuticals for therapy. The licensee shall use the following prepared radiopharmaceuticals O in accordance with the product labeling, package insert, or other manu-(_/ facturer's instructions for use: (a) Iodine-131 as iodide for treatment of hyperthyroidism, cardiac dysfunction, and thyroid carcinoma; (b) Phosphorus-32 as soluble phosphate for treatment of polycythemia vera, leukemia, and bone metastases; (c) Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of malignant effusions; (d) Gold-198 as colloid for intracavitary treatment of malignant effusions; (e) Any byproduct material in a radiopharmaceutical and for a therapeutic use authorized by the Food and Drug Administration. E 6 35.304' Safety instruction. (a) The licensee shall provide oral and written radiation safety instructions for all personnel caring for the patient undergoing radio-O LJ 71 Enclosure 1
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p pharmaceutical therapy. To satisfy this requirement, the instructions O must describe procedures for: (1) Patient control; (2) Visitor control; (3) Contamination control; (4) Waste control; and (5) Notification of the radiation safety officer in case of the patient's death or medical emergency. it > / (b) The licensee shall keep for two years a list of individuals receiving instructions required by paragraph (a) of this section, a 2 description of the instructions, the date of instruction, and the name of the individual who gave the instruction. g -. _ O VD Subpart G-@up,Lgources - for brachytheraET) 6 35.400 Use of sources for brachytherapy. The licensee shall use the following sources for therapeutic purposes in accordance with the product labeling, package insert, or other manu-b facturer's instructions for use: (a) Cesium-137 as a sealed source in needles and applicator cells ! for topical, interstitial, and intracavitary treatment of cancer; (b) Cobalt-60 as a sealed source in needles and applicator cells , for topical, interstitial, and intracavitary treatment of cancer; l (c) Gold-198 as a sealed source in seeds for interstitial treatment of cancer; i (d) Iridium-192 as seeds encased in nylon ribbon or as wire for interstitial treatment of cancer; (e) Strontium-90 as a sealed source in an applicator for treatment l of superficial eye conditions;
- (f) Iodine-125 as a sealed source in seeds for interstitial I treatment of cancer; and (g) Tantalum-182 as wire.
S 35.404 Release of patients treated with temporary implants. ; ,p (a) The licensee shall not release from confinement for medical b care,a patient treated by the temporary implant of a source listed in 72 Enclosure 1
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$ 35.400 until a source count and a radiation survey of the patient \'
r~)T nwas confirm that all/ phnt: have been removed. (b) The licensee shall keep a record of source counts and patient surveys for two years. Each record must include the name of the patient, the number of sources implanted, the number of sources removed, and the i exposure rate from the patient expressed as millirem per hour and measured within one meter of the patient.
/0 6 35.405' Safety instruction.
(a) The licensee shall provide written radiation safety instruc-tions to all individuals caring for the patient undergoing brachytherapy. To satisfy this requirement, the instructions must describe: l (1) gtientcontrol; (2) gisitorcontrol;and (3) Procedures for notification of the radiation safety officer j , in case of the patient's death or medical emergency; and."size and appear- l v) s ance of the brachytherapy sources. ! (b) The licensee shall keep for two years a list of individuals
~
receiving instructions required by paragraph (a) of this section, a l description of the instructions, the date of instruction, and the name of the individual who gave the instruction. i i ( 35.406. Brachytherapy sources inventory. 42+/*h 7j !- The-Heensee sherH-estaM4sh-and-i=pl rat i written-brechyuici w V , settree-inveni.viy pi vuedura. T6 prucedure must require the maintenance of-e-brachytherapy-source accountability-ledgerthat gives-the-location-of' / each brasnyi.iiciovy eeurce at-ell-times / SubpartH-fGroupVII)gealedsourcesfordiagnos3) w. I 6 35.500 Use of sealed sources for diagnosis. l The licensee shall use the following sealed sources for diagnostic purposes in accordance with the product labeling, package insert, or other manufacturer's instructions for use: (a) Iodine-125 as a sealed source in a device for bone mineral analysis;-and # , t
- 73 Enclosure 1
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( Subpart I--fro M 55D ,) 6'35.600 Use of a sealed source in a teletherapy unit. ; The regulations and provisions of this subpart govern the use of teletherapy units that contain the following sources for the treatment , of humans: (a) Cobalt-60 as a sealed source; and (b) Cesium-137 as a sealed source.
