ML20137Q531
| ML20137Q531 | |
| Person / Time | |
|---|---|
| Issue date: | 01/12/1982 |
| From: | Mcelroy NRC |
| To: | |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230032 | |
| Download: ML20137Q531 (384) | |
Text
{{#Wiki_filter:r q 4A 73-/ PD/2 05 PART 35--HUMAN USE OF BYPRODUCT MATERIAL Subpart A--General Information 35.1 Purpose and scope 35.2 License requirements 35.8 Regulatory Flexibility 35.15 Definition:, 35.16 Application forms 35.17 License term 35.18 Amendments 35.19 Applications for research 35.20 Renewals Subpart B--General Administrative Requirements 35.30 ALARA 35.31 Radiation Safety Committee 35.32 Evidence of training 35.33 Radiation Safety Officer 35.34 Records retention 35.35 \:slting physicians 35.36 Mobile departments 35.37 Records and reports of misadministrations Subpart C--General Technical Requirements 35.50 Calibration of dose calibrators 35.51 Calibration and check of survey instruments 35.52 Check of equipment in diagnostic human use 35.53 Assey of radiopharmaceutical doses 35.60 Syringe shleids McElroy 1/A 1 January 12 , 19112 0509230032 000406 3 00$30616 PDR
35.61 Vial shields 35.68 Authorization for calibration and reference sources 35.69 Requirements for possession of sealed sources 35.70 Surveys for ambient radiation exposure rate 35.75 Release of patients 35.80 Mobile departments 35.90 Storage of volatiles and gases 35.91 Storage of waste 35.92 Decay in storage Subpart 0--Group General /I 35'.100 Eligibility 35.101 Training and experience 35.102 Authorized use % 35.013 Equipment Subpart E--Group II/III 35.200 Eligibility 35.201 Training and experience 35.202 Authorized use 35.203 Equipment 35.204 Permissible levels of molybdenum 35.205 Confinement of aerosols and gases Subpart F--Group IV/V 35.300 Eligibility 35.301 Training and experience 35.302 Equipment 35.303 Safety procedures McElroy 1/A 2 January 12, 1982
Subpart G-Group VI 35.400 Eligibility. 35.401 Training and experience 35.402 Equipment - 35.403 Release of patients 35.404 Transfer of sources between licensees Subpart H--Group VII 35.500 Eligibility 35.501 Training and experience Subpart I--Group VIII 35.600 Eligibility 35.601 Training and experience 35.602 Training and experience of qualified expert 35.603 Authorized use 35.604 Authorized in'ventory 35.605 Information to be submitted with application 35.610 Emergency instructions 35.620 Doors and interlocks 35.630 Equipment 35.632 Full calibration measurements 35.633 Periodic spot-checks 35.641 Radiation measurements for new installations 35.642 Facility checks for new installations 35.643 Reports for new installations 35.644 Five year. inspection McElroy I/A 3 January 12, 1982
Subpart J--Groups of human uses of byproduct material 35.901 Group General /I (uptake, dilution, excretion) 35.902 Group II/III (imaging) 35.903 Group IV/V (radiopharmaceuticals for therapy) 35.904 Group VI (sealed sources for internal or contact therapy) 35.905 Group VII (sealed ~ sources for diagnostic human use) 35.906 Group VIII (teletherapy units) Subpart K--Training and experience requirements 35.950 Radiation Safety Officer 35.951 Authorized users for Group General /I (uptake, dilution, excretion) 35.952 Authorized users for Group II/III (imaging) 35.953 Authorized users for Group IV/V (radiopharmaceuticals for therapy) 35.954 Authorized users for Group VI (sealed sources for internal therapy) 35.955 Authorized users for Group VII (sealed sources for diagnostic human use) 35.956 Authorized users for Group VIII (teletherapy units) 35.957 Qualified Expert for Group VIII (teletherapy units) McElroy 1/A 4 January 12, 1982
SUBPART A -- General Information 635.1 Purpose and scope. Th'is part prescribes requirements for human use of byproduct material. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. Unless specifi-cally exempted, the provisions of Parts-19, 20, 21, 30, and 170 of this chapter apply to applicants and licensees subject to this part. 935.2 License requirements. No person shall receive, possess, use, or transfer byproduct mate-rial for any human use except in accordance with a specific license issued pursuant to the regulations in this part. 635.15 Definitions. As used in this part: (a) "ALARA means (b) " Authorized user" means a physician licensed by the Commission or an Agreement State for the human use of byproduct material. (c) " Human use" means the internal or external administration of byproduct material, or the radiation therefrom, to human beings; (d) " Institution" means-a facility in which several medical disciplines are practiced pursuant to the policy guidelines established by a unified management; McElroy 1/A 5 January 12, 1982
(e) " Management" means those persons authorized by the charter of the medical institution to make its policies and direct its activities; (f) " 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 administra-tion 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 result in ~a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent. (g) " Mobile department" means a. service in which licensed materials are transported to one or more non-facilities for use therein by or in
.the presence of an authorized user.
(h) " Physician" means an individual 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. (i) " Radiation Safety Officer" means the individual' identified on the license who is responsible for the establishment and implementation of a program to assure the safe use of licensed material. McElroy-1/A 6 January 12, 1982 L
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) (j) " Sealed source" means any byproduct material that,is encased j in a capsule designed to prevent leakage or escape of the byproduct , material. j (k) '" Supervision" means th'at.the authorized user has adequately 1 instructed physicians (s) in training and all employees who administer to , humans byproduct material or the radiation therefrom in the man 1
- use and has determined that they have received training in the safe use
- of these materials. It also means that the user periodically reviews the work of those supervised and is assured that proper records are made of each use. The authorized user need not necessarily be present for each radiopharmaceutical administration.
(1) " Transfer" means the change of control over licensed material from a licensee authorized under an NRC or Agreement State license to a l licensee authorized under a different NRC or Agreement State license. I i 935.16 Application forms. Applications for specific licenses or for amendment or for human use under this part shall be filed on form , "Applica- , tion for Materials License--Medical." The completed. application form i
- and license fee shall be mailed to....
I j 935.17 License term. Licenses will be valid for five years from the date of issue. 935.18 Amendments, j Amendments shall be filed on form , " Application for t. i
-Materials License--Medical." Only the information needed to identify 1
j McElroy 1/A 7 January 12, 1982
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the-licensee, the information blocks concerning the topic of the requested amendment, and the signature and date~1ines need be completed.- 935.19 Applications for research (a) Applications for human use in an institution may include an application for a-Type A specific license of broad scope (10 CFR 38) for research which does not involve human use. The Radiation Safety Committee shall rev.iew and approve each proposed use by a majority of those members voting on the proposed use. (b) For proposes described in (a) above, the institution-may have on hand for a radionuclide not more than 100 (one hundred) times the microcurie amount specified at 10 CFR 30.71 Schedule B, and the total amount of licensed material on hand shall not exceed 100 (one hundred) millicuries. SUBPART B-- General Administrative Requirements
$35.30 ALARA.
Each institution shall establish a program to maintain individual and collective dose as low as reasonably achievable. (a) Management shall develop and implement a policy to maintain individual and collective doses as low as reasonably achievable. (b) The Radiation Safety Committee shall: (1) review and approve on the basis of safety considerations each proposed user and use of byproduct material, i McElroy 1/A 8 January 12, 1982
l 4 (2) review at least quarterly with the assistance of the Radiation Safety Officer occupational radiation exposure records of all personnel [ working with byproduct material, a (3) review at least annually with the assistance of the Radiation
- Safety Officer the radiation safety program and promptly forward to
. management the findings of that review, and (4) establish a . table of investigational levels for occupational
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- radiation exposure which, when exceeded, will initiate an investigation ,
i j and consideration ~ of corrective action by the Radiation Safety Officer.
'(c) The Radiation Safety Officer shall: , (1) be responsible for the day-to-day operation of'the radiation safety ;,rogram, 2
(2) implement a safety education program for personnel working in I or frequenting areas where byproduct material is used, l
- .(3) investigate known instances of deviation from good practice l j and implement corrective action as necessary, and l
l (4) investigate and report to the Radiation Safety Committee find-i_ ings and corrective actions taken in instances in which occupationally exposed personnel have exceeded investigational levels. i : { (d) Each authorized user shall be responsible for the training and [ continuing education of personnel and the safe use of material under his I prisdiction. j ( F 1 4
- 635.31 Radiation safety committee !
I Each institution ~shall establish a Radiation Safety Committee to ; i oversee the use of licensed material. i I h l
- McElroy 1/A 9 January 12, 1982 l !
(a) Membership shall include at least a physician specializing in nuclear medicine, a person with special competence in radiation safety, a representative of management, and a representative of the nursing service, and a representative from each major department where byproduct material is used. , (b) The Committee shall meet a least quarterly. (c) A quorum of not less than 50% shall be present to conduct business. (d) The Committee shall be responsible for monitoring the institu-
' tional program to maintain-individual and collective exposure as low as reasonably achievable..
(e) The Committee shall review on the basis of safety and approve or disapprove the name of'each individual who is to be listed as an autho-rized user or radiation safety officer on a license application or appli-f cation for amendment. (f) If the institution has been issued a Type A specific license of broad scope under 635.19, the committee shall also review on the basis of safety and approve or disapprove each proposed use. (g) The minutes of each Radiation Safety Committee meeting shall include at least the date of the meeting, members present, members absent, summary of deliberations, recommended actions, and program reviews. The minutes shall be kept fcr review by the Commission for the duration of the license. (h) Each authorized user and radiation safety officer shall main-tain for inspection by the Commission evidence of training and education sufficient to meet the requirements of the group or groups for which use is authorized. McElroy 1/A 10 January 12, 1982
i 635.32' Radiation Safety Officer. ; The Radiation Safety Officer shall authorize the purchase of, receive, distribute, and establish policy for the disposal of all licensed material, and establish and maintain all documentation required under this part, i establish and implement procedures for emergency action, periodic radia-tion surveys, inventory of licensed material, safety-during use, perfor-
- mance checks of safety equipment, and training.
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- 635.33 Records retention.
Records necessary to show compliance with each' administrative or ' technical requirement on this part shall be maintained for review by l e the commission. The records shall be maintained for two years unless ; otherwise stated in the requirement. , S35.34 Visiting physicians. ! For a period not to exceed sixty (60) ' days in any calendar year, a physician visiting an institution is authorized to use licensed material i for human use under'the terms of the institution license without amend-ment of the license, provided: (a) the visiting physician has the prior written permission of . management and the institution's Radiation Safety Committee, 4 (b) the visiting physician.is specifically named ~as a user on a Nuclear Regulatory Commission or agreement state ~ license authorizing human use, (c) the visiting physician performs only those procedures for i ' which he is specifically authorized by a Nuclear Regulatory Commission-license or agreement state license, and McElroy 1/A .11 January .12, 1982. I l-
1 (d) the institution maintains for inspection by the Commission 1
- copies of the written permission specified in subitem (a) above and of the license (s) specified in subitems (b) and (c) above.
935.35 Mobile departments. (a) Mobile departments shall maintain for inspection by the Commis-sion a letter of authorization signed by the management of each facility at which licensed services are rendered. l (b) -Mobile departments based in an institution.shall conduct all l licensed activities under the jurisdiction of a license issued to that i institution. 1 (c) Mobile departments may only conduct work described at 5935.901, 2 . 35.902, and 31.11, and calibration and quality control of equipment used j ] in support of procedures described therein. 935.36 Records and reports of misadministrations. (a) When a misadministration involves any therapy procedure, the i j licensee shall notify, by telephone only, the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. The licensee shall also notify the referring physician-of the affected patient and the patient or a responsible relative (or guardian), unless the referring physician personally informs the licensee either that he.will inform the patient or that,.in his medical judgment, telling the patient or.the
- patient's responsible relative (or guardian) woul'd be harmful to one or the other, respectively. These notifications shall be made within 24 >
hours after the licensee discovers'the misadministration. If the referring physician, patient, or the patient's responsible relative or
'McElroy 1/A 12 . January 12,.1982
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i guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the-4 patient or the patient's responsible relative or guardian without first i consulting the referring physician; however, the licensee shall not i delay medical care for the patient because of this. (b) Within 15' days after an initial therapy misadministration i report to NRC, the licensee shall report, in writing, to the NRC , Regional Office initially telephoned and to the referring physician, and t furnish'a copy of the report to the patient or the patient's responsible relative (or~ guardian) if either was previously notified by the licsnsee i under paragraph (a) of this section. The written report shall include ! the licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative-(or guardian), and if not, why not. The report l shall not include the patient's name, or other .information which could 4
- lead to identification of the patient.
(c) When a misadministration involves a~ diagnostic procedure, the licensee shall notify, in writing, the referring physician and the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. Licensee reports of diagnostic misadministrations are due i within 10 days after the end of the calendar quarters (defined by March, June,' September, and December) in which they occur. These written reports
- i. I
- j. shall include the licensee's name; the referring physician's name;.a l description of .the event; the effect on the patient; and the action- taken !
to prevent recurrence. The report 1should not include the patient's name
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l or other information which could lead to identification of the patient. ! l r b McElroy 1/A. 13 January 12, 1982- ! i I
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(d) Each licensee shall maintain for Commission inspection records of all misadministrations of radiopharmaceuticals or radiation from teletherapy or brachytherapy sources or interstititial implant sources. These records shall contain the names of all individuals invovled 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). SUBPART C -- General Technical Requirements .635.50 . Calibration and check of dose calibrators. Dose calibrators used to determine amount of radioactivity shall be checked and tested prior to clinical use and regularly thereafter. (a) Dose calibrators shall be checked for constancy on a frequently used setting at-least once on each day of use prior to use with a sealed source of not less than 10 microcuries of radium-226 cr 50 microcuries of any other gamma emitting radionuclide. (b) Dose calibrators shall be tested for accuracy at installation and at least annually thereaf ter by assaying at least two sealed sources , containing different radionuclides whose activity has ~been determined by , the manufacturer to an accuracy within 5 percent, and whose activity is 1 McElroy 1/A 14 January 12, 1982
at least 10 microcuries for radium-226, and 50 microcuries for any other gamma emitting radionuclide. (c) Dose calibrators shall be. tested for linearity at installation
-and at least quarterly thereafter over the range from the highest dose administered to 10 microcuries.
(d) Dose calibrators shall be tested for geometry dependence at installation over the range of volumes and configurations normally used. Records of this test shall be maintained for two years after the last clinical use of the dose calibrator. (e) Appropriate checks and tests noted above shall also be done following adjustment or repair of the dose calibrator. (f) Should any test. indicate an error in excess of 10 percent, the calibrator shall be repaired or assays shall be mathematically corrected for the error. 935.51 Calibration and check of survey instruments. (a) Ionization survey instruments shall be calibrated annually and following repair and shall be checked for function with a check source 4 { before and after each use. ; (b) Other surve'y instruments shall be calibrated on receipt and following repair, and shall be checked for function with a check source before and after each use. (c) A point shall be considered calibrated if the indicated expo-sure rate differs from the calculated exposure rate not more than 10 per- , cent or if .a correction chart or graph is attached to the meter by not more than 20 percent. 1 McElroy 1/A 15 January 12, 1982
(d) Scale readings above 500 milliroentgens per hour need not be calibrated. The maximum calibrated exposure rate shall be noted on the meter.
-(e) Records of function checks required at (a) and (d) above need not be maintained.
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(f) Documentation of the calibration shall include a description of the calibration procedure including source radionuclide and estimated activity. , i 935.52 Check of equipment in diagnostic humari use. (a) Equipment to be used to assess uptake, dilution, or excretion of licensed. material in conjunction with hurran use shall be checked at l
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least once on each day of use for background count rate and constancy. [ This check shall be done prior to administration of a dose of licensed f r material to a human. l t (b) Equipment to be used for imaging in conjunction with human use j shall be checked at least once on each day of use for background count rate, uniformity of response throughout the image field, and geometric [
- linearity throughout the image field'. This check shall be done prior to f l
, administration of a dose of licensed material to a human. I i i i
$35.53 Assay of radiopharmaceutical doses. '
r Each radiopharmaceutical dose for human use shall be assayed immediately prior to administration to assure that the activity in the ! dose is within 10 percent of the activity prescribed. . l McElroy 1/A 16 January 12, 1982 i
1 F 1 j 1 935.60 Syringe shields. A syringe shield.shall be used when administering doses by injec-i tion unless, in the opinion of the person performing the injection, the use of the shield would cause extravasation. i i a
$35.61 Vial shields, p
Multi-dose vials containing material to be administered shall be i enclosed in vial shields. ' 4 935.68 Authorization for calibration and reference sources. Any person licensed under this part is also here by authorized to l receive, possess, and use byproduct material in sealed sources for check, < i l calibration, and reference purposes. Sources may not exceed 6 milli-i
- curies each.
t $35.69 Requirements for possessionL of sealed sources. j i (a) -Any licensee who possesses a sealed source shall cause each i ) . sealed source containing byproduct material to be tested for leakage. i j and/or contamination at intervals not to exceed six months. In the absence of a certificate from a transferor indicating that a test has been made within six months prior to the transfer, th'e sealed source _ j shall not be used until tested for leakage. The leak test shall be l capable of detecting the presence of 0.005 microcuries of radioactive 9
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. material on the test sample. The test sample shall be taken from the j- sealed source or from the surfaces of the device.in which the sealed
. source is permanently mounted or stored on which contaimination might be i
McElroy 1/A 17 January 12, 1982
expected to accumulate. For teletherapy sealed sources the test shall be taken with the source in the "off" position. Records of leak test results shall be kept in units of microcuries. (b) If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Parts 20 and 30 of this chapter. A report shall be filed within 5 days of the test with the appro-priate Nuclear Regulatory Commission Inspection and Enforcement Regional Office listed in Appendix.D of Part 20 of this chapter, with a copy to Director of Inspection and Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, describing.the equipment involved, the test results, and the corrective action taken. , (c) The following sources are exempt from the leak test requirements: (1) Seeds of iridium-192 encased in nylon ribbon (2) Seeds containing only iodine-125 l (3) Sources containing only hydrogen-3 ' (4) Sources containing.only licensed material with a half life of ; less than 30 days ; l (5) Sources containing only licensed material as a gas ! (6) Sources' containing 100 microcuries or less of beta and/or gamma- f i emitting material or 10 microcuries or~1ess of alpha emitting material. i i (7) Sources stored and not being used; such sources shall, however, ! be tested for leakage prior to any use or transfer unless they have been o leak-tested within six months prior to the date of use or transfer. ! (d) Any licensee who possesses and uses a sealed source shall follow the radiation cafety and handling instructions approved by the Atomic 1 F McElroy 1/A 18 January 12, 1982
, v--
i Energy Commission, the Commission, or an Agreement State and furnished by the manufacturer on.the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form. (e) Any license who possesses a sealed source shall conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the Commission and shall include at least the quantities and kinds of : l byproduct material, location of sources, and the date of the inventory. 4 935.70~ Surveys for ambient radiation exposure rate. ( (a) Areas where radiopharmaceuticals are prepared for human use or administered to humans shall be surveyed at the end of each day of use with a low range survey meter to assure that all byproduct material has been properly secured. l (b) Areas where fresh or waste human use licensed byproduct mate-rial is stored shall be surveyed at least once each week with a low range survey meter. 935.75 Release of patients. No patient who has been administered a radiopharmaceutical. may be released from the facility until the residual activity is less.than 30 millicuries. McElroy 1/A 19 January 12, 1982
l i 935.80 Mobile Departments. In addition to other requirements in this part, licensees operating a mobile department shall comply with the following requirements. (a) The user shall bring in to each facility all byproduct material l to be used and, before leaving, remove.all unused byproduct material and all waste generated in the course of the use of byproduct material. ; (b) Byproduct material shall be secured or under the physical super-vision of the user at all times. (c) Prior to administration of byproduct material to humans each piece of equipment transported to the location of use shall be checked for function as described in 635.50, 935.51, and $35.52 as appropriate. (d) Prior to departure the user shall perform a survey for ambient radiation exposure rate with a low range survey meter to assure that all byproduct material has been removed from the location of use. (e) A physician shall be present within the facility during each administration. He shall have 30 hours of radiation safety training. g35.90 Storage of volatiles and gases. Volatile radiopharmaceuticals and gases shall be stored in a fume hood or be doubly contained to prevent the unintended release of material. 635.91 Storage of waste. 4 i Each waste container shall be securely closed prior to storage and labelled at least with the identity of the longest lived isotope therein and the date of sealing. 1
- McElroy 1/A 20 January 12, 1982
635.92 Decay in storage. The licensee is authorized to hold radioactive material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash provided: (a) Affected radioactive waste shall be held for decay a minimum 1 of ten (10) half-lives. (b) Prior to disposal as normal waste, radioact'ive waste shall be
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monitored to determine that its radioactivity cannot be distinguished from background with low-level laboratory survey meter. All radiation labels will be removed or obliterated. 4 (c) Generator columns shall be segregated so that they may be moni-tored individually without any shielding to ensure decay to background .; levels prior to disposal. SUBPART D -- Group General /I l 635.100 Eligibility. Any physician may apply, except for use in an institution, then management must apply. S35.101 Training and experience.
! Each authorized user must meet the training and experience require-l ments specified in S35.951.
I t L i McElroy 1/A 21 January 12,-1982 , 2
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535.102 Authorized use. (a) If not for the indications on the package insert, the user shall nevertheless comply with insert instructions on form, dose, and range. (b) If neither for insert indications nor consistent with form, dose, and range instructions, comply with Taplin petition. 535.103 Equipment. The following shall be on hand and available for use in working order: (a) One detection device suitable for the studies of uptake, dilu-tion, and excretion performed under the license. (b) One sealed source or device suitable for checking the constancy of the detection device. (c) One low-level survey meter. (d) One syringe shield for each type of syringe used to administrator radiopharmeuaticals by injection. (e) One dose calibrator. 1 SUBPART E -- Group II/III 935.200 Eligibility. Any physician may apply, except for use in an institution, then management must apply. McElroy 1/A 22 January 12, 1982 L-
935.201 Training and experience. Each authorized user must meet the training and experience require-ments specified in $35.952. g35.202 . Authorized use. (a) If not for the indications on the package insert, the user shall nevertheless comply with insert instructions on form, dose, and ! range. (b) If neither for insert indications nor consistent with form, dose, and range instructions, comply with Taplin petition. 635.203 Equipment. , The following shall be on hand and available for-use in working order: (a) One imaging device suitable for the studies performed under t
. the license.
(b) One sealed source or device suitable for checking image field uniformity. (c) One device suitable for checking image field geometric linearity. (d) One low-level' survey meter. (e) One syringe shield for each type of syringe used to administer radiopharmaceuticals by injection. (f) One dose calibrator. (g) If radioactive gases or aerosols are used,.one shielded system that is either vented to the outside atmosphere through an air exhaust or provides for collection and disposal of the gas or ae-osol. McElroy 1/A 23 January 12, 1982
I 635.204 Permissible levels of molybdenum, ' Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/ technetium-99m generators shall test each generator eluate for-molybdenum-99 breakthrough. Elvate containing more than 1 microcurie [ of molybdenum-99 per millicurie of technetium-99m or doses containing r more than 5 microcuries of molybdenum-99 shall not be administered to humans. I b
$35.205 Confinement of aerosols and gases. i Radioactive aerosols or gases must be administered with a closed, l shielded system that either is vented to the outside atmosphere through I an air exhaust or provides for collection and disposal of the aerosol. l l
l SUBPART F -- Group IV/V r 635.300 Eligibility. f Any physician may apply, except for use in an institution, then management must apply. ' 635.301 Training and experience. , i Each authorized user must me'et the training and experience require-ments specified in 635.953. ; I 635.302 Equipment. The following shall be on hand and available for use in working order: j (a) One low-level survey meter, f i McElroy 1/A 24 January 12, 1982 f
(b) One ionization-type survey meter. (c) One dose calibrator.
' S35.303 Safety procedures.
The authorized user shall establish and implement written radiation safety instructions for all personnel caring for the patient, and shall make such measurements as are necessary to assure compliance with 10 CFR 20 requirements. SUBPART G -- Group VI S35.400 Eligibility. Management of an institution may apply
$35.401 Training and experience.
Each authorized user must meet the training and experience require-ments specified in 635.954.
$35.402 Equipment.
i The following shall be on hand and available for use in working order: t (a) One ionization-type survey meter. (b) One device suitable for shielding sources during transport between locations of storage and use. (c) Devices suitable for remote handling of sources. McElroy 1/A 25 January 12, 1982
$35.403 Release of patients.
The licensee shall assure that patients treated with temporary implants remain hospitalized until a source count and a radiation survey of the patient confirm that all implants have been removed. 935.404 Transfer of sources between licensee ~ SUBPART H -- Group VII
$35.500 Eligibility.
Any physician may apply, except for use in an institution, then management must apply. 635.501 Training and experience. Each authorized user must meet the training and experience require-ments specified in 635.955. SUBPART I --~ Group VIII
$35.600 Eligibility.
Any physicion may apply, except for use in an institution, then management must apply. I S35.601 Training and experience. Each authorized user must meet the training and experience require-ments specified in 935.956. McElroy 1/A 26 January 12, 1982
635.602 Authorized use. The machine shall be used only for human use. If in an institution it may also be used for training of medical and allied health personnel and research. The license will not authorize: (a) Installation, relocation, or removal of teletherapy units containing sources, or teletherapy units not containing sources. (b) Source exchange. (c) Any maintenance or repair 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 or result in increased radiation levels. I S35.603 Authorized inventory. The total authorized activity as working and replacement sources will be specified in the license i'ssued. In addition, the licensee is
- authorized to possess, use, transfer, and import the uranium contained as shielding material in the teletherapy units authorized by the license.
635.604 Information.to be submitted with application. (a) The applicant shall supply such information deemed necessary by the Commission to determine the safety of the facility. This includes, but is not necessarily limited to, drawings, plans, elevations, shielding information, interlocks, viewing systems. (b) No changes may.be made in the treatment room shielding,,loca-tion of the unit within the treatment room, or use of the teletherapy , i McElroy 1/A 27 January 12, 1982 n- - -.- .. . . - . - - , - . . - , ,, . - - - - . - - - , - - - . - , - , . -w--,. .- ..-
unit that could result in increased radiation levels in areas outside the teletherapy treatment room without authorization of the Commission. 635.610 Emergency instructions. . A set of written emergency instructions shall be posted at the ; teletherapy machine console. These instructions shall inform the machine operator of the procedure to be followed should he be unable to turn the machine's primary beam of radiation "off" with controls outside the treatment room, and procedures to be followed in the event of any other ( abnormal operation of the machine. ! l 635.620 Doors and interlocks. (a) Access to the teletherapy room shall be controlled by a door f ' i at each entrance. Such doors shall be normally closed. l t (b) Each entrance to the teletherapy room shall be equipped with l an electrical interlock system that will turn the teletherapy machine's ! I primary beam of radiation "off" immediately upon opening of that entrance [ door. The interlock system shall be connected in such a manner that the teletherapy machine's primary beam of radiation cannot be turned "on" l i until all treatment room entrance doors are closed and the beam "on-off" l control is reset at the control panel. 635.630 Equipment. l r The licensee shall have available for use and in working order at i least the following. I [ i h McElroy 1/A 28 January 12, 1982 ; t
(a) One survey meter which has been calibrated within the past twelve months shall be on hand at all times. (b) A radiation monitoring device which continuously monitors the teletherapy beam condition and is equipped with a back-up battery power supply for emergency operation in each teletherapy room. This device shall energize a visible signal to make the operator continuously aware of the teletherapy beam condition in order that appropriate emergency procedures may be instituted to prevent unnecessary radiation exposure. Operating procedures shall require daily operational testing of the installed radiation monitor. Whenever the continuous radiation monitor-ing device is not operational, any person entering the teletherapy room following an irradiation shall enter with an operable, calibrated radia-tion survey meter and shall determine the beam condition. (c) A dosimetry system that has been calibrated by the National Bureau of Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine. The dosimetry system shall have been calibrated within the previous two years and after any servicing that may have affected system calibration. (Orton AAPH petition:) Alternatively, the dosimetry system which is used may be calibrated at intervals not to exceed four years if midway (plus or minus six months) between calibrations the system is intercompared with another dosimetry system which has been calibrated by the National Bureau of Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine within the past twelve months and the results of the intercomparison indicated that the calibra-tion factor had not changed by more than 2 percent. A teletherapy unit McElroy 1/A 29 January 12, 1982
b with a radioactive source shall be used as the source of radiation fcr the intercomparison and the intercomparison shall be conducted under the supervision and in the presence of at least two qualified experts. (d) A dosimetry system used for spot-check measurements. It may be calibrated by direct intercomparison with a system that has been i calibrated in accordance with paragraph (c) of this section. This inter-comparison shall have been performed within the previous year and after 1 3 each servicing that may have affected system calibration. Dosimetry systems checked by this method shall not be used for full calibration
- measurements. Alternatively, the spot-check system may be the same system used to meet the requirement at (c) above.
(e) A prinary viewing system permitting continuous observation of l the patient from outside the treatment room during patient irradiation,. l situated in such a fashion that it can be easily seem from the operator's I j console. If the primary viewing system is electronic, there shall be a I' secondary viewing system which is not electronic. ] 035.632 Full calibration measurements. i (a) Any licensee authorized to use teletherapy units for treating humans shall cause full calibration measurements to be performed on each i teletherapy unit: ) (1) Prior to the first use of the unit for treating humans; (2) Prior to treating humans: (i) Whenever spot-check measurements indicate that the output value [ I differs by more than 5 percent from the value obtained at the last full i calibration corrected mathematically for physical decay; , I I l McElroy 1/A 30 January 12, 1982 l I
i (ii) Following replacement of the radiation 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) At intervals not exceeding one year. l (b) Full calibration measurements' required by paragraph (a) of this section shall include determination of: (1) The exposure rate or dose rate to an accuracy within 13 percent for the range of field sizes and for the range of distances (or for the axis distance) used in radiation therapy; (2) The congruence between the radiation field and the field indicated by the light beam localizing device; (3) The uniformity of the radiation field and its dependence upon the orientation of the useful beam; (4) Timer accuracy; (5) Shutter error; and (6) The accuracy of all distance measuring and localization devices used for treating humans. (c) Full calibration measurements must be made in accordance with the procedures recommended by the Scientific Committee on Radiation Dosim-etry of the American Association of Physicists in Medicine. These proce-dures are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379-396 which has been approved for incorporation by reference by the Director of the Federal Register. Copies of the document are available for inspection or may be obtained from the U.S. Nuclear Regula-l tory Commission, Public Document Room, 1717 H Street, NW., Washington, McElroy 1/A 31 January 12, 1982
r DC 20555. A copy of the document is also on file at the Office of the Federal Register, 1100 L Street, NW., Room 8301, Washington, DC 20408. A notice of.any change in the material will be published in the Federal Register. (d) The exposure rate or dose rate values determined in paragraph (b)(1) of this section shall be corrected mathematically for physical decay for intervals not exceeding one month. (e) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (d) of this section shall be performed by an expert qualified by training and experience in accordance with 635.602 935.633 Periodic spot checks. (a) Any licensee authorized under this part to use teletherapy units for treating humans shall cause spot-checks .to be performed on each teletherapy unit at intervals not exceeding one month.
-(b) Measurements required by paragraph (a) of this section shall include determination of:
(1) Timer accuracy and shutter error; (2) The congruence between the radiation field and the field indicated the light beam localizing device; (3) The accuracy of all distance measuring devices used for treating humans; (4) The exposure rate, dose rate, or a quantity related in a known manner to these rates for one typical set of operating conditions; and l McElroy 1/A 32 ' January 12, 1982-
(5) The difference between the measurement made in paragraph (b)(4) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e. , the value obtained at last full calibration corrected mathematically for physical decay). (c) Measurements required by paragraph (a) of this section shall be performed in accordance with procedures established by an expert qualified by training and experience in accordance with 935.602. (A qualified expert need 'not actually perform the spot-check measurements.) If a qualified expert does not perform the spot-check measurements, the results of the spot-check measurements shall be reviewed by a qualified expert within 15 days. (d) Electrical interlocks on entrance doors to the teletherapy room shall be tested for proper operation at least once every month. In the event of malfunction of_ any door interlock, the teletherapy machine control shall be locked in the "off" condition and not used, except as may be necessary for repair or replacement of the interlock system, until the interlock system is shown to be functioning properly. (e) Monthly checks shall also be made of all indicator and warning lights on the unit, console, or in the facility; the viewing system; operability of doors from inside and outside; and if applicable, func-tion of power-operated doors with the teletherapy unit electrical power turned'off. Any item checked and found not working properly must be promptly repaired. McElroy 1/A 33 January'12, 1982
r t 535.643. Radiation measurements for new installations. Prior to initiatio.' of a treatment program, and subsequent to each installation of a teletherapy source, radiation surveys and tests shall be performed.in accordance with the following: (a) The teletherapy source housing, with the teletherapy source in the "off" position. The maximum and average radiation levels at one meter fron the teletherapy source in the "off" position shall not exceed 10 milliroentgens per hour and 2 milliroentgens per hour, respectively. (b) All areas adjacent to the treatment room with the teletherapy i source in the "on" position. The survey shall be performed with the largest clinically available treatment field and a phantom in the primary beam of radiation and shall clearly establish: (1) That radiation levels in restricted areas are not likely to cause personnel exposure in excess of the limits specified in Section 20.101, Title 10, Part 20, Code of Federal Regulations, Chapter 1,
" Standards for Protection Against Radiation (10 CFR 20), and (2) That quantities of radiation in unrestricted areas do not exceed the limits specified in Section 20.105(b), 10 CFR 20, and (c) The intensity of the primary beam of radiation from the tele-therapy source, expressed as RHM and determined during the full calibration.
635.642 Facility checks for new installations. The following systems shall be tested for proper function promptly after installation of a source. (a) Electrical interlocks on entrance doors to the teletherapy treatment room. McElroy 1/A 34 January 12, 1982 t
r (b) The teletherapy source "on-of" indicators at the source housing, on the teletherapy machine console, and in the facility. (c) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restri.ction of source housing angulation or elevation, carriage or stand travel and operation of the beam "on-off" mechanism). 635.643 Reports for new installations. Copies of the results of the surveys and tests required at 9935.641 and 35.642 shall be sent to the following two addresses not later than thirty days following each installation of a teletherapy source: (al the Material Licensing Branch, U.S. Nuclear Regulatory Commis-sion, Division of Fuel Cycle and Material Safety, Washington, DC 20555, and (b) the appropriate U.S. Nuclear Regulatory Commission Regional Office of Inspection and Enforcement. 635.644 Five year inspection. Each teletherapy machine shall be fully inspected and serviced during source replacement or at intervals not to exceed five (5) years, whichever comes first, to assure proper functioning of the source expo-sure mechanism. Thir inspection and servicing must be performed by persons specifically authorized to do so by the U.S. Nuclear Regulatory Commission or an Agreement State, and a report of the inspection and servicing must be kept on file for review by the Commission for the duration of the license. McElroy 1/A 35 January 12, 1982
F SUBPART J -- Groups of human uses of byproduct material 935.901 Group General /I (uptake, dilution, excretion). Use of prepared radiopharmaceuticals for certain diagnostic studies involving measurements of uptake, dilution, and excretion. This group
.does not include imaging or localization studies.
(a) Iodine-131 as sodium iodide (NaI131), iodinated human serum albumin (IHSA), labelled rose bengal, triolein, or sodium iodohippurate. (b) Iodine-125 as sodium iodide (NaI125), iodinated human serum albumin (IHSA), oleic acid, or sodium fothalamate. (c) Cobalt-58 for the measurement of intestinal absorption of cyanocobalamin. (d) Cobalt-60 for the measurement of intestinal absorption of cyanocobalamin. (e) Chromium-51 as sodium radiochromate. (f) Iron-59 as citrate. (g) Technetium-99m as pertechnetate. (h) Any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or. excretion for which a " Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA). 635.902 Group II/III (imaging). Use of prepared radiopharmaceuticals, generators, and reagent kits for certain diagnostic studies. (a) Molybdenum 99/ technetium-99m generators for the elation of tech-netium-99m as pertechnetate. McElroy 1/A 36 January 12, 1982
F (b)- Prepared radiopharmaceuticals and reagent kits for ti.e prepara-tion of technetium-99m pertechnetate labelled radiopharmaceuticals: (1) sulfur colloid; (2) pentatate sodium; (3) human serum albumin microspheres; (4) polyphosphates; (5) macroaggregated human serum albumin; (6) etidronate sodium; (7) stannous pyrophosphate; (8) human serum albumin;
~(9) medronate sodium;
~(10) gluceptate sodium; (11) oxidronate sodium; and (12) disofenin.
(c) Tin-113/ indium-113m generators for the elution of indium-113m as chloride. (d) Iodine-131 as sodium iodide, iodinated human serum albumin, macroaggregated iodinated human serum albumin, colloidal (microagregated) iodinated human scrum albumin, rose benegal, or sodium idohippurate. (e) Iodi.ne-125 as sodium iodide or fibrinogen. (f) Chromium-51 as human serum albumin. (g) Gold-198 in colloidal form. (h) Mercury-197 as chlormerodrin. (i) Mercury-203 as chlormerodrin. (j) Selenium-75 as selenomethionine. (k) Strontium-85 as nitrate. l McElroy 1/A 37 January 12, 1982 l l
(1) Ytterbium-169 as pentatate sodium. (m) Indf uni-113m as chloride. (n) Any byproduct material in a radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing byproduct material for which radiopharmaceutical or generator or reagent kit a " Notice of Claimed Investigational Exemption of A new Drug" (IND) has been accepted by the Food and Drug Administration (FDA). 935.903 Group IV/V (radiopharmaceuticals for therapy). Use of-prepared radiopharmaceuticals for ~certain therapeutic purposes. (a) Iodine-131 as iodide for treatment of hyperthyroidism and cardiac dysfunction. (b) Phosphorus-32 as soluble phosphate.for treatment of polycythemia vera, leukemia, and bone metastases, and as colloidal chromic phosphate for intracavitary treatment of malignant effusions. (c) Gold-198 as colloid for intracavitary treatment of malignant effusions. (d) Iodine-131 as iodide for treatment of thyroid carcinoma. (e) Any byproduct material in a radiopharmaceutical and for a therapeutic use for which a " Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administra-tion (FDA). 635.904 Group VI (sealed sources for internal or contact therapy). Use of sources and devices containing byproduct material for certain therapeutic purposes. McElroy 1/A 38 January 12, 1982
s t, < (a) Cesium-137 encased in nee'dles and applicator cells for topical, interstitial, and intracavitary treatment of cancer.
- s. '(b) Coibalt-60 encased in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer.
(c) Gold-198 as seeds for interstitial treatment of cancer. (d) Iridium-192 as seeds encased in nylon ribbon for interstitial i treatment of cancer. 1 (e) Strontium-90 sealed in an applicator.for treatment of superficial eye conditions. (f) Iodine-125 as seeds for interstitial treatment of cancer. s t
$35.905 Group VII (sealed sources for diagnostic human use).
Use of_ sources and devices containing byproduct material for certain diagnostic human uses. l l (a) Iodine-125 as a sealed source in a device for bone mineral analysis. (b) Americium-241 as a sealed source in a device for bone mineral analysis. 935.'906 Group VIII (teletherapy units). Use of a sealed source in a teletherapy unit for the treatment of humans. If in an institution the unit may also be used for training and research subject to the review and approval of necessary-institutional, eaq local, State and Federal bodies. (1) Cobalt 60 as a sealed source. (2) Cesium 137 as a sealed source. 4 McElroy 1/A 39 January 12, 1982
The qualified expert who calibrates and checks the radiation output of the teletherapy unit must meet the following training and experience requirements: (a) Is certified by the American Board of Radiology in Therapeutic Radiological Physics, Radiological Physics, Roentgen-Ray and Gamma-Ray Physics, or X-ray and Radium Physics; or (b) Has the following minimum training and experience: (1) A Master's or Doctor's degree in physics, biophysics, radio-logical physics, or health physics; (2) One year of fulltime training in therapeutic radiological physics; and (3) One year of full-time experience in a radiotherapy facility including personal calibration and spot-check of at least one teletherapy unit. Licensees that have their teletherapy units calibrated by persons who do not meet these criteria for minimum training and experience may request a license amendment excepting them the requirements of 635.602. The request should include the name of the proposed qualified expert, a description of. his training and experience including information similar to that specified in this section, reports of at'least one calibration and spot-check program based on measurements personally made by the pro-posed expert within the last 10 years, and written endorsement of the technical qualifications of the proposed expert from personal knowledge by a physicist certified by the American Board of Radiology in one of the specialities listed in this part. The individual's qualifications will be evaluated by NRC's consultants'in medical physics.
.McElroy 1/A 40 January 12, 1982 i
SUBPART K--Training and Experience Requirements 335.950 Radiation Safety Officer
$35.951 Authorized Users for Group General /I (uptake, dilution, excretion).
(a) Each authorized user must be a phyt,ician. (b) The training and experience specified in (c), (d), and (e) below must have been obtained within the five years preceding the date of application or the authorized user must have had continuing involve- . ment in the procedures since the time of training. (c) Each authorized user shall have had approximately 200 hours of training in the basic radioisotope handling techniques specifically applicable to the use of unsealed sources. This training should consist of lectures, laboratory sessions, discussion groups, and supervised experi-ence in a nuclear meJicine laboratory in the following areas and for approximately the number of hours indicated: (1) Radiation physics and instrumentation (100 hours), (2) Radiation protection (30 hours), (3) Mathematics pertaining to the use and meaurement of radio-activity (20 hours), (4) Radiation biology (20' hours), and (5) Radiopharmaceutical chemistry (30 hours). (d) Each authorized user shall have had approximately 500 ho'urs of experience under the supervision of an authorized user. This experience should have included the work indicated: (1) Ordering, receiving, and unpackaging radioactive materials safely, including performance of the related radiation surveys, McElroy 1/A 41 January 12, 1982
g (2) Calibration of dose calibrators and diagnostic ~instrumenta-tion, and performance of operational checks on survey meters, (3) Calculation, preparation of patient doses, including radiation safety considerations, (4) Administration of doses to patients, including proper use of syringe shields, (5) Appropriate internal control procedures to prevent the mis-administration of materials to patients, and (6) Emergency procedures to handle and contain spilled materials safely, including related decontamination procedures. (e) Each authorized user shall have had approximately 500 hours of clinical experience under the supervision of an authorized user. This experience should have included the work indicated: (1) Supervised examination'of patients to determine the suitability for radioisotope diagnosis and recommendation on' dosage to be prescribed, (2) Selection of the proper radiopharmaceutical and dosage, calcula-tion of the related radiation dosed and collaboration in the interpreta-tion of the radioisotope test results, (3) Followup of patients when required, (4) Study and discussion with the supervising authorized user of case histories to establish the most appropriate diagnostic procedures, limitations, contraindications, etc. (f) Any physician who does.not meet the qualifications described
~
in (c), (d), and (e) above may submit with the application a description of past training and experience and a listing of the specific procedures for which authorization is requested. This information will.be reviewed 1 McElroy 1/A 42 January 12', 1982
~ ~
by the Commission with the assistance of the Advisory Committee on the Medical Use of Isotopes. Authorization will be granted or denied based on the findings of the review. (g) A physician holding any one certification, and recertification if required by the certifying body, indicated below is prima facie deter-mined to have met the training and experience requirements described in (c), (d), and (e) above: (1) American Board of Nuclear Medicine in Nuclear Medicine, (2) American Board of Radiology in Diagnostic Radiology with Special Competence in Nuclear. Radiology, or (3) American Osteopathic Board of Radiology in Diagnostic Radiology or in Radiology. 635.952 Authorized Users for Group II/III (imaging). (a) Each authorized user must be a physician. (b) The training and experience specified in (c), (d), and (e) below must have been obtained within the five years preceding the date of application or the authorized user must have had continuing involve-ment in the procedures since the time of training. (c) Each authorized user shall have had approximately 200 hours of training in the. basic radioisotope handling techniques specifically applicable to the use of unsealed sources. This training should consist of lectures, laboratory sessions, discussion groups, and supervised experi-ence in a nuclear medicine laboratory in the following areas and for approximately the number of hours indicated: l (1) Radiation physics and instrumentation (100' hours), 1
\
McElroy 1/A 43 January 12, 1982
(2) Radiation protection (30 hours), (3) Mathematics pertaining.to the use and meaurement of radio-activity (20 hours), (4) Radiation biology (20 hours), and (5) Radiopharmaceutical chemistry (30 hours), (d) Each authorized user shall have had approximately 500 hours of experience under the supervision of an authorized user. This experience should have included the work indicated: (1) Ordering, receiving, and unpackaging radioactive materials safely, including performance of the related radiation surveys, (2) Calibration of dose calibrators and diagnostic instrumenta-tion, and performance of operational checks on survey meters, (3) Calculation, preparation of patient doses, including radiation safety considerations, (4) Administration of doses to patients, including proper use of syringe shields, (5) Appropriate internal control procedures to prevent the mis-administration of materials to patients, and (6) Emergency procedures to handle and contain spilled materials safely, including related decontamination procedures. (7) Election of Tc-99m from generator systems, assay and testing l of the e'uate for Mo-99 and alumina contamination, and processing the eluate with reagent kits to prepare Tc-99m labelled radiopharmaceuticals. (e) Each authorized user shall have had approximately 500 hours of clinical experience under the supervision of an authorized user. This experience should have included the work indicated: McElroy 1/A 44 January 12, 1982
E (1) Supervised examination of patients to determine the suitability for radioisotope diagnosis and recommendation on dosage to be prescribed, (2) Selection of the proper radiopharmaceutical and dosage, calcula-tion of the related radiation dosed and collaboration in.the interpreta-tion of the radioisotope test results, (3) Followup of patients when required, (4) Study and discussion with the supervising authorized user of case histories to establish the most appropriate diagnostic procedures, limitations, contraindications, etc. (f) Any physician who does not meet the qualifications. described in (c), (d), and (e) above may submit with the application a description of past training and experience and a listing of the specific procedures for which authorization is requested. This information will be reviewed by the Commission with the assistance of the Advisory Committee on the Medical Use of Isotopes. Authorization will be granted or denied based on the findings of the review. (g) A physician holding any one certification, and recertification if required by the certifying body, indicated below is prima facie deter-mined to have met the training and experience requirements described in (c), (d), and (e) above: (1) American Board of Nuclear Medicine in Nuclear Medicine, (2) American Board of Radiology in Diagnostic Radiology with Special Competence in Nuclear Radiology, or (3) American Osteopathic Board of Radiology in Diagnostic Radiology or in Radiology. McElroy 1/A 45 January 12, 1982 L
635.953 Authorized Users for Group IV/V (Radiopharmaceuticals for therapy). (a) Each authorized user must be a physician. (b) The training and experience specified in (c) and (d) below must have been obtained within the five years preceding the date of application or the authorized user must have had continuing involvement in th6 proce-dures since'the time of training. (c) Each authorized user shall have had approximately 80 hours of training in the basic radioisotope handling techniques specifically applicable to the use of unsealed sources for approximately the number of hours indicated: (1) Radiation physics and instrumentation (25 hours), (2) Radiation protection (25 hours), (3) Mathematics pertaining to the use and meaurement of radio-activity (10 hours), and (4) Radiation biology (20 hours). (d) Each authorized user shall have had clinical experience under the supervision of an authorized user. This experience should or shall have included the work indicated: (1) Clinical experience in the diagnosis of thyroid function and/or cardiac conditions and active participation in the treatment of ten patients using iodine-131 for treatment. (2) Active participation in the treatment of three patients with polycythemia vera, leukemia, and/or bone metastases using soluble phosphorus-32 for treatment. (3) Active participation in the treatment of three patients using colloidal phosphorus-32. McElroy 1/A 46 January 12, 1982
I (4) Active participation in the treatment of three patients with thyroid carcinoma using iodine-131. (5) Active participation in the treatment of three patients using colloidal gold-198 for intracavitary treatment. (e) Any physician who does not meet the qualifications described in (c) and (d) above may submit with the application a description of past training and experience and a listing of the specific procedures for which authorization is requested. This information will be reviewed by the Commission with the assistance of the Advisory Committee on the Medical Use of Isotopes. Authorization will be granted or denied based on the findings of the review. (f) A physician holding any one certification, and recertification if required by the certifying body, indicated below is prima facie deter-mined to have met the training and experience requirements described in (c) and (d) above: (1) American Board of Nuclear Medicine in Nuclear Medicine, or (2) American Osteopathic Board of Radiology in Radiation Oncology. S35.954 Authorized Users for Group VI (sealed sources for internal therapy). (a) Each authorized user must be a physician. (b) The training and experience specified in (c), (d), and (e) below must have been obtained within the five years preceding the date of application or the authorized user must have had continuing involve-ment in the procedures since the time of training. (c) Each authorized user shall have had approximately 200 hours of training in the basic radioisotope handling techniques specifically McElroy 1/A 47 January 12, 1982 i k
r i applicable to the use of sealed sources for therapy procedures for approximately the number of hours indicated: (1) Radiation physics and instrumentation (110 hours), (2) Radiation protection (40 hours), (3) Mathematics pertaining to the use and meaurement of radio-activity (25 hours), and (4) Radiation biology (25 hours). (d) Each authorized user shall have had approximately 500 hours of I experience under the supervision of an authorized user. This experience should have included the work indicated: 9 (1) Ordering, receiving, and unpackaging radioactive materials safely, including performance of the related radiation surveys, i (2) Performance of operational checks on ion chambers and survey meters, (3) Safe handling of sealed sources during preparation, insertion, and removal, and 4 (4) Quality control and emergency procedures, j (e) Each authorized user shall have been active practice in thera-peutic radiology with a minimum of three years experience of which at I least one year shall or should have been in a formal training program I approved by the Residency Review Committee for Radiology of the accredita-tion council for Graduate Medical Education. (f) Any physician who does not meet the qualifications described in (c) and (d) above may submit with the application a description of past training and experience and a listing of the specific procedures for which authorization is requested. This information will be reviewed i McElroy 1/A 48 January 12, 1982 __ __1
I by the Commission with the assistance of the Advisory Committee on the Medical Use of Isotopes. Authorization will be granted or denied based on the findings of the review. (g) A physician holding any one certification, and recertification if required by the certifying body, indicated below is prima facie deter-mined to have met the training and experience requirements described in (c) and (d) above: (1) American Board of Radiology in Radiology or in Therapeutic Radiology, (2) American Osteopathic Board of Radiology in Radiation Oncology, (3) British Faculty of Radiology in Radiology if the applicant has on hand for review by the Commission evidence of specialization in radiotherapy, (4) British Royal College of Radiology in Radiology if the applicant has on hand for review by the Commission evidence of specialization in radiotherapy, or (5) Canadian Royal College of Physicians and Surgeons in Therapeutic Radiology. 635.955 Authorized Users for Group VII (sealed sources for diagnostic human use). The authorized user shall be a physician. 635.956 Authorized Users for Group VIII (teletherapy). (a) Each authorized user must be a physician. McElroy 1/A 49 January 12, 1982
(b) The training and experience specified in (c), (d), and (e). below must have been obtained within the five years preceding the date of application or the authorized user must have had continuing involve-ment in the procedures since the time-of training. (c) Each authorized user shall have had approximately 200 hours of training in the basic radioisotope handling techniques specifically applicable to the use of unsealed sources. This training should consist of lectures, laboratory sessions, discussion groups, and supervised experi-ence in a nuclear medicine laboratory in the following areas and for approximately the number of hours indicated: (1) Radiation physics and instrumentation (100 hours), (2) Radiation protection (30 hours), (3) Mathematics pertaining to the use and meaurement of radio-activity (20 hours), (4) Radiation biology (20 hours), and (5) Radiopharmaceutical chemistry (30 hours). (d) Each' authorized user shall have had approximately 500 hours cf experience under the supervision of an authorized user. This experience should have included the work indicated: (1) Ordering, receiving, and unpackaging radioactive materials safely, including performance of the related radiation surveys, (2) Calibration of dose calibrators and diagnostic instrumenta-tion, and performance of operational checks on survey meters, (3) Calculation, preparation of patient doses, including radiation safety considerations, (4) Administration of doses to patients, including proper use of syringe shields, McElroy 1/A 50 January 12, 1982 i
(5) Appropriate internal control procedures to prevent the mis-administration of materials to patients, and (6) Emergency procedures to handle and contain spilled materials safely, including related decontamination procedures. (e) Each authorized user shall have had approximately 500 hours of clinical experience under the supervision of an authorized user. This expe'rience should have included the work indicated: (1) Supervised examination of patients to determine the suitability for radioisotope diagnosis and recommendation on dosage to be prescribed, (2) Selection of the proper radiopharmaceutical and dosage, calcula-tion of the related radiation dosed and collaboration in the interpreta-tion of the radioisotope test results, (3) Followup of patients when required, (4) Study and discussion with the supervising authorized user of - case histories to establish the most appropriate diagnostic procedures, limitations, contraindications, etc. (f) Any physician who does not meet the qualifications described in (c), (d), and (e) above may submit with the application a description of past training and experience and a listing of the specific procedures for which authorization is requested. This information will be reviewed by the Commission with the assistance of the Advisory Committee on the 1 Medical Use of Isotopes. Authorization will be granted or denied based on the findings of the review. (g) A physician holding any one certification, and recertification if required by the certifying body, indicated below is prima facie deter-mined to have met the training and experience requirements described in (c), (d), and (e) above: McElroy 1/A 51 January 12, 19A?
(1) American Board of Radiology on R'adiology or Therapeutic Radiology. 635.957 Qualified Expert .for Group VIII (teletherapy units). The qualified expert who calibrates and checks the radiation output of_the teletherapy unit must meet the following training and experience raquirements: (a) Is certified by the American Board of Radiology in Therapeutic Radiological Physics, Radiological Physics, Roentgen-Ray and Gamma-Ray Physics, or X-ray and Radium Physics; or (b) Has the following minimum training and experience: (1) A Master's or Doctor's degree in physics, biophysics, radio-logical physics, or health physics; (2) One year of fulltime training in therapeutic radiological physics; and (3) One year of full-time experience in a radiotherapy facility including personal calibration and spot-check of at least one teletherapy unit. Licensees that have their teletherapy units calibrated by persons who do not meet these criteria for minimum training and experience may request a license amendment excepting them the requirements of 935.602. The request should include the name of the proposed qualified expert, a description of.his training and experience including information similar to that specified in this section, reports of at least one calibration and spot-check program based on measurements personally made by the pro-posed expert within the last 10 years, and written endorsement of the McElroy 1/A 52 January 12, 1982
r T, 1 I technical qualifications of the proposed expert from personal knowledge by a physicist certified by the American Board of Radiology in one of the specialities listed in this part. The individual's qualifications will be evaluated by NRC's consultants in medical physics. McElroy 1/A 53 January 12, 1982 [
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2 [J /s/g g duf sdn] O' Part 35--Human Use of Byproduct Material 6
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3 1 O SUBPART A -- General Administrativ_bInformation
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~~ ^
, ' Purpose and scope This part prescribes regulations governing the licensing of byproduct' material for human uses. It describes special requirements for issuance of specific licenses authorizing human use of byproduct material. The provisions and requirements of this part are in addition to, and not in substltution for, m,u,;%
other requirements of this chapter. In particular, the provisions of Partl30pd i'10 A of this chapter apply to applicad$ns and license [s subject to this part. / A
Table of Contents Subpart A--General .Information 35.1 Purpose and scope 35.2 License requirements
-35.15 Definitions 35.16 Application; forms 35.17 License term 35.18 Amendments Subpart B--General. Administrative Requirements 35.30 ALARA-35.31 Radiation Safety Committee 35.32' Evidence of training 35.33 Radiation Safety Officer 35.34 Records retention 35.35 Visiting physicians 35.36 Mobile departments 35.37 Records and reports of misadministrations Subpart C--General Technical Requirements 35.50 Calibration of dose calibrators 35.51 Calibration and check of survey instruments 35.52 Check of equipment in diagnostic human use 35.53 Surveys for ambient radiation exposure rate 35.54 . Requirements for possession of sealed sources 35.55 Syringe shields O 35.56 35.57 Release of patients Storage of volatiles and gases 35.58 Labelling of waste 35.59 Decay in. storage Subpart D--Group General /I 35.100 Eligibility 35.101 Training and experience 35.102 Authorized use Subpart E--Group II/III 35.200 Eligibility 35.201 Training and experience 35.202 Authorized use 35.203 Permissible levels of molybdenum 35.204 Confinement of aerosols and gases Subpart F--Group IV/V 35.300 Eligibility 35.301 Training and experience 35.302 Safety procedures Subpart G--Group VI 35.400 Eligibility
'35.401 Training and experience 35.402 Release of patients 35.403_ Transfer of sources between licensees i
Subpart H--Group VII O 35.500 Eligibility 35.501 Training and experience Subpart I--Group VIII 35.600 Eligibility 35.601 Training and experience 35.602 Training and experience of qualified expert 35.603 Authorized use 35.604 Autnorized inventory 35.605 Infonnation to be submitted with application 35.610 Emergency instructions 35.620 Doors and interlocks 35.630 Equipment 35.632 Full Calibration measurements - 35.633 Periodic spot-checks 35.641 Radiation measurements for new installations 35.642 Facility checks for new installations 35.643 Reports for new installations 35.644 Five year inspection Subpart J--Groups of human uses of byproduct material 35.901 Group General /I (uptake, dilution, excretion) 35.902 Group II/III (imaging) 35.903 Group IV/V (radiopharmaceuticals for therapy) 35.904 Group VI (sealed sources for internal therapy) O 35 $os cro"9 vit (seeied se"rces for die 9"ostic ""=e" "se) 35.906 Group VIII (teletherapy units) O
John Cook 1/A 2 - Den-ter3,1981{L
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O f u.z License requirements. ,e/ M No person subject to the regulations in this part shall receive, possess, use, or transfer byproduct material for any human use except in accordance with a specific license issued pursuant to the regulations in this part.
