ML20236S376

Policy & Guidance Directive (Pgd) 1-26, Processing of Exemptions for Matl Licensees (Formerly P&Dg 84-12,Rev)

ML20236S376
Person / Time
Issue date:	07/21/1997
From:	Patricia Holahan, Piccone J, Gary Purdy NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20236S370	List: ML20236S368 ML20236S376
References
PGD-1-26, NUDOCS 9807240289
Download: ML20236S376 (32)

Text

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United States l Nuclear Regulatory Commission l

l Policy and Guidance Directive (PGD) 1-26 (Formerly P&GD 84-12, Rev. 2)

PROCESSING OF EXEMPTIONS FOR MATERIAL I

LICENSEES Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards J

REVIE BY N

PREPARED Gary W. Purdy, BIOB BY: h Y2bh /.!u Patri sa K. Hol ,BIOB Of f5' CONC 'NCE CO,NC "fo'CU

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I PROCESSING OF EXEMPTIONS FOR MATERIAL LICtiN.3EEf.

Table of Contents Eible l 1. Purpo s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...... .. .. .. ...... 2 l

Ba ckg ro u nd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. .... ............. 2

3. General G uida nce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3.1 Exem ption s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3.2 Temporary Exemptions for Humanitarian or Emergency Reasons . . . . . . . . . . . . . . . 3 3.3 Exemptions Requiring Coordination with NMSS. . . . . . . . . . . . . . ............. 5

4. Administrative Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .....5

5. Re s ou rce s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... ..... .. . ....... .5 APPENDIX A R o utine Exemption s. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 APPENDIX B STANDARD LETTER FORMAT for Temporary Exemption from NRC Regulation or License Condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 APPENDIX C Examples of Exemptions Requiring Coordination with NMSS . . . . . . . . . . . . . . . . . C- 1 l

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PROCESSING OF EXEMPTIONS FOR MATERIAL LICENSEES

! 1. Purpose This Policy and Guidance Directive (P&GD) provides guidance to the regions for processing requests for exemptions. Materiallicensees may be granted exemptions from certain sections of the NRC regulations upon provision of information which includes a justification for the exemption request, applicable compensatory safety measures, and assurance that consideration of all reasonable attematives for compliance with the regu'ations have been exhausted. Appendix A provides additional guidance on exemptions to sections of the regulation. Some exemptions may be granted on a temporary basis as explained in paragraph 3.2 below and Appendix B.

2. Backaround P&GD FC 84-12, Revision 2; Grantino Exemptions and Special Authorizations, dated November 12,1986, provided guidance to the regions for granting special authorizations and exemptions from specific NRC regulations. P&GD FC 92-03, Exemotions from 10 CFR 35.400 for Uses not currently Authorized for Iridium-192 Seeds Encased in Nylon Ribbon and Palladium-103 Seeds as Brachytheraov Sources. dated August 17, 1992, provided guidance to the regions for granting exemptions from 10 CFR 35.400. P&GD 2-16, Generic Exemption for Newfv-Manufactured Radicaraohv Eouioment. dated March 7,1995, provided guidance to the regions to exempt a licensee from 10 CFR 34.20(e) which specified the ANSI-N432, Section 8.9, prototype endurance test. This P&GD supersedes P&GD FC 84-12, Revision 2 and P&GD 92-03. P&GD 2-16 is superseded by the addition of 10 CFR 34.20(f) to the Part 34 rulemaking published in the Federal Register on May 31,1995.

This P&GD provides:

1. guidance and a listing of exemptions that may be approved by the regions with accompanying guidance for additional information needed and the applicable license condition;

2. guidance regarding the procedures and criteria for granting temporary exemptions for emergency or humanitarian reasons and a standard form setter; and

3. a listing of exemption requests that should be referred to -

the Division of Industrial and Medical Nuclear Safety (IMNS) or the appropriate NMSS division for approval.

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3. General Guidance 3.1 Exemotioris i The exemptions contained in Appendix A may be granted by the

! regions without coordination with Headquarters. All requests for an l exemption to the regulations must not present an undue risk to public l health and safety, and be consistent with the common defense and l security. ,

The request must be accompanied by:

a. a description of the exemption needed and why; 1

b. compensatory safety measures as necessary to provide an l equivalent level of health and safety as the regulation for l which the exemption is being requested; and

c. the licensee's assuranc.e that consideration of all reasonable attematives for complying with the regulation has been exhausted.

l Each Appendix A section describes the specific part of the regulation l which may be considered for exemption, any other commitment or l additional information that the licensee must submit prior to issuance of the exemption, and the license condition to be issued upon review

. and determination that the exemption should be granted. This guidance will be updated when current rulemaking initiatives preclude the need for issuance of the exemption or other exemptions that the regions may issue without coordination with Headquarters are identified.

3.2 Temnrary Exemptions for Humanitarian or Emeroency Reasons The regions may grant a temporary exemption to NRC regulations or license conditions, on a case-by-case basis, without referral to the Director, IMNS, NMSS, in certain circumstances in which:

l a. A normal license amendment is not appropriate because of the non-recurring, short duration (normally 7 days or less) nature of the exemption; and

b. The non-compliance would normally result in a Severity Level IV violation per NUREG-1600, General Statement of Policy and Procedures for NRC Enforcement Actions.

Decisions to grant temporary exemptions should only be exercised when NRC is clearly satisfied that such actions are consistent with the protection of public health and safety. A temporary exemption should PG 1-26 07/25/97 3

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be granted only after a determination has been made that the circumstances surrounding the request are exigent, temporary, and that an exemption will not endanger life, property, or the common defense and security, and is otherwise in the public interest. Such exemptions should not be exercised repeatedly for the same set of circumstances for the same licensee.

All licensee requests for temporary exemption to the regulation must be accompanied by:

a. A discussion of the requirements for which an exemption is requested and identification of the specific regulation or license condition involved;

b. A discussion of circumstances surrounding the situation, including the need for prompt action, a description of why the situation could not be avoided, and the probable consequences were the request not granted;

c. A preliminary evaluation of the safety significance and potential consequence (s) of granting the proposed request; and

d. A discussion which justifies the duration of the exemption.

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The licensee's request should normally be faxed to the Director, f._ Division of Nuclear Materials Safety (DNMS) within the appropriate NRC region. The Director, DNMS at each NRC region, is authorized to grant the exemption request per l Management Directive 9.29, " Organization and Function:

Regional Offices." However, if circumstances do not permit time l for the fax, the licensee may make the request orally and read or describe the above information to the NRC staff. The oral i request must be followed (within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) by written l docurrentation of the above information. The follow-up written request must confirm the information submitted orally and upon j which the NRC relied in granting the exemption.

i The exemption may be Cranted orally by the Director, DNMS or the acting Director, DNMS. Following the granting of the request, the Director, DNMS, shall promptly send a letter to the licensee utilizing the standard format contained in Appendix B documenting the circumstances surrounding the request, the exemption granted, and the duration of the exemption. The letter will normally be issued within 3 working days of the receipt of the licensee's written request. The license should then be amended to incorporate the temporary exemption and commitments made by the licenser and an entry made to the Licensing Tracking System (LTS). Copies of the letter sent to the licensee should be provided to the Office of Enforcement, and the Director, IMNS, NMSS.

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I 3.3 Exemptions Reauirina Coordination with NMSS All requests for exemptions not described in paragraphs 3.1 and 3.2, should be considered as non-routine and should be forwarded to the appropriate NMSS Division Director. The regions should follow the guidance contained in P&GD 90-4 for technical assistance requests and submission of exemption requests for consideration of approval.

All exemption requests should be entered into the LTS upon receipt.

Examples of exemptions which require coordination with NMSS before processing by the region, and which also should be recorded in the LTS are identified in Appendix C. In addition, when an exemption is being considered, the region should submit its evaluation of the merits of the exemption from a technical standpoint as well as any generic implications, such as a need for rulemaking.

4. Administrative Procedures l The LTS allows recording o' exemptions granted. The LTS worksheet l

contains an exeroption data field which should be annotated to identify the j section of the regulation to which the exemption was granted. For example, t

if an exemption is granted to allow relief from 10 CFR $35.647 to extend the time for servicing and inspection of a teletherapy unit, then the entry should

, be 35.647. Do not use abbreviations or entries other than the specific i

section of the regulation. If an exemption is not effective after a specific date, then the date should be entered in the LTS in parentheses following the section, i.e., 35.647 (8/31/98). P&GD 1-22, Rev.1, Policy and Criteria l for Initial Processina of Incomina Licensina Actions. dated April 15,1997, ,

! states that all exemptions requested, granted, and denied will be entered in 4 l the LTS. If the LTS has not been modified to acccminodate these actions, l the regions should continue to maintain a list as directed in P&GD 1-?2. If l you need assistance regarding entry of data on the LTS worksheet, p4ese 1 j contact the regional license reviewer or the licensing management system coordinator. l

5. Resources i This directive reduces the overall agency resources required to process several specific exemption requests, by authorizing the regions to grant those specific exemption requests without prior coordination with headquarters. Many of these exemptions may not be necessary once rulemaking is finalized.

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APPENDIX A The following format is used throughout this Appendix to allow the user to locate information quickly. The following box has a description in l

each segment that explains the information that will be located in that segment.

The first box segment describes the section of the regulation from which an i

, exemption could be requested by a licensee. ,

The second box segment describes any additional information a licensee will l need to submit or commit to other than information described in paragraph 3.1 l of the Policy and Guidance Directive.

The third box segment describes the license condition to be used once the l region determines the exemption should be granted.

i APPENDIX CONTENTS l

! l. 10 CFR 35 Recordkeeping or posting . . . . . . . . . . . . . . . . . . . . . . . . . A-2 35.315(a)(4) and 35.415(a)(4) . . . . . . . . . . . . . . . . . . . . . . . A-3 35.400(d) and (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 3 5.404( a ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5 3 5. 64 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -6 ll. 10 CFR 36

36. 2 3( a ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

36. 23( b ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 36.2 3( c ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9

36. 2 3(d ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

36. 23(f). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 1 36.27(a) and 36.27(b) . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . A-12  ;

36.31 (a ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

36. 31 ( b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A 14 36.67(b)(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-15  ;

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!. 10 CFR 35

! A. Recordkeeping or posting Requests for relief from recordkeeping or posting requirements, in Part 35.

l Information as described in paragraph 3.1 is sufficient.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 35.__, the licensee may use the alternative method for (recordkeeping or posting) as described in i the letter / application dated .

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B. 635.315(a)(4) and 635.415(a)(4)

Regions may grant exemptions from $35.315(a)(4) and $35.415(a)(4) which require surveys in contiguous areas after the administration of a therapeutic radiopharmaceutical dosage or implantation of sealed sources for brachytherapy, respectively.

The following describes additional information needed:

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1. . The licensee must provide a detailed description of the rooms used for therapy, including the adjacent areas and the area above and below such rooms used for therapy. A sketch of the treatment rooms and adjacent areas i should be submitted with the layout of the rooms and adjacent areas indicated.

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2. The licensee must describe how it will evaluate the dose rates in areas adjacent to treatment rooms, and provide sample calculations. All assumptions used in the evaluation must be clearly identified. The licensee must describe

, what shielding is present in the walls / floor / ceiling. The licensee must state that if any of the parameters used in the initial evaluations change, (room layout, i increase in source activity, ...), a new evaluation will be performed.

3. The licensee must provide enough information to determine that the requirements in $20.1301(a) will be met. The licensee must also address how it will determine that dose limits to members of the public and other patients in unrestricted areas from multiple therapy patiente or subsequent hospital stays in the same calendar year will not exceed 100 millirem per calendar year.

l The following license condition should be used for exemptions from 10 CFR 35.315(a)(4):

"Notwithstanding the requirements of 10 CFR 35.315(a)(4), the licensee may use the alternative method for determining the dose rates in contiguous l

restricted and unrestricted areas described in the letter / application dated The following license condition should be used for exemptions from 10 CFR 35.415(a)(4):

l "Notwithstanding the requirements of 10 CFR 35.415(a)(4), the licensee may l use the alternative method for determining the dose rates in contiguous restricted and unrestricted areas described in the letter / application dated ."  ;

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C. 635.400(d) and 635.400(a)

Regions may grant exemptions from the use requirement in $35.400(d) for iridium-192 and $35.400(g) for palladium-103 to allow other than interstitial treatment of  ;

cancer.

For the exemption to be granted, the licensee must specify iridium-192 (Ir-192) encased in nylon ribbon and palladium-103 (Pd-103) seeds, No additional radiation i safety procedures need to be identified. Ir-192 and Pd-103 have been used for i intracavitary use for many years and sources in the Sealed Source and Devicts

! Registry which have passed the testing criteria for interstitial use can be used in - l I

intracavitary or topical applications. Requests for authorization of gold-198 and iodine-125 seeds for intracavitary and topical applications should be coordinated with NMSS as identified in Appendix C.

The following license condition should be used "Notwithstanding the requirements of 10 CFR 35.400(d) and (g), the licensee .

l may use iridium-192 as seeds encased in nylon ribbon and palladium-103 as j seeds for topical, interstitial, and intracavitary treatment of cancer. The licensee may deviate from the manufacturer's radiation safety and handling . i instructions only to the extent that the instructions are not applicable to the  !

l type of use proposed by the licensee."

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D. 635.404(a)

Regions may grant exemptions from the requirement in $35.404(a), that prohibits

the release from confinement for medical care, a patient or human research subject with eye plaque implants until all sources have been removed.

Although the eye plaque implant is temporary, in that it will be removed after several days, the manner in which it is used is similar to a permanent implant. Because the

! implant is sutured into place, the device cannot be removed by the average patient, nor is it likely to become dislodged or lost.

l For the exemption to be granted, the licensee must adequately commit to comply l with the requirements described below to ensure adequate protection of public health and safety and to meet the survey requirements for permanent implant patients specified in $35.75(b). Specifically, the licensee must commit to comply with the following provisions:

1. The measured dose rate from the pation must be less than 5 millirems per hour at a distance of 1 meter, l 2. The patient will be provided with radiation safety guidance on j how to maintain doses to other individuals as low as reasonably achievable.

3. A radiation survey of the patient will be made with a radiation detection survey instrument after removing the eye plaque, prior to release of the patient to ensure that all sources have been removed.

4. Upon removal of the eye plaque, the plaque will be disassembled and a physical inventory of the seeds will be conducted to confirm that all sources have been recovered.

5. The licensee must also address any specific radiation safety instructions to be provided to patients.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 35.404(a), the licensee may release from confinement for medical care a patient with a temporary eye plaque implant in place, in accordance with procedures described in letter / application dated A-5

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r l Regions may grant exemptions to $35.647 to extend the time for servicing and l inspection of a teletherapy unit.

1 Information as described ir, paragraph 3.1 is sufficient.

l Standard License Condition 91 should be used. In general, the maximum interval from one inspection and servicing to the next is 6 years.

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11. 10 CFR 36 Although many provisions of 10 CFR Part 36 apply to converted teletherapy l units, compliance with certain applicable provisions of the rule may be impractical, and exemptions will be granted from specific sections of 10 CFR l Part 36, provided that the licensee requests and technically justifies the exemption. The following are technical justifications and commitments

! acceptable for exemptions from specific sections of 10 CFR Part 36.

A. 636 23(a) ,

1 l Regions may grant exemptions to $36.23(a) which states, in part, that " . The personnel entrance door or barrier must have a lock that is operated by the same j key used to move the sources."

Provided that :ne licensee commits to have the operator present for the entire period of time that the key is in the control panel. For converted teletherapy units, the use of a single key or even several keys on a key-ring may be impractical. The key-switch on many control panels is a 3-position switch which controls electrical l power to the teletherapy unit. The key can only be inserted / removed in the "off" .

position, and in this position the main power and control circuits are without l electrical power. Power is required to move collimators, activate field lights, align system, etc. Requiring a single key would not allow the licensee to operate these powered systems.

The following license condition should be used: l l

"Notwithstanding the requirements of 10 CFR 36.23(a), the licensee may use separate keys to operate the lock on the personnel entrance door or barrier and to move the sources in accordance with procedures described in the letter / application dated .

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B. A36.23(b)

Regions may grant exemptions to 936.23(b) which states, in part, that "... each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed."

The region may grant the licensee an exemption from this requirement provided that the licensee has an electrical interlock system meeting all of the conditions specified in $35.615(b) on each entrance to the radiation room. Alterations of the electrical interlocks of the teletherapy unit to meet the requirements of 36.23(b),

may cause the interlock system to function incorrectly. A working electrical interlock system on each entrance suffices to prevent personnel entry while the source is exposed. In addition, the licensee must commit to having an operator present during the entire irradiation who can visually observe the entrance, and to having a radiation monitor that can be read prior to entering the radiation area.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 35.23(b), the licensee is exempt from having an independent backup access control to detect personnel entry while sources are exposed based on the commitments described in the letter / application dated l

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, C. 636.23M l

Regions may grant exemptions to 936.23(c) which states, in part, that ..."The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high."...

l Alteration of the interlock system to meet this requirement would prevent entry to the treatment room to remove a patient in the event of a stuck source. The region may grant the licensee an exemption from this requirement provided that the licensee l

has an electrical interlock system which will retract the source, upon opening i access doors to the irradiation room and commits to its use, in addition, the licensee must commit to having an operator present and having a radiation monitor in the room, as discussed above. -

The following license condition should be used:

l "Notwithstanding the requirements of 10 CFR 35.23(c), the, licensee is exempt l from having the monitor integrated with personnel access door locks to prevent room access when radiation levels are high based on the commitments l described in the letter / application dated l

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D. 336.23(d)

Regions may grant exemptions to 936.23(d) which states, in part, that ..." visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position.".

An acceptable justification is that an audible alarm within the treatment room may I cause undue distress to the patients (human or animal). If the licensee commits to having a visual alarm provided on the outside of the treatment room, and to having the operator visually check the room prior to starting treatments, the regions may ,

grant the licensee an exemption from this provision of the regulations. I The following license condition should be used:  !

"Notwithstanding the requirements of 10 CFR 36.23(d), the licensee is exempt I from having a visible and audible alarm within the treatment area, based on the i commitments described in the letter / application dated l

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E. 636.23m Regions may grant exemptions to $36.23(f) which states, in part, that "Each radiation room at a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door...has been closed within a preset time..."

Exemptions may be granted to licensees having teletherapy units that are being used for irradiation of materials only (no patients), provided the licensee commits to the operator visually verifying that the room is not occupied prior to closing the door, and that the converted teletherapy unit (irradiator) activates a visual and audible alarm in the teletherapy room for at least 15 seconds prior to moving the source from the shielded position. This visual / audible alarm must be interlocked witn the i teletherapy unit such that the source will not move to the exposed position until the visual / audible alarm has been activated and is finished alarming. The use of a visual / audible alarm in a patient treatment room may cause anxiety for patients.

l Therefore, licensees having teletherapy units that are being ussd for both patient treatment (human or animal) and object or ma:arial irradiation may be authorized an exemption from $36.23(f) without the need to have a visual / audible alarm, if the licensee commits to having an operator visually verify that the room is not occupied prior to closing the door and if the licensee has a means of visual observation of the l

area as required in $35.615(e). If the unit is not used for patients, then the audible / visible alarm described above is required.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 35.23(f), the licensee is exempt from having a control.that prevents the sources from moving from the shielded position unless the contro! has been activated and the door or barrier to the radiation room has been closed within a preset time based on the commitments described in the letter / app!ication dated .

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l-I F. 636 27(a) and 36.27(b) m Regions may grant exemptions to $36.27(a) which states, in part, that .. "The sources must automatically become fully shielded if a fire is detected." and l

936.27(b) which states, "The radiation room at a panoramic irradiator must be l equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas."

l The Statements of Consideration state that the purpose of fire extinguishing system l is to prevent a fire from damaging the access control system or preventing the sources from being shielded. Most converted teletherapy units are designed to retract the source when the electrical power fails, as may occur during a fire. The licensee may be granted an exemption from these requirements by the region provided that the licensee commits: to have smoke detectors, fire extinguisher and a

, fire alarm at the site to detect and fight small fires, and to alert authorities of the fire; to have a means of measuring the radiation levels in the radiation room during an l electrical failure; and to instruct the operators to retract the source prior to exiting for a fire involving major portions of the facility, provided this action does not jeopardize the operator's safety.

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'Notwithstanding the requirements of 10 CFR 36.27(a) and (b), the licensee is exempt from (as reauested by licensee) based on the commitments described in the letter / application dated  ;

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G. E36 31(a) l l Regions may grant exemptions to 936.31(a) which states, in part, that .. 'The key must be attached to a portable radiation survey meter by a chain or cable. [..] The door to the radiation room must require the same key."

Converted teletherapy units require that the source activation key be inserted in the

( console to provide power to the unit to activate field lights and align the head; .

therefore, the region may grant the licensee an exemption from this requirement l provided that the licensee commits to having administrative controls in place to insure that personnel entering the radiation room use a portable survey metar to verify that the source has retracted. The licensee must also commit to attach the ,

survey meter to the exposure room door key.

l The following license condition should be used:

l 'Notwithstanding the requirements of 10 CFR 36.31(a), the licensee is exempt from the requirement to have console key attached to a portable survey meter by a chain or cable and that the door to the radiation room require the same key, based on the commitments described in the letter / application dated

." The radiation room door key shall be attached to the portable survey meter e

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i H. 636 31(b)

Regions may grant exemptions to 936.31(b) which states, in part, that "The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in... transit."

in converted teletherapy units the source is moved nearly instantaneously from the shielded to the exposed position. Most teletherapy units are designed with two indicator lights. The green light indicates the source is in the fully shielded position; the red light indicates the source is exposed. During transit k,g.th lights are on indicating that the sowce is in transit. To require that the licensee install an electronic system to indicate "in transit" for the period of time the source is in transit, less than a second, does not provide any additional protection. Illumination of both lights simultaneously accomplishes the same safety goal as an "in transit" indicator; therefore, the region may grant this exemption provided the licensee submits a j

description of its device indicators.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 36.31(b), the licensee is exempt from the requirement to have a separate position indicator to indicate when the source is in transit, in accordance with letter / application dated .

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l. 636 67(b)(2)

Regions may grant exemptions to 936.67(b)(2) which states, that a licensee must, ,

" Activate a control in the radiation room that permits the sources to be moved from j l the shielded position only if the door to the radiation room is locked within a preset l time after setting the control."

Due to the risk of malfunction associated with alterations to the existing electrical interlocks of the teletherapy unit necessary to comply with this regulation, and the licensee's commitment to administratively control access to the room to meet the j intent of this regulation, the region may grant this exemption, if the licensee l demonstrates that a retrofit to install such a control would not be possible with the teletherapy unit; and the licensee commits to the following:

a. The operator will close the doors jmmediatelv upon completion of the  ;

visual inspection required by 936.67;b)(1). l

b. The operator will verify that each door has locked automatically before stepping to the control panel. -

The following license condition should be used: j l *Notwithstanding the requirements of 10 CFR 36.67(b)(2), the licensee is exempt from the requirement to have a control in the radiation room which must be activated prior to irradiation which would not allow the Jource to be moved from the shielded position unless the door to the radiation room is ,

locked within a preset time, based on the commitments described in the  !

j letter / application dated .

l  :

l A-15 l

1' t

l APPENDIX B l

Standard Letter Format for Temporary Exemption from NRC Reaulation or License Condition DOCKET NO.

l LICENSE NO.

(Name of Licensee)

! (Address) l

SUBJECT:

TEMPORARY EXEMPTION TO NRC (REGULATION QR LIST THE LICENSE CONDITION)

Pursuant to the written request dated (date of reauest) for temporary exemption (s) from the requirements of (NRC reautation or license condition) by (name and oosition of reauestor j representing the licensee), the following temporary exemption (s) is (are) granted for the specified penod of time:

~~

l 1

[Each temporary exemption granted should be listed l separately with documentation of the circumstances I surrounding the request and the duration of time for which the exemption is granted.)

If your understanding of the above temporary exemption differs from that set forth above, you are to notify (Contact) l immediately, at (Tel. Number).

l

. Director

! Division of Nuclear Materials Safety l

l B-1 L

1.

APPENDIX C

! Examples of Exemptions Reauirina Coordination with NM_31

1. All exemption requests pursuant to $$20.2002,20.2301,30.11(a),34.51,35.19, ,

36.17(a),39.91,40.14(a), and 70.14(a), with the exception of those listed in l Sections 3.1 and 3.2 of this guidance, or specifically listed in other policy and guidance directives.

2. Relief from any of the provisions of the revised 10 CFR Part 20, including, but not limited to:

l l a. Requests to increase the dose limit for individual members of the public l

from 100 millirem in a year to 500 millirem in a year, pursuant to

$20.1301(c).

l

b. Relief from the 2 millirem in any hour limit for an unrestricted area in  !

l $20.1301(a)(2).

1

c. Pursuant to $20.1204(c)(2), requests to adjust the Derived Air I Concentration (DAC) or Annual Limit on intake (ALI) values to reflect the  ;

actual physical and chemical characteristics of airborne radioactive l l material.  !

d. Any requests for relief from the provisions for disposal into sanitary l L sewerage ($20.2003), including relief from or special authorization l concerning the solubi'ity criteria in $20.2003(a).

3. Requests for relaxation of, or exemptions from the training and experience  !

l requirements of 10 CFR Part 35 for physicians, teletherapy physicists, nuclear l pharmacists, and radiation safety officers. These requests are coordinated with l

l the NRC's Advisory Committee on the Medical Use of isotopes (ACMUI).

4. Authorization to use " decay-in-storage" as a means of disposal, and other )

decay-in-storage issues (e.g., maximum half life greater than 120 days or

~

number of half lives kept less than 10), other than that authorized in $35.92.

See Policy and Guidance Directive 94-05, Uodated Guidance for Decav-in-Storaos for Soecific Guidance.

5. Requests for relief from 35.400 (d) and (g) for authorization of gold-198 and iodine-125 seeds for intracavitary and topical applications.

C-1

Technical Assistance Request l

Created on: 01/17/96 include in New Regulation? meg l Ticket Num: IMNSS236 I Sent to: Cool Needed by: 03/31/96 Requester: Madera Region: Region til Reviewer. Colleen Casey

Subject:

REQUEST TO APPROVE MEDICAL PHYSICISTS FOR AUTHORIZED USE OF HDR WITHOUT AMENDMENT TO LICENSE Categories: Medical Topic (s): HDR l

images:

R 0117C.TIF Generic Response YES Available?

I License #: 34-01856-01 Licensee Name: St. Vincent Charity Ho spital Licensee Address:

I l

Problemlissue:

1 Licensee wants authonzation for their Radiation Safety Committee to evaluate and approve medical l physicists for their HDR brachytherapy program, without amendment of their license. The licensee agrees l that the RSC will evaluate the physicists in accordance with 10 CFR 35.961 and points out that 10 CFR l 35.13 already gives them the flexibility to evaluate and approve their own physician users. The licensee feels this autonomy is necesswy to ensure a practical continuum of patient care since the physicist or RSO and authorized physician user must be physicatly present for all HDR treatments.

Action Required:

Evaluate the licensee's request and determine whether we can permit their RSC the requested flexibility in naming their own HDR physicists. If approved, please specify what, if any, additionalinformation is required and recommend licensing language if a speciallicense condition is proposed. If the request is not approved, please explain why it won't be allowed to facilitate the licensee's understanding.

Recommended Action:

I l

l, I

,o .

l Approve. The branch would consider granting this request, subject to certain additional limitations and I commtments, as follows:

• The licensee's RSC must commit to evaluating HDR physicists who are certified by one of the specialty I

boards in 10 CFR 35.961 or are named on a current NRC or Agreement State license or are named as authorized physicists under a Type A broad scope licensed program; and

" The proposed physicist meets the recentness of training in 35.972; and

"* The proposed physicist possesses recent, substantial device-speedic training and experience, preferably obtained, in part, from an HDR manufacturer; and

"" Physicists whose training and experience must be evaluated under 35.961(c) will be referred to the regional othce for amendment.

It should also be confirmed and unoerstood by the licensee that the physicist must meet the definition of

" physicist"in 10 CFR 35.2. l l

Each physicist authorized by the RSC should be added to the NRC license at the next amendment and i

the region should be notified in a manner similar to 10 CF 35.14(a).

