ML20196A993

Forwards RAI Re 980520 Request for Amend to License SNM-362 for 11 Specific Exemptions from 10CFR36.Addl Info Should Be Submitted within 45 Days of Ltr Date

ML20196A993
Person / Time
Site:	07000398
Issue date:	11/18/1998
From:	Soong S NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Pevey L NATIONAL INSTITUTE OF STANDARDS & TECHNOLOGY (FORMERL
References
NUDOCS 9811300213
Download: ML20196A993 (6)

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November 180 1998 s

Mr. L. E. Pevey, Chief Occupational Health and Safety Division U.S. Department of Commerce NationalInstitute of Standards and Technology Building 301, Room B124 Gaithersburg, Maryland 20899 )

SUBJECT:

REQUEST FOR EXEMPTIONS FROM 10 CFR PART 36

Dear Mr. Pevey:

This refers to your application dated May 20,1998, requesting an amendment to Materials 1 License SNM-362 for 11 specific exemptions from 10 CFR Part 36 for the use of irradiators for i non-human research. ]

1 Our review of your application has identified additional information that is needed before final j action can be taken on your request. The additionalinformation, specified in the enclosure, l should be provided within 45 days of the date of this letter. The enclosure lists the requested exemptions with the NRC's comments. Please note that bold text in the NRC comments indicates where a response is required before further NRC action.

If you have any questions regarding this matter, please contact me at (301) 415-8155.

1 Sincerely, Original signed by:

i Sean Soong l Licensing Section 2 '

Licensing Branch Division of Fuel Cycle Safety  ;

and Safeguards, NMSS

Enclosure:

As stated 4 Docket 70-398 License SNM-362

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% ,,y # November 18, 1998 Mr. L. E. Pevey, Chief Occupational Health and Safety Division U.S. Department of Commerce NationalInstitute of Standards -

and Technology Building 301, Room B124 Gaithersburg, Maryland 20899

SUBJECT:

REQUEST FOR EXEMPTIONS FROM 10 CFR PART 36

Dear Mr. Pevey:

This refers to your application dated May U,1998, requesting an amendment to Materials License SNM-362 for 11 specific exemptions from 10 CFR Part 36 for the use of irradiators for non-human research.

Our review of your application has identified additional information that is needed before final action can be taken on your request. The acMitionalinformation, specified in the enclosure, should be provided within 45 days of the date of this letter. The enclosure lists the requested exemptions with the NRC's comments. Please note that bold text in the NRC comments indicates where a response is required bvore further NRC action.

If you have any questions regarding this matter, please contact me at (301) 415-8155.

Sincerely,  ;

9 Sean Soong #

Licensing Section 2 Licensing Branch Division of Fuel Cycle Safety and Safeguards, NMSS

Enclosure:

As stated Docket 70-398 License SNM-362 l

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Request for Additionalinformation Application Dated May 20,1998 '

Department of Commerce, National Institute of Standards and Technology (NIST) ,

Docket No.70-398 The specific exemptions requested by NIST are listed below with NRC's comments. Bold text '

indicates where a response is required from the licensee before further NRC action.

1) 36.23(a) "The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources." l Comment: For converted teletherapy units, the use of a single key or even several j keys on a key-ring may be impractical. The key switch on many control  ;

panels is a 3-position switch which controls electrical power to the -

teletherapy unit. The key can only be inserted or removed in the "off" position, and in this position the main power and control circuits are i without electrical power. Power is required to move collimators, activate ,

field lights, align systems, etc. Requiring a single key would not allow the l l

licensee to operate these powered systems.  ;

NIST indicates that the current procedure requires the conso!e to be i active as the personnel door entry interlock is tested and that the console key may not be removed nor may the personnel entrance door be ,

opened without closing the shutter to the source. In addition, NIST indicates that a radiation monitor will be installed inside the entry door j that will generate a visible and audible signalif the door is opened and a i radiation level above normal background exists. NIST may be exempted  :

from this requirement, provided that NIST installs the additional l radiation monitors inside the entry doors of radiation rooms B034  !

and B036, and commits to have the operator present for the entire period of time that the key is in the control panel and/or commits to locking the entrance door leading to the two radiation rooms, restricting access to the operator performing the irradiation, and requiring that entrance into the irradiation rooms will alert the operator or a responsible person who would contact the operator.

2) 36.23(b) . . . each entrance to a radiation room at a panoramic irradiator must

! have an independent backup access control to detect personnel entry while sources are exposed." in addition, detection of entry must shield

! the sources and the alarm (backup access control) must also Lert at l least one other individual who is onsite of the entry.

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. 2 Comment: The licensee may be granted an exempt'on from the requirement to have a backup access control alarm provided that the licensee has 4 an electrical interlock system meeting all of the conditions specified 3 in $35.615(b) on each entrance to the radiation room, and the licensee commits to the conditions specified in 935.615(b) in their .

license. In addition, the licensee should install the additional radiation monitors inside the entry doors of radiation rooms B034 1 and B036, commit to having an operator present during the entire  ;

Irradiation who can visually observe the entrance and/or commit to ,

locking the entrance door leading to the two radiation rooms, l restricting access to the operator performing the Irradiation, and l

] requiring that entrance into the irradiation rooms will alert the l

operator or a responsible person who would contact the operator. l 1

] 3) 36.23(c) " . . The monitor must be integrated with personnel access door locks to j prevent room access when radiation levels are high."

l Comment: NIST stated the applicable portion of the regulation to be " Attempted '

) personnel entry while the monitor measures high radiation levels, must

. activate the alarm described in paragraph (b)." The licensee may be granted an exemption from this requirement provided that the licensee has an electrical interlock system and commits to its use,  ;

as described above. In addition, the licensee should install the

additional radiation monitors inside the entry doors of radiation rooms B034 and B036, commit to having an operator present during the entire irradiation who can visually observe the entrance andor

commit to locking the entrance door leading to the two radiation

rooms, restricting access to the operator performing the irradiation,

, and requiring that entrance into the irradiation rooms will alert the operator or a responsible pers,on who would contact the operator.-

4) 636.23(d) NIST requests exemption from the following portion: "Before the sources move from their shielded position . . . , the source must automatically activate conspicuous audible and visible alarms . . . " In addition, the regulation requires that "the alarms must give individuals enough time to i leave the room . . ."

Comment: The licensee has committed to perform a visual inspection of the small, 9' x 16', room prior to each irradiation, and as described, the requirement to activate the associated time-out delay of 30 seconds within the radiation room prior to exposing the source would ensure that the operator entered the room to perform this inspection. Due to the small size of the room, this " inspection" would meet the intent of the regulation, which is to alert anyone within the room that an irradiation is about to

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begin; therefore, This exemption maybe granted provided that the  !

beam catcher pits, as shown on the drawing, are also included in I the visual inspection or are not a potential place where a person in '

the radiation room may be overlooked.  ;

5) Q36.27(a) NIST requests exemption from that part of this regulation which states:

"The radiation room ., . . must have heat and smoke detectors . . . The '

sources must become fully shielded if a fire is detected."

Comment: See No. 6

6) 36.27(b) NIST requests exemption from that part of this regulation which states: I "The radiation room. . . . . must be equipped with a fire extinguishing i system. . . "

Comment: NIST indicates that their Fire Protection Group has determined "that the only . . . source of ignition in the room is electrica! . . ." and that other  ;

combusubles ". . . and explosives are administratively controlled so that l quantities are insufficient to threaten damage to (the) source encapsulation or shield integrity." NIST also indicates that the signal from the heat detector will alert the NIST Fire Protection Group. Most j converted teletherapy units are designed to retract the source when the electrical power fails, as may occur during a fire.  !

NIST needs to describe why a fire will not prevent the source (s) l from returning to a shielded position. With a satisfactory answer, NIST may be granted an exemption from these requirements due to the lack of combustibles in the radiation rooms ard the assurance by NIST that no damage will occur to either the source encapsulation or shield integrity and provided that NIST comm!ts: to have smoke detectors, and fire extinguishers, to detect and fight small fires, as well as a fire alarm nearby the radiction rooms; to have a means of ,

measuring the radiation levels in the irradiation rooms 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.

7) 36.31(a) NIST requests exemption from that part of this regulation which states:

"The (console) 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."

Comment: 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 licensee may be granted an exemption from this requirement provided that the licensee commits to have administrative controls in place to insure that personnel entering the radiation rooms use a portable survey meter to verify that the source has retracted or describe why an individeal, I

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. . 4 i not using a survey meter, who enters the irradiation room would not be overexposed should multiple system failures result in inoperable monitors and a source stuck in the exposed position.

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8) @36.51(d) NIST requests exemption from that part of this regulation which states:

"The licensee shall conduct safety reviews for irradiator operators at least annually." NIST summarizes further requirements as: "with specific e topics [ inclusion), written test, emergency event practice drill."

Comment: NIST has not provided an adequate reason to support granting this

, exemption. Stability of the staff is not an acceptable reason for l eliminatir.g training, and NIST has not demonstrated why it would be j unable to comply with the regulation in this regard.

9) 936.51(e) NIST requests exemption from that part of the regulation which states:

"The licensee shall evaluate the safety performanca nf each irradiator l operator at least annually . . . "

l Comment: See No. 8 1

10) G36.51(g) NIST requests exemption from that part of this regulation which states. 1

" Individuals who must be prepared to respond to alarms required by  !

l (various sections of Part 36) shall be trained and tested on how to respond. Each individual shall be retested at least once a year."

Comment: See No. 8

11) s36.67(a) NIST requests exemption from that part of this regulation which states:

"Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine )

l that the source has returned to its fully shielded position."

Comments: NIST provided the following reasons why they need this exemption: age l and expense of modifying facility, existing safety features, such as, l stability of staff, and multiple redundant interlock and monitor systems.

However, NIST needs to describe why an Individual, not using a l survey meter, who enters the irradiation room would not be L

overexposed should multiple system failures result in inoperable i monitors and a source stuck in the exposed position. For example, if the teletherapy head were fixed so that it could not be directed away from ,

!. the floor and a collimated beam was always required, NIST could argue l l that NRC exposure limits would not be exceeded.

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