ML20210R770
| ML20210R770 | |
| Person / Time | |
|---|---|
| Issue date: | 08/11/1997 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20210K626 | List: |
| References | |
| FRN-62FR42219, RULE-PR-35 PROC-970811, NUDOCS 9709030319 | |
| Download: ML20210R770 (38) | |
Text
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UNSEALED BYPRODUCT MATERIAL - LOW DOSE DIAGNOSTIC STUDIES NOTE Following Commission approval of the staff's program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language, using a modality based approach. These draft modalities are being provided to the Part 35 Working Group at a very early stage in their development because they are key to the discussion of significant issues associated with the regulation of the medical use of byproduct material, which is an agenda item at the August 19-20 meeting of the group. It should be noted that at this point in their development that they have not undergone a thorough review, including a review to ensure that they reflect the Commission's direction. In fact, in some cases, the draft documents contain different alternatives to regulation of a specific area. Hopefully, these differences will stimulate input and additional alternatives from the Working Group. 1 , i g90g319970810 33 M2FR42219 PDR _
, a UNSEALED BYPRODUCT MATERIAL 1 August 11, 1997 WORKING DRAFT LOW DOSE PART 35 MEDICAL USE OF BYPRODUCT MATERIAL UNSEALED BYPRODUCT HATERIAL" . LOW l DOSE DIAGNOSTIC STUDIES (ekcept studies involving dosages of' sodium:fodide I;131 in quantities greater t1an 30.microcuries)'~~
3 Subpart A General Information .. ...................... 3 Section 35.1 Purpose and scope .. ................ 3 Section 35.2 Definitions ..................... 8 Section 35.5 Maintenance of records . . . . . . . . . . . . . . . . . Sectior 35.6 Provisions for research involving human subjects . . . . 8 Section 35.7 FDA other Federal, and State requirements . . . . . . . 9 Section 35.8 Information collection requirements: OMB approval ... 9 Section 35.11 License required ................... 9 Section 35.12 Application for license, amendment. or renewal .... 10
.................. 10 Section 35.13 License amendments Section 35.14 Noti fications . . . . . . . . . . . . , . . . . . . . . 11 Section 35.15 Exemptions regarding Type A specific licenses of broad 12 scope .............................. 12 Section 35.18 License issuance . ..., ............
12 Section 35.19 Speci fic exemptions . . . . . . . . . . . . . . . . . . 12 Subpart B -General Administrative Requirements ..........,...... 13 Section 35.21 Radiation Safety Officer ............... Section 35.22 Radiation Safety Committee .............. 14 Section 35.23 Statements of authority and responsibilities ..... 15 Section 35.25 Supervision . . . . . . . . . . . . . . . . . . . . . . 16 Section 35.29 Administrative requirements that apply to the provision 17 of mobile nuclear medicine service ... ........... Section 35.xx Identification-of Pregnant' or Breast 1 feeding' Women
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.. 18 Section 35.31 Radiation safety" program changes ~........... 18
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Section 35.33 Notifications. reports, and records of misad-inistrationsforalreportablemedicalfevent ........ 20 Subp3rt C General Technical Requirements . . . . . . . . . . . . . . . . . . . . 22 Section 35.50 Possession, use calibration and check of dose calibrators .......................... 22 Section 35.51 Calibration and check of survey instruments . . . . . . 23 Section 35,52 Possession, use. calibration, and check of instruments to measure dosages of alpha or_ beta emitting radionuclides ... 24 Section 35.53 Measur = nt Determinatior) of dosages of unsealed byproduct material for~ medical'use ' . . . . . . . . . . . . . . . 2E Section 35.57 Authorization for calibration and reference sources . . 20 Section 35.59 Requirements for possession of sealed sources and brachytherapy sources ...................... 26
e 2 August 11. 1997 UNSEALED BYPRODUCT MATERIAL WORKING DRAFT LOW DOSE Section35.60 Shielding 1andlabell_ngfofvialslandsyringesSyringe 28 > shields :~J 1abels ....'.........'.......... Section 35.70 Surveys for contamination and ambient radiation exposure 29 rate. .............................. Section 35.75 Release of individuals containing radiopharmaceuticals 30 er perm:ne=t "p! nts ...................... Section 35.80 Technical requirements that apply to the provision of 31 mobile nuclear medicine service ................. Section 35.90 Storage of volatiles and gases ............ 31 32 Section 35.92 Decay-in storage ................... Section 35.100 Use of unsealed byproduct material for uptake. dilution, and excretion studies (except. studies
- involving " dosages of' sodium 11odide:1;131 in? quantities greater than 30.microcuries)
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32 Section 35.120 Possession'of' survey instrument '~. . . . . . .". . . 33 33 Subpart E Imaging and Localization . . . . . . . . . . . . . . . . . Section 35.200 Use of unsealed byproduct material for imaging and localization studies (except studies involvingidosages:of sodium iodide I-131 in quantities greater than 30 microcuries) ..... 33 Section 35.204 Permissible molybdenum 99 concentration ~...... 23 34 Section 35.205 Control of aerosols and gases ............ Section 35.220 Possession of survey instrument ........... 35 35 Subpart J F--Training and Experience Requirements . . . . . . . . . . . . . . . . 35 Section 35.900 Radiation Safety Officer . . . . . . . . . . . . . . . 36 Section 35.901 Training for experienced Radiation Safety Officer . . Section 35.910 Training for uptake, dilution, and excretion studies (except diagnostic. studies involving? dosages 1of sodium iodide 11;131
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36 in quantities greater than 30 microcuries) .;.l. ~.~ .~ . l . Section 35.920 Training for imaging' and localization studies (except
;- diagnosticstudiesinvolving'dosagestofsodium;1odideil-131in 38 quantities greater than 30'microcuries)~ . . . . . . . . .'. : . .
40 Section 35.970 Training for' experienced' authorized users . ..... Section 35.972 Recentness of training . . . . . . . . . . . . . . . . 41 Section 35.980 Training for an authorized nuclear pharmacist .... 41 Section 35.981 Training for experienced nuclear pharmacists . . . . . 42 42 Subpart KG --Enforcement ............................ 42 Section 35.990 Violationc .......,.............. Section 35.991 Criminal penalties . . . . . . . . . . . . . . . . . . 43 Section 35.999 Resolution of conflicting requirements during transition period ........................ 43 f
o 3 August 11. 1997 UNSEALED BYPRODUCT MATERIAL WORKING DRAFT LOW DOSE Subpart A General Information Section 35.1 Purpose and scope. This part prescribes requirements and provisions for the medical use of byproduct material and for 1ssuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20. 21, 30, 71, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted. Section 35.2 Definitions. Address of use means the building or buildings that are identified on the license and where byproduct material may be received, used or stored. 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. AL^PA (n low at rc=0" bly =M0vab!c) mean: ekMg every renenable ef fort te -uintat" expcture; to radiation n ' - beh: the d0cc 't-it; n is practica4+ (1) Contistent with the purp0:0 for 9tch the 'icensed activity is undertaken. (2) Taking into account the state 0f tech"010gy, the ^co"0-ic Of 4mr0Vc-^nts ir relatic" to benefit; to the public health :nd : fety and Ot wr ;0ciet:1 and ^cicecone-ic consideration;. and 44k relation to utilizatic" Of nuclear energy in the public Mterest. Area of use means a portion of an address of use that has been set aside for the purpose of receiving, using, or storing byproduct material. Authorized nuclear pharmacist means a pharmacist who is: (1) Board certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties: (2)' Identified as an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in the practice of nuclear pharmacy: or-(3) Identified as an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is-authorized to permit the use.of byproduct material in the practice of nuclear pharmacy. 0diatrict who 4s: Authorizedusermeansaph{sician. (1) B0:rd certified by at cnt ^"^ Ofdentist.Or^hlist^dMeetsithe the bO:r 35j50.Or35.950: reg irements in Piragr:ph (:) of Sections 35.910, or (2) is 4 identified as an authorized user on a Commission or Agreement State licens'e that authorizes the medical use of byproduct :rsterial: or
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- 4. m. _ . .