REMARKS: this licensee has a recent history (April .luly 1995) of applying to Region lil to add an obviously unqualified physicist to their license as an HDR physicist. The proposed physicist in question l did not meet 35.961 in that he possessed only a Bachelor's degree and he did not have the requisite l teletherapy (or brachytherapy) medical physics experience. He did, however, qualify as an assistant RSO l for the HDR program, due to his previous experience as an Assistant RSO and his training and l experience with HDR programs.

When his lack of qualifications as a HDR physicist was brought to licensee management's attention, the  !

l licensee responded by changing their request to name him as Assistant RSO for HDR program, to fulfill the physical presence requirements.

l l

The region mentions this for background information only and does not intend to unduly bias the HQ reviewer either way.

L Relevant Backup Material:

l N/A ,

l inst modified by Notes Guest 1MMSSMQMRC on 15-Aug-97 at 05:40 PM l

l l

l 2

i

l. .

l.-

l I Response to l Technical Assistance Request l

l From: Donald Cool l Date Completed: 12/18/96 l Generic Response? YES DATE OF TAR: 01I17/96 TICKET NUMBER: IMNS5236 NEW REG BIN NUMBER:

Requester: Madera Region: Region Ill

Subject:

REQUEST TO APPROVE MEDICAL PHYSICISTS FOR AUTHORIZED USE OF HDR WITHOUT AMENDMENT TO LICENSE Topics: HDR l

l

Response

I am responding to your technical assistance request dated January 17,1996, (attached) wherein St.

Vincent Charity Hospital in Cleveland, Ohio, requested authorization for the radiation safety committee (RSC) to evaluate and approve medical physicists for the licensee's high dose rate (HDR) brachytherapy l program without seeking a license amendment. The licensee states that medical physicist services at its hospital"is provided by a ... professional group and with tumover and staffing situations that arise, it i would be more conducive to patient care if the hospital has the right to name their HDR physicists."

According to the licensee, "without this authorization, patients may not get the treatment they need due to a named physicist not being available or able to assist in the treatments."

Although 10 CFR Part 35 is silent on medical physicists per se " teletherapy physicists," which are a type of medical physicist, are addressed. NRC staff uses the current requirements in 10 CFR 35.961,

" Training for teletherapy physicist" as a model when identifying necessary training and experience requirements for an HDR medical physicist. Such practice is consistent with Policy and Guidance Directive 86-4, Revision 1:"INFORMATION REQUIRED FOR IJCENSING REMOTE AFTERLOADING j DEVICES." The licensee has agreed to use the criteria in 35.961 when evaluating a medical physicist's t

qualifications to be approved by its RSC for the HDR program. We interpret the licensee's request as seeking approval for it to authorize, without first applying for and receiving a license amendment, a medical physicist treeting the relevant training and experience requirements. If the request involved a teletherapy physicist, an exemption from 10 CFR 35.13(c), requiring a license amendment before a licensee changes radiation safety officers or teletherapy physicists, would also be necessary. However, in this case, a license amendment is needed because the license condition permitting the licensee to name authorized users does not mention medical physicists.

In addition, the medical physicist applicant must possess recent, device specific training and experience j

{*= .

for each model of HDR device to be used by the licensee. It should be noted that Broad Scope licensees have, for some time, been authorized to approve physician authorized users, which requires a review process similar to that used for naming medical physicist (s) for the HDR program.

Since the process, authority and responsibility, for a licensee of broad scope to name a medical physicist for the HDR program, differs Uttle from that of naming their own physician authorized users, the licensee's request to name their own medical physicists for the HDR program should be granted, subject to certain commitments, as follows:

1. Authorization is limited to naming those physicists who meet the requirements of 10 CFR 35.961 (similar experience in HDR brachytherapy specific tasks shall be substituted for those listed in 10 CFR 35.961(c)), or who are named on a current NRC or Agreement State license, or a permit issued by a licensee of broad scope as an HDR medical physicist.

2. The physicist meets the recentness of training requirement in 10 CFR 35.972; and,

3. The physicist possesses recent, device specific training and experience for each make and model of HDR device used by the license as specified in Policy and Guidance Directive FC 86-4, Rev.1.

This TAR response provides guidance which is generically applicable to all medical licensees of broad scope who request the authority to name medical physicists for their HDR program without seeking license amendments. The regional staff may authorize such requests based upon the guidance provided herein, and without further coordination with headquarters, using the following standard license condition:

'The licensee's Radiation Safety Committee may approve medical physicists for their HDR i brachytherapy program. Authorizations are limited to naming those physicists who meet the I requirements of 10 CFR 35.961 (substituting similar experience in HDR brachytherapy specific  :

I tasks for those listed in 10 CFR 35.961(c)), or who are named on a curren. ..'RC or Agreement I' l State license, or a permit issued by a licensee of broad scope as an HDR medical physicist. In l addition, the physicist must meet the recentness of training requirement in 10 CFR 35.972; and, the physicist must possess recent, device specific training and experience for each make and model of HDR device used by the license as specified in Policy and Guidance Directive FC 86-4, l Rev.1. A record of such authorization must be maintained for subsequent inspection". i I

Auschment: Tar dtd 1/17/96 l Attachment (s):

N/A lost trodified by Pat Vacca/NMSS/HQ/NRC on 24-Fet>98 at 01:01 PM i

Mr. Joseph G. Klinger 5. Please clarify the intent of Condition 174, is it to be used f every licensee possessing a sealed source or device, and, if so, why?

Response: This condition has been deleted. The regions h ve been informed that this

, condition should not be used as there is a confi ct with 10 CFR 32.210.

l l 6. The Department has a condition limiting licensees to rec ipt, possession or transfer of l not greater than 999 kilograms of depleted uranium for hielding purposes. We believe l this condition is an old NRC condition which is no long necessary and, therefore, l does not appear in your latest draft. Please confirm th 't this is the case and not merely an oversight.

Response: You are correct. Thi? condition has become obsolete and has been deleted.

7. At one time, the NRC had several conditions g decommissioning regardp/

of licensed facilities. There are also conditions listed in P&G 94-02 for Remediation Contractors.

Please indicate what has happened to these as th do not appear in this draft.

Response: This omission was an oversight. These conditions will be included in the final document. Thank you for bringing this mission to our attention, if you have any questions regarding these response , please contact Patricia M. Vacherlon at (301) 415-6376, E-mail PMV@ NRC. GOV.

Sincer ly, l

Rich rd L. Bangart, Director Offi e of State Programs

Enclosures:

As stated l

l Distribution:

DIR RF (8S165) DCD (SP07)

SDroggitis PDR (YES,f_) (NO _)

DOCUMENT NAME: G:\KPH\lLL1M.KP g

• SEE PREVIOUS CONCURRENCE.

TS recolve e copy of this document, Indicate in the box: *C = o apnout. ttachment/ enclosure *&* a CDpy with 8ttachment/ enclosure "N" = No copy

~

OFFICE OSP l O$P 4ID' ] NMSS l NMSS ,

[_ _ OSP:D NAME KHsueh:nb PHLofiauf I / PMVacherlon CXHaney JV RLBangart DATE 07/07/98

• 07/lh/98/ 07/ /98 07 % /98 07/ /98 I OSP FILE CODE: SP-AG-8 1

i Mr. Joseph G. Klinger 5. Please clarify the intent of Condition 174. Is it to be ed for every licensee possessing a sealed source or device, and, if so, why?

Response: This condition has been deleted. The re ons have been informed that this condition should not be used as there is d conflict with 10 CFR 32.210.

6. The Department has a condition limiting licensees o receipt, possession or transfer of not greater than 999 kilograms of depleted uraniutn for shielding purposes. We believe this condition is an old NRC condition which is na/ longer necessary and, therefore, does not appear in your latest draft. Please con Irm that this is the case and not merely an oversight.

Response: You are correct. This condition has become obsolete and has been deleted.

7. At one time, the NRC had several conditions garding decommissioning rp/ of licensed facilities. There are also conditions listed in ppg 94 02 for Remediation Contractors.

Please indicate what has happened to these s they do not appear in this draft.

Response: This omission was an oversight. These conditions will be included in the final document. Thank you for bringing this omission to our attention.

If you have any questions regarding these resp,onses, please contact Patricia M. Vacherlon at (301) 415-6376, E-mail PMV@ NRC.OOV.

Sincerely, Richard L. Bangart, Director Office of State Programs

Enclosures:

As stated Distribution:

DIR RF (8S165) DCD (SP07)

SDroggitis PDR (YESf_) (NO_)

DOCUMENT NAME: G:\KPH\lLL1M.KP / ghout attachment / enclosure

• SEE PREVIOUS CONCURRENCE.

n r.e.i . cop , of this document. indicai. in th bar: C= og v *E" = Copy with attachment / enclosure N' = No copy

]

OFFICE OSP l O(IPQQ' 3__j NMSS l NMSS

• OSP:D NAME KHsueh:nb PHLofiauf ' PMVacherlon M CXHaney RLBangart gE 07/07/98

• 07/ O/98 07/ /$/98' t 07/ /98 07/ /98 l OSP FILE CODE: SP-AG-8 l 1

L n

l Mr. Joseph G. Klinger l

/

5. Please clarify the intent of Condition 174. Is it to be used for every licenses possessing a sealed source or device, and, if so, why?

Response: This condition has been deleted. The regions have been i ormed that this condition should not be used as there is a conflict with 10 FR 32.210.

6. The Department has a condition limiting licensees to receipt, po ession or transfer of l

not greater than 999 kilograms of depleted uranium for shieldin purposes. We believe this condition is an old NRC condition which is no longer nece sary and, therefore, does not appear in your latest draft. Please confirm that thi s the case and not merely an oversight.

Response: You are correct. This condition has become solete and has been deleted.

7. At one time, the NRC has several conditions regardipg decommissioning of licensed facilities. There are also conditions listed in P&G 94-02 for Remediation Contractors.

Please indicate what has happened to these as t ey do not appear in this draft.

Response: This omission was an oversight. T se conditions will be included in the final document. Thank you for bringin this error to NRC's attention.

if you have any questions ragarding these re onses, please contact Patricia M. Vacherlon l at (301) 415-6376. For any further informat' n, please contact Kevin Hsuch at (301) 415-2598.

l Sincerely, Richard L. Bangart, Director Office of State Programs

Enclosures:

As stated Distribution:

DIR RF (8S165) DCD (SP07)

SDroggitis PDR (YESf_) (NO_)

DOCUMENT NAME: G;l PH\lLL1M.KPPH Ta receive a cop r of this documerd, indicate in the box: *C* = Copy without affachment/ enclosure "E* = Copy with attachment / enclosure *N" = No copy OFFICE OSP. mph l OSP:DD l NMSS l NMSS OSP:D l NAME KHsueh:nb PHLohaus PMVacherlon CXHaney RLBangart DATE 07/ 7 /98 07/ /98 07/ /98 07/ /98 07/ /98 OSP FILE CODE: SP-AG-8

LuoL) GesttwuJ w ROUTING ANDTRANSMITTALSLIP DATE: July 9,1998 PARALLEL CONCURRENCE REOUESTED

1. P. VACHERLON - CONCURRENCE

2. C. HANEY - CONCURRENCE LETTER TO: JOSEPH G. KLINGER, CHIEF DIVISION OF RADIOACTIVE MATERIALS ILLINOIS DEPARTMENT OF NUCLEAR SAFETY FROM: RICHARD L. BANGART, DIRECTOR OFFICE OF STATE PROGRAMS

SUBJECT:

DRAFT UPDATE CF STANDARD LICENSE CONDITIONS YOUR COMMENTS / CONCURRENCE ARE REOUESTED BY C.O.B.. TUESDAY. JULY 14.1998 OSP CONTACT: KEVIN HSUEH,415-2598 PLEASE CALL KATHALEEN KERR (415-3340) FOR PICK UP.

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TASK DESCRIPTION - DRAFT UPDATE OF STANDARD LICENSE CONVICTIONS (SP-98-031 REQUESTING OFF. - IL

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REQUESTER

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- J. KLINGER WITS

- 0 FYP

- N PROG. .KPH PERSON

- STAFF LEAD - KPH

-~~ . --

PROG. AREA -

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PROJECT STATUS -

--- . -~~~~ --

OSP DUE DATE: 6/12/98 PLANNED ACC. -N LEVEL CODE - 1 l

L _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .

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{s gpg DEPARTME v,

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>n AR SAFETY 10 l PARK;D RIVE SPRI',

I h M O 5/'62704 Jim Edgar T M785-9 [ Thomas W. Ortciger Governor 217 . , D) Director May 26,1998 Mr. Richard L. Bangart, Director 3 Office of State Programs 5 I U.S. Nuclear Regulatory Commission

• 5$2  !

Washington, DC 20555-0001 E l 9 I

Subject:

Draft Update of Standard License Conditions (SP-98-031) g  ;

Dear Mr. Bangart:

i' Thank you for the copy of your draft standard conditions. We revised our conditions in November of 1996 and will be revisiting this process shortly. We will consider your draft while updating our standard conditions. Our review noted several i

significant changes to your conditions. Our comments are as follows: l

/ 1. Please provide a copy of P&G l-26 that you have referenced throughout this draft regarding issuance of exemptions by the regions.

2. Several conditions for supervision refer to qualifications required under the regulation rather than specifying an individual name. We have done this as well on several types of licenses. This may cause difficulties in reciprocal recognition oflicenses or authorized users.

t/ 3. We find Condition 20 very helpful and plan to implement a similar condition for high dose rate afterloader (HDR) medical physicists. Would you please send us a copy of the Technical Assistance Request and the response to this .,

request for Region III that is referenced here?

i

,,u. Lim M $-%

j fGk M 4? WA -

V Office of State Programs Page 2 l

4. Condition 40 C. should include language to the effect "...shall not be put into use until tested and results received." This same comment is true for Conditions 40 E(v). and 41 B.

l 5. In Condition 41 C., you have limited storage-only licensees to a three year leak test. This requirement does not seem to give any relief to the licensee with devices on three year leak testing intervals. As a rule, we do not require leak testing until the device is put back into use or transported.

