ML20210N005

Responds to 970721 Request Re Mounting of Fixed Gauging Devices & Use of NRC Std License Conditions.Refers to Notes Following Std Conditions 66.,67., & 68 in Encl Printed Copy of Std Licenses Conditions

ML20210N005
Person / Time
Issue date:	08/19/1997
From:	Woodruff R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:	Roxburgh A SOUTH CAROLINA, STATE OF
References
NUDOCS 9708220318
Download: ML20210N005 (21)

Text

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August 19,1997 Mr, Andrew M.- Roxburgh '

- Health Physicist Division of Radioactive Materials Licensing and Compliance Bureau of Radiological Health Department of Health and Environmental Control 2600 Bull Street:

Columbia, SC 29201-1708

SUBJECT:

REQUEST FOR INFORMATION

Dear Mr. Roxburgh:

This is in response to your request of July 21,1997 concerning the mounting of fixed gauging ~  !

devices and the use of NRC standard license :onditions. I have attempted to call you on two - 1 occasions, however, your office related that you were out on inspections, I'm sending you a printed copy of the standard licenses conditions that we use, and please notice the " Reviewer Note" that follows some of the conditions. In particular, please refer to the notes

- following standard conditions 66.,67., and 68.-I believe that the notes are self explanatory and will provide additional guidance, that our reviewers follow.

Please feel free to contact me at any time if additionalinformation is needed.

Sincerely, 1-fS/

Richard L. Woodruff Regional State Agreements Officer

Enclosure:

-Standard license conditions Distribution: ,

Reading file DCD (SPO2)-

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S IGNATUM  !

NAME PWoodruf f DATE COPY 1 - - Y ES x No YE3 No  : YES NO YES No YES No YES NO OFFICIAL RECORD COPY DOCUMENT NAMEt pt\sc\amr,ttr,231 9708220318 970819 PDR STPRQ ESGSC- t PDR STP%, Sf SAi

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From FC 83 20 Rev 2 (10/08/93)

HQ Revised June 1993 RII Revised May 1994 e (R2]

PG 2 16, 3/7/95 radiog.

NOTE: (The macro ALTQ, looks for these only ont c:\wp51\m1p\stdcond...so it should always be your master set.)

STANDARD LICENSE CONDITIONS (Use F2...F2 to search for topic, e.g. T1 for " Place of Use")

Place of Use.....T1 Supv Genl........T2 Supv Lim Med.....T3 Supv-Brd Med.....T4 Supv Pacemkr.....T5 Supv Huc Phars...T6 Supv Broad.......T7 Supv Port-Gage...T8 Supv Radiog......T9 Supv Well Log....T10 SupvaIrrad.......T11 RadSafeOfficer...T12  !

Leak Tests.......T13 " Tie Down".......T14 Gas Chromatogr...T15 FEMA.............T16 Portable Gauges..T17 Radiography... .T18 Well Logging.....T29 Fixed Gauges.....T20 Irradiators.. ..T21 Shielding-DU.....T22 Nuclear Pharm....T23 Teletherapy... ..T24 CardiacPacmkrs...T25 Medical General..T26 Medical Broad....T27 Med Brachy HDR...T28 Waste Diaposal...T29 Incineration.....T30 Transportation...T31 Distribution.....T32 Miscellaneous....T33 New Licenses.....T34 Eye Plaques......T35 EmergPlan Decomm.T36

= ( Start F2. . .F2 Search Below Here ]

PLACE OF USE T1 1 Licensed material shall be used only at the licensee's facilities located

.at .

2. Licensed material may be used at the licensee's facilities located at and at temporary job sites of the licensee anywhere 'n the United States.

(Reviewer Note: This condition should only be used for Federal Agencies.]

3. Licensed material may be used at the licensee's facilities located at and at temporary job sites of the licensee anywhere in the United States where the U.S. Nuclear Regulatory Commission maintains jurisdiction for regulating the use of licensed material.

4. Licensed material may be stored at the licensee's facilities located at and may be used at temporary job sites of the licensee anywhere in the United States where the U.S. Nuclear Regulatory Commission maintains jurisdiction for regulating the use of licensed material.

5. Licensed material shall be used only at temporary job sites et the licensee g

anywhere in the United States where the U.S. Nuclear Regulatory Commission maintains jurisdiction for regulating the use of licensed material.