- 55. / 5 +g --
--Definitions g/~ .i..n hM "]A'l"' 'o mdd j f 0 h 2 "> .
> 9 ,I As used in this part:
tO M ll A [- Ja["Humanuse"meanstheinternalorexternaladministrationof byproduct material, or the radiation therefrom, to human beings; (jd Jb)'3" Physician"meansanindividuallicensedbyastateorterritoryof A, the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
/
o on ,, .n d' (1) " Authorized user" means a physician licensed by the NRC or an Agreement
]
State for the human use of byproduct material. (5) 1 ; & u f, .,. t. A;. , , ..s/) N ,wJ.m uj & .ypo ' r.a.~ m , w sud exa ,Jf..A < *4 th c. d' " ^" *" A' };,' ", , n ket k ee n d , & s..r s.,,,, e s y w a,v to * ~ . na ol< *J f b" "d ' A, ' (k) " Supervision" me'ans that the' authorized user has adequately instructed s g is ol + ,0 J v u %/i> +: W C .nD,.,, physicians (s) in training and all employees who7dmThisTe? BPM-to-h 4fn -/, thespecifichumanuseandhasdeterminedthatthe!havereceivedtrainingin /\ i the safe use of these materials,in humansg It also means that the user 4 0- - periodically reviews the work of those supervised and. ass'ures-himselfj that g]
- . c)a , wag p,ijn John Cook 1/A 3 December 3r19%1,~
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.aJ 4M proper medica,1 records are made of each use. -It%ernot mean-that th fuser g y.
c.c m er - ee 4s/necessarily present for each radiopharmaceutical administration. 3 g U) ' Transfer"means the change of control over licensed material from a licensee authorized under an NRC or Agreement State license to a licensee ,q/ /4 , authorized under a different NRC or Agreement State license. / 't , - d (g ) " Sealed source" means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material. J i De fi n i tion -of-a - Mi s admi n i s trati o v 2 (e) ' For4topact/ isadministration' means the administration of: ,f g
$ (4) A radiopharmaceutical or radiation from a sealed source other than the one intended; ical i l (O (b) A radiopharmaceut d or radiation to the wrong patient /
b-(0(c) A radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; (4,(df A diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than 50 percent;f '. ig M ' M ^ //'Of l O
- i. ..
l l. avaaa< tece-berj/0,If[2 ! John Cook 1/A. 4 4 1981 ). $ -l I [5)(e) A therapeutic dose of a radiopharmaceutical differing from the 1 j prescribed dose by more than 10 percent; or L i .L I4 (6)(-O A therapeutic radiation dose from a sealed source such that* errors inthesqidcecalibration,timeofexposure,andtreatmentgeometryresultin (1) i a calculated total treatment dose differing from the final prescribed total 1 j treatment dose by more than 10 percent. ,
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] (1) " Management"means those persons authorized by the charter of the medical " '
institution to make its policies and direct its activitiesJ l p) -pu)> bf,hv ' ww,. a fu d'*1 n y-' ';h >^* " yf 'rd'~A aY"y *' i'6"A ,Ja, _
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15.16'//s,o.a,f.a av J Applications n.m jw for
; L specific licenses for human use under #~/ d "i'"i,i i 4 a l shall be filed on form , " Application for Materials License-- M:
Hedical." JLs,c,ab'gj.,Q,6,,,,st.d.cj r/a/4,nwh 4 l 1 I 7
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l John Cook 1/A 5 ha<u./Q/ff2 December .,498& l l ' 9 r i _s>A'f< .
..w e;4 PAj,TJj-GeneralAdministrativeRequirements A
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t nada!4 Mw gwyr , mf, *<h y e'.i M w n )~4prd. y + w~7 6 ! y % ? ? ,i- o Gv.~ jAf" ! / For, a.period .A wnot to exceed. sixty (60) days in any calendar year, agvisiting -q, h v/g, phpiciangisauthorizedto'uselicensedmaterialforhumanuseundertheterms @s t g /p ym.T i m nA He,v of thgicense, provided;the+is4 ting physician:; ? /(T ; p*O um w,u d a nd rf.< mEl$m'a (a)huyasthepriorwrittenpermissionofttheMspital?3Administratee-and tsf t g Madical Isotopes -Committee andiadiation Safety
- committee, ad jam w (b)h,sspec+ificallynamedasauseronaNuclearRegulatoryCommissionlicenset '
authorizing human use, and (c)h,)kr$gky%.werforms only those procedures for which he is specifically 7author a Nuclear Regulatory Commission lic.ense, oys. 00 m xlW am.s kn (O 1 The-+icensee-shaWmaintaigforinspectionbytheCommissiong copies of f the written permission specified in subitem .m b(a)! ,34 above,Jand W of the license (s) speciff subitems (b) and (c) above/' These7ecortis shali trmaintI1Md. 4eppiim(5[ years-from-the_ time t'he-licensee grants-its_ permission %r - /T M l L subitem-(a)-abover l , wh w%&,0 i. . , :n yf u .< a . - u } 36.34' Unlessotherwisestatedherein,recordsrequiredfinthispastshall I o 3-i ained r bemmaint.o.m m .for, se.cu.two years.
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A "A ' (N ~ w .. , ports-of-therapy-misadministration!**Y L-F~N' '!*'" nr*J., 9)p/nmucs . a - r,sd '< < ~ ni,ve. :? s a > J W*Re/ .
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f nuay /}i /[O n 5a V EM Al.hf A M' Each institution shall establish a program to maintain indiv_idual and collective exposure as low as reasonably achievable. The +ragrein ( sham 4e-monitored 4y-the-Ra d i a tierr5 a fety-Commi t tee-with-th e a s s i s t a nce L Of ficer., 6 31 of-e athe h Radiation-SafetyU$tc k e,s Gpfg Cowuu 35.jJ Each institution shall establish a Radiation Safety Committee to 7 oversee the use of licensed material. (a) Membership shall include at least a physician specializing in nuclear medicine, a person with special competence in radiation safety, a representative of management, and a representative of the nursing service. (b) The comittee shall meet at least quarterly. (c) A quoreum of not less than 50% shall be present to conduct business. (d) The committee shall be responsible fer. monitoring the institutional program to maintain individual and collective exposure as low as reasonably achievable. (e) The comittee shall review and approve or disapprove the name of each individual who is to be listed as an authorized user [on a license application or application for amendment. n ude Fo u/</[yfea. o (f) The minutes of each Radiation Safety Comittee meeting shall include at least the date of the meeting, members present, members absent, summary of deliberations, recommended actions, and program reviews. The minutes shall be kept for review by the commission for the duration of the license, o o
.l, >t mu d lllO i
John Cook 1/A. 6 Gere+er.,19g ; i -
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@ (s) !=cdiate-telephane ieperg When a misadministration involves any q j therapy procedure, the licensee shall n~otify, by telephone only, the appropriate 1 l
; NRC Regional Office listed in Appendix D of Part 20 of this chapter. The l' 1
licensee shall also notify the referring physician of the affected patient and ! the patient or a responsible relative (or guardian), unless the referring
! ' physician personally informs the licensee either that he will inform the !
i patientorthat,inhismedicaljudgment,tellingthepatientorthepatient's [ responsible relative (or guardian) would be harmful to one or the other, j 4 respectively. These notifications shall be made within 24 hours after the l I licensee discovers the misadministration. If the referring physician, patient, [
! t j 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 i I
j Q not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee ( i ! ] shall not delay medical care for the patient because of this, f pv , (b) Witten-reportg Within 15 days after/thyinitial therapy misadministra 7 [
- tion report to NRC, the licensee shall report, in writing, to the NRC Regional i f j
Office initially telephoned and to the referring physician, and furnish a copy i j of the report to the patient or the patient's responsible relative (or guardian) l
)
ifeitherwaspreviouslynotifiedbythelicenseeunderparagraph/(a)ofthis I
/ . ! section. The written report shall include the licensee's name; the referring i
physician's name; a brief description of the event; the effect on the patient;
, the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative (or guardian), and if not, why ! not. The report shall not include the patient's name, or other information ,
[ j which could lead to identification of the patient. ! I f
; i I
l
*}a va < to, ll/L John Cook 1/A 7 Deew ber-3 M.SBI'
-Report *of diagnostic misadministrations' er __4 2__ - '
G)Whenamisadministrationinvolvesadiagnosticprocedure,thelicensee /[ t 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 which could lead to identifi-cation of the patient. O
-Reco rds _o f_ al L m i s admi ni s trat i ons 7, N)EachlicenseeshallmaintainforCommissioninspection,recordsofall j i
misadministrations of radiopharmaceuticals or radiation from teletherapy or
; t ,, ..,.v- :. .
brachytherapy sourceg These records shall contain the names of all individuals 4 invovled 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. V J u.v v : c, 1 l l
I Opis ae /d,/f/2-John Cook 1/A - 8 fjecemberaq981-Right'; and-duties cf Ikensees m (d Aside from the notification requirement, nothing in this section shall -- affect any rights or duties of licensees and physicians in relation to each other, patient' or responsible relatives (or guardians), j SUBPART C -- General Technical Requirements , o j~ q '; .J . : .,,a>, M.s ,3s.s3inpuuin g gu '
% e+ w u / w.+ w 4.
h)(ppuyav/;[e*fsari-)(4[^1nylicenseewhopossessesase d7 sealed source contpaining 1. byproduct materiah, other-then hyde ge-3, within2a Q i. ~
/, [
he+f-Hf; ;c;;ter tt;n thirty dey;-in :n3 fe,a Eter the 8'/p to be tested for A leakage and/or contamination at intervals not to exceed six months. In the absence of a certificate from a transfer,or indicating that a test has been , made within six months prior to the transfer, the sealed source shall not be c,s M 4e ' used until tested /, providedhhowevee r -that-no-leak-tests-are-required wheny Mq * (t ' [ (a)-The- {)ourcel contain)a100 microcuries or less of beta and/or 3 gam
! emitting material or 10 microcuries or less of alpha-emitting material, f ory- bb i .
(K l (1 !k l 4)-Ty4Q s)ources i{ stored and .lg not being usedg such ; sou shall,however,betestedforleakagepriortoanyuseortransferunlessthey,(
;have been leak-tested within six months prior to the date of use or transfer.
l df)'t,The leak test shall be capable of detecting the presence of 0.005 microcuries of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which
.'. Qavuaug .'b /f?&
John Cook 1/A 9 december 9-196L,-- 9 i the sealed source is permanently mounted or stored on which contaimination n . - . a . -. ~ s e . . . . . , , . , < . . 7 might be expected to accumulate. 3 Records of leak test results shall be kept in units of microcuries.and-maintained-for inspection-by-the-Commissiong
/
( (((-31 If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall immediately withdraw the sealed
; source from use and shail cause it to be decontaminated and repaired or to be disposed of in accordance with Parts 20 and 30 of this chapter. A report shall be filed within 5 days of the test with the appropriate Nuclear Regulatory Commission Inspection and Enforcement Regional Office listed in Appendix 0 of Part 20 of this chapter, with a copy to Director of Inspection and Enforcement,
. U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, describing the O r"'.'.' ""d '"' ca r r'w'i c 'c
'a"' a**"4 wa> 9' ' 'x'd > '"* '
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(f){DAny licensee who possesses and uses ,a sealed soude",shalli ( Q NFollow the radiation safety and handling instructions'npproved by theAtomicEnergyCommission,theCommission,oranAgreementStatear$dfurnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form. , , ($;;,rL u cin. ~ "A
' * " h)
/) (2NConductaquarterlyphysicalinventorytoaccountforallsources 4 //f '
received and possessed. Records of the inventories shall be maintained for s la ? inspection by the Commission and shall include'the quantitles and kinds of ' byproduct material, location of sources, and the date of the inventory. l c ,; v. ,w m u um
John Cook 1/A - fam<ary f), !)D 10 ADeces ei 3, 19$1" e h ,.w ,n i;>> 0l i:;a cw . :h - M 'M Dose calibrators used to determine amount of radioactivity shall be /
-f' .
2 tested for constancy at least once on each day of usef, for accuracy at ' installation, and at least annually thereafter, for linearity at installation , and at least quarterly thereafter, and for geometrical variation at installation. Records for geometrical variation shall be kept for two years after last clinical use of the dose claibrator. Appropriate testU bove shall'also be b' done following adjustments or repair of the dose calibrator. g.
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M Survey instruments shl1 be calibrated annually and following repair. / (t.' % vi G w h n, u i, . ;. , .c . .. , , . a , ..a . .a ,.a i.. , n.1 y a.,ci.
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-j, F '>1 y/
half-life of less than 65 days for decay-in-storage before disposal in oridinary
, i trash provided:
Y f (a) Effected radioactive waste shall be held for decay a minimum of ten (10) / half-lives. (b) Prior to disposal as normal waste, radioactivt waste shall be monitored to determine that its radioactivity cannot be distinguished from background stw with typica)~ low-level laboratory survey /intrumen,ts. All radiation 7A7 f.s labels will be removed or obliterated. M Generator columns shall be segregated so that they may be monitored
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g to ensure decay to background levels prior to disposal.. ' c ,k :. ll,;,U }) j.:Q' l'
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q 35.52' Check of equipment bbe-used in-conjunction-wi-th diagnostic 1 human use. V (a) Equipment to be used to assess uptake, dilution, or excretion of licensed material in conjunction with human use shall be checked at least once on each day of use for background count rate and detection efficiency. This check shall be done prior to administration of a dose of licensed material to a human. (b) Equip.nent to be used for imaging in conjunction with human use shall be checked at least once on each day of use for background count rate, unifonnity of response throughout the image field, and geometric linearity throughout the image field. This check shall
. be done prior to administration of a dose of licensed material to a human.
35.53 Surveys for ambient radiation exposure rate.#'f**"'""+"*"' (a) Areas where ^~ad m+=r4aF+3 prepired for human use or administered to humans shall be surveyed at the end of each day of use with a low range survey meter. (b) Areas where IIEsHHXHIHIXIXIE fresh or waste human use material is stored shall be surveyed at least once each week with a low range survey meter.
>2 n lo jage ? h % A4 s . y . F . e lh 35.55' A+ syringe shield shall be used when administering doses by injection unless, in the opinion of the person performing the injection, the use n of the shield would cause extravasation. 41 -tha<c M.
U aid.u d pin un 35.56-LNo patient who has been administered a radiopharmaceutical may be released from the facility until the residual activity is less than 30 millicuries. r+ % p f e Ic. ht a 35.57' Volatile radiopharm%.maceuticals and gases shall be stored in a fume hood or be doubly contained to prevent the unintended release of material. 35.58 sLie J Eachit r< of Mir waste container shall be sealed prior to storage and labelled at least with the identity of the longest lived isotope therein and the date of sealing. o /C
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a
aiway/QfffL John Cook 1/A 11 december Tr1981
.r'i U Subpart D-- Group General /I O b
.i ga a M /O Eligibility:fgny physician may apply, ' for use in an institution, only~
,3~
management clay' apply.
'%; .a n J w +
- Eh e l' A 35.10/[ygg authorized usermust ( meet the following training and experience y/d requi e,ents:
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b) 'ls:? k> ik o J.cank s /k,wlwco^l I'"^ U *""
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,~gya,naf,,pMi'iubpart
/
- Group II/III -
t ,
#rr Mya a
Eligibilig .any 1 physician may app.lyf [or use in an institution, pwonly
~ /)
V managementmayapply.
%23/ The' authorized user (s) must meet the following training and experience /, /
.s requiments:
l (INSERT T & E REQ) n 2d2 Authorized use. (A)Ifnotfortheindicationsonthepackageinsert,theusershallnevertheless comply with insert instructions on form, dose, and range. m
.' _ }nuuta '
'kfflI John Cook 1/A- 12 cflecamber e, 198 .
j (b)Ifneitherforinsertindicationsnorconsistentwithform, dose,and n range instructions, comply with Taplipe petition. t f>.
--Additio1Tal- requirement 5 g b.vdsth %I' 21 'd Y *N**
gg,2 o 3 'AEachlicenseepreparingtechnetium-99mradiopharmhceuticalsfrom /\ [ ] b molybdenum-99/etechnetium-99m generators shall test tI We' generator eluates for e -/
,- o
,a,q,n n . n . ,, a O.1 . " ~w.a.-,, i~ ~ ~ n ,- ~ ,,,.; ,.,;,
mol,y,bdenum-99
+ cu s > ~*" of breakthrough woup wa :ws3in-accordance-withf adioactive aerosoly s
n j- must be y a p..
'dministered with a closed, shielded system that either is vented to the <
outside atmosphere through an air exhaust or provides for collection and disposal of the aerosol. _ , , , . ,, y;
,, is 4 , -
e Insert-fe ther requirements-for stovage of volat 44e-compounds and aEFotps. t i insert-fttrther-requirements 4ce daily -hand coni.aininatinn chetK for anyl C person-who-prepares-radiopharmaceuticals cr-injecti jistiEiits withy
+
radiopharmacefiticals, g~l g h Subpart -- Group IV/V
.t 35340 gaf
~
Eligibility:r-Any physician may apply j j [or use in an institution, 4rdythw 7
,.pf management may apply.
w wg nJ C<p.u w h~ Gel
> M ?J/J Theauthorizeduser(s)'mustmeetthefollowingtrainingandexperience 7gg!
O . requirements.
. . , - . . . - ,n. - - - - m -,y - r~. , -n.---m- - - ,ye -,re-m. g ,
- y:aug / h I'/El-John Cook 1/A 13 < December"371SB,1~
r _
- 4
'd (INSERT T & E REQ)
Insert-requirementdor-storage-of volatile-compounds, C. t The authorf2e user shall assure that patients wh d ill be administered iodine-131 for the treatme taf thyroid
/
carcinoma or therapeutic quantities of
- , . g g . >. >
gold-198 shall remain hospitalized in n NRC N/N) licensed institution until -
/
the,7 residyal-ecti'v'ity 55, L : y . e . .. s :. ~ is 30 millicuries or i sxQ,9,~ . . ,. b a. i : - at c,..b Osi.L2.j. .,s ,,u A / , % [ a! x L U~~,d r' ' "
- c i . :-
ui. . . . - - n u. . s 4 = < ~/'" *'
- / < k r c c a ~j ..c . .. <,. Subpart
., , ; ; a,--,,Group ., : , .VI, ,,., 2. .a ~ . i> Y 7
7 si +L ,Eligi_bility:_f Management of an institution may apply. J' (s s st.H I ha. v. , , w 1 < < .: + . n . p (
) u r ir. s . . p + a -.n.. .,s< *
, ' ' ~ ' *j *4 : i y
- d ' Y, a . . < . tx .*z 4..+.4,.- . " -
- > r'.a c. s u :- . t:.
7 3f C'The lic'en"see shall assure that patients treated with temm'porary implants >
.{--cobalt-60 remain hospitalized until a source count and a radiation survey of _,
the patient confirm that all implants have been removed.
? 35A' U . - l. c ; :a i. > f < <
j . - Y Subpart -- Group VII 3 [(
.-(consider incorporation in Group General /l or other alternatives) -
3M
,, w. 4 aj,a:q*,6 i n v v:I d ' ' "" , l'" "' ' ** " "
Eligibility.g Any physician 'or, management;- if in an institution, may- j >- 4 C< ~ applyr -
..a s J w p a >. a
.w .
j( {0 $ Gu i C'T , 2 *! VW ~ ' ' UW o h/
%,.,, j-
Q m & g / D , / y S 2-John Cook 1/A 14 d ecember 3,---1931 ,
'?
Subpart[--Telethereprcbf M N d,., u ai t' hh g* ? Eligibil tygAny physician may apply, ff for use in an institution,j only g ,/ <l w managemen may apply. , J 7.- q p .a..c. ,a a <,p :'" a 35;_ J /J The authorized user must meet the following training and experience ,f requirements:e.
,m, y ,,m ,wc+s.e' w // d dp d s
7(, G O l$ :LJLltl G~N NJ C thj'.)h4 .11:.Y cl lib lks +146,1b.*w J f.< # y 'h f u NG ' . .h w,:d - m c.r.a d & p u w a t au sc.' ,, j ; y w . cec.a y i m & - aw ~/:.:M,w.vk,x.7 f ' J mj. z ? n., ;&,
@ SERT-T4-E REQ 3 ~~Z" Y n u,a..a,tu.&gfMf'lf, ,
'i
{j % t $ up orized use.fThe machine shall be used only for{those-purposes--specifie{'] 7 slac -- / ," ag
.n 7 YjTMs licensejdoes not authorize:
la) Installation, relocation, or removal of teletherapy units containing sources, or teletherapy units not containing sources. - SLC7IB. .- - -- a r n (b) Source exchange. - (c) Any maintenance or repair 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 safetyoftheunit(andresultinincreasedradiationlevels. / . (a
}20masy /f /9tf 2-John Cook 1/A 15 fiecamher 3,1981_ 5 i
O_ 35.644N Authorized inventory. The total activity as working and replacement b~ sources s hall be as specified in the license ' issued. In addition, the e licenseeisauthorizedtopofess,use, transfer,andimporttheuranium g, contained as shielding material in the teletherapy units authorized by the license.
, j njnn<akn !obfulk Y w %j f S"
) 366M G;The applicant shall supply such information deemed necessary by the 9 f Commission to determine the safety of the facility. This includes, but is not necessarily limited to, drawings, plans, elevations, shielding information, interlocks, viewing systems. , ,_ . 3
; (4) j kA y fl) ro r pg'O n &
~~ -'
Supbart ---Teletherapy g 4 I g.w m an d% c Em 35 d A set of written emergency instructions shall be posted at the teletherapy ./ 4 - machine control. These instructions sh_all inform the machine operator of the procedure to be followed should he be unable to turn the machine's primary beam of radiation "off" with controls outside the treatment room, and procedures to be followed in the event of any other abnormal operation of the machine. 35,&2O [/cet u d S k Io'ld 7 r (c). Access to the teletnerapy room shall be controlled by a door at each
-r 4 6LC69' entrance. Such doors shall be normally closed.
L L
- 6/Eachentrancetotheteletherapyroomshallbeequippedwithanelectrical #)
I [terlock in system that will turn the teletherapy machin ! d l radiation "off" immediately upon opening offany, entrance door. The interlock / ;- l ~1 system shall be connected in such a manner that the SLC69B teletherapy machine's --
/
4 4
, ,- --++._r4 - ,~e w sw, .rm-, w , r---,n. - ~ - - < - - - - - - -r. >- --we ~- - r w n,
John Cook 1/A-tvt&y /d, If? 16 hembee-3n1981-3 primary beam of radiation cannot be turned "on" until all treatment room i entrance doors are closed and the beam "on-off" control is reset at the control panel. I
-Subpart--- Teletherapy 7 -
fE b ] Equipment.jThe licensee shall have available for use and in working f order at least the following. , 1 ;,; . t st_ (a) gne survey meter which has been calibrated within the pastt(6-or-12) _gg monthsd.:S4 o< hd d .44/ da-- (b){} Each teletherapy room shall-be equipped with a radiation monitoring AI._ device which continuously monitors the teletherapy _ beam condition and is 1 equipped with a back-up battery power supply for emergency operation. This ! device shall energize a visible signal to make the operator continuously aware , of the teletherapy beam condition in order that appropriate emergency procedures ! may be instituted to prevent unnecessary radiation exposure. Operating procedures shall require daily operational testing of the installed radiation monitor.( M Whenever the continuous radiation monitoring device is not operational, any person entering the teletherapy room following an irradiation shall enter with an operable, calibrated radiation survey meter and shall determine the beam condition. O
l ,y py /f /ff2-John Cook 1/A 17 1eeembertp981-7 r ( (c) a dosimetry system that has been calibrated by the National Bureau of Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine. The dosimetry system shall have been calibrated within the previous two years and after any servicing that may.have i 1 affected system calibration.
;> % Ij.y /7*,WIM"j (d) a dosimetry system used solely for. spot-check measurements. It may q be calibrated by direct intercomparison with a system that has been calibrated (c) g&c rce f ais w in accordance with paragrap ,d'of this section. This alterratric cM4 beet 4 met y shall have~been performed within the previous year and after each q7 servicing that may have affected system calibration. Dosimetry systems ckhed.,
-pfeMbratpby this alternative method shall not be used for full calibration. 47-measurements. This may be the same system used to~ meet the requirement'at c above.
(e) a primary viewing system permitting continuous observation of the patient from outside the treatment room during patient irradiation, situated in such a fashion that it can be easily seem from the operator's console.
-Subpart - -Teletherapy 7 :
;f M W Req @ aman + +a PerJor Full Calibration Measurements-cf Telether:p -p tinitg -
(a) Any licensee authorized-under-635r1{ to use teletherapy units for -my treating humans shall cause full calibration measurements to be performed on
~
each teletherapy unit: , [jf7f[ /
'a nu ar /3,/ffL-17a (c) (consider using paragraph c above and add the following from the Orton AAPM petition) Alternatively, the dosimetry system which is used may be calibrated at intervals not to exceed four years if midway (plus or minus six months) between calibrations the system is intercompared with another dosimetry system which has been calibrated by the National Bureau of Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine within the past twelve months and the results of the intercomparison indicated that the calibration factor had not changed by more than 2 percent. A teletherapy unit with a radioactive source shall be used as the source of radiation for the intercomparison and the intercomparison shall be conducted under the supervision and in the. presence of at least two qualified experts. g3 /7 p fv }
O
. c .- - - . . - . - . - - - - - -
,,'- tu p Up f?- l John Cook 1/A- 18 -4ecembe
- i ,
I- ; ; I (1) Priortothefirstuseoftheunitfortreatinghumans[:j ; la i 3 (2) Prior to treating humans: l l ' l ! t I (i) Whenever spot-check measurements indicate that the output value i \ t differs by more than 5 percent from the value obtained at the last full ! calibration corrected mathematically for physical decay; I i l (ii) Following replacement of the radiation source or following f I reinstallation of the teletherapy unit in a new location; { l
- b
+
i j (iii) Following any repair of the teletherapy unit that includes removal l Q of the source or major repair of the components associated with the source 3 exposure assembly 1 and i Yi A/ s , (3) At intervals not exceeding one year. f l [ 1 (b) Full calibration measurements required by paragraph (a) of this ; i / section shall include determination of: t I j
~
(1) The exposure rate or dose rate to an accuracy within 13 percent for - s , the range of field sizes and for the-range of distances (or for the axis ; j distance) used.in radiation therapy; I 4 i - l J t (2) . The congruence between the radiation field and the field indicated ; O by the light beam localizing device; t
. ,- m- , L-,,,,_ ,v. ,,.v -,- ,,,,y,, ,_-m.,_,- , , , - - ,--_._._.__,m_ __ , . . . . _.._r.,_--.-..m. .-.__,,...m_.
hamus< Ih ifD John Cook 1/A 19 4ecember-4 J981- . 7 4 (3) The uniformity of the radiation field and its dependence upon the orientation of the useful beam; j (4) Timer accuracy; andg' T 7 (s5) CAdir e r ra r; #wl y (d g The accuracy of all distance measuring. devices used for treating - humans. , i (c) Full calibration measurements shall be made in accordance with the procedures recommended by the Scientific Committee on Radiation Dosimetry of
- the American Association of Physicists in Medicine (Physics in Medicine and
, Biology, Vol. 16, No. 3, 1971, pp. 379-396) /W h rd:dd<w 'e O-
- O
. i (d) The exposure rate or dose rate values determined in paragraph (b)(1) of this section shall be corrected mathematically for physical decay for l intervals not exceeding one month. (e) Full calibration measurements required by paragraph (a) of this i section and physical decay corrections required by. paragraph (d) of this section shall be performed by an expert qualified by training and experience I in accordance with-635:24g ?C o& ' ~ d' )! . I f }
,._-~.- ~ ,,. , ,
}nena t'Z,Ifl$L John Cook 1/A 20 AMessee--3r1 B&
-Subpart---Teletherapy'{ - - - - ' - .
M 33 Rcqua ement brper4o periodic spot-checkjmeasurements-of-te4etherapy-uni-tsg 47 (a) Any licensee authorized underj 63rr13 to use teletherapy units for f; treatinghumansshallcausespopheckmenenramant to be performed on each teletherapy unit at intervals not exceeding one month, r i j (b) W y measurements required by paragraph (a) of this section shall include-determination of: I ' 4 . r . M3 (1) Timer accuracy; / lO (2) .The congruence between the radiation field and the field indicated
- by 6
@ This incoproation by reference provision was approved by the Acting g j Director of the Federal Register on August 6, 1976. Copies are availabe for I
k[4' inspection or may be obtained from U.S. Nuclear Regulatory Commission, Public Document Room, 1717 H Street, NW, Washington, DC 20555. l
- >the light beam localizing device; i
(3) The accuracy of all distance measuring devices-used for treating l . l l humans i i i
t .
.~
a >kvz; A, If 8% John Cook 1/A- 21 D}ecembe , _S8W-s (4) The exposure rate, dose rate, or a quantity related in a known manner to these rates for one typical set of operating conditions; and (5). The difference between the measurement made~in paragraph (b)(4) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay). (c) Spot-chec{ measurements required by paragraph (a) of this section 3 shall be performed in accordance with procedures established by an expert
- p. u qualified by training and experience in accordance with'S35.24. (A qualified 'i
] expert need not actually perform the spot-check measurements.) ): If a qualified expert does not perform the spot-check measurements, the results of the spot-check i measurements shall be reviewed by a qualified expert within 15 days. 4 (M Electrical interlocks on entrance' doors to the teletherapy room shall be A tested for proper operation at l' east once every month. -Recordes- of- test-results s shall- be maintained- for-inspection by the-Commission.; . , i
; ~~
J , In the event of malfunction of any door interlock, the teletherapy machine j control shall be locked in the "off" condition and not used, except SLC--690, as .._ may be necessary for repair or replacement of the interlock system, until the interlock system is shown to be functioning properly.
~
O l l
1, John Cook 1/A~. dnauge /Z, ifY2-l 22 faceder 3,1961-- 5-g)n,ug aah ad du4 A ej O a Jr. Md-alsp 'all indicator and warning lights on thegmacMng, console, or 4 47 g p q *! L,1 f g facility; the viewing system;p',j doors from inside and outside; jif applicable, w s ump. asishapn function of power-operated doors withf60-C h ectricity. turned off. d7 4 de<44 g aJpwd mt Mny psyd y J ja p.,,f ujad. Subpart M e'.etherapy- j-L i
-Qualified expert. 2g
'm. ,.
.~ _ _ _ _ .
The licensee shall determine if a person is an expert qualified by trai~riing ; fandexperiencetocalibrateateletherapy.unitandestablishproceduresfor j-
)
The licensee shall / ((and determinethatthequalified.review the results expert:._) of) 7_ spot-check measurements. _ . c N ~ _ O - b (a) Is certified by the American Board of Radiology in Therapeutic I we hp I4 ! Radiological Physics, Radiological Physics, Roentgen-Ray and Gamma-Ray { Physics, or X-ray and R'adium Physics: or U j' (b) Has the following minimum training and experience: I t i (1) A Master's or Doctor's degree in ph'ysics, biophysics, radiological j physics, or health physics; l i (2) One year of fulltime training in therapeutic radiological physics; i i nd Mrad }
- n: E p1.e> J 1
'o l t
__m_ . ... _. C mcuu / f I, N L John Cook 1/A 23 .0 embeF- 1981-
)
l (3) One year of. full-time experience in a radiotherapy facility including
- personal calibration and spot-check of at least one teletherapy unit.
I i .
\ -
Licensees that have their teletherapy. units calibrated by persons who do I t not meet these criteria for minimum training and experience may request a ( ; n.w licenseamendmentexceptingthemfortherequirementsofpS35:2.{. The request, ; - i accompanied by the appropriate amendment fee (S170.31 of 10 CFR Part 170), should include the name of the proposed qualified expert, a description of his ' training and experience including information similar to that specified in A.m,~ > i jfe35.24(b), reports of at least one calibration and spot-check program based on i .; measurements personally made by the proposed expert within the last 10 years, f and written endorsement of the technical qualifications of the proposed expert , s n ~ % .j ia u , . n ,) from personal knowledge by a physicist ' certified'ti9 the specialities listed q t , w wt in" 535.24(a). The individual's qualifications will be evaluated by NRC's consultants in medical physics.\q \4 ' The-amendment-request-should-be. addressed +to(
-License' Management- Branch,- U.S.-- Nuclear-Regulatory Commission, . Washington,- DC.; -g.;
,,x e
**====,%
-Subpart--- -Tel etherapg 7; b In naliaW on Aurveys {
y y . w f a h a h .i % s m W [n ra d * % d t h s l g Prior to i.nitiation of a treatment program, and subsequent to each /g installation of a teletherapy source,. radiation surveys and tests shall be perfortied in accordance with the following:
- \
t O l
" - f-
- s ~ - - e y-,+$ y - i ew--P- +-F-m' " - -w==*d-'" "-7v v "r-f -- +"- W? -*~+-+r P"----*- '-T
John Cook 1/A - 24
<witab a embe ll>lfN 1 &l--
O f., A rsdiat-ion surveynhaH-be,nade-of: 2-Q' h.(yTheteletherapysourcehousing,withtheteletherapysourceinthe dq "off" position. The maximum and average radiation levels at one meter from the teletherapy source in the "off" position shall not exceed 10 milliroentgens per hour and 2 milliroentgens per hour, respectively. If4tF) All areas adjacent to the treatment room with the teletherapy AT L source in the'"on" position. The survey,Axcept-4 tem-(c-), shall be ~ performed g
, ray pvIm rpas M L with a phantom in the primary beam of radiation and shall clearly establish: A .
i ( (a)[Thatradiationlevelsinrestrictedareasarenotlikelytocause gy personnel exposure in excess of the limits specified in Section 20.101, Title 10, Part 20, Code of Federal Regulations, Chapter 1, " Standards for Protection 2 , Against Radiation)t(10 CFR 20g ) j ,al f .Ir> ' (b) That quantities of radiation in unrestricted areas do not exceed the limits specified in Section 20.105(b),.10 CFR 20 vd' 4j 4 (c) The intensity of the primary beam of radiation from the teletherapy source, expressed as RHM and determin during the full calibration. j
, . 3 5 :rA 2. . Naukb; chds h ud wbJ/ L.,;
8 Tests shall be made to determine proper operation of: - + (4) 1 4 (k)/' Electrical interlocks on entrance doors to the teletherapy treatment gy 1 room. ('
.--.myy , ,. - - ---.--g7 -
.---wwg,w--,_ , -.-..--y
,..y 7y p w- -w., ---- , , ,
.- rguw /E, /f[f2-John Cook 1/A 25 Decembee4-- 981-
?
O o) 4 (44{ The teletherapy source "on-of" indicators at the source hou es,valt ; b ,E h theteletherapymachinelcontrchpan , and in the facility. A b *i (.iii)[ Electrical or mechanical stops. installed for the purpose of limiting j[y 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).
"y , 9 3 ggc [m rwa W MM ,
3- p& aid *g 3g,H I & % #
' Au p[A-report-of u ,w y h e . u m a the w oresults d n n , %of.i the above y A ,,,,a u s asurveys shall be sent
, w ,i n p and tests \yaysppaaa a
'I l rf b 4.s ,.
j the Material Licensing Branch, U.S. Nuclear Regulatory Commission, Division of
')
J Fuel Cycle and Material Safety, Washington, DC 20555,gnet4eter-than-th4rtyg g (3& day; f011cwingaach-insteHatimr of a i.eletherapy-source. ^ccpyofsvQ (Q ; .q.; . a report-shaRbe-sentjtothe(AU.S.NuclearRegulatoryCommissioyRegion-(typegqs appropriate Regional Office of Inspection and Enforcement --see-list-attached) 7
-Subpart - . Teletherapy c _ _ . ,
~
l_ .gy dg/f l
\h g OD nb n.1 y/ change,gmade s
k in the treatment room shielding, location of the unit %M}
} within the treatment room, or use of the teletherapy unit th;t could I i !
l result in increased radiation levels in areas outside the teletherapy I j 3 ; %f od.m*ylm ai lh cuu a%r>v. /j k,1 /s j uw /!\ . l treatment roomjshaM-be-evaluated-by-a-radiation 5Ur,ey d6 in-accordance, 4 , .-/
~ ~ ~ Yith Lodii.ho$15 t Endaportedbthe1ommission within-thirty-(30)(
days-following e mp]etion-of-the-change (s)r g y y,pyj jaw ga 59uhow - Each teletherapy machine shall be fully inspected and serviced during source replacement or at intervals not to exceed five (5) years, whichever comes
0 > !n a t. l2, 1 John Cook 1/A 26 . mber-3-1901. ,0Q 2 l first, to assure proper functioning of the source exposure mechanism. This inspection and servicing must be performed by persons specifically authorized to do so by the U.S. huclear Regulatory Commission or an Agreement State, and a report of the inspection and servicing must be kept on file for review by the
% D de.:+n'd' s'iJu a. ~
Commissic h_ Office vf In3peWon end- Enforcement- g q y Lwe Subpart -- Groups of "sa). uses of byproduct material
/! 2 k
? %'j0 I - -
- Group General /I Use of-prepared radiopharmaceuticals for certain diagnostic studies involving measurements of uptake, dilution, and excretion. This group does not
(~') j include imaging or localization studies. [A) 15), Iodine-131 as sodium iodide (Haltat ;cJ,m W tuo m m->+ A - " U 's
/9 L jari&d wc6<>pC,X 4 m a sedwn b) L,puxa& . ~
(2) Iedint-lalas-4cdinated-human-scrum cibusin-61HS% 5
,, j, , ,a1, di (Nt.T"%, .
-(d (.3h Iodine-125 a'sjiodinated human serum albumin (IHSA3 e64c au4 eu ,4 Tff
'f Dbu > .. ,o /Jat.t anzic . .c.
- (c.) p) Cobalt-58 for the measurement of intestinal absorption of A /l 4 f cyanocobalamin; hjk)f Cobalt-60 for the measurement of intestinal absorption of 4
1 cyanocobalamin; ll n - r I
2Kuan l$, l l-John Cook 1/A 27 -eecember-3, I c bV ( 161- Chromium-51 as sodium radiochromate ,
/
Iodine-131 ,5 eedium iodiue, iudineted human seruan oibumin, iabeted-roseg 7{ bengot , trivlein, Or- 30d!"- iedeb.ippur te;g , Indi;.e--125 23 :Odi"- i^4W, icdinated humen =erua elbumin, eleie-ee44-op - sedi= icthaieaeta; g
. Cobalt-50 as labeled-cyancacbalemin, C-obelt- 00 e= 1ebchd-eyenocobalemin O (() Iron-59ascitrate, A
/
(g) Technetium-99m as pertechnetate A g bb)Anybyproductmaterialinaradiopharmaceuticalandforadiagnosticuse f involving measurements of uptape, dilution, or excretion for which a " Notice pj of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA). N'N ~ '
~~-
- Group II/III. '
.,{
Use of prepared radiopharmaceuticals, generators, and reagent ~ kits for .l 1 certain diagnostic studies. i O phdyym pnvy l 1
.c _ . . . _ __ ~.
n46 /E, /f.Yb 27a (a) Molybdenum 99/ technetium-99m generators for the elution of technetium-99m as pertechnetate. (b) Prepared radiopharmaceuticals and reagent kits for the preparation of technetium-99m pertechnetate labelled radiopharmaceuticals: (1) sulfur colloid; (2) pentatate sodium; (3) human serum albumin microspheres; (4) polyphosphates; (5) Macroaggregated human serum albumin; (6) etidronate sodium; (7) stannous pyrophosphate; (8) human serum albumin; O (9) medrenete sediemi (10) gluceptate sodium;
-(11) oxidror. ate sodium; and (12) disofenin.
(c) Tin-ll3/ Indium-ll3m generators for the elution of indium-113m as chloride, p 4 &l}s ja El n v
pr?uu, /2, /ffL John Cook 1/A - 28 -December 3, 1981 O (d) (1{ Iodine-131 as sodium iodide, iodinated human serum albumin,
]{
macroaggregated iodinated human serum albumin, colloidal (microagregated) iodinated human serum albumin, rose benegal, or sodium idohippuratep (b,(27 Iodine-125 as sodium iodide or ~ fibrinoge@ f7 7 s 4 [j)13% Chromium-51 as human. serum albumin @
/7 d G}( % Gold-198 in colloidal forng j.fg x 2
(( Mercury-197 as chlormerodrin @ //[G [g)(6 ' Mercury-203 as chlormerodrig /[G t [j)(7{Sdlenium-75asselenomethionineg g gg
'l
[b(8f Strontium-85 as nitrat g
'isG
/l fi-j9] uTechn.H"--99m-as pertechnei.ai.e, sulfui cullvid ur-macreaggregated' =T q
h,--e c o r n. -higu { [d(-10[ Ytterbium-169 as pentatate sodiug /f
//
ME #' (d(11) Indium-113maschlorideQ O
~
.'. M'Ogur {2, /ffl John Cook 1/A 29 # December-3 987 e b ( W Any byproduct matenia Lin_a-radiopharmaceutical prepared-fromqa r4 agent-kit--listed-in-paragraph-(c)(4)-of-this-section;-and- $^"'# F< %) fit-)--Any-typroauct material in a rid 6 pharmaceutical and-for a dingribstic use__ involving-imaging-or-local-izing-for-which-a2 Notice oLClaimed_ Investigational __Exeinption. fon a-New-Drug"-{IND)-has-been accepted-by-the-Food,aQug JLdministration~(FDAJ~~' t
-(-1-)~M61 ybd e num-994techneti nm- 49 m __ g enerators-f o e-t he-e4 ut i on -of-t-echnetium-99 as pertecnuetates
( 2-)-Tec hne t-i um- 99m-a s- pe rtechneta te-f o r- u s e-wi th're' age'nt- ki ts -f o r prepuration-ano use of'Yddfopharmace0ticals~containing-technetium-99m as pr.avided-in-paragraphs-(c)(4).and.(5).of-this section;, (-3)-m-113Aindium .113m_generatorsMor-the-elution-of-the fiiiffu~m:11E 7 g generat:r:v for-the elution of the indium-113m7s chloride:- L, g k hi- p?scN5%=" A 14)-Reagent-kits- for preparat-ion-of-technetium-99-labeleCl: v /g,?
-(!) Sulfurco11oid;
(-ii-)-Pentatate sodi e O
~.,
'/E,/ffL 2 >%us John Cook 1/A 30 -96eembe -
c' GiM)-Human-serum albumin microspheres; (iv) Polyphosphatest (v)- Macroaggregated -human're rum-e l bumi n t
-(vi.)-Etidronath'so~disi; 4x.f i)-Human-serum-albumin;
/
(ix)-Medron'at'e~iEdibm; (x)-Gluceptate sodiumf _( xi)-0xidronate-sodiumpnY (fi) disofeni1tr 3 gg kbid .a ufopwaaa Nedn'y % [n),(57 AnyAgenerator or reagent kit for preparation and diagnostic use of a l' - h G ') sg,panaa.Jeo .- radiopharmaceutical containing byproduct material for whichg generator or g
~
reagentkita"NoticeofClaimedInvestigationfExemptionofAnewDrug"(IND) g i has been accepted by the Food and Drug Administration (FDA). , t O
ll, /l[l-
~
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... SECY-83-62 February 10, 1983 RULEMAKING ISSUE (Notation Vote)
For: The Commissioners Fron: William J. Dircks, Executive Director for Operations ,
Subject:
PROPOSED REVISION OF 10 CFR PART 35 " HUMAN USE OF BYPRODUCT MATERIAL"
Purpose:
To obtain Commission approval of a notice of proposed rulemaking. Category: This paper covers a significant policy on licensing of byproduct materials. Issue: Simplification of the regulations for licensing of human use of byproduct material. Overview: The staff is proposing a major revision to 10 CFR Part 35, Human Use of Byproduct Material. It includes procedures for streamlining the material licensing process and combines the general and specific medical licenses. The NRC issues licenses to medical facilities and individual physicians for the use of radioactive materials in medical diagnosis and treatment of humans. During the past three decades, nuclear medicine has grown annually at a rate of about 15 percent. There are currently 2,631 NRC medical licensees. In 1981, NRC staff received 73 applications for new licenses, 244 renewal applications, and 1,303 amendment applications for a total of 1,620 requested licensing actions. The current regulations for human use of byproduct material in 10 CFR Part 35 provide for specific and general licenses. Most medical institutions and physicians operate under a specific license which covers a broad range of nuclear medicine procedures. Application is made on a standard NRC form and supplemented with detailed documentation of radiation safety procedures, personnel qualifications, facilities and equipment. Each application is reviewed in detail prior to issuance of a license. A few nuclear medicine procedures are authorized by general license. A general license authorizes physicians to use small quantities of certain prepackaged radiopharmaceuticals, and is obtained by filing a registration form. Section 35.31 specifies safety measures and possession limits. The NRC staff does not perform a technical review of the registration but only validates it.
Contact:
William J. Walker 427-4052 g3@s 4#9ho ECY NOT per is identical to advance copies that were This p p 3;--circulated on 2/14/83.
---: u w x ~ ;a: m 7 m e ; m x y g 3 g g g g g g ny 3
-m v
)I, The Commissioners . Proposed Action: By memorandum dated January 7,1982, the Commission issued its FY 1983-87 Policy and Planning Guidance (PPG). . The key guidance elements were the Commission's intent that (1) regulations reflect the reality of nuclear technology, (2) the regulatory process, particularly the licensing program, be efficient and cost effective, and (3) regulatory decisions be reached without unwarranted delay. To_ conform with this guidance, the staff is proposing to simplify the materials licensing program for medical licensees. The specific objectives are to: e Make regulations consistent with the well established safety technology and extensive training of nuclear medicine professionals in medical uses of radioisotopes. e Reduce the regulatory and administrative burden on medical licensees without compromising safety. e Decrease license processing time. e Improve quality assurance in the licensing process. o Improve records management and reduce paper flow.
, e Improve resource utilization by focusing staff resources on the more important safety issues, developing guidance, integrating technological developments, and implementing regionalization.
Key features of the proposed rule change designed to meet these objectives include: e Consolidation of those requirements for nuclear medicine that are now dispersed throughout existing regulations, branch policy positions, standard conditions of licenses and guidance protocols into a concise and coherent set of regulations, o Reduction in the amount of information that must be submitted with a license application by focusing on information essential for safety and eliminating nonessential information. f I
i
)
'The Commissioners 3 e A simplified application form supported by new review procedures to reduce the paperwork burden on the applicant and staff and providing a basis for computerized management of the review process, e Combining specific and general licenses into a single standard i
. license thereby eliminating a dual licensing system.
e Greater flexibility under the license thereby reducing the number of applications for license amendments.
Background:
At the outset of its effort to revise the medical licensing process, the staff considered incorporating all routine uses of radiopharma-ceuticals into a general license. However, it became apparent that for typical nuclear medicine programs, the types and quantities of radionuclides employed and the manner in which they are used requires 3 pre-licensing assurance that certain key features have been properly addressed for safe nuclear medicine practice. The staff, therefore, developed streamlined specific license rules and an application form which focuses on key safety issues requiring pre-licensing confirmation while eliminating non-essential information. Since administration of radiopharmaceuticals under the present
. general license is much less than one percent of total nuclear medicine administrations and the number of users is very small, the general license has been eliminated to avoid operating a dual licensing and registration system. Physicians desiring to continue use of material for which they are authorized under the ? general license will be issued a specific license for those uses.
The rtaff estimates that no more than 50 of the 650 physicians registered for the general license will apply. The burden on those persons will be kept to a minimum. However, such physicians, previously exempt from provisions of 10 CFR 19, 20 and 21 will now be subject to those and to the provisions' of 10 CFR 35. Under the proposed rules, the applicant will develop (or adopt from a regulatory guide) safety procedures appropriate to the use of byproduct material that will be requested in the application. The applicant then completes Form NRC-313MH (in Enclosure 1) and mails it to NRC. When the application is received by the licensing
! section-it will be screened for completeness, accuracy and unusual requests. Deficient or unique cases will be referred to a technical
l l The Comissioners reviewer for action. The staff is in the process of adopting a computer-based management information system (MIS) to further increase the efficiency of the review process by aiding the staff in screening applications. An estimated 75 new medical standard licenses will be issued in the first year. Other specific licenses of limited scope will be converted to the new " standard" license at renewal time. This ' will allow a gradual conversion of all 2600 licensees. Specific licensees of broad scope (broad license) will not be converted to the standard license. The special needs of the broad licensee require that they continue to receive a case-by-case review. The Agreement States are in favor of the NRC approach of consolidating all essential safety requirements in the regula-tions and support this step. However, most Agreement States believe that the implementing procedures, which are required by the regulation to be established, should be submitted for review as a part of the application in order to achieve an adequate level of safety. They also believe that any revisions to the procedures should be submitted for review and approval. This regulation would not be made a matter of compatibility with the Agreement States because it deals with licensing procedures. Nevertheless, the States believe they will receive pressure from their licensees to adopt the NRC system. In formulating the method of implementing the rule, the NRC staff recognized that there may be a need for differences between NRC and Agreement State procedures. The staff does not believe that safety is compromised, but rather it is enhanced by the proposed revision because the regulations would become the primary source of requirements for the medical use of radioisotopes and would serve to regulate the daily use of material at medical facilities. The safety procedures then would set forth the detailed steps to be followed in order to satisfy the regulatory requirements. In its inspection and enforcement role the NRC would be concerned with I whether or not the requirements in the regulation are being met l and not with the details of the procedures used to meet them. Adoption of this concept permits significant simplification of the licensing process, thereby achieving important savings in resources by both NRC and its licensees. NRC may supplement its review with an early on-site post-licensing visit. Ability to do so is enhanced by decentralization. , l Substantial savings may be realized by NRC medical licensees as i described in the Value/ Impact Statement (Enclosure 3). Total savings for licensees resulting from all of the proposed changes in licensing could be $8,492,700 to as much as $11,906,500 per year. I 1 1
/
t The Commissioners i Recommendation: The concepts embodied in the proposed rule have been reviewed at meetings with committees of the Society of Nuclear Medicine, the Health Physics Society, the American Association of Physicists in i Medicine and informally with other professional groups such as the American College of Radiology and American College of Nuclear Physicians. Based on the verbal reaction of these groups there l appears to be a broad basis of support in the medical community. The Advisory Committee on the Medical Uses of Isotopes endorses - the proposed-rule. The Commission:
- 1. Approve a notice of proposed rulemaking (Enclosure 1) that would consolidate all human use requirements for the new !
medical standard license into 10 CFR Part 35. : Certify that this rule, if promulgated, will not have a negative economic impact on small entities since it is expected that the rule will result in substantial cost savings to licensees. .This certification is necessary to satisfy the requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
- 2. Note:
The rulemaking would be published in the Federal Register
~
a. for a 60-day public comment period;
- b. The staff conclusions, set forth in Enclosure 2, provide the analysis called for by the Periodic and Systematic Review of Regulations;
- c. Neither an environmental impact statement nor a negative declaration need be made in connection with this rulemaking because it is nonsubstantive and insignificant from the standpoint of environmental impact (Enclosure 3).
- d. The Chief Counsel for Advocacy of the Small Business Administration will be' informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act;
The Commissioners e. The proposed rule contains information collection requirements that are subject to review by OMB. Upon Commission affirmation, formal request for OMB review and clearance will be initiated;
- f. The Agreement States have requested that a representative
. designated by them be allowed to present their views on this proposal to the Comission when the Comission ,
meets to consider'the proposal.
- g. A public announcement (Enclosure 4) will be issued when the proposed rule is filed with the Office of the Federal Register; and
- h. The appropriate Congressional Committees will be informed (Enclosure.5).
- 1. Copies of the Federal Register notice of proposed rulemaking will be distributed to all Comission licensees. The notice will be sent to other inter-ested parties upon request.
1 Will m J. Dircks Executive Director for Operations
Enclosures:
- 1. Federal Register Notice of Proposed Rulemaking
- 2. Periodic.and Systematic Review
- 3. Value/ Impact Analysis
- 4. Draft Public Announcement-
- 5. Draft Congressional Letter Commissioners' comments or consent should be provided directly to the
. Office of the Secretary by c.o.b. Tuesday, March 1, 1983.
Commission Staff office comments, if any, should be submitted to the Commissioners NLT Tuesday, February 22, with an information copy to SECY. If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected. DISTRIBUTION: Commissioners EDO OGC ELD OPE ACRS SECY ASLBP REGIONAL OFFICES ASLAP' OCA l OIA , OPA
[7590-01] e NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 32, 35, and 40 HUMAN USES OF BYPRODUCT MATERIAL AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule. .
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to simplify the process for licensing medical uses of radioactive byproduct material. Theproposedrevisionwouldprimfrily affect future NRC licensing actions for hospitals, clinicsi~and individual physicians.
By clarifying and consolidating all essential safety needs now contained in license conditions, regulatory guides and staff positions, the proposed regulation provides a single source of human use requirements. This would reduce the' administrative burden on the licensee. The proposed regulation also provides the basis for a more efficient license application and review process that would conserve licensee and NRC resources. The 1 proposed revision to the regulations is needed to provide a more efficient method for licensing the medical uses of byproduct material. l DATE: Comment period expires (insert date 60 days from date of publication in Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments filed on or before this date. ADDRESSES: Submit written comments and suggestions to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Service Branch. Copies of the preliminary value/ impact analysis and the comments
-received-may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, D.C. Single copies of the preliminary i
value/ impact statement are available from Maureen Moriarty, Office of o 1 . 1 Enclosure.1 i
[7590-011 4 Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commis-sion,. Washington, D.C. 20555, Telephone: (301)427-4232. FOR FURTHER INFORMATION CONTACT: Dr. William Walker, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Telephone: (301)427-4232.
- SUPPLEMENTARY.INFORMATION: -
Uses of Byproduct Material in Medicine , Radioactive ma'erials t are used in drugs and sealed sources in the field of nuclear medicine. Drugs labeled with radioisotopes are known as radiopharmaceuticals. Patients receiv'e these materials by injection,
' inhalation, or oral administration. Physicians use specialized detecting equipment to visualize the distribution of a radioactive drug within an organ system in the body. Using this technology, it is possible to locate tumors and blood clots, measure physiological function, and monitor the. effectiveness of trea'tment. Larger quantities of radio-pharmaceuticals are administered therapeutically to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 15 to 20 million nuclear medicine procedures are performed in this country annually.
Sealed radioactive sources that produce high radiation fields are used in teletherapy units to treat cancer. Teletherapy units provide shielding and collimation to direct the radiation beam to the affected part of the patient's body. An estimated 2 million teletherapy treat-ments are performed annually by NRC licensees. Much smaller sealed sources are designed to be implanted directly into a tumor or applied on the surface of an area to be treated. This procedure, known as brachy-therapy, limits the radiatio ~n field to the affected area and spares healthy tissue from radiation damage. NRC licensees perform approximately 10,000 brachytherapy treatments annually. NRC's Role Twenty-six states have assumed responsibility for regulating certain radioactive materials by agreement with the NRC. They issue licenses for human uses of byproduct material. The NRC issues licenses to medical 2 Enclosure 1
[7590-01] facilities and individual physicians in non-Agreement States. These
' licenses define the use of radioactive materials for diagnostic and therapeutic medical procedures in' humans. During the past three decades, j
- the medical use of radioactive material has grown about 15 percent per year. NRC currently has 2,631 medical licensees. In 1981, NRC staff received 73 applications for new licenses, 244 license renewal applica-i tions, and 1,303 license amendment applications for a total of 1,620 licensing actions. .
NRC's Current Licensing Practices
; The current regulations in 10 CFR Part 35, " Human Uses of Byproduct Material," provide for general and specific licenses for human use'. The general license ($ 35.31) authorizes physicians to use small quantities of prepackaged individual doses of radioactive materials. Physicians simply submit a registration form to NRC and a validated copy with an assigned registration number is returned to the applicant.
Most medical institutions and physicians engaged in nuclear medicine i need more byproduct material than can be safely permitted by a general license. A specific license, which authorizes a larger inventory of byproduct material and a wider variety of uses, may be issued for one or more of six groups of human use (Groups I-VI, defined in the current S 35.100). These license applications are reviewed individually by NRC. Each group contains related diagnostic or therapeutic procedures. A separate specific license is also issued for use of teletherapy units. NRC has published many NUREG reports'and regulatory guides that con-tain radiation protection procedures applicable to specific licensees. These publications address three general areas: radiological health and safety, personnel training and experience, and facilities and equip-ment. Experience has shown that if licensees follow these procedures,- i the human uses of byproduct material generally do not pose a hazard to t workers and the public. j Problems'with Current Practice i The General License l J Issuing a general license for all in-vivo medical use of radioisotopes to qualified applicants would be the simplest approach for NRC and licensees. ; 3 Enclosure 1 1
[7590-011 It would not achieve the objective of maintaining an acceptable level of safety for the regulated industry. The concept of a general license assumes that the quantities and forms of the licensed material present such a low level of hazard that a case-by-case review of applications, on-site inspections, and periodic license renewals are unnecessary. The concept of a specific license, on the other hand, incorporates all three of these
~
features. For these reasons, materials that are now specifically licensed could not be adequately regulated unde'r a general license. - It is no longer necessary to have an in-vivo medical general license.
- The tests authorized under 6 35.31 have been superseded by new in-vitro procedures with more specificity and greater diagnostic accuracy. These developments have been reflected by a significant decrease in the medical community's use of the in-vivo general license.
Although NRC has on file 650 in-vivo general licenses under S 35.31, only five new applications were received by NRC in 1981. To determine the status of general license use, the staff performed a telephone survey by attempting to contact 10 percent of the current registrants. Less than j 9 percent of the current registrants still use material under a general
- license. Many have moved, are deceased or otherwise could not be located.
The staff has concluded that the general license no longer serves a useful role in licensing the human use of byproduct' material. l The Specific License A major problem with current licensing procedures is that radiation protection requirements are not located in one document. Currently guidance is scattered among several regulations, Inspection and Enforce-ment (IE) orders that modify a license or group of licenses, regulatory guides, technical reports (NUREGs), and as conditions attached to indi-
- vidual licenses.
. Suggestions for good practice contained in Regulatory Guide 10.8,
- " Guide for the Preparation of Applications for Medical Programs," and its 16 appendices and the bulletins issued by the NRC Office of Inspec-tion and Enforcement have come to be incorrectly perceived as regulations, t
I 4 Enclosure 1 4
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- ~.
g a - _ [7590-01] 4 The revision of Part 35 would correct the piecemeal fashion in which the regulations have been amended over the years to address specific problems. When preparing a specific license application for review under the
. current licensing procedure, the applicant must include sufficient information for NRC reviewers to conclude that all safety requirements for human use will be met. In addition, the applicant must describe the procedures that will be used to meet the requirement of the regulations.
, Therefore, applicants include copies of their procedures with their ,
applicationpackage. In many cases, the procedures are edited' versions of procedures described in Regulatory Guide 10.8. When NRC receives the application, a licensing reviewer evaluates
- the applicant's experience, facility, equipment, and procedures in detail. If the application is found to be deficient, a " deficiency letter" is sent to the applicant explaining what specific additional information is required. Review of the application is not resumed until the written response from the applicant has been received. Staff studies indicate.that about 40 percent of all applicants receive either a defi-ciency letter or phone call for additional information. However, in many cases, because of the conservative licensing and review practices, the letters frequently request clarification of information that does not involve significant matters of safety. Deficiency letters greatly increase the time required to complete licensing actions.
When the application, including any additional information, is approved, the NRC issues a specific license that grants the authority for human use of byproduct material. Requirements in addition to those contained in the regulations may be incorporated in the license as conditions of use. Since the licensee must conform with conditions specified in the license, the license also serves to regulate radiation safety in the day-to-day use of byproduct material. The specific license is valid for five years. Before uses, personnel, l or procedures may be changed, the license must be amended. Amendments to a specific license involve an application, review, and approval ' process similar to that for new licenses. Renewals are treated in the same manner as new license applications. 5 Enclosure 1 r 3, .--e c r. . . , - - _ _ . _ _ _ ~ . - ,- - _ _ . , , .r-., ._n,.,., - , _ _ - . , , ,,,.e - - _ ~ _ _ , . . _ _ . _ - . , _ _ ,
[7590-01] Proposed Procedural Approach and Supporting Rationale NRC intends to modify its regulation of the medical,use.of byproduct material. The Commission has a two-step plan: (1) revise the regulations to provide a single source of the requirements specifically related to human use of byproduct materials, and (2) revise the medical license rev.iew process. The latter step would allow use of an automated , management information system (MIS). '
! NRC's current license review process was appropriate for tHe early .
stage of technological development in nuclear medicine. At that time, radiation safety problems were not well defined, regulatory requirements had not caught up with developing technology, and training curricula had not been established. Therefore, it was necessary to review each - } individual program to ensure that the applicant had adequate personnel, l facilities, and equipment. The current review process is now becoming unnecessarily burdensome for both licensees and NRC. In deciding on the } proposed action, the staff recognized that past NRC policy has been to issue general licenses for materials in forms or quantities that present little or no hazard to the user or public. Specific licenses are issued when there is a need for continuing regulatory surveillance. The pro-posed revision of the licensing process also takes into consideration the following: (1) the safety technology is now more fully developed, ' (2) safety requirements are well defined and (3) several professional boards, which require extensive academic and clinical experience prior to certification, have become established. The proposed revision of 10 CFR Part 35 is consistent with the Commission's general policy on human use of byproduct material issued !' February 9, 1979 (44 FR 8242), which states "NRC will continue to regu-late the medical uses of radioisotopes, as necessary, to provide for the j radiation safety of workers and the general public." In proposing this revision, NRC seeks to ensure that the degree of regulation is commensu-
- rate with the risk posed to health and safety by the various medical i
- uses of byproduct material.
The procedural revisions primarily address problems that complicate the licensing process. They do not directly address radiation protection 1 6 Enclosure 1 i
[7590-01] issues. NRC believes that the nealth and safety of people involved in human use of byproduct material are.being adequately protected at present. Since most radiation protection practices will be unaffected by the revision, NRC fully expects th'e current level of health and safety protection required of medical licensees to be maintained under the revised regulations.
! NRC proposes to simplify the licensing process for medical licensees by transferring all human use requirements to 10 CFR Part 35. These .
4 regulations would become the prilery source of requirements for the
- human use of byproduct material and would serve to regulate the daily uses of radioisotopes at medical facilities. However, licensees would e
not face new regulatory burdens because, in most cases, these requirements currently appear as license conditions which must be met. I In conjunction with this effort the staff will revise Regulatory j Guide 10.8, " Guide for the Preparation of Applications for Medical Programs." The revised guide will contain procedures acceptable to the Commission for meeting the major requirements in the proposed regulations for human use. Licensees who wish to use alternative, but equivalent, i 3 procedures may do so. > i l NRC further proposes to simplify current licensing practice by } eliminating the requirement that applicants submit for review detailed 4 procedures describing how they intend to meet requirements in the regu- ; j lations. Licensees will still be required by the regulations, however, to establish and implement these written procedures and have copies available for NRC inspections. ! Since procedures would no longer be submitted to NRC for review, the practice of including these procedures as conditions of use on the license would be eliminated. This simplification would permit licensees , to modify procedures to meet NRC requirements without obtaining a license 4 amendment. In its inspection and enforcement role, NRC would be concerned ! with whether the requirements in the regulations are being met, not with the details of the procedures used to' meet them. A license amendment would still be required for changes in types of medical use or any l change in professional staff. Overall, the number of amendment requests is expected to decrease substantially as a result of this simplification. l 7 Enclosure 1
[7590-01]. Because lengthy procedural descriptions are presently affixed to licenses as conditions of use, applications can be 50 pages or more in
- length. Under the proposed approach, the licensee would operate the facility according to the requirements for human use in the regulations.
Day-to-day practices would be essentially unchanged under this scheme,
; but the volume of paperwork transferred between NRC and its medical , . licensees.and the volume of the license itself would be greatly reduced.
I Institutions that have broad licenses authorizing research and develop- . ment of human uses of byproduct material in addition to medical uses that are generally recognized as safe will still have to submit appro-priate procedures for review. Each will be exempted by license condi-
; tion from those sections of Part 35 that would unduly inhibit its medical ! research program. Broad license applicants who wish to be authorized for in-vitro and animal research under the authorization of the Radiation F l Safety Committee and human use as described in Part 35 will also continue f to be required to submit appropriate descriptions of procedures-for
] review in accordance with 10 CFR Part 33. i To summarize, placing all human use requirements in the regulations ' and eliminating submittal of procedure descriptions would expedite the ] licensing review process. NRC estimates that eliminating staff review of procedures would decrease the necessary review time by about 50 percent. l NRC estimates that the proposed simplifications would decrease the. rate l of deficiency letters for medical applicants by greater than 95~ percent. i This would result in a reduced process burden for NRC and faster turn-around time for licensees. Since the NRC processing time would be !
- reduced, NRC staff would have time to conduct postlicensing inspections j of medical applicants shortly after the start of operations, j NRC plans to modify an existing MIS to further increase the '
j efficiency of the review process. The MIS would be designed to decrease l delays in the licensing process caused by paperwork processing. It . } would aid the staff in their review of applications. Furthermore, the l l MIS can be used to compare application data with licensees of similar ; type and size. Unusual. variations will automatically be brought to the ( ) attention of the reviewer. This prelicensing audit capability would -l identify conditions that may warrant further evaluation ~of the l 1 i ( ' 1 I 8 Enclosure 1
[7590-01] 4 applicant's program by the reviewer. The MIS would provide for: ' (1) automated screening of applications for completeness and (2) an - automated data base management system that would permit preparation of descriptive statistics and evaluation of trends. These are impractical with the current manual processing and hard copy filing systems. The MIS would also benefit licensees by reducing delays in the review process. Although the MIS would enhance the improveaents of the proposed . j revisions, definite gains in efficiency would be made in ttae licensing i review process without modifying the existing MIS. However, it is estimated that review time could be reduced by an additional 10 days per application by using the MIS' combined with the other processing revisions. The time gained by NRC staff through the proposed simplifications would
- be focused on reducing the backlog of medical licensing actions and on evaluation of other safety issues.
Under the proposed revisions, the license would authorize medical use of byproduct materials. Licensees would be regulated by the require-ments for use specified in the regulations. This would simplify condi-4 tions for NRC inspectors because they would only need to be familiar l with one set of regulations rather than a different set of license I conditions and procedures at each facility. l 3 Scope of Revision of Human Use Regulations (10 CFR Part 35) : NRC is proposing a revision of the human use regulations to (1) provide the necessary changes to clarify and simplify the medical
- licensing process and (2) include staff resolutions of recent issues and j of petitions for rulemaking that pertain to medical licensees. Most of
{ the changes involve a transfer of a recommended practice or requirement from another NRC document to the regulations without modification of the f requirement itself. i Discussion of Proposed Regulations ) The primary purpose in initiating this revision to'the regulations i is to simplify the regulatory process by providing licensees with a , I single source of requirements for the human use of byproduct material. i I 9 Enclosure 1 ; i' ___ . ___ _ - __ _ _ - . _ . _ .- - . _ _ _ -. _ _._ - ._ -_ _ - _ . ~ - . _ . _ _- -- __ _
[7590-01]' Radiation protection procedures now contained in several existing regu-lations,' Inspection and Enforcement orders that modify a single license f or group of licenses, technical reports (NUREGs), standard conditions j of licenses, and regulatory guides would be consolidated into a concise , set of regulations. The requirements that apply to all licensees appear
- first, followed by the' specific requirements for each of the six basic j types of use. The provision for general licenses has been eliminated f
from the proposed regulations, and all human use will be specifically . licensed. (Current ~ general licenses will be incorporated in the - l specific license system. General licensees-will be limited to the ; j methods of use described in the current 6 35.31, and relieved from
- those provisions of the proposed Part 35 that are unnecessarily burden-ll some for those authorized amounts and methods of use.) The proposed j specific licenses differ from the current licenses because they would not specify addition'al requirements except in unusual cases.
- Items of general information, general administrative requirements, ;
and general technical requirements are addressed first. These are found j in Subparts A through C, respectively, of the proposed regulations. Subparts D through I contain the additional technical requirements that , j apply to licensees for each of the six types of human use. Subpart J lists the training and experience requirements for each type of use, and l j Subpart K lists the penalties for violations of the regulations. ! l In order to maintain consistency among the various parts of NRC's regulations, conforming amendments have been made to the affected sections ; !- of Parts 30, 32, and 40. These conforming amendments can be found I immediately after the revised Part 35. A section-by-section discussion j of the proposed revision of Part.35 follows: [ Subpart A--General Information l 6 35.1 Purpose and scope. l The regulations in this part apply to all persons licensed by the Commission to intentionally administer byproduct material or the ! radiation from byproduct material to humans, and to individuals working I under their supervision. < j i l I I 10 Enclosure 1 i
[7590-01] S 35.2 License _ required.
, This section requires that persons who handle byproduct material 2
have a license issued by the Commission or an Agreement State. The' Commission uses the specific licensing process to limit the use of byproduct material to applicants who have the equipment, facilities, training, and experience needed to ensure its safe use. Individuals who are working under the supervision of an authorized user do not need a license. This does not relieve them of the requirement to conduct their . work in accordance with requirements of the license and the regulations I of this chapter. The licensee remains responsible for the noncompliance
~
of such agents or employees, and may be subject to sanctions for failure j to comply.
$ 35.8 Reporting, recordkeeping, and application requirements:
OMB Approval. 4 Thisisection certifies that the Office of Management and Budget has reviewed and approved the information collection requirements contained i i in this part. i : { I i S 35.15 Definitions. ! ', The term " Agreement State" was included to identify those states that have agreed to assure the safe use of byproduct material within , their borders. ; The word "ALARA" was added to identify the acronym for the phrase ! ( "as low a's reasonably achievable."
- The term " authorized user" was added to identify individuals who
)
are identified by name on a license and who are authorized by the ;
- Commission or an Agreement State to administer byproduct material, or !
1 the radiation therefrom, to humans for medical care. ! l 4 The term " human use" was included to help identify the scope of l ! this part. The word " intentional" was added to the current definition i
~
of the term human use to make it clear that occupational and nonoccupa-tional exposures under the regulations of Part 20, accidental exposures, r i i 11 Enclosure 1 l
y . - - , . - -- - j , , [7590-01] and unwanted exposures from other sources of radiation (e.g., nuclear powered cardiac pacemakers, smoke detectors, and radioactive waste) are not considered human use. The word " institution" was added to identify organizations with medical byproduct Inaterial programs in which the safe use of byproduct material depends on the cooperation of individuals from several different departments. The word " management" was added to identify the individual responsible - for defining the licensee's policy and allocating personnel, budget, and space resources. The word " misadministration" was included to define those instances . t in which a mistake has been made in the human use of byproduct material. The definitions are consistent with the current S 35.41. 4 The term " mobile service" was added to describe the transport of byproduct material for the purpose of offering diagnostic nuclear medicine services at addresses other than the principal business address j of the licensee, i The word " output" was added to describe the amount of radiation in a teletherapy beam. The word " physician" was included to identify individuals licensed to practice medicine and therefore eligible to apply for a license to use byproduct _ material in the practice of medicine. The term " qualified teletherapy calibration expert" was included to replace the term " qualified expert" which is used in the current S 35.24. The new term better reflects the training, experience, and responsibilities of that individual. 4 The term " Radiation Safety Officer" was added to identify the individual identified by name on a license and who is responsible for managing the licensee's radiation safety program. The term " sealed source" was included to identify byproduct material i that is spocially encapsulated to prevent leakage or escape during use and storage. It is the same definition as used in S 30.4. i The term " visiting authorized user" was added to identify authorized users who, while working for a licensee on a temporary or occasional basis,
- use byproduct material under the restrictions of the temporary employer's license, which does not identify the visitor as an authorized user.
12 Enclosure 1
[7590-01] S 35.16 ' Application for license, and S 35.17 Amendments. The criteria that will be used by the staff to evaluate-requests for licenses, amendments, and exemptions are identified in S 35.28, License issuance, of this discussion of proposed regulations. S 35.16 Application for license. A physician in private practice may apply for a license. An indi-vidual physician may not apply for a license if his use of material is . in connection with the provisions of nuclear medicine services by an institution, i.e., an organization which provides various medical services. At an institution, only management may apply for a license. The individual physicians would be listed as authorized users. Thit requirement reflects the need for coordination with other employees who me not be under the administrative control of the authorized user. An application must be filed on Form NRC-313MH because it elicits informa-tion in an orderly, readable manner. It will also allow for uniformity in Commission information handling systems. This section also reflects the Commission's decision to delegate to Regional Administrators some of the licensing functions which, until recently, were conducted in the headquarters. This program was described in a Federal Register notice published May 27, 1982 (47 FR 23138). S 35.17 License Amendments. The Commission believes that, since exposures should be kept as low as reasonably achievable (ALARA), the licensee must obtain an amendment for any changes to the license that'might increase the potential for radiation to workers and the general public. The Commission has deter-mined that certain changes are potentially significant for the following reasons and thus will require an amendment: (1) A change in type of human use or receipt of byproduct material may increase radiation exposure. (2) The use of byproduct material at an address not identified on the license may allow an increase in unmonitored radiation exposure levels. (3) A change in either the individual listed as the Radiation Safety Officer, as an authorized user, or as the qualified teletherapy calibration expert requires an amendment request so that the Commission 13 Enclosure 1
- j. [7590-01]* ,
i i
- may determine that the training and experience of the new individual is i , sufficient to ensure safe use of byproduct material.
. (4) Any other program changes that might result in an increase of j radiation exposure to workers or the public requires an amendaent. t
- $ 35.18 Notifications.
A notification requirement was added to require the licensee to notify the_ Commission if an authorized user, Radiation Safety Officer (R50), or qualified teletherapy calibration expert'is no longer affiliated ; f with the licensee's byproduct material program. The NRC would no longer I be assured that the collective training and experience of the licensee's ! 1 t remaining personnel is adequate to assure the safe use of byproduct mate- + 3 t j rial for all the types of use authorized by the license. (For the pur- j j pose of-this statement of consideration, the term " type of use" refers
- to titles of Subparts 0 through I. For example, uptake, dilution, and j' excretion is a type of use. Imaging is a type of use.) The Commission f has made a judgment that notification within 30 days is sufficient.
[ Technicians who have worked under the supervision of the authorized ! l user can adequately assure the safe receipt and proper storage of j byproduct material for a few weeks. This parallels the Commission's j judgment that common carriers who handle byproduct material packages need not be licensed. However, over a longer period of time, absence ' of.an individual to oversee program responsibilities may increase the ' j- probability of an accumulation of unused byproduct material or unauthor-q ized use of restricted areas. This presents an unacceptable potential j
; hazard. !
$ 35.28 License issuance. 1
- The Commissicn has selected a license term of five years. A shorter j term would not benefit the public health and safety because medical
- programs do not generally change significantly over that period of time.
A shorter term may unduly interfere in patient care because the licensee i j) would spend an inordinate amount of time requesting renewals. Over a l ! longer term, the descriptive information submitted on.the application . may no longer accurately describe the scope of the byproduct material. l i program and resources available. ) i 14 Enclosure 1 ! i s .
[7590-01] i The applicant must use Form NRC-313MH because it was specifically designed to elicit the information the Commission needs to complete
- a safety review of the applicant. The Commission will apply certain standards when reviewing an application to assure that the safety of i workers ar.d the public will not be compromised if the license is granted.
I The staff must be assured that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property (S 30.33(a)(2)), and that the authorized users are qualified .
- by training and experience to use the material-for the purposes listed in the application in such a manaer as to protect health and minimize j danger to life or property (S 30.33(a)(3)), and that the applicant has i established procedures adequate to assure the safe use of byproduct
+
material. It is the sense of Congress that fees may be necessary to j recover operating costs. The Commission's discussion of this topic is j found in 36 FR 145, published January 6,1971. i S 35.29 Specific exemptions. l The Commission may allow exemptions from the requirements of this f part if the applicant can show the exemption will not compromise the
, health and safety of the' worker and public.
i l Subpart B--General Administrative Requirements , i S35.30 ALARA program. , An ALARA program is a management tool needed to assure that all
; reasonable efforts are made to assure the safe use of byproduct material in institutions. (See ' Management Organization and Administration for ALARA' by Kathren, Health Physics, Vol. 42, No. 2, February 1982,
- p. 119-131, and ' Radiation Safety in a Nuclear Medicine Department,'
by Gandsman et al., Health physics, Vol. 38, No. 3, March 1980, p. 399-408.) Many workers from different departments within an institution j might be occasionally exposed to byproduct material. The Commission l has made a judgment that a formal ALARA program is the only management tool that can assure that sources of radiation and work procedures are regularly reviewed for safety. Specific duties usually considered part
! of an ALARA program are required by SS 35.31 and 35.32.
j 15 Enclosure 1
[7590-01]. . S 35.31 Radiation Safety Committee. The propos,ed Part 35 requires institutional ' licensees to establish a Radiation Safety Committee to oversee the use of byproduct material. Under this proposal, committee membership must include a physician identified on the institution's license as an authorized user of byproduct material for each type of use permitted by the license, the institution's Radiation Safety Officer, a representative of the institution's management and a representative crf the nursing service. A similar requirement was . published as a proposed rule on April 9, 1979 (44 FR 21023). The NRC is not soliciting comments on the Radiation Safety Committee j rule of Part 35 because an opportunity to comment on the rule has already been provided in the recently completed rulemaking on the Radiation Safety Committee. That rulemaking will be incorporated in the final wording of Part 35. The Committee must revicw (1) the qualifications of each individual to be listed as an authorized user, and (2) each proposed method of use. This is to assure the safety of workers and the public. In its reviews, the committee should consider compliance with NRC regulations, special physical or chemical containment problems, the amount of byproduct material that will be used, and the relative hazard of the material. The committee must review occupational exposures quarterly. A more frequent review would inappropriately emphasize normal and expected statistical variations in exposure data. A less frequent review would allow an unnecessary or unnecessarily high exposure to continue ' uncorrected for an unacceptably long period. The quarterly review should be based on two trigger levels for individual exposures. The lower level would be a minimum level below which no action need be taken. Above the minimum level, the source of exposure should be determined and consideration given to reducing the I exposure. The higher level should trigger immediate intervention by the Radiation Safety Officer to reduce the exposure. The committee should review the appropriateness and completeness of the intervention, and should develop a permanent solution to maintain exposures at a lower level. 16 Enclosure 1
[7590-01] ] The annual review of the safety program should include the status j of current'use of all byproduct material. In the Commission's judgment, , a review at-least once each year is adequate to assure that exposures , remain ALARA considering the few program changes typically made during any single year. More time between reviews might not permit the committee to make timely recommendations for avoiding unnecessary worker or patient exposures; L , , S 35.32 Radiation Safety Officer. l An individual with special expertise is needed to coordinate the j safe use of byproduct material in accordance with the license and ! regulations. This is the Radiation Safety Officer (RS0). In S 35.32, { paragraphs (a) through (e) specify the RS0's safety responsibilities. ] 6 35.33 ~ Administrative Requirements for Authority and Responsibilities. l To assure that proper records are kept, responsibility for record-j keeping required by this part rests with the RSO and the committee. j Records that describe the licensee's receipt, use, and disposal of
- byproduct materal, equipment checks, and surveys must be kept. The ;
j licensee must also keep records that show that the RSO, the authorized ! users, and qualified teletherapy calibration expert meet the training 3 and experience requirements of Subpart J. These records may be either j copies of certifications by certifying bodies listed in that subpart, or I a transcript of appropriate training courses and a narrative of 'experi- I
- ence which together meet the appropriate requirements of Subpart J. For RSO's authorized users, and qualified teletherapy calibration experts !
! who do not have a certification, the preceptor's statement, form NRC-313M f j Supplements A and B which is appended to Regulatory Guide 10.8, ! constitutes an adequate record. t S 35.34 Visiting authorized user. l j In the Commission's judgment, the uninterrupted provision of j necessary medical services occasionally requires a visiting authorized user to work for a licensee for a limited period. The sixty-day limit j of S 35.34 will allow licensees to provide uninterrupted service at l I i i 17 Enclosure 1 l ) 4' a
[7590-01] 1 f times when its permanent staff may be unable to do so. Since the visit-ing authorized user has the required training and experience, public , health and safety will not be adversely affected at the visited medical i facility. Visits of more than 60 days in one year suggest that the l visiting authorized user is an integral part of the institution's health care delivery system, and should be identified as an authorized user on I the medical facility's license. *
$ 35.35 Mobile service administrative requirements.
Mobile service licensees are required to have a letter of permission j from the management of each client facility. This will assure that the j client management is aware of and in agreement with the human use of , j byproduct material within the facility. 1
- S 35.37 Records and reports of misadministrations.
The proposed Part 35 maintains the misadministration definitions } and reporting and recordkeeping requirements of the current Part 35. No ! changes have been made to these requirements. NRC is not soliciting comments on the misadministration requirements of the proposed Part 35 because they are identical to the requirements of the current Part 35. NRC is reviewing the misadministration requirements in a separate staff j i action. The public will have an opportunity to comment on any change to ' the misadministration requirements if and when a change is proposed. ) , S 35.38 Supervision. ! 1 The authorized user is qualified to use byproduct material in the ) practice of medicine. Frequently, specific. tasks may be delegated
- (under S 35.2(b)) to individuals with'less training and experience.
j Therefore, it is necessary that a qualified individual instruct them, ! oversee their work on a frequent basis, and be available to promptly respond in unusual or emergency situations. When using byproduct l material, supervised individuals must comply with instructions, t l procedures, and the regulations. i I
- 18 Enclosure 1 i
,--w.---.r.-w- - - - - . , - ~ - - , - , , - - - - - - - . - - - - - - , , - m.. ..-n- , , - - , - , - - - --n,,,---w--m,---, ,----,n. -
,--en-. .-.
[7590-01]- 1 S 35.49 Suppliers. The authorized users may use only radiopharmaceuticals that have been manufactured and distributed under procedures that were reviewed for safety by the NRC, the Food and Drug Administration (FDA), or an Agreement State. In certain institutions, the FDA has vested in a Radioactive Drug Research Committee (RDRC) (pursuant to 21 CFR 361.1) the right and responsibility to review for safety certain new radio-pharmaceuticals that are in the research stage. It is the Commission's . judgment that the, review criteria established by the FDA and followed by the RDRC are sufficient to assure the health and safety of the public and workers. Subpart C--General Technical Requirements S 35.50 Calibration and check of dose calibrators. Accuracy means the ability to exactly measure a specified quantity. Linearity means the ability to exactly measure a range of quantities. A dose calibrator must be tested for these characteristics to assure that the amount of material given is the prescribed amount. The American National Standards Institute (ANSI) recommends these test frequencies to assure the proper operation of dose calibrators. (See ANSI N42.13-1978.) The activity levels of the accuracy check sources were chosen because a lower activity would invalidate the accuracy test due to expected statis-tical fluctuations. To choose a higher activity would present an unnecessary source of radiation exposure to workers. The geometry test assures that the shape of the syringe or vial containing the byproduct material does not affect the dosage measurement. The daily constancy check assures that the dose calibrator has worked consistently since it was last tested. 5 35.51 Calibration and check of survey instruments. The 1000 mR/hr limit was chosen because that is the highest radiation exposure rate that is likely to be encountered in the medical environment. This calibration frequency is consistent with ANSI N323-1978 Section 4.7.1. 19 Enclosure 1
[7590-01T
$ 35.53 Measurement of Radiopharmaceutical Dosages. l This section requires that the licensee assay each radiopharmaceutical !
dosage before it is administered to a patient and keep a record of the , assay results. This procedure is currently required by all specific licenses for medical use of byproduct material to assure that the patient receives the intended dose. A similar requirement was published as a proposed rule on September 1, 1981 (46 FR 43840). The comment period on the proposed rule expired . November 30, 1981. Eighteen coments were received. t The NRC is incorporating the dosage measurement proposal in this revision. The proposed Part 35 dosage measurement requirement differs f' from the 1981 proposal only in its recordkeeping requirement. The Part 35 proposal requires the dosage measurement record to include the patient's name and identification number. This information is not required by the 1981 proposal. NRC invites comment on the requirement that dosage measurement records include patient information. NRC is not soliciting comment on other portions of the dosage measurement require- , ments because th'ye are substantively the same as the 1981 proposal. Comments received in response to the Part 35 revision and the 1981 dosage measurement proposal will be addressed in the statement of consideration published with the final rule revising Part 35. 5 35.58 Authorization for calibration and reference sources. ( These sources are needed to test the proper function of radiation ' safety instrumentation. They represent a small radiation hazard in rela- r tion to the amount of radioactivity used in patient care. The activity level was chosen to allow licensees to have a range of sources with several energies and half-lives available to fully test their equipment. l 5 35.59 Requirements for possession of sealed sources. , The user must follow the manufacturer's instructions becaust they have been reviewed for safety considerations by the Commission or an Agreement State. The six-month test interval is in the current regula- ! tions and has been recommended by the National Council on Radiation i 20 Enclosure 1 i
=
[7590-01] 1 , Protection and Measurements (NCRP)1 in Report No. 57, Instrumentation i and Monitoring Methods for Radiation Protection. More frequent testing , is inconsistent with ALARA considerations governing worker exposure I ) because it would cause occupational exposure with a negligible probability , j of finding a leaking source. Less frequent testing does not adequately ] assure safety. The test procedures described maximize the probability j of detecting contamination from a leaking source. Report No. 57, Sec-j tion 3.3.5.3 recommends a maximum permissible removable contamination . l l limit of 0.005 microcuries for sealed sourers. This level is consistent ! l with the requirements of other parts of the current regulations (see, ] for example, SS 31.5 and 34.25), and is only slightly higher than the . l minimum detectable activity exhibited by instrumentation available to j licensees. The Commission has made a judgment that this level provides j the most conservative detection level technically achievable at a ) { reasonable cost. The Commission has made a judgment that records l l retention for 3 years is sufficient to show the existence of a working ! l sealed source leak test program.- To conduct a physical inventory more ! i frequently is inconsistent with ALARA exposure goals. To inventory less ! j frequently may allow an unacceptable radiation exposure to go on for too l long without detection. The Commission has made a judgment that the l l } exempted sources do not present a contamination hazard because of the i j small amount of radioactivity in the sources, the method in which they [ l are constructed, the short half-life of the byproduct material, or the l j small hazard of the byproduct material. i l
$ 35.60 Syringe shields.
Syringes that contain byproduct material present an external radia- l 1 tion hazard and should therefore be shielded at all times. In some cases I' l' the use of-the shield could interfere significantly with the injection ! j of the material. Since this would limit patient benefit, the higher ! I L $ 4 I 1The National Council on Radiation Protection and Measurements (NCRP) r ! is a nonprofit corporation chartered by Congress in 1964 to draft pro- ! I posed recommendations on protection against radiation and radiation I ! measurements, quantitles, and units, particularly those concerned with , j radiation protection. {
- i I
j ' l j 21 Enclosure 1 'i l l I !
[7590-01] radiation exposure received by the technician in the absence of a shield is warranted. Where the harm from extravasation, for example, is greater than the benefit of reduced worker exposure, a shield need not be used. l 5 35.61 Vial shields. A vial radiation shield can significantly reduce the radiation exposure to the fingers and hands of an individual handling a vial of byproduct material. . SS 35.62 Syringe labels, and 35.63 Vial labels. Some misadministrations have been caused by accidentally transposing two vials or syringes. The proper labelling of containers will help to avoid this type of mistake. S 35.70 Surveys for contamination and ambient radiation exposure rate. Since radiopharmaceuticals are frequently handled, it is plausible that a syringe or some radioactive waste may be mislaid. This would - result in unnecessary radiation exposure to workers and the public. The survey will bring this problem to the attention of workers. The weekly survey of waste storage areas will ensure that exposure to workers in that area and to uncontrolled areas will be monitored and that special steps will be taken if greater than average use of radiopharmaceuticals results in higher than average exposure levels in the waste storage area. The Commission has made a judgment that records retention for one , year is sufficient to show the existence of a working survey program. S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. A patient whose body contains byproduct material is a potentially l hazardous source of radiation. While the Commission had considered release limits based on residual activity in the patient, it has made a judgment that exposure rate at a specified distance best measures the l relative radiation hazard from the patient. For iodine-131, the most common therapeutic radiopharmaceutical, the 6 mR/hr limit would result in a whole body dose equivalent to a co-worker or family member of about I l 22 Enclosure 1
[7590-01] 500 millirem, assuming that individual spends eight hours per day at an average distance of 1 meter from the patient. The Commission considered a lower limit that would require a longer period of patient confinement. The Commission has made a judgment that further reductions in public exposure are not reasonably achievable considering the potential for detrimental effect of an unnecessarily long hospital confinement. S 35.80 Mobile service technical requirements. - The Commission has limited mobile service licensees to transport.ing byproduct material as unit dosages because, at this time, there is insufficient assurance that the facilities and equipment needed to pre-pare bulk radiopharmaceuticals and perform quality control measurements can be frequently transported and still work reliably. The mobile service must remove all radioactive waste generated during the use of byproduct material at a client facility because it is unlikely that the client facility has a license to receive and process radioactive waste. The mobile service licensee must consider client facilities as unre-stricted areas because there is no assurance that the licensee can control access to areas of use while working in a facility that is under another person's administrative control. The equipment check required by 6 35.80(d) is necessary to assure the proper function of safety instrumentation and equipment after trans-port and before byproduct material is handled. The survey required by
$ 35.80(e) is to assure that all byproduct material has been removed from the location of use. The mobile nuclear medicine service must carry a calibrated survey meter to monitor exposure and contamination in case of a traffic or other accident that may result in a release of byproduct material. The Commission has made a judgment that records retention for one year is sufficient to show the existence of a workir.g exit survey program.
SS 35.90 Storage of volatiles and gases, and 35.205 Control of aerosols and gases. Some radiopharmaceuticals present an inhalation or immersion hazard (e.g., iodine-131 and xenon-133). That hazard can be minimized by 23 Enclosure 1
[7590-01]. storing these in a fume hood or double airtight barrier, and by using them with a collection or ventilation system.
$35.92 Decay-in-storage.
For most hospital waste, decay to background levels is essentially complete over a period of days or months. The requirements of S 20.301, directed primarily at longer half-lived material, are not necessary for short half-lived human use waste. Because the special handling required . for long half-lived material is typically not needed for human use waste, 6 35.92 exempts this waste from the requirements of S 20.301. A half-life of 65 days was chosen as the decay in storage half-life cutoff limit because storage in excess of 650 days is more appropriately con-sidered as permanent storage. Ten half-lives was chosen as a decay period because such a time period will assure that, in most cases, byproduct material will have decayed to levels below those in S 30.71, which are quantities that, under specific conditions, are exempt from a requirement for a specific license. Waste must be monitored to assure that long-lived waste was not accidentally mixed with short-lived waste. When the waste is monitored, neither the waste nor the survey instrument may have any radiation shielding. Shielding of the waste or detector might hide the presence of long-lived byproduct material in the waste. The Commission has made a judgment that records retention for two years is sufficient to show the existence of a working decay-in-storage program. Subpart 0--Group General /I (uptake, dilution, excretion)
$5 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies, and 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
Drugs approved for human use by the FDA have a label or package insert that specifies the FDA-approved use, physical form, route of administration, and dosage range. NRC relies primarily on FDA's deter-mination of a radioactive drug's safety and effectiveness when it-is used according to the package insert. By restricting the physician to the FDA-approved physical form, route of administration, and dosage 24 Enclosure 1 9
- - _ _ ~
-' ~
[7590-01] . A range, NRC assures the safety of the public while allowing the physician flexibility regarding the choice.of the clinical procedure. h Manufacturers are currently distributing general license
- radiopharmaceuticals under a license issued pursuant to section 32.70.
'If this revision is adopted by the Commission, these manufacturers would have to apply for a license amendment to distribute radiopharmaceuticals t pursuant to section 32.72.
Subpart E--Group II/III (imaging) S 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. Xenon-133 as a gas or saline solution has been added to this group.
-Manufacturers are currently distributing the product under a license issued pursuant to Part 30. If this revision is adopted by the Commis-sion, these manufacturers would have to apply for a license amendment to distribute xenon pursuant to section 32.72.
Through continuing medical research, new uses may be found for existing approved radiopharmaceuticals. These new uses, which may
, require a different dosage, route of administration, or physical form, may not appear on the manufacturer's label or package insert instructions.
It was such a situation that resulted in a petition filed by Dr. George V.
.Taplin (Docket No. PRM-35-1) requesting an exemption for Tc-19m pentetate aerosol used for. lung function studies. A proposed rule was published on April 13,1982 '(47 FR 15798). The commcnt period on this proposed ;
rule expired June 14, 1982, and 35 comments were received. The NRC is incorporating this proposed exemption into this revision of Part 35 ; without soliciting public comment because there are no substantive changes to the rule as proposed. Comments received on the proposed rul, will be addressed in the statement of consideration published with the final rule revising Part 35. S 35.204 Permissible molybdenum-99 concentration. When molybdenum-99 undergoes radioactive decay, clinically useful technetium-99m is produced. Occasionally, unwanted molybdenum appears in'the technetium solution.
^
25 Enclosure 1
- - _ . ._, _ _ _ _ , , _ . .._c. _. ._ .. . _ _ - . _
[7590-01] The permissible concentration of molybdenum-99 was chosen to be consistent with the permissible concentration listed in the United States Pharmacopeia (USP). The USP is the nationwide standard for all , pharmaceuticals used in the practice of medicine. It is the judgment of the Commission that to introduce a different standard would,'in this case, be confusing and unproductive. Since diagnostic dosages of technetium-99m are generally 30 milli-curies or less, the maximum permissible level of molybdenum-99 in such .
- a dosage would result in a patient receiving an undesired 4.5 microcuries of molybdenum-99. The molybdenum would be taken up primarily by the liver. The dose to the liver would be about 0.2 rads as a result of the molybdenum concentration. The Commission has made a judgment that this radiation dose is insignificant compared to the radiation dose which would be received by the patient due to the administration of the technetium.
r Subpart F--Grcup IV/V (radiopharmaceuticals for therapy) S 35.300 Use of radiopharmaceuticals for therapy. Drugs approved for human use by the FDA have a label or package insert that specifies the FDA-approved use, physical form, route of administration, and dosage range. NRC relies primarily on FDA's deter-mination of a radioactive drug's safety and effectiveness when used according to the package insert.
$$35.304 Safety instruction, and 35.405 Safety instruction.
In the hospital setting, the use of byproduct material presents special training problems which, in the judgment of the Commission, are not addressed in Part 19 because they are unique to the medical environ-ment. For example, visitor control in a hospital cannot be accomplished by physical barriers which might impede the delivery of emergency medical care. Also, after administration, the byproduct material is contained in an ambulatory human. Therefore, the Commission has made a judgment that worker instruction in addition to that required by Part 19 is i necessary. (This parallels special instruction required, for example, for radiographers and radiographer's assistants pursuant to 6 34.31 of i i Enclosure 1 t 26 o
-. -- - . - - ~ .- a,. , .-,
-[7590-01]
tnis chapter.) The Commission has also made a judgment that record
, retention for two years is sufficient to show the existence of a work-ing safety instruction program.
Subpart G--Group VI (sources for brachytherapy) S 35.400 Use of sources for brachytherapy.
- This section identifies brachytherapy sources that may be used in -
human use. The list was taken from the current S 35.100 Schedule A Group VI. . Tantalum wire has been added. 35.404 Release of patients treated with temporary implants. A responsibility of the Commission is to restrict the movement of byproduct material when the public exposure would be increased. Brachy-therapy sources for temporary implant have high levels of radiation, and remain radioactive for a long period of time. Loss of control of these sources and their release to unrestricted areas may result in potentially lethal radiation exposure to members of the public. The Commission has made a judgment that temporary confinement of the brachytherapy patient is necessary to-assure public safety. Section 35.404 requires that the licensee confine the patient until all temporary brachytherapy sources have been removed. The Commission has made a judgment that records retention for two years is sufficient to show the existence of a working source control program. Subpart H--Group VII (sealed sources for diagnosis) S 35.500 Use of sealed sources for diagnosis. This is a new use group established to incorporate the recent development of medical devices which use a sealed source of byproduct material to create a beam of ionizing radiation. These devices are currently available to persons licensed under. Group VI of the current Part 35. Since the devices represent a lower level of hazard than the other sealed sources in that group, the Commission has determined that
'these devices should comprise a new group.
27 Enclosure 1
[7590-01) Subpart I--Group VIII (teletherapy) S 35.600 Use of a sealed source in a teletherapy unit. This is a new use group established to acknowledge a well estab-lished medical procedure. Safety measures that apply to all licensees within the group have been used over the years and are reflected in i these proposed regulations. S 35.604 Information to be submitted with application. This requirement identifies the information needed to describe the unique characteristics of a teletherapy . installation. The plans, eleva-I tions, and shielding are needed to assure that the requirements of S 20.105 will be met. The interlock information is needed to assure against accidental exposure of workers and members of the general public. ' The viewing system is needed to monitor the orientation of the patient and the teletherapy unit, thereby assuring the safe exposure to radiation. S 35.605 Maintenance and repair restrictions. This section provides that only specially licensed persons may maintain, adjust, or repair teletherapy units.' S 35.606 Amendments. Amendments are required for items identified in paragraphs (a)
~
through (f) because any change described inEthese paragraphs could result in an increase in radiation levels in excess' of the levels auth-orized in S 20.105. The service of a qualified teletherapy calibration expert is a critical component in assuring the safe use of a teletherapy unit. The Commission has made a judgment that only an individual with proper training and experience can determine the operating characteristics of the licensee's teletherapy unit. S 35.610 Emergency instructions. Emergency instructions must be posted to remind individuals of the proper tasks'to be completed.in case of an emergency and to identify individuals to be notified in an emergency. 28 Enclosure 1
f [7590-01] S 35.620 Doors, interlocks, and warning systems. NCRP Report No. 57, " Instrumentation and Monitoring Methods for Radiation Protection," on page 42, states that a survey of a new tele-therapy facility must determine that'". . .All entrances into the irradiation room or other high radiation areas are provided with barriers equipped with interlocks that are not dependent on the operation of a single circuit, and that will interrupt radiation production when the barrier is opened." There have been incidents in irradiation facilities . in which personnel were unnecessarily exposed to radiation because door interlocks or alarms were intentionally bypassed for convenience. See, for example, cases 19, 21, and 28 in NUREG/BR-0001, " Case Histories of Radiography Events," vol. 1, 1980. If the interlocks and warning systems had not been bypassed, personnel would not have been irradiated. The Commission, however, has made a judgment that the dual warning system of a door interlock and a radiation monitor in the teletherapy room obviates the need for the dual circuit door interlock recommended in the report. S 35.621 Radiation monitoring device. The radiation. monitoring device is needed to indicate radiation levels in the teletherapy room in the event of the failure of the inter-locks or the warning system.- There have been a number of documented instances in which individuals have been unnecessarily exposed following the failure of the source retraction mechanism, coupled with a failure of the primary beam condition indicator system. Section 35.621 requires licensees to install a permanent radiation monitor in each teletherapy room, to check its operation before using the teletherapy unit, and to use a portable survey instrument or personal audible alarm dosimeter if the monitor is inoperable. Identical req'uirements were published as a proposed rule on April 28, 1982, (47 FR 18131). The NRC is incorporating the rulemaking on teletherapy monitoring. and servicing in this rulemaking on the revision of Part 35. NRC is not soliciting comment on the new teletherapy requirements of the proposed Part 35 because they are identical to the requirements of the earlier 29 Enclosure 1
[7590-01]. 1982 proposa', Comments. received in response to the Part 35 revision and the 1982 teletherapy monitoring and servicing proposal will be addressed in the statement of consideration published with the final rule revising Part 35. S 35.622 Viewing system. Occasionally a patient moves during a therapeutic administration. This could result in a 200 rad dose to healthy tissue. The viewing , system is needed to monitor the orientation of the patient and the teletherapy. unit, thereby assuring the safe application of radiation. S 35.630 Dosimetry equipment. Dosimetry equipment is needed to assure that the dose prescribed is the dose actually given. The equipment requirements are the same as the current 66 35.22 and 35.23. This section also contains the resolution of the petition filed by the American Association of Physicists in Medicine, Petition Docket No. PRM 35-2 (see 47 FR 4311; January 29, 1982). Currently, regulations require that primary dosimetry equipment be calibrated every two years. The petitioner requested this two year requirement be relaxed to four years if, at the two year mark, the primary dosimetry system is compared with a system which was calibrated within the past two years, and the results of-the comparison indicate-that the calibration factor used to convert an instrument reading to a dose measurement had not changed by more than two percent. Intercompari-son meetings are occasionally scheduled by several qualified teletherapy calibration experts within a geographic area. Each expert takes a dosimetry system to the meeting. Each dosimetry system is then exposed to the same radiation dose from a teletherapy unit. The response of
-each dosimetry system can then be compared to the response of the other systems. If each system measures the same radiation dose in rads, this provides assurance that each system is working properly. This suggestion has been incorporated into these proposed regulations. The petitioner also asked that the licensee be required to make quarterly constancy checks to assure the consistency of operation of the dosimetry system.
30 Enclosure 1
-- , - ,. .-. - . .n. . , . , - . . .,
[7590-01] The Commission did not incorporate this suggestion because the exposure rate indicated by constancy check devices may vary by as much as two percent even though the calibration factor for the dosimetery equipment has not changed. As a result, monthly constancy checks would not necessarily provide increased assurance of proper operation. S 35.632 Full calibration measurements. The required frequency of full calibrations remains unchanged from . that of the current Part 35. The test for timer accuracy has been. clarified to include on-off error. The accuracy of localization devices i which are used to position the teletherapy patient has been added to minimize the risk of unintentionally irradiating healthy tissue. The function of mechanical and electrical interlocks which are used to limit the directions in which the beam can be aimed has also been added. The licensee need no longer perform all measurements with a calibrated dosimetry system. Instead, the calibrated dosimetry system need only be used for one representative measurement, and then a relative exposure rate system can be used to complete the calibration. The exposure rate from a radioactive source goes down as time progresses due to source radioactive decay. To assure accurate dose delivery, the regulation requires that licensees mathematically take this into account in calculating patient doses. The regulation requires that the licensee use time periods of not longer than one month when making decay calculations. This will assure that the actual dose-does not differ from the calculated dose by more than'one percent due to this decay error. SS 35.633 Periodic spot-checks, and 35.642 Facility checks following installation of a source. A monthly spot-check is required by S 35.22 of the current regulations. The following changes have been made. Timer accuracy has been clarified to include on-off error. The accuracy of localization devices has been added. The qualified. teletherapy calibration expert must review the results of the spot-check measurements within fifteen days, and must notify the licensee in writing of the results of the 31- Enclosure 1 4'
. ~ , - _ _ - _ , , - ., - _- , . . , - , -v-,- _- ,
[7590-01]- monthly check. The purpose of this notification requirement is to assure the licensee and the Commission that the check results'were reviewed by a qualified individual. The Commission has made a judgment that the risk to the public health and safety over fifteen days is minimal. A requirement to check certain safety systems in the teletherapy
- facility has been added. These checks are needed to assure that safety-systems required by other sections of the regulations are working properly.
These checks need not be performed by the qualified teletherapy calibration , expert. Devices which are not working must be promptly repairea in order to assure the safety of the teletherapy facility. S 35 641 Radiation measurements following installation of a source. The Commission has used these maximum and average permissible source leakage radiation levels for several years as license conditions. They are consistent with guidance from the NCRP. See NCRP Report No. 33,
" Medical X-ray and Gamma ray Protection for Energies up to 10 MeV -
Equipment Design and Use," Section 4.2.2. The Commission has made a judgment that they are sufficiently restrictive to keep exposures as low as reasonably achievable. S 35.644 Reports following installation of a source. Given the potential for higher exposure to workers and the public, the radiation survey information required by Section 35.644 is needed to assure that teletherapy sources have been properly installed and are sufficiently shielded to assure compliance with the exposure limits of Part 20. S 35.645 Five year inspection. Many licensees replace teletherapy sources at five year intervals. Requiring a mechanical check at five year intervals helps to keep occupa-tional exposures as low as reasonably achievable. The mechanic who exchanges sources and inspects units can remove the source, inspect the drawer mechanism, and then install the new source. More frequent checks would require greater time near a very radioactive source. Less frequent l l 32 Enclosure 1
, ,_ . - - , - , e ,m , - - - - , - , -e .
r- - _ - - .
- - ._-. . . . . - - . . ._-_ . - . . =
[7590-01] checks would not be sufficient to assure the continuous proper operation of the exposure mechanism. The identification information in the record . is needed.to establish which unit was inspected, when, and by whom. The remaining information is needed so the Commission may determine that the i inspection was of sufficient depth to assure the health and safety of workers and the public. Subpart J--Training and Experience Requirements . A combination of theoretical.and practical training and experience is necessary to assure the safe use of byproduct material. The criteria in this subpart were developed by the staff with the advice of the Advisory Committee on the Medical Use of Isotopes (ACMUI). The require-ments for the Radiation Safety Officer have not been published before. The requirements for authorized users are similar to those published as an amendment to Appendix A of Regulatory Guide 10.8, " Guide for the q Preparation of Applications for Medical Programs," in the Federal Register on December 2, 1982 (47 FR 54376). The requirements for the Qualified Teletherapy Calibration Expert are similar to those required of a
- Qualified Expert-pursuant to the current 9 35.24.
95 35.900(a), 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.941(a), 35.960(a), and 35.961(a) concerning certification. The Commission has made a judgment that in some. cases, certifica-tion by an appropriate professional board constitutes proof of ade-quate training and experience because the criteria which must be met to i attain certification are more stringent than the training and experience required by the Commission. 1 5 35.900(b) Authorized user as a Radiation Safety Officer. The training and experience required by the Commission includes I safety considerations for the byproduct material that the au'thorized user may use. Therefore an authorized user is qualified to oversee the ] safe use of byproduct material that he is authorized to use pursuant to the conditions of the license. 33 Enclosure 1
[7590-01]' I S 35.900(c) Training within the last five years or-continuous involvement. Radiation safety regulations and practices may be expected to change with time. The Commission has made a judgment that training received within the preceding five years is sufficiently up-to-date to assure the safe use of byproduct material. If an individal received training more than five years prior to the application but has had continuing involvement-in the field, conformance with Section 19.12, Instructions - to Workers, assures that the individual has had continuing instruction in. radiation safety. 4 99 35.900(d) and (e), 35.910(b), 35.920(b), 35.930(b), 35.940(b), 35.941(b), 35.960(b), and 35.961(b) Training and experience. The criteria identified in these sections were developed by the staff with the assistance of the ACMUI over the past several years. The Commission has made a judgment that, for'each type of use, the training and experience described is necessary to assure the safe use of byproduct material. SS 35.910(c) and 35.920(c) Integrated programs. The Accreditation Council for Graduate Medical Education (ACGME) I reviews and approves training programs for physicians. Approval of these training programs-is based, in part, on adequate radiation safety content. The Commission has made a judgment that individuals who have successfully completed an approved training program have received
- sufficient training and experience to use byproduct material safely.
SS 35.901 and 35.970 Current radi_ation safety officers and authorized users. The staff has reviewed'and found acceptable the training and experience of each individua.1 who is currently listed as a radiation safety officer or an authorized user. Further review of the creden-tials of these individuals is unnecessary. 34 Enclosure 1 i (
[7590-01] 6 35.971 Three month training program. In addition to the ACGME, the American Board of Radiology, the American Board of Osteopathic Radiology, and the American Board of Nuclear Medicine review and approve nuclear medicine training programs for physicians. These three boards independently arrived at the conclu-sion that,' while currently acceptable, a three month training program may not allow sufficient time.in.the future to provide the training and experience needed to develop a satisfactory level of expertise in nuclear . medicine, including radiation safety. All three boards and the ACGME are therefore planning to require that, by August 31, 1987, training programs be of six months duration. The Commission has made a judgment that, in'the meantime, individuals who have successfully completed an approved three month training program have received sufficient training and experience to use byproduct material safely. DERIVATION TABLE-The following' derivation table indentifies the origin of each section of the proposed regulations. Sources of the proposed regulations include 10 CFR Parts 19, 30, and 35, Federal Register Notices (FR), frequently used license conditions, licensing staff policy, regulatory' guides (RG), Office.of Inspection and Enforcement bulletins, and the United-States Pharmacopeia, and new text prepared by staff. NEW SECTION NUMBER ORIGIN Subpart A--General Information 35.1 Purpose and scope. 35.1 revised 35.2 License required. 35.2 revised 35.8 Reporting, recording, and new text application requirements: OMB Approval. 35 Enclosure 1 t
~ .- -- - .. .. - . _ -. . ._ .
[7590-01]' 35.15 Definitions. ALARA acronym Authorized users term used on licenses Human use 35.3'(a) revised Institution new term i Management new term Misadministration 35.41 verbatim Mobile service new term - i
~0utput new term Physician 35.3(b) revised Radiation Safety Officer term used on licenses i
Sealed source 30.4(r) verbatim Visiting authorized user new term 35.16 Application for license. 35.4 revised 35.17 Amendments. new text; compare 30.38 35.18- Notifications. new text 35.28 License issuance. new text, compare 30.36 35.29 Specific exemptions. new text; compare 30.11 Subpart B--General Administrative Requirements 35.30 ALARA program. new text; see RG 10.8 Appendix 0 revised 35.31 Radiation Safety Committee. 35.11(b) revised 35.32 Responsibilities of the RG 10.8 Radiation Safety Officer. 35.34 Visiting authorized user. license condition 35.35 Mobile service administrative licensing policy requirements 35.37 Records and reports of 35.42 verbatim misadministrations. l 35.38 Supervision. expanded from RG 10.8 p'. 3 35.49 Suppliers. 35.14 revised 4 e 36 Enclosure 1
[7590-01] Subpart C--General Technical Requirements 35.50 Calibration and check of RG 10.8 Appendix D2 revised dose calibrators. ! 35.51 Calibration and check of RG 10.8 Appendix D1 revised survey instruments. 35.53 Measurement of radio- proposed rulemaking 35.15 pharmaceutical dosages. (46 FR 43840; September 1, 1981) - l 35.58 Authorization for calibration 35.14(d) revised and reference sources, j 35.59 Requirements for possession 35.14(e)(1)(i),35.14(f) 2 of sealed sources. revised 35.60 Syringe shields. Inspection and Enforcement 1 letter April 16, 1979 35.61 Vial shields. Inspectiun and Enforcement letter April 16, 1979 35.62 Syringe labels. n'w e text
- 35.63 Vial labels. new text 35.70 Surveys for contamination RG 10.8 Appendix I revised ,
J and ambient radiation , exposure rate. 35.75 Release of patients containing new text j radiopharmaceuticals or permanent implants. 35.80 Mobile service technical. licensing policy j requirements. - 35.90 - Storage of volatiles and gases. RG 10.8 Appendix M revised l 35.92 Decay-in-storage. license condition Subpart D--Group Gen' e ral/I (uptake, diluton, excretion) 35.100 Use of radiopharmaceuticals, 35.31 and 35.100 (I) revised
, for uptake, dilution, and excretion studies.
l
+
t i 37 Enclosure 1 1
- m - g-.,--- ,-
g._.,., , 7-,-,-e.-.. e --, ,,m , m, . . - - -- -,-.p. g.,,.y,., , n,me.m, , , . .m,
[7590-01]- i 35.200 Use of radiopharmaceuticals, 35.100 (II) and (III) revised-generators, and reagent kits for imaging and localization
. studies.
