ML20137Q557
| ML20137Q557 | |
| Person / Time | |
|---|---|
| Issue date: | 02/13/1984 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230048 | |
| Download: ML20137Q557 (308) | |
Text
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U REVISION OF PART 35 g. N PLANNED OUTLINE OF COMPLETE PACKAGE THAT WILL BE FORWARDED TO MR. DAVIS FOR TRANSMITTAL TO MR. DIRCKS. n.
- 1. Notes of general interest and clarification for reviewers.
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- 2. Davis to Dircks memo. One paragraph summary.
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- 3. Commission Paper (Dircks to Commission memo). Lengthy summary. Q h
- a. Overview of industry and current regulatory program.
- b. Background, including features of SECY-83-62 and Commission instruc-tions in response to it.
- c. Decision 1: Revise the regulations.
- i. Options <
ii. Discussion
- d. Decision 2: Revise the licensing program.
- i. Options ii. Discussion
- e. Effects.
- f. Recommendations.
- g. Notes (administrative notations) i 8509230048 850906
[ 30616 PDR 1
.a
l' i' .f. i 4. Enclosure 1: Federal Register Notice.
- a. One paragraph ~ Summary.
- b. By product Material in Medicine.
- i. Use for Patient Care ii. State and Federal Regulation
- c. NRC's Regulatory Program
- i. Current Licensing Practice ii. Problems With Current Practice
- d. Proposed Revision of the Regulatory Program l
- i. Overview
! 11. Codification of Requirements in the Regulations iii. License Application, Issuance, and Authority and Responsibility iv. Enforcement ( v. Amendments l ( vi. Summary of Changes Proposed in the Regulatory Program
- e. Notes
- i. Word Usage ii. Records Retention iii. Effect on Broad Licensees iv. Transition Policy
\ f. Discussion of Proposed Regulations l
t j ,
- g. Derivation Table
, h. Administrative Statements (Administrivia) {.
- i. Part 35-Human Use of Byproduct Material 1
i , 1
- j. . Conforming Amendments i
e 2 l
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,m 5. Enclosure 2: Memo Chilk to Dircks dated June 23, 1983. / \
( ,/ {6. Enclosure 3: Periodic and Systematic Review.
- 7. Enclosure 4: Regulatory Analysis.
- a. Alternatives.
- i. Current ii. Proposed iii. Hybrid " plan"
- b. Cost of selected alternative to various hypothetical licensees
- i. Private practice ii. Hospital with a diagnostic service iii. Hospital with a diagnostic service and radiopharmaceutical therapy iv. Hospital with a diagnostic service and brachytherapy
- v. Hospital with a diagnostic service and teletherapy i
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) vi. Mobile nuclear medicine. service
- 8. Enclosure 5: Draft Public Announcement.
- 9. Enclosure 6: Draft Congressional Letter.
- 10. Enclosure 7: Environmental Impact Analysis.
'11. Enclosure 8: Summary table of Comments on content of SECY-83-62 regulation.
- a. Suggestions for additional requirements
- b. Drafting committee response p
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[12. l Enclosure 9:Summary of citations issued to human use licensees in 1982 II
- a. ' List of citations and their legal basis
- b. How the citations would be enforced under the proposed regulatory program
- 14. Enclosure 10: Regulatory Guide 10.8
- a. Instructions for application j b '. Appendices and model procedures I
9 z 4
2 /3 Af' , ] a NOTES OF GENERAL INTEREST AND CLARIFICATION FOR REVIEWERS L!
- 1. Contrary to the Part 35 strategy plan element 1 that said "only editorial and non-substantive changes" would be made to the regu-lation, several changes that some reviewers may consider substantive have been made because the individuals who suggested the changes were able to support their suggestions with clear reference to health and safety.
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- 2. I have tried to indicate where all changes were made in the draft Federal Register Notice dated 12 07 83 that some of you have seen.
- 3. The patient excreta exemption that is in the current Part 20 has not been included because it will require an extensive environmental impact analysis. This problem will be handled at a later date as a separate rulemaking.
~ m 4. There will be no " tie-down" license condition. The regulation requires that authorized users be named on the license. See 35.15. The regulation requires that the licensee follow his own procedures. See 35.31b2. The regulation allows licensees to modify procedures with the advice and consent of the RSO and management. See 35.31b3 and 35.32b4. ,
- 5. The 12 07 83 draft that some of you have seen indicated that there would be a conforming amendment to Part 71-Transportation. Current-ly 00T, and therefore NRC, exempts physicians from transportation regulations. The plan was to expand this exemption, for the sake of consistency, to supervised individuals; this would have been done as a joint rulemaking with DOT. Background meetings indicate that D0T staff is divided on the propriety of this exemption. Therefore, this issue may be handled at a later date as a separate rulemaking.
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- 6. There is a conforming amendment to 631.11 that grandfathers human p use licensees who are also doing in vitro work under 635.14(c).
( (Many people have thought that nuclear medicine clinics that are doing in vitro work would have to file a form NRC-483.) 5
__. _ . _ --_. _ _ _ _ . ~ . _ . , _ _ _ _ _ . . . . _ _ _ _ _ _ _ 2 U BY n U DRAFT MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
- PROPOSED REVISION OF PART 35
((x ///cd I llIcSca/ Uw 0{ ~1y/cbd iil'l* Thezstaffhaspreparedaprgposedrevisionof10CFRPart35,"HumanUseof Byproduct Material." forko,mment. The proposed revision is based on SECY-83-62 and the Commission's reponse to that proposal. Individuals'from h S Q E, RI, RII, RIII, RIV, RV, RES, OPE, SP, ADM, ELD, and two Agreement States-helped h
- b 4 k M N hi Iproposal. jh O d d.unend Mp A" "'d A a.
O & gu[akg,. The followingO nab,ith offices have concurred a r.L Ah c.munwati with the proposal, indicating havtthat kovtheyAcach/ed have no objection to publishing the proposed revision for comment: [ fill in] S.2 ' c,!,L hp.amtrl 5X% nd wa 62Cca{nnt;w~i N" i ** 1*^ '"' rymd Li>bi,g.:ysten., ,4s/ is pod of /h rw dueu;;ib / ca:L & puy4bd {n Mc wtd>&ptd.
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L .utd a- 7 John G. Davis, Director Office of Nuclear Material Safety and Safeguards Encl: Proposed revision of 10 CFR Part 35 ; I i l I 1 v 02/08/84 [McElroy/ DRAFT TRANSMITTAL MEM0] l
/
2 /3 Bf DRAFT COMMISSION PAPER For: The Commissioners From: William J. Dircks, Executive Director for Operations wiedr a.1
Subject:
PROPOSED REVISION OF 10 CFR PART 35 '}$UdsNiDOSE OF BYPRODUCT MATERIAL"
Purpose:
To obtain Commission approval of a notice of proposed rulemaking. gwhnu u>wnOfu W Category: Thispapercoversasignificantpolicygo{licensingvfbyproduct o , materials. ""' W " ssue: Revision of the 4+emeM regulations and change in the method of v e licensin9 chtsmarf use of byproduct material gg mesa / Overview: The phrase 'Wuse" is used to refer to the intentional irradiation of humans by medical practitioners in the practice of the healing . - wfud arts. The staff is proposing to revise the regulations governing,htmen-
.ntidual use and to change the method by which persons are licensed forghumanw use of byproduct material. The staff M repared an earlier proposal which was circulated as SECY-83-62. This new proposal reflects guid-ance from the Commission to the staff on that earlier proposal (Enclosure 2), and additional comments from headquarters and regional staff and the Agreement States Q i.} ere recei M .
g,p, b/s ^J, j>hyvc ha L The NRC issues licenses to bothg~"~' '- andjprivate prac-tice phycicianQor the use of byproduct materials inpedi diag-nosis and treatment of humans. During the past three decades,juse has y SM _w
,&wfuchruitual
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Contact:
, Norman L. McElroy .- 427-4052 c;
02/49/84 > CFlO CFK 3W 3
The Commissioners 2
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grown annually at a rate of about 15 percent. There are currently about2200hospitalsandh0 te prac e sicians*who are NRC licensees. In 198S NRC staff received @ applications for new licenses, h renewa,l agplications, and @ N ndment applic for a total of requested licensing actions. so ihls Most ec ica' institutienfandprivatepracticephysiciansoperate under a specific license which authorizes many types of byproduct use y materialsg recedures. An application is made on a standard NRC form N supplemented M Ietailed descriptions of radiation safety proce-dures, personnel qualifications, and facilities and equipment. Each application is reviewed in detail before a license is issued. There aus y are also a few nuclear medicineg reccdurc, authorized by general license. A general license authorizes physicians to use small quanti-ties of certain prepackaged radiopharmaceuticals, and is obtained Cet A simply by filing a registration form. jSection 35.31 specifies safety i " (j\ measures and possession limits. The NRC staff does not perform a technical review of the registration form but only validates it. The staff is proposing to simplify the regulatory program for medical licensees. The specific objectives are to: Make regulations consistent with well established technology and standards, Write all prescriptive requirements in simple English and codify them in the regulations, and Assure uniformity among the regions in licensing and inspection. Key features of the proposed rule change designed to meet these objectives include: i t i
\J 02/09/84 CP 10 CFR 35 L M
The Commissioners 3
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irudY Consolidation of the requirements that apply to g use that are now dispersed throughout existing regulations, branch policy positions, standard conditions of licenses and regulatory guid-ance into a concise and coherent set of regulations, and Allowance for greater flexibility under the license, thereby reducing the number of amendment requests. In preparing this proposal, the staff has taken direction from the Commission's policy (Policy and Planning Guidance, 1984, NUREG-0885, Issue 3, page 7 item 2, and page 8 item 3) that "...NRC regulations should allow individual licensees the flexibility to select the most cost effective ways to satisfy NRC safety objectives... Existing regulatory requirements that have a marginal importance to safety should be eliminated..." 73 / \ \ ickground: The previous proposal, SECY-83-62, had two key features. The drafting m./ 1s 40mmittee4 t ried to incorporate in[a single codified regulation all parut the standards that apply specifically to the/mmarf use of byproduct material. The current Part 35, current Regulatory Guide 10.8, and a list of frequently,used license conditions served as the principal references. The ing cea""itte8 believed that the proposed regula-tion was sufficiently stringent and specific to provide clear guidance and a basis for enforcement action that was not based on statements made by the licensee during the application process. Therefore, # r uas the sec nd key feature y rafting-committee-recerend. that appli-cants3no longer be required to submit,for agency review and approval uda 4 n uluy. the detailed, site-specific, procedures hat would be followed to p5 u.c effect compliance with the regulations. The applicant wouldjmerely certif that adequate procedures had been developed. Also,s4eee-6ccetraining and experience requirements would W now appear in the regula<ic. s y tions, applicant authorized users would, simply Ac clicwcd tu certif that they met the training and experience requirements. !al \.
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02/09/84 CP 10 CFR 35 h
The Commissioners 4 [] V, Some individuals on the NRC staff and most of the Agreement State program directors opposed the proposal. Some felt that the regulatory text was incomplete. Manyfeltthat,tohurethepublichealthand safety, it Necessary to review an applicant's/ procedures for com-pleteness and adequacy. The Commission directed the staff (Enclosure 2) to revise the proposal, 4 keeping in mind four general directives that are discussed in the following paragraphs.
"(1) The Commission approves the consolidation of the essential safety elements ... into a Part 35 rule." The fra t'i[g cer-"t#has-sel-4ected-and-analy g hnical comment 5lthat werE' received frcm head-3 ,7.u~
quarters and regional staff and the Agreement Statesf Many4suggestdo w have been incorporated in the proposed regulation. Inmany[cYesthe
-p\ ccr-ittee didnut!selieve-thesuggestionscould[standthetestofneed
. w uae ut am mmmu.
basedonpublichealthandsafetyj A summary t s!rOf tcchnice! pcommentsandtheirresolutionisattachedMEnclosure8)
"(2) The Commission has decided to continue the pre-licensing review of physicians' qualifications ..." The Enclosure 1 preamble has been revised to reflect this directive. TheCommissionshouldnotethat[
for tiic sake of consistency in u se vi uposed regtdatiegNRC would </ro require pre-licensing review of Radiation Safety Officer qualifica-tions (consistent with current practice), and Qualified Teletherapy Calibration Expert qualifications (contrary to current practice, ir) , eualus/es m wp oun + L, , which the licensee that individual's qualifications de the standards in current Part 35). This new requirement should not impose a significant burden on the industry because informal. con. tact with ht.u h ut regional inspectors indicated that roughly 70% of tAese 4 experts hold certification from a specialty board that the staff proposes to recog-nize as evidence of adequate training and experience. O O 4 02/09/84 CP 10 CFR 35 b
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"(3) The Commission has decided to continue the pre-licensing review of applicants' operating procedures ..." The staff will continue to review procedures submitted in support of an application in order to determine whether they are sufficient to meet the requirements of the regulations. (Consistent with current practice, an applicant will be allowed to simply certify that he will follow a model procedure supplied in Regulatory Guide 10.8 that was developed by NRC with public comment, or will be allowed to submit an alternative procedure for review. "any new modal-procedures-have-been-developed-foe--
so nov applic=N' censidwation )!ce/ergtoalloweachlicenseetomake prompt use of new safety methods and to adjust procedures to meet new needs caused by changes in need for patient care services or patient load, licensees will be free to modify their procedures without NRC review or approval as long as they meet the requirements of the 1,osp a a regulations. At a( iesrt4 tut 4ed the Radiation Safety Committee must y awn (m-i review and prank pracap/ worove a a modified' procedurebefore g u n s. m cason eit may be implemented. Atj Mest4 tut 4en' facilities, the MO and' manag,rinement must review and ( & es Aw/p 64b ' approve podi.ficationf -(-This : y-be compared te technical-spec 4f-i-
-cations-that-apply-to7eacto r i itens~ees. Within-the contsXt- Miid requi-rements of-the~regtrl'attonsM1censees would be ff66~to make changes-in-procedural-detaH-to meet ~dhiniel operating needsd@A licensee will be cited for failure to meet the requirements of the regulations or license conditions (which would list, for example, authorized users, locations of use, authorized methods of use, authorized byproduct material and inventory limits, and other site-specific limitations), failure to have the written procedures
- required by the regulations, failure to follow those procedures, failure to have the records required by the regulations, or failure to follow technically valid procedures.
"(4) The staff should clarify how it will implement the proposed requirements regarding license amendments, while continuing to ensure safety in the licensee's operations." The Enclosure 1 preamble has e
cT O 02/09/84 CP 10 CFR 35 7
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The Commissioners 6 (v\ been clarified to indicate when a license amendment request must be submitted and what information will be needed to support it. Amend-n ment requests will be required for
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b #Y'Y] (a) new users { supported b[ training and experience; / riec) (fasmuftp.rE 5
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(b) new types of use,fsupptfd rted by all procedures needed for that ' A M type of use 7 g , w j; g ,( s g a w & p /,;,p t w w ej A 4is,w Na/ Lor >>jei c<.rsmQ *Wjf jf[n/,y/) (c) a new method of use dupp' h ,by the specific procedure needed for the, method of useg and (d) new locations of use--[supp'p a complete new application if the base of operation changes, or simply the additional address p e s sorn ifsatellitegper:ti;n?wereapprovedontheoriginallicensef i A ticaonenfec;;,7, ant (policyjduringthetransition, peri;dwasalso added. perma rm4 Proposal: The staff 4 puggetti~ysthat the Commission publish for public comment
- d u>,pNsn & ~ 4 adel a proposed revision of Part 35 and a new g method for licensinghuman.
use of byproduct material. Three alternative courses for the-Commission are discussed below. Alternative 1: Take no action. 4 Alternative 2: Publish the proposed revision of Part 35 attached as Enclosure 1. wt/h w,dcI5>' Alternative 3: Publish the proposed revision of Part 35 after modifying the preamble op p fue a ts & a to require that Ticensees 3 submit [prce:dars' eedifications for NRC review and approval. N A A A 6 A 8 v>t/ r4 pt Am@ mh pupay clavja
'i 02/09/84- CP 10 CFR 35 i
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l The Commissioners 7 i n , V) I Discussion of Alternative 1: Qfpod I glitheindividualswhocommentedontheproposedrevisionthatwas submitted in SECY 83-62 agreed that the current Part 35 was in need of revision because it is difficult to read and does not contain all the
,id;< a1 requirements necessary for radiation safety in the)mmatftse of by-product materials. The Commission " approved the consolidation of essential safety elements" (Enclosure 2). The staff is not-aware-of mg anyone&awdust., ksAs v whc mou d-recommend-reteAv o whe:d //,dWcmawa' aqsw ning-the-current-PartM 5 uver.fi.he n
proposed revision c Mt M /cS 6 Effect of Selecting Alternative 1: < g;;sni Because the c Part 35 does not contain all the pr4t-i safety elements for pumentuse, the NRC would have to continue to review sad,a /M u h t. detailed applications and require that licensees follow procedures that 4 ('b were reviewed and approved by NRC. This alternative does not provide anygreaterdegreeofsafetythantheotheralternativedbutismore ad .s costly to both NRC and licensees than Alternative,s 2, and denies the
- industry the benefit of a clear, consolidated codification of the
,w/ical on Mmunt.s nst u 7 regulatlens offered by both of the other alternatives. It is difficult i to maintain standardization under this scheme because the legal basis
, un op au,t <numW for controlling a licensee"is the'p,icensee's l application.rcther than=
the regulations. /3uauct ooch ajf /246m '^5 j*n 6 //e m'h w l c9da .yl u Ha/- n /}'wn '
- a clv SA4#4" i
- Discussion of Alternative 2
l The NRC would publish in the Federal Register for comment the proposed regulations and licensing method described in Enclosure 1. An appli-cant would submit: 1. evidence of training and experience, 2. a a ,/iaw g on, C A description of facilities and equipment and 3,.4 procedures);Lall for pre-
-l ican; j n3 ceview and approva' llcwcvar3 pe t
licensee (would be free to
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pify' facilities and procedures or replace equipment with approval of
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s 4 auws 4!st /L appScam/ dad adcsaan BahAc ard expensaco, focinha ad e,ddgmend, d sau4% ay'<G poaaw' .w. A v A fram tJouN !o usuub. O 4 O & /b The Commissioners 8 n e> % cact. the RSO and the Radiation Safety Committee (RSC), as leng agthe eedt** Jacet4ergconform with the requirements of the regulations. et y n saa J s h a.v r h Proponents: The proposed licensing method provides for agency review before allowing a program to begin. The implementation of 4-safe #& program requires the support of the individuals who have special safetytraining.(Ifthattrainingisnotcvidentinthekeyindivid-p n,t hec M uh the licensehould5t be ~ issued. ) Issuance of the license -shculd stend ea evidencerthat the agency has found the applicant trained to know safe from unsafe and legal from illegal, and that the applicant is sufficient j 4y' tequipped to handle, material safely within the scope of use permitted by the license. Licensure would connote that those key individuals are also competent to recegnize and 4 ple-ma -ent procedaic mud i f icalica l.s eka.that @provi.de a level of safety consistent M t ern %ea so with the requirements of the regulations, and to select replacement w equipment and to medH facilities to the extent consistent with those (A) C/ q'*JM Tw e mprovsd patient care or safety, or_ reduced requirementsp. , purpcx c*g.n s e.,a+ se ra.u p r-costj -5 9 cdi'icatim m :: ld not ha made caprie40u';1yj#ccau : they would have to be approved by the RSO and management or the RSO and RSC before being implemented. This method allows the licensee the flexi-bility to meet new site-specific needs. License processing would be i _ compatible with both hard copy and computer assisted information systems. Cfje e Naru 11bw aga vapNno A J-04cncnts: %p icenseesl are small feeH4t4es--that-are4taffed_bga few authorized user physicians, and technicians who have graduated from a two year formal training program or have been trained at-the-m no sw facility- by, an authorized user or co-worker. They might cmploy a wm my p part-timejconsultarit who is qualified to review changes en-the-bas 4s-of- safetyr,pk,oabut that individual may not be aware of the ramifications aa implicit in a proposed modif4 cationwbecause he is not thoroughly familiar with the day-to-day operations. On a private practice license, the authorized user may also be the RSO and management, and h 02/09/84 CP 10 CFR 35 l , l s; The Commissioners 9 l D. \ b' ~ therefore would be reviewing his own handiwork for safety ~conside-iss,.r/W rations. At apinstitut-iogthe only two individuals on the RSC who are required to have had radiation safety training are the authorized user and'RSO, who may be the ones proposing the change. Therefore, in either case there would be no independent agent required to review noout aawco #me[ifications.J Effect of Selecting Alternative 2: The staff recommends that the Commission select Alternative 2. The staff does not expect any change in worker or public dose or significant costs or savings to any entity if the Commission follows s thg,Arecommendations. Rather s the proposal would-require ses,e redi-rectica Of treining, end Other ic;curc-es % would probably be per- )( e ceived as a change from the current policy of strict prescriptiveness i .p toapolicygrantingmoreauthorityforthelicenseewho[musthandl'a'
- - material safely. A
- E 1 '
'7'"f h f Qshorttextualanalysisfodowhorthefourgroupsthatwouldbe ' af fic~te -more complete regulatory analysis is attached as Enclosure 4. NRC Under-the decentra-Htatica program acw completedr-elmost-aH-human-use- -k [ licensing)isnet. hcndled by i gj viauai:, win; als_o-de(61spectig The i avs ghp , training of thaca indjuit: W wod1d have to redirected because it now stresses checking the application for completeness and adequacy and then inspecting the licensee for compliance with the application. av' Under the proposal the inspectors would have to be trained to recog-je w ai ,,a.,u,a gw.e .O,se+ < < s u. .aarr.n-nize, in the field, program-elemente that do not meet the;, standards, FeQtti red-by the regulatiog The inspector would have to ' e b more p thoroughly familiar with the regulation, but would no longer have to .s, 02/09/84 CP 10 CFR 35 N. The, Commissioners 10 O , fu l s,p% &,y A familiar 2'2edimself with each licensee's preced:res% before conducting ag g ection. This would help to ensure uniformity among the regions. Meee a major goal A f-the-drafting-committeeYwas to prepare the state-ment of consideration',# regulation, and regulatory guide in plain English, the staff expects fewer deficient applications. Agreement States hw/p Nu 1MfRffMENT4TATES: PLEASEJROV10E_IEXT FOR THIS-SECTION.-- Licensees The requirements in the proposed regulation were taken from the current regulation, licensing policy, frequently used license condi-tions, and standards recommended in M urrent regulatory guid Hfw muG 73 puowed)by many licensees. Therefore, the staff does not expect any increase or decrease in worker dose or any significant cost increase. There may be some insignificant savings in amendment fees for those licensees who need to hkyiheir procedures. IMnce more-14sensring- ' l,",I. %. guidance-will acw'ba available to the pubFicy icensees may have a m eaL Y 'I ' clearerunderstandingoftheregulatoryprocessingeneralandithe]n yrppi iudule requirements. ggg e.m n uo n Hd m mjku<J L, uje A *""'"~' The Public Most man-made non-occupational dose is the result of intentional irradiation of individuals for their own medical benefit under trie prescription of a state-licensed physician. Therefore an attempt to reduce public dose _would, except in rare circumstances, be a clear intrusion into the practice of medicine. -Cein.ei ning custs omavf rigr, ?; -since they-ere-ultimately-borne-by-the publik hecause the staff does t not foresee any significant changes in, day-to-day operations within ( : NRC, the Agreement States, or licensees, the staff does not expect any -( j f cost or savings for the put,i jt. c)s />hnf 02/09/84 CP 10 CFR 35 r .[) "%g UNITEt STATES
- 41 NUCLEAR REGULATORY COMMISSION WASHINGTO 4, D. C. 20555 V %, j# Ref: SA/ LAB hPR 2 6 1984 A yuuw HM 6 ad ^"b lo M A v &Ll2 M h ,, _
d2Ak s vifI dwva,.4q as tati sMyU/w *u y lo ua v.:al odn k d' M m MEMORANDUM FOR: Richard E. Cu iningham, Director Division of FJe1 Cycle and Material Safety Office of Nuclear Material Safety and Safeguards FROM: G. Wayne Kerr, Director Office of Sttte Programs
SUBJECT:
PROPOSED REV [SION OF 10 CFR PART 35 AND REGULATORY GUIDE 10.8 We have reviewed the subject documents and we feel that the Agreement O States' views should be summa rized in the memorandum to Mr. Dircks and d h th: Cc.T.;issien g per as foiiows: ' y owns. ~
/"The Agreement States 4sup' port the consolidation of various regulationsandrequirementspertainingtothemedicaluseofg byproduct material into one document 10 CFR Par-t-35u %ey have providedsometechnicalcommentsoniherevisedPart35. The Agreement States strongly object to the proposat-of-not-requiring-licensees'to follovr-the radiation-safety procedures submitted with-their-appl.ication-and permitting licensees to change radiation safety procedures without pr-ioe agency review and approval.
Although the Part 35 revision would not be made a matter ofsuf5# compatibilitybecauseitdealswithlicenging?recedures,the u States believe they will rccciva pressure 7from1their licensees to adopt the NRC system. -A letter frc= the-Chairman-of-the-Agreement St=tauetting-forth_the overalLAgreement-State-viewpoint on-this-
. matter ds enclosed-(Enclosure _) "-
Our input for page 3 of enclosure 4 vs provided in the enciosure"t07 hts memorandum along with some suggested changes to the Commission paper. Copies of comments from individual S :ates have been sent to Mr. McElroy as received. We expect to receive s averal more comments within the next week or so, p We recommend that you prepare a poin,t by point analysis of the comments 'v/ from the States showing which comments were accepted, which were O le
The Commissioners 11
/m'\
\ >
G Discussion of Alternative 3: The NRC would retain the current licensing method under which an m uri w applicantsubmith: 1. evidence of training and experience, 2. a u t s an s. . c. description of facilities and equipment, and 3., procedu)rs%e a44--fee-ua is um e.a
-review,- and,,when licensed,4is required to use byproduct material in accordance with the statements made in the application. The licensee would have to submit all changes in facilities, equipment, and proce-dures for NRC review and approval.
Proponents: The requirement that licensees use material in accord y c0 with the procedures in the application provides assurance that 1.icensees have safe procedures available, and provides a clear basis for enforcement action in cases of noncompliance. -Titis-is--themtrty waytoassniepublicheali.oandsafetNWhen questica h cedure) r A_ s f/badequacy or completeness ee4
*Cs4 p+<es, the license reviewer s/,,,v ww is 2M (v) consult reference works or co-workers rather than having to make a quick technical judgment during a field inspection. This also allows the license reviewer to exercise a certain amount of flexibility to meet each licensee's specific needs. Most Agreement State program directors believe this method of licensing is necessary ia order to answer any questions that the applicant or reviewer has, and to resolve any differences'of opinion on what is required for compliance. This method may require less extensive training for field inspectors because the inspection is based on compliance with a site-specific step-by-step radiation safety program.
ofju ks f0ppenents: 4he-appl 4 cant-has-no public-not, ice-beforehand-of-whethew
-cons erva tive-o r44 be ral-rev i ewe rwill-ha ndl e- hi s -a ppl i c a t i o n-o r-how many rounds-of4f-ic4 enc-y-letter--responses-wil-1-be-needed-to-convince-lpauat the-rev-iewer-that-the-applicant-can-handle- materia} safely; 3 SincQe licensee is required to use material in accord with the application In Lwa f^ and letters written in its support, to remain in compliance 3 Q y not i replace any equipment or service contractor or change any facility 02/09/84 CP 10 CFR 35 11
The Commissioners 12 A { . ,. .- N ppj ,,/ 2 - m o - t (7
~
described, or, modi-ff any/+nprocedure without requesting a license amend-w u>u,+mOv . , ment.h p;n h up> led , review of a[ application,e'does detai w a>w+.wwc. not assure safe use, but rather simply existence of adequate facilities, equipment,
,u/ae caw .
andsprocedureg=safeusecanonlybehe,,sured by(/ unannounced inspection w ( f lema G;,J M ~.iiWC7&G% %&Jf^A3 f . % Cpsavid<a L latsaaw1s ef haf cwwndm ent. Most citations are not issued for failure to< follow a certain pro-
/e S u d /y cedure orgh ave a particular production model piece ofslea equipment r ly avail-able, but rather for doing nothing when something isg required, or doing so,mething that is clearly forbidden. Many expeet; believ: thatA the h t M elements of a medical radiation safety program are well defined and easily codified. Therefore g except in peculier circ M wak
-stances (thereis[,noneedtocontinuewithcase-by-caseregulation.
Sid W'fTMs licensing policy grequir6'more extensive training for e reviewersg is prone to backlog due to the . bulk of material sub-mitted for review and the number of license amendments needed I 44 mD & r.iplKny y.w.c. M usy m tjn u a., Mtw n,
. I, Effect of Selecting Alternative 3: \v/
The industry would benefit by having a clear, consolidated set of regulations. The -additicasfrequirement to submit changes in facili-wa n unc, ties, equipment, and procedures 4 for NRC review and approval would be costly to both NRC and licensees, but would not be likely to result in a higher degree of safety than that provided by Alternative 2 and r, t/w t% would not provide any strongera basis for enforcement actions. Further-more, if the licensee made a determination that a M4 cat 40Wwould ge w y result in safer or more efficient operations, the review and approval
,H requirement would prohibit, prompt adoption.of the medWicet4on Recommendation: The Commission:
- 1. Select Alternative 2.
C (
.w 02/09/84 CP 10 CFR 35
//
The Commissioners 13 m
.(v) 2. Approve publication of a notice of proposed rulemaking (Enclosure 1) that would describe a new licensing method and would consolidate all human use requirements into 10 CFR Part 35.
Certify that this rule, if promulgated, will not have giyn Nazxt nelgatr g 4 economic impact on small entities. This certification is necessary to satisfy the requirements of the Regulatory Flexi-bility Act, 5 U.S.C. 605(b).
- 3. Note:
- a. The rulemaking would be published in the Federal Register j forhdaypubliccommentperiod;
/20
- b. The staff conclusions, set forth in Enclosure 3, provide the analysis called for by the Periodic and Systematic Review of
/
t Regulations;
'k
- c. Neither an environmental impact statement nor a negative declaration need be made-in connection with this rulemaking y because it is nonsubstantive and insignificant from the standpoint of environmental impact (Enclosure 7);
- d. The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regard-ing economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act; 4,erda
- e. The proposed ruleg nformation collection requirements that are subject to eev4ew-by-0ML-Upon-Commission-affir%
-ienT-fo rma l - req ue s t-f o r - OMB - re v i ew -a nd-el ea ra nce-w i 1 be-iM tiated; ,
( N St., sJn$sh c h4ldnd $ $ f $ N $ S S. S W j')-
\ / 80 sud Aw JuwsalmM 2 &0l'"Q'Almf'D'b>W
,]l nykW awl cp: <c v& !)' O A
,,.j 02/09/84 /F*#' '"f" CP 10 CFR 35
i The Commissioners ggj g ggg g) A gu v 9 avdsp p m, ma.c us; 3v y
- g. 'A public announcement (Enclosure 5) will be issued when the proposed rule is filed with the Office of the Federal Register; 4 jf. The appropriate Congressional Committees will be informed (Enclosure 6); and s' )< Copies of the Federal Register notice of proposed rulemaking uams will be distributed to all/ Commission licensees. The notice willbesenttootherinterestedparties,upYnrequest.
William J. Dircks Executive Director for Operations
Enclosures:
74 ~ Federal Register Notice of Proposed Rulemaking
-( ) Memo Chilk to Dircks dated June 23, 1983.
L d. Periodic and Systematic Review
- 4. Regulatory Analysis
- 5. Draft Public Announcement Draft Congressional Letter 6.
7. 8. Environmental Impact Analysis y Summary Wof comments on, content c. SECY-83-62,regeht4efr f"j g Ngg
- 9. Summary table of h" sn t!se Jicensee citations issued in 1982
--le.- Draf t. Reguhtery-fiuide-10rEh,sd L
Commissioners' comments or consent should be provided directly to the Office of the S::cretary by . Commission Staff Office comments, if any, should be submitted to the Commissioners with an information copy to SECY. If the paper is of such a nature that-it requires additional time for analytical review and comment, the Commis-sioners and the Secretariat should be apprised of when comments may be expected. DISTRIBUTION: Commissioners EDO OGC ELD OPE ACRS SECY ASLBP ASLAP [REGIONALOFFICES
'TA
'q A 02/09/84 CP 10 CFR 35 90
^ d e n z/-- nN A d[ J3, te/
P,/Ud EW._ - e~ _ 2-/8-gf [7590-01] k __ggyjufd'- /o --ee n ?{w Y V k'An& ' O
,,.~.
( P ks) DRAti NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 31, 32, 35, and 40 AUOT/94 44tfMAN USES OF BYPRODUCT MATERIAL AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.
'"'S
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to revise
( '
) a,.s ,v. Ja Ai r3 /sa its regulations to modify the process for licensing) medical us ,rs"of radioactive byproduct material. The proposed revision would primarily affect /-utur-e-#RG-4icensing w+ionsJoY hospitals, clinics, and individual physicians.
ns k By clarifying and consolidating all the essential safety j require-ments that are now contained in the regulations, license conditions, regulatory guides, and staff positions, the proposed regulation provides
-ist s typdud ms4G, asinglesourceofrequirementsforhumanusephereby-reducing-the adminis t ra ti v e- bu rden-on-the-4i c e n s ee The proposed regulation also provides the-basis-for aMowing-moreY flexibility' in icenseeshpdat(ing '
aazan :afs4 Jof their day-to-day, procedures, that-would-conserve-licensee and-NRC' resources TheproposeQevisionh e regulations would provide a more (n ) efficient method for regulating the medical uses of byproduct material. d U2/08/84 1 Enclosure 1 d'
[7590-01] (DD r DATE: k
! ]! 'w./
Comment period expires (insert [ days after FRN). 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. ADDRESSES: Submit written comments and suggestions to the Secretary of theCommission,U.S.NuclearRegulatoryCommission, Washington,D] 20555, Attention: Docketing and Service Branch. Copies of the preliminary regulatory analysis and the comments received may be examined at the Commission's Public Document Room at 1717 H Street NW Washington, D Single copies of the preliminary _c regulatory analysis and environmental impactj are available from Norman L. McElroy, Office of Nuclear Material Safety and Safeguards,
' m 7
U.S. Nuclear Regulatory Commission, Washington, D C 20555, (301)427-40 f Telephone: V/06 FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, n Washington, D C 20555, Telephone: (301)427- M Y 4tb2 SUPPLEMENTARY INFORMATION: BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care Radioactive materials are used in drugs in the field of nuclear
,- medicine. Drugs labeled with radioisotopes are known as radiopharmaceuticals.
(\._.s') 02/08/84 2 Enclosure 1
}3
[7590-01] O In diagnostic nuclear medicine, patients receive these materials by D) injection, inhalation, or oral administration. Physicians use radiation detection equipment to visualize the distribution of a radioactive drug within the patient. Using this technology, it is possible to locate tumors g lood ci d assess organ function, or monitor the effective-ness of a treatment. In therapeutic nuclear medicine, larger quantities of radiopharmaceuticals are administered 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. Sealed radioactive sources that produce high radiation fields are usedinthefieldofbdiationtherapytotreatcancer. A very high W
#6 ku.,
radioactive source pan bc placed in a teletherapy pait-that$an be adjusted to direct a radiation beam to the part of the patient's body to Og be treated. An estimated 2 million teletherapy treatments are performed
\
'~~'
/
annually by NRC licensees. Smaller, less radioactive sealed sources are designed to be implanted directly into a tumor area or applied on the surface of an ares to be treated. This procedure is known as brachy-therapy. NRC licensees perform approximately 10,000 brachytherapy treatments annually. Sealed radioactive sources can also be used in machines that are used for diagnostic purposes. The source provides a beam of radiation that is projected through the patient. A device on the other side of rpNd the patient detects the amount or, distribution of radiation that goes throughthepatientywhichcn.provideinformationabouttissueswithin the patient. This is a relatively new development in the field of k w.busurne medicine and the NRC has no estimate of the number of procddures per-4 l formed annually. (v) 02/08/84 3 Erclosure 1 fr
c [7590-01] el) StatedAFederal Regulation y p) JV .sv e n-Twenty ,g states, known as Agreement States, have assumed respon-sibility for regulating certain radioactive materials within their (CLb Md of woud a wH,my Jp 4 G/wnk. % Oc6 ) respective borders by agreement with the wRC. 4They issue censes for 4 maad humaajuse of byproduct material. In non-Agreement States, the NRC c;w/%hha (awcuy hap %4 A e6Au'c.)) These issues licenses to medical feeiMtiesj(,andjindividual physicians. licenses authorize certai(uses of raciioactTve materiafs,QL&1c) c e 41therap_euj;ic) medical-procedurn_in humanst'%
}NRC'SREGULATORYPROGRAM Current Licensing Practice The current regulations in 10 CFR Part 35, " Human Uses of Byproduct
' Material," provide for general and specific licenses for(fiuiiib use. The col mu Og general license in,6 35.31 authorizes physicians to use small quantities
\ 9
'* a. typoluct of prepackaged individual do s of padioacti d aterials. Physicians
!simplysubmitaregistrationformNRC-483toNRC,a validated copy [
withaFass-igue(registrationnumberisreturnedtotheapplicant. Most medical institutions and physicians who use byproduct material en L lneedmorebyproductmaterialthancanbe permitted p general g w
. license.popA specific license, which authorizes a larger inventory of byproduct material and a wider variety of uses, may be issued for one or muscd ",,.
more of six types ofthuman>use, defined as Groups I-VI in the curr.nt S 35.100. Each group is comprised of a number of diagnostic or thera-peutic procedures that have been grouped together because they require Ap c w n ha,4 a s p simila[Aradiationsa'fetyprecautionsforsafeuse. A separate specific license may also be issued for use of a teletherapy unit. AH-these- , O Jo apHK'}& applications are much more detailed than a general license 02/08/84 , 4 Enclosure 1 0E
[7590-01]
,tahek sf'G '
application and actually contain the applicant's step-by-stepj proced6res, do4 \ ant ary vyd are reviewed < individually by.NRC.- f/4"N p e)- p too nospi % >and Jahr o w?e /tm' 3 , In 1989, the NRC NRC95currently has about 2p4"Ys0(medical licensee c,a q$ received @ new applications for specific licenses, @P license renewal i 179E applications, and @ license amendment requests for a total of,about ' 2562. - - - - -_ licensing actionss(TheNRChasinued650generallicenses,and)' i sMnicer) _ _
'n 198$ received @ new applications.] __
~~~
'To help licensees design their radiation safety programs,~the NRd '
has published many NUREG reports and regulatory guides that contain radiation safety guidance. These publications address three general areas: radiological health and safety, personnel training and exper-ience, and facilities and equipment. Experience has shown that if m4SI licensees follow the guidance in the publications; the p use of f byproduct material generally poses no hazard to workers and the public. ( Problems with Current Practice The General License. Thh ogram is based on the fact that the
~
f quantities and forms' of mat 6 rial that are authorized by a general license
- J present a very low health ri,sk. Isseng-a(general licenseJfer all iri vive--
b Tuse of radioisotopes to qualified applicants would be the simplest approach ~
'for the NRC and licensees. Unfortunately, it would not assure an a,cceptable level of safety in the regulated industry.
believes it is no longer "
>The NRC b I ive to issue Auman-tts general licenses. The tests authorized under 9.35.31 have been super-i c t. _
y J seded by new ,in-vitr6 procedures with gere spe+i4icity-and' greater diagnostic accuracy. These developments have been reflected by a significant decrease in applications for tpd eneral license'.' As noted v 02/08/84 5 Enclosure 1 ( h
~
[7590-01] above, although NRC has on file 650 in-vivo general licenses under
. p) ; AwwCw~ 9 U S 35.31, only (ijpe)new applications were received by NRC in 1981!
To determine the status of general licen,se use, the staff performed a telephone survey p apting to centu 0 percent of the current
& A registrants. The survey, indicated that less than 9 percent off the
' current registrants still use material under a general license; many arenowusingbyproductmaterialunderaspecificpRCNicense. Because of the low level of use of the general license, the NRC has concluded
- x.u o(
thatitnolongerservesausefulroleinlicensingtheganuseof byproduct material. J The Specific License. Because of the Jnc-reased' potential radiation hazard to workers and the public, the specific license program incor-O porates three regulatory features: case-by-case review of applications, on-site inspections, and periodic license renewals. A major problem with the current licensing program is that radiation protection requirements are not located in one document. 9 Requirements are scattered in the regulations, Inspection and Enforce-ment (IE) orders that modify a license or group of licenses, and [ [w conditions attached to individual licenses. Suggestions for good practice are contained in NRC regulatory guides and technical reports (NUREG's). For example, Regulatory Guide 10.8, " Guide for the Preparation of Applications for Medical Programs," and NUREG-0267,
" Principles and Practices for Keeping Occupational Radiation Exposure at Medical Institutions As low As Reasonably Achievable," contain many
,,,9 nrk n p i recommendations that the NRC believes are,ceit-ical for the safe use of C \ byproduct material. The revision of Part 35 incorporates those f
(Q i 02/08/84 6 Enclosure 1
)h
4 owdf 4lic4n b& ssnwfwd [h awca. lu k w n a M ana & 4 je/ s the e. adia a n1.wCctuG <~ vaan .tocu muA.[7590-01] Y 0/h4NowxvkW pachic aud h emasva[ck &uuw & a,yfca Abd a yd Aca c.m p & & Au k f ,u.p s fey e,g ol, recommendations, and also corrects the piecemeal fashion in which the (A. D') regulations have been amended over the years to address specific problems. When preparing a specific license application for review under the current licensing program, the applicant must include sufficient infor-kw y mation Q NRC reviewers Ao ccr,cludc that byproduct material will be used safely. Applicants include, as an integral part of the application ud&n rR In many package, copies of their proposed step-by-step jprocedures. cases, the procedures are edited versions of procedures described in Regulatory Guide 10.8. When NRC receives the application, a licensing reviewer evaluates the applicant's training and experience, facility, equipment, and u/arLn rg procedures in detail. If the application is found to be incomplete or inadequate, a " deficiency letter" is sent to the applicant explaining (' what additional information is needed. Review of the application is not resumed until a written response from the applicant has been received. Staff studies indicate that about 40 percent of all applicants receive either a deficiency letter or phone call for additional information. because-of-the-conservative-1-icensing7nd~Teview practices-needed due +e
-the-incompleteness-of the_ragulations. Deficiency letters are costly for ud :-
the NRC and the applicant and greatly increase the time p to complete licensing actions. When the application, including any additional submitted infor-mation, is approved, the NRC issues a specific license that grants the imidad authority forAumadse of byproduct material in accordance with the p/W swihd ~ procedures :,ubmitted witgthe application. Requirements in addition to those contained in the regulations are frequently incorporated in the (A) license as conditions of use. Since the licensee must comply with 02/08/84 7 Enclosure 1 l)1
[7590-01] conditions specified in the license, the license, rather than the b- regulations, is frequently used to regulate radiation safety in the day-to-day use of byproduct material. The specific license is valid for five years. The license must be amended before methods of use or procedures may be added or changed, or say,,;/ a.t&Asn.J p/ skam /s a sn.4uk&. beforepdding "thori7ad inyers( Amendments to a specific license involv an application, review, and approval process similar to that for new li- ! censes. Renewals are treated in the same manner as new license applications. This gulatory process was appropriate during the evolution of the use of byproduct material in medicine. Radiation safety problems were not well defined, regulatory requirements had not caught up with
; developing technology, M hysician training curricula had not been
"""I'f A-
,ut //w aat m }nned Zi.weg ;.rspuma jfn suunn -n+h*
establishedy j Therefore, it was necessaryv't(review each individual ysa by "3 radiation safety program to ensure that the applicant had adequate (v/ personnel, facilities, and equipment. f f[ ph - PROPOSED REVISION OF THE REGULATORY PROGRAM 1 Overview NRC intends to modify its regulation of the medical use of by-The Commission plans to revise the regulations to l Nproductmaterial. mddal provide a single source of requirements specifically related to puma # use of byproduct materials, and within the boundaries set by the regula-taun.', Map tions,allowmedicallicenseestomodifytheirprocedures& 4
, facilities, and equipment so they can make prompt use of new safety methods and also
.b w.d' meet new needs caused by changes in K for various patient care ser-P vices orpp atient load. The proposed revision of 10 CFR Part 35 is ma'ad O, ,
consistent with the Commission's general policy on,huma use of byproduct U 02/08/84 8 Enclosure 1 (
f ktwal cy. thJ aIutmu'fa fn mirv ULGA , un/w., s C,[7590-01] v p' k ikts> m c a rn , % u , u p n , a ,:.1 o , n ,3 h % , 4 Maran is, 20, 21, ad 60 m//.u% bf Je lhd Eb Y'" ' e M fing to material issued February 9,1979(44FR8242)g.which}tates"NRCwill V' continue to regulate the medical uses of radioisotopes, as necessary, to provide for the radiation safety of workers and the general public." Codification of Requirements in the Regulations NRC proposes,to simplify regulation of medical licensees by incor-ms cal porating all Aumate'use requirements in 10 CFR Part 35. Theseanadu* regula-l
,m au s/
tions would become the primary,, source of re,quir & ementsforthe, heman (use of byproduct material, and-woule-serve-to-regulete-theQt'o' day use_ sjef - l radleisotopes-for-pet 4ent-car Licensees would not face significant k aa new regulatory burdens because, in most cases, these requirements, cur-w p:ul rently appea{ as license conditions,whieh-eust-be-metg nder U the proposed s e442'L<$ s revision, the license would authorize % use of byproduct materials for specified types of use. Licensee's"would be regulated by the-require- \
/ m k % U ./
mants for-use-codi4ied- i he regulations. This would simplify inspec-tions for NRC because inspectors would only need to be familiar with one set of regulations rather than a different set of license conditions and Adabh aff
, procedures at each facility.
s
!LicenseApplication, Issuance,andAuthorityandResponsibility 5 .--
r gi&@ 7 - m l 41 The NRC staff will continue to review the.precedures ethi-tted-by l nthsdiaa1.k% ujoti pufat & a
. the-appl 4 cant-Tn eeder to determine __._ whetherithy re sufficient to meet /
~ - - _ _ _-
l ' the requirements of the regulations., A new revision of Regulatory [ Guide 10.8,"GuideforthePreparationofApplicationsforMedical i (&ffu
- Programs," will contaiMmodel procedures that the applicant can use to i pl0sGe%
l develop site-specific procedures,Q'te rcet-the-requirements-in-the-regula--- (p L
) VIf the applicant's program3s ncom is,w plete or inadequate, NRC
, - )gHjbair.,gs, yc uv,u.4 02/08/84 9 Enclosure 1
/
o g as n ,, - a m a _snac w / pupsw a anc/eayed. eL agkom csmp4G kw AK3/3. Atfin ad9 n naadav: & in as u a & B $ 4, y A s / u s a , y ues f & w/icad> a Aca&w f aca; a pewow ide m A omkcan aa'at sna&k6 au /uyaas&M; adod & app (t%bru; *maaGca/ uoc ");
& jays:c- n /6 caos Aa4fawusjam /so y 0,bu;ana' A 4amib>:
&Qcipcc f 6 aa&z
?!7m o; sad man ~baan 195
*gmijnw& n'e Ano6aEn, raff,cpay s2>>f' w>z&
Q atufpnan; afmaci-6 asso ni a y as ese of a man;>J
#d muaf k sian' >awco daaa' ma anor 4,prsAct^
,,,aau ,e- ,,a.,es, ya a. m e hibi cen/avu J & y,Jcn e scymx luu 3
4 6e A & dy;M K aoukowy a s m 9 c G 'i m b a )> & Aaue fnoa2/cunc~a 20aa'/ k y Q
$y b ,//caAbu 9 7d e a m t '~ ,, x a ,' d 4 . u 'i;:,ab $c& sy,)s6ca$ n, aAO;Go, b & #C ggj.hu i2mi,4ykt vn Aujs' wu. Hl, ya
[7590-01] T (o
'V
)
!will etep-preeening the spi > Meat-ion-and "il, issue a deficiency letter Ak
- that describes, apparent shortcomings in the applicant's program and a metin * @!k -
)
! requests clarificatiory. Me onsristent with current practice, appli-r.
i icants will alternatively be allowed to simply certify that they will hfollowthemodelproceduredevelopedbyNRCstaffandpublishedin Regulatory Guide 10.8 to meet a certain requirement.) [ N d ' To allow each licensee to make prompt use of new safety methods and agaohu ssry .6 m a,d toadjustgprocedures'tomeetnewneedscausedbychangesin, nee (for patientcareservicesor[patientload,licenseeswillbefreetomodify their procedures without NRC review or approval,after follomg an ^ s, M q uia 4 M d internal review and approval process. The right to modify procedure 3 does not relieve the licensee from the requirement to comply with the er&J ow/d regulations. At an institution',s the Radiation Safety Committee W review and approve a modified procedure before it be implemented. At non-institution facilities, the, d d management d review and P ., . . approvea procedure-modificat4ong This regulatory scheme would not incorporatethecurrentrequirement[thatlicenseesusebyproductmaterial in accordance with the statements made in the application. This change' would bring the regulatory scheme into accord with the general licensing requirements in 630.33(a) which address equipment and facilities and i j training and experience, but not procedures. OwTheb)h.proposed regulations require specific training and experience i ('for the use of material in each use group. Proposed authorized user 1
~ _ _ _ - -250 %
l (AU) physicians,g@adiation Safety Officers *(RS0)]and qualified teletherapy calibration experts (QTCE; identified in current Part 35 as the Qualified Expert) will have to submit summaries of their training f3 and experience. This is currently required for AU's and RS0's, but (v) 02/08/84 10 Enclosure 1 gi
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[7590-01] would be a new requirement for QTCE's, whose credentials are currently D reviewed by the licensee. The staff will review those individuals' l training and experience against the standards in the regulation before authorizing them to work as an AU, RSO, or QTCE. (Also consistent with current practice, any individual who does not meet the standards may ask for an exemption from the training and experience requirements. The NRC staff will review the individua training and experience with the assistance of its Advisory Committee on the Medical Use of Isotopes, and ma issue the exemption as a license condition.) { m ylw nwu sn **/ 4$^~I'y %"* ' # I Enforcement htuGn pia <
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f Q Under this regulatory scheme, a licensee will be cited for failure to meet the requirements of the regulations or license conditions (which O would list, for example, authorized users, locations of use, authorized methods of use, authorized byproduct material and inventory limits, and other site-specific limitations), failure to have on hand the written procedures required by the regulations, failure to follow the procedures on hand, failure to have the records required by the regulations, or es failure to follow technically valid procedures. Use of material without authorization,either by license or by virtue of working under supervision, I g y pctuw would be a violation of the regulations ich would subject the fed M # to an enforcement action. Amendments As mentioned above, under the current regulatory scheme, the nn. Wen re licenseeisrequiredtohandlematerialexactlyaccordingtothepro-'p( 4 cedures submitted with the application. The NRC frequently receives 3 02/08/84 11 Enclosure 1 p
l [7590-01] l ud.a !w o requestsforpermissiontomodifyday-to-dayoperatTn(ff procedures. N Since the regulations will now contain sufficient prescriptive and performance criteria on which to base enforcement actions, the NRC would allow licensees to modify their procedures. This would eliminate the licensee's need to prepare a formal amendment request for the NRC and ch.wd W v pay an amendment fee in order to make podif.icatiodin procedures. This would not relieve the licensee from the regulatory requirement to comply to c r2 CLij D- Z . with the regulations in Part 35 or other parts of4 T-itle-10" l Four types of #
$dm 11 still equirep Y[a n M 1 (1) New users. The NRC will review the training and experience of each proposed AU, RSO, and QTCE-as described above before listing the individual on a license. gg 3 (2) New type of use. equestg to add a type of use (for example, adding radiopharmaceutical therapy to a license that authorizes radio-pharmaceuticals for imaging) to an existing license 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 t be submitted in support of the request will be reviewed for completeness and adequacy with respect to the new type of use before the amendment is issued. hvcbp+4nd nup oJe /d o2/p nro (3) New method of use.
C Tw type [of a N ent ill be needed: udhling a (a) If a new radioactive materialbecomes JRAM)available, Y and the a procedur s eeded for its sah. use are identical to the procedures already established for an already established and authorized use (for l tN1 ! in Hwut amtd na nt wM k example,anewimagingagentadministeredbyintravenousinjection),4the uf w^d'S# E ir ushSJ newRA(willbeaddedbyrulemakingtothelistofmaterialsinthe j l} l appropriate use group specified in the regulations. The NRC will mail l- 02/08/84 12 Enclosure 1 , i i Gy O..-- l
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[7590-01] p to licensees a notice that says those who are authorized to use material
.l i .,aG V #
in that group may begin using the new) LAM the effective date of the nabud final rule that adds the newKto the regulations. Mftdividual m Licen:;ing action wili ve i.aken N ats.lioJcNvo m b (b) If a neg g becomes available but its safe use depends on following a new procedure that current licensees have not submitted and NRC has not reviewed, two actions will be taken. ws&ust (i) The new, will be added by rulemaking to the appropriate use group in the regulations but authorization to use it will be limited to u/>o ude ' x.-. Ludo persons a licensed after it was added to the use groupghese persons-3 _wou ve submitted the new rocedure for review in their appli-cation packages. (ii) NRC will mail to current licensees a notice that says they may
-amJt/
apply for authorization to use the newgRAMF With that notice, NRC will also supply a model procedure, which would become a new appendix in
.n.olidal Regulatory Guide 10.8, for the new,RAMf- Those licensees who want to use marEl the new will have to submit a request for amendment which includes a proposed procedure that will be reviewed by NRC for completeness and adequacy.
(4) New location of use. Two types of amendment may be needed: (a) A request to leave one location of use and begin working in a new location, for example when moving a private practice to a new office or when moving into a new hospital building, will have to be supported by a complete new application package. (b) Some licensees receive packages, prepare radiopharmaceuticals,
- and package waste at a central facility, but actually use the byproduct
) material at satellite locations. This might be a mobile nuclear medicine l %.J 02/08/84 13 Enclosure 1 L-____-___---------------__----------
[7590-01] service that provides diagnostic services at clients' facilities such as =V clinics, small hospitals, or nursing homes, or it may be a licensee that has a principa facility and outlying clinics. If the licensee has been approved to offer service at satellite locations, a request to add another satellite 'ocation will only have to identify the new location. (Due to the training, space, and equipment commitments needed for safety during therapy procedures, the NRC nerally not authorize licen-Jh u fyP ' sees to perform therapies at satellite locations. Arequest(willbe handled on a case-by-case basis.) hyy2ta ?) W Summary of Changes Proposed in the Regulatory Program In summary, the regulation will be amended to require that licensees meet standards that are currently imposed by license conditions. The O NRC will continue to review user training and experience. The NRC will
,te.4 h N r d s review site-specificjprocedur'es #orf completeness and adequacy and issue deficiency letters if necessary, but will allow licensees to modify proceduresthatweresubmittedinsupportoftheapplicationifthel . nda RadiationSafetyCommittee,ormanagementandRS0outsideaginstitu-tion, approves the modification. However, the right to modify procedures does not relieve the licensee from the requirement to comply with the regulations. Amendments will generally be reviewed just as new applica-tions are reviewed, but they may incorporate by reference the original application and any previous amendments.
O LJ 02/08/84 14 Enclosure 1 7; b 1
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Word Usage tque' In preparing the proposed revision of Part 35, one goal was to remove language that might be misinterpreted. The following words used in the revision may require clarification. Juuf (D .d.rw 1 I. Type of use and group. In the current Part 35 there are six
" groups" of use described in S 35.100. Each group is comprised of a set of medical procedures that require similar training and equipment for radiation safety purposes. The word " group" has not been used in the proposed revision in order to avoid confusion between the old and new Part 35. The revision uses the phrase " type of use" for this concept.
Some types of use are amalgamations of old groups, and some types are fg t i new. The six types of use are: (1) uptake, dilution, and excretion -- Subpart D; (2) imaging and localization -- Subpart E; (3) radiopharma-ceutical therapy --Subpart F; (4) brachytherapy -- Subpart G; (5) sealed sources for diagnosis --Subpart H; and (6) teletherapy -- Subpart I. J E. Method of use and procedure. The word " procedure" is frequently used in supporting documentation for byproduct materials programs. Sometimes it refers to a specific set of steps that must be taken to effect an end, for example a procedure for ordering and receiving pack-ages. Sometimes it is used to indicate a type of medical examina on or bEva nC { (her , for example a thyroid uptake study or a cesium implant therapy, without indicating the amount of byproduct material used or the specific steps taken in handling it. The word may also be used to indicate the number of patients cared for over a period of time, for example an b) (J average workload of fifteen procedures each day. In order to avoid 02/08/84 15 Enclosure 1
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[7590-01] confusion, the phrase " method of use" appears in the proposed revision. [m \ () Each type of use is comprised of several methods of use. Each method of use should identify, explicitly or by context, the radionuclide, its chemical and physical form, method of administration, and purpose (diag-nosis or therapy). y 7. Dose and dosage. In pharmacy, the word dose is used to indicate the amount of chemical administered; in radiation biology it is used to p wilin w indicatetheamountofionizingenergyabsorbedjandinradiationsafety as a u:.n H . n d a w it is used to indicate a worker's exposure to radiation. In order to g avoid confusion, the word dosage is used in the proposed revision to pus.uc&iE indicate quantitiesa that are# measuredwiththebaseunitCurie.adhe
;ws.ut d ,uJ64w aswfu' Juc n ake <p.:g% ^
word dose n to indicate quantitiesgthat are measured with the base unit rad or rem. Q \ 1 6 4. Record and report. A record is a user retrievable notation or
'd complete document. It may consist of something as small as a check-mark on a form or something as extensive as a survey of a newly installed teletherapy unit with appended calculations to demonstrate compliance with the limits on exposure in uncontrolled areas. A report is a transfer of information which might be made face to face, by telephone, telegram, computer link, or hard copy transmittal.
6I Test and check. For many pieces of equipment, drafting committees comprised of industry experts have prepared standards of performance and com'plete calibration protocols. If a piece of equipment is subjected to the protocol in the calibration laboratory and meets all the standards, then the ability of the equipment to perform as expected in normal field use is assured. In the proposed revision this concept [ of complete examination is referred to as a " test." During field use it
\s' 02/08/84 16 Enclosure 1 01 0
i [7590-01] p is common practice to subject a piece of equipment to a quick examination to determine whether it is[e bl[ This procedure does not examine all parameters of equipment performance. In the proposed revision this concept of perfunctory examination is referred to as a " check." 6 Ef. Location of use, facility, and area. The phrase " location of ,
,ick Gf-use" is used to describe the building or buildings (typically identify a single street address) where byproduct material is used. The phrase
" facility" connotes a room or contiguous rooms where byproduct material is used, such as a nuclear medicine clinic comprised of an office, an imaging room, and a dosage preparation and waste storage room. The word
" area" connotes the space used by a worker when performing a specific task connected with receiving, handling, or storing byproduct material.
'/ 6. Chemical form. The current regulation requires that if a Hoct radiopharmaceutical is used for indications other than,jdescribed in the s
package insert, the user must never-the-less follow instructions on t chemical and physical form, dosage, and route of administration. The proposed revision has deleted the word chemical in its restatement of this requirement because to change the chemical form would be to create a radiopharmaceutical other than the one received from the authorized distributor. Deletion of this word in the proposed revision does not authorize Part 35 licensees to manufacture radiopharmaceuticals.
$/. Available for use. In many cases the regulation states an equipmentpossessionrequirementbecahthepieceofequipmentis I considered by experts to be an integral part of the radiation safety program. In a few cases the need for a piece of equipment is sporadic and normally scheduled weeks in advance. For example, a licensee who ) has a diagnostic sealed source in a device (see S 35.500) usually only v
02/08/84 17 Enclosure 1 b(D
f ). ObraGsLwd u.ma . 1G5AdsEEtb?%n k caed b Ac4 L d'y h dy umhng al ar l w.ut, jl, q,7y cw a (> As J uad h u d g a q .,a 7 a s '/& c, x g n a ,i , q ,s ,y 4 s , g g
'_'g q, ,; _ ,g,
}h swa wayJ e ud /n ch);qsa.
,p needs a survey instrument when receiving or returning a radioactive 5 i
'Ns' source; there is no need to have the instrument on hand every day. The phrase "available for use" is intended to connote that the licensee either may possess equipment or contract for measurement services, but is not required to have regular day-to-day possession of the described l e L- +quipment. n o / u se ~f An
/0g. Operable. The word " operable" isg +a seme--people, conspicue r in4t-s absencc frdthe proposed regulation. If a sevey-instru ent.,.
pru ej ojspa:< ,# ,,J A, Feem-moniton,-gas-trap,-on-fume-hoodd is not operable [, whether due to
,/x 4 c,u A 4 - " # '? j 4 dead or absent batteries 3 j o [ incomplete or improper maintenan~ce,ji't b oo N f f O lenge&a-working-survey-instrumentT room-monitoraas trapror-fume hoodr-end-is-more appropr.iately-described,-for-safety-purposes,-as-en-assemtriage of metal and plastic that once served a useful purpose.-
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kY- NMf> Yf f 'b1f d JCC2:>9&&rch /A: 4kr h *b 'h A ^'M " Record [ Retention 'j" 'n' A N* U 'f' ' " "' / '*' The Commission requires that licensees make and retain records as ,,s evidence of compliance with regulations and license conditions. A review of records during inspections is the least burdensome way that the Commission may be assured that the licensee has developed and implemented a radiation safety program. However, permanent retention of all required records, or retention between inspections, would be unreasonable and would run counter to recent guidance to regulatory agencies that was issued by the Office of Management and Budget. Therefore the Commission has, in the proposed revision, generally adhered to the following policy.
- 1. For recurring records that are created on a daily basis, for n
f) v example end-of-day surveys, tha Comiss-ion-bas-made-a-judgment-that-t __ _ 02/08/84 18 Enclosure 1
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[7590-01] I p ; reco rds-re ten t i on-fomyea r- p rov i de s-adequa te-e v i denc e-e f-compl i a nce-(with-requirements; s w & ,,,s+ i % rfor non-recurring, a sporadic, or periodic records, such.as pxwswuh
! individual patient dosagej gr survey instrument calibrations y respectivelyA the Commission has made a judgment that records retention for two years l
iprovides adequate evidence of compliance with requirements.
- h. In a few cases a record is only created once or the Commission considers the record to be critical evidence of compliance with regula-tions that, if not followed, might cause an immediate discernible impact on a worker or member of the public. See, for example, requirements for the geometry test for a dose calibrator and the teletherapy dosimetry equipment calibration, respectively. In those cases the gommission has it a. c p M c e y a,f n n x n ., b made a judgment that retention for the duration of the license is O necessary.
C g80 y M nme>' ' [In a separate project the ptef-f isjbeginnin(g te dcvely compre- \ f hensive records retention policy that may conflict with the policy ' reflected in this proposed rulemaking. Readers should note tha W c ke of 'Jaifereft" somerecordsretentionrequirementsmaybechanged/ x the comprehensive policy is implemented. ) Effect on Broad Licensees In addition to the more common " group" licenses the NRC issues that l l authorize byproduct material for uses described in the groups, the NRC has also issued about 100 " broad" licenses under Part 33 that include nu self use. There are two types, a pure broad license and a hybrid broad license. (% 02/08/84 19 Enclosure 1
\0
I [7590-01] , s> d u About 50 pure huma{use-broad licenses have been issued. They are issued to large academic institutions that have had several years experi-h:,2.0 Wn enceusingradioactivematerialsd vest in each institution's Radiation Safety Committee (RSC) the authority to permit medical practitioners to use byproduct material for, human-use-i both patient care and medical 4pnm W research,gadindividualstousebyproductmaterialforre,searchintest g ,
,a .sta.J tubes and animals, and to review the facilities and safety j procedures all these individuals will use. Before NRC issues a pure broad license
& iWJ it reviews the applicant's administrative and, safety procedures, the training and experience of the RS0 and each individual member of the n a ,,y >,wd RSC, and the standards and j procedures the RSC will use when it reviews permit requests. This type of license is needed to allow for the orderly evolution of the medical sciences. The NRC will continue to review RS0 (9
\'j and RSC committee member qualifications on a case-by-case basis because the size and individuality of each broad license program precludes the preparation cf generic prescriptive qualifications. These licensees would be required to comply with the proposed prescriptive and perfor-mance criteria of Part 35, but would be exempted from the training and
,, ym. f u% ud experience requirements of Subpart J and the, materials and)use restric-F-
tions,,~of proposed SS 35.49, 35.100, 35.200, 35.300,35.400, and 35.500. vadak/ About 50 human-us hybrid broad licenses have also been issued. They are similar to the pure broad license described above, except that the RSC only has the authority to permit individuals to use material in nadaif test tube and animal research, and only authorizes human'use in accor-dance with the groups in current S 35.100. The NRC continues to review the training and experience of medical practitioners before allowing , ,Q bc.wh j them to use material for human use. ncej the control of human use in 02/08/84 20 Enclosure 1 1 L{ h
[7590-01] m these cases is the same as that exercised over the more common group
)
V licensees, the basis for a determination of compliance will be the same as that described below for group licensees. deau s
>4ince, whether at a group or broad license facility, teletherapy is separately licensed "for treatment of humans" and the NRC reviews qualifications of proposed users and safety procedures, no significant inconsistencies with current teletherapy programs or new teletherapy programs are expected.
&dk S/a _v feL k +1+ L__ S " 'h e jg pg$
Transition Policy f M p q M b h "5 Under the current regulatory program, the license document with the gaans appended application is used to regulate each individual licensee.,f4ece-o the requirements in the proposed revision were taken from commonly used / O- license conditions and regulatory guidance that most licensees have incorporated in their applications, the Commission does not expect any significant inconsistencies between current licensee radiation safety programs and radiation safety programs of applicants who apply after the effective date of the proposed regulations. Therefore, current licensees will be cited if they do not comply with the new regulations. However, if there is nconsistency between a license and the regulation (for example a license may require survey instrument calibration biennially, but the proposed regulation would require calibration annually) with the license less stringent than the regulation, thy license would be con-Caaast sidered an exemption from the regulation. J W ee,the less stringent license requirement was reviewed for safety considerations and approved bytheNRC,bh nconsistenche would not result in an increased risk
) to workers or the public. On the other hand, if the license requirement a
02/08/84 21 Enclosure 1
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[7590-01] m is more stringent than the regulation, the license requirement will stand in place of the regulation because.it may serve to balance another license requirement elsewhere that is less stringent than the proposed regulation. In the case of record retention, the regulation will take prece-dence.because j in the past,the Commission has not offered much guidance on this topic.and many applicants have either not specified a period of retention or have incorporated a single, all encompassing record reten-tion phrase "until the Commission authorizes their disposal" rather than
/c/AC shouldering the burden of justifyingea shorter period. If a record h He wmt w been-cre=+=d 2nd-i [is substantively idcaticel t d record described in the proposed regulation and no-clear#andM retention requirement has been stated for that ord, licensees could 4 4edheretentionfM& d guid rdin the final rulemaking. Licensees would still have to comply with any record retention requirement for a partic r topic that is specifically stated or referenced in a license condition or another Part (forexamplePart20)oftheregulations.(Forexample,surveysthat provide the basis for occupational dose records or measurements of g effluent release are governed by Part 20.)
, ne - -
The NRC particularly requests public comment on this transition policy and would like to know if licensees envision problems of inter-pretation or compliance that the staff might not foresee. DISCUSSION OF PROPOSED REGULATIONS The primary purpose in initiating this revision to the regulations is to simplify the regulatory process by pr,ovi ing licensees with a singlesourceofrequirementsforthe$ use of byproduct material. v i 02/08/84 2E " " l( b
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'A 1 Radiation protection standards now contained in several existing O regulations, Inspection and Enforcement orders that modify a single license or group of licenses, technical reports (NUREGs), standard conditions of licenses, and regulatory guides would be consolidated into a concise set of regulations. The requirements that apply to all licen-sees appear first, followed by the specific requirements for each of the six basic types of use.
2/
- foj>The general license in current S35.31 has been eliminated from the g ggp proposedregulationshandall%dd(dsewillbespecificallylicensed.
pai ve + cyc Q% Gw%d n,0 Current h=cn-us eral licensees will 4be incorporated in NRC's filing isystemforkeepingtrackofspecificlicensecs,buttheywillbelimitedto the methods of use described in the current S 35.31, and relieved, by license e apwamuT3 condition, from th,pse previsicas of--t-he-proposed-Part-36 that are more p u uu'stemw iburdensome than the currentArequirements,for human use general 'icense
- The only action they will need take is to respond affirmatively to a,
//d av M : notice that asks if they want to continue to have an NRC license, limited
;to the methods of use authorized by the current general license. They will not be assessed application7 emendmenhorrenewalfeesas ong as
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their[da(6*ri % T _ __ imitedtoth'pkdescribedincurrentS35.31 he current Part 35 also grants a general license for in vitro work described l in $31.11 to group licensees without requiring that they submit an in l vitro registration form. Under the proposed regulation, applicants would , a w C< a ihm n Wh s,y/ cdon. -- - l :have to specifically request this authorization.3 Part 31 will be amended
' rp i
to1continue this authorization for current in vitro licensees. k "D "' n ti a.u c tL J., w :ii i d;, k usjat te ys ,u p a ,,a,m y g u ,i. In the proposed regulation, items of general information, general administrative requirements, and general technical requirements are addressed first in Subparts A through C, respectively. Subparts D (v) 02/08/84 23 Enclosure 1 g &cw/ Abow nh nad 4 nw L. my en ~ n % p . p w .. w , .. k aph, wndiv. i;L ntaf 3Schit . a- %;choM a - 2 <lU S & c' N ad l l% (Q
.._ _ _ _ _ _ ~ ~ -
r!-' - J yh 4/.$l 4 t'L / % hx S% cAsrufc4 f 'u ~Merm [7590-01] f[
, /%fini10* Ar ' */?b/k.d & c{/3ypwdu!< M.>atid
- A k% .i scop ej Hs pw.x . -
p through I contain the additional technical requirements that apply to licensees for each of the six ypes of . Subpart J lists the training and experience requirements, 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 sec-tions of Parts 30, 31, 32, and 40. These conforming amendments can be found immediately after the revised Part 35. A section-by-section discussion of the proposed revision of Part 35 follows. [#1h ./ /b Sbduy f. aua f .% wfbM&,
/.
Authority jJ g ;m ,7y/fs , This listing provides notice that the NRC may initiate criminal
/w o w'a, prosecution of persons who do 7nof./ edwith comply a;HjuMy the prescriptive require-g p ments issued under sec.161b or the recordkeeping and reporting require-D) /
ments issued under sec. 1610. Subpart A--General Information L S 35.1 Purpose and scope. l The regulations in this part apply to all persons licensed by the l Commission to intentionally administer byproduct material or the radiation from byproduct material to humans, and to individuals working under their supervision. S 35.2 License required. This section requires that persons have a license issued by the Commission or an Agreement State before they handle byproduct material
^
for M use. The Commission uses the specific licensing process to 02/08/84 24 Enclosure 1 d
[7590-01] (] limit the use of byproduct material to persons who have the equipment, L/ facilities, training, and experience needed to ensure its safe use. Individuals who are working under the supervision of an authorized user ixwmd donotneedalicensg,butthisdoesnotrelievethemoftherequirement to conduct their work in accordance with requirements of the license and the regulations of this chapter. The licensee remains responsible f'sr the noncompliance of such agents or employees, and may be subject to sanctions for their failure to comply.
.atr'ihv c:$lchv S 35.8 j,;f,,ing Repor4 r-recordkeepi w nd-applicatdog requirements: OMB Approval.
paddo uAn This section . cert-ifie t the Office of Management and Budget has reviewed and approved the information collection requirements contained (3 in this part. ! ) xv S 35.15 Definitions. yp//es e&ulwfo The, term"AgreementState",_was-inelude(9futo w m,3 ,,, u ww b /, -ident4f(those state thathavepagreegwithNRCtoassut
, thesaf(useo bypro uct material within their borders.
The word "ALARA" was added to identify the acronym for the phrase "as low as rea onably achievable." lsta d 8 p alw The term " authorized user" was added to identify individuals who are identified by name on a license and who are authorized by the Commission or an Agreement State to administer byproduct material, or the radiation therefrom, to humans for medical care, and supervise its use by others. I I
\d 02/08/84 25 Enclosure 1 iU J
(*.%pkacs'ALpocAksfavdkAs a acms rag is;/4 a 4%, ' um uteladab fi muh if Chas? A.a/ J/El acs esta M [7590-01] '. fl Nh2anayd Mhl .s hwodg4rwfghi/4nas.Jrnut' AWhE6raae s/sd/mf' sr Zmptt' M A//2C y Acp$ctiet n .s uMajawcmVUw' L "f :M nrrdia/wpds&na o as amny)f A Eud k A' whnw op e-;Jhpde//a, p The term " dentist" was added to identify a group of practitiondrs t i C/ licensed by the States who might use byproduct materials in their practice. g
& cw The term " e" was included to help identi fy the scope of this part. The word " intentional" was added to the >:urrent definition i
of the term " human use" to make it clear that occupational and non-occupational 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 Mad waste)arenotconsideredhumanuse.-h inassd The word 'jinstitution" was added to identify organizations wiui -- udd&na medica!-byproduct material programh in which the safe-use ,45-pogssd of byproduct = asterial depends on the cooperation of individuals from several different departments.
\
The word " management" was added to identify the individual respon-sible for defining the licensee's policies and allocating personnel, budget, and space resources. The word " misadministration" was included to define those instances ir udd+f in which a mistake has been made in the use of byproduct material. sc The definitions are 'c(o.mnw n;i; tentMou wit sa current 9 35.41. l The term " mobile nuclear medicine service" was added to describe the transport of byproduct material for the purpose of offering diagnos-tic 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. I i Ng/ 02/08/84 26 Enclosure 1
]
[7590-01] l The word " physician" was included to identify individuals licensed (G by the States to practice medicine and therefore eligible to apply fer :
-licence to use byproduct material in the practice of medicine.
% ~
The word " podiatrist" was added to identify a group of practi-tioners licensed by the States 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 S 35.24. The new term better reflects the training, experience, and responsibil-ities of the individual who is responsible for calibrating a licensee's teletherapy unit. The term " Radiation Safety Officer" was added to identify the individual named on a license and who is responsible for managing the licensee's radiation safety program. i 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 S 30.4. vis;Ree Theterm"provisionapauthorizeduser"wasaddedtoidentifyauthorized users who, while working for a licensee on a temporary or occasional basis, use byproduct material under the restrictions of the temporary employer's license, which does not identify the visitor as an authorized user. This l nLaud N provisien:F authorization - +4an fr= a frequently used license condition.
, S 35.16 Application for license.
t' At an institution, only management may apply for a license and the -- en //a/6,xna individual physicians would be listed'as authorized users. An individual ephid
/m physician may not apply for a use within a 'jinstitution (an organization k%
02/08/84 27 Enclosure 1
[7590-01] that provides various medical services). This requirement reflects the 'kA) v need for coordination with other employ.ees who may not be under the administrative control of the authorized user. For use based outside an institution, such as for private practice or mobile service, any person may apply. An application must be filed on Form NRC-313 because it i elicits information in an orderly manner that will allow for uniformity in application review procedures. Teletherapy applications must be submit +.ed separately because the scope and nature of information neede.d is much different than that snthal needed for the other types of e. This requirement does not imply that the applicant should have two separate safety programs. This section also reflects the Commission's decision to delegate to Regional Administrators some licensing functions which, until recently, were conducted in the headquarters. ~This program was described in a C)T (
' s FederalRegisternoticepublished[ April 14, 1983 (48 FR 16030)y and M ar, 4 7, /9 H ( Y 7 1 12. z sr s h '
iff/ (H M W M S 35.17 License amendments. The Commission requires that the licensee obtain an amendment for any changes in the byproduct material program that might increase the potential for radiation exposure to workers and the general public, or w d d ils s.pe chw />up
- W*
make it difficult for the Commission to determine whether a licen:cc is-i cc pi;am.e witn in reyuiai.itnis( The Commission has determined that certain changes are potentially significant for the following reasons and thus will require an amendment: (1) The NRC must be assured that the licensee has adequate training
,and experience and facilities before authorizing a change in the type or arn a h d method of or amount of byproduct material used. Such a change might also indicate a need for increased inspection frequency.
02/08/84 e 28 Enclosure 1 , 1,
[7590-01]
,r m (2) The use of byproduct material at an address not identified on
'D) the license would make it impossible for the Commission to make unannoun-
% Cmm6;su dw w & ~~J mpch6 h aw sp b-dyM-ced inspections.p For the purpose of this part, the phrase " location of em/
use",; refers to a building. ,Acept iur i.el e uivi a oving from one room to another within a building would not constitute a change in location ofuse.)t (?) The Commission must be assured that the training and exper-ience of Radiation Safety Officers, authorized users, and qualified teletherapy calibration experts is sufficient to ensure that they are able to understand and follow regulations for the safe use of byproduct material. S 35.18 Notifications. A notification requirement was added to require the licensee to
%, notify the Commission if an authorized user, Radiation Safety Officer (RS0), or qualified teletherapy calibration expert is no longer affil-LJ4ad & ^Y
^ the NRC iatedwiththelicensee'sbyproductmaterialprografbec:=Y
/w auww e c -
wouldno/ longer be as that the collective training and experience en of the licensee's remaining personnel is adequate to dysure the safe use of byproduct material for all the types of use authorized by the license. The Commission has made a judgment that notification within 30 days is sufficient because technicians who have worked under the supervision of en the authorized user can adequatelycgssure the safe receipt and proper storage of byproduct material. y a few wca d -(This paraiieis Uie ! -Cc=inica's judgnent that cc- sn cerriece who handic bypred= t material l
'(J~N 02/08/84 29 Enclosure 1
}, tf
[7590-01] p dages r.ced . t be 'icenced). --However,-over arlangerperiod-of-timert. absence of an individual to oversee a byproduct material program may increase the probability of an accumulation of unused byproduct material' or unauthorized use of material. This presents an unacceptable potential hazard. 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 past exper-ience indicates that medical programs do not generally change signifi-cantly over that period of time. A shorter term may unduly interfere in patient care because the licensee would spend an inordinate amount of accabnraOy dualfd time requesting renewals. A longer term may410 d t unintentional abandonment of the license. (3 The applicant must use Form NRC-313 to provide for an orderly safety review of the applicant's program. The Commission will apply certain standards when reviewing an application so as to ensure that the safety of 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 (9 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 danger to life or property (S 30.33(a)(3)), and that the applicant has established procedures adequate to assure the safe use 9t%uudwr fue of byproduct material. j {t is the sens,e of Congress that --fee: may-be t f'N RiwSCO, Ja4d/ ab AAUnsow~ adOnyac//nu, imaJf du a0' wallcUr4 ;6 N1 sdc Jud5 i 6' ; 02/08/84 30 Enclosure 1 L) J
1 [7590-01] ! L.-
/^N neceSSa@OMVer Upuralilly L.udls. *hSCOr is0iGn'5 DISCUS $iGn Of' ! \
V titiv i.opic is in 3FFTT45, published January 6,1971. # j S 35.29 Specific exemptions. p putoj n gM%v w arwmd'nddqt$1 Apersonmaygg t-an exemption from any requirement of this part. The Commission may allow the exemption if the applicant can show that it will not compromise the health and safety of workers and the public. C% ACocew ha/6(nc.vvw hfMil} *nt/m;Jlm Fxa4 W cf u g o x 4 as Ca d a n g . m d a n u . Subpart B--General Administrative Requirements 635.30 ALARA program. An ALARA program is a management tool needed to assure that all reasonable efforts are made to assure the safe use of byproduct material,
.9-in-4att4teti enk (See ' Management Organization and Administratior for ALARA' by Kathren, Health Physics, Vol. 42, No. 2, February 1982,
- p. 119-131, and ' Radiation Safety in a Nuclear Medicine Department,' by Gandsman et al., Health Physics, Vol. 38, No. 3, March 1980, p. 399-408.)
ny workers from different departmentf3 @1;n an institution *might be occasionally exposed to byproduct material. The Commission has made a judgment that a formal ALARA program is the only management tool that c euptafwc ef c&a,,Ad ari c:&chk a osc, ard enau t<_ - can wwwprovide-assurance-thatfsd 4 udacu
-sources-of-radiation-and work procedures in-ac 4argeJasi+ity-aryegular bewNfor- m Specific requirements usually considered part of an ALARA program are required by SS 35.31 and 35.32. pnce-outhide--of--an--institutio he safe use of byproduct material.
l doesnotusuallydependonthecooperationofindividualsfromseveraladnm$Ad% r . wa _S4ifferent departments 6
- and-in-most-cases-the-authorized-users-ere-also%
am capa c 'E $cn M ; / 4 /i m / A h u a J , JacA %llT'c k *$7' Yf Dciscq t y '* m/ Ajmial + ! ..r af mA duyfA ppa >~' bca<x l 02/08/84 31 Enclosure 1 .> S
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[7590-01] f% Itiiemanagement,non-institutionallicenseesneednothaveaformal written ALARA program. S 35.31 Radiation Safety Officer. The Radiation Safety Officer (RS0) is an individual with special expertise who is needed to coordinate the safe use of byproduct material in~accordance with the license and regulations. ? S 35.32 Radiation Safety Committee. The proposed Part 35 requires institutional licensees to establish a Radiation Safety Committee to oversee the use of byproduct material./Q Y 92o Or y"aderthicpreposeh%committeemembershipmustincludeaphysician identified on the institution's license as an authorized user of by-product material for each type of use permitted by the license, the institution's Radiation Safety Officer, a representative of the insti-tution'smanagementandarepresentativeofthenursingservice.[A e ('similarrequirementwaspublishedasaproposedruleonApril9,1979 c(44 FR 21023),.s +. itutions that only request a license for diagnostic p -- sealed sources will be exempted from this requirement by license con- , dition because the radiation safety prograpue-te-the-nature-of-theA
.c seurce =d-itt method-of-use gwould not depend on the cooperation of individuals from several different department T M N"C h not seHeRing-comments-on-the-Radiation Safety Committe~e~ rule ~of~Part~35' because an opport0nily~to comideht'orthe~ rule'has71 ready'been provided~
in the-recently-completed ^ rulemaking'oYthe~ Radiati~on Safety'Committeer* _5 That-rulemaking,-published p a final rule on September 13, 1982 (47FR40@g hes-bean i ncorporated-i m t he-p ropos ede rd i ng - o f- P t-35.- J ~ a 'ya a;/ k ma cla w lcdAM&^f y~
@an Aulafuw ts twoww M r,awve n ,; $n/u.nanwj,iddm Mu rex tad'." "' "3' ;[y, i
i 02/08/84 sa&adin jat4l6, & 32 Utb cla*U $5 A" I'" Enclosure 1 L
'l 2
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& ,v a a b u $ , ,a a l a p a , z u n c. f d :vn w n m s u
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_ do .>u/ Aws AL ,ina///-aunat # ,,nuaukcu/guzl'l'c, a # q l iinanajanuC dallastA suHe>>jiy,&alo ' m:cdcca/ u.vA/a
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ad aao I /M D AXa'y e 7 i
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1 [7590-01] To assure the safety of workers and the public in light of site- [;
specific exigencies, the Committee must review on the basis of safety (1) the qualifications of each individual to be listed as an authorized user, and (2) each proposed method of use. In its reviews, the committee should consider compliance with NRC regulations, special physical or chemical containment problems, the amount of byproduct material that will be used, and the relative hazard of the material,
!all in light of the licensee's facility and staff.
The committee must review occupational exposureg. A@@morep ("frequenhhan gterl would inappropriately emphasize normal and expected statistical variations in exposure data. A less frequent
,,d awa pu Ho,e/ rme sf g;a , ,
review would,ja44ew-en unnecess,ary or unnecessarily high exposure-to-
-cont-inuewncorrected-for-an-unacceptstrlyiong period t' The quarterly a res.
r review should be guided by two trigger levels for individual yposures,<_ ( 'I
%J The lower level would be a minimum level below which no action taken.
Above the minimum level, the source of exposure should be deter-mined and consideration given to methods of reducing the exposure rate. The higher level should trigger immediate intervention by the Radiation Safety Officer to reduce the exposure. The committee should review the appropriateness and completeness of the intervention, and should develop ses y a permanent solution to maintain y posures at a lower level. The annual review of the safety program is needed to determine its adequacy in light of the current and projected use of all byproduct material. In the Commission's judgment, a review at least once each year is adequate to assure that exposures remain ALARA considering the few program adjustments typically made during any single year. More time [
'q,'
02/08/84 33 Enclosure 1 - k 1
v ,- [7590-01] i between reviews might not permit the committee to make timely reco 3 mendations for avoiding unnecessary worker orI patient I S 35.33 l Requirement for Authority and Statement of Responsibilities . To ensure that material is used safely, the RSO and Committee nee a clear statement of their duties from management so that questions about authority, responsibility, and jurisdiction do not keep these individuals from acting. t/is23 S 35.34 Reewicicaat authorized user. The uninterrupted provision of medical care occasionally requires a visiting authorized user to work for a licensee when its permanent sta may be unable to do so. This was allowed in the past by a standard license condition. If the licensee had a copy of an,okru bcen:ee's NRC license that m listed the visitor as a<* authorized user, the visitor could work under the license for sixty days each year without requesting a n- license ame d ment. The scope of this concept has been expanded to allow NRC licensee to employ Agreement State authorized users d to remove the sixty day fimelimit. In order to reduce paperwork burden, the licensee does not Ih @ {avetoaddthevisitorasanauthorizeduseruntilanamendmentrequest,,
-s led for some other purposey Since the previ+iena-1 authorized user's training and experience has been reviewed by a regulatory age ,
g dVpublic health and safety will not be adverselyg,g' affectedd A S 35.35 Mobile nuclear medicine service administrative requirements. in dMobile & nuclear medicine service has been limited to diagnostic i uman use because the inherent hazard of therapeutic amounts of byproduct u 02/08/84 34 jh 2s a n i El n p u d u & 4 w Enclosure 1 y n ,ylcLwow twve w ^*"."'** pa c-A1. . (o D
i } i iO _ bu/
. Y& bX/AouM i$gea' pj Mao Ahuac, fan i asasa naa /an o.6,pu, n v; dab Aw,sy amb acs undad a,, cab O ,, pw ,, ;,,,j. ,jg g, ; ,mu
\ coa & -a s Eb yys, uw-ch av sapats as of atuopos, h 4% y' i i fe AfC f/s v;uk 6- ed &
/
Aw M C,f M A h b {. 7/ 8 , / iNL M O. i J f I lO l j ._ l~ u- -- . _ - _ _ _ _ _ _ _ - - _ _ _ _ _ _ _ h& - - - -_ - - - bi
[7590-01] h material makes it unsuitable for use in locations where the licen J might not have clear and direct control over personnel, facilities, or equipment. These licensees are required to have a letter of permission from the management of each client A cili assure that the client
.mc#ed management is aware of and in agreement with the homen use of byproduct s
4 material within the facility. l i h .p - The Commission did not authorize transportation of merP' "~ ~- y ^'- ' f " #'t efgenerators puj wt,wda because physicians are-exemptedan-S-71r9-from-t-ranspo
-tdon requirs.yAmenNu.La.
- nt &? 4 < 1 .af ouw wuhl le 9tq/d s wyimaand-these-materials-tannot-te 7 p y ttd 13 f h tv. safely--transported < n&my /c /b f ess-they ere-properl ckaged.
i Mobile service maya b e provided to "-"~ "' ~"
--" licensed _
t
, clients y
m caa- ef & -yin @titu%J/ab da:C" Y the Tvoner- because,(they-have-no-othee-access-t.c- sen ices alid > wpcMiSQ,
; the-htten-because_they-may.ocdas& enuc&c unnJnncuy to c loabk.
! io nal.ly-need -a s s i s ta nce-duri ng-periods-lef hi;;h-patient-load-or. technologist-. absence..
) L dp $5~
S 35.37 Records and reports of misadministrations. t The proposed Part 35 retains the misadministration definitions and reporting and recordkeeping requirements of the current Part 35. A afpateel g discussion of these requirements ts-+n 45FR 31701, published May 14, < 1980. -NRG-is-not-soliciting-comments-on the misadministration-require-u ents of-the-proposed Part-35-because-they are-the-same.-as-the-require - "
--ments of-the-current Part J5-- 09 Octeber 29, 1982w the Commission,in SECY 82-388, disapproved-the-staf41-s-recemnd=tinn +n i prepese withdrawal of this requirement and cowladtd &l l tlould. csm dard.
b mb k WH/ut'tt. mu of N) W' L 4 1 02/08/84 35 f Enclosure 1
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l9
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Jhu aedw a/Ards /A> Awwo 4 iniaAx (~ Aw /ha Aadkd;wq~ hah (if ptsjwnv /Aa/ was dueoi JJi puyere f/Abau/dmysdw a b atsa & hamas 4 a:pnd b a u n
~
breb, aca<1aMe y'ayment; ei kend load sw a.aMoca/kw fp pas, l n 4 snala c4 x sij/Aa/aia ka ' faAbn/can, adats>tw ata) %, stado. & ned ecmg/4 licews,Ini anylw' rion inw/miadi a- slend q 9' .e , m1ab //a!l Weze co>so/M a/Atw l plamou /di e. Jb .acad w;// Le ad
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l _ _ _./' MA man a saisa /&w s a ly adadsnarak/of adduws e,y/ad o an,aun -ssem-asp r wa/in ; s 5 c m -/ [fM - det.nGw;q C.OV h wj's c' ? * -
. 3Sn p,
$le N2C l(.u nd pd/ildahrcb O M*; dc h fa!id 6 A n'" Oa
/6 tachis i ej audeNu- abU d'fACA;. si eMIv N(15"g0 *$ 0f]~
d d/ec/dal ccwiw kw/ 6ho /t A.ufnuke A tu/J ovunumiJy's Avdich MA Th MM A/12C ax/k dipw60p& t/ou Ap&c. //iswhoNWT.unnLJ n wh/40 ySC/W jevih4 fed ,2> c.u h,e kb HJ as d&ra A's n ek 53 8 Supervisionr Q / 7 gj jf m g ,gf g ,
% The authorized user is qualified to use byproduct mater'iaFin'the --
practice of medicine. Frequently, specific tasks may be delegated (under S 35.2(b)) to individuals with less training and experience. However, it is necessary that a qualified individual instruct them, oversee their work on a frequent basis, and be available to promptly i respond in unusual or emergency situations. -When-using-byprodtrctNtP- ' S u g u % .v pisa M.d ,
-rial q supervised individuals aust' comply with instructions, procedures, and the regulations.
cd h S 35.49 Suppliers. In order to authorize only the use of materials reviewed by the government for safety and effectiveness considerations, authorized users may use only byproduct material that has been manufactured and distributed under procedures that were reviewed for safety by the NRC, the Food and DrugAdministration(FDA),oranAgreementState.fIncertaininstitutions) , 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 research projects that involve the administration of radiopharma-ceuticals to humans for medical research. It is the Commission's judgmen that the review criteria established by the FDA are, when followed by the RDRC, sufficient to assure the health and safety of the public and
~~-~~--
The NRC will continue its current practice of allowing, on a case-by-case basis, re-transfer of radiopharmaceuticals between Part 35 li-censees if an applicant specifically requests an exemption from this section and shows the exemption is in the public interest. 02/08/84 36 Enclosure 1
f Cniwnaikpauut 6 mhierk 9 Ghs Bjm %
,g,wjI,pgj g/g u s j,utzfz Q gjo p ,,gg w , [7590-01]
Alt.v) Yrl% N Y /00 / 6. (m
\
Subpart C--General Technical Requirements L S 35.50 Possession, use, calibration, and check of dose calibrators. A dose calibrator is needed to ensure that the dosage of material given is the dosage that was prescribed. It must be tested for accuracy, the ability to exactly measure a specified quantity, and linearity, the i ability to exactly measure a range of quantities. The requirements are generally co..sistent with the recommendations of the American National Standards Institute. (See ANSI N42.13-1978. In the interest of economy and efficiency, the NRC uses voluntary national standards in its regula-tory program if they provide adequate assurance of safety.) The activity levels of the accuracy check sources were chosen because a lower activity would invalidate the accuracy test due to expected statistical fluctua-tions, and a higher activity would present an unnecessary source of [G radiation exposure to workers. The radionuclides required reflect the fact that dose calibrators are not as accurate as might be expected for the photon energies commonly used for imaging (see " Joint NCDRH and State Quality Assurance Surveys in Nuclear Medicine," HHS Publication e FDA 83-8209). The linearity test should only be done over the range e between highest individual dosage measured and 10 microcuries to dnsure that the dosage given is the dosage that was prescribed. It is not necessary to test for linearity for all amounts that might be measured, for example the first elution from a fresh generator or a multidose vial, because this would subject the worker to unnecessary radiation [Arsps !d.uJ M metreadw %wof k QCMA46 M&WA *
- W##
dose.M wou!d require using4hc ccmplete c; cur,t-fe test, thereby y ., edihsinkcaux Ng au cs hy; such dorsju du puaw/ sn9 n m&ut we A n dep44t4ng-the-etinic-inventory ivr ich The geometry test assures j
@ @ s. Shuj % &g uns au/ k.n aua ( s amd}
} that the shape of the syringe or vial containin ,g the~ byproduct material n/
02/08/84 37 Enclosure 1
/
[7590-01] does not affect the dosage measurement. The daily constancy check assures that the dose calibrator has worked consistently since it was last tested. Licensees whose level or scope of use does not indicate need for a dose calibrator may request an exemption from this section. The request should be supported by a description of an alternative method that the licensee will use to measure radiopharmaceutical dosages. S 35.51 Calibration and check of survey instruments. The 1000 mR/hr limit was chosen because that is the highest rad-iation exposure rate that is likely to be encountered in the medical environment. The calibration frequency and the other prescriptive and lperformancerequirementsinthissectionaregenerallyconsistentwith (N ANSI N323-1978. S 35.53 Measurement of radiopharmaceutical dosages. This section requires that the licensee assay the radioactivity of each radiopharmaceutical dosage before it is administered to a patient and keep a record of the assay results. This is required to ensure that the patient redeives the intended dosage. The time at which the measure-ment must be made has been purposefully omitted to allow for flexibility in licensee's procedures. 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. The NRC is incorporating the dosage measurement proposal in this revision. The proposed Part 35 dosage measurement requirement differs from the 1981 proposal in its recordkeeping require-ment. The Part 35 proposal requires the dosage measurement record to 02/08/84 38 Enclosure 1
[7590-01]
,A include the patient's name, and identification number if one has been I -( d jassigned,andprescribeddosage.
wm - This information .isiiot required by the 1981 proposal. uRC i.Tiii.e> cc.. i.c..t-on-the requirement that ~uusege meas u reme n t - reco rd s-i nclude-peti ent-i n fo rma ti o n.- NRC"i s*"hb t's'dl ici ttig consent-on.-other-portions-of-the dosage measurement ~ requirements-because. Mey-arenubstantively"the's'ame' as thel'981~jiF6posal? Comments received-in.zesponse-to>the -1981-dosage measurement.proposaLwi.1Lbe-addressedMn the -e tetementmf consideration ~ published'With'the" finhl*f0le'r'eVising-
% ST.
S 35.58 Authorization for calibration and reference sources. These sources are needed to check and test radiation instruments and to mark images. They represent a small radiation hazard in relation [ to the amount of radioactivity used in patient care. The activity level
\'
was chosen to allow licensees to have a range of sources with several energies and half-lives available. S 35.59 Requirements for possession of sealed sources. The user must follow the manufacturer's instructions because they l have been reviewed for safety considerations by the Commission or an Agreement State.41The six-month test interval has been recommended by the National Council on Radiation Protection and Measurements (NCRP)1 in Report No. 57, " Instrumentation and Monitoring Methods for Radiation Protection." More frequent testing is inconsistent with ALARA 1The National Council on Radiation Protection and Measurements (NCRP) is a nonprofit corporation chartered by Congress in 1964 to draft pro-posed recommendations on protection against radiation and radiation ( measurements, quantities, and units, particularly those concerned with radiation protection. CarW IVL 2P Pubki 4 ro;, Ab. 2<<f3c as,spn4 tJak jey ern,h17cpu4aud tecik A udah ? 02/08/84 39 Enclosure 1
[7590-01]
- considerations,governingworker-exposure $ecauseitwouldcausew>$m (m)
N _ e' dau .shmnu& Jh Lf 6d ,aR nda .mly w :QMly $ub occupationWexp sure withenegligibl obability of finding a leaking
' source. The test procedures described are intended to maximize the probability of detecting contamination from a leaking source. Report
+
No. 57, Section 3.3.5.3 recommends, minimum detectable limit of 0.005 micro-
& wT curies for equipment-ttsed-t8 measur,e leak test samples. This level is e
also consistent with the requirements of other parts of the current i regulations (see, for example, 96 31.5 and 34.25), and is only slightly 4 ' higher than the minimum detectable activity exhibited by instrumentation N ' available to licensees. The Commission has made a judgment that this
% 13 /,w e s h 7
/
w level provides the juost-conservat-ive detection level technically achiev-able at a reasonable cost. It is noted that this requirement would reduce the current permissible amount of detectable contamination from h
\j teletherapy sources ten-fold, from 0.05 microcuries to 0.005 microcuries jforpurposeofconsistency.MTheCommissionhasmadeajudgmentthatthe exempted sources do not present a contamination hazard because of the small amount of radioactivity in the sources, the method in which they
, are constructed, ).he,huri. half 1+fe of the byproduct-material the small hazard of the byproduct material.$To conduct a physical inventory more frequently than quarterly is inconsistent with ALARA exposure goals. To inventory less frequently may, in case of a misplaced source, allow an unacceptable radiation exposure to go on for too long without
{ detection.Theradiationsurveyassuresthatsourcesaresafelystored. S 35.60 Syringe shields. , m 66 Syringes that contain byproduct material arCan external radiation cwa [a t I 8 hazard>and should therefore be shielded at all times. In some cases the
'%~.)
02/08/84 40 Enclosure 1
~njp, g[C enw: ara us&v 4'+uu LYg. d ye aidsu~ % .uaw,,v," NN
\
at&Nusld os /n f.rm, j y,,, ,
,vudl.g+1o g,
Nda. g jfc ; 4 w; a. ,,d " g.,' '[7590-01] f utb%v t,pugt s/ odds doJA k u.at A<~ dmkg aswJod ds94. f cua f4 kwaa.L I,wy ajaited b .u nave Hs sh,Jj An nam *,y t .n use of a shield when making an injection could interfere significantly g sd"s up $ "g p\ .u.s.Sw tsz d with the injection. Sincr this would jeopardize patient benefig jn *
- M*#'
such cases the higher radiation exposure to the hands that is received rys. by the technician who does not use g a shi+ eld is warranted. -Fee-exampi g kshieldneednotbeusedwhentheriskofspoilingtheinjectionis greater than the benefit of reduced worker exposure.
$ 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 trans-posing vials or syringes. 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 exposure rate survey will bring this to the attention of workers. The weekly exposure rate survey of waste storage areas will ensure that exposure rates in that area will be monitored so that special steps can be taken if greater than average use of radiopharmaceuticals results in higher than average exposure rates in the waste storage area, m./ 02/08/84 41 Enclosure 1 f r p* . \r{
J [7590-01] nuw ak can?.'wuna<G>d t 73 The Commission knows that ajwipe test made several days after
}
(/ spillage of a short-lived radiopharmaceutical will probably not detect any contamination. The periodic contamination survey serves as a check of workers' physical control of radiopharmaceuticals. If contamination is found, it indicates that controls or safety measures may be inadequate
, ,or are not always being used.
i i S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. A patient whose body contains byproduct material is a potent-ially ^ uwal us w ha acu- fudueA rc or'En4'ha hazarduus source ofg radiationf The Commission proposes to allowVrelease Q p%r limits based on residual activity in the patient or exposure rate at a specified distance from the patient at the licensee's option. The
,v,//fe errh O \ !
30(Cilburden limit is based on a recommendation of the NCRP and current licensing practice. The 6 mR/hr at one meter limit is based on the ino tth u r ie s exposure rate from 30 gCp of iodine-131, the most commonly used thera- ! peutic radiopharmaceutical. The Commission is considering allowing the
- n,itt, c un e ,_
l option because the 30 6Ci limit is consistent with NCRP guidance, but some individuals believe that the exposure rate is more relevant and easier to measure. The Commission believes that either limit provides an adequate measure of safety for the general public, and has made a l i judgment that further reductions in public exposure are not reasonably l achievable considering the cost and potential for detrimental effect from an unnecessarily long hospital confinement. m
/ \ \ l x._/
02/08/84 42 Enclosure 1
T- [7590-01] S 35.80 Mobile nuclear medicine service technical requirements.
/ \ \"' ) The Commission has limited radiopharmaceutical transportation by dr&dsse v4/s ypspst nAbpAnm.w"N.
these lic sees to unit dosages /becauce they annear tn he inhorontly-lpf p 3 $,, .
- - .- /
sMer-un er-accident-condhions:-end-there-does-not appaar tn-be-suf-fi-
!eient accd-fe, bulk radiopharmaceuticah in mobil u ucleaf,,,mgdicine,
.servicerqThe 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 license to receive and process radio-Thf ersteise /9%
~
lactivewaste. Ihfr/licenseemust/constantigcontroljbyproductmaterial.~ ecauseg cinc b here 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 ~ client facilities should be considered
!asunrestrictedareasj#rd4 n .
Equipment checks are needed to assure the proper function of equipment ( ) >
\
) after transport and before byproduct material is handled. A survey is needed to assure that all byproduct material has been removed from the location of use. The mobile nuclear medicine service must carry a calibrated survey meter to monitor exposure and contamination in case of any accident that may result in a release of byproduct material.
S 35.90 5torage of volatiles and gases. SO Some radiopharmaceuticals present an inhalation or immersiony%LOaza # pfh ,tc bs chwasfO'f0:W4. ,u.L an(/ (e. g. ,y, iodine-131andxenon-13{p:hn/Ti(at'hazardqcanbeminimize
).
nwfiub
~
mil. & V storing these4 in a fume hood or phepictight' barrierJ(such as a folded plastic bag within a folded plastic bag). 4 n i \ ( -
/
02/08/84 43 Enclosure 1 9l
[7590-01] S35.92 Decay-in-storage. V For most hospital radiopharmaceutical waste, decay to background 1 levels is essentially complete over a period of days or months. The l wut 49& a requirements of S 20.301, directed primarily at longer half-lived material, are not necessary for short half-lived radiopharmaceutical waste.
-Because-the--spec 4al-handMng-required for long half-14ved-material-i-s- -usuatly not needett-femadiopharmaceutical-waste,$4u/
short half-lived waste c&>v
-wouM be exempted from the requirements of S 20.301. A. decay period of 2 upmA a Hawnd-N/M.htfrW n s.tdkaefd 7.
ten half-lives was chosen because4secha-t-ime-peMod willvQure3 that, Jho W in most cases, byproduct material will have decayed to levels below those in S 30.71, which are quantities that, under certain ordinary conditions, are exempt from a requirement for a specific license.
.snnyashavuuuni du Qecay-in-storage =yy ='y bc neu,for radioactive material with a half-
- life of 65 days or less 7 This-ha'f-life etoff 'imit was-dese because storage in excess of 650 days is more appropriately considered ermanent
; (Gnwknf s% mtpudla, & tmmu;1oirn a,y cauv, w .1 c.w - by - me kd, storage. A Waste must be monitored to assure that long-lived waste was upda h du.ur bryn-heed m.ML n 4 mem/m fwe luf AM.)
not accidentally mixed wifh short-lived waste and that no waste has been added to the container since it was sealed. When the waste is monitored, neither the waste nor the survey instrument may have any radiation shielding because it might hide the presence of long-lived byproduct material in the waste. The requirement to remove or obliterate radiation labels is in S20.203(f)(4) and is included here for completeness. Generator columns must be individually monitored because they contained larger amounts of radioactivity and also may have small amounts of long-lived contaminants. /7 (v) 02/08/84 44 Enclosure 1 p'
[7590-01] p Subpart D--Uptake, dilution, and excretion -fGreg General /I )A
! I G' .
SS 35.100 Use of radiopharmaceuticals for uptake, dilution and excre-tion studies, and 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. 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-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 range: NRC assures the safety of the public while allowing the physician flexibility regarding the choice of the clinical precedure. The FDA
;[ also authorizes the Radioactive Drug Research Committee (RDRC) at an institution to review and approve the use of radioactive materials for
,oc.ucal n hu.T.;n un forjresearch purposes. The Commission believes that the guidelines used by the FDA when reviewing the credentials of the RDRC members, and the guidelines that the FDA requires the RDRC to use when i evaluating research proposals, are adequate to assure the safety of i
brkers mmiaimand the public u.o ernnut without
' H o//sa, unduly an o. restricting u 1 R -ca w 6 m , medical A k w h research. hM The radiopharmaceuticals listed in $35.100 were taken from those d' f listed in the current SS35.31 and 35.100(a). Those listed in S35.200 were taken from current SS35.100(b) and (c). Mercury-203 was not in-cluded in the proposed revision because the Commission believes that there are other radiopharmaceuticals available that provide equivalent diagnostic information with much less radiation dose to the patient.
/
\y t$addphumauaZEd au%yJ ' w f472e ,cag,,we n,. w;,L h-%
ADL %.K,nu Ji,,wa,sAdua-a+ap
, kcausL a- a 4cuam p a d it.
02/08/84 45 Enclosure 1 n s2)
[7590-01] l Manufacturers are currently distributing generally licensed radio-t pharmaceuticals under a license issued pursuant to S32.70. If this revision is adopted by the Commission, these manufacturers would have to apply for a license amendment to distribute radiopharmaceuticals pursuant to $32.72. l
- S35.120 Possession of survey instrument.
L A low level survey instrument _is needed to check areas of use for contamination. Since the total amount of radioactivity used for uptake, , L ' dilution, and excretion studies is relatively small, the Commission does t not believe the licensee needs an ionization survey instrument to measure dose rates. Subpart E--Imaging and localization (Cre p II/I ----- r-S 35.200 Use of radiopharmaceuticals, generators, and reagent kits for j- imaging and lucalization studies. I Xenon-133 as a gas or saline solution has been added to this group. l l Manufacturers are currently distributing the product under a license j issued pursuant to Part 30. If this revision is adopted by the Commis-
- l. sion, these manufacturers would have to apply for a license amendment to distribute xenon pursuant to 632.72.
l Through continuing medical research, new uses may be found for existing approved radiopharmaceuticals. Th- ;w uses, which may require a different dosage, route of administration, or physical form, i may not appear on the manufacturer's label or package insert instruc-i tions. 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 [ s/ 02/08/84 46 Enclosure 1
O u;, n uta>>y,t swi a uc e es c i
,- . :9 ,
- ,;;;) y //jsu 4,
- u l,( j{k $$ /t $0 f '
0l Al 0
/ % w h - x 2 .>. J /s b / k ein-n/ -Fr.,/ cc/c - 33 A ad /u b b, 6b / k-C ; .
O
- . 1
[7590-01]
,o Tc-99m pentetate as an aerosol for lung function studies. A proposed f )
C/ 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 of t;,mte f a u4nujupand .kcaw revision of Part 35 without soliciting public comment becauseAthere are no substantive changes to the rule as adopted. S 35.204 Permissible molybdenum-99 concentration. Wh en molybdenum-99 undergoes radioactive decayy eMnicaHy-usefd t Q 60% ua w ta,w o u d gchnetium-99m is producecf Unwanted molybdenum may appearjin the technetium solution. The permissible concentration of molybdenum-99 was chosen to be consistent with the permissible concentration listed in the United States Pharmacopeia (USP), the nationwide standard for all pharma-ceuticals used in the practice of medicine. It is the judgment of the Commission that the USP standard provides an adequate level of safety and to require a different standard would be confusing and unproductive. Since diagnostic dosages of technetium-99m are generally 30 millicuries 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 molyb-denumtyconcentration. Mdiq Rx p,w,.,Gp(.t concuDohw k .yo ypia&.Gvilq ie The Commission has made a' judgment that,th rc.
,Qf;af radiation dose is insignificant compared to the radiation dose which would be received by the patient due to the administration of the techne-tium. %t'
,,., 4likNA 4}}ny !/t' l4 YlmLI a nv s . A fnw & . < /.t. b Ifu nL ', -
v 02/08/84 47 Enclosure 1 N
[7590-01] The person who elutes the generator must measure and keep a record C +of the molybdenum concentration. Persons who receive prepared radio-
. pharmaceuticals do not have to make this measurement [ M a4 M / # #
al.c (1sparc.d if Anfa' W ,*nado /% twtaam>f (sce%fwnf
& s / /c 030 3 Y).
- S 35.205 Control of aerosols and gases.
The Commission believes that a system that provides for the col-lection or controlled dispersal of aerosols and gases is needed to
' reduce exposure to workers and the public. If control is by dispersal j2J,/05 W
;in the atmosphere, licensees should note S'20.106, which limit the jamountofradioactivityintheeffluentstream.
$nourl hk S 35.220 Possession of survey instruments.
The licensee needs a low level survey instrument to check for contamination and an ionization type instrument to measure dose rates in areas where large amounts of radioactive material are stored. Subpart F--Radiopharmaceuticals for therapy (Grcup IV/'!) C S 35.300 Use of radiopharmaceuticals for therapy. The radiopharmaceuticals listed in S35.300 were taken from those , g- and (e). listed in the current SS35. ,100(d) N ' Drugs 4 approved for p use by the FDA,have a label-erg ackage-insert that specifies the FDA-approved use, physical form, route administration, and dosage range. NRC relies primarily on FDA's deter-mination of a radioactive drug's safety and effectiveness when used according to the package insert, and therefore would require that ,the l'% i Aj) 02/08/84 48 Enclosure 1
'7b
sqc 85.205 e as eu a d A ssudsnsAido aa/hrujid 4y /Ak pand'qad adl I,p"c"a%nd enkmed 1k 4% plaa eyorau 4 n acovald a/Tu a . og'ra a ya, uhaad aa worhu oms se , a%puod a /A avmospw is conumd, w.d. Umwa, 6ecauae cwenAkal houv vedh/akru uno aa ausm a,)4cAnu' /c class ,yuhd p m a.A faohim, >% Auma ima d How siec,s, n - p - s,cy,c ww nu 9 9a -n- le w / pedc1
/atw, 4 Emuu muld assafn is/ /L a Ageof si/yte y asa&6e conpatty spu as aa sa1ou,awks a o gamy abt 24l? l La$a. \
k4/,saa ,; & a w (, b
1 [7590-01] l l tq i licensee use the radiopharmaceuticals in accordance with the package
,j
\, insert.
SS35.310 Safety instruction, and 35.410 Safety instruction. In the hospital setting, the use of byproduct material presents special training problems which are not addressed in Part 19 because they are unique to the medical environment. For example, visitor control in a hospital cannot be accomplished by physical barriers which might k fu&E>@ impede the delivery of emergency medical carg. Also, after administra-tion, the byproduct material is contained in an ambulatory human. There-fore, the Commission has made a judgment that worker instruction in addition to that required by Part 19 is necessary. (This parallels special instruction required, for example, for radiographers and radio-
/n'j 4
& t% t>m.a.na a f or% w grapher's assistants pursuant to S 34.31 of tMs--chapte{q. )
w ._ S35.315 Safety precautions Because of the special contamination hazards of radiopharmaceutical therapy patients, a private room with private sanitary facilities is needed to protect the public, who might be visiting nearby patients, from unnecessary exposure to radiation. The RSO must be notified in case of the patient's death or medical emergency in order to determine
!whether special contamination control procedures must be implemented.
S35.320 Possession of survey instruments. The licensee needs a low level survey instrument to check for con-tamination and an ionization type instrument to measure dose rates in A areas where large amounts of radioactive material are stored. lC,) 02/08/84 49 Enclosure 1 g>J
4 4 9 l I
~
.- , / / l Y, h' Vih'l 's GR l E '
/
, /
na
/. . j- , ,
/; ,
LAa j j O i 4 i 6 i e e T I J l 3
u i [7590-01] ! Subpart G--Sources for brachytherapy (Group VI) S 35.400 Use of sources for brachytherapy. V This section identifies brachytherapy sources that may be used in " m/w.l huma use. The list was taken from the current S 35.100(e), which is a list of sources commonly used for patient care. -Tantalum-wire-has-been a-M< S 35.404 9elease of patients treated with temporary implants. 5 er.iponsibility of the Commission is to restrict the movement of byproduct. <aterial when the public exposure would be increased. Brachy-therapy sources f or umporary implants have high levels of radiation, and remain radioat.'.ive 'or a long period of time. Loss of control of these sources and their r.-lease to unrestricted areas may result in ( potentially lethal radi, tion exposure to members of the public. The imp /ast Commission has made a judg.ent that temporary confinement of the W an
-ther atient is necessary 'o 49sure public safety. Section 35.404 requires that the licensee cont:ne he patient until all temporary irnphd achyther g sources have been r;... e-i. TM records required by this
-section may be amalgamated with the receds required by S 35.406; there
;is no need for duplication.
S 35.406 Brachytherapy sources inventory. Because of the particular hazard of brachytherapy sources due to their high activity and small size, the Commission believes that an j/ cecal q ~waLatihv M w r I'}- inventory procedure that requires a countandfine(entryeachtime ' , O r* @ en f a source is handled will help to gysure that if a source is misplaced, 02/08/84 50 Enclosure 1 9
b, [7590-01] ys aWa*
'MMt will quickly become apparent to the licensee, who can then promptly k) begin a search for the source.
;S35.415 Safety precautions. ,
p
, c >W Because of the high exposure rates around peachyther y patients, a
! private room is needed to protect the public, who might be visiting
! tv l nearby patients, from unnecessary exposre to radiation. The RSO must be notified in case of the patient's death or medical emergency to ensure lthat control of hr.ElipIherapy> sources is retair.ed.
;>ufanf S 35.420 Possession of survey instrument.
The licensee needs a high level survey instrument to me'isure exposure rates in storage areas and uncontrolled areas around a patient's h room, and to check to be sure all sources have been removed from the patient before release from confinement. Subpart H--Sealed sources for diagnosis (Group VII) S 35.500 Use of sealed sources for diagnosis. This is a new use group established to incorporate the recent f4af f development of medical devices whicVuse a sealed source of byproduct material to create a beam of ionizing radiation. These devices are /AW js available to persons licensed to use materials listed in
'S 35.100(f). Since the devices represent a lower level of hazard than theotherpeal urces in that, group, the Commission has determined that these devices should comprise a new group.
T J 02/08/84 51 Enclosure 1
r [7590-01] p S 35.520 Availability of survey instrument. i C The licensee needs a survey instrument to measure the exposure as us+ u u d #L U rates around a packaged sealed source th'at is to be returned to the manufacturer, and to survey for contamination in case of an accident that might have compromised the integrity of the sealed source. However, k u. + hwa p e a source exchange is an infrequent and scheduled event, and, sinc P a hazardous accident would be a very rare occurrence, the Commission believes that it is sufficient, for safety purposes, to require the licensee to make arrangements to borrow or rent an instrument or contract with a measurement service when measurements are necessary. Subpart I--Teletherapy (Group VIII) S 35.600 Use of a sealed source in a teletherapy unit. x } This is a new use group established to deal with a well-established
,m m type of use. Safety measures that apply to all licensees within this group have been used over the years and are reflected in these proposed regulations.
6 35.605 air restrictions. Maintenance and rep,iG) s>w t This section providesjthat only specially licensed persons may maintain, adjust, or repair teletherapy units because this type of work requires special training and equipment in order to be done safely. 6 35.606 Amendments. Amendments are required for items identified in paragraphs (a)
/
(%_j3) through (f) because any change described in these paragraphs could 02/08/84 52 Enclosure 1 Cl V
II - [7590-01] I W8result in an increase in radiation levels in excess of the levels j ( authorized in S 20.105. The service of a qualified teletherapy calibra-e tion expert is a#r,e n acedn% w pMtieeW ing the safe use of a tele-therapy unit. The Commission has made a judgment that only an individual with proper training and experience can determine the operating character-istics of the licensee's teletherapy unit. S 35.610 Posted instructions. Emergency instructions must be posted to remind individuals of the proper steps to be taken in case of an emergency and to identify indivi-duals to be notified in an emergency. The Commission believes this is also an appropriate place to remind workers that it is important to ensure that only the patient is in the room before turning the unit on.
'\(O The reminder is necessary because it is possible that when two workers are stationed on one: teletherapy unit one worker may inadvertently turn the unit on when the other worker is still in the treatment room, or a worker may turn the unit on to check its operation af ter a patient or u i} k a / W M co-worker has entered the treatment room e6 9 em et b the worker at 4
the control console. S 35.615 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 irrad-iation room or other high radiation areas are provided with barriers equipped with interlocks that are not dependent on the operation of a J single circuit, and that will interrupt radiation production when the 02/08/84 53 Enclosure 1 [ - J
[7590-01] O
- \
barrier is opened." There have been incidents in irradiation facilities s / N.s 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/BR-0001, " Case Histories of Radiography Events," vol. 1, 1S30. 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. The beam condition indicator light will indicate to workers about to enter the room whether the unit is turned on or off. S 35.620 Possession of survey instrument. - j g, ( The licensee needs a survey instrument on hand in-order M ma x urn s
}
-exposure-eates in case the radiation monitoring device or the teletherapy eni-t f ail s.
S 35.621 Radiation monitoring device. The radiation monitoring device is needed to indicate radiation levels in the teletherapy room in the event of the failure of the inter-i
; locks or the warning system. There-ha v e-been-a-numbee-of-reported-eua unnecessarily exposed following rinc4 dents- in which individualsjgbe the failure of the source retraction mechanism g upled with a failure
;of the primary beam condition indicator system. Therefore, S 35.621 requires licensees to install a permanent radiation monitor in each teletherapy room, to check its operation before using the teletherapy
/ N I )
U 02/08/84 54 Enclosure 1 ) L)
a4._ _ - - - -,-.-,a-- _ ._- - _ O 1 I f
- , ~)
g
,= }
i -_,
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i I
- s ' '
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t'in t J : )<J# Ol i t S l t 4 5 1, J O,
'l 1i 4
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- - v - ww
_ _ _ _ _ = _ , _ _ _ _ _ .. . _ . _ _ . _ . - -_ . . _ . _ _ _ _ _ _ _ __ 1 [7590-01] unit, and to use a portable survey instrument or personal audible alarm I U dosimeter if the monitor is inoperable. Gm;/wv Id;c.tiegrequirementswerepublishedasaproposedruleon c.&
- April 28, 1982, (47 FR 18131)y M en r
- quir;;;r,te were adopted in a final rule published January 18, 1983 (48 FR 2116). The NRC is incor-i porating the rulemaking on teletherapy monitoring and servicing in this rulemaking on the revision of Part 35. "PI-ivnet-soliciting-comment off
.the-new-teletherapy-requirements *of-the proposed-Part-35-because-they ar.e. identical to the requirements-of-the earlier 1982 rulemaking.'
i S 35.622 Viewing system. [ If a patient moved during a therapy administration, this could
,.is;rou ui n .hz. ban hos/,ual w "
!resultina30[raddosetohealthytissuej Therefore, a viewing system is needed to monitor the orientation of the patient and the teletherapy unit to assure the prescribed application of radiation.
S 35.630 Dosimetry equipment. jg, y/jg, Dosimetry equipment is needed td assure-that- MI Jux pi ncrioea is i th ' d;;; :: telly ;;ien. In order to help g sure accuracy.i must be
-u /ht &!& n ~(v~)
calibrated. The equipment requirements are the same as the current SS 35.22 and 35.23. This section also contains the proposed resolution 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 t is two year requirement be relaxed to four years if, two years after calibration, the primary dosimetry system is compared with a system that was cali-02/08/84 55 Enclosure 1
[7590-01] brated within the past two years, and the results of the comparison indicate that the calibration factor used to convert an instrument
-reading to a dose measurement had not changed by more than two percent.
(Intercomparison meetings are occasionally scheduled by several quali-fied teletherapy calibration experts within a geographic area. Each expert takes a dosimetry system to the meeting, where each dosimetry system in turn is 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 rad-iation 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 j of the dosimetry system. The Commission did not incorporate this sug-i V gestion because the apparent exposure rate of constancy check devices as l indicated by the dosimetry system may vary by as much as two percent even though the calibration factor for the dosimetery equipment has not l l changed. Therefore, the Commission does not believe that periodic constancy checks would necessarily provide increased assurance of proper operation. l l S 35.632 Full calibration measurements. Full calibrations are needed to ensure that the is the s.unf M b 7 dose that eqprescrAedl The required frequency of full calibrations 3 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 j are used to position the teletherapy patient i - localization devicesg}Mc b Ld 02/08/84 56 Enclosure 1 i l
. NE6&or%wpucxdnto n n w jpucedmc., /dat wwscast7p [7590-01]
- jd4M 3 mith gwaAuzt k ptsutby waakO:cd/ m ae,wA,)%d47
-7cymnos in m M s M /k %mwiN Jc(dya M e,puo p,.aggy,,g y g$#g cou sac.
" has been(added to mif-zeA//sta the risk of unintentionally irradiating
, s i j healthy tissue. The function of mechanical and electrical interlocks re used to limit the directions in which the beam can be aimed, and thereby reduce the exposure rate in uncontrolled areas, has also been added. The licensee need no longer perform all measurements with a calibrated dosimetry system. Instead, the calibrated dosimetry system need only be used for one representative measurement, and then a relative ym.a exposure rate asystem can be used to complete the calibration. This would
/nirr$yat systems that cannot be iallow for use of computer-controlled mezcurr
'eesi1y x u>paMr of walis $ibrat-ion.wpacia chipped-for~ca ufalinal;afj/c
'4 ,m j ,i. naaxumwCa.iyaf/u m:nwt f q iuf :.nu hYJ.
% (
The exposure rate from a radioactive source goes down as time en progresses due to source radioactive decay. To g ure accurate dose delivery, the regulation requires that licensees mathematically take m this into account in calculating patient doses. The regulation requires h V that the licensee use time periods of not longer than one month when making decay calculations. This will ure that the actual dose does i not differ from the calculated dose by more than one percent due to this l j decay error. SS 35.633 Periodic spot-cheeks, and 35.642 Safety checks for teletherapy l t facilities. A monthly spot-check is required by S 35.22 of the current regu-lations to ensure that the teletherapy unit is giving the expected j ,ru w u & M pa ' u h radiation doso. The following changesjhave been'made. Timer accuracy has been clarified to include on-off error. The accuracy of localiza-
? [ vat, ysu c/40 en ma11 m uawc/ aswdEuknv e f n.hsw.
tiondeviceshasbebnadded.4 The qualified teletherapy calibration i expert must review the results of the spot-check measurements within i V 02/08/84 57 Enclosure 1
[5Nu.riuk4 k k g& e.,w i iry ,u/G L19 ;
; y, 33 kl a; $wd on L faE/ Af p endr%Lff dh Mu& Ma&.nosi
~
e sj.: ,y,w ,gf /w, jiy Anc a;p [7590-01] Na s fle>n m n n wank( one.d a saua n3 stud gN de a f M i d G nxLuf;% My par. Am> Ouwl. m fifteen days, and must notify the licensee in writing of the results of the monthly check, to assure the licensee and the Commission that the check results were reviewed by a qualified individual. The Commission has made a judgment that a response period of less than fifteen days would be unreasonably expensive. $ A requirement to check certain safety
' systems in the teletherapy facility has been added. These checksfr 'hbh' ore needed to assure that safety systems required by other sections of
$uf the regulations are working properlygneed not be performed by the qual-ified teletherapy calibration expert. Devices that are not working must be promptly repaired in order to assure the safety of the teletherapy i facility.-
s/ % r e.JerM s Ms u h Son m.u'd bjdh cu afs a M .).ip;ds.v we uuaf ouv jww/toforano aa.t% yShnV,w%u, %g JJ ed lianth y Mrufwbovwt/crfmy 19hn Hu v.ssso?) syskew . & & ft{;J. S 35.641 Radiationsurveysfortelethgpyfacilities. O
\ d The Commission has used these maximum and average permissible 'J source leakage radiation levels for several years as license conditions.
They are consistent with guidance from the NCRP in its Report No. 33,
" Medical X-ray and Gamma-ray Protection for Energies up to 10 MeV -Equip-i l' ment Design and Use," Section 4.2.2. The Commission has made a judgment that they are sufficiently restrictive to keep exposures as low as reasonablyachievable.hdn l
S 35.643 Modification of teletherapy unit or room before beginning treatment program. The section is needed to require that licensees take prompt action to reduce exposure rates in uncontrolled areas that may be caused by errors in design or construction. . l % walol& au b uyus dwidJ"2<!blNN0h"***O '" '
!fY' b 91 a/uw dis ss h,-as wp&t, aku 6 is is h~ ~u"*"kjy'""'g u e,, n. en,w w n L wum n i on A d' L ""'I Aa'nnn4%facpocaww ci imwnaf qawn,w unMprh 'n u'9}syu Enclosure ~1 02/08/84] a n p A m w o s A a .
~ , o y) d '
[7590-01] i s S 35.644 Reports of, teletherapy surveys, checks, tests, and measurements. pm,o6 pup b aab!/d Anfu m wh Given the potential for high exposure to wor ers and the publicl, the radiation survey information required by S 35.644 is needed to unis assure that teletherapy ave been properly installed and are sufficientlyshieldedtoadurecompliancewiththeexposurelimitsof urd Part 20. S 35.645 Five year inspection. Many licensees replace teletherapy sources at five year intervals. Requiring a mechanical check at five year intervals helps to assure the f/s$ source exposure mechanism is in good working order and will not stick in the exposed position. 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 record is needed to establish which unit was inspected, when, and by whom. The remaining information is needed so the Commission may determine that the inspec-tion was of sufficient depth to assure the health and safety of workers and the public. ! 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 i > Advisory Committee on the Medical Use of Isotopes (ACMUI). The
- 02/08/84 59 Enclosure i
[7590-01]
' \
i l A requirements 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 teletherapy calibration expert are similar to those required of a qualified expert pursuant to the current S 35.24. W O'M <' 'd'4 M nwant y k t wp:/hia'M ws>rkhwA y d4 %i swund JJ M mdv~Nxeau
% m u,> + upaa mi +
Ains>,; " ~@~'>-
' =P * *"d . sh,,stad4 ar.d VaaM]COM o w ' '-
- a. m 4t42 * &c ~ C4 & lntacu.
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-p a idia tionbyanappropriateprofessionalboardconstitutegproofofadequate 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. S 35.900(h 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 the conditions of the license. F fy p % w of YrL5f. S 35.9@fe)--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 02/08/84 60 Enclosure 1
Y [7590-01] l received within the preceding five years is sufficiently up-to-date to
'V'/ assure the safe use of byproduct material. If an individal received training more than five years prior to the application and has not had continuing involvement in the field, training must be repeated.
~r h y _,[ -
1 SS 35.900(d), 35.910(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 e and experience described is necessary to g ure the safe use of byproduct material. The duration of training and experience is usually specified in classroom (not credit) hours. Training may be received as part of a [] formal program at an accredited university, at a proprietary school, f an equipment oh armaceutical manufacturer,-as-pHvate-tuto# l0C .+//u uk diq m oc;p a Q v.a k k f L i M .7 a.-cnd w I/ uu '~ a In cnw . instruction orelsewhere.]Supervigedworkexperiencemustberechved asM.niyJ u v at an institution under an appr.priate g preceptor because usually only eb a'a/y such an individual is qualified to teach the fieM use of byproduct material', and, if the experience were not received at an institution, the student would be itss likely to receive experience with all the methods of use commonly used or all the management problems associated with the safe handling 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
/
{3) As these training programs is based, in part, on adequate radiatiot safety 02/08/84 61 Enclosure 1 GC
[7590-01] content. The Commission has made a judgment that individuals who have k successfully completed an approved training program have received suffi-cient 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 credentials of these individuals is unnecessary. h/ys w t iEG Abtg LWf S 35.971 Three munui 1. raining progran8-- 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 medicine, including radiation safety. All three boards and the ACGME
- g. i $tdd/h&
9-am therefore plentting to regttire-thatwby--Aueen 31. um g raining programs be o ix 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. ei h>G2&!h l} N l k. 02/08/84 62 Enclosure 1
l O' s/ Sfc:^t 4.
/ /{'f4; sin' : a (; A SJ 'a .
f ' I t
,'.',4 s i
c;,>>
.f a .. x;u -
/
r/ O l l l 1 I l l l l t l l l 4 l l O
[7590-01] p) I V S 35.990 Violations. This section gives notice that the Commission will initiate legal proceedings if necessary to enforce requirements. S 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.
- e. rofM A%"y r3 J h,,Wtonforming amendmentpandfathe'rJfhuman use licenseespAo-are aJse us yproduct material for in vitro work under the provisions of N M G
.m,~. wwwwa SS 31.11 and 35.14(c)z.I j n the. future,gapplicants will have to specifi-cally request permission to use S 31.11 materials as a separate line item on their applications,po-tha tthe-& " Commission-wi+1 knowpf
- hcw iiiany-persons-ere-doing-inwi-tro-testingr The use of materials listed in n_.
S 31.11 will only be subject to the requirements of that section;
'\ Consistent with current regulat prwtice(theuseofmaterialslisted g x in 6 31.11 will not be subject to the requirements of Parts 19, 20, 21, and 35 except for the Mock Iodine-125 disposal, loss or theft, and notification clause of S 31.11(f).
DERIVATION TABLE The following derivation table indentifies the origin of each section of the proposed regulations. Sources of the proposed regula-tions include 10 CFR Parts 19, 30, and 35, Federal Register Notices s (FR), frequently used license conditions, licensing staff policy, cuWM regulatory guides (RG), Office of Inspection and Enforcement bulletins, the United States Pharmacopeia, and new text prepared by staff. O V 02/08/84 63 Enclosure 1 CL
' l
~. - - - . . - _ - . . - - . _ . . . . . _.. __ - _ - - .. - .
i- [7590-01] 4 i
% NEW SECTION NUMBER ORIGIN Subpart A--General Information 35.1 Purpose and scope. 35.1 revised 35.2 License required. 35.2 revised 35.8 Reporting, recordkeeping, and new text l application requirements:
z OMB Approval. 35.15 Definitions. Agreement State 20.3
- ALARA acronym Authorized users term used on licenses
. Dentist new term l AlislW uma us e -- 35.3(a) revised) pus ar--' - I I,nstitution new term Management new term Misadministration 35.41 i j Mobile nuclear medicine service new term i j Output new term Physician 35.3(b) revised 4 Podiatrist new term l Qualified teletherapy calibration expert new term ! Radiation Safety Officer term used on licenses Sealed source 30.4(r) verbatim f 4 I 1 02/08/84 64 Enclosure 1 l 1 4.m_.c.,.__.--__.-.y,...,,,4 v_.,.w_,,,,_,,_~,,9,...,__,,7.,._,ym, ..y_-,w,, ,,-,,w,,.,,,,-,
[7590-01] fJin b$ - Previsiona authorized user new term; similar to " visiting V authorized user" license condition 35.16 Application for license, 35.4 revised amendment, or renewal. 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 Officer. RG 10.8 35.32 Radiation Safety Committee. 35.11(b) revised 35.33 Requirements for authority new text and statement of responsibilities. V,s;He 35.34 Er.ov4+iomrt authorized user. license condition 35.35 Mobile nuclear medicine service licensing policy administrative requirements. B. 3t. Cadean. p j '% puy ava clogn. wa) Cib , 35.37 Records and reports of 35.42 werbati M misadministrations. 35.38 Supervision. expanded from RG 10.8 p. 3 35.49 Suppliers. 35.14 revised x 02/08/84 65 Enclosure 1
[7590-01] CN, Subpart C--General Technical Requirements ( ! E 35.50 Possession, use, calibration, RG 10.8 Appendix D2 revised, and check of dose calibrators. and new text 35.51 Calibration and check of RG 10.8 Appendix D1 revised, 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. 35.59 Requirements for possession 35.14(e)(1)(i), 35.14(f) of sealed sources. revised 35.60 Syringe shields. Inspection and Enforcement
,m \
(~ 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. 0) V 02/08/84 66 Enclosure 1 ,
[7590-01] p {35.80 Mobile nuclear medicine service licensing policy \ ] L/ f technical requirements. 35.90 Storage of volatiles and gases. RG 10.8 Appendix M revised 35.92 Decay-in-storage. license condition Subpart D--Uptake, dilution, and excretion 4Geoup-Gener41/I}A 35.100 Use of radiopharmaceuticals, 35.31 and 35.100 (I) revised for uptake, dilution, and excretion studies. 35.120 Possession of survey instrument. RG 10.8 page 5 Supart E--Imaging and localization 4Cecup II111W 35.200 Use of radiopharmaceuticals, 35.100 (II) and (III) revised O 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. 35.220 Posession of survey instruments. RG 10.8 page 5 Subpart F--Radiopharmaceuticals for therapy-(Group-IV/V)A-35.300 Use of radiopharmaceuticals 35.100 (IV) and (V) revised for therapy. 35.310 Safety instruction. 19.12 revised ,e ~ (x 35.315 Safety precautions. RG 10.8 Appendix K 02/08/84 67 Enclosure 1 [ l^
[7590-01] 35.320 Possession of survey instruments. RG 10.8 page 5 ( Subpart G--Sources for brachytherapy -(Greep W-)- S--- 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. 35.406 Brachytherapy sources inventory. RG 8.18 page 8 35.410 Safety instruction. 19.12 revised 35.415 Safety precautions. RG 10.8 Appendix L 35.420 Possession of survey instruments. new text Subpart H--Sealed sources for diagnosis-(Creap VI @
\ 35.500 Use of sealed sources for new text diagnosis.
35.520 Availabilty of survey instrument. new text Subpart I--Teletherapy-(Creog VI-1 7 35.600 Use of a sealed source in new text a teletherapy unit. 35.605 Maintenance and repair license condition restrictions. 35.606 Amendments. new text 35.610 Safety instruction. license condition and new text 35.615 Doors, interlocks, license condition and warning systems. 02/08/84 68 Enclosure 1 77
c [7590-01] 35.620 Possession of survey instrument. new text 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 surveys for license condition teletherapy facilities 35.642 Safety checks for license condition teletherapy facilities. 35.643 Modification of teletherapy new text unit or room before beginning a treatment program. l 35.644 Reports of teletherapy surveys, license condition ! checks, tests and measurements. 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 i training exception. 35.910 Training for uptake, Revision or roaor21 oa;4eter ua c4t dilution, and excretion Noti c e-( 47 - F R -5347 E;_ December -2 , studies. -1982)- 02/08/84 69 Enclosure 1 h
[7590-01] (~]/ 35.920 Trt.ining for imaging Revision of Federal Register i
'V and localization studies. Notice (47 FR 53476; December 2, 1982) .
35.930 Training for therapeutic use Revision of Federal Register 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, 1982) 35.950 Training for use of sealed new text c) I sources for diagnosis. Training for teletherapy.
-y [
35.960 { Revision of Federal Register Notice (47FR53476 December 2,h
@)-.. - ___.b 35.961 Training for qualified 35.24 revised teletherapy calibration expert.
35.970 Experienced physician training new text exception. 9/ 35.971 .Ned ghysician training new text exception. 35,fje $ fran&w f lawI - g, C /C LV o i U 02/08/84 70 Enclosure 1 [
[7590-01]
\ Subpart S--Enforcement 35.990 Violations. new text ADMINISTRATIVE STATEMENTS S w f'p. %
Environmenb1 Impact - Negative Declaration The proposed le, if adopted, would not result in any activity that significantly af( cts 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 propo 'ed rule. The environmental pa t im\ appraisal forming the basis for this deter-t mination is available for ins ection at the NRC Public Document Room,
\ ) \
1717 H Street NW., Washington, DC, and as noted in the " Addresses" section. Paperwork Reduction Act Statement The Nuclear Regulatory Commission wl. I submit this proposed rule to the Office of Management and Budget (0MB) o_r any review that may be
\
necessary under the Paperwork Reduction Act, Public L. 96-511. The SF-83
" Request for Clearance," the Supporting Stateme and any other docu-mentationsubmittedtoOMB,havebeenplacedinth1CPublicDocumen Room at 1717 H Street NW., Washington, DC 20555, for ihspection, and copying for a fee.
AJ s 02/08/84 71 Enclosure 1
/C
0 f fpff
} -
i 1 t O C
,,.+ FINDING OF NO SIGNIFICANT ENVIRONMENTAL IMPACT: AVAILABILITY _
The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the conmission's regulations in Subpart A of l 10 CFR Part 51, that promulgation of this regulation is not a major Federal action significantly af fecting the quality of the human environment and therefore an environmental impact statement is not required. The environmental assessment and finding of no significant impact on which this determination is based are available for public inspection at the NRC Public Document Room, 1717 il Street NW, Washington, dj. Single copies of the environmental assessment
~
#ir. ,M !/o y.
and finding of no significant impact are available f rom finsert-ncme, cddr% l an d-tale phona-numbe r-of-s tafi-con tactb ft. % PAPERWORK REDUCTION ACT STATEMENT t s This proposed rule amends information collection requirements that l l are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). l This rule has been submitted to the Office of !!anagement and Budget for review and approval of the paperwork requirements.
/.<,-* REGULATORY g ALYSIS The Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives I
considered by the Conmissiof The draf t analysis is availabic for inspection in the NRC Public Document Room,1717 il Street NW, Washington, DC. Singic copies lll< 16 !Iref. of the analysis may be obtained from 4 insert name,-adtress,-and-talephone.
.aumber.of_a arr eontact)._
e The Commission requests public comment on the draft regulatory analysis. Comments on the draft analysis may be submitted as indicated in the ADDRESSES heading.
}ly l0I
[7590-01] 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 pdvers[ economic impact on a substantial number of small entities. The NRC has issued approximately 9 2600 medical licenses under 10 CFR Part 35. Of these, approximately 2 2200 are held by institutions, and approximately 600 by individual physicians. Most of the institutional licensees are community hospitals.
-that-range-in-size-from-75-bed facilities-to 750 bed facilitiesI' The N4 FR M 7j $g & y9,NH)
Small Business Administration size standards, 13 CFR Part 121, classify mys,.ws si;w a hospitaljas a small '6ntity if us-espac4ty4s4ess-than-150-beds-or-i-f-amyc 3 itsjgross annual receipts do not exceed $y.5 million. Under these size s oont y standards,-a-+wbstantial-numbe-of NRC medical licensees could be con-GI sidered "small entities" for purposes of the Regulatory Flexibility Act. Althoughl the number of medical licensees that would fall into the small entity category stitute[asubstantialnumberforpurpo.sesof
- -G, ,# r 't .
the Regulatory Flexibility Act[here should not be a n' g4t4v(economic e
- ~
ImpactonthesesmallentitieshTheprimaryobjectiveoftheproposed k, e__~ - rule is to simplify the medical licensing process by consolidating M requirements without lessening the protection necessary -to-preserve-public health and safety. This will be accomplished through incorpora-tion of frequently used license conditions into the regulations and the elimination or modification of requirements that are not essential to the protection of public health and safety. These steps will make it easier for a licensee to determine what is required to obtain a license requiredoflicensees,ikf")"~~ ~
~~ ! and what it.
02/08/84 72 Enclosure 1 j[
[7590-01] m aG f , gx;au, s a (A d I j The Commission has prepared a preliminary ve M /imro d d oi.ement
;for this proposed regulation which contains information concerning the anticipated economic effect of this regulation on licensees and presents the basis for the Commission's belief that the proposed regulation would r,4,v j..u al is not result in hdditional a cost to any licensees. It is available for public inspection in the NRC Public Document Room at 1717 H Street NW Washington, DC.
Singlecopiesareavailablefrom44erman4gcElroyb
-Of fice-of-Nuclear-Material-Sa fety-and-SafeguardsrUrSr-Nuclear-Regulatory-
-CommissionrWashingtonr0C-Telephone;---(301)427_4052.-
Because of the widely differing conditions under which licensees covered by this proposed regulation operate, the Commission specifically seeks public comment from small entities. Any small entity subject to 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) How the regulation, as modified, would still adequately protect O) (J public health and safety. 02/08/84 73 Enclosure 1
/Dg
r 7] l
/ h"4 ewd [7590-01]
i List of Subjects in 10 CFR Parts 30, 31, 32, 35, h M- kles-of-cGeneral Applicability-to-Domestic-tricensdag-of-Byproduet-Meterial-Part 30 - Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reportingf requirements.
-General-Domestic-L4cene: 'or- Sypr;&ct-Material Part 31 - Byproduct material, Labeling, Nuclear mater als, Packaging and i
containers, Penalty, Radiation protection, Reportin requirements, Scientific equipment.
-Spec i f i c- Dome s t i o-L i c ense-to-Manu f ac t ure-o n-T rans fon-Cer ta i n-I tems fontaining-Byprodeet-Meteefels Part 32 - Byproduct materials, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting Y requirements.
c f k Js Y fte tu,tN w , CsO/UA~
U * 't h
[' '" 5"i um = Usa Of Eyproduct Matental- U Part 35 - Byproduct material, Drugs, Health devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting I and recordkeeping requirements.
-Domee t4 e-t4 ee*+i ne -o f-Sourc e-Ma twi41 Part 40 - Government contracts. Hazardous materials - transportation, jp)
Nuclear materials, Penalty, Reporting 5 requirements, Source material, Uranium. 1 l ( l 02/08/84 74 Enclosure 1 ( l00
r- [7590-01] l unsvaa..mn:pj f7-Per:uant-to-),the Atomic Energy Act of 1954, as amended, the Energy ( ) 5 d f.d. V' Reorganization Act of 1974, as amended, and section 553 of -t4t4e-5-of Ms // K up s;n A the-United-States-con, net-ite is hereby tven--that adopt of- the following revision of 10 CFR Part 35 and the following amendments to {10 CFR Parts 30, 32, and 40,is centem;;1stee
- 1. 10 CFR Part 35 is revised to read as follows:
pKDNS PART 35--HUMAfrUSE OF BYPRODUCT MATERIAL Sec. Subpart A--General Information i 35.1 Purpose and scope. 35.2 License required.
.;,jr.,>unnv a/4chv i 35.8 Mor44ngr-recordkeepinu, and oppHeation 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. Subpart B--General Administrative Requirements ! 35.30 ALARA program. l 35.31 Radiation Safety Officer. 35.32 Radiation Safety Committee. 35.33 Requirement for authority nd statement of responsibilities. l v' 02/08/84 75 Enclosure 1 , l[
r [7590-01] es 35.34 Visiting authorized user. ( ) l V 35.35 Mobile nuclear medicine service administrative requirements. 3s.36 I?an.'s .:p' T, pofwr w %e. ! 35.37 Records and reports of misadministrations. 35.38 Supervision. 35.49 Suppliers. I i l Subpart C--General Technical Requirements j 35.50 Possession, use, calibration, and check of dose calibrators, i j 35.51 Calibration and check of survey instruments. l l 35.53 Measurement of radiopharmaceutical dosages. l 35.58 Authorization for calibration and reference sources. I 35.59 Requirements for possession of sealed sources and brachytherapy l sources. r 35.60 Syringe shields. 35.61 Vial shields. l 35.62 Syringe labels. l 35.63 Vial labels. i 35.70 Surveys for contamination and ambient radiation exposure rate. 35.75 Release of patients containing radiopharmaceuticals or permanent I i implants. 35.80 Mobile nuclear medicine service technical requirements, j 35.90 Storage of volatiles and gases. 35.92 Decay-in-storage. l Subpart D--Uptake, dilution, and excretion-(Group-General /I-)-C X i l 35.100 Use of radiopharmaceuticals for uptake, dilution, and excretion studies. 02/08/84 76 Enclosure 1
/DN
m [7590-01] o 35.120 Possession of survey instrument. U Subpart E--Imaging and localization -(Greug II/III) '~ ( 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. 35.220 Possession of survey instruments. Subpart F--Radiopharmaceuticals for t,herapy 4 Creep IV/V) % / 35.300 Use of radiopharmaceuticals for therapy. 35.310 Safety instruction. 35.315 Safety precautions. O
, 35.320 Possession of survey instruments.
SubpartG--Sourcesforgrachytherapy(GiuupVI)~~ X 35.400 Use of sources for brachytherapy. 35.404 Release of patients treated with temporary implants. 35.406 Brachytherapy sources inventory. 35.410 Safety instruction. 35.415 Safety precautions. 35.420 Possession of surv>v instrument. Subpart H--Sealed sources for diagnosis In min Viti > \' 35.500 Use of sealed sources for diagnosis. 35.520 Availability of survey instrument. ( 02/08/84 77 Enclosure 1 {0
r [7590-01] l Ds Subpart I--Teletherapy (Crevi, VIII)
- sj 35.600 Use of a sealed source in a teletherapy unit.
35.605 Maintenance and repair restrictions. 35.606 Amendments. 35.610 Safety instruction. 35.615 Doors, interlocks, and warning systems. 35.620 Possession of survey instrument. 35.621 Radiation monitoring device. 35.622 Viewing system. 35.630 Dosimetry equipment. 35.632 Full calibration measurements. Periodic spot-checks. 35.633 35.641 Radiation surveys for teletherapy facilities. fm l 1 ( v) 35.642 35.643 Safety checks for teletherapy facilities. Modification of teletherapy unit or room before beginning treatment program. 35.644 Reports of teletherapy surveys, checks, tests, and I measurements. 35.645 Five year inspection. l l l 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 and localization studies. 35.930 Training for therapeutic use of radiopharmaceuticals.
/ 35.940 Training for therapeutic use of brachytherapy sources.
02/08/84 78 Enclosure 1 l
[7590-01] 35.941 Training for ophthalmic use of strontium-90.
'v 35.950 Training for use of sealed sources for diagnosis.
35.960 Training for teletherapy. 35.961 Training for qualified teletherapy calibration expert. 35.970 Experienced authorized _ user training exception. cv' 35.971 ,Ne / physician training exception. 35, f 78 $ a r M J Cd.x I {. ' Subpart K--Enforcement 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). U) For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
/ b j
/
2273); Sg 35.2,),35.17, 35.30(a) and (g), 35.31(a) and (b), 35.32, 35.33, n.rg(x , , 35.34(a),33 .38, 35.49, 35.50(a)-(d), 35.51(a)-(d), 35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.62, 35.63, 35.70(a)-(f), i i , , ,M < (s)- 'k) 35.75,35.80(a)-(e),35.90,35.92(a),35.100,35,120,35.200,35.204(a) and (b), 35.205, 35. 220, '.35; 300,' 35. 310(a), 35. 315, 35. 32d, 35.40d, u sin . / 35.404(a),35.406(a)j,35.410(a),4 35.500,35.52d,35.600s '35.605, 35.606, u s # .,, nw
~
35.610(a) and (b), 35.615, 35,620, 35.621(a)-(d), 35.621(f) and (g),
~
35.625, 35.630(a) and (b), 35.632(a)-(f), 35.633(a)-(i), 35.641(a) and (b),35.642(a)and(b),35.643(a)and(6),35.645(a)and(b),35.900, 'y, n r: , " - 35.910,35.920,35.930,35.940,35.941,35.950,35.960,,and;,35.961.jare lissuedundersec.161b,68 Stat.948,asamended(42U.S.C.2201(b)); i andSS35.18,35.30(c),35.31(b),l35.33(b),35.34(c),35.35(b),[3'5.37(a)-(d),
/
h . 3 2 (4 ), , W W6), 02/08/84 79 Enclosure 1 {O
[7590-01] s i / / / / 35.50(e), 35.51(e), 35.53(c), 35.59(d) and (e)(2), 35.59(g) and (i),__ g
~3 J ; / / / r /.
35.70(g), 35.80(f), 35.92(b), 35.204(c), y
$ / JS, */9 N 1, J (35. 310(b),
/ '35. 404(b)
/
95:405Q.406(b)and(y),35.410(b),j35.610(c),35.621(e),35.630(c), J 35.632(g),35.633(j),35.641(c),35.642(c),35.643(c),35.644,and
- 35.645(c) are issued under sec. 1610, 68 Stat. 950 as amended (42 U.S.C. 2201(o)).
Subpart A -- General Information S 35.1 Purpose and scope. This part prescribes requirements for issuance of specific licenses
,oa.hi sI authorizing the twaan use of byproduct material. This part also pre-mu/ud scribes requirements for the 4mman 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.
6 35.2 License required. (a) No person shall manufacture, produce, acquire, receive, possess, im/d5df use, or transfer byproduct material for 4mman.use except in accordance 1 with a specific license issued by the Commission or an Agreement State and as allowed in paragraph (b) of this section. (b) An individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the ( supervision of an authorized user as provided in S 35.38, unless prohibited by license condition. 02/08/84 80 Enclosure 1 , U ll o
[7590-01] f),,lnouhvafahav S 35.8 ReporMner-recordkeeping,-- &nd appl 4 cation requirements: l l (G
.~
V) OMB approval. l (a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management (n'a l sf H!a and Budgetj for approval as required by the Paperwork Reduction Act -tPub,- OJ u.'.c. not et sep. ). L 06-5-1% A0MBVapproved the information collection requirements etr
/. c n % put uekv c.,r.el mw,n/m 3160 A _
r(1) The OMB control number is ] g s(2)CMB approval expires g (b) The approved information collection requirements include-the-applieation,- rh urdReeping, ana reporting requirements contained in
//si Attr ey SS 35.16,j/ a .~
h 35.17, 35.18, 35.30(c), 35.31(b), 35.32(a), 35.33(b), 35.34(c), 35%> 35.35(b),335 37(a)-(d), 35.50(e), 35.51(e), 35.53(c), 35.59(d), (e), (g), and (1), 35.70(g), 35.80(f), 35.92(b), 35.204(c), 35.310, 35.404(b), 35.406, s"/ 35.410(b), 35.606, 35.610, 35.621(e), 35.630(c), 35.632(g), 35.633(e) and (j), 35.641(c), 35.642(c), 35.643(c), 35.644, and 35.645(c). 6 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.
kcd Rf p8!w
" Authorized user" means a physician, dentist, or podiatrist who is identified as an authorized user on a Commission or Agreement State plut5ef license that authorizes the-human use of byproduct material.
" Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of t
V) Puerto Rico to practice t' e art of dentistry on humans. 02/08/84 81 Enclosure 1
/ II
C) # /? / #
"due y aa ~ snw>u wposh f uphsiaA y Awlau //sk hao /eu at awdo y A paysw f aawiy, awnj, os sEniy yp1sa'act snaraw/
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& fa w $w y ua aao adAd 4 ise4/y
& t ru = ,4 : l f 4 m T D I E L w p A y.6 c 4
- D
' diacrau (( LW - a ,% ow . L?ds?' nwindik=rhSf%fa'athe[/cd4/67 yptoad snah4b ptopaev. Jlc & & uad cu / % % /s auAhi lanoao 4 aa lly oaarf nnara h b b a m w $s, ev/ai2s'ty y mo/ i&4;fa' a a cyp,udw. o a n+
k 4 [7590-01] ! 4 ,yabh
" h men use" means the intentional internal or external administration
\
of byproduct material, or the radiation therefrom, to human beings in i ayeX ,) the,practicW of medicine in accordance with a license issued by a State or Territory of the United States, the District of Colcmbia, or the Commcnwealth of Puerto Rico,in-the art - of-media f sO G<d' } 'gnstitution" means an organization in which several medical j disciplines are practiced. } " Management" means the chief executive officer. l " Misadministration" means the administration of: j (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 administra-tion other than that intended by the prescribing physician; (4) A diagnostic dosage of a radiopharmaceutical differing from
, the prescribed dosage by more than 50 percent;
} (5) A therapeutic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10 percent; or (6) A therapeutic radiation dose from a sealed source such that I errors in the source calibration, time of exposure, and treatment ; geometry result in a calculated total treatment dose differing from the 4 1 > final prescribed total treatment dose by more than 10 percent.
" Mobile nuclear medicine service" means the transportation and use i
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 i
l in a known saanner to these rates from a teletherapy unit for a specified i
\
set of exposure conditions. 02/08/84 82 Enclosure 1
[7590-01] A " 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.
" 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.
W V, v Hn y I I "Pm . g.unai authorized user" means an authorized user who is not identified on the license of the person for whom he is working.
" Qualified teletherapy calibration expert" means the individual identified as the qualified. teletherapy calibration expert on a Commission license.
" Radiation Safety Officer" means the individual identified as the O Radiation Safety Officer on a Commission license.
L) " Sealed source" means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material. 9 ' 6 35.16 Application for license, amendment, or renewal. h .i.i m*ed /k u 2u/ M (a) i i Foruse3napAnstitution,onlymanagementmayapply. g For use avl kd udnd j :;idg a{ nstitution, any person may apply. (b) An application for a license for human use of byproduct material < as described in SS35.100, 35,200, 35.300, 35.400, and 35.500 of this nwhiedand .w copy sy part must be made by filing 3 Fofm NRC-313, " Application for Materials License." For guidance in completing the form refer to the instructions contained in Regulatory Guide 10.8 Revision 2, " Guide for the Preparation of Applications for Medical Programs." A request for a license amendment aaaryta arJ m 47 or renewal may be submittedgin letter format. 02/08/84 83 Enclosure 1 (I
i [7590-01] Cs (c) An application for a license for human use of byproduct material (V) a w,,u/n.t na upy -y as described in 935.600 of this part must be made by filing orm NRC-313. For guidance in completing the form refer to the instructions contained i in Regulatory Guide 10.[,"GuideforthePreparationofApplicationsfor l Teletherapy Programs." A request for a license amendment or renewal may lbesubmittedinletterformat.na>,
.rngM)&na'ne cefy g
aus j (d) The applicant shall mail the completed,appication-. form' as directed below. (1) If the applicant is not a Federal agency and is located in
& CoM h) CJesbis, Connecticut,gDelaware, Maine, Massachusetts,NewJersey, Pennsylvania, or Vermont, the applicant shall mail or deliver the completed appli-cation form to U.S. Nuclear Regulatory Commission, Region I, Material
; Licensing, 631 Park Avenue, King of Prussia, Pennsylvania 19406.
1 (2) If the applicant is not a Federal agency and is located in
'Q/ ,2 A r % , n & un ovL4md9 Virginia West Virginia,3the applicant sha mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region II, Moo Material Licensing Section, 101 Marietta Street, Suit , Atlanta,
, Georgia 30 . (3) If the applicant is not a Federal agency and is located in i Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wis-consin, the applicant shall mail or deliver the completed application 4 form to U.S. Nuclear Regulatory Commission, Region III, Material Licen-sing Section, 799 Roosevelt Road, Glen Ellyn, Illinois 60137. (4) If the applicant is not a Federal agency and is located in Oklahoma, Montana, South Dakota,, r Wyoming, the applicant shall i mail or deliver the completed application form to U. S. Nuclear Regulatory l commission, Region IV, Material Licensing Section, 611 Ryan Plaza Drive, s , Suite 1000, Arlington, Texas 76011. 02/08/84 84 Enclosure 1 (
/{h
A a ---,,_, _ _ . _ _ . , . _ _. a - __s _ T I i l i Ji.,
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,.;) ; c'd: ei 3,p. < . ;e ,in. , p ::& la , a .,n,z A G; T(E. ,u , ; sp g ,, f]:, r:;.2s 4.,,/?W daa;ar Wt >..vn c.,, ,
-a : xw,,, .> % ,~ ;. A n .( &c/ i%-
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[7590-01] (5) If the applicant is not a Federal agency and is located in N frvo v Alaska, Hawaii, oryphterritmy or possession-in-the-Pac 4fi2,, the applicant shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region V, Material Licensing Section, 1450 Maria Lane, Suite 210, Walnut Creek, California 94596. (e) If the applicant is a Federal agency / f-th: applicant i :n # 2;;:ncy--of--the-District-of-Columbig if the applicant is located in a State, territory, or possession that is not mentioned in paragraphs (d)(1) through (5)[of this section, the applicant shall: rtytid y Of(NL (1) Mailthecompletedpp,.licatien-fc...totheDirectorgfNuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or (2) Deliver the completed application form to the Commission offices at: (i) 1717HStreetNWgWashington,DC,or (ii) 7915 Eastern Avenue,W!'hte Osilding Silver Spring, Maryland. 6 35.17 License amendments. A licensee shall apply for and must receive a license amendment: , (a) Before using byproduct material for a method or type of bumafr whad use not permitted by the license issued under this part; yhilhV (b) Beforethelicenseepermitsanyone,exceptaprev4Miona( authorized user described in S 35.34, to work as an authorized user under the license; cy,4w (c) Before the licensee termFts en individual not-listed on-the-licansa.-tn.,per_ form the duties 4f-the Radiation Safety Of ficer, eor Qual-ified Teletherapy Calibration Expert'; 02/08/84 85 Enclosure 1 lfb
[7590-01] U
'} (d) Before receiving byproduct material in excess of the amount authorized on the license; and
, (e) Before adding to or changing the location or locations of use or mailing address identified on the license.
S 35.18 Notifications. The licensee shall notify the Commission by letter 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 report to the appropriate address identified in S 35.16. 35.28 License issuance. [Vj 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 " Application for Materials License" in accordance with the instructions in 635.16; (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 (O i, upon its own initiative, grant such exemptions from the regulations in 02/08/84 86 Enclosure 1 []
[7590-01] 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. Subpart B--General Administrative Requirements 9 35.30 ALARA program. g *u J pt9
'0 wW (a) Each3 institution licensee shall set 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 oper-
'ation of the program as required by the regulations or requested by the Radiation Safety Committee.
d (2) The program must include an annual review by the Radiation Safety Committee of the types and amounts of byproduct material used, occupational dose reports or summaries, and continuing education and training for all personnel who work with or in the vicinity of byproduct material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain individual and collective occupational dose as low as reasonably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits. M a written description of the ALARA (c) Thelicenseeshallp program for the duration of the license. The written description must include: (1) A commitment by management to keep individual and collective occupational dose as low as reasonably achievable; ( 02/08/84 87 Enclosure 1 Y {tJ i
[7590-01] [7 (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 exceeded, will initiate a prompt investigation of the cause of the exposure by the Radiation Safety Officer and a consideration of actions that might be taken to reduce the probimbility of recurrence. 6 35.31 Radiation Safety Officer. (a) Each licensee shall appoint a Radiation Safety Officer who is
% b a> $ A( w responsible for implementing the radiation safety program.j T,he Radiatio
[\ dt/ g Safety 0fficer, sust-be reponsible-to-the-1icenseels-management-for-r.c f that radiation safety activities are being.ccrrectl,yper ensurpng formed a,J .ws4Gup ,agm Y mun-inaccordancewithapprovedproceduresjintheda'ilyoperationofthe licensee's byproduct material program. (b) The Radiation Safety Officer shall: (1) CL !</ow Investigate +kner nstances-o i a wnhadhN%!affy deviation ,>ifrom y practice and implement corrective actions as necessary; (2) Establish and implement written policy and procedures for: (i) Authorizing the purchase of byproduct material; t (ii) Receiving and opening packages of byproduct material; (iii) Storing byproduct material; j (iv) Keeping an inventory record of byproduct material; (v) Using byproduct material safely;
, emt tp:wua, acubQ Nff s, /nce 5, hfh wan O'jiL"h' "#>
aLyna4, 4ud o#w 02/08/84 88 Enclosure 1 1 I) !C 1
[7590-01] m (vi) Taking emergency action in the event of loss of control of (s byproduct material; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of byproduct material pa (x) Training personnel who work in or frequent areas where byproduct material is used or stored; (xi) Keeping a copy of all records and reports required by the es elvcense regulations, a copy of the regulations, a copy of Ahe-44 /;ewhyC.uget yrl i cat 4en-4-- and license and amendments, and the written policy and procedures required by the regulations. n avl #/ g a d 0 11 f h t " ? % (3) For use not at institution, approve or disapprove podificatic Du m cWP
) of piccedre" with the advice and consent of management; and (Q n on.n af (4) For use at y institution, assist the Radiation Safety Committee in the performance of its duties.
6 35.32 Radiation Safety Committee. nudical y EachinstitutionflicenseeshallestablishaRadiationSafety Committee to oversee the use of byproduct material. Management may establish more than one committee to meet these responsibilities, but each committe9that is established shall meet the administrative require-ments. To satisfy this requirement: (a) The committee must meet the following administrative requirements: (1) Membership must consist of at least three individuals and must 6 include an authorized user / each type of use permitted by the license, 0 the Radiation Safety Officer, a representative of the nursing service, 02/08/84 89 Enclosure 1
\ b0
[7590-01]
/~}
-i-f-there ic on 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 a 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 management representative. (4) The minutes of each Radiation Safety Committee meeting must include: (i) The date of the meeting; (ii) Members present; (iii) Members absent; yd dhtwtu ' (iv) Summary of deliberations;
,,m A l (v) Recommended actions and the numerical results of all ballots; Q ))
and (vi) ALARA program reviews described in S35.30(b)(2) (5) The Committee must provide each member with a copy of the meeting minutes, and tain 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; arl A ug.1J k /4 fwdy e4 c ya w SJoh ,,; Lly/ Is/ G A (2) Review y on the basis of safety 3and approve or disapprove any e individual who is to be listed as an authorized user-of the Radiation n 6.4/iu ad/M fy O & A m Svp F' Safety Officergbefore submission of the license application or application for amendment; (3) Review on the basis of safety and approve or disapprove each i ( v
') proposed method of use of byproduct material; 02/08/84 90 Enclosure 1
/7 /
[7590-01] (4) Review on the basis of safety and approve'6r disapprov3with
\O)
V the advice and con _sent of the Radiation Safety Officer and the management V udh% nh5 pa cfww representative, procedures and modi-f4 cat' ions-ofyn-prccc i rci for the safe use-of-byproduct-materta[; (5) Review quarterly, with the assistance of the Radiation Safety Officer, occupational radiation exposure records of all personnel working with byproduct material; (6) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; (7) Review annually, with the assistance of the Radiation Safety Officer, the byproduct material program; and (8) Establish a table of investigational levels for occupational [ dose that, when exceeded, will initiate investigations and consider-
\"
ations of action by the Radiation Safety Officer. 6 35.33 Requirement for authority and statement of responsibilities. (a) The licensee shall provide the Radiation Safety Officer, and av,c duf ataQnstitutiontheRadiationSafetyCommittee,sufficientauthority and organizational freedom to: (1) Identify radiation safety problems; (2) Initiate, recommend., or provide solutions; and (3) Verify implementation of solutions. (b) The licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation w d:cQ Safety Officer, and at ad gi nstitution the Radiation Safety Committee, b
- d I
02/08/84 91 Enclosure 1 Q (L -
[7590-01] bdN9 n S 35.34 -Provisiona/ authorized user. ~\ p1,&s (a) A licensee may permit any previsional authorized user to use nadia.{ licensed material for( use under the terms of the licensee's license jn &y .4yc rach yen A if: e c,/;,3 (1) The previsicrd authorized user has the prior written permission of the licensee's management and, if e occurs on behalf of an institution, the institution's Radiation Safety Committee; (2) The licensee has a copy of a Commission or Agreement State 2dw/ihesI ? %lin license that 3Est{heaprovisional authorized user as an authorized user
,oudad for pue d use; and adNns (3) The peevi+iena4 authorized user performs only those procedures for which he is specifically authorized by a Commission or Agreement State license.
(b) The licensee need not apply for a license amendment in order x' ,,v/s3
.to permit a provisiemrPauthorized user to use licensed material as described in paragraph (a) of this section.
-(c) The-Heensee must reque3L Lh4L the provisional authorized-uses be-Msted-as an7uthorized user-the next-time 7he9tcensee applies-for-a--
hoe amFndmeht'UrTe;.sch v - (d) The licensee shall retainfor two years after the provisdeneF
,a.<,,,
hhorizeduser'slastuseoflicensedmaterial)copiesoftherecords a., + es specified in this section+unless the provisionar authorized user has been listed as an authorized user on the licensee's license. 6 35.35 Mobile nuclear medicine service administrative requirements. ec4w me#duc (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 chapter A :.:.t.ve. chub who a's rd hve aw AC m901hrwnt U*2 JJ m ,+,& anaEuhtsidd n n,,a s,o,dc. 02/08/84 92 Enclosure 1 (7~ ) .
[7590-01]
,p) midECIW
[i (b) Mobilejservice licensees shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of byproduct material. Stc4th 930 9 35.37 Records and reports of misadministrations. (a) When a misadministration involves any therapy procedure, the licensee shall notify by telephone the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. The licensee shall also notify the referring physician of the affected patient and 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 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 shall report, in writing, to the NRC Regional 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 clude the 02/08/84 93 Enclosure 1 l
.- _ ..- -- . . . . - . - _ . . . . . . _ . - _ . - - . . - . - - ~ - - - . - - - - - - . - - - - - - - - - - - - - . ~ - - - . - - - -
f l 1 , I i i
/aa i% Ant 4 a/gw c caw. . o 1 e y } ; A'fJ ! ~~f}
Ll W $ t' ll s,,dl />'Kd/ 05'il'):]0 LL/},0tj !,/l$ Glf~ l 2,4tuj)ix/4b rM ! et&' :c.rd :6 J> w l ' ,,e , u n & : w au ; l ;$ r pla w w>uw ,/6
- b',~
sw>uc, / n ,-ua>uu', a a,n>+me 1 ! 4% 1ks:cca ,,nay no acave, aa, aw& ifJ1c l aw.ao) avauaw l Jaswd H.d deu snM!cd/>u/ &niil ieb (ceu;x' ku :% ag kkyy%A;>:/ h jun.:c,y cl \ ,wussi, n av:matme>d, & A ~< A b i r c: w % A ucs,JeuJ > cA dcka ces:7 0,6 [b i$ banhML ,dla$/ tt5$ru k //s fwta$w J(' llLD e t npwaawco, a u m u/ u c n c w "/e. . a o s amqa a c a w - w o f-gu,pwat dmpww, a au:vi,can>, ; , /k ussa>u , As claoye, w ,ium nu/u - d ud/aN>v l a&r wa&& #w' wek ce>w&wd je/k' /rw/,w /Au
.! /
dzs/ &, #1 naZiyib /6 laa'ca/inu b 'l[ {0, '/as, ans' #w agma}kw q <a 3pcEd anMwyd uh a ; o>u>w r n, e aw amuu," s kamw
>/f&ymo>Osny>,ud% e/>wumanv a>:au7m>a '
an:& nfik
,up ocwawe. -
?
i 1]( !
[7590-01] licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; 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 occur. 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. so n kuquM (d) -Each licensee shall p tain for7the-i;rctica of the 'icc d a 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. (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). k 02/08/84 94 Enclosure 1 1V
\v
[7590-01]
, -~m 9 35.38 Supervision.
, I v The licensee who permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an a //.nJak " authorized user as puthoritsIby 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 material; (2) Review the supervised individual's use of byproduct material andtherecordskepttoreflect[ se; (3) Require the authorized user to be immediately available by telephone to the supervised individual; and (4) Require the authorized user to be able to be physically 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: s (1) Follow the instructions of the supervising authorized user; (2) Follow the procedures established by the Radiation Safety Officeriand A (3) Comply with the regulations of this part and the license conditions with respect to the use of byproduct material. 6 35.49 Suppliers. ,. in t<ti ca [ 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 regulations in 02/08/64 95 Enclosure 1 l if'
[7590-01] HA p Part 30 and SS 32.72, 32.73, or 32.74 of this chapter or4 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; ud/ ( (c) Radiopharmaceuticals authorized by a Radioactive Drug Research h Committee that has been approved by the Food and Drug Administration y rsuant to 21 CFR 361.1; and (h) Teletherapy sources manufactured and distributed in accordance Wu with a license issued persuant to Part 30 of this chapter orgequivalent regulations of an Agreement State. O 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: (1) Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the require-ment of this paragraph, the check must be done on a frequently used setting with a sealed source of not less than 10 microcuries of radium-226 or 50 microcuries of any other photon emitting radionuclide; (2) Test each dose calibrator for accuracy upon installation and O at least annually thereafter by assaying at least two sealed sources 02/08/84 96 Enclosure 1 ,
[7590-01] i containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, whose activity is at least 10 microcuries for radium-226 and 50 microcuries for any other
! photon-emitting radionuclide, and at least one of which has a principal
! photon energy between 100 kev and 500 kev; (3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the
- t highest dosage that will be administered and 10 microcuries; and i
(4) Test each dose calibrator for geometry dependence upon installa-tion over the range of volumes and volume configurations for which it will be used. 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
\j '
calibrator. (d) The licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is , greater than 10 microcuries and shall repair or replace the dose calibrator et erndwee iftheaccuracyerrorexcgeds10 percent. 4 (e) The licensee shall retain a record of each check and test i required by this section for two years unless directed otherwise. (1) The record required in paragraph (b)(1) of this section must l include the model and serial number of the dose calibrator, the identity i
< of the radionuclide contained in the check source, the date of the j
check, the activity measured, and the initials of the individual who I performed the check. l 1
\
02/08/84 97 Enclosure 1
[7590-01] (2) The record required in paragraph (b)(2) of this section must V include the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radio-nuclide 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-i ration of the source measured, the activity measured for each volume ; l m ' measured, the date of the test, and the signature of the Radiation Safety Officer. i l 9 35.51 Calibration and check of survey instruments. (a) The licensee shall calibrate the survey instruments used to showcompliancewiththispartbeforefirstuse, annually,andfollowing repair; (b) To satisfy the requirements of paragraph (a) of this section, the licensee shall: (1) Calibrate all scale readings up to 1000 milliroentgens per j > hour with a radiation source; (2) Calibrate two readings on each scale that must be calibrated; and i i
; 02/08/84 98 Enclosure 1 g j
() -
[7590-01] (3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration. (c) To satisfy the requirements of paragraph (b) of this section, shll thelicensegy,: , (1) Consider a point as calibrated if the indicated exposure rate q 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. (d) The licensee shall check each survey instrument for proper operation with the dedicated check source before and after each use. N Thelicenseeisnotrequiredtokeeprecordsoftheseynctiunchecks. f (e) The licensee shall retain a record of each calibration required in paragraph (a) of this section for two years. To satisfy the require-ments of this paragraph, the record must include: { (1) A description of the calibration procedure; and i (2) A description of the source,radisnsclid[used and 4t: :rtified ast4*R e certified exposure rates from the source, and the rates
- indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration.