6 In Conditions 42 and 43, you may wish to include the phrase "the licensee must conduct its program in accordance with ... the most recent documents listed below..." to cover subsequent procedural revisions. Also in Condition 43, the Department is still not in favor of granting ministerial changes to medical l_ programs as this term offers too broad an interpretation.

l 7. In Condition 48, as we understand it, only the tritide foils are a ventilation concern and the Ni-63 foils are not subject to any airborne release.

j 8. Conditions 71,72 and 73 are very good conditions for gauge i

installation / relocation / maintenance, and we plan to revise ours accordingly.

l 9. Conditions 77 and 80 are very good conditions that identify components related i to radiation safety that should not be replaced except by the manufacturer. This i

has become an issue in Illinois since we have several new service licenses involved in this type of maintenance.

l

V10. In Conditions 84-92, please describe the history that led to the development of

! these conditions for non-human use of teletherapy units. We have been using modified medical requirements to provide for radiation safety aspects of this use j while relieving the users of most of the human use/ quality control requirements.

l I

l t

I

- - - _ - - - - - - - - - _ - - - - - - - . - - . - - - 1

d Office of State Programs Page 3 l

11. In Condition 133, are the dose rates noted in Item I consistent with those found v in the device registries for HDR's or does this have to be modified for each type?

12. In Condition 141, you have listed a decay-in-storage condition authorizing decay-in-storage of radionuclides with a half-life less than or equal to 120 days.

The Department currently limits Illinois licensees to decay-in-storage for radionuclides with half-lives of 90 days or less. We have looked at increasing the half-life for decay. However, we believe this may allow licensees to store waste on-site for too long a period and could lead to the loss of control cf their waste programs.

13. In Condition 159, you may also wish to incorporate the policy for issuance of product registries found in P&G 84-22, rev.1. The Department has used this as a standard condition for manufacturers / distributors for several years and found it very useful. l

/ 14. Please clarify the intent of Condition 174. Is it to be used for every licensee possessing a sealed source or device, and, if so, why?

/I5. The Department has a condition limiting licensees to receipt, possession or transfer of not greater than 999 kilograms of depleted uranium for shielding 4 purposes. We believe this condition is an old NRC condition which is no longer necessary and, therefore, does not appear in your latest draft. Please I confirm that this is the case and not merely an oversight. '

/ 16. At one time, the NRC had several conditions regarding decommissioning of licensed facilities. There are also conditions listed in P&G 94-02 for Remediation Contractors. Please indicate what has happened to these as they do not appear in this draft.

1

4 Office of State Programs Page 4 We appreciate the opportunity to comment on these conditions. This process should help the NRC and the States maintain similar language in their respective licensing documents and eliminate any unknowns in recognition oflicensees' authorizations / limitations, particularly when operating under reciprocity.

If you have any questions regarding these comments, please contact me or Gibb Vinson at (217) 785-9947.

Sincerely, 6.

opph . Klinger, Chie

' vision of Radioactive Materials JGK:CGV:kjg cc: Jim Lynch, States Agreements Officer i

i 1

m_.______._ _ _ _ _ _ _ _ _ _ . _ _ _ . . _ _ __ . _ _ _ _ _ _ _ _ _ _

l DATED: APRIL 17,1998 SIGNED BY: RICHARD L. BANGART FOR PAUL H. LOHAUS ALL AGREEMENT STATES OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-98-031) i Your attention is invited to the enclosed correspondence which contains:

)

l lNCIDENT AND EVENT INFORMATION.... .. ..

PROGRAM MANAGEMENT INFORMATION.. .

TRA'.NING COURSE INFORMATION.. . . . ... .

TECHNICAL INFORMATION..... .. . .. . .. . . ...XX DRAFT-UPDATE OF STANDARD LICENSE CONDITIONS OTHER INFORMATION... .. ... ..... . ...

Supplementary information: Enclosed for your review and comment is draft copy of updated standard license conditions. The update was prepared based on NRC staff review of 10 CFR, Generic Technical Assistance Requests (TARS), Policy and Guidance Directives, NUREG 1556 volumes, and the current standard license conditions. Please provide any comments on the draft directly to Patricia K. Holahan, Dh /sion of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety an d Safeguards by May 15,1998. Ms. Holahan can be reached at ,

(301) 415-8125 or by Fax at (301) 415-5369. For any further information, the CSP contact is listed below; i CONTACT: KEVIN HSUEH TELEPHONE:(301) 415-2598 FAX: (301)415-3502 INTERNET: KPH@NRC. GOV l

l Paul H. Lohaus, Deputy Director j Office of State Programs l

Enclosure:

' As stated w WO3[t1(Ce A9_72C =;59Ak1

1 .

i DRAFT FOR COMMENT Rules: 1. New Conditions added are in italics.

2. Changes in 1993 conditions are in strikeover-bbb and added words in italics.

3. Part of conditions needing OMB clearance are redlined.

4. License conditions granting exemptions per P&GD 1-26 that regions can use without NMSS consultation are added in the subject area and are in italics.

5. Each area should have at least two reserved condition numbers; therefore license conditions will have the new and old number 1 assigned to help in review against the June 1993 edition of the standard license condition.

Rev!:ed June 1993 CT 1997 DEC 1997 l

1 STANDARD LICENSE CONDITIONS l PLACE OF USE  :

1

1. Licensed material sha# may be used only at the licensee's facilities located at

2. Licensed material may be used or stored at the licensee's facilities located at and at temporary job sites of the licensee anywhere in the Uniteo States.

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

3. Licensed material may be used and stored 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.

l

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 shan- may be used only at temporary job sites of the licensee l anywhere in the United States where the U.S. Nuclear Regulatory Commission maintains jurisdiction for regulating the use of licensed material.

i l 6. The !!Oentee may not p0 : :: nd ute mater!:!: Outhorized != !!em: S, 7, 2nd 8, unt"' 1) the !! ent',e 500 cenet uc+ed the fac!!itie :nd obtained the equipmert deceribed !q the app!! cation and euppeding documentation; and 2) the U.S.

Nu !:Or 90;u!:t0n/ C0m"'!:0!On, Reg!On , ^M Ch! f, , 500 b n "Ot!f:ed ! r!"ng th:t Octiv: tie: uthorized by the !!Oence r;"! be i 't!:ted.

l 4

l i l (RESERVED)

[ NOTE: The above condition is removed by the withdrawal of P&GD )

92-04 on 7/10/97] )

l 07. (RESERVED) I In accordance with the requirements set forth in 10 CFR 30.36(b d), 40.42(d) and 70.38(d), the licensee shallpromptly notify the U.S. Nuclear Regulatory Commission, in writing, of a decision not to complete the facility, acquire l equipment, orpossess and use authorized material.

[ NOTE: New condition in accordance with P&GD 92-04 will be kept and i used on all new IIcenses where the new appilcant does not have other 1

current licenses. Used on example IIcense in NUREG 1556, Volume 1.,

May 1997.]

i

8. (RESERVED)

9. RESERVED)

SUPERVISION - GENERAL 10, 8: Licensed material shall be used by, or under the supervision of,__.

11.

9: Licensed raaterial shall be used by, or under the supervision and in the physical i presence of, l l

l 12.

40 Licensed material shall be used only by 13.

44. Licensed material shall be used by, or under the supervision of, individuals who satisfy the requirements of 10 CFR 33.15. l 14.

42: (RESERVED) 4 15.

43 (RESERVED)

SUPERVISION - LIMITED MEDICAL 16.

44. Licensed material listed in item 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 Use l

l SUPERVISION - BROAD MEDICAL 17.

44 The use of licensed material in or on humans shall be by a physician, dentist, or podiatrist as defined in 10 CFR 35.2.

D 1 i

l I

l 1

18.

46. ohy:! !an , dertiste, or podiatr!:t: design:ted to =0 !! ented meteria! M or en I humen: the!! meet the trair5g crMeri ett:b!! hed !" 10 Pa + CFR 25 Subpe t J :nd ch:!! b- de:!gnated by the !!:ent:::': Radiction S fety Com-tee.

The !! entee': cha!! m:intain record: Of %dividual de:!gnated 2: u:er: for 3 l year: c'ter the individu !' !::t use Of !! enced m:teri !.

l Individuals designated in writing to work as authorized users or authorized l l nuclear pharmacists, as defined in 10 CFR 35.2, shall meet the training and '

\

experience criteria establishedin 10 CFR Part 35, Subpart J and shall be l designated by the licensee b Radiation Safety Committee.

[ Reviewer Note

Conditions 4417 and 4418 are used together.

l Modification from RI] )

i i t

19. J l 47, Licensed material for other than human use shall be used by or under the l

supervision of individuals designated by the Radiation Safety Committee.

20.

I

44. (RESERVED) l The licensee's Radiation Safety Committee may approve medicalphysicists l l for their HDR brachytherapy program. Authorizations are limited to naming those physicist as who meet the requirements of 10 CFR 35.961 (substituting i similar experience in HDR brachytherapy specific tasks for those listed in 10 i CFR 961(c), or who are named on a current NRC or Agreement State license, or a permit issued by a licensee of broad scope as an HDR medicalphysicist .

In addition, the physicist must possess recentness of training requirement in 10 CFR AS,972; and, the physicist must possess recent, device specific training and experience for each make and model of HDR device used by the license :: spec!!!cd!" c!!cy and Guidance Direc!!ve FC 961, Rev 1. A-record c!cuch authon':3!!cn me ! be m !n!:!ned !cr subsequen' %:pecties l Note: the above condition from Generic TAR response issued 12/18/96 to Rill.

21.

48: (RESERVED)

SUPERVISION - PACEMAKER 22.

20: The physicians responsible for implantation, follow-up, explanation, and return of nuclear-powered pacemakers to the manufacturer for proper disposal are SUPERVISION - NUCLEAR PHARMACY 23.

g a . u...m . mm.e.

. . . . im.a.:.

.. .... . a.a

. .,, m..,m. .m.a. i.m. m. .m. .a. i.t.,. .__ w.

v..

,n..,,

.. ., n. . um.. mw.,m.i., .,,

~. ~..m.. m.

the auther!:ed p! ace of =e vehenever !!:enced materia! !: being used.

Rev!:v; : Note: Une Cond!!!cn 21 edth Condit!0n 8 cr 22]

[ Radiopharmacy rule made above condition obsolete]

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

r 1

i

(1) a pharmacist working or designated as an authorized nuclearpharmacist in accordance with 32. 72(b)(2) and 32. 72(b)(4) of 10 CFR Part 32, or (2) authorized nuclear pharmacists, (name) (name). or (name).

[New condition above from example license Draft Reg Guide DG 0006, March 1997]

1 SUPERVISION - BROAD - i

24. . .

)

33, Licensed material shall only be used by, or under the supervision of, individuals designated by the Radiation Safety Committeec . Chairperson. The licensee shall maintain records of individuals designated as users for 3 years after the individual's last use of licensed material.

[ Reviewer k Note: Authorized user for Type A Broad License]

25. 4 33r (RESERVEO) ..

Licensed material shall be 'used by or under the supervision of individuals designated in writing by the Radiation Safety Officer. The licensee shall maintain records of individuals designated as users for 3 years after the -  ;

individual's last use of licensed material.

[ Reviewer k Note: Authorized user for Type B Broad License.)

26.

L . 24, (RESERVED) l Licensed material shall be used by or under the supervision of individuals meeting the requirements stated in 10 CFR 33.15(b)(1) and (2). The licensee shall maintain records of individuals designated as users for 3 years after the E individual's last use of licensed material.

)

! [ Reviewer's Note: Authorized user for Type C Broad License.]

27. (RESERVED)

SUPERVISION - PORTABLE GAUGES

28. -

26. Licensed material shall only be used by, or under the supervision and in the l physical presence of, individuals who have received the training described in

, application dated and have been approved in writing by the Radiation l Safety Officer. The licensee shall maintain records of individuals designated J

. as users for 5 years following the last use of licensed material by the l- individual

[ NOTE: This condition appears in NUREG 1556, Rev 1.]

29.

36. Licensed material shall only be used by, or under the supervision and in the physk.sl 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 i I i

p L - - - _ - - - - - - - _ - _ - - - _

l t who have been designated by the Radiation Safety Officer. The licensee shall l maintain records of individuals designated as users and their training for 5 years following the last use of licensed material by the individual.

30.

l 37. (RESERVED) l SUPERVISION - RADIOGRAPHY 31.

28, ?^ 'ndP/! den!: !!:ted b^!cw are the On!y p^r ^n: authcrized by th!: !!:ence te ::t !

rMegrapher: cr radiographer:' : !: tant: :: d&ed !a 10 CF9 34.2: i Radegr:pher: 9:diographer': A :!: tant:

Licensed material shall be used by, or under the supervision and in the f

1 physicalpresence of, individuals who have been designated in writing by the Radiation Safety Officer and have been trained:

A. As specified in application / letter dated (and the letter dated ):

and B. In accordance with tho provisions of 10 CFR 34.43.

[ NOTE: New license condition as stated in NUREG 1556, Vol 2.]

32.

20. (RESERVED) l SUPERVISION -WELL-LOGGING

33. ,

30: The individuals listed below are the only persons authorized by this license to act I as logging supervisors or logging assistants as defir.ed in 10 CFR 39.2:

Loaaina Supervisors Loaaina Assistants 34.

34. (RESERVED) l SUPERVISION -IRRADIATOR I 35

32. (RESERVED) 36 l 33 (RESERVED)

MDIATION SAFETY OFFICER 37.

34, The Radiation Safety Officer for this license is i

(

38.

, 35 (RESERVED)

A. The Radiation Safety Officer (RSO) for this license is insert name of RSO.

B. Before assuming the duties and responsibilities as RSO for this license, insert name of RSO shall have successfully completed one of the training courses described in Criteria in Section 8.8 of NUREG- 1556, Volume 1, dated May 1997.

[ Reviewer Note: Use this condition on portable gauge IIcenses perNUREG 1556, Vol.1.]

OR B. Before assuming the duties and responsibilities as RSO for this license, insert name of RSO shall have successfully completed one of the training courses described in Criteria in Section 8.8 of NUREG- 1556, Volume 4, dated insert correct date .

. [ Reviewer ?! ate: Use this condition on fix,sd gauge licenses per NUREG 155o, Vol. 4.]

39. (RESERVED)

LEAK TESTS 40.

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 or by an Agreement State.

B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals nct 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 1 until tested. )

i D .Each sealed source fabricated by the licensee shall be inspected and 2 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 (iii) the half-life of the isotope is 30 days or less; or I (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or L__________-.-_______________________ _ _ _ _ . - - . -

x

^

(v) they are not designed to emit alpha particles, are 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 3 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 (c)(2) and the source shall be removed immediately 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, Pc;!cr AFN: Ch!:f, Regional Office referenced in Appendix D of 10 CFR Part 20. The report shall specif/ the source involved, the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries

and shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspection.

G. The licensee is authorized to collect leak test samples for analysis by Alternatively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services. (This part of the

, . condition is used for licensees NOT authorized to perform leak

. test analysis.)

OR 1 G. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission L

or an Agreement State to Perform such services. (This pa:t of the condition is used for licensees authorized to collect and analyze leak test samples)

L l

l , ,

~

l.

41.

' E (MSEWEO) ~

A. Sealed sources shall be tested forleakage and/or contamination at intervals not to exceed the intervals specified in the certificate of registration issued by NRC under 10 CFR 32.210 or by an Agreement

-State.

B. In the absence of a certificate from a transferorindicating that a leak test has been made within the intervals specifiedin the certificate of registration issued by NRC under 10 CFR 32.210 or by an Agreement State prior to the transfer, a sealed source received from another .

person shall not be put into use until tested.

C. Sealed sources need not be tested if they are in storage and are not being used. However, when they are removed from storage for use or transferred to anotherperson, and have not been tested within the required leak test interval, they si'all be tested before use or transfer.

No sealed soame shall be stored for a period of more than 40 3 years without being tested forleakage and/or contamination.

[ModNFed to be equivalent to program code for storage only inspection kequency] -

D. 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 (c)(2) and the source shall be removed immediately from service and decontaminated, repaired, or disposed ofin 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, Regional Office referenced in Appendix D of 10 CFR Part 20 "^"~~ ^ ~ ^'

The report shall specify the source involved, the test results, and corrective action taken.

E. Tests forleakage and/or contamination snall be performad by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perform such services. In addition, the licensee is authorized to collect leak test samples But not perform the analysis; analysis ofleak test samples must be performed by persons specifically licensed by the Commission or an Agreement State to perform such services (This part of the condition is used for licensees NOT authorized to per16rm leak test analysis.)

-OR l .E. Tests forleakage and/or contamination shall be performed by the .

licensee or by other parsons specifically licensed by the Commission

or an Agreement State to perform such services. In addition, the licensee is authorized to colloct leak test samples for analysis by l

l I

l persons specifically licensed by the Commission or an Agreement

\ State to perform such services. (This part of the condition is used l for licensees au:horized to collect AND analyze leak test samples) i F. Records ofleak test results shall be kept in units of microcuries and shall ba maintained forinspection by the Commission. Records may be l disposed of following Commission inspection.

[ Reviewer Note: New condition from NUREG 1556, Vols.1,4, and 5 use the above condition for portable and fixed gauges, and self-shielded irradiator licenses]

" TIE DOWN"

42. )

l 34L Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and pocedures contained in the documents, including any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govem unless the statements, representations and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A.

B. (Documents sheuld be listed chronologically)

C.

[ Reviewer Note: Use for all licenses except medical] j 43.

39. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance wid the statements, representations, and i procedures contained in the documents, including any enclosures, listed below, except for minor changes in the medical use radiation safety l procedures as provided in 10 CFR 35.31. 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. i B. (Documents should be listed chronologically) 4

[ Reviewer Note: this condition should only be used for medical licensees.]

44.

40 (RESERVED) i 45.

44, (RESERVED)

GAS CHROMATOGRAPHY

46. (RESERVED)

l 4A '- !!eu of u:!ng the 00rven"One! red!:t!cn 0:et!On 00!0re (megente er purp!O on-y0!!O ; - 5:0kground) : prev!ded !" 10 C- 20.203(a)(1), the !!Oente i:

breby auther!:ed te !:be! detecter 00!!:, 00nt !rin; !!conced m:teri:! and u:Od M ge: Chromatography device:, re" - Ote-ed or tamped redi.dien-saution SymbO!:.

[R:r!::::: Note: 10 CF9 20.1M1(b) Obv!:!c: the n::d for this 00nd!!!0n. 00 not 000 th!: On any !!Oen:e: :P.er m!9t]

47,

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 erform such services.

48.

44. A. Detector cells containing a titanium tritide foil or a scandium tritide foil shall only be used in conjunction with a propei1y operating temperature control mechanism which prevents the foil temperature from exceeding that specified by the manufacturer and approved by NRC in the certificate of registration refened to in 10 CFR 32.210 or equivalent registration from an Agreement State. I B. When in use, detector cells containing a titanium tritide foil or a scandium tritide foil shall be vented to the outside.

i 1

[ Reviewer Note: Condition 4844.B should not be used with portable field devices.]

49 46, (RESERVED) 50.

46 .(RESERVED) 51.

47.(RESERVED)

FEMA 52.

48. A. Each sealed source containing licensed material to be used outside of a shielded exposure device shall have a durab!e, legible, and visible tag perma sently 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 (a) and a minimum of the following instructions:

DANGER - RADIOACTIVE MATERIAL - DO NOT HANDLE - NOTIFY Civil AUTHORITIES IF FOUND.

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

53.

49. (RESERVED) 54.

60. (RESERVED) 1 1

1

PORTABLE GAUGES 55.

64r Each portable nuclear gauge shall have a lock or outer locked container  !

designed to prevent unauthorized or accidental removal of the sealed source l 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.  ;

56 62 The licensee may remove detach the source or source rod from (manufacturer)  !

• ?cde! qumbr: gauges for the purpose of cleaning, maintenance, or repair of the gauge (s) in accordance with procedures outliried in (application / letter)( dated / received) (fill in date). [This condition is used/f !

the licensee is authorized to perform non-routine maintenance] i 57.

63. 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 l such services. [This condition is usedif he IIcensee is not authorized to perform non-routine maintenance]

58.

64, (RESERVED) l Sealed sources or source rods containing licensed material shall not be l opened or sources removed or detached from source rods or gauges by the  !

licensee, except as specifically authorized.

59. l 66: (RESERVED)

A. If the licensee uses unshielded sealed sources extended more than 3 feet j below the surface, the licensee shall use surface casting that extends from the lowest depth to 12 inches above the surface and other appropriate procedures to reduce the probability of the source or probe becoming lodged below the surface. If it is not feasible to extend I the casing 12 inches above the surface, the licensee shall implement procedures to ensure that the cased hole is free of obstruction before making measurements B. If a sealed source or a probe containing a sealed source becomes lodges below the surface and it becomes apparent that efforts to recover the sealed source or probe may not be successful, the licensee shall notify the U.S. Nuclear Regulatory Commission and submit the report required by 10 CFR 30.50(b) (2) and (c)

[ Note to the Reviewer: Conditions 58 and 59 are usedin NUREG 1556, Vol. IJ

60. (RESERVED)

RADIOGRAPHY 61.

66: A- Nett?het:nding the periodic leak tect required by 10 CFR 3125(b), the i

4 '

,_ . :_ __. a_.

. , _ . . . . . . . . . . _ - _ . .a. . __ ,.,...___.._

_, i . , . . a :_, ,. _ _u._, .. . .. . . .._.

. .. ... .u. . .. . .

a. _ a. .

.-. _u: . .- .. ,..a - _ .. vu.. . . ._. . ._ au. _ ,. _. .w:. _,:a:_ ..a . u. n. u.

..a a ,_ i -u_ a :s_ .a. _. . _,_ a o m._,.

. _ . . _ _ ... , _ . _ .. ..............-.__..,_...i,.m_ur_. . _ - . _ . .

. ..,_.. u. .n.. u...a a ,_ i a,

_ _ _ . _ _ . . . . . _ . . _ , _ . . . m.

....au:

. ._.._....w. . . - . ...- . . _....

._.,......a..u....,.,.___

A. " ^ " = _

• _ _ ^ ' . . .. ., .., ' . " . . . " . . ' . . . ' . ' . ' ' .. .* ,. _ * . - - ' . . ' " " * . ^ . ' . " . . ' ' . . " . ' . " , " . "

. (e)" re ;se ent d- net epp'y te rM ;;rephy eeuree thet ere ,

.._a.. .m.a

.... .- . .a. . u:~. .,. . ..a vu. .. ..

. _ a ,__ .u.:.,. ..a

. u._n..

son:No sealed source or device containing licensed material shall be stored for a period of more than 40 3 years without being tested for leakage and /or contamination.

Please note the above is on the example license in NUREG 1556, Vol. 2,  !

however both 34.27(c)(3) and (e) state stored sources and DU in storage need l

- not be leak tested. Therefore only part of this cnition is struck. j B. The licensee is authorized to analyze leak test samples in accordance with (application / letter) dated f@ in the date.

C. Sealed sources authorized for a use other than radiography shall be l tested forleakage in accordance with 10 CFR 3426 27. i

[ Reviewer Note: B. C should be used only if the license provides for I use of sources other than radiography sources, e.g., a source contained in an instrument calibrator.)

r 62.

Sf7- r u..ir_

. . . _ _ _.. . __ . -i. _. ..

...-.___ u .._

,:,.a .,. .:....

..ar------s_ ..... a .... .a a' - --- - - - - -

a. . _.. ,1,ia:.._

4. n._o ,,, ~ w a. e.n.

,-A:

..u... .. ...u.. .- _.a: . .. a:. . ,. .a..m

_,,...a. .u. .. _. . .,i_ . ._- _- ,

. .. ...... .... . ._.'a. m.,. . ,

ua,o . .:,: a. :.= .h..t i:a ..

,-,au. la.A .

. . . _ . . . . .. .__ . ]

1 4 c.

. .. ... . w,-~_ _ ... _.... ...... . :_ a_. ~. . . . . ..a. ..u. .. . -. -.. ..a.. , _, . . .,~ . _:,:a. _ in.

On. 0,L...<.a,1aa.. A

. _ . _ . . . < n._i a, .. .< n.01. <.a. ,ma k,.l. M...,

a i ..me. .. .O $ k.,, p._n,.. . O... ..

i l

S- .000 6 ef the !!ce- :: :h-t; th:t ne mer then the mei um :meent of l l

,a: . -a:. .a.., _, . . .,_ _ _ :,:a - - - - -

r--

1,. .w:. i:, _. . ...-.

~ ' - ' - - - - - - - -

.a_a ,__ .u -

o

._. _ _ . . . . I F-'

..,_-_~.._-,..a.n..-_-.. , .a u., , , _ _ _ _ . . _a..: a. ,. _a - ' - - - " - ' ' - ' -

,a. .a l __,7 . . . . - . . . . , - ....- - , -

\

!- C.,'"_'-."..-'.'..":":~..'..'.a'.".-"_:',._,'...'.~.._.d..-.':__.-".."._.,_

.kn. . . _,.:,:.a_ := < n. r.c. o, .o A. . n <

)

. . . .... a_ .. ... .._ a.. . .a. .n . .. . _ _ ._ ._-

L (RESERVED) [ NOTE: Source loading is stated on certificate of registration and also see NUREG 1556, Vol. 2, Exampic License Condition 13].  ;

63.  !

68, (RESERVED) 64

60. (RESERVED)

WELL-LOGGING

65. (RESERVED) sa see ~_ . _- ". . . '. d- . ~. . i~.'. :. . . , *. . a ~.. ". ._ : : ~. ., _"_ : _ _ ". .. . . . . . ". . :.'. "...". "_ ~. .-

!e;!b!: nd v!!!b!: mar 4ng :: epee!f::d != 10 CFD 39.31(2). The !:b-! meet be en the :m:!!::t compenent that cente!n: the !! enced meteri:!"thich it trentp~+ed 2: : ::per:t: piece Of equ!pment Regulation 39.31(a) is specific as to labeling. This condition is redudant- covered in regulation.

66.

61. A.. Notwithstanding the periodic leak test required by 10 CFR 39.35, the requirement does not apply to sources, except sources containing more tnan 10 microcuries of plutonium, that are stored and not being used. The sources exempted 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 40-3 years without being tested for leakage and/or contamination. 1

[ Note the above is not covered in P&GD 1-26, and must be coordinated with HQ l prior to use.

B. The licensee is authorized to analyze leak test samples in accordance with (application / letter) dated M in the date.

C.

B. Sealed sources authorized for a use other than well logging shall be tested for leakage and shall be inventoried in accordance with 10 CFR 39.35 and 39.37.

l I

1 I

I

o 67.

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.

68 63.(RESERVED) 69.

64. (RESERVED)

FIXED GAUGES I

70.

65, Each gauge shall be tested for the proper operation of the on-off mechanism (shutter) and indicator, if any, at intervals not to exceed nO !Onger thOn 6 months i-te /O!O or at such longer intervals as specified in the certificate of l registration issued by the NRC under 10 CFR 32.210 or by an Agreement i State.""'."........"'.-^_'.".-..~.~..'--~.~..'^.d'.,"".

_r7 . ,

[ Note: the above is modifiedper draft NUREG 1556, Vol. 4) 71.

66 ' ~. .'.

. _". . _-'.t ~. . '. ,. :. ".

. .  :.. _". _ :.. :. ~. .'.. .. ' ". . ,'-. .,

. d,, .~. .'.' .*.:~,, .'. , ",, .'. . .'.. ' ferve,

.,..a...__a..,_r,.,,,,a._~.,~...a..s,:~..,. ___. . .. .. - . ....wa,n. . w.

. .,~

_s. m.. a wm .w n. .~. ~., _ ~. . is .w. n..,,_,. ~ i,. m..w a. ,.a. .,, _s. m,, _

, , . . . . . . .y n. .e . . . . . . . . . . , , . . . . ,... .. . . , . . . . . . . . , , , . , .

.~ . . , ,~..~..,._.,.:~..,.e.

n. a. ...:. . . .;a.

. _ _ ..ae

w. n., _ ~ ..e , .

_ .. ...awi,, . . . . . -.. .. ,_ . i . . . ..:~..,.i.m.,.

wm

,y ,

pereene epecia ce"j!! cent-d by the Cc--!r!cn er en A. gree ent etete to

_ sms., m.w e m:-me i s. e. n ..:~. r_i ~ _ m.. .a ne ~,,. a ,,, e. i-a I r"''---"""'"'"-' - - - - - - ' " ' " * '"r--"'"**""'"--r"""'"' - - - " ' -

I e

_ n _ .rAme.

_ . - .... . ,.b. 5%.s. . A..rs. ..M.

w an.. A..r.l s k.s s,.re A.n. ..e .,

. . . . . , , , . . . e ~ .A.IE. . n A.. f-. , I.!,..s. ,.e -M. , s. * $%..

. - . . . , k..

