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,;- r 'PMTED STATES i
,i- NUC.2 AR 3 EGULATCR'/ CC.', .YlCC:0':
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s _. 3 ... . APR 2 6 1983
;I"0PA.?AT; Enit: Sanuel J. Chil'(, Secretary
,f fice of the Secretary FP.0M: Patricia C. Vacca Joseph Del' edico
'Iaterial Licencia,; Branch Division of Fuel Cycle and 7'atarial ' afety, ', .c3 SUCJECT: STAFF ".E0JI:!":E"TO--PtICFD'G 0?! MECY 33-42 This is la ref arence to Itaa 2 of your .accorandun date I A ril l 19, l') G 3
(;t 03041)), requesting that ue nari: up the staff pronocal with chany that woul:1 catisfy otar concerns. Enclosure 1 is the i _> luac ted qar':-up. In preparin;; t'ais docu.,ent, T:.9S . anacciaent rerpiested that ua: e Consider only substantive concerna of health and safety significance as op*:osed to philosophical issues.
- Co.:plete the project withia 4 - 5 wor::iar; days, s .
l 8 Devote pei..ary attention to the regulation as opposed to the j noplication f or.2. < Uecause of the short turn-around ti ae, this docu.c.er.t is core concept than polished product and representa only one approach to the prooleq. The tns': force coul1 refine this concept or develop a vivle alternative uith input f ro ,t tite Cornission, CLO, othe r ""C O f fices, an<l the Agree-nent States. In the laterast of ti:e we had to nake sone a ssuaptions a!'out the acplication Corr.:. 'lc envialon a form that unn '. i lacorporate features sinilar to [sa;es ?, 5, 6, and 7 of the current r' ora "RC 31? (~ nclocur a 2). The Lafornation on this form wo.il.1 allou a pre-11.cenains determinn-tian of the adenttacy of: 4 Padiation safety procedures and instructiano. 9 Traiain ; and experience of non-board cortific'8 pl.; s t elan s. 4 "acilitica and equicnent. 85092304S5 850906 PDR PR PDR 35 SOFR30616
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Althou,;h the application for:a would request this inforuation and :::!C woul.1 reviev it, the re;,ulation incorporates tne Chair saa's su ,3estion that licensees be given the flenibility to chna;e their procedures without a.cendin;; the licence. (Sea the proposed Section 35.2G2.) Also in the interest of tiae, we re.aoved xenon 133 f rom Subpart E (Section 33.200). Xenon requires special ventilation, equincent, calculations, and procedures. Our quick repair would require the applicant to apply for specific authorization by submittin : in f o r: nation si;ilar to that requested in Appendix 'I of the current leculatory Guide lo.S (Enclosure 3). It eay be possible to establish a new subpart for radioactive 3ases and place all of the necessary requireuents directly into the regulation, but this of fort 'roul1 take core tiae than we have been allotted. Enclosure 4 la a list of additional itcas that should be exm ined before the rule is published in proposed form. tlhile these are pert'aps less
" substantive" than the issues that our nark-up addresses, we believe that they should be resolved 1,cfore publication.
)U eA-.
Patricia C. Vacca Joseph Deliedico
!aterial Licensing Granch niviaion of Fuel Cycle and
;aterial Safety
Enclosures:
- 1. :Iarked-up revision of 10 CFil 35
- 2. Fora ';RC-313:i
- 3. Appendi: 5 h of Reculatory Guide 10.'!
- 4. !!eco..wendations for other chan.;os ta the revulation cc u/ encl:
- !J! alker, .' MSS VL:. iller, V:13S D1Chapell, l'MS3
" d Ce n dingb ac. , 4:3S Dadausahardt, :NSS JGDavis, J.iss
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[7590-01]
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35.31(a)(4)and(a)(5),35.32(f)-(i),35.34(c),35.37(a)-(d),35.50(d), 35.51(e), 35.53(c), 35.59(d) and (e), 35.59(g) and (i), 35.70(d), 35.80(f), 35.92(b), 35.204(c), 35.304, 35.404(b), 35.405, 35.610, 35.621(e),35.630(c),35.632(g),_35.633(j),35.641(c),35.642(c),35.644, and 35.645(c) are issued under sec. 1610, 68 Stat. 950 as amended (42 U.S.C. 2201(o)). Subpart A -- General Information _. 6 35.1 Purpose and scope.
.y This part prescribes requirements for issuance of specific licenses
- authorizing the human us,e of byproduct material. This part also pre-scribes requirements for the human use of byproduct material in order to provide for the protection of the public health and safety. The provi-I 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.
S 35.2 License reouired. (a) No person shall manufacture, produce, acquire, receive, possess, use, or transfer byproduct material'for human use except in accordance with a specific license issued by the Commission or an Agreement State
; and as allowed in paragraph (b) of this 'section.
, (b) An individual may receive, possess, use, or transfer byproduct
. material under the supervision of an authorized user as provided to l" , . S 35.38, unless prohibited by license condition, p.
6 35.8 Reporting, recordkeepina, and aoplication recuirements: OMB aporoval. P (a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget for approval as required by the Paperwork Reduction Act (Pub.
, L. 96-511). OMB approved the information collection requirements on 47 Enclosure 1 w- --wv' s-wm e-- _ _ _ _ _ _ _a.--, . . , . _____ _ _ _ _ _ _ _ _ _ . _-_______.___ _ _ _ _ _ .
, [7590-01]
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(1) The OMB control number is (2) OMB approval expires . (b) The apporved information collection requirements include the application, recordkeeping,' and reporting requirements contained in
$$ 35.16, 35.18, 35.30(d), 35.31(a), 35.32(f), (h) and (i), 35.33(b),
35.34(c), 35.35(b), 35.37(a)-(d), 35.50(d), 35.51(e), 35.53(c), 35.59(c), 35.59(d) and (f), 35.70(c), 35.30(e), 35.92(b), 35.204, 35.304(b), 35.404(b), 35.405, 35.604, 35.610, 35.621(d), 35.630(c), 35.632(g), 35.633(e) and (j), 35.641(c), 35.642(c), 35.644, and 35.645(c). S 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.
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" Authorized user" means a physician who is identified as an authorized user on a Commission or Agreement State license that
' authorizes the human use of byproduct material.
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" Human use" means the intentional internal or, external
.administratior) of byproduct material, or the radiation therefrom, to O
human beings.
" Institution" means an organization in which several medical disciplines are practiced. .
" Management" means the chief administrative officer of a licensee.
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" Misadministration" means the administration of:
(1) A radiopharmaceutical or radiation from a sealed source other than the one intended; (2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; (4) A diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than 50 percent; (5) A therapeutic dose of a radiopharmaceutical differing from the prescribed dose by more than 10 percent; or (6) A therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry 48 Enclosure 1
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. [7590-01]
. -1 result ih a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent.
" Mobile service" means the transportation and use of byproduct material for human use and for checks and tests of equipment used in conjunction with human use by the licensee.
" Output" means the exposure rate, dose rate, or a quantity relatedIin a known manner to these rates, for a specified set of exposure conditions.
" 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.
" 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 '
radiation safety officer on a Commission license.
, " Sealed source" means any byproduct material that is encased,in a capsule designed to prevent leakage or escape of the byproduct material.
" Visiting authorized user" means an authorized user who participates
- , in the human "use of byproduct material at a location other than that e
identified on the license ~ that identifies the physician as an authorized user. 6 35.16 Acolication for license, amendment, or renewal. An application for a license, a license amendment, or the renewal of a license for human use of byproduct mgterbthgs provided by this part must be made by filing Form NRC-3134/y 'pplfcation for Materials _ License--Human Use." For use by an' institution, only management may apply. For use outside an institution, any physician may apply. The
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applicant shall mail the completed application form as directed below. (a) If the applicant is a Federal agency, if the applicant is an
, agency of the District of Columbia, if the applicant is located in a State not mentioned in paragraph (b) or (c) of this section, or if the application is only for a teletherapy unit, the applicant shall:
49 , Enclosure 1
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[7590-013 (1) Mail the completed application form to the Director of Nuclear Material _ Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, or (2) Deliver the completed application form to the Commission-of,fices at: (f). 1717 H Street, N.W., Washington, D.C., or (ii) 7915 Eastern Avenue, Willste Building, Silver Spring, Maryland. (b) If the applican't is not a Federal agency and is loc'ated in 79 Connecticut, Delaware, Maine, Massachusetts, New Je'rsey, Pennsylvania, or Vermont, and the application is not only for a teletherapy unit, the applicant shall mail or deliver the completed application form to U.S. Nuclear. Regulatory Commission, Region I, Material Program Section No. 2, 631 Park Avenue, King of Prussia, Pennsylvania 19406. (c) If the applicant is not a Federal agency and is located in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or ,
& Wisconsin, and the application is not only for a teletherapy' unit, the 3 applicant s' hall mail or deliver the completed application form to U.S.
' Nuclear Regulatory Commission, Region III, Material Licensing Section, fe, 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
1 6 35.17 License Amendments. A licensee shall apply for and must receive a license amendment: (a) Before using byproduct material for a method of human use not . permitted by the license issued under this part; (b) Before the licensee permits a physician, other than a visiting authorized user described in S 35.34, to work as an authorized user under the license; (c) Before the licensee permits an individual not listed on the license to perform the duties,of the Radiation Safety Officer; (d) Before receiving byproduct material in excess of the amount authorized on the license; (e) Before supplying mobile nuclear medicine service to a location not identified on the license; and (f) Before making any changes in the licensed program that could result in a reduction of radiation safety. 50 Enclosure 1 k--_------.-a-----,._-- -----u------------- - - - - - - - - - _ - - - - - - - . - - . - - - - - - - - _ _ - - - - _ . . . - - - - - - - . - - - - - . - - - , - - _ - - - , - - - . . - - ---__------------_--_------A
, [7590-01]
S 35.18 Notifications. Theggngshall notify the Commission in writing on Form NRC-313h$ within thirty days when an authorized user, Radiation Safety Officer, or qualified teletherapy calibration expert, permanently dis-continues performance of duties under the license. The licensee shall mail the form to the appropriate address identified in 6 35.16. S 35.28 License issuance. The Commission shall issue a license for the human use of byproduct
. _ , material for a term of five years if: 4 revised )-~"
(a) The applicant has filed Form NRC-313%"Applicatio'n for Materials License--Human Use";
~ (b' ) The applicant has paid any applicable fee as provided in
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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.
^ fJS 2fa. See aHechef- . 5/a.
-- e: , ~.... ,. w . ,)c 6 35.29 Soecific exemotions. .
The Commission may, upon application of any interested person or
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upon its own initiative, grant such exemptions from the re~g ulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Subpart B--General Administrative Requirements 9 35.30 ALARA program. ;
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(a) Each 'n tit;ti d licensee shall establish a pr' gram o to 'l , 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 cperation of the program. 51 Enclosure 1
35.28a. Changes in procedures and instructions. Without prior Commission approval, the licensee may make changes to the procedures and instructions described in the license application, provided that the revised procedures and instructions continue to fulfill the requirements of this part.
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I (2) The program must incluce a periodic review of byproduct material use, and continuing education and training for all personnel wno work
- , with or in ttle vicinity of byproduct material. The review and education -
must assure that individuals make every reasonable effort to maintain individual and collective occupational dose equivalent as low as reason-7 . ably achiev.able, taking into account the state of technology, and the cost of improvements in relation to benefits. 4 (c) The licensee shall keep a written description of the ALARA program for the' duration of the license. Tl)e written description must include: (1) A commitment by management to keep individual and collective dose equivalents as low as reasonably achievable; (2) d 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
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(4) Personnel exposure investigational levels that when exceeded. will initiate a prompt investigation of the cause of the exposure and a consideration of actions that might be taken to' reduce the probability ; of recurrence. 6 35.31 Radiation Safety Committee. Each institutional licensee shall establish a Radiation Safety
, Committee to oversee the use of byproduct material. Management may establish more than one committee to meet these responsibilities, but each committee that is established shall meet the administrative requirements. To satisfy this requirement:
(a) The committee must meet the following administrative requirements: (1) Membership must consist of at least tlTree individuals and must include an authorized user for each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, 4 and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee ' deems appropriate, e 52 Enclosure 1 s .. . . e ws- ' ' _ m.%..e, -*+ e =+ - - -
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l (7590-01] I (2) The committee must meet at least quarterly. (3) To establish a quorum and to conduct business, one-half of the committee's membership must be present, including the Radiation Safety Officer and the management representative.
- (4) The minutes of each Radiat, ion Safety Committee meeting must include
(i) The date of the meeting; (ii) Members present; - (iii) Members absent; (iv) Summary of deliberations; . (v) Recommended actions and the numerical results of all ballots; and (vi) ALARA program reviews. (5) The Committee must provide each member with a copy of the meeting minutes, and maintain one copy for the duration of the license. (b) To oversee the use of licensed material, the Committee must: (1) Be responsible for monf toring the institutional program to maintain individual and collective doses as low as reasonably achievable; (2) Review on the basis of safety and approve or disapprove any individual who is to be listed as an authorized user or the Radiation Safety Officer prior to the license application or application for ,,. amendment; . (3) Review and approve or disapprove on the basis of safety
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considerations each proposed method of use of byproduct material; (4) Review quarterly, with the assistance of the Radiation Safety Officer, occupational radiation exposure 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
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cause and subsequent actions taken; (6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program; and (7) Establish a table of investigational levels for occupational dose equivalents that when exceeded, will initiate investigations and ! considerations of action by the Radiation Safety Officer. 53 Enclosure 1 9
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l ? 6 35.32 Radiation Safety Officer. [ Each '.;;it tia- ' licensee a eni;;;i_ shall appoint a Radiation Safety Officer who is responsible for establishing and maintaining the [ radiation safety policies designated by management. The Radiation Safety Officer must be a member of the Radiation Safety Committee and responsible to the licensee's management for ensuring that radiation safety activities are being correctly performed in the daily operation of the licensee's radiation safety program including: { (a) Investigating known instances of deviation from good practice ! and implementing corrective action as necessary; (b) Investigating and reporting to the Radiation Safety Committee the findings and actions taken in instances in which occupationally 1 exposed incividuals have exceeded investigational levels; and (c) Assisting and advising the Radiation Safety Committee in performing those functions specified in 6 35.31(b). l 6 35.33 Administrativejequirementsfor,/uthorityandIesponsibilities. I l (a) The licensee shall provide the Radiation Safety Committee and l . Radiation Safety Officer sufficient authority and organizational free' dom to: (1) identify radiation safety problems; (3) . initiate, recommend or provide solutions; and (3) verify implementation of solutions. 5 (b) The licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Committee and Radiation Safety Officer. To satisfy the requirements of this section, in addition to the functions specified in 99 35.31 and 35.32, the Radiation Safety Committee or Radiation Safety Officer must perform
, or ensure performance of the following functions:
(1) Authorizing the purchase or receipt of byproduct material and its distribution; t [ (2) Establishing written policy and procedures for disposal of all byproduct material; (3) Establishing and ensuring implementation of written procedures for: , (1) Emergency actions; - (11) Periodic radiation surveys; . (iii) Periodic inventory of byproduct material; l 54 Enclosure 1
, [7590-01)
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(iv) Safety during use of byproduct material; (v) Performance checks of safety equipment and survey instrumentation;.and - (vi) Training of personnel.
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[Aff Ed. -- t:H :' : ; :e :-i :L ;i; (5) Maintaining records to show compliance with the training and
, experience requirements of Subpart J of this part, which includes:
(i) For the Radiation Safety Officer, a photocopy of that indivi-dual's certificate as listed in 9 35.900 or a completed Form NRC-313M-Supplement A; , (ii) For the Qualified Teletherapy Calibration Expert, a photocopy of that individual's certification as listed in S 35.961 or a completed Form NRC-313M-Supplement A; and (iii) For each authorized user, a photocopy of that individuald s license to practice medicine, and either a photocopy of a certification that is listed as appropriate for the types of use in whic the authorized dri userisengaged,acompletedFormNRC-313M-Supplement {A B, or a fu(p.~-, , photocopy of an NRC or Agreement State license issued by (** insert , effective date of final rule **) that identifies the individual as an authorized user for the types of use.In which the authorized user is engaged; and ,, (6) Estab1fshing and maintaining a recordkeeping system for records required by this part, including the minutes of meetings of the Radiation Safety Committee required under S 35.31(a) and records of the Committee's review and deliberations required under $ 35.31(b). 6 35.34 Visiting authorized user. (a) A licensee may permit any visiting authorized user to use I W nsed material for human use under the terms of the licensee's license for sixty days in any calendar year if: (1) The visiting authorized user has the prior written permission of the Ifcensee's management and, if such use occurs on behalf of an institu-tion, the institution's Radiation Safety Committee; , 55 Enclosure 1
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i 35.33. Administrative requirements for authority and responsibilities. (b)(4) Establishing and implementing a radiation safety education program for personnel working in or frequenting areas where byproduct material is used and stored. To satisfy this requirement, the radiation safety education program shall provide traininge w (N upon employment and at least annually thereaf ter),,an[ (ii) lii the items specified in g19.12 of this chapter; and '
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(iii) in those procedures and instructions.,developed by/ the , licensee to comply with the requirements of this part that are f ..& g." applicable to the employee's duties.- Ut
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(7590-01] r (2) The licensee has a copy of a Commission or Agreement State license that lists the visiting authorized user as an authorized user for human use; and
,(3) The visiting authorized user performs only those procedures for which the visiting authorized user is specifically authorized by a .
Commission or Agreement State license. (b) The licensee.need not apply for a license amendment authorizing the short-term use described in paragraph (a) of this section. (c) The licensee shall maintain for two years copies of the written permission specified in paragraph (a)(1) of this section and of the license specified in paragraph (a)(2) of this section. - 6 35.35 Mobile service aeninistrative reouirements. , Ice 444 s he Commission will only license mobile service in accordance g g,47pd. with Subparts 0, of this part and 5 31.11 of this chapter. (b) Mobile s'ervice licens - 11 maintain a letter authorizing
. ;.* <' V use of byproduct material signed by the mana of each location
"**II' where services are rendered.
.- f 6 35.37 Records and reports of misadministrations.
(a) When a misadministration involves any therapy procedure, the licensee shall. notify, by telephone only, the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this chapter. The licensee shall also notify the referring physician of the affected patient and the p*atient 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 , theother,respeci.ively. Tfiese notifications shall be made within 24 hours after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not ! delay medical care for the patient because of this. 56 Enclosure 1 l
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33.35. "obile service administrative requirements. (a) The Commission will only license cobile services in accordanca with Subparts D, E and 11 of this part and f31.11 of this chapter, except that the license will authorize neither clution of generators nor the preparation of radiophar.maceuticals from reagent kits at locations serviced by the nobile service. (b) The Commission will only license nobile service licensees to provide services to persons who do not hold an NRC license. (c) Mobile service Itcensees shall maintain a letter authorizing use of byproduct material signed by the management of each location where services are rendered.
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f,a( ,f,'- s Y p56 35 35 vaD 35 35a appears to be idantical to proposed 35.ma. The D' beliavns that to rostrict a :$3 bile ser rice to unlicensed clierds would unr:acessarily interfere with the delivery of cedickl care. For ===71 a, this would prohibit a :x:b,ile servita frc= providi:ig
- technical assistance to a small licensee whosa sola technicisn is on vacation. 7&D 35 35c is ids =tical to pro;osed 35 35b.
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[7590-01] (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 (1) of this section. The written report shall include the licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recur-rence; whether the licensee informed the patient or the patient's responsible relative (or guardian), and if not, why not. The report shall 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 0 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 shall 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. (d) Each licensee shall maintain for Commission inspection records of all misadministrations of radiopharmaceuticals or radiation from diagnOSbh teletherapy or brachytherapy sources or interstitial implant sources. These records shall 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. These records shall be preserved until the Commission authorizes their disposition. (e) Aside from the notification requirement, nothing in this section shall affect any rights or duties of licensees and physicians in relation to each other, patients, or responsible relatives (or guardians), i l 57 Enclosure 1
[75'0-01] 9 S 35.38 Superv'i s ion. The licensee who permits the receipt, possession, use, or transfer of byproduct material authorized by an individual under the supervision of an au'thorized user as authorized by S 35.2(b) shall: ' (a)(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material; (2) Review the supervised individual's use of byproduct material and the records kept to reflect such use; (3) Require the authorized user to be immediately available by telephone to the supervised individual; and (4) Require the authorized user to be physically present and avail-able 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 9 35.2(b) to: (1) . Follow the instructions of the supervising authorized user; (2) Follow the procedures established by the Radiation Safety Officer pursuant to 6 35.32; and
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(3) Comply with the regulations of this part with respect to the
, use of byproduct material. .
S 35.49 Suppliers. ' The licensee may use for human use only: (a) Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regula-
, tions in Part 30 and $$ 32.72, 32.73, or 32.74 of this chapter or equivalent regulations of an Agreement State; (b) Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with an approval by the Commission pursuant-to S 32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for human use; and (c) Radiopharmaceuticals authorized by a Radioactive Drug Research Committee that has been approved by the Food and Drug Administration pursuant to 21 CFR 361.1.
58 Enclosure 1
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[7590-01] r
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Subpart C--General Technical Requirements q 35.50 Calibration and check of dose calibrators, g g g gj (a) The licensee shall: . ggg, (1) Check each dose calibrator for constancy daily prior to use. fr g j To sat. fy the requirement of this paragraph, the check must be done on a frequen y used setting with a sealed source of not less than 10 micro-f h... curies of ra um-226 or 50 microcuries of.any other gamma emitting
-[])% Y'/t radionuclide; u e
, ci
~
(2) Test eat dose calibrator for accuracy upon installation and C at least annually the. eaf ter by assaying at least two sealed sources containing different ra anuclides whose activity the manufacturer has determined within 5 percen of its stated activity, and whose activity is at least 10 microcuries to radium-226, and 50 microcuries for any other gamma-emitting radionuclict - (3) Test each dose calibrator 'or linearity upon installation and at least quarterly thereafter over the ange of its use between the highest dose administered and 10 microcur Ns; and (4) Test each dose calibrator for geo., try dependence upon . Installation over the range of volumes and con urations for which it is normally used.
- The licensee shall keep a record of this test for ths. duration of the use of the dose calibrator.
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(b) The ifcensee shall also perform appropriate cnec. and tests required by this section following adjustment or repair of th dose calibrator. . (c) The licensee shall mathematically correct readings for an error in excess of 10 percent if the dose is greater than 10 microcuri and the radiopharmaceutical emits a photon with an energy greater than 25 key. j) G/) The ifcensee shall keep records of the checks and tests required by this section for two years unles directed otherwise. (1) The record required in paragraph (1) of this section must
, include the model and serial numbtr of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the 59 Enclosure 1
Subpart C--General Technical Requirements 35.50. nequirement for dose calibrator; calibration and check of dose calibrator. (a) Eacl' ' licensee required to assay radiopharmaceutical dosages under 935.53 shall have a dose calibrator in his posses-sion and available for use. (b) The 11censeo shall: (1) Test each dose calibrator daily for constancy of oper-ation as follows: (1) Assay at least one of the reference sources required under (c) below, using the appropriate instrument setting (i.e., Ca-137 on the Cs-137 setting). (11) Compare the net activity reading on the dose calibrator to the predicted activity of the reference source. (2) Test each dose calibrator upon installation and at least annually f or accurate response over the rance of radionuclide energies to be assayed in daily operations. This test shall be conducted as follows: (1) Assay the reference sources required under (c) below, using the appropriate instrument setting for each source. (ii) Compare the not activity reading on the dose calibrator for each reference source to the predicted activity of that reference source. (3) Test each dose calibrator for itnearity upon installation and at least every three months as follows: (t) Assay a vial of technetium-99m, the activity of which is equni to the highest activity of any radionuclide that is assayed in daily operations. (11) Using the same source or serial dilutions of the a ue source, repeat step (t) at known activity points over the full range of activitles that are assayed in daily operations. Theso known activity points nay be obtained by diluting the source, allowing it to decay, or surrounding the source with lead siceves from a coucercially available linearity test kit. (iii) Compare the instrument reading at each activity point with the predicted activity of the source at that point. 59a
(4) Unleas correction factors have been supplied by t,he manufacturer of the instrucent, test each dose calibrator upon installation for geometry dependence as follows: (1) Assay a fixed amount of a given radionuclide in the various containers and volunes that are assayed in daily operationt,. (11) Cocpare the instrument reading for each container and volume with the instru=ent reading for the container and volune selected as the standard reference. (c) Use the reference standards listed in Table 1 for performina accuracy and constancy tests on the dose calibrator. (d) The licenseo shall also perform appropriate chec'<s and tests required by this section following adjustment or repair of the dose calibrator. (e) '1he licensee shall mathematically correct radiophar-maceutical dosage assays for any instrument error datected in (b) and (d) above if the error is in excess of 10 percent, the dose is greater than 10 .uierocuries, and the radiopharanceutical emits a photon energy greater than 25 key. - Table 1. Dose Calibrator Reference Standards r /M Radionuclide Activity Calibration Accuracy
,O Y s'* ,P Cesiun 137 LOO microcuries or core Uithin 5' l
Cobalt 57 One millicurie or more t.*i t h in 57. Yo.D 35 50s na r aycos that there :hould bs,c cicar staAcent that - tha licsnsee ::nst posses's a d:se calhrator. V E 35 5051 23 parapa;h d.:as not a,h; ear to accseplish en ccre thn: proposed 35.'50a2 ' ' ' vaD 35 5052 na se53egtad parapaph veuld regi.ro that tue epcific r:Aicnuclid.aa b3 usad, cnd c:tabliahan higher actifity 1.evels than nro st:tod in the pro;$ sed dr ft. Itisnotnaceaaarytfuse Cz-137 a.d Cc-37 to test the accuracy of a does calibrator; other r:dionuclidst :.ra atailable.o The T7 belio-Es that 50 'uCL is a nuffici.antly high act'irity I to to,ct for acctdacy. V3.D 35 5Cb3 re 1, the T7 beliaves that' to tost 'ror 11nourity outside the ranss of patient dosage ceasuremets is unnecessary and
.inco,nslatoct vith /JX1A principles. re 11, tha T? believes that j
~
testih. *by cerial dilutiona io inaccur:to and inconsistant with AIMtA principles. VAD 35.!Obh Tha persgrs;h does not nppsse to add to propeced 35 50a4 ED 35 50c C3sito-137 and Co-57'are 'not unigsly qualifind for use wh:n testing a do:s calibratcr. It in r.at naccass:r to u:: a r . celibrated cource when check!.n3 fer cen: tan:7 y. & . q.u -:r'.1 ,
-w$
. ,? ... ! MD 35 50d This d elicetes proposed 35 50b.
" _. O. N.%
ft
; - J M D'O~3 @ Gb0Q Qd)0pboo camecoEO OG % "'
. - ~ .
, [7590-01]
^
r check, the activity measured, and the initials of the individual who performed the check. . (2) The record required in paragraph (2) of this section must include the model and serial numbei of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test,.the results of the test, and the signature of th Radiation Safety Officer. (3) The record required in paragraph (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
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signature of the Radiation Safety Officer. p (4) Therecordrequiredinparagraph{g)(4)ofthissectionmust include the model and serial number of the dose calibrator, the configu-ration of the source measured, the activity measured for each volume measured, the date of the test, and the signature of the Radiation Safety Officer.
<, e _mz__ __;_m_u g 3, ; _ , . . _ .
,_m3, (a) The licensee shall calibrate survey instruments annually and 8 follow repair; g)
- g g. (b) i satisfy the requirements of paragraph (a), the licensee g ,
shall: gg g (1) Calibrate 1 scale readings up to 1000 milliroentgens per hour; and
.jE{ ,
(2) Calibrate two readi, on each scale that must be calibrated; -
')',e - , 7p g and
?~ (3) Conspicuously note on the ina ument the apparent exposure
> rate from a dedicated check source as dete , ned at the time of calibration and the date of calibration.
(c) To satisfy the requirements of paragraph ( of this section,
~
the licensee may: (1) Consider a point as calibrated if the indicated exp re rate differs from the calculated exposure rate by not more than 10 per t; and 60 Enclosure 1 P
h ! 35.51. Pequirement for survey instruments; calibration and check of survey instruments. (a) The licensee shall have in his possession and available for use the following radiation detection instruments: (1) A low-level survey meter capable of detecting 0.1 mil 11 roentgen per hour. l (2) A high-level survey meter capable of reading up to 1
! Poentgen.per hour.
[Ed. Note: Licensees who have only Subpart D materials would need an exemption from (2) above. Licensees who have only Subpart H materials would need an exemption from (1) and (2) above. ELD can 1 provide the wording.] (b) The licensee shall calibrate survey instruments annually and following repair. (c) To satisfy the requirements of paragraph (b), the 1
,1 licensee shall:
E
, (1) Perform the calibration with radionuclide sources at
, distances sufficient to approximate point sources; and i
! (2) Calibrate all scale readings up to 1 Foentgen per hour; and (3) Calibrate two readings on each scale up to 1 Foentgen per .
hour; and
; (4) 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.
(d) To satisfy the requirements of paragraph (a) of this
- section, the licensee may
s (1) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 10 i 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 calibration chart or graph is conspicuously attached ,
to the instrument; and (3) Have the suryny instrument calibrated by a person or firm outside of the licensee's organization provided that the licensee obtains written assurance that the calibration has been performed + as specified in paragraphs (c) and (d) above. j 60a
0 1 (e) The licensee shall check each survey instrument for function with the dedicated check source before and af ter each use. The licensee is not required to keep records of these function checks. (f) The licensee shall keep a record of e.tch calibration required in paragraph (a) above for the duration of use of the ins t rume nt. To satisfy the requirements of this paragraph, the record cust include: p (1) A description of the calibration procedure; and
N (2) A description of the source radionuclide used and its
. g estima ted activity.
N b VE 35 51a na 'TI'a3 eas that there should be a clear statement that
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the licensee :c.st, possess a survey instrument. De % and the ir.^istry, are dividad en the racessa:7 rangs of mea:re.re:m=t capability. The suggested wer d
'" co.:ld be used to elic'it riblic' cec =eip..
. . . s .
VE 35 51b n is duplicates poposed 35 51a. YG 35 51c Suggsstad el is universsi practics. re c2, ces proposed bl. re c3, see popccad b2. rs c4 ces pope:cd b3 V3 '35 51d r3 di cnd d2, sac poposed e1 :nd c2. Sugp sted d3 ' acco::pliEh6s nothing. De burdan of pcof aircady lics on the - s licensee.3 - 72 35 514 Sis du_clicct03 FC_"~ ed 35 51d. Ya 35 51f 'L'4s duplicates Fro.uised 35 51f. 60b i i
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?
[7590-01]
) Consider a point as calibrated if the indicated exposure rate differs t
~i the calculated exposure rate by not more than 20 percent if a correction c t~or graph is conspicuously attached to the instrument.
(d) The licen shall check each_ survey instrument for function with the dedicated check urce before and after each use. The licensee is not required to keep recor a f these function checks. (e) The licensee shall keep a cord of each calibration required in paragraph (a) above for the duration i use of the instrument. To satisfy the requirements of this paragraph, t. ecbrd must include: (1) A description of the calibration procedur and (2) A description of the source radionuclide used its esti-mated activity. w Se e nea) }G 3552 n, 36. 53 bi 35*SA c. d9n y Slo b ldo GNL'At I s
. i ~
g 6 35.53 Measurement of radiocharmaceutical dosaces. -
The licensee shall: -
C,- (a) Assay before human use the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a radionuclide that
^q /
emits electromagnetic radiation in the form of gamma rays or x rays.
' (b) Assay before human use the activity of each radiopharmaceutical
~
dosage with a desired activity of 10 microcuries or less of a radionuclide
- that emits ele.ctromagnetic radiation in the form of gamma rays or x rays to verify that it does not exceed 10 microcuries.
(c) Keep a record of the measurements required by this section for two years. To satisfy this requirement, the record must contain the: (1) Generic name of the radiopharmaceutical, its lot number, and
- expiration date; (2) Patient's name and identification number; (3) Total activity of the dosage at the time of measurement, or a notation that the total activity is less'than 10 microcuries; and (4) Date and time of the measurement.
See. new g 35.57 on p. gd c# ~f 7 p , ~ , -"
^
@ 35.58 Authorization for calibration and reference sources.
Any person authorized by 6 35.2 for human use of byproduct material [ Q' (/ g may receive, possess, and use byproduct material in sealed sources J manufactured and distributed by a person licensed pursuant to 6 32.74 of i, 61 Enclosure 1 e ' s g
=
9 l
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35.52a. Procedures for ordering and receiving packages containing radioactive material. (a) The licensee shall establish and inplement written procedures for ordering radioactive materials. As a :sinimum, 4 these procedures shall be suf ficient to ensure that the radionuclide and chemical or physical form ordered are authorized by the license and that, considering the quantities on hand, the quantity ordered will not exceed the possession limits on the license. (b) The licensee shall establish and implement written procedures for receiving packages containing radioactive caterial during normal working hours and during of f-duty hours. As a ninimum, these written procedures shall require: E (1,) That packages containing radioactive caterial be delivered to a specified location in the licensee's facility; (2) That individual (s) be desi,;nated who will accept packages containing radioactive material that are delivered af ter normal
- working hours; and f
(3) That tlIe individual (s) designated as required in sub-paragraph (2) be given written instructions. As a mininum, these written instructions shall: s i, opec u y wouw Lu cout wt if a gackuse appeaco -c i uc . damaged; and (11) 3e sufficient to ensure that packa,;es containing
" radioactive material that are delivered after normal working hours are ' secured adainst unauthorized removal and in such a manner that radiation levels in unrestricted areas meet the requirements in y20.205(b) of this chapter.
3.Q 8
.&cYn
.\e . 4-
.. t x Dni3J42a Racsipt of material in a:ccess of that permitted by the s .
licen.se would be a violatics that, the "I assumes, would driva the licensee to estnNT%h the proced:re out of self-preservation. de licensee his a Ested financial' interest in every other item cited i - becausa if the ps:kage is not receited by the ,wper person, And f ^ s! cured, it cr/ belostbut=uststill'he;Iidfo'r. Sactien
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2).205b naed not be repeated here. l _ ~ ]~ 61a 3Q \ i$a
B e 35.52b. Procedures for safely opening packages containing radioactive caterial. The licensee shall establish and impleacnt written procedures for safely opening packages containing radioactive material. As a miniinum, these written procedures shall require: (a) That each package containing byproduct material be opened in accordance with the established written procedure. (b) That each package be conitored to determine that the surface exposure rate is less than 200 milliroentgens per hour. (c) That if the surface exposure rate exceeds 200 milliroentgens per hour, the individual shall stop the procedure and notify the radiation safety officer immediately. (d) That the final source container shield be wipe tested and that the wipe be checked with a calibrated low-level survey meter ot other suitable detection instrumentation to detect the presence
,of unacceptable contamination levels.
,/, * (.Ll(kX/ -
s 's.
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NIO VN.35tEb netion_@.:'05d reg 21res that e52U1' ice.uee ha packass CFaning _t:~002dMh- Eead*- g o d m ed t y , h . Part 20.'becc:ne :$ thing i it is',ce"r s
- to the huma.. use of byproduct material.
- 61b
1 35.52c. General rules for safe use of radioactive materials. The licensee shall establish and implement written procedures governing the safe use of radioactive caterial. As a minimum, these written procedures shall require: (a) The use of laboratory coats or equivalent protective clothing at all times in areas where unsealed radioactive naterials are being used or stored; and l (b) The use of waterproof gloves at all times when handling radioactive material; and (c) That hands and clothing be nonitored every time that an j individual exits an area where unsealed radioactive materials are i used or stored; and (d) That individuals do not eat, drink, smoke, or apply cosuetics in any area where radioactive caterial is used or stored; and (e) That individuals do not store food, drink, or personal effects in any area where radioactive material is used or stored; >> and (f) That each individual wear his or her assigned film or TLD l 4 whole body monitoring badge at all times in areas where radioac-i_ l tive material is used or stored; and I (g) That each individual wear his or her assigned film or TLD , finger badge at all times during activities that involve elution, i preparation, assay, or administration of millicurie quantities of radioactive caterial; and (h) That individuals do not pipette radioactive solutions by mouth. t y ', " *
- 6 -
7
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. .faq .2 ($ l' I
<n.
? 61c i l . I
35.57 Authorization to perform in vitro tests under the :;eneral license issued pursuant to y 31.11. Any person authorized by g35.2 of this part for hur.an use of
~
byproduct material is also authorized to use byproduct naterial under the general license in g31.11 of this chapter for the specified-in vitro uses without filin;; Forts NRC-483 as required by g31.11(b): Provided that:
- a. The licensee is subject to the other provisions of g31.11,
- b. The licensee's work done pursuant to this authorization for the general license is physically and administratively separated f rots the hutaan use activities conducted under the licensee's specific license.
. I s
\ . (. . ~,Y:s, m p61d V4D jh,5 ED cer.cra with ths 'E rec;= sal that this request si::: ply be added to~ the applicaticn for:a es c. '4a entry. So's proposed foimlac-313miitem4.
W 4 i 61d e
r [7590-01] - P this chapter or equivalent Agreement State regulations for check, cali-bration, and reference use if such sources do not exceed 6 millicuries each 6 35.59 Reouirements for possession of sealed sources. (a) A licensee in possession of a sealed source for human use shall use the source in accordance with the instructions supplied by the manufacturer, and shall maintain such instructions in a legible form
, convenient to users of the source.
(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 a licensed transferor indicating that ,. the source was tested within six months prior to transfer to the licensee; and .0W.. (2) T ce for eakage at intervals not to exceed six '
- months g or be t the un,o:=such s ho er m ervn Ls as are.
x . . :: t _ . _ . ':: 'N :::::d ":t '"- r: ":: t:u ,y approved by the Commission or an Agreement State f:. ' :L t::t h :t 1:ng: bt:.t.,dnbbd6C b65 On Wbt MOAUIYCY4f'f# IONYl Af~hE00hU** (c) To satisfy the leak test requirements of this section~, the licensee must: (1) Tako the tact emmp]g f em the eg3]cd coup;; Or f;;;;; th; " surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate; (2) Take the test sample from a teletherapy source with the sou'rce , in the "off" position; and (3) Measure the sample so that the test can detect the presence of 0.005 microcuries of radioactive material on the sample. . (d) The licensee shall keep leak test records for three years. The records must contain the model number and serial number of each source tested, and the identity of each source radionuclide and its
~
estimated activity, the measured activity of each test sample expressed in microcuries, a description of the method used to measure each test sample, the date of the test, and the signature of the Radiation Safety Officer. (e) If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall: 62 Enclosure 1
, . ~ . _- .
[7590-01] (1) Immediately withdraw the sealed source from use and store, - decontaminate, repair, or dispose of the source in accordance with Parts 20 and 30 of this chapter;.and (2) File a report within five days of the leak test with the appropriate Nuclear Regulatory Commission Regional Office listed 'in Appendix 0 of Part 20 of this chapter, with a copy to Director of Inspec-tion and Enforcement, U.SJ Nuclear Regulatory Commission, Washington, b 0.C. 20555, describing the equipment involved, the test results, and the corrective action taken. de-1o (f) The licensee need not perform a leak test on the following _ s
!b, sources:
i I (1) Sources containing only byproduct material with a half-life of
'g y less than 30 days;
,g 9 (2) Sources containing only byproduct material as a gas; -
- 1/ (3) Sources containing 100 microcuries or less of beta or gamma-
.'E c
M emitting material or 10 microcuries or less of alpha emitting material;
',ll A (4) Sources stored and not being used. The licensee shall, however,
.'lh test each such source for leakage prior to any use or transfer unless it
]j ,}8 n ~ has been leak-tested within six months prior to the date of use or
, transfer; l]e $- (5) Seeds of' iridium-192 pncasad in nyinn ribban-e d f 'S 'N ' (6). Sources containing only hydrogen-34 0
;- ; a : _ n , : w ,, . , s . , ,,3 g, { (2) ' : : :' t:-t: ' -1??.
N g* (g) Any licensee in possession of a sealed source shall conduct a
, .] quarterly physical inventory,of all sealed sources in the licensee's a
g possession. The licensee shall keep inventor" records for two years. M
$ The inventory records must contain the model and serial number of each j@ hj source, the identity.of each source radionuclide and its estimated l[ activity, the location of each source, and the signature of the Radiation
( Safety Officer. (h) Any licensee in possession of a sealed source shall' survey with a low range survey meter quarterly all areas where sealed sources are stored. (i) The licensee shall keep a record of the surveys required in paragraph (h) of this section for two years. The record must include 63 . Enclosure 1 m_ . _ _ ._ _ _ _ _ _
..~
[7590-01] the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area expressed in
~
millirem per hour, the inodel 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-w{ rial to be administered in a radiation shield.
] y (b) The licensee shall require each individual who administer's a j radiopharmaceutical by injection to use a syringe radiation shield unless I the use of the shield is contraindicated for that injection.
e jj 6 35.61 Vial shields. 3 The licensee shall require each individual prepa~ ring or handling a
~
v vial that contains a radiopharmaceutical to keep the vial in a vial
~
^, . x radiation shield.
. ?A e g g 35.62 Syringe labels.
5; Tho litancee cha!! cer. picucu ]y ];b;] cach Syrirga radict,iun O
.'E shield that contains a syringe with a radiopharmaceutical to be admini-g rf gg stered with the radiopharmaceutical abbreviation.cr ty;: :# di:;; : tic
, g8a f
- t dy c r t h e r:p; p dre " "^ - ^ '-^ d p
UN , 9 35.63 Vial labels. -
~
.y I The licensee shall conspicuously label each vial radiation shield
] that contains a vial of a radiopharmaceutical to be administered with y ,o the chemical name or its abbreviation.
D
- e. S 35.70 Surveys for contamination and ambient radiation exoosure rate.
b (a) The licensee shall survey with a low range survey meter at
$h; 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.
Se.e. msert on f Wa & Ti? RW' ' 64 Enclosure 1
35.70. Surveys for contamination and ambient expcsure rate. (c) The surveye required in paragraphs (a) and (b) above shall be sufficiently sensitive to detect 0.1 milliroentgens per hour. (d) The licensee shall establish decontamination action levels and shall ensure that the radiation safety of ficer is notified whenever those levels are exceeded. L I 64a
[7590-01] (6) (g) The lice'nsee shall survey for removable contamination once each week all area where radiopharmaceuticals are routinely prepared for use, administered, or stored. - - ((J (4) The licensee shall keep a record of the surveys for one year. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area expre.ssed in millirem per hour or disintegrations per minute, the model number of the instrument used to make the survey to analyze the samples, and th'e. initials of the individual who performed the survey. 6 %.15 Release of patients containino radiocharmaceuticals or permanent b imolan 2.
/eXf, p.$6h. The licensee sha ..
authorize release from confinement for medical care of any patient admini ad a radiopharmaceutical or permanent
, d, .<
implant until the exposure rate from the patl 's less than 6 milli-
'..' ),. roentgens per hour at a distance of one meter.
. g..e ,-e f.,
.. . . v.
J~ 6 35.80 Mobile service technical requirements. ~ A licensee providing mobile service shall: (a) Transport to each location of use only syringes or vials
. containina unit do w s of neanarad ridioph3cmgegntje3]e;
.htSed eftu) (b) gg-/j.r., ~,. _ _ _ _ _
g m -'.3 .o.- m- >~-vu ei - a.. a m u - ...asu ea. uu ve u:cd c.d, 5;f;r: 1:1.Hg, c:::.: :' c_::d i,pr;d.;; .m.m. .m. mum all
' \
,./. . ,.j. , .d er-- 4,%a mc+e;
.- : ( fc1 Secure or keep under const' ant surveillance and immediate
. . :3 ' ,
,J// .' O j
control all byproduct material;
[f.)Gd1 Check equipment transported to the location of use as described inSj35.50and35.51,priortohumanuse; fagerif, Acu) (c' :.., : : ! #br:ted :u~c; c'e " ~h ~hi* '"' #c being [-[) dad "e'd '
*-?mpe-t byp edrt at:" :7, :nd ; c c:) S, : iic t .; diction det .[cdIh' expe r^ :t #t' : ': :ng: _ c s ;) ;t:r p. . , t _;;;. t.. m '.um the 1~2'#:^ typr: duct ;tc..;l m , mom (d Keep a record of the surveys required in subsection p for one year. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in 65 Enclosure 1
35.75. Release of patients containing radiopharmaceuticals or permanent implants The licensee shall not authorize release from confinement for medical care any patient: (a) Administered iodine 131 or colloidal gold 198 until the residual activity is 30 millicuries or less; or (b) Administered a permanent brachytherapy implant until the exposure rate from the patient is less than or equal to 6 milliroentgens per hour at one mater from the patient. w. i g bd ,:/
\
)E*Y 'f ca,,)gul-j,d 'j s c ~
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- 65a 1
-______-^ ________2-__
35.80. Mobile service technical requirements. (b) Ensure that at least one physician designated on the license as an on-site physician is present at the location of use whenever byproduct material is used at that location. (c) firing into each location of use all byproduct material to be used and, before leaving, recove all unused byproduct material and all associated waste. (The facility utilizing the cobile service cannot receive, possess, or store byproduct material other than the anount of material renaining in the patient.) (f) Recalibrate, in accordance with the manufacturer's instructions, all diagnostic equipment transported to the location of use. This recalibration shall be prior to human use. (3) Eefore leaving each location of use, perform a survey to ensure that all source.n of radioactive material have been removed
. s
- <,5 and that the location .s f ree of radioactive contamination.
- f,' ' V \*
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- 1. , '. - 9J' "Y
p65b V&D 35. sob Tne 5 believes that'an on-site p$ysician'is r.ct necced for the types of studies that a mobile scriice can perfore. The hasard of the studies is reupay co=perabla to that of ghing a blood sample or having a stor,ach x-ray.. VaD 33.C0c This duplicate $ r.eF5 ec M 5'2-v33 33fE0f TE T7 does not believe uncalibrated equi;=ed, poses a risk but is ar, enable to including the sd2stier. to elicit public comment. W_3 33 803 n.is sppears to dupliczte .=opossd 35.GCb and f. l l l 65b
~
[7590.01] 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. See nen) -S:35.90 Storace of volatiles and cases.
. The lic 11 store volatile radiopharmaceuticals and beXt, g radioactive gases in a fume no 4 a container eith two airtight j p., barriers against release.
L' 35.92 Decay-in-storace.
, (a) The licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of S 20.301 of this chapter if the licensee:
(1) Holds byproduct material for decay a minimum of ten (10) half-lives; (2) Monitors byproduct material prior to disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation . level with a low range survey meter set on its
'most sensitive scale and unshielded; (3) Removes or obliterates all radiation labels; and-(4) Separates and monitors each genera' tor column individu. ally without any ' shielding to ensure decay to background radiation level prior to disposal.
g g(4) (b) For paragraphs (a)(1), e d (a)(2),of this section, the licensee
... shall keep a record of each disposal for two years. The record must
/rfpu;s y
include the date of the disposal, the date on which the byproduct material C
' f. b was stored, the model number of the survey -instrument used, the background 3diation level.aand the name of' the individual who performed the disposal.
[the results of Use whohrring regoored in paragraph @.), Subpart 0--Group General /I (uptake, dilution, excretion) 9 35.100 Use of radiocharmaceuticals for untake, dilution and excretion studies. (a) The licensee shall use the following prepared radiophar-maceuticals for diagnostic studies involving the measurement of uptake, 66 Enclosure 1 w _ = . - - _.- .- - -
35.90. Special requirements for use of volatiles and gases. The licensee shall: (a) Store volatile radiopharmaceuticals and radioactive gases in a fume hood with adequate airflow or in a container with two airtight barriers against release. (b) Conduct procedures that involve opening and preparing therapeutic liquid iodine 131 solutions in a fume hood with adequate airflow. (c) At least every six months, measure the airflow rates in each area where radioactive gases are used or stored to ensure continued complaince with g320.103 and 20.106 of this chapter. (d)' Test radioactive gas trapping devices at least monthly to ensure that they are performing according to the manufacturer's _, specifications and to ensure continued compliance with gg20.103
. 7 ' and 20.106 of this chapter.
<\ ,f(, rl.w%\
.P
~
i pc6a VG 35-9'h This
- s ,s"' ar to pre.'rsed 35 ~
VE 35. cod, ci and a Theaa ce2sures are app: oprie.e for hist volume users of I-b.31. The TF is a:Ena'le b to incorxriting them in g Subnart F.
~
Fcr diaz.ostic cuantitias, the I? believes the suggested:
~
. J . - s reclirements an onrly prescriptin.-
66a
(7590-01] dilution, or excretion in accordance with the product labeling or pack-age . insert instructions for use supplied by the radiopharmaceutical manufacturer, except as provided in paragraph (b) of this*section: (1) Iodine-131 as sodium iodide, iodinated human serum albumin e (IHSA), labeled rose bengal, or sodium iodchippurate; (2) Iodine-125 as sodium iodide or iodinated human serum albumin (IHSA); (3) Cobalt-58 as labeled cyanocabalamin; (4) Cobalt-60 as labeled cyanocobalamin; (5) Chromium-51 as sodium chromate or labeled human serum albumin; (6) Iron-59 as citrate; (7) Technetium-99m as pertechnetate; (8) Any byproduct material in a radiopharmaceutical-and for a diagnostic use involving measurements of uptake, dilution, or excretion
, authorized by the Food and Drug Administration (FDA), or by the licensee's Radioactive Drug Research Committee that has been approved by the FDA pursuant to 21 CFR 361.1.
(b) The licensee using a radiopharmaceutical listed in paragraph (a) 0,f this section~for a clinical procedure other than one specified in the product labeling or package insert instructions for use shall comply with i.n' e prouuct. ola' el$ng or package insert instructions regarding physicalMd e)1ern [ cal form, route of administration and dosage range. _ Subpart E--Group II/III (imaging) 6 35.200 Use of radiopharmaceuticals, generators, and reagent kitr for imaging and localization studies. (a) The licensee shall use the following radiopharmaceuticals, generators, and reagent kits for imaging and localization studies in
,[ accordance with the product. labeling.or package insert or other manu-A 7 facturer'.s instructions for use, except as provided in paragraphs (b)
's i and (c) of this section:
k\ - (1) Molybdenum-99/ technetium-99m generators for the elution or extraction of technetium-99m as pertechnetate; g (2) Technetium-99m as pertechnetate; , N _i.gz -2,.M has said that, if the p67 35.lcob A profe85*D:51 " l**
, .veuld not be unius cheaLeal form h3s been ch % s s .
* 'ha lidad radia.*ar=hercals. ,
h_u:w w _ , -r-F. a wo ".N ff
- - - g ff,
[7590-01] (3) Prepared radiopharmaceuticals and reagent kits for the preparation of the following technetium-99m labeled radiopharmaceuticals: (i) Sulfur colloid; . . (ii) Pentetate sodium; (iii) Human serum albumin microspheres; (iv) Polyphosphate; (v)' Macroaggregated human serum albumin; (vi) Etidronate sodium; (vii) Stannous pyrophosphate; (viii) Human serum albumin; (fx). Medronate sodium; (x) Gluceptate sodium; (xi) 0xidronate sodium; ,
; (xii) Disofenin; and (xiii) Succimer.
(4) Tin-113/ indium-113m generators for the elution of indium-113m as choride; i.; (5) Iodine-131 as sodium iodide, iodinated human serum albumin, macroaggregated iodinated human serum albumin, colloidal (microaggregated) ,
~
iodinated human serum albumin, rose bengal, or sodium iodohippurate; , f.'h (6) Iodine-125 as sodium iodide or fibrinogen; .] ~ ' ' m m a-4..- c, (8) . Gold-198 in colloidal form, , . .p p ,, (9) Mercury-197 as chlormerodrin; q ' ?. ' , ,/, (10) Selenium-75 as selenomethionine; ,p# ;
'..o ,
(11) Strontium-85 as nitrate; j ' (12) Ytterbium-169 as pentetate sodium; , (13) Indium-113m as chloride; C." "..x.- 12: ;; ; ;;; :- :: : ::'d': ; j [/8/)(18) Any byproduct material in a radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing byproduct material authorized by the Food and Drug Administra-tion or by the licensee's Radioactive Drug Research Committee that has been approved by the FDA pursuant to 21 CFR 361.1. l (b) The licensee using the radiopharmaceuticals listed in ; L paragraph (a) of this section for clinical procedures other than those t 68 Enclosure 1 i I
s .. . ~
. [7590-01]
I specified in the product labeling or package insert shall comply with , the product labeling or package insert regarding: .
. ., l~~
(1) Physical formouA themeal form J- % Iw r cW, [ (2) Route of administration; and a (3) Dosage range. i (c) The following radiopharmaceuticals, when used for the listed clinical procedures, are not subject to the restrictions in paragraphs (a) and (b) of this section: (1) Technetium-99m pentetate sodium as an aerosol for lung function studies. 4 S 35.204 Permissible molybdenum-99 concentration. (a) The licensee shall not administer to humans a radiopharmaceuti-
- cal containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m; 7
(b) The licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/ technetium-99m generators shall test each generator eluate or extract for molybdenum-99 concentration. (c) The licensee shall maintain a record of molybdenum concentration
. t'est results 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 of the molybdenum expressed in'microcuries, the date of the test, and the initials of the individual who performed the test. j. 6 35.205 Control of aerosols and cases. The licensee who administers radioactive aerosols or gases shall do so with a system that will prevent the unintended dispersal of the byproduct material. The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container. 69 Enclosure 1
~
[7590-01] Subpart F--Group IV/V (radiopharmaceuticals for therapy) S 35.300 Use of radiocharmaceuticals for theracy. The licensee shall use the following prepared radiopharmaceuticals. in accordance with the product labeling, package insert, or other manu-facturer's instructions for use: (a) Iodine-131 as iodide for treatment of hyperthyroidism,. cardiac dysfunction, and thyroid carcinoma; (b) ' Phosphorus-32 as soluble phosphate for treatment of polycythemia l vera, leukemia, and bone metastases; (c) Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment'of malignant effusions; - (d) Gold-198 as colloid for intracavitary treatment of malignant effusions; (e) Any byproduct material in a radiopharmaceutical and for a therapeutic use authorized by the Food and Drug Administration.
@ 35.304 Safety instruction.
dict. (a) The licensee shall provide oral and written radiation safety
/h0Rl SXdIj instruc
- n's for all personnel caring for the patient undergoing radio-
/0*)Odt- pharmaceutic therapy. To satisfy this requirement, the instructions
,, must cescr10e proc res for:
('CP , ' , (1) Patient conte - I".s "* (2) Visitor control; { ($ ' J;b-(3) Contamination control; a , (4) Waste control. (b) The licensee shall keep for two yea a list of individuals receiving instructions required by paragraph (a) o is section, a description of the instructions, the date of instruction, nd the name of the individual who gave the instruction. e 70 Enclosure 1
. s .
l 35.304. Personnel instruction concerning radiopharmaceutical therapy. The licensee shall provide oral and written instruction concerning patient control, visitor control, contamination control, and waste control to all personnel caring for each patient undergoing radiopharmaceutical therapy. These instruc-tions shall be sufficient to ensure that: (a) Patients treated with iodine 131 or gold 198 are confined to a private room with a private toilet for the duration of
. treatment, except for special medical purposes approved by the radiation safety officer; and (b) The room of any patient treated with iodine 131 or gold 198 will be maintained as a restricted area as defined in
~ 320.3(a)(14) of this chapter for the duration of the treatment and until surveyed for contamination and released for unrestricted use following the treatment; and (c) Contaminated items are not released for unrestricted use or disposal; and (d) The radiation safety officer will be notified if the 3 therapy patient dies or requires surgery during the treatment.
, m.v l} .
A . (' , s. g ,
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3f7Ca 71D 35 304 he introd.ictor/ parapaph 12 sMar to propened, 33.^n % re =_, the T t.s3 mL 1selievs a 7.,ntts teilet in a critical safat r need for relic;har:::aceutical therdr patie=ta. re b, sectien 20.105 absad;r ids =tifies those instances in which a licansee rust dac1p an area restricted. Thors is r.o need to e reiterate tha=. re e, relessa of ecutifted the=s would be contrary to 20 301. There is no need to reit.erate this, Tae . T is 2:mnahls to incInding suggested parapa;h d.
, s .
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i 70a
[7590-01]- Subpart G--Group VI (sources for brachytherapy)
@ 35.400 Use of sources for brachytheracy.
8 The licensee shall use the follo' wing sources for therapeutic purposes T- ' in accordance with the product labeling, package insert, or other manu-h. O, 19 facturer's instructions for use: 0 M (a) Cesium-137 as a sealed source in needles and applicator cells h for topical, interstitfal, and intracavitary treatment of cancer; h: (b) Cobalt-60 as a sealed source in needles and applicator cells di e .a for topical, interstitial, and intracavitary treatment of cancer; g .m (c) Gold-198 as :c m d :=r:0 " seeds for interstitial treatment a N of cancer;
# ii .,
(d) Iridium-192 as seeds encased in nylon ribbon c: :: : for
" s interstitial treatment of cancer;
*l1a
.ts (e) Strontium-90 as a sealed source in an applicator for treatment o .
Po l] .of superficial eye conditions; d 3' "( (f) Iodine-125 as c :c m d : = r= " seeds for interstitial
' El i- treatment of cancera-ve4-
, (6 L.. i ., 1:2 . . m.
El ' N$ s 35.404 Release of natients wasted with teenerary i lar.ts.
'4 (a) The licensee shall not release from confinement for medical
}'
..ti. ,E care a ' patient treated by the temporary implant of a source listed in ,
a S 35.400 until a source count and a radiation survey of the patient g . confirm that all implants have been removed. . A g (b) The licensee shall keep a record of source counts and patient surveys for two years. Each record must include the name of the patient, ( the number of sources implanted, the number of sources removed, and the exposure rate from the pati.ent expressed as millirem per hour and measured within one. meter of the patient. 6 35.405 Safety instruction. det AttAI (af ine i m_c.: N 11 orovide written radiation safety instruc-YT.Ngf- tions to all individuals caring for the pauent u.m . ;:"- M chytherapy. f
- 4 gdc, '!' (*g '^* t t
t- i v i ,f CV e 71 Enclosure 1
35.405. Personnel instruction concerning brachytherapy. The licensee shall provide oral and written instruction concerning (1) patient control and visitor control and (2) the size and appearance of the brachytherapy sources, to all personnel caring for each patient undergoing brachytherapy. These instruc-tions must be sufficient to assure that: (a) For the duration of treatment, patients treated with brachytherapy sources be confined to a private room with a private toilet except for special medical purposes approved by the radiation safety officer; and (b) The room of any patient treated with brachytherapy sources will be maintained as a restricted area as defined in 920.3(a)(14) of this chapter for the duration of the treatment and until surveyed for the presence of displaced sources and released for unrestricted use following the treatment; and [Ed. Note: Some sources such as iodine 125 seeds may deserve an exemption from paragraph (b). ELD can supply the wording.] (c) Patient clothing, linen, bandages and dressings are not released for unrestricted use or disposal until surveyed for the presence of displaced sources; and
. (d) The radiation safety officer be notified if (1) sources g become loose or separated from the patient, or (2) the patient dies or requires surgery during the course of treatment; and
., y ,
(e) Brachytherapy sources be handled at all times with remote
. handling tools and never by hand.
.A
'M* ,
p?la. MD 35 405 ta 27 is s: enable to ir.:1ums cource descriptien in t.he Eg: ired training. The 7 dass =ct beWre a i=ivd6;toilst is a critical sdfaty 5. sed for bracigtherayf petices.' re b, cactien 20.105 idanti"Sas these instances in which P. licensee '. nust
. . . t . . . . .
declare an area restricted. Procosed 35.f,OL ,ould accc=plish tha esas parpose $s the sug;;2sted. regire=s=t for cu: ref =g a reos for displaced sources. re e, tha loss of a caed 9euld be n i centrary to 20 301.
- 2ta !?,is acensble to includi g suggeded l
parag: aph 'd. Sechion 2).101 establishes dose lwts fcr the j
, .* =
s j hmvh. l MtI!. M I ,: c, d, S u d b d ' '. 9/ % -
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[7590-01]
. satisfy this requirement, the instructions must describe procedu - for:
h (1) Patie ontrol; and
,. g( ' (2) Visitor contr'
.[f jj (b) The licensee shall ke- for two years a list of individuals
/j / receiving instructions required by para h (a) of this section, a
~
p 3' description of the instructions, the date of in of the individual who gave the instruction. ction, and the name
~t
$3S. 4%f Aleu) secherb JetJr. 72a.
Subpart H--Group VII (sealed sources for diagnosis) 6 35.500 Use of sealed sources for diaonosis. The licensee shall use the following sealed sources for diagnostic
. purposes in accordance with the product labeling, package insert, or other manufacturer's instructions for use:
(a) Iodine-125 as a sealed source in a device for bone mineral analysis; and (b) Americium-241 as a sealed source in a device for bone mineral analysis. Subpart I--Group VIII (teletherapy)
@ 35.600 Use of a sealed source in a teletheracy unit. <
The regulations and provisions of this subpart govern the.use of teletherapy units that contain the following sources for the treatment ' of humans: (a) Cobalt-60 as a sealed source; and (b) . Cesium-137 as a sealed source. l 35.604 Information to be submitted with aoolication. The applicant shall supply such information deemed necessary by the Commission to determine the safety of the teletherapy facility. This' includes, but is not necessarily limited to plan / and elevation /,drw9stws
, shielb- . ing information and calculations, and descriptions of interlocks, viewing systems, and other safety systems.
72 Enclosure 1
( 35.406. Accountability of brachytherapy sources The licensee shall establish and implement written procedures for accountability of brachytherapy sources. To satisfy this requirecent, these procedures shall: (a) Designate the individual on the licensee's staf f respon-sible for the accountability program. (b) Require the maintainence of a brachytherapy source accountability ledger that shows the location of each brachytherapy source within the licensee's facility at all times. (c) Require that the appropriate notations be made to the ledger each time that a source is checked out or returned to storage. 4 '5
/
. j
-v6 -
{ .\ 372a V1D 35 406 'me T? believes that the 12 e; of the sugpsted s ctica
, is aceg=yli.da,2 by p;caed 35.Lotb, but is acenable to 'includir.g the suggested language. ,
e 4 72a i k_
. [7590-01]
6 25.505 "cintenance and-reeaHrestrictions. gh o person specifically licensed by the NRC or an Agreement
, g State to pe,rform '
erapy unit maintenance and repair shall maintain,- r adjust, or repair the source "
,Ar the shutter or other mechanism of a 2, teletherapy unit that could expose the sou reduce the shielding f h. ,,a -8 ?around the source, or result in increased radiation lev l '. , rA '
- f'# U. 6 35.606 Amendments.
The lice'nsee shall apply for and must receive a license amendment prior to: (a) Making any change in the treatment room shielding; (b) Making any change in the location'of the teletherapy unit within th'e treatment room; (c) Using 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; (e) Removing the teletherapy unit; (f) Changing the source; or (g) -Allowing an individual not listed on the licensee's license to perform the duties of the qualified teletherapy calibration expert. 6 35.610 Emergency instructions. The licensee shall post written emergency instructions at the teletherapy unit console. To satisfy this requirement, these instructions ' must inform the operator of: (a) The procedure to be followed to ensure that only the patient is in the treatment room before turning the primary beam of radiation
**I
_ gj)
,4. . (b) The procedure to be followed ,should the operator be unable to
- i '(' . '
' turn the primar beam of radiation off with controls outside the treatment roomfa$
' UW0 0W
- h W#)
(c) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted in the event of any abnormal operation of the teletherapy unit or console. 73 Enclosure 1
35.605. Restrictions on work done on teletherapy units. The following shall be performed only by persons specifically licensed by NRC or an Agreement State to perform such services: (a) Installation, relocation, or removal of teletherapy units containing sources; and (b) Source exchange; and (c) Any maintenance, repair, or adjustment operations on a teletherapy unit involving work on the source drawer, the shutter, or other mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels.
, f
- r. v,g -w
> jW' a s uf
~1732 75D 35 605 ne c'ce.51 reqdrs=ents in :nw,sted '35 605a r4 b m i ,
already est by reqd:dng a license a=ent:me, before Innir4 a ta'Istherapy unit (see p:~3 posed 35 606). suggested e is identical to Mposed 35.605 h l 73a
l [7590-01] s 35.620 Doors. interlocks and warnino systems. _ (a) The licensee shall control access to the teletherapy room by a door at each entrance. (b) The licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will: (1) Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed; (2) Turn the primary beam of radiation off immediately when an entrance door is opened; and
(3) Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatreent room entrance doors are closed and the beam.on-off control is reset at the console.
(c) The licensee shall equip each entrance to the teletherapy room with a beam condition indicator light. 6 35.621 Radiation monitoring device. (a) The licensee' shall install a permanent radiation monitor in
'l each telether'apy room capable of continuously monitoring beam status.
, A. (b) Each radiatigngnitor must be capable of providing visible
} (', . notice of a teletherapy malfunction 3 that may result in an exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual entering the teletheraov room.
, (c) Each radiation monitor must be equipped with an emergency power supply separate from the power supply to the teletherapy unit. ,
This emergency power supply may be a battery system. (d) Each radiation monitor must be checked for proper operation each day before the teletherapy unit is used for treatment of patients. (e) The licensee shall maintain a record of the monitor. check required by paragraph (d) of this section for. two years. The record must include the date of the check, notation that the monitor indicates when the source is and is not exposed, and the initials of the individual who performed the check.
, (f) If a radiation monitor is inoperable for any reason, the
., , Q V licensee shall require any individual entering the teletherapy room to
{,f, 7 , use a urvey instrument or
---h praferiy Yre.h,ngaudible alarm personal dosimeter to 74 Enclosure 1
[7590-01] for any malfunction of the source exposure mechan. ism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked for proper operation at the beginning of each day of use. (g) The licensee shall promptly repair or replace the radiation monitor if it is inoperable.
, 6 35.622 Viewing system.
The licensee shall construct or equip each teletherapy room to
,. permit continuous observation of the pat.ient from the teletherapy unit F console during irradiation.
< l, l
{05. b23 kek) 6dCNbA) 800 fRf0 ?bYT-S 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 Association of Physicists in Medicine. The calibration must have been
. performed within th'e previous two years and after any servicing tha'tmay have affected system calibration; or -
(2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have oeen intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the Na'tional Bureau of Standards or by a calibration laborato accredited by the American Association of Physicists in Medicine ihe 3 intercomparison meeting must be sanction'ed b g alibration laboratory
, , , or radiologic physics center accreditedg by tr.c '.~. a ,' _ u
~
, (,"p.
.m. ..
"'3: Ri;t: ' 'idic . x. 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 factor. The licensee shall use a teletherapy unit with a cobalt-60 source when intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, and a teletherapy unit with a cesium-137 source when intercomparing 75 Enclosure 1
.s s 35.623 Requirenent for electrical and/or mechanical stops to limit s
use of the primary beam of radiation. Prior to inititation of a treatment program, each telettierapy unit shall be equipped with electrical and/or mechanical stops limiting use of the primary beam of radiation so as to ensure compliance with g20.105(b) of this chapter as evidenced by a special teletherapy survey as required by gg35.640 and 35.641 of this < part. ?!ecessary use restrictions shall be fully described in the l
, special teletherapy survey reports submitted in accordance with 335.644 of this part.
M k N i i I C $5 a l J 75a
[7590-01] output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrica] or mechanical stop, each beam condition indicator light, the viewing system.and doors, and the signature of the individual who performed the periodic spot-check. See p.80a.fer~ u deX6 #b . ; ::.C21 t di:ti: ::::ur r:rt: ' ' '- ": t :1 ' : t i : :' : ::u :e. M (;) f;r: % = r .:: rJ :ft:r ::b S:tcil:ti;r ;f : t:1;th r:py l h d5. Ik0 AAN . w , , _ x_ __n, . c NW OfMM/N _ _. ~. . , . _ __..__...~_._-..-~.y (1) The maximum and average radiation levels at one meter from the garagraph h ch yg/, q teletherapy source when in the off position do not exceed 10 milliroentgens
. ,.V per hour and 2 milliroentgens per hour, respectively; and
- . ,, W (2) With the teletherapy source in the on position with the largest
's-q?' f, clinically available treatment field and with a phantom in the primary beam of radiation.
(i) [diationquantitiesinrestrictedareasadjacenttothe
, treatment room are not likely to cause personnel exposures in excess of the limits speci ied in S 20.101 of this chapter, and
, r
,'[
(ii) Tha [ diation 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 :,pecified in that paragrapn, tne licensee shall lock the control in the off posit, ion 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
, ,, j, .~ (2) Until the licensee has received a specific exemption pursuant
, ' ('l' . -
to S 20.501 of this chapter. he ,ffd1 (c) i licensee shall maintain a record of the radiation g.cg g measurements made owing installation of a source for the duration of g Acu) the license. The record
- include the date of the' measurements, the model number and serial number or instrument used to measure radiation (d,)grg levels, each radiation level measured ar the teletherapy source while in the off position and the average of al . asurements, a plan of each area that was surveyed, the measured exposure rate
- several .
points in each area expressed in millirem per hour, the calcula c 80 Enclosure 1
_,. .. .. q..
; t. ' .lr , tly '
j; 35.640. Circumstances requiring a special teletherapy survey. T A special teletherapy survey as further described in g 35.641 J- )[ and 35.642 nust be performed: r' (a) Before a treatment progra.s is begun and af ter each i' ' installation of a teletherapy source; and 1
,t:
(b) Af ter any changes are made in: (i) The treatment room shielding; and (ii) The location of the teletherapy unit within the treat-ment room; and (iii) The use of the teletherapy unit that could result in
' f. . increase radiation levels outside the treatment room; and (c) After relocation of the teletherapy unit to a new facility.
y .s . 35.641. Radiation cleasurements required for a special teletherapy
',, survey.
(a) Under the circumstances described in 335.640, the licensee shall nake measurements to-verify that: 4
}
l 80a \ ... _ _ _ _ _
.a ~
35.641. Radiation measureiaents required for a special teletherapy survey. (c) The licensee shall maintain a record of the radiation measurement made in accordance with the requirements of sub-paragraphs (a) and (b) of this section for the duration of the license. The record must include the date of the measurement, the manufacturer's name, model number and serial number of both the teletherapy unit and source, the circumstance in (35.640 that required the measurements, the manufacturer's name, model number and serial number of the instrument u. sed to measure radiation levels, each radiation level measured around the teletherapy source while in the off position and the average of all measurements, a plan of each aren that was surveyed, the measured exposure rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Of ficer. 35.642. Facility checks required for a special teletherapy survey. (a) Under the circumstances described in j35.640, the licensee shall promptly test all systems listed in 3 35 633(g) for proper function. 80b C-i ___
~
o . [7590-01]
- n. i u a t ' t, ^:di:ti- r : W " e-- -4 '- m,-h
-:: :t;l :rd - ~ :t ':t:1 :r :, :-d '": : '7:'- '"-o " ion e , cm., a c c : - ..
Se e, . $0 h h >- M rsh k ; :: 7 -
;;;,2; ;';;;; - , ;
- - :_; ; , ; ;r__ _c f 36~6MJ Old ra m
-ur
,r______
.-.- . . ~ .
_u_,, _.___ , c.. _. .2 5 25.522W ': pr:;;r '_ .:ti' 2'tcr :::' '.: t: :t':
- ' : i:':t';;;;y
, ., . P " m .
v
'l. ';. - $
(b) If the results of the checks required in paragraph (a) of this
' section indicate the malfunction of any system specified in S 3f.633(g),
the licensee shall lock the control console in the off position and not , use the unit except as may be necessary to repair, replace, or test the malfunctioning system. (c) The licensee shall maintain a. record of the facility checks following installation of a source for the duration of the license. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer. . Reoortsofs S 35.644 '^pecN '-- bEILUtrAf'y
':"'- ' SurVCQS.
The licensee shall mail copies of the results of the surveys and y.* tests required at SS 35.641, 35.642, and the output from the teletherapy source expressed as roentgens per hour at a distance of one meter from the source and determined during the full calibration required in S 35.632, to the following two addresses within thirty days following
--?m.. ., _
....m
....w _ . _ - . .
(a) The ' Material Licensing Branch, Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, and - (b) The appropriate U.S. Nuclear Regulatory Commission Regional Office list'ed in Appendix 0 of Part 20 of this chapter. 9 35.645 Five-year insoection. (a) The licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not r oompleHon d de thangs de.seribed in 53G40 dd
~~'
Affe6bkk 4. 'SfCCN!d 81 Enclosure 1 pdekrapq survep
[7590-01] to exceed five years, whichever comes first, to assure proper functioning JCe attu k_ of the source exposure mechanism. dn p. OA (gjp/) This iilspectiori and servicing may only be performed by persons
, specifically licensed to do so by the Commission or an Agreement State.
, / [d)f Qd The licensee shall keep a record of the inspection and servicin'g
' V
-(;\i/ ' T i for the duration of the license. The record must contain the insoecto mann
- name, the inspector's lice umber, the date of insoection, iintJsre/r's the;model t tsa m e, number and serial number o 4 Med $ourCt> e teletherapy unitaa list of components inspected, a list of components serviced and the type,of service, 'a list of components replaced, and the signature of the. inspector. m Subpart J--Training and Experience Requirements 6 35.900 Radiation Safety Officer, Except as provided in 6 35.901, the licensee shall require an indi-vidual fulfilling the responsibilities of the Radiation Safety Officer as provided in 6 35.32 to: 1 (a) Be certified by:
. (1) American Board of Health Physics in Comprehensive Health
* ~
Physics; (2) American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or (3) American Board of Nuclear Medicine Science in Nuclear Medicine Science; or (b) Be an authorized user for those byproduct material uses that come within the Radiation Safety Officer's responsibilities; or
. (c) Have had classroom and laboratory training and 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; (4) 20 hours of radiation biology; (5) 30 hours of radiopharmaceutical chemistry; and (6) One year of full time experience in medical radiation safety at an institution under the supervision of the individual listed as the
. 82 Enclosure 1 we -_mthh_m__.___e_e_.;________.
35.645. Five year inspection. (b) Amendaents to teletherapy licenses in effect as of :farch 4, 1983, which extended the time interval for the inspection and servicing requirement of paragraph (a) of this section shall remain in effect and are not rescinded by this section. I 4 t 82a
l [7590-01] . Radiation Safety Officer on a Commission or Agreement St' a te license that authorizes the human use of byproduct material. (d) The training and experience specified in paragraph (d) of this section must have been obtained within the five years preceding the date of application or the Radiation Safety Officer must have had experience equivalent to one year of full time employment in medical radiation safety within the last five years. 6 35.901 Radiation safety officer training exception. An individual identified as a Radiation Safety Officer on a
- n. Commission or Agreement State license on (*** insert effective date of final rule ***), who oversees only the use of byproduct material for which the licensee was auth'orized on that date, need not comply with the training requirements of 9 35.900.
6 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 . 5 35.100(a) to:
(a) Be certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; or (2) Diagnostic radiology with special competence in nuclear
, radiology by the American Board of Radiolo , or
,. M the pressous [We years)
(3) Diagnostic radiology or radiology SheAmericanOsteopathic, Board of Radiology; or (b) Have completed 200 hours of training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals. To satisfy this requirement, the training must include classroom and laboratory instruction and supervised experience in a nuclear medicine laboratory as follows: (1) 100 hours of radiation physics and instrumentation; (2) -30 hours of radiation protection; (3) 20 hours of mathematics pertaining to the use and measurement I of radioactivity; (4) 20 hours of radiation biology; and (5) 30 hours of radiopharmaceutical chemistry; or 83 Enclosure 1
- - - - - - ? -- - -- - -- - - - - - _ _ - . _ , - - - - - - - . - - , - - . - -, - - - - - - - - _ _
[7590-01] (c) Have 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 this section within five years of the date of application for a license, or have had experience equivalent to one year of full time employment in nuclear medicine within the'last five years. 35.920 Training for imaging and localization studies. Except as provided in 9 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit listed in 5,35.200(a) to: > (a) 8e certified in: - (1) Nuclear medicine by the American Board of Nuclear Medicine; or (2) Diagnostic radiology with special competence in nuclear radiology by the American Board of Radiology; or
- p,glys the jverseds [Ve ydr.5)
(3) Diagnostic radiology or radiology by 3 the American Osteopathic
/ oard B of Radiology; or
, 4. , - (b) Have completed 200 hours of instructiog, 500 hours of supervised work experience and 500 hours of supervised clinical experience.ljn basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits /
(1) To satisfy the requirement for instruction, the classroom and laboratory training must include:
, (i) 100 hours of radiation physics and instrumentation; (ii) 30 hours of radiation protection; (ii i.) 20 hours of mathematics pertaining to the use and measurement of radioactivity; -
(iv) 20 hours of radiopharmaceutical biology; and (v) 30 hours of radiation chemistry. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include: 84 Enclosure 1
[7590-01] (i) Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnos' tic instruments and , performing survey meter checks for proper operation; . (iii) Calculating and safely preparing patient doses; (iv) Using administrative controls to prevent the misadministration f of byproduct material;
} (v) Using emergency procedures to handle and 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 must be under the supervision of an authorized user at an institution and must include: (i) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations or contraindications; (ii) Selecting the proper radiopharmaceutical and dosage; (iii) Administering doses to patients making proper use of syringe radiation shields; (iv) Calculating the radiation dosage and collaborating with the authorized user in the interpretation of radioisotope test results; and , I (v) Patient followup; or * (c) Have 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, wo'rk experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section within five years of the date of applicati.on for a license, or have had experience equivalent to one year of full time employment in nuclear medicine within the last l five years. l j . 85 Enclosure 1 i l
[7590-01]
% 35.930 Training for therapeutic use of radiocharmaceuticals.