@ S.604 Information to be submitted with application.
The applicant shall supply such information deemed necessary by the Commission to determine the safety of the teletherapy facility. This includes, but is not necessarily limited to plan and elevation drawings, shielding information and calculations, and descriptions of interlocks, , viewing systems, and other safety systems. S 35.605 Maintenance and repair restrictions. Only a person specifically licensed by the NRC or an Agreement State to perform teletherapy unit maintenance and repair shall maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels. 6 35.606 Amendments. The licensee shall apply for and must receive a license amendment prior to: (a) Making any change in the treatment room shielding; (b) Making any change in the location of the teletherapy unit within the treatment room; (c) Using the teletherapy unit in a manner that could result in i increased radiation levels in areas outside the teletherapy treatment I room; ,O , 74 Enclosure 1 :
[7590-01] (d) Relocating the teletherapy unit; (e) Removing the teletherapy unit; (f) Changing the source; or (g) Allowing an individual not listed on the licensee's license to perform the duties of the qualified teletherapy calibration expert.
}bnA 6 35.610 -E_. .~y instructions.
Thelicenseeshallpostwritten;;;rg;r.)finstructions at the teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of: (a) The procedure to be followed to ensure that only the patient is in the treatment room before turning the primary beam of radiation on; I ,; (b) Theproceduretobefollowed,[J.;uldq(i)theoperatorbeunableto A turn the primary beam of radiation off with controls outside the treatment room orj(ii) any other abnormal operation occur?; and (c) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted in the event of any abnormal operation of the teletherapy unit or console. 6 35. N Doors, interlocks, and warning systems. (a) The licensee shall control access to the teletherapy room by a door at each entrance. (b) The licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will: (1) Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed; (2) Turn the primary beam of radiation off immediately when an entrance door is opened; and (3) Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console. (c) The licensee shall equip each entrance to the teletherapy room with a beam condition indicator light. O 75 Enclosure 1
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q 6 35.621 Radiation monitoring device. V (a) The licensee shall install a permanent radiation monitor in each teletherapy room capable of continuously monitoring beam status. (b) Each radiation monitor must be capable of providing visible notice of a teletherapy unit malfunction that may result in an exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual entering the teletherapy room. (c) Each radiation monitor must be equipped with an emergency power supply separate from the power supply to the teletherapy unit. This emergency power supply may be a battery system. (d) Each radiation monitor must be checked for proper operation each day before the teletherapy unit is used for treatment of patients. (e) The licensee shall maintain a record of the monitor check required by paragraph (d) of this section for two years. The record must include the date of the check, notation that the monitor indicates when the source is and is not exposed, and the initials of the individual who performed the check. V (f) If a radiation monitor is inoperable for any reason, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked for proper operation at the beginning of each day of use. (g) The licensee shall promptly repair or replace the radiation monitor if it is inoperable. 6 35.622 Viewing system. The licensee shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation. 6 35.630 Dosimetry equipment. (a) The licensee shall have a calibrated dosimetry system available m for use. To satisfy this requirement, one of the following two conditions (0 must be met. 76 Enclosure 1
1 [7590-01] l (1) The system must have been calibrated by the National Bureau of ,V Standards or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the National Bureau of Standards or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the l intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to change the calibration factor. l The licensee shall use a teletherapy unit with a cobalt-60 source when intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, and a teletherapy unit with a cesium-137 source when intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units. g (b) The licensee shall have available for use a dosimetry system l for spot-check measurements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section. (c) The licensee shall maintain a record of each calibration, intercomparison, and comparison for the duration of the license. For ! each calibration, intercomparison, or comparison, the record must include 1 the date, the model numbers and serial numbers of the instrument that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factors that were deduced, the names of the individuals who performed the calibration, intercomparison, 77 Enclosure 1
