ML20216J673
| ML20216J673 | |
| Person / Time | |
|---|---|
| Issue date: | 03/13/1998 |
| From: | Pederson C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Carpenter J External (Affiliation Not Assigned) |
| References | |
| NUDOCS 9803240028 | |
| Download: ML20216J673 (3) | |
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pc0 March 13, 1998 John Carpenter Radiation Safety Officer Mobile Testing Suite 144 1575 North Rivercenter Drive Milwaukee,WI 53212
Dear Mr. Carpenter:
This is in response to your August 19,1997, letter to Mr. A. Bill Beach of this office. In your letter, you requested the NRC definition of licenses. I apologize for the tardiness of this response.
A license is defined in 10 CFR 30.4 as "a license for byproduct material issued pursuant to the regulations in this Part and Parts 31 through 36 and 39 of this chapter." Further, medical use is defined in the same section as "the intentional intemal or external administration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user as defined in 10 CFR Part 35." Finally, person is defined in this section as "any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, . . . ."
10 CFR 30.31 specifies the two types of licenses, general and specific. Per this regulation,
" specific licenses are issued to named persons upon applications filed pursuant to the regulations in this Part and Parts 32 through 36 and 39 of this chapter. Generallicenses are effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons." As noted above, persons can be anything from an individual to an institution or group.
The medical use of byproduct materialis regulated by 10 CFR Part 35.10 CFR 35.11 requires that a specific license be obtained for a person to use byproduct material for medical use.
10 CFR 35.11(b) further requires that an individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of )
an authorized user as provided in 10 CFR 35.25, unless prohibited by license condition. I 10 CFR 35.2 defines an authorized user as "a physician, dentist, or podiatrist who is: (1) Board p certified by at least one of the Boards listed in paragraph (a) of 35.910,35.920,35.930,35.940, 35.950, or 35.960; (2) identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (3) identified as an authorized user on a permit issued by a Commission or Agreement State specific licensee of broad scope r that is authorized to permit the medical use of byproduct material. The Boards identified in t paragraphs 35.910,35.920,35.930,35.940,35.950, and 35.960, are primarily the American Osteopathic Board of Radiology, the American Board of Nuclear Medicine, the American Board of Radiology, the Royal College of Physicians and Surgeons of Canada, and the American Osteopathic Board of Nuclear Medicine. p3 9003240028 980313 PDR MISC "*
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1 J. Carpenter J The NRC licenses the use of byproduct material. A license is issued to a " person," as broadly defined above, which specifies the authorized uses of the byproduct material. A physician could hold an NRC license to use byproduct material. However, if a physician is part of a group l
practice or hospital, for example, the license would typically be issued to the medical group or the institution. The license would then specify, by name, the authorized user (s) of the byproduct material who meet the requirements specified for authorized users. In some cases, large medicallicensees are permitted to designate their own authorized users. However, the users designated by the licensee must still meet tha NRC requirements specified for authorized users.
10 CFR 30.5 states that except as specifically authorized by the Commission, in writing, no interpretation of the meaning of the regulations in this Part and Parts 31 through 36 and 39 by an officer or employee of the Commission other than a written interpretation by the Genera!
Counsel will be recognized to be binding upon the Commission. If, after reviewing the above information, you desire a binding interpretation of the term license, you should write the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
If you have any questions concerning this information, please contact Mr. Monte Phillips of my staff at (630) 829-9806.
Sincerely, 1 Original Signed by R. Caniano for Cynthia D. Pederson, Director Division of Nuclear Materials Safety DOCUMENT NAME: G:\LTRS2LIC\MTLS\98 MOBILE.LO1
- See Previous Concurrences To receive a copy of this document, indicate in the box:"C' = Copy without enclosure *E*= Copy with onclosure*N's No copy OFFICE Rlll:DNMS - l Rlll:DNMS I Rlli:RC l Rill:DNMS l NAME *Casey/dp *Phillips *Berson Pederson 91LQo l DATE 03/ /98 03/ /98- 03/ /98 03/U/98 0' l OFFICIAL RECORD COPY
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- : J. Carpenter: - The NRC licenses the use of byproduct material. A license is issued to a " person," s broadly defined above, which specifies the authorized uses of the byproduct material. A p sician' could '
hold an NRC license to use byproduct material. However, if a physician is part of a group -
practice or hospital, for example, the license would tvpically be issued to the medical group or the institution. The license would then specify, by name, the authorized user (s) of the product I material who mfet the requirements specified for authorized users. In some cases, large
'/'j medical licensdB are permitted to designate their own authorized users. However, the use designated by th licensee must still meet the NRC requirements specified for authorized users.
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T, - 10 CFR 30.5 states that except as specifically authorized by the Commission in wnting, no
- interpretation of the meaning of the regulations in this Part and Paris 31 through 36 and 39 by an officer or employee of the Commission other than a written interpretation by the General Counsel-
- will be recognized to be binding upon the Commission. If after reviewing the above information t you still desire a binding interpretation of the term license', you should write the Office of General Counsel, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
. If you have any questions concoming this information please contact Mr. Monte Phillips of my staff at (630) 829-9806.
Sincerely, Cynthia D. Pederson, Director Division of Nuclear Materials Safety i 1
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