ML20058G810
| ML20058G810 | |
| Person / Time | |
|---|---|
| Issue date: | 11/08/1990 |
| From: | Kammerer C NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Eckoff R IOWA, STATE OF |
| References | |
| NUDOCS 9011140008 | |
| Download: ML20058G810 (11) | |
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' UNITED STATES '
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. WASHINGTON. D. C,20555
' November 8, 1990 j
Iowa Department of Public Health-l ATTN: Ronald D. Eckof f, M.D., M.P.H. -
i Acting Director Lucas State Office Building Des Moines, IA 50319-0075 l
Dear Dr. Eckoff:
This is to confirm the' discussion Ms. B.J. Holt,;NRC. Regional State Agreements-l Officer, held with you and Messrs. Kelly, Flater and Hokel on July 20,'1990,:
j following our review and evaluation of the Iowa radiation control program-Mr. A. Bert Davis, Administrator for the NRC Region-III office, also 1
participated in the meeting.
Our. staff has determined, as a result of.the regulatory review, that we cannot.
at this time offer a finding that:the Iowaiprograta for regulating agreement 1
materials is adequate to protect-public health and safety and.ccmpatible withi the NRC's program for regulating'similar materials; Significant problems were.
identified in two Category Indicators--Technical-Quality of-Licensing Actions and Enforcement Procedures. These are discussed below.
4 Several deficiencies were noted in the licensing casework reviewed, including an inadequate evaluation of a licensee's proposed storage facility. and.
failure to evaluate the supporting documentation in two renewal applications-for appropriate radiation safety precautions and_ compliance with current regulations. Of particular concern 1s the latter where:a large in-air-1rradiator at the University of Iowa was not evaluated for compliance with.
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State regulations regarding testing of door interlocks for proper functioning prior to operation.. Appropriate procedures had been: submitted by the i
licensee for the initial license, but'omitted in:the renewal appl.ication.-
This deficiency was not identified by the reviewer, nor by;the. inspector during a subsequent inspection.
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The State does not have adequate procedures for implementing its enforcement program, resulting in uncertainties on the part of the, staff in the handling :
of cases requiring enforcement actions and possibly inconsistencies in-administration. Also, errors and' omissions of? safety. violations were found' l
in enforcement letters.-
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9011140008 901108 j
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e Ronald D. Eckoff, M.D., M.P.H.
2 Our review disclosed deficiencies ir. several other program areas, including procedural development and documentation, staff supervision, and inspection reports. Most of these problems and those noted above appear to be either directly or indirectly related to the program's low technical staffing level.
The radiation control program is implemented on a day-to-day basis by a full-time junior level employee who has.been with the State for less than a year and a supervisor who devotes only65% of. his time to program activities.
With 219 licensees, the current staffing level is 0.85 person-year per 100 licenses instead of the reconsnended 1-1.5 person-years. Our experience has been that a low staffing level is often a-precursor to serious problems in State programs.
An explanation of our policies and practices for' reviewing Agreement State-programs is included as Enclosure 1. contains our summary of-assessments regarding the program. -These should be reviewed and a response addressing each recommendation is requested.
We wish to commend the State for planning and conducting an exercise to test the recently developed emergency response plan for non-reactor radiological incidents. Organizi;ig an exercise as complex as the one you implemented is time consuming rid resource intensive; however, the' experience gained justified the effort. We also wish to acknowledge your staff's prompt, on-site. response to reports of incidents and alleged incidents. This speaks highly for your management team, especia111 since a numbar of incidents involved non-licensees; and members of tne general public.
I appreciate the courtesy and. cooperation you and your. staff extended to Ms. Holt during the program review, and I am looking-forward to your responses to our recommendations. A copy of this letter and the enclosures are provided for placement in the State Public Document Room or otherwise to be made available for public examination.
Sincerely, original signed by Carlton Kammerer Carlton Kammerer Director State Programs Office of Governmentai and Public Affairs
Enclosures:
As stated cc:
J. M. Taylor, Executive Director for Operations, NRC A. B. Davis, Regional Administrator, Region III State Liaison Officer State Public Document Room NRC Public Document Room' I
See' attached distribution.
Ronald D.'Eekoff, M.D.,'M.P.H.
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~DATE :9/26/90*:.9/26/90*. :9/26/90*..:10/2/90*-
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APPLICATION OF " GUIDELINES FOR NRC REVIEW OF AGREEMENT STATE RADIATION CONTROL PROGRAMS" i
~The " Guidelines for NRC Review of Agreement State Radiation Control.
Programs" were published in the Federal Register on June 4 1987, as an NRC Policy Statement. The Guide provides 29 indicators for. evaluating Agreement' State program areas. Guidance as to their relative.importance to ca Agreement State program is provided by categorizing the indicators into two 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 one or more. 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 probleas 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 l
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 and 1s-compatible with the NRC's program.