Except as provided in 6 35.970, the licensee shall require the authori, zed user of a r'adiopharmaceutical listed in S 35.300 for therapy to: (a) Be certified i o r" t
-(4) /uclear medicine by the American Board of Nuclear Medicine; ee-
.g.;p.(2) L.uth. ...:i u ( t': 'u rf::- 0:t:: :t'#: M:-d of
<W I ,
h di:':L , :: 4*r' ' N. -(b) Have completed 80 hours of instruction # and have had supervised K clinical experience.in basic radioisotope handling techniques applicable
~
totheuseoftherapeuticradiopharmaceuticalsf (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 an institution and must include: (i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dy fanction in 10 individuals; (ii) Use of soluble phe:phorus-32 for the treatment of polycythemia vera, leukemia, or bone metastases' in 3 individuals; (iii) Use of colloidal phosphorus-32 for intracavitary treatment of malignant effusions in 3 individuals; (iv) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals; and (v) Use of colloidal gold-198 for intracavitary treatment of malignant effusions in 3 individuals. 86 Enclosure 1 ee.--- - -. .--ames.= --mme-
[7590-01] 6 35.940 Training for theraceutic use of brachytheraoy s5urces. Except as provided i'n 6 35.970, the licensee shall require the - authorized user using a brachytherapy source listed in 6 35.400 for therapy to: (a) Be certified in: (1) Radiology or therapeutic radiology by the American Board of Radiology;- (2) Radiation oncology by the American Osteopathic Board of
~l Radiology;
~
(3)iphiogl di ,gthaspec li i ogin adiotherapy, tyr t-
. 43ene A
., British , Faculty o Radiology [org... . . M r. Royal College of Radiolog; b
,[ ), F,~ dor (4) Therapeutic radiology by the Canadian Royal College of e .
Physicians and Surgeons; or EA. (b) Have completed 200 hours of instruction and 500 hours of 4 suoervised work exoeriencelin basic radioisotope handling technioues [ apolicable to the therapeutic use of brachytherapy sources and pe u rd 3 years k of supervised clinical experience. (1) . To satisfy the requirement for instruction, the classroom and laboratory training must include: (i) 110 hours of radiation physics and instrumentation; I (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: 4 (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Checking survey meters for proper operation; (iii) Preparing, implanting.and removing sealed sources safely; 87 Enclosure 1 ey' ,+ - - . . , . . - c, ---r-~#-- ., r-- - - - - . - - - . _ - - . , _ ,--m.-.-.e -- .,,_7,__ ,- _m_ ..-,4-,--,,7,.- , ----
[7590-01] (iv) Using administrative controls to prevent the misadministration of, byproduct material; and (v) Using emergency procedures to handle and control byproduct material. ' (3) To satisfy the requirement for a period of supervised clinical experience, training must include one year in a formal training program approved by the Residency Review Committee for Radiolg,of]he Accredi-tation Council for Graduate Medical Education, and,two years of clinical
},,'(,'g/
experience in therapeutic radiology under the supervision of an authorized user at an institution. 9 35.941 Trainina for ophthalmic use of strontium-90. Except as provided in 6 35.970, the licensee shall require the authorized user using only strontium-90 for ophthalmic radiotherapy to: (a) Be certified in radiology or therapeutic radiology by the American Board of Radiology; or (b) Have completed 24 hours of instruction in basic radioisotope handling techniques specifically applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervi::ed clinical training in ophthalmic radiotherapy. (1) To satisfy the requirement for instruction, the classroom and laboratory training must include: (i) 6 hours of radiation physics and instrumentation; (ii) 6 hours of radiation protection; (iii) 4 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv)' 8 hours of radiation biology. s (2) To satisfy the requirement for a period of supervised clinical
<- A i r
..n '
training in ophthalmic radiotherapy, training must include the use rtof) a+ an tas4<ku+to strontium-90 under the supervision of an authorized (user,for the ophthalmic treatment of five indi'viduals and must include the examination of each individual to be treated, calculation of the dose to be. administered, post-administration followup, and review of each individual's case history. 88 Enclosure 1
[7590-01]
@ 35.960 Trainino for teletheracy.
Except as provided in g 35.970, the licensee shall require the authorized user using a sealed source lis.ted in 6 35.600 in a teletherapy unit to: - See Acal b d
,g,-*r(a) "^
._", . '.._. , _ . _ . m., , ...m n~_.,u,~___,.>-
s na:,--
.> work 7 (b) Have compleged .Wtr hours .of. instruction4 500 hours of supervised
, .y experience, and 384r5 . .
* ~
., v u o_.
of supervised clinical experience; in f g :f .\ basic radioisotope technicues acolicable to the use of a sealed source
,I* inateletheraovunitj
( (1) To satisfy the requirement for instruction, the classroom and I laboratory training must include: (i) 100 hours'of radiation physics and instrumentation; (ii) 26 hours of radiation protection; (iii) h hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 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: N8 W "N ., ecking the operation of survey meters; b ' ii) Calculat... iation doses to be administered; on fAf Y ((iii)' Using administrative u
- ls to prevent the misadministration g J of byproduct material; and
< \ ,1 , m (iv) Implementing emergency procedures to be follow
- the event of the abnormal noeration of a teletheraov unit or console.
(3) To satisfy the requirement for supervised clinical experience, training under the supervision of an authorized user must include: (i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications; (ii) Selecting the proper dosegnd hoto tE is b he admarts.sfered,; (iii) Calculating the teletherapy doses and collaborating with the authorized user in th'e4 io m ,..-- ...mm vi A J.m y, . d .a , and s{ Post-administration followup and review of case histories. f'rev()iv) ca e.f modafy erpdrertW progress and posible treed fo . reaCf10n h t-AAIa.fIbrt *, 89 Enclosure 1
-w .,,--e,- -.----,.----..nn--- , , . -m -
-w.------m- ,-.e- -,~,----w-- ---p - - - , -,,-g ---- ---r-- -,,-m-- - --
35.960. Training for teletherapy. (a) De certified in: (1) Radiology or therapeutic radiology by the American Board of Radiology; or (2) Radiation oncology by the American Osteopathic Board of { -. Radiology; or (3) Radiology, with specialization in radiotherapy, as a British " Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or 6
+
t 5 - i
+
1 I 1 i l 89a h __s- _ _ _ - _ = _ = _ = = = _ _ _ = _ - _ = _ - _ - _ .
35.960 Training for teletherapy. (b)(2)(1) Review the initial source calibration and periodic spot-check measurements of teletherapy units; and (ii) Initial source calibration of sealed sources other than teletherapy sources that are used for treatment purposes; and (iii) Calibration of ion chambers and survey meters; and (iv) Preparation of treatment plans and treatment times for teletherapy and brachytherapy; and (v) Knowledge of appropriate radiation safety, quality control, and emergency procedures for handling and using scaled Sources. 1 89b 1 t
. ~ _ . .. . _ _ _ ____ _ _ _ _ _ _
(#te) adId/0jI6L/_f yS'CS} OF' [7590-01] 6 35.961' Training for cualified teletheracy calibration excert. [d) The licensee shall require the individual calibrating or checking the radiation output of a teletherapy unit as a qualified teletherapy calibration expert as provided by 96 35.632 and 35.633 to: h)M Be certified by the American Board of Radiology in: h) fed Therapeutic radiological physics; or [U Gd Roentgen ray and gamma ray physics; or 4&*) d )( ray and radium physics; or [g)/) Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one yean of
' full time work experience under the supervision of a qualified teletherapy calibration expert at an institution where teletherapy is performed. To satisfy this requirement, the neophyte qualified teletherapy calibra. tion expert must have performed the tasks listed in 95 35.59, 35.632, 35.633, and 35.641 of this part under the supervision of a qualified teletherapy calibration expert during the year of work experience. '
U.) See neu.) ledi p. fo r S 35.970 Experienced physician training exception. ' A physician 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 procedures for which the physician was authorized on that .date, need not comply with the training requirements of Subpart J. 6 35.971 New physician training exception. A physician who, by August 31, 1987, has successfully completed a three month nuclear medicine training program approved by the Accredita-tion Council for Graduate Medical Education need not comply with the requirements of SS 35.910 or 35.920. Subpart K--Enforcement 6 35.990 Violations. - (a) An injunction or other court order may be obtained to. prohibit a violation of any provision of:
, (1) The Atomic Energy Act of 1954, as amended;
_ full'}Ike 1br$tollIy ort tbtr*0t f u,Nc (Ti.Ol6lCjlC4l f $U #Y erit. gear' f 90 Enclosure 1 W ::y225 ovt $/ )* p 90 V9At
35.961. Training for qualified teletherapy calibration expert. l (b) Licensees that have their teletherapy units calibrated by persons who do not meet the criteria in p35.961(a) , may request ' a license amendment excepting them from the requirements of g35.961(a). This request, accompanied by the appropriate amendment , tee (3170.31 of 10 CFR 170) must include the name of the proposed qualified expert, a description of his training and experience including information similar to that specified in 335.961(a)ls), reports of at least one calibration and spot-check program based on measurements personally made by the proposed expert within the past 10 years, and written endorsement of the technical qualifica-tions of the proposed expert from personal knowledge by a physicist certified by the American Duard of Radiology in one of the specialties listed in 335.961(a)(1). Tho individual's qualifications will be evaluated by NRC's consultants in medical ; physics. The araendment request should be sent to the appropriate address shown in f35.16. 4 h 1 I f 90a
- i I
l
.. . . . ~
[7590-01] (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: (1) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 under section 234 of the Atomic. Energy Act of 1954; (2) Section 206 of the Energy Reorganization Act of 1974; (3) Any rule, regulation, or order issued under these Acts; (4) Any term, condition, or limitation of any license issued under these Acts; or (5) Any violation for which a license may be revoked'under section 186 of the Atomic Energy Act of 1954. (c) Any person who willfully violates any provision of the Atomic Energy Act of 1954, as amended, or any regulation or order issued under the requirements of the Act may be guilty of a crime and, upon conviction, may be punished by fine or imprisonment or both as provided by law. Regulations issued under the Act include regulations issued under sec.161, and cited in the authority citation at the beginning of this part for the purposes of sec.' 223.
- The following amendments are also made to existing parts of the regulations in this chapter. The authority for these conforming amendments is: Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 U.S.C. 5841).
PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF ' BYPRODUCT MATERIAL
- 2. Section 30.4 is amended by revising paragraphs (h) and (1) to read as follows:
6 30.4 Definitions, n n n a n (h) " Human use" means the intentional internal or external l administration of byproduct material, or the radiation therefrom, to human beings; ! n * * * = l 91 Enclosure 1 l
[7590-01] (1) " Physician" means a medical doctor or doctor of osthopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drt.gs in the - practice of medicine; a a *
- a
- 3. Section 30.34 is amended be revising paragraph (g) to read as follows:
6 30.34 Terms and conditions of licenses. ' s g (g) A licensee may prepare technetium-99m radiopharmaceuticals 4 only with technetium-99m that contains less than 0.15 microcuries of c: c molybdenum-99 per millicurie of technetium-99m. The licensee shall j i perform tests and maintain the records required by 6 35.204. PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
.E
$ 31.11 General license for use of byproduct material for certain in 0
n vitro clinical or laboratory testing. e a n n x n 4 Section 31.11(b) is amended by deleting "635.14(c)" and gk 7 inserting % c 4. [(36,57
- a 8 PART 32 - SPECIFIC DOMESTIC LICENSE TO MANUFACTURE OR
'i- kT s ti .
TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS
- 5. Section 32.70 is removed.
E 6. Section 32.72 paragraph (a)(4)(i) is revised to read as follows: s e
- g8.U. ~S 9 32.72 Manufacture and distribution of radicoharmaceuticals containing a, E P byproduct material for medical use under arouo licenses.
; ,N (a) An ' application for a specific license to manufacture and
/
f,~' distribute radiopharmaceuticals containing byproduct material for use by persons authorized pursuant to Part 35 of this chapter will be approved u if: g x x n n n N 92 Enclosure 1
l .
'~
j - [7590-01] I L (4)(i) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay, and the label affixed to each package, or the leaflet or brochure that
. accompanies each package, contains a statement that the unit dosage
~
radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to Part 35, as appropriate, or under an equivalent license of an Agreement State.
.. *
- a a a 1
7. Section 32.73 paragraphs-(a)and (a)(5)(ii) are revised to read as follows: 5 32.73 Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceutical containing byproduct material.
.(a)
(5) *** (ii) A tatgm is approved .;c ;1 _;gtgt higgeneratororreagentkit(asappropriate)
- 3 3 persons licensed by the U.S. Nuclear Regulatory ,ggy Commission to use byproduct material identified in 6 35.200 of 10 CFR #
Part 35 or under an equivalent license of an Agreement State.
, a a =
- 8. >
Section 32.74 paragraphs (a) and (a)(3) are revised to read as follows: 9 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical Ose. (a) An application for a specific license to manufacture and e 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 69 35.400 and 35.500 of this , chapter will be approved if: A . A
- A
. A (3) The label affixed to the source or 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 of source or device) is licensed by the U.S. Nuclear Regulatory Commission 1 1
)
i l
. i 93 Enclosure 1 l l
. . ~~
*~
.o'
, [7590-01]
for distribution to persons licensed to use byproduct material identified in $$ 35.58, 35.400, and 35.500 of 10 CFR Part 35 or under an equivalent license of an Agreement State. PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL
- 9. Section 40.4 is amended by revising paragraph (g) to read as follows:
9 40.4 Definitions, s ', a
- a a *
, (g) " Physician" means a medical doctor or doctor of osteo' pathy licensed by a State or Territory of the United States, the District of of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; n a s n n
. Dated at Washington, D.C. this day of 1982.
. For the Nuclear Regulatory Commission.
Samuel J. Chilk, < Secretary of the Commission. 94 Enclosure 1
.o. . -
l . . j NRC FORM 313M U.S. NUCLE AR REGULATORV COMMISSION Approved by OM8 19 an f 10 CFR 35 APPLICATION FOR M ATERIALS LICENSE - MEDICAL /
$8,,$'30 83 i
INSTR UCTlONS - Comonte items I througn 2611rnos e an inorias apohcaroon or an apooncar:an for renewat of a tocense. use sucotementat sneers enere necesury. Irem 26 must be completed on all apohcations and signed Retaon one coov. Submat ongmat and one cocy of enr.re auchcatoon to : 0, rector. O!! ice of fluclear Staternais Safery and Safeguaras. u 5 Nuciear Regutatory Commission. &ashmgton. D C. 20555 Upon aoorovatof thos apohcatoon. the acchcant ewit recerve a Matenals Locense. An NRC Matenais Locense is issued on accora* ance owth the generat requirements contained in Title 10. Code of federal Regulations. Part 30. and the Licensee os subiect to Title 10. Code of federal Reguoarrons. Parts 19. 20 ed J5 and the hcense fee provosion of Totte 10. Code of feueral Regulatsor's. Part i10 rne hcense fee category should be stated m Item 26 and the.oporoonate fer enclosed. 1.a. NAME AND M AILING ADDRESS OF APPLICANT (msatucon, 1.tx STREET ADDRESS (ES) AT WHICH R ADIOACTIVE MATERIAL firm chnic. physician,etcJ INCLUDE ZIP CODE W1LL BE USED lit different from 1.<1 INCLUDE zip CODE TE LEPHONE NO.: ARE A CODEI )
- 2. PERSON TO CONTACT REGARDING THIS APPLICATION 3. THIS IS AN APPLICATION FOR: / Check approonate stem)
- a. O NEW UCENSE ts O AMENOVENT TO LICENSE NO.
TE LEPHONE NC.; ARE A CODE I )
- 4. INDIVIDUAL USERS (Name moividuals who wr// use or directly S. RADIATION SAFETY OFFICER (RSO) (Name ofperson designated supervose use of radioactive matenat. Complete Suppiements A and B as radiation saferv off,cer. If orner than onrbedualuser, complete resu-for each indowedual.) me of tramong and encenance as ur Sucolement A.)
6.a. RADIOACTIVE MATERIAL FOR MEDICAL USE MAXIMUM MARK MAXIMUM ITEMS POSSESSION ITEMS RADIOACTIVE MATERIAL DESIRED ADDITIONA L ITEMS: POSSESSION LIMITS __D E SI R E D LIMITS LISTED 1N: . X (In milheuries} "X fin millicuries) 10 CFR 31,11 FOR IN VITRO STUDIES IODINE 131 AS lODIDE FOR TRE ATMENT OF HYPE RTHYROIDISN1 s 10 CFR 35.100. SCHEDULE A, GROUP 1 AS NEEDED PHOSPHORUS 32 AS SOLUBLE PHOSPH ATE FOR TREATMENT OF POLYCYTHEMIA VER A, LEUKEMIA AND BONE METASTASES to CFR 35.100, SCHEDULE A, GROUP 11 AS NEEDED PHOSPHORUS-32 AS COLLOID A L CHROMIC PHOSPHATE FOR INTRACAVITARY TREAT-10 CFR 35.100, SCHE DULE A. GROUP lit MENT OF MALIGN ANT E FFUSIONS. GOLD.190 AS COLLOID FOR INTRA. 10 CFR 35.100 SCHEDULE A, GR OUP IV CAVITARY TRE ATMENT OF MAllGNANT AS NEEDED E F FUSIONS. IODINE.131 AS lODIDE FOR TRE ATMENT 10 CFR 35.100. SCHEDULE A, GROUP V AS NEEDED OF THYROlO CARCINOMA XENON.133 AS GAS OR G AS IN S ALINE FO R 10 CFR 35.100. SCHEDULE A. GROUP VI BLOOO FLOW STUDIES AND PULMONARY I_ FUNCTION STUDIES 6.b. RADtOACTIVE MATERI AL FOR USES NOT LISTED IN ITEM 6.a. <Seaiedsources no so JmCiumsfor cahbration and reference standards are authotored under Seebon 35.14fd),10 CFR Part 35. and NEED NO T BE LISTEOJ CHEMICAL MAXIMUM NUMBER ELEMENT AND MASS NUMBER AND/OR OF MILLICURIES DESCRIBE PURPOSE OF USE PHYSICAL FORM OF E ACH FORM e e .
.,e &m e
NaC POaM sisu
, ggi,j ,- p r f.
ENCLOSURE 2-p .