,..sg.s. a.re.n. .e .inw. . .. .,ieme .

, ('. .A. _.sw.Ic e In s, a.,. .a n. A.n, ..e-. ....n. .. n... c...... ..a. ..  !

r o. . .,u . . .- u. ,.,,. ~. . ,.n e. r.,. ~. .,. a. a.:~. . ,. a.n...... .u. .~. ,. ~,, . . n . . u.. . . . ~. . .~ s,, ,s. ,.. m .., s. .

c . . . . . . .

....:n. ,. s.. m..._.n. e m. . :, e. , #, a.. m_ a ~. ,. ~. . ~. . : ~. . ,

m.,

. . .w ~. . , n. . ,._ e _. . . .w. . ... ~ . . l a ei,.

___. ...... .. a. ., ,,... nc... a. : a..:m.:a,.. ,.m. _

y.,..

s.,.,,_ .w. ~.,,. m :m.a.:~. i, Installation, initial radiation surveys, relocation, removal from service, dismantling, a gnment, replacement, disposal of the sealed source and non-routine maintenance or repair of components related to the radiological safety of the gauge (i.e., the sealed source, the source holder, source drive

! mechanism, on-off mechanism (shutter), shutter control, shielding) shall be

l. performed only by persons specifically licensed by the Commission or an Agreement State to perform such services.

[ Reviewer Note: This condition is used when the licensee is NOT muthorized to perform any non-routine operations. The above condition is modified per draft NUREG 1556, Vol. 4) 72.

67.,'~.._'_'"..~'.~..:".:.."..".:..*.:~..'.-".',>,#..~_-'.:~..'.,~..,~..~.".."..'~,..'.-~.'.':~',',',d_.':._~.-

. . . . .A. s,. .%.s.Is. .m,e .

...M, mlA entrAme- .,-.eu.. ll b sg sdMs,..M$%.s r""' '"""'J Mr w.s es.re Ar.d's

"' I P"'""'""

s,.elfle il. , ne.ne.a k.s w. ("ha sw.m ic e la n nr e.s.

A a r= = =n r.. Q . .'... .a s%.s4a rm

.r " "" ' "" I """"""I 'U'""""'**"'"r""

0.Ch 00 /C^#. O n On NCO On IOhO r O O'/ COO On nC O..' On, a .. _~,. ~,a a: _ e a , < ,. s-a e m . _~. . w,,n wm _sm .ma ~,im

'*r---"" =" "r-"--'"'----~~"'-"""'","''''-"'",

o-1 i

e-byp r= = - !5:2!!y !!:ened by the Cem-!rien er = Agre:m=t St:te te p-de- cuch :er:! : .

rg o.

. .. .. - .u m.. .. . . i i.. c. m. m.a,

1. . . e. .r..,w.., . . . . . . . . . . w. . . u. ._.. . .. . . . .:n......m<m._ l r"" i

" ":d -'!v t!= but n~' meintrance er rep:!r.]

A. The licensee orpersons specifically licensed by the Commission or an Agreement State to perform such services may perform (modify as l necessary to identify overations that the licensee may oerform) i installation. initial radiation surveys. relocation. removal from service i dismantling, alianment, replacement. disoosal of the sealed sourde l i

and non-routine maintenance or reoair of comoonents related to the i radioloaicalsafety of the cauae.

1 i

[ Reviewer Note: Part A of this condition is used to specify which non-routine operations may be performed by a licensee, if the licensee may perform all listed operations Part B of this condition is not used.] .

l l

(Modify as necessary to identify operations that the licensee may B.

L NOT perform) Installation. initial radiation surveys. relocation.

l removal from service. dismantling. alianment. replacemen1 l disposal of the sealed sources and non-routine maintenance or repair of components related to the radiological safety of the aauae shall be performed only by persons specifically licensed by the Commission or an Agreement State to perform such services.

[ Reviewer Note: Part B of the condition !s used to specify which non-routine operations a licensee is NOT authorized to perform. If  !

the licensee may perform all listed operations, use only Part A cf  !

the condition. The above condition is modified per draft NUREG 1556, Vol. 4]

73.

68, ' ete!!:tien, i t!:! r:d!:t!= eure:y:, re!ce: Con, remev:! ' rem er!! e, er =y l

!mi!:r 2-*!v!!y re:t5 dev!:= :=te!r:ng !!:ened meteri:! ch:!! 50 p-dermed l l On!y by p r:=: : pee!50 !!y !!:==d by the Com-!=!= Or = ^.;reemet.

St te te p-der euch zers!cee. 'he !!:== m:y :t!:!!y t me=t the dev!:e 1

! 0-!y w ,....".. :. .w^.rd=ce vi;t" vi ;"er net u-'! n: previded by the mrefecturer;

........,.... s....-.

. .: _ ,,,m.m.. w

. . . . , . .......a....a.._.....Mw,,,m...,,

, _:< -n

!! ==d by the CO --!r!cn er = Agr= met St te t: !=t:!! g=ge. he u_. .. ,_ ,..y

.. , _.........'a'r-'s"'

. .:  :, m, ..mi ,.. s - . . : . --- ---. .,. . --. a r,--. i . ,

'"r-'-"""""""F""""'"'""""'I

.se m _ A ! n.mM t . .w

___ _ . _ . _ _ .. .k.. M...

. . . . e.m.m. *.,.... m . aI.m.M. .e .m. s.e,A_. , . . .

1.m

..ln.mM e wImlMI. ..a ,

m.,.w.

d=!='t = cf m=h=!:m; =d th:t r'" not r^-d t t cre=ed r:d!:t!= !cre!:

2": ::ce--!b!: cre= 2'^ut the d=? e.

w .,.w r o. ... .: . . . . u. m.. .. .. . i.i,. ...c. m.m. .a.a.rm. .,..n..o

.. . . . . . . . . . . .... n.

......e... w ,.

.. .... ..m.a.

auth^te!!^^ =!y !O m=n! ;=gej The licensee may initially mount a gauge if permitted by the certifiMe of registration issued by NRC or an Agreement State and under the following conditions; w _ - _ - __ _ ____-____- ___- _ __-____ _ :____ - _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ - _ _ _ _ - . _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ - _ _ _ _ _ - _ _ _ _ - _ _ - _

A. the gauge must be mounted in accordance with written instructions provided by the manufacturer; B. the gauge must be mounted in a location compatible with the " Conditions of Normal Use" and " Limitations and/or Other Considerations of Use" in the certificate of registration issued by NRC or an Agreement State; C. the on-off mechanism (shutter) must be locked in the off position, if

. - applicable, or the source must be otherwise fully shielded;

D. the gauge must be received'in good condition (package was not l

damaged); and E. the gauge must not require any modification to fit in the proposed l location.

l L ..

L Mounting does not include electrical connection, activation or operation of the gauge. The source must remain fully shielded and the gauge may not be used until it is installed and made operational by a person specifically licensed by the Commission or an Agreement State to perform such operations.

[The above condition is modified per draft NUREG 1556, Vol. 4]

74.

64 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 is performed to determine radiation

,. levels in accessible areas around, above and below the gauge with the shutter l open. This survey shall be pe_rformed only by persons authorized to perform such services by the Commission or an Agreement State. A record of the results of this survey shall be maintained for the duration of the license.

t 75.

l 74 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.

76.

274. 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 radiation beam. The licensee shall review and modify as appropriate its " lock-out" procedures whenever a new gauge is obtained to incorporate the device rnanufacturer's recommendations.

77.

7A @ESEWED)

The licensee rwy maintain, repair, or replace device components not mlated to the radiological safety of the gauge (i.e., the sealed source, the source holder, source drive mechanism, on-off mechanism (shutter), shutter control, shielding); and that do not result in the potential for any portion of the body to come into contact with the primary beam or in increased radiation levels .in accessible areas.

[The above condition is aded per draft NUREG 1556, Vol. 4]

I

~..

j i l

L l-78.

74. (RESERVED) l 79.

74. (RESERVED) )

i IRRADIATORS

80. l 4 T'-!!rerrr che!! net p-'er repr! . Or "rret!O= Of the ! retter ive!v5g

!. remere! Of :h!:!S; er re- er te the !!00med meter!0!. emere! rep!rrement, j end fereee! c' eee!ed eeure-- i- the i-red!cter ehe!! be p- 'e- ed by e

{

p r:en ep 09er"y !!^^- rd by the Cem-59n er en ^.;r:: ment State to '

u... ,. ._... ....w.. .. .- ~.:. .. _ _ .

lP.ci';;;r '"t: ' ' 0 t'.!: 00d50r '^r :: 'Othd ! r !OT:.]

i The licensee shall not repair, remove, replace, or alter any of the following:

l electrical, and mechanical systems that control source and shielding

[ movement, the irradiation's shielding or safety interlocks, or any component that may allect safe operation of the irradiator. These activities may be -

7 performed by a person specifically licensed by the Commission or an i Agreement State to perform such services. (This condition is used for '

licensees NOT authorized to perform non routine maintenance.)

OR l Except for the repair or maintenance operations described in (letter / application) dated (fillin the date). the licensee shallnot repair,

- remove, replace, or alter any of the following: electrical, and mechanical systems that control source and shielding movement, the irradiation's  !

[' shielding or safety interlocks, or any component that may alfect safe operation i l Of the irradiator. These activities may be performed by a person specifically licensed by the Commission or an Agreement State to perform such services.

(This condidon is used forlicensees authorized to perform nor> routine l maintenance.)

L [ Note: New condition per NUREG 1556, Vol. 5]

l 81. 1 l 76. - For each J. L. Shepherd and Associates, Mark I or Model 81-22 cesium-l 37 Irradiator installed and used, the licensee shall: 1 i

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

(1) Operate at all times when the irradiator is in use; and (ii) Activate a visible and audible alarm when radiation exceeds 2 o _ __ _ _ _ _ __ __ _ _ _ _ - - _ _ _ _ --- ___ _____ - - - - - _ - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

1 t .

l 1

millirems per hour; and ,

iii) Detect any radiation leaking from the irradiator door; and (iv) Be visible to the irradiator user when he is next to the irradiator; or D. If a room monitor is not installed, have available a calibrated and operable survey meter which will be used to:

(1) Determine the radiation level at the irradiation door when the door is closed; and (ii) Check for any increase in radiation levels each time the irradiator door is opened.

E. If abnormal radiation levels or any malfunctions of the irradiator are detected at any time, stop using the irradiator and notify the Radiation i Safety Officer, and if required by 10 CFR Parts 20,21. or 30 report by I telephone, to NRC, Regional office referencedin Appendix D of 10 l CFR Part 20; and 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.

l L 82.

4 The procedures contained in the manufacturer b instruction manual for the-Model device the irrad'ator authorized by this license 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.

83 (RESERVED) l 4 The Heen::: !: authorized te ute the fe!!:rd ng te:!:d curce: i- the i r:d!:ter-  !

Y :nuf -'urer UN 84.

L 4 (RESERVEO)

Notwithstanding the requirements of 10 CFR 36.23(a), the licensee may use separate keys to operate the lock on the personnel entrance door or berrier and to move the sources in accordance with procedures described in the '

letter /applicaticr. Jated (NOTE: Condition applies only to converted teletherapy units Region may use without consultation with NMSS in accordance with instructions in P&GD 1-26, July 1997) 85.

80. (RESERVED)

Notwithstanding the requirements of 10 CFR 36.23(b), the licensee is exempt l

l-4 from having an independent backup access control to detect personnel entry while sources are exposed based on the commitments described in the letler/ application dated (NOTE: Region may use for converted teletherapy units without consultation with NMSS in accordance with Instructions in P&GD 1-26, July 1997) 86.

84 (RESER'!EO)

Notwithstanding the requirements of 10 CFR 36.23(c), the licensee is exempt from having the monitorintegrated with personnel access doorlocks to l prevent room access when radiation levels are high based on the commitments described in the letter / application dated (NOTE: Region may use for converted teletherapy units without consultation with NMSS in accordance with Instructions in P&GD 1-26, 1 July 1997) 87.

8 27 (RESERVED)

Notwithstanding the requirements of 10 CFR 36.23(d), the licensee is exempt l from having a visible and audible alarm within the treatment area, based on the commitments described in the letter / application dated (NOTE

Region may use for converted teletherapy units without _

consultation with NMSS in accordance with Instructions in P&GD 1-26, July 1997) l

88. Notwithstanding the requirements of 10 CFR 36.23(f), the licensee is exempt from having a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time based on the commitments describedin the letter / application dated (NOTE: Region may use for converted teletherapy units without consultation with NMSS in accordance with Instructions in P&GD 1-26, July 1997)

89. Notwithstanding the requirements of 10 CFR 36.27(a) and (b), the licensee is exempt from (as reouested by licensee) based on the commitments described in the letter / application dated

l. (NOTE: Region may use for converted teletherapy units without

'~

consultation with NMSS in accordance with Instructions in P&GD 126, July 1997)

90. Notwithstanding the requirements of 10 CFR 36.31 (a), the licensee is exempt from the requirement to have console key attached to a portable su:vey meter by a chain or cable and that the door to the radiation room require the same key, based on the commitments described in the letter / application dated j The radiation room door key shall be attached to the i portable survey meter.  !

(NOTE: Region may use for converted teletherapy units without consultation with NntSS in accordance with instructions in P&GD 1-26, July 1997)

E--------_-_-_-----_-------_------------------------ _ -- - - - - - - - - - - - - - - - - - - - _ - - - - - _ - - - - - -

4-f l./

91 Notwithstanding the requirements of 10 CFR 36.31(b), the licensee is exempt

[ from the requirement to have a separate position indicator to indicate when

[ the source is in transit, in accordance with leller/ application dated (NOTE: Region may use fra converted teletherapy units without consultation with NntSS in accordance with instructions in P&GD 1-26, July 1997) _

l

92. Notwithstanding the requirements of 10 CFR 36.67(b)(2), the licensee is exempt l from the requirement to have a controlin the radiation room which must be activated prior to irradiation which would not allow the source to be moved from the shielded position unless the door to the mdiation room is locked i within a preset time, based on the commitments descn' bed in the l

letter / application dated .

1 (NOTE: Region may use for converted teletherapy units without i consultation with NMSS in accordance with Instructions in P&GO 1-26, l July 1997)

NUCLEAR PHARMACIES i

I

? 93 (RESERVED) sA A =_"__:_,^....___*.:_a_d:_,_..__d.~."...'~..d:_+:'._>_"__<.~..'........___-"...".

IMHe4 herr m o__u a,m____a,a:_u_ _...:_a..u. _.u TT7 -- - - " ' ' - * - - * ' ' "

- r.. - --A:_ - e a ' ' . ' ' e' P'

. r -- --. 'a- .- ur '-'.'

ni -__. -. .n' ,. . - i _- n-a:_. 'r u n i s m..

__,_ _. -' " -' rr --- - - - -

'rr-- \' '-' '/ C'

, . &.i,* en.i u. ' ~__ _-

a. _. '. ua:_' =,a. . e u.:_- a..--

i _.. ..._ .:-

_ .a . :_ _. ...a... .e. _.,__

. . , . :_ . _,~..

. . _ u -. . . n_ ,. .,. n.s.

. . . . .. u. n,s _ , . .,.

(4) o.,__,_ a ,._ _...-

. . ._. .a.m.,...

._ _.u._ _. _ _ .a

. _ . . c a.. .u. __ .u. .. -. _._ A:_.

. . . . . . . . , _ _ . a. .

.. . e _n.i._,,....__. . _ . a u. n.i. ~.. ,.~.. ..&. .w_ . en_.i . u...

.. . . ._ _~_ _ ,_a.a

_ _ __ .. i u. . n . .

g. o _~_._a_

. ._, . . _ _,,u: , ._ .,.u..,_. . . _-~_ _ . _: a. ,

_ ... .. ...&. .:_u. e. n.i u._. _ ~_

_ . . _ ,_..aa

. _ _ . .._ i u. n _a _ .

,,a:

.__.~r'-'-------s - ~ . :,r'a. r-_ -_a ,__ -__a , . . u a. - ,,

'-e--= - -

• p.

&.i,&. e n.i u. ... , _- -.r---- -- ' ' - ' ' ' . -' '-' - - - - -'a _iun unu a:.__..amus,a:a.":w. a.

--r-----

m i ~_.~_ _.a_- _- - ...a.u .u. .. a.r,'_, ~_ . .." _. ,taa u., .u. .. .' .' ~.. . _-- a .u-- -----'

. tty .- .- .- .. . . . . _ _ . .

.7....___.7 .

r-----""-

.. IND,-and

. .. :_ .. &. ..,. u. . .. % a u , .u _ _ . _ a .u n_ .a..y.. .

.7..y_._._..... . . . _ _ . _ . -r-

- -- 'v - -' " ' ' -

...a. .a:~. a *u 'a,, ,_r i un ., ~. : :-a. a: : a r-'---r----""-------'-----'"' --'Y'

[ Radiopharmacy rule made condition obsolete - MEMO 5/30/97)

. 94. (RESERVED) 8 47 7. ". ". __..__ _ . "._."_.a __+_ .

. .- ... . *... . _..d_ r ._ __ __ ._"_:._ _ ~_. .. .- m o n. d .."." ._ ~ ,_. *.

c a. _~_ _.a - , w :. .a.,. .a :~. . .. ._:. u. ..a. .y

. . . . . _ _ . _ _ . . . . .. . . . . . . . . . . . . . . . . w.. .u.. _. . .._. . . .,_.. . , ~.. . u. .. i ui

j. .a A..,

..  :- .k.. .m. in-Sim.. . _ a., .ka n.e.k. ..

. ... .. .. ..a.

.k. ._e , amm_

_. m....__.k.m. -a.s.a.

.e a.,

,_.,_. u a.

[ Radiopharmacy rule made condition obsolete - MEMO 5/30/97]

95. (RESERVED) a wwr

o. ,_.i.a.

y .

u..__._..._____..g......__

,a:...:x...a ._ _.~...n_ ~.. s.. r='----- .. .. a.-4n reo,m enn

.. am ,mm..... las a.,. . . _ _ . _,_.._....U..v...m. a,i..,..-. . C.,..... . . . . . . _ _ _ _ _ _ .

[ Radiopharmacy rule made condition obsolete- MEMO 5/30/9 7]

l l

l 96.

86, Radioactive waste may be picked up from the licensee's's customers and disposed of in accordance with the procedures, statements, and representations in 97

, 87-r (RESERVED) 98.

i 8 87 (RESERVED) 99.

8 97 (RESERVED) t 100.

99- (RESERVED) l l TELETHERAPY 101.

94 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.

[ NOTE: Region may use without consultation with NMSS in accordance with instructions in P&GD 1-26, July 1997] l 102. (RESERVED) l 92, Nctith: tending the requirement: cf 10 CFR 35.M1 pedcr- the dutie l Of 'he tc!ctherapy phy:!c!:t for there fu!! ce!!bration and epct check:

meceurementr ep c!5ed !a 10 CFR 35.632 and 10 CFR 35.63'

! (NOTE: Region may NOT use without coordination with NMSS in accordance with instructions in P&GD 1-26, July 1997) j 103. ,

I l 93, The teletherapy physicist for this license is l 104.

94r The !!cence i: exempt ' rem decc--icticMg fnencia! 20 urance requirement:

! for pc:cettien Of !!cenced materia! M ten!cd scurce: !" quantit!e: greater  ;

than the !-!!:in 10 CFR 30.35(d) fer the perpece of cource change: Only.

T5!: exemptice it granted for no more than 30 day fer any one-seurse-change. 6 l [ NOTE: Region may NOT currently use this condition without l coordination with NMSS in accordance with Instructions in P&GD 1-26, I l July 1997.)

l 105. a G&r (RESERVED) l 106.

9 67 (RESERVED)  !

- CARDIAC PACEMAKERS l

107.

97. (RESERVED)

M :cerdance 'd*510 CFR 15, the !! entec ch !! not rece!'/c cr transfer !n t 4 l I I

I

.__m._____.__ _ _ _ _ _ _ _ _ _ _ _ _ _ .-_____._ - - - _ _ _ _ - . - _ _ _ _ _ _ _ - - _ _ - - _ ._ - - - - - _ - . - - - - - -

ny cin;!e tr:nesc+!On One (1) gram er mere of p!ctonium 23S Ocntained !=

nut!e r per: red p20^m ker: 9thout "Otifying the D:vi:!On of cue! Cy0!e S:fety :nd S:feguard: and T ran ped tion, U. S. Nue!e:r Regu!:ter/

Com .! :!=, W: h:ngton, DC 20555. M 2dd!!!On, the !! ence che!! Omp!cte e,a ar ..;w .. uon e_ ra 4 ,,. . ~ ,;,ma n., 4 n r eo in ca (NOTE 5e[etedIn av 1994AltI IssSa?ce of P&Gb 8329 REV 2) 108.

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.

109.

99, The licensee shall report by telephone to the U.S. Nuclear Regulatory Commission, Regional office referenced in Appendix D of 10 CFR Part 20

^"N Chief, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads in accordance with 10 CFR 30.50 (b)(2). A written report giving details of the adverse reaction and/or malfunction shall be submitted within 30 days in accordance with 10 CFR 30.50(c)(2).

110.

400. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region _. ATTN Chief, . within 10 days of loss of contact with a nuclear pacemaker patient.

111.

404, 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.

112.

403. (RESERVED) 113 403 (RESERVED)

MEDICAL - GENERAL 114 (RESERVED) 404, Nc+d'h:t:nding the re;sement: Of 10 CFR 35 20(2), the !! entee i not req &ed to deve!up :nd !mp!ement = ^L*R^. program [Revi ::r Note: U:

C=dit!cr 10' fer.!! n:= =!y cutheri:!n; 35.500.] Now covered by 20.1101

, 115. (RESERVED) j 40s. Netw+het:nding the re;*em=t: Of 10 CFR 35.22 the !! ence: !: not re;ees tc =teeh = R=ea.i= S0fe.y C-m=.

[Revic=cr Note: U e COnd!!! r 105 fer :netitut!=:!!! enter; which j en!y zutherize 35.500 devicer]

1 i

l

? l l

1 I

(MUST consult with NMSS; not approved by PGD 1-26) 116.

4067 Needles or standard medical applicator cells containing licensed material as wire shall not be opened by the licensee.

117 (RESERVED) 407, NetMh tending the p' Wden: Of 10 CFR 35.49," Sup;!!: :," the u _- :. ~ ..wm, . a .- ,_:. .- <.~ - -~. .a . ,,_ ..aw pr^^^tre: cetFned i-l (Radiopharmacy rule made condition unnecessary.)

118.

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

(Reviewer Note: Use Condition 408118 for limited medical use programs that have non-broad human research programs.)

119.

4097 (RESERVEO)

Notwithstanding the requirements of 10 CFR 35.400(d) and (g), the licensee

may use iridium- 192 as seeds encased in nylon ribbon and palladium- 103 as seeds for topical, interstitial, and intracavitary treatment of cancer. The licensee may deviate from the manufacturer k radiation safety and handling instructions only to the extent that the instructions are not applicable to the type of use proposed by the licensee.

(Note: The above condition doec NOT require coordination with NMSS per P&GD 1-26) 120.

440- (RESERVEO)

Notwithstanding the requirements of 10 CFR 35. .the licensee may use the altemative method for (recordkeeping orposting)__as described in l theletter/ application dated _ '

(Note: The above condition does NOT require coordination with NMSS per P&GD 1-26 l 121. Notwithstanding the requirements of 10 CFR 35.315(a)(4), the licensee may use the allemative method for determining the dose rates in contiguous restricted and unrestricted areas described in the letter / application dated l

(Note: The above condition does NOT require coordination with NMSS per P&GD 1-26 122. Notwithstanding the requirements of 10 CFR 35.415(a)(4), the licensee may use the alternative method for determining the dose rates in contiguous restricted ar,d unrestricted areas described in the letter / application dated (Note: The above condition does NOT require coordination with NMSS per P&GD 1-26 123 Notwithstanding the requirements of 10 CFR 35.404(a), the licensee may release e_______.________. _ _ _ _ _ _ _ _ _ _ . _ _

,3 from confinement for medical care a patient with a temporary eye plaque implant in place, in accordance with procedures described in letter / application l dated .

(Note: The above condition does NOT require coordination with NMSS per P&GD 1-26 i

MEDICAL-BROAD '

124.

111. The licensee shall conduct a physical inventory every 3 months to j account for all sources and/or devices received and possessed pursuant to 10  !

CFR 35.59,10 CFR 35.400 and 10 CFR 35.500 and every 6 months for all other sources and/or devices.

Records of inventories shall be maintained for 5 years from the date of each inventory, and shall include the information required in 10 CFR 35.59(g).

125.

44 & Nettih tending the r-';uirement: Of 10 CF9 35.19( ) nd (b),10 CF9

.o. c. <. n.n., <. n. e..co. o <

.. c.o.n.n. , . n. e.co. o..c.o.n.n. , . n. e.co. o.c.a.

. . n.n. .-. .a. <. n. e.co. o.c.

. .. an.n.

the !! ence: m:y c:e fer 2ny med! ! u e Ony by preded mater!:! Or re ;ert Yt The !! enter th:!! ^^:=c: nd u= by product meted ! for med!: ! u= i-2:=rd:n= w:'" the prendptiv: Ond p-derm:nce crited: != the Other

, ed!cnc ef 10 CF9 35. Th!: dee: not re!!=: the !!:en=e frem ^mp!ying I

w th rp-!!::b!c Urited St:t= Feed and Drug AdmM!:tr:t!= (FDA) :nd Other Feder:! and St:te r-';u!remente.

I Notwithstanding the requirements of 10 CFR 35.49(a) the licensee may use l any byproduct material for 10 CFR 35.400 and 35.500 uses. 1

[ NOTE: Condition modified by Memo dated May 30,1997, Guidance on the RADIOPHARMACY RULE, you may use for Broad Medical Licensees, l however, in accordance with PGD 1-26 regions MUST consult with NMSS for approval to use.)

126. (RESERVED) 44 & The !!= nee the!! pan:= :nd u e bypreded m:tede! fer hum:n ree:rch ute != :=0rdence W:'" the pre :dpt!ue 2nd pederm=0 edted: !=

!! :ed!On: Of 10 CF9 o d 35 ==pt section: 35.49(2) end (b), 35.1^^,

o.c._ . o n.n. , .e. .a. o.c. . a.n.n. .

[ Radiopharmacy rule made condition obsolete - MEMO 5130/9 7]

127.

444, (RESERVED) l- 128 l' 446. (RESERVED) i 129. I 446r (RESERVED) l 130 l lI

! 447. (RESERVED)

MEDICAL-BRACHYTHERAPY REMOTE AFTERLOADERS 131 448, in lieu of 10 CFR 35.404(a), immediately after retracting the source from the patient into its shielded position in the remote afterloading device, a j i

l i

I t

E.- R l

F 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 shall be maintained in lieu of the record required in 10 CFR 35.404(b).

132 44 4 in lieu of the source inventory required in 10 CFR 35.406, the licensee shcII:

A. Promptly determine that all sources have returned to the safe, shielded

, position at the conclusion of each remote afterloading brachytherapy L

. procedure.

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

C. Make a record of the survey including the survey instrument used, dose rate expressed in mrem /hr (uSieverts/hr), time, date and name of the '

l. individual making the survey.

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

i 133.

43Ch ' .,

- Prior to initiation of a treatment program, and subsequent to each source exchange,d;; t'.- for each high dose rate remote afterloading brachytherapy unit d:r!rer nd tret the!! b p-t=:d h ceretn= rit' th f0!!c;;'..;:

A. A radiation survey shall be made of:

I j 1. The irradiator source housing, with the source in the shielded position.

.The maximum radiation levels at 100 centimeters from the surface of the main source safe shall not exceed 0.25 mil!iroentgen per hour, j

2. All areas adjacent to the treatment room with the source in the

' " irradiation" position. The survey shall clearly establish: 1 (a) That radia' ion levels in restricted areas are not likely to cause l

personal exposure in excess of the limits specified in 10 CFR l 20.1201.

4 1

(b) That radiation levels in unrestricted areas do not exceed the limits i specified in 10 CFR 20.1301. 1

, A.~ The source housing, with the source in the shielded position. The maximum rsdiation levels at 100 centimeters from the surface of the main source safe shall not exceed 0.25 milliroentgen per hour. l I' B. All areas adjacent to the treatment room with the source in the exposed  ;

\

position. The survey shall cleady establish:

(1) Thet radiation doses to occupationally exposed individuals do not exceed the limits specified in 10 CFR 20.1201(a), 20.1207, and 20.1208. ,

l (2) That radiation doses to individualmembers of the public do not exceed the limits specified in 10 CFR 20.1301(a).