35.204 Permissible molybdenum-99. US Pharmacopeia concentration. 35.205 Control of aerosols RG 10.8 Appendix M revised I and gases. . Subpart F--Group IV/V (radiopharmaceuticals for therapy) 35.300 Use of radiopharmaceuticals 35.100 (IV) and (V) revised for therapy. 35.304 Safety instruction. 19.12 revised i Subpart G--Group VI (sources for brachytherapy) 35.400 Use of sources for 35.100 (VI) revised i brachytherapy. [ 35.404 Release of patients treated 35.14(b)(5)(vii) revised with temporary implants. 1
- 35.405 Safety instruction. 19.12 revised Subpart H--Group VII (sealed sources for diagnosis)
- 35.500 Use of sealed sources for. new text diagnosis.
Subpart I--Group VIII (teletherapy) 35.600 Use of a sealed source in new text a teletherapy unit.
- 35.604 Information to be submitted 30.33(a)(2) revised with application.
35.605 Maintenance and repair license condition restrictions. 35.606 Amendments. new text + 35.610 Emergency instructions.' license condition i 4 35.620 Doors interlocks license condition and warning systems. t 38 Enclosure 1
[7590-01] 35.621 Radiation monitoring license condition device. 35.622 Viewing system. license condition 35.630 Dosimetry equipment. 35.22, 35.23 revised 35.632 Full calibration 35.21 revised measurements. 35.633' Periodic spot-checks. 35.22 revised and license condition . 35.641 Radiation measurements license condition following installation of a source. 35.642 Facility checks following license condition installation of a source. 35.644 Reports following installations license condition of a source. 35.645 Five year inspection. license condition Subpart J--Training and experience requirements 35.900 Radiation Safety Officer, new text 35.901 Radiation Safety Officer new text Training Exception. 35.910 Training for uptake, Revision of Federal Register dilution, and excretion Notice (47 FR 3228; January 22, studies. 1982)
.35.920 Training for imaging and Revision of Federal Register localization studies. Notice (47 FR 3228; January 22, 1982 35.930 Training for therapeutic use Revision of Federal Register of radiopharmaceuticals. Notice (47 FR 3228; January 22, 1982) 35.940 Training for therapeutic Revision of Federal Register use of brachytherapy sources. Notice (47 FR 3228, January 22, 1982) 39 Enclosure 1
_ _ _ . _ _ . . - . . = . - - . - .. - .- _ __ -_ ._. .. - . _ _ _ [7590-01] 35'.941 Training for ophthalmic Revision of Federal Register use of strontium-90. Notice (47 FR 3228; January 22, 1982) 35.960 -Training for teletherapy. Revision of Federal Register Notice (47 FR 3228 January 22, 1982)
; 35.961 Training for qualified 35.24 revised teletherapy calibration .
expert. 35.970 Experienced physician training new text
- exception.
l 35.971 New physician training new text i exception. Subpart S--Enforcement 35.990 Violations. new text i i Paperwork Reduction Act The Nuclear Regulatory Commission will submit this proposed rule to the Office of Management and Budget (OMB) for any review that may be ' i necessary under the Paperwork Reduction Act, Public L. 96-511. The SF-83
" Request for Clearance," the Supporting Statement, and any other docu -
.; mentation submitted to OMB, have been placed in the NRC Public Document Room at 1717 H Street NW., Washington, D.C. 20555, for inspection, and copying for a fee. i i Certification Under the Regulatory Flexibility Act l Based on the information available at this stage of the rulemaking ; proceeding, in accordance with Section 605(b) of the Regulatory Flexi- ' bility Act of 1980, the Commission certifies that this proposed rule, if [ promulgated, will not have a significant adverse economic impact on a f substantial number of small entities. The NRC has issued approximately l l t i I i I 40 Enclosure 1 1 , 1 . t
.. . -- - _ . -= . _. - - _ . _ =
[7590-01] 1 2600 medica'i licenses under 10 CFR Part 35. Of these, approximately 2200 are held by institutions, and approximately 300 by individual physicians. Most of the institutional licensees are community hospitals that range in size from 75 bed facilities to 750 bed facilities. The Small Business Administration size standards,13 CFR Part 121, classify a hospital as a small entity if its capacity is less than 150 beds or if its gross annual receipts do not exceed $1.5 million. Under these size standards, a substantial number of NRC medical licensees could be - considered "small entities" for purposes cf the Regulatory Flexibility Act. Although the number of medical licensees that would fall into the small entity category constitutes a substantial number for purposes of I the Regulatory Flexibility Act, there should not be a negative economic impact on these small entities. The Commission believes that the proposed ' rule would result in cost savings to almost all licensees. The primary i objective of the proposed rule is to eliminate unnecessary administrative paperwork burdens on medical licensees by simplifying the licensing process without lessening the protection necessary to preserve publ.ic health and safety. This will be accomplished through incorporation of existing licensing amendments into the regulations, the elimination or modification of requirements that are not essential to the protection of public health and safety, by simplification of the licensing application form, and by establishment of a computerized licensing ~information system. These steps will not only make it easier for a licensee to determine what is required to obtain a license but should also substan-
- tially reduce the economic burden on medical licensees that is associated with the present licensing system.
The Commission has prepared a preliminary value/ impact statement for this proposed regulation. The preliminary value/ impact statement contains information concerrung the anticipated economic effect of this ' regulation on licensees and presents the basis for the Commission's belief that the proposed regulation would result in cost savings to all licensees. The preliminary value/ impact statement is available for public. inspection in the NRC Public Document Room at 1717 H Street NW., Washington,.DC. Single copies of the preliminary value/ impact statement { 41 Enclosure 1 i 1
[7590-01]> are available from Maureen Moriarty, Office of Nuclear Material Safety ' and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. Telephone: (301)427-4232. Because of the widely differing conditions under which licensees covered by this proposed regulation operate, the Commission specifically seeks public comment from small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the-Commission of this in a comment that indicates: (1) The licensee's size i,n terms of annual income or revenue, l
. number of employees and, if the licensee is a treatment center, the h number of beds and patients treated annually; r 1 (2) How the proposed regulation would result in a significant ; economic burden on the licensee as compared to that on a larger licensee; (3) How the proposed regulations could be modified to take into j account the licensee's differing.needs or capabilities; i
(4) The benefits that would be gained or the detriments that would be avoided to the licensee, if the propo' sed regulations were modified as suggested by the commenter; and } (5) How the regulation, as modified, would still adequately protect public health and safety.
- Environmental Impact - Negative Declaration
- The proposed rule, if adopted, would not result in any activity that significantly affects the quality of the human environment. The Commis-sion has determined that under the National Environmental Policy Act, and j the criteria in 10 CFR Part 51, an environmental impact statement is not
- required for this proposed rule.
The' environmental impact appraisal forming the basis for this deter-mination is available for inspection at the NRC Public Document Room, i 1717 H St, NW., Washington, D.C. i ; 1 i i 42- Enclosure 1 l r
, , - - - - - ,% --.. ,_ . . . - --,----y.~m- m-.-------.-m -,-. , , ,--. n- e,.,.- .- 3,--.y. .wrw-- *v-- ee,- -m --- - + ~e-w'. m + - - -
, _ . . = _ ._ _. ___ _. . - _ _. . _ _ _ _ _
[7590-01] t 4 i , List of Subjects in 10 CFR Parts 30, 32, 35 and 40 Rules of General Applicability to Domestic Licensing of Byproduct Material i Part 30 - Byproduct material, Government contracts, Intergovernmental
- relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting requirements. .
Specific Domestic License to Manufacture or Transfer Certain Items Containing Byproduct Materials . Part 32 - Byproduct .asterials, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting requirements. Human Use Of Byproduct Material Part 35 - Byproduct material, Drugs, Health devices, Nuclear materials, ~ Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements. Domestic Licensing of Source Material Part 40 - Government contracts, Hazardous materials - transportation, ] Nuclear materials, Penalty, Reporting requirements, Source material, Uranium. ! Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and section 553 of title 5 of the United States Code, notice is hereby given that adoption of the following revision of 10 CFR Part 35 and the following amendments to 10 CFR Parts 30, 32 and 40 is contemplated.
- 1. 10 CFR Part 35 is revised to read as follows: 1 PART 35--HUMAN USE OF BYPRODUCT MATERIAL i
Sec. Subpart A--General Information 35.1 Purpose and scope. l 35.2 License required. ' i 35.8 Reporting, recordkeeping, and application requirements:
~0MB approval.
, 43 Enclosure 1 i ;
. -- . -. ._ ~ . . _ - _ . - ._ . _ . -
[7590-01] 35.15 Definitions. , 4 35.16 Application for license, amendment, or renewal. ! 35.17 License amendments. 35.18 Notifications. 35.28 License issuance. ! 35.29 Specific exemptions. i Subpart B--General Administrative Requirements , 35.30 ALARA program. l 35.31 Radiation Safety Committee. 35.32 Radiation Safety Officer. 35.33 Administrative requirements for authority and responsibilities. 35.34 Visiting authorized user. 35.35 Mobile service administrative requirements. 1 1 35.37 Records and reports of misadministrations. 35.38 Supervision. 35.49 Suppliers. Subpart C--General Technical Requirements 35.50 Calibration and check of dose calibrators. j 35.51 Calibration and check of survey instruments. 35.53 Measurement of radiopharmaceutical dosages. 35.58' Authorization for calibration and reference sources. 1 35.59 Requirements for possession of sealed sources.. i 35.60 Syringe shields.
- 35'.61 Vial shields.
t
~35.62 Syringe labels. *
- 35.63 Vial labels. '
35.70 Surveys for contamination and ambient radiation exposure rate. 35.75 Release of patients containing radiopharmaceuticals or permanent implants. ] 35.80 Mobile service technical requirements. ' j 35.90 Storage of volatiles and gases.
- 35.92 Decay-in storage.
i l 44 Enclosure 1
- i
. [7590-01]
Subpart D--Group General /I (uptake, dilution, excretion) 35.100 Use of radiopharmaceuticals for uptake, dilution, and excretion studies. , Subpart E--Group II/III (imaging) 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. ' 35.204 Permissible molybdenum-99 concentration. . i 35.205 Control of aerosols and gases. Subpart F--Group IV/V (radiopharmaceuticals for therapy) 35.300 Use of radiopharmaceuticals for therapy. 35.304 . Safety instruction. 'i Subpart G--Group VI (sources for brachytherapy) 35.400 Use of sources for brachytherapy. 35.404 Release of patients treated with temporary implants. 35.405 Safety instruction. 1 Subpart H--Group VII (sealed sources for diagnosis) i 35.500 Use of sealed sources for diagnosis. Subpart I--Group VIII (teletherapy) , 35.600 Use of a sealed source in a teletherapy unit. 35.604 Information to be submitted with application. l 35.605 Maintenance and repair restrictions. I 35.606 Amendments.
; 35.610 Emergency instructions. '
j 35.620' Doors, interlocks, and warning systems. l 35.621 Radiation monitoring device. ] 35.622 Viewing system. j 35.630 Dosimetry equipment.
! 35.632 Full calibration measurements. -
35.633 Periodic spot-checks.
- 35.641 Radiation measurements following installation of a source.
j i 45 Enclosure 1
'k [7590-01]
- e. .
] 35.642 Facility checks following installation of a source. 35.644 Reports following installation of a source. '
- i. 35.645 Five year inspection.
i Subpart J--Training and experience requirements l'
- 35.900 Radiation Safety Officer. .
l 35.901 Radiation safety officer training exception. 35.910 Training for uptake, dilution, and excretion studies. . I 35.920 Training for imaging and localization studies. 35.930 Training for therapeutic use of radiopharmaceuticals.
- 35.940 Training for therapeutic use of brachytherapy sources.
l 35.941 Training for ophthalmic use~of strontium-90. '
; 35.960 Training for teletherapy.
- 35.961 Training for qualified teletherapy calibration expert.
] 35.970 Experienced physician training exception. j 35.971 New physician training exception. ;
! I j Subpart K--Enforcement ; 35.990 Violations. -
i 4 Authority: Secs. 81, 161, 182, 183, 60 5 tat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, ! as amended by Pub. L. 94-79, 89 Stat. 413 (42 U.S.C. 5841). For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. ; 2273); SS 35.2, 35.17, 35.30(a)-(c), 35.31(a)(1)-(a)(3), 35.31(b), 7 35.32,35.33,35.34(a),35.38(a),35.38(c)-(e),35.49,35.50(a)-(c), 35.51(a)-(d),.35.53(a) and.(b), 35.59(a)-(c), (e)(1) and (h), 35.60, i 35.61,35.62,35.70(a)-(c),35.75,35.80(a)-(e),35.90,35.92(a)(1)-(4), . 35.100, 35.200, 35.204(a) and (b), 35.205, 35.300, 35.400, 35.404(a),
- 35.500, 35.600, 35.605, 35.606, 35.620, 35.621(a)-(d), 35.621(f) and
- - (g), 35.622, 35.630(a) and (b), 35.632(a)-(f), 35.633(a)-(i), 35.641(a) p and (b), 35.642(a) and (b), 35.645(a) and (b), 35.900, 35.910, 35.920, ,
j 35.930,.35.940, 35.941, 35.960, and 35.961 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and SS 35.18,35.30(d), l l 46 Enclosure 1 9
~. . , . . _ _ . . - __... _ _ _ . . _ . _ _ . _ . _ _,-... _-. ._.. - _ _ _ _ .-.,,- . _ . . . -.
[7590-01] 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. This part prescribes requirements for issuance of specific licenses authorizing the human use of byproduct material. This part also pre-scribes requirements for the human use of byproduct material in order to provide for the protection of the public health and safety. The provi-sions and requirements of this part are in addition to, Ond not in substitution for, other requirements of this chapter. The requirements and provisions of Parts 19, 20, 21, 30, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted. 6 35.2 License required. (a) No person shall manufacture, produce, acquire, receive, possess, 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 in S 35.38, unless prohibited by license condition. f 35.8 Reporting, recordkeeping, and application requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget for approval as required by the Paperwork Reduction Act (Pub. L. 96-511). OMB approved the information collection requirements on 47 Enclosure 1
<- -n -
[7590-01]- c
- (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
$9 35.16, 35.18, 35.30(d), 35.31(a), 35.32(f), (h) and (i), 35.33(b),
i 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), 35.80(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). 6 35.15 Definitions.
" Agreement State" means any State with which the Commission or the
- Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as' amended.
"ALARA" means as low as reasonably. achievable.
! " 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.
" Human use" means the intentional internal or external !
I
- administration of byproduct material, or the radiation therefrom, to i
human beings.
- i " Institution" means an organization in which several medical
! disciplines are practiced. i
" Management" means the chief administrative officer of a licensee.
j " Misadministration" means the administration of: (1) A radiopharmaceutical or radiation from a sealed source other 4
.than the one intended; j (2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administration
~
l ] 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;
- I (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 .
l 48 Enclosure 1
.----,,.,s- , m ,' w er oe------,--r--e,~~-re .v+~--w-n.,-,--ee--e-- e ----r- r-~ ---- , y v,-mew - ,,-e---v ~->-s-s , *e- ny
[7590-01] result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent.
" Mobile service" means the transportation and use of. byproduct material for human use and for checks and tests of equipment used in conjunction with human use by the licensee.
" Output" means the exposure- rate, dose rate, or a quantity related in a 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 identified on the license that identifies the physician as an authorized user.
S 35.16 Application for license, amendment, or renewal. An application for a license, a license amendment, or the renewal of a license for human use of byproduct material as provided by this part must be made by filing Form NRC-313MH, " Application for Materials License--Human Use." For use by an institution, only management may apply. For use outside an institution, any physician may apply. The 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
[7590-01]- (1) Mail the completed application form to'the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 1 Washington, D.C. 20555, or (2) Deliver the completed application form to the Commission offices at: (i) 1717 H Street, N.W., Washington, D.C., or (ii) 7915 Eastern Avenue, Willste Building, Silver Spring, Maryland. (b) If the applicant is not a Federal agency and is located in . Connecticut, Delaware, Maine, Massachusetts, New Jersey, 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 applicant shall mail cr deliver the completed application form to U.S.
; Nuclear Regulatory Commission, Region III, Material Licensing Section, l 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
i l 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
[7590-01] 6 35.18 Notifications. The licensee shall notify the ' Commission in writing on Form NRC-313MH 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. 6 35.28 License issuance. . The Commission shall issue a license for the human use of byproduct material for a term of five years if: (a) The applicant has filed Form NRC-313MH " Application for Materials License--Human Use"; (b) The applicant has paid any applicable fee as provided in Part 170 of this chapter; (c) The Commission finds the applicant equipped and committed to
. observe the safety standards established by the Commission for the protection ~of the public health and safety; and q (d) The applicant meets the requirements of Part 30 of this chapter.
6 35.29 Specific exemptions.
.The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this part as it determines.are authori7.ed 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 Ad'ainistrative Requirements 6 35.30 ALARA program. (a) Each institutional licensee shall establish a program to maintain individual and collective dose equivalents as low as reasonably achievable. (b) To satisfy the requirement of paragraph (a) of this section: (1) Management, the Radiation Safety Officer, and all huthorized users must participate in the establishment, implementation, and operation of the program. 51 Enclosure 1
l
.,- [7590-01]-
\3 (2) The program must include a periodic review of byproduct material use, and continuing education and training for all personnel who work with or in the vicinity ~of byproduct material. The review and education must assure that individuals make every reasonable effort to maintain individual and collective occupational dose equivalent as low'as reason -
~
ably achievable, taking into account the state of technology, and the cost of improvements in relation to b.enefits. (c) The licensee shall keep a written description of the ALARA . l , program for the duration of the license. The written description must include: (1) A commitment by management to keep individual and collective dose equivalents as low as reasonably achievable; (2) A requirement that the Radiation Safety-Officer brief management once each year on the byproduct material program; (3) Personnel exposure investigational levels that, when exceeded,
,, , will initiate an investigation of the cause of the exposure by the Radiation Safety Officer; and l (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.
I ,. requirements. To satisfy this requirement: (a) The committee must meet the following administrative ' ^ requirements: (1) Membership must consist of at least three individuals and must include an authorized user for each type of use permitted by the license, the Radiation Safety Officer,'a representative of the-nursing service, 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.
4 i 52 Enclosure 1 i
[7590-01] 9 (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 Radiation Safety Committee meeting must include:
* (i) The date of the meeting; (ii) Member's 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. l (b) To oversee the use of licensed material, the Committee must: (1) Be responsible for monitoring the institutional program to
,, maintain individual and collective doses as low as reasonably achievable; f (2) Review on the basis of safety and approve or disapprove any individual who is to be listed as an authorized use'r or the Radiation )
Safety Officer prior to the license application or application for amendment; f (3) Review and approve or_ disapprove on the basis of safety 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 E '<cause and subsequent actions taken;
.(6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety-prograq v d (7) Establish a table of iwnie s ional levels.for occupational dose equivalents that when exceeded, wi,( initiate investigations and considerations of action by the Radiation Safety Officer.
I l s 53- Enclosure 1
, ___ ____.- si
[7590-01]. 1 35.32 Radiation Safety Officer. Each institutional licensee organization shall appoint a Radiation Safety Officer who is responsible for establishing and maintaini.ng 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 tha 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 , exposed individuals have exceeded investigational levels; and (c) Assisting and advising the Radiation Safety Committee in performing those functions specified in S 35.31(b). S 35.33 Administrative Requirements for Authority and Responsibilities. (a) The licensee shall provide the Radiation Safety Committee and Radiation Safety Officer sufficient authority and organizational freedom to: (1) identify radiation safety problems; (3) initiate, recommend or provide solutions; and (3) verify implementation of solutions. (b) The licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Committee and Radiation Safety Officer. To satisfy the requirements of this section, in addition to-the functions specified in SS 35.31 and 35.32, the Radiation Safety Committee or Radiation Safety Officer must perform or ensure performance of the following functions: . (1) Authorizing the purchase or receipt of byproduct material and its distribution; (2) Establishing written policy and procedures for disposal of all byproduct material;
-(3) Establishing and ensuring implementation of written procedures for:
(i) Emergency actions; (ii) Periodic radiation surveys; (iii) Periodic inventory of byproduct material; 4 54 Enclosure 1 _ ~ _ ._ _
[7590-01] 1 (iv) Safety during use of byproduct material; (v) Performance checks of safety equipment and-survey instrumentation; and (vi) Training of personnel.
.(4) Establishing and implementing a radiation safety education program for personnel working in or frequenting areas where. byproduct material is used and stored; (5) Maintaining records to show compliance with the training and .
experience requirements of St bpart J of this part, which includes: (1) For the Radiation Safety Officer, a photocopy of that indivi-dual's certificate as listed in S 35.900 or a completed Form NRC-313M-Supplement A; (ii) For the Qualified Teletherapy Calibration Expert, a photocopy of that individual's certification as listed in 6 35.961 or a completed Form NRC-313M-Supplement A; and (iii) For each authorized user, a photocopy of that individual's license to practice medicine, and either a photocopy of a certification that is listed as appropriate'for the types of use in which the-authorized user is engaged, a completed Form NRC-313M-Supplement A or 8, or a photocopy of an NRC or Agreement State license issued by (** insert effective.date of final rule **) that identifies the individual as an I authorized user for the types of use in which the authorized user is engaged; and
.(6) Establishing and maintaining a recordkeeping system for records I
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 S 35.31(b). S 35.34 Visiting authorized user. (a) A licensee may permit any visiting authorized user to use licensed 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 licensee's management and, if such-use occurs on behalf of an institu-J tion, the institution's Radiation Safety Committee; 55 Enclosure 1
[7590-01] (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 administrative requirements. (a) The Commission will only license mobile service in accordance with Subparts 0, E and H of this part and 9 31.11 of this chapter. (b) Mobile service licensees shall maintain a letter authorizing use of byproduct material signed by the management of each location where services are rendered.
- 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 D of Part 20 of this chapter. The licensee 4 shall also notify the referring physician of the affected patient and the patient or a responsible relative (or guardian), unless the referring physician personally informs the licensee either that he will inform the patient or that, in his medical judgment, telling the patient or the patient's responsible relative (or guardian) would be harmful to one or the other, respectively. These notifications 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 l them as soon as practicable. The licensee ~is not required to notify the j patient or the patient's responsible relative or guardian without first l consulting the referring physician; however, the licensee shall not delay medical care for the patient because of this.
56 Enclosure 1 il y -r -m wr-- y-w-- - + , - ,m
[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 shal1 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. Licen~see 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 1 patient. i (d) Each licensee shall maintain for Commission inspection records of all misadministrations of radiopharmaceuticals or radiation from I 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). 57 Enclosure 1 9
- ,- , - - - - - , -e, .
[7590-01] S 35.38 Supervision, j The licensee who permits the receipt, possession, use, or transfer-
~
of byproduct material authorized by an individual under the supervision
- f. of an authorized user as authorized by 6 35.2(b) shall:
radiat af t a opr at to at nd du ' u e of uct 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-1 able to the supervised individual on one hour's notice. The supervising authorized user need not be present for each use of byproduct material. l (b) Require the supervised individual receiving, possessing, using i or transferring byproduct material under S 35.2(b) to: (1) Follow the instructions of.the. supervising authorized user; (2) Follow the procedures established by the Radiation Safety Officer pursuant to S 35.32; and . (3) Comply with the regulations of this part with respect to the use of byproduct material. 6 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-l tions in Part 30 and $$ 32.72, 32.73, or 32.74 of this chapter or-t equivalent regulations of an Agreement State; (b) Reagent kits that have been manufactured, labeled, packaged, i 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 l (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. 4 58 Enclosure 1 [ j: _. m- . . _ ~ - ~ _ _ . ,___._ _._ - - _ _ _
[7590-01] Subpart C--General Technical Requirements 9 35.50 Calibration and check of dose calibrators. (a) The licensee shall: (1) Check each dose calibrator for constancy daily prior to use.
~
To satisfy the requirement of this paragraph, the check must be done on a frequently used setting with a sealed source of not less than 10 micro-curies _of radium-226 or 50 microcuries of any other gamma-emitting . radionuclide; (2) Test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, and whose activity is at least 10 microcuries for radium-226, and 50 microcuries for any other gamma-emitting radionuclide; (3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the highest dose administered and 10 microcuries; and (4) Test each dose calibrator for geometry dependence upon installation over the range of volumes and configurations for which it is normally used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator. (b) The licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator. (c) The licensee shall mathematically correct readings for any error in excess of 10 percent if the dose is greater than 10 microcuries and the radiopharmaceutical emits a photon with an energy greater than 25 key. (d) The licensee shall keep records of the checks and tests required by this section for two years unless directed otherwise. (1) The record required in paragraph (a)(1) of this section must include the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the 59 Enclosure 1 f
[7590-01]- check, the activity measured, and the initials of the individual who performed the check. (2) The record required in paragraph (a)(2) of this section must include the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the signature of the Radiation Safety Officer. (3) The record required in paragraph (a)(3) of this section must . include the model and serial number of the dose calibrator, the calcu-lated activities, the measured activities, the date of the test, and the signature of the Radiation Safety Officer. (4) The record required in paragraph (a)(4) of this section must include the model and serial number of the dose calibrator, the configu-ration of the source measured, the activity measured for each volume measured, the date of the test, and the signature of the Radiation Safety Officer. 6 35.51 Calibration and check of survey instruments. (a) The licensee shall calibrate survey instruments annually and
; following repair; < , (b) To satisfy the requirements of paragraph (a), the licensee shall:
J (1) Calibrate all scale readings up to 1000 milliroentgens per hour; and 1 (2) Calibrate two readings on each scale that must be calibrated; j and
, (3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration and the date of calibration.
(c) To satisfy the requirements of paragraph (a) of this section, , the licensee may: (1) Consider a point as calibrated if the indicated exposure rate
~
differs from the calculated exposure rate by not more than 10 percent; and 60 Enclosure 1 f
[7590-01] (2) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent if a correction chart or graph is conspicuously attached to the instrument. (d) The licensee shall check each survey instrument for function with the dedicated check source before and after each use. The licensee is not required to keep records of these function checks. (e) The licensee shall keep a record of each calibration required in paragraph (a) above for the duration of use of the instrument. To . satisfy the requirements of this paragraph, the record must include: (1) A description of the calibration procedure; and (2) A description of the source radionuclide used and its esti-mated activity. 6 35.53 Measurement of radiopharmaceutical dosages. The licensee shall: (a) Assay before human use the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a radionuclide that-emits electromagnetic radiation in the form of gamma rays or x rays. (b) Assay before human use the activity of each radi: pharmaceutical dosage with a desired activity of 10 microcuries or less of a radionuclide that emits electromagnetic radiation in the form of gamma rays or x rays 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. 6 35.58 Authorization for calibration and reference sources. Any person authorized by 6 35.2 for human use of byproduct material may receive, possess, and use byproduct material in sealed sources manufactured and distributed by a person licensed pursuant to S 32.74 of 61 Enclosure 1 f .
. . . -. - _ - _. . . . = - .-
~
[7590-01]' this chapter.or equivalent Agreement State regulations for check, cali-bration, and reference use if such sources do not exceed 6 millicuries each, f 35.59 ~ Requirements 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 l the source was tested within six months prior to transfer to the licensee; and (2) Test the source for leakage at intervals not to exceed six , months unless the manufacturer has indicated that the source has been j approved by the Commission or an Agreement State for leak testing at longer intervals.
- (c) To satisfy the leak test requirements of this section, the i licensee must
I (1) Take the test sample from the sealed source or from the
- . surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate; (2) Take the test sample from a teletherapy source with the source in the "off" position; and l (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 l more of removable contamination, the licensee shall: 62 Enclosure 1 _' l
[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 D of Part 20 of this chapter, with a copy to Director of Inspec-tion and Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, describing the equipment involved, the test results, and the . corrective action taken. (f) The licensee need not perform a leak test on the following sources: (1) Sources containing only byproduct material with a half-life of
-less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage prior to any use or transfer unless it has been leak-tested within six months prior to the date of use or transfer; (5) Seeds of iridium-192 encased in nylon ribbon; (6) Sources containing only hydrogen-3; (7) Wires of iridium-192; and (8) Wires of tantalum-182.
(g) Any licensee in possession of a sealed source shall conduct a quarterly physical inventory of all sealed sources in the licensee's possession. The licensee shall keep inventory records for two years. The inventory records must contain the model and serial number of each source,.the identity of each source radionuclide and~its estimated activity, the location of each source, and the signature of the Radiation Safety Officer. (h) Any licensee in possession of a sealed source shall survey with a low range survey meter quarterly all areas where sealed sources are stored. (1) 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 *
[7590-01] Y the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area expressed in millirem per hour, the model number and serial number of the survey ' instrument used to make the survey, and the signature of the Radiation Safety Officer. j S 35.60 Syringe shields. l (a) The licensee shall keep syringes that contain byproduct mate- . i
- rial to be administered in.a radiation shield.
(b) The licensee shall require each individual who administers a radiopharmaceutical by injection to use a syringe radiation shield unless the use of the shield is contraindicated for that injection. S 35.61 Vial shields. The licensee shall require each individual preparing or handling a vial that contains'a radiopharmaceutical to keep the vial in a vial radiation shield. 6 35.62 Syringe labels. The licensee shall conspicuously label each syringe radiation shield that contains a syringe with a radiopharmaceutical to be admini-stered with the radiopharmaceutical abbreviation or type of diagnostic study or therapy procedure to be performed. 9 35.63 Vial labels. The licensee shall conspicuously label each vial radiation shield l that contains a vial of a radiopharmaceutical to be administered with the chemical name or its abbreviation. 6 35.70 Surveys for contamination and ambient radiation exposure' rate.
, (a) The licensee shall survey with a low range survey meter at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.
(b) The licensee shall survey with a' low range survey meter at least once each week all areas where radiopharmaceuticals or radio-pharmaceutical waste is stored. 64 Enclosure 1 fl
.-.,,..e , , - - - .. . . - - - - -
-- - . . . - _ . r - , - ..r,- -
[7590-01] ' (c) The licensee shall survey for removable contamination once each week all area where radiopharmaceuticals are routinely prepared for 4 use, administered, or stored.
; (d) 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 i was surveyed, the measured exposure rate at several points in each area t expressed in millirem per hour or disintegrations per minute, the model ; number of the instrument used to make the survey to analyze the samples, [ and the initials of the individual who performed the survey. ! i
; 9 35.75 Release of patients containing radiopharmaceuticals or permanent h l implants.
The licensee shall not authorize release from confinement for medical care of any patient administered a radiopharmaceutical or permanent ! l ' implant until the exposure rate from the patient is less than 6 milli- , l roentgens per hour at a distance of one meter, i 6 35.80 Mobile service technical requirements. i A licensee providing mobile service shall: j (a) Transport to each location of use only syringes or vials ! containing unit doses of prepared radiopharmaceuticals; . (b) Bring into each location of use all byproduct material to be l used and, before leaving, remove all unused byproduct material and all ( t associated waste; ! 9 (c) Secure or keep under constant surveillance and immediate 3 l control all byproduct material; [ [ (d) Check equipment transported to the location of use as described j in SK 35.50 and 35.51, prior to human use- I (e) Carry a calibrated survey meter in each vehicle that is being t l used to transport byproduct material, and survey for ambient r'adiation l exposure rate with a low range survey meter prior to departure from the ! location of byproduct material use; and (f) Keep a record of the surveys required in subsection (e) for i 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 l
, 65 Enclosure 1 _,' ;
-- . , - - _ , = - -. . _-_
[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. 35.90 Storage of volatiles and gases. The licensee shall store volatile radiopharmaceuticals and radioactive gases in a fume hood or in a container with two airtight barriers against release. . 6 35.92 Decay-in-storage. (a) The licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of S 20.301 of this chapter if the licensee: (1) Holds byproduct material for decay a minimum of ten (10) half-lives; (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 generator column individually without any shielding to ensure decay to background radiation level prior to disposal. (b) For paragraphs (a)(1) and (a)(2) of this section, the licensee shall keep a record of each disposal for two years. The record must include the date of the disposal, the date on which the byproduct material was stored, the model number of the survey instrument used, the background radiation level, and the name of the individual who performed the disposal. Subpart 0--Group General /I (uptake, dilution, excretion) 6 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies. (a) The. licensee shall use the following prepared radiophar-maceuticals for diagnostic studies involving the measurement of uptake, 66 Enclosure 1
[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 (IHSA), labeled rose bengal, or sodium iodohippurate; (2) Iodine-125 as sodium iodide or iodinated human serum albumin (IHSA); (3) Cobalt-58 as labeled cyanocobalamin; . (4) Cobalt-60 as labeled cyanocobalamin; (5) Chromium-51 as sodium chromate or labeled human serum albumin; (6) Iron-59 as citrate; (7) Technetium-99m as pertechnetate; (8) Any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion authorized by the Food and Drug Administration (FDA), or by the 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) of this section for a. clinical procedure other than one specified in the product labeling or package insert instructions for use shall comply with the product labeling or package insert instructions regarding physical form, route of administration and dosage range. Subpart E--Group II/III (imaging) 6 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. (a) The licensee shall use the following radiopharmaceuticals, generators, and reagent kits for imaging and localization studies in accordance with the product labeling or package insert or other manu-facturer's instructions for use, except as provided in paragraphs (b) and (c) of this section: (1) Molybdenum-99/ technetium-99m generators for the elution or extraction of technetium-99m as pertechnetate; (2) Technetium-99m as pertechnetate; 67 Enclosure 1 .,
[7590-01],
, t
) (3) Prepared radioph'armaceuticals and reagent kits for the l 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; , j (viii) Human serum albumin; t (ix) Medronate sodium; l (x) Gluceptate sodium;
- (xi) 0xidronate sodium; (xii) Disofenin; and j (xiii) Succimer.
k (4) Tin-113/ indium-113m generators for the elution of indium-113m as choride; (5) Iodine-131 as sodium iodide, iodinated human serum albumin, j macroaggregated iodinated human serum albumin, colloidal (microaggregated) j iodinated human serum albumin, rose bengal, or sodium iodohippurate; (6) Iodine-125 as sodium iodide or fibrinogen; (7) Chromium-51 as human serum albumin; (8) Gold-198 in colloidal form; (9) Mercury-197 as chlormerodrin; (10) Selenium-75 as selenomethionine; (11) Strontium-85 as nitrate; , ! (12) Ytterbium-169 as-pentetate sodium; i (13) Indium-113m as chloride; (14) Xenon-133 as a gas or saline solution; , (15) Any byproduct material .in a radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing byproduct material authorized by the Food and Drug Administra-tion or by the licensee's Radioactive Drug Research Committee that h'as been. approved by the FDA pursuant to 21 CFR 361.1. l (b) The licensee using the radiopharmaceuticals listed in j paragraph (a) of this section for clinical procedures other than those i 68 Enclosure 1 _~
[7590-01] specified in the product labeling or package insert shall comply with the product labeling or package insert regarding: (1) Physical form; (2) Route of administration; and (3) Dosage range. (c) The following radiopharmaceuticals, when used for the listed
~c linical 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. 6 35.204 Permissible molybdenum-99 concentration. (a) The licensee shall not administe. to humans a radiopharmaceuti-cal containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m; (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 test results for two years. The record must include, forseach 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. 9 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 f Y
[7590-01] Subpart F--Group IV/V (radiopharmaceuticals for therapy) 6 35.300 Use of radiopharmaceuticals for therapy. 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 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. 9 35.304 Safety instruction. (a) The licensee shall provide oral and written radiation safety instructions for all personnel caring for the patient undergoing radio-pharmaceutical therapy. To satisfy this requirement, the instructions must describe procedures for: (1) Patient control; (2) Visitor control; (3) Contamination control; and (4) Waste control. (b) The licensee shall keep for-two years a list of individuals receiving instructions required by paragraph (a) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction. - 70 Enclosure 1 f i
[7590-01] Subpart G--Group VI (sources for brachytherapy) I 6 35.400 Use of sources for brachytherapy. The licensee shall use the following sources for therapeutic purposes in accordance with the product labeling, package insert, or other manu-j facturer's instructions for use: - (a) Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer; . (b) Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer; (c) Gold-198 as a sealed source in seeds for interstitial treatment of cancer; j (d) Iridium-192 as seeds encased in nylon ribbon or as wire for interstitial treatment of cancer; (e) Strontium-90 as a sealed source in an applicator for~ treatment of superficial ' eye conditions; (f) Iodine-125 as a sealed source in seeds for interstitial treatment of cancer; and (g) Tantalum-182 as wire. 6 35.404 Release of patients treated with temporary implants. (a) The licensee shall not release from confinement for medical
- care a patient treated by the temporary implant of a source listed in S 35.400 until a source count and a radiation survey of the patient confirm that all implants have been removed.
(b) The licensee shall keep a record of source counts and patient surveys for two years. Each record must include the name of the patient, the number of sources implanted, the number of sources removed, and the exposure rate from the patient expressed as millirem per hour and measured within one meter of the patient. i 1 6 35.405 Safety instruction,. (a) The licensee shall provide written radiation safety instruc-tions to all individuals caring for the patient undergoing brachytherapy. 71 Enclosure 1 fl
-, , - , . , , - m -- , - - - _ _ - r-w., - v ------ e- --,-r- , -
,-r-i-
[7590-01]. To satisfy this requirement, the instructions must describe procedures for: (1) Patient control; and (2) Visitor control. (b) The licensee shall keep for two years a list of individuals receiving instructions required by paragraph (a) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction. . Subpart H--Group VII (sealed sources for diagnosis) 6 35.500 Use of sealed sources for diagnosis. 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) 6 35.600 Use of a sealed source in a teletherapy unit. The regulations and provisions of this subpart govern the use of teletherapy units that contain the following sources for the treatment of humans: (a) Cobalt-60 as a sealed source; and (b) Cesium-137 as a sealed source. 6 35.604 Information to be submitted with application. The applicant shall supply such information deemed necessary by the Commission to determine the safety of the teletherapy facility. This includes, but is not necessarily limited to plans and elevations, shield-ing information and calculations, and descriptions of interlocks, viewing systems, and other safety systems. 72 Enclosure 1 f
-_ .. _ ~ _ __.. _ . _ _ _ - . . - . _ . _ _ _ _ _ . .
[7590-01] . 6 35.605 Maintenance and repair restrictions. Only a person specifically licensed by the NRC or an Agreement State to perform teletherapy unit maintenance and repair shall maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels. < 6 35.606 Amendments. . The licensee shall apply for and must receive a license amendment Il prior to: (a) Making any change in the treatment room shielding; I (b) Making any change in the location of the teletherapy unit within the treatment room; (c) Using the teletherapy unit in a manner that could result in l increased radiation levels in areas outside the teletherapy treatment I 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 I j perform the duties of the qualified teletherapy calibration expert. i e 6 35.610 Emergency instructions. : t l The licensee shall post written emergency instructions at the ; teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of: f (a) The procedure to be followed to ensure that only the patient l is in the treatment room before turning the primary beam of radiation !
- on; ,
(b) The procedure to be followed should the operator be unable to turn the primary beam of radiation off with controls outside the treatment i room; and ' (c) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted in the event of any abnormal operation of the teletherapy unit or console. ; i 5 73 Enclosure 1 ,'[ i y
[7590-01] 6 35.620 Doors, interlocks, and warning systems. l (a) The licensee shall control access to the teletherapy room by a I door at each entrance. 4 (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 i
on unless each treatment room entrance door is closed;
, (2) Turn the primary beam of radiation off immediately when an .
entrance door is opened; and (3) Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance 2 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. 1 S 35.621 Radiation monitoring device.
! (a) The licensee shall install a permanent radiation monitor in ,
each teletherapy room capable of continuously munitoring beam status. (b) Each radiation monitor must be capable of providing visible notice of a teletherapy malfunction that may result in an exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual entering the teletherapy room. (c) Each radiation monitor must be equipped with an emergency l 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 licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor 74 Enclosure 1 ,
'I [7590-C'] 4 for any malfunction of the source exposure mechanism that may result
. in an exposed or partially exposed source. The instrument or dosimeter must be checked for proper operation at the beginning of each day of use.
(g) The licensee shall promptly repair or replace the radiation monitor if it is inoperable. 6 35.622 Viewing system. The licensee shall construct or equip each teletherapy room to' . permit continuous observation of the patient from the teletherapy unit
; console during irradiation.
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 the previous two years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months 4 by the National Bureau of Standards or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine. 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 f y - - -e:- - -- - w.--, - - g n n ,-mr ,m-, ,4 - - , , - - , , , ,we-, ,
1 [7590-01]. j dosimetry systems to be used for' calibrating cesium-137 teletherapy units.
, (b) The licensee shall have available for use a dosimetry system I 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 1 performed within the previous year and after each servicing that may
; have affected system calibration. The spot-check system may be the same .
- j. system used to meet the requirement in paragraph (a) of this section.
(c) The licensee shall maintain a record of each calibration,
; intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instrument that
, were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factors that were deduced, and the names of the individuals who performed the calibration, intercomparison, or comparison. j f 35.632 Full calibration measurements.
- (a) Any licensee authorized to use a teletherapy unit for treating I
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 human's under the following conditions: l (i) Whenever spot-check measurements indicate that the output i differs by more than 5 percent from the output obtained at the last full
; calibration corrected mathematically for physical decay; j (ii) Following replacement of the source or following reinsta11ation of the te;1etherapy unit in a new location; (1', f ) Following any repair of the teletherapy unit that includes I
removal of the source or major repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding one year. (b)' To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of: I 4 i 76 Enclosure 1 ._' i
[7590-01] (1) The output within 13 percent for the range of field sizes and for the range of distances used in radiation therapy; (2) The coincidence of the radiation field and the field indicated by the light beam localizing device; (3) The uniformity of the radiation field; (4) Timer accuracy; (5) On-off er-or; 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 6 35.630(a) to measure the output for one set of exposure conditions. l 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 Bioloqy Vol. 16, No. 3, 1971, pp. 379-396, which has been approved for incorporation by reference by
[ the Director of the Federal Register. Copies of the document are avail-able for inspection or may be obtained from the U.S. Nuclear Regulatory Commission, Public Document Room, 1717 H Street NW, Washington, D.C. 20555. A copy of the document is also on file at the Office of the Federal Register, 1100 L Street NW., Room 8301, Washington, D.C. 20408. A notice of any change in the material will be published in the Federal, Register. (e) The licensee shall correct mathematica,lly 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 i expert. ] (g). The licensee shall keep a record of each calibration for the duration of the license. The record must include the date of the cali-bration, the model number and serial number of the teletherapy unit, the 1 77 Enclosure 1 f
-m... ,...,. , - - - - . , ,--~-...n, - - - --
[7590-01]. model number and serial number of the ins'truments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a radiograph of a single field with the location of the light field indicated on the radiograph, the measured timer accuracy for a typical treatment time, the calculated on off error, the estimated accuracy of each distance measuring or localization device, and the
. signature of the qualified teletherapy calibration expert. .
1 . 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; l (5) The output for one typical set of operating conditions; and l (6) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output,. expressed as a percentage of l the anticipated output (i.e., the value obtained at last full calibration ! corrected mathematically for physical decay). (c) The licensee shall use the dosimetry system described in 6 35.630(b) to make the measurement required in paragraph (b)(5) of this section. (d) The licensee shall perform measurements required by paragraph (a) l 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 l 78 Enclosure 1 _~
[7590-01] 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 assure 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 two years. The record must include the date of the spot-check, the model number and serial number of the teletherapy unit, the model number and serial number of the instrument used to measure the output of. the teletherapy unit, the measured time accuracy, the calculated on-off error, a radiograph of a single field with the location of the light field indicated on the radiograph, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, the difference between the anticipated
+ 79 Enclosure 1 f i
. -[7590-01].
i output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition _ indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot-check. 6 35.641 Radiation measurements following installation of a source. (a) Before human use and after each installation of a teletherapy source, the licensee shall perform radiation surveys to verify that: . (1) The maximum and average radiation levels at one meter from the teletherapy source when in the off position do not exceed 10 milliroentgens per hour and 2 milliroentgens per hour, respectively; and (2) With the teletherapy source in the on position with the largest ., clinically available treatment field and with a phantom in the primary beam of radiation, i (i) That radiation quantities in restricted areas adjacent to the treatment room are not likely to cause personnel exposures in excess of the' limits specified in S 20.101 of this chapter, and (ii) That radiation quantities in unrestricted areas adjacent to the treatment room do not exceed the limits specified in S 20.105(b) of this chapter. (b) If the results of the surveys required in paragraph (a) of this section indicate any radiation quantity in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the off position and not use the unit: (1) Except as may be necessary to repair, replace, or test the teletherapy unit shielding or the treatment room shielding; or
- , (2) Until the licensee has received a specific exemption pursuant to 9 2.0.501 of this chapter.
.(c) The licensee shall maintain a record of the radiation measurements made following installation of a source for the duration of the license. The record must include the date of the measurements, the model number and serial number of the instrument used 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_ area that was surveyed, the measured exposure rate at several point's in each area expressed in millirem per hour, the calculated 80 , Enclosure 1 f 4
[7590-01] maximum quantity of radiation over a period of one week for each . restricted and unrestricted area, and the signature of the Radiation Safety Officer. 6 35.642 Facility checks following installation of a source. (a) The licensee shall promptly test all systems listed in S 35.633(g) for proper function after each installation of a teletherapy source. . (b) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in S 38.633(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. 6 35.644 Reports following installation of a source. The licensee shall mail copies of the results of the surveys and 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 each installation of a teletherapy source: (a) The Material Licensing Branch, Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, and (b) The appropriate U.S. Nuclear Regulatory Commission Regional Office listed in Appendix D of Part 20 of this chapter. S 35.645 Five year inspection. (a) The licensee shall have each teletherapy unit fully inspected and serviced during teletherap source replacement or at intervals not 81 Enclosure 1 f
-- -- - g -
[7590-01]. 4 to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism. (b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State. (c) The licensee shall keep a record of the inspection and servicing for the duration of the license. The record must contain'the inspector's name, the inspector's license number, the date of inspection, the model number and serial number of the teletherapy un.it, a list of components . inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector. Subpart J--Training and Experience Requirements
! 6 35.900 Radiation Safety Officer.
I Except as provided in 6 35.901, the licensee shall require an indi-j vidual fulfilling the responsibilities of the Radiation Safety Officer 4 as provided in 6 35.32 to: (a) Be certified by: (1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or (3) American Board of Nuclear Medicine Science in Nuclear Medicine Science; or (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 licurs 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 f
[7590-01] Radiation Safety Officer on a Commission or Agreement State license that authorizes-the human use of byproduct material. (d) The training and experience specified in paragraph (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. S 35.901 Radiation safety officer training exception. An individual identified as a Radiation Safety Officer on a Commission or Agreement State license on (*** insert effective date of final rule ***), who oversees only the use of byproduct material for which the licensee was authorized on that date, need not comply with the training requirements of 6 35.900. 6 35.910 Training for uptake, dilution, and excretion studies. Except as provided in SS 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical listed in g 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 Radiology; or (3) Diagnostic radiology or radiology by the American Osteopathic 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 of radioactivity; (4) 20 hours of radiation biology; and (5) 30 hours of radiopharmaceutical chemistry; or 83 Enclosure 1 f
_ [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. . . S 35.920 Training for imaging and localization studies. Except as provided in.S 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit listed in 6 35.200(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 Radiology; or (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or (b) Have completed 200 hours of instruction, 500 hours of supervised work experience and 500 hours of supervised clinical experience in 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; (iii) 20 hours of mathematics pertaining to the use and measurement of radioactivity; (iv) 20 hours of radiopharmaceutical biology; and (v) 30 hours of radiation chemistry. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution ar,d 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 diagnostic instruments and performing survey meter checks for proper operation; (iii) Calculating and safely preparing patient doses; (iv) Using administrative controls to prevent the misadministration of byproduct material; (v) Using emergency procedures to handle and contain spilled . byproduct material safely and using proper decontamination procedures; and (vi) Eluting technetium-99m from generator systems, assaying and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals. (3) To satisfy the requirement for supervised clinical experience, training must be under the supervision of an authorized user at an institution and must include: (i) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations or contraindications; (ii) Selecting the proper radiopharmaceutical and dosage; (iii) Administering doses to patients making proper use of syringe radiation shields; (iv) Calculating the radiation dosage and collaborating with the authorized user in the interpretation of radioisotope test results; and (v) Patient followup; or (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, 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. 85 Enclosure 1 _'
[7590-01], I 9 35.930 Training for therapeutic use of radiopharmaceuticals.
, Except as provided in 6 35.970, the licensee shall require the authorized user of a radiopharmaceutical listed in 6 35.300 for therapy to:
(a) Be certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; or (2) Radiation oncology by the American Osteopathic Board of Radiology; or . (b) Have completed 80 hours of instruction, and have had supervised clinical experience in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals. (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 dysfunction in 10 individuals; (ii) Use of soluble phosphorus-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. i l l 1 86 Enclosure 1 _- e
i [7590-01] S 35.940 Training for therapeutic use of brachytherapy sources. Except as provided in 6 35.970, the licensee shall require the , authorized user using a brachytherapy source listed in S 35.400 for ! therapy to: 1 (a) Be certified in: i (1) Radiology or therapeutic radiology by the American Board of I Radiology (2) Radiation oncology by the American Osteopathic Board of f; Radiology-(3) Radiology, with a specialization in radiotherapy, by the ! British Faculty of Radiology or the British Royal College of Radiology; f or (4) Therapeutic radiology by the Canadian Royal College o.f Physicians and Surgeons; or (b) Have completed 200 hours of instruction and 500 hours of { supervised work experience in basic radicisotope handling techniques l applicable to the therapeutic use of. brachytherapy sources and a period ! of supervised clinical experience. f (1)~ To satisfy the~ requirement for instruction, the classroom and r laboratory training must include. [ (i) 110 hours of radiation physics and instrumentation; ! (ii) 40 hours of radiation protection; I (iii) 25 hours of mathematics pertaining to the use and measurement ; of_ radioactivity; and i (iv) 25 hours of radiation biology. ; i (2) To satisfy the requirement for supervised work experience, : training must be under the supervision of an authorized user at an institution and must include: (i) Ordering, receiving, and unpacking radioactive materials
)
safely and performing the related radiation surveys; (ii) Checking survey meters for proper operation; (iii) Preparing, implanting and removing sealed sources safely; 87 Encicsure 1 f; l i
[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 Radiology of the Accredi-tation Council for Graduat'e Medical Education, and two years of clinical . experience in therapeutic radiology under the supervision of an authorized user at an institution. 9 35.941 Training for ophthalmic use of strontium-90. Except as provided in 6 35.970, the licensee shall require the authorized user using only strontium-90 for ophthalmic radiotherapy to: (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 supervised clinical traini~ng in ophthalmic radiotherapy. 4 (1) To satisfy the requirement for instruction, the classroom and laboratory training must include: (i)' 6 hours of radiation physics and instrumentation; (ii) 6 hours of radiation protection; (iii) 4 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 8 hours of radiation biology. (2) To satisfy the requirement for a period of supervised clinical training-in ophthalmic radiotherapy, training must include the use of strontium-90 under the supervision of an authorized user for the ophthalmic treatment of five individuals 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 f i
[7590-01] 6 35.960 Training for teletherapy. Except as provided in 6 35.970, the licensee shall require the authorized user using a sealed source' listed in 6 35.600 in a teletherapy unit to: (a) Be certified in radiology or therapeutic radiology by the American Board of Radiology; or (b) Have completed 170 hours of instruction, 500 hours of supervised work experience, and 500 hours of supervised clinical experience in .
, basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit.
(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; (iii) 20 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 work experience, training must be under the supervision of an authorized user at an institution and must include: (i) Checking the operation of survey meters; (ii) Calculating radiation doses to be administered; (iii) Using administrative controls to prevent the misadministration of byproduct material; and (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console. (3) To satisfy the requiremant for supervised clinical experience, training under the sucervision of an authorized user must includa: (i) Examining individuals ~and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications; (ii) Selecting the proper dose; (iii) Calculating the teletherapy doses and collaborating with the authorized user in the interpretation of teletherapy results; and ' (iv) Post-administration followup and review of case histories. 9 I' 89 Enclosure 1 _
^
, -~
[7590-01]. 9 35.961 Training for qualified teletherapy calibration expert. The licensee shall require the individual calibrating or checking the radiation output of a teletherapy unit as a qualified teletherapy calibration expert as provided by 99 35.632 and 35.633 to: (a) Be certified by the American Board of Radiology in: (1) Therapeutic radiological physics; or (2) Roentgen ray and gamma ray physics; or (3) X-ray and radium physics; or .
, (b) Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time work experience under the supervision of a qualified teletherapy calibration expert at an institution where teletherapy is performed. To satisfy this' requirement, the neophyte qualified teletherapy calibration expert must have performed the tasks listed in SS 35.59, 35.632, 35.633, and 35.641 of t.his part under the supervision of a qualified teletherapy calibration expert during the year of work experience.
6 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 train.ing program approved by the Accredita-tion Council for Graduate Madical Education need not comply with the requireraents 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; 90 Enclosure 1 f .
[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 fer 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 0F BYPRODUCT MATERIAL
- 2. Section 30.4 is amended by revising paragraphs (h) and (1) to read as follows:
j 30.4 Definitions. (h) " Human use" means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human beings; l l 91 Enclosure 1 _'
[7590-01} (1) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine;
- 3. Section 30.34 is amended be revising paragraph (g)-to read as follows:
6 30.34 Terms and conditions of licenses. . (g) A licensee may prepare technetium-99m radiopharmaceuticals only with technetium-99m that contains less than 0.15 microcuries of i molybdenum-99 per millicurie of technetium-99m. The licensee shall perform tests and maintain the records required by 6 35.204. PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 6 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.
- 4. Section 31.11(b) is amended by deleting."635.14(c)" and inserting "Part 35."
PART 32 - SPECIFIC DOMESTIC LICENSE TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS
- 5. Section 32.70 is removed.
- 6. Section 32.72 paragraph (a)(4)(i) is revised to read as follows:
6 32.72 Manufacture and distribution of radiopharmaceuticals containing byproduct material for medical use under group licenses. (a) An application for a specific license to manufacture and distribute radiopharmaceuticals containing byproduct material for use by persons authorized pursuant to Part 35 of this chapter will be approved if: 92 Enclosure 1 _' 4
[7590-01] (4)(i) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay, and the label affixed to each package, or the leaflet or brochure that accompanies each package, contains a statement that the unit dosage radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to Part 35, as appropriate, or under an equivalent license of an Agreement State.
- 7. Section 32.73 paragraphs (a)and (a)(5)(ii) are revised to read as follows:
6 32.73 Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceutical containing byproduct material. (a) (5) ***
; (ii) A statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed oy the U.S. Nuclear Regulatory Commission to use byproduct material identified in 6 35.200 of 10 CFR Part 35 or under an equivalent license of an Agreement State.
- 8. Section 32.74 paragraphs (a) and (a)(3) are revised to read as 4
follows: l' 6 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use. < (a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to Part 35 of this chapter for use as a calibration or reference source or for the uses listed in SS 35.400 and 35.500 of this chapter will be approved if: (3) The label affixed to the source 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 93 Enclosure 1 _~
[7590-01] for distribution to persons licensed to use byproduct material identified in 66 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: . 6 40.4 Definitions (g) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; Dated at Washington, D.C; this day of 1982. For the Nuclear Regulatory Commission. Samuel J. Chilk, Secretary of the Commission. 94- Enclosure 1 _-
[7590-01] Appendix A--Form NRC-313MH Form NRC-313MH is appended for the convenience of those who may wish to comment on the proposed regulations. It is not a part of the regulations. However, the Commission does solicit comments on its content. If the proposed regulations are adopted and codified in Title 10 of the Code of Federal Regulations, the form will be used for
- applications for the human use of byproduct material.
