ML20053E280
| ML20053E280 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1982 |
| From: | James O'Reilly NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Stumbo W KENTUCKY, COMMONWEALTH OF |
| Shared Package | |
| ML20053E281 | List: |
| References | |
| NUDOCS 8206070761 | |
| Download: ML20053E280 (7) | |
Text
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MAY 211982 W. Grady Stums M.D., Secretary Department for Human Resources 275 East Main Streat Frankfort, Kentucky 40621
Dear Dr. Stumbo:
This is to confirm the discussion Mr. Richard L. Woodruff, Region II State Agreements Representative, held with Mr. Irving Rell of your staff following our review and evaluation of the State Radiation Control Program. The review covered the principal administrative and technical aspects of the program. This included an examination of the programs' legislation and regulations, crganization, man-agement and administration, personnel, licensing, compliance, and the field evaluation of a State inspector.
Our review used as a reference, the " Guidelines for NRC Review of Agreement State Radiation Control Programs".
These guidelines were published in the Federal Register on December 4, 1981, as a final general statement of policy.
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 two categories.
Category I Indicators reflect on a State's ability to adequately protect the public health and safety. Category II Indicators are essential in order to avoid the develop-ment of problems in one or more the principal program areas, i.e.,
Category I Indicators. When one significant Category I comment is made, the deficiency may seriously affect the State's ability to protect the public heaith and safety and the matter needs to be addressed on a priority basis.
If there is more than one signficant Category I comment made, then improvements in those areas are criti-cally needed. In such cases, we will need a timely response from the State and NRC staff recommendations for adequacy and compatibility will not be offered until after the response is received and evaluated.
In the latter case, a follow-up review would be made within six months.
As a result our review of the State's program and the routine exchange of infor-mation between the Nuclear Regulatory Commission and the State of Kentucky, the NRC staff is not able to make a finding that the Kentucky program for regulation of agreement material is adequate to protect the public health and safety until we receive and evaluate your response to this letter.
In this review we found that 98 licenses were overdue for inspections, of which 64 licenses were everdue for more than three months including a Priority I licensee. This represents an increase in the overdue inspections from 25's to 37*;
since the last review when we also expressed concern over the backlog. Status of the inspection program is a Category I Indicator. We recommend that an inspec-tion program be implemented that will reduce the number of overdue inspections.
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W W. Grady Stumbo, M.D., Secretary 2
MAY 21 1982 The inspection backlog is pr imarily related to the professional staffing level for radioactive materials which is currently 0.76 person year per 100 licenses, well below our recommended guideline of 1.0 to 1.5 person years per 100 licenses.
Staffing level is a Category II Indicator.
Kentucky Regulations require all radioactive material licenses to be renewed on an annual basis, whereby during the past year, many of the renewal license applications have required exten-sive reviews, thus reducing the staff time available for field inspections.
In addition, emergency planning requirements associated with the Zimmer and Marble Hill nuclear power plants are projected to require considerable staff time during this coming year, making the staffing level even more critical.
It was noted that four persons have left the program since the last review and the program had one vacancy which was lost due to the decentralization of the x-ray program.
We are especially concerned over this finding since the staffing situation is virtually unchanged from the 1981 review. At that time the staffing level was 0.7 person years per 100 licenses and there was also a vacancy.
It appears that the steps outlined by the Department in response to last year's comments have not alleviated the problem (Enclosure 1). We recommend that every effort be made to increase the staf fing level of the materials program to the suggested range of 1.0 to 1.5 person years per 100 licenses.
In response to our comm'nts following our 1980 review, you stated that the fee schedule was being reviewed. We noted again during this review that the fee schedule had not changad; however, we were provided with a draft copy of proposed rule changes which would revise licensing fees and establish a schedule for inspection
'e e s.
The minimal fee schedule currently in effect only generates approximately 5% of the cost of the materials licensing and inspection program.
Currently, 16 cf the 26 agreement state programs have fee schedules, several of which are being upgraded. Several other states are either considering fees, or in the process of obtaining the necessary legislation. We fully support the fee concept and we recommend that Kentucky upgrade its fee system to improve the fiscal base for the Radiation Control P ogram.
I would appreciate receiving your responses to these comments.
Enclosed with this letter are additional comments regarding the technical aspects of the program (Enclosure 2).
In general, the technical staff should be commended on the quality of their activities; however, improvement in some of the program areas is needed.
These comments were discussed with Mr. Hughes and his staff, and you may wish to have Mr. Hughes address them in your reply to this letter.
In accordance with our practice, I am enclosing a second copy of this letter which should be placed in your State's Public Document Room or otherwise made available for public review.
W. Grady Stumbo, M.D., Secretary 3
AIAY 211982 I appreciate the courtesy and cooperation extended by your staff to Mr. Woodruff and the other NRC staff during the review.
Sincerely,
/
James P. O'Reilly Regional Administrator
Enclosures:
1.
Kentucky DHR Response to 1980 Comments on Radiation Control Program 2.
Comments and Recommendations on Technical Aspects of Kentucky RCP cc w/ encl:
David T. Allen, M.D., M.P.H.
Commissioner, Bureau of Health Services Irving Bell, Director Division for Consumer Health Protection Donald Hughes, Manager Radiation Control Branch G. Wayne Kerr, Director Office of State Programs, NRC bcc w/ encl:
Commorwealth of Kentucky Public Document Room NRC Public Document Room D. A. Nussbaumer, Assistant Director for State Agreements Program, OSP R. E. Trojanowski, RII RII R
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l ENCLOSURE 2 COMMENTS AND RECOMMENDATIONS ON TECHNICAL ASPECTS OF THE KENTUCKY RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS I.
MANAGEMENT AND ADMINISTRATION Management is a Category II Indicator.
The following comments with our recommendations are made:
i A.
Comment A number of inspection reports were observed in which the inspector, reviewer, and person signing the enfcrcement correspondence were the
-same person. Supervisory review of inspection reports and enforcement actions should be performed.
Recommendation We recommend that all inspection reports and enforcement correspondence be reviewed by the inspector's supervisor.
B.
Comment It was noted that all inspection reports were typewritten in a narra-tive format. The NRC and many agreement states have adopted a field report format consisting of the inspector field notes and the inspec-tion plan. The field report is used only for routine inspections and the more formal narrative reports are used for special inspections or investigations.
This type of field report allows for more effective use of personnel resources. Examples of. forms used by other programs were provided during the review.
These forms are a combination of checklist and questions that serve as an inspection plan, documentation of inspection findings, and narrative statements that can be added as appropriate to describe the licensee's program and document health and safety deficiencies.
Recommendation We recommend that Kentucky utilize a field type report for routine inspections in lieu of the narrative reports now in use.
4 4
Enclosure 2
II.
PERSONNEL Training is a Category II Indicator. The following comment with our recom-mendation is made:
Comment It was noted that one inspector has not received training on the inspection of teletherapy units. NRC sponsors a seminar on spot-check " Calibration of Teletherapy Machines"; however, the basic procedures and techniques for inspection of teletherapy licenses should be provided through accompaniments with qualified teletherapy inspectors and supervisors.
Recommendation We recommend that all materials inspectors be trained in the procedures and techniques of conducting a teletherapy license inspection.
III. LICENSING Licensing Procedures are a Category II Indicator.
The following comments with our recommendations are made:
A.
Comment During the review of the license files, a number of licenses weta noted to be renewed in their " entirety"; however, the information referenced in the " tie-doun" condition had dates that were several years old.
Recommendation We recommend that licenses refer only to current applications and sup-porting documents and references to superceded, outdated materials be deleted whenever a license is renewed in its entirety.
B.
Comment In general, the licensing actions performed since the previous review were well drafted and of very good quality; however, some improvements are needed as follows:
1.
License back-up information was missing from some files.
2.
Some files need to be reorganized.
The license and back-up information had not been separated from inspection reports and enforcement correspondence.
3.
Molybdenum-99 breakthrough test records should be maintained by the licensee for three years.
l I,-
I Enclosure 3
4.
Broad medical licensees should have a. license condition clearly stating that materials ~ for human use be used only by physicians approved by the isotope committee.
5.
In some cases, additional information was needed from the licen-see, s ch as: (a) radiation surveys performed; (b) frequency of surveys; and (c) procedures for dose calibrator calibration and QA test performed.
Recommendation We recommend that your licensing procedures be modified to provide:
(a) additional file maintenance; (b) correction of the standard license conditions involving " breakthrough records" and the " human use"; and (c) additional licensing guides for the applicant's use.
IV. COMPLIANCE A.
Inspection Reports are a Category II Indicator. The following comments with our recommendations are made.
1.
Comment Kentucky regulations require all persons to make every reasonable effort to maintain radiation exposures and releases of radioactive materials in effluents to unrestricted areas as low as reasonably achievable ( ALARA).
In general, inspection reports did not identify or document the scope of licensee ALARA programs.
Recommendation We recommend that licensee ALARA programs be identified and documented in the inspection reports.
2.
Comment It was noted that an inspection was performed on a Priority I licensee in November 1981, but the inspection report had not been i
completed at the time of this review.
Also, four inspections involving compliance actions required almost 30 days to issue the compliance letter. These compliance letters were not overdue but i
the State is reminded that inspection reports should be completed in a timely manner and compliance letters issued within 30 days of the inspection.
I Recommendation We recommend that the completion of inspection reports be closely-monitored by supervision to assure that timely enforcement action is taken.
l 4
f
1 Enclosure 4
B.
Independent Measurements are a Category II Indicator.
The following comment with our recommendation is made:
Comment Agency instruments should be calibrated at intervals not greater than that required of licensees being inspected.
Instruments used -for
" spot-check" output measurements of teletherapy equipment must be calibrated at intervals not exceeding two years. Although no tele-therapy inspections have not been performed since the previous review, the instruments normally used for " spot-check" measurements are overdue for calibration.
Recommendation We recommend that the instrumentation used for teletherapy " spot-check" measurements be calibrated prior to use for this purpose.