6 35.53 Measurement of radiopharmaceutical dosages. The licensee shall: O , V 02/08/84 99 Enclosure 1 Dl
[7590-01]
,mc4 Y (a) Assay befo use the activity of each radiopharmaceutical
[]- dosage that contains more than 10 microcuries of a photon-emitting radionuclide; yrs.baj, (b) Assay befor Quman use the activity of each radiopharmaceutical dosage with a desired activity of 10 microcuries or less of a photon-emitting radionuclide to verify that the dosage does not exceed 10 microcuries; (c) Retain a record of the measurements required by this section for two years. To satisfy this requirement, the record must contain the: (1) Generic name, trade name, or abbreviation of the radiopharma-
,, a f."> b s n u/,dt j ceutical, its lot number, and expiration datej (2) Patient's name, and identification number if one has been assigned; p
( (3) Prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 10 microcuries; (4) Date and time of the measurement; and (5) Initials of the individual who made the measurement. l 9 35.58 Authorization for calibration and reference sources. Any person authorized by 6 35.2 for human use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use: (a) Sealed sources that were manufactured and distributed by a person licensed pursuant to S 32.74 of this chapter or equivalent Agree-ment State regulations and that do not exceed 6 millicuries each; 02/08/84 100 Enclosure 1 g 1b
[7590-01] s (b) Any byproduct material listed in SS 35.100 or 35.200 with a half-life not longer than 100 days in individual amounts not to exceed 15 millicuries; (c) Any byproduct material listed in SS 35.100 or 35.200 with a half life longer than 100 days in individual amounts not to exceed 200 microcuries each;098 A k (d) Technetium-99m in individual amounts not to exceed 50 millicuries. S 35.59 Requirements for possession of sealed sources and brachytherapy sources. (a) A licensee in possession of any sealed source or brachytherapy lsourceshall-usethesourceinaccordancewithradiationsafetyand lhandlinginstructionssuppliedbythemanufacturer,andshallmaintain
//6 % y instructions in a legible form convenient to users of the source.
(b) A licensee in possession of a sealed source shall: (1) Test the source for leakage before its first use unless the flicenseehasacertificatefromthesupplierindicatingthatthesource 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 fStateanddescribedinthelabelorbrochurethataccompaniesthesource. (c) To satisfy the leak test requirements of this section, the licensee must: (1) Take a wipe 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 or wash the source in a small volume of detergent solution and treat the entire N volume as the sample; 02/08/84 101 Enclosure 1 a f
[7590-01] (2) Take teletherapy source test sample when the source is in the k ;
"off" position, and (3) Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample.
(d) The licensee shall retain leakage test records for two years. The records must contain the model number and serial number if assigned of each source tested, 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.
(e) If the leakage 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 it jinaccordancewithParts20and30ofthischapter;and (2) File a report within five days of the leakage test with the appropriate Nuclear Regulatory Commission Regional Office listed in Appendix D of Part 20 of this chapter, with a copy to Director of Inspection and Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, describing the equipment involved, the test results, and the eeneeNaction taken. (f) The licensee need not perform a leakage test on the following 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; 02/08/84 102 Enclosure 1 , 4 l )4
a _. _m, a_..A--_u om_2 _ -- - - _ - - _ _- -- - ----- --- ,I 9 i ( } l i i f l
.t.lu%lflw: i//.?)\ A u L-
, L 4. 's O
i h' l 1 0 l
[7590-01] (3) Sources containing 100 microcuries or less of beta or gamma-D 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 has been leakage-tested within six months prior to the date of use or transfer; (5) Seeds of iridium-192 encased in nylon ribbon;4 M6}- , Sources _containing_only-hydrogeTPtn b * () Wires of iridium-1920 nd
/0) Wi res-of-tantalum-18%
(g) Any licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all such sources in the licensee's possession. The licensee shall retain each inventory five. [~ 'q record for s. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, and the signature of the Radiation Safety Officer.
-(h) Any licensee in possession of a sealed source or brachytherapy source shall survey with a low range survey meter quarterly all areas where such sources are stored. This does not apply to teletherapy lsourced in teletherapy units or sealed sources in diagnostic devices.
(i) The licensee shall retain a record of each survey 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 d 02/08/84 103 Enclosure 1
/
{
[7590-01] 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-rial to be administered in a radiation shield. { (b) The licensee sha require each individual who administers a radiopharmaceutical by injection to use a syringe radiation shield unless the use of the shield is contraindicated for that injection. [ U wdu e;&iJ.a[aha mtu n & f ham *""O b A " * -y*A*yh'2** "" pJia&<,& S 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. S 35.62 Syringe labels. The licensee shall conspicuously label each syringe, or syringe radiation shield that contains a syringe with a radiopharmaceutica}-te-Je-administer h 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 that contains a vial of a radiopharmaceutical -to-be-administere(with yApwntauanM
.the chemi name or its abbreviation.
-s 02/08/84 104 Enclosure 1
) )Of
[7590-01] , 'N 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 s., b a a ' w that are, greater 1[han 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 and shall require that the individual who is performing the survey imme-diately notify the Radiation Safety Officer if an exposure rate exceeds an action level. (e) The licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored. (f) The licensee shall conduct the surveys required by paragrapi (e) of this sectio as to be able to detect contamination on each wipe f i
; sample of 200 disintegrations per minute.
(g) 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, u 02/08/84 105 Enclosure 1 [7
a.ma,. __ - a w.-- s, - a -- . 4 - A a A ~= = ~= ~ ~ ' == ~ 4 [
' ;//, , -j, , $.6 i l ' d ' ' ' '
\
l l l O i \ i O J s
-,._._,-------,r----,-.----,--.-+--w-w, ,- -a '"~
[7590-01] q (h) The licensee shall retain a record of each survey for i (v) es year. The record must include the date of the survey, a plan of each area that was surveyed, the actiol.-level established for each area, the , measured exposure rate at several points in each area expressed in 1 millirem per hour or disintegrations per minute, the model number of the instrument used to make the survey or analyze the samples, and the
- initials of the individual who performed the survey.
S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. (a) The licensee shall not authorize release from confinement for medical care y patient administered a radiopharmaceutical until either: (1) The exposure rate from the patient is less than 6 milliroentgens b per hour at a distance of one meter; or (2) The activity in the patient is less than 30 millicuries. (b) The licensee shall not authorize release from confinement for medical care of any patient administered a permanent brachytherapy I implant until the exposure rate from the patient is less than 6 milli-roentgens per hour at a distance of one meter.
,9 35.80 Mobile nuclear medicine service technical requirements.
2 A licensee providing mobile service shall: (a) Transport to each location of use only syringes or vials - W containing m it dcsc;a ci prepared radiopharmaceuticals; (b) Bring into each location of use all byproduct material to be b g used and, before leaving, remove all unused byproduct material and all associated waste-1 02/08/84 106 Enclosure 1
^
1 o l l
) )d'
.,,_ . a .a.a_ -- _ a__ - - - - _ _
O 1 l l l l i k A I i e
, ' ,f .$Wf , 4 ? ) w.
O I I i 4 l l i i I G5 r .-- - - -- r,- ,. - -- , -- -_-n- -__,ww.m_ww,_ m, _ _+- p e e o ~e**'
l . [7590-01] l (c) Secure or keep under constant surveillance and immediate control all byproduct material when in transit or at a location of use; (d) Check survey instruments and dose calibrators as described in SS 35.50 and 35.51, and check all other transported equipment for proper function before administering byproduct material to humans at each location of use; (e) Carry a calibrated survey meter in each vehicle that is being f,p hun +Ji.><tfa4 % used to transport byproduct material, andyurvey for-ambient-radiation eha
-exposure-rate with a low range survey m prioMo-departttre-from-the-
~
Inentin4(6f radi_opharmace M ejto ensure that all radiopharmaceuticals I and all associated waste have been removed; and (f) Retain a record of each survey required in paragraph (e) of this section for ear'. The record must include the date of the
,m
( 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. S 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 triers against release. S 35.92 Decay-in-storage. (a) The licensee may hold byproduct material with a physical t [ half-life of less than 65 days for decay-in-storage before disposal in t p) i ordinary trash and is exempt from the requirements of S 20.301 of this d chapter if the licensee: 02/08/84 107 Enclosure 1 ,
[7590-01] C (1) Holds byproduct material for decay a minimum of ten (10) k half-lives; (2) Monitors byproduct material at the container surface prior to disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a low range
!surveymeterseto'nitsmostsensitivescaleandwithnointerposedshielding; (3) Removes or obliterates all radiation labels; and (4) Separates and monitors each generator column individually 1
iwith all radiation shielding removed to ensure that it has decayed to background radiation level prior to disposal. (b) For paragraph (a) of this section, the licensee shall retain a record of each disposal for two years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the model number of the survey instrument used, the background radiation exposure rate, the radiation exposure rate measured at the surface of each waste container, and the name of the individual who performed the disposal. SubpartD--Uptake,{ilution,andexcretionprcupCtr.cral/I) 6 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies. (a) The licensee may use the following prepared radiopharmaceuticals
-jfordiagnosticstudiesinvolvingthemeasurementofuptake, dilution,or excretion:
(1) Iodine-131 as sodium iodide, iodinated human serum albumin
. (IHSA), labeled rose bengal, or sodium iodohippurate; 02/08/84 108 Enclosure 1 ,
)Y
[7590-01] I
,o (2) Iodine-125 as sodium iodide or iodinated human serum albumin e \
t,V e (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 for which the Food and Drug Administration (FDA) has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDAh'Mi ch-has-been-authorized-by-a-R adieset44e-be;; Researd Cummittee-that-has-beerrapproved ty the FDA pursuant to O QCTR301-1; U (b) The licensee using a radiopharmaceutical listed in paragraph (a) of this section for a clinical procedure other than one specified in the jproductlabelorpackageinsertinstructionsforuseshallcomplywith i the product label or package insert instructions regarding physical form, route of administration and dosage range. S 35.120 Possession of survey instrument. Each licensee authorized to use byproduct material for uptake, dilution, and excretion studies shall have in his possession a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour. O . 02/08/84 109 Enclosure 1 fill _
[7590-01] s Subpart E--Imaging and localization Greg II/TTT) 4 q3
,' V S 35.200 Use of radiopharmaceuticals, generators, and reagent kits for
.,,x-
> imaaing:and localization studies.
(a) The licensee may use the following radiopharmaceuticals,
. generators, and reagent kits for imaging and localization studies:
i (1) Molybdenum-99/ technetium-99m generators for the elution or extraction of technetium-99m as pertechnetate; (2) Technetium-99m as pertechnetate; 3 (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;
'='-\O)
(fv) Polyphosphate; (v) Macroaggregated human serum albumin; (vi) Etidronate sodium; _(vii) Stannous pyrophosphate; (viii) Human serum albumin; (fx) Medronate sodium; (x) Gluceptate sodium; (xi) 0xidronate sodium; (xii) Disofenin; and 1 (xiii) Succimer.
) Tin-113/ indium-113m generators for the elution of indium-113m l I
a's choride; ' s v " 02hD8/84 110 Enclosure 1 i Y
\ ()-
[7590-01]
} (5) Iodine-131 as sodium iodide, iodinated human serum albumin, b macroaggregated iodinated human serum albumin, colloidal (microaggregated) iodinated human serum albumin, rose bengal, or sodium iodohippurate;
/f (6) Iodine-125 as sodium iodide or fibrinogen;
, 4 (,1) Chromium-51 as human serum albumin;
- 7 (8) cold-198 in colloidal form; 5 (9) Mercury-197 as chlormerodrin; 9 ()6) Selenium-75 as selenomethionine;
/o (II) Strontium-85 as nitrate; i " (15) Ytterbium-169 as pentetate sodium;
--(M)-Indium-'113m as chlorided-
/ 2 (14') Xenon-133 as a gas or saline solution;
, glupush6
/y(J5) Any byproduct material in ajradiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical b containing byproduct material for which the Food and Drug Administration has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application (NDA)$ ee-wh4eh h= kca X authorized-by a-Radioactive-Orug-Research Committee that-has-beerrapproved by-the-FDA pursuant'to~21 CFR-36171-(b) The licensee using the radiopharmaceuticals listed in paragraph (a) of this section for clinical procedures other than those specified in ithe product label or package insert shall comply with the product label
;or package insert regarding physical form, route of administration, and 1 dosage range.
- (c) The licensee shall elute generators and prepare reagent kits (inaccordancewiththemanufacturer'sinstructions.
C 02/08/84 111 Enclosure 1 I
/
[7590-01] I (d) The following radiopharmaceuticals, when used for the listed ('~~ clinical procedures, are not subject to the restrictions in paragraphh fa) 4 ( n an+ (b) of this section: J (1) Technetium-99m pentetate as an aerosol for lung function studies. S 35.204 Permissible molybdenum-99 concentration. (a) The licensee shall not administer to humans a radiopharma-ceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m. (b) The licensee who prepares technetium-99m radiopharmaceuticals from molybdenum-99/ technetium-99m generators shall measure the molyb-denum-99 concentration in each eluate or extract. (c) The licensee who must measure molybdenum concentration shall
% ts.:) cx el e rrent a!se tain a record of ghe measure for two years. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries, the measured activity l
of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the date of the test, and the initials of the individual who performed the test. S 35.205 Control of aerosols and gases. , (a) The licensee who administers radioactive aerosols or gases
!shalldosowithasystemthatwillkeepairborneconcentrationswithin l lthelimitsprescribedbySS20.103and20.106ofthischapter.
l - 02/08/84 112 Enclosure 1 l . (
ss tos y3 fy> p+f" 4 A> Ji/n nainup,as 4. n s/niw w s u be gao,- -r s Aw-a aadcatesan
%ed n & /uylas/ acSvify a,/p hamd4A E a- sin & emfew ana' Ha inteaoad Qi/ 66 as exhaust Aad,J& amoan/ o,/ W /wa'id afk a 70/ /s adua A conam&adad.y, ": \ k A seqa&nal An?i/"~=:#d r Ad 2 Add a c?paune A /o /L/ 26 ffb ch,ok.
Js caar -i w su a a YIL /OCAL s'kd$fsf/ h dakub Y l/ uh 4 eau 3/ a y spw, o '[ld nlaae Mad a uda/s wacuaa a nn a -n sA o>%pssu du Aao etapea'; n of & w>w skaM %ga/ //u
<2)/f esnamaaAsm}v i Mi aw a du secujafi:ms) AmM JaNi qpa's A lo Ar 20 s/ /b claps.
O
/
//ftv )t(5
[7590-01] (b) The system must either be directly vented to the atmosphere O- through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container. (c) The licensee shall only administer radioactive aerosols and gases in rooms that are at negative pressure compared to surrounding irooms. 3 (d)+ The licensee shall check the operation of collection and ventilation systems each six months.
%$Wp //2 6 6 35.220 Possession of survey instruments.
Each licensee authorized to use byproduct material for imaging and localization studies shall have in his possession a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour and a portable high level ionization type radiation survey instrument that has a scale with a full scale deflection of 1 roentgen per hour. Subpart F--Radiopharmaceuticals for therapy fCr p IV/VP -- [\ 6 35.300 Use of radiopharmaceuticals for therapy. The licensee may use the following prepared radiopharmaceuticals: (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; O 02/08/84 113 Enclosure 1 S LkY
[7590-01] (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 use5W euu.v.iteu uy the Food and Drug Administration /M ed &d*' ogggg af ga;,,ad hva//;w%i[r:ny No-f a L U13 ahoy , ,,, q/ w&
, jjea D,4 uj,ucca h
- M O )-
6 35.310 Safety instruction. (a) The licensee shall provide oral and written radiation safety instructions for all personnel caring for the patient undergoing radio-pharmaceutical therapy. To satisfy this requirement, the instructions Y' 'U" mustdescribehceduresf (1) Patient control; (2) Visitor control;
'D (3) Contamination control; (4) Waste control; and (5) Notification of the radiation safety officer in case of the patient's death or medical emergency.
(b) The licensee shall keep for two years a list of individuals receiving instructions required by paragraph (a) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction.
'6 35.315 Safety precautions.
(a) The licensee shall provide each individual hospitalized for i /T radiopharmaceutical therapy a private room with' private sanitary facilit,ies. O A 02/08/84 114 Enclosure 1 l L()
[7590-01]
,q (b) ThelicenseeshallnotifytheRadiationSafetygficerimmediately \
V) in case of the patient's death or medical emergency. (c) The licensee shall post the patient's door with a " Radioactive Materials" sign and note in the patient's chart where and how long visitors may stay in the patient's, room. ,, ,,f
/ x N i> s,u; a " tw (d) The authorized user and RSO must specifically authorize visits A
by individuals under age 18 on'a case-by-case basis. (e) The licensee shall either monitor material and items removed Hw ,c-fromthepatient'sroomtodeterminethat/t(radioactivitycannotbe distinguished from the natural background radiation level with a low range survey meter set on g most sensitive scale and with no interposed m.- shielding, or handle.it ,as radioactive waste. s pnin aa,n - 4 " -' w 4? j4,, l,C,
. - f i
(f) The licensee shall survey 4 for removable contamination before b assigning another patient to the room. The room must not be reassigned i l v until removable contamination is less than 200 disintegrations per):D0
.& n square centimeters, h -- e ec e nd t., , ,
y) mb Abu Jap 95 sdw bro E,)'hju/I-<~a<',c dug a rak - t3!, L Su >:.a dd/., .uwa /h. /Alo.:sJ I.a b y'tw' "..a u "d' t"i' A'I (r ' ' ' u
' Y"b .
l S 35.320 Possession of survey instruments. t.u;sa k ho J a [s, _ j Each licensee authorized to use byproduct material for radiopharmaceutical therapy shall have in his possession a portable low level radiation l l survey instrument whose most sensitive scale has a full-scale deflection i ! of not more than 1 milliroentgen per hour and a portable high level l l ionization type radiation survey instrument that has a scale with a full 1 scale deflection of 1 Roentgen per hour. kuj l qmudAy .f 2o O/G Vs) mms .-{ ts cl.- u J aid tt !a.,)'c>w'mw< s o>a ua at, //[ dd, % m a s./.of & < lh v i J A f L.> Jwa . i (I) ac:e 4,ms. - ws,..s u ~aka- g 'h e uan s ~a I h..a w QQ/ r.h ., e a.it // .>m.:.u& wt 4 3 02/08/84 115 Enclosure 1 ) 1
, d<
\i
i [7590-01] r] z , Subpart G--Sources for brachytherapy g roup-V W v 9 35.400 Use of sources for brachytherapy. The licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions: (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;
- (c) Gold-198 as a sealed source in seeds for interstitial treat-l ment of cancer; l (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 (O}
of superficial eye conditions; <o'
- t j (f) Iodine-125 as a sealed source in seeds for interstitial treatment i
- ofcancergand-l
-(g)-Tantalun-18? ac wirer-(._,
6 35.404 Release of patients treated with temporary implants. l I i (a) fhelicenseeshaljnot_releasefromconfinement.for. medical. 7 l Lu.aJ;a:ily ajar mwn l care a patient _ treated __b heitemporary implant of y A .t,vaqsource 41ste tw
-&-3&r400juntl' ' c set dsil wJ sa radiation survey of the patient -is-mad all sources have been remobb 4"p>:at myxanf uv6/aA' hts w A'#"""d (b) The licensee shall retain a record of patient surveys for two J w y years. M3 ;u c,rwi.y nam'e of the pa,tient and'the exposure Each record must include the4 g j rate from the patient expressed as millirem per hour and measured within one meter of the patienty '# # "
"' ""h*
a 1 /Kr eiu d46 [ N .w h d d 2/1/84 116 Enclosure 1 qc
lhnca iAsE nuko Aub .u uenMrj .s>cef W, w , k .y61 aA
/atollhad //urofy y scwtcLa. [7590-01]
[ S 35.406. Brachytherapy sources inventory. , P (a) Each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall insediately count the number returned to ensure that all sources taken from the storage area ihavebeenreturned. ! (b) The licensee shall make a record of brachytherapy source use which must include: (1) The names of the individuals permitted to handle the sources, (2) The number and activity of sources removed from storage, the i
' room number of use or patient's name, the time and date they were removed from storage, the number and activity of the sources in storage after '
{theremoval,andtheinitialsoftheindividualwhoremovedthesources I from storage;
.4 chWP l (3) The number and activity of sources returned'ps, u; e room number of use or patient's name, the time and date they were returned to l
storage, the number and activity of sources in storage after the return, , and t initials the individual who returned the sources to storage. l A a re p // u ' ! (c) The licensee shall retain the recor[ required in paragraph (b) and fc) ! ts l of this section for two years. i 6 35.410 Safety instruction. i (a) The licensee shall provide written radiation safety instruc- , tions to all individuals caring for the patient undergoing implant (
- therapy. To satisfy this requirement, the instructions must describe:
i (1) Size and appearance of the brachytherapy sources; i I ! 02/08/84 117 Enclosure 1
\
o'D
(>) c f0 $MY ll 6Df 2Tl $0$YN ab ce fa&me A6 Lw.ae daE nnak u nada&W acway f & p2&rkamd Ma auw <p cas s = = enp w aat as am /due / eau muofsad. Au 6ue daas:aufe a acmd r/ aub n hWN/s g Lv
[7590-01] O (2) Safe handling and shielding instructions in case of a dislodged source; (3) Procedures for patient control; (4) Procedures for visitor control; and (5) Procedures for notification of the Radiation Safety Officer in case of the patient's death or medical emergency. (b) The licensee shall retain for two years a record of individuals receiving instructions required by paragraph (a) of this section, a i description of the instructions, the date of instruction, and the name of the individual who gave the instruction. , 3 I 6 35.415 Safety precautions. (a) The licensee shall provide each individual hospitalized for implant a private room. l (b) The licensee shall notify the Radiation Safety Officer immediately in case of the patient's death or medical emergency. (c) The licensee shall post the patient's door with a " Radioactive Materials" sign and note in the patient's chart where and how long visitors may stay in the patient's room. (d) The authorized user and RSO must specifically authorize visits by individuals under age 18 on a case-by-case basis. S 35.420 Possession of survey instrument. f Each licensee authorized to use byproduct mattrial for implant I therapy shall have in his possession a portable high level ionization type radiation survey inttrument that has a scale with a full scale deflection of 1 Roentgen per hour, 02/08/84 118 Enclosure 1 j
,p o . _ _ - - .
[7590-01] Subpart H--Sealed sources for diagnosisproup-VII-)' v 6 35.500 Use of sealed sources for diagnosis. The licensee shall use the following sealed sources in accordance
;with the manufacturer's radiation safety and handling instructions:
(a) Iodine-125 as a sealed source in a device for bone mineral analysis; (b) Americium-241 as a sealed source in a device for bone mineral analysis; and (c) Iodine-125 as a sealed source in a portable device for imaging. 6 35.520 Availability of survey instrument. Each licensee authorized to use byproduct material as a sealed [ source for diagnostic purposes shall have available for use a portable V low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour or a portable high level ionization type radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour, that hasqL. J/t 4C m n d :.m .fA+v& r A been calibrated in accordance with 6 35.51 of this part. Subpart I--Teletherapy (Group-VIII) M % 6 35.600 Use of a sealed source in a teletherapy unit. The regulations and provisions of this subpart govern the use of (n a ,v.b < a t u u. teletherapy unitsgthat contain the following sources'e for-the-treatment-of-humans;-- ( L 02/08/84 119 Enclosure 1
/( 3
[7590-01] p (a) Cobalt-60 as a sealed source; and (b) Cesium-137 as a sealed source. 6 35.605 Maintenance and repair restrictions, y,juv /Gp (J N ij. O w. m t w w Only a person specifically licensed by the #RC'or an Agreement State to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or 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. S 35.606 Amendments, j The licensee shall apply for and must receive a license amendment v 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) Usin0 the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room; (d) Relocating the teletherapy unit;, j)mRemoving_the_taletherapymnitth C (,() Allowing an individual not listed on the licensee's license to perform the duties of the qualified teletherapy calibration expert. V 02/08/84 120 Enclosure 1
')
1 [7590-01] 9 35.610 Safety instruction. l V (a) The licensee shall post written instructions at the teletherapy unit console. To satisfy this requirement, these instructions must i inform the operator of: , (1) The procedure to be followed to ensure that only the patient , 1 is in the treatment room before turning the primary beam of radiation p h /c4 v
*'t i Cuafw'l' " */D + der CAUi'?b *?"9'I'~
on; (2) The procedure to be followed if: (i) gheoperatorisunabletoturntheprimarybeamofradiation offwithcontrolsoutsidethetreatmentroom[org ! 4Hf kny other abnormal operation occurs; and (11 1) The names and telephone numbers of the authorized users and w . Radiation Safety Officer to be immediately contacted in the event of any abnormal operation of the teletherapy unit or console. l 0 (b) The licensee shall provide instruction in the topics identified , l in paragraph (a) of this section to all individuals who operate a teletherapy l 1 unit. , (c) The licensee shall retain for two years a record of individuals receiving instructions required by paragraph (b) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction. 6 35,615 Doors, interlocks, and warning systems. l (a) The licensee shall control access to the teletherapy room by a ! door at each entrance. , I (b) The licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will: v , c 02/08/84 121 Enclosure 1
f l [7590-01] I i (1) Prevent the operator from turning the primary beam of radiation ! V 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 l l 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. 6 35.620 Possession of survey instrument. Each licensee who is authorized to use byproduct material in a l teletherapy unit shall have in his possession either a portable low level radiation survey instrument whose most sensitive scale has a
/
full-scale deflection of not more than 1 milliroentgen per hour or a portable high level ionization type radiation survey instrument that has a scale with a f"P scale deflection of 1 Roentgen per hour. S 35.621 Radiation monitorina device. (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 telethorapy unit malfunction that may'> result'. sin an exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual entering the teletherapy room. U 02/08/84 122 Enclosure 1 l 1 ) .:
[7590-01] ' (c) Each radiation monitor must be equipped with an emergency [ V power supply separate from the power supply to the teletherapy unit. I 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 check required by ; paragraph (d) of this section for two years. The record must include I 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. l (f) If a radiation monitor is inoperable for any reason, the t-licensee shall require any individual entering the teletherapy room to l use a survey instrument or audible alarm personal dosimeter to monitor f for any malfunction of the source exposure mechanism that may result in [ k 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. i 02/08/84 123 Enclosure 1
/3t'I l
[7590-01] (] 9 35.630 Dosimetry equipment. (a) The licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met. (1) The system must have been calibrated by the National Bureau of Standards or by a calibration laboratory accredited by the American mn Pm) Association of Physicists in Medicine f The calibration must have been performed within the previous two years and after any servicing that may nave 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 v accredited by the A>acicer. A55%ietion-of-physic 44ts-WHedicine-(AAPM)F The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the 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 N factor /q$helicenseeshalluseateletherapyunitwithacobal-60) (suurce'when
- - intercomparing (dosimetry systems to be used for calibrating
~
cobalt-60 teletherapy units and'(a teletherapy unil with a cesium-137
. GL ..
s Q when intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units y //t E u r-n d >//'" ' (b) The licensee shall have available for use a dosimetry system A
) for spot-check measurements. To satisfy this requirement, the system 02/08/84 124 Enclosure 1
)q 5r
[7590-01] p)
\
L' may be compared with a system that has been calibrated in accordance with paragraph.(a) of this section. This comparison must have been performed within the previous year and after each servicing that may i have affected system calibration. The spot-check system may be the same l system used to meet the requirement in paragraph (a) of this section. (c) The licensee shall retain a record of each calibration, inter-comparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the l r$ date, the model numbers and serial numbers of the instrument that were l 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, or comparison, and evidence that the intercomparison meeting was sanctioned b]
\
by a calibration laboratory or radiologic physics center accredited by AAPM. 6 35.632 Full calibration measurements.
,,e tuab h (a) Any licensee authorized to use a teletherapy unit for treating-humans-shall perform full calibration measurements on each teletherapy unit: 'A
,, a L u !' d (1) Before the first,use of the unit fer treating buiiianh; and mu.ncd h &
(2) Before , treating-humans'under the following conditions: (1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full sdk&.1 ," calibration corrected mathematically for physical' decay; I C 02/08/84 125 Enclosure 1 C lbI
[7590-01] l-(ii) Following replacement of the source or following reinsta11ation t' 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 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: 4 (1) The output within 13 percent for the range of field sizes and l y&>,n s W a w for the distance or range of distances used padiation4he 4 (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 b the orientation of the useful beam; (4) Timer accuracy; (5) On-off error; and (6) The accuracy of all distance measuring and localization devices i ,nadice/t42 ~ used for pating-humen[ (c) The licensee shall use the dosimetry system described in S 35.630(a) to measure the output for one set of exposure conditions. amu 2hin The4radiatinmeasurementsrequiredinparagraph(b)(1)ofthissection may then be made using a dosimetry system that indicates relative dose rates, e (d) The licensee shall make full calibration measurements required i rohwv by paragraph (a) of this section in accordance with the4 procedures recommended by the Scientific Committee on Radiation Dosimetry of the 1' / //d American Association of Physicists in Medicine These-procedu are 02/08/84 126 Enclosure 1
Whljuga 2/ 9/AYuA W bM S afj> SnMW2GU f 5 d*MW" Auc6&u 9' /}ymidt en Mt./ded Ndw dwM"~ Ako/M E%[7590-01] Vd 14, N 6, if ?3, pp, W/ / '79j, described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, \ v) pp. 379-3967which hcp&y been approved for incorporation s//hu apaw k+0 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 20555. A cop,y of the document s. ts,also s on file at the Office of the Federal Register, 1100 L Street NW Room 8301, Washington, D 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 this section and physical decay corrections required by paragraph (e) of \ this section must be performed by a qualified teletherapy calibration expert. (g) The licensee shall retain a record of each calibration for the duration of the license. The record must include the date of the cali-bration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers 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 02/08/84 127 Enclosure 1
)LN
[7590-01] measuring or localization device, and the signature of the qualified l teletherapy calibration expert. 9 35.633 Periodic spot-checks. (a) The licensee authorized to use teletherapy units for treati g-P.;... - 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 _/ pudnafas used for Areating human ; j (5) The output for one typical set of operating conditions; and 1 (6) The difference between the measurement made in paragraph (b)(5) i l of this section and the anticipated output, expressed as a percentage of I ! 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 6 35.630(b) to make the measurement required in paragraph (b)(5) of this section. r ! (d) The licensee shall perform measurements required by paragraph (a) { f of this section in accordance with procedures established by the qualified j teletherapy calibration expert. That individual need not actually perform the spot-check measurements. 02/08/84 128 Enclosure 1
) b7.-
[7590-01] 1 A
\
(e) The licensee shall have the qualified teletherapy calibration
\
expert review the results of each spot-check within 15 days. The quali-fled teletherapy calibration expert shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for two years, gg (f) The licensee authorized to use a teletherapy unit for trcatirig Jmmans shall perform spot-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; (2) -The-function okelectrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction jO of source housing angulation or elevation, carriage or stand travel and b operation of the beam on off mechanism); , (3) MT eam condition indicator lights on the teletherapy unit,
- on the control console, and in the facility;
- (4) iewingsystem!
(5) -OperabH4ty-of treatment room doors from inside and outside the treatment room; and (6) ,0perabH4ty4mklectrically assisted treatment room doors with the teletherapy unit electrical power turned off, t j (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. I 02/08/84 129 Enclosure 1 4
) lb'
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- g wy.
[7590-01] ('7 (j) The licensee shall retain 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 number, and serial number for 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 timer accuracy, the calculated on-off error, 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 localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature v of the individual who performed the periodic spot-check. {635.641 Radiation surveys for teletherapy facilities.
,,a,a (a) Beforeghuma , after each installation of a teletherapy source, and after making any change for which an amendment is required Iby 9 35.606(a)-(d),the licensee shall perform radiation surveys to verify that:
(1) The maximum and average radiation levels at one meter from the w;iL 8: os a a..I s :r!!w .; % a + ln v m >/ La.> ten sdla teletherapy source wheq in the off positionjdo 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 clinically available treatment field and with aVphantom in the primary v beam of radiation, that i l 02/08/84 130 Enclosure 1 M
[7590-01] p (i) Radiation quantities in restricted areas adjacent to the s ! V 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. (b) If the results of the surveys required in paragraph (a) of this section indicate any radiation quantity in excess of the respective 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. (c) The licensee shall tain a record of the radiation measurements made following installation of a source for the duration of the license. The record must include the date of the measurements, the reason the
!surveyisrequired,themanufacturer'sname,modelnumberandserial
[numberoftheteletherapyunit,thesource,andtheinstrumentusedto c/fd M G # measure radiation levels, each n diation4 evel measured around the tele-j therapy source while in the off position and the average of all measure-
~
,3 , tw.wd rf & W r,u a rww gg ,
ments, a plan of'eactf areaythat was surveyed, the measured fexposure' rate
~m. s i 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 l
Safety Officer. t i V 02/08/84 131 Enclosure 1
/
)sh
r [7590-01] l [] 6 35.642 Safety checks for teletherapy facilities. l
\\ '! c/.cc4 (a) The licensee shall promptly gt>all systems listed in S 35.633(g)
,for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by 9 35.606(a)-(d).
(b) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in a 35.633(g), l the licensee shall lock the control console in the off position and not Mec/u use the unit except as may be necessary to repair, replace, ordgD.the malfunctioning system. (c) The licensee shall retain a record of the facility checks following installation of a source for two years. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indi-cator light, the viewing system, and doors, and the signature of the
't.J Radiation Safety Officer.
S 35.643 Modification of teletherapy unit or room before beginning a treatment program. If the survey required by 9 35.641 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 9 20.105(b) of this chapter, before beginning the treatment program the licensee shall: (a) Either equip the unit with stops or add additional radiation W shieldingtoensurecompliancewith620.10g (b) Perform the survey required by S 35.641 again; and N.J 02/08/84 132 Enclosure 1 I
[7590-01] p (c) Include in the report required by 9 35.644 the results of the initial survey, a description of the modification, and the results of the second,surve s~ . . p / 2a.ym) e/ gy /1,,g y /f n / a ,u s a w n a b n uwu S E*d'"*' 7" # asu p w mat 17 1s u.iss o >- 9 35.644 Reports of teletherapy surveys, checks, tests, and measurements. The licensee shall mail an original and a copy of il, . a t, d the records required in 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 appropriate U.S. Nuclear Regulatory Commission Regional Office listed in 935.16 of this ,P_ art within thirty days following X' Icompletion of the action which initiated the record requirement. t 9 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 fiva years, whichever comes first, to assure proper functioning 3 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 Jname,theinspector'slicensenumber,thedateofinspection,themanufac-fturer'snameandmodelnumberandserialnumberforboththeteletherapy i junitandsource,alistofcomponentsinspected,alistofcomponents serviced and the type of service, a list of components replaced, and the signature of the inspector. 02/08/84 133 Enclosure 1 , ! p .
[7590-01] f C (d)': Amendments to teletherapy licenses that extended the time k- interval for the inspection and servicing requirement of paragraph (a) of 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 9 35.901, the licensee shall require an indi-vidual fulfilling the responsibilities of the Radiation Safety Officer as provided in 9 35.32 to: (a) Be certified by:
-(1) American Board of Health Physics in Comprehensive Health Physics; v
(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 (k) Be an authorized user for those byproduct material uses that 6 comegithin the Radiation Safety Officer's responsibilitie tsf 1, (0) Have had 200 hours of classroom and laboratory training and one year of experience 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; i. k 02/08/84 134 Enclosure 1
s [7590-01] A (4) 20 hours of radiation biology; I t' (5) 30 hours of radiopharmaceutical chemistry; and v (6)&dOne
,,ad year of full time experience in gedical radiation s&,W safety j at a6 institution under the supervision of the individual ITstTDas the bn Radiation Safety Officer on a Commission or Agreement State license that
. ,udMJ J%
authorizes the ' human use of byproduct materiab
~~ ~"
(Q fI7~
-~ - --- - - ^
N%>(ti)-The training an.d. experiencespecifiedin,paragr:ph(c)-c(this I cus/ M yt4enimust have been obtained within the five years preceding the date joJiddx/ y , sum of application or the R:dicti;r, Safety Officar must have hadjexperience [( i 3 una /h Mhd MO' d #W #' ## "WM equivalent-td-one year-of-full-time amployment -irr medical radiation-Q~ mfety within-the-1ast-five-years- ,_ / - -
, _ ,, /, ,
70)) / l ~ ' S 35.901 Radiation Safety Officer training exception. , An individual identified as a Radiation Safety Officer on a Commission 3 - or Agreement State license on (*** insert effective date of final rule
***)gwhooverseesonlytheuseofbyproductmaterialforwhichthe licensee was authorized on that date need not comply with the training requirements of 6 35.900.
S 35.910 Training for uptake, dilution, and excretion studies.
. Except as provided in 69 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical listed in S 35.100(a) to be a physician who:
(a) Is certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine;,or (2) Diagnostic. radiology with special competence in nuclear radiology T by the American Board of Radiology; or 02/08/84 135 Enclosure 1
\
[7590-01] (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or M % d k n) (b) Has completed 80 hours of t ci-irig in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, 0 and40hoursofsupervihedclinicalexperi,ence.q)Tosatisfythebasic Wuctaw N ' - inel"de. classroom and laboratory trainfrig requirement, mod Mc/o/ Othe t-aining ="e instruction (,and-supervised-experience-in-a-nuclear medicine _. laboratory bcfellesi<._, i. (J) 25 hours of radiation physics and instrumentation; lL (2) 25 hours of radiation protection; Gi (7) 10 hours of mathematics pertaining to the use and measurement of radi,oactivity; (f) 10 hours of radiation biology; and () 10 hours of radiopharmaceutical chemistryh Jg (c) Has successfully completed a six-month training program in 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 thissectionjithin3veyearsofthedateofapplicationforalicense, 6 r 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 and localization studies. Except as provided in S 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit (w listed in S 35.200(a) to be a physician who:
)
02/08/84 136 Enclosure 1 jnD
I [7590-01] 6 of byproduct material;
/
(v) Using emergency procedures tyand contain spilled byproduct material safely an[i usinc proper decontamination procedures; 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 eedi f eraaceuticals i 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) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations or contraindications; . y;hhlO g .ta d M M V y
) (ii) Selecting the pyrope? radiopharmaceutical and calculating '(the c
dosage,; (iii) Administeringdosagestopatienthandsek.3 eroper & r8 us # syringe radiation shields; (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and / (v) Patient followup; or a six-montn T.raintny piugram in
~
- (c) 7 as successfully completed nuclear medicine that has been appro"ed by the Accreditation Council for Graduate Medical Education and that <ncluded classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.within fivc yeers of 02/08/84 - 138 - Enclosure 1
\3'\
[7590-01] g'N ( (a) Is certified in: i b (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) Has completed 200 hours of instruction in basic radioisotope 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 superyised clinical experience. (1) To satisfy the q[quirement) tructio% the classroom and laboratory training must include: (i) 100 hours of radiation physics and instrumentation; [ (ii) 30 hours of radiation protection; (iii) 20 hours of mathematics pertaining to the use and measurement of radioactivity; , 6 (iv) 30hoursofradiopharmaceuticalchemistryfand (v) 20 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 or M institution and must include: k (i) Ordering, receiving and ung king radioactive materials safely and performing the related radiation surveys; ! (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meter; A (iii) Calculating and safely preparing patient dosages; i ) (iv) Using administrative controls to prevent the misadministration (_/ 02/08/84 137 Enclosure 1 l
\
1 [7590-01] f'^\ of byproduct material; (v) UsingemergencyprocedurestoJandle-an contain spilled byproduct material safely and using proper decontamination procedures; 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 mutt be under the supervision of an authorized user at an institution and must include: L ^ (i) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitation or (h l' y contraindications; g,h blu ,.c and nMM&y
,J )
' (ii) Selecting the propit radiopharmaceutical and calculating {the '
c dosage,; (iii) Administering dosages to patients and eek;ns pre p; &ust h # syringe radiation shields; (iv) Collaborating with the authorized user in the interpretation , of radioisotope test results; and (v) Patient followup; or (c) Has successfully completed a six-month training program in 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 yeer5 ef V ~ 02/08/84 138 Enclosure 1 g
\l7
[7590-01] ' (} the date of application for a license, or have had experience equivale ,nt
\ I V to one year of full time employment in nuclear medicine within the last >
five years. 6 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 to be a physician who: (a) Is certified in nuclear medicine by the American Board of Nuclear Medicine; or (b) Has completed 80 hours of instruction in basic radioisotope handling techniques applicable to the use of therapeutic radiophar-r' maceuticals,andhapg*hadsupervisedclinicalexperience.
.a-(1) To satisfy the~ requirement for instruction, the classroom and 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 aj M t. 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; L (ii) Use of soluble phosphorus-32 for the treatment of polycythemia
-C\ vera, leukemia, or bone metastases in 3 individuals;
( ) v 02/08/84 139 Enclosure 1
[7590-01]
- fN (-iM}--Use- of colloidalephosphorus-32jor--intracavitary-treatment-of-I
-mal-ignan t- ef f u s i o ns-i n-3 -i nd i v i dual s i J id (iv) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals; and - - - - - - - - .
.V (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 6 35.400 for therapy to be a physician who: D
-(a) Is certified in:
i (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 4
" Fellow of the Faculty of Radiology" or " Fellow of the Royal College of d
Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians , and Surgeons; or (b) yascompleted200hoursofinstructioninbasicradioisotope handling techniquesa pplicable to the therapeutic use of brachythera y .
~
(As ur Mu seTNs piaKs of KvvyJr5 a:A fy f ',' m m m + y f [ sources and 500 hours of supervised work experience and rs of
- supervised clinical experience.
(1) To satisfy the requirement for instruction, the classroom and i laboratory training must include: i N 02/08/84 140 Enclosure 1 /
\
[7590-01] (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 y f (iv) Using administrative controls to prevent the misadministration G
} of byproduct material; and 1
(v) Using emergency procedures togndhnmd' 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 , , w H1 Ckw ;/td. a,, A fdachrd Ad,67 4.% an<nk ,s dc.tupuSm Baum w tation Council for Graduate Medical Education and an additional two years of clinical experience in therapeutic radiology under the supervi-
,ad&si sion of an authorized user at a institution. OA 5"f > We2/ d'hobrF"*d '"" g .
trAt(5jt/fu f 6 35.941 Training for ophthalmic use of strontium-90. Except as provided in S 35.970, the licensee shall reouire the authorized user using only strontium-90 for ophthalmic radiotherapy to n ( ) be a physician who: QJ 02/08/84 141 Enclosure 1 I b
(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 supe vision of an authorized user at an institution and must include: (i) Review of the full ca libration measurements and periodic spot ' i
-checks; (ii) Preparing treatment p ans and calculating treatment times; (iii) ,Using administrative controls to prevent misadministrations; '
~
(iv) Implementing emergenc? procedures to be followed in the event of the abncrmal operation of a ;elethsrapy unit or console; and M Checking end Using 5d ,=y meters. ~ l
- (3) To satisfy the requir ement for supervised clinical experience, tem 4 + ; u n_ , Lne supervisiun, f an evtherized-usac mut ._
r7590-n11 O
~
(i) Examining individuals and reviewing their case histories to 6vdy4t19sy-determine their suitability for tela +h?"?py. treatment, and any limitations or contraindications;
\
I j,, Jy /40 ef; mw *"'b p Nw (ii) Selecting the proper 4 dose andf.g it ig _to-be jdminist--
- . ~ - -
l (iii) Calculating the t:!:th:r ;;y do and p ,liaborati , ith the' 4 authori 3 Idie p tha = 6 eL p=tientsLprogress and. consideration-c w theneed.to. modify.orf Qinal.ly prescribed. dose-as-warranted by.patientsb
-reaction-to-radiad;and (iv) Post-administration followup and review of case histories, in
- k
/
3 .m.wol Training for qualified keletherapy caliu' raliun-expert The licensee shall require t e individual calibrating or checking L m - 1
[7590-01] [x (a) Is certified in radiology or therapeutic radiology by the
' American Board of Radiology; or (b) E s completed 24 hours of instruction in basic radioisotope h
hndling licable to the use of strontium-90 a kstechniques as 'M pu e+petHfica+ Au sf %guhe i>J; 4;y m oph %4vs4]y, &
~
for ophthalmic radiotherapy, and a period of supervised clinica 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 hnime nf mathematics pertaining te the uce end =cc:;urc=cr,t of radioactivity; and (iv) 8 hours of radiation biology.