If.one or more significant Category I'connents are provided, the State will be notified that the program deficiencies may seriously affect-the State's ability to protect the public health and safety and.that'the need for improvement in particular program areas is critical.
If, following receipt-and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of. adequacy and compatib41ty as appropriate.or defer such offering until the State's actions are examined and their effectiveness confirmed in a. subsequent review.
If additional information is needed to evaluate.the State's-l actions, the staff may request the'information through follow-up correspondence or perform a special limited. review. NRC. staff may h'old a special meeting with appropriate State representatives. No significant i
items will be left unresolved overia prolonged. period. - The Connission will ~
be informed and copies of the-review correspondence to the States will be placed in the NRC Public Document Room.
If the' State program does not improve or if additional significant Category I deficiencies have developed, a staff finding that the program is not adequate will be considered and the' NRC may institute proceedings to suspend or revoke all or part 'of the-Agreement in accordance.with Section 2741of the Atomic Energy Act of 1954, as amended.
l ENCLOSURE:1 l
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SUMMARY
OF THE ASSESSMENTS AND COMMENTS' FOR THE-
' IOWA RADIATION CONTROL PROGRAM FOR THE PERIOD MAY 28,1988 T0 JULY. 20,1990 l_
Scope of Review This program review was conducted in accordance with the NRC Policy Statement,
" Guide 11r.es for NRC Review of Agreement, State Radiation Control Programs,"
l published in the Federal Register on June 4,'1987. The administrative and-technical aspects of the State's program were' reviewed against the'29 program-indicators provided in the Guidelines.- The review-included an examination of the program's funding-and personnel: resources; licensing, inspection and) enforcement activities; and incident response capabilities.
In addition, J
there was a field accompt..; ment of the' new: State inspector _ and'an evaluation :
of the State's' responses to an NRC questionnaire.
The review was the third regulatory program review and was conducted:in Des Moines, Iowa, during the period July 16-20,'1990. 'The State was represented q
by Donald A. Flater, Chief, Bureau of Radiological Health and Bruce Hokel, i l Supervisor, Radioactive Materials, Iowa Department.of. Public Health. :; The NRC '
was represented by B. J. Holt, Region III State Aoreements Program Officer.
J Conclusion Significant' problems in two Category I Indicators were noted'.during the program. review. These will need to be resolved prior to offering a finding that the Iowa program for the control of agreement materials is adequate-to protect public health and safety and compatible with the NRC's program for' regulating similar materials.
In addition, problems in seven-Category II Indicators recessitated coments and recommendations 1toithe' State..'
a Status of Previous NRC-Comments and-Recommendations g
l The 'second regulatory program review was.cond6cted May 24-27,:1988. and coments and recommendations were sent to the State in a <1etter dated August.26 1988; At that time, the program was found adequate to protect public healthfand safety L
and compatible w1;h the NRC's programt The two comments on; staffing level and inspection procedures.were satisfactorily resolved by the State.
A mid-review visit to the' State's program was conducted June 12-14,s1989..
.Several recomendations' were made in a; report to the. State dated August.4,1989.
L All recommendations were resolved except those for. administrative procedures,
- 1icensing procedures, inspection procedures and inspection reports. These.have-been repeated as current comments.
j Current. Review.Coments and. Recommendations The State satisfies the guidelines-in 20 of the 29 indicators used for evaluating Agreement State program areas. ' Specific comments and recommendations for the remainingeindicators are as fo11cws:-
ENCLOSURE.2 4
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ADMINISTRATIVE PROCEDURES (Category II Indicator) 1
,Connent l
TheRadiationControlProgram(RCP)!shouldestablishwritteninternal procedures to assure that thelstaff performs:its duties'as required and to' provide..a high degree of uniformity and: continuity-in regulatory practices..
In response to comments.and recommendations from previous reviews and visits, the State has begun to document some administrative procedures.
However, procedures have not been documented for. handling' incoming mail 6 from licensees, filing and maintaining theLfiles of license and inspection:
documents, processing fees, assigning license numbers,; entering.new-licenses into the inspection system,- tracking expired licenses, and.
tracking licenses due for inspection.' The RCP management recognizes.thei need:for-having written procedures describing administrative functions however, this task has been assigned a lower priority.because of the' lack c
of staff resources.
Recommendation.
H We recommend program management place: higher priority onLcompleting written procedures, and: provide the resources necessary to _ complete the task.
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OFFICE. EQUIPMENT AND SUPPORT SERVICES (Category 'II)l l
Comment The RCP has several IBM personal computers and software packages for word l
processing and data management. An information management group in the Department of Public Health is:also available to assist the program with computer needs.
Yet, the RCP staff continues to manually track the -status of incoming license requests, license numbers, fees, etc. The staff l
reported some problems in tracking certain' licensing actions. These can be attributed to the use of a manual recordkeeping system.
Recommendation I
We recommend that the State evaluