ML20210H734

Processing of Exemptions for Material Licensees

ML20210H734
Person / Time
Issue date:	07/25/1997
From:	Gary Purdy NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20210H680	List: ML20210H674 ML20210H734
References
PG-1-26, NUDOCS 9708140162
Download: ML20210H734 (23)

Text

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N United States Nuclear Regulatory Commission Policy and Guidance Directive (PGD) 1-26 (Formerly P&GD 84-12, Rev. 2)

PROCESSING OF EXEMPTIONS FOR MATERIAL LICENSEES Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards PREPARED BY: hBY -

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• Attachment I s - _

PROCESSING OF EXEMPTIONS FOR MATERIAL LICENSEES Table of Contents Paag

.. . .2

1. Purpose . . , . . .

. .2

2. Background . . . . .

.s. . . .. .3 General Guidance .

3. . . . .

. 3 3.1 Exemptions. . . . .

.3 3.2 Temp, ary dxemptions for Humanitar in or Emergency Reasons .

l l 5 3.3 Exemptions Paqwrir.g Ooordination with NMSS. .

l 5

4. Administrative Procedures.

5

5. Resources APPENDlX A Routine Exemptions. .A-1 APPENDIX B STANDARD LETTER FORMAT for Temporary Exemption from NRC Regulation

.B-1 or License Condition . . .

APPENDIX C

.C-1 Examples of Exemptions Requiring Coordination with NMSS . . . ..

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=

4 1

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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 alternatives for compliance with the regulations 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 be5w anu ,

Appendix B.

2; gackaround .

P&GD FC 8412, Revision 2; Grantino Exemotions 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 Newiv Manufactured -

Radicaraohv Eculoment. 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 8412, Revision 2 and P&GD 92 03. P&GD 216 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 additionalinformation -

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 letter, 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.

PG 1-26 07/25/97 2

3. General Guidance 3.1 Exemptions The exemptions contained in Appendix A may be granted by the regions without coordination with Headquarters. All requests for an exemption to the regulations must not present an undue risk to public health and safety, and be consistent with the common defense and security.

The request must be accompanied by;

a. a dcscription of the exemption needed and why;

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

c. the licensee's assurance that consideration of all reasonable alternatives for complying with the regulation has been exhausted.

Each Appendix A section describes the specific part of the regulation which may be considered for exemption, any other commitment or 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 Temporary Exemotions for Humanitarian or Ememency Reasons The regions may grant a temporary exemption to NRC regulations or license conditions, on a case by-case basis, without referral to the DirectorilMNS, NMSS, in certain circumstances in which:

a. A normallicense amendment is not appropriate because of tho non-recurring, short duration (normally 7 days or less) natura af 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 satis fied that such actions are consistent with the protection of public health and safety. A temporary exemption should 07/25/97 PG 1-26 3

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, iriJuding th, .eed 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.

The licensee's request should normally be faxed to the Director, 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 Management Directive 9.29,

• Organization and Function:

Regional Offices." However, if circumstances do not permit time for the fax, the licensee may make the request orally and read or describe the above information to the NRC staff. The oral 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 documentation of the above information. The follow up wri"in request must confirrr the information submitted orally and upon which the NRC relieo in granting the exemption.

The exemption may be granted 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 licensee 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.

PG 1-26 07/25/97 4

__ . _ _ _ _ _ . _._ _ _ _ . ~ . _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ . . _ __

l 3.3 hemptions Reauirino 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 repion, 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 suomit its evaluation of the merits of the exemption from r technical star.dpoint as well as any ganene implications, such as a need for rulemaking.

4. Administrative Procedures The LTS allows recording of exemptions granted. The LTS worksheet contains an exemption data field which should be annotated to identify the section of the regulation to which the exemption was granted, For example, if an exemption is granted to allow relief from 10 CFR S35.647 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 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 122, Rev.1, Policy and Criteria for initial Processino of Incomina Licens;.,c Actions, dated April 15,1997, states that all exemptions requested, granted, and denied will be entered in the LTS. If the LTS has not been modified to accommodate these actions, the regions should continue to maintain a list as directed in P&GD 122. If you need assistance regarding entry of data on the LTS worksheet, please contact the regional license reviewer or the licensing management system coordinator,

5. Resources _l 1

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.

PG 1-26 07/25/97 5

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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 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 exemption could be requested by a licensee.

The second box seamen'. describes any add tlonalinformation a licen: t will need to submit cr commit tc r :her than information described in p agraph 3.1 of the Policy and G ..iance Directive.

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

APPENDlX CONTENTS

1. 10 CFR 35 Recordkeeping or posting . . . . . . . . . . . . . . . . . . . . . . . . . A 2 35.315(a)(4) and 35.415(a)(4) , . . . . . . . . . . . . . . . . . . . . . . A-3 3 5.400( d) a n d (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 3 5. 4 04( a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A 5 3 5. 647 . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . A 6

11. 10 CFR 36 3 6. 2 3 ( a ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -7 3 6.2 3(b ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 36.2 3(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 36.23(d) . . . . . . . . . . . . . . , , . . . . . , . . . . . . . . . . . . . . . . . . . A-10 3 6.2 3(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 A-1

' l. - 10 CFR 35 A. Recordkeeping or posting Requests for relief from recordkeeping or posting requirements, in Part 35.

Information'as described in paragraph 3.1 is sufficient.

The following license condition should be used:

"Notwithstanding ..ie requireme its of 10 CFR 35. , the licensee may use (recordkeeping or posting) as desenbed in-the alternativo methoc. for "

the letter / application dated l

-A-2

- l l

B. 635.315(a)(4) and 635 415(a)(*)

Regions may grant exemptions from @35.315(a)(4) and 635.415(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:

1. The licensee must provide a detailed description of he rooms used for therapy, includina the adjacent areas end the area above and below ="ch rooms used for t. ..apy. A sketen cf the t9atment rooms and adjacent areae should be submitted with the layout of the rooms and adjacent ares., indicated.

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, increase in source activity, ,), a new evaluation will be perf orme .

d

3. The licensee must provide enough information to determine that the requirements in 620.1301(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 patients or subsequent hospital stays in the same calendar year will not exceed 100 millirem per calendar year.

The following license condition should be useo 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 determi' ng the dose rates in contiguous restricted and unrestricted areas desenbed in the letter /appHeation dated n

The following license condition should be used for exemptions from 10 CFR 35.415(a)(4):

"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 and unrestricted areas described in the letter / application dated A-3

.~

C. 435 400(d) and 635.400(a)

Regions may grant exemptions from the use requirement in $35.400(d) for iridium-192 and 935 400(g) for palladium-103 to allow other than interstitial treatment of cancer.

For the exemption to be granted, the licensee must s 92) encased in nylon ribbon and palladium 103 (Pd 103)pecify iri seeds, No additional radiation safety procedures need to be identified. Ir-192 and Pd-103 have been used for intracavitary use for many years and sources in the Sealed Source and Device Registry which havv passed the testing criteria Or interstitial use can be used in intracavitary or topical 6pplicetions Requests for authorization of gold-19A aad iodine-125 seeds f., intracavi'ry and topical applications should be coordinatec 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 may use iridium-192 as seeds encased in nylon ribbon and palladium-103 as seeds for topical, interstFial, and intracavitary treatment of cancer, The licensee may deviate from the manufacturer's radiation safety and handling instructions only to the extent that the instructions are not applicable to the type of use proposed by the licensee."

A-4

D. 635 404(aL Regions may grant exemptions from the requirement in 935.404(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.

For the exemptim t be granted, the licensee must adequately commit to amply with the requirements desmbed below to ensure adequate protection of pub!!c health and safety and to meet the survey requirements for permanent implant patients specified in 535.75(b). Specifically, the licensee must commit to comply with the following provisions:

1. The measured dose rate from the patient must be less than 5 millirems per hour at a distance of 1 meter

2. The patient will be provided with radiation saiety guidance on how to maintain doses to other individuals as low Os 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 erisure that all sources have been removed.

4. Upon removal of the eye plaque, the plaque will be disassembled and a physicalinventory of the seeds will be conducted to i

confirm that all sources have been recovered.

5. The licensee must also a diress any specific radiation safaty 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 l

A-5

i E, 635 647 Regions may giant exemptions to 935.647 to extend the time for servicing and inspection of a teletherapy unit.

Information as described in paragraph 3.1 is sufficient.

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

A-6

ll. 10 CFR 36 Although many provisions of 10 CFR Part 36 apply to converted teletherapy units, compliance with certain applicable provisions of the rule may be impractical, and exemptions will be granted from specific sections of 10 C 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)

Regions may grant exemptions to 636.23(a) whch sta:es, in part, that ".. The--

personnel entrance door or barrier must have a lock that is operated by the sam key used to move the sources." .

Provided that the licensee commits to have the operator present for the entire period of time that the key is in the control panel. For converted teletherapy the use of a single key or even several keys on a key ring may be impractical. Th key switch on many control panels is a 3-position switch which controls el power to the teletherapy unit. The key can only be inserted / removed in th position, and in this position the main power and control circuits are without 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 th powered systems.

The following license condition should be used o

. Notwithstanding the requirements of 10 CFR 36.23(a), the licensee may

.I use separate keys to operate the lock on the personnel entrance door or barrier and to move the sources in accordance witn procedures oescr" r in the letterlapplicatinn dated .

A-7

B. 636 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 sys'em meeting all of the conditions specified in @35.615(b) on each entrance to the radiation room. Alterations of the electricalinterlocks of the teletherapy unit to meet the requirements of 36.23(b),

may cause the interlock system to function neerrectly. A working electrical interteck system on each entrance sufices to prevent personnel entry while the sr rve is l 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 ently while sources are exposed based on the commitments described in the letter / application dated 1

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C. 636,23(c)

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." .

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 has an electrical interlock system which will retract the source, upon opening access doors to the irradiation room and commits to its use. in addition, the

' licensee must comtr" to navinn an operator present and having a radiatior mnrut" in the room, as discue-9d abow. _

The following license condition should be used:

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

l A-9

D. 436 23(d) - +

e Regions may grant exemptions to 636.23(d) which stc.tes, in part, that . ." visible a F audible alarms to alert people in the radiation room that the sources will be moved j;

2-from their shielded position." '

An acceptable justification is that an audible alarm within the treatment room may

- 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 licens6r exemntion from this provision of the regulations.

• The following lice ,a conddon should be used.

-" Notwithstanding the requirements of 10 CFR 36.23(d), the licensee is exen a from having a visible and audible alarm within the treatment area, " based on the

- commitments described in the letter / application dated l

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- A-10

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. 1 E. @36 23(f)

Regions may grant exemptions to @36.23(f) t thewhich states radiation room at a panoramic irradiator must contain a contro sources from moving from the shielded position unless the co activated and the do_or...has been closed within a preset time. "

Exemptions may be granted to licensees having e commits to telether used for irradiation of materials only (no patients), provided the lice l sing the door, the operator visually verifying that the room is dnotdible occupied prior and that the converH teletherapy unit (irradia'or) rce activates e

J a vis alarm in the teletherapy room for d ition until attheleast 15 teletherapy unit such that the source will not i move The use ofto a the expose p visual / audible alarm has been activated and i is t f finished r patients. alarm ng.

visual / audible alarm in a patient treatment room h patient may cause anx Therefore, licensees having teletherapy units b l rm, that uthorized if the are being an treatment (human or animal) and object or material l t ccupied irradiation m exemption from @36.23(f) without the need to have a visual /au licensee commits to having an operator visually verify that th lb rvation of the h the prior to closing the door and if the licensee h audiotelvisible alarm described above is required The following license condition should be used: ee is exempt li "Notwithstanding the requirements of 10 CFR 35.23(f), hi lded the cens from having a control that prevents the sources i t the from mo

position unlesc the coi, trol has beenh activated ommitments and th t radiation room has been closed withm a preset time based o described in the letter / application dated __

c A-11

I F, 636 27(a) and 36 27(b)

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

$36.27(b) which states, 'The radiation room at a panoramic irradiator must be 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 unrestrict3d areas."

The Statements of Consideration state that the purpose of fire extinguishing system is to prevent a fire irom damag.'ng the access control system or preventing the sources from being shieided: Most converted teletherapy units are desicrad *.o retract the source 4.;ien the e's-trical 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 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.

The following license condition should be used.

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

• A-12

9 G. 636 31(a_)

Regions may grant exemptions to @36.31(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 provided that the licensee commits to having administrative controls in place to insure that personnel entenng the radiation rot m use a portable survey meter te verify that the se'.'rc: has retracted. The licensee must also commit to attach the survey meter to the exposure room door key.

The following license condition should be used:

"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 ano 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 A-13

Hi 436 31(b)

Regions may grant exemptions to $36,31(b) which states, in part, that "The con. ole 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 both lights are on i

indicating that the sourcc .:s in transit. To requ're that tha licensee install -"

electronic systera to Nicate " transit" for the period of time the source is in treasit, less than a second, cees 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 desenption 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 A-14

b l A36 67(bM2)

Regions may grant exemptions to $36.67(b)(2) which states, that a licensee must,

" Activate a control in the radiation room that permits the sources to be moved from -

the shielded position only if the door to the radiation room is locked within a preset j 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 regula9n, and the licensee's commitment to administratively control access to the room to meet the l e

intent of this regulaw the region rL6y grant this exemption, if the licensee demonstrates that a retroft to install such a co" trol would not be possible wun the teletheraoy unit; and the licensee commits to the following:

e i a. The operator will ciose the doors immediately upon completion of the

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

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

The fc! lowing license condition should be used:

l i

"Notwithstanding the requirements of 10 CFR 3S.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 source to be i 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 letter / application dated t

i i

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,-4 APPENDIX B 3,tgadard_ Letter Format for Temporary Exemption from NRf:_Regula,tlon or

- License Condition -

DOCKET NO.

LICENSE NO. _,

i (Name gf Licensee)

(Address)

SUBJECT:

TEMPORARY EXEMPTION TO NRC (REGULATION

- QB LIST THE LICENSE CONDITION]

Pursuant to the written request dated (dJte of reqye.51) for temporary exemption (s) from the requirements of (NRC reculation or license condition) by (Dyme and position of reouestor representina the licensee), the following temporary exemption (s) is (are) granted for the specified neriod cf time:

[Each temporary exsmption Oranted should be listed separately with documentation of the circumstances 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 tu'ove, you are to notify (Contact) immediately, at (Tel Number)

. Director Division of Nuclear Materials Safety B-1

,x 1

APPENDIX C J

9 Example.s of Exemptions Reauirina Coordination with NMSS

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 -

Sections 3.1 and 3.2 of this guidance, or specifically listed in other policy and 1 guidance directives.

2. Relief from any of the provisions of the revised 10 CFR t' art 20, including, but -;

i not limited to:

a- Reques' 3 increase the dose lim

t for individual members of the public -

- from 100 millirem in a year to 500 millirem. ir' a year, pursuant to

$20,1301(c).

- h. Relief from the 2 millirem in any hour limit for an unrestricted area in l

S20.1301(a)(2).

c. Pursuant to $20.1204(c)(2), requests to adjust the Derived Air 4 Concentration (DAC) or Annual Limit on Intake (All) values to reflect the actual physical and chemical characteristics of airborne radioactive C material. ~

e i d, - Any requests for relief from the provisions for disposal into sanitary sewerage (920.2003), including relief from or special authorization

' concerning the solubility criteria in $20.2003(a).

Requests for relaxation cf, or exemp;ons from the training and wperience

[

3.

requirements of 10 CFR Part 35 for physicians, teletherapy physicists, nuclear j

pharmacists, and radiation safety officers. These requests are coordinated with the NRC's Advisory Committee on the Medical Use of Isotopes (ACMUI).

1

4. Authonzation 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, Updated Guidance for Decav-in-Storaoo for Specific Guidanco.-

1

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

C-1 L ._ ,

l l

January 29, 1997 MEMORANDUM TO: }h.gh L. Thompson, Jr.

Acting Executive Director for Operations FROM:

John C. Hoyle, Secretary /s/

STAFF REQUIREMENTS SECY-96-249 - STAFF SUBJr"*.

RESPONSE TO SRM ON SECY-96-147 REGARDING REDUCING NEED FOR EXEMPTIONS AND CONSISTENCY OF THS EXEMPTION PROCESS The Commission hah approved cetaaning (1) the current criteria contained in l' Jfx 51.12 for considering exemption requc.cs from reactor licensees, and (2) the current gt.neral criteria for considering specific exemptions requested inr materials licenst.s.

In addition, the Commission agrees that the staff's own internal procesa for the staff's evaluation of exemption requests is the adequate. With regard to this internal staff review process, staff <hould develop more explicit guidance to ensure the qual. ',-objectivity and consistency of exemption packages.

7/31/97) tEDO)

(CECY Suspense:

The Commission is concerned, however, that the recent commission focus on exemptione (to identify regulations that are unclear or difficult to comply with so that such regulations may be corrected) may have caused a misunderstanding by the staff andin resulting affected the application of the exemption criteria, 1 i

an attempt by the staff to limit or reduce the number In fact,of the exemptions that the NRC considers and grants.

Commission has not set any particular goals or limits on the number of exemption requests that can be considered or granted.

The Commission-believea that the staff should apply the regulucory criteria for exemptions objectively and witho"* a preconceived notion that exemptions should either be limited or circumscribed or, conversely, readily available for anyone who seeks an exemption. Objective evaluation of exemption requests will ensure that inappropriate regulatory requirements will be more readily-identified through the number of exemption requescs that are received.

If particular regulations are unclear or difficult to comply with such that they engender an inordinate volume of exemption requests (so called " recurring exemptions"), the staff should seek promptly to modify and correct these regulations and, in the interim period before completion of the corrective rulemaking, grant those exemptions In that are properly justified under the addressing the " recurring exemption" exemption criteria.

problem, the staff should expeditiously proceed with the rulemaking fixes to those regulations Thesethat have engendered corrective rulemaking recurring exemption requests.

~

t Cfm@ v % tb~2' ~hY Attachment 2

actions should not be delayed to incorporate " performance-based" regulatory concepts where such concepts are not necessary toCandidate rulemaking address the " recurring exemption a issue.

activities resulting from reviews of experience with exemptions should continue to be noted and progress reported in the semiannual updates of the Rulemaking Activity Plan.

As a general practice, the grant or denial of specific exemptions is purely a staff responsibility that does noc involve thethe Commission reserv Commissioners. However, responsibility for policy determinations that guide these staff l

actions.

To allow for routine Commission monitoring (for .

" recurring exemption" requests), the staff should include in the semiannual updates of the Rulemaking Activity Plan a listing and description received and the of the applications for exemptions that have beenxemption a denied-during the period which is tne subject of the semi;r...aal update. l cci - Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Dia:

Commissioner McGaffigan OGC OCA 010 Office Directors, Regions,_ACRS, ACNW, ASLBP (via E-Mail)