ML20137J257

Forwards Response to Question Re DSI-7, Matls/Medical Oversight

ML20137J257
Person / Time
Issue date:	12/10/1996
From:	Blaha J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Boyle R, Lubenau J, Sorensen J NRC
Shared Package
ML20137J180	List: ML20137J177 ML20137J183 ML20137J197 ML20137J211 ML20137J229 ML20137J234 ML20137J249 ML20137J257
References
COMSECY-96-057, COMSECY-96-57, DSI-7, FACA, NUDOCS 9704030256
Download: ML20137J257 (3)

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UNITED STATES s

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December 10, 1996 NOTE TO COMMISSIONER ASSISTANTS OCM/SJ OCM/KR OCM/GJD Marylee Slosson g Myron Karinan Brad Jones j

Annette Vietti-Cook Mort Fleishman Terence Chan Karla Smith L Jack Sorensen

_ Anthony Markley James Johnson Seth Coplan L Joel Lubenau Brian Holian Lil Van Cise m Keith McDaniel L Regis Boyle Ann Haikalis Donna Smith

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Bob Mc0sker Joanne Field i

Jackie Silber l

Janice Dunn Lee Chuck Ogle OCM/ND OCM/EM g Scott Moore Gerry Schuetze g Maria Lopez-Otin g Joe Gray Evelyn Williams Roger Davis L Janet Schlueter l

Judy Ledbetter L Charleen Raddatz James Beall Leslie Hill Tony Hsia Jeffry Sharkey j

Frances Marek

_ Alice Gehl Cathy Grimes Vicki Bolling Linda Lewis i

FROM:

James L. Blaha l

Assistant for 0 ations, OEDO

SUBJECT:

RESPONSE TO QUESTION ON DIRECTION-SETTING ISSUE PAPER 7 4

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In a recent briefing on DSI 7, comissioner McGaffigan asked staff to provide the basis for certain items in that document mentioned as possibly needing revision or rescission.

Attached for your information H the staff's response.

Attachments:

As stated cc:

J. Taylor, EDO (w/o attachment)

J. Milhoan, DEDR (w/o attachment)

H. Thompson, DEDS (w/o attachment)

J. Blaha, A0/0EDO (w/ attachment)

K. Stablein, OEDO (w/ attachment)

C. Defino, OEDO (w/ attachment)

SECY (w/ attachment)

OGC (w/ attachment)

OCA (w/o attachment)

OPA (w/o attachment) 9704030256 970401 PDR NRCSA I

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i QUESTION:

Please provide the basis for each of the items mentioned in the sentence on page 16 of the DSI 7 issue paper

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" Examples of staff-identified and staff-suggested refuirements needing revision or possible rescission include the As Low As Reasonably Achievable (ALARA) program, the Quality Management Program, the misadministration definitions and reporting, dose calibrator checks, surveys, calibration of devices 4

(using industry standards where possible) and training and experience requirements."

As Low As Reasonably Achievable (ALARA)

ALARA is covered sufficiently in 10 CFR Part 20.

Its repetition in 10 CFR Part 35 appears unnecessary.

Further, the use of ALARA in medical practice has resulted principally in the use of syringe shields, which suggests that its broad application to medical practice is not cost-effective.

Furthermore, the concept of ALARA is not applicable to patients in the traditional se:mc, in that individuals are deliberately being exposed to radiation to effect a desired medical result, and thus the focus must be on occupational exposure.

Ouality Manacement Procram (OMP) 3 Staff wants to reconsider QMP based on NRC's experience to date and to understand the basis for the medical community's view that j

QMP is expensive but is not cost effective.

The staff's particular concerns are to move away.from prescriptive implementation of the objectives of a QMP<specified in 10 CFR 35.32 and to reexamine the applicability of these objectives for each type of medical use.

Misadministration definitions and reoortina -

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Several situations need attention.

Among them, the present regulations don't r.ecognize that different types of medical uses may well have different thresholds for what is sufficiently abnormal to be classified as a " misadministration."

Another situation is the case where a patient receives a very low dose, or n2 dose, say as a result of an equipment failure.

This is not now reportable, but it is in the NRC's interest to know what happened.

The staff believes that this issue should be examined for each type of medical use to more closely align information needs with regulatory uses.

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Dose calibrator checks -

Part of the basis for this regulation appears to have been overtaken by technology.

Calibrators are more stable now than

.i when the regulations were oricinally promulgated.

Further, calibration regulations for licensees using only unit doses now appears unnecessary.

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Surveys -

NRC has some prescriptive requirements that are not needed, such as weekly surveys for beta emitters, when we also require daily surveys for gamma emitters.

The gamma surveys will uncover any contamination that the beta surveys would have found.

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Calibration of devices -

Technical evolution has made our re.gulations on device calibration out-of-date.

Trainina and exnerience reauirements -

The existing training and experience requirements contained in Part 35 have not kept up with changes in medical uses. For example, the requirements for diagnostic uses should be less than for therapeutic, yet the reverse is currently true.

Further, several other physician specialists, such as cardiologists, are now involved with the medical use of byproduct material.

This makes the simple concept of a single authorized user physician obsolete, and dictates that a revised approach to the training and experience requirements in Part 35 be examined based upon the types of treatments being performed and the types and quantities of materials being used.

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