INFORMATION REQUIRED FOR ITEMS 7 THROUGH 23 l For items 7 through 23, check the appropriate box (es) and submit a detailed description of all the requested information. Begin f each item on a separate sheet. Identify the item number and the date of the application in the lower right corner of each page. If y;u indicate that an appendix to the medical licensing guide will be followed, do not submit the pages, but specify the revision number and date of the referenced g"ide: Regulatory Guide 10.8 , R ev. Date:
- 7. MEDICAL ISOTOPES COMMITTEE 15. GENERAL RULES FOR THE SAFE USE OF RADIOACTIVE MATERIAL (Check Onel Names and Specialties Attached; and Appendix G Rules Followed;or Duties as in Appendix B;or Equivalent Rules Attached (Check Onel Equivalent Duties Attached 16. EMERGENCY PROCEDURES (Check Onel
- 8. TRAINING AND EXPERIENCE Appendix H Procedures Followed;or Supplements A & B Attached for Each Individual User; Equivalent Procedures Attached and Supplement A Attached for RSO. 17. AREA SURVEY PROCEDURES (Check Onel
- 9. INSTRUMENTATION (Check Onel Appendix 1 Procedures Followed;or Appendix C Form Attached;or Equivalent Procedures Attached List by Name and Model Number 18. WASTE DISPOSAL (Check Onel
- 10. CAllBRATION OF INSTRUMENTS Appendix J Form Attached;or Appendix D Procedures Followed for Survey Instruments; or Equivalent information Attached Equivalent Procedures Attached;and ' ^
19. (Check Onel Appendix D Procedures Followed for Dose Calibrator; or Appendix K Procedures Followed;or Equivalent Procedures Attached Equivalent Procedures Attached
- 11. FACILITIES AND EQUIPMENT 20. THERAPEUTIC USE OF SEALED SOURCES Description and Diagram Attached Detailed information Attached;and
- 12. PERSONNEL TRAINING PROGR AM Appendix L Procedures Followed;or (Check Onel Description of Training Attached Equivalent Procedures Attached PROCEDURES FOR ORDtiRING AND HECElVING PROCEDURES AND PRECAUTIONS FOR USE OF
- RADIOACTIVE MATERI AL 21. RADIOACTIVE GASES (e.g., Xenon - 133)
Detailed Information Attached Detailed Information Attached PROCEDURES FOR SAFELY OPENING PACKAGES
" " ^" " ^ "
- 14. CONTAINING RADIOACTIVE MATERIALS 22. RADIOACTIVE MATERIAL IN ANIMALS (Check Onel Detailed Information Attached Appendix F Procedures Followed;or PROCEDURES AND PRECAUTIONS FOR USE OF 23 R ADIOACTIVE MATERIAL SPECIFIED IN ITEM G.b Equivalent Procedures Attached Detailed information Attached NRC FORM 313M is ati Page 2 e 4
- _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ - - _w
- 24. PERSONNEL MONITORING DEVICES TYPE (Checa eoroor,are boef SUPPLIE R EXCHANGE FREQUENCY PI L%i 4.WHOLE BOOY TLD 0 THE n (Soccityl viLM
- b. FINGER ito O TH E r1 (30eco tyl PILM c WRIST TLO OTHER (Specify)
- d. OTHER (Sorcitvl
- 5. FOR PRIVATE PRACTICE APPLICANTS ONLY a HOSPIT AL AGHEEING TO ACCEPT P ATIEN T3 CCN T AINING H AD:OACTIVE M ATE HI AL N AME OF HOSPITAL u, ATTACH A CCPY OF THE AGREENIENT LETTER SIGNEO SY THE HOSPITAL AD\tlNISTRATOR.
** " # "'8' c. f4 HEN REQUESTING THERAPY PRCCEDURES, ATTACH A COPY OF R ADI ATION SA8ETY PRECAU.
CI T Y STATE ZIP CODE 7 TONS TO BE TAKEN ANO LIST AVAILABLE R ADI ATION DETECTION INSTRUNtENTS,
- 26. CERTIFICATE (This item mus t be completed by applican ti The ecclecant and any of ficii6 esecut ng tnis certificate on benalf of the ecolecant eemed in item la certil1 that en's apps. cat.on <s prepared in conformity mth Title 10, Code of Fetteral Regulations. Part 30 ar4 35, and anat all entormation conts.ned herein,includ ag any suppsaments attached hereto. is true and sorteet to the best of our knowledge and belief,
- b. APPLICANT OR CERTIFYINO OF FICI AL ISofnJrur*/
- a. LICENSE FEE REOUIREC (See Seetoon I10 3t.10 CFR !?01 < n N AMg Irrce orpranti m TITu til LICENSE FEE CATEG0HY:
- c. OA TE (2) LICENSE FEE ENCLOSED: $
NRC FOHM 313M 19 all Page 3
._-._________-____O_--~~_._____ 7 :,
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PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93 579), the f ollowing statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on NRC Form 313M. This information i, maintained in a system of records designated as NRC 3 and described at 40 Federal Register 45334 (October 1,1975).
- 1. AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201(b)).
- 2. PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staff pursuant to the criteria set forth in 10 CFR Parts 30 3G to determine whether the application meets the reouirements of the Atomic Energy Act of 1954,as amended, and the Commission's regulations, for the issuance of a radioactive material license or amendment thereof.
- 3. ROUTINE USES The information may be used: (a) to provide records to State health departments for their information and use, and (b) to provide information to Federal, State, and local health officials and other persons in the event of ince.
dent or exposure, for their information, investigation, and protection of the public health and safety. The information may also be disclosed to appropriate Federal, State, and local agencies in the event that the information indicates a violation or potential violation of law and in the course of an administrative or judicial proceeding. In addition, this in-formation may be transferred to an appropriate Federal, State, or local agency to the extent relevant and necessary for a NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you. A copy of the license issued will routinely be placed in the NRC's Public Document Room,1717 H Street, N.W., Washington, D.C.
- 4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECTONINDIVIDUAL OF NOT PROVIDING INFORMATION Disclosure of the requested information is voluntary. If the requested information is not furnished, however, the application for radioactive material license, or amendment thereof, will not be processed.
- 5. SYSTEM MANAGER (S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety, Of fice of Nuclear Mate-rial Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
l l NRC FORM 313M (9 Bil Page 4
NRC FORM 313M SUPPLEMENT A U.S. NUCLEAR REGULATORY COMMISSION TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER
- 1. NAME OF AUTHORIZED USER OR RADIATION SAFETY OFFICER 2. STATE OR TERRITORY IN WHICH LICENSED TO PR ACTICE MEDICINE
- 3. CERTIFICATION SPECIALTY BOARD CATEGORY MONTH AND YEAR CERTIFIED A B C
- 4. TRAINING RECEIVED IN BASIC RADIOlSOTOPE HANDLING TECHNIQUES TYPE AND LENGTH OF TR AINING LECTURE / SUPERVISED FIELD OF TRAINING LOCATION AND D ATE (S) OF TR AININO LABORATORY LABORATORY A B COURSES EXPERIENCE IHours) (Hours)
C D
- a. R ADI ATION PHYSICS AND INSTRUMENTATION
- b. R ADI ATION PROTECTION
- c. MATHEVATICS PERTAINING TO THE USE AND MEASUREVENT OF R ADIOACTIVITY
- d. R A01 ATION 810 LOGY
- e. R ADIOPH A R VACE UTIC AL CHEMISTRY
- 5. EXPERlENCE WITH RADIATION. (Actualuse of Radioisotopes or Equivalent E>rperience)
ISOTOPE MAXIMUM AMOUNT WHERE EXPERIFNCE WAS OAINED DUR ATION OF EXPERIENCE TYPE OF USE NRC FORM 313M Swupiement A 19 811 Page 5 m_m. _ . _ . . e
a 2, a NRC FORM 313M SUPPLEMENT B U. S. NUCLE AR REGULATORY COMMISSIOM (9 811 PRECEPTOR STATEMENT r Supplement 8 must be completed tw the applicantphysician'spreceptor. If more than onepreceptoris necessary to cocument expenence, obtain a separate statement from each.
- 1. APPLICANT PHYSICI AN'S N AME AND ADDRESS KEY TO COLUMN C FULL N AME PE RSON AL PARTICIPATION SHOULD CONSIST OF:
14upervised exam nation of patients to determine the su tability for radioisotope diagnosis and/or treatment and recomme cation for prescribed dosaga. STREET AOORESS 2 Collaboration in dose calibration and actual administrabon of dose to the patient including calculation of the radiation c0se, related measurements and plotting of data. ClTV l ST ATL l ZIP CODE 3.Adecuate period of traimng to enable physocian to maeage radioactive patients and follow patients througn diagnosis acc.o* : .rse of treatment.
- 2. CLINICAL TR AINING AND EXPERIENCE OF ABOVE NAMED PHYSICI AN NUM8ER OF CASES INVOLVING COMME N TS ISOTOPE CONDITIONS DI AGNOSED OR TRE ATED PE RSON AL / Additional mfonnation or comments mav PARTIClPATION be submrtred on duchcate on separate snet:s i A 8 C D DI AGNOSIS OF THYROID FUNCTION DETE RMIN ATION OF SLOOD ANO BLOOD PLASM A VOLUVE I.131 LIVER FUNCTION STUDIES or 1125 FAT ABSORPTION STUDIES l K10NEY FUNCTION STUDIES IN VITRO STUDIES l OTHE R l125 OETECTION OF THROV80 SIS 1 131 THYROIO IM AGING P 32 EYE TUMOR LOC ALIZATION l
j Se 75 P ANCRE AS IMAGING Yli 169 CISTE RNOGR APH Y g, g 33 BLOOO FLOW STUDIES AND PULMON ARY FUNCTION STUDIES OTHE R l BRAIN IM AGING l CARDI AC IMAGING TH YROIO IM AGING SALIV ARY G1 AND IMAGING IC 03'" 8LC00 POOL IMAGING PLACENTA LOC All2 ATION I i LIVE R AND SPLEEN IV AGING l l LUNG IM AGING SONE IV AGING l OTHE R l NRC FORM 313M SUPPLEVEN T 8 i9 111 Page G l k l
PRECEPTOR STATEMENT (Continued)
- 2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN (Continued)
NUMBER OF CASES INVOLVING COMMENTS ISOTOPE CONDITIONS DIAGNOSED OR TREATED PE RSON AL (Additumalinformation or comments inay be PARTICIPATlON submited on duplicse on separate sheetsi A B C D P-32 TREATMENT OF POLYCYTHEMIA VER A. (sebk) LEUKEMIA. AND BONE METASTASES
/ dall INTRACAVITARY TREATMENT TRE ATMENT OF THYROID C ARCINOMA 1131 TREATMENT OF HYPERTHYROIDISM Au 198 INTRACAVITARY TREATMENT C&GO INTE RSTITI AL TR E ATMENT ar Cs137 INTRACAVITARY TREATMENT INTERSTITI AL TREATMENT Ir 197 Go60 tr TELETHE RAPY TRE ATMENT Cs-137 So90 TRE ATMENT OF EYE DISE ASE R ADIOPHARMACEUTICAL PREPARATlON f,9$ GENERATOR II l j93 GENERATOR Tc-99m REAGENT KITS Other
- 3. DATES AND TOTAL NUMBER OF HOURS RECEIVED IN CLINICAL RADIOlSOTOPE TRAINING
- 4. THE TRAINING AND EXPERIENCE INDICATED ABOVE 6. PRECEPTOR'S SIGNATURE WAS OBTAINED UNDER THE SUPERVISION OF:
- a. NAME OF SUPE RVtSOR th NAME OF INSTITUTION 7. PRECEPTOR'S N AVE (Please type orpnnt)
- c. M AILING ADDRESS is, ca T v
- 6. DATE
- b. MATERI ALS LICENSE NUMBERIS)
NRC FORM 313M SUPPLEMENT B l (9411 i .........
.. Page 7
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APPENDIX M /
"TJ g/ # /b %
T PROCEDURES AND PRECAUTIONS FOR USE OF RADIOACTIVE' ,1 GASES' W (e.g., Xe-133) j[ _
- k+ 9
\ , :l/ ~
The following information should be submitted in support 4 Emergency Procedures s} of requests to use Xe 133 ; h ' [ j
/j Describe the emergency procedures to be followed in,
- 1. Quantitles to be used case of an accidental release of Xe-133. This should a.
include such considerations'ademporary evacuation Patient information ~ of the area or utereasing] hit ventilation ot the area. ft) Number of studies expected per week $. is } Air Cancentrations of Xe 133,in/Restnetid Areas f21 Average activity per patient . d JJ No licensee shall permit pqy individual in a restrtered
- b. area to maale a quantity of radioactive material in any State the desired possessionlimit. This should be swriod of one calendar quarter greater than the quantity sufficient to provide for shipments whose cali-that would resutt from inhMa' tion for 40 hours per weeit bration dates are several days after receipt.
for 13 weeks at uniform concentrations ot radioactive 1- material of I t 10~5 gCUml. 1
- 2. Use and Storage Areas You may evaluate your situatton ny maxmg actual mea-
- s. Describe the arcats)in whien you plan to use and surements of Xe 133 eoncentrations or by means of store Xe 133. A diagram such as thatin Figure .\f-l calculations. If you ehoose the latter approach. you is acceptable. Include in the diagram the availa-may inake simplifying assumptions. PROVIDING they bility of shielding matertals and the pratimity to are reasonable; conservative, and stated explicitly in unrestricted areas. your request.
b. Describe the ventt!stion in all areas where Xe !33 in actualuse and storage. some Xe 133 will he released is used and stored. IVentilation features snould into the room from the storage and admmistration also be indicated on a diagram suen as that in devices. rebreathing apparatus. cotlection systems. and Figure s! l.) The location at suppiy and exhaust escape from the partent. All sourees of ioss must be . vents the meeaured airtlow rates for each vent. considered weten estimating the traction of Xe 133 and the fraction of att that is rectreulated by the that is lost. system should be indicated. Describe any changes in flow rates that may exist between heatmg and The following procedures may be useu to calculate the cooling seasons. air concentration of Xe 133 in restrtcted areas: M- e. AI! areas where xenon is used should be under 4. Estimate the maximum amount of activity to be negative pressure. State the type and frequency used per week ( A). (at least semiannually) of pertodic measuremen ts that you wdi make to determtne that strtlow b. Estimate the fraetton of Xe 133 thatis lost durmit rates are maintained as desenbed m Item 2b. use and storage t f L This fractionas loss must in-elude ALL sources of loss. a.g.. during patient L Procedures for Rourme Use aaministration. sturage. and diwosai.
- 4. Desenbe the orocedures to be followed for *outine e. Determine the measured atrilow rate m the arest u use of Xc 133. givmg particular attention to ut mterest and calculate thevoiume 9f att avail-radiologican safety factors. able per week for Jilution of the Xe 133 a VI
's if you plan to use a special apparatus for admin- d. For restricted areas, j *0.103 ot 10 CFR Part 20 istration and eollection of Xc 133. specify "te requires that manufacturer's name and model number ind incluoc a desenprion of its destgn characterts.
racs.tinclusion of a brochure would be helpful.) 3 , f i ; , g o fg !mi.
~
V Ef4 CLOSURE 3 10.M1 m- ~~ __ .- . ___. __ ._ __ .__________ . _ . _ _ _ _ _ . _ , . _ . _ _ _ _ _ _ _ - _ _ = _ __.
SilPPLY VENT llALLWAY O exiiaus've"r ! u e l { l Z 12S FI 3/ MIN _ flEST llOOM flEST ilOOM BUILDING EXTEftlOft kV m c,, ISOTOPE ' 300 PilEPAfl ATIOPJ FT3/ MIN k I Al O CAMEll A IlOOM [ I I g fl AL LWAY ' s 100 3 F1 3/ MIN f DilESSING O 75 ilOOM FT3/ MIN O V a DilESSING MJ 160 flOOM I FT3/ MIN \ V//////I
/ ,
/00 F1 3/MIPh ///7[,
ll AL L WAY
%C AL E i" = 4' FIGUllE M 1 EXAMPLE OF AN ACCEPTABLE TYPh :i" LAYOUT DIAGHAM FOR . I A FACILITY DESClllPTION INCLUDING VENTILATION FLOW IlATES
~
4
- a. o *
- e. Sample Problem
! ytaximum Xe.13]
%~ennlation Released ,ver A nuclest medicute laboratory plans to use 10 mci Rare Xe 133 per patient and wdiperform a maximum J0 Hour weet ifr J/m nf mC) of 10 studies per week. What ventdation rate is required to ensure compliance with 120.103 of 100 10 CFR Part 20? 67.9 500 330.7 1.000
- e 79.2 Maximum activity used per week 4 ,10 MCI. x 10 patients patient wees
- 2. Disposal of Xe-133 by Dilution through Exhaust 3 Systems (less destrable).
t I x 10 E mu One methoc for alsoosal of Xe 133 is by release to the atmospnere through an azr exnaust system.
= 1 x losuC
"'" 1.icensees are required to perform surveys imes-surements or :siculanons) to ensure that they are in compdance mth paragraph :0.Itc1 and Assume a loss rate of 20 percent (f)
. ]:0.106 of 10 CFR Part 20. Paragraph 20.!(c) V= A*I requtres that the concentntions of Xe-133 in 1 x 10.s gCi/mi effluents to unrestncted stess be as !aw as is reasonably acntevaele by the current state of tecnnology. anc ]:0.106 reout es that the con-
, I t 105 uCi/ week t 0?) centrations. Averaged over a pened of I yest.
4 shall not exceec 3 s 10 uCimt
! x 10*8aCI/mi Many facdines do not have sufficient sinlow to
= 2.0 x 10' milweek. 2ch2 eve the necessary adution. The followmg prce ced. ire may e' e used to estimate ene encentrations The required ventdation rate is of Xe-133 *n effluents to unrestneted areas 2.0 t 10' mloveek 40 httweer i1) Esneate the maximum amount of Xe 133 to be reiessed per yest (M. This should in-1.7 t 106 ciude si! anticipated tosses banng saminis-
+
3 nt/hr = 30 ft 3/mm tntion storage and disposai. ft / min (2) Determme the clow rateof the exnsust sys. The answer shows that. in order to meet the tem. 2nd desen'c e the methods and equip-requirements of ( 20.103 of 10 CFR Part :0. the imagmg room i RESTRICTED AREA) must have ment used for messunns the airtlow rates. 3 a ventdation rate of at least 30 ft / min with no (3) Calculate the sittlow per year (V). recirculation of sar. Where pnctical. the vencla-tion rate should be greater than that shown (4) Calcul2te che sversge ccncentrations for un-necessary by the esiculations. Consider every testnctec stess. Seenon 20.106 of 10 CFR siternative in order to mamtain the air con. Part 20 recutres tnat centnrion of Xc-133 as low as reasonably achievacle in accordance with paragraph 20.lfc) C = 1 .53 s 10*7 gC/ml. of 10 CFR Part 20. V If the ventdation rate is inadequate to meet the requtremenis of 100.103 of 10 CFR Part O. con- 15) Sample Problem sider methods of increasing ventilation oe ce auc* ing the patient load A nuclest medicine laboratory pians to use 10 mC;er;*attentand willperformamax-Imum of 10 stucies per week. A rume hood The following table ::ves the smount of Xe 133 is svaziaoie for disposal of Xe-i33 2nd has that can be released per week without exceeding 2 measurec strtl,0w of 163 ft/ min with an the permissible levels for Xe-133 in restricted openms of 3 fr- What is the average con-steas. centnrion of Xe-133 at the ;otnr of re! esse 10.3-53
e' . from the fume hood exhaust? (NOTE:All wtll perform in .iccordance with ] 0.001 of xenon that has been released e.g., collec- 10 CFR Part 20. tion bags, filters. must be considered.)
- b. Adsorption of Xe-133 onto Charcoal Traps 3
3, 10 oatients 3 10 mci 10 pCI 3 This is the disposal method of choice. The advan-ween patient mCL tage of this disposal method is that Xe-133 is trapped onto charcoal or other adsorbing medium. 5: wMs x Filters containing Xe-133 are then stored for YT decay. A = 5.2 x 106 gCi/yr One difficulty with this approach is that charcoal is not 100 percent effic:ent for trapping Xe-133. V = 168 31- x 3 ft3 x 1.49 If this is your method of disposal, you should mm consider the following pomts: x 10 8 8 *UYT f1) Describe how you will handle the problem ft 3/ min of leakage from such trapping devices. Ex-haust from trapptng devices and from areas V = 1344 N3- x 1,49 x 10'8 "UYf of use and storage may be vented to the out.
*2A 3 ft / min doors or other unrestricted areas. Submit calculations to show that air concentrations 83 V = 2.01 x 10 muyr of Xe-133, averaged over ! year, do not exceed 3 x 10 gCumi. (See example in C = 5.2 x 10' gCUyr
- .01 x 10'3 muyr () Desenbe how you will ensure that collec-tion and trapptng devices are performmg C = 2.6 x 10'7 gCumi according to specifications. both initially
. tad on a contmuing basis. Include in your The foilowing table gives the amount of Xe-133 desenption how you will monitor traps to that can be released perweekwithout exceeding determme when saturation occurs and t~11ter anaverage concentration of 3 x 10 gCUml. must be replaced. Where adequate manu-facturer's instructions relevant to trap test-Aremse Release of ing may be incorporated in the application.
Exh.nur Rare Xe-133 per week J
/fr / min / /mCf/ (3) Desenbe your procedures for handling satu-rated filters. Your discussion should include 100 8.6 a desenption of the area (a diagram would 500 42.8 be useful), avastable shiekling, proximity to 1.000 35.6 restricted areas ventilation, and an evalua-1,500 123.4 tion of average concentrations of Xe-133 in air. (See example in Item Se.)
If the exhaust is released to a restricted area e.g., USEFUL CONVERSIONS l a roof to which access is controlled, you should also desenbe the physical controls you use to I MCI = 103 gCl restrict access to the restricted area: the number, wording, size, and location of warning signs I ft 3 = 2.33: x 102 m3 = 2.332 x 104 mi placed in the vicinity of the restnered area: your program for ensunns that personnelentenns the I ft 3/ min = 1.699 x 10* mUhr restucted area receive proper instruction in accordance with j 19.!: of 10 CFR Part 19;your = 6.797 x 10 7ml/40-hr week program for ensurms that personnel entenng the restncred area are monitored in accordance with = 1.484 x 10gg muyr
} :0,000 of 10 CFR Part :0;and the surveys you - I week = 168 hr 10.3-54 < .-__---m n.-_ .r- - _ _ _ = ___= - _ = _ _ ._______:____-__-__________-_____.__-____-
f so e s
'tECO:!MENDATIONS FOR OTHER CHANCES TO THE ;tEGULATION w{h ,
5p f i Section 35.15: AK,M bW 9 Assign letter to each of the words defined in this section./ (d e ! 9 Make changes necessary (e.g., define " podiatrist", " dentist";,< ' '/i i revise " human use") to resolve issues raised by Lixi, Inc. jpP JP 68 G A.-end the definition of " authorized user" to include the special responsibilities of a physician as opposed to those % I Q j of an authorized user on an industrial license. '[c, 44# p O Define "on-site physician" in terms of the physician who has at [ least 30 hours of training in basic radioisotope handling ygs , techniques and who may be present at the locations serviced ! by the cobile service licensee. Section 35.16: .
.' r, t
,odl fS" 4 Paragraphs _(a) - (c) are not very clear and should be _ d SW, Wrtd ""\
revised. T.OM'^# r r ' j 8 The establishment of licensing functions in Regions II, IV ,
,fW<<y rgu's. A and V should be recogni=ed and appropriate changes made. ~ ~3 4(2*il}, ,
t Section 35.30: 8 More work is needed on this section to make all conforaing - CSILQ])iWill%dli [ changes to require that all licensees (not just institutional.f # ,p 'g rlG/(.* @' M .Cv W.Q.M licensees). must have an ALARA program. d
,. I '
Section 35.32: (W7fdl' i 9 More work is needed on this section to make all confcnin ' chant;es to require that all licensees (not just institutional grgf h % Q)2
- licensees) cust have a Radiation Safety Of ficer. ; I
Section 33.34: 0 Suggest that this provision be changed to require that the /-
- , visitor be SPECIFICALLY named as a user on a CURREMT NRC _ gg,Mub) % h M license (i.e, his name actually appear in the license condi- U tion that reads
- Licensed material shall be used by
)
ENCLOSURE 4 l l k______________________________._
- Section 35.53:
4 Suggest that the regulation continue the authorication for higher activities of certain short-lived radionuclides for , , , calibration and reference standards. These standards need- "O pt a not be scaled sources. The current authorication is in g35.14(d). Section 35.75: 4 Recommend that further study be made of the levels at which .. iodine-131, colloidal gold-198 and permanent implant patients may be released from a hospital. The originally suggested yd measurenent of 6 :ft/hr at 1 meter assumes that the radioac- gy 'Nncf
,(
tive material is acting as a point source. This is not a _.
"h3,gW mMhg '
valid assuaiption for many cancer patients treated with iodine-131 for =etastases. Also neither the existinr; license .u'lh, 9f f/[6 ifT condition on this matter, nor SECY '33-02, nor our mark up copy considers the radiophar.:iaceutical therapy patient as a gp [j f potential cause of contanination (e.g., his hone, family, '$,A1 etc.), but only'as a potential source of radiation exposure. 'U.* More consideration needs to be given to these matters. Sections 35.100, 35.200 and 35.300: 9 It is not clear what is intended in the paragraph of each of these sections that includes a provision riailar to the following: "Any byproduct caterial in a radiopharnaceutical and for a diagnostic use . . . . authorized by the Food and Drug Administration or by the licensee's Radioactive Drug Research Committee . . . . 2J b'-
- 1. If "authori:cd by the Food and Drug Administration" ueans '
,F that the radiopharmaceutical is the subject of a " Notice
- f.
of Claimed Investigation Exemption for a t eu Drug" (It:D) / \pg h accepted by the FDA, then the regulation should so state. Otherwise, the wording should be clarified. C;;d.
- 2. FDA's re;;ulations in 21 CFR 361.1(a) (copy attached) are P , a' quite specific as to the types of studies that come under R the purview of an RDRC. It is not clear why SECY 83-62 4Q. . JP &;,j 'p -
centions RDRC-approved studies in the referenced sections, 9 4, of the regulation when FDA does not pe rmi t them to - O' Jar approve studies that have an inmediate diagnostic or therapeutic benefit to the participating patient.
- 3. ? ot all licensees have or need a Radioactive Drug Re- r'
,gh l
i search Committee (P.DRC). RDRCs are established under FDA regulations and approved by FDA. FDA intends that an 3 RNC at a major uedical center (e.g. , NI'l) could provide i
.. s .
assistance to smaller hospitals la the community. Accordingly, the words "the licensce's" could be replaced by "a". Sections 35.100, 3 5.200, 3 5.300, 35.400 and 35.500: ,1.
.Y 0 1
9 It is not clear why each of the referenced sections begins by 'M 6s requiring the licensee to use the radiopharmaceutical, scaled source, senerator and/or reagent kit in accordance with the OP-f g~h'j f ' '* instructions in the manufacturer's package insert. This is more restrictive than the current regulations. The current ' regulations require that licensees ELUTE GENEP.ATORS OR [_/p s/ '[g l - if,
- PROCESS RADIOACTIVE !!ATEAI AL UITH A MEACENT KIT in accordance y' {. 3'j with instructions in the manufacturer's brochure (see iD ',e 335.14(b)(4)(1)). In the case of scaled sources the current regulations require that the licensee follow the RADIATION e SAFETY A!!D ilA"0 LING I"STRUCTIO"S in the manufacturer's brochure (see 335.14(b)(5)(iv)). The statements used in SECY 33-62 should be revised to incorporate the current require-cents only.
Section 35.606: 0 Suggest that soce additional consideration be 3 1ven to requiring a license amendment in each of the cases specified in SECY 33-62; license amendments are not now required in g!j each of these cases. For example, if a teletherapy license 7 already authorizes the exact sealed source that the licensee wants to install in his unit (i.e., by nanufacturer's name and nodel number; activity of new source is within possession linits specified on the license), there is no need for an amendment. Section 35.610: O Paragraph (a) is not related to emergency instructions. Either the title of this section should be changed or the ',.N requir ments in paragraph (a) should be uoved to another section. Section 35.620: e The title of this section is aisleadin3 After reading the text of this section, one realizes that the interlocks and - Mll warning systeos pertain to entrances / doors, not to every N' Interlock and warning systen required for teletherapy licensees. x --
.c ew
_4_ Section 35.530: 9 This section of the regulation should be revised to require that, regardless of the length of time between calibrations, the licensee must perform constancy tests of his dosicetry *y! system. This recoamendation is consistent with those of , NRC's consultants in a telephone conference call pertaining to the resolution of the AAPM Petition for Rule Making and
' 'jj n
I* with those in NCRP Report 69 (see paragraph 5.3). Section 35.622: 4 Suggest changing title of this section and adding a require ,jjs%If ment for an aural connunication system; see HCRP Report 34, paragraph 6.1.6. Section 35.910: 4 Sugge s t that this section be reexamined.
\
- 1. No clinical experience is required for the non-Board certified physician.
[f .
- c e'
.d Y
- 2. Also it is not clear why 200 hours of didactic training
. cf >#
is required for the physician wanting to use only Gen / Croup I materials.- Originally NRC increased the ' [Y ' didactic training in basic radioisotope handling tech-
'niques to 200 hours because of the increased radiation safety problees associated with the use of generators and reagent kits, materials and procedures that are not included in Gen / Group I.
Section 35.930: 0 _Suggest that this section be reexanined. r
- 1. The Advisory Committee on the Medical Uses of Isotopes g 1
approved certification in Radiation Oncology by the . Anerican Osteopathic Board of Radiology as being evidence gy *'gh of adequate training and experience for Group V proce-
, dures (i.e., use of lodine-131 to treat thyroid cancer ,. Uyj' and use of colloidal gold-193). The Committee did not ,_ . U make a similar recommendation with regard to Group IV procedures. In view of the fact that use of iodine-131 to treat thyroid cancer presupposes experience with diagnosis of thyroid function and treatment of hyper-thyroidism,.then the problec is with the physician's l apparent lack of clinical experience with both soluble l and colloidal forms of phosphorus-32.
i
- ~ _ _ - - - - - -~ -
..- a*
- 2. It is not clear how a non-Board certified physician will ever qualify for Groups IV/V hecause clialcal experience with colloidal gold-198 is required, but this caterial is not co.aaercially available in the United States. Also it !
is not clear if the present practice of authorizing a M physician for some of the clinical procedures in a given Croup will be continued. For example, will a physician with soluble phosphorus-32 experience be authorized to ,. [g &[ use just that material? If the present practice is to be V*y continued, then this section needs to be revised and to show clearly that, in order to be authorized to use iodine-131 for treatment of cancer, the physician aust a; have fulfilled the clinical experience requirements to use iodine-131 to treat hyperthyroidism. t *- l Section 35.950: 0 Reconcend adding a new section to establish training and W :k / experience require =ents for physicians who wish to use dia.;nostic sealed sources. The Task Force has developed a jJ- [QV y
, text for this new section.
Conforming acendment to Section 32.72: 8 Sudgest deleting the phrase " unit dosage" because this makes ;_, gb 332.72 nore restrictive than it is now. Currently, there is >1 no prohibition against the nanufacture and distribution of nuitidose containees. i 9 Suggest that the required licensing statement specify for which Groups (or pursuant to which section of the regulation) the recipient must be licensed in order to receive the specified caterial. For example, under the current regula- q tions iodine-131 might be authorized for distribution to ' persons licensed for Grens I and II, if the iodine-131 were - h.{ d intended for diagnostic uses only-Conforming acend.aant to Section 2.74: 9 Suggest that the required ?icensing statement make it clear i exactly which licensees may receive a particular sealed ,h ' l source or device. For example, brachytherapy sources should i
- he authorized for distribution to Group VI licensees caly.
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Title 21-Food and Drugs Chapter I-Food and Drug Administration f 361.1
..RT 332-ANTIFLATULENT PROD. ' siology, or biochemistry, but not in-dCTS FOR OVER-TH E-COUNTER i SubP art C-[ Reserved} tended for immediate therapeutic, di- - tiUMAN USE ,
SubP art D-Labeling agnostic, or similar purposes or to de-termine the safety and effectiveness of s'vbpert A-General Provisi*"* the drug in humans for such purposes 5 332.30 Labeling of antiflatulent prod. (Le., to carry out a clinical trial). Cer-
~~ "**** tain basic research studies, e.g., studies 1 Scope. l (a) Indicctions. The labeling of *.he t2 determine whether a drug localizes
> Subpert 5--Active ingredients product shall identify the product as . In a particular organ or fluid space an " antiflatulent" and/or "to alleviate and to describe the kinetics of that lo-
't.10 Antinatulent active ingredients. or relieve the symptoms of gas." calization. may have eventual thera-
).15 Crmbination with non antinatulent ,
(b) Directions for use. The labeling peutic or diagnostic implications, but activ2 ingredients. of the product contains the recom- the initial studies are considered to be mended dosage per time interval (e.g basic research within the meaning.of subpert C-{Keserved) ' every 4 hours) or time period (e.g 4 this section. .,= times a day) broken down by age (b) The conditions under which use subpert D-tabet,ng . groups if appropriate, followed bY of radioactive drugs for research are j h30 Labeling of antinatulent products. "except under the advice and supervi* considered safe and effective are: i sion of a physician." The words "or as (1) Approvcl by Rcdioactite Drda 2.31 Professional labeitng. . i : needed" may be used af ter the recom- Research Committee. A Radioac:fve acmir.rry: Secs. 201. 502. 505. 701, 52 i mended dosage per time interval or Drug Research Committee, compcsed 5-5Yas aNend d y io sta ! time period. and approved by the Food and Drug nde b and 72 btst. 948 (21 U.S.C. 321. 352. 355. [39 FR*19877. June 4.1974, as amended at Administration in accordance with paragraph (c) of this section. has de-3 (5 U.S.C. 553. 554. 702. 703. 704); 21 40 FR 11719. Mar.13.1975) R :.100. unless otherwise noted. j
~
N termined, in accordance with the 8 332.31 Professional labelin'g. standards set forth in paragraph (d) of
,oURec 39 FR 19877. June 4.1974. unless Ierwise i noted. (a) The labeling of the product pro. this section, that. .
vided to health professionals (but not (1) The pharmacological dose is to the general public) may contain as within the limits set forth in para-Subprrt A-General Prov. .isions i
! additional indications postoperative graph (b)(2) of this section:
gas pain or for use in endoscopic ex. (11) The radiation dose is within the 32.1 Scope. - nWnadon. limits set forth in paragraph (b)(3) of in crer.the. counter antiflatulent l (b) Professionallabeling for an anti. this section: - flatulent antacid combination may (iii) The radiation exposure is justi-oduct in a form suitable for oral ad. - nistration is generally recognized as contain information allowed for fled by the quality of the study being { re and effective and is not misbrand- health professionals for antacids and undertaken and the importance of the , if it meets each of the following antiflatulents. information it seeks to obtain: (iv) The study meets the other re-
- 2diti:ns and each of the general i quirements set forth in paragraph (d) nditi:ns established in 1330.1 of PART 361-PRESCRIPTION DRUGS of this section regarding qualifications ;
lis chapter. .' FOR HUMAN USE GENERALLY REC- of the investigator, proper licensure
, 1 OGNIZED AS SAFE AND EFFECTIVE for handling radioactive materials, se- l l Subpyrt S-Act,ve i ingred,ents i AND NOT MISBRANDED: DRUGS lection and consent of research sub.
USED IN RESEARCH jects, quality of radioactive drugs 32.10 Antiflatulent active ingredients. ,e used, research protocol design, report-5 361.1 Radioactive drugs for certain re. Ing of adverse reactions. and approval 1 Simtthicone; maximum daily dose J mg. There is no dosage limitation 8'8rch u'*8- by an appropriate Institutional this time for professionallabeling. i (a) Radioactive drugs (as defined in Review Committee: and I l 310.3(n) of this chapter) are general. (v) The use of the radioactive drug 32.15 Combination with non antiflatu. i ly recognized as safe and effective in human subjects has the approval of IInt cctive ingredients. I when administered. under the condi. the Radioactive Drug Research Com. tions set forth in paragraph (b) of this mittee. tn antiflatulent may contain any section, to human research subjects (2) Limit on pharmceofogicci dose. n: rally recognized as safe and effec- during the course of a research project The amount of active ingredient or
. 7 entacid ingredient (s) if it is indi. Intended to obtain basic information combination of active ingredients to be a:ed for e solely for the concurrent regarding the metabolism (including administered shall be known not to , ,.ipttrn t d of gas associated with kinetics. distribution, and localisation) cause any clinically detectable phar- (
g artburn, scur stomach or acid indi. of a radioactively labeled drug or re- macological effect in human beings. If 1
- n. -
garding human physiology, pathophy. the same active ingredients (exclusive 155 8 - - - - 4 5 I s _ . . . . . . _ _ . . . _ . . . . _ . _ .
. _ _ _ _ _ _ m _ _ _ . . _ _ _
, [7590-01]
dosimetry systems to be used for calibrating cesium-137 teletherapy units. * (b) The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement,-the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected, system calibration. The spot check system may be the same system used to meet the requirement in paragraph (a) of this section. , (c) The licensee shall maintain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must incl'ude the date, the model numbers and serial numbers of the instrument that gf d,,,% were calibrated, intercompared, or compared as required by pa and (b) of this section, the correction factors that were deduced, [
. the names of the individuals who performed the calibration, intercomparison, or comparison Qnd CYldence tlM.h O!1 InWe,0Mjobl$cr) nfet bIng W4G l 9 h b Ahor) ldbet'ahrf orradihytClhystCS &Cnler 06 35.632 Full calibration measurements.
(a) Any licensee authorized to use a teletherapy unit for treating humans shall perform full calibration measurements on each teletherapy unit: (1) Before the first use of the unit for treating humans; and (2) Before treating humans under the following conditions: (i) Whenever spot-check measurements indicate that the output , differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for physical decay; (ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; (iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with ' the source exposure assembly; and 3 (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: . 76 Enclosure 1 l 1 l
e .- . [7590-01] d or.for~ l*be $xts di$ h n Ct.) (1) The output withip ' 3 percent for the range of field sizes and
'r.
m/ for the range of distancesfused in radiation therapy;
.* 'l,,'.
(2) The coincidence of the radiation field and the field indicated by.the light beam localizing device;
-.'4 (3) Theuniformityoftheradiationfiidhrdf[S/ (Mdf/)CC. yod
[ ,1 (4) Timer accuracy; tbt on fM */1 8[ M e FM da m,; (5) On-off error; and (6) The accuracy of all distance measuring and localization devices used for treating humans.