95 Enclosure 1 _' ,
FORM NRC 313MH U.S. NUCLEAR REGULATORY COMMISSION Aporoved OMB APPLICATION FOR 10 CFR 35 Connd No. MATERIALS LICENSE HUMAN USE INSTRUCTIONS - Complete items I through 26 if this is en inntial application or en application for renewal of a license. Use supplemensel shorts where necessary. Item 23 must be completed on allapplications and signed. Resean one copy. Upon appronel of this applicanon. the applicant war recewe a Meterials License. An .NRC Masensis License is issued in accordance w.th the general requerements conseined in Tiste 10. Code of Federal Regulosions. Pert 30. end the Licensee is subject to Tide 10. Code of Federal Replenons Parts I9. 20 and 35 and she license fee preenneon of Title 10 Code of Federal Requietions, Pert i 70. ne license fee casesory should be usated in Isem 26 sed the oppropnste fee enclosed. PARTI 1.a. NAME AND MAILING ADCRESS OF APPLICANT 8. HOW MANY PREPARED CO3ES OF Tc49m ARE RECEIVED WEEKLY 7 .
- 7. FOR THE FOLLOWING.GIVE ESTIMATED NUMBER OF i
ADMINISTRATIONS AND TOTALmCi RECEIVED FROM TELEPHONE NO Aree Code f SUPPLIERS PCR THE PERIODS INDICATED.
- 12. STREET ADDRES$(es) AT WHICH RADIOACTIVE .
MATERIAL WILL SE USED Of different from 1.a.) ISDTDPE Administrations MCI DIAGNOSTIC Tc49m per wk per wk DIAGNOSTIC 1131 per wk per wk DIAGNOSTIC 1125 per wk per wk
- 2. RADIATION SAFETY OFFICER DIAGNOSTIC Xe.133 per wk per wk ALL OTHER DI AGNOSTIC per wk per wk TH ER APEUTIC I.131 per ye per yr THERAPEUTIC SEALED CFFICE SOURCES 3125 **' V' P V' TELEPHONE NO.: Area Code i 1 THERAPEUTIC SEALED
- 3. THl3 APPLICATION FOR: SOURCES It 192 # i
- s. O NEw uCENSE ALLOTHER ,,, y, ,e, y, !
THERAPEUTIC t
- 13. D eMe" cme"T To 'icense "o. t
- 8. WHAT IS THE TOTAL ACTIVITY OF Cs.137 PCSESSED IN
- c. RENEWAL OF LICENSE NO. BRACHYTHERAPY SEALED SOURCES 7
- 4. RADICACTIVE MATERIAL g,,;,,,, 9. TYPE OF FACILITY . se. GENER AL HOSPITAL. V A Check p- HOSPITAL, NURSING HCHE. PRIVATE PR ACTICE, ;
RADICACTIVE MATERIAL less Lim'ts(in CUNIC, MOSILE SERVICE. ETC. l L11TED IN: Desired Mdlisanes) ; 1 NO2 llmobde service.stasch list ofclients on separate sheet. , l 10 CFR 31.11 FOR IN VITRO i
- 10. TOTAL NUMBER OF FULL TIME ECUIVALENT NON-HUMAN USE PHYSICI ANS ON INSTITUTION AL STAFF ,
IDo':umen ation attachsel 10 C" R 35.100 GENERAL / GROUP 1 As Neocod 11. NUMBER OF FULL TIME EQUIVALENTSUSERVISED FHYSICIANS IN TRAINING FOR: . 10 CFR 35.200 GRCUPS 191!1 As Neocad ' Nuclear Medicme 10 CFR 35.300 GROUPS IV/V As Needed ! _ Tem 10 CFR 35.400 GROUP VI _ Srechythernov ! Sr-90 CPTHALMIC APPLICATOR . 10 CFR 35.500 GROUP.vil 12. NUMBER OF FULL TIME EQUIVALENT NUCLEAR 10 CFR 35.800 GROUP Vill NOTE: tjuosnons 13 and it help hRC determsne e licensee's 5.a. HOW MANY Mo.99/Tc49m GENERATORS ARE i RECEIVED WEEKLY 7 sserus (5 U.S.C.as 608e et. smelt seq.).enney"Quesaons i3 and i5 epply oniy tounder the R sassitu tions. 5b. WH AT SIZE ? MCI 13. INSTITUTION AL CAPACITY (Numtwr of beds) . 1 i
-i
. ._. . . - _ . _ . . - . . . _ _ . - . _ _ _ _ _ . -._= _. .- . _ . - - - - . , . .r
. e
" M*""f**" M*d'M *-
PART I (continued) DIAGNOSTIC INSTRUMENTS:
- 14. IF NUM8ER CF BEDS IS NOTAPPLICA8LE.DO ANNUAL i GRCSS RECEIPTS CF THE APPLICANT EXCEED 1.5 Upeke Probes MILLICN DOLLARS 7 Rectdineer Scanners [ \
O '*** Yes No ,
- 15. TOTAL P ATIENT C AYS FOR PAST CALENDAR YEAR TELETHER APY UNIT FOR ENTIRE INSTITUT1CN:
Source
~
Patient Viewing
- 18. ESTIMATED NUM8ER OF TELETHERAPY PATIENTS TREATED ANNUALLY: Thion )( ,
- Mirrors PARTII Downetry Symm
- 17. IF APPLICATION IS FCR GROUP Vill-TELETHERAPY, y ATTACH DI AGR AM OF TELETHER APY TREATMENT
"**'N' AREA. AND SAFETY FEATURES. t
- 18. PERSONNEL MCNITORING DEVICES CHECK APPRCPRIATE BOXES. OTHER Liouid Scintdistion Whoie Body- Fam, TLD, Other Counters Aree Monitors \ [
Finger- Fam. O Tto. Otaer v. - x\ /
/
(Soucifyl Wrist. Fi'm, CTLD, COther Well Counters Ges Aoministration,
) '
a (Soecifyl d Troos>ng, Concen-Cther (Soecify) tretion, Monitoring Devtes Porticulene Aomen-Give name and eaarves of suopiier istration Trapping, 1 Concentration. Monitoring Devees GIVE FLOOR SPACE ALLOCATED FOR THE ! ING AREAS:
- 19. EQUIPMENT INDICATE THE TOTAL NUMBER ON MAND. inuging A Sq. Ft.
INDICATE THE MANUFACTURER AND MODEL NUM8ER OF THE INSTRUMENT TH AT WILL BE USED TO SATISFY ing Room Sq. Ft. RECulREMENTS OF to CFR 35. i , ,,,,,,,_ , - , , -,En. - n .Pa t. -. j SURVEY METERS:
- 21. ROOM VENTILATICN DATA .
@ $1arage (Insging j i
eenisetton Pe contage of System Air j Recirculated % % 1 Crystal l Nogetsve Pressure C Yes Q Yes ! DCSE CALISRATORS O No O No l Give name and sodrous of contract ceaibreten servce Ventilation Hood O ves O va l (if soo4Wel of survey meters and dose celebrators. O No O No l If more then one,atteen sheet: [ 22. STATE THE CALCULATED % OF MAXIMUM PERMISSIBLE CONCENTRATION (MPCI OF Xe 133110 CFR 20) AT THE i POINT OF RELEASE TO THE OUTSIDE ATMCSPHERE PER i TWEEK. I i 4 s 5
+
. * + - - -@ 'N e -w hom..4 m + ..,,,%_ ,, , _ , , , _
.9 t
PARTlli Name License Number
- 23. . PERSONNEL REQUtREMENTS (use extra sheets if necessary)
. NOTE: Speerfic training and esperiense requwoments and other definitions reisted to personnel queufications are contained in 10 CFR 35.
RADIATION SAFETY OFFICER 1.NAME
- 2. CERTIFICATICN: ABR A8HP AC8R ABNM O otner<saecifvi 2 3. CUALIFICATION: MO DO O eso MA/Ms sa/es i esmtv en.: i meet or . e d tne ir. ning and amoon.nes ,eavirem.nts for R.di.non s.foty Officer as stated in 10 CFR 3s. ,
s;, nature cm (of Radiation Safety Officer)
- f QUALIFIED EXPERT FOR CALIBRATICN OF TELETHERAPY MACHINES 1.NAME
- 2. CERTIFICATION: O AsR A B H P O o d-ris.eeifvi
- 3. FULL TIME
. EMPLOYEE OF: Lconese Consultant
- 4. CUALIFICATION: MD PhD D Ma>Ms =^/as I certify that I meet or exceed the training and emperience requirements for Qualified Expert as stated in 10 CFR 35.
' ~ ~
(of Qualified Expert) AUTHCR12ED USERS
~
1.NAME MD DO
- 2. USE GROUP (S) Gen /l it/tli Diviv vi vii viii O Sr-90
- 3. MEETS TRAINING AND EXPERIENCE REQUIREMENTS SY:
- a. Aporoonste Soord Certification ASP.M O^*a O^ona otaer <saecifv>
- b. Training and Ezoo wnce as specified in 13 CF9 35 subesetton J.
- c. Request for enamotion frorn to CFR Training and Exoenence Requirements (Documeetscon stracnoc).
(of Authorized User)
- 1. NAuf Q Mo D Co
- 2. usE GRoLetsi O Genei wiii ruv O vi vii O vm O sr-9o
- 3. MEET 5 TRAIN!NG AND EXPERIENCE RECulREMENTS SY:
a.' ] Acoroonste Board Certification O Asf>M OAna AceR otaer (saecifv>
- b. Q Training and Emoonence as specified in 10 CFR 35 subesetion J.
L
- c. O R est for e= emotion fro 10 CFR Treinen, .nd E,oor ence R.auirem.ars cooeumont.uon .it.en.di.
sieneture om t, (of Authorized User) l 9
-_ w.=w n - -
r e o =o - ~ - -
-n.- -
+m e e m,--e.,..w---
M \ PART lil (Continued) 33- AUTHORIZED USERS (continued) 1.NAME MO Do
- 2. USE GROUP (S) hGen/l O iiiiii iviv vi vii Oviii Sr-90
- 3. MEETS TRAINING AND EXPERIENCE REQUIREMENTS SY:
- a. Approonete Board Certificacon A8NM ABR ACBR Ootaerisooofv) ti. Tremmg and Exponence se specified in to CFR 35 subesction J.
- c. ] Recuest for exemption from 10 CFR Tramme and Experience Requirements (Documentation artscaed). ,
signoture cete (of Authorized User) 1.NAME O Mo Goo
- 2. USE GROUP (S) Gen /l it/lti IV/V VI Vil Vllt $p.gQ
- 3. MEETS TRAINING AND EXPERIENCE REQUIREMENTS BY:
- a. Aporoprate Board Cartification A8NM ]A8R AOBR Ootaer isoec fvi
- b. Trommg and Exponence as specified in 10 CFR subsection J.
- c. O a a
- f ar aatiaa 'r== io cFa tr mme nd E a n ac a auir m nis ioacu- ai aaa # ca ai-I Signature Date (of Authorized User) 1.NAME MD Do
- 2. usE GRouPtsi Gen /i O iiiiii Diviv vi vii O vili Sr 3. MEETS TRAINING AND EXPERIENCE REQUIREMENTS BY:
as Approonete Board Certification A8NM ABR AOBR otaer (Specify)
- b. Training and Exponence as specified in 10 CFR suosection J.
- c. ] . Request for esemption from 10 CFR Traming end Exponence Reaunements (Documentation attacae3).
Signature Date (of Authorized User)
- 1. NAME OMo Goo
- 2. USE GROUP (S) O cENei Qiiiiii D i <iv vi O vil viii Sr-90
- 3. MEEE TRAINING AND E)PF.RIENCE RECUIREMENT5 BY:
- a. ] A9proprote Board Certificatior6 A8NM CABR O^osa oia r isoecifv>
- b. Trsining and Exponents as specified in 10 CFR subsection J.
- c. Reauest for exemption from to CFR Training and Expere Requirements (Docun entation attached).
Signature Date l (of Authorized User) I f
e , PRIVACY ACTSTATEMENT Pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Pubile Law 93 579), the following statement is furnished to individuals who supply information to the Nucteer RegulatoryCommrssion on Form NRC.313MH. This information is maintained in a system of records cesignated as NRC.3 and described at 40 Federa 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 (3) The information is evaluated by the NRC staff pursuant to the criteria set forth in 10 CFR Parts 30-36 to determine whether the application meets the requirements of the Atomic Energy Act of 1954,as amended, and the Commission's regulations, for the issuance of a radioecdve material IIcense or amendment therect
- 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 inci.
dont 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 potental 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 tnat agency's decision about you. A copy of the license issued will routinety be placed in the NRC's Public Document Room,1717 H Street, N.W., Washington, D.C. ' 4. WHETHEF. UlSCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF NOT PROVIDING INFORMATION Disciosure of the recuested information is voluntary, if the requested Information is not furnished, however, the application for radioective meterial license, or amendment thereof, will not be processed.
- 5. SYSTEM MANAGER (S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety, Cffice of Nuclear Mate-rei Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
h I b
' = = --_ n ..- _ _ - .
- 24. Title 10 of the Code of Federal Regulations, Parts 19, 20, 21, 30, and 35 require that you develop certain written procedures. From the following list, check those procedures which you must have developed, and indicate _the date on which each was implemented.
INSTRUMENT CHECKS AND Call 8R ATIONS WASTE DISPOSAL (Aal Groups: See Section 35.50,35.51) (Groups 1-VI: Section 35R) ! (Dates (Dates PERSONNEL TRAINING O USE OF RADIOACTIVE GASES (All Groups: Section 19.12) (Groucs ll/lil: Section 35.90) (Datel IDetal GENERAL RULES FOR THE SAFE USE THERAPEUTIC USE OF RADIO-CF RADIOACTIVE MATERIAL PHARMACEUTICALS , (All Grouce: Section 352) , (GroupsIV/V: Section 35.303) . ( (Cates (Datel '
, ORDERING AND RECEIVING O THERAPEUTIC USE OF RADIOACTIVE MATERIAL SEALED SOURCES (Groups I . VI: Section 352) (Groups Vl/vlil: Section 35.404. 35.610) !
(Dates (Datel 5 OPENING PACKAGES O EMERGENCY PROCEDURES (Groups I-VI: Secnon 35.32) (Group Vill: Section 35.610) L (Dates (Datel j
.O AREA SURVEY: (Alt Groups: Sectron 35.701 ALARA (Allinstituttoris: Section 35.30) ;
(Detel (Datel i
- 25. I MERE 8Y CERTIFY THAT EVERY REASONA8LE EFFORT WILL BE MADE TO MAINTAIN RADIATION EXPOSURES, AND 7 RELEASES OF RADIOACTIVE MATERIALS IN EFFLUENTS TO UNRESTRICTED AREAS, AS LOW AS REASONA8LY ACHIEVA8LE :
(ALARA). (NOTE: EXCRETA FROM INDIVIOUALS UNDERGOING MEDICAL DIAGNOSIS OR THERAPY WITH RADIOACTIVE { MATERIAL IS EXEMPT PROM ANY LIMITATIONS IN THE REGULATIONS PERTAINING TO DISPOSAL SY RELEASE INTO SANITARY SEWERAGE SYSTEMS (SEE 10 CFR 20.303.1.) RADIOACTIVE MATERIAL WILL BE USED BY CR UNDER THE SUPERVISION OF THE AUTHORIZED USERS ON THIS LICENSE. AUTHORIZED USERS LISTED HEREIN MEET OR EXCEED THE TRAINING AND EXPERIENCE REQUIREMENTS FCR EACH USE [ GROUP SPECIFIED BY THE USER CN THE AUTHORIZED USERS LIST. l ECUIPMENT FOR THOSE TYPES OF USE FOR WHICH APPLICATION IS MADE WILL BE ON MAND,IN WORKING CRDER, AND CALIBRATED AS REQUIRED. PERSONNEL WCRKING IN OR FREQUENTING ANY PORTION oF A RESTRIC ED AREA HAVE BEEN INSTRUCTED AS SPECIFIED , IN 10 CFR 19.12. ! f A RADI ATION SAFETY CQMMITTEE HAS BEEN ESTA8L!SHED (APPLIES GNLY TO INSTIT1.lTION AL LICENSEES). ; I FURTHER CSRTIFY THAT THE INFORMATION CONTAINED HEREIN 13 CORRECT TO THC BEST OF MY KNOWLEDGE AND I BELIEF. I UNDERSTANO THAT FAILURE TO COMPLY WITH THE REGULATICNS M AY SUBJECT THE LICENSEE TO SUCH I CIVIL CR CRIMINAL PENALTIES AS PROVIDED BY I.AW. Signature Name : Title De ;
- 26. FEE CATEGORY FEE ENCLCSED S (10 CFR 170, Section 170.31)
I
'I; 1
5 9 ENCLOSURE 2 PERIODIC AND SYSTEMATIC REVIEW I f i
?
?
w
i PERIODIC AND SYSTEMATIC REVIEW - 10 CFR PART 35 t l I I Introduction ' Task IV G.2 of the TMI Action Plan directed the staff to review all ; existing regulations for content, quality and clarity. SECY 81-435 and 435A established specific review criteria and created the Regulations Coordinating , ! Committee (RCC) to plan, schedule, and coordinate the review. Under the RCC j charter, one guideline for setting the priority of specific regulations for review was a Commission or staff initiative for a major revision of an existing rule. The Periodic and Systematic Review of 10 CFR Part 35 is in response to (i a staff decision that a substantial revision of the general medical licensing requirements of Part 35 was necessary. l It should be noted that the reevaluation of Part 35 does not address the l misadministration sections of the rule (SS 35.41 - 35.44). When these provi- ; I sions were first promulgated, th'e Commission established a specific time 3 period for.their evaluation. Due to this separate time period, and the unique f nature of the misadministration issue, the proposed revision to Part 35, and i the Periodic and Systematic Review, do not include this subject within their , scope of analysis. i Analysis
- 1. The Need for the Regulation.
f Under 10 CFR Part 35, the NRC issues licenses to hospitals and physicians i for the use of radioactive materials for diagnostic and therapeutic purposes. ? The NRC currently has approximately 631 medical licensees, and 15 to 20 million nuclear medical procedures are performed in the United States each year. The facilities, personnel, program controls, and equipment used in these procedures must be carefully reviewed through the licensing process to ensure the safety of the public, patients, and occupationally exposed workers.
- 2. Direct and Indirect Effects. -
The nuclear medicine field has grown substantially over the past three decades, as evidenced by the increase in license applications, renewals, and l 1 Enclosure 2 7 m Ju
amendments. In addition to this growth, many new and complex diagnostic and therapeutic procedures have been developed. In order to ensure coverage of these new developments, many safety requirements have been added as license amendments, or have been recommended in regulatory guides, rather than being incorporated into the regulations. Over the past several years the changes in nuclear medical procedures have stabilized, and uniform and comprehensive safety requirements can now be established in the regulations themselves in order to establish a more coherent . regulatory framework. The current practice of stating the licensing requirements and guidance in several different sources has resulted in negative impacts on both the licensees and the NRC staff. The applicant is often uncertain about the exact requirements for a complete license application. This results in either an application that provides a substantial amount of extraneous information or in one that does not provide enough of the information necessary to make a licens-ing decision. This requires additional NRC staff time in writing deficiency letters to obtain additional information or clarification, or in reviewing large amounts of unnecessary information. This results in frequent delays in the licensing process and has led to a backlog in license appl.ications. In
- addition, the existing regulations severely limit a licensee's flexibilty in selecting the most cost-effective method for complying with NRC requirements since even a .ninor program deviation requires a license amendment. These negative effects of the existing regulatory framework have initiated the reevaluation and revision of Part 35. For a detailed analysis of the effects of the proposed revision to Part 35, see the Value/ Impact Statement prepared as part of the rulemaking package.
- 3. Alternative Approaches.
The reevaluation of Part 35 included the consideration of two alternatives to the existing licensing system. The first alternative would be a specific license of limited scope that summarizes rather than details the applicant's program. This " standard" license would provide the necessary protection of the public health and safety but also would provide maximum' flexibility to i licensees to tailor their program to their specific needs and to make minor changes incorporating industry developments without having to amend the license. The licensing process would be simplified by incorporating existing generic 2 Enclosure 2 f~
- ---,~,sv,,w- w -r--s.- *r--w~
license conditions into the regulations, eliminating or modifying existing requirements, simplifying the license application form and by establishing a , computerized licensing information system. j The second alternative would utilize a general license system that would
- allow the use of limited quantities of specific byproduct materials without any program review by NRC. The alternative would depend on specific and rigid regulations. However, NRC policy has been to only issue general licenses for
- byproduct material in forms or quantities that present little or no hazard to ,
the user or public. Under this alternative,-all licensed physicians would I automatically be generally licensed for all uses on the effective date of the rule. Alternative one, the " standard" license, was selected as a reasonable licensing procedure which is neither as complex as existing procedures nor as difficult to ensure compliance with the regulations as would be the general license.
- 4. Public Comment.
A basic part of the rationale for revising Part 35 is to provide for public comment on regulatory requirements before they are imposed in final form. The existing system of imposing requirements through . licensing amend-4 ments did not allow for advance public comment. Incorporating generic licensees amendments into the regulations will allow public comment on these regulatory requirements before they are finalized. In addition, existing licensees, nuclear medicine associations, and state government personnel were contacted on the development of'the proposed rule. 4 L
- 5. The Regulation Is Written in an Understandable Manner.
Revision of.Part 35 has, in part, been prompted by the lack of clarity in the existing rule. The proposed revision is designed to be clear, coherent, and understandable.
- 6. Reporting Burdens.
Although the current reporting and recordkeeping activities, and th'e burdens associated with these requirements, have been cleared by the OMB under the Paperwork Reduction Act, the proposed revision will eliminate or modify 1 3 Enclosure 2 y i
many of the existing requirements. The rationale for the revision is aimed at the reduction of the paperwork burden on both licensees and the NRC staff. For specific information on the information collection activities of the proposed revision, see the OMB supporting statement in the.rulemaking package.
- 7. .Name, Address, Telephone Number of a Knowledgeable Agency Official, i
-Thi in' formation will be included as part of the Federal Register Notice that publishes the proposed rule. ,
- 8. Plan for Evaluation.
Implementation of the revised licensing system under Part 35 will be continuously monitored to ensure that the regulatory objectives are achieved. The' prepared revision is itself the result of a reevaluation' of the existing j- rule, which should eliminate the need for a new reevaluation until so desig-nated as part of the Regulations Coordinating Committee schedule of priorities for review. t h 1 4 i 4 Enclosure 2
- t -
-a. y - -_a., . - _ ,s a __ - 6 9 9
, a NCLOSURE 3 VALUE/ IMPACT STATEMENT e
VALUE/ IMPACT STATEMENT -
- 1. PROPOSED ACTION The proposed' rule consolidates those requirements for nuclear medicine that are now contained in existing regulations, branch policy positions, standard conditions of licenses and guidance protocols into a concise and
- coherent set of regulations. The proposed rule will make' licensing require-ments clear and understandable to licensees while providing a basis for 4
reduction in the amount of information that must be submitted with a license application. It also adds new requirements to the regulations, principally by incorporating already proposed rules. If the proposed rule is accepted, new review procedures for license applications that provide the licensee with greater flexibility for following the regulations consistent with good radia-tion safety practice will be possible. This feature, when combined with a simplified licensing application form, is expected to reduce the paperwork burden on the applicant and staff, reduce the number of license amendments submitted, decrease the administrative prerequisites to license issuance, and decrease the time required to review applications and issue licensing decisions. Additional savings can be achieved through computerized management of the review process, an option possible under the prop; sed rule. By reducing the paperwork burden on the staff, resources will be freed to address programmatic safety issues promptly as the field progresses and to make onsite review visits if necessary after issuing new licenses. Furthermore, onsite reviews provide more useful and realistic information about radiation safety conditions
~
than can be determined by the application review process used under existing rules. i
- 2. DISCUSSION OF ALTERNATIVES The typical nuclear medicine service provides a battery of diagnostic nd therapeutic procedures utilizing radiopharmaceuticals and radioactive devices.
The radioactive materials are utilized in a variety of chemical and physical forms (gas, liquids and solids), and in such quantities that radiation levels of roentgens per hour can be produced. Mistakes or accidents can lead to high 1 . Enclosure 3 .7 4
-c --.er -- , - - - n
external exposure, internal deposition or spread of contamination in the laboratory and other hospital areas. Therefore, any alternative selected to regulate nuclear medicine must provide sufficient requirements for training, facilities and equipment, and operating procedures to be adequate for protec-t,fon of the public health and safety. The adequacy of the licensee's operation can only be ensured through a combination of regulations, licensing and inspec-tion. The alternatives for regulation of nuclear medicine are a function of which element of the combination (regulations, licensing, and inspection) is , emphasized. The current procedure of isseing specific licenses of limited scope for the medical uses of radioisotopes is complicated, time consuming, and frequently confusing to the applicant. In the consideration of alternatives a number of issues were addressed, including the method by which the licensee applies, the content of the application, the existing NRC requirements and regulations, and
- the guidance provided to the licensee for meeting NRC requirements. All of these elements were evaluated in order to properly define an acceptable '
improved alternative to the current procedure for licensing. The alternatives that were considered. ranged from minor changes in existing procedures to the most liberal licensing concept, that of issuin~g a general license similar to the one now available to physicians under the provisions of 10'CFR 35.31. Alternatives were considered in development of the rule to provide for a reasonable licensing procedure that was neither as complex as existing procedures nor as nonspecific as a general license while maintaining the same level of protection for the public health and safety as that afforded by current procedures. A. Specific License (" Status Quo") Specific licenses are issued to qualified physicians and medical
-institutions for specified quantities and uses of byproduct materials. 'An applicant files a written copy of radiation safety procedures with the application for NRC review and approval prior to the license being issued.
The license is issued for a five-year period. Renewal requires a complete submission of all information whether changed from the original application or. not. Inspection of a specific license is straightforward, because the complete i details of the applicant's radiation safety program are on file at NRC for review by the inspector.
~2 Enclosure-3 J W
- 1. Advantages
- a. The applicant's detailed preparation of procedures and the ,
comprehensive review performed by NRC staff prior to issuing a license encourages compliance. However, com-pliance can only be assured by direct observation as with an inspection.
- b. Custom license conditions can be imposed by the NRC staff .
~
on the licensee to meet specific operational needs.
- c. Applications containing detailed procedural descriptions provide inspection personnel with information which other-wise would not be available prior to a visit. However, these descriptions may be outdated or otherwise untimely, as they could have been' filed with an application five or more years previous.
- 2. Disadvantages
- a. Those requirements an applicant'must meet in order to be issued a specific license are not consolidated in a single document. The applicant is sometimes unaware of require-ments and is often confused by this lack of consolidation.
This leads to the generation of one or more rounds of deficiency letters.
- b. Applications are voluminous because of the amount of-detail required'under existing procedures.
- c. Detailed ~ reviews by staff are necessary under the existing rule. The current rule does not contain sufficient detail about the minimum requirements to maintain a safe nuclear medicine _ operation. The licensee must assemble these requirements from several other source documents and consolidate them in the application. This places a great demand on license review' resources, resulting in frequent delays in issuing licenses and amendments. Further delays 3 Enclosure 3 _-
result from generating deficiency letters and awaiting replies.
- d. Existing procedures lead to a license review backlog.
- e. A licensee's flexibility to select the most cost-effective method for meeting NRC's requirements is limited by NRC's current practice of incorporating extensive details in .
licensing conditions. This in turn means that changes, even minor ones, in a licensee's program require a license amendment.
- f. NRC is now in the process of regionalizing the materials licensing function. There must be consistency in the licensing process among the regions. If.a custom review of individual procedures submitted by each applicant is necessary, as with the " Status Quo," detailed NRC proce-dures would have to be developed and implemented to ensure some measure of consistency among the five regional licens-ing groups. Constant monitoring of these procedures would be necessary. Even then, consistency in the processing of cases could not be assumed.
B. General License General licenses are granted under detailed regulations that allow the use of small quantities of specific byproduct materials for a few procedures without review by NRC. A registration form is filed with the Commission to identify licensees. Compliance with regulations can only be determined through inspection. Due to the small amount of material authorized, these licensees are not currently inspected.
- 1. Advantages
- a. The granting of a general license through regulations eliminates the licensing step involving a formal review of 4 Enclosure 3 _
m..
9 the application and provides the greatest conservation of licensee and NRC resources.
- b. Licensing delays are eliminated.
- c. Applicant and.NRC paperwork is reduced.
- d. -The general license is adaptable to regionalization. .
- 2. Disadvantages
- a. Regulations for general licenses must be specific and rigid because there are no provisions for imposing addi-tional restrictions on an individual general license once authorization is granted. For this reason, little or no flexibility in methodology to accommodate individual operations is permitted and innovation, even where it may be warranted, is inhibited.
- b. Problems of health and safety are not detected by NRC l because these licensees are not inspected,
- c. New uses, procedures, health and safety controls, etc., .
could not be implemented by an individual licensee until provided for in regulation changes. There could be delays in implementation of significant safety-related actions by licensees. i i
- d. Public health and safety could not be assured under a ,
general license as now applied because NRC policy has been to issue general licenses for byproduct material in forms or quantities that, even without NRC surveillance, present little or no hazard to the user or public. General licensees are not now inspected, licenses do not expire, licensees do not need to develop written safety procedures and are exempt from the provisions of 10 CFR Parts 19, 20, and 21. 5 Enclosure 3 _-
- 3. DECISION ON PROCEDURAL APPROACH-Many alternative procedures, ranging from one in which very little is required of the licensee and increasing in complexity to include the present practice of issuing a specific license, were considered. Neither the general license nor the " Status Quo" are effective alternatives for licensing the human use of byproduct material. The " Status Quo" imposes a burden on the licensee and the NRC staff beyond that required to protect the public health .
and safety. A general license does too little to assure this protection. The best alternative must incorporate features of both types of licenses. A. Acceptable Alternative Procedural Approach The most reasonable alternative to the general license or the " Status Quo" is a specific license of limited scope with (1) an application that summarizes rather than details the proposed radiation safety program, and (2) a more focused review procedure. Fo.r the purpose of clarity, this form
~
of specific license would be called a standard medical license. A distinction is necessary because unlike~the current specific medical license, it contains elements similar to a general license and could be considered a hybrid. It-would provide the necessary and sufficient authority for use of the byproduct material consistent with other accepted hazards in the medical environment. ~ The medical standard license would combine the best features of existing general and specific licenses. The proposed regulations provide flexibility for the licensee to tailor his radiation safety program to specific needs and
~
to maka minor program changes incorporating new medical developments without amending the license. The license review would be focused on key safety issues. It is anticipated that inspection resources would have to be increased very little under the proposed system although an early on site review of the operation would be highly desirable.
- 1. Advantages of the Standard License
- a. The proposed procedure would focus licensing and inspection :
resources on a few key safety issues. 6 Enclosure 3 _'
- b. The standard license would provide maximum flexibility, consistent with necessary regulatory controls, to 1
accommodate the specific needs of applicants.
- c. It will reduce paperwork and. licensing resource requirements for applicants and NRC.
- d. It facilitates regionalization by providing a basis for .
consistent policy among NRC regional licensing operatirns.
- e. Preliminary contacts indicate that the proposed rule has-a broad base of support in the medical community.
! 2. Disadvantages
- a. The proposed rule would not completely eliminate licensing resource requirements as would a general license.
- b. There is a perception of diminished control over licensee operations when the licensee is no longer required to submit detailed radiation safety procedures for review by NRC. This belief stems from the assumption that an appli-cant-would be forced to learn requirements as procedures were developed and written for the application. There is now evidence that a substantial number of applicants
, employ professional consultants to write the procedures.
Several cases have recently come to light where, although
- very detailed procedures were submitted to NRC, the licensees did not follow them. The staff no longer assumes that an applicant, and not a consultant, has prepared the application. This problem can only be solved by prompt review of the' applicant's operation onsite.
- 4. VALUE/ IMPACT OF THE PROPOSED ACTION Medical licensees will have to satisfy very few additional technical requirements under the proposed rule beyond those they satisfy under existing 7 Enclosure 3 ._-
t
. ~_
regulations and license conditions. The net cost incurred for satisfying new technical requirements should be less than 5500 per licensee. However, sub-stantial administrative cost savings will be realized under the new rule and licensing procedures. Current requirements are contained in a variety of sources including regulations, guides, license conditions and the applicant's own submissions. Because of the confusica this creates, and to avoid the delay caused by deficiency letters, applicants frequently make unnecessary commitments (procedures, equipment purchases, etc.) to assure meeting all NRC . requirements. Thus, licensees will benefit from reduced compliance costs because the NRC regulations will be simplified and codified, and will allow flexibility in the selection of the cost effective means of meeting regulatory requirements. Revenue losses caused by licensing delays will also be greatly reduced. Applicants will benefit further by elimination of the costs to prepare lengthy formal license applications, renewal applications, and amendment applications. A. Licensee The present licensing system restricts the applicant's options for meeting regulatory requirements. Under the current system, it has been considered necessary to rely on standardized procedures to assure safety for many varied
- contingencies. An applicant who meets training and experience requirements under the proposed rule is considered to be an adequate judge of the safest and most cost effective program under the constraints of clear, concise and complete regulations. The cost savings to the applicant, when afforded this flexibility, is considerable. The proposed rule would be equivalent to a set of standards for the licensee's safety program while providing flexibility in
, the methods used to meet the standards. Representative examples of these standards would be: surveys for contamination and ambient radiation exposure
, rates, calibration of survey instruments, and storage of volatiles and gases. A major impact on NRC license applicants under the current licensing . procedure is the loss of revenue caused by delays in issuing new licenses. An average of 67 workdays now elapses from the time NRC receives an application for a new byproduct materials license until it is ' issued. When fully implemented, the new procedures will reduce processing time to 10 days. The 57 workdays avoided under the proposed scheme are currently i 8 Enclosure 3 _' 4 _-.-,_.y _ , . - _ ,+ _ _ - . _ , . - - . _ _ m -
consumed mostly by administrative paper handling. Following initial review of the application, a written request for clarification (a " deficiency" letter) must be prepared, typed, proofread, signed and mailed. The applicant must then prepare a response, and have it typed, proofread, signed and mailed. Resolution of these problems by telephone is possible in a few instances. However, in most cases, an applicant's response must appear as part of the written application file. The proposed rule would eliminate the need for deficiency letters in an estimated 95 percent of all cases. The reduction in , time to issue a new license can be achieved with or without an automated management information system (MIS). In' order to accurately define lost revenues caused by licensing delays, the financial commitment incurred by the applicant during the delay period must be estimated. Experience has shown that many applicants for new medical licenses have made sizable resource commitments prior to submitting an application. Current NRC practice implies a necessity to assemble the components of a nuclear medicine operation in order to satisfactorily describe them. The applicant's prelicense investment of fiscal and space resources may include specialized physicians and technical staff, sophisticated nuclear instrumentation, and dedicated facilities. Applicants generally make such early commitments to employees because there is a shortage of nuclear medicine physicians and technicians. Instrumen-tation must be ordered and installed, and cosmetic improvements are frequently made for improved space utilization and patient comfort. For the purpose of impact analysis, the following assumptions are made-about the typical nuclear medicine service:
- 1. Interest (debt services) on $750,000 loan for construction or modification of facilities and for equipment purchase, $750,000 at 15 percent per annum: $469 per day.
- 2. Nuclear medicine service's allocated contribution to hospital ,
overhead: $100 per day.
- 3. Nuclear medicine physician salary ($80,000 per annum) plus benefits (1.4 times base): $467 per day.
- 4. Nuclear medicine technologist's salary ($22,000 per annum) plus benefits (1.6 times base): $147 per day. ;
- 5. Nuclear medicine service work load: 15 in-vivo diagnostic studies per day.
9 Enclosure 3 f i
- 6. One nuclear medicine physician and three technologists to perform 15 in-vivo studies per day.
- 7. Radiopharmaceuticals and supplies for 15 studies: $250.
- 8. Average patient billing for study: $200.
The following additional assumptions may be made for a facility performing in vitro radioimmunoassay (RIA) tests:
- 1. One quarter of all new applicants for a medical license request authorization for in-vitro RIA. -
- 2. Gross income generated from in-vitro RIA equals the gross income from in-vivo studies, 100 RIA tests per day and an average patient billing of $30 per test.
- 3. The debt service and contribution to overhead for an in-vitro RIA.
laboratory: $150 per day.
- 4. One full-time technologist is needed to run the RIA laboratory.
- 5. Prepackaged RIA kits and supplies: $500 per day.
Much of this information was taken from " Planning Guide for Radiologic Installations; Fascicle 6: Nuclear Medicine Facilities," by the Committee on Department Planning, Commission on Radiologic Equipment and Facilities, American College of Radiology (1978). It was updated by personal communicationst Time will be expressed in workdays, not calendar days. The above costs do not include (1) benefit, loss when an idle fixed facility is not being used for alternate purposes, or (2) cost of administration of the daily operation of a nuclear medicine service other than the contribution to cover overall hospital management costs. For the purpose of establishing these assumptions, a nuclear medical service with a total annual (1981) patient billing of $2.2 million located in a large metropolitan area was contacted. Approximately $1.0 million of the total billing was generated from an average of 20 in-vivo' studies per day and the remainder from in-vitro RIA tests. A conservative estimate of the savings to the nuclear medicine industry from streamlining the licensing procedure is based on an assumption that no applicant has an investment prior to license issuance. To quantify this estimate, two components are considered: (1) income loss if potential of 15 studies per day are not performed for 57 days and 75 new applicants received by NRC per year; and (2) the cost (saving) of operad ons expressed as staff salaries, debt service, a management allocation, and radiopharmaceuticals and supplies not expended when studies are not performed. From evaluation of l
^
10 Enclosure 3 _
these two factors, a conservative estimate of the savings to an individual applicant can be made (Case I): estimated ~ cost to _ avoidable , total billings provide service loss of revenue , or [ scans per day x scan revenue x days delay]
- cost of [1phy 1'c n+3 tech o gists + supplies + debt service] .
= net revenue; and, substituting the previously assumed values for the above: ;
ns ars [15 x 200 x 57 days]
- (57 days') x [467 lars + (3 technologists) (147 d t no ogist)
+ 250 d liars + 469 d liars t day day i
= $78,261 per applicant
?
~
For 75 new applications per year, the cost to the medical industry in Case I, the most conservative estimate would be:
$5,869,575 per year ;
The situation in Case I is idealized and does not realistically estimate the average applicant's prelicensure resource commitment. Many applicants > purchase the necessary equipment and prepare the facility before applying for ; a license. In Case II we will assume that one half of all applicants make such commitments. In that situation the cost of interest on capital investment ! must be added to the lost revenue for: i i
$78,261 + $469/ day (57 days) = $104,994 per applicant (equipment purchased and facilities prepared before application filed) t 11 Enclosure 3 f F
Cost to the industry annually if only half of all new applicants purchase equipment and prepare facilities at licensing would be: ($78,271)(f5)+($104,994)(fE)=$6,872,063 Other resource commitments are frequently made before a license is approved. Many applicants employ a full-time nuclear medicine technologist to plan the operation of the nuclear medicine service. It is assumed that three-fourths of the applicants make this commitment (Case III). These applicants would expend an . additional $8379 in salary. In Case IV, because of a chronic shortage of trained nuclear medicine physicians, almost half of new applicants hire them before licensure. Many feel this early commitment is necessary to ensure availablity of these specialists. In Case IV, the applicant incurs an additional expense of $26,619 in salaries and benefits. In the last situation, Case V, 10 percent of all applicants are assumed to request in-vitro radioimmunoassay (RIA) authorization, and to purchase the equipment before filing an application. Although more than 10 percent perform RIA testing, many do only the limited number of procedures possible under the - general license pursuant to 10 CFR Part 31.11. since the average licensee's
~
total billings for these-procedure are approximately the same as those for in-vivo studies and because the investment is much smaller, an applicant's lost revenue is greater.
$171,000 - 57 days [ technologist ($147/ day) _ debt, ($500/ day) salary service
- supplies ($150/ day)] = $125,571
- l
- However, total impact on the nuclear medicine industry is small because this cost affects only 7 or 8 licensees per year. Based on 75 new applications each year, the impact on the medical industry caused by licensing delays under the current NRC procedures are summarized in the table below
12 Enclosure 3 _~
Incremental Sum of Fraction of Annual Basic impact on impacts on applicants industry Case
- assumption applicant applicant incurring impact impact I no $ 78,261 78,261 all $5,869.575 prelicensing investment II interest on 26,733 104,994 1/2 6,872,063 equipment and facility III salary for 8,379 113,260 3/4 7,343,382 one technologist IV salary for 26,619 139,880 1/2 8,341,594 one physician <
V Radioimmuno- $125,571 $265,450 1/10 $9,283,377 assay lab. investment x Applicants who make a resource commitment at a given' case level are assumed to have also made the commitments for the preceding case levels, i.e. , Case V applicants have all the same commitments as Case I through Case IV applicants in addition to having applied for in-vitro authorization. Under the current system, the training and experience of each new physician to be added to a license for use of byproduct material is evaluated by the NRC staff before authorization is granted. Again, because of the shortage of-nuclear medicine physicians, most of these individuals are placed on hospital staffs before the application is forwarded to the NRC. Currently an average of 55 workdays elapses, including applicant deficiency response time, before the processing of an amendment to add a new physician user is completed. Each year, about 200 licensees request addition of a new physician user to an existing license. To retain a nuclear medicine physician on staff costs an estimated $469 per day to the medical facility. These applications could also be processed within 10 workdays or less. Even when it is assumed that half of the hospital's cost is recovered by having the nuclear medicine physician cover for other medical staff positions, the cost of amendment delay to licensees would be $2,110,500 annually. The assumption of 50 percent recovery is based on a comparison of salaries for recent medical school graduates and board certified specialists. 13 Enclosure 3 f
Professional and clerical time for preparing an application for a new nuclear medicine license is estimated to cost $1238 under current NRC proce-dures. This assumes 2 days of professional nuclear medicine physician time at $469 per day and 3 secretarial days at $100 per day. A significant reduction in clerical effort based on time needed to do the detailed typing of an appli-cation and supporting documents is expected to save almost $335 per new application (one-half day professional time and one day secretarial time). Assuming 75 new applications per year, the annual saving would be $25,125. . The new procedures will eliminate the necessity for up to 95 percent of the amendments that result from existing NRC requirements.* The NRC reviewed 1,300 requests for amendments to_ medical licenses in 1981. An amendment is estimated to now cost the licensee $335 to prepare (one-half day professional time and one day secretarial time) and requires a $40 NRC license amendment fee. Savings from elimination of the necessity to file 1235 amendments will total approximately $487,500 to licensees annually. Total savings to be realized by NRC medical licensees from all of the proposed changes in licensing could be from $8,492,700 to as much as $11,906,500 per year. B. NRC Operations - The proposed rule will make significant improvements in NRC's operations. The principal value to NRC will result from converting the current detailed review of new specific license applications to a system employing a simplified review supported by the current practice of postlicensing visits to new licensees by NRC staff. NRC regionalization plans call for all byproduct material licensure to be done in the regions. Under a program of full regionali-zation, licensing and inspection services may be performed by the same staff. Time consuming review of detailed license submissions and reliance on license conditions are currently necessary because current regulations do not adequately address many. activities having important implications for radiation safety. The revision of the radiation safety requirements will permit a streamlined license process without sacrificing safety. The existing system of handling license renewals is_ inefficient in its use of staff resources. Each license action is reviewed by a professional staff member. The proposed revision, by reducing the information to be sub-mitted, would decrease staff time required for each case review; this would 14 Enclosure 3 ,' g --
E allow an increase in licensing actions completed per month and a decrease in existing case backlogs. A reduction of both the number of amendment requests and size of new applications will result in further savings due to a reduction in the volume of paper processed and filed. A major benefit to the NRC from the proposed rule would be conservation of limited professional resources now applied to license review. Improvement of. the overall regulatory process, including the development of guidance related to public health and safety in medical uses of byproduct material, . would result from the redirection of staff resources. Review of 75 new licens-ing applications annually, each requiring 10 professional staff hours at
$58 per hour, costs NRC $43,500. Review of 250 renewals per year requires 10 hours of professional staff time each, and costs NRC a total of $145,000 annually. Review of 1,300 amendments requests per year requires 4 hours of professional staff time each, and costs NRC a total $301,600 annually. Total annual NRC professional staff costs for review of new, renewal, and amendment requests for nuclear medicine licenses are estimated to be $490,100. Under the current NRC fee structure only $103,750 of these costs is recovered.
Under the proposed rule, overall professional staff costs for processing new applications would be slightly increased when the balance _between' increased travel cost to each new applicant's facility (licensing or inspection staff) and the reduction in staff review time is considered. Review and issuance of new licenses would cost $58,500 per year, based on NRC " cost" of $58 per hour for professional staff, 10 hours per case and $200 travel per case and 75 new cases per year. The NRC cost to issue a new license may increase because travel cost may have to be included in the total. However, the NRC inspection manual gives first priority to inspection of new licensees. These are to be scheduled within the first six months of operation. Cost could be minimized by rescheduling these for the first 60 days after the new license is issued. The professional costs for issuing medical renewals would be reduced to $14,500 per year based on the current load of 250 renewals each year, and one hour of professional time to process each one; it would cost $3770 per year to issue medical amendments based on receiving only 5 percent of the current 1300 amend-ment requests, and one hour of professional time to process each one. This results in a total cost of $76,770 per year. j l 15 Enclosure 3 f
NRC Cost Comparison Medical License Reviews Dollars (annual) l Current Proposed Process New 43,500 58,500*
- Applications Process renewal 145,000 14,500 applications Process amendment 301,600 3,700 applications Total 490,100 76,770
- Includes cost of a postlicensure visit to each new licensee.
This should not be necessary in all cases. Under the existing fee structure, NRC would achieve full recovery of costs. The dramatic cost savings are possible because renewals are currently reviewed with the same thoroughness as new applications and, under the proposed scheme, most amendment requests that are currently received would be unnecessary. Office of Inspection and Enforcement inspection cost could increase over present levels if early experience shows additional surveillance was warranted. Such a.need is possible but not expected because inspection reports indicate that compliance with the regulations and licen'se conditions is in most cases satisfactory. Savings in review and paper handling time resulting from con-solidation of requirements in one place are expected to result in a substantial overall saving to NRC. The beneficial effect of the propose'd rule on regional licensing operations will be significant. It will ensure consistency of licensing actions between regions by providing a clear and uniform regulatory basis for making licensing decisions and conducting compliance inspections. i 16 Enclosure 3 _-
C. Public There will be no decrease _in safety to the general public because the new procedures do not relieve licensees from meeting current safety standards. There will be improvements in the regulation of safety of the general public because the new procedures will permit NRC to place more emphasis on inspection and generic radiation safety problems. Patients will benefit from more prompt availability of vital health care services and new state-of-the art procedures if NRC places licensing emphasis on specific performance criteria and relaxes . present restrictions on the physician's choice of specific clinical and safety procedures. Reductions in licensees' costs will mean there should be no increase in overall public health care costs due to NRC regulation of nuclear medicine s.ervices. D. Agreement States Most Agreement States are in favor of placing the requirements in the regulations and support this revision of the regulations. However, the Agree-ment States are concerned about the impact of the proposed licensing proce-dures. Many feel that a prelicensing review of safety procedur'eslis neces-sary to ensure safety. Their contention is that they may be pressured by their own licensees into adopting NRC's revised review procedu'res. The NRC staff believes that, since the Agreement States are not required to maintain compatibility with NRC in the area of medical licensing, they would have the option of incorporating into their programs those features that they find desirable while rejecting those features that they find objectionable. In implementing the rule, the NRC staff recognizes that there may be a need for differences between NRC and Agreement State procedures. The staff feels that the current effort will not decrease, but will enhance safety through three major features: (1) redirecting staff resources from case-by-case reviews to developing guidance and integrating technical developments into licensing decisions, (2) specifying all essential safety requirements in the regulation, and (3) detailing in the regulations the minimum acceptable training and experience for medical users of radioisotopes. NRC may supplement these features with an early on-site post-licensing visit. 17 Enclosure 3 _'
F
. i E. Other Federal Agencies With the exception of government entities that are NRC medical licensees, l such as Veterans Administration (VA) and Department of Defense (D00) medical r
facilities, there will be no impact on o.ther Federal agencies. The impact on i VA and D00 medical licensees will be the same as on all other licensees. [ I
- 5.
SUMMARY
AND CONCLUSIONS !
)
l The proposed rule and concomitant simplifications of the NRC medical ; licensing program would result in a more understandable licensing process and l cost savings to' licensees, the public, and the NRC'. This process would be accomplished by a series of changes, the most important of which would be [ amendments to the regulations, revisions to regulatory guides, development of I a new licensee application form, and postlicensing visits. ; J
! In arriving at these proposals, the staff considered the use of both .
general and specific licenses for structuring a more efficient licensing i procedure. The general license was conceptually unsuitable because it lacked continuing regulatory surveillance. However, calling the new docu- ! l ment a specific license implied the " Status Quo." The new license, there- 1 ? fore, will be called a " medical standard license" although it is a form of I specific license. - Simplification of the licensing process is possible because current licensing procedures were established when safety considerations in nuclear medicine changed rapidly to keep pace with the many advances in the field. The high degree of sophistication in the field has contributed to a relative 4 stabilization of radiation safety methodology. Licensees should now assume more responsibility for decisions on how to best implement s'afe procedures [ 1 while conforming to the revised rules. This new degree of flexibility will benefit the licensee, the NRC staff and the public. There will be increased emphasis on those aspects of licensing that are most important to radiation ' safety. At the same time, licensees will be given greater latitude to determine how best to conform their practices to meet stated requirements. Radiation protection would not be reduced through this simplification. Y l 18 Enclosure 3 9
e S 9 r
}
I f I ENCLOSURE 4 l t ORAFT PUBLIC ANN 0UNCEMENT f P l i f i M N
NRC PROPOSES TO SIMPLIFY MEDICAL LICENSING PROCEDURES The Nuclear Regulatory Commission is proposing to revise its regulations to simplify the licensing process for the medical uses of radioisotopes. The NRC issues licenses to medical facilities and individual physicians for . the use of radioactive materials to diagnose and to treat patients. At present, the regulations for human use of radioisotopes, contained in Part 35 of NRC regulations, provide for issuance of general and specific licenses. The general license authorized physicians limited use of small quantities of prepackaged radiopharmaceutical kits. Only a registration form is required for a general license; whereas a specific license requires an application form. Specific licenses are issued for one or more of six groups of human uses organized in ascending order of radiation hazard potential, each contain-ing related diagnostic or therapeutic procedures. A separate license is issued for teletherapy units. Applicants for specific licenses must submit enough information to show that all requirements will be met. This includes a description of the procedures used in meeting these requirements. The Commission's radiation protection requirements cover three general areas: radiological health and safety; personnel training and experience; and facili-ties and equipment. However, current requirements are found throughout regulations, regulatory guides, lists of standard license conditions and other sources. Therefore, the primary purpose of the proposed revisie is to provide a single source for the requirements. Under the proposal, all requirements would be clarified and consolidated into one place, Part 35, which would serve to regulate the daily e:,es of radioiso-topes. The regulation would first present the requirements that apply to all licenses and then detail the specific requirements for each of the various use groups. The general license would be eliminated, and the radiopharmaceutical kits would be included in the lowest hazard group. The revised regulation would give both licensees and NRC staff a clearer basis for licensing, operation and inspection activities. l 1 Enclosure 4 f i ' 1
The regulatory guide for medical programs would be revised so that it will contain at least one procedure acceptable to NRC for meeting each of the human use requirements. Licensess would then have access to a suitable procedure for meeting the requirements, although alternative but equivalent procedures could be used. The requirement for NRC review and approval of the procedures would be eliminated. To further increase efficiency, a computerized information system would be . used as a tool in the staff review of applications. The system can be used to cross-check application data from licensees of similar type and size; to permit preparation of statistics; provide prompt replies to technical questions and to evaluate trends. The NRC staff believes that these procedural changes could result in considerable cost savings for medical licensees. For example, an average of 94 days now elapse from the time of an application to license issuance, including the time required for the applicant to respond .to NRC requests -for additional information. The simplified process could reduce this time to 10 days. This decrease in time could save new license appl _icants from $8 to
$11 mil-lion annually in revenue during the time lost waiting for licenses.
The primary benefits to the NRC would be faster license processing; reduction and eventual elimination of backlog; redirection of staff resources to other important or newly evolving safety issues; and more accurate cost recovery than possible under the present system. In addition, the volume of paperwork handled by both the NRC and the licensee would be greatly reduced. The proposed revision of Part 35, which is basically a restructuring of already existing requirements, does not change current safety standards. It is being published for public comment in the Federal Register on . Interested persons are invited to submit comments or suggestions to the Secretary of the Commission, Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Service Branch, b'y (60 days) . 2 Enclosure 4 7 _- ~
, - _ , .- ~
O W e ENCLOSURE 5 DRAFT CONGRESSIONAL LETTER e-
O [ DRAFT CONGRESSIONAL LETTER Enclosed for the information of the subcommittee are copies of a Notice of Proposed Rulemaking to be published in the Federal Register. This proposed rulemaking would simplify the present medical licensing process by clarifying and consolidating the requirements for medical uses of byproduct material. . The proposed revision will primarily affect future NRC licensing actions for hospitals, clinics and individual physicians. The proposed revisions to the existing regulations, which would be combined with a simplified licensing application form and a computerized management information system, will be of sufficient importance in reducing the paperwork burden on both the licensing applicant and the NRC staff. The result will be more staff availability to focus full attention and resources on the primary issue, radiation safety. Time saved by the staff will also free resources to address more comprehensively the following two key areas: Programmatic safey issues would be dealt with in a more timely manner, and, Onsite visits by the licensing staff would be initiated to determine more useful and realistic information about radiation safety conditions. The typical nuclear medicine laboratory provides a battery of diagnostic and therapeutic procedures utilizing radiopharmaceuticals and radioactive devices. Mistakes or accidents can lead to high external exposure, internal disposition or spread of contamination in the laboratory and other hospital areas. There-fore, the method selected to regulate nuclear medicine must provide sufficient control to assure that training, facilities, and equipment, and operating procedures are adequate to protect the public health and safety. 1 Enclosure 5 f
v \ Medical licensees will have to satisfy the same technical requirements under the proposed rule as they satisfy under existing regulations and license .condi-tions; therefore, the net cost incurred for satisfying technical requirements will be essentially unchanged. However, substantial administrative cost savings will be realized under the new rule and licensing procedures. Current requirements are contained in a variety of sources including regulations, guides, license conditions and the applicant's own submissions. Because of the confusion this creates, and to avoid the delay caused by deficiency . letters, applicants frequently overcommit to assure meeting all NRC require-ments. Thus, licensees will benefit from reduced compliance costs because the NRC regulations will be simplified and codified, and will allow flexibil-ity in-the selection of the cost-effective means of meeting regulatory requirements. Revenue losses caused by licensing delays will also be greatly. reduced. Applicants will benefit further by elimination of the costs to pre-pare lengthy formal license applications, renewal applications, and amendment applications. The proposed rule would be equivalent to a set of performance standards for the licensee's safety program while providing flexibility in the methods used to meet the standards. E 2 Enclosure 5 7
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MIEFIEG OIE SECT 83-62, PIIOPOSED IEEVISICIE TO 19 CFR PART 35, "RUMAN USE OF SYPIBODUCT MATERIAL" Lasament washington, D.C. Pngst 1 - III Dnet wesday, April 19, 1983
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1 I Wa!TED STATES OF AMERICA r 2 30 CLEAR REGULATORY C04MI55!0s 3 -- - a BRIEFING De SECY-83 PROPOSED REVIston TO 5 10 CFR PART 35 *NUMAR USE OF SYPRODUCT MATERIAL" s -- - 7 PUSLIC REETING e -- - e Reclear Regulatory Coenission Countssioners' Conference Room m lith Floor 1717 "H" Street. M.W.