6 (RESERVED) 7 (RESERVED)

SUPERVISION - GENEPAL T2

8. Licensed material shall be used by, or under the supervision of,

[ 9. Licensed material shall be used by, or under the supervision and in the

! physical presence of, ,

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10. Licensed material shall be used only by ,

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11. Licensed material shall be used by, or under the supervision of, individuals who satisfy the requirements of 10 CFR 33.15. ,

12. (RESERVED)

13. (RESERVED)

SUPERVISION LIMITED MEDICAL T3

14. Licensed material listed in Icem 6 above is only authorized for use by, or under the-supervision of, the following individuals for the materials and' uses indicated:

Authorized Users Material and Uns SUPERVISION - BROAD MEDICAL T4

15. The use of licensed materialuin or on humans shall be by a physician,  !

dentist, or podiatrist as defined in 10 CFR 35.2.

16. Physicians, dentists, or podiatrists designated to use licensed material in or on humans shall meet the training criteria established in 10 CFR Part 35 Subpart J and shall be designated by the licensee's Radiation Se.fety Committee.

(Reviewer Note: Conditions 15 and 16 are used together]

17. Licensed material for other than human use shall be used by or under the supervision of individuals designated by the Radiation Safety Cormittee.

18. (RESERVED)

19. (RESERVED)

SUPERVISION -

PACEMAKER TS

20. The physicians responsible for implantation, follow-up, explanation, and return of nuclear powered pacemakers to the manufacturer for proper disposal are .

EUPERVISION - NUCLEAR PHARMACY T6

21. At least one individual named in Condition shall be physically present used.

at the authorized place of use whenever licensed material is being (Reviewer Note: Use Condition 21 with Condition 8 or 22)

SUPERVISION,- BROAD T7

22. Licensed material shall only be used by, or under the supervision of, individuals. designated by the Radiation Safety Committee,  ;

Chairperson.

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b 23. (RESERVED). .

2 4 '. (RESERVED)-

SUPERVISION - PORTABLE CAUGES T8

-25. Licensed material shall only be used by, or under the supervision and in

.the-physical presence of, individuals who have received the training described-in application dated- and have been approved-in-writing by the Radiation Safety Officer.

26. Licensed material-shall only be used by, or under the supervision and in the physical presence of, or individuals who have successfully completed the manufacturer's training program for gauge users,.

-have been instructed in_the licensee's routine and emergency operating procedures'and who have been designared by the Radiation Safety Officer.

27. (RESERVED)

'SugERVISION - RADIOGRAPHY TS

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28. LThe individuals listed below are the-only persons authorized by this license to act as radiographers or.radiographers' assistants as defined in-10 CFR 34.2:

_ -Radiocranhern Radiooranher's Assistants l

29. (RESERVED)

SUPERVISION .

WELL. LOGGING T10 30 The individuals. listed below are the only persons authorized by this1 license to act as logging supervisors or logging assistants as defined in _ _

10 CFR 39.2:

Locaina sueerviners Leocino Annistants 31- . (RESERVED)

SUPERVISION ~ -

IPRADIATOR Til 132. (RESERVED)

33. (RESERVED)

RADIATION SAFETY OFFICER- T12

34. The Radiation Safety Officer for this license is .

35. '(RESERVED) l

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LEAK TEETS T13 NOTE TO REVIEWER: PLEASE REVISE LEAX TEST CONDITION AS NECESSARY

36. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

B. Notwithstanding Paragraph A of this Ccndition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

C. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

D. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage, and contamination prior to any use or transfer as a sealed source.

E. Sealed sources need not be leak tested if (1) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or I

( (iii) the half life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma j emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, ara in storage, and are not being used. However, when they are removed from storage for use or transferred to another person, and have not been tested within the required leak test interval, they shall be tested before use or transfer. No sealed source or detector cell shall be stored for a period of more than 10 years without being tested for leakage and/or contamination.

F. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. If the test reveals the presence of 0.005 microcurie or more of removable contamination, a report shall be filed with the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30.50 (b) (2), and the source shall be removed imnediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations.

The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region __

ATTN: Chief, , m . The report shall specify the source involved, the test results, and corrective action taken.

G. The licensee is authorized to collect leak test samples for analysis by .

Alternatively, tests for leakage and/or contanination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.

OR l

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H. Tests for leakage' and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission

- or an Agreement State to-Perform such services.

37 -(RESERVED)-

" TIE DOWN" -T14

_38,_ Except as specifically provided otherwise in this license, the-licensee  !