[7590-01] q or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM. S 35.632 Full calibration measurements. (a) Any licensee authorized to use a teletherapy unit for treating humans shall perform full calibration measurements on each teletherapy unit: (1) Before the first use of the unit for treating humans; and (2) Before treating humans under the following conditions: (i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for physical decay; (ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; (iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with a the source exposure assembly; and (3) At intervals not exceeding one year. (b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of: (1) The output within 13 percent for the range of field sizes and for the distance or range of distances used in radiation therapy; (2) The coincidence of the radiation field and the field indicated by the light beam localizing device; (3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (4) Timer accuracy; (5) On-off error; and (6) The accuracy of all distance measuring and localization devices used for treating humans. (c) The licensee shall use the dosimetry system described in 9 35.630(a) to measure the output for one set of exposure conditions. The radiation measurements required in paragraph (b)(1) of this section may then be made using a dosimetry system that indicates relative a t A .~
) h;c AaL 78 Enclosure 1
[7590-01] (d) The licensee shall make full calibration measurements required V by paragraph (a) of this section in accordance with the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine. These procedures are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379-396, which has been approved for incorporation by reference by the Director of the Federal Register. Copies of the document are avail-able for inspection or may be obtained from the U.S. Nuclear Regulatory Commission, Public Document Room, 1717 H Street NW, Washington, D.C. 20555. A copy of the document is also on file at the Office of the Federal Register, 1100 L Street NW., Room 8301, Washington, D.C. 20408. A notice of any change in the material will be published in the Federal Register. (e) The licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month. (f) Full calibration measurements required by paragraph (a) of g this section and physical decay corrections required by paragraph (e) of d this section must be performed by a qualified teletherapy calibration expert. A fr o (g) Thelicenseeshall1eeparecordofeachcalibrationforthe duration of the license. The record must include the date of the cali-bration, the cturer's name number and serial number of both the teletherapy unit and the source, the model number 3and serial number 3 of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a radiograph of a single field with the location of the light field indicated on the radiograph, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or locali-zation device, and the signature of the qualified teletherapy calibration expert. O 79 Enclosure 1
[7590-01] 6 35.633 Periodic spot-checks. (a) The licensee authorized to use teletherapy units for treating humans shall perform spot-checks on each teletherapy unit once in each calendar month. (b) To satisfy the requirement of paragraph (a) of this section, measurements must include determination of: (1) Timer accuracy; (2) On-off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing device; (4) The accuracy of all distance measuring and localization devices used for treating humans; (5) The output for one typical set of operating conditions; and (6) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e. , the value obtained at last full calibration corrected mathematically for physical decay). (c) The licensee shall use the dosimetry system described in S 35.630(b) to make the measurement required in paragraph (b)(5) of this section. (d) The licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the qualified teletherapy calibration expert. That individual need not actually perform the spot-check measurements. (e) Thelicenseeshallhavea!hualifiedteletherapycalibration [ expert P r':c.; t h ;;;t- de d . - . ..... W ot review the results of spot-check sammenents within 15 days. The qualified teletherapy calibration expert shall promptly notify the licensee in writing of the results of each spot-check measwoment. The licensee shall keep a copy of each written notification for two years. (f) The licensee authorized to use a teletherapy unit for treating humans shall perform]n,t-checks of each teletherapy facility at intervals not exceeding one month. (g) To satisfy the requirement of paragraph (f) of this section, checks must assure proper operation of: (1) Electrical interlocks at each teletherapy room entrance; 80 Enclosure 1
[7590-01] i ; l (2) The function of electrical or mechanical stops installed for i the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism); (3) All beam condition indicator lights on the teletherapy unit, on the control console, and in the facility; (4) The viewing system; (5) Operability of treatment room doors from inside and outside the treatment room; and (6) Operability of any electrically assisted treatment room doors with the teletherapy unit electrical power turned off. (h) The licensee shall lock the control console in the off position if any door interlock malfunctions, and shall not use the unit until the interlock system is repaired. (i) The licensee shall promptly repair any system identified in paragraph (g) of this section that is not operating properly. (j) The licensee shallh a record of each spot-check required by paragraphs (a) and (f) of this section for two years. The record must include the date of the spot-check, the manufacturer's name, model l number and serial number of both the teletherapy unit and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, the measured time Daccuracy, k the calculated on-off error, a radiograph of a single field with the loca- . tion of the light field indicated on the radiograph, the measured timer ! accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, nota- i tions indicating the operability of each entrance door electrical inter-lock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual [ i who performed the periodic spot-check. l i I 6 35.641 Radiation measurements following installation of a source. l (a) Before human use and after each installation of a teletherapy [ i source, the licensee shall perform radiation surveys to verify that: i
- O
! I r l 81 Enclosure 1
_. . -. - . - - = _ - - ._- -- ._ h [7590-01] (1) The maximum and average radiation levels at one meter frc:n the 4 teletherapy source when in the off position do not exceed 10 milliroentgens per hour and 2 milliroentgens per hour, respectively; and (2) With the teletherapy source in the on position with the largest j clinically available treatment field and with a phantom in the primary l beam of radiation, that (1) Radiation quantities in restricted areas adjacent to the treatment room are not likely to cause personnel exposures in excess of the limits specified in S 20.101 of this chapter, and (ii) Radiation quantities in unrestricted areas adjacent to the treatment room do not exceed the limits specified in S 20.105(b) of this chapter. l (b) If the results of the surveys required in paragraph (a) of this section indicate any radiation quantity in excess of the respective l limit specified in that paragraph, the licensee shall lock the control in the off position and not use the unit: ; (1) Except as may be necessary to repair, replace, or test the teletherapy unit shielding or the treatment room shielding; or (2) Until the licensee has received a specific exemption pursuant to S 20.501 of this chapter. l (c) The licensee shall maintain a record of the radiation ! measurements made following installation of a source for the duration of I the license. The record must include the date of the measurements, the manufacturer's name, model number and serial number of the instrument used to measure radiation levels, each radiation level measured around the tele-therapy source while in the off position and the average of all measure-ments, a plan of each area that was surveyed, the measured exposure rate at several points in each area expressed in millirem per hour, the calculated
- maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation 3
Safety Officer. ( 6 35.642 Facility checks following installation of a source. (a) The licensee shall promptly test all systems listed in 9 35.633(g) for proper function af ter each installation of a teletherapy
, O' source.
82 Enclosure 1 , t
[7590-01] (S ) (b) If the results of the checks required in paragraph (a) of this sectionindicatethemalfunctionofanysystemspecifiedinS49633(g), the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or test the malfunctioning system. nf (c) The licensee shall A in a record of the facility checks following installation of a source for $ [ U stian af t% license. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer. S 35.643 Modification of teletherapy unit or room before beginning a treatment program. If the survey required by S 35.641 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than l (7 those permitted by 6 20.105(b) of this chapter, before beginning the
/
treatment program the licensee shall: (a) ptherequiptheunitwithstopsoraddadditionalradiation shielding to ensure compliance with 6 20.105; (b) Perform the survey required by 9 35.641 again; and l (c) In::1ude in the report required by 6 35.644 the results of the initial survey, a description of the modification, and the results of j the second survey.
*N P l 6 35.644 Reports of teletherapy surveys./and tests c /._ #m orn $
The licensee shall mail copies of the results of the surveys and tests required at SS 35.641, 35.642, 35.643, and the output from the teletherapy source expressed as roentgens per hour at a distance of one meter from the source and determined during the full calibration required in S 35.632, to the following two addresses within thirty days following each installation of a teletherapy source: (a) The Material Licensing Branch, Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission, Washington, D.C. C') 20555, and 83 Enclosure 1
[7590-01] [ l n (b) The appropriate U.S. Nuclear Regulatory Commission Regional A Office listed in7 ppendix-0-of--Part-20:of-thisshapter2 l G M,n j /[, fd. ' l 6 35.645 Five year inspection. (a) The licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism. (b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State. (c) The licensee shall keep a record of the inspection and servicing for the duration of the license. The record must contain the inspector's name, the inspector's license number, the date of inspection, the model number and serial number of the teletherapy unit, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector. (d) Amendments to teletherapy licenses that extended the time interval for the inspection and servicing requirement of paragraph (a) of O' this section that were in effect on March 4, 1983 remain in effect and are not rescinded by this section. Subpart J--Training and Experience Requirements 6 35.900 Radiation Safety Officer. Except as provided in 6 35.901, the licensee shall require an indi-vidual fulfilling the responsibilities of the Radiation Safety Officer as provided in 6 35.32 to: (a) Be certified by: (1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or (3) American Board of Nuclear Medicine Science in Nuclear Medicine Science; or p (b) Be an authorized user for those byproduct material uses that V come within the Radiation Safety Officer's responsibilities; or 84 Enclosure 1