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- 11\ uc4++An. A. 4,,gv,che + 4. u ygn,,
Ac T E I T. n. .s vi iW ,wi gr - (2' Ecither in the diagnostic clinical 3rocedures manual or in any appropriate record in accordance with the cirections of the authorized user . for diagnostic procedures, b
, -.w e , . . - , -- ..-,4 -v,.,%-...,.. , . ..cw.e,,.,m,-- -----..aee,._,..,m,--.r.w-re.am. ------e-wW.. w..r*e- - - - e- w',-- --r- -*r.*ee .-e~-< 4 4- % 3-
UNSEALED BYPRODUCT MATERIAL 6 August 11. 1997 LOW DOSE WORKING DRAFT progsp.4ty g4n,m svs ,,m
.,rs usvn, # e ..
n.i rme s , .v. n,. _..~ rm + m,rn_ator o. ,. r s.44e%r,mr,u
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+m, 4..~h n + m + s iuvss _.an e v.~ n smauv # ,m s . v, ,s , sn.t vs.1 hm,4hs j, u sv,v1 a rs. v. us uvsw m mr 4. + t mm, aus .e m. m. u. . m. m . me m ~ s , v.
t sn m s et k,, + aer . , m+Yn $, r't +v3 . P f_%1 _ a rr n P s. +. .r an.9 -u . ~b ,n V V_.n r t.i r,n $,k M, GMor-b.s1 _l,'_s r'.,u $ Y.n .r _3 s,ti.
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.~.v. u s s. . . . , ~ . . .,,u v. v .
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. _ , nere4knA.
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~~Am i. n. . i m.. . e, + ri m e nd. A_n ume s n n .s.gM u n r.r _e r.4. ~hnA. A_n e uy s ng nwenndr smssu- i. E. m i, r es.nrvsi v.
, n r 4 nms,e i s A 4 n shs rmm.senii+ 4 r s 1 vv Anesnn +hsn e nA svus 4 i,im 4 vu Is A. ii A. t h. s1ne tm { riuuvve
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. v, v rs m dose-Sealed source means any byproduct material that is encased in a capsule designed to prevent m nhm,4r4,+
leakage or escape of the , byproduct . Amm,u, , ( 4, mA se material, +n,ism+ y y,javs,s, m. . .m s n, e t h..m 4 ,n, A 4. m 4. a,u ums, su. a u v uu , su u, +,, h.n s s hars' 1mv v u dr i, rs 4. c./,+ nn s l'.nm.m 4,.s r. r i, v' nn, l i, e%sn,n, e. sn .
%'Y U s s" -
Unit dosage means a dosage intended for medical use in a single patient or human research subject that has been obtained from a manufacturer or preparer Itcensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements. wr 4, m. mnuvi ,1 Airme+4mm ss e s mm mu sn,is e sm_m,ramr
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1 91
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,, h,a,r s n ru s t, 4. s=
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, , m.m s kGr.
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i UNSEALED BYPRODUCT MATERIAL 7 August 11. 1997 ! LOW DOSE WORKING DRAFT ; (5) F0" high d0ce-rate re-^te after10: ding brachyther:py: t'^ , radicitet^p0. tre:t ent tit ^. :nd total d0te; Or ; i (6) F0r 21' Other brachytherapy: j (1) P"icr to 4 p!:ntatic=: the radfeisotep^. "u-ber Of ;0erces. :nd 00erce t
- Str^^gth ; M (14) After 4 plart: tic" but prior to cc pletion O' the 'rocedure: the
,.m 4ma,.JL. treat =nt cite. :nd tot:1 tou ce str^^gt" :n exp0;ure ti-^ (Or.-
radicit0t^^e .um
- m+ a w
[5553E651lEt.'ISI15557h:=ndedat56rP34120. July 25.1991:-59"9 l 61781. Mc. 2. !??O 60 " 18525. Sept. 20. 1995) Section 35.5 Maintenance of records. Each record required by this part must be legible throughout the retention
- period specified by each Commis . ton regulation. The record may be the original or a reproduced copy or a micreform provided that the copy or microform is authenticated by authorized ptesonnel and that the microform is ca)able of producing a clear copy throu(,,1out the required retention period. T1e record
- may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.
Records such as letters, drawings, specifications, must include all aertinent information such as stamps, initials, and signatures. The licensee s1all maintain adequate safeguards against tampering with and loss of records.
- [53 FR 19247. May 27. 1988)
Section 35.6 Provisions for research involving human subjects. A licensee may conduct research involving human subjects using by material provided that the research is conducted, funded, supported, or produc regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its NRC license before i conducting-such research. Both types of licensees shall, at a minimum, obtain i informed consent'from the human subjects and obtain prior review and approval of the research activities by an " Institutional Review Board" in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
- [59 FR 61781. Dec. 2, 1994)-
Section 35.7 FDA. other Federal, and State requirements. Nothing in this FDA. Other Federal, and partState relieves the licensee requirements governing fromradioactive complying withorapplicable drugs devices. [59 FR 61782. Dec. 2. 1994)
I ' O 8 August 11. 1997 UNSEALED BYPRODUCT MATERIAL WORKING DRAFT LOW DOSE Section 35.8 information collection requirements: OMB approval. (a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 350) et sec.). OMB has ap> roved the information collection requirements in this part uncer control num)er 3150 0010. (b) The approved information collection requirements contained in this part appear in Sections 35.6. 35.12, 35.13. 35.14. 35.21. 35.22. 35.23. 35.29. 35.31. 35.50. 35.51. 35.52, 35.53. 35.59, 35.60. 35.61. 35.70. 35.80. 35.92. 35.204. 35.205. 35.310. 35.315, 35.404. 35.406, 35.410. 35.415, 35.606, 35.610. 35.615. 35.630. 35.632. 35.634. 35.636, 35.641, 35.643, 35.645. 35.647. 35.980, and 35.981. (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved as follows: (1) In Section 35.12. Form NRC 313 is approved under control number 3150 0120. (d) OMB has assigned control number 3150 0171 for the information collection requirements contained in Sections 35.32 and 35.33. [51 FR 36951. Oct. 16. 1986, as amended at 57 FR 41378. Sept. 10. 1992: 59 FR 61782. Dec. 2. 1994) in Section 35.8. paragraph (b) is revised to read as follows: 6 35.8 In, formation co,llection requirements: ,0MB approval. (b) The approved information collection requirements contained in this part appear in il 35.6. 35.12, 35.13. 35.14, 35.20, 35.21. 35.22, 35.23. 35.29, 35.13, 35.50, 35.51, 35.52. 35.53, 35.59, 35.60, 35.61. 35.70. 35.75. 35.80. 35.92. 35.204, 35.205. 35.310. 35.315, 35.404. 35.406. 35.410. 35.415, 35.606, 35.610. 35.615, 35.630. 35.632, 35.634, 35.636, 35.641. 35.643, 35.645, 35.647, 35.980 and 35.981. *
- Section 35.11 License required.
(a) A person shall not manufacture, produce, acquire, receive, possess, use. or transfer byproduct material for medical use except in accordance with a specific license issued by the Comission or an Agreement State, or as allowed in paragraph (b) or (c) of this section. (b) An 'ndividual may receive, possess, use, or transfer by)roduct material in accordance with the regulations in this chapter uncer the supervision of an authorized user as provided in Section 35.25. unless prohibited by license condition. (c) An individual may prepare unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in Section 35.25.
a w UNSEALED BYPRODUCT MATERIAL 9 August 11. 1997 LOW DOSE WORKING DRAFT unless_ prohibited by license condition. , l [51 FR 36951. Oct. 16. 1986, as amended at 59 FR 61782. Dec. 2. 1994) Section 35.12 Application for license, amendment or renewal. (a). If the application is for medical use sited in a medical institution, only the institution's management may apply. If the application is for medical use not sited in a medical institution, any person may apply. (b) An application for a license for med1 cal use of byproduct material as described in Sections 35.100 and! 35.200 . 35.300. 35.400. :nd 35.500 of this < part must be made by filing an" orig"inal and one copy of Form NRC-313.
" Application for Materials License. For guidance in completing the form.
refer to the instructions in the most current versions of the appropriate Regulatory Guides. A request for a license amendment or renewal may be submitted as an original in am s mm u , s m., <m,and, u one,- m.,, copy m <m,in_A4,, letter, format. ..m m< m m mAm,+ -,+m,4,, ,,
+Ec' Es ,'+ 2 [e'((m 2A[hu,T4'14((',n n[4[4I,1" Amr((4b;A'
!!J i!"'; _ , 4Thh[+7mh 7 F;;; LU " br[ b "dnf e [< !'.";..GL['C ";.J'ils4;f 4 L;"<L"," ;;<!;"i; 7"! 72;+ ~3i 4;;,' 7;' d;". ";7',,,;;m s "" ;;im;' Jill':1,1;"i si" 6Ll.1 'si.J,"
; , . . . . _? , . . . . . . .
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...,_.........y (dc) for copies of regulatory guides, application forms, or to submit an application or an amendment request refer to Section 30.6 of this chapter.
(ed) An applicant that satisfies the requirements specified in 10 CFR 3.1.13 may apply for a Type A specific license of broad scope. El " 35951. Nt.15.1095. = ==ded at 59 FR 51782. Mc. 2.1991) Section 35.13 License amendments. A licensee shall apply for and must receive a license amendment: (a) Before it receives or uses byproduct material for a clinical procedure permitted under this part but not permitted by the license issued pursuant to this part: (b) Before it permits anyone to work as an authorized user or authorized nuclear pharmacist under the license, except an individual who is: 4" (1) An authorized user certified by the Org:ri: stirs speci' icd 5:r: graph ':) 35.950, Of S=ti= 35.910 . Srti=2.0 25.920. S= tim 35.930. S=t10"meetsith 5.9t0. S= tio" er Sect 10" 35.950 ~ -- ~- .-
~ T (2)' An authorized nuclear pharmacist certified by the organization specified in paragraph (a) of Section 35.980:
(3) Identified as an authorized user or an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy. , or --
. resp (ectively:4) Identified as an authorized user or'an authorized nuclear pharmac
I UNSEALED BYPRODUCT MATERIAL 10 August 11, 1997 i LOW DOSE WORKING DRAFT on a permit issued by a Comission or Agreement State specific licensee of broad scope that is authorized to pennit the use of byproduct material in medicaluseorintheprat.ticeofnuclearpharmacy,respectively.
-(c) Before it changes Radiation Safety Officers er .elether:py ohysicists:
(d) Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license; and (e) Before it adds to or changes the areas of use or address or addresses : of use identified in the application or on the license. [51 FR 36951. Oct. 16.- 1986. as amended at 59 FR 61782. Dec. 2. 1994) Section 35.14 Notifications.
-(a) A licensee shall provide to the Commission a copy of the board ,
certification. the Commission or Agreement State license, or the permit issued by a licensee of broad scope for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user or an authorized nuclear pharmacist pursuant to Section 35.13 (b)(1) through (b)(4). t (b) A licensee shall notify the Commission by letter no later than 30 days after: (1) An authorized user, an authorized nuclear pharmacisty orlRadiation Safety Officer. Or teletherapy 'hysicist permanently discontinues performance of duties under the license or las a name change; or (2) The licensee's mailing address changes. (c) The licensee shall mail the documents required in this section to the appropriate address identified in Section 30.6 of this chapter. . [59 " 51782. Mc. 2l 1991) Section 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee. possessing a Type A specific license of broad scope for medical use (a) is exempt from theoffollowing: The provisions Section 35.13(b): (b) The provisions of Section 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license: (c) The provisions of Section 35.14(a): and (d) The provisions of Section 35.14(b)(1) for an authorized user or an authorized nuclear pharmacist. [59.FR 61782. Dec. 2. 1994) Section 35.18 License issuance. The Comission shall issue a license for the medical use of byproduct
! material for : terr of 'i= yc:r: if: >
t
-r ..e n- ow -e --, - ~ .
..p,e
,7- -, -- , - - ,-m,,---,,rn -a,,-,- ,w , +.r,
1
.. l l
August 11. 1997 l UNSEALED BYPRODUCT MATERIAL 11 WORKING DRAFT LOW DOSE (a) The applicant has filed form NRC 313 " Application for Materials License" in accordance with the instructions in Section 35.12: (b) The applicant has paid any applicable fee as provided in part 170 of this chapter: (c) The Comission finds the applicant equipped and committed to observe : the safety standards established by the Comission in this Chapter for the ; protection of the public health and safety; and (d) The applicant meets the requirements of part 30 of this chapter. . Section 35.19 Specific exemptions. The Commission may, upon application of any interested person or upon its own initiative. grant. such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the conmon defense and security and are otherwise in the public interest. The Commission will review requests for exemptions from training and experience requirements with the assistance of its Advisory Committee on the Medical Uses of Isotopes. Subpart B- General Administrative Requirements 1 S^ction 35.20 ^1^R^,progra--- (2) Each 'icentee shall de"010p and 4 pl=ent : e-itten r: diction , protectic" progra- that includ= provi:10= for keeping dess ^1^R^. (b) TO : tisfy the require =nt Of paragraph ( ) Of t"tr. =ction: (1) ^t : = dical instituti0m =n ;==t. 4"the %diation Safety Officer.
=d all ruthori:^d =er: -=t p:rticipate the progr - n requ =ted by the Radiatic" Safety CO-itt00.
auth0ri (2) for Od'ic0=05 =cr metthat are not p:rticipate in -^ thedical i=titutic=. pr0gr= === 0nt the n requ5ted'=by and5diation a'l e s <m+ m nvr, n, , ,- m, . .- 4() Th0 progr = et include noti c to w^rk0r Of the progrd: edt=ce i. v- , 5 y
=d =rkers' re:pe";1bility to help keep d0e ^quival=t; ^1^R^. : revi^w Of t10=1 cu r1 = cf the type =d : =unt: Of byprod=t =teri:1 = 0d.urn 0= up:d
=
do:M. ch=gn in radiett0n ::fety procedur= =d efety ed= 2410" =d trai"in^ for 21' per:0nnel w"O =r -^=k with Or 4r the 00-t!"ch;f vici"ity o bypr0d=t =t^ rial . The purp000 Of the rev10w is t0 0=ure that lic=== =ke : ren0=bl0 Off0rt to =Mtair individual =d C0ll^ctive Occup: tic =:1 dO n fita^. Section 35.2?. Radiation Safety Officer. (a) A licensee shall. appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee.-through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.
UNSEALED BYPRODUCT MATERIAL 12 August 11. 1997 LOW DOSE WORKING DRAFT (b) The Radiation Safety Officer shall: (1) Investigate overexposures accidents. spills, losses, thefts, enauthorized receipts, uses, transfers. disposals, misad-in htrations
. reportable medical event, and other deviations from approved radiation safety practice and' implement corrective actions as necessary:
(2) Establish, collect in-One binder er '410. and 4mple-^9t written policy
)rogram:
and p1) ater.a' :rocedures forpahace Authorizi.Tthe implementing the~ radiation safety Of- byproduct (ii) Receiving and-opening package 10f byproduct 93teriM+ (iii) Storing byproduct aterial: (iv) cep4ng -ar -iaventory record of byproduct .aterial: 4M&449-byproduct material safely; (vi) Teing cecrgency action i' centrcl cf -byproduct "'ateria1 R 105t+ (vii) Perfor-ir9-periodic radiation surveys + 4111) Perforske-cAec4: Of curvey instrument and other safety equipmentt (h) Disp 004ng of byproduc4 material:
- 4) TrainMg personnel "50 wor' Acr frequst-area "here byproduct material 10 used--Or 'tcred; (x43) Keep 4ng a copy of all records and reports required by the Commission regulations, a copy of these regulations. a copy of each licensing recuest and license and amendments. and the written policy and procedures requiret by the regulations.
(34) Brief management once each year on the byproduct material program: (45) Establish personnel exposure irventi' exceeded, wi'l in4tiate an-investigation bye th'ational Radiation kvch Safetythat, r/her Offker Of the-sauce of-the exposupe+ (56) Establich personnel exp0;ure dave;tigational leveh that, when exceeded, will initiate a pro pt investigatier by the Radiation Safety Offker of-the cause of the exposure and a consideration of actions that -ight be taken to reduce the 'robability Of recurrenset (67!) for medica' use not at a med ka! institution, aApprove or disapprove minor changes in radiation safety procedures that are not potentially important to safety with-the advice and conrent of aragement; and (78) for medical-use at a medical irr,titution, aAssist the Radiation Safety Committee,1flonetis required.in @e pei'formance of its duties. Section 35.22 Radiation Safety Comittee. Each medical institution licensee.exceptlicensees only using byproduct material pursuantito 35;100:or 35.200, alone or in combinationi shall establish a Radiation Safety Committee ~to' oversee the~use of byproduct material. (a) Each Committee must meet the following administrative recuirements: (1) Membership must consist of at least three individuals anc must include an authorized user of each tvpe of use per itted by the license, the Radiation Safety Officer. a representative of the nu, ing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other (2) The members Committee may must be included meet as the licensee at least quarterly.[ prepare deems minutesapproplriate. of each Peeting@ndfmai,ntairilaicophof(the minutes 7for;the durationjohtheilicense.
UNSEALED BYPRODUCT MATERIAL 13 August 11. 1997 LOW DOSE WORKING DRAFT (3) The Committee must have written policies and procedures for conduct of its meetings and business to ensure adequate oversight of the licensee's radiation safety program. Te establi@ a quoru and-t+-<-endast-4m4 ness. at-
.least-one hal' of t-he Cc-tttee': m mbership "s t=be present. 4ncluding the Ra44414si-Safety Of'ic-er--and the -anagemert ' representative-( A) The mtst+G-of--cachao 44ation Safety Corittee meeti"9 "utt include +
444-T4xHiate of the meet 4n9+ 4444-44esten-presentt 41 i t ) "^"ber+-atse@ 444--Summary of-deliberat4ons and discussions: (v) o^ccrended action; and-the "umerica' result; Of all ballets; and (vi) AL??A progra- revte.v; described 4" Sectic" 35.20(c). (5) 44e-Com-ittee "st--pro ptly provide ca9 ~^mber enth a copy e' the meet 4eg -inutes, end retatn one copy for the du"atica Of the 'icense-(b) To oversee the use of licensed material, the Committee must: (1) Review recommendations on ways to maintain individual and collective doses ALARA: (2)(1) Review, on the basis of safety and with regard to the training and experience standards in subpart JF of this part, and approve or disapprove any individual who is to be listed as an authorized user. an authorized nuclear pharmacist, or the Radiation Safety Officer or a teletherapy-fay:1cist before submitting a license application or request for amendment or renewal; or (ii) Review, pursuant to Section 35.13 (b)(1) through (0)(4), on the basis of the board certification, the license, or the permit identifying an Individual, and approve or disapprove any individual prior to allowing that individual to worc as an authorized user or authorized nuclear pharmacist: (3) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under Section 35.31 of this part: (4) Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material: (5) Review quarterly. with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; and (6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program. [51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782. Dec. 2, 1994] Section 35,23 Statements of authority and responsibilities. (a) A licensee shall provide the Radiation Safety Officer, and at--a _ medical institat4en the Radiation Safety Comittee, if suchia ~comittee 1s 7 required; sufficient authority, organizational freedom; and management l prerogative, to: 1
UNSEALED BYPRODUCT MATERIAL 14 August 11. 1997 LOW DOSE WORKING DRAFT (1) Identify radiation safety problems: (2) Initiate, recommend, or provide corrective actions: and (3) Verify implementation of corrective actions. (b) A licensee shall establish and state in writing the authorities, duties, responsibilities, and radiation-safety activities of the Radiation Safety Officer and at a medical institution the Radiation Safety Committee, and retain the current edition of these statements as a record until the
' Commission terminates the license.
Section 35.25 Supervision. (a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by Section 35.11(b) of this part shall: (1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material and 1" the "ag=ent ^
~ ram:
lic^^:ce : wrttt^" qua'ity (2) Require the su)ervise"'d individu5""1;to follow the instructions of the supervising authorizec user, follow the written radiation safety and quality "er rement procedures established by the licensee, and comaly with the reguiationsofthischa 1 respect to the use of bg)roduct s ., Periodically material: and pter^dand revice the supervi the license
!"dividual' conditions wit use Of byproduct mMetal and- the record; L ept te reflect this u;c.
(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by Section 35.11(c). shall: (1) Instruct the supervised individual in the ) reparation of byproduct material for medical use and the principles of anc procedures for radiation safety and i" the lic^":^^*: written quality "en:g^=ent ""0 appropriate to that individual's use of byproduct materiE: gram, as (2) Require the supervised individual to follow the instructions given pursuant to paragraph (b)(1) of this section and to comply with the regulations of this chapter and license conditions; and (3) Require the supervicing authorized nuclear 1; Or utheri:^d user te periodically revi^w the "R w^ofpharmacist er physician 20 the supervised i" divide:1 :: it pertain; to 'repari"g byproduct "eterial for -^dic:1 use and th0 r^"^"t !^^t !0 T0fl^"! ! 2! '; Ort . (c) A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual. [51 F9 25951. Oct. 16. 1991. :: :m nded at 55 FR 21121, July 25. 1991, 59 rR 51782, M . 2. 100i] Section 35.29 Administrative requirements that apply to the provision of mobile nuclear medicine service.
.(a) The Comission will license mobile nuclear medicine service only in
UNSEALED BYPRODUCT MATERIAL 15 August 11, 1997 LOW DOSE WORKING DRAFT accordance with subparts D-and E and-H of this part and Section 31.11 of this chapter. (b) Mobile nuclear medicine service licensees shall obtain a letter signed by the management of each client for which services are rendered that authorizes use of byproduct material at the client's address of use. The mobile nuclear medicine service licensee shall retain the letter for three years after the last provision of service. (c) If a mobile nuclear medicine service provides services that the client is also authorized to provide, the client is responsible for assuring that services are conducted in accordance with the regulations in this chapter while the mobile nuclear medicine service is under the client's direction. (d) A mobile nuclear medicine service may not order byproduct material to be delivered directly from the manufacturer or distributor to the client's address of use. [51 FR 36951. Oct.16,1986, as amended at 53 FR 19247, May 27, 1988)
UNSEALED BYPRODUCT MATERIAL 16 August 11. 1997 WORKING DRAFT LOW DOSE Section 35ixx Identification of Pregnant or Breast-feeding Women. The licensee shall establish and implement policies and procedures to provide reasonable assurance that a radiopharmaceutical will not be unintentionally administered to a pregnant or breast feeding woman. Section 35.31 Radiation safety program changes. (a) A licensee may make minor changes in radiation safety procedures that are not potentially important to safety, 4 .c. - in isorter41-shan9eGr amendment except that were for described in the application for license, renewal Of Sueh those chan w4,4m-41es ,3399es-4 in Sections ,;+id^-. ~435.13 - _1 4 + i. ".", +vand
. '. ar,~r_ 35.606 of this part. D:a ple
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- reportable medicallevent.
1 (a) Fora-ic:&4nie,trntesreportabl_elmedical[ event: (1) The licensee shall notify by telephone the NRC Operations Center 2 / no later than the next calendar day after discovery of the -1 :&i-istrat9n reportableimedicalfevent. 2 / The commercial telephone number of the NRC Operations Center is (301)
~
816-5100, l -- (2) The licensee shall submit a written report to the ap3ropriate NRC Regioral Office listed in 10 CFf< 30.6 within 15 days after ciscovery of the m494.'inistratio^ reportable"medicalievent. The written report must include the licensee's nam 6 +.'.~^ ~.^ . y ",v,i "T. i. ^, "r . .,"*., 4. 4. .' . ' ', - . ~ ^ . ' a brief description of the event: why the event occurred: the effect on the "di"1& ?.c r^"ci"cd
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h (b)-Each licensee shall retain a record of each mitadministratic" reportable'medicaltevents for 5 years. The record must contain the names of all individual:. involv'ed"(including the 3rescribing physician, allied health 66 s n m 4. .r, sA v .m. i. n. 4. e.t. e. .s t. 4. an, J aunl MAi i s i v i Vau pers.onne1i LIle i ,n.A. 1
- 4. u. 4. A..s i.s 1 u..h.v n e,www e n i. o. nwA. &. w individual, and that individual's referring physician, if applicable), the ~
indi~vidual's involved patient'sLor human ~researchtsubject's social security number or other' identification ~ number if ~one has' been assigned, a brief description of the -itadministration reportable medicallevent, why it occurred, the effect on the individual improvements"n'eeded to prevent recurrence, and the actions taken to prevent recurrence. Nothing in this section f m. r ,u. 4. (C).Ae4A- - - + u..n . w -n~.+ 4. f 4. r a. . i. wnn. . . w ,m~ . . +. . ,, affects any rights or duties of licensees and physicians in relat. on i to each other to individuals receiving -itadmiristration involvedlintreportable medical events, or to that individual's responsible" relatives ~or guardians. [56 FR 34122. July 25. 1991, as amended at c9 FR 14086. Mar. 25, 1994: 60 FR 48626. Sept 20, 1995) e_nr w.v+ 4 ~, .ww. , e A <o eawyy, m , 4, ~. ie, . (~.
