ML19354D822
| ML19354D822 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1989 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC |
| Shared Package | |
| ML19354D201 | List: |
| References | |
| NR-174-D-101-E, SSD-94-15, SSD-95-51, NUDOCS 9001220194 | |
| Download: ML19354D822 (6) | |
Text
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1 MEMORANDUM FOR: Those on Attached List FROM:
Richard E. Cunningham Director
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Division of Industrial and
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4 Medical Nuclear Safety, NMSS
SUBJECT:
POLICY AND GUIDANCE DIRECTIVE FC 8g. 03; CRITERIA i
FOR DENYING APPLICATIONS FOR MATERIAL LICENSES This directive provides guidance on when and how to deny an application for a material license (i.e., a license issued pursuant to 10 CFR Parts 30 through 39, 40, or 70 that is within the purview of the Division of Industrial and Medical Nuclear Safety).
For the purposes of this directive " application" means any request for a new license, an amendment to an existing ifcense, or renewal of an existing license. The tem " applicant" refers to the person requesting the licensing action and, as appropriate, includes current licensees.
GENERAL GUIDANCE Applications for material licenses should be denied pursuant to 10 CFR Section 2.103(b) if the staff cannot make the findings required by the regulations (e.g.,10CFRSection 30.33, 40.32, or 70.23, as appropriate) because either:
1.
The. applicant does not satisfy the substantive requirements even after
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pmviding infomation on which the staff can make a decision, OR 2.
The applicant has not submitted adequate infomation (see 10 CFR Section 2.108). Denial pursuant to 10 CFR Section 2.108 presupposes that:
The staff has requested the additional information needed to make the a.
required findings; b.
The applicant has had at least 30 days in which to provide the needed infomation; and The applicant has failed to respond or its response is not adequate.
c.
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9001220194 900117 PDR ORG NOMA PDC
Those on Attached List JUN 161933 i
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Note that failure to provide information should not be used as a basis for denial when the infomation submitted is adequate for a decision on the merits of the application. To ensure that cenials, where appropriate, are issued in a timely manner, it is important for the staff to: perform followup on oral and written comunications with applicants; in special i
situations, grant extensfuns for replies; and pre sare denial correspondence in acccrdance with Policy and Guidance Directive JC 83-11, Revision 1 dated August 2, 1985.
GUIDANCE FOR UNUSUAL CASES As early in the review process as possible, identify and coordinate with the Chief, Medical Academic, and Comercial Use Safety Branch (or, as appropriate, the Chief, Fuel Cycle Safety Branch), Office of Nuclear Material Safety and Safeguards, any application:
i 1.
In which the staff has any question about the applicant's suitability (e.g., psychological problems; substance abuse); integrity (e.g., lack of 1'
candor or submission of inaccurate or misleading infonnation); or ability-or commitment to comply with the Nuclear Regulatory Comission's regulations (e.g., financial instability or past inspection and enforcement history); OR 2.
Which contains an unusual request; OR 3.
Which raises novel legal or technical issues.
Early identification and coordination with Headquarters' staff are needed to ensure that the staff promptly prepares a letter of denial, if appropriate, or that Regional and Headquarters' staff agree on an appropriate strategy for handling the application.
The low frequency of issuance of denials, especially in unusual cases, necessitates case-by-case consideration.
SAMPLE DENIALS Enclosed are a summary sheet that describes selected cases and copies of the denial letters that were issued in these cases. These documents should provide not only historical pers sective on the types of requests that have been denied, but also language t1at may be used in the preparation of similar letters. As other applications are denied, the sumary sheet will be revised and sent to you with copies of additional denials for inclusion with this directive.
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Those on Attached List JUN I 61989 I
If you have any questions on this directive, please contact Patricia Yacca on
'(FTS) 492 0615.