[7590-01] (c) Have had classroom and laboratory training and experience as V follows: (1) 100 hours of radiation physics and instrumentation; (2) 30 hours of radiation protection; (3) 20 hours of mathematics pertaining to the use and measurement of radioactivity; (4) 20 hours of radiation biology; (5) 30 hours of radiopharmaceutical chemistry; and (6) One year of full time experience in medical radiation safety at an institution under the supervision of the individual listed as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the human use of byproduct material. (d) The training and experience specified in paragraph (c) of this section must have been obtained within the five years preceding the date of application or the Radiation Safety Officer must have had experience equivalent to one year of full time employment in medical radiation safety within the last five years. 6 35.901 Radiation safety officer training exception. An individual identified as a Radiation Safety Officer on a Commission or Agreement State license on (*** insert effective date of final rule ***), who oversees only the use of byproduct material for which the licensee was authorized on that date, need not comply with the training requirements of 6 35.900, 6 35.910 Training for uptake, dilution, and excretion studies. Except as provided in SS 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical listed in 6 35.100(a) to b * / / #'" " " " D (a) A certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; or (2) Diagnostic radiology with special competence in nuclear radiology by the American Board of Radiology; or (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or 85 Enclosure 1
[7590-01] (b) Hayekompleted200hoursoftraininginbasicradioisotope V handling techniques applicable to the use of prepared radiopharmaceuticals. To satisfy this requirement, the training must include classroom and laboratory instruction and supervised experience in a nuclear medicine laboratory as follows: (1) 100 hours of radiation physics and instrumentation; (2) 30 hours of radiation protection; (3) 20 hours of mathematics pertaining to the use and measurement of radioactivity; (4) 20 hours of radiation biology; and (5) 30 hours of radiopharmaceutical chemistry; or (c) H(v/successfullycompletedasix-monthtrainingprogramin nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section within five years of the date of application for a license, 7-~ or have had experience equivalent to one year of full time employment in nuclear medicine within the last five years. 6 35.920 Training for imaging ind-loca14zati es. Except as provided in 6 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit listed in S 35.200(a) tob ' /A Y""" (a) Je}c'ertified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; or (2) Diagnostic radiology with special competence in nuclear radiology by the American Board of Radiology; or (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or (b) Ha[vedompleted200hoursofinstructioninbasicradioisotope handling techniques applicable to the use of prepared radiopharmaceuti-cals, generators, and reagent kits, 500 hours of supervised work experi-ence and 500 hours of supervised clinical experience. 7 (1) To satisfy the requirement for instruction, the classroom and o C laboratory training must include: i 86 Enclosure 1 1
[7590-01]
- n\ (i) 100 hours of radiation physics and instrumentation; C/ (ii) 30 hours of radiation protection; (iii) 20 hours of mathematics pertaining to the use and measurement of radioactivity; (iv) 20 hours of radiopharmaceutical biology; and (v) 30 hours of radiation chemistry.
(2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include: (i) Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing survey meter checks for proper operation; (iii) Calculating and safely preparing patient doses; (iv) Using administrative controls to prevent the misadministration of byproduct material; (v) Using emergency procedures to handle and contain spilled byproduct material safely and using proper decontamination procedures; V and (vi) Eluting technetium-99m from generator systems, assaying and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals. (3) To satisfy the requirement for supervised clinical experience, training must be under the supervision of an authorized user at an institution and must include: (i) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations or contraindications; (ii) Selecting the proper radiopharmaceutical and dosage; (iii) Administering doses to patients making proper use of syringe radiation shields; (iv) Calculating the radiation dosage and collaborating with the authorized user in the interpretation of radioisotope test results; and (v) Patient followup; or (3 ,j
)
87 Enclosure 1
[7590-01] (c) Ha've'Iuccessfullycompletedasix-monthtrainingprogramin {#') nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section within five years of the date of application for a license, or have had experience equivalent to one year of full time employment in nuclear medicine within the last I five years.
. a !' S 35'.930 Training for therapeutic use of radiopharmaceuticals.
Except as provided in 6 35.970, the licensee shall require the authorized user of a radiopharmaceutical listed in 6 35.300 for therapy 9 s u %) whJ
+% a phy$s (a) Je certified in nuclear medicine by the American Board of Nuclear Medicine; or (b) Hahompleted80hoursofinstructioninbasicradioisotope handling techniques applicable to the use of therapeutic radiophar-maceuticals, arid have had supervised clinical experience.