-shall conduct its program in accordance with the statements, l representations, and pt;;edures contained in the documents,--including any

-enclosuresj listed below, The Nuclear Regulatory Commission's regulations shall govern unless the statements, representations and procedures in the licensee's application'and correspondence are-more-restrictive--than the regulations A,

B.~ (Documents should be listed chronologically)

C.

(Roviewer Note: Use for all licenses except medical]

39, Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents,> including any enclosures,: listed below, except for minor changes in-the medical:use radiation safety procedures as provided in 10-CFR 35.31,- The Nuclear Regulatory Commission's regulations shall govern unless the statements, repretentations, and procedures in the licensee's application and

-correspondence are more restrictive than the. regulations, A.

B. (Documents should be listed chronologically)

(Reviewer Note: this condition should only be used for medical licensees.) ,

40, (RESERVED)

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b41. (RESERVED)

6-GAS CHPOMATOGRAPHS .T15

42. _In lieu of using the conventional radiation caution colors-(magenta or purple on yellow background) as provided in 10 CFR 20.203 (a) (1) , the licensee is hereby authorized to label detector cells, containing licensed material and used in gas chromatography devices, with conspicuously etched or stamped radiation caution symbols.

(Reviewer Note: 10 CFR 20.1901(b) obviates the need for this condition. Do not use this on any licenses after 1/1/94.)

43. Maintenance, repair, cleaning, replacement and disposal of foils contained in detector cells shall be performed only by the device manufacturer or other persons specifically authorized by the Commission or an Agreement State to perform sue?. services.

44. A. Detector cells containing a titanium tritide foil or a scandium tritide foil shall only be used in conjunction with a properly operating temperature control mechanism which prevents the foil temperature from exceeding that specified by the manufacturer and approved by NRC.

B. When in use, detector cells containing a titanium tritide' foil or a scandium tritide foil shall be vented to the outside, (Reviewer Note: Condition 44.B should not be used with portable field devices.)

45. (RESERVED)

46. (RESERVED)

47. (RESERVED)

FEMA T16 48 A. Each sealed source containing licensed material to be used outside of a shielded exposure device shall have a durable, legible, and visible tag permanently attached by a durable ring. The tag shall be at least 1 inch square, shall-bear a conventional radiation symbol prescribed in 10 CFR 20.1901 and a minimum of the following instructions: DANGER RADIOACTIVE MATERIAL DO NOT HANDLE NOTIFY CIVIL Atrn!ORITIES IF FOUND.

B. Replacement of tags and rings shall be carried out by the licensee in accordance with instructions contained in procedures provided by the Federal Emergency Management Agency.

49. (RESERVED)

50. (RESERVED)

PORTABLE GAUGES T17 51 Each portable nuclear gauge shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The gauge or its container must be locked when in transport, storage or when not under the direct surveillance of an authorized user.

52. The licensee may remove the source rod from (manufacturer) model numbers for the purpose of cleaning, maintenance, or repair of the l

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gauge (s) in accordance with procedures outlined in application / letter dated / received .

53. Any cleaning, maintenance, or repair of the gauge (s) that requires removal of the source rod shall be performed only by the manufacturer or by other persons specifically licensed by the Commission or an Agreement State to perform such services.

54. (RESERVED)

)

55. (RESERVED)

RADIOGRAPHY T18

56. A. Notwithstanding the periodic leak test reqaired by 10 CFR 34.25 (b),

the requirement does not apply to radiography sources that are stored and not being used. The sources exempted from this test shall be tested for leakage before use or transfer to another person. No sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or contaminacion.

B. Sealed sources authorized for a use other than radiography shall be tested f or leakage in accordance with 10 CFR 34.25.

L (Reviewer Note: B. should be used only if the license for use of sources other than radiography sources, e.g.provides

, a source contained in an instrument calibrator.)

57. The licensee is authorized to receive, possess, and use sealed sources of

' iridium 192 or cobalt 60 where the radioactivity exceeds the maximum amount of radioactivity specified in this license provided:

A. Such possession does not exceed the quantity per source specified in Item 8 by more than 20 percent for iridium 192 or 10 percent for cobalt 60; and B.

Records of the licensee show that no more than the maximum amount of radioactivity per source.specified in this license was ordered from the supplier or transferor of the byproduct material; and C. The levels of radiation for radiographic exposure devices and storage containers do not exceed those specified in 10 CFR 34.21

58. (REFER PG 2-16, MARCH 7, 1995) (NEW LICENSES ONLY)

Notwithstanding the requirements of 5 34.20(a), and pursuant to 5 34.51, radiographic equipment authorized for use in radiographic operations under this license need not comply with the torque criteria of Section 8.9.2 (c) of American National Standard N432-1980.