- Washington D. C.
nr Tuesday. April 19. 1983 13 The Commission met in open session, pursuant to 14 notice, at 10:03 o' clock a.m. . NU4Z10 J. PALLADI9O. Chairnan m of the Commissioe. presiding. ms COMMISSIONF.R5 PRESENT: sy 40mZ10 J. PALLA0!MO. Chairman of the Comnission VICTOR GILINSKY, Member of the Connission ye J0MN F. APEARME, Member of the Coenission THOMAS ROBERTS, Nember of the Connissian w JAMES K. ASSELSTIME Member of the Co,nission 3, STAFF ARD PRESENTERS SEATED AT CO*PI55104 TABLE: 21 5. CHILK J. MALSCH
,, J. ZERSE J. DAVIS
,3 R. CUN4!MGH4" W. WAIKER
,, 5. OLMSTEAD W. SPELL as R. R0RIN50m O. LINTOM K. WHATLEY J. OELMEDICO P. VACCA nummmmmmmmmmmmmme
DISCLAIM R This is an unofficial transcript of a meeting of the United States helear Regulatory Commission held on April 19, 1983 in tJte Commission's offices at 1717 N Street. 5.W., Washingtse D. C. The meeting was open to public attesulance and observation. This transcript has not been reviewed, corrected, or edited, and it umy contain inaccuracies. The transcript is intended solely for general informational purposes. As provided by 10 CFR 9.103, it is not part of the fonmal er inforumi record of decision of the matters discussed. Expressions of opinion in this transcript de not necessarily reflect final determinations or beliefs. No pleading 3r other paper may be filed with the Commitssion in any proceeding as the result of or addressed to any statement or artassent contained herein, except as the Comission usy authorize.
P. K 0, C,_ [ [ D_1 N E $_ I ( CMAIRRAN PALLAD!m0: Good norning. ladies and , een tlemen. The Commission has before it consideration and action by notation vote a proposed rule-making that would sigolf+cantly alter the licensino processing for medical use 8 in hvoreduct materials. The purpose of this mornene's meettne is to learn 8 free the staff what the proposed revision entails and some 8 sf the rationale behind the changes that are being suggested, and also to hear from representatives of several groups who 33 would be directly affected by the proposed revisten.# With us this mornine in addition to the staff are 4 Mr. William Spell who will comment from the viewpoint of the Agreement States. Dr. Raioh Robinson.' President of the American 4 College of Nuclear physicians representing the views of that to organization and the Society of Nuclear Medicine, and Mr. 87 l. Otha W. Linton who will speak on behalf of the American 18 College of Radiologists. g se 2
! understand that there are dif ferences of opinion as both within the 4RC staff and amone the organizations d
21 represented this morning with regard to some features of the i 22 nroposed revision. One of the purposes of this meeting is 23 to identify and discuss these issues. I would invite the 34 speakers to comment on them at the appropriate time. Unless M other Commissioners hava opening comments. I would turn the L
3 1 meoting cuor to Mr. Daois, 2 COMMISSIONER AHEARME: Could I ask one questlem? g 3 Since many of the questions that we might have of NM55 may be 4 addressed by the following speakers, will we be able to get a back to questioning 4 MSS af ter the other three speakers, e in which case I would hold most of my questions until then? l y CHAIRMAR PALLADIMO: I would expect that we would a be able to do so. sure. s COMMISSIONER AHEARNE: Fine. i w CHAIRMAN PALLADINO: Are there any other comments? i, (No response.) CHAIRMAR PALLAnlMO: We will try to allow the n is presentations to go as smoothly as nossible so we have time f to return to questions. I w g MR. DAVIS: Thank you. Mr. Chairman. First as you g say, we are here today to talk about a proposed rule-making to Part 35 of the " Human use of Byproduct Material." Byproduci 37
, ma t e , t a l licensing as I am sure fou know is one of the oldest l
.I of the regulated activities by MRC. It has been regulated by g ,, ls , MRC and its preceding agency. AEC. for about 35 years. t At one time 'lt was the principal licensing activity of the 4EC. COMMISSIONER GILINSKY: In the good old days. MR. DAVIS: In the good old days. Medical licensing , t of course, is a subpart of this byproduct material licensing
' and constitutos o major use of radicactivo matorfol.
2 Currently under NRC jurisdiction. there are about p -
. :, :> ~ ,.
2.'500 hospitals and physicians ,that are Itcensite and about an ! ~/ j
- equal number, perhaps a few more, by the Agreement States. "
,s , ~c A
' These administer about 15 to 20 million medical procedures per i
e year using radioactive materials. 7 I In turn, we have a fairly large workload of e applications associated with the handling and regulation of I a these licenses. We get about 2.500 applications ke9 year
# for some either new license, modification to a license or 11 a renewal of medical license. So it is a fairly large flow of
'2 work. ,> iC s u.) M u a .-a. / n': < - d.
u Over the years th'e' licensing 'pNogram has been
- - - i k
l 14 modified princloally on an ad hoc basis. About 18 months ; I M ago, we began a systematic look at medical licenses and what M you see today is a result of that systematic leek. l' !! a# Dr. William J. Walker, Jr., who handles the medical l [j 17 l 1 18 and acadenic licensing section in cur division of Fuel Cycle
- i to Material Licensing will be our principal speaker.
't COMMISSIONER GILINSKY: Does " doctor" mean medical ll as
$ doctor?
21 ) l' 22 MR. DAVIS: No. He would make more stoney outside. 23 In any event. he will be handlino it. We have a briefing l 2e prepared which will speak to why we think the change is needed ( 25 in doing the re-look, what our goals'were and in general terms 1
l 8 chat the changos cro that te Oro prcposicq. 2 Basically the changes which Dr. Walker will go into
;{
3 in some detail are two, a change to the rules and then a
. . , 1 4 change to the processing internally of appilcations. So a there are two approaches which are contemplated. l e Now there are other staff members here in the 7 audience. two of whom wrote the Commission expressing sone a concern about the approachr being proposed and both of thes l
s are here to answer any questions you may desire to olace to i l
~
' " ' U l De them. 9% "*F 11 COMMISSIONER GILIRSKY: I hope we will be able to 12 hear briefly from them at the conclusion of the presentation.
13 MR. DAVIS: However you desire to interface with
"~ - ~
14 them. is fine. I wil1 turn'this now over to Dick Cunningham is who heads the division under which this is done. De MR. CultMINGHAM: Mr. Chairman. I think just to I g 17 expand a little bit on what John said and why we Changed this is rule, if you look back over the last 30 years in nuclear i g to medicine. it has been marked up untti about five years ago as with rapid growth in technologies. New technologies were a
- d 21 developed quite rapidly.
i 22 Over past five years though. nucle 9r medicine has 22 pretty well stabilized in the develoonent of technologies 24 although new radiopharmaceuticals are being added to the list i I 25 of drugs used for patient management. But the technology 1 , , , .
= w. , 8 l
l . ---. .-. - . . _ _ .
l 6 1 involving procod::res safety proccduroc, and so fcrth have j l 2 fairly well stabilized and we have what is now a rather large l Q s d/ s .
-r : "
s and saature nuclear medicine industry. The consegmence ' a though of this growth in technology over the last compte of ! 5 decades has resulted in regulattens not keeping up to date l e with -- complete integrated regulations not keeping op to y date with these changes. s . .o ., u a Our licensing procedures are scattered threven a regulations, guides. license conditions, staff technical l
- l se positions and so forth. The consequence of this prellferation I
si of bi ts and pieces of rules and requirements has been that i
. u 'u. '
1 ar,u.
. ( '. ,
l 12 we 'get poor applications of ten and the license reviewers 1 13 must spend a lot of time reviewing the details of the applica- l { . .
< ~
f tion to be sure that everything. is in_ place.
34 is Given the resources we have and the pressure to act
,, on these applications quickly as quickly as we can for good
. ..a I
37 reason because they affect the abiliti ef hospitals and j l
, ,, . < , , .n w .. ,
la physicians to manage patients, the staff has had little time i I
,, to concentrate on the sajor issues of safety significance.
f'
, Just as an example, a few years ago, we were advised i by our medical advisory committee as well as some other ,
., organizations that we ought to substantially increase the training requirements for physicians practicing a broad range n
. I
, of nuclear medicine. The staff action on that was delayed
( aim st a year simply because of the need and the pressure to I a t
l 1 review applicaticos. It ecs chest that time that se 4::cided { l l f 2 a major everhaul was needed in these regulations se that we k l a could streamline what was required from applicants consolidata I a i t, integrate it and put it in one place se that we could 5 tse our resources addressine the major safety issues. trainteg. g for example. ,,.. 1" , ]k c s .x~- ...( 3 ,; n.,..y. y No matter how detailed we would look at procedures e in nuclear medicine practice, the quality of the program e sittmately rests on the training of the physician. If you Jr is have been in nuclear medicine laboratories and see the i, movement of patients and the volume of traffic throegh these, a yee know that in the final analysis what you are really u looking for are well-quali fled practioneers. f - w It' is these kinds of issues that we should be
, add res si ng. That resulted in forming the task force which
, Bill Walker headed to try to streamline and integrate these
,7 regulations and get them in one place to the extent possible
, and allow the staf f to concentrate its resources on those I matters which are of more importance to safety significance.
j , Mt th that supplement to what John said, I will i turn it over to Bill to explain what we did and why we did it. MR. WALKER: Thank you Mr. Cunningham.- Mr. Chairmas and Mr. Commissic,ners, I have slides prepared and I think each of you has a copy of these. and I will speak from these ( , i f I may, please. I think it is important to point out that I
8 tha task forco that Cctually werkCd Ca the rovistoa of the g 2 rules and the procedures was composed of representatives 3 free all the major offices of mRC, mR$5. Research. ELO. 4 The Office of Adelaistration. Inspection and Enforcement s including representatives free each of the regional offices. e the Office of State programs and -two representative, were 7 appointed from the Agreement $tates te sit en the task force. 8 The major draf ting coenittee, as it were, was e composed of representatives free RMSS Research and from ELD. M The first thing that I think we need to address 11 is why we wanted to change this. The current requirements 12 as they are imposed on'awclear medicine are patchwork. The 13 current Part 35 was put together in 1967. It has been l I - _ _ 14 amended quite frequently since then. l counted this morning is something on the order of about 26 or 27 amendments to those is reoniations. Many of these were added in what was or appeared 'I n to be appropriate fashion, but makes it very difficult to read. g to It is now confusing not only to the applicants but m to the NRC staff that must impose the regulations. The 2 as regulation, however, is s pplemented with requirements from s 3, numerous other sources, guides, individual policies, standard i 22 conditions which have been developed over the years by the i 27 staff. , 24 The need to support such a cumbersome set of as requirements means that the licensing process itself must be
1 cumbercome. So me teed to 1cck at overhaoling the 11ce:3 sics 2 process itself because the current process is neither efficient 3 nor effective. I think we can point to the fact that 4 frequently questions are asked from this Commission about s our backlog. I think Mr. Davis and Mr. Cunningham have shown a that that was part of our problem. 7 COMISS104ER AMEARNE: Could feu just give me a e feeling for how big a backlog there ist e MR. WALKER: -I have some figures. I thought we to might have a question on that one. The backlog if you count is actier ever 30 days that are pending at this particular 12 point and these are 30 calendar days in-house, total actions, 13 there are 18g of them right now.
~
ta' C0MISSIONER AMEARNET Did John say you have about is 2,500 per year? is MR. WALKER: Oh, no. i sy C0MISSIONER AHEARNE: How many do you have per yearl is MR. WALKER: Total actions ner year, we are project-l to ing 6,700 total actions per year. 20 C0MISSIONER AHEARNE: All right, 6,700 per year 21 and you have 189 that are over 30 days. 22 MR. WALKER: Correct.- In house at the current a time, me have all actions of any age approximately 1,200 of them right nou. 2s C0MISSIONER AHEARNE: What is the average time
s . . ee I it tokos to got this prccess to actico? 2 COMMISSIONER GILINSKY: Did you say there were only 3 sixty some-odd that have been here over 30 days? a COMMISSIONER AMEARRE: One headred eighty-nine. 5 which is a pretty small number. s COMMISSIONER GILINSKY: That is what I thought. 7 MR. WALKER: But these are over 30 days and there e are a number of those that have been here a considerable e length of time beyond that. w COMMISSIONER ANEARNE: What is the average length si it takes you for an action? 12 MR. WALKER: I have some figures on that, too. 13 It depends on the action itself. f g4
~
COMMISSIONER AMEARNE: Obviously there is wide
,, variety.
,, MR. WALKER: The processing time on medical I
,7 applications for March in 1983, it was 77 days and 219 actions. I I
g So tha t gives you some idea of where we are right now. I
; y COMMISSIONER ASSEL5 TINE: Bill, when you say 219 fa , actions for medical applications. I take it that includes i , new applications, renewals and modifications.
, MR. WALKER: And amendments. Correct.
COMMISSIONER ASSELSTINE: Does nost of the effort
, basically go to new applications?
( ,- MR. WALKER: Our priority system calls for us to
= - .. 1 prccess a cew cypticatico first. 2 COMMISSIONER ASSELSTINE: I gather the renewals. 3 you don't go through and check everything all over again. 4 It is the responsibility of the applicant to identify the 5 areas where they are changing. 8 MR. WALKER: That is correct. y COMMISSIONER ASSELSTINE: How many new applications a do you get per year? 3 MR. WALKER: We are expecting receipts for new se applications projected for the year of 700. This is just 3
,t medical. These are all applications. I didn't break 12 all of these down. The processing time, however, that 1 13 gave you was for medical applications.
34 COMMISSIONER ASSELSTIME: Could you give me a general idea of new applications for medical? A number. g MR. WALKER: I would say probably in the order of 45 to 60 days. g COMMISSIONER ASSELSTINE: Number in a year.
,, MR. WALKER: Number in a year, the '83 receipts for
, new medicals was 128.
COMMISSIONER GILINSKY: These licenses are for 3
, what now?
MR. WALKER: The greatest najort ty of then are for
, nuclear medicine services diagnostic type implementation.
3 COMMISSIONER GILINSKY: They permit what? Use of
. . .~
l 1 radioactiva isotepas for scoe parted of time er c: hot? l l 2 MR. WALKER: The license is is sued for a period ! 1 I 3 of five years and is renewed af ter that five years. 4 COMMIS510NER GILINSKY: So presumably people can s send in an application well in advance of the end of the l s five year period? It doesn't sound like a couple of months I 7 is a ' great burden. ! s MR. WALKER: We send out reminder notices at 99 3 days before ' the expiration date. We include in the packet se various information that they need for renewal. So we is are talking -- but the times I am giving you are the times 12 from the time we receive the renewal application. 13 COMMISSIONER GILINSKY: i unoerstand that, i4 I guess the situation was more under control that I thought. i ig MR. MALSCH: Actually for renewals. if they submit to a timely application, the license is continued autonatically 37 in effect untti the staff acts on it.
,, MR. DAVIS: There are three different types of
- , applications here. One is for new, and by new we mean an 3, institution or a physician who has not previously used the g ma teri al . Those are the ones which run the opportunity if
, we delay of interfering with the practice of nedicine.
23 COMMISSIONER GILIMSKY: Except that one doesn't just go into nuclear medicine all of a sudden. There is a long g planning period no doubt.
I Mt. SEVI5: I tooid haps so.
- C0fGEI55IONT4 GILInstY: And part of that planning
} 3 period is planning to get a license, a Rt. DAVI5: The second are amendments which are. 5 of course, are authorizations to change what they are detag on a pre-existing license. That is the largest flow of e 7 applications. We get about 2,000 of those per year. i I e COMMISSIONER GILINStY : Can you just give me one e example of what we are talking about here? se MR. DAVIS: How abast the example of extending the n use LJ a different use? COMMISSIONER GILINStY: Add additional isotopes to 13 the list? l MR. WALKER: Add addltional isotopes to the list u or ' add a new user or change a radiation safety officer. is
,, some+hing like that.
,7 CHAIRMAN PALL ADINO: Do they involve a change in a procedures?
,, MR. DAVIS : They may or may not.
CHAIRMAN PALLADINO: I meant, included among
, them may be some that involve a change in the procedures.
, MR. DAVIS: Yes, i t could be.
CHAIRMAN PALL A0lMO: It could La other procedures g in the license?
, MR. DAVIS : Yes. The third category is the renewals
so
- I acd that is the o::o charo the timely applicotloo t:ccid coply.
g 2 These are the ones that get the lower priority and we get 3 about -- we are projecting about 550 of these. a CHAIRMAN PALLADINO: I was ooing to say, aside 5 from the timing and workload problem. if there is confusion a among the regulations. I think -- 7 COMMISSIONER AMEARNE: I was just trying to get an a understanding. They mentioned that they were trying to make s it more efficient and talked about the bactiog, so I wanted to to get a handle on that. 11 You also said that you want to make it more 12 effective. Do you have some indication that the current 13 approach is not ef fective? i4 MR. WALKER: It is not ef fective in soliciting is the submissions that we want from the license' simply because is the licensee frequently does not understat. i:nes e . 17 COMMISSIONER AMEARNE: I made the assumption that I is ef fectiveness was that there was adequate protection of the
.i j i, public health and safety.
- f 3 COMMISSIONER GILINSKY
- Are patients protected?
a i 21 MR. WALKER: ' think patients are well protected. 3 COMMISSIONER AHEARNE: As far as that type of y ef fectiveness is concerned, the fundamental mission of the NRC 3 of providing adequa te protection of public heal th and safety G a through the regulated use of radioactive materials, you are
I not raisicg f oto q=ostico offcctivacoss of that, cro yOc? 2 MR. WALKER: No. I as talking about the effective-3 ness. I think, of the process itself that we are looking at. 4 COMMISSIONER ASSELSTINE: If as you said before, 5 that the present jumble of guidance whether it is in the e regulations or in various other guidance documents is 7 confusing and the licensees er applicants don't understand 8 or may not understand all of those requirements. It seems e to me that does have an implication on public health and up safety. is COMMIS$10NER AHEARNE: Jim. I can see that that nr could have a potential for it but I was trying to draw a ut contrast between in the 1970's there were really real charges ( . . . . . ut of the effectiveness with the public being adequately ; Hg orotected. I wondered whether that was the issue here. m COMMISSIONER ASSELSTINE: All right. I 3 37 MR. CNNINGHAM: If I may expand on this a little ; e
~
up bit, as Commissioner said we don't get that many receipts of I y, new applications simply because most hospitals have nuclear a medicine services. 3 y By far the bulk of our work is in the license 22 amendments. Those license amendments are rather important 23 because many of them involve adding a new drug to the proca-3 dure or a new physician that is allowed to use or work under ( the license and so forth. 3
1 Whec it 32ts to offcctiveness thora aro novoral 1 2 ways to leek at it. Certainly if effectiveness means 3 ef ficiency, thee the consolidated procedures hels. There is l . l 4 as Commissionar Asse15 tine pointed out, effectiveness in - 4 5 the people who use these things fully understanding what they a are required to de and why they are required to do it. 7 There is another part of effectiveness. To the e estent that the system is inherently taefficient. the delays e in issuing those amendments means that certain types of drugs N3 in that period are not available for patient management. t i 11 That af fects public health and safety la a way that is 12 somewhat differest than we normally consider it but it is 13 there. I '
- . -- _ i 14 COMRISSIONER GILINSKY: You are talking about is something like a two month period, is that it? Does this 4
un 77 days characterize the time for areadments? j . 37 CORRISSIONER AMEARNE: If I understood your numbers un correctly. It would be over 200 actions and a total of 77 )
, \ l I
i days, is that correct? i ne f= ya MR. MALKER: Yes. 1 5 7, COMMISSIONER GILINSKY: Earlier, it sounded like it !
- } !
- would be less than that. .
l 22 23 COMMISSIONER AHEARNE: Less than three days per y action.
- ( 25 COMMISSIONEP GILINSKY: I see.
1 l
' . ea 1 COMMISSIONER ASSELSTINE: Ycs, that is right.
2 COMMISSIONER GILINSKY: I avess I didn't fellow a that. a CDRMISSIONER AMEARNE: When I asked you what was 5 the average tin.. you gave se, you said here is the number e of actions and here is the number of days. 7 MR. WALKER: That is' correct. a CDRMISSIONYR AHEARNE: My interpretation of what a you meant was that the sus total of all of the days that were we taken for all of those actions. i si CORMISSIONER GILINSKY: It is like a third of it. f i 12 CORMISSIONER AHEARNE: So, do I divide the 13 number of actions by the number of days to get the average g 34 days per action? ! is MR. WALKER: No. These are the average days per is action. s j 37 COMMISSIONER AHEARNE: Seventy-seven days. y; COMMISSIONER GILINSKY: No. It is 77 days before
; u, the thing gets out. People aren't working on it for 77 days.
fa 3, MR. WALKER: They may have started working on it 5 the first day it came in but from the time it coris in to 21 i r our door the first time until we sign the license and tend 22 it out is averaging 77 days. 73 COMMISSIONER GILINSKY: How aany man-days or 3 ( , woman-days per action?
I I MR. DAVIS: You aro tolkicg. how much time does it )
-2 take to issue a license. Is that your question? 1 3
l COMMISSIONER AMEARNE: Yes. I i 1 8 New much applied s taf f time? MR. DAVIS: l 3 COMMISSIONER AMEARNE: Yes. s MR. DAVIS: We will have to get yee tha t . info rma ti on. 7 COMMISSIO9ER GILINSKY: Do you have any idea? 8 MR. DAVIS: It varies greatly. e MR. WALKER: We do have work factors that we 18 calculated. 11 CHAIRMAR PALLADINO: Nowever, I would caution 12 ac' inst jumping to saying it takes so many staff hours to 13 do scmething because sometimes to make a telephone call for 14 se takes three days. 18 (Laughter.) 14 CHAIRMAR PALLADINO: Because I try to call and I I g 17 don't get somebody and they have to Call back. You all have is had the same thing happen. Then when I get the person, they 2 to have to check the information and accumulate it to respond zo to questions. So I caution. 21 COMMISSIONER GILINSKY: But this is the way we plan i 22 our work. 23 MR. DAVIS : What I can prepare you which we don't have with us, we can give you the work factor for new I 25 applications, amendment applications and renewal applications.
10 l ! 1
- - C0fetISSIONER AMEARNE
- Fiso, cDich weald bo yocr
! 2 3 planning factor. 3 MR. DAVIS: That is what we use in the budget. a C0mISSIONER AHEARRE: You had said that you have l ( 1 5 ! about 6,700 actions per year. Is that right? l - MR. WALKER: That was for all materials. COMMISSIONER AHEARME: You also said that you have ' s about 189 which are over 30 days at the present time. i MR. WALKER: That is correct. MR. DAVIS: Is that just medicals or all of them? 4 We may be operating off of two bases here.
** I thought he said 1,200 COMMISSIONER GILINSKY:
'* 1ess than 30 days and 189 over 30 days.
- f
' One of them is for MR. WALKER: I have two lists.
all actions in house pending at this time. I have another
" l i s t -'-
'E
'I
! COMMISSIOMER GILINSKY: We are not talking about
" medical licenses?
'A " MR. WALKER: These are all materials licenses.
1 20 CHAIRMAM PALLADINO: Can we concentrate on medical? '5 21 Why are we talking about g COMMISSIONER GILINSKY: , 22 the others? 23 COMMISSIONER AHEARNE: 8ecause they are under this 1 N rule. l 25 COMMISSIONER GILINSKY: I thought they were not l
.- . 4.
' CCvorGd by this relo.
' The medical days de not change very
( MR. WALKER: 3 as far as looking at a license at the industrial auch'
- side and the medical.
- COMMISSIONER AHEARNE: Just looking at the actions a covered by this rule, strictly by this rule, can you tell as ,
7 how many you expect per year? How many did you get last year? s MR. WALKER: In 1983. our expected receipts for 8 new licenses are 128. We expect 1.972 amendments and 556 renewals. Il COMMISSIONER AHEARNE: About 2.700 total actions. 12 MR. WALKER: Approximately. yes, sir. l l 13 COMMISSIONER AHEARNE: Covered by this Part 35. l I 14 Yes, sir. MR. WALKER: ; 1s COMMISSIONER AHEARNE: Can you then go on to talk to about how long it takes you to handle these? I g 17 MR. WALKER: Yes. In March of 1983, we handled 219 1s medical applications. g 1s COMMISSIONER AHE4RNE: That includes what? l$ j 20 MR. WALKER: News, renewals and amendments. A 21 The average length of time for those was 77 days. I 22 MR. DAVIS: That is dwelling time inside. l 23 COMMISSIONER GILINSKY: How large a staff works on 24 toese? How many persons would work on these 2.7007 I 25 MR. WALKER: Currently there are five in my ser. tion
'"~r p.--m ,
! 21 1 l- . workicg on theso right cow. Th3re is a reglesal office to 3 ' .t. Region I and im Regies II. There are three peeple in Regies i 3 i III at this time and I believe there are three, aise, full-4 -! time reviewers la Region I. . s Now they don't work just on medical licenses in the ^
- regions. It is a little difficult to say how their time is split up because they will be working on several types e
of licenses. COMRISSIONER AHEARRE: When you talked about the 2,700 though and the 21g and the 77 days, did that include
" the regions?
12 MR. WALKER: That included the regional totals
'3 as well.
( -- - . _ . _ _ . CHAIRMAN PALLADIN0: We are spending quite a bit
of time on this aspect and if that is what the Commissioners
wish, fine, but we do have a lot of other material .to cover
'7 l and I would suggest that we proceed. .
COMMISSIONER GILINSKY: It looks like about one man day per application. f 30 MR. WALKER: I would have to go back and work. out 21 some sort of a ratio of the number of actions they are doing e 22 in the region that are medical versus the other ones. If you 23 are talking about per medical application. I don' t believe 38 that is true. ( 25 MR. DAVIS: But, again, we have the work factors
,. . l ! t ::hich we devolcped for the budget which we c111 be gicd to let down to you.
y 2 3 MR. WALKER- Set we are keeping track of a large i a number of numbers and I think it would be best if we went i s back and gave you these f rom the work factors. g CHAIRMA4 PALLADINO: Why don't you sobet t those D ' y separately. Co m !5510 ret GILINSKY: I thought these 2.700 s ! e that John added up were the medical ones. l is MR. WALKER: Yes, these are nedical. l C0m !SSIONER GILINSKY: You have 2.700 and you have 1 in 12 about ten people working them, so each one does about 270. 13 MR. WALKER: For the regional participants, we
't don't have the fraction of the'f r time Tight now t they 34 3,
are spending working on medical.
,, C0f9115510NER GILINSKY: I assumed that five-sixths 37 of them were working on the medical ones.
g C0fel!5510NER AHEARNE: At most, it could be off I by a f a c to r o f two . l , a COMMISSIONER ASSELSTINE: That is right. It would lla , , be downward in any event. l5 ,, COMP 55IONER GILINSKY: If you assume that every single ore of them is working on the medical licenses 3 completely, you get the same nur'.er within an hour. a man-hour, 0 MR. WALKER: We will generate some more numbers to m I
1 varify that. I thick that weeld be best. ~ 2 To continee, ser mest reason was to improve the a standardizattom and coasistency in licensing. a The system requires easy individual judgments en (
- e the part of the technical staff. The only way yee can i
- g achieve a solform application review or unifere applical. ion ,
l l y of these regulatory centrols is if you are working from a a **11-defined base of' requirements. g ComI5510mER GILIRSKY: Let me ask yes. Is there I ! is some NRC pebitcation which is a guide to getting a Itcense 3, or an apolicants' kit or regulatory guide that brings all of ' 12 this together for people?
,3 NR. DAVIS: There is f aformation that w'e send to
- ~
34 applicants that describe how' to fill out the application.
,s C0mISSIONER AHEARNE: There is a reg guide 10.8 l
De which is called Guide for the Preparation of Applications for
't 37 Medical Programs.
g ) se C0mISSIONER ASSELSTINE: That is really keyed in l'l j te to the application as well . j <r a C0mISSIONER GILINSKY: Is the process still confus-j5 21 ing with this guide? j 22 MR. WALKER: The guide askes it easier. O th our a form and with our guide and we say th.at if you come back and l i y tell us you are going to everything i n the guide, then we will if 3 pive you a Itcense. -
- - - - - - - - - --w
i 24 s
- CORRI55IONER GILICSKY: What w0s the rcfere:co i i
- 4 earlier to peer applications? You said something about l 3 l
getting a lot of poor applications and that this was a problem? 4 That worried me a little bit. s MR. CuanI4GMAM: It is a problem that it leads to e inefficiencies. We have to write back deficiency letters. . 7 The applicant doesn't know where all of the reqvf rements are e and where to look for information and so on and so forth. e il COMMISSIDMER GILINSKY: Doesn't a poor application
,, h reflect on the applicant?
11 MR. CURRINGHAM: Not necessarily. It reflects on 12 his ability to know where to go and exactly what the license 13 reviewer is going to think is necessary for him to meet to .f _. _ 14 get a license. 15 COMMISSIONER GILINSKY: Will this guide tell his how to prepare an application in a satisfactory way? We are y I 17 dealing with pretty intelligent people. 1s l MR. WALKER: Most of the things that we ask questions j Ni about are for the most part omissions. We don't usually make 30 them or the majority of them aren't you did it absolutely J I' wrong, go back and redo the whole thing. It is that you f 22 didn't know what to submit to us on your application and come
. back ar.d tell as that you, in fact, are going to do that.
** COMMISSIONER GILIMSKY: Can you give ne an examplet l
25 I think as an example, he may submit to MR. WALKER:
so 1 l es a Ices lengthy prccMoro cod to that prcccdcro ha may
- . I j.
+ 2 est include To that that he is seing to keep people free 3 petting their leech in the refrigerater with isotopes. ' l l 4 Ne doesn't intend to let his peoele de that. ! 5 (GNRISSIONCR GILINSKY: How de you know that? l
- e NR MALKER
- Mell. I --
I 7 COMMISSIONER GILINSKY: Have we had any cases like 8 that? e NR. MALKER: Oh. yes. we have had cases like that. M but most of these cases have been cases where the guy has 11 already said that he wasn't going' to do that and 50 submitted 12 it to us. 13 It is set a matter of really his inteat but the ( - - . . - ._ 14 matter of whether or not he is going to do it or not. is These are very few and f ar between. We do get cases te like that but they are very few and far between. I g 17 CEAIR9mm PALLADIN0: I wonder if we are spending s our time on the most important aspects of this. From what I g m I have read. there are reasons for making changes. I would l l 3D like to hear a little bit more about some of the changes that u I 21 are proposed. For example. I gather the license now has i 22 procedures in them which is different from what I believe 23 we s > in reactors and those are the sources of nany of the he problems and how you are going to hir.dle it under the new I situation would be of semething of loterest to ne. a
' CgRRIS$30SEE GILINSEY: TecD specs cro o part of 2 the license.
3 NR. DAVIS: But they are met preceduras.
- MR. WALKER: They are not precedures.
s COMMISSIONER GILINSKY: I war. der if the tech specs e aren't more s aalegeus to the procedures you are talking about 3 7 bere. But in any case, why don
- t we go on.
O CHAIRMAN PALLA0!NO:' The tech specs do not inc1wde s the volumes of precedures that are on the shelf that they l m refer to. I do think that we ought to discuss at least 11 some of the aspects of their writing procedures and whether 12 se not there are guidelines that are percedures and whether u they comply with them. Those are some of the things that I i
~ ~ ' '~
14 think are open questions. is COMNISSIONER GILINSKY: For myself. I was trying to is moderstand what the question was to which this is the answer. I
~
17 MF. WALKER: Let me go just a little bit further. l l m I think once I get into the changes that we are proposing a specifically, I think that you will see. I am going over sone go of they why at this particular point. y, I think the last and final thing is that we were 22 really responding also to the Commission's policy and program 1 23 guidance when the Commission, itself, said that we should make j h, our regulations reflect the reality of nuclear technology. as That the regulatory process , particularly the licensing
1 prCgree sh0cid b2 of fictCat Ocd ef fcctico C 4 ficolly that l jg 2 regul atory decisions should be reached witbest unwarranted 3 del ays. a Our goals in everything we did were number one, S to maintain safety. This is not to say that everything that i 4 e had been put down before and had been considered by somebody 7 as an important safety iten was not relocked at. We wanted to a make sure that when we changed or when we incleded an item e of safety, that it was realistically an item of safety Ni and consider its true tapact on the overall safety of the is caera tion. 12 I have also ready mentioned. I think, enough -- is COMMISSIONER GILIRSKY: What sert of assweptions ( - - . - _ ia go in to assuming that when you drop various requirements is that you maintain safety, which isn't to say tiat there may not is be good reasons for dropping the requirements, but how did j sy you go about concluding th'at the dropping did sot involve any 18 reduction in safety? g i, CHAIRMAN P ALL ADIRO: That is what I .want to get to. f: , MR. '4 AL KER : I think it is a process whereby the 2 staff individuals look at an item and decide and I as t alking 21 ie about people who are well trained and experienced in the area 7, 23 of implementing these various safety aspects. look at these 24 things and realis tically evalua te wha t the impilcations a re. We also did such things as look at the regulations 3
28 s
. to 500 if the regulations already provided for somethlag . t i which we were duplicating in part 35.
3 CORRIS$104ER GILINSKY: Are you goine to go into 4 detail? 5 MR. WALKER: Yes. I would like to contimme right e on to that. Our proeosed changes teek place in two ways. 7 l We consolidated all of the requirements and updated these a requi remen ts . 9 The second part is we looked at the process and is saw how to upgrade that process so that we could develop the 13 l most effective and efficient process of licensing consistent 12 with our need to make a finding of safety on the part of the 13 ( , _ licensee. , 14 Let's go right to the major changes. This was 15 in the first sheet you have here. to consolidate and update
;, the requirements. Currently, we place these requirements in 11 censes on the licensees through regulation, branch policies, NB
,l standard conditions of licenses and guidance protocols. l 4 MI The applicants frequently do not understand the [I l s dif ference betwees a requirement and good practice and they 5 are confused as to what to submit to us. So we propese to 2r consolidate all of the essential safety requirements into
*' consise and coherent regulations.
- No one can argue with that COMMISSIONER AME ARME :
" obviously.
1
l 1 1 RR. BAVIS: I would hope not. 4 2 CORRI5510RER AREARRE: The only issue clearly is ; A , 3 901s3 to be whether the werd
- essential" is agreed to.
a CGnRISS10mER A55EL5 TINE: Tha t's r i gh t. s RR. WALKER: That tiews sert of my presentatten. t e I think when you say that yee put the requirements -- when y you have leaked at the safety requirements very carefully a and then yee incersaca sa all of these into a single e document that can be used is a searce for both the licensee, se for the licenst ag staf f and 'er other staf f eesters sock as n Inspection and Enforcement. CORRI55!OmER AMEARat: I don't thin 4 any of us are ur a getag to argue with that as a so ad goal te strive fer. It i T he q ue's ti on i t'. are all of the essential E[ sounds great. g requi rements in there? g COMMISSIONER GILIESKY: The Chairman had earlier a n made reference to changes in the way the precedures are going g to be handled. That and one other ites was among -- I Training qualificattens. g , CORRI55 toner ASSELSTINE: CORRI5510mER GILINSKY: -- training qualifica ttens , fa ,, s ,, were aseng these raised by some of the members of your staf f. l I
- I don't see either of these covered by any of thes'e' bullets.
i I 23 I wonder if you could touch en those since you are talking ; about all essential safety requirements consolidated in Concise and Coherent regulations. Could y0u just hit those 25 i
)
1 i
l . I two pelots? The diffcroot way that yes would be trc-otics 2 precedores and what the significance of all that is and 3 what we are doing new and how i t wi l l be done -- l a CHAIRMAN PALLA0!NO: I think he has that. It is s en the second page. " Change in a licensee's precedure requires e a license amendment." as an example on the next page. 7 CORRISSIONER GILINSKY: It says, " amendment required i e only for significant changes." If you want to wait until e t hen , fi ne.
- g CHAIRRAN PALLADIR0
- I was urging as to let him si go through these, g COMMISSIONER ASSELSTINE: I think it is more than 13 just on amendments though. It is new amplications as well.
'd se CORRI5510NE R' GIL INS KY : Thlf ts at such a level
, of generality as John points out, one can hardly with but
, at the same time, we are not coming to grips with the
,, regulations.
,, COMMI55104ER AHEARNE : Realistically, one of the 4I
- , big issues is right now they have to put down procedures and f3 as in your proposal they are not going to have to put down all 5 ,,
those procedures. I think that is a major change and you ougnt to address it and tell us about it. That is obviously
,3 one of the issues that have been raised, tha t does not nalntair,
~
l
,, safety, so please tell us why you think it would be a good j
( idea. 25 1 l
^ 1 MR. WALKER: I think that thea co sot cat to [ a restructure the regulation, we set out to look at all of the 3 requirements and to put into the regulation those things 4 from fairly standardized procedures which had been developed 5 and which are included in 10.8 those things which were a essential for the -licensee to comply with. 7 If he complies with the regulation, then those a reqairements are included in the regulation. e COMMISSIONER GILINSKY: Are you saying that you se have a model set of procedures in the regulations? si MR. WALKER: Models which don
- t include all of the 72 detail that a licensee would put into a written procedure 13 but include the key elements. For instance, on survey meters.
! ~
34 we state to what level they sh'ould be calibrated. 'We state is essentially items- of the calibration procedure which we think
,, are essential to having a calib ated instrument. How he j
,, puts those together into a specific procedure to say that se I am going to use the source and put it tem feet away and 2
to calibrate my instrument and this sort of thing. those parts f E
, of the procedures are required.
d , It is required for him to develop a written
, procedure that will incorporate these things in the regulation. '8 , COMMISSIONER GILINSKY: How do we know if the procedures make any sense?
( a MR. WALKER: I think we rely on several things.
> .. . l 1 NonScr cco, if you elli Icck a t the now training and experience requirements that are now incorporated into the 3 regulation, this is where we. in fact, say that the ohysician's qualification er the user's qualifications l are now adequate to insure that he has had training to know 8 how to do these things. I If it doesn't make sense, then we haven't done a a very good job of developing the training and experience qualifications for these users. We put this into the regula-
" tion specifically to meet that need. There have been a number
" of actions --
12 COMMIS510RER GILINSKY: What are these training 13 requirements ?
~
~1 MR. WALKER: They are inc'luded back in the back 18 here and I think probably an example, the most f.ecuent one. "
18 the training for imaging and localization studies. On the I 17 application, the user himself states what he is applying for l is in terms of use and states that he meets one of three sets 2 M of qualifications. One, he has appropriate board certifica-These have been looked at very carefully to see f! 20 tions. 21 the requirements of the board, the training that is required 22 before the individual meets the board plus the areas -- 23 COMMISSIONER GILINSKY: Goes he send in a copy of 24 a board certification? 4 Mot at this point, he doesn't. At this l 25 MR. WALKER: l l l
1 poict it is very oosy for es if ha says what his came is 2 and that he is board certified by ABR for us to go to the 3 ABR certification list and find out whether he, in fact, is a certified. s COMMISSIONER E!LI4 SKY: Do we do that? e MR. WALKiR: We do tha t now. I have one staf f 7 member, a licensing assistant. who checks the qualifications e as they come in against the requirement. The requirement e now is in the guide. It is not in the regulation. There is is frequent confusion on the part of both the administration of is hospitals and physicians themselves as to whether or not 12 that is just guidance or whether it is a real requirement. 13 When it placed in the regulation, there will be no doubt that
" ~ ' -
34 that is a requirement.' is We have put in here. I think our paragraph 35.g20 to which is a training requirement for imaging and localization 37 sgudies, we go through this. is CHAIRMAN PALLADIN0: Are you talking reg guide or f, is regula tion? m MR. WALKER: This is the regulation now. t 3, COMMISSIONER GILIN"Y : Then what? You said that Ir y there were three alternatives. g MR. WALKER: The board certification is the first alternative and we list the boards in 35.920. We then say I g that he has trai ni ng -- the second alternative is to have
^ 34 1 trof olcg ocd oxporlocco os spect ficd la ?0 CFR. We say
. 2 that he should have completed 200 hours of lastructies.
3 500 hours of supervised work experience, 500 hours of a supervised clinical exoerience in basic radioisetepes s handling techniques ' applicable to the use of prepared a radiopharmaceuticals, generators and reagent kits. Then y we go further to break this down and to hours of radiation e physics, radiation protection. e COMMISSIONER GILINSKY: This is the requirement? to MR. WALKER: This is a requirement in the new
,, reg ul a ti on .
12 COMMISSIONER GILINSKY: How does he deal with that 13 possibility? What sort of question do you ask him? a iT MR. WALKER: We ask Tim, does he meet this 15 requirement. Then he has to state that he does, in fact, It mecc this requirement. 37 COMMISSIONER GILINSKY: Did you run a check on that g of any sort? I j w MR. WALKER: There will be a check on that at the i fa , first inspection. f ,, COMMISSIONER ASSELSTIME: Which may not be fore I
, several years af ter the . license is issued.
3 MR. WALKER: Right now, IE visit each new licensee 3 approximately within the first six months of operation, a medical licensees.
~
CRAIRMAR PALLADINO: Coming back to prcccdsros. 2 I think we can take some lessons from the reactor business. 3 One, the precedures de not necessarily have to be a part of 4 the regulation but they should be called for -- there should s be a call for compliance with them which is one of the 4 things that I thi nk is missing in here. tha t if we prepare 7 the regulation, there is no requiremant that they comply with s- them. s I am not sure that there is any review of them to. made.
- RR. WALKER: Yes, r.ir. I believe there is.
12 COMMISSIONER GILINSKY: In the reactor : .e. we
,3 de review them very carefully.
~
gj[ CHAIRMAM PALLADINO: That's right. And we do a lot
,, of pretesting. We observe. We inspect. If we want to te borrow taking the procedures out of the regulations from the s'
,, reactor business. then I think we ought to also borrow or Is censider whether we want to borrow the oreinspection. We go ;
I
; me inspect before we grant the license or as part of the granting la 20 of the license.
5 ,, These are some of the things tha t I was wondering i r about that we might discuss at least in connection with g procedures. l 3 COMMISSIONER ASSELSTIME: At least under the present i ,, process, you have a review of the procedures because they are
-.-r- --w- - + g- w
. submittod oc part of tho applicatica ocd yce also havo l
2 enforceability because they are part of the license under q 8 Isn* t that right? the present process.
- Before anyone gets a license, you all will have 8 revtewed and approved the procedures and the procedures are e spelled out as part of the license application so they are 7 also enforcing it. l l
s CHAIRMAN PALLADINO: Having it spelled out as part
' of a license application night be something that is wortt.while
# taking out of the license, but somewhere the procedures ought 13 to be reviewed and approved.
12 C0fBEISSIONER AMEARNE: I think that one fundamental 13 difference though at least in my understanding of the past 14 has been whereas in the reactor business, we have a lot of 15 people doing inspections so we go to plants. We go through ta those. g 17 CHAIRMAN PALLADIN0: I am saying we ought to do is similar things. g 2 19 COMMISSIONER GILINSKY:
- s a practical matter, it is l 20 very difficult to go out to 2.700 locations.
21 COMMISSIONER AHEARNE: The argument has been that i 22 in this area what you do is you send the material in and we 23 review it and what seems the anamoly here is because of the 24 workload, we are going to propose dropping that knowing full 25 well, we know the dif ficulty we have had in getting more I
.. . 37 peoplo to de rGgiC2Ol ICsp2cticos cad co arGQ't GTOQ geleg to 2 have'these additional people out there.
( 2 COMMISSIONER ASSELSTIMEi That's right.
- We have 128 new ones per year.
CHAIRMAN PALLADINO:
- COMMISSIONER ASSELSTIME: But you have 2.600 e existing enes though.
7 CMAIRMAN PALLADINO: I am thinking if a new applica-
' tionceses.in. I think the procedures somewhere ought to be 8 emanised, approved and a pre-license inspection be made.
to How big a package are we COMMISSIONER GILINSKY:
" talking about here when we talk about procedures? What is 12 i nvolv ed ? When we talk about reactors, we have books full of 13 procedures, but what are we talking about here?
k 18 MR. WALKER: You are talking about what you see in 15 10.8. And 10.8 includes model procedures. That is about -- l
's COMMISSIONER GILINSKY: How many pages are we l ! 1 17 talking about roughtly?
l te COMMISSIONER ASSELSTIME: It is in one of these g j to a tta cheem ts . 2e MR. WALKER: Fifty or sixty pages. 21 COMMISSIONER ASSELSTIME: It is 62 pages. t 22 COMMISSIONER GILINSKY: That is a typical procedure 23 that yes would expect and we are talking about the current 24 rules or future rules, you would expect that good practice I 25 requires procedures of this sort be developed before nuclear l
medicico is practiccd. Is that right? i CONNISSIONER ASSELSTINE: Ir f act, an applicant can 3 3 simply reference those, can't he? MR. D4VIS: That is one of the purposes. If he 4 i will follo. these procedures, then you don't have to de an ,nd,w,d..i ,ev,e. o, p,oce.. es. If - does .ot ..iio. these procedures -- COMtISSIONER ASSELSTIME- He cas propose as a alternative. MR. DAVIS -- he can propose some other method of meeting the requirements. l What we have tried to do is bring the require.nents together out of a variety of documents and I use requirements is' ~ le a less precise ters than reactors because some of our requirements have been expressed almost exclusively le positions and reg guides, and bring those into a decoment i is iI where you don't have to reference seven er eight thlags
- .I.
17 to find out what the requirements are, propose to his a 1 standard procedure to meet these requirements and them you ![. 19 4 go by that and we proceed with the processing of the
- a f 2e l
- applica tion.
I' c
'l:
If he doesn' t like those procedures for some 22 i particular reason and he wants to do it another way, he 1 23 can submit his own custom way of meeting those. requirements j 24 a t which time, as I understand it, these would be reviewed. 25 l u I I i l
39 1
. COMMISSIONER GILINSKY: I understood onder the new
't i rules, he would met have to submit .another set of procedures.
3 COMMISSIONER ASSELSTIRE: That's right. 4 RR. WALKER: This would %sve to meet these 5 requirements that are in the regulation and these requirements e again that we -- . 7 COMMISSIONER GILIESKY: Suppose he wants to depart a from these medel procedures that you have written does he 9 have to submit changes to you under your new proposed le regula tions ? 11 MR. WALKER: Only if he was depeeting from. one of , those essential items that we have incorporated into the 13
; regulation such as to calibrate your instrument to plus or 14 minus 10 percent.
Is COMMISSIONER GILINSKY: Not merely if he is y departing from your model procedures?
! MR. WALKER: Not merely if he is departing from the ~
IS l model procedures, yes. d
- HB CHAIRMAN FALLADIM0: Is there any procedure with
" which he must comply even though he had written thes? It S
21 j is not clear that there is a compilance called for in these 22 procedures. 23 MR. WALKER: Under the new regulation, under 35.'3. 24 COMMISSIONER AHEARNE: Do you have a page number? O 3 MR. WALKER: Page 54 of Enclosure 1. We have l
40 1 l - administrative requirements for the licensee and the Radiatloa 2 P Safety Committee and the Radiation Safety Officer. We make i ! 3 l l the licensee responsible for not only establishing but ' 4 assuring implementation cf his written precedures which 5 should cover emergency actions, periodic radiation surveys, e periodic inventory of byproduct materials, safety during the , 7 use of byproduct material. e CHA:RMAN PALLADINO: Where are you reading this? 9 COMMISSIONER AHEARNE: Section 35.33. 10 MR. WALKER: At the bottom of page 54, paragraph 11 (b). (1). (ii) and (111). l 12 COMMISSIONER ASSELSTINE: But if you also look at 13 page four of the paper that you all sent up. you say "Is its
}. - - - .
inspection and enforcement role the NRC would be concerned with m whether or not the requirements in the regulation are being to y met and not with the details of the procedures used to meet g 17
- them." I took that to mean that if it is not in the te I regula tions , you don' t worry about i t. It is just now what 2 to you codified into the proposed rule and the other elements of the procedures that the applicant or the licensee would' 4
' use to satisfy he regulations may not even look at those 5
as part of the inspection program. MR. WALKER: Tha t s tatement may be somewhat misleading. I think that the full intent of this was that the licensee develop and implement his own procedures. If he 1
s
.. . 4y t - has written arocedures and he is not fwliowing his procedures.
O then I as sure, that tha t wouldn't -- 3 COMMISSIONER GILINSKY: What check do you have on 4 his written. procedures? How do you know other than the fact 5 that he says he has procedures that he has them or that they e are any good? ' 7 MR. CUNNINGHAM: For certain types of procedures a and Bill mentioned them, w'e will not review the procedures. 9 There is a requirement that he has procedures, that these 10 procedures be written and that his staff is tra.ned to follow 11 these procedures. 12 The details of the procedures are met ones which 13 we would review. This really boils down to a fundamental ( 14 question of whit we are trying to accomplish. The things 15 that we have considered and which as best we can determine is y are the major safety related issues are well identified and g 17 .. will be exanined. is I We have training requirements on physicians that i lib probably exceed when you consider the typical way these i !I physicians develop in a four-year residency program or some-
#' thing like that, probably exceed other training requirements.
I' What we are heavily dependent on are the ability of these physicians to operate safely. Remember what we are
** talking about mainly is occupational public safety not how they manage their patients.
1 COIWIISSIONER GILIR$KY: Szt to dea't check en the
. 2 training in advance of granting them a license. They simply
; 3 check a box.
~
4 NR. CUNNINGHAM: We confirm that they have the s training.
, C0fullSSIONER GILINSKY: How do yow do that?
7 NR. CUNNINGHAM: Checking the list of residency a boards. e MR. WALKER: They send us the same sort of thing se in these da/s. I discussed this Just to ,ake sure my
,, perception hadn't changed since the last time I looked.at u one with the individual on my staf f that is now looking at a training and experience requirements being submitted by 34 physicians. If she comes with problems, she will escallate 3, i t to the senior reviewer, but for the most part she sees
,, these things. When they don't meet the current criteria
,, which has been published in the reg guide, she will go back to and "requently q :ery them just on the information that they.
have subsitted.
} ,,
, COfGIISSIONER Gli.INSKY: What do they submit?
p MR. WALKER: They submit a record of the number of I E hours that they have spent in the various types of training, radia tion protection instruction. 3 COMMI5510NER GILINSKY: It sounds like they would no ( longer have to do that? 3
43 RR. WALKER: There is no certification on here at 4 all. This is simply their own statement of how they perceive the training they have received. The only one tha t there is. a a certification on is the clinical part where they have had to 5 deal with the clinical use in patients. In that one. that 5 must be signed by the preceptor. . 7 The otner form which they now submit is nothing more e than their own evaluation of their requirements which is 9 not drastically different than uhat we are asking here i a except that we are making them certify here whereby we don't l 11 l make them certify on the current one. O MR. CURNINGHAM: part of the problem in the training 13 { .. __ requirements is that there was_a fair _ amount of confusion M among the physicians as to what the training requirements a actua11y were. M 3 The rule clarifies that. If somebody is going to
! falsify an application, there isn't too much we can do about u' t ha t.
l If they understand what the requirements are and they 4
- W certify that they have these requirements, we won't go much L
k furti er than that except picking it up in at inspection time and checking boards and things like that. We really can't prevent on this scale and it isnot
imaginable that there would be any wide scale falsification of meeting the requirements for training.
COMMISSIONER GILINSKY: But there could be a i
i diff0roct lotsrprotatico abOct the degree to thicD o porticolod l 2 training is relevant and so on. i e a MR. WALKER: That is the purpose of the regulatloa. 4 COMMI55104ER GILIMSKY: It is a littia easier to ! 5 check to box than to subm6t evidence of such tralming. e NR. CUNNIiGHAM: It is not greatly different fros l i 7 what we are doing except that we tried to make the training } s requirements more specific and put them in a rule. s I want to go back asain to the training versus ne procedures. We- do have extensive training requirements on n these people. We have identified those elements related to l
-i 12 safety that we feel are leportant. l l
13 If you will look at what we are trying to accomplish ,p 3 is and really recognize w~ hat goes on i n lI nuclear medicine j y, laboratory where the record would indicate that occupational j l ,, exposures are running well below ten percent of the limits. i :*
,7 There are ALARA requirements that they have to follow in
( g these rules, also, a procedure for ALARA. l I I g , Then you have to raise the q Jestion how much time
,f ,,
should we be spending and utilizing our resources og the ! a 1 d p important safety elements considering what these doses are
'$ generally running and the operatirq experience and now much
- I 23 time we sh vid be looking at these detailed procedures as ,
! , to where somebody wears a la5 coat or doesn't wear a lab coat <
~ a which doesn't make a lot of difference in general safety *
! I i
l I 2 I
45
. regulements. .: 3 That is the -kind of thing we are deallag with in 3
trying to trade of f here. a CORRISSIONER AMEARME: Although I have been helping s slow the pace down, we have at least another 30 minutes of a ether people. 7 CHAIRMAN PALLADIMO: I was going to suggest that a maybe we see if you have any other significant points that s you want to bring out. I think we ought to hear the visitors. Is I would make a comment that my general reaction was that this 11 is a very good step forward except for a few key questions 12 such as' procedures and how we are going to make sure that they 13 g , , are complied with and that they are reviewed. 14 But I think that many other features of the is proposal have merit. 4 , y Do you have any other points? l 17 I MR. DAVIS: I guess you are going to get another shot 18 i at us af ter you listen to the rest of tk.e staf f and maybe g n the points will come out dur.ing tP.at. CHAIRMAN PALLADINO: All right. We have had the s I' j people come in and I think it is encumbent upon us to listen 22 to them. I wonder if we might have Mr. Spell Dr. Robinson
.' and Mr. Linton come to the table and have them make their.
presentations and then we can rais auestions either with the I staf f or wi th other members of the staf f.
s C6 s I was going to suggest tha t we take them in the 2 ( order that I have en my piece of paper. Mr. Spell, then Dr. 3 . Robinson, then Mr. Linton. 4 MR. SPELL: Chairman Palladino and Commissioners. 5 my name is William H. Spell. I am Administrator of the e nuclear Energy Division for the Office of Environmental 7 Af fairs. Department of Natural tesources of the State of a Louisiana. e g I am appearing before you today as Chairman of to a rather loosely knit organization which I have chosen to 11 call the Association of Agreement States. It is not a formal 12 grouping but it is a group that meets once a year to discuss 13 g , _ problems of mutual irterest with the NRC. 14 I won't go into the history of the Agreement States is and, why we are interested in this particular aspect. I think
, that has been adequately brought out.
17 I' I would like to point out, also, that I have been l l s l asked to reoresent the Conference of Radiation Control program 2 m Directors because this group has representation in all 50 s tates and is composed of some states which are licensing states where they license naturally occurring and accelerator for juiced isotopes. On my right is Mr. K i rk Whatley. Chief of the Radioactive Material Licensing, for the State of Alabana, I M Department of Health. Mr. Whatley has served on an ad hoc
.. . l, 4y a committoo appointed by the Ceoforer.co of Rodlotloo Centrol 1
2 Program Directors to review the salient features of 10 CFR 35 , i 3 in this particular revision. He alont with Mrs. Mary Lou a Slazek of the state of Oregon have been intima tely involved 3 in that. They did meet at one time with the NRC task force. 4 Newever. I believe. Dr. Walker was absent at that particular y meeting. I i e They have been in contact mostly Lf mall and tele-a phone. I believe. Mr. Whatley is very intimately involved j l up with the proposed changes to 10 CFR Part 35. I am indebted j is to Pr. Whatley and others in the Agreement States who have 12 provided information to me in the preparation of these comment 1. 13 At the last Agreement States meeting in Gaithersburg
.i -
this past September, t'here was' enough concern over the
~
1 g4 i
; is proposed changes to 10 CFR 35 to prompt a resolution to be
,, passed that requested that the Agreement States be afforded I
,, an opportunity to testify before the Commissioners prior the j
is rule-making, and for this, we do express our appreciation.
, I j
g ,, We de comment the efforts of Commission staff in l ,, incoroorating the various loosely woven requirements, the !a 'l
,, license sonditions, the things that are contained in the r
7, Regulatory Guides and getting these all into a single
~
] 3 constse, hopefully consise document. We have no criticism. In f act, we do commend this particular action. 3 I The thing that we are prim .rily concerned on is the 25 4 1 l 7 .
! **
- 48 l 1
) - method of implementing these proposed changes and in doing so 1 2 d continuing, we hope, to protect the public health and safety. ! 3 ' We don't know, at least I don' t know, the answer l * , to why is it necessary to change the method of implementation. i 5 i I have asked a few questions here. > a One, is it necessary because of the Commission's , .: y commitment to decentralization? Is it because there is a 4 s 3 backlog of licensing actions? Is it because we see very
! e '
l little evidence of injury to the general public and therefore to we feel like we can lighten up on the requirements? Is it 11 because of the Commission's commitment to charge fees and if f 12 it were to require additional staff, would the Commission be i 13 g able to raise sufficient fees to cover the cost without 1 14 1 causing a furor and that might not be the right word? i 15 ) COMMISSIONER GILINSKY: pardon me for interrupting 1 is j g you, but I wonder if you could just along the way explain
! what you mean by the method of implementation?
l CHAIRMAN PALLADIN0: Thank you. I had the same a 1. question. MR. SPELL: The method of implementation that I 4 g ,j as talking about is primarily the lack of the pre-licensing
" review that you have been discussin_g. That is the key issue there. I think, that the Agreement States are concerned about.
