ML20154P707
| ML20154P707 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/1986 |
| From: | Grace J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Ledbetter J GEORGIA, STATE OF |
| References | |
| NUDOCS 8603200400 | |
| Download: ML20154P707 (5) | |
Text
M f & ded2 MAR 0 71986 Uth1)
James G. Ledbetter, Ph.D.
Comissioner Georgia Department of Human Resources State Office Building 47 Trinity Avenue Atlanta, Georgia 30334
Dear Comissioner Ledbetter:
This is to confirm the discussion Mr. Richard L. Woodruff, NRC State Agreement Representative, held on February 14, 1986, with Ms. Marjorie F.
- Smith, Messrs. Bobby G. Rutledge and Thomas E. Hill following our review and evaluation of the State's radiation control program.
The results of our review indicate that the Georgia Radiation Control Program is adequate to protect the public health and safety.
However, we are unable to offer a statement of compatibility pending the State's corrective actions for a Category I deficiency.
Status of Regulations is a Category I Indicator.
Pursuant to NRC Guidelines, State regulations should be amended as soon as practicable, but no later than three years, following the regulation adoption by NRC.
The Georgia Rules and Regulations for Radioactive Materials, Chapter 290-5-23, became effective on July 12, 1982.
The NRC has adopted several regulations that are deemed a matter of compatibility which have not been adopted by the State.
Therefore, we recomend that the Georgia Rules and Regulations for Radioactive Material be amended as soon as possible to effect compatibility with the NRC regulations.
We believe the main reason the amendments hav~e not been timely is due to the policy of issuing bound copies of the complete regulations whenever an amendment is made.
This necessitates a complete reprinting, which involves additional technical and administrative efforts, and reprinting and binding all of which increase costs.
Your program staff has proposed a procedure under which the regulations would be maintained on a word processor, appropriate pages revised as needed and, after approval, distribution to licensees in a loose leaf fonnat.
We believe this concept has merit and should be considered.
Following our February 1983 review, we comented on the need to eliminate overdue inspections.
The. State developed an action plan which was reviewed in detail during this review.
The plan appears to be working and the progress is being monitored by upper management.
We are pleased with the State's progress in this area.
We would appreciate your review of our recomendations and receiving your specific plans to improve the agreement materials program.
When the revised regulations are issued, we will be in a position to consider a finding of compatibility for the program.
D 8603200400 860307 1
PDR STPRO ESGG
(
James G. Ledbetter, Ph.D.
2 contains additional comments regarding the technical aspects of our review of the program.
These comments were discussed with Mr. Rutledge during our exit meeting with him. Mr. Rutledge was advised at the time that a response to these findings would be requested by this office and you may wish to have Mr. Rutledge address the Enclosure 1 coments. contains an explanation of our policies and practices for reviewing Agreement State programs. is a copy of this letter for placement in the State's Public Document Room or otherwise to be made available for public review.
I appreciate the courtesy and cooperation extended by your staff to Mr. Woodruff during the review.
Sincerely, (Original signed by J. Nelson Grace)
J. Nelson Grace Regional Administrator
Enclosures:
1.
Comments and Recommendations on Technical Aspects of the Georgia Radiation Control Program for Agreement Materials 2.
Application of " Guidelines for NRC Review of Agreement State Radiation Control Programs" 3.
Letter to James G. Ledbetter, Ph.D.
from J. Nelson Grace, dated 3 /7 /86 cc w/encls:
Marjorie F. Smith, Acting Director Office of Regulatory Services Bobby G. Rutledge, Director Radiological Health Section G. Wayne Kerr, Director Office of State Programs, NRC NRC Public Document Room bec w/encls:
R. L. Woodruff
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ENCLOSURE 1 COMMENTS AND RECOMMENDATIONS ON TECHNICAL ASPECTS OF THE GEORGIA RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS I.
LICENSING Licensing Procedures is a Category II Indicator. The following connent with our recommendation is made.
COMMENT Standard license conditions and procedures comparable with current NRC standard license conditions and procedures should be used to expedite and provide uniformity in the licensing process.
1.
The standard " user" condition utilized for individual bone-mineral analyzer licenses stipulates that "... material shall be used by, or under the supervision of (the individual physician)." The phrase "...
e under the supervision of..." should be reserved for institutional licensees who may be authorized to train other physicians.
2.
Some medical group licensees were authorized to possess up to 200 millicuries of iodine-131 (any form) for therapy uses, however, the license contained no requirements for bioassays.
RECOMMENDATION We recommend that the State utilize the following procedures:
1.
Bone mineral analyzer licenses issued to individual physicians should clearly indicate that the license does not authorize the individual user to train other physicians in the use of the device.
2.
Applicants for medical licenses who propose to use radioiodine should follow the regulatory guidance in NRC Regulatory Guides 8.20 and 10.8 for bioassay programs.
II. COMPLIANCE Inspection Reports is a Category II Indicator.
The following comment with our recommendation is made.
COMMENT Inspection reports should be uniform and adequately document the results of inspections.
It was noted that inspection reports do not uniformly document transportation requirements applicable to licensees or compliance with these requirements.
a
RECOP#fENDATION We recommend that the State review their inspection report forms, and revise them as appropriate to provide uniform documentation of licensee compliance with transportation requirenents.
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l ENCLOSURE 2 APPLICATION OF " GUIDELINES FOR NRC REVIEW 0F AGREEMENT STATE RADIATION CONTROL PROGRAMS" The " Guidelines for NRC Review of Agreement State Radiation Control Programs,"
were published in the Federal Register on December 4,1981 as an NRC Policy Statement.
The Guide provides 30 Indicators for evaluating Agreement State program areas.
Guidance as to their relative importance to an Agreement State program is provided by categorizing the Indicators into 2 categories.
Category I indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e., those that fall under Category I Indicators.
Category II Indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I Indicators.
It is the NRC's intention to use these categories in the following manner.
In reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety. If at least one significant Category I comment is provided, the State will be notified that the program deficiency may seriously affect the State's ability to protect the public health and safety and should be addressed on a priority basis.
When more than one significant Category I comment is provided, the State will be notified that tne need for improvement in particular program areas is critical.
The NRC would request an immediate response, and may perform a follow-up review of the program within six months.
If the State program has not improved or if additional deficiencies have developed, the NRC may institute proceedings to suspend or revoke all or part of the Agreement.
Category II comments would concern functions and activities which support the State program and, therefore, would not be critical to the State's ability to protect the public.
The State will be asked to respond to these comments and the State's actions will be evaluated during the next regular program review.
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