(1) To satisfy the requirement for instruction, the classroom and l laboratory training must include: (i) 25 hours of radiation physics and instrumentation; (ii) 25 hours of radiation protection; (iii) 10 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) ~20 hours of radiation biology; (2) To satisfy the requirement for supervised clinical experience, training must be under the supervision of an authorized user at an institution and must include: (i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; (ii) Use of soluble phosphorus-32 for the treatment of polycythemia vera, leukemia, or bone metastases in 3 individuals; (i,fi) Use of colloidal phosphorus-32 for intracavitary treatment of malignant effusions in 3 individuals; (iv) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals; and
)
88 Enclosure 1
[7590-01] m (v) Use of colloidal gold-198 for intracavitary treatment of \ malignant effusions in 3 individuals. 6 35.940 Training for therapeutic use of brachytherapy sources. Except as provided in 6 35.970, the licensee shall require the authorized user using a brachytherapy source listed in S 35.400 for therapy toi a /'A y M "'" > 25 (a) Be certified in: g (1) Radiology or therapeutic radiology by the American Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with a specialization in radiotherapy, as a British g
" Fellow of the British Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b) Ha'veTompleted200hoursofinstructioninbasicradioisotope q handling techniques applicable to the therapeutic use of brachytherapy U sources and 500 hours of supervised work experience and three years of supervised clinical experience.
(1) To satisfy the requirement for instruction, the classroom and laboratory training must include: (i) 110 hours of radiation physics and instrumentation; (ii) 40 hours of radiation protection; (iii) 25 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 25 hours of radiation biology. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include: (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Checking survey meters for proper operation; (iii) Preparing, implanting and removing sealed sources safely;
)
i 89 Enclosure 1 ] _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ - - - - - - - - - _ -- -- - _ -- _ _ J
[7590-01] (iv) Using administrative controls to prevent the misadministration N of byproduct material; and (v) Using emergency procedures to handle and control byproduct material. (3) To satisfy the requirement for a period of supervised clinical experience, training must include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accredi-tation Council for Graduate Medical Education, and an additional two years of clinical experience in therapeutic radiology under the supervi- p sion of an authorized user at an institution. s pE 0 6 35.941 Training for ophthalmic use of strontium-90. Except as provided in 6 35.970, the licensee shall require the [ authorized user using only strontium-90 for ophthalmic radiotherapy to':' Ss (a) yBe certified in radiology or therapeutic radiology by the American Board of Radiology; or (b) Hahompleted24hoursofinstructioninbasicradioisotope p 'd handling techniques specifically applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy. (1) To satisfy the requirement for instruction, the classroom and laboratory training must include: (i) 6 hours of radiation physics and instrumentation;
.(ii) 6 hours of radiation protection; (iii) 4 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 8 hours of radiation biology.
(2) To satisfy the requireme'nt for a period of supervised clinical training in ophthalmic radiotherapy, training must be under the super-vision of an authorized user at an institution and must include the use of strontium-90 for the ophthalmic treatment of five individuals and must l include the examination of each individual to be treated, calculation of the dose to be administered, post-administration followup, and review of each individual's case history. (3 %) 90 Enclosure 1
[7590-01] ghepchtlMf"b o S 35.950 Training for use of sealed sources for diagnosis. U The
=
6 35.500 authorized. user usi,s p prua,~,,4,*, _xcept as n9 ~a provided
- -sealed in sou.rce in a device listed in
- ~ ~ ~ ~
6 35.9k1
\
- q >h :
(a) Begertifiedin (1) Radiology, diagnostic radiology with special competence on nuclear radiology, or therapeutic radiology by the American Board of Radiology; or (2) NuclearmedicinebytheAmericanBq9hofNuclearMedicine;or (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or (b) H4)ecompleted urs of instruction in basic radioisotope handling techniques specifically applicable to the use of the device, ,, and- paried of ;upcrviced cF aical trefain;; in its u;r (4-)-(To satisfy the requirement for instruction, th'ej elr re^- =nd-laboratory t / r_aining must include:J~"-~~~~~" ( b $ hours of radiation physicsgiid instrumentation; (-ik) 28 ' hours of radiation protection *M'~ - (iii) 4 - t.en ['- (o't%ii_oactivit%gmathematics pertaining to thluse and me 'd -- c- ,.. A (4v) -m 8 hours of ra diition biologyif (2) Te-::ti;fy tre iq uire cat for + peried-of supcrviced clinical j _ [4 training in the use of tle devic,ehraining ;;;u;t--include 1.he use Of the Avice under the- superv4sion-ef-an-authorizedmser-forfourhours- :nd f* must. inc19 d e the-proper-use-of-the device rd the-examinat-ion-of-patientsd;y ute ef-the device. 6 35.951 Training exemption for use of sealed sources for diagnosis. (a) A physician identified as an authorized user for the human use of a sealed source in a device listed in 6 35.500 on a Commission or Agreement State license on (* *
- insert effective date of final rule I
* * *) need not comply with the requirements of 9 35.950, in order to use that device.