59. (RESERVED)

WELL-LOGGING T19

60. Each source holder or logging tool containing radioactive material shall bear a legible and visible marking as specified in 10 CFR 39.31(a). The label must be on the smallest component that contains the licensed material which is transported as a separate piece of equipment.

61. A. Notwithstanding the periodic leak tes't required by-10 CFR 39.35,-the requirement does not apply to sources, except sources containing plutonium, that are stored and nct being used. The sources exempted r

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from this periodic test shall be tested for leakage before use or transfer to another person.. No sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or'

-contamination.

B. Sealed i i rces authorized for a use other_than well logging shall be tested f, leakage and shall be inventoried in accordance with 10 CFR 39.35 and 39.37 62.- The-licensee shall not vacate or release to unrestricted use a field office or storage location whose address is identified in Condition 10, without prior NRC approval.

63. (RESERVED) 64 (RESERVED)

FTYED GAUGES T20

65. .Each gauge shall be tested for the proper operation of the on off mechanism and indicator, if any, at no longer than 6 month intervals or at such-longer intervals as specified by the manufacturer and approved by NRC.

66. Installation, initial radiation . survey, relocation, removal from service, maintenance, and repair of devices containing sealed sources shall be performed by f anerooriatelv trained individual within licennee's organizatient or by persons specifica11,v licensed by the Commission or an Agreemont State to perform such services. Installation,-replacementi and disposal of sealed sources shall be performed only by persons specifically

,, licensed by the Commission or an Agreement State to perform such services.

(Reviewer Note: Use Condition 66 when only the gauge manufacturer will perform all service activities, including mounting, or when the licensee ~has designated a qualified individual to perform these activities,)

- 67 Installation, initial radiation survey, relocation, or removal from service of devices containing sealed sources shall be performed by or by persons specifically licensed by the Commission or an Agreement State to perform such services. - Maintenance and repair of devices and installation, replacement, and disposal of sealed sources shall be performed only by persons specifically licensed by the Commission or an Agreement State to perform such services.

(Reviewer Note: Use Condition 67 when the licensee will perform limited activities but not maintenance or repair.)

68. Installation, initial radiation surveys, relocation, removal from service, or any similar activity with devices containing licensed material shall be performed only by persons specifically licensed by the Commission or an Agreement State to perform such services. The licensee may initially mount the device only in -accordance with written instructions provided by the manufacturer;=however, the device may not be used until surveyed by a person specifically licensed by the Commission or an Agreement State to install gauges. The licensee may maintain, repair, or replace device components not directly associated with the devices's sealed source, its related shie.1 ding, or the device's on off mechanism; and that will not result in increased radiation levels in accessible arean about the device.

(Reviewer Note: Use Condition 68 when the licensee has requested 1

9 authorisation only to mount gauges.)

69, Prior to initial use and after installation, relocation, dismantling, alignment- or any other activity involving the source or removal of the shielding, the licensee shall assure that a radiological survey ie performed to determine radiation levels in accessible areas around, above and below the gauge with the shutter open. This survey shall be performed only by persons authorized to perform such services by the Commission or an Agreement State.

70. The licensee shall operate each gauge within the manufacturer's specified temperature and/or environmental limits such that the shielding and shutter mechanism of the source holder are not compromised.

71. The licensee shall assure that the shutter mechanism is locked in the closed position during periods when a portion of an individual's body may be subject to the direct radiatien beam. The licensee shall review and modify as appropriate its " lock-out" procedures whenever a new gauge is obtained to incorporate the device manuf acturer's recommendations.

72. (RESERVED)

IRRADIATORS T21

73. (RESERVED) 74 (RESERVED)

75. The licensee shall not perform repairs or alterations of the irradiator

,, involving removal of shielding or access to the licensed material. Removal replacement, and disposal of sealed sources in the irradiator shall be performed by a person.specifically licensed by the Commission or an Agreement State to perform such services.

(Reviewer Note: Use this condition for self contained irradiators.]