Or!ginal Siped By Glen L S}oblom Richard E. Cunningham Director Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated
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0FFICIAL RECORD COPY I
St#9ERY OF SELECTED CASES AS OF
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REASON FOR TYPE OF REQUESTED DATE OF DENIAL DENIAL (PERTINENT APPLICANT'S NAME APPLICATION AUTHORIZATION DENIAL PURSUANT TO REGULATION)
Ao Accurate Inspection New Radiography 9/88 10 CFR 2.103 Inadequate training and of Missouri. Inc.
experience (10 CFR 30.33 (a)(3)); inaccurate infonnetton (10 CFR 30.9)
So Brigham and Amendment Relief from 10 CFR 4/88 10 CFR 2.103 Does not protect public Women's Hospital 35.60(b) re:
health and safety; may lead labeling syringes to misadministrations; does and syringe shields not fulfill intent of i
regulation C.
Department of Health Amendment Relief from 10 CFR 11/84 10 CFR 20.501 Does not protect public and Human Services 20.205(b) re:
health and safety; does not National Institutes monitoring external fulfill intent of regulation i
of Health L
surfaces of incoming l
i packages De Lixi, Inc.
New License pursuant to 7/85 10 CFR 2.103 a.
Device not covered by i
10 CFR 32.51 to 10 CFR 31.5 distribute lixiscope b.
Training in radiation to persons generally licensed pursuant to safety required (10 10 CFR 31.5 CFR 32.51(a)(2)(1))
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Loss of source and doses exceeding limits possible (10 CFR 32.51 (a)(2)(ii))
E.
Nuclear Theory and New License pursuant 6/89 10 CFR 2.108 Failure to provide adequate Technologies 10 CFR 32.11 to infonmetion distribute irradiated i
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exempt from licensing Enclosure 7
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! I6 19E9 REASON FOR TYPE OF REQUESTED DATE OF DENIAL DENIAL (PERTINENT i
APPLICANT'S NAME APPLICATIDM AUTHORIZATION DENIAL PURSUANT TO REGULATION)
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Perf-Master, Inc.
New Well logging 5/86 10 CFR 2.103 Possession of licensed material without valid license (10 CFR 30.3);
lack of candor with staff in violation, and careless disregard, of regulations G.
Radiology Associates Amendment Extension of time 10/78 10 CFR 2.103 Equipment inadequate of Framingham, Inc.
interval for service (10 CFR 30.33(a)(2)) if and inspection of not inspected and serviced teletherapy unit from at intervals not to exceed a maximum of 5 years 5 years to 7 years i
H.
Radiology Ultrasound Amendment Use of Sr-90 plaque 7/86 10 CFR 2.103 a.
Medical treatment not Nuclear Consultants, to treat skin cancer P.A.
authorized by 10 CFR 35 b.
Equipment inadequate (10 CFR 30.33(a)(2)) in that treatment not shown to be safe and effective; reviewed by Advisory i
Comaittee on Medical Use of Isotopes in accordance with Medical Policy Statement (44 FR 8242) l I.
Sager X-Ray Company New Radiography 5/88 10 CFR 2.103 Inadequate training and experience (10 CFR 30.33(a)
(3)) as damonstrated by poor past perfctmance as Agreement State licensee J.
Terre Haute Regional Amendment Addition of 9/80 10 CFR 2.103 Therapist not a physician l
Ilospital therapi.st as defined in 10 CFR 35.3(b) m m..
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JUN 16 1999 REASON FOR TYPE OF REQUESTED DATE OF DENIAL DENIAL (PERTINENT APPLICANT'S NAME APPLICATIC.M AUTHORIZATION DENIAL PURSUANT TO REGUt.ATION)
Ke Well Log, Inc.
New Well logging 1/89 10 CFR 2.103 Inadequate training and experience (10 CFR 30.33(a)(3)) as demonstrated l
by possession of ifcensed material without valid ifcense (10 CFR 30.3); lack of candor (which occurred before effective date of 10 CFR 30.9)
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(None; Sample Renewal Renewal of any (None) 10 CFR 2.108 Failure to provide adequate documents from type of license Policy and Guidance information; see P&GD FC 83-11 Directive (P&GD) for additional administrative FC 83-11) detaffs I
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