[ COMMISSIONER GILINSKY: Good. MR. SPELL: As I indicated, I don't have the answers I l
os - i to thoso qeastions and I Jcst coot to point cet Scne thfaco
. 2 that I feel like may occur as a result of changing this.
t 3 For example, in the decentralization process, there 4 are some features there that we like very mur . . We Itke to s he able to deal with the regional offices and the people 6 there and they have been extremely helpful to 95. y We feel perhaps that if the licensing process e is carried on in t'e regional of fices it perhaps may cause s 50*e uniformity to be lost that has previously been in effect. to I am not sure that will be the case, but it is possible.
,, In talking about the backlog of licenses. I checked 12 with the State of Texas. They have approximately 600 medical 33 licenses. I am told that it takes two reviewers and these g _
34 are experienced reviewers and about half of a supervisor's time to oversee this. They have about a two-week turnaround 15
,, time for the licenses.
37 In my own state, we have about 300 medical licenses 18 and we have about two and one-half man-years or person-years g 19 of effort in both the licensing and the inspection part of it. fs So I only bring these figures to your attention to show that 3 i it can be done ii less than 77 days. 21 e One of the questions that I would raise with regard to the 77 days is, there must be some reason that it takes 77 days and I would propose that possibly part of the reason 24 I
l 50 ! l
' l
. changing the method of doing it may not reveal all of these
- problems prior to issuing the license.
Q
- That is one thing that I think does need to be addressed.
- I feel that a backloa of licenie applications and a requests for amendments or renewals should not.be the sole ,
basis for changing a regulation or a method of doing business.
- On the other hand, if we have improvement, significant
' improvements in health and safety, that in itself is
" significant reason for changing the regulations.
81 As I have indicated, probably, the greatest 12 concern of the States to the entire aroposal is the lack of a I '3 pre-licensing review of radiation safety procedures and i M physician qualifications. M We have had various estimates given as to the number M of deficient applications, somewhere in the 40 percent range, i . 17 and perhaps the number of physicians who at least thought
- g 1
# they were qualified but apparently - ee not based on someone's ,
j2 8 review, were about 15 percent. I don't claim these figures l
' l, 3D to be accura te. ,
4 4
- 21 ComISSIONER AHEARME
- Where are those?
'I*
i 22 MR. SPELL: I really cannot remember who told me l 23 the 15 percent figure. It may have been Mr. Wha. ley. It i i M may have been Commisston s taf f. I really don't know where I 25
, that came from.
1 l
}
)
51 1 COMMISSIONER AHEARRE: What about the 40 percent 2 member? < 3 Mt. SPELL: The 4C percent. I believe is a 4 Commission figure. I believe I heard that figure this 5 morning already. I f I di d no t. I apologize. CORRISSIONER AHEARNE: So that is the basis of your \ i 7
"40" and the "15" you are not sure of?
e MR. SPELL: That is correct. 9 I think. the point I was trying to make here is to that you are not going to have 100 percent of the people 11 who advance the proposal that they are qualified who actually 12 are. 13 g ... __ The problem then is if we ao not look at these 14 questions, a set of procedures could be implemented or an unqualified physician could be allowed to practice for a is period of time before these deficiencies are noted. Then g 17
- the question is, what would happen if this takes place and 18 l 1s this good health physics practice in allowing this.
4 is The question of compatibility. I don' t think needs to be addressed at this point except to say that even though I' it is not a matter of compatibility, the Agreement States do 22 license about twice as many medical Itcenses as the Commission
,23 does. For this reason we perhaps have a very significant 24 interest in it because we feel that there may be pressure on the states to adopt similar if not identical regulations.
! 1 { We aise have a possible problem with suppliers of 2 1% radioactive drugs who may have difficulty if we don't maintain ) i 3 I 4 some degree of unifornity in knowing exactly what the ! a j procedures are in each of the states. We have already given i 5 I them their share of headaches. I think. e philosophically, maybe we ought to consider whether 7 i or not abandoing the reviews of procedures for medical app 11-8 cations sets a precedent to do the same thing in other areas i J e that we regulate.
. 10 l In my own state we certainly would not want to l lighten up on the things that we require for industrial
' 12 radiography and some research applications need a greater ! 13 review of the procedures that are being prep:; sed. j4 .
} M I have given you some figures for the period
{ January 1.1982 throagh June 30, 1982 the last data that I have available and it does show that the NRO administered
~ ! 2.622 medical Sy-product material licenses while the States
- l cc11ectively administered 4.691. It is not quite two-to-one.
! but it is close.
'I s
- The inspection data 15 I think, also significant.
.I 21 The NRC would. I believe, need to have a greater commitment 22 in the inspection ef fort if they were to go the way that it
# has been proposed. Fre.sently the number of medical license 24 inspections for- the NRC for that period of time that I just
,' mentioned was 51 broad licenses, some of which were medical, l l l
gy 1 and 314 othee medical license inspections. For the same I period of time the Agreement States performed 54 broad license 3 i inspections and 1,001 other nedical license inspections. a met necessar11y the same priority system was used in each casec 5 Me support the concept that a good review of an e application for a medical license can prevent a complete . 7 eisunderstanding later on. It nay be one in which the e licensing agency can be perceived to, he guilty of contributory e negligence. is I would propose this as a question to be considered. t1 I am not a lawyer and I don't pretend to know the answer to 12 it but if we do not do an adequate job of protecting the 13 4 _ public health and safety, then_I think_anyone could at any time they themght they had been injured bring such charges against the agency. It has happened in some cases. I think. In order for this proposed change to work, there
'! has to be an exceptional commitment on the part of NRC to de
{ more at the regional level particularly with regard to A inspections. Y 20 i. An inspector at a medical institution is someone 3 2 21 who is not there necessarily by invitation. He is probably z 22 marginally welcome if at all. He is invited to do his job
*3 and get out as fast as he can and he does have some pressure-
- not to interfere with the practice of medicine.
( 25 This is understandable. There are patients there.
1 54 I I believe firmly in uw own mind that the actual review 3 process can he done at someone's office rather than in the 3 actual inspection setting. a I don't think this particular aspect has really 5 been addressed and there is no indication that the Value/ Impact Statement has addressed the actual impact on the regional offices. That is something that I think should be done. One of the .hings that I would like to bring out is that I am not sure that all of the states have had the opportunity to review the draf t that is before you.
'I COMMISSIONER AHEARNE: I would say it a little more
'3 strongly. . .
MR. SPELL: Not all of the states have had an opportunity to review the draf t that is before you. For this
" reason. to make the statement that the Agreement States are
'7 in favor of the total document is without basis. I would not want my state to have its name as being in favor of it 8
and I think most of the others would not also. 8 I have not chosen to go into some of the very small 21 items that obviously have to be worked out but there are many 22 health and safety deficiencies in there.
.23 I have asked Mr. Whatley if he would be prepared 24 to comment on a few of the significant ones that he saw 3 outstanding in the document and if you would like to hear them,
aa 1 1 I thick h2 con give you several amanples of significant 0 ne itn ,,a serety i tens unicn ,ita,e ,eed to n, s,ootnea l 3 over or actually cnonged in order to be good practices. l 4 CHAIRMAM PALL ADINO: We have used up nore than ten 5 minutes although it has been a ,ery, very helpful presentation, i e COMMISSIONER GIL!mstv : I wonder if we could just 1 hear a word on the procedures issue bef ore we go en to another a speaker. l s CHAIRMAM P ALL ADINO: I was going to go en to another ] to speaker. 11 COMMI5510RER GILIMSKY: Could we just take 60 . l u seconds to get your view on that? l 13 g _
!s that acceptable? , __
14 CHAIRMAM PALL AD!a0: Si x ty seconds -- I will yield. MR. WH ATL E Y : In my personal opinion. I feel that there are semerous sections in this regulation which in g 0 my opinion do not reflect an adequate health physics safety program. For ins tance, the leak test procedures. It requires b a test sample be taken from a source. It leaves it up to the 38 interpretation of the Itcenset what is a test sample. d " Someone in ny of fice says he would take a chisel {. 22 and a hanser and take a test sarole. Then an inspector goes 23 out and he is forced to be make an evaluation on that. There 3* is no requirement that a standard source be used for converting 25 counts oer minute into microcuries to determine whether the 9-
a 1 I sserce is 1cating or not. 2 Survey measures are required to be calibrated to a 3 ten percent accuracy with a source of estimated activity. 4 I don't understand that. 5 In my opinion again, there are problems with e survey requirements, when to survey. the type of survey 7 seasures to use, procedures for dolmq the survey. s CHAIRMAN PALLADINO: Could we get spee of these 9 submitted to us? Io MR. SPELL: They have been submitted. Mr. Cha i rma n. i It They have been submitted in writing by various members of tne 12 states and, of course, any other version that cones out will 13 he c ommen ted o n l i k ewi se , s i r. 14 MR. WHATLEY: I have served on the task force, st r. is and many of these comments have beer. subeltted before to the l task fo rce. Those are some. I could go on. 17 CHAIRMAR PALLADINO: But in the interests of letting is the others speak, maybe that is far enough for the monent. 19 MR. SPELL: I will be happy to conclude. It will take about 30 seconds. I would like to commend the Office of l 21 State Programs' staf f for keeping us involved in this process U and to of fer the services of the Agreement States in
" developing a set of requiations that we can all live with.
We recognize that we all have a stake in this ef fort and we 25 will do = ha t we can to assist. p
i
$7 l 1
Thank yes very much. Mr. Chairman. I CNAIRMAN PALLADINO: Thank yes very much, he will 3 go to Dr. Robinson, a Mt. ROSIR504: Chairman Palladine. Members of the 5 C ommis s ion . I am Ralph G. Robinson. Head of the Olvision of a Nuclear Medicine at Kansas University Medical Center and 7 president of the American College of Nuclear Physicians which e is an organization of approntmately 1.200 physicians actively a engaged in the practice of nuclear medictme. se These comments are presented on behalf of the 11 College and also represent the views of the Socity of Ruclear 12 Medicine, a professional organization cf over 10.000 scientist 1 , 13 [
- physicists, pharmacists physicians. t.,echselogis ts and other la professionals involved in nuclear medicine. The combined 15 membership of tehse organizations represent the nuclear medt-16
, cine community in the United States. 17 ( The College and the Society are grateful for this MI opportunity to appear before you and peesent our views on the
- MB
} proposed revision of the Nuclear Regulatory Commission's L regula tions for Human Use of Byproduct Materials.10 CFR 35. t We urge the Commission to act favorably and move the proposal forward for pubitcation in the Federal Register.
. 4o set of regulations af fects the day-to-day practice 3a of nuclear medicine more directly than 10 CFR Part 35. The I tcenses issued by MRC under these regulations define the
L SS perameters under which the use of byproduct radioactive 2 J materials for diagnostic and therapeutlC medical purposet 3 occurs. Therefore, the proposed revisions under consideration a today are cf the utmost importance to the membership of the 5 College and the Society. s Mr. Chairman and members of the Commission. we would 7 like tocompliment you and your staf f for their initiative to 8 consolidate and streanline the requirements of 10 CFR 35. For ' s a number of years the caclear medicine community has operated to under requirements scattered amont several documents inclu-si ding Inspection and Enforcement orders, regulatory guides. 12 technical reports and various conditions attached to individual 13 11 censes. , , ,_ 14 This has of ten resulted in confusion and unnecessary is and/or duplicative paper work. It is. me believe, to the is advantage of all af fected partiesincluding NRC, the nuclear 17 physician and most importantly the patient that regulatory 1 18 j requirements be developed as succinctly and clearly as possible . 3 m The proposed revision of 10 CFR 35 will accomplish much of that objective and we strongly urge you to support this effort. Existing licensing review procedures relating to the Human Use of 8yproduct Materials are curbersone and unneces-sarily lengthy. In our view. the informational requirements 25 currently required to complicate the licensing process tor
59
~ ' forcing applicants to include detailed copies of procedures
# to be used in complying vith the retoulatory requirements in 3 addition to the necessary information relating to radiation
- safety.
5 The volume of information currently required of ten 8 results in the need for more information from the reviewer's i perspective. Frequently this need for additional information a does not concern matters of radiation safety, which are of l 8 primary concern to the College, the Society and the Commission. 1
# but rather involve minor procedural issues. This often 11 results in " Deficiency Letters" which greatly increase the 12 time required to complete a license review and creates a ,
13 prolonged paper shuffilag exercise.
~
,i 14 I might add to my statement that you have before 15 you, just to second some of the sta f f comments made earlier 18 that many of the problems arise in license amendments which j 17 may be minor changes in procedures but require a formal , I 18 Itcense amendment and add to the 2.000 submissions annually g l f, to to the Commission and may slow the introduction of new 20 diagnostic procedures in the medical practice. { 8 The modifications proposed in this draft will help 21 22 eliminate some of the unnecessary paper requirements, produce more timely decisions and better r.flect the sophistication i 23 24 of today's nuclear medicine practice, thereby enabling the 25 medical community and MRC to more appropriately focus their
s . . 60 resources.
! We understand that information relating to procedures 3
and other requirements must still be developed and maintained 4 by the licensee. Thus, the substantive details needed by MRC 5 for judging the adequacy of a licensee will be maintained and a readily available for inspection. - l 7 l We also concur with the recommendations contafaed a l la the draf t to eliminate the general license. In view of s the advances in thepractice of nuclear medicine, the general 10 license approach in effect creates a dual licensing system. 11 The use of specific licenses and specific licenses of bread 12 scope obviates the need for a general license category. 13 g _ Mr. Chairman,and members of_the Commission, while 14 we are in general agreement with and strongly support the 15 thrus t of the proposed revisions, there are some specific requirements in the current draf t that we feel should be 3
! modified.
l j t a However. It is our intent to address these issues m through official comments from our respective organizations
! " once the proposed revisions appear in the Federal Register.
- " We will provide a detailed analysis once the full text of the proposed revision is published.
*' In summary, let me reiterate our general support for l the proposed revisions, and assure the members of the Commis-
- sion that the nuclear medicine community shares your I
61 I ' ' 1 commitment to provide for the safe and effective delivery of !{ I nuclear medicine patient care, ranging from eeblie service l 3 to the most sophisticiated hospital setting. The College and the Society have had a long-standing
- and continuing interest in maintaining quality health care and 8 probably have more quality assurance efforts underway than any,
# other medical specielty. We believe that the proposed revi-8 sions will serve to enhance the objectives of the Commission
' and of the nuclear medicine practitioner.
- Thank you again for this opportunity to appear 38 befare you and I would be happy to answer any questions now 12 or later if you would like to go on to the next speaker.
83 Thank you. { 84 CHAIRMAR PALLADINO: Any nuestions? 15 COMMISSIONER G!LINSKY: Yes. You seen to be saying 4 that it is a great bother to be seeding copies of procedures l 17 to the NRC. Since these procedures have to be developed 4 any way, I understand you to be saying that the equivalent
- 2. 4 procedares would get developed no matter what. What is the ig 20 difficulty about sending them in?
21 Let me add another point here. I sense that you a 22 are saying that reviewers are being unreasonable in the way
.23 they review these procedures and nit-sick them with the 34 things that are really vital. Is that a correct Jnderstanding as of what ycu are saying?
62 ! 1 MR. R0814S04: We are not saying that any one is l 2 i mi t-pic king. We are saying that if we send in 50 or 60 pages 3 of detailed procedures, it is quite likely that there may be 4 a minor error somewhere which will result in a Deficiency 5 Letter and stop the whole process for two or three months. s If in our view the detailed procedures are not 7 that important to the operation of a facility which is judged e on its overall merits in terms of its ability to safely 9 handle, store and receive, the staf fing of that facility as se detailed in an application and the training and experience 11 requirements which have been strengthened in the past year 12 and added to the rewrite but, in fact. are already in olace. 13 ( _ that a minor change in. procedure or the need to include 40 or 14 50 pages of procedures themselves, we think are~ unnecessary. 15 We have to keep them. We do keep them. They are le y avaflable for inspection. If there is a minor problem with g 17
. one procedure that is found on an inspection, then it would 18 l be noted and corrected. But I don' t think that should 1
g impede the entire licensing process.
- COMMIS510MER GILINSKY: But, as has been mentioned 21
) here earlier, we can't inspect these licenses in the way we inspect reactors, for example, where we have resident inspectors and teams coming out regularly and procedures really get quite a scrubbing. At least they will in the f u ture. That is not possible here and really pretty much the 1
- _ _=
63 1
~
only check you get is this review at the time of application. I. 2 4 Clearly one can't go through 50 pages in detail, but I would 3 l assume that the reviewers are trying to hit the important ! 4 points. If they were being unreasor.able that is a separate l 5 management prablem. l e CHAIRMAN PALLADINO: I wouldn' t necessarily take 7 it as given that we can't inspect the new applications if a the number is on the order of 120 in a year. 9 COMMISSIONER GILINSKY: That is a separate issue to that I think we need to take a look at. I am not as familiar 11 with hospitals as I as with reactors, but certainly procedures 12 are vital. I don't think you would aroue otherwise. 13 ( . _ MR. ROBINSON; No. an_d all of our procedures are 14 written down and we are inspected not just by the Nuclear is Regulatory Commission or the Agreement States, but we have joint Commission on Accreditation Rules. We have a variety 3 g 17
. of rules. We have many procedures is place. I am not sure is ,I they all have to be part of the application document.
12 18
. Here, we are simply agreeing with an opinion that :
is developed by MRC s ta f f.
" COMMISSIONER AHEARNE: On page four. you mention f
E
# some specific requirements with which you disagree. What is your position on the cualification requirements section?
** MR. ROBINSON: We are fully supportive of the
( "' qualification requirements with one very minor exception which l l 1
- 64 1
l I know Mr. Linton is going to address and tha t is the 1,000 2
- f. hour training requirement which is listed in the proposed 3
revision as I think arbitrarily defined and divided in half, 4 , 500 clinical and 500 laboratory. : 5 You have already specified the mueber of hours of actual instruction in each sub area that must be included. We would support the concept that requiring 1,000 hours of supervised training without further subdividing that and 1eaving that up to the training director would be a legitimate thing to do. COMMISSIONER ASSELSTIME: Dr. Robinson. I wonder if 12 I could ask you to comment on the point by Mr. Spell and that 15 would you agree that it might be easier to resolve the questions about the procedures or about coampliance with elements of the regulation during a licensing review process
~
rather than when an inspector visits and is actually in the lI l 'I setting where you are trying to provide services as well? There are additional complications if we are I swinging the burden now to the inspection part when our inspectors actually come to visit you or your institutions. I 21 MR. ROBINSON: Well, they are visiting my institution 22 today, but I said that I would be here instead. Backing up 23
, for a moment, that is a bit of a complicated question. I se will try to be brief. It was brought out earlier and I )
3 appreciate the consent about our intelligence earlier that
65 1 between the regulatory guide 10.5 and the really rather 2 l ) several pages of forms that ==:t be sent in as well as ' 3 l procedures and all of this, I have been through those guides ! a and I find them c'onfusing. I think the proposed document in s l general certainly greatly simplifies and brings together in ! e one place many of the things that are necessary for the 7 license application. s I think the applicant and the reviewer and the field s inspection people will all benefit by having this brought w into one place. 4 11 We have problems on inspections. The field guides r2 for inspection have taken on the aura of regulations. The 13 staf f here has recognized that. I think that if we could 14 bring all this in under Part 35 and spell it out as. it has W i been proposed, it would be simpler for everybody and still is
, adequately protect the health and safety of the public.
17 COMMISSIONER GILINSKY: I don't think there is a lot e of argument about bringing things together and having clearer is regulations. The real question is the content and the way
" we are going to go about carrying out our responsibilities.
" You are basically arguing for a little less of a look t'han
" is being taken at the present time and I guess there are mixed
" views on that.
" MR. RORINSON: I am speaking first to nuclear 3
, medicine. I am not speaking to radiation therapy and Mr. l
66 1
~
Spell's problems with leak testing sources and some of the 2
- things that he has mentioned. Ize also a preceptor. I 3
write those preceptor letters that were referred to earlier. 4 I, and I think most people like myself, take that as a 5 l rather serious obligation and that is part of the process of a application of license. 7 For each resident as he begins to finish his a training, we sit down and review exactly what he did do in e nuclear medicine, actually how many days he spent. We to figure out he number of hours by going over his exact 11 schedule. We look at the classes that he took and how many 12 hours. We look at the exact number and type of procedures. 13 J
. _ clinical procedures, that he p_articipa_ted in and we develop a 14 separate letter for each and every one of them and it reflects is that training and the fact that I have verified it.
I would simply say and there has been a little bit 1 17 / perhaps of an attitude that a lot of people are going to.be 5 m J licensed who shouldn't, that are going .o take advantage of g M . this, and I would say that in medicine, one, we are concerned - when people violate rules of any sort. The first thing that
" happens if someone gets a violation or a citation from NRC
" is that his medical staff is going to wonder why and he may
-" lose his staf f privileges and without his staff privileges, he
" is out of business in a practical sense. He can no longer
" receive the radioactive materials. He has no place for ther
67 1 2 to be shipped. He has no license,. 3 Even if he has his own license, he is out of a a facility. s I think that physicians will take these very a seriously and will do a better job of compliance if they. are y easier to understand. s COMMISSIONER GILINSKT: If I understood the earlier e Presentation correctly, the sort of letter that you were is talking about, would no longer be required? ii MR. ROBINSON: I am going to continue to provide 12 them myself as documenta tion of experience. You have in this 33 draf t a requiremeni for 1.000 hours and certain number of is hours of lecture. You'r experience req'virements are quite is detailed and lengthy and I see that there would be no change l in that, is COMMISSIONER GILINSKT: If I understood correctly, iy is it was really up to the doctor to check that he did, in fact. is comply with the requirements. I
.MR. ROBIMSON: He checks of f that he has a residency or is board-certified.
3, , CHAIRMAN PALLADIN0: We are going to run out of time 22 g soon. This is a very valuable dialogue and I appreciate it. 3, but I do want to give Mr. Lintor. a chance to make his presen-tation and I . hope still to get back to some of the staf f 1 l
= .
3 menb2rs tha t had' scc 2 di f fering views. 2 Mr. Linton.please proceed. 3 MR. LINTON: Thank you. Mr. Chairman. Gentlemen.
- my name is Otha W. Linton. I an director of government s relations for the Aermican College of Radiology. Many of the e members tre licensees of the Commission or the Agreement States .
7 My comments here represent the opinions of two of a the college's commissions where most of the members have had e an opportunity to discuss the concept and in some cases to review the text. 11 We think Mr. Chairman, that proposed part 35 12 should be completed, submitted for public review and adopted 13 by the Commission. As nearly as a document can be judged in 34 advance, it should meet mest of the goals it sets for itself is in alri ty, consistency, economy and efficiency for all con-M cerned. We found it easy to read and follow. Appilcants
~
17 for licensure should find their tasks made substantially l l i a simpler. i # In previous testimony, the College has suggested a that the paternalistic anachronism of federal control of-a medical uses of byproduct material has largely been succeeded 27 by the medical mechanisms of specialty training and creden-a tialing boards. as COMMISSIONER AHEARNE: Could you tell me when in a a time frame, when did the credentialing boards come into
1 omistence? 2 MR. LINTON: The American Board of Radiology which 3 predated the whole atomic age began offering a medallion 4 for special competence in raclear nedicine at the end of the 5 1950's. The American Board of Nuclear Medicine dates to, s I believe, 1964. Dr. Robinson? 7 MR. ROBINSON: Final approval .1972. s MR. LINTON: All right. It had been in motion. g COMMISSIONER AHEARNE: So anything that we might to have seen since 1972 has occured since the credentialing si boards existence? 12 MR. LINTON: Yes, sir. You have a proud paternalism l there. l 33 t - . _ _ l 34 COMMISSIONER AMEARNE: Another way of looking at I it can be that if any problems have occurred, major problems ! 15 i l to have occurred since then, then it says that the credentialing ; l 37 boards didn't solve all of the problems. , l is COMMISSIONER GILINSKY: You had some pretty dreadful i l to '"'5-
, MR. LINTON: If the Commissioner would infer from my comments that we have solved all of the problems, I owe ycu
, an apology.
COMMISSIONER AMEARNE: All right. 3 COMMISSIONER GILINSKY: I must say that I have to 3 25 add a comment. To have a representative of the medical l
70 8 profession accostag ocysne of taking poternalistic attitudo 2 is , I think, a little bit much. 3 (La ugh te r. ) 4 MR .LINTON: All right . si r. You have Concluded 5 that you have a presence here and so our comments are directed l toward tha shape of that presence. We do note that you s 7 recognize tDe professional credentials and, of course, we are 4 s grateful for the chance to have one' document which would tell e us al . we need to know and respond to. l I us We are corcerned. Mr. Chai rman, because a recent
- study such as the one by the Hospital Association of New n York State suggested ttat as much as 25 percent of the o hospi tal deltar is spent in complying with regulatory p __
w requirements of all kinds from federal, state and local 3 agencies. Amy reduction in such requirements in the cost of a responding to'them can only be applauded in these days of it n soaring health costs and dramatic ef forts to reduce them. m C3MRISSIONER AMEARNE: You say that 25 percent of g the dollars 'were spent in complying with regulatory require-3 y ments. Is the implication that those were requirements that 3 need not be complied with so this 25 percent was wasted? FM . LINTON: Not entirely, si r. The question of l 3 3 how overlapping and duplicative and redundant adds to it in y great cost. COMMISSIONER AHEARRE: I aw sure. We are familiar. a
1 10 our other sid2 ;f the oorld in rogo10 tory roquirceeats 00 2 licensing reactors and there is also an issue that of ten g 3 comes up and this is a regulatory burden and it is a require-4 ment and some of the requiremenns are there for essential 5 safety. I just wanted to make that clear. g MR. LINTOM: The requirement. let's say, for fire 7 code is not one that any of us quarrel with or clean food 3 er so forth. But the costs are substantial. CHAIRMAN PALLADINO: Meyertheless, might you not have 9 to independently imposed some of these same requirements on n yourselves. This is what makes it difficult to evaluate 12 a statement Itke tha t. MR. LINTOM: Yes, indeed, sir. In the state of 13 I _ ' ~ 34 Maryland, something like 120 agencies 1mpose some kind of equirements on hospitals. Are we are suggesting is that any 15 is streamlining would be to the benefit of all of us. gy CHAIRMAN PALLADINO: I could understand the benefit g of streamlining but these numbers are hard to interpret and
! they do give inlications that sometimes I don't think are ; m fz 3, necessarily correct. l d MR. LINTOM: Very good, sir. As a matter of fact, 7,
i r in the nuclear medicine department, the figure was slightly lower than the overall 25 pcercent. 22 g. We do make three suggestions, Mr. Chairman, for possible changes in those. One of them, Dr. Robinson has
p 72 1 already discussed. One of them relates to a requirement of i 2 1 Part 35.75 relating to the institutional stay of patients i 3 in which we suggest essentially a two-tiered approach, one. 4 where the amount of radioactivity is significant and one. 5
- where our committees felt that it is not significant.
e ; ! The third point which we suggest is the dropping - i 7 of Part 35.37 the so-called "misadminis tration rule." As we a understand it, sir. this would require an action by the e Commission to reverse a recent vote and it is a request to which we are considering submitting in a petition. 11 CHAIRMAN PALLADIN0: What is 35.37 again? 12 MR. LINTON: Misadministration rule. The earlier 13 ( material available from the staff indicated that a violation 14 1 rate of less than 0.01 percent which we suggest makes it is 4 a bother rather than a benefit to anyone concerned. HB COMMISSIONER GILINSKf: It isn't like everybody g g 17
- is filling these things out and we are only getting one-NB l hundredth of one percent significant reports. It is only j Mp reported if there has been a misadministration.
MR. LINTON: That is correct. sir. COMMIS$10NER GILINSKY: So you can turn this right
** around and say that as long as the number of misadministrations is low, it should be no bother for physicians. I don't under-stand your point at all.
MR. LINTON: My point is that it was re;arded as a
.. . 7
} 73 i 1 bother, sir, and one which we think is emproductive.
. 2 We also were somewhat concerned about the legal 3
point of self-incrimination because early in the drafts. 4 the information was provided not only to the Commissies 5 l to which there was no objection but aise to other parties. I e COMMISS!7NER GI' INSKY: It seems to me that . 7 people have a reasonable right to know how many of these a misadministrations there are and I thipk we have te be able 9 to keep track of the nature of these misadstaistrations to 1o make sure that we are carrying out our respessiblittles 11 and also' to make sure that everyone can benefit and learn 12 the lesson from them. 13 g _ MR. LINTON: , The Commission obviously took that 14 position in its recent vote, sir. 15 CORMISSIONER GILINSKY: We would very much ifke is y to hear an opposite view explained. If what I as soggesting 1 17 d is wrong, then by all means. I would like to have it corrected. Is MR. LINTOR: If the Chairman wishes to take the time, i is sir, we would be glad to enlarge on this. i CHAIRMAM PALLADIN0: Enlarge two minutes worth, i MR. LINTON: Dr. Rchinson would like to give me help here.
$ MR. ROBINSON: We understand that this particular 24 question is the subject of a separate review and we did not 25 address that in our formal comments. However, from the
- - - - - - ~ _
l 73 l 1 physician's perspective, I would like to just comment that I
- 2 several studies have been done on therapeutic drugs. These f 3
l are drugs which were taken in high dose moltiple times per ; l a \ day for periods of time up through days er years in some ( 5 cases. e It is a fact and perhaps an unfortunate fact that , l 7 about 30 percent of therapeutic drugs in this country are e misadministered either by the doctor, by the pharmacist, e by the nurse on the floor or finally, by the patient who l MB just didn't understand the directions. Est we don't go 11 around filling out forms about that and we are trying to 12 improve that and the patient package insert. has come along 13
) _ and thirgs like that to try to improve the compliance in ]
14 taking the drug. They take too big a dose, too little a 15 ' dose, wrong time of day -- all those things are misadministra-w t, tions. !
'g n . So we practice in a climate where it is very u
l difficult to get therapeutic drugs properly administered. j m Then we turn to the dirgnostic level where they are radio-8 s active but they are given in small quantities and in micro-21 grams of drug, usually only once, and we are required to report what we consider to be minor problems.
- Of the hundreds of misadministrations, they 3e probably occurred out of five or ten million administrations O
25 or whatever the numbers work out to be -- it is a very small
O i 1 numb 2r. But than co ficd this sert of hecd1100 to ocory 2 major newspaper in the country as a result of your staff g l 3 study which added up that 800 people got alsadministrations i a so the headline goes out over the wire service and was 5 developed from a story written in Science Trends and they e only picked up, of course, the first part, that 800 people 7 got the wrong dose of radioactivity and this is really a a major problem. i e We get a very black eye with the public. That is l l so absolutely impossible to recant that sort of bad press. n That is just one example. n COMMISSIONER GILINSKY: When you referred to the i i n earlier figure as 30 percent, those were non radioactive? ,
' ~
w MR. R081NSON': Yes, ' sir, ant those were therapeutic g levels of drug. g COMMISSIONER GILINSKY: It may well be that when -- p MR. ROBINSON: That sounds large, but that is the I* g climate that the physician views the problem. That is his }I g perspective. I say that that other problem is a problem
, and yet it is one that is very difficult to approach.
(d Meanwhile probably 98 percent of the mi< administrations we 3
, consider to be of a minor nature but they are required to be reported.
, MR. LINTON: That was really the basis of our earlier point.
a COMMISSIONER AHEARNE: That is a distinction. I
l ie . . l 76 i \ 1 !' think, and there were two problems that I think you idertified. l i 2 I One is perhaps a problem of the level at which reporting should 3 l be done and the second is the dif ficulty in getting a fair a press treatment in the area of nuclear activity. We can 5 help you with the first, but the second is beyond our control. 8 MR. 408I4505: Yes. We understand that. 7 CHAIRMAR PALLADINO: Perhaps you can help us find i l s a way to deal with that. l 1 (Laughter.) e MR. LINTOR: Mr. Chairman. this was our only chance 11- ) to bring that point to the attention of the Commission. , a However, we would not like it to detract from our basic n g __ support of Part 35 and. our pet.i tion tp to adopt it and M move it fo rwa rd. m I Thank you, sir.
'is CHAIRMAR PALLADINO: Thank you. Any other 3
I questions? We want to allow time for exploring the differing opinions by the staff. i = l COMMISSIONER AMEARNE- I have one question that I l L
" want to ask Mr. Spell. On the general license elimination, you didn't address that?
" MR. SPELL: I do have a personal feeling en that.
l We never did go to the general license and if that is an
- indication to you, we feel like we have a better handle.
" COMMISSIONER AHEARNE: So eliminating it?
- a.: g --- y . -
t Mt. SPELL: Would not affect us in our state. I
. 2
- think Mr. Whatley may wish to comment.
3 COMMISSIONER AHEARNE: Mr. Whatley. 4 MR. WMATLEY: No. I agree with what Mr. Spell said. 5 COMMISSIONER AHEARNE: Would it be correct that the e Agreement States' as a group never really specifically , 7 addressed that to your knowledge? s Mt. SPELL: I can't comment. I don't know. But I e have a feeling that you may find it somewhere saybe evenly to split. maybe 30 to 50 percent split on the ones that did 11 and didn't. 12 CHAIRMAN PALLADIN0: Gentlemen, thank you very much 13 g _ for being with us and for your enlighte'#$d comments.
- ~
MR. SPELL: Thank you. 15 MR. WHATLEY: Thank you. Is ! MR. R081MSON: Thank you. 3 g 17
. MR. LINTON: Thank you.
11B l CHAIRMAN PALLADIN0: I would ask the Commission-how j 19 My suggestion would they would want to proceed at the moment. 1 2 a be to see if we have Patricia Vacca and Joe DelMedico here. 5 I' MR. DELMEDICO: Yes, we are here. 22 How about joining us at the CHAIRMAM PALLADINO: ta bl e . We would like to hear the thrust of your comments 24 on the proposed rule. ,a I' Mr. Chairman, I am Joe DelMedico. MR. DELMEDICO: \ .
yg 1
~
I as a member of the Medical and Academic staff. As you know 3 i from previous correspondence. I perceive two major problems. 3 The first is that there will be no pre-licensing review of 4 the applicant's procedures and controls as they relate to 5 radiation safety. S I would have less concern if the new regulations l 7 spelled out the same operating procedures that we presently a require in the license application. However, it does not. 9 Attached to your copy of 'this statement which I will NB - provide in a moment.you will find a table that I prepared 11 after I reviewed the proposed regulation. It Among other things, the table identifies a number of 13 spec 1fic operating procedures and safety instructions that we
] ,
M presently require in the license application. In the proposed regulation, these are replaced by vague requirements
" to implement " safety procedures." " patient control instructions," and " contamination control instructions." all l of unspecified nature.
d
< 2.
My understanding is that an inspector could issue f a notice of violation only in the case whcre no procedures { I' had been impl emen ted. If some procedures have been implemented 22 but they are inadequate or inaccurate. MRC would have no 23
. recourse.
24 This remains true regardless of what may or may not as The problem be written in the companion regulatory guide.
i stems from the fact that tha new regolation does cet dictato 2 the specific coatent of the required procedures. The same ? holds true for the required instructions. My second major 3 i i 4 concern is that there will be no pre-licensing review of the s Physician's training. 1 CNAIRMAN PALLADIN0: If they were approved if we g 1 y went through the process of approval of a procedure, then i e presume an inspector would have a way of measuring against? l ' MR. DELMEDICO: Yes, sir. After they are approved 9
, a they are added to what we call the " tie-down" condition in the 3, license. It is a condition that says that you shall operate in accordance with the statements that you. made in letters 12 4 13 dated thus and so date.
I ~ ~ CHAIRMAN PALLADIN0: All right.
,4 MR. DELMEDICO: My second major concern is that there will be no pre-licensing review of the physician's training and here I mean physicians who are not board-37 certified because as you have heard, that is very easy to is g
, check. We presently conduct this review to determine that the training is sufficient to avoid unwarranted radiation la i ,,
exposure to the physician, medical workers and to the public
! including patients.
COMMISSIONER AHEARNE: Do you have a rough idea of how many physicians who have the licenses are board-certified versus how many aren't. what percentage is the split? l l
l 4 :. . gg I 1 RR. BELMEDICO: Let ca coswer you to a difforoot 2 way. When an applicant comes in, all they have to do is 3 write that they are board certified and a date. A licensing a assistant checks this information in the reference book that 5 we have and the amendment is put out immediately. s The ones who are the problens a you might espect 7 are the ones who are not board-certi fled, the ones who might s- be more marginally qualified. s COMMISSIONER AHEARNE: I was just trying to get a se feeling for the percentage of the problem. Is it one si percent who aren't board-certified or 50 percent? 12 MR. DELMEDICO: I would say just roughly from my 13 experience, 40 percent are board-certified, .40 percent of 1 the applications that ise get are boart-certified and 60 34
,, percent are not.
,, The proposed rule instead requires that the
,y licensee keep a brief description of this training on flie is for review by inspectors. However, inspectors may decide
, ,, that they will not routinely review this information to
, determine whether or not the physician is qualified.
As we all know, an inspection is not a review of
, a program in i ts totality. It is merely an audit. I can
, certainly understand the basis for such a decision.
It is a bit late to be checking a man's credentials af ter he has already held an NRC license for six months and
El y has used that license to parform 1,000 er more nuciaar J 2 medicine procedures. 3 Review of physician qualificat .ns has tradittomally
, been a licensing not an inspection f unction. Such deterais-5 ations would range from difficult to down right confrontational i
e if they had to be made on the spot in front of the physician. 7 From my own experience, I know that these reviews can take a weeks while the physician gathers additional documentation.
, In addition, such reviews may require consultation
,, with MRC's advisory committee on the medical uses of isstepes or contacts with the directors of training programs and se on.
,3 You can well leagine the uncomfortable decisions
( that an inspector ouid have to .ame. rs this physician not qualified or is his documentation merely inadequate? Should the nuclear medicine department be shut down until this can I u be determined? . Should patients awaiting vital nuclear med cine procedures be sent back to the k r m s undene? l 1
, , At the present time, we in licensing pay attention l
(* l ll " to'the quality of the physician's trainine not just the l !i f quantity. 21 l l This distinction would be lost under the proposed i rule. Let's suppose that the physician received his hours of training from an equipment manufacturer who s tands to make 24 I e $200,000.00 sale of nuclear medicine equipment. It is rather a
L St I onlikely that any physician would fall such e course even if 2 he never bothered to show up. 3 The licensing staff discovered that one such a program included an eight-home tour of the City of Milwaukee 5 as part of the core curriculum.
-e (Laughter.)
7 CNAIRMAR PALLADIRO: Wouldn't the preceptor have to o step in there7 o RR. DELMEDICO: There are two parts to a physician's se training. One is hours, more er less classroom hours, in si basic radioisotope handling techniques. The physician s2 documents these himself on what we call Supplement "A*. The s2 g _ second is a preceptor form which discusses the various 34 nemhers of cases that a physician has actually oerformed as onder a preceptor position. I so - y In the optimal cases such as Dr. Robinson's these g 37
. programs are integrated. But this is met a requirement.
se I It is not a requirement now and it is not a requirement in j us the proposad rule. A physician Can take.the basic radioisotop0 zo 8 handling hours from one place and serve a preceptorship which generally means not handling eaterial and learning how to handle material, but rather how to sit behind a viewbox in interpret studies at another institution.
- The Commission's emperience with serious medical misadministrations seems to ~ indicate that they are caused by l
m o . . t hasan error and due to lack of attenties to detail. It t 2 appears as though these errors cannot be reduced through ' 3 further regula tion. One tning is for certain. This problee 4 will still be with us in the future. ; 5 If we discontinue our pre-licensing review of a physician training, sooner or later we are bound to have a 7 serious therapeutic misadministration linked to an enqualified E physician. 9 Media interest at that point would result in a l, se pubitc relations disaster. f In closing let me emphasize that my concerns are 12 not so much wi th the new regulation but rather with the 13 pr.oposed me thod o f impl ementa t_f on. Unfertunately, this ' 14 SECY paper does not separate the two so that they can be l 15 voted on individually. The proposed regulatten would work rather well if we kept our current level of pre-licensing 17 review. Any deficiencies could then be made up by license conditions. De Alternatively, the proposed regulation could be l changed to dictate specific equipment. procedures'and 1 instructions similar to ones that we currently.regt f re in the license applications. E' In any event, I believe tha t there should also be a
** pre-licensing review of the physician's training and as experience.
w. i g4 1
- Thank you.
2 CHAIRMAR PALLADIRO: Joe, do you have specific 3 olaces where you would make suggested changes to Part 35 in
* 'line wi th your comments?
s' MR. DELMEDICO: Certainly the first and mest l 8 important change that I would make is for ERC to retain the 7 pre-licensing review of the physician's training and experience . . 8 CHAIRRAN PALLADINO: Suppose I were to believe what
' you say and I vanted to make a recommendation that we go l l
*D this way. I don' t feel that I am smart enough to toew what i 11 part I should put it in there and I was wondering if you had 12 some thoughts along those directions or could develop them? 1 13 MR. DELMEDICO: I prepared a listing of the major
- - - __ l 14 dif ferences between the current regulation and the proposed 15 reg ul a ti on.
18 COMMISSIONER GILIMSKY: I think what the Chairman 17 is sugoesting if I understood Correctly, is a marked-up Copy me of the regulation incorporating those changes that you would N like to see in there. 20 CHAIRMAN PALLADIN0: Specifically, those two points 21 you raised. 22 MR. DELMEDICO: I certainly could do that. I have
,23 not done tha t.
CHAIRMAN PALLADIN0: I would find that hel p f ul . as 25 MR. DELMEDICO: It would require someone to give me l l
as l a permission to speed the hours to de that. l 2 (Laughter.) 3 CHAIRRAS PALLA0!W: I think we can work that out. l l a COMMISSIONER ASSELSTINE: Perhaps we ought to hear 5 from Pat as well. e CHAIRMAN PALLADINO: Oh, yes. I certainly want to 7 hear from Pat. 1 e MS. VACCA: Mr. Chairman and Mr. Commissioners. ) g thank you for giving me the opportunity to speak to you today i jo on this matter. My name is Patricia Vacca. I. too, as with i
,, the Material Licensing Branch in the Medical and Academic 12 Licensing Section.
13 As Joe has indicated, we both have 3 :ven you i l 34 previous documents indlcating ihat our principal concerns are
,, about this docessent. I womid like to give you three pieces
- ,, of background information. In view of the fact that most of .
l gy the issues that come before you are reactor oriented, you 18 are probably not super familiar with all of the things that
, go on in the materials area. _
, I took the opportunity to look at MUP.EG-0714 and g I believe you have some copies of handouts on this matter.
That document has occupational radiation exposures for 1979, the most recent year that is available, and shows that medi Itcensees are .second only to power reactors in the number of personnel overexposures reported in 1979. Reactors reported l l
=. .
86
. I 27 overexposures while medical 15censees reported 13. In 2
total occupational collective dese, reactors showed am 3 eetimated 39,759 person-ress w'aile medical licensees were a i sone:hing just ever 9,200 person-rems. 5 It sheeld be noted that not all of the medical e They can be from . exposures are from 3RC licensed materials. 7 MRC materials. from X-ray uses and other things that are not a licensed by NRC er from some combination. It is not clear e exactly what extent of that total occupational exposure is e due to things that come under NRC's purview. 11 It is interesting to note that in the EUREG 12 document they mention that the doses incurred by medical 13
- __ workers are of particular interest because the majority of l
Sa workers are young women and that estimates by EPA indicate a that 20 to 24-year old females in the medical field comprise m one-fourth of all the women workers in the United States 17 radiation work force and since some of these people could be e in the earlier stages of pregnancy. the total occupational e dose could result in somewhat greater semantic risk than you might first thing from the numbers.
" The second point I would like to bring to your
# attention is the types of licensees that are principally af fected by Part 35. We are not talking about the broad type A licenses that are university-based medic:1 centers.
We are not talking about MIH. so don't keep NIH in mind as
gy 3 the typical example. These are' broad licenses or 2 places that de met only the well-established diagnostic 3 and therapeutic studies, but they are the folks who develop l l a the new diagnostic studies, the new therapy procedures. 1 5 They do research op humans, normal volunteers , on patients. 8 They do laborabory research, animal research, et cetera. y These are not the kinds of licensees that are a principally affected by this change. The broad licensees e have well trained staff. excellent facilities, equipment y and they operate with the decisions being made on a day-to-3, day basis by their own in-house radiation committee using u criteria that have been approved by the licensing staff. u The people who are really affected by this regula-I g tion are the group medical licensees, the small community l
,, hospitals, physicians in their private offices and if they
,, have one or maybe a few trained physicians they are in good s
g shape and they may have a few technologists and a technologist 3g . or a physician is the person who doubles as tne Radiation I , Safety Of ficer. 2 m fa ,g If you can just keep in mind the kind of licensee i ce are talking about, and one that I have in mind is a 26 licensee that I have had frequent communication with. It is an 85-bed hospital in a small town on Intersta te 80, west of Laramie, Wyoming. They don't have the same capabilities as 3 an MIH. I
- . _ _ - . _ , . . _ , . . - , _ _ . _ _ . ~ . , _ . - . _ _ , . . ._
- 1 as 1 i Also, the people who are representine the major i organizations in many cases are people from large institutions 3
that have broad licenses that have the greater resources than 4 our broad licensees do and they may not keep in mind or have ! s in mind clearly all the problems that a smaller licensee have. f l e As has been indicated before by you. I certainly 7 am not opposed to the idea of putting all our requirements in s one place and improving the efficiency of the licensing s process. My concerns are on the two issues that Joe nentioned, to our review of physician's qualifications as well as our 11 review of the applicant's radiation safety procedures. 12 With regard to physician qualifications. I think 13 _ that it is important that we sake a determination before the ) 14 license is issued that the proposed user is qualifies by is training and experience to use the radioactive material safely. ) )- On that application form that you have heard about.
,e
) the proposed new application form, there are three boxes that could be checked. One has to do with the board j 3' certi fica tion. If a physician checks that. box, as has been
" indicated already, tha t is easy enough for' us to double 22 check and review and make sure that the person truly is board-
One other box that the
. certi fied by the appropriate boa rd.
** person can check says I request an exemption from the require-ments and the form says that the documentation is attached.
i 89 j
. i Again in that case we would ha looking at the i I, 2 l4 physician's qualifications. his trainina, experienr- as
! 3 we do in the present case. 4 What I am concerned about is if the physician, 5 the non-board-certified physician checks off the box that ( e says " training and experience as specifield in 10 CFR 7 Subsection J," s xperience has shown that most of the b-*rd-a certified physicians and these are the people who are likely 9 to check off that last box do not now provide NRC on the to first go around with adequate docunentation of their 11 training and experience. 12 We usually have to go through any where from one 13 g . _ to three rounds of correspondence to get the additicaal 14 information we seek or for the licensee or applicant to come is to the conclusion that he wants to withdraw the request because the physician needs some additional training. 17 I' The training and experience criteria that me are is l using today is essentially the same as that proposed in the j to SECY paper. I think in all probability we can-expect that 2 most non-board-certified physicians will not have sufficient a 3 j documentation in their files to show that they meet the 22 training and experience criteria or requirements that would
,23 be in a new Part 35.
24 COMMISSIONER AHEARNE: Could you make a rough
" estimate? In the group that you say you go through the one ,
I
90 t to three roonds of questions, what fraction ends up withdrawiaq l l 2 versus what fraction ends up getting approved af ter all this? 3 R$. TACCA:~ ! think after all is said and done, a a very large percentage eventually have shows enough information either for the staff in our branch to make a e determination or if we have some qualms to go to our . 7 advisory committee. e You are correct that in many, many cases whether 9 it be 90 percent of those cases, we eventually wind up a coming to the conclusion that the person does have adequate 11 training and experience. l u I 'as not correct or incorrect. CCMRISSIONER AHEARRE: U _ I am just asking the question. ,
}
M MS. )ACCA: But there is a large percentage a where you come to the conclusion that a person after all of 1 this has adequate training and experience. In perhaps g 10 or 15 percent of the cases, the application is withdrawn.
- That is pretty high. 1sn't 0 CORRISSIONER GILIRSKY:
b
- it?
a MS. VACCA: These are numbers off the top of my 6
- hea'd. I do not have any statistics on that. I am not sure 8 that it is easily available. It is not a large percentage E in any event.
l 8 My concern would be offset. as I believe Joe has a indicated, by MRC continuing to obtain and review before the 9
1
~
license is issued documentation on the training and 2
' experience of these non-board-certified physicians.
The other principal concern I had has to do with 4 the radiation safety orocedures. Today as you probably know. 5 one of three things that an applicant or a Itcensee might a be sending to us. , i 7 He could send us copies of the various procedures a that he has that he is going to use, that he has either 9 developed or has had developed for him by a consultant. 10 Secondly, he might commit to following a certain set of 11 i procedures that is in the regulatory guide.10.8. Or it 12 l might be some combination of those. He likes some of the l 13 lg procedures in the regulatory guide but he doesn't like others 14 so he develops his own. 15 In the current version of Part 35 that you have before you in this SECY paper. I know there are some examples 17
! of instances where procedures are mentioned and some detail ul l 1s gone into, for example, the calibration of survey meters.
g up
. I am concerned about those instances in the SECY I ao i pa er where Part 35 does not mention certain kinds of
' I' radiation safety procedures. that I believe are important to 22 health and safety. For example, I do not see in there procedures
'" that would insure accountability of sealed sources that are
'l used for therapy. We have had a lot of instances where the l l l l I
,y I i
* - sources have been lost, patients sent home with the sources in !
l them, various and sundry other problems associated with those 3 sealed sources. One of the things that we have tried to do 4 to offset those problems has been to request licensees to 5 have better accountability procedures. 4 I don't see that particular requirement in this 7 version of Part 35. 8 I as also concerned because certain procedures are 9 mentioned but without sufficient detail that you could have a 10 clear understanding of exactly what i t is that the agency Il expects is going to be included in those procedures. 12 I take as an example the requirement to have some 13 procedures with regard to contamination control for iodine
]
14 therapy patients. I have certain ideas about what that might 15 contain. Joe may have others. Each of you may have other ideas. But it is not clearly specified in the regulation as
' far as I am concerned what those minimal criteria actually are.
h is $] It seems to me that there are several different options that the Commission could take with regard to the 30 One obviously would be to continue the current procedures. I 9 21 practice of reviewing the appilcant's radiation safety 22 procedures just as we are now. 3U A second option would be to incorporate'into Part
- 35 procedures equivalent to or very sinilar to those found in 25 the various appendices to reg oulde 10.8.
w m - m
1
' l A third po, int might be tha t the regulation in all '
2 instances say that licensees shall have thus and so kind of 3 procedures. The licensee must follow the precedures they have 4 l in place and that the procedures contain certain specified 5 minimum features. e Lastly, I suppose there is the option of revising . 7 the application form so that the licensee says yes. I have a so-and-so kind of procedures. I will follow those procedures e and as a minimun, my procedures contain I. Y and Z 10 factors whatever they are that might be identified by MRC 11 either in terms of a licensing guide or perhaps on the ! 12 application form. ' 13 These are just four options that I thought about. 14 I, of course, have not di2 cussed these with ELD. I don't l know to what extent each is viable. I think the SECY paper only outlines one option 17 and I think that the most key factor in my concerns about is Part 35 are how it would be implemented and some of these is other options might be things that could be considered. If we continue to review an applicant's procedures
*' before . issuing a license, then it is not so important. I 22 don't think, that Part 35 is specific with regard to content f of certain types of procedures or if the regulation doesn't
- specifically mention a certain set of procedures because 25 this is something that could be 'resolvei in the licensing
1 l
,4 1
l process. 2 lI On the other hand. if the staff does not review the 3 procedures in the licensing process, then I think some major 4 l changes would need to be made in Part 35 and if those changes 5 I are not nade then I think we would expect that licensees a could be operating for some period of time before they are , inspected either with no procedures in place or using e inadequate procedures. It is not clear to me the exact extent 9 to which NRC inspectors will have the time to devote to l lo the reviewing in detail the various procedures and also the 11 9'2quacy of those procedures will come into question when 12 the inspector appears on the scene. ! 13 In general. I think, adequacy of the procedures
]
14 established now during a licensing process and the inspector 15 only has to be concerned with whether or not the procedures y are being followed. That is a general statement. It is not g 17
- true in every single case, but I think it is fairly true. l ~
IS l Those are the principal things I wanted to bring g to to your attention. Thank you. CHAIRMAN PALLADINO: Thank you. Any questions? I' COMMISSIONER ASSELSTINE: I have just a couple, 22 l Pat. You mentioned the 85-bed hospital near Laramie, Wyoming N and it sort of struck a responsive chord.
* (Laughter.) -
! COMMISSIONER ASSELSTINE: I guess one of the l
\ .o . o l 95 l i . I questions I wanted to ask you was how burdensome are the 2 application requirements that we have for a small hospital i l 3 like that and to the extent that you think that they are 4 burdensome, are there ways of reducing that burden while at 5 the same time preserving the pre-licensing review of such ! e things as training and procedures ? 7 I guess the same thina would also apply to smaller a users than that. 9 MS. VACCA: In the case of the 85-bed hospital, lo their heart is in the right place or at least their words 11 are in the right place. They are telling us that they are 12 ' very anxious to keep on our good side and do everything 13 according to the rules.and regulations and our expectations 14 as is probably true with most of our licensees. 15 I would think that' for the licensee who finds the is procedures in the regulatory guide acceptable, that he would 17 not have a great amount of trouble filling out the application is form nor complying with the procedures. The procedures were 19 developed origina'ly, those procedures in the various 2 appendices in the reg guide, were developed originally with 21 some hel from the committee of the American Association of II Physicists in Medicine. They have been modified during the 23 public comment period on the reg guide. They have also been 24
. modi fied through staff experience. There may be some points in there that are perhaps overly conservative and that one
96 1 could look at with a f resh view and perhaps take scae of those r 2 l out. 3 I don't really think that the current licensing 4 process is all that burdensene. I appreciate the fact that s licensees have to come to us and make some changes in the a procedures and perhaps there are some things in the options 7 that I mentioned that might offset some of those amendments. a Perhaps we could go to a procedure where we would e say, we mus t have procedures for whatever the subject matter le package opening and as a mininum your procedures must 11 incorporate factors A. 8 and C without telling them. "Put 12 your gloves on first. Now wait four steps over there and 13 pick up this thing in your rig 4t handj_e1 cetera. Some of the procedures are perceived as being that l 15 prescriptive. I disagree. I don' t think they are that bad. is But there is some room for improvement in them. 17 COMMISSIONER ASSELSTimE: So by in large, you is wouldn't view even the present approach as a limiting or is restricting the ability of small hospitals and doctors to provide these kinds of services in rural areas, for example? MS. VACCA: No. I have two licensees in Wyoming that are having trouble. Their principal problem is 23
. recruiting physicians.
CHAIRMAN PALLADINO: Pat. could I pick up a follow-25 up question. Suppose the precedures were not part of the 1
s , 1 97 1 I license but they were approved. That would cause you no i 2 problem, would it, if there was a process for approval? 3 MS. VACCA: I am not too sure. I didn' t quite 4 follow that discussion earlier. 5 COMMISSIO54R GILINSKT: Are they, in fact, part of a the license? 7 CHAIRMAN PALLADINO: Yes, and one of the problems a is that every time you want to make a little change in 9 procedure, it takes a licensing amendment. Let's assume lo that it was taken out of the license but there was still an 11 approval? 12 l COMMISSIONER GILINSK': This sort of tie-down 13 l _ that you were talking about earlier. 14 MS..VACCA: This tie-down condition? l 15 CHAIRMAN PALLADINO: That would give you no j i 16 ! problem or would it? 17 MR. DELMEDICD: It might provide some problems to , is the inspector because he looks to that tie down condition 19 to issue citations. COMMISSIONER GILINSKY: The Chairman is asking if 21 there were such a tie-down, but I don' t know that there is really an important dif ference in it. 23 CHAIRMAN PALLADINO: Following somewhat the way l \ 24 we do with reactors. That is what I was getting at. i 25 COMMISSIONER AHEARME: In reactors, we will approve
1 9 1 the procedures. 2 COMMISSIONER GILINSKY : Having reviewed them. 3 COMMISSIONER AHEARME- We will review them and 4 approve them and then if LSey deviate from then, they can be 5 l cited. The procedures aren't a specific piece of the license. I e It is a question of the formality they have to go through to 1 \ change it. That is the issue. But it still has the pre- ! s approval and in your term a tie-down is there. 9 l CMAIRMAN PALLADINO: Amy further questions. Jim? l to COMMISSIONER ASSELSTIME: I have one further 11 question. 12
'at, you have mentioned a few substantive concerns 13
- g. ,
about the p. ovisions in the revised version of Part 35 and 14 ' I know we hearo some of those from the Agreement States i 15 representatives as well, both you and Joe.