76. For each J. L. Shepherd and Associates, Mark I Cesium 137 Irradiator installed and used, the licensee shall:

A. Permit the use of the irradiator only when a calibrated and operable radiation survey meter or room monitor is available; and B. Permit the irradiator door to be opened cnly after the operator has checked visual indicators to verify that the source has returned to its safe storage positioni and C. Have room monitors installed that will:

(i) Operate at all times when the irradiator is in use; and (ii) Activate a visible and audible alarm when radiaticn exceeds 2 millirema per hour; and (iii) Detect any radiation leaking from the irradiator door; and l

(iv) Be visible to the irradiator user when he is next to the irradiator; or {

i D. If a room monitor is not installed, have available a calibrated and operable survey meter which will be used to:

(i) Determine the radiation level at the irradiation door when the door is closed; and

10 (ii) Check for any increase in radiation levels each time the irradiator door is opened.

E. (RESERVED)

F. Not repair or authorize repairs of the irradiator except by the manufacturer or other persons specifically authorized by the Commission or an Agreement State to perform such services.

77 The procedures contained in instruction manual for the Model device shall be followed and a copy of this manual shall be made available to each person using or having responsibility for the use of the device.

78 The licensee is authorized to use the following sealed sources in the irradiator:

Manufacturer Model No.

-79. (RESERVED)

80. (RESERVED)

SHIELDINGE DU T22 81 (RESERVED)

NUCLEAR PHARMACIES T23

83. A. Radiopharmaceuticals dispensed and/or distributed for human use

, shall be either:

(i) Repac). aged from prepared radiopharmaceuticals that are the subject of an FDA-approved "New Drug Application" (NDA) or for which FDA has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND) ; or (ii) Prepared from generators and reagent kits that are the subject of an FDA approved NDA or for which FDA has accepted an IND.

B. Prepared radiopharmaceuticals for which FDA has accepted an IND and radiopharmaceuticals prepared from generators or reagent kits for which FDA has accepted an IND shall be dispensed and/or distributed:

(i) In accordance with the directions provided by the sponsor of the IND; and (ii) only to physicians who have been accepted by the sponsor of the IND to participate in clinical evaluation of the drug.

84 The licensee shall elute generators and process radioactive material with reagent kits in cccordance with instructions furnished by the manufacturer on the label attached to or in the lesflet or brochure that accompanies the generator or reagent kit.

85. Reagent kits may be redistributed to persons licensed pursuant to 10 CFR 35.200 or under equivalent licenses of Agreement States.

86. Radioactive waste may be picked up from the licensee's customers and disposed of in accordance with the procedures, statements, and representations in .

87 (RESERVED)

88.- (RESERVED) i i

89. (RESERVED) I

90. (RESERVED)

TELETHERAPY T24 91 Notwithstanding the requirements of 10 CFR 35.647, the licensee is authorized to extend until the time interval for inspection and servicing of its teletherapy unit.

92. Notwithstanding the requirements of 10 CFR 35.961 may perform the duties of the teletherapy physicist for those full-calibration and spot-check measurements specified in 10 CFR 35.632 and 10 CFR 35.634.

93. The teletherapy physicist for this license is .

t 94. The licensee is exempted from decommissioning financial assurance j

requirements for possession of licensed material in sealed sources in quantities greater than the limits in 10 CFR 30.35 (d) for the purpose of source changes only. This exemption is granted for no more than 30 days for any one source change.

(Reviewer Note: Possession Limit Exemption for Teletherapy Licensees.)

95. (RESERVED)

96. (RESERVED)

CARDIAC PACEMAKERS T25 97 (RESERVED)

98. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise in use.

99. (RESERVED) 100. (RESERVED) 101. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. Procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient.

102. (RESERVED) 103. (RESERVED)

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MEDICAL GENERAL T26 104. Notwithstanding the requirements of 10 CFR 35.20 (a), the licensee is not required to develop and implement an !LARA program.

(Reviewer Notes' Use Condition 104 rar licenses only authorizing 35.500 1 105 Notwithstanding the requirements of 10 CFR 35.22 the licensee is not required to establish a Radiation Safety Committee.

(Reviewer 35.500 authorizing Note: Use Condition 105 for institutional licenses only devices.)

106. Needles or standard medical applicator cells containing licensed material as wire shall not be opened by the licensee.

107. Notwithstanding the provisions of 10 CFR 35.49, " Suppliers," the licensee is authorized to receive from in accordance with procedures outlined in .

108. The licensee shall possess and use byproduct material for human research use in accordance with the prescriptive and performance criteria in all sections of 10 CFR Part 35.