(b) A physician who has successfully completed a three-month or six-month training program in nuclear medicine that was part of a training program approved by the Accreditation Council for Graduate Medical Educa- . J tion need not comply with the requirements of 6 35.950. j 91 Enclosure 1
[7590-01] 6 35.960 Training for teletherapy. ('N'") Except as provided in 6 35.970, the licensee shall require the authorized user using a sealed source listed in S 35.600 in a teletherapy unit to: (a) Be certified in: (1) Radiology or therapeutic radiology by the American Board of Radiology; or (2) Radiation oncology by the American Osteopathic Board of Radiology; or (3) Radiology, with specialization in radiotherapy, as a British
" Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b) Have completed 200 hours of instruction in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit, 500 hours of supervised work experience, and three years of super-vised clinical experience.
(V4 (1) To satisfy the requirement for instruction, the classroom and laboratory,t aining must include: (i) 00 hours of radiation physics and instrumentation; (ii) 40 hours of radiation protection; (iii) 25 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 25 hours of radiation biology. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include: (i) Review of the full calibration measurements and periodic spot checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent -t4e misadministrations; ef bypre&ct eteric';- / (iv) Implementing emergency procedures to be followed in the event A of the abnormal operation of a teletherapy unit or console; and l (v) Checking and using survey meters. . 92 Enclosure 1 L
[7590-01]
,~ (3) To satisfy the requirement for supervised clinical experience, training under the supervision of an authorized user must include:
(i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications; (ii) Selecting the proper dose and how it is to be administered; (iii) Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed dose as warranted by patients' reaction to radiation; and (iv) Post-administration followup and review of case histories. 9 35.961 Training for qualified teletherapy calibration expert. The licensee shall require the individual calibrating or checking the radiation output of a teletherapy unit as a qualified teletherapy calibration expert as provided by 69 35.632 and 35.633 to: (a) Be certified by the American Board of Radiology in: m (1) Therapeutic radiological physics; or (2) Roentgen ray and gamma ray physics; or (3) X-ray and radium physics; or (4) Radiological physics; or (b) Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics andf e year of full time work experience under the supervision of a qualified teletherapy calibration expert at an institution where teletherapy is performed. To satisfy this requirement, the neophyte qualified teletherapy calibration expert .aust have performed the tasks listed in SS 35.59, 35.632, 35.633, and 35.641 of this part under the supervision of a qualified teletherapy calibration expert during the year of work experience. n/Anip/ w 6 35.970 Experienced ;$pidar training exception. ( A~ physician [ identified as an authorized user for the human use of [byproductmaterialonaCommissionorAgreementStatelicenseon j (*** insert effective date of final rule ***) who performs only those
~gllj y, p.futh Y 93 Enclosure 1
[7590-01]
/s
,~ procedures for which the phy;ician was authorized on that date need not V' ) comply with the training requirements of Subpart J. 6 35.971 New physician training exception. A physician who, by August 31, 1987, has successfully completed a three month nuclear medicine training program approved by the Accredita-tion Council for Graduate Medical Education need not comply with the requirements of SS 35.910 or 35.920. Subpart K--Enforcement 6 35.990 Violations. (a) An injunction or other court order may be obtained to prohibit a violation of any provision of: (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974; or (3) Any regulation or order issued under these Acts. (b) A court order may be obtained for the payment of a civil (",i ( ,/ penalty imposed for violation of: (1) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 under section 234 of the Atomic Energy Act of 1954; (2) Section 206 of the Energy Reorganization Act of 1974; (3) Any rule, regulation, or order issued under these Acts; (4) Any term, condition, or limitation of any license issued under these Acts; or (5) Any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954. (c) Any person who willfully violates any provision of the Atomic Energy Act of 1954, as amended, or any regulation or order issued under the requirements of the Act may be guilty of a crime and, upon conviction, may be punished by fine or imprisonment or both as provided by law. Regulations issued under the Act include regulations issued under sec. 161, and cited.in the authority citation at the beginning of this part for the purposes of sec. 223. p G 94 Enclosure 1
[7590-01] -O The following amendments are also made to existing parts of the regulations in this chapter. The authority for these conforming amendments is: Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 US.C. 2201); X sec. 201, Pub. L. 93-438, 88 Stat. 1242, as amended (42 U.S.C. 5841). PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL
- 2. Section 30.4 is amended by revising paragraphs (h) and (1) to read as follows and by adding new paragraphs (x) and (y) as follows:
6 30.4 Definitions. (h) " Human use" means the intential internal or external administration of byproduct material, or the radiation therefrom, to human beings in the practice of medicine in accordance with a license issued by a State or Territory /ftheUnitedStates,theDistrictof Columbia, or the Commonwealth of Puerto Rico in the art of medicine. -(p) (1) " Physician" means a medical doctor or doctor of osteopathy , licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine;, 7 (x) " Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice the art of dentistry on humans. (y) " Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Common-wealth of Puerto Fico to practice the art of podiatry on humans.