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Subpart C--General Technical Requirements
lUNSEALEDBYPRODUCTMATERIAL 20 August:11. 1997 LOW-DOSE WORKING DRAFT -; Section 35.50 Possession, use, calibration, and check of dose calibrators. 1
. . - (a)sThis ;sectionTdoesYhot%1y;to(unit %sges Toffphotoniemitting . . .
radionuclides'that;aresobtainec from:aimanufactureelor/preparerglicensed pursuantitol10;CFR;32.72;ordequiyalentjAgreementistateirequirementst~~~' (ab) A licensee shall possess and use a dose calibrator to measure the activity of dosages, ekeept4forJunitidodgesi of photon-emitting radionuclides : prior,to administration ~to"sach~ patient'or"h0 man research subject. (bc) A licensee shall: (1) Check'each dose calibrator for constancy witn a dedicated check source
- at the beginning of each day of use. To satisfy the requirement of this paragraph. the check must be done on a frequently used setting with a sealed
! source of not less than 10 microcuries of radium 226 or 50 microcuries of any: 1' other photon emitting radionuclide: (2) Test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, 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 a range from the highest dosage that will be administered to a patient or human research subject to 1.1 megabecquerels (30 microcuries): and-(4) Test each dose calibrator for geometry dependence upon installation over the range of vo.umes l 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) A licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator. (d) A 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 if the accuracy or constancy error exceeds 10 percent. ' (e) A' licensee shall retain a record of each check and test required by this section.-for three years unless directed otherwise. The records required in paragraphs (b)(1) through-(b)(4) of this section must-include:
~.(1)--For paragraph:(b)(1) of this section.- the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check
-source. the date of the check, the activity measured.'and the initials of the
' individual who performed the check:
(2) For paragraph (b)(2) of this-section. the model and serial number of the dose-calibrator, the model and serial number of each source used, the- - identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the identity of the individual
- performing the test.
qw 4--'C'8
--- - y v re e'- "'- 94W w
s UNSEALED BYPRODUCT MATERIAL 21 August 11, 1997 LOW DOSE -WORKING DRAFT (3) For paragraph (b)(3) of this section, the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the identity of the individual performing the test. (4) For paragraph (b)(4) of this section, the model and serial number of the dose calibrator, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the identity of the individual performing the test. [51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988: 59 FR 61783, Dec. 2, 1994) Section 35.51 Calibration and check of survey instruments. (a) A licensee shall calibrate the survey instruments used to show compliance with this part before first use, annually, and following repair. The licensee shall: (1) Calibrate all scales with readings up to 1000 millirem per hour with a radiation source: (2) Calibrate two separated readings on each scale that must be calibrated; and (3) Conspicuously note on the instrument the apparent exposure rate from a
- dedicated check source as determined at the time of calibration, and the date of calibration.
(b) When calibrating a survey instrument, the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or graah to the instrument. (c) A licensee shal' check each survey instrument for proper operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks. (d) A licensee shall retain a record of each survey instrument calibration ! for three years. The record must include: (1) A description of the calibration procedure: and (2) The cate of the calibration, a descri ation of the source used and the certified exposure rates from the source, anc 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. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247. May 27_, 1988] Section 35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides. (a) This section does not apply to unit dosages of alpha- or beta-emitting radionuclides 0 that arc Obtained fro- a n nufacturer Or prep rcr 3 ui4:10nt ^.grec=nt St:tc requirc= nts. lice (b)^ sed For purruant other thanteunit 10 dosages CFP 32.72 obtor 0^'ained pursuant to paragraph (a) of this
L UNSEALED BYPRODUCT MATERIAL 22 August 11, 1997 LOW DOSE WORKING DRAFT section, a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject, In addition, the licensee shall: (1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity. and geometry dependence, as appropriate for the use of the instrument: and make adjustments when necessary; and (2)Checkeachinstrumentto7 ensure 4GFConstancyandproperoperation?at ~ the begira4ng Of each d:y of MC E69 FR 61783, Dec. 2, 19943 Section 35,53 Measurc=nt Determination of dosages of unsealed byproduct material for medical use ' r Alicenseeshall: determine"andLrecordtheactivitif~of:eachdosag~e"at?the ~~ " "~ ~ time of administrationifor' medica 1Tuse. '
._ (a)ForjaunitdosageuthisdeterminationEmaybe~madeLeither~birdifect
~
measurement = or by~'aldecay~ correction,c basedton the measurement' made byf~the
'~ ~ ~ ~ ~ ~ " ~ ~ ^ ' " ~ ~ ~
32[72fsupplier; (b);For-a dosage ofJa? photon'-emitting"radionuclideUpreparedLbf"Tthe ~~ this determination must.be1made byfdirectimeasurement:~~ licenseen?Forsa
(c) dosage of anialphagoriasbetalemittingiradionuclideXpfeiarEd byiLthe license ' this ; determination mayt be made'by~ direct!.measurementior; >y^;a '~ "~' ~ ~ ~ ~ ~ " ~ ~ ~
combination:;ofmeasurementland;calcul.ation] d (a) Mc=re the activity of cach do::ge of a photon e-itting radionuclide prior to cdical use. (b) Measure, by direct caturement or by cc-bination of mes:urement: and calculations, the activity of each do::ge of an alph: Or a bet 0-itting radionuclide prior to cdical use, except for unit dO :ge: Obtained frc 0
- nufacturer er preparer 'icerred pursuant to 10 CFR 32.72 cr equivalent Agrec=nt State require =nts:
(Ed) Retain a record of the =: urc=nt determinations required by this section for three years To satisfy this requirement ' the'irecord must contain the: (1) Radfonuclide? Ggeneric name, trade name, or abbreviation of the radiopha'rmabeutidal./ a w,.u a~ - and its lot number, and expiration date: :nd the
' ~'
' ~ E i'Pa' tie'nt's or human research subject's name, and 6E identification number if one has been assigned:
(3) Prescribed dosage and activity of the dosage at the time of mcSurcm:nt,administrati;on,oranotationthatthetotalactivityislessthan
4 UNSEALED BYPRODUCT MATERIAL 23 August 11. 1997 LOW DOSE WORKING DRAFT 1.1 megabecquerels-(30 microcuries): and (4) Date and time of the catur=0ntfsdministMtibn3 -ad (5) Initial: Of the individual Mc nde'thM5cofd.~^ gR {5( Oy6.1985 :: sended at 53 FR 192" May 27.1938; 59 FR
- . . . . ~ . . . ~ . ,
A Section 35.57 Authorization for calibration and reference sources. Any person authorized by Section 35.11 of this part for medical use of-byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use: (a) Sealed sources manufactured and distributed by a person licensed pursuant to Section 32.74 of this chapter or equivalent Agreement State regulations'and that do not exceed 15 millicuries each: (b) Any byproduct material listed in Sections 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 Sections 35.100 or 35.200 with a half-life longer than 100 days in individual amounts not to exceed 200
' microcuries each: and (d) Technetium-99m in individual amounts not to exceea 50 millicuries.
Section 35.59 Requirements for possession o_f sealed sources and brachytherapy 50erces. (a) A licensee in possession of any sealed source er brachytherry 50urce shall follow the radiation safety and handling instructions suppliec by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users. (b) A licensee in possession of a sealed source shall: (1)' Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee: and (2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State and described in the label or brochure that accompanies the source. (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 volume as the sample:
(2) Take teletherapy and Other device sarcc t0 t ::=ples een the 50erce it in the "Off" p0 ition: and -
i UNSEALED BYPRODUCT MATERIAL 24 August 11. 1997 LOW DOSE WORKING DRAFT (32) Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample. (d) A licensee shall retain leakage test records for five 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) Imediately withdraw the sealed source from use and store it in accordance with the requirements in parts 20 and 30 of this chapt e : and (2) File a report within five days of the leakage test with the appropriate NRC Office listed in Section 30.6 of this chapter, with a copy to Director. Office of Nuclear Material Safety and Safeguards. U.S. Nuclear i Regulatory Commission. Washington. DC 20555, describing the equipment involved, the test results, and the action taken. (f) A 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: (3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha-emittirg material: and (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within six months before the date of use or transfer: ad IEi CanAr af 4 e4 A4i mi 10") nnesenA
~
4n nulnn eshhnn (95AlIbensee'iniossessionbfa'seaieisou~rci5rbrachytherapycource shall conduct a quarterly abysical inventory of all such sources in its possession. The licensee slall retain each inventory record for five years. 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 nominal activity, the location of each source, and the signature of the Radiation Safety Officer. (h) A licensee in possession of a sealed source Or brachytherapy 50urc0 shall measure the ambient dose rates quarterly in all areas where such sources are stored. This doc" =0t apply to teletherapy cource: in teletherapy unit; Or ensinA e ~ni irr ae in A4snnnet4e
~ '
Anu4rne
'~
(Y) ~A lic'e~ns'e[s5aTl r'e'tain"a' rec'ord of each survey required in paragraph (h) of this section for three years. The record must include the date of the survey. a plan of each area that was surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the survey instrument used, and the signature of the Radiation Safety Officer. [51 FR 36951. Oct. 16. 1986, as-amended at 52 FR 31611. Aug. 21. 1987: 53 FR 19247. May 27. 1988) n 35.60 Shielding?and) labeling]f3ials3nd[ syringes Syr4"ge chicid: and
UNSEALED BYPRODUCT MATERIAL 25 August' 11. 1997 LOW DOSE WORKING DRAFT (a) ^ 'icenre shal' keep syr4"ge that contain byproduct material to be d inistered in a radiation chield. (b) To identify 1t: contents, a ' ice"=c chall con picucutly label cach GyN^ge or syringe radiation bicld that contain : cyringc "ith a radiopharmaceutical. The label must shove the radiophar aceutical name or it; abbreviation. the clinical procedure to be performed. Or the patient's or the hu ar research subject *: -ame. (c) ^ 'icensee cha'l require cach individual "hc prepare a radiophar aceutical 'it to unc : cyringe radiation sbicld vhe" prc:aring the kit and chal' require cach individual to unc : Cyringe radiatic" c'icld '.-hen ad-irister4ng ? radiopharmaceutics' by injection unles the use Of the chield is C0"traindicated fc- that patient or human rc:carch subject. i smnnAnA Co CD 9 i.oO A,1 frr i. C D. _Of DR~ 1. . / _V & . i. f. . i. n_or , .s.se__ _3+ ~ , f.1. ".10 A.~. -. fh . ~ (a)JLicenseesshalliinstruct"individualsWhoiprepare"6Kadminidter radiopharmaceuticals:in the proper,_ shielding of radiopharmaceuticakvials andi; syringes containing byprodugt materialxand in the properfusecof syringe radiation shields.