C. Records of the survey results shall be maintained forinspection by the Commission for 3 years.

134.

424- 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:

1 A. Installation and replacement of the sealed sources containedin each high i dose rate remote afterloading brachytherapy device (s) unit.

B. Any maintenance or repair operations on 'the any high dose rate remote afterloading brachytherapy unit (s)-l and associated equipment listed in item 9, Subitem (s) involving work on the source safe, the source drive unit, or other mechanism that could expose the source, reduce the  !

shielding around the source, or compromise the safety of the unit and result in increased radiation levels.

135.

422 (RESERVEO)

The Medical Physicist for this license is 136.

423 { RESERVED)

\!:d!::! hy !c!:!: th !! mcc!"'c train ng cd!cd ce!:b!!:hcd ::nder 10 CF 35.961 nd i

che!! be det!;ncted != vid t'ng by the !!cencee's Red!: tion S fety Cc-""te.

l 137 424, (RESERVEO)

The Medical Physicist (s) for this license (isfare) or

! individuals designated in writing by the licensee b Radiation Safety Committee and who meet at least one of the following criteria:

t A. the training and experience criteria established in 10 CFR 35.961(a) or (b); or

{ B. identified as a Medical Physicist on a Commission or Agreement State license that authorizes the use of a high dose rate remote aftedoading brachy 1herapy device; or C. designated as a Medical Physicist by a Commission or Agreement State i

l

b i

i .

license of broad scope that authorizes the use of a high dose rate remote aftedoading brachytherapy device; or l

D. identified as Teletherapy Physicist on a Commission or Agreement State license and has completed the manufacturer b training on the use of a l i

high dose rate remote afterloading brachytherapy device; or i

1 E. designated as a Teletherapy Physicist by a Commission or Agreement '

State license of bmad scope and has completed the manufacturers ,

l training on the use of a high dose rate remote afterloading 1 l- brachytherapy device; and, having received training, for the specific make(s) and/or model(s) of remote afterloading device (s) used by the licensee.

[ Reviewer k Note: This condition is for use with Ilmited Part 35 licensees who have requested to authorize their own HDR physicists (medical physicists) in \

accordance with the criteria set forth in 10 CFR 35.961 and commit to training l the physicists for the specific make(s) and/or model(s) of remote afterloading l devices (s) theypossess.)

i t

MEDICAL-BRACHYTHERAPY REMOTE AFTERLOADERS (High, Medium, and i Pulsed Dose Rate) i 138.

A.eene _____ . .. e ..m.

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A. Access to the treatment room housing each high doce rate remote afterloading brachytherapy unit shall be contro!!ed by a door at each entrance.

B. Each entrance to the treatment 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 each entrance door to the treatment room shall be tested for proper operation at least once each day of use. Records of test results shall be maintained for inspection by the Commission for a period of three years.

D. In the event of malfunction of the door interlock, the unit shall be locked in the "off' 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.

139.

42 & (RESERVED) 140 437, (RESERVED)

WASTE DISPOSAL 141.

42 & (RESERVED)

The licensee is authorized to hold radioactive material with a physical halflife ofless than or equal to 120 days for decay-in-storage before disposalin ordinary trash, provided:

A. Waste to be disposed ofin this manner shall tn held for decay a minimum of ten half-lives.

B. Before disposal as ordinary trash, the wasta shall be surveyed at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed ' shielding to determine that its radioactivity cannot be distinguished from background. All radiation labels shn!! be removed or '

obliterated.

C. A record of each such disposalpermitted under this License Condition shall be retained for three years. The record must include tho date of disposal, the date on which the byproduct material was placedin t

storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the

r disposal.

I 142 a .,

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[ Note this condition same as regulation in 10 CFR 35.92)

( .143.  !

430r (RESERVED) 144 444. Radioactive waste possessed under this license shall be stored in accordance with the statements, representations, and procedures included  ;

with the licensoe's waste storage plan described in the licensee's letter dated

{

j i

[ Reviewer Note: Use this condition when a waste storage plan has been i submitted.]

445 132. (RESERVED) 446 _j 133. (RESERVED)

INCINERATION 147.

4341 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 l

gaseous effluent from incineration does not exceed the limits specified for air in Appendix B, Table 11,10 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 authorization if the licensee requests ash disposal as ordinary waste and provides information required by the Commission.

l.

l 1

I~ Otherwise, all ash residue from incineration is to be treated as radioactive waste.)

l 148.

436: (RESERVED)

TRANSPORTATION

! 149.

436, The licensee is authorized to transport licensed material only in accordance with the provisions of 10 CFR Part 71," Packaging and Transportation of Radioactive Material." j 150. '

437, (RESERVED) 151.

4387 (RESERVED) l l

DISTRIBUTION 152.

439- (RESERVED)

'153 440. The licensee may distribute material from [ Reviewer note: For use on distribution only licenses]

154 444 Pursuant to 10 CFR 32. _ ,the licensee is authorized to distribute the(smoke detectors or self-luminous products) 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.

l 155. i 442. The following (smoke detectors or self-luminous products) may be l distributed provided the amount of (isotooe) contained in the device does not '

exceed the amounts specified in the following table:

Device Model Maximum Quantity per Device  !

156.

443. The licensee shall submit periodic material transfer reports as specified in 10 CFR 32.

157.

444, Each device distributed under this license shall be manufactured, tested,  !

and labeled in accordance with the statements, representations, and l procedures contained in (application (s)/ letter (s)) dated

[ Reviewer's Note: Conditions 154 -157 are for exempt distribution licenses only.]

I

158 L 445, This license does not authorize commercial distribution of licensed I

material to persons generally licensed pursuant to 10 CFR Part 31 or to persons exempt from licensing pursuant to 10 CFR 3048 30.14 through 30.20, inclusive, or equivalent regulations of any Agreement State.

159.

44 & (RESERVED) i Each device distributed pursuant to the conditions of this license shcll be in accordance with the following table:

Max imu m

Acti vity Device ModelNumber Isotone Source ModelNumber Per Source 160.

447, (RESERVED)

MISCELLANEOUS 161 44 & Licensed material shall not be used in or on human beings.

162 449. This license does not authorize comme cial distribution of licensed material.

163 450. This license does not authorize possession or use of licensed material.

164 461 This license does not authorize distribution to persons licensed pursuant to 10 CFR 35.100,10 CFR 35.200,10 CFR 35 300,10 CFR 35 A00,10 CFR

• 5.500, or 10 CFR 35.500 32.72 or 32.74; to persons exempt from licensing; or to generallicensees.

(NOTE: Condition modified by Memo dated May 30,1997, on Guidance on the RADIOPHARMACY RULE. Use for Manufacturers and Distributors) 165.

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

166.

463- The licensee shall not use licensed matenal in field applications where

activity is released except as provided otherwise by specific condition of this license.

167.

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

168.

466. The licensee shall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license. Records of inventories shall be maintained for 5 years from the date of each inventory, and shall include the quantities and kinds of byproduct material,' manufacturer's name and model numbers, location of the sources and/or devices,~ and the date of the inventory.

169 44 & Experimental animals, or the products from experimental animals, that have been administered licensed materials shall not be used for human consumption.

L 170 l- 467 Pursuant to 10 CFR 20.1301(c)] and in reliance on statements, procedures and j representations made by the licensee in the aoolication/ letter dated the

! following maximum radiation levels are hereby authorized in the following unrestricted areas:

Maximum Radiation Level Unrestricted Area (Note: The above condition requires coordination (TAR) with NMSS P&GD 1-26) l 171.

L 448. The licensee shall not acquire licensed material in a sealed source or

! ' device that contains a sealed source unless the source or device has been l registered with the Nuclear Regulatory Commission under 10 CFR 32.210 or.

! with an Agreement State.

! (Reviewer Note: This condition may be used when the reviewer doesnt specify manufacturers or model numbers (e.g., gas CHROMATOGRAPHY, bone mineral analyzers).]

172. (RESERVED)-

'46 4

173, l

4407 (RESERVED)

L 174.

l 444. (RESERVED)

Except for maintaining labeling as required by 10 CFR Part 20 or 71, the licensee shall obtain authorization from NRC before making any changes in the sealed source, device, or sourc& device combination that would alter the description or specifications as indicated in the respective Registration

Certificates issued either by the Commission pursuant to 10 CFR 32.210 or by an Agreement State.

(NOTE: New condition from NUREG 1556, Volume 1, use with any license that authorizes sealed sources and devices) l EMERGENCY PLANS / DECOMMISSIONING

, (Also see teletherapy condition no.104) 175.

462 ln 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.

176 463. In addition to the possession limits in item 6. the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR [30.35(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.]

177.

464, 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 178.

465, 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 B ofIQ CFR Part 30, or 100 mci] as specified in 10 CFR [30.35(d) or 40.36(b) or 70.25(d).

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

179.

46&(RESERVED) 180.

467, If only one radionuclides is possessed, the posse ,sion limit is the quantity specified for that radionuclides in 10 CFR 33.100, Schedule A, Column 11. If two or more radionuclides are possessed, the possession limit is determined as

L.

follows: for each radionuclides, determine the ratio of the quantity possessed to the applicable quantity specified in 10 CFR 33.100, Schedule A, Column 11, for that radionuclides. The sum of the ratios for all radionuclides possessed under i the license shall not exceed unity.

[ Reviewer Note: To limit the possession limit for a Type C Broad License to eliminate the need for financial assurance for decommissioning also use standard condition no.176]

181.

468, if only one radionuclides is possessed, the possession limit is the quantity specified for that radionuclides in 10 CFR 33.100, Schedule A, Column I. If two or more radionuclides are possessed, the possession limit is determined as follows: for each radionuclides, determine the ratio of the quantity possessed to the applicable quantity specified in 10 CFR 33.100, Schedule A, Column I, for i that radionuclides. 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 j eliminate the need for a decommissioning funding plan also use standard {

condition no.178.) l 182.

469, (RESERVED)

A. If only one radionucide is possessed, the possession limit is the quantity specified for that radionuclides in 10 CFR 33.100, Schedule A, Column ll. If two or more radionuclides are possessed, the possession limit is determined as follows: For each radionuclides, determine the ratio of I the quantity possessed to the applicable quantity specified in 10 CFR 33.100, Schedule A, Column 11, for that radionuclides. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

B. Notwithstanding Paragraph A of this Condition and 10 CFR 33.100, Schedule A, Column 11, the applicable quantities for the following radionuclides are reduced to:

Carbon 14 100 millicuries Krypton 85 100 millicuries lodine 129 10 microcuries Any byproduct materialother than alpha emitting byproduct materialnotlistedin 10 CFR 33.100, Schedule A 100 microcuries (Reviewer k Note: This condition Ilmits the possession limit for a Type C Broad License to eliminate the need for financial assurance for decommissioning).

I 183.

474 (RESERVED)

A. If only one radionuclides is possessed, the possession limit is the quantity specified for that radionuclides in 10 CFR 33.100, Schedule A, Column I. If two ormore radionuclides are possessed, the possession limit is determined as follows

for each radionuclides, determine the ratio of the quantity possessed to the applicable quantity specified in 10 CFR 33.100, Schedule A, Column I, for that radionuclides. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

B. Notwithstanding 10 CFR 33.100, Schedule A, Column I, the applicable quantities, for the purpose ofperforming the unity calculation as providedin Section A of this condition, for the following radionuclides are:

Carbon 14 10 curies Krypton 85 10 curies Iodine 129 1 millicurio Any byproduct materialother than alpha emitting byproduct materialnot listedin 10 CFR 33.100, Schedule A 10 millicuries (Reviewer k Note: This condition limits the possession limit for a Type B Broad License to reduce to $750,000, the requirement for financial assurance for decommissioning.)

184.

47-b (RESERVED) 185.

47it (RESERVED) 186.

473- (RESERVED) 187.

474 (RESERVED) 188.

47& (RESERVED) 189.

47& (RESERVED) 190.

473. Irradiation and distribution of foods for human consumption shall be in accordance with the rules and regulations of the Food and Drug Administration.

191.

47% Replacement-exchange of the source / source-holder combination for sources identified in 35.500 may be performed by the licensee in accordance with the instructions contained in the manufacturer b manual.

]

(Reviewer k Note: To be used in llcenses authorizing 10 CFR 35.500.)

l 1

1 l

i l

4 1

1 l

I o------________________.---__-__ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - -

l STANDARD CONDITIONS FOR EXEMPTIONS REQUIRING NMSS COORDINATION:

192, Notwithstanding the requirements of 10 CFR 34.20(a), and pursuant to 10 \

CFR 34.51, radiographic equipment authorized for use in radiographic l operations under this license need not comply with the torque criteria of l Section 8.9.2(c) of American National Standard N432- 1980 \

(Note: The above condition requires coordination (TAR) with NMSS l P&GD 1-26) 193 Individuals designated in writing to work as authorized users or authodzed nuclearpharmacists, as defines in 10 CFR 35.2, shall meet the training and experience criterla established in 10 CFR Part 35, Subpart J and shall be

' designated by the licensee k Radiation Safety Committee. (( Exceptions may be made on a case-by-case basis in accordance with the procedures describedin the letter (s) dated. )) The licensoe shall maintain records ofindividuals designated as users for 3 years after the individual k last use oflicensed material.

(Note: The above part of the condition in (( )) requires coordination (TAR) with NMSS P&GD 1-26) 194. Notwithstanding the requirements of 10 CFR 35.961 may perform the duties of the teletherapy physicist for those fulhcalibration and spot-check measurements specified in 10 CFR 35.632 and 10 CFR 35.634. l (Note: The above condition requires coordination (TAR) with NMSS P&GD 1-26) 195.

94- The license is exempt from decommissioning financial assurance requirements l for possession of licensed material in sealed sources in quantities greater l 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 j change. i l [ NOTE: Region may NOT currently use this condition without l coordination with NMSS in accordance with instructions in P&GD 1-26, July 1997.)

l t .

d

[ NRC FORM SC (7-94)

NRCMD 3.57 i

COVER SHEET FOR CORRESPONDENCE USE THIS COVER SHEET TO PROTECT ORIGINALS GF MULTI-PAGE CORRESPONDENCE

?'

b' _ i