, Is year feeling basically that the proposed b 11 revision to Part 35 that we have before us could be cleaned M I us h up fairly quickly and easily from that standpoing or are l
A MB the problems such hat it really needs a fresh look before we act on it? d Is it something that in essence should be sent back to the staff to be worked on setting aside for the moment this issue of the review of procedures and training as part of the license appi tcation process? MR. DELMEDICO: Tha t wculd be my recommenda tion. I ,
99 I l . have personally a great problem, mysel f, as an NRC employee l l
- l. 2 making comments during the public comment period, for example.
3 COMMISSIONER AHEARME: I have had the same 1 4 ) di f ficul ty. 5 ' MR. DELMEDICO: If we have concerns as employees. s I think we need to reach the Commission in advance of that 7 point and by the same token, I think when a rule goes out a for public comment, it should be in fine shape. 9 Also, if you make comment CHAIRMAN PALLADINO: to that results in a change and that hadn't been a substantive 11 for issue for the public to comment on, you have to go out 12 comments again. l 13 2 -- COMMISSIONER AHEARNE.: That,_still doesn't get to 14 the question. is COMMISSIONER ASSELSTINE: My question was, is it in is good enough shape th. ae kinds of problems that exist now g g-17 can be corrected f airly quickly and easily or is this some-
- l NB thing that really needs to go back to the staff for a fresh 4 m look in terms of what is in this revised Part 357
" COMMISSIONER AHEARME:
As a working assumption, s
" is there were some provision incorporated that picked up the l
** pre-licensing reviitw of procedures and qualifications.
COMMISS11NER ASSELSTINE: That's right. Incidentally. I was waiting CHAIRMAN PALLADINO: to get the staf f back to ask them the sane question.
l
~
100 1 MR. DELMEDICO: In the past year and a half that
- I the rule has been in the process of being written. I have 3
perceived that these are major philosophical differences. 4 COMMISSIONER AHEARME: Yes. 5 MR. DELMEDICO: I haven't been able to make a dent s in them as you can well imagine. 7 Certainly if agreement were reached that we do need a to review physician qualifications and we do have to have 9 hospitals and physicians tied to some rather specific proce-10 dures, yes. I suppose that the basic package could be cleaned 11 up rather quickly. 12 COMMISSIONER AHEARNE: In other words, the rest of 13 ( , _ it, the 0;111ng together in one place, those aspects of it 14 are a*' right. 15 LOMMISSIONER ASSELSTIflE: That is really the
, question. Sett ng a side the question of the pre-licensing l 17 I ! review of trainins ani procedures, does Part 35 do what l is
,! it was intended to aa, that is, to pull together in one place ' 2 le l virtually all of these ass 3ntial elements so that you had )
- i. '
I i in one place all of those eh?ments that you wanted to impose i f as requirements or are there ca lugh problems there that it really needs to go back for . e... .i i . nork? 23
. MR. DELMEDICO: No. I dea't believe ttst there are problems there. I had to use the SECY oaper a great deal in I'
( preparing my original letter to you and also in this
101
- 1 discussion. I found it rather easy to use and well organized.
COMMISSIONER ASSELSTIME: All right. Good. 3 CHAIRMA1 PALLADINO: I wanted to give the staff a 4 few minutes to make comments. We will try to adjourn in the 5 next five minutes. s j Thank you both very much for your comments. We . 7 appreciate it very much. 8 John. I thought it would be appropriate to give you s a chance to comment particularly on the two points that have 10 been raised having to do with the pre-licensing review of 11 procedures and training. j l 12 MR. DAVIS: We should have tracked you though more of this than we thought y.ou woul,d_ want to be tracked 14 through. But we have Bill and he is going to track you 15 in just a few minutes into what we would do with the new rules having to do with procedure.
~
17 I think it has been rightly characterized. There is is
! a dif ference in philosophy, but I am not sure that the dif fer-d is j ence in philosophy is a wide difference in philosophy.
I " i Basically what we had hoped to do in this new 21
}
procedure with regard to the procedures themselves is to come
- to some degree of standardization. Secondly, while the rule, i tself, would require, that they meet certain standards and then not get so involved with the detail of how each specific hospital meets that standard. So that when for some reason
102 1 they feel they have to change the details, they have to come 6 back to us for an amendment to the license. 3 CHAIRMAN PALL.tDINO: You weeld perceive approving 4 the procedures? 5 MR. DAVIS: I would say that the licensees. if they a neet the basic requirements, should have some flexibility 7 in how they meet those requirements and the option to change a those detailed procedures without having to come to us for 9 pre-review. When we talk about procedures, as I understand 10 these procedures, they vary from somewhat general to 11 extremely specific. 12 I think the thing to do is to let Bill walk through 13 this as to what we had in mind so you will have at least a l 14 better understanding of what. I guess, is now a minority l 15 view. 18 (Laughter.) 17 CHAIRMAN PALLADINO: We can characterize views 18 as ninority or majority. 19 MR. DAVIS: The view of how we thought we were guaranteeing safe +.y and how we did not see this rule as a 21 dramatic walk back from safety but merely a cleaning up of 22 the way to get there. Bill, why don' t you pick i t up? 23
. MR. WALKER: Since we are working with the training and e>perience, the pre-review of physician training and experience and procedures, I would like to start with the
~
1 l physicians. 2 - CHAIRMAR PALLA31NO: With what? 3 MR. WAL KER: The physician's training and experience, l 4 how we propose te do it and why we don
- t feel that it will be i 5 I drastically different enough to give us any less assuraince thar-e we are getting right now. .
7 , As I pointed out, there is already a new requirement l for the physicians to actually sign his nane that he does. 9 in fact, meet these with a very specific reference to the 10 place where the requirements are contained in the regulations. 11 There is another requirement that the highest management of 12 the licensee sign the application and the statements are made 13 ( _ that the people who have said _that they have this traini'ag, 14 in fact, do comply with the regulation. 15 The last point it mentior.s that he may be subjtect to such civil and criminal penalties as provided by law if he nakes a statement in here that is not true. This is a i.
! war.ning to that man who is very atuned t malpractice and j is ; everything else, that he is, in fact, making a very sounel a statement.
A I' h COMMISSIONER AHEARNE: What page was that on? E 22 MR. WALKER: Sir, tha t is at the very end of
** enclosure 1 and it is on the application form, itself. Tha t 24 should be the last page before the first green page that you k "
have there. M // !9)JjiJ:tj y; j.zi! ,j J M? N
105 1 continuing education. 2
- Mere is a matter that we will probably have this guy 3
withdraw his application because although he has all this 4 training, he didn't have it five years ago. 5 But this is one of very few. Most of the time a when it is something like this he can come back and this one , 7 may also be able to do this and document that, in fact, the i a only reason that he didn't come in the first time was .that the 9 documentation was fairly cowplete except for one small point. 10 He is roll quali fied. Even those occasionally that miss 11 meeting the full qualifications have had very extensive 12 training that includes a large amount of radiation safety 13 and although they may not meet our formal requirements. I { 14 don't think that they are so ill-informed or so ignorant of 15 radiation safety principles as to present much of a hazard. I think that is an important point.
! COMMISSIONER GILINSKY: Let's turn this whole thing 18 around. Why have any requirements at all? Why don't we l
g 19
. Just leave it to the medical profession? I suspect that that i " would be something that they would favor.
i 5
' Maybe we go back to the same sort of j MR. WALKER:
22 a thing, a philosophy that has sort of crept into licensing
- and that is, if there aren' t enough --
" MR. OLHSTEAD: The answer to that is very simple.
I You are required by law to have requirements.
P 104 1
- 1 COMMISSIONER ASSELSTIME: So you say block 25 is !
2 signed oy the supervisor, not by the physician. j J 3 MR. WALKER: By the hospital administrator or the l 4 hospital director. 5 COMMISSIONER GILIMSKY: What is your estimate e of the number of applications that are withdrawn now? We 7 talked about that earlier. 8 MR. WALKER: I would say less than five percent. s - I think we ought to go back and get you a figure on that to but it is very rare that they are withdrawn. 11 COMMISSIONER GILINSKY: That is one out of twenty. 12 Let's assume that everyone was acting in good faith and 13
-- thought they were qual _ified an_d turnr_out not be qualified.
{ D 14 MR. WALKER: Less than five percent. I don't know 15 quite how much less than five percent. It may be considerably
' Most of the physicians do, in fact, have the training.
more. There may be in a couple of instances, and we are working with up ~ l one right new where the individual had the training required j ts , a to do this but it is older than five years. lil 5 i
'" This is one which he may or may not have been clear
" on from the current format of the re,quirements and under the j
22 l new regulation, we make it quite clear that this five years
of uninterrupted or somewhere in there, he has received some 24 continuing education. This is the princ1[le that all of the physician specialities follow. It is this principle of l
106
- 1 COMMISSIONER AHEARNE: But here we have a proposed 2
rule. We can also have a proposed piece of legislation. 3 MR. OLMSTEAD: There are many options. 4 COMMISSIONER AHEARNE: I think Commissioner Gilinsky 5 is addressing fundamental health and safety questions and 6 philosophy. 7 COMMISSIONER GILINSKY: We also have tremendous a latitude in setting standards. 9 MR. CUMMIMGHAM: This question has been raised a lo number of times and there is a substantive question of the 11 need to regulate this. I think from what we have seen years 12 ago when we put the general license into effect and continued 13
- it just from the comments we hear today about what is 14 perceived as a lessening of regulation, you can see the 16 difficuity it runs into.
16 We haven't reduced the safety requirements. But
' the perception of it raises a hornet's nest. I think if one is were to try to abandon regulatory requirements on physicians 19 and hospitals all tooether, it would be unsuccessful.
COMMISSIONER GILINSKY: But you are saying that you
' would run into public relations problems. What are the health 22
, and safety problems? Are we doing something that needs to be l done or are we just doing something that people expect that really doesn't need to be done? 25 You always have to ask the question MR. CUNMINGHAM: ,
107 compared tz erhat? 2 I CWNRISSIONER GILINSKY: Compared to having doctors
~3 basically regula te themselves.
4 WR_ c1NRINGHAM: Certainly, these radioactive drugs 5 if mishandiest can cause safety problems. There is no question s about that, now if you compare it to other risks that are , 7 available fn the hospital which are largely unregulated, a I think they are somewhat comparable. Fluoroscopy machines, e all kinds sf therapeutic drugs , all of these present risks to to patients and they are available without the deeree of 11 regulation war have. n fut if you compare it to risks in the nuclear 13 g industry wtich we regulate then it is a different question. 14 WR - WALKER: There is an important difference in 15 the use of radioisotopes in a medical situation and the use
, of therapettH c drugs or surgery or anything else. The risk is e
II "
. to the patiemt in these other specialties. In our case, the l'
NB risk is not cualy to the patient but to the people using the 2 radiopharmaceuticals and to the other people employed in the hospital as well as the pubilc. Therefore, i t is a different situation and requires di f ferent nesgulations to govern i t. f mtstISSIONER GILINSKY: I guess I am not sure
- where you come out on this. We were talking about training qualificatioms and you set a certain standard that I guess you
*. . 108
~
think it is very important to be maintained, but you say l ( that even if it is not met, those people are really qualified. It sounds like we have the wrong standard. 4 MR. WALKER: No. What I am saying is that the 5 relative risk is not as grea t as it would be as if you had 8 a completely untrained individual in charge of this, so:meone . who wasn't at least striving to meet some sort of the standard.
- COMMISSIONER GILINSKf: Is it important for NRC to
' Would they not be maintained otherwise?
set these standards?
" MR. WALKER: It is important for us to determine 12 the qualifications of the individual. )
'3
. _ COMMISSIONER _GILINSKY: Why is it important for us
'# Would not the doctors 'do that themselves or the to do that?
is hospitals? Is The staff is following the medical MR. WALKER: {
'I policy s tatement which the Commission has' --
is 'I am trying to understand [* COMMISSIONER GILINSKY: 1 f I' what your view is so we can understand whether we are doing i j 20 the right thing or .se aren't? 5 21 MR. CUMNINGHAM: I think the answer is that to the g 22 best of our knowledge, we are doing the right thing and we 23 have the training qualifications set at a level which appears 24 to be appropriate. We have done this with the advice of our 3 25 medical advisery committee. It is our bes' estimate of what j
mt l
- 109
- 1 those training goalifications should be.
I CHAIRMAR PALLADINO: 8111. you were trying to make 3 ' a point or two. Have you made your. points? 4 MR. WALKER: Only that this training is well 5 documented new in the regulations.
; e CHAIRMAN PALLADINO: How about this part where
} 7 you just certify? I can understand saying I certify that I e as certified. s CONMISSIORER GILINSKY: Soard-c erti fi ed. 10 i CHAIRMAN PALLADINO: Board-certified. I certify 11 that I have the 500 hours of training in this area and l 12 wha tever is required, but when you get to that other category 13 that says that I certify that -I did this and so under item J. { 14 COMMISSIONER A"EARNE: That is the 500 hours. CHAIRMAA PALLADINO: Is that what the 500 hours 157 Hi Where is the uncertainty that was described earlier?
" The uncertainty that was CORMISSIONER AHEARNE:
' described earlier is that the person doesn't have to show
{
- 1s where they get that 500 hours. They just certify that they 20 l have met that requirement.
2 21 j COMMISSIONER ROBERTS: Under threat of civil and 22 crimina l penalt:les .
#3 And they must maintain the records, MR. DALVIS:
24 of course, om fi. le. <t CHAIRMAN PALLADIt0: They what?
119 1 NR. Davis: They most maintain en file the records 2-that serves as a basis for that statement but they don't 3 submi t it to es for pre-review. a CMAIRMAR PALL AD!n0: I gather that right new they 5 de sabeit it to you under tie present rules? e NR. WALKER: Ther de het it is saly as it is in 7 this case, a personal certification that they have received it. 8 It is mething mere. 9 CNAIRMAR PALL ADIRO: Do you review what comes in? m NR. WALKER: We leek a t i t to see i f i t, la fact. 11 seets what we have set as a standard. 32 CORRISSIONER AMEARNE: And if you have questtoms? t3 NR. WALKER: If we have questions. then we util ge la back. m CMAIRMAR PALLAOlm0: Se that is the one philosophical 4 dif ference at least en this point. 17 RR. WALKER: Yes, but I' don't think it is a very a wide one. m MR. OLMSTEAO: To just give you a little practical experience, what happens when the certification is falsified I' is we. issued an enforcement order and it went out and I the Justice Department was informed and the doctor acceded to the revocation of his license on the grounds that the Justice Department wouldn't prosecute him. That is what actually happened.
111 COMMISS!0NER AHEARME: How did we know it was 2 ' falsified? 3 I MR. OLMSTEAD: We had an informer in the particular 4 case that I am awa re of. 5 CHAIRMAM PA".ADIMO: As you said earlier, when a e person is intent upon falsifying, he will do it but sometimes 7 you think you are in compliance but you aren't because you a can't interpret the rules, is there some harm in having this ) e ] supporting informa tion sent to you to review it? Io MR. WALKER: The only ha rm is that once an individual , 11
' is identified as a user, i f i t takes several months for us to I 12 negotiate placing him on the license, he is essentially in a I professional limbo. He may have already made a move from his g .
previous location to the new location. 15 COMMISSIONER GILINSKY: Wouldn't the new hospital to or practice or whatever have expected to get the sort of 17 documentation that would make clear tha e he would qualify for a license? 'Wouldn't they review that before he moved and they accepted hin and new arrangements were made? And what is the dif ficulty about xeroxing that and sending it to the NRC? 22 CHAIRMAN PALLAD!fl0: At review time. 3 COMMISS10'8ER AHEARNE: I gather the problem comes when the documentation is not complete. MR. WAL KER : That is true.
112 1 COMMISSIONER GILIMSKY: Which means that they nay l 3 j not have been very careful. The more I listen to this, it 3 seems to me that it adds an element of _ discipline into the 4 process. 5 COMMISSIONER AHEARNE: Could you answer the question a that was raised by the other staf f members? John mentioned 7 that the informa tion has to be kept on file under your a proposal. Would you expect tne inspector in doing this 9 inspection to look at that documentation and then reach the l 10 same kind of a co9clusion that your reviewer would? What does 11 , the inspector then do? The informa tion is adequate, what would I 12 l you under your proposal have the inspector do at that stage? 13 _ MR. WALKER: ,I would_ think that it would be 14 appropriate for him to look at it. 15 l COMMISSIONER AHEARNE: He looks at it and it is l l 1e inadequate. What does the inspector now do? Does he cancel 17 , the license? ! 18 MR. DAVIS: I would anticipate that he would go 19 into an inspection made and give the individual the opportunity 20 to develop the informa tion which is missing 21 COMMISSIONER GILINSKY: Suppose it takes a week to l get i t and the guy is there for that afternoon? 23 MR. DAVIS: It would be submitted to him as part 24 of the enf orcement action. CHAIRMAN PALLADINO: In the interest of time, I think
113 you sense an interest on the part of the Commission to get i that loop closed on this training certi fica tion. 3 l COMMISSIONER ASSELSTIME- And procedures. l
- l CHAIRMAN PALLADINO: I don' t know how many people but I think I can count at least three or four.
6 (Laugh ter . ) . CHAIRMAN PALLADINO: And go i nto the procedures l and here it gets a little trickier perhaps at least in ascertaining where people stand, where the Commission stands. Again, I thought the model that you were.trying to follow was going to the reactor model where tne procedures are taken out 12 of the licenses themselves, so tha t you don't have lic asse 13 amendments involved. _ ,_ 14_ Then i f we follow the reactor nodel, you would still i is have approval of a procedures. l 16 COMMISSIOMER GILINSKY: Initially. 17 MR. DAVIS: Here again, I will have to talk to 18 DeYoung. Is it correct that all " the procedures at a reactor 19 l are approved by the NRC? 20 COMMISSIONER GILINSKY: No. 21 COMMISSIONER AHEARNE: We have changed since TMI. 22 (Laugh ter. ) 23 MR. DAVIS: Are you certain? 24 COMMISSIONER AHE AR'IE : On thi s side of the tab'e, we 25
' -"""'+7 *- N -- -.c -m, ,_ ,,, , , , , , , , , , , , ,
114 I i are never certain. ? 2 i COMMISSIQnER GILINSKY: For a reactor, you are 3 really talking about energency procedures. 4 MR DAVIS: Let me interject one thing here though. J 5i
! think if you look at the rule and here again believe it 6
or not are astute enough to recognize that you do have some 7 concerns about i t, but i f you look at the rule what we a attempted to do in the rule as I understand it is to focus 9 I attention on those matters which the staf f believes is 10 important to sa fety. 11 Obviously, there are some dif ferences of opinion 12 as to the level of safety associated with each of the 13 elements within the procedure ._ So consequently, it was 14 an a ttempt to focus, an attempt to get the at ention of the staf f on those things which were important to safety more
~
is than the details of all of the procedures which may come in 17 and I don *t know whether we didn't get the message across
- 1s or we missed the mark, but in any event, we do recognize 19 that you do have concern about our not prerevi ewing every l l
20 3rocedure and prechecking every amendment to a procedure f before the licensee can begin to use the material for which 22 Se is asked. 23 I don't really know enough CHAIRMA1 PALL ADINO: about the process eve n on reactors. 25 On reactors, it is the
# COMitIS$10ME R G IL INSKY :
115 1 emergency procedures. CHAIRMAN PALLADINO: What I am not sure about in the 3 reactors is what procedures we looked at, what we prove and 4 wha t we don't. 5 MR. DAVIS: I am told that it has to do with the e importance to safety. - 1 COMMISSIONER AHEARNE: Yes. s MR. DAVIS: Which is what we thought we were dcing 9 in this one, to l CHAIRMAN PALLADINO: Maybe you are, but I was i 11 anticipating that this process would involve review of, ! 12 let me say, major important or otherwise similarly character- l 13 ,
- ized procedures. - - ._ j 14 MR. OLMSTEAD: I would like to mention something because I think there has been a misimpression created about is the enforceability of the procedures. This rule does have
! 17 es in it that the reactor rules do for procedures the feat 18 l that don't have to be part of the license in that if the
\
l n inspector goes in and the procedures are not there, that is j a ci table violation. 21 COMMISSIONER GILINSKY: Not there at all . 22 Not there at all or if they f ail MR. OLMSTEAD: l
#3 to implement the provision of the rule that requires procedures 2' to do speci fic things. They might have a procedure that l
25 covers three out of four things and not the fourth. Tha t would l i
l 116 i l still be a citation, a violation. 2 If you take the procedures out of the license which 3 is wha t we do in the reactor area, then there is normally a 4 mechanism to change the procedures by something like a 5 radiation sa fety review causi ttee and that feature is in th:s a rule, too. 1 1
! The only differentiation is that they haven't e
identified critical procedures that have to be submitted. e COMMISSIONER GILINSKY: The difference is that we 10 are in very close contact with the reactor licensee. 11 MR. OLMSTEAD: I understand that there are some 12 major policy questions for you, but I didn't want you to have 13 the impression that they weren't enforceable. CMAIRMAN PALLADINO: That was one of my questions. 1 15 I wasn't sure whether they were enforceable. ; le l MR. DAVIS: They are enforceable. COMMISSIONER GILINSKY: To the extent that you are i 1s dealing with parts of the regulations as they would be j to codified in this part. ftR. OLMSTEAD: But failing to have procedures could not occur under this regulation and be in compliance with the regulation. COMMISS 10tlER GILI NSKY : Failing to have the 2' procedures entirely. MR. OLMSTEAD: Fa iling to have a procedure called
117 1 for by the regulations and it specifically calls forth those 2 types of procedures that are required. 3 MR. DAVIS: It calls for certain subjects which 4 is what the staff believed to be important to safety. 5 CHAIRMAN PAL' ADINO: Let me make a sugges tion. I e do have to adjourn pretty soon, but rather than try to jump 7 to a conclusion even though I have developed a little bias, a I would like to explore my bias a little more and maybe others want to, i think on this point it might be well for the 10 Commissioners to indicate any guidance they would lika to , 11 uffer on the procedures r1ther than try to do it hurriedly l 12 right now. 13 _ COMMISSIONER ASSELSTINE: I,am inclined to agree 14 with that. I think the procedure and the substance tends to be mixed up a little bit, too, in the way the rule is done. COMMISSIONER AHEARNE: Wha t I would like to do is j to follow up on your earlier suggestion to see an alternative and since there are at least two elements of staff who felt very strongly about an alternative approach, at least I would
'U like to see tha t alternative approach.
21 CHAIRMAN PALLADINO: You mean what I had asked Joe j
" DelMedico?
-" C0riMISS10NER AHE ARNE : Yes.
24 CilAIRMAN PALLADINO: I was not envisioning what I 3 had asked Joe DelMedico to be a major undertaking, but rather
118 1 where in the rules he would implement a suggestion. 2 COMMISSIONER GILINSKY: The two principal ; 3
)
suggestions. l 4 COMMISSIONER ASSELSTIME: Yes. I would agree with 5 that. s COMMISSIONER AHEARNE: Tha t would help. I think. 7 CHAIRMAM PALLADINO: This has been a very valuable e meeting. Incidentally, I do find great merit in a number 9 of aspects of your rule. 10 MR. DA.IS: I wish we could have a list of those. 11 (Laughter.) 12 COMMISSIONER AHEARNE: I would like to make two 13 _ connents. First. I will take another,look at the threshold 14 for this Administration, a point that was raised. I would 15 like to thank Mr. Spell, Mr. Whatley, Mr. DelMedico and is Ms. Vacca. 17 I guess my point is that one of the difficulties is that I know I have as a Commissioner is understanding 19 when there are serious issues and they, I believe, in this l particular case enabled me to understand that there was a
' serious issue here which I would never have gotten from the ** I think tha t is just unacceptable.
staff p:per. I am not saying I fault where the staff came out. That is not the iss ue. Sta f f, seems to me, have good reasons 25 l in their judgment for the position tnat they have ended up
119 1
- with and senior ma na geme n t th , concludes that is where the l staff's position is , tha t is what senior management was 3
supposed to do. -I in no way fault that you have reached 4 this conclusion. 5 What I fi nd unacceptable is that coming up to the a Commission for this kind of a major policy decision just 7 the almost to tal absence of the seriousna's of this other side, e l It did take the Spell Whatley De1 Medico and Yacca to bring 9 that f o rwa rd. I thank them very much for it. 10 I am not sure where I come out on the issue. I 11 am not sayi ng tha t I agree with them. But it is just that
- 12 our role is principally trying to decide on policy and we have 13 to understand what the serious issues are.
14 COMMISSIONER GILINSKY: I must say that I anyee entirely wi th John. CHAIRMAR PALLADINO: Any other comments? 17 (No response.) CHAIRM AN PALLADINO: I want to thank our outside 19 vi sitors also for thei r participa tion. 20 Yes, it was very good. COMMIS510NER GILINSK* : 21 CHAIRMAN PALLADINO: He stand adjourned. 72 (Whercapon, at 12: 47 o' clock p.m., the Connission 73
. meeting was adjowrned, to reconvene at the Call of the Chair.)
24 j ,, , n
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, This is to certify -hat the attached prceeedir.gs tercre the wlear Regulatory:Cdsmiission 4
in the matter of: 3riefing on SECY-83 Proposed Revision to 10 CFR Part 35 %een use of Byproduct Material"
* \
Ca:e Of Fraceeding: Tuesday, April 19, 1983 Do: Met h=ber: e Pla.e af .:roceeding: Roosi 1130,1717 H St. , N.W. Washington, D.C. to were held as he- ei= appears , ar.d that this is the original t ra r.s: rip t there f f:r the files of the Co:=ris s ion. , i3 Marilynn M. Nations id
- fficial Reporter (Typed) is is
#7 Official Reporter (Signature) se 19 20 28 22 23 2n s
2s 1 7AYLOE ASSOCIATis memistesso Poortssio* eat. mspostvens fooRFot.X. Vi4GINIA
MPRJL 15, 1::f6) l SCHFDULING NOTES l TITLE: BRIEFING ON SECY-83 PROPOSED REVISION TO 10 CFR PART 35 " HUMAN USE OF BYPRODUCT MATERIAL" SCHEDULED: 10:00 A.M., TUESDAY, APRIL 19,1983 l l l DURATION: 1-1/2 HRS i l PURPOSE: TO DISCUSS PROPOSED REVISIONS TO PART 35 SPEAKERS: 1. (20 MIN) BILL WALKER, NMSS l
- 2. (10 MIN)
WILLI AM SPELL / REP. OF AGREEMENT $TATES l
- 3. (10 MIN)
DR. RALPH ROBINSON, PRESIDENT THE AMERICAN COLLEGE OF NUCLEAR PHYSICIANS (ALSO REPRESENTING THE SOCIETY OF NUCLEAR MEDICINE) 1
- 4. (10 MIN)
OTHA W. LINTON, DIRECTOR OF GOVERNMENTAL RELATIONS l AMERICAN COLLEGE OF RADIOLOGISTS 1 1 DOCUMENTS: SECY-83-62 ; OTHER DOCUMENTS TO BE DETERMINED l I l
__ g _ , _a_,_ ,,,, _ _ _m ,, , 9 a PROPOSED RULEMAKING i 1 10 CFR PART 35 i i j " HUMAN USE OF BYPRODUCT MATERIAL" i i 1 i l t o t
\
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0 y e IWUOR CHANGES
~
UP6RADE THE PROCESS (CONT'D) CURRENT PROPOSED e LIMITEo COMPUTER USE PoSSIBLE IN e ExPANoEn usE oP COMPUTER P0ssIBLE LICENSING PROCESS e LICENSING DELAYS EID BACKLO6GED e R0uTINE APPLICATIONS PROCESSED APPLICATIONS WITHIN TWO WEEKS AND EVENTUAL ELIMINATION OF BACKLOG 9
l ACHIEVEG0ALS I 1 i 0 MAINTAIN SAFETY 1
.i RECOGNIZE LICENSEE EMPHA8IS ON SAFETY Focus on inroaTANT issue 8 Focus oF NRC sx LLs i
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SOE OPTIONS REGARDifG RADIATim SAFE 1Y PEEMES e CONTIME ONENT PRACTICE T REVIEMitG RADIATim SAFDY PROCEbiES e IEORMATE INTO 10 GR PART 3511E PROCEMES IN TIE APP 901CES IN REGULATORYGUIDE10.8 e EVISE 10 GR PART 35 TO SPECIFY ERTAIN MINIM FEATWE5 THAT EACH TYPE T PEEME IUST IfG1R e AT TIE & APPLICATION, STAIN CDMillfMT FM APPLICANT THAT E HAS PROCEMES RR SPECIFIC RADIATION SAFEiY ACTIVITIES Af0, AS A MINIM, HIS 190GME5 IlulEE X, Y, E Z 04HE X, Y, M Z ME MiY FEATWES IDENTIFIED BY K)
.r-- l COMMENTS OF MILLIAt R. SSELL REP 9ESENTING THE ! l SSSOCIAT!:N OF AGREEMENT 3TATES AND THE I CON: ERENCE OF RADI ATION CONTROL 290 GRAM 217ECT00.S. IMC. BEFORE THE
'J. S. '!UCLEAR RE3ULATORY C0 T.135!3*:
IN THE MATTER OF RE'/ISIO!!S 7010 CFR. PART 35 l
"iSHINGTON, 3. C.
AP91L 19. 1933
O COMPENTS OF ';.'ILLIAM H. SPELL 9EP9ESE!4 TING THE ASSOCIATION OF AG=EEMENT STATES AND THE CONCE2ENCE OF RADI ATION COMMOL h0GRA:4 S!* ECTO:5. INC.
*E:0"E THE U. S. I'UCLEAS REGUL AT'19Y CC AMI SSION
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I'4 THE MATTE: OF REVIS!ON'S TO ' A3T 35 0F ItTLE 10 2F THE ___ 0F FEDEStL REGULATIONS: lwAl? MAN U tLLADING AND CL*MISSIONERS. MY NAME' !S *..'!LLIE u ~ H 3PELL. I TM n0*INIST=AT00 Oc THE .,UCLEAo c.NE1GY -,!/! SON. ' =-
. :r OF ENV ! 90NME'4T AL ACCA!"~. '_0UISIANA 3EPART. MENT OF "A _. __ .4 IESCU*CES. I o*ESENTLY SE2VE AS Cdtt3 MAN OF THE GLOUP C- -
AGSEE*ENT STATES d"!CH " AVE ENTESED INTO AN A 33 E E M E'4 T 'f l T - . -a
~ ".lC. Suo SU ANT TG 3ECTION 274.8 0F Tug ATOMIC NE GY ACT OF 12 r - :
205 THE OU9 POSE 0: EGULATING. TOGE!"E7 4IT4 THE 'P.C. BY-PSO U - 5303CE AND SPECIAL 'fuCLEAR MATE *itt IN THE 3TATES. I dave - 2_ B E E!! 2ESIG'4ATED BV TdE EfECUTIVE C0iMtTTEE TO ACT ON BEdALF 0:- CON: E ENCE Or 3.A0ltT10N CD'4 TROL U:0GSAM 3tDECToos. I '!C . > 7 ,,.r - I'47CLIEMENT WITH T-E USE AND CONT 70L Oc SADIATION WAS S E E' ; 41GHE3 EDUCATION 03 l'4 (OUIS T A*! A'S 3EGUL ATORY P30GR AM ::? THE = = r ,2 - 2 E::S.
'.' : T H ME ~20A' 15 ".9 :'t '.'d*,TLEY. Cd!E: Oc lADICAC_ - " i* '* E *.!CE'ISI'1G. 2171510'l 3F lA010 LOGICAL MEALTH OF TdE '.L LT -
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1 THE STATES C C MM E!!D TdE COMP.15510N STA:: F00 ITS E::00 5 To DEVELOP A 90/ISION WHICd INCORP00ATES 07 '4E 7 7ECuloEMENT5 0- i L ICENSE CONDI TI^NS AND THE 3 TEN STUOMG SUGGESTIONS O' 'lE:ULAT00Y
#*JIDES r ?!o ECT' < INTO THE EGULtTIONS. THIS P70CEnu'E STRENGT' ENS THE ENFC: CEMENT A3PECT 0 -E 3C'S REGULATO9Y PROGRAM, ANO [ A'i E 'ECEIV:0 NO S13N! !C. TNT Co!TI'!SM 0 THIS ASPECT OF THE CEV:SIM.
r"E i ! ^ 5 L' E 5 idiCH WA'/E 3EEN DA13E0 CENTER MOSTLY ON THE . VET 00 0: I "PL E.w E N T I N's P00 POSED d a'!GE S AND ON oo0TECTING THE PJELIC HEALTH AND SA: ETY. IT IS IMP 03 TANT TO NCTE THAT THE B JL( :; MY
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NECESSARY 70 N'J 3E T"E M ET40 0F IMPLEMENTING lna a n: ,.
.S IT DECA 1SE 0: 7" IJMM!S$10N,3 COMMITMENT TO G EC E'!T' AL I Z A T I CN . 15
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TO THE POPULA 10N F 0M ME:lCAL USES OF DAD 10NUCLIDES: E230, lE bio'JL D L I G " T E 's 'uE ? E Q U I ') E ' E N T S,: IS IT BECAUSE THE CO*M I E 10?;
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l 1 o I i I AM TOLD THAT IT TAKES TWO REVIEWERS AND ONE ADMINIST:ATOR l TO OVERSEE APP 90XIMATELY E30 MEDICAL LICENSES IN THE STATE OF TEXAS. .tN D THEY HAVE A TWC 'dEEK TUoNAROUND TIME FOR LICENSES AND 0 AMENDMENTS. 3R ABOUT 300 tlCENSES. IT TAKES ABOUT 2h PERSON-YEARS OF EFFORT FOR BOTH LICENSE REVIEWS AND INSPECTIONS IN MY GWN I STATE Oc LOUISIANA. CUoRENT PD0JECTIONS OF TUONAROUND TIME FOR
'MC L 'CENSEES SUGGEST THAT SOME CONSIDEDATION OF 'iAYS TO I MP'iOV E .
ECF I C I ENC t MAY BE IN ORDER. 4 BACKLOG OF LICENSE APPLICATIONS AND REQUESTS F0o AMENDMENTS OR R ENEW AL SHOULD NOT BE THE SOLE SEASON ! FOR CHANGING A REGULATION 09 A METHOD OF 001'IG BUSINESS. ON THE l GTHE0 HAND. IMPROVEMENTS IN HEALTH AND S AF ETY GIVE SUFFICIENT REASON C00 SUCH CHANGES AND ARE TO BE COMMENDED WHENEVED IMPLEMENTED. PROBABLY. THE GREATEST CONCE3N OF THE STATES TO THE ENTISE P?OPOSAL IS THE LACK OF A PSE-LICE'ISING SEVIEW CF DADI ATION SAFETY P9OCEDURES AND PHYSICIAN QUALIFICATIONS. '!Aol00S ESTIMATES HAVE i PLACED THE NUMBER OF DEcICIENT SIEW APPLICATIONS PoESENTLY BEING RECElvED AT ABOUT I4 0" AND THE NUMBER OF PHYSICI ANS WHO THOUGHT i THEY WEDE QU AL I F I E D. BUT WHO WERE NOT, AT 15". IT IS NOT AT ALL l l CLEAo 40!! THE PROPOSED CHANGES MILL REDUCE THE PESCENTAGE. CNDED THE Po0 POSED CHA'lGES. DEF I C I ENC I ES COUL D BE IMPLEMENTED BY THE LICENSEE 00 AN UNQUAlicIED PHYSICIAN COUL D PRACTICE NUCLEAR
*1E D I C I '! E OR TugoAPY, AN D N 0'4 E WOULD BE DETECTED UNTIL AN INS?ECTION IS CONDUCTED. IF TuEN. TO DELAY THE DETECTION CF DE- l
- !CicNCIES IN A SUBST ANTI AL 'tuMBES OF PROGR AMS MAY DESULT IN UN-
'! E C E S S A 2 < CA01ATION E t?OSuoE S WHICH COUL' 4 A (E BEEN PoEVENTED. l NIS SIMDLY 15 '!0T 3000 MEALN D4YSICS P3 ACTICE.
It!CTHEP ASPcCT 30 THY 0: C 0'IS ! JE' AT 10N IS THAT 0: "COMPATI-31LITY." *'HILE IT WAS REE'l S TFED TH AT Tel s wlLL NOT B E A u. AT T E R 2C C0wP AT ABILIT( FOR M2EENE'F 3T ATES. IT IS GENE 7 ALLY AGREED THAT THESE "EEDS TO 3E A DE1'EE 2F UNic00MIT( A"C'iG TuE STATES AND TuZ
'3 C . Ic THF '.'3C'S c!NAL DEVISION IS PESCE!/ED AS BEING LESS
oESTolCTIVE ON THE MEDICAL COMMUNITY, THE7E WILL BE CONSIDERABLE PSESSUoE ON THE STATES TO ADOPT SIMILAR. IF NOT I DENT IC AL. 7.EGUL A-TIGNS. C URTHE:M09E, SUCH 7EGUL AT10NS COULD HAVE AN ADVE9SE IMPACT ord COMMERCIAL SUPPLIECS OF 9ADIDACTIVE DRUGS. ?!E P9OBABLY HAVE ALREADY GIVEN THIS GDOUP Oc LICENSEES ENOUGH HEADACHES WITHOUT COMPOUNDl!!G THE P90BLEM. PHILOSOPHIC ALLY. PE: HAPS WE SHOULD CONSIDE7 3HETHER OR NOT A= A'! DON I NG oEVIEWS OF PDOCEDURES FOR MEDICAL APPLICATIONS SETS A P'R EC E D ENT TO DO THE SAME IN ALL OTHER AREAS WE REGULATE. I CAN iSSU2E YOU THE STATES A?E NOT 7EADY TO DO THIS. PARTICULARLY IN CERTAIN INDUST 91AL AND RESEARCH SETTINGS. IT DOES APPEAR THAT THE PoCa0 SED APPROACH PLACES A GREATE3 RUDDEN ON INSPECT 005 TO UNCOVER P:0BLEMS. AND THIS IS IN AN AREA WHEDE THE ?3C HAS SHOWN A LOW foe 1UENCY OF INSPECTIONS IPs THE PAST. F01 EXAMPLE. FOR THE PERIOD 1/1/32 THOOUGH C/30/82. TPE LAST PERIOD FOR WHICH STATISTICS ARE AV AIL ABLE. THE 'MC ADMINISTERED 2522 MEDICAL BY-Po000CT MATE 31AL LICENSES WHILE THE ST AT ES COLLECTIVELY ADMINISTERED C91 MEDICAL LICENSES OF ALL DESCRIPTION. FOR THE SAME PERIOD. THE l3C P E D:00MED 51 890AD LICENSE AND 314 OTHE9 MEDICAL LICENSE
!?!SPECTIONS. WHILE THE AG?EEMENT STATES PEOF00MED 54 B10AD LICENSE WD 1931 OTHEo MEDICAL LICENSE INSPECTIONS. I'l BOTH CASES. SOME OF THE B20AD LICENSES NESE MEDICAL LICENSES. IN ALL C Al7 NESS. THE SAME P110 PITY SYSTEM FC9 INSPECTIONS IS NOT IN 'JN IF OR M 'J S E T"00UG40Ur, IHE 3TATES SUPPOST THE CONCEPT THAT A GOOD DEV!Ed Oc U!
A P o'. ! C A f t 0 N 00 A MEDICAL LICENSE CAN PUEVENT % COMPLETE '4! SU'lDEo-ST T ING LATE 3 04. CNE l': WHICH THE LICENS!1G A3ENCY MAY oE PE9-CEl.ED TO BE GUILTY OF C C'!To ! RUT 00Y ' E GL I G E'!C E . UlS CONCE915 THE 3rPES. BECAUSE THE 3TATES 00 NOT POSSESS TdE .EGAL ST A:F TO COPE diT8 THIS T rPE OF P'0BLEM VE9Y 0: TEN. I 1 1
l . O I'l 0 0 D E ' = 0 9 IMPLEMENTATION 0; THE l3C'S P00 POSED CHANGES TO 10 3 35 T0 scoK, 1T APPEARS THAT THERE MUST BE AN EXCEPT!0 MAL COMMITMENT 01 THE PART OF THE ICC TO CO MCRE AT THE REGIONAL LEVEL. BOTH IN ?cVIEWS OF APPLICATIONS FO? MEW LICENSES, RENEWALS AND AMENDMEN?S. AND IN THE INSPECTION E:30RT. IN MOST MEDICAL INSTITUTIONS. AN INSPECT 00 IS SOMEONE WHO IS MAoGINALLY WELCOME, IF AT ALL. IT IS DIFFICULT FOR ME TO EN/ISION HOW THE INSPECTOR CAN PeoCO?M A POST-LICENSING ?EVIEW OF THOSE THINGS THAT IN THE PAST WAVE BEEN CONSIDEoED NECESSAoY PRIOR TO THE ISSUANCE OF A LICENSE. 'HYSICI A'IS MILL LIKELY NOT HAVE TI?E TO DISCUSS ITEMS IN DETAIL WITWOJT INTE?RUPTION AND PATIENT NEEDS WILL ALWAYS COME FIRST. ASSU11NG THE LAG BETWEEN LICENSitG AND INSPECTION TO BE SHORT. THERE MAY BE LARGE I NEFF IC I E1:CIES NOT HERE-TO-FORE ADD 3ESSED THAT A7E BUILT-IN WITH THIS <!ND OF SYSTEM. IF IT TAKES AN EXPERIE';CED LICENSE WoITER TEN (10) HeuoS TO REVIEW AN APPLI-CATION 1*1 HIS OFFICE. HOW MUCH LONGER WOULD IT TAKE THE INSPECTOR IN THE FI ELD? IN FACT. I HAVE SEEN NO INDICATION THAT THE COMMIS-S10N'S '.' ALU E/ hP AC T ~3TATEMENT ADDRESSES THE ADDED COST TO THE ScFICE OF INSPECTION 3 ENFORCEMENT DUE TO A3CED DUTIES INVOLVING l THE ?EVIESS JF Po0CEDUSES F03 ADEQUACY AMD REVIEWS OF PHYSICIAN QUAllc! CATIONS. IT APPEtoS THAT THE VERSION Oc 10 C~4 35 WHICH IS BEING OcFEoED T03AY 15 NOT TdE ONE WHICH ALL STATES HAVE HAD AN OPP 03-TUN!TY TO DEil Ed. C dRTHERM03E, TO STATE Td.AT THE AGREEMENT 3TATES ; TOTALLY SUPPO?T T"E POESENT VEoSION IS 31TdOUT BASIS. SINCE ONL f A VeoY FEM HAVE SEE'1 IT. 'iUCH LESS COMMENTED O': T. NE ASE NOT E/E'1 l 337E NueT"E3 03 ':0 T PoEVIOUS COMMENTS OF A TJMBEo 3F THE STATES dAYr 3 E E'. 314 E's S:7!CJS CONSIDERATION. IT IS THIS (IND OF 2 EGO-LATION 0:V E L :Pv E';T 991CM Pc0MPTED AN E A :',. l ER RESOLUTION AT THE ic03EME'1T I JNEJ VE ET ING 3; THE 3C-AGREEMENT STATES, TO W!T: l l
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"THE AGREEMENT STATES ENCOURAGE ?RC TO DEVELOP CRITERIA
- 0R REVISING OR 9EVELOPING REGULATIONS BASED ON HEALTH AND SAFETY AND TO SOLICIT CONCURRENCE Fo0M STATES ON C
THESE PD0 POSED RULES POIOR TO PUBLISHING IN THE EDERAL REGISTER (E.G. , USANil'M MILLS REGULATIONS)." TO SOME EXTENT. THIS HAS BEEN DONE. 3UT WHEN A STATE ENTERS INTO AN AGoEEMENT WITH THE 'RC. THE 7ESULT IS A PL E DGE . EACH TO THE OTHER. TO EXERCISE THEIR BEST EFFORTS IN PROTECTING THE PUBLIC HEALTH AND SAFETY. "E BELIEVE THAT IT IS TIME TO CONSUMMATE THE P ARTNE95 HIP BY ALLOWING THE STATES TO PARTICIPATE MORE FULLY IH THE DEVELOPMENTAL STAGES OF 9EGULATIONS WHICH IMPACT THE STATES. EVEN IF THE REGULATIONS ACE NOT TO BE MADE A MATTER OF COMPATABILITY. JUST AS THE 'RC AND OTHER FEDE9AL 4GENCIES ASSIST THE STATES IN DEVELOPING DEGULATIONS. WE OFFER THE FULL COOPERATION AND ASSISTANCE OF ALL THE STATES WITHl!! THE LIMIT OF 000 9ESPECTIVE 9ESOURCES AND TRUST THAT OUR COLLECTIVE EFFORTS WILL DESULT IN A MARKED IMPROVEMENT IN PROTECTION OF THE PUBLIC HEALTH AND SAFETY. AS WELL AS THE ENVIRONMENT.
- 17. CHA!1 MAN. THANK YOU AGAlH COR ALL0HING THIS OPP 00TUNITY TO PROVIDE COMMENTS ON SUCH AN IMPORTANT ISSUE. IIo. '!HATLEY AND I SH ALL BE PLEASED TO TRY TO ANSWER ANY QUESTIONS YOU MAY CARE TO ASK.
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COteENTS FOR TIE SER2E.AR prr:sa ATERY N
% proposed Part M frasi TIE ASEREAN O 8 FE OF panans (Y:V 1
r j oen w. une ! oei.=cor, c- n.a.u i i t f l t b l 4 l t i 5 l l 1 1 t d i 4 f i
. . . _ _ . . . - _ _ _ _ _ _ . . . _ - _ _ . _ ~ . _ _ _ , _
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l l My name is Othe W. Linton. I am director of goversssent relations for the American , 1 College of' Hadiology, a natiomet pro (==innal society of 15,000 physicians and raciation ) i scientists. Radiologists speesetse in the uses of x-cays and radioactive substances to ; diagnose and treat disease. Many members of the College hold various types of licensure j from the Nuclear Regulatory Commissics and the agreement states. ! My comments regarding the draft Part 35 represent the opinions of the College l Commissions on Nuclear Ma&-== and Radiation Therapy. They have annadored the concept in the draft and some members have reviewed parts of the pi-:-;-: :4 text. We think that the proposed Part 35 should be completed, submitted for public review and adopted by the e-==iari. As nearly as a document can be judged in advance, it snould meet most of the goals it sets for itself in clarity, consistency, economy and efficiency for aR concerned. We found it easy to read and follow. Applicants for licensure shondd find their tasks made substantially simpler. In previous testimony, the Colleee has suggested that the paternalistie anachronism of federal control of medical uses of by. coduct material has largely been succeeded by the medical mechanisms of specialty training and credentialing boards. We have noted, as well, the creation of radiation control programs in the states, resulting from the 1959 amendments to the Atomic Energy Act. Yet, in 1979. the Commissma concluded j that it has a continuing role in this area. Thus, oer present comments relate to our mutual oojective of making your regulations as practical and reasonable as possible. To an encouraging extest, the draft regulations recognize the existence of professional credentials as meeting the federal standards for proficiency and competence. This is more explicit than is earlmer versions, and commendably so.
4 We also find commendatde the concept of tmnging into one relatively re and consasteet part the commiemians requirements for medical users of byprodnets. We think that the comaussion's responsibilities can be met by emphasis upon the desmonstrated competence of licensees to use isotopes safely and effectively, rather than is esplicating the criter:a for medical competence found in professional credentials. A recent study by the Bospital Association of New York State suggested that 25 percent of hospital dollars usere spent in complying with regulatory requerements of federal, state and local agenes==- Any reduction in such requirements and the ecsts of respondng to them can only be applauded in these days of soaring health ecsts and
&amatie efforts to reduce them.
Within the current & aft of Part 35, several points warrant brief mentica for your consideration.
- 1. Our committees suggest anrylification of Part 35.75 relating to the instituticaal stay of patients containing radioactive materials. Patients receiving doses of 154 to 200 millieuries should be hospitalised and the discharge critenom is a valid one. it is objective, cost effective and reasonably safe for the teetnical personnel making the determinative measurements. I In our opinica, a distinetma should be made regarding patients uno receive therapeutic doses of less them 30 millieuries. Unless there is other cause for hospitalization, it is our opinion that patients receivmg rin== of 30 millieuries or less need no hospital commitment and need no measurement of external dose to assure the l
safety of others. We urge application of a "deminimus" ecocept to avoid coamplicatmg ; this circumstance.
l l l One complication, if yes have noted, is that all of an in health care are being i pressed currently Isy other agencies of the federal government to reduce costs by every avaalable mease. Adding or re-emphasazing a requirement which would require hospitalization for technical raamaan would be a protdes for all of us. We don't wish to place money over safety. But we do need a supportatne halance,
- 2. In Part 35.929, our committees feel thr:t the total amount of training specified as as alternative to recogmzed board certification is appropriate. However, as written, the allocation between work experience (500 hours) and ehmical experience (544 hours) is unduly rigid. We would welcome an opportunity for more detailed discussion of this in the public comment period. l
- 3. Part 35.37 should be dropped. As we understand it, this will require an action by the commissica to reverse its recent vote. The ACR and other concerned organizations anticipate submitting a formal petition for such action, if necessary to gain reconsideration.
. The reports to NRC since the "masaduninistration rule" was adopted indicate l clearly that a violation rate of less than .01 percent makes the result not worth the effort, either for the commission or for others concerned. We will not argue the details of the ruling here, since the comment notes the intent to furmsh another forum for that. Scwever, we note with dassay that when the ACR and others requested under the Freedom of Information Act SECY 82-384, it was refused by staff. In the absence of national security issues, we strongly urge the commission's reconsadoration of this refusal. If the commissioners had good esuse to retain the requirement, public disclosure mignt help us to understand those reasons. If not, then we have all the more reason for insisting upon reconsideration.
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With those suggesticas for change and on behaN of the Amnerican CoUege of Raeeingy, I urge your favoratie action an proposed Part 35 toward its =huion for putsue comment and subsequent adoption. I would be pleased to respond to questions. 1 l l l
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3 g(-lk jj I' f 110 Casuectum Awemme. N W,.Sune MO-hemason, DC. 2DRE _ ,_ Amentan A245711eo The Sooety' CoNege of of Nuclear Nuclear Medicuie W STATEMENT BY TIIE AMERICAN COLLEGE OF NUCLEA31 PIIYSICIANS AND 1 THE SOCIETY OF NUCLEAR MEDICINE BEFORE TIIE ; NUCLEAR REGULATORY COMIISSION April 19, 1983 l l l l
l 1 Lit v _( f iim connecticue Awnue. N w..sune 7ao.weheetm oc amw C _ I _ Arnerican 202-as7.iioo The Soc @ College of of Nuclear Nuclear Medicine Physicians t 1 I i i 1 Chairman Palladino, Menbers of the Commission: I
! am Ralph G. Robinson, I!ead of the Division of Nuclear 3!edicine at Kansas l'niversi t y 'fedical 1 Center and President o f t he .\nerican College of '
t
; Nuclear Physicians which is an organization of ;
approximately 1,200 physicians actively engaged in the pract ice of Nuclear ?!edicine. . These conments are presented on behalf of the College and also represent the views of the 1 i Society of Suclear 3fedicine, a professional l organization of over 10,000 scientists, physicists, , pha rnac i s t s , physicians, technologists and other I professionals involved in Nuclear iledicine. The conbined membership of these organizations repre-sent t he Nuclear *!cd icine communi ty in the United States. I The College and the Soc iety are grateful for this , opportunity to appear before you and present our j views on the pcoposed revision of the Nuclear l Regulatory Commis< ion's regulations for iluman itse of Bvproduct ifa t er ia l s (10 CPR 35). Ne urge the Connission to act f avorably and nove the proposal forward for publicat ion in the Federal Neg i s t er. I 6
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l l ACNP/SN31 4/19/83 Page 2 No set of regulations affects the day-to-day practice of Nuclear ifedicine more directly than 10 CFR Part 35. The licenses issued by NRC under these regulations define j the parameters under which the use of byproduct rad ioact ive materials for diagnostic and therapeutic nedical purposes occurs. The re f o re , the proposed revisions under considerat ion today are of the utnost importance to the membership of the College and the Society. Mr. Chairman and >fenhers of the Commission we would like to compliment you and your sta ff for their initiat ive to consolidat2 and streamline the requirenent s of 10 CFR 35. For a numbet of years the Nuclear Medicine community has operated under requirements scat tared among several documents, including Inspect ion and Enforcenent orders, regulatory guides, technical reports and various conditions attached to individual licenses. This has of ten resulted in confusion and unnecessary and/or duplicative paper work. It is undoubtably to the advantage of all af fected parties including NR C, the Nuclear physician and most importantly t he pat ient that regulatory requirenent s be developed as succiactly and clearly as possible. The proposed revision o f 10 CrR 35 will accomplish much of that obj ect ive and we st rongly urge you to support this effort. Etisting licensing review procedures relating to the iluman i l itse of Bypre.3uct sta t e r ia l s are cunbersome and unnecessarily l lengthy. In our view, the informational requirements currently i
l - l ACNP/SN)! 4/19/53 i Page I l required complicate the licensing process by forcing appli-cants to include detailed copies of procedures to be used in complying with the regulatory requirements in addition to the necessary ir.fornat ion relat ing to radiation safety. The relume of informat ion current ly required of ten result s in the ..eed for nore informat ion f rom the reviewer's pe r smec t ive. Frequently this need for additional in fo rma t ion does no t concern natters of radiat ion safety, which are of primary concern to the College, the Soc iety and the Concission, but rat h er involve ninor procedural issues. This of ten resuit t in ".ncficiency 1.etters" which greatly increase the c ine required to conplete a license review and creates a prolanged paper s'~uf fl ing excerc i s e. The moji ficat ions preposed in this draf t will help clininate
; some of the unneces<sry paper requirements, produce more time Ey decisions and bet ter rerlect the sophist ication of todar's N1 clear 5fedicine pract ice, there-by enabling the l sedical community and NRC to more appropriately focus their re sotur:e s .
We understand that infornation relating to procedures and otter requi renent s mus t still be developed and maintained by the licensee. Thus, the substantive details needed hv ' NRC for iudging the adequacy of a licensee will be maintained and re2J ily ava ilabl e for inspection. l l l l l l l 1
ACNP/S21 4/19/82 Page 4 We also concur with the recommendations contained in the draft to eliminate the general license. In view of the advances in the practice of Nuclear Medicine, the general license approach in effect creates a dual licensing system. The use of specific licenses and specific licenses of broad scope obviates the need for a general license catagory.
)
Mr. Chairman and Members of the Commission, while we are in general agreement with and strongly support the thrust of the proposed revisions, there are some specific requirements in the current draft that we feel should be modified. Itowever, it is our intent to address these issues through official comments from our respective organizations once the proposed revisions appear in the Federal Register. We will provide a detailed analysis, once the full text of the proposed revision is published. In summary, let me reiterate our general support for the proposed revisions, and assure the members of the Commission that the Nuc1 car Medicine community shares your committment l to provide for the safe and ef fective delivery of Nuclear l Medicine patient care, ranging from mobile service to the j most sophisticated hospital setting. The College and the Society have had a long-standing and continuing interest
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in maintaining quality health care and probably have more l l 1 l 1
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l ACNP/SNM ' 4/19/83 Page S quality assurance efforts underway than any other medical specialty. We bel; eve that the proposed revisions will serve to enhance the objectives of the Commission and of the Nuclear 3fedicine practitioner. Thank you again for this opportunity to appear before you and I will be happy to answer any questions. l I l l i l
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