(Reviewer Note: Use Condition 108 for limited medical use programs-that have non broad human research programs.]  ;

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109. (RESERVED) 1 110. gAESERVED) I MEDICAL - BROAD T27 l l

111. The licensee shall conduct a physical inventory every 3 months to l account for all sources and/or devices received and possessed pursuant to l 10 CFR 35.59, 10 CFR 35.400 and 10 CFR 35.500 and every 6 months for all other sources and/or devices.

I 112. Notwithstanding the requirements of 10 CFR 35.49 (a) and (b) , 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400-and 10 CFR 35.500 the licensee may use for any medical use any byproduct material or reagent kit. The licensee shall possess and use byproduct material for medical use in accordance with the prescriptive and performance criteria in the other i sections of 10 CFR Part 35. This does not relieve the licensee from I I

complying with applicable United States Food and Drug Administration (FDA) and other Federal and State requirements.

113. The licensee shall possess and use byproduct material for human research use in accordance with the prescriptive and performance criteria in all sections of 10 CFR Part 35 except sections 35.49 (a) and (b) , 35.100, 35.200, and 35.300.

b 114. (RESERVED) 115. (RESERVED) 116. (RESERVED) 117 (RESERVED) tenicAL. BRACHYTHERAPY REMOTE AFTERLOADERS T28 (See Also 125.A)

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'118. In lieu of 10 CFR 35.404 (a), immediately after retracting the source from the patient into its shielded positio.4 in the remote afterloading device, a '

i radiation survey shall be made of the patient and the remote afterloading device with a portable radiation detection survey instrument to confirm that the source has been removed from the patient. Records of the survey -I shall be maintained in lieu of the record required in 10 CFR 35.404 (b) . i 119. shall:

In lieu of the source inventory required in 10 CFR 35.406, the licensee A. Promptly determine that all sources have returned to the safe, shielded position at the conclusion of each remote afterloading brachytherapy procedure.

B. Promptly make a survey of the area of use to confirm that no sources have been misplaced.

C. Make a record of tha survey including the survey instrument used, dose l rate expressed in mrem /hr (psieverts/hr), tim 3, date and name of the individual making the survey.

D. Retain the record of the survey in lieu of the record required in 10 CFR 35.406(d).

120. Prior to initiation of a treatment program, and subsequent to each source exchange, using the remote afterloading brachytherapy devices, radiation surveys and tests shall be performed in accordance with

( the following:

A. A radiation survey shall be made of:

1. The irradiator source housing, with the source in the shielded position. The maximum radiation levels at 10 centimeters from the surface of the main source safe shall not exceed 1 milliroentgen per hour,

2. All areas adjacent to the treatment room with the source in the "irtadiation" position. The survey shall clearly establish:

(a) That radiation levels in restricted areas are not likely to cause personnel exposure in excess of the limits specified in 10 CFR 20.1201.

(b)

That limits radiation specified levels in unrestricted in 10 CFR 20.1301). arvas do not exceed the 121. The following shall be performed only by manufacturer's representatives or persons specifically authorized by the Commission or an Agreement State to perform such services:

A. Installation and replacement of the sealed sources contained in the afterloading brachytherapy device (s).

B. Any maintenance or repair operations on the remote afterloading brachytherapy unit (s) listed in Item 9, Subitem (s) involving work on the source safe,- the source drive unit, or cther mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels.

122. NON STANDARD (TAR 6/29/94)

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A. Notwithstanding the requirements of 10 CFR 35.315 (a) (4), the licensee may use the alternative method for determining the dose rates in contiguous restricted and unrestricted areas after administration of the dosage describe in the letter / application dated B. Notwithstanding the requirements of 10 CFR 35.415 (a) (4), the licinsee may use the alternative method for determining the dose rates an .

l contiguous restricted and unrestricted areas af ter implantation of the sealed source described in the letter / application dated 123. A. The licensee may not possess and use materials authorized in Items 6, 7, and 8, until: 1) the licensee has constructed facilities and obtained the equipment described in the application and supporting documentation; and 2) the U.S. Nuclear Regulatory Commission, Region

__, ATTN: Chief, , has been notified in writing that activities authorized by the license will be initiated.

B. In accordance with the requirements set forth in 10 CFR 30.36(b), the licensee shall promptly notify the Nuclear Regulatory Commission, in writing of a decision not to complete the facility, acquire equipment, or possess and use authorized matarial.

124. (RESERVED) 1 MEDICAL-BPACMYTHERAPY P. EMOTE AFTERLOADERS (High, Medium, and Pulsed Dose Rate)

' 125. A. Access to the rooms housing the afterloading brachytherapy device shall be controlled by a door at each entrance.