~(b) Licensee shallihave written ~policie nand proceduresLforilabeling~of a radiopharmaceutical vials and syringes; ora syringe. radiation shieldstt'o ~
minim 12e>the5likelihood;of terrors:in administrations. C nrv + 4 nn. m.
, 9C sn v f1 wwww U, 4 ru31, c
s
- h. 1si n1, usAr u..A u 1. u w w 1r.shale
'a) ^ licensce chall require cach individual preparing or hardling a vial that contain a radiopharmaceutical to keep the vial in a "ial radiation chield.
(b) Tc identify its centents, a licensec chall conspicucutly labe' cach via' radiation chield that contain a vial of a radiophar aceutical. The label uct chee; the radiopharmaceutical name or it: abbreviation Section 35.70 Surveys for contamination and ambient radiation exposure rate. (a) A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely arepared for use or administered. (b) A 'icensee shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste is stored. (c) A licensee shall conduct the surveys required by paragraphs (a) and (b) of this section so as to be able to detect dose rates as-low as 0.1 millirem per hour. (d) A licensee shall establish radiation dose rate trigger levels for the surveys required by paragraphs (a)-and (b) of this section. A licensee shall recuire that the individual performing the survey immediately notify the Raciation Safety Officer if a dose rate exceeds a trigger level.
. (e) A licensee shall survey for removable contamination once each week all
. UNSEALED BYPRODUCT MATERIAL 26 August 11. 1997 LOW DOSE WORKING DRAFT areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
(f) A licensee shall conduct the surveys required by paragraph (e) of this section so as to be able to detect contamination on each wipe sample of 2000 disintegrations per minute. (g) A licensee shall establish removable contamination trigger levels for the surveys required by paragraph (e) of this section. A licensee shall recuire that the individual performing the survey immediately notify the Raciation Safety Officer if contamination exceeds the trigger level. (h) A licensee shall retain a record of each survey for three years. The record must include the date of the survey, a plan of each area surveyed, the trigger level established for each area, tne detected dose rate at several points in each area expressed in millirem per hour or the removable
' contamination in each area expressed in disintegrations per minute per 100 square centimeters, the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
[51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988) Sectior35.759elcateof[natientsorhuarresearchsubjectscontaining radiopharmaceutic l Or permanent i= plants. (a) .^ 'icen:ce may not authoriac relca:0 from confinement for medica' care any patient or humar rc carch subject administered a radiopharmaceutical urt41 n4ther. V Y bf3%T q (1) The measured doce rate ' rom the "atient er the human research subject is 1000 thar 5 -11'4 rem: per hour at a fistance of 1 eter; or (2) The activity in the patient or the human recar@ cubject is le than 30 -illicuries. (b) ^ 11cen ce ay not authoriac relcate from confinement for medical carc of any atient or hum:n rc carch subject administered a permanent impM until tic ~^ Sured donc rate frc- the patient or the human rescarch subject is 10 ; than 5 ~4irem: per hour at a distance of 1 =cter rt o
- C, D, C.17. 0 A. . f_bu- . O
-.i. nn~ A., '1
-Section 35.75 is raised to read as follows:
Section 35.75 Release of individuals containing radiopharmaceuticals of
;'^"="^^t 4 ";'10"t c .
(a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent 1 plants cc^taining radicactive materia' if the total effective dose equivalent to any other individual from exposure to the released individual is (
. _ - \
UNSEALED BYPRODUCT MATERIAL- 27 August 11. 1997 LOW DOSE WORKING DRAFT not likely to exceed 5 millisieverts (0.5 rem).2 (b) The licensee shall provide the released individual with instructions, including written instructions, on actions recomended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem).- If the dose to a breast-feeding infant or child could exceed 1 mil 11 sievert (0.1 rem) assuming there were no interruption of. breast-feeding, the instructions shall also include: (1) guidance on the inte_rruption or discontinuation of breast-feeding and (2) information on the rationale guidance.]and potential, consequencessiflanyi of failure to follow the (c) The licensee shall maintain a record of the basis for_ authorizing the release of an individual, for 3 years after the date of release. if the total effective dose equivalent is calculated by (1) using the retained activity rather than the activity administered. (2) using an occupancy factor less than 0.25 at 1 meter, (3) using the biological or effective half-life, or (4) considering the shielding by tissue. (d) The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem). Section 35.80 Technical requirements that apply to the provision of mobile nuclear medicine service. A licensee providing mobile nuclear medicine service shall: (a) Transport to each address of use only syringes o? vials containing prepared radiopharmaceuticals or radio)harmaceuticals that are intended for reconstitution of radiopharmaceutical (its: (b) Bring into each address of use all byproduct material to be used and, before leaving, remove all unused byproduct material and all associated waste: (c) Secure or keep under constant surveillance and-imediate= control all= byproduct material when in transit or at an address of use: (d) Check survey instruments and dose calibrators as described in Sections 35.50 and 35.51. and check all other transported equipment for proper function before medical use at each address of use: (e) Carry a radiation detection survey meter in each vehicle that is being used to transport byproduct material, and, before leaving a client address of use, survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure that all radiopnarmaceuticals and all ascoriated waste have been removed: (f) Retain a' record of each survey required in paragraph (e) of this section for three years. The record must include the date of the survey, a C . Regulatory Guide 8.39, " Release of _ Patients Administered Radioactive Materials," describes methods- for calculating doses to other
-individuals and contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).
~ _ _ _ . _ _ _ _ . .~ . _ _ _ _ ___ _
w UNSEALED BYPRODUCT MATERIAL 28 August:11, 1997 LOW DOSE WORKING DRAFT plan of each area that was surveyed. the measured dose rate at several points in each area of use expressed in millirem per hour, the instrument used to make the survey and t1e initials of the individual who performed the survey. (51 FR 36951, Oct.16,1986. as amended at 53 FR 19247. May 27, 1988) Section 35.90 Storage of volatiles and gases. A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shipper's radiation shield and container. A licensee shall store a multi dose container in a fume hood after drawing the first dosage from it. Section 35,92 Decay-in storage. (a) A licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of Section 20.2001 of this cnaater if it: (1) Holds byproduct material for decay a minimum of ten half-lives; (2) Monitors byproduct material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding: (3) Removes or obliterates all radiation labels: and (4) Separates and monitors each generator column individually with all radiation shielding removed to ensure that it has decayed to background radiation level before disposal. (b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section for three years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used. the background dose rate, the dose rate measured at the surface of each waste
- container, and the name of the individual who performed the disposal.