- 3. Section 30.34 is amended revising paragraph (g) to read as X follows:
S 30.34 Terms and conditions of licenses. (g) A licensee may prepare technetium-99m radiopharmaceuticals only with technetium-99m that contains less than 0.15 microcuries of 95 Enclosure 1
[7590-01] g molybdenum-99 per millicurie of technetium-99m. The licensee shall
' V' perform tests and maintain the records required by S 35.204.
PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 6 31.11 [ Amended]
- 4. Section 31.11(b) is amended by deleting "S35.14(c)" and inserting "Part 35."
PART 32 - SPECIFIC DOMESTIC LICENSE TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS 6 32.70 [ Removed]
- 5. Section 32.70 is removed.
- 6. In S 32.72 the introductory text of paragraph (a) and paragraph (a)(4)(i) are revised to read as follows:
6 32.72 Manufacture and distribution of radiopharmaceuticals containing
) byproduct material for medical use under group licenses.
(a) An application for a specific license to manufacture and distribute radiopharmaceuticals containing byproduct material for use by persons authorized pursuant to Part 35 of this chapter will be approved if: (4)(i) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay, and the label affixed to each package, or the leaflet or brochure that accompanies each package, contains a statement that the unit dosage radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to Part 35, as appropriate, or under an equivalent license of an Agreement State. 7., In S 32.73 paragraph (a)(5)(ii) is revised to read as follows: 6 32.73 Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceutical containing byproduct material. th (a) *** 96 Enclosure 1
[7590-01] (3 (5) (ii) A statement that this generator or reagent kit (as appropriate) is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in S 35.200 of 10 CFR Part 35 or under an equivalent license of an Agreement State.
- 8. -In 6 32.74 the introductory text of paragraph (a) and paragraph (a)(3) are revised to read as follows:
S 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use. (a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to Part 35 of this chapter for use as a calibration or reference source or for the uses listed in SS 35.400 and 35.500 of this chapter will be approved if: (3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the ['3 radionuclide, quantity and date of assay, and a statement that the (name of source or device) is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use byproduct material identified in SS 35.58, 35.400, and 35.500 of 10 CFR Part 35 or under an equivalent license of an Agreement State. PART 40 - DOMESTIC LICENSING 0F SOURCE MATERIAL
- 9. Section 40.4 is amended by revising paragraph (g) to read as follows:
6 40.4 Definitions. (g) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of O 97 Enclosure 1
[7590-01]~ Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; Dated at Washington, D.C. this day of 1982. For the Nuclear Regulatory Commission. Samuel J. Chilk, Secretary of the Commission.
~ ~ ~ .
//}f7 7/ - /bc!1- $lcJa50 A b ^'I Gf}( [l Jhc fih.qcdarb Y&n-y$ju.7 t hbu 9d bah 8 A'NL l AINA""!
a y d w c t 5 0 i<l> v ca ?ck.dk):.W jf , jl.$nu Y/. 9 a a n:; w b d ? S'#' S j''
,pgfg /c,uasfaJf!!h
6 7/.9 - + .O 98 Enclosure 1
F [7590-01] Appendix A--Form NRC-313MH Form NRC-313MH is appended for the convenience of those who may wish to comment on the proposed regulations. It is not a part of the regulations. However, the Commission does solicit comments on its content. If the proposed regulations are adopted and codified in Title 10 of the Code of Federal Regulations, the form will be used for applications for the human use of byproduct material. O
-O 99 Enclosure 1
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