B. The entrance to the irradiation room shall be equipped with an electrical interlock system that will cause the source to return to the shielded position immediately upon opening of the entrance door.

The interlock system shall be connected in such a manner that the source cannot be placed in the irradiation position until the entrance door is closed and the source "on off" control is reset at the control panel.

C. Electrical interlocks on the entrance door to the irradiator room shall be tested for proper operation at least once each day of use.

D. In the event of malfunction of the door interlock, the irradiation device shall be locked in the "offa position 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.

126. (RESERVED) 127 (RESERVED) 128. (RESERVED)

WASTE DISPOSAL T29 129. 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. Radioactive waste to be disposed of in this manner shall be held for decay a minimum of 10 half-lives.

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B.. Before disposal as ordinary trash, byproduct material shs11 be

~

surveyed at the container surface with the appropriate survey meter -

set on its most sensitive scale and with no -interposed shielding to determine that its radioactivity cannot be distinguished from background. All radiation-labels shall be removed or obliterated.

C.- A record of each disposal permitted under this License Condition shall be retained for three years. The-record must include the date of disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose-ratn, the dose rate measured at the surface of each waste container, and the name of the individual who performed the-disposal.

130. (RESERVED) 131. Radioactive vaste possessed under this license shall be stored in accordance with the statements, < 7resentations, and procedures included with the licensee's waste storag, plan described in the licensee's letter dated .

(F.eviewer Note n- Use this condition when a vaste storage plan has been submitted.)

132. (RESERVED) 133. (RESERVED)

,, INCINERATION T30 134. Pursuant to 10 CFR 20.1302 (c) and 10 CFR 20.2002, the licensee is authorized to dispose of licensed material by incineration provided the gaseous effluent air in Appendix B,_from Tableincineration 2, does nc: exceed the limits specified for 10 CFR Part 20.

(Reviewer Note: The part of,this former standard condition:

regarding ash-residue disposed of as ordinary waste is deleted. A TAR must be sent to NMSS to obtain this authorize. tion if the licensee requests ash disposal aus ordinary-waste and provides information required by the Commission. Otherwise, all ash residue from

= incineration is to be treated as radioactive waste.1 135. (RESERVED)

TRANE PORT;',T4Q}[ .T31

- 136.LThe licensee is authorized to transport licensed material only in-accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."

137. = (RISERVED) 138. (RESERVED)

DISTRIBUTION T32 4

139. (RESERVED) 140.:The licensee may distribute material from .

(Reviewer note: For use on distribution only licenses]

141. Pursuant to 10 CFR 32..__,.the licensee is authorized to distribute the (nmokn detectorm or,gglf-lumin9um eroducts) specified in Condition to

. persons exempt from the requirements for a license pursuant to 10 CFR 30 __,;or equivalent provisions of the regulations of any_ Agreement State.

-142. The following famnke detectors or self-luminous nroductal may be

. distributed provided the amount of timetooei_ contained in the device does not exceed the amounts specified in the following table:

Davice Model Maximum ouantity ner Device 143. The licensee shall submit periodic material transfer reports as specified in 10 CFR 32. .

144._Each device distributed under this license shall1be manufactured, tested, and labeled in accordence with the statements, representations, and procedures contained in (aonliention f al / letter (s)) dated .

145. This license does-not authorize commercial distribution of licensed material to persons generally licensed pursuant to 10 CFR Part 31 or to persons exempt from licensing pursuant to 10 CFR 30.18, i

• 14 6. - (RESERVED) 147 (RESERVED)

MISCELLANEOUS T33

,, 148. Licensed material shall not be used in or on human beings.

149. material.

This license does not authorize commercial distribution of licensed 150.,This license does not authorize possession or use of licensed material.

151. This. license does not authorite distribution to persons licensed pursuant to 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, or 10 CFR 35.600.

152. The_ licensee shall not-use licensed material in or on human beings except as provided otherwise by specific condition of this license.

153.1The-licensee shall not use licensed material in field applications where cctivity is released except as provided otherwise by specific condition of

-this license.

154. Sealed sources or detector cells containing licensed material shall not be opened or sourcep removed from. source holders by the licensee.

155. The licensee shall conduct a physical ir.ventory every 6 months to account for all sources and/or-devices received and possessed under the license.