,n,.
('v) (2) To satisfy the requirement for a period of supervised clinical training in c phthalmic radiotherapy, training must be under the super-naded visionofanauthorizeduserataginstitutionandmustincludetheuse of strontium-90 for the ophthalmic treatment of five individuals,//d a# f-mustynclud examination of each individual to be treatech c,alculation of t dos"e] E-~b{ administere g administration of the dosej Y ct-ad + ictra -
.--tien owup[andreviewofeachindividual'scasehistory.
S 35.950 Training for use of sealed sources for diagnosis. Except as provided in S 35.970, the licensee shall require the authorized user using a sealed source in a device listed in S 35.500 to be a physician, dentist, or podiatrist who: (a) Is certified in (V 02/08/84 142 Enclosure 1 fl
- - . - . - - . - - a _-_a w. - - - --
O, 1 (w bf S jus h ^* ItY: . y) h s 'd ' . h$' s
/ e V$. $!. j.'
l't ) l (f C' b' l' L'- < N-
/
/
/
O
[7590-01] i A (1) Radiology, diagnostic radiology with special competence on (
\ nuclear radiology, or therapeutic radiology by the American Board of Radiology;,or (2) Nuclear medicine by the American Board of Nuclear Medicine; or (3) Diagnostic radiology or radiology by the American Osteopathic ,
Board of Radiology; or (b) Has completed 8 hours of instruction in basic radioisotope handling techniques specifically applicable to the use of the device . To satisfy the requirement for instruction, the training must include: , (1) 3 hours of radiation physics, mathematics pertaining to the nco and moacuromont nf radinactivity, and instrutnentation; (2) 3 hours of radiation biology; and (3) 2 hours of radiation protection and training in the use of the device for the purposes authorized by the license. S 35.960 Training for teletherapy. 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 be a physician who: (a) Is certified in: (1) Radiology or therapeutic radiology by the American Board of Radiology; pt (2) Radiation oncology by the American Osteopathic Board of Radiology; wG-(3) Radiology, with specialization in radiotherapy, as a British
" Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or 02/08/84 143 Enclosure 1
,Cl
\4
[7590-01] O (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or 4 yas completed 200 hours of instruction in basic radioisotope j licable to the use of a sealed source in a telethera (techniques app $s n /L acM p~>acAke a j- Abands e hree p & years h fa % 4 y Q & d) }.< l unit, 500 houbpervisie~d work experience, of super -
! vised clinical experience. L"~
(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 :sthc=stics pcrtaining to the use and iiiessuieinent, , 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 misadministrations; (iv) Implementing emergency procedures to be followed in the event , of the abnormal operation of a teletherapy unit or console; and (v) Checking and using survey meters. f // (2) Tc ntisfy tb.: requir;...;.. . fe, ouverwised clinice! evn=rienco, i training under the supervision of a 1 authorized user must include: !C 02/08/84 14q Enclosure 1 f
[7590-01] (3 (i) 110 hours of radiation physics and instrumentation; i y) (ii) 40 hours of radiation protecti n; (iii) 25 hours of mathematics pertai ing to the use and measurement of radioactivity; and (i v.) 25 hours of radiation biolo . (2) To satisfy the requirement or supervised work experience, training must be under the supervis' n of an authorized user at an institution and must include:
,s (i) Ordering, receiving, an unpacking radioactive materials safely and performing the related radiation surveys; (ii) Checkingsurveymetersforproperoperation; ,
(iii) Preparing, implantin abdremovingsealedsources. (iv) Using administrative coi ltrols to prevent the misadministration
- of byproduct material; and Usingemergencyprocedrestogndic anu control byproduct (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 . ,
w #< Camim 4 m As%And d%;-of /4 annu dc, tap #d dwM MW tation Council for Graduate Medical Educatio and an additional two years of clinical experience in therapeutic radiology under the supervi-
~O sionofanauthorizeduserata[ institutiond Ja/cmirMWa92'M g).
( --
~,e w i- ,
6 35.941 Trainingforophthalmic[Jseofstrontium40. Except as provided in S 35. O, the licensee shall require the authorized user using only stro tium-90 for ophthalmic radiotherapy to
- be a physician who:
02/08/84 M4t' Enclosure 1
/AN/u d\
[7590-01]
'N (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 rS
- the need to modify originally prescribed dose as warranted by patients' reaction to radiation; and i (iv) Post-administration followup and review of case histories.
6 35.961 Training for qualified teletherapy calibration expert. The licensee shall require the individua-1-caFibrating-or-checking _ the r:diatics-eutput-of a teletherapy unit--as-a qualified teletherapy calibration expert 2: provided by 33-632 and-35:633 to: (a) Be certified by the American Board of Radiology in: (1) Therapeutic radiological physics; f (2) Roentgen ray and gamma ray physics; [ (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 and also one year of full time work experience under the supervision of a qualified teletherapy wdad calibration expert at ad institution,where teletherapy-is-performed. To 4g % satisfy this requirement, the neophyte qualified teletherapy calibration 0 02/08/84 145 Enclosure 1
. _ _ _ - - - - - /f *
[7590-01]
' '7 expert must have performed the tasks listed in SS 35.59, 35.632, 35.633, I 'N and 35.641 of this part under the supervision of a qualified teletherapy calibration expert during the year of work experience.
S 35.970 Experienced authorized user training exception. A physician, dentist, or podiatrist identified as an authorized user for the human use of byproduct material on a Commission or Agreement State license on (*** insert effective date of final rule ***) who performs only those methods of use for which he was authorized on that date need not comply with the training requirements of Subpart J. y
! k 9 35.971 nhysician training exception. _
& MMu m/ Q_
[ndas successfully completed /,aM
~
A physician who, { ugust 31, lo I th ree month nuclear medicine training program k /ohe D y the Accredita-
- V (tionCouncilforGraduateMedicalEducation,need_not. comply.with_th_e l
) requirements of SS 35.910 or 35.9 D ( g g SaixGu n_c/ C " d*j-
/b
~
~ ~ ~ ~ ~
)
- ,$w / $ //6D Subpart K--Enforcement i 9 35.990 Violations. I (a) An injunction or other court order may be obtained to prohibit a violation of any provision of: t (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 penalty imposed for violation of: 02/08/84 146 Enclosure 1 _ - _ _ _ _ . _ _ _ . - - _ _ . - _ _ _ . _ . M$
[7590-01] (] (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; (I:) 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 ronuiromont9 nf tho Act mgy ha guilty nf a crime and, upon cen..jetjen, may be punished by fine or imprisonment or both as provided by law. Regulations issued under the Act include regulations issued under sec. 161, c, and cited in the authority citation at the beginning of this part for (Q') the poses of sec. 223. f ,
)bl491 he 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 U.S.C. 2201);
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 0F BYPRODUCT MATERIAL
- 2. Section 30.4 is amended by revising paragraphs (h) and (1) to t t readasfollowsandbyaddingnewparagraphs(g)and(y)asfollows: )(
t 4 6 30.4 Definitions. ( n ) * * * *
- m ,'
02/08/84 147 Enclosure 1
[7590-01] pydae ,it 7 (h) "fluman$se" means the intential j 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 of the United States, the District of Columbia, or the Commonwealth of Puerto Rico in the art of medicine. (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;
* * * * +
T (*] " Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of (Oj Puerto Rico to practice the art of dentistry on humans. v t, (/) " Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Common-wealth of Puerto Rico to practice the art of podiatry on humans. e --* t -
- o
- 3. Section 30.34 is amended by revising paragraph (g) to read as follows:
9 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 molybdenum-99 per millicurie of technetium-99m. The licensee shall perform tests and maintain the records required by 6 35.204. 02/08/84 148 Enclosure 1 /
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[7590-01] m PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL h f :n v'A' d N
/wwuz/ Swa ,In uu ld 31p u.sa ;I ; sun /aaff cci la No is 6 31.11 + Amended T- n ja& ddu g Wg -
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- 4. Section 31.11(b) E reviced to read as follows:
j\ (b) No person shall receive, acquire, possess, use, or transfer
; byproduct material pursuant to the general license established by paragraph (a) i of this section:until he has filed form NRC-483, " Registration Certificate-In (0 O Vitro Testing with Byproduct Material Under General License," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory commission, Waghingtnn, Or Ub 20555 aad received frc:. the Cc:;;;;;ission a
, validated copy of Form NRC-483 with registration number assignedhr ^---
c_ WD .mdad,
;!-unless he has a license that authorizes the y [use of byproduct material and that expires before [*** insert five years after effective
/ i date of final rule ***] or unless he has a license that authorizes the
! wdil in >
t pumanuse of byproduct material and also authorizes the use of byproduct material consistent with the requirements of this section. 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 para-graph (a)(4)(i) are revised to read as follows:
i n (.)\ 02/08/84 149 Enclosure 1
.)
[7590-01] (' 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 staleirient that the radiophaiiliaceuti-cal is licensed by the U.S. Nuclear Regulatory Commission for distribu-I tion to persons licensed to use byproduct material listed in SS 35.100, n I35.200, or 35.300, as appropriate, or under an equivalent license of an Agreement State. l 7. In 6 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. (a) (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 6 35.200 of 10 CFR Part 35 or under an equivalent license of an Agreement State. b 02/08/84 150 Enclosure 1 ,
[7590-01] L
- 8. In S 32.74 the introductory text of paragraph (a) and para-
% graph (a)(3) are revised to read as follows:
6 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 er device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the (name O of source or device) is licensed by the U.S. Nuclear Regulatory Commission
.k for distribution to persons licensed to use byproduct material identified in SS 35.58, 35.400, or 35.500 as appropriate of 10 CFR Part 35 or under an equivalent license of an Agreement State.
PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL
- 9. Section 40.4 is amended by revising paragraph (g) to read as follows:
SS 40.4 Definitions. l (g) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of 02/08/84 151 Enclosure 1
[7590-01] Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; t
- r-1 1
h j Dated at Washington, D.C. this day of 198p.
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For the Nuclear Regulatory Commission. ' l , i i 4-i
- Samuel J. Chilk, 1
{ Secretary of the Commission. i i J 1 7 i l l 1 02/08/84 152 Enclosure 1 f ,
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Acticn:- Davis, NMSS j p g %^ UNITED STATES Cys: Dircks - c/" E NUCLEAR REGULATORY COMMISSION Roe - .3 g WASHINGTON.D.C.2065s Rehm i$' gt Stello ;@-
-S - June 23, 1983 GCunningham$?
V mw] *n** " Q:. Hinogue fi ' errx:E Or THE , , ' - Dgynyng .%~~ ff'i . . sacntrany EZE Kerr, SP y;L- ; p ~ ',;.;; . '- x ~- Regions I-V D'alk, HMSS
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MEMORANDUM FOR: William J. Dircks, Executive Director Felton
- y. . .
for Operations Philips p) W.- Samuel J. Chilk, Secr i'. FROM:
- e .
- o.
SUBJECT:
SECY-83-52 (10 CFR PAR <
- 5) -
3+: - , . , i.~ > . ; .; . Y ,.. . (. (. [ This is to advise you that the Commission (with all agreeing)
.. has made the following decisions with respect to the staff's
,]dA . .c. proposed changes to 10 CFR Part 35 (SECY-83-62) : u. { (1) The Commission approves the consolidation of the essential safety elem'ents from regulations, guides and branch gg; J' positions into a Part 35 rule. f:l+. ' . j h - (2) The Commission has decided to continue the pre-licensing review of physicians' qualifications in processing i.g] applications for human use of byproduct material in'
. nuclear medicine and instructs the staff to amend the n
-c2 ;5.. . draft Part 35 accordingly. .
.:.m v. .w w:'^ The Commission has decided to continue the pre-licensing 0,1 (3)
A- review of applicants' operating procedures by NRC -
~.: licensing staff. The Commission. instructs the staff TJ to make the changes as needed to reflect its decision -
that opernting procedures are to be reviewed prior to
~@@i. .M sij; 1 -licensing. -
g] $q.m .;s.- The staff should clarify how it will implement the proposed M*.t:i (; '(4) requirements regarding license amendments, while - e,.c,.1 ? f. . continuing to ensure safety in the licensee's operations. y . , .:
,, '-( 5 ) The staff should provide the Commission with a proposed N
.g Part 35, revised as directed above, by August 30, 1983.
.- (EDOSuspense: August 23, 1983)
.,+ .
cc: Chairman Palladino g Commissioner Gilinsky (N ' Commissioner Ahearne Commissioner Roberts
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O PERIODIC AND SYSTEMATIC REVIEW - 10 CFR PART 35 Introduction Task IV G.2 of the TMI Action Plan directed the staff to review all existing regulations for content, quality and clarity. SECY 81-435 and 435A established specific review criteria and created the Regulations Coordinating Committee (RCC) to plan, schedule, and coordinate the review. Under the RCC charter, one guideline for setting the priority of specific regulations for review was a Commission or staff initiative for a major revision of an existing rule. The Periodic and Systematic Review of 10 CFR Part 35 is in response to a staff decision that a substantial revision of the human use licensing require-ments of Part 35 was necessary. It should be noted that the re-evaluation of Part 35 does not address the misadministration sections of the current rule (SS 35.41 - 35.44). When these provisions were first promulgated, the Commission established a specific time fx period for their evaluation. Due to this separate time period and the unique (\]
\
nature of the misadministration issue, the proposed revision to Part 35 and this Periodic and Systematic Review do not include this subject within their scope of analysis. Analysis
- 1. The Need for the Regulation.
Under 10 CFR Part 35, the NRC issues licenses to hospitals and physicians for the use of radioactive materials for diagnostic and therapeutic purposes. The NRC currently has approximately 00 medical licensees, and 15 to 20 million nuclear medicine procedures are performed in the United States each year. The proposed facilities, personnel, program controls, and equipment used in these procedures are carefully reviewed during the licensing process to ensure the safety of the public, patients, and occupationally exposed workers.
- 2. Direct and Indirect Effects.
The nuclear medicine field has grown substantially over the past three decades, as evidenced by the increase in license applications, renewals, and v 32/08/84 1 Enclosure 3 I
lq amendments. In addition to this numerical growth, the scope of use has expanded Q dramatically over the years. In order to adequately regulate new developments, many safety measures were added as license amendments or recommended in regula-tory guides, rather than being incorporated in the regulations. However, over the past few years nuclear medicine procedures have stabilized, and uniform and comprehensive safety requirements can now be codified in the regulations in order to establish a more coherent regulatory program. The current practice of publishing the licensing requirements and guidance in several different sources has resulted in negative impacts on both the licensees and the NRC staff. The applicant is often uncertain about what must be included in a license application. This results in either an application that provides a substantial amount of extraneous information or in one that does not provide enough of the information necessary to make a licensing decision. This requires additional NRC staff time to review large amounts of unnecessary information or to write deficiency letters that request additional information or clarification. In either case, there are frequent delays in the licensing process that lead to a backlog in license applications. The existing regulations also severely limit a licensee's flexibility in selecting \j the most cost-effective method for complying with NRC requirements since even uhhiktk saA V a minor, program chdnge must be approved by a license amendment. $ These negative effects of the existing regulatory program have initiated the reevaluation and revision of Part 35.
- 3. Alternative Approaches.
For a detailed analysis of the effects of the proposed revision to upJm aqm a of 5 th,en ule:: king Part35, seethe!alue/ImpacQtatementpreparedasY g package. ' ACluCR Ll Y In developing an earlier staff proposal on the revision of Part 35, SECY-83-62, the staff considered reducing the number of requirements to a few,
,daaa and simply providing guidance for good practice. M such a regulatory scheme might not have protected the public health and safety, probably would have left the industry in a state of confusion given the very prescriptive ,
regulatory scheme used for the past several years, and might have made enforcement actions more difficult, the staff did not consider this to be a /N reasonable alternative. 02/08/84 2 Enclosure 3 f
e. I (p.t , 7- The staff finally proposed in SECY-83-62 that, rd the safety i
=( ) requirements had been codified, applicants simply be allowed to certify that
- v'
.they had met the training and experience standards and would comply with the regulations. In its response to SECY-83-62 (Enclosure 2), the Commission directed the staff to continue pre-licensing review of physician qualifica-tions and operating procedures. The SECY-83-62 alternative is therefore no longer reasonable. j The staff also considered that, sjn Tc the safety requirements had been codified, applicants be required to submit evidence of training and experience and a radiation safety plan that described the licensee's general radiation
~
safety policy and critical safety elements that would be incorporated in site-specific procedures. The staff decided that this alternative was inconsistent with Commission instructions. } The alternative eclected by the staff to regulat.e Uie S ma q 3e of byproduct material, the alternative directed by the Commission, includes
- codification of all generic requirements and staff pre-licensing review of training and experience and procedures.
[n\ s V
/ 4. Public Comment.
One important reason for revising Part 35 is to allow public comment on requirements before they are imposed in final form. The existing system of imposing requirements through license conditions does not allow for public comment. Incorporating generic license conditions into the regulations will allow public comment on these requirements before they are finalized. In addition, a few representative licensees, some nuclear medicine professional { associations, and Agreement State government personnel were contacted on the development of the proposed rule.
- 5. The Regulation Is Written in an Understandable Manner.
The revision of Part 35 has, in part, been prompted by the lack of clarity in the existing rule. The proposed revision is designed to be clear, coherent, and understandable. r i V 02/08/84. 3 Enclosure 3 , i
I M ri : ~ 4 1
- p. 6. . Reporting. Burdens.
j Although the current reporting and recordkeeping activities, and the burdens associated with these. requirements, have been cleared by the OMB under 4 the Paperwork Reduction Act, the proposed revision will modify many of the existing requirements. For specific information on the information collection activities of the proposed revision, see the OMB supporting statement in the rulemaking package.
- 7. Name, Address, and Telephone Number of a Knowledgeable Agency Official.
This information will be included as part of the Federal Register Notice that publishes the proposed rule.
- 8. Plan for Evaluation.
Implementation of the revised licensing system under Part 35 will be continuously monitored to determine whether the regulatory objectives are achieved. The proposed revision is itself the result of an evaluation of the existing rule. The staff does not foresee need for another evaluation before the one required as part of the Regulations Coordinating Committee schedule of priorities for review.- L f f
- h. ,
l_ \^- t v j i-02/08/84. 4 Enclosure 3
n v REGULATORY ANALYSIS FOR THE PROPOSED REVIS0N OF PART 35 L $rwNP b This regulatory analysis was prepared following instructions to Office Directors from the Executive Director for Operations, circulated December 13, 1982. Under those instructions, Part II.A, this proposed rulemaking is not subject to a mandatory regulatory analysis review. However, in the footnote on page 1 of the guidelines, the EDO directed that "... other rulemaking actions not covered by the mandatory review categories ... should also be supported by an analysis based on the guidance provided in Part III.B of the Guidelines but much less detail is required."
- 1. STATEMENT OF PROBLEM p This proposed rulemaking affects all persons who are licensed'by the NRC to irradiate individuals with byproduct material, or its radiation, in the practice of the healing arts. This industry is currently subject to all the general radiation safety materials regulations (Parts 19, 20, 21, and 30),
Part 35, " Human Uses of Byproduct Material," licensing branch policies, a few generic orders, and many generic license conditions. The problem with this regulatory scheme is three-fold: 1. All the regula-tory criteria are not published in a single unified text, therefore the applicant or licensee must look in several places to find all the standards that apply to his program; 2. Licensing branch policy and a listing of the applicable generic license conditions are not generally available to the public, therefore the applicant cannot accurately plan for resources needed to meet regulatory burdens until the license is in hand; and 3. Since the requirements are scattered, in order to assure the public health and safety the staff requires that applicants submit'for review many detailed procedures that will be followed when the license is issued. Then, they are required by license condition to conduct their programs in accord with the statements made in the application. v 02/01/84 4 1 Enclosure 4 C{
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This proposed rulemaking may be taken at this time because the staff does n) (v f not believe that dramatic new types of use that would require generic license conditions will evolve in the next decade; rather, the staff believes research will be devoted to refinement of current methods and development of new materials for which the radiation safety measures are similar to the safety measures for materials currently authorized for use. Even if we do see new technologies that have to be handled on a case-by-case basis, that portion of any licensee's program designed to provide conventional patient care will benefit from the clarification and codification of regulations. If no action is taken, the staff believes the industry will continue to be confused about whether a specific standard is a requirement or a suggestion. The codification of all regulations in a single document may result in fewer enforcement actions because all requirements will be in one text and all licensees will be working under the same set of requirements.
- 2. OBJECTIVES b '
o The purpose of this proposed rulemaking is to codify' in plain English, f \ inudic al (j allradiationsafetyrequirementsspecifictothehuma(useofbyproduct material. The staff and the industry generally agree that the requirements in the proposed rulemaking are needed to protect the public health and safety.
- 3. ALTERNATIVES In developing an earlier staff proposal on the revision of Part 35, SECY-83-62, the staff considered reducing the number of requirements to a few, and simply providing guidance for good practice. Since such a regulatory scheme might not have protected the public health and safety, probably would have left the industry in a state of confusion given the very prescriptive regulatory scheme used for the past several years, and might have made enforcement actions more difficult, the staff did not consider this to be a reasonable alternative.
The staff finally proposed in SECY-83-62 that, since the safety require-ments had been codified, applicants simply be allowed to certify that they had met the training and experience standards and would comply with the regulations. G' 02/01/84 2 Enclosure 4 iCh, iI, 1
4
, In its response to SECY-83-62 (Enclosure 2), the Commission directed the staff to continue pre-licensing review of physician qualifications and operating procedures. 2: SECY-S242-alternative-4s-therefore no-longer reasonableQ
, The-staff also considered that, since the safety requirements had been codified, applicants be required to submit evidence of training and experience and a radiation safety plan that described the licensee's general radiation
-safety policy and critical safety elements that would be incorporated in ! site-specific procedures. The staff decided that this alternative was incon-sistent with Commission instructions.
) The alternative selected by the staff to regulate the human use of byproduct material, the alternative directed by the Commission, includes codification of all generic requirements and staff pre-licensing review of training and experience and procedures. 7
- 4. CONSEQUENCES j Some general comments on the consequences of the proposed action are
(" made below. Since the Commission has selected an alternative,vthe ,o .ap t costs and c
- q benefits of the other alternatives have not been analyzed! A detailed burden i analysis (expressed in dollars and man-hours) for the directed alternative follows the narrative portion of this regulatory analysis. da.ud ew #+ sn, y-In geierelg the staff does n,ot believe there will be any significant ec7,mu m x Ao incre
- :: in or reHef-f-rom-regulator;.c.dyl utdan on licensee g NRCj er Agr;;;:nt Stata.s NRC would have to redirect its training effort because it currently emphasizes review of applicants' procedures at the NRC office rather than an i on-site review of work methods at the licensees' facilities. However, the long-term benefit" h e a pe d afetyf riente [ inspection based on a uniform, nationwide code of standards.
[ [ AGREEMENT STATES: PLEASE PROVIDE A PARAGRAPH DESCRIBING THE CONSEQUENCES OF THE PROPOSED ACTION ON YOUR OPERATIONS.] 4 k G 3a i 1 y 1 I 02/01/84 3 Enclosure 4 i. Y
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suggested' Changes
- 1. Draft memo John G. Davis to Wil liam J. Dircks
" Individuals from NMSS, IE, RI , RII, RIII, RIV, RV, RES, OPE, SP, ADM, ELD and two Agreement Staues helped prepare this proposal."
We suggest two new sentences .tfter " ELD" to read as follows: 0 - Two State persons who represented the 27 Agreement States 3 d provided comments and vie spoints during the development of 8 this proposal. In additi on, the February 13, 1984 version of/ N the Part 35 proposal witt the revised regulatory guide 10.8 was sent to all Agreement States for review and comment.
- 2. Page 4, enclosure 1 Change 26 Agreement States to read 27.
- 3. Page 18, enclosure 1, item 8 Operabl e. !
Change "an assemblage of meta' and plastic" to "an instrument or device."
- 4. We recommend that the Commissi on paper and the regulations clearly /
pd state that any modification ci procedures by the licensee be documented by date and signatt res of those authorized to approve changes, and maintained on file for a minimum of five years.
- 5. Reg. Analysis (P_3 encl 4)
Many Agreement States are in favor of consolidating the various regulatory requirements and support this revision of the regulations. However, the Agreement States are concerned about the impact of the proposed licensing procedures. Agreement States regulate aboint 4700 medical licenses. Most States feel that a
/.ub5/W~prelicensing review of4 safety procedures anddegree changes to the They procedures is necessary to ensure a proper of safety.
believe that f4 W re to require licensees to follow the procedures submitted and permitting the licensees to make changes to procedures without prior review and approval is an unwarranted relaxation of regulatory control.@Their contention is that they will be under pressure from their own licensees to adopt NRC's , revised system of regulating the medical use of byproduct material, I with which they don't agree.
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wofrun/ The staff does not expect any relief from regulatory burdenorjadditional s, burden for licensees because the requirements in the regulation have, for the most part, been taken from requirements imposed by other means. There may be fewer noncompliance citations because all the generic requirements will be published in one place. The staff does not foresee any impact on other NRC programs or require-ments. The staff does not foresee any significant transition problem because, as currently written, each license can stand by itself without reference to the current or proposed Part 35. The staff does not foresee any scheduling, enforceability, policy, institutional, or legal problems.
- 5. DECISION RATIONALE The staff is recommending the proposed revision because it clarifies requirements and grants some authority to licensees to modify their procedures, facilities, and equipment to meet needs caused by changing patient care needs.
The proposed revision is complete and the staff does not foresee any need for wide-ranging revisions, additions, or deletions for at least the next decade.
- 6. IMPLEMENTATION)Cs l Since they are fairly complete and site-specific, the current licenses will stand alone to provide for public health and safety. As licenses come ,
due for renewal, they can be reviewed and issued under the proposed regulatory method. Since the equipment and procedures specified in the regulation are similar to those required of. current licensees, the staff does not foresee any awaa a X need for significant expenditures 4 of time or money for renewal licensees or new applicants. However, the staff has specifically requested public comment . on the transition policy described in the preamble to the Notice of Proposed Rulemaking. The staff is not aware of any relationship between this part and other ! existing or proposed requirements that would affect those requirements or ! cause a need for a reassessment of other actions, systems, or analyses. ! 's 2 02/01/84 4 Enclosure 4 { }OT__
f,U' 1 u Burdenaof Proposed Revision of Part 35
<7, _
( . On the following pages, the cost of complying with each individual section of , the proposed regulation is estimated. Then, six hypothetical licensees that are representative of the medical industry are described. For each of the six licensees, the total regulatory burden is estimated by adding the burden due i to each section with which the licensee would have to comply (not all sections i apply to all licensees). In most cases these are not new burdens because ) similar requirements are currently imposed by license condition. j Explanation of column descriptors and entries c6 DEFGHIM: Describeswhichclassoflicenseemustcomply;(JSubpartsDthrough I in proposed Part 35; M refers to mobile service. Sec: The subsection where the requirement is stated. R/0: R denotes a requirement; O denotes a privilege (with concomitant burdens if the privilege is exercised) contained in proposed Part 35. Freq:[Sy-5 w-weekly years;a-annually;6m-eachsixmonths;qquarterly;m-mont (50 weeks per year); d-daily (250 days per year); o , - - - .
- 2xd-twice daily. Note-that'some frequencies are specified in the \.\
a= + regulation, and some have been assumed (superscripted "a") for ./ purpose of estimating total cost. Ccdes'__ ). - , I ! Hrs for Records: An estimate of hours spent preparing records, reports, and logs, either by a professional (Pro) or by a technician or secretary (Tec). For recurring actions, this is the time needed to do the action once. Cost of paper, forms, and filing space are insignificant and are not included. Hrs for Work: An estimate of hours spent doing something, other than records 4 generation, that is required of either a professional (Pro) or a technician or secretary (Tec). For recurring actions, this 1 02/01/84 5 Enclosure 4 Oh J
I is the time needed to do the action once. These estimates are based on the experience of staff when previously employed by l licensees. Eqpt & Supplies: An estimate of cost of capital equipment and consumable supplies needed based on catalogue prices from nation 4 I wide retailers. Capital equipment is amortized over 5 years. Contract cost: An estimate of the fee charged for a service by an outside contractor. Based on informal surveys.
$/yr: Dollar cost for compliance each year.
Pro Hrs /yr: Total professional time consumed per year for compliance. Tec Hrs /yr: Total technical and secretarial hours consumed per year for compliance.
\
N, RG, LC, or R: N-a new requirement imposed by the proposed Part 35 RG-a recommended procedure, contained in a regulatory guide, that is frequently adopted by applicants LC-a frequently imposed license condition, I&E order, or licensing branch policy R-a current regulation Note: RG, LC, and R imply similar, not identical requirements t v 02/01/84 6 Enclosure 4 i 7 09'
Hrs for Hrs for Pro Tec Recoros Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R (Several footnotes follow the Table) 635.2 License Required. DEFGHM R Sy 190t 40 R I R Sy 3001 60 R S35.16 Application for license, amendment, or renewal. DEFGHM R Sy 202 10 4 2 R I R Sy 4021 10 8 2 R S35.17 License amendments. All 0 Sy 2 2 1 401 8 0.4 0.2 R 635.18 Notifications. 3 All R Sy 0.5 0.5 0.1 0.1 N S35.30 ALARA program. Inst R a 104 10 RG 5 a35.31 RadjationSafetyOfficer. All R m 8 96 RG i S35.32 Radiation Safety Committee.
-_nst R q 26 87 40 8 R S35.37 Records and reports of misadminstrations.
DEHM c R 3y 8 1 1 0.3 0.3 R S35.50 Possession, use, calibration, and check of dose calibrators. DEFM a R 2000 400 RG DEFM bl R d .02 .02 10 RG DEFM b2 R a .20 .20 500 100 0.4 RG DEFM b3 R q* .50 1 6 RG DEFM b4 R Sy 1 1 0.4 RG S35.53 Measurgment of radiopharmaceutical dosages. DEFM R 15xd .02 .02 150 RG S35.59 Requirements for possession of sealed sources and brachytherapy sources. DEFM bcd R 6m 0.5 0.5 1509 30 1 R G bcd R 6m 1 1 759 15 2 R HI bcd R 6m 0.5 0.5 759 15 1 R All g R qtr 0.5 0.5 4 R DEFGM hi R qtr 0.5 0.5 4 N S35.60 Syringe shields. EM R 30010 60 RG 02/01/84 7 Enclosure 4 ,- c3
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, JFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R 635.61 Vial shields. DEM R 50011 100 RG S35.62 Syringe labels. DEM 8012 80 N S35.70 Surveys for contamination and ambient radiation exposure rate. DEM a R d 0.2 0.4 150 RG DEM b R w 0.1 0.1 10 RG DEM e R w 0.2 0.5 35 RG S35.75 Relgase of patients containing radiopharmaceuticals or permanent implants.13 F M R m 500 6000 LC 935.80 Mobilg nuclear medicine service technical requirements. M d R 2xd a 0.4 100 LC e R 2xd 0.2 0.2 100 LC 635.92 Decgy-in-storage. DEFM 0 m 0.5 1 18 LC 635.120 Possession of survey instrume t V 635.204 Pegmissiblemolybdenum-99 concentration. E R d .02 .04 15 R 635.205 Controls of aerosols and gases. E ab R 200014 400 RG E d R 6m 0.1 0.2 0.6 RG 635.220 Possession of survey instruments. E lo 500 5019 150 RG E hi 1000 5019 250 RG S35.310 Sa{etyinstruction. F R m 0.1 0.5 3.015 7 36 RG 935.315 Safetyprecautions. F a R m 45018 5400 RG a F c R m a
- 0. 2?6 2 RG F e R m 3 G17 J 12 @ 4# RG G p R m o .2. o.1 -- 6 935.320 Possession of survey instruments.
F 10 R 500 5019 150 RG F hi R 1000 5019 250 RG 935.404 Rejeaseofpatientstreatedwithtemporaryimplants.
- a R m 0.1 0.1 1 1 RG
\
02/01/84 8 Enclosure 4
}0 b
I em Hrs for Hrs for Fro Tec
) Records Work Eqpt & Contract Hrs Hrs N, RG, JFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R 635.406 Brgchytherapy sources inventory.
G a R m a 0.1 1 RG G b R m 0.2 2 RG S35.410 Sa{etyinstruction. G R m 0.1 0.5 3.015 7 36 RG S35.415 Sa{etyprecautions. G a R m 45016 5400 a G c R m 0.2 2 RG S35.420 Possession of survey instrument. G R 1000 5019 250 RG S35.520 Agailabilityofsurveyinstrument. H R q 10018 400 RG S35.610 Sa{etyinstruction. I R y 0.1 0.5 4 - - 1.018 1 2 RG )( S35.615 Doors, interlocks, and warning systems. I b R 200 40 LC O c R 100 20 LC
~~
S35.620 Possession of survey instrument. I hi R 1000 50 250 RG S35.621 Radiation monitoring device. I a R 750 150 R I d R d 0.02 0.1 30 R S35.622 Viewing system. I R 1000 200 LC S35.630 Dosimetry equipment. I a R 2y 2500 400 700 R N A S35.632 Full calibration measurements. I R a 16 16 32 R 935.633 Periodic spot checks. I a R m 0.5 1 18 R I f R m 0.5 1 18 LC S35.641 Radjation surveys for teletherapy facilities. ! I al R Sy 0.5 1 0.3 LC I a2 R Sy 8 4 4 12 4 LC (% ,'
)
02/01/84 9 Enclosure 4
- 2'
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, IFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R 635.642 Safgty checks for teletherapy facilities. I a R Sy 0.5 el 0.3 N 8 635.645 Five year inspection. I R Sy 20002o t- 400 LC X 02/01/84 10 Enclosure 4 20%
O Footnotes 1A fee required by Part 170. 2 Assume one amendment for a new user or use over 5 years. 3 Assume one key individual leaves over 5 years. 4 Preparing the program is part of the application time. This cost assumes six hours to prepare an annual briefing and one hour for the RSO to deliver the briefing to three administrators. sAssume eight hours once each month to investigate a deviation from good practice. Developing policy and procedures is part of the application time. Procedu?e modification is not required and therefore not costed. Helping the Radiation Safety Committee is costed in 935.32. 6 Typing and distributing minutes. 7 Assume RSO needs three hours to prepare agenda, and five individuals attend a one hour meeting. 8 Assuming 15 procedures per day, 250 days per year, and a frequency of
/ \ 0.01% (see SECY-82-388 p 2), there will be about one misadministration every three years.
9 Radioactive check sources to convert wipe sample cpm to microcuries. toAssume two at $150 11 Assume five at $100(. eacL 12 Assume 4000 labels per year at $10 per 500. taDiagnostic dosages do not require patient confinement for radiation safety purposes. Assume one radiopharmaceutical therapy procedure each month with one additional day of confinement (beyond that needed for patient ' care) in a private room at $500 each day. Permanent implant administra-tions generally do not require patient confinement for radiation safety purposes. 14 Cost of a closed, shielded gas collection system. 15 Assume RSO briefs six nurses for one-half hour. 16 Assume three days in a private room at $500 instead of a semi private room at $350. . 17 Assumed time needed to decontaminate room.
\ /
v' 18 Assume the RSO briefs two technicians each year. 02/01/84 11 Enclosure 4 e
Footnotes (Continued) (v 19 Calibration service. 20 Assume two days at $750 each day, plus $500 total per diem and travel. 2iDraft Regulatory Guide 10.8 for all applications except teletherapy, and a draft Regulatory Guide that is being developed for teletherapy, are avail-able for use by applicants. Except for site-specific information that must be submitted, applicants can certify that they will follow the model proce-dures in the guides, or mark-up the model procedures to meet their site specific needs and submit clean mark-ups for staff review. This burden estimate assumes that most applicants will use most of the model procedures. (O v) 02/01/84 12 Enclosure 4 7/0
Sections not costed (/' 35.1 Purpose and scope. 35.8 Reporting, recordkeeping, and application requirements: OMB approval. 35.15 Definitions. 35.28 License issuance. 35.29 Specific exemptions. 35.31 Radiation Safety Officer. Having an RSO is required by the general criteria of 930.33 which require that the applicant be qualified by training and experience. Development of procedures is costed @ 935.16. 35.33 Requirement for authority and statement of responsibilities. This is part of the management responsibility to provide a position descrip-tion for am worker.
+1 o Jian 35.34 Rrov4s4onaF authorized user. This is an option, not a requirement.
The review process may be conducted during the meetings costed at
$35.32.
35.35 Mobile nuclear medicine service administration requirements. W% As.L 4n. c/ q p cy c. s a.u s u . O ( 35.37abde Records and reports of Tnisadministrations. Therapy misadministrations are very rare (see SECY-83-388 p 2). Investi-gating and making a record of a misadministration is costed @ 935.31 as part of a deviation from good practice. 35.38 Supervision. This is part of the management responsibility to supervise employees. 35.49 Suppliers. 35.50cde Dose calibrators do not break down frequently. Records are costed within the prescriptive requirements to test or check the calibrator. 35.51 Calibration and check of survey instruments. The calibration cost is included as a contract cost in the section that requires possession of the instrument. The survey instrument check (d of this section) is included in the time needed to make a survey. 35.58 Authorization for calibration and reference sources. l 35.59e Leaking sources are very rare. 35.63 Vial labels. Vial shields can be permanently labeled in a few minutes. 35.90 Storage of volatiles and gases. A plastic bag within a plastic bag will meet the requirement of the regulation, k l l 02/01/84 13 Enclosure 4
35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies.
, \j 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
35.205c Control of aerosols and gases. Negative pressure in imaging rooms can be achieved by closing the door, turning off or covering supply vents, and fully opening exhaust vents. 35.300 Use of radiopharmaceuticals for therapy. 35.400 Use of sources for brachytherapy. 35.500 Use of sealed sources for diagnosis. 35.600 Use of a sealed source in a teletherapy unit. 35.605 Maintenance and repair restrictions. 35.606 Amendments. None of the changes which require an amendment request are frequently made. 35.615a Doors, interlocks, and warning systems. Doors are usually installed for compliance with Part 20. 35.643 Modification of teletherapy unit or room before beginning a
/ treatment program. A modification for safety purposes is not t,] usually necessary.
35.644 Reports of teletherapy surveys, checks, tests, and measurements. The licensee need only submit a copy of a record which was costed in another section. The following sections.were not costed because they are industry-specific training and experience standards generally required by 930.33(a)(3). 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 and localization 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. l 35.950 Training for use of sealed sources for diagnosis. U 02/01/84 14 Enclosure 4
>lk
35.960 Training for teletherapy. 35.961 Training for qualified teletherapy calibration expert. 35.970 Experienced authorized user training exception. 35.971- ician training exception. 35.990 Violations. O 1 0 02/01/84 15 Enclosure 4
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j& p /4s Case Description and Regulatory Burden per year (see following tally sheets) l
- 1. A nuclear medicine diagnostic clinic that is not based in a pe smen hospital /and conducts 15 procedures each day. Annual regulatory burden: $1618, 110 professional hours, and 398 technician hours.
Augp /b b
- 2. A nuclear medicine diagnostic clinic that is based in a hospital p e t.w as and conducts 15 procedures each day. Annual regulatory burden:
$1618, 160 professional hours, and 406 technician hours.
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- 3. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and one radiopharmaceutical therapy procedure each month." I regulatory burden: $13,018, 179 professional hours, and 466 technician hours. AddI / 06 7
t,' ') 4. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and one brachytherapy procedure each month. kNa1regulatoryburden: $7033, 177 professional hours, and 448 technician hours dd/ b/ M6
- 5. A hospital with a nuclear medicine clinic that conducts 15 diagnostic L,ma procedures each day and has one cobalt-60 teletherapy unit. Annual regulatory burden: $3211, 233 professional hours, and 463 technician hours dd/hg /44
/5 ghra : I
- 6. A mobile nuclear medicine service that conducts $rocedures 8 t,u w a each day at each of two client locations.3 Annual regulatory burden: ,
$1618, 110 professional hours, and 598 technician hours. u'// h /$d k~ ..
wj 02/01/84 16 Enclosure 4
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1 2 3 4 5 6 Pro Tec Pro Tec Pro Tec Pro Tec Pro Tec Pro Tech 5:cticn $ hrs hrs $ hrs hrs $ hrs hrs $ hrs hrs $ hrs hrs $ hrs hrs 35.2 40 40 60 40 35.16 4 2 4 2 8 2 4 2 35.17 8 0.4 0.2 8 0.4 0.2 8 0.4 0.2 8 0.4 0.2 35.18 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 35.30 10 35.31 96 96 96 35.32 40 8 35.37 0.3 0.3 0.3 0.3 0.3 0.3 35.50 500 16.8 500 16.8 500 16.8 35.53 150 150 150 35.59bcd 30 1 30 1 15 1 15 1 30 1 35.59g 4 4 4 4 35.59hi 4 4 4 4 35.60 60 60 60 35.61 100 100 100 35.62 80 80 80 35.70 195 195 195 6000 200 3 18 18 18 35.120* 150 150 150 35.204 15 15 15 35.205 400 0.6 400 0.6 400 0.6 35.220* 250 250 250 35.310 7 36 35.315 5400 12 24 35.404 1 1 35.406 3 35.410 7 36 35.415 5400 2 35.610 1 2 35.615 60 35.621 150 30 35.622 200 35.630 700 35.632 32 35.633 18 18 35.641 12.3 4 35.642 0. 3 35.645 400
) expenditure also meets requirements of 99 35.320, 35.420, 35.520, and 35.620.
02/01/84 17 Enclosure 4
.plD
CASES (Continued) : 1 2 3 4 5 6
$ 1618 1618 11400 5415 1593 1618 subtotal P-hrs 110 160 19 17 73 110 T-hrs 398 406 60 42 57 598
$ 1618 1618 1618 carryover P-hrs 160 160 160 ,
T-hrs 406 406 406 !