[51 FR 36951. Oct.16.1986, as amended at 53 FR 19247. Hay 27, 1988: 56 FR t 23472. May 21, 1991: 58 FR 67660. Dec. 22. 1993) Subpart 0--Uptake, Dilution, and Excretion Section 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies (except4studiestinvolvingiidosagestof
~ ~^~
t sodiumTiodides131?in
~ ~ ' ~ ' ~ ~ ' ~
entit1(greateithan130 mi.c_rocuries). 2 A licensee may use for u)take, dilution, or excretion studies any unsealed byproduct materia 1Eexcepticosages?offsodiuniTiodide51s131?liniquantities
' greater 1thanT30?microcuriesTprepsed"for medi' cal Use~that~i"s' eith'er'T ~'
" ^(a)'Obtained froma manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements: or
UNSEALED BYPRODUCT MATERIAL 29 August 11. 1997 LCM DOSE WORKING DRAFT (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specifiec in Section 35.920. or an individual under the supervision of either as specified in Section 35.25. [59 FR 61784. Dec. 2. 1994) Section 35.120 Possession of survey instrument. A licensee authorized to use byproduct material for uptake, dilution, and excretion studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour. Subpart E- Imaging and Localization Section 35.200 Use of unsealed byproduct material for imaging and localization studies (except studies involving dosages of Lsodium . iodide!I-131?i_n quantities greater than 30 microcuries). A licensee may use for imaging and localization studies any unsealed byproduct material, except dosages of sodium' iodide 1-131 in quantities greater than 30 microcuries, prepared for medical use that is either: (a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist. a )hysician who is an authorized user and who meets the requirements specifiec in Section 35.920, or
- an individual under the supervision of either as specified in Section 35.25.
[59 FR 61784. Dec. 2. 1994) Section 35.204 Permissible molybdenum-99 concentration. (a) A licensee may not administer to humans a radiopharmaceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium 99m. (b) A licensee that uses molybdenum-99/ technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in the' first eluatelor extract andLat the7beginning;of ea'ch week.Jof medical'use.ato~ demonstrate. compliance;with;(a) ~eac r luate c or (c) A licensee that must measure molybdenum concentration shall retain a record of each measurement for three years. The record must include, for each measured elution or extraction of technetium-99m. the measured activity of the technetium expressed in millicuries, the measured activity of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the time and date of the measurementi. and the iritiah of the %dividual He made the measurement.
e l i 30 August 11. 1997 UNSEALED BYPRODUCT MATERIAL WORKING DRAFT LOW DOSE- [51 FR 36951. Oct. 16, 1986 -as amended at 53 FR 19247.-May 27, 1988) Section 35.205 Control of aerosols and gases. (a) A licensee that administers radioactive aerosols or gases shall do so , in a room with a system that will keep airborne concentrations low enough so. as not to exceed the limits >rescribed by Sections 20.1201 and 20.1301-of this chapter. The system must eitler be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container. (b) A licensee shall administer radioactive gases only in rooms that are at negative pressure compared to surrounding rooms. (c) Before raceiving, using, or storing a radioactive gas, the licensee
'shall calculate the amount of time needed after a spill to reduce the concentration in the room low enough so as not to exceed the limits prescribed by Section 20.1201 of this chapter. The calculation must be based on the highest activity of gas handled in a single container, the air volume of the room, and the measured available air exhaust rate.
(d) A licensee shall make a record of the calculations required in paragraph (c) of this section that includes the assumptions. measurements, and calculations made and shall retain the record for the duration of use of the area. A licensee shall also post the calculated time and safety measures to be
-instituted in case of a spill at the area of use, (e) A licensee shall check the operation of reusable collection systems each month, and measure the ventilation rates available in areas of radioactive gas use each six months.
[51 FR 36951. Oct. 16, 1986, as amended at 53 FR 27667 July 22, 1988: 59 FR 41643. Aug. 15, 1994) Section 35.220 P0zczion Of curry instr =cnts.
^ 11cen ce authori cd to u 0 bypr0 duct = teri:1 for d=ging and locali:: tion studies shal' have in it ^0zczien a port:b!c radiation
'i det= tion curvey instr =cnt apable Of detecting d=0 ratz Over the range of 01 -1' lire per 50er to 100 -"11"= per 50ur and : port:ble radiation c=urc=nt survey instr =cnt apable of =nuri g d=0 r:t= Over the range 1
'"i"4 r= per hour to -1000 -ill4 r= per hour Section 35.220 Possession of survey instrument.
- A licensee authorized to use byproduct material-for imaging and localization
. studies shall have in its possession a portable radiation detection survey-instrument capable of detecting dose rates over the range r of 0.1 millirem per hour to 100 millirem per hour, and ~(eiceptiforilicehsees kh&are"anthorized MMEfM(ugiy[dosagp1 a portable radiation'"mds0'rennt~suWsy ^instbusnt"~
o e
-UNSEALED BYPRODUCT MATERIAL 31 August 11, 1997 LOW DOSE WORKING DRAFT capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.
Subpart J f--Training and Experience Requirements Section 35.900 Radiation Safety Officer. Except as provided in Section 35.901, the licensee shall require an individual fulfilling the res)onsibilities of the Radiation Safety Officer as provided in Section 35.32 to )e an individual who: (a) Is certified by: (1) American Board of Health Physics in Comprehensive Health Pnysics: (2) American Board of Radiology: (3) American Board of Nuclear Medicine: (4) American Board of Science in Nuclear Medicine: (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy: (6) American Board of Medical Physics in radiation oncology physics: (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine: (8) American Osteopathic Board of Radiology: or (9) American Osteopathic Board of Nuclear Medicine: or (b) Has had classroom and laboratory training and ex)erience as follows: (1) 200 hours of classroom and laboratory training tlat includes: (1) Radiation physics and instrumentation: (ii) Radiation protection: (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology: and (v) Radiopharmaceutical chemistry; and (2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material: or ! (c) Be an authorized user identified on the licensee's license. [51 FR 36951. Oct. 16. 1986, as amended at 59 FR 61786. Dec. 2. 1994) Section 35.901 Training. for experienced Radiation Safety Officer. An individual identified as a Radiation Safety Officer on a Commission or
. Agreement State license before October 1. 1986 need not comply with the training requirements of Section 35.900.
Section 35.910 Training for uptake, dilution and excretion studies (#8@
O 4 32 August 11. 1997 UNSEALED BYPRODUCT MATERIAL WORKING DRAFT l LOW DOSE ' diagnostic studies involving'dosageslof sodium;iodidef1713111n quantities greater than 30-microcuries). l Except as provided in Sections 35.970 and 35.971, the licensee shall reauire the authorized user of a radiopharmaceutical in Section 35.100(a) to l be a physician who: (a) is certified (1) Nuclear medicine 4n bh the American Board of Nuclear Medicine: (2) Diagnostic radiology by the Aufrican Board of Radiology: or (3) Diagnostic radiology or radiology by the.tcerican Osteopathic Board of Radiology: (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada: or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine a medical specialty board whose certification process-includes all' of the ~ training and experience requirements in 635,910(b) of. this section and whose certification has been accepted by the NRC: or (b) Ha had classrocm and laboratcry training in basic radici:ctope 1icable to the use of prepared radiopharmaceuticals, handling and super" techaique ap^T experience as follce: iced clinica (1) 10 hour;. Of classroom and laboratory trairi"g that in 8 de : (i) Radiation phy'.ic and 4" trumentation: 44i) Radiation protection: (iii) Mathematics acrtai-ing to the use and merurement of radicacti"ity. (iv)RadiationbicIcgy.a^d (v) Radiopharmaceutica' chenistry, and (2) 20 hour; of supervised cli"ical experience under the supervision c' an authorized user and that includes: (i) Examin4"g patients or Mmar rc:Carch subject and-review ng th^4- ease 4 historie to deter""nc their sui 4ebi'ity for radici 0tcpc diagnctis, ! li"'itat4cnc. Or contrai"dications: (ii) Select 1"g the suitabic radioph&Fm&GeutiC8 Snd C8ulati"O and measuring the dccages; 4444 ^dmirister4ng-dssage; to patient or human rc carch subject: and
~
using syri~;c radiation chicidM (iv) Collabcrating ' ith the authorized user 4" the 4nterpretation of radicinctope test results: and (v) Patient er Nmar research subject followup (b)! Has :' completed' 40 hourslofJtraining that' ~includssT cl assroom and laboratory training and supervised work experience in basic radioisotope _ handling techniques apphcablesto,the use of; prepared radiopharmaceuticals; ! ~ The classrcom'and"1aboratory training shall:iincliideF
~
i (i)cRadiation physics and instrumentation: l (ii) Radiation protectionF ' ~ o f (iii)~ Mathematics pertaining to'the"use and'measUrementTofTradi~a'ctivity:
^
[(1v);Radiopharmaceutical, chemistry: and ~ l l t I i l
1 a l l l UNSEALED BYPRODUCT MATERIAL 33 August 11, 1997 LOW DOSE WORKING DRAFT
-(v)? Radiation 1 biology l TheTuperVised workleiperience under[the;Tsuper.visionTof~an. JauthorizedTuser.