. (c) The licensee shall use the dosimetry system described in S 35.630(a) to measure the output for one set of exposure conditions.
The radiation measurements' required in paragraph (b)(1) of this section may then be made using'a dosimetry system that indicates relative outputs. (d) The licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine. These procedures are described in Physics in Medicine and Biolocy Vol. 16, No. 3, 1971, pp. 379-396, which has been approved for incorporation by reference by the Director of the Fe'deral Register. Copies of the document are avail-able for inspection or may be obtained from the U.S. Nuclear Regulatory Commission, Public Document Room,1717 H Street- NW, Washington, D.C. 20555. A copy of the document is also on file at the Office of the Federal Register, 1100 L Street NW., Room 8301, Washington, D.C. 20408.
. A notice of any change in the material will be published in the Federal ,
Register. (e) The licensee shall correct mathematically the outputs determined
'in paragraph (b)(1) .of this section for physical decay for intervals not exceeding one month.
(f) Full calibration measurements required by paragraph (a) of 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 keep a record of each calibration for the
, duration of the license. The record must incfug the date of the cali-
. J' bration, the model number and serial number of the teletherapy unit, the
,-(, ',.9 '
rnamLftteku.r~eds rnin 4, g + (and b$tt SOUFCC 77 Enclosure 1
?
- 9
[7590-01]
.' model number and serial number 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 j typical treatment. time, the calculated on-off error, the estimated
/ accuracy of each distance measuring or localization device, and the
.' signature.of the qualified teletherapy. calibration expert.
9 35.633 Periodic spot-checks. (a) The licensee authorized to use teletherapy units for treating
} humans shall perform spot checks on each ' teletherapy unit once in each calendar month. -
- (b) To satisfy the requirement of paragraph (a) of this 'section, measurements must include determination of:
, -(1) Timer accuracy;
, (2) On-off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing device; '
(4) The accuracy of all distance measuring and localization devices used for treating humans; (5) The output for one typical set of operating conditions; and (6) The. difference between the measurement made in paragraph (b)(5)
. of this section and the anticipated output, expressed as a percentage of e; the anticipated output (i.e., the value obt'ained at last full calibration d ;;.. corrected mathematically for physical decay).
y (c) The licensee shall use the dosimetry system described in f 35.630(b) to make the measurement required in paragraph (b)(5) of this section. (d) The licens~ee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the qualified teletherapy calibration expert. That individual need not actually perform the spot-check measurements. (e) The licensee shall have a qualified teletherapy calibration expert perform the spot-check measurements or review the results of the 78 Enclosure 1
, _ _ _ _ _ - . - ---- - - - ~ - ~ * ^ -
['590-01] 7 , spot-check measurements "within 15 days. The qualified teletherapy calibration expert shall promptly notify the licensee in writing of the results of each spot-check measurement. The licensee shall keep a copy == of each written notification for two years. (f) The licensee authorized to use a teletherapy unit for treating humans shall perform. checks of each teletherapy facility at intervals not exceeding one month. (g) To satisfy the requirement of paragraph (f) of this section, checks must ass'ure proper operation of: (1) Electrical interlocks at each teletherapy room entrance; (2) The function of electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);
-(3) All beam condition indicator lights on the teletherapy unit, on the control console, and in the facility; (4) The viewing system; (5) Operability of treatment room doors from inside and outside the treatment room; and (6) Operability of any electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
. (h) The licensee shall lock the control console in the off position if any door interlock malfunctions, and shall not use the unit until the' interlock system is repaired.
(i) The licensee shall promptly repair any system identified in paragraph (g) of this section that is not operating properly.
,' (j) The licensee shall keep a record of each spot-check required by paragraphs (a) and (f) of this section for The record two vears's. name manufachtLrer tM must' includeboth the date of the spot-check, the,model number and s,erial and source s
{,-y,
-! number of the , teletherapy unit3the model number and serial number of the instrument used to measure the output of the teletherapy unit, e e
-.,a + : ,,7 ,--,-,7 9gys :.y - " r:', 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 79 Enclosure 1
Draft response to Enclositre 4 of Chilk/Vacca&DelMeuco metra A-26-83 7 Part 35 Task Force resper.se to ite=s raised in Enclosure 4 of vacca and De1 Medico nmorandum to Chilk dated April 26,19!!t3 35 15
- 1. This reconsnendation is cedrar/ to DRR raidence.
- 2. The TF is still working on these definitions.
i 3 ]!1D advises against retting escridive regairements in a definition. 4 The TP believns the har.ard of diagostic radiopherssceuticals is such that "eupervicion" meets the need. 35 16
- 1. The TF disagrees, but is willing to consider alternste langasgs.
- 2. This was not the esse when the TP eim21sted the draft for cont.urence.
It will be included. 35 30
- 1. The TF does not believe a licensee with one physician and a few technicians needs a fornal written AIARA progran. The pl7sician would be the only individual q2alified to sit on the owrsi#
committee. 35 32 The TF agrees that an applicants shculd idedify an RSO. 35 34
- The TF belicws thic would be unduly Mstrictiw. It would not 811cw q alified physicians identified on an Agreemerd State license or working un, der an NRC Pread License to aasiat an NRC licenseo.
35*50 The 'N does not believe these materials are frequently itsed, but is amenable to the suggestion.
, /
.- . _ . __ - - .. .-. _-- _= . - _ - . - - -
35 75 he TF acrees that I 'I31 in a har patiant in nnt a pnint acure*+ However, for oafety purposes the TF believes that thin rabo resuitc in about the same degree of esfety as the curredly imposed (by lb: ente condition) SOmCL release limit. It in technli:any illfficult and inconsisted with AIARA principles to verify comp 11snee with the curredly imp 3 sed licence condition. The peoposed rulemaking descrh.bes a measurement that aq- licensee can make. The TF helieve.1 thnh there i is insufficied hformstion from NCP? and other er;erts on which to
's draft a regalation that properlf balances the patient's welfare with h // M the asfety of tme rab ie. The TF believes that veludary guidance fec= the physician to the petient is the best resolution of this problem at this tiam. .
35 100, .200, .300
- 1. The inted of the wordhg was to include both EU'n and !TDA'c. Beth are mechanisms used by the FDA to reg 21ste the distribution of pharmaceuticals.
- 2. Under the curred reg.dation echeme it is not clear to the licana**
whether, despite the f act that his RIRO has apprevnd a hrma . use radiopha maceutical study, the proposed study could be carried out legs 11y under the NRC license used to procure the rAllorharmaceutical. This is trae because the proposed use may be codrary to the instrue.- i tiens on the radiopharmsecutical label that licensees would be ree.iired to follow. (see the opening paragraph of the etteit aaettons, and the discussion of sections 35100 throu@ .500 below) 3 me TF is swad that not ever/ licenseo has a RDRC. The 17 is amenable to the suggestion.
35 100, .200, .300, .400, .500 The Merpretation that. the 1.tcansaa in not lit-ited to uxes dem ribed an the radiaphpetdical label in not reengnimd in the irniust.ry. See the confusing wording of curred oection 351h(b)(1), for exszpie. No expert outsida tha aganny who has maan tha penprueil woriling bra told the W that the propo cd rc0tricti0n would inhibit the p: actice of reedicine. This also applies to gemraatcrc and scaled BOurC68. 35.606 The W believes that th. chen;;es idedified in this proposed section are of sufficient ment to q2 ire notification to. the agnef, k 35 610 The N is amenable to retitling of the section. 35 620 The W does not underettel why the title is 2:d.sleading. The section req 2 ires a door at each entrance, electrical Merlocks that wil'I. turn the unit off if soccone enters the roon when it ta hershi on, and indicstor lights that would warn ar individaal that the unit is turred on and shculd therefore mt etter tha room. Wlunec the title, "Decrs, interlocks, and warning eystems." 35 630 Some experts in the intistry have indicated that conustrein11y nynilabic censtancy e eek deviece are not =ufficient.ly precisc to req 2 ire their use by li ensees. Were the use of a constancy check device m q2 ired, the agnp., vnuld havn to spacify an actitm level i et which mescurement in trucc. ation would have to be recalibrated. } The amropriste action level (on he order of a 2% discrepancy) is siadler to the in precision of constan check devicec uced by conc experts. e ..
i i l 35.622 The TF does mt beliew en aural cour:micetion system is nouded to al pe[ationeremergencies. 35 910 he TF will cen=ider suggestions fer regiired clinical experience and alternate suggestions for formal training. 35 930
- 1. The TF believes the level of hazard and safety techniq2es for
~
I-131 tEid P-32 are sufficiently einD.ar to ellow a board-certified physician to use either safe
- 2. Concerning colloidal gold-198, this reg:irecient was taken from the revised treining end experience criterie recenth published in the Federal Register (Januey 21, 1982). The TF is emnable to withdrawing the retairement. If a phycicien hua cl1 the trasnity regaired, he may use all the material identified. If he does not have all the trairAng req 2 ired, he us;r apply for an exemption under proposed section 35 29 35 950 We TF has developed training and experienet criteria for hitnac itse with diagnostic sealed sources. The TP proposes to add this section before p2blishing the proposed rulensking in the FR.
32 72
- 1. The TF agrees with the reco.=__aendation.
- 2. The TF belims that the supplier has made a good faith effo:t to lir.it distribu on to licensed individi by req 11 ring that distri-bution be li d$ed .o persons licensed for h use. The supplier should not be req 2 ire. h*w safety men m e et wuld intentict purchases by prevaricating practitioners.
32 74 See discussion 32 72 No. 2 above. 4 N S
+
hYi'l Ib laf $ 0 DRAFT Task Foce Response to Vacca and DelMedico Enclosures 1, 2, and 3 (Markup of Part 35 and suggest' ions) attached to Chilk/Vacca&DelMedico memo dated April 26, 1983 NOTES: 'l. " Proposed refers to the doev'rmnt submitted by the Task Force (TF).
- 2. "V&D" and " suggested" refer to the' markup and other enclosures I
submitted by Vacca and DelMedico. ENCIOSURE 1 p49 35 16 The form number should be changed so that applicants don't use an old form. p51 35 18 See 35 16 comment. 35 28 See 35 16 comment. 35 28a This proposed change would place the staff in the role of providing, > and requiring the use of, free consultation whether needed or not'. Furthermore, it would not provide the regulatory restraing that the, TF infers is desired by Vacca and DelMedico because a disingenuous applicant could submit conservative procedures for review and then, on receipt of his ' license, revise them. 35 30 The TF does not believe a small licensee with one physician and a few technicians needs a formal ALARA program. The physician would be the only individual qualified to sit on the oversight committee. p54 35 32 The TF agrees that each licensee should identify an RSO. p55 35 33b'4 The TF believes the licensee is best qualified to determine the necessary training frequency. For procedures that are done on.y once every several months, training should precede each procedure. For procedures that are done each day and audited by the authorized user or RSO, there is no need for periodic training. V&D b411 and b4ili simply restate current 1912 and are superfluous. 35 33b5111 The TF agrees. p56 35 35 V&D 35 35a appears to be identical to proposed 35 80a. The TF believes that to restrict a mobile service to unlicensed clients would unnecessarily interfere with the delivery of medical care. For example, this would prohibit a nobile service from providing technical assistance to a small licensee whose sole technician is on vacation. V&D 35 35c is identical to proposed 35 35b. p57 35 37d The TF agrees.
p59 V&D 35 50a The TF agrees that there should be, a clear statement that the licensee must possess a dose cal'ibrator. V&D 35 50bl The paragraph does not appear to accomplish any more than proposed 35 50a2 V&D 35 50b2 The sugges,ted paragraph would require that two specific radionuclides be used, and establishes higher actifity levels than are stated in the proposed draft. It is not necessary to use Cs-137 and Co-57 to test the accuracy of a dose calibrator; other radionuclides, are available. The TF believes that 50'uCi is a sufficiently high activity' to test for accuracy. V&D 35 50b3 re i, the TF believes that' to test for linearity outside the range of; patient dosage measurements is unnecessary and inconsistent with ALARA principles. re ii, the TF believes that testing'by serial dilutions is inaccurate and inconsistent with ALARA principles. V&D 35 50b4 The paragraph does not appear to add to proposed 35 50ah. V&D 35 50c cesium-137 and co-57 are not uniquely qualified for use when testing a dose calibrator. It is not necessary to use a calibrated source when checking for constancy. V&D 35 50d This duplicates proposed 35 50b. V&D 35 50e This duplicates proposed 35 50c. p60 V&D '35 51a The TF agrees that there should be a clear statement that i the licensee must possess a survey instrument. The TF, and the industry, are divided on the necessary range of measurement capability. The suggested wording could be used to elicit public comment. V&D 35 51b This duplicates proposed 35 51a. V&D 35 51c Suggested c1 is universal practice. re c2, see propased bl. re c3, see proposed b2. re ch', see proposed b3 V&D 35 51d re dl and d2, see proposed el and c2. Suggested d3 accomplishes nothing. The burden of proof already lies on the licensee.: V&D 35 51e This duplicates proposed 35 51d. V&D 35 51f This duplicates proposed 35 51f. p61a V&Di35 52a Receipt of material in excess of that permitted by the license would be a violation that, the TF assumes, would drive the licensee to estab'lish the procedure out of self-preservation. The licensee has a vested financial interest in every other item cited
because if the package is not received by the proper person, and j secured, it may be lost but must still be paid for. Section 20.205b need not be repeated here. _ p61b V&D 35 52b . Section 20.205d requires that each licensee have package opening procedures. The entire suggested section" belongs in Part 20.because nothing in it is peculiar to the human use of byproduct material. l p61c V&D 35 52c See p61b comment. p61d V&D 35 57 ELD concurs with the TF proposal that this request simply be added to the application form as a line entry. See proposed form NRC-313MH item 4.
'p62 35 59 ' The TF agrees wit'h the suggested wording.
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p63 35 59f This seems a good time to get industry comment o'n whetheh iridium and tantalum wires should be available. p64 35 62 The TF believes the suggested change would be unduly, prescript,1ve. The TF would like public commen, on this. p64a 35 70 The'TF agrees with the suggested wording.
-p65a V&D 35 75a It is technically difficut1 and inconsistent with ALARA principles to verify compliance witli the suggested wording.
p65b V&D 35.'80b The TF believes that'an on-site physician is not needed for the types of studies that a mobile service can perform. The hazard of the studies 'is roughly comparable to that of giving a blood sample or having a stomach $t-ray. V&D 35 80c This duplicates proposed 35 80b. V&D 35 80f The TF does not believe uncalibrated equipment poses a risk but is amenable to including the suggestion to elicit
-- public comment.
V&D 35 80g This appears to duplicate proposed 35 80b and f. p66a V&D 35 90a This is similar to proposed 35 90. V&D 35 90b, c, and d These measures are appropriate for high volume users of I-131. The TF is amenable to incorporating them in Subpart F. For diagnostic quantities, the TF believes the suggested requirements are ' overly prescriptive. , p67 35 100b A professional nuclear pharmacist has said that, if the chemical form has been changes, the licensee would not be using one of the listed radiopharmaceuticals.
F
- p68 -35 7.00alk The TF docs not believe there is any need to delete this diagnostic gas,' administered by inhalation from the group of diagnostic liquids administered by injection. Xenon is a noble gas whose MPC is based on submersion in a cloud. If there is excessive spillage it will be detected by the technicians' film badges. l p69 35 200bl Seep 67 comment. !
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- p70a V&5 35 304 fhe introductory paragraph is similar to proposed 35 304a. re a, the TF does not believe a private toilet is a ,
critical safety need for radiopharmaceutical therapy patients. re b, section 20.105 already identifies those instances in which a licensee must declare an area restricted. There is no need to reiterate them. re e, release of contaminated items would be
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contrary to 20 301. There is no need to reit.erate this. The TF is amenable to including suggested paragraph d. p71 35 400 d and g This seems a good time to get industry comment on whether iridium and tantalum wires should be available. 3 p71a V&D 35 405 The TF is amenable to including source description in t.he r'equired training. The TF does not believe a privat 6 toilet is a critical safety need for brachytherapy patients. re b, section 20.105 identifies those instances in which a licensee nust
' declare an area rest'ricted. Proposed 35 404 woul'd accomplish the same purpose as the suggested' requirement for surveying a room for displaced sources. re c, the loss of a seed would be contrary to 20 301. ' The TF is amenable to including suggested paragraph'd. Section 20.101 establishes' dose limits 'for the
' hands.
p?2a .V&D 35 406 The TF believes that the intent of the suggested section is accomplishe,d by proposed 35 404b, but is amenable to ' including the suggested language. [ p73a V&D 35 605 The control requirements in suggested 35.605a and b are already met by requiring a license amendment before moving a ! te'letherapy unit (see proposed 35 606). suggested e is identical to proposed 35.605 p74 35.621b' The TF agrees. 35.621f The TF believes that if it is not properly operating, it is not a survey instrument. c.
p75a 35 623 It is not necessary to use mechanical or electrical stops to ensure compliance with 20.105b. They are one of several alternatives available to the licensee to' comply with the
. requirements of that'section.
p76 35.630c The TF agre'es. s p77 35 632bl Several physicists reviewed the language used by the TF and found it sufficiently descriptive without the pa'renthetical insertion. 35.632b3 The TF agrees. 9: 35.632g The TF agrees. p79 35.633j The TF agrees that the additional identifiers should be added. The TF believes that timer accuracy and on-off error are both critical element's of a spot che'ck program and should be recorded'. p80a V&D 35 640 The TF is amenable to the suggested wording. p80b V&D 35.641c The sugg'ested wording is virtually identical to the proposed wording. The TF agrees. V&D 35.642 The TF agrees. p81 35.644 The TF agrees. p82a V&D 35.645b The TF agrees. p82 35 645c The TF agrees. p83 35 910a3 The TF agrees. , pB4 35 920a3 The TF agrees. p86 35 930a2 This certification was approved.for high activity radio-pharmaceutical therapy authorization in a FR notice published January 21, 1982. p87 35 940'b See the TF wording in subsection 3
-p88 35 941b2 The proposed wording matches that published in a FR notic.e on January 21, 1982.
p89a V&D 35 960 The TF agrees. pB9 35 960b The TF agree's. *** BILL-CHECK THIS*** p09b V&D 35 960 The TF agrees except for 11, which is out of place here. p90 35 961b re for mal training and work experience, the TF agrees. i'
- p90a V&D 35 961b This information should be stIbmitted under proposed
! 35 29, exemptions. p92 31.llb The TF proposes a separate line item on the . application form rather than an undocumented license. ; l l
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j p93 32 73a511 The proposed wording simply changes the section citation for Part 35 The TF does not understand the need for the suggested wording. ENCIOSUIE 2 Enclosure 2 is the form that is currently used for Part 35 applications. The TF believes the proposed form elicits sufficient information to establish eligibility for licensure and to provide a legal basis for appropriate enforcement" actions. i ENCIOSUIE 3
! Enclosure 3 would require that special calculations be done before using
< Xe-133 gas. The calculations would be required to ensure that the
.Xe-133 concentration in the imaging clinic air does:not exceed MPC.
The TF notes that xefton is a' noble gas. The' MPC Is based on external exposure due to submersion in a cloud, not internal dose. Therefore, the 1 exposure would b'e adequately measured by whole body dosimeters. 4 i 1 l t i I}}