$ 1618 1618 13018 7033 3211 1618 -
TOTAL P-brs 110 160 179 177 233 110 [3aA8f//T-hrs 398 406 466 448 463 598 i f fi & / f/z x y a cbju Mwd inf>.sw .?ony'bWp ; SG'
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02/01/84 18 Enclosure 4 f
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O DRAFT PUBLIC NOUNCEMENT
.A short public announcement, extract from the Federal Register Notice preamble and edited with the assistance of th Office of Public Affairs, will be inserted here.
9 . I i . i e f l l i i-f l
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y DfAM ff/04/C /)A4VddAkO/?fH NRC PROPOSES TO SIMPLIFY MEDICAL LICENSING PROCEDURES
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/ The Nuclear Regulatory Commission is proposing to revise its regulations-
, to simplify and make more efficient the regulatory process for the medical uses of radioisotopes.
The NRC issues licenses to medical facilities and individual physicians for the use of radioactive materials to diagnose and to treat patients. Specific licenses are issued for one or more of six groups of medical uses organized in ascending order of radiation hazard potential, each containing related diagnostic or therapeutic procedures. A separate license.is issued for teletherapy units. Applicants for specific licenses must submit a substantial amount of information to show that all radiation safety requirements will be met, including a description of the procedures used in meeting the requirements Commission's radiation safety review covers three general areas: radiological health and safety procedures; personnel training and experience; O and fec4iities end equipment. rem =6ue to the regid evoiution in the medical use of radioisotopes over the last thirty years, current requirements are found throughout the regulations, regulatory guides, standard license conditions and other sources. Therefore, the primary purpose of the proposed revision is to consolidate the requirements. the proposal, all requirements would be clarified and published in one place, Part 35 of NRC regulations, which would serve to regulate the day-to-day uses of medical radioisotopes. The revised regulation would give both licensees and NRC staff a clearer basis for licensing, operation, and inspection activities. k V f//dL y5 e
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A draft regulatory guide for medical programs has been prepared. It contains a model procedure acceptable to NRC for meeting each of the medical use requirements. Licensees could use the model procedure for meeting the requirements or could prepare their own procedures. The NRC staff will continue to review the applicant's radiation safety procedures to determine whether they are adequate to meet the requirements of the regulations. However, to permit licensees to make prompt use of new safety methods and to adjust their radioisotope programs to meet new needs caused by changes in demand for patient care services or patient load, licensees would be able to modify their procedures without NRC review provided the regulations are met. Modifications would require approval of the licensee's Radiation Safety Officer, and at a hospital, its Radiation Safety Committee. Y Some types of program changes @ would still require a formal NRC review and license amendment include new physician user, new medical use, and O aew 1ocatioa or use-i The proposed revision to Part 35 of NRC regulaticns is being published for public comment in the Federal Register on . Comments should be submitted within 120 days to the Office of the Secretary, Nuclear Regulatory Commission, Washington, D. C. 20555, Attention: Docketing and Service Branch. O E/kLS10
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y' [)h{f PI (GJ/(u(?[($!$Ub b 4[T"I& gRC--PROPOSE 5 -TG SIMPt IFY-MEDICAt-LICENSING-PROCEDURESA ,s - f Ow /1f.n. ddMrncMJ) %.) i.. The Nuclear Regulatory Commission is proposing to revise its regulations-
, tosimplifyandmakemoreefficient[theregulatoryprocessforthemedical uses of radioisotopes. MM A2"'"
""d #1 #f " y m s ,, a d m zo The NRC issues. licenses to medical facilities and individual physicians -j u 4 pu &
for-theuse of radioactive materials to diagnose and to treat patients. @fde.v Specif-ic4feenses-are-issued-for-one-or-more of siqYoups of medical'uses organized in-ascending-order-of-radiation-hazard-potential,-each-containing related_ diagnostic _or_ therapeutic-proceduresr-A-separate-license is-issued-for-teletherapy-units. [thlicant2fer M: specifM1icense(must submit a substantial amount of information to show that all radiation safety c sup ~ < . - u ,,, w requirements will be met, including a description of the4 procedures used in meeting the requirements,*mddd /dc'/'Ilo) ed ef"@en'x t', M ley uW ' dm"'"f w a up o ,enes c -
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TheGM,ss[.onhi--radiation-safety- review covers three generaLareas .6av4 radiological-health-and_ safety _ procedures;-personnel-training-and experience;- /. .- W A and-facilities-and-equipment. Howeverz(uetotherapidevolutioninthe i medical use of radioisotopes over the last thirty years, current requirements are found throughout the regulations, regulatory guides, standard license conditions and other sources. Therefore, the primary purpose of the proposed revision is to consolidate the requirements der the proposal, all requirements would be clarified and published in one place, Part 35 of NRC regulations *c-which-would-serve-to-regulate--the-day-te-day-uses-of-medical radioisotopesgThe revised regulation would give both licensees and NRC staff a clearer basis for licensing, operation, and inspection activities. 2, MK .qa iva , " /D < e app 26 c' G- ' 20 MMovM w.M c O, l i,a a J , a a tsaas n a.c n uit. ,u; d w m , l O EAA'L 6 &
s A draft regulatory guide for medical programs has been prepared. It C)s r - -- -- contains a model 4proced~ur~eiacceptable to NRC for meeting each-ofP the medical kuserequirements. Licensees could use the model procedure for meeting thG requirement (orcouldpreparetheirownprocedures. The NRC staff will continue to review the applicant's radiation safety procedures to determine whether they are adequate to meet the requirements of the regulations. However, to permit licensees to make prompt use of new aune wns safetymethodsandtoadjusttheirradio,isotopgprogramstomeetnewneeds caused by changes in demand for patient care services or patient load, licensees would be able to modify their procedures without NRC review provided the regulations are met. Modifications would require approval of the licensee's Radiation Safety Officer, and at a hospital, its Radiation Safety Committee. 1 K5 i i Some types of program changes whic ,would still require a formal NRC ada i
} review and license amendment include.new physician user,,s- new medical use,s and O 'ae*> iocetioaor use-w/ )
1 TheproposedrevisiontoPart35ofNRCregulationsfsbeing' published for public comment in the Federal Registertonx , vComments-shottidie submitted withinJ20 days-to-the-Office--of-the-SecretaryrNuclear-Regulatory tonmissioni-WashingtonrDr-Cr-20555,-Attention: Docketing-and-Service-Branch. M [ 2 /c A v.z t " f " ? ' % d A W d m l i T s ~ us sa.o a /f scfnaE*$ ~ h u " f"'* ~ @ ~ ~"* a
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~# ) Off/$/eEf$$!0Y I The Honorable Richard L. Ottinger, Chairman Subcommittee on Energy Conservation and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515 ATTN: Mike Ward 316 House Annex #2 cc: The Honorable Carlos Moorhead ATTN: Chris Warner 2322 RHOB The Honorable Alan Simpson, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510 ATTN: Jim Curtiss
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cc: The Honorable Gary Hart ATTN: Keith Glaser A728 Immigration Building
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The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515 ATTN: Henry Myers 1327 LH0B cc: The Honorable Manuel Lujan 1329 LHOB p) L s ENCLOSUREg cv
i DRAFT CONGR SSIONAL LETTER A short letter to congressional overs ght committees, based on the Federal Register Notice preamble and edited ith the assistance of the Office of Congressional Affairs, will be ins ted here. I
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DRAFT ( x ENVIRONMENTAL ASSESSMENT FOR THE PROPOSED REVISION OF 10 CFR PART 35, " HUMAN USE OF BYPRODUCT MATERIAL;" FINDING 0F NO SIGNIFICANT IMPACT.
- 1. Introduction The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations that govern the use of byproduct material for patient diagnosis and therapy. Most of the revision would consist of a clarification and consoli-dation of requirements that are part of the application review process or that are currently imposed on licensees as license conditions or inspection and enforcement orders. The revision would also change the method of applying for a " human use" license.
Since some of the regulations may have a physical effect on the human environment, the staff has prepared the following Environmental Assessment.
- 2. Need for the Revision; Rejection of the No Action Alternative Guidance in the safe use of byproduct material in patient care is currently scattered among the regulations, orders, license conditions, guides, and technical reports. A document that consolidates the critical elements in the guidance is needed to ensure that each individual who needs the information will receive all the information. The document could be a NUREG Report, a Regulatory Guide, or a revision of the regulations. The NRC chose a revision of the regulations in order to reduce the time needed to issue a license and to ensure uniformity of requirements throughout the NRC-licensed medical industry.
There are currently about 2$00 " human use" licensees. Each year, the NRC re cu e receives about @ new applications, @ renewal applications, and 1@00 amendment requests. In order to ensure that the applicant has made a commitment to use byproduct material safely, the staff thoroughly reviews each procedure that an k 02/08/84 1 Enclosure 7
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f
applicant proposes to use. Since some of the safety criteria that the NRC
! j considers critical are not in the regulations, the application and license are the primary documents used to establish the licensee's responsibility for the safe use of byproduct material. In order to simplify the licensing process without compromising the safety of workers and the public, the Commission believes it is necessary to have the critical safety prescriptive and perfor-mance criteria in the regulations. (Publication of a NUREG report or a Regulatory Guide would provide a consolidated document, but neither has regulatory force.)
Therefore, the Commission has determined that, in order to make the licensing process more efficient and to reduce the amount of time needed to issue a license, amendment, or renewal, the regulations must be revised.
- 3. The Proposed Action and Its Tmpact
- a. Specific Sections. Most of the propo:ed revision deals with the rN safe use of byproduct material in the workplace. The following sections deal V: with exposure of the public and the environment.
S 35.75 Release of patients containing radiopharmaceuticals or permanent
, implants. This section requires that the licensee not release a patient until the exposure rate from the patient is less than 6 milliroentgens per hour at a distance of one meter. The Commission notes that a study of the radiation exposure of family members of patients who were administered 8 to 150 milli-curies of I-131 indicated that the median exposure to a family member living with the patient was 19 milliroentgens (AJPHv68n3 Mar 78pp225-230). Currently, according to a frequently used license condition, the licensee may release a patient who contains less than 30 millicuries of radioactivity. (For I-131, the most hazardous frequently used radiopharmaceutical, this amount of activity would create an exposure rate of about 6 milliroentgens per hour at a distance of one meter from the patient.) The Commission notes that the International Commission on Radiological Protection has, for many years, recommended limits on radiation exposure of individuals. "The dose equivalent limits . . . /7 recommended by the [ICRP] have been in effect for over 20 years. They have l 1 'm i
02/08/84 2 Enclosure 7 h
f- been widely used internationally and have been incorporated into legislation
/
in a number of countries and regions. Furthermore, there is no evidence to indicate that the [ICRP's] recommended system of dose limitation has failed to provide an adequate level of safety . . . The [ICRP's] recommended whole body dose equivalent of 5 mSv (0.5 rem) in a year, as applied to critical groups, has been found to provide this degree of safety. . ." [ Annals of the ICRP, Pergammon Press, Oxford. ICRP Publication 26, adopted January 17, 1977, paragraphs 77 and 119.] Therefore the Commission has determined that neither the exposure to a family member nor the exposure rate to other individuals or the environment would produce any discernible effect. (See also the discussion of $$ 35.90 and 35.205 that follows.) S 35.80 Mobile service technical requirements. A mobile service transports and uses byproduct material away from the licensee's base of operation. (The safe transportation of the byproduct material is regulated by the Department of Transportation.) The licensee will be authorized to transport prepared unit dosages, but not multi-dose vials or radionuclide generators. This will
,m ensure that only byproduct material to be used for patient care will be (a) transported. The regulation requires that the licensee ensure, by radiation survey, that all byproduct material, except that administered to the patient, has been removed from the place of use.
Concerning the transportation of by product material, the Commission notes the following information that has been extracted from " Final Environ-mental Statement on the Transportation of Radioactive Material by Air and Other Modes" NUREG-0170 v 1 USNRC Dec. 1977.
"[page iv] Radiation exposure of transport workers and members of the general public along the transportation route occurs from the normal permissible radiation emitted from packages in transport. More than half of the 9800 person-rem exposure resulting from 1975 shipments was received by transport workers associated with the shipments. The remaining 4200 person-rems was divided among approximately ten percent of the U.S. population. None j
of these exposures would produce short-term fatalities. On a statistical basis, expected values for health effects that may result from this exposure {d 1 i 02/08/84 3 Enclosure 7
em are 1.7 genetic effects per year and 1.2 latent cancer fatalities distributed
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(Q over the 30 years following each year of transporting radioactive material in the United States at 1975 levels (Chapter 4, Section 4.9). More than half of this effect results from the shipment of medical-use radioactive materials where the corresponding benefit is generally accepted (Chapter 1, Table 1-2).
" Transportation accidents involving packages of radioactive material present potential for radiological exposure to transport workers and to members of the general public. The expected values of the annual radiological impact from such potential exposure are very small, estimated to be about one latent cancer fatality and one genetic effect for two hundred years of shipping at 1975 rates (Chapter 5, Section 5.9). More than two-thirds of that impact is attributable to nuclear fuel cycle and other industrial shipments (Chapter 1, Table 1-2). [Only 13% of the impact is attributed to medical shipments.]. . .
" Examination of the consequences of a major accident and assumed subsequent release of radioactive material indicates that the potential consequences are s not severe for most shipments of radioactive material (Chapter 5, Section
\ 5.6). The consequences are limited by one or more parameters: short half-life, nondispersible form, low radiotoxicity. . .
"[page vii] On the basis of the analysis and evaluation set forth in this statement and after weighing the small adverse environmental impact resulting from transportation of radioactive materials and the costs and benefits of the alternatives available for reducing or avoiding the adverse environmental effects, the staff concludes that:
- a. Maximum radiation exposure of individuals from normal transpor-tation is generally within recommended limits for members of the general public (Chapter 3, Section 3.5). There are transportation operations at a few locations where some transport workers receive radiation exposures in excess of the recommended limits established for members of the general public. In most cases, these operations employ radiation safety personnel to establish safe procedures and to train and monitor transport workers as though they were radiation workers.
02/08/84 4 Enclosure 7 3
%9
- b. The average radiation dose to the population at risk from normal transportation is a small fraction of the limits recommended for members of the general public from all sources of radiation other than natural and medical sources (Chapter 3, Section 3.5) and is a small fraction of natural background dose (Chapter 3, Section 3.3). . .
"[Page viii] Based on the above conclusions, the NRC staff has determined that the environmental impacts of normal transportation of radioactive material
, and the risks attendant to accidents involving radioactive material shipments are sufficiently small to allow continued shipments by all modes." Currently only about 30 of the Commission's 2600 human use licensees are authorized to transport byproduct material for mobile service. The NRC does not expect any significant increase in mobile service, and therefore does not expect any significant increase in risk due to transportation. S35.90Storageofvolatilesandgases,andh35.205Controlofaerosols X n and gases. These sections allow the storage of volatile radiopharmaceuticals (s and gases in a fume hood, and the venting of waste material to the atmosphere. The purpose of these sections is to protect employees from inadvertent release of byproduct material in the workplace. The release of byproduct material to the environment is regulated by Part 20, " Standards for Protection Against Radiation." The Commission notes that the ICRP has calculated the concentration of a radionuclide in an effluent stream that would cause a member of the population at large to receive an exposure of 0.5 rem in one year. "
. . .the [ maximum permissible concentration] values for [the population at large] are one-tenth of the occupational values for. . .the 168 hour week." [ Health Physics, v3, June 1960. " Report of Committee II on Permissible Dose for Internal Radiation (1959)", p5] The maximum permissible concentration values in 10 CFR 20 Appendix B for soluble Tc-99m, insoluble TC-99m, insoluble I-131, and Xe-133 are equal to one-tenth of the "168 hour week" values referred to in the previous sentence. The appendix B value for soluble I-131 is more restrictive than one-tenth of the "168 hour week" value. (These are the radionuclides 02/08/84 5 Enclosure 7
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SUMMARY
TABLE OF COMMENTS ON CONTENT OF SECY-83-62 REGULATION
% OVERVIEW
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Many indi iduals recommended that commonly used general safety measures be included in he revision of Part 35 that was contained in SECY-83-62. For example, they wo ld require use of gloves and laboratory coats for individuals handling radiophar aceuticals, require use of whole body dose monitors for all Part 35 radiation w rkers and finger dose monitors for individuals who elute generators or handle rachytherapy sources, specify frequency of radiation worker training, requi e the use of-radionuclide sources for survey instrument calibration, package o ering and opening procedures that are more stringent than required in the cu ent Part 2 , requirements that food not be stored J along with byproduct mate ial and radioactive solutions not be pipetted by mouth, and specify frequen y of a,ir hmpling measurements. The Task Force believe that i such regulations are needed to ensure 'q , worker or public protection, an identical case is easily made for placing such
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\v/ requirements on almost all ot er cl. asses of censees. Therefore, to assure uniformity and consistency, su h requireme s would be more properly placed in Parts 19 and 20. The suggeste req irem ts have not been incorporated in the proposed revision of Part 35 bec use ey are not specific to medicine. Generally, only requirements that are specific to the human use of byproduct material were included in the revi ion. The few exceptions to this statement are requirements that might apply t some other groups of licensees but are considered critical elements in a me ical radiation safety program and whose absence, in light of the specificity f other Part 35 requirements, might be construed as an indication that the re uirement was not meant to apply to Part 35 licensees. Examples are perfor ance requirements for survey instru-ments and contamination surveys. Many individuals also recommended th t more safety measures that are specific to medicine be included in the re ision. Some examples that were submitted are: 1. recalibration of imaging quipment that was transported in support of mobile service, 2. storing and preparing volatile radiopharmaceuti-cals and gases in a fume hood, 3. testing frequency for radioactive gas p) LJ 02/09/84 1 Enclosure 8
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i i trapping devices, 4. provision of private room with private toilet for hospitalized radiopharmaceutical and brachytherapy patients, and treating such rooms as restricted areas during therapy, 5. control of contaminated items and associated waste, 6. use of remote handling tools for manipulating brachytherapy sources, and 7. use of electrical or mechanical position limit switches on teletherapy units if the room shielding is inadequate. Many of these comments have been incorporated. There were many suggested general and medical-specific requirements that l might be good practice but are not necessary to keep worker and public doses as low as reasonably achievable below permissible limits. The goal of the drafting committee was to include only those requirements that are specific to the medical use of byproduct material and for which a clear safety need was defined. Basis of the Table Source documents that were reviewed to prepare this table are identified below. Most comments were keyed to a section of the SECY-83-62 regulation that is identified as a subheading. (If in parenthesis, a commenter suggested a new section not in SECY-83-62.) The content of the suggestion is summarized in the left column, and the source document is identified by number and page. In the right column, a / indicates that the comment was added and the new section number is given (a few sections that were in SECY-83-62 have been renumbered); a 0 indicates that the comment was not incorporated and the reason is given. Since this is a summary table, comments have been dramatically condensed. Comments that are addressed in the new Statement of Consideration (S of C) are not included in this table. To make a critical review the reader must refer to the source documents. Copies are available from Norman L. McElroy, NMSS, (301) 4"7-4052. 02/09/84 2 Enclosure 8
\
l 4 S ource Documents 4 9 1. Memo from Vacca and DelMedico (NRC staff) to Chilk dated April 26, 1983.
- 2. Memo from Whatley (Alabama) to Nussbaumer dated May 25, 1983.
- 3. Letter from Shealy (Conference of Radiation Control Program Directors) to j Kerr dated October 7, 1982.
4 2 i t 1 S . e i i i i l l i i L j ! i r l i I 4 i O ! t j 02/09/84 3 Enclosure 8
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7
G 35.2 License required (m Clarify reference to Agreement 0 - defer to ELD. \s) States - 3p1 6 35.15 Definitions Define podiatrist, dentist - 1 Enc 1 4 4 - added. See 35.15. Describe responsibilities of auth 0 - ELD recommends responsibilities in user - 1 Encl 4 regulations, not definitions. Define supervision - 2p10d 4 - already in SECY-83-62 @ 35.38. Clarify " visiting authorized / - See " provisional authorized user." user" - 3p1 6 35.16 Application form Clarify the wording - 1 Enc 14 4 - 35.16. Reflect full regionalization - / - 35.16. 1 Encl 4 t t X Use an application form that elicits J - the new form will elicit most infor-more information -1p49 mation that is currently requested. See 35.16 9 35.17 License amendments Restrict " locations of use" (e) 4 - Section (e) has been restricted, and clarify "other program (f) deleted. changes" (f) - 3p1 CN 6 35.28 License issuance ( Licensee may modify procedures without Commission approval - 4 - RSO and management approval required. See S of C. 9 35.30 ALARA program All licensees must have an ALARA 0 - only needed at institutions. program - 1p51, Encl 4 See S of C. 6 35.31 Radiation Safety Committee Clarify ALARA program review - 4 - 35.30b2. 3p2 6 35.32 Radiation Safety Officer All licensees must identify RSO V - added @ 35.31 1p 54, 1 Enc 1 4 6 35.33 Authority and Responsibilities Specify annual worker training and 0 - frequency belongs in Part 19, content -1p55a suggested phrases restate Part 19 requirements. Ov 02/09/84 4 Enclosure 8 q ((L-
S _ 6 35.34 Visiting authorized users i Only NRC authorized users as 0 - No safety basis, unduly restrictive. d visiting authorized users - 1 Enci 4 Retain records - 3p2 / - 35.34d S 35.35 Mobile nuclear medicine service administration requirements No generators or kits on mobile 4 - Already in SECY-83-62 @ 35.80a. service vans -1p56a Mobile services may only have 0 - unnecessary interference with non-licensees as clients -1p56a delivery of patient care. See S of C. Mobile service must have ltr of / - already in SECY-83-62 @ 35.35b. authorization from client management -1p56a 6 35.50 Dose calibrator requirements Have a dose calibrator on hand 4 - 35.50a. Ip59a' Calibration procedure to test 0 - much more prescriptive than ANSI dose calibrator - 1p59a. 3p2 standard N42.13-1978 6 35.51 Survey meter requirements Have a survey meter on hand - 1p60a 4 - 35.120, 35.220, .. 35.620 1p60a Calibrate annually - 1p60a / - already in SECY-83-62 @ 35.51a. Survey meter calibration procedure / - comment 1 unnecessary, 2-4 Ip 60a, 2no10g already in SECY-83-62 @ 35.51. /',. Performance standards for survey / - two of the three suggested elements t meters - Ip60a were already in SECY-83-62, the third allowed contractor service and ELD says is unnecessary. Check instruments before and after / - already on SECY-83-62 @ 35.51d. each use - 1p60a Keep a record of the calibration - / - already on SECY-83-62 @ 35.51e. Ip60a (6 35.52) Procedures for ordering, receiving, and opening packages Don't order more or different than 0 - violation of license authorized - 1p61a Have written procedures for receiving / - 35.31b2ii. material - 1p61a Train package receivers 1p61a 0 required by Part 19 Have opening procedures - 1p61b 0 - required by Part 20 Critical elements for opening 0 - noted in Part 20 procedures 1p61b (6 35.52) General rules for safe use Critical safety elements when 0 - applicable to entire nuclear industry, handling material - 1p61c not peculiar to medicine. 02/09/84 5 Enclosure 8 M)
,m (9 35.57) In vitro testing per 31.11 l i Allows general license without 0 grandfather current users, in future,
() registering - 1p61d request as a line item. See S of C. S 35.58 Authorization for calibration sources (-- Expand list of sources - 1 Enci 4j 4 - 35.58. )( 6 35.59 Requirements for possession of sealed sources Clarify leak test interval - 1p62 4 - 35.59b2. Clarify leak test procedure - 2no10h 0 - unduly prescriptive. Clarify teletherapy leak test J - 35.59c. procedure - 2no101 9 35.62 Syringe labels Label syringes with radiopharm 0 - unduly prescriptive. abbreviation - 1p64 See 35.62. 35.70 Surveys for contamination and exposure rate Detect 0.1 mR/hr - 1p64a 4 - 35.70c. Establish action levels - 1p64a J - 35.70d. S 35.75 Release of radioactive patients 30 mci for radio pharms and 0 - 30 mci in patient can't be measured. 6 mR/hr @/m for perm. implants - 35.75 would allow either. See S of C. Ip65a ('T More control over patients - 0 not a significant public health (J) 1 Encl 4 concern. 6 35.80 Mobile service technical requirements Have an on-site physician - 1p65b, 0 - unnecessary hazard is comparable to 1 Encl 4 giving a blood sample or having a stomach x ray. Take all material in, remove it all J - already in SECY-83-62, when you leave - 1p65b See 35.80b Recheck diagnostic equipment at J - 35.80d. each site - 1p65f Remove all material before leaving - J - already on SECY-83-62. 1p65b See 35.80b. Make close-out survey - 2no10e. 4 - already in SECY-83-62. See 35.70. 6 35.90 Storage of volatiles and gases Storage in a fume hood or airtight 4 - already in SECY-83-62. container - 1p66a See 35.90 Handle therapy iodine dosages 0 - unnecessarily restrictive in a fume hood - 1p66a Check your fume hood biannually - 0 - belongs in Part 20. Ip66a Test trapping devices monthly - 0 - belongs in Part 20. but see 35.205. Ip66a .O Pre-license review of use areas - J - added to Regulatory Guide 10.8. t i 2no10f V 02/09/84 6 Enclosure 8
l ,q Require " operable" fume hood 0 - unduly prescriptive. If its not with minimum face velocity operable, it's not a fume hood. I (V ) stated - 2no10m See S of C. S 35.100 Radiopharmaceuticals for uptake Comply with chemical form - 1p67 0 - see preamble re " word usage." Specify IND, NDA drugs - 1 Encl 4 / - 35.100, 35.200. RDRC's are for research, not 0 - Added to clarify that, although patient care, so delete this - not for patient care, such human use 1 Encl 4 is authorized. Make "any licensee's RDRC," not J - 35.100a. just "the licensee's RDRC." - 1 Enci 4 Loosen restrictions on authorized J - 35.100, 35.200. use - 1 Enc 1 4 6 35.200 Radiopharmaceuticals for imaging Delete xenon gas 1p68, also 0 - it is a diagnostic radiopharmaceutical RG 10.8 p51 was appended used for imaging. Although it requires some different safety procedures, the level of user training needed and risk to patient are similar. Comply with chemical form - 1p69 0 preamble re " word usage." 6 35.304 Safety instruction Confine patients to a private room V - 35.315
/O with toilet - 1p70a Keep'the patient's room as a 0 restricted area is defined in Part 20.
restricted area - 1p70a Control contaminated items - 1p70a 0 - not specific to human use. Notify RSO of emergencies - 1p70a J - 35.315. 9 35.400 Brachytherapy sources Delete iridium and tantalum as 0 - the drafting committee would like wire Ip70a public comment on these. 6 35.405 Safety instruction Add source description to V - 35.410. training - 1p71a Confine patients to a private room J - added private room. See 35.415. with toilet - 1p71a toilet not needed for safety. Survey waste for displaced sources - 0 - not needed. but see 35.406. Ip71a Notify RSO of emergencies - 1p71a J - 35.415. Handle sources with remote tools - 0 - not specific to human use. but 1p71a See 35.400 introductory text. (6 35.406) Brachytherapy sources inventory Designate a responsible individual - V - already in SECY-83-62. Ip71a See 35,33b 31ii. Keep an inventory - Ip71a 9 - already in SECY-83-62 see 35.59 g, 35.406 Keep a ledger of source use - 1p71a J - already in SECY-83-62. See 35.404. I p\ But due to the hazard of these sources C and the extent of misunderstanding here, suggested elements have been added. 02/09/84 7 Enclosure 8 oc
}H k
6 35.605 Maintenance and repair restrictions [m) Don't move unit or source - 1p73a J - already in SECY-83-62. See 35.606. V Don't work on the unit - 1p73a 4 - already in SECY-83-62. See 35.605. 6 35.606 Amendments Delete identical source exchange 4 - deleted. See 35.606 requirement - 1 Encl 4 6 35.610 Emergency instructions Add an element - 1p73 4 - added. See 35.6106ii. Change title - 1 Enci 4 4 - changed. See 35.610. 6 35.620 Doors, interlocks Words are misleading - 1 Enci 4 0 - no one else complained of the wording. See re-numbered 6 35.615. 6 35.622 Viewing system t t Add aural communication - 0 - No apparent safety need. k 1 Encl 4 (6 35.623) Electrical and mechanical stops Use mechanical and electrical stops 0 - stops are only one of several ways to ensure compliance with limits to ensure compliance with area dose for unrestricted areas - 1p75a rate limits. O ( Add "or abnormality" - 1p73 6 35.630 Dosimetry equipment 4 - 35.630.
' Add constancy check - 1 Enc 14 0 - AAPM is revising its recommendation on this topic.
6 35.632 Full calibration measurements Add "or axis distance" - 1p77 0 - the singular is among the plural. See 35.632bl. Add " dependence on orientation" - J - 35.632b3. 1p77 Add " manufacturer's name" - 1p77 4 - 35.632g. 6 35.633 Spot checks Add " manufacturer's name" - 1p79 4 - 35.633j Delete " measured time accuracy and 0 - these are important spot-check on-off error" - 1p79 items. (6 35.640) Circumstances requiring special survey Events requiring special survey 4 - added. See 35.641a. 6 35.641 Radiation surveys Survey record elements - 1p80b J - most were already in SECY-83-62. The other have been added. Define scatter phantom - 2no100 0 - unnecessarily detailed. (U) 02/09/84 8 Enclosure 8 ggt
- f. 6 35.644 Survey reports Extended inspection interval V - 35.645d.
(s authorized - 1p82a 6 35.910 Training for uptake . . . Training within last five years - V - 35.910a3. Ip83 200 hours seems too stringent; J - The training requirement has been no clinical experience reduced to parallel training require-required - 1 Encl 4 ments for similar amounts of material. See 35.910 (cf 33.15b). 6 35.920 Training for imaging . . Training within last five years - V - 35.920a3. Ip84 6 35'930 Training for radiopharmaceutical therapy Delete A0BR - 1p86 4 - deleted. See 35.930a. 6 35.940 Training for brachytherapy Add "3 yr clinical experience" - 1p87 4 - 35.940b. 6 35.941 Training for Sr-90 Add " training at an institution" - V - 35.941b2. 1p88 g 6 35.950 Training for diagnostic sealed sources No training has been specified - V - 35.950. 1 Enci 4 6 35.960 Training for teletherapy Add certain certifications - 1p89a 4 - 35.960a. Revise classroom training - 1p89 4 - 35.960b. More critical elements for work 4 - added one, two were already in, experience - 1p89b two are inapplicable. More critical elements for clinical 4 - 35.960b3. experience - 1p89 Require calibration and spot-check 0 - required, in 35.961, of the more experience - Ino10p appropriate individual. 6 32.72 Pharmaceutical distributors Delete " unit dosage" - 1 Enc 1 4 4 - deleted. See 32.72a4i. Add group numbers - 1 Enci 4 4 - 32.72. 6 32.74 Source or device distributors Add group numbers - 1 Encl 4 4 - 32.74. 6 35.961 Training for teletherapy expert Add a certain certification - 1p90 V - added. See 35.961a4. Clarify two years' experience - 1p90 4 - added. See 35.961b. Training exemption request - 1p90a 0 - see 35.29. O 02/09/84 9 Enclosure 8 M)
3 (V
SUMMARY
OF COMMENTS ON PROPOSED REVISION OF 10 CFR PART 35 THAT WAS DISTRIBUTED FOR COMMENT ON FEBRUARY 15, 1984 rers Comment ( OPE Memo Cunningham/ Jupiter dated March 19, 1984 IE Memo Cunningham/ Grace dated March 21, 1984 ADM Memo Cunningham/Norry dated March 28, 1984 RM Memo McElroy/ Clark (Cost Analysis Group) dated April 6,1984 RES Memo Cunningham/Goller dated May 10, 1984 SP Memo Cunningham/Kerr dated April 26, 1984 RI Memo Cunningham/ Martin dated March 30, 1984 RII Memo Cunningham/Stohr dated Apail 6, 1984 RIII Memo Cunningham/ Hind dated Mar:h 30, 1984 RIV Memo Cunningham/Bangart dated April 2, 1984 RV Memo Cunningham/Scarano dated April 6, 1984 M Memo Glenn/Mallett dated Jantary 11, 1984 [] G Memo McElroy/Glenn dated Jan;ary 20, 1984 P Memo Glenn/ Potter dated January 11, 1984 NV Letter Nussbaumer/Vaden dated March 13, 1984 ND Letter Nussbaumer/ Mount dated March 22, 1984 OR Letter McElroy/Blazek dated March 23, 1984 AL Letter McElroy/Blazek dated March 23, 1984, with attached comments by Whatley NM Letter Nussbaumer/Garcia dated March 23, 1984 ) GA1 Letter Blazek/Connell dated March 23, 1984 GA2 Letter Nussbaumer/Rutledge dated April 2, 1984 CRCPD Letter McElroy/Hazle, Chairman, Conference of Radiation Control Program Directors, dated March 29, 1984 TN Letter Nussbaumer/ Graves dated April 19, 1984 C0 Letter Nussbaumer/Hazle dated April 11, 1984 TX Letter Nussbaumer/ Lacker dated April 23, 1984 O 1 Enclosure 8 oq .
- AZ Letter Nussbaumer/Tedford dated April 24, 1984 tabt .O at' Brier'"9ae9'"t'aceirovdesMarch9,1984 RIIb Briefing Region II/McElroy dated March 20, 1984 RIIIb Briefing Region III/McElroy ht h March 23, 1984 13.x&
RIVb Briefing Region IV/McElroy WMarch 21, 1984 RVb Briefing Region V/McElroy da" tid March 22, 1984 O f r i O 2 Enclosure 8 9
l
.J' 1
'C TABLE OF CONTENTS J
Page
- Staff Paper............................................................ 4 Discussion of Alternatives............................................. 6 Changes in Procedures.................................................. 10 Cost Analysis.......................................................... 14 Records Retention...................................................... 15 Word Use............................................................... 17 Licensee Management.................................................... 18 Radiation Safety Officer and Radiation Safety Committee................
19 A k~ < i' DoseeCalibrator........................................................ 20 i,; y
. - Survey; Meters.......................................................... 22 tc, Syringe Shiel ds and Other Safety Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Supervision............................................................ 25 Sbrveys................................................................ 26
,4 Radioactive Gases...................................................... 28 1
' ' Mobile Nuclear Medicine Services....................................... 29 m
)
Brachytherapy.......................................................... 31 Te1etherapy............................................................ 32 Byproduct Material Suppliers........................................... 34 1 Training and Experience................................................ 35 Miscellany.................................. . ...................... 36 x i m l)~s 3 Enclosure 8
/
\ *
<}
g-s3it...g - y STAFF PAPER O V f Comment: In the staff paper,.it appears NRC has already selected Alternative 2 and the request for comments s a perfunctory act. Response: The staff has decided to recommend Alternative 2 to the Commission. The staff has asked for comment because the proposal may have unintended or unknown consequences, or other persons may have additional or alternative suggestions. Each comment has been read and considered. Many valuable comments have been incorporated in the package. We have not received any comments that lead us to believe that the basic proposal is flawed. Comment: If 40% of applications that are now received are deficient, doesn't this' indicate that a lot of applicants don't have adequate training? Aren't you just turning your back on a big problem? Response: No. Many requirements are in standard license condition and branch policy statements that are not generally available to the public. There are many critical safety elements in the application guide that are required of all licensees (despite the front page disclaimer that " compliance with regulatory guides is not required"). Since the applicants don't know all the rules governing the review and approval of applications, it should come as no surprise that many applications are deficient. We believe the unannounced inspection is a better proficiency test. Inspection results for 1982 are summarized in Enclosure 9. Almost all of the 1240 citations issued in 1982 are for items that are better described as early
' signs of safety program degredation, but that do not present a worker or public safety hazard.
I ,e yutid Comment: Some of the ')::ritica safety elements" are guidelines. The application is like house plans to show compliance with the building code. There is no need to standardize all houses. Ifo. ~ /t/m; 4 d a// /mp k/s / d a4 h . Response: The analogy is excellent. (Many radiation safety experts would disagree with your suggestion that in some cases we have codified" good A practice.yInmostcaseswehavebeenchastisedforleavingsomethingout.) I Once you have a building permit for a house, you may make minor changes in room 4 Enclosure 8 b 9
layout or design that are consistent with the building code. The " building fu.6# n) germits" office relies on inspectors in the field to determine compliance with _ the code and workmanship standards,'lnot the architect'sfcfr'awingsf'#" Comment: Are you saying that the licensing process is no longer important? ew.Lu Response: No. We do, however, believe that the licensing process has-assumed % too much responsibility in the regulatory program. Its role in the medical industry should be reduced. jk cupc/a u ks/ phE/ 4 4Gnanu 1A#w s y u,'qwurJ h ;[.uu 0;l >>l& NL 2. H D n'~' E ' i 4 O 4 i 4 i a i 2 O 3 5 Enclosure 8 i tj
DISCUSSION OF ALTERNATIVES Comment: The proposed Alternative 2 would be acceptable if (among o.her things) the licensee were only allowed to modify procedures for which requirements are identified in the regulation. Response: No. -The-listing-of-what could or could not be modified would constitute another administrative step. The actions that require a license amendment (new users, new locations, and new types of use), are identified in . . . the regulation. d *'N ### # ^#'!' Yy NM'N" " IY ' fymJx.&%.yGPvdm ' Commen_t: Inspectors will spend more time reviewing procedures in the field. O Sometimes there are evolutionary equipment or procedure changes that are better evaluated in the office. Also, in addition to having to familiarize themselves with programs on the spot, inspectors will have to spend a lot of time on followup inspections. Response: Watching a worker do something is quicker and more relevant to safety than reading what he is supposed to do. The evolutionary changes in ~ ~~ safety equipment that you refer to are very infrequent,' Oiic [something has N _ _- - -- - .. .. .- ) ('been done incorrectly, whether in violation of regulation or. procedure, a lot
\of inspection _and_ licensing _ti,me is consumed./ A detailed review and approval processisfverycostlywayof ssuring that things won't be done incorrectly.
For the level of hazard ials that are authorized, that expense does not seem to be justified. ( Comment: Clarify that we lose a " safety valve" if there is no procedures modification review mechanism exercised by a regulatory agency. Response: The statement 1.s the closing sentence of " Objections-Alternative 2" of the staff paper. Comment: The regulation does not clearly prov,ide for a citation for a failure h to follow procedures, 9 16g3MJ- N Response: Yes, it does. ThejRS0)mustimplementtheprocedures. Implement l means, "to carry out, accomplish, or ensure fulfillment of." < ? m mdu 8 ub>Wwpd']IMnLQd hjipdlLjd4WLnknf hD [h hwu ykHtS N1 :Qrd 0/Y" U 1 bi w WE f ly ll l5((ou)Lf% k hld S:n~ ~ 6 Enclosure 8 L. 9
f Comment: You say that savings amendment fees under your proposed Alternative 2 are insignificant and yet you say that "the effect of selecting Alternative 3" is costly to both NRC and licensees. From these statements, it is difficult to understand why you have chosen to recommend Alternative 2 when l there is no disadvantage to Alternative 3. Response: The disadvantage of Alternative 3 is that the model procedures in
- the licensing guide become, for practical purposes, regulations. The savings M8 amendment fees is what is insignificant to both individual licensees and the industry as a whole (one or two thousand amendments per year from the entire industry, at $40 each). Alternative 3 is costly to NRC because the fee does not cover the expense of reviewing the request and these reviews consume staff time that could be more productively spent on other projects _ that have A c.,vumvc & s/ -~
greater impact on public health and safety. The,/pc, review is cost 4y-te licensees A because it adds the following costs: transmittal letter, paperwork involved in issuing a check to pay for the amendment, and whatever expenses might be incurred while awaiting the authorization to make the requested changes. Comment: The Commission's instruction that the staff should approve licensees' I procedures has been ignored. When the Commission said, " continue the pre-licensingreviewoftheapplicants'operatingprocedure[s,"itmeantmore than a review for the sake of reviewing. Response: In the earlier submission the staff had proposed that the pplicant res M n uw pu,v u viam merely certify that he had adequate procedures,j Therefore, the wor
~
"prelicen# sing" is an important modifier in the instruction. -If-the A
.fommissioners 4 -instructions 4 ave not been followed,- they-will-let-us-knowd Comment: When discussing Alternative 1 in the staff paper, you say you were not aware of anyone who would retain the current regulation over the proposed regulation. In fact, many individuals would retain the current system in favor l
of Alternative 2. 1 Response: You are correct. But most persons who disagree with this proposal l recommend the proposal described in Alternative 3, which is an alternative ) licensing method based on the same set of regulations. Of all of the NRC, Agreement State, and informal industry comments received, only a handful of 1 i O 7 Enclosure 8 cc
persons have clearly recommended retention of the current Part 35 over the codification provided in the proposal. This is not to suggest we are taking votes. Rather, it appears that almost everyone who has seen the package falls into one of two camps: (1)gublishthe package for comment, or (2) modify the package to require NRC approval of equipment, rooms, and procedures and changes thereto (or some combination of those three), and then publish the package for comment. There are five principal levels of regulation:
- 1. Registration: Send in your name and address.
- 2. Self-certifq;akm Promise you will follow the regulations.
If your
- 3. g how % commitment: To get a license, describe your program.
needs change, you may make the changes to your program that are consistent with your license and the regulations.
- 4. 'gontrolbylicense: To get a license describe your program. If your needs change, get NRC permission before making program changes.
- 5. Supervision: Operate your program under the direct personal supervision of an NRC inspector.
Level 1 does not provide an adequate assurance of public health and safety for the materials used in medical programs. The staff recommended Level 2 in the April 1983 submission and the gmmissioners rejected it. Level 3 appears in ) 1 this package as Alternative 2, and is recommended by the staff. Level 4 appears in the package as Alternative 3. When weighed against the benefit to society, Level 5 is too costly. g/r rd v>AvonwnCw6vrt MVII 3 - Comment: You say industry is confused about whether a specific standard is a requirement or a suggestion. If NRC selected Alternative 3, industry would no longer be confused and you would retain what many believe are necessary procedures for radiation safety. Response: For the purpose of this discussion, we may say NRC has two kinds of standards: (1) regulations, license conditions, and orders, and (2) regulatory guides. Failure to comply with the first standards can result in citations, fines, or imprisonment. There is no penalty for not complying with a 8 Enclosure 8 q60
regulatory guide procedure because it is an example of a way of a hieving sw td compliance with the regulations. We contend that the gettier elements of the medical radiation safety procedures have been codified in the regulation, and what has not been codified is not of great safety significance.
'Thereforeg to adopt Alternative 3 would require NRC staff to review,i$idhs'That are not of great safety significancej D O'
Comment: Contrary to what you say, Alternativ' 1 (no action) does provide more safety than Alternative 2 because in many cases the application review process
-is a learning experience for the applicant. It is easier to prevent a problem than it is to clean up afterward.
Response: The application review process you refer to is retained in this ( draft.
\ -
t . jfu un u> hd M b !!L C$G c u alc f00 c.Lbu.O a u - a a a.l,rcq:cc(at " w O O 9 Enclosure 8 g,L7 f
CHANGES IN PROCEDURES A O 'X
. Comment: Inspectors will have to spend more time in the field reviewing procedures because this will not be done during the licensing process.
Inspectors will have neither the time nor the reference materials needed in 4 order to make an adequate review. Response: Inspectors should not review written procedures in the field. They should watch workers working, and spot-check records for completeness. A 4 procedure is a written description of what a worker will or will not do. The thing that is important is what a worker actually does or does not do. Comment: Why should the licensing staff spend its time reviewing procedures if ~8 they won't be enforceable? Response: TheprQicensingreviewprovidesforafindingofacceptable , training and experience, facilities and equipment, and a management commitment 4 to safety. Wrso, note-the-Comeksfoners' indruuunns-trr-Ent1MIrr~e%c i'
-Comme n i. . Require a l i ceri se-ameridii,en t for use of new rooms within a licenseei'~5--
-feeH4tyr-6 ensee needs the authority to use additional rooms for the byproduct materials program, or to reduce the floor space associated with the program, in order to respond to changes in patient load level, available
[ equipment, and space needs. The licensee will have to keep a record of room changes. See a new Section 35.36.
/of 0 Comment: Contrary to.what you say, under the current licensing system, '#
licensees do not have to get an amendment before changing the equipment they use. Comment: Changing rooms where byproduct material is used should not require an amendment. Comment: Changing rooms should require a license amendmen Response: Many licensees identify equipment by name and serial number and rooms that will be used for storage or use of byproduct material and their applications. The Office of the Executive Legal Director advises that, if he makes changes, he is no longer in compliance with the requirement to conduct his program in
, O V
1 10 Enclosure 8 g@
accordance with representations in the application. Therefore under the O current licensing system, the licensee must get an amendment before changing either equipment.cr--roc =s of-tney 44 M Comment: Although the draft regulation requires the implementation of written procedures, there is no standard for minimum content, nor a requirement that modified procedures be similar to those submitted for NRC review. This complicates inspection and enforcement. i Response: Minimum procedure content is specified in the regulation for almost all the procedures required. (See Sections 35.30, 35.32, 35.33, 35.34, 35.37, 35.38, 35.50, 35.51, 35.53, 35.59, 35.70, 35.75, 35.80, 35.92, 35.204, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.610, 35.621, 35.630, 35.632, 35.633,
! 35.641, 35.642, and 35.645.) There is no need for modified procedures to be j similar to original procedures. There is a regulatory requirementJthat the f j licensee's activities be in accord with his procedures and the regulations.
j Comment: Licensees could follow technically invalid procedures for several years because of our low inspection frequency. Inspection time, fines, shutdowns, and possibly even worker dose will increase. Inspactions will have to be more frequent. g a. , i Response: The alternative you recommend, the NRC review and approval, is j expensive and tiae consuming for both the licensee and NRC, and does not provide assurance of safe use. Only an unannounced inspection can do that. Because all inspectors will be working from a single codified 30 page regulation, inspections of compliant licensees should be quicker. Total NRC time spent on non-compliant licensees should be reduced because NRC will be looking at the end product rather than the planned process. We disagree with j the perceived need for more frequent inspections. l l Comment: Many citations are for not following procedures that licensees said i they would follow. Why is it acceptable for applicants to say they will follow a procedure from a guide? Response: If a person is planning on willful negligence, the prior submission of a long application is unlikely to deter him, while it increases the burden 11 Enclosure 8 q,LO
on others. Almost all procedure citations are for not doing anything when something is required, or for doing something that is @early prohibited. a
-Comment: You should require clear, separate documentation of procedure changes. What is to prevent the licensee from changing his procedures even as the inspector is conducting his review?
Response: A new Section 35.36, has been added. It requires the licensee to conduct a formal review and approval process before making any procedure changes. Comment: The internal review process that you require would not be a real c/ review because the autthorized user who is proposing the change may be the only radiation expert in the hospital. Response: This is noted in the staff paper section " Alternative 2- g g g b m>>cui,3." M Comment: Today,about40%ofh[c n 6 e deficient; yet, you say there will be no further need for deficiency letters. Do you mean to say that procedures must be accepted as valid even though they contain gross radiation and safety problems? Response: Deficiency letters currently issued are necessitated in large part because requirements are buried in Part 35, or are in license conditions and branch policy statements that are not generally available to the public, or regulatory guides that are fuk d5Pported to be for guidance only. By codifying all the requirements in one place, the applicant can use the regulation as a check list to determina whether his application is complete. If it is, it is less
'likely that a deficiency letter will be needed. If an applicant submits an inadequate application, a deficiency letter will be issued.
Comment: You should only allow changes in procedures that will not decrease c-N the effectiveness of the licensee's radiation,an rsafety program. Response: The phrase "if the modification does not reduce the program effectiveness and meets Title 10 requirements" has been suggested before. A licensee may design a very safe program that is too expensive or inflexible to j meet changing patient care needs. He should not have to pay an amendment fee ( to modify his program as long as it continues to meet the regulatory standards. lO 12 Enclosure 8 ( QAcY
a ! --) Comment: You should develop evaluation criteria that the licensee must use to ' measuretheeffectoghrchangesheismakinginhisprocedure. Response: The standards are in the regulations. If the licensee is doing something contrary to regulation and doesn't have an exempting license condition, he is subject to enforcement action. A notation that procedural I modifications must be in accord with the regulations appears throughout the preamble. [L 0%0 mjuf> g 7t hh62 ;, puw[ /s.; ,4W dbVObf bhZ' d&W - /doAg ;?6f Skcaltl $O emoulwct 66J pva&cadng pspo:e4 A"'6^ O
/b:Jwet, ,;/ dse Asf /(0-vo
^
c4ao ED. k [;[ylf,lC/b "pTLlGD!Vt [ kk ' O E' 1 1 i i
- O i
l 1 i i i J t t i i Q ' 13 Enclosure 8 i / 1.LD
.. .~ _ ._ .- -- - - _ - .- - - - . . . . -
a COST ANALYSIS O Comment: In the cost analysis you should estimate: how many licensees are ps represented by each " hypothetical licensee"; the increase in burden due to the rulejtheburdenoftheotheralternativesdescribedintheCommissionpaper; j and the NRC staff retraining cost. Response: Done. Comment: You say there is no negative impact on small entities, yet, for your hypothetical licensees, the additional costs will range from $1,600 to $13,000. Also, an extra 400 to 600 technician hours will be needed for each licensee. Response: The numbers you cite are the total regulatory burden; they do not represent new costs. Enclosure 4 has been revised to show total burden and new burden. O v L l i l O 14 Enclosure 8 7b7
RECORDS RETENTION
'n v
Comment: Licensees should be required to keep all records since the last inspection, or at least longer than just 2 years. Response: No. The Office of Management and Budget (OMB) must approve record retention requirements. In response to that requirement, the Office of Admin-istration has prepared a draft record retention rulemaking that establishes uniform retention periods of 2, 5, or 10 years or life of the license or piece of equipment. This Part 35 draft is consistent with that policy. .Jhe OW suggestion is essentially an open-ended retention period; OMB does not aTlow them without good cause. Comment: Why must the licensee record patient identification information on the dosage log sheet? The dosage is recorded in the patient's treatment record. Response: Not all licensees record dosages in patients' files. The intent of the requirement is to reduce the chance of misadministrations by checking both name and identification number. O Comment: Many sections require that the radiation safety officer sign numerous records such as daily checks on dose calibrators. One of the stated objectives for the revision of Part 35 was to reduce paper work on licensees. The necessity of having the RSO sign routine, day-to-day generated documents is questioned and is likely to become a matter of routine without any meaning. A more practical approach would appear to require the person performing the test to make the record and initial it and notify the RSO of test results outside an established range. Then the RSO could review records on a weekly basis. Response: The RSO does not sign the daily checks you refer to. The individual who makes the check initials it. The RSO generally does not sign routine, day-to-day records; usually, whoever creates the day-to-day record initials it. It is the licensee's responsibility to establish whatever management mechanism is needed to ensure management intervention when trigger levels are exceeded. A specified frequency of review was considered but not included because of the range of licensee program sizes. O
- 15 Enclosure 8 r
[
I i/ 1 Comment: Yourrecordlsretentionperiodthatpertainstopatientdosage (] records may be shorter than the retention period required by State law. These records should be retained indefinitely, or as long as required by other applicable law. Response: No. The licensee bears the burden of ensuring compliance with other laws that regulate his activities. The NRC cannot tailor its regulations to suit each State's medical regulations, nor can it say, " Keep a record as long as someone else makes you," because that does not provide a clear or meaningful standard. Comment: In listing information collection requirements, you have required more than what is reasonably needed for radiation safety. This kind of information should be mentioned in a regulatory guide, but not in a regulation. Response: Your point is well taken, but the burden is balanced by the fact that each listing does provide an explicit check list of what the NRC considers elements of an adequate record. No changes have been made. ( I 16 Enclosure 8
<2
l l WORD USE ! O- Comment: You should use the word " operable" to describe survey meters and l.' other equipment. Response: No. The word does not add to enforceability. The statement of consideration y whtch wiii be pubMThed1Trthe Tegarkt" cry gutQvides unambiguous notice that equipment that isn't working cannot be used to meet safety requirements. Comment: Please clarify what you mean by a " dedicated" check source. Response: the preamble section entitled " Notes." Done g $ w Comment: " Management" should be defined to include "or designee." Comment: By requiring the " licensee" to calibrate the survey meters, you i preclude the use of calibration services. Response: Legal staff advises that " designee" is implied in legal construction. Compare the word " licensee"--A licensee may be a non-living l business entity. The wording of the requirement places a legal responsibility O on the licensee that may be fulfilled by full- or part-time employees or
"#!M Y#b . '
contractors. fet U /dd* 6 1 l Comment: Your notes on word usage should be codified in the regulation. Response: No. The regulation contains the definitions needed to clarify the l requirements. The word usage notes will be published, along with an edited statement of consideration, in the regulatory guide in case of question of j ' regulatory intent or interpretation comes up at a later date. I Comment: Define "promptly." l Response: No. When used with its normal definition (" performed readily or immediately"), legal staff advises that a word need not be defined in the l regulations. Contrast the wnrd " person" whic defined in Part 30 because it is used in other than its normal definition (a' legal definition rather of a sa twv business or government entity, than the normal "An individual human being"). It> a t d1 W s
- O i
17 Enclosure 8 i_.. .
LICENSEE MANAGEMENT O Comment: There should be some kind of ALARA program for all licensees, not just medical institutions. The draft Part 20 requires one. Response: No. The ALARA program elements in the regulation may be generally characterized as steps to ensure information flow between managers with overlapfngresponsibilities. At a non-institutional license, such formalized communication is unnecessary. If Part 20 is revised, the conflict will be resolved at that time. - Comment: You should require that mobile service licensees include authorized users on the management team. This will ensure appropriate management control. Response: For the level of hazard of materials authorized, there does not appear to be a strong need for NRC to dictate corporate organization. O O 18 Enclosure 8
-i20
RADIATION SAFETY OFFICER AND RADIATION SAFETY COMMITTEE q Comment: You should clarify the responsibilities that must be borne by the df radiation safety officer and by consultant radiation safety officers. Response: Whether consultant or full-time, the regulations require the licensee's management to provide a statement of authority, a list of duties, and provision of adequate resources. The degree of specificity you suggest is inappropriate for two reasons: (1) Some safety tasks don't apply to all licensees; and (2) if you leave an important task out, the courts assume you did so purposefully since you tok the time to go to such great detail. O Comment: Clarify how many physicians must be on the radiation safety committee. Response: If one physician is authorized to use all materials listed on the license, he is the only one needed. If one physician is authorized to use materials for nuclear medicine and another physician conducts teletherapy, both must be on the committee. Alternative wording is invited. () v Comment: Why must committee minutes note the numerical results of ballots? Response: The requirement was suggested because it is the one quantitative , measure of committee concurrence that is easily recorded. Comment: If the radiation safety committee only reviews a user's credentials "on the basis of safety," that will be an incomplete review. Response: Agreed. The requirement has been revised to include "and in comparison to the training and experience standards in Subpart J of this part." Comment: You could develop a more concise rule if you simply designated the private practice authorized user as the radiation safety officer and radiation safety committee. Response: Correct, but then he would have to be exempted from the formal ALARA program requirement and the committee meeting requirements. Conciseness may be purchased at the expense of clarity. No changes have been made. O V 19 Enclosure 8 3
'l l
DOSE CALIBRATOR
*/
O I Comment: The standard of accuracy for the dose calibrator that you list in the d Draft Regulatory Guide is more stringent than the requirement in the regulation. Which standard applies? i m ag,sc Mmg Response: The regulatory guide ntL1hhes a trigger level that initiates i l equipment repair before the licensee goes out of compliance with the ! regulation. If a licensee has adopted the guide standard and has not initiated repair after going outside the range allowed in the guide standard,fhe has not implemented the procedure. If he has not initiated the repair after going outside the regulatory standard, he is out of compliance with the regulation. Comment: Many licensees who have pre-measured unit dosages don't believe they need a dose calibrator. Physicians don't test the potency of non-radioactive drugs that they administer to patients. Response: Other drugs don't decay with time the way radiopharmaceuticals do. A dose calibrato: only costs about $2,000. It takes only a few seconds to measure each dosage. The benefit to the public appears to be worth the cost. O Comment: The dose calibraton linearity should only be tested to the highest dosage ordinarily measured, not the highest dosage ever measured. Response: No. Therapy dosages, which are not ordinarily measured because they are not frequently administered, are 10-fold higher than diagnostic dosages. The linearity test provides the only assurance that the higher measure is accurate. Comment: If the dose calibrator manufacturer supplies geometry dependence test results, there is no need for the licensee to repeat the test. Response: If the detector was internally damaged in transit from the distributor to the receiver, the manufacturer's test result would no longer be valid. y Comment: The NRC should publish a position statement on the temporary use of il radiopharmaceuticals without measuring the dosage in those cases where the licensee's dose calibrator is broken. O 20 Enclosure 8 371
.. . . _ - = _ _ - - _ _ _ .
? . Response: Agreed. However it will be developed independent of this project. l O Comment: You should require that the dose calibrator be tested for accuracy with sources similar in energy to the materials that will be assayed. Response: Done. ! Comment: You should require that daily dose calibrator constancy checks be made with low, medium, and high energy sources. The proposed requirement is much less stringent than our current guidance. Response: The daily constancy check in this draft is based on Section 4.5.1 of the ANSI standard for dose calibrators. Our current regulatory practice goes beyond the recommended requirement. Comment: You should require that the dose calibrator be tested for linearity from [ to tIie highest activity measur D g/A d i Response: ANSI Section 4.2.2 says " Calibration of the equipment should cover as completely as practicable the activity ranges for which it will be used, [ l particularly those ranges of activity of radionuclides to be administered to l patients." There is no public health and safety need to check linearity from 2 curies to 10 microcuries. This may cause unnecessary worker dose, The chairman of the ANSI N42.13 drafting committee indicated in conversation that the majority of the committee recommended that the calibrator only be tested for linearity up to the highest dosage administered. I l l t i i 1 O : l 21 Enclosure 8 i b 4.
SURVEY METERS O Comment: When calibrating survey meters, the licensee should be required to use a nuclide source whose activity is known within 5%. Response: No. Survey instruments can also be calibrated with X-ray machines. When calibrating with nuclide sources, the activity is not the descriptor of interest--the dose rate at a specified distance, which depends on how the source itD fabricated and encapsulated, is what is important. 5 Comment: Require that licensees use a low range, thin-end-window survey meter when making surveys in the nuclear medicine clinic. Response: No. The licensee bears the responsibility of selecting equipment that is capable of making the measurements required. Comment: ,You-should require that survey meters be calibrated on each scale at two points that are separated by 50%. Response: No. All of the citations for survey meter calibration that were issued in 1982 (see Enclosure 9) were for failure to calibrate the instrument, O not for calibrating it incorrectly. This continues to be the case with the current citations. Comment: Why do you require the high range survey instrument to be an ionization type of survey meter? Response: Only an ionization chamber type of survey instrument is actually capable of measuring exposure rates. See NCRP Report 57, Paragraph 3.2.4.1. l I l l 1 0 22 Enclosure 8
i 1 [ r l SYRINGE SHIELDS AND OTHER SAFETY PRECAUTIONS
;O Comment: You should require that the licensee use syringe shields when preparing kits.
Response: That was the intent. The wording has been clarified. l Comment: You should require that technicians who handle radiopharmaceuticals must wear laboratory coats and gloves. Response: No. Gloves and laboratory coats do not provide a significant
; barrier against contamination, and sometimes actually cause the spread of 1 . contamination instead of helping to contain it. ! N 2/ f Comment: You should require that technicians use syringe shields when drawing dosages out of multidose vials. For 20 millicuries of Tc-99m in 2 cc, the ]
j finger dose rate is 0.6 rem per minute. If a technician draws 10 dosages each I day, and each withdrawal takes 10 seconds, the technician will get i rem each l day to the finger. A syringe shield will reduce this by a factor of about 100.
; Response: The recommendation to use syringe shields when drawing dosages has O #et bee" 4 c1=oe8. ! It appears all of your dose rates came from Barrall and Smith (B&S) AAPM j Monograph 1, 1976. Nuclear medicine technicians do not hold syringes as in B&S i Figure 1 (copy attached); common practice is to hold the back half of the barrel where there is no radioactivity; the 2 cc dosage volume they use is out of date (see HP v. 41, n. 3, p. 535, Figure 1, copy attached -- I cc is a more representativenumber).
For the dose per year to the tip of the finger, assuming 1 mR/ mci-min (HP ! p. 538, average value for unshielded index finger; compare B&S p. 84, post-l tion 4 measure of 1,100 mR/hr for 20 mci that is equivalent to 0.9 mR/ mci-min), average dosages of 10 mci (New England Nuclear catalogue: MOP 10 to 20 mci; , gluceptate 10-20 mci; MAA 1-4 mci; pertechnetate for brain 10-20 mC1, thyroid 1-10 mC1, blood pool 10-30 mC1), 10 dosages per day (your number), 0.2 min per i dosage (12 sec, you said 10 sec), and 250 days per year, the estimated finger-tip dose per year due to drawing dosages is:
- O i
I ^ 23 Enclosure 8 f 1 9)
1 mR 10 mci 0.2 min 10 dosages 250 da 5 rem x x x x = mci-min dosage-draw draw da yr yr One may respond by saying that we can save the 5 rem per year dose with a on_e__4 time purchase of a $200 syringe shield. .I d&segrer ? The first thing the tech- J nician would do after drawing the dosage is remove it from the shield to measure it. If the dosage is high or low, the next step would be to put the syringe back in the shield to return it to the vial and adjust the volume, and then remove the syringe again to remeasure it. It appears the increased handl-ing will consume most of the projected dose savirgs, rendering the expenditure unproductive. QLfi4 f l 0 i i l l O i i l 24 Enclosure 8 ! . . - - .- - - --- -_ 1
SUPERVISION Comment: The " supervision" section that requires the physical presence of the < authorized user on one hour's notice seems unduly stringent. Other hospital personnel can take care of the patient, and the technician can clean up spills. Comment: In addition to the authorized user, the radiation safety officer should also be immediately available and physically present on one hour's l l notice. Response: The requirement that the authorized user be physically present given one hour's notice provides for proper response to spills and losses and active authorized user oversight of supervised individuals by requiring geographic l proximity. (This will eliminate a user in one State " supervising" someone in l another State.) If there is a clear public need, for example in the more l expansive western states, the license reviewer may provide relief by exemption from this requirement. $/su o N dd d 4 /%2 w c da' h 44 m r/ad (k . 2 Comment: The licensee should review the procedures that an authorized user will use for supervising workers, and the qualifications of the workers. O Response: Such a requirement would represent a major policy shift with implications for other industries that are regulated by the NRC, and is therefore outside the scope of this project. Comment: List those duties that can be delegated and those duties that cannot be delegated. Response: In an early draft, we tried to list delegable duties and found that the list was more confusing than the simple direction to exercise supervision. The listing would most probably be either incomplete or confusing. O 25 Enclosure 8
l t I SURVEYS
!O v
Comment: Will the applicant specify contamination action levels in his application? Response: No. The radiation safety officer will set the levels; see Section 35.70(d). Comment: If high contamination levels are found during a contamination survey, the surveyer should take immediate steps to prevent the spread of contamination. - Response: No. Immediate notification of the radiation safety officer is required. He is best suited to oversee the control and cleanup of the spilled material. Comment: Many licensees use a survey instrument to assay contamination wipe samples. Provide the guidelines on converting cpm or mr/hr to dpm. Response: Done. More information has been provided in the regulatory guide. (] Comment: The permissible contamination limit in patient rooms that are about to be released for unlimited use is too high. Respory : A wording mistake was made in the earlier draft. The limit is 200 dpv/~.00 cm8 . Comment: Weekly removable contamination surveys do not provide worders with adequate awareness of potential hazards. They should be made more frequently. Response: Many of these surveys yield results that are below the NRC's recommended action levels. For the level of hazard caused by surface contamination in nuclear medicine hot labs, it is difficult to defend a more frequent survey, Comment: Most nuclear medicine departments cannot measure DPM on wipe samples. Instead they should be required to refer their removable contamination measurements to background count rates. Response: That kind of standard ignores the efficiency dependence of the detector used to measure the wipe sample. The proper units for surface r b 26 Enclosure 8 i'/h
contaminations standards are dpm/cm2 and measurements must be recorded in those O ""'* - Comment: 200 dpm/100 2cm is too restrictive a contamination limit for restricted areas. Response: The regulation does not set a limit on contamination in restricted areas. The licensee does that. The technician is then required to notify the radiation safety officer if a limit for an area is exceeded. Comment: The end-of-day survey section should require cleanup if removable contamination is found. Otherwise we can't issue a citation. Response: Yes, you can. The survey section requires the surveyor to notify the radiation safety officer if action levels are exceeded. One of the radiation safety officer's duties is to "take emergency action in the event of loss of control" of material. Either restricted access to the area or cleanup are two appropriate actions. Doing nothing is not an appropriate action. The licensee would be cited for failure to take emergency action following loss of control of material. O I O 27 Enclosure 8 -- - - - - -- - - - - - -- 1
RADI0 ACTIVE GASES O . Comment: Must the licensee initially open volatiles and radioactive gases in a fume hood? Response: No. The licensee is required to store those materials in a fume hood or within a double container designed to prevent disbursement. Comment: The Draft Regulatory Guide that you have prepared, in Appendix Q, refers to measuring xenon concentrations with a film badge. This is questionable as an acceptable monitoring procedure. Response: The appendix talks about measuring worker dose from noble gas concentrations with a film badge. The permissible concentration of xenon is based on external dose due to submersion, a quantity that is measured by a film
. badge.
Comment: Are you no longer concerned with ventilation rates in xenon rooms? 'tY Response: A new section has been added that requires calculations to establish room evacuation times for all rooms where gas is used or stored. The requirement is needed because normal room ventilation rates are usually not sufficient to ensure a timely clearance of leaked or spilled gas. O 28 Enclosure 8
MOBILE NUCLEAR MEDICINE SERVICES Comment: You should allow mobile services to carry multi-dose vials. The vials are just as safe to transport as unit dosage syringes. Response: Done. A licensee pointed out that a unit dosage may be outside the desired prescription range if the mobile van arrives early or late. If the client had an extra patient, the van would not have a dosage on hand for the patient. Comment: You proposed to allow mobile services to have licensed hospitals as clients. Is this a change in materials licensing policy? NRC usually doesn't allow this. Response: The permission has been withdrawn from this draft. If an inspector were to find uncontrolled material, he would not be able to determine who was responsible for its loss. Comment: You require that the mobile service consider his area of use at the client's facility to be an unrestricted area. If he can't control the area, he () shouldn't be allowed to use the material. Response: A full-time employee of the client such as a housekeeper or security guard may not be aware of the mobile service contract, and may be reluctant to follow safety instructions given by an outsider. Therefore, the mobile service must exercise greater control than that required of in-house nuclear medicine services. Thus the wording, " Client facilities should be considered as unrestricted areas." No change has been made. Comment: The proposal requires that only the management of a client facility be allowed to request services from a mobile nuclear medicine service. . However, service might be suppliedgjif a physician at a client hospital h requested service without his management's approval. Response: This would only happen if the physician misrepresented himself as management, or if the mobile licensee ignored the regulation that requires him to have on hand an authorization letter from the client's management. O 29 Enclosure 8 Qb
Comment: You should allow mobile services to use I-131 for treating "'/ I'- hyperthyroidism, instead of restricting them to only diagnostic work. (]) + Response: The drafting committee purposely omitted all radiopharmaceutical fj. therapy procedures for mobile service licenses. If there is a need, it may be licensed'onacase-by-casebasisifaccompaniedbyalicense[onditionthat
- exempts the licensee from Section 35.35 and also identifies the authorized therapeutic radiopharmaceuticals.
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BRACHYTHERAPY Comment: You should require that brachytherapy sources be manipulated with remote handling tools. Response: No. The licensee is required to follow the safety and handling instructions supplied with the source and approved by NRC or an Agreement State. Not all brachytherapy sources need to be handled with a remote handling tool. komment: Why do you require licensees to survey once each quarter around brachytherapy storage areas? Response: If the number of brachytherapy sources in the inventory increases, or if sources have not been properly stored, dose rates around the storage area ay go over permissible limits. Comment: Brachytherapy sources aren't always promptly returned to storage. The licensee should count them at the time they are removed from the patient to be sure all of them have been removed. O Response: Such a requirement might be inferred to require counting them in the patient's room. It is not common practice to take a source out of one patient and immediately put it in another patient; given that, then wherever a source 1 is taken to after removal becomes an area of storage, and a count must be made. Comment: Brachytherapy users a+str need a low range meter to make a quarterly storage area survey as required in the proposed Section 35.59(h).
/w u,+ cu t ,Aa aou a,ppaa 43 u kias q s u .
Response: A quartet 4y- survey may-be-cont-racted 'outy The meter th,at the l licensee must have on hand is needed to survey around each patient's room after the brachytherapy sources have been implanted, n,,;La j^u w qc e & Comment: Licensees should be required to survey 4theareawhereprachytherapy seeds are implanted in case they are lost in the surgical dressing. '* " #' i / [ Response: -Dono c ej/t A L M o .a q ultu Q /a f Ha ib:J m yt imc2tv o
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0-/ $ & 301h/?A. JU n ,,i u m ;zkyA&E k gy , & bd }aau unt[su c;/ qud tJALtl JOte:CLJ W fb ? bG b1l-O a I 31 Enclosure 8
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TELETHERAPY O Comment: Require both low- and high-level survey meters for teletherapy licensees. If the radioactive source gets stuck in the "on" position in a teletherapy unit, a GM survey meter may saturate or pin the indicator. Response: No. For day-to-day use, a survey meter is needed only as a go/no go indicator in case the teletherapy room monitor fails. In case of a stuck source, the dose rate near the entrance will still be low enough to be measured with either kind of survey meter. Then, the next steps are to remove the patient and secure the room, not to measure the dose rates around the teletherapy unit. Comment: You should require that technicians continuously observe teletherapy patients. Response: No. Such a requirement appears to be unenforceable, and better I mandated by the physician for purpose of patient care. Comment: You should require that the licensee terminate teletherapy treatments O if the patient viewing system breaks. Response: No. The viewing system allows the technologist to monitor the patient's position with respect to the treatment beam so he can terminate the treatment if the patient moves. The decision on whether to interrupt patient care because of a broken viewing system is properly placed on the physician's shoulders. If a patient is cooperative, enforcing such a requirement may place the patient at a greater, not a lesser, risk because you would be denying him his cancer treatments. Comment: A new teletherapy calibration procedure was recently published. You Y should require that 1 ensees use the new procedure. gg
Response
The ptatement-ofensiderat-iorrf'has na 4.vna been revised to in#te-tA. f 4eletherapy enmmunit4 to sugge:t ethwAcalibration protocol, g . cuMgmeet the regulatory requirement. Mot all licensees have the equipment needed to follow the new calibration protocol
&y)U1 O "A h
- yk, 32 Enclosure 8 SW
Comment: You say to measure radiation " quantities" around new teletherapy O. #"its- oo"'t vo# ee" "1eveis"7 Response: No. The word " level" connotes a continous or instantaneous rate. The regulation actually limits the total amount of radiation (millirems) that has been integrated over a period of time at a point. That concept is better characterized as a quantity. Comment: Licensees should mount the teletherapy radiation monitor device so that it can be seen without entering the room. Otherwise, you have to be in the room with the teletherapy beam on to check the monitor. Response: The monitor should be mounted so that you see it when you enter the room and therefore know if you are entering a safe or unsafe room. The monitor can be checked each morning with a hand-held check source in those cases in which it cannot be viewed either by a closed circuit television or through a viewing window. O l l O 33 Enclosure 8 9
BYPRODUCT MATERIAL SUPPLIERS Comment: Delete the authorization for drugs that have been approved by a radioactive drug research committee.
- y u Response: done. pFurther review A f14censee-f44 has indicated that only a few are currently authorized to use Radioactive Drug Research Committee authorizations. Applicants will be notified in the regulatory guide that they may be request specific authorization to use radiopharmaceuticals that have been reviewed and approved for medical use by an FDA-approved Radiosctive Drug Research Committee.
Comment: Many of the listed radiopharmaceuticals are no longer used routinely. f Therefore they should not be listed. Response: Mercury-203 has been withdrawn because the radiation dose is much higher and the imaging quality much lower than for mercury-197. Otherwise, if the Food and Drug Administration has approved a radiopharmaceutical for safety and efficacy, and if the radiopharmaceutical is not hazardous to workers the public, to not allow its use would be an unnecessary intrusion into the p O arect4ce er e84c4"e-Comment: Since you also control suppliers, couldn't you just list permissible isotopes and type of use (i.e., " imaging"). Then, when a new pharmaceutical is developed, you would just have to amend the suppliers' package inserts. Response: We have considered this. However, policy to date for all materials mc .K (not just '@esCuse materials) has been to control both the distributor and the purchaser. We will continue to research the effects of the suggested change, but as a separate project. The purpose of the current project is to codify our current requirements. Comment: Can a hospital supply other hospitals with materials without being licensed as a nuclear pharmacy? Response: This is not the usual case. However, if the license reviewer believes the arrangement is safe and in the public interest, an exception from the authorized supplier requirement can be made. O 34 Enclosure 8 2h
TRAINING AND EXPERIENCE Q, Comment: There is no assurance of adequacy of authorized users' training. Can [ NRC accredit sources of instruction or examine proposed authorized users? Response: The problem is not unique to medical users, but rather applies to all industries under NRC jurisdiction. It should be settled as a separate policy issue, not as a minor issue in this proposed rulemaking. No changes have beem made. Comment: Can license reviewers approve new authorized users if their training meets Subpart J standards? t Response: Yes. The application instructions have been clarified. 7 Comment: The 8 hours of training required of podiatrists is insufficient. N Response: For the one device they would be authorized to use, the amount of CP training appears o be sufficient. The 8-hour standard was developed in a separate project and was simply adopted here. f Comment: Only properly trained individuals should be allowed to transport materials. Response: The Department of Transportation regulations apply to the transportation of byproduct material. No changes have been made. komment: Can physicians be authorized even though they don't meet the training i and experience standards to " nth" degree?
\ Res Yes. Exceptions are allowed pursuant to Section 35.29.
b ponse: Comment": Why do you want to list the radiation therapy physicist en the [ license? We don't do that now. Response: In light of an incident a few years ago, in which several therapy misadministrations were precipitated by the physicist's inadequate training and experience, it would be inconsistent to require identification of the authorized user and radiation safety officer on the license, but not the i radiation therapy physicist. LO 35 Enclosure 8 ,
MISCELLANY q Y Comment: You should clarify that persons who are now working under a general licenseauthorizedbySection35.33whoyousaywillbeexemptfromfeesinthe future, will be restricted to the materials and uses allowed under Section 35.31 when they receive their specific license. If they want to use more material than is allowed by the general license, they should be required to pay application amendment renewaLand inspection fees just like everyone else. ] Response: Done. r f Comment: Because of the size and specificity of this proposal, a 120-day comment period is needed. Response: Done. Comment: The current draft of the proposed Form NRC-313 is worded to indicate that the licensee may not change procedures without NRC approval. This conflicts with the Commission paper. ( Response: The conflicting sentence on the form has been deleted. ( Comment: You should provide more guidance for small research programs. Response: No. Refer requestors to NRC Regulatory Guide 10.2, 10.5, and 10.7. b Comment: How much will it cost to convert in vitro general licenses to specific licenses? Currently, persons who hold a medical license are
' authorized, by the regulation, to also do in vitro work.
Response: Nothing. In vi.tro general licensees are unaffected by the revision. Human use licensees who are doing in vitro work under the provision of current Section 35.14(c) are grandfathered by a conforming amendment until renewal time. New and renewal applicants will have to request the in vitro materials as a separate single line item. Comment: The February 1984 draft that was distributed for comment would allow the licensee to identify provisional authorized users (authorized users who have authorization already by virtue of being listed on another person's 36 Enclosure 8 Zb
g 6)kth k b! Cctl U + fArn'A.:re.c! iv /b?Djd : Ab Ms a V/Uhtf whas,fae' s cxs&L, license), and allow them to work as authorized users until an amendment or renewal request was submitted. A provisional authorized user might do procedures for which he has not been authorized, either by misunderstanding or intent, for several years instead of just for 60 days as permitted under the current visiting authorized user license condition. Several authorized users may come and go without notice to the regulatory agency. Response: Ignorance of the law is not an acceptable excuse. If a physician can't understand limits on his scope of us there is little assurance that he can understand the limits on its duration However, given the risk of loss of management control in situations where key users are regularly replaced, and given the unclear status of the occasional visiting user, who supervises use for one day, compared to the full-time user who should take an active part in the safety program, the 60 day limit has been reinstated. Comment: In drafting a standard for release of patients who contain byproduct material, you have switched from the current requirement that patients who contain more than 30 millicuries not be released to a standard based on the dose rate at a distance from the patient. Do you mean that the dose rate at a distance is the only way to measure the residual activity in a patient who is about to be released? Resoonse: There are only a few ways to determine how much radioactivity is in a patient. Measuring of the amount of material that has been excreted and subtracting it from the amount administered may be more hazardous to the worker than other methods. Retention calculations are based on standard man averages, not the pharmacokinetics observed in the ili patient. The dose rate measurement at a distance is meaningful, inexpensive, easy, and relevant. Other suggestions for patient release standards are welcome. O' A Comment: Changes in NRC regulations will fect Agreement State and NARM State 7 programs. Response: The NR is aware of the fact that the effects of its policy sometimesgobeyonhitsownjurisdiction. However, the probability of extramural effects cannot to stay the NRC from doing its job as it sees best. ,C hi bc;M SQ ano
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Comment: You should require that permanent implant patients be given radiation ( safety instructions before they leave the hospital. Response: No. In the two instances where there is a clear hazard to the public and the patient's family members, permanent implant and radiopharmaceutical therapy, the regulation would not allow release of the patient above specified radiation levels. Below those levels, personal circumstances and needs of the patient and his family must be balanced against the radiation dose to the family and the public. The physician is best suited to determine what instructions should be given and to whom. Comment: In the enforcement paragraph of the statement of considerations you discuss enforcement against an individual. You normally cite the licensee. Has policy changed? Response: No. The paragraph said that licensees may be cited for several types of infraction. The closing sentence notes that if a person uses material and is neither named on a license nor working under supervision, then that ! person will be cited. l For diagnostic radiopharmaceuticals, will you limit the inventory s Comment: amount to a specified number of millicuries, or continue to use the phrase "as needed" on the license. ! Response: We will continue to allow inventories "as needed" for diagnostic radiopharmaceuticals. Comment: You should delete incorrect dosage as a misadministration. Response: It appears that the Commission wants to deal with misadministration I as a separate issue. The current wording was purposely retained. Comment: Why don't you allow decay of radioactive waste with a half life longer than 65 days, or decay for fewer than 10 half lives? ! Response: The 65 day, 10 half-life limit appears to have met most of the licensees' needs. A sentence has been added to the statement of considerations noting that the Commission will consider, on a case-by-case basis, applicants' requests for longer-lived material, or for a shorter decay period. O 38 Enclosure 8
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SUMMARY
OF HUMAN LICENSEE CITATIONS ISSUED IN 1982 This table is a summary, by category, of all the citations issued to human use licenseesina for 14
% violation of (1) NRC regulations, (2) NRC orders, (3) license conditions, or (4) commitments made in the license application.
The raw data was supplied by the Division of Fuel Facilities, Materials and Safeguards, Office of Inspection and Enforcement. It is routinely collected as part of their inspection and enforcement program. The left-most column is the legal basis for the citation. It might be a violation of: a section of the regulations or clear violation of the license, for example adding authorized users without NRC approval, or using more material than is allowed by the license; an order or conditioned permission mailed to licensees in response to a generic safety problem (LTR); n s a violation of a standard license condition (SLC); or a violation of the () license condition that requires the licensee to use material in accord with representations trade in the application (APPL), that perhaps included a promise that a certain regulatory guide (RG) procedure would be used. The second column shows the legal basis for the citation under the proposed regu-lation. The third column is a short description of the citation topic, and the fourth column notes the number of citations issued to human use licensees a s .u xteq f Cl' g g ,j tSt,S su du.15 & k f R E W es /, w / Of the 1240 citations issued in 198/,1197s(96.5%)wouldcontinuetobe citations under the proposed regulations. Furthermore, due to the completeness of the proposed regulation, there may be a much clearer legal basis for more types of citations that could not be issued in the past. jM44cnd u
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F-7 OLD NEW TOPIC NUMBER LICENSE REQUIRED 30.3 30.3 license required 2 30.34c 30.34c use only at location on license 19 35.2 35.2 license required 1 35.14b2 35.200 et al. use only material listed in regs 2 35.14c 35.2 unauthorized user 1 35.14d 35.58 use only calibration sources listed in regs 4 RG10.8D 35.58 et al. use proper, authorized calibration sources 10 SLC 35.2, 35.17 license or amendment required 22 APPL 35.17 unauthorized RSO 1 SLC 35.100 et al. use only for authorized purposes 1 APPL 35.38 unauthorized users 1 POSTINGS 19.11a 19.11a post regs 12 19.11b 19.11b post other documents 7 19.11c 19.11c post NRC Form 5 11 19.11d 19.11d post conspicuously 6 TRAIN WORKERS
19.12 19.12 train workers 31 SLC 35.610 practice teletherapy emergency plan 1 WORKER AND PUBLIC DOSE LIMITS 20.101a 20.101a worker dose limits 12 20.102a 20.102a determine prior dose 1 20.103 20.103 limit airborne concentrations 2 20.105b 20.105b 2 mR/hr and 100 mR/wk 23 20.108 20.108 make bioassays 17 20.202 20.202 supply personnel monitors 52 20.207a 20.207a control dose in unrestricted areas 31 20.401a 20.401a keep worker dose records 14 20.405a 20.405a report worker overexposures 2 20.407 20.407 report worker dose summary 3 RG10.8L 20.202 supply personnel monitors 1 EQUIPMENT APPL 35.120 et al. have a survey meter 12 RG10.801 35.51 calibrate survey meters 39 RG10.8D2 35.50 dose calibrator geometry test 16 RG10.802 35.50 dose calibrator accuracy test 28
.RG10.802 35.50 dose calibrator linearity test 128 p)
( RG10.8D2 35.50 dose calibrator constancy check 61 V RG10.802 35.50 use proper dose calibrator test sources 1 02/08/84 2 Enclosure 9 m,O
cgw OLD NEW TOPIC NUMBER s PACKAGE RECEIPT 20.205b 20.205b monitor packages 10 30.51a 30.51a keep records of receipt and disposal 10 30.51c3 30.51c3 keep records 5 years 2 RG10.8G 35.31 establish an ordering procedure 2 MATERIALS CONTROL 20.207b 20.207b watch material in unrestricted areas 9 20.402a 20.402a report loss or theft immediately 1 20.402b 20.402b report loss or theft in 30 days 1 20.403b 20.403b report incidents 1 RG10.8M 35.90, 35.205 store and control gases 1 SAFETY MEASURES 20.203 20.203 use signs and labels 16 20.203f 20.203f use labels for containers 3 RG10.8G NC wear gloves (22) RG10.8G NC monitor hands - ( 3) RG10.8G 35.60 use syringe shields 16 RG10.8G NC wear lab coats (4) RG10.8G NC don't eat or drink in lab (14) k DOSAGES TO PATIENTS 35.14b4 35.204 measure Mo-99 concentration 16 35.14b6 35.100, 35.200 follow package insert 14 35.43 35.37 report misadministrations 3 RG10.8G 35.53 measure dosages 4 APPL 35.50 use a dose calibrator 5 SURVEYS 20.201a 20.201a make precautionary surveys 37 20.20lb 20.20lb make necessary surveys 151 20.40lb 35.40lb keep survey and monitor records 54 35.14b5iii 35.404 survey implant patients 1 35.25 35.644 survey new teletherapy units 5 RG10.8I 35.70 make daily surveys 80 RG10.8I 35.70 make weekly surveys 11 RG10.8I 35.70 keep survey records 3 WASTE DISPOSAL 20.301 20.301 authorized methods 21 20.302 20.302 get permission for other methods 1 20.303 20.303 sewerage release limits 1 x 20.305 20.305 don't incinerate 2 I 20.401c3 20.401c3 keep disposal records 4 d RG10.8J 35.92 decay-in-storage method 2 02/08/84 3 Enclosure 9 2i[
[~~' i \ OLD NEW TOPIC NUMBER
\j SEALED SOURCES 35.14e 35.59e test for leakage 55 35.14e 35.59c record leakage in "microcuries" 5 35.14f 35.59g inventory quarterly 8 TELETHERAPY CALIBRATIONS AND CHECKS 35.21a 35.632 calibrate if output is off 5% 2 35.21a 35.632a calibrate after source drawer repair 4 35.21b 35.632d calibration procedure 6 35.22 35.633 make spot checks 4 35.22 35.633 check timer accuracy 2 35.22b 35.633b check field / light coincidence 2 35.22b 35.633b compare measured to calculated output 3 35.25a 35.644 keep calibration records 3 TELETHERAPY EQUIPMENT AND PERSONNEL 35.23a 35.630a have dosimetry equipment 1 , 35.24 35.961 qualified expert training 6 35.25c 35.961 qualified expert training records 1 LTR 35.615 install radiation monitor in ,
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SLC 35.615 use doors and interlocks 1 TRANSPORTATION 71.5a 71.5a follow 00T regulations 11 ADMINISTRATIVE MATTERS RG10.8B 35.32a have a radiation safety committee 15 f RG10.80 35.30 review worker doses quarterly 2 RG10.80 35.30 review materials program annually 1 Total citations issued in 1982: 1240 Citations not covered (NC) in proposal: 39 Citations covered in proposal: 1201 A
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