^(1)' Ordering, receiving 1and' unpacking l radioactive _'materialsisafelyland performing the related radiationJsurveys:
'(11) Calibrating dose calibrators and diagnostic. instruments and performing checks for' proper 1o>eration.of survey. meters:
, i(iii) Calculating.and safe'yLpreparing patient g humanjresearch~; subject dosages:
'(iv)LVsing administrative controls to prevent" error, in theladministration
~ ~ ~ ~ ~ ' ~ ~ ' ~
of:byp)roductarocedures
~~
material;.-and(v .Using' byproduct materialfsafely;;and toicontainispilled ~ ' using proper;cecontamination procedures.-
+-en (c) PS: succe;; fully co=pletGj si" month training progra"' 4r nuclear m!icine as part of a + raining progra-' that has beer approved by the Accreditation Counci' for Graduate Medical Education and that included clastroc -and laboratory training, work experience, and superviced clinical experience ir all the topics identi'ied in paragraph (b) of thi Section (51 F9 36951. Oct. 15. 1985, a; a ended it 59 " 61786. Dec. 2. 1991)
Section 35.920 Training for imaging and localization studies (except diagnosticistudies involving dosagesiofisodium iodide;I-131 in; quantities greater than. '30 microcuries). Except as arovided in Section 35.970 or 35.971, the licensee shall require the authorizec user of a radiopharmaceutical, generator, or reagent kit in Section 35.200(a) to be a physician who: (a) Is certified in by : (1) Nuclear medicine by the American Board of Nuclear Medicine: (2) Diagnostic radiology by the American Board of Radiology: (3) Dia Radiology: gnostic radiology or radiology by the American Osteopathic Board of (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada: or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine aTmedical? specialty board %ose?ertification process:: includes 1alliof the training and experience lrequirementsfin? 63Si920(b):of this:sectioniandtose '
~ ~ ~ ~ '
certifigation has;been; accepted byytheLNRC:'"or ~ ~ ' s (b) Has had completedV120;hodr;5Tofitralhihg thhtlincTudesi classroom and laboratory training 'and supervised :workJ experience ~ in ' basic ~radioi sotope handling techniques applicable to the"us~e of~prejared radiopharmaceuticals, generators, and reagent kits; and supervised wor; experience .
UNSEALED BYPRODUCT MATERIAL 34 August 11, 1997 L0rl DOSE WORKING DRAFT The superv1:cd clinical experience at follow to 4"clude: (1) 200 hours j e4 classroom and laboratory training shall -that includes: l l (1) Radiation physics and instrumentation: , (ii) Radiation protection: (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiopharmaceutical chemistry: and (v) Radiation biologyp;--and The 424 500 hours of supervised work experience under the supervision of an authorized user shall that includes: (i) Ordering, receiving. and unpacking radioactive materials safely and performing the related radiation surveys: (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters: (iii) Calculating and safely preparing patient or human research subject dosages: (iv) Using administrative controls to prevent the ricadetaistration errors inithe-administrationofbyproductmaterial:
' ' (v)'Using 3rocedures to contain spilled byproduct material safely and and
- using (vi p) roper cecontamination procedures:Eluting technetium-99m from generato the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; -and sm (3) 500 hours of supervi,ced ".lirical experience under the supervision Of ur. ww. m,s vo + s , 4.wu.,. mauss, o,m. + s.s w +.
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d 1 i 35 August 11, 1997
- UNSEALED BYPRODUCT MATERIAL WORKING DRAFT i LOW DOSE Section 35.970 Training for experienced authorized users.
i Physicians. dentf:tc. Or p0 districts-identified as authorized users for the medical. dental. Or pedistric use of b Agreement State license issued , 1. before Apr4{ 19# XX/XX/XX whoproduct caterial o perform only those methods of use for which they were authorized ori~that'date need not comply with the training requirements of subpart J. 4 Section 35.971 Physiciar training 1= a three -nth program
^ physician who. before July 1. 1991. began a threc Onth nuclear medicine training program appr0"Od b" the Accreditation Counci' for Graduate '!cdical Education and h : Succes; fully co pleted the program need ^0t co ply with the requirc ent: Of Section: 35.910 or 35.920 Section 35.972 Recentness of training.
The training and experience specified in this subpart must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. [59 FR 61786. Dec. 2. 1994] Section 35.980 Training for an authorized nuclear pharmacist. The licensee shall require the authorized nuclear pharmacist to be a pharmacist who: (a) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical S>ecialties, or (b)(1) Has comp'eted 700 hours in a structured educational program consisting of both: (i) Didactic. training in the following areas: (A) Radiation physics and instrumentation: (B)-Radiation protection: (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use: and (E) Radiation biology; and (ii) Supervised experience in a nuclear pharmacy involving the following: (A) Shipping, receiving, and aerforming related radiation surveys: (B) Using and ]erforming chects for proper operation of dose calibrators, survey meters, anc , if appropriate, instruments used to measure alpha- or beta-emitting radionuclides: . (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects: (D) Using administrative controls to avoid mistakes in the administration
, a L
- UNSEALEDIBYPRODUCT MATERIAL 36 August 11, 1997 ,
LOW: DOSE WORKING DRAFT
= of byp)roduct material:(E Using procedures'to prevent or minimize contaminatio decontamination procedures: and
-(2);Has obtained written certification, signed by a preceptor authorized ,
nuclear pharmacist, that the above training has been satisfactorily. completed t and that the individual has achieved a-level of competency sufficient to independently operate a nuclear pharmacy. [59 FR 61786. Dec. 2, 1994] Section 35.981' Training for experienced nuclear pharmacists. A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before ' - it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in
-Section 35.980(b)(1) before December 2, 1994, and who is working in a nuclear t
-pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with the requirements on preceptor
- statement (Section 35.980(b)(2)) and recentness of training (Section 35.972)
- to qualify as an authorized nuclear pharmacist.
i
-[59 FR 61787. Dec. 2. 1994: 59 FR 65244. Dec. 19, 1994]
i Section 35.990 Violations. (a)-The. Commission may obtain an injunctio'n or other court order to prevent a violation of the provisions of-- (1) The Atomic Energy Act of 1954, as amended: (2) Title II of the Energy Reorganization Act of 1974. as amended; or-(3)=A regulation or. order issued pursuant to those Acts. -
-(b) The Commission'may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:
(1)-For violations of--
. (i) Sections 53. 57, 62. 63 : 81, 82.101. -103,104,107, or 109 of the ;
Atomic Energy'Act of 1954.-as amended: _ (ii) Section 206 of the Energy Reorganization Act:
-(iii)l Any rule, regulation or order issued pursuant to the sections Jspecified in paragraph (b)(1)(1) of this section _
-(iv) Any term, condition or limitation of any license issued under the
; sections specified in paragraph:(b)(1)(1) of this _section.
(2) For=any violation for which a license may be revoked under section 186 of the: Atomic Energy Act'of'1954, as amended. t . ,
~$
-y a
UNSEALED BYPRODUCT MATERIAL 37 August 11. 1997-LOW DOSE WORKING DRAFT [57 FR 55074, Nov. 24, 1992) - Section 35.991 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for-criminal sanctions for willful violation of. _ attempted. violation of, or conspiracy to violate, any regulation issued under sections 161b,1611, or 1610 of the Act. For purposes of section-223. all the regulations in part 35 are issued under one or more of sections 161b.1611. or 1610, except for the sections listed in paragraph (b) of this section.
--(b) The re9ulations in part 35 that are not issued under subsections 161b.
.1611. or 1610 for the purposes of section 223 are as follows: Sections 35.1, 35.2. 35.7. 35.8. 35.12. 35.15, 35.18. 35.-19, 35.57, 35.100, 35.600. 35.901, '
35.970 -35.971, 35.990, 35.991, and 35.999. [57 FR 55074..Nov. 24, 1992. as amended at 59 FR 61787 Dec. 2. 1994] Section 35,999 Resolution of conflicting requirements during transition _ period. If the rules in this part conflict with the licensee's radiation safety 3rogram as identified in its license, and if that license was approved by the Commission before ^pril 1.1987 XX#XX/XX and has not been renewed since April 1.1987, then the requirements in'the license will' apply. However, if that licensee exercises its privilege to make minor changes in its radiation safety procedures that are not potentially-important-to safety under Section 35.31 of this chapter. the portion changed must comply with the requirements of this part. At Nuclear Regulatory Commission the time of license renewal and thereafter, these amendments to this part shall apply. 5 r- _~}}