156. : Experimental animals, or the products from experimental animals, that have been administered licensed materials shall not be used for human consumption, 157. Pursuant to 10 CFR 20.1301(c) and in reliance on statements, procedures and representat(ons made by the licensee in the nonlication/ letter dated the following maximum radiation levels are hereby authorized in the-following unrestricted areas:

Miximum Radiation Level Un re s t rictral,,Arag 158. The licensee shall not acquire licensed r.aterial in a sealed source or device that centains a sealed source unless the source or device has been registered with the Nuclear Regulatory Commission under 10 CFR 32.210 or with an Agreement Ctate.

(Reviewer Note: This condition may be used when the reviewer doesn't specify manufacturers or model numbers (e.g., gas chromatographs, bone mineral analyzers).)

NEW LICEN9ES T34 (R2] (Restored 5/94) 159. A. The licensee may not possess and use materials authorized in Items 6, 7, and 8, until:

i 1) the licensee has constructed facilities and

! obtained the equipment described in the application and supporting documentation; and 2) the U.S. Nuclear Regulatory Commission, Region l __, ATTN: Chief, , has been notified in writing that activities authorized by the license will be initiated.

B. In accordance with the requirements set forth in 10 CFR 30.36 (b) , the I

licensee shall promptly notify the Nuclear Regulatory Commission, in writing of a decision not to complete the facility, acquire equipment, or possess and use authorized material.

EYE PLAOUE9 T35 (R2] (Added 5/94) 160. Not withstanding the requirements of 10 CFR 35.404 (a), the licensee

' may release from confinement for medical cara a patient with a temporary eye plaque implant in place, provided that: the survey requirements for permanent implant patients specified in 10 CFR 35.75 (b) are met; and a non-hardening bonding agent is used between the insert and the metal shield for all temporary eye plaques, to enhance plaque integrity and prevent seed loss. Upon removal of the eye plaque, the licensee shall make a radiation survey cf the patient with a radiation detection survey instrument to confirm that all sources have been removed. This survey must include disassembling the plaque to conduct a physical inventory of the seeds. Th3 licensee shall retain a record of the patient survey in accordance with 10 CFR 35.404 (b) .

Notwithstanding, the requirements of 10 CFR 35.406 (a) , after removal of each eye plaque, the patient may be released from the medical

)~ treatment facility after an inventory of the sources in each eye plaque is performed to confirm recovery of all sources.

Notwithstanding the temporary nature of each eye plaque implant, the licensee must meet the requirements of 10 CFR 35.415 (a) (5) .

EMERGENCY PLAN 9 /DECOMMT 99IONING T36 (Also see teletherapy condition no. 94) )

I 161. (RESERVED) l l

162. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material to quantities below the limits specified in 10 CFR 30.72-which require consideration of the need for an emergency plan for responding to a release of licensed material.

163. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR (3 0. 3 5 (d) or 40.36 (b) or 70.25 (d)) for establishing decommissioning financial assurance.

(Reviewer Note: This is a general possession limit for no decommissioning financial assurance for cases where the possession limit is not explicit in license Item 8.)

164. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of to quantities less than in accordance with the provisions of 10 CFR .

165. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of (unsealed licensed material or readily dispersible source material) to quantities less than (10 or 10 times the applicable limits in Appendix C of 10 CFR Part 20, or 100 mci] as specified i

in 10 CFR (3 0. 35 (d) or 40.36 (b) or 70.25 (d) .

(Reviewer Note : This is a general possession limit for intermediate level decommissioning financial assurance.]

166. (RESERVED) 167 If only one radionuclide is possessed, the possession limit is the quantity specified for that radienuclide in 10 CFR 33.100, Schedule A, Column II.

If two or more radionuclides are possessed, the possession limit is determined as follows: for each radionuclide, determine the ratio of the gubntity possessed to the applicable quantity specified in 10 CFR 33.100, Schedule A, Column II, for that radionuclide. The sum of the ratios for all radionuclidos possessed under the license shall not exceed unity.

[ Reviewer Note: To limit the possession limit for a Type C Broad License to climinate the need for financial assurance for decommissioning also use standard condition no. 163.]

4

- 19 -

168. If only one radionuclide is possessed, the possession limit is the quantity specified for that radionuclide in 10 CFR 33.100, Schedule A, Column I. If two or more radionuclides are possessed, the possession limit is determined at follows: for each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in 10 CFR 33.100, Schedule A, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(Reviewer note: To limit the possession limit for a Type B Broad License to eliminate the need for a decommissioning funding plan also use standard condition no. 165.]

169, (RESERVED) 170. (RESERVED)

- 171. (RESERVED) 172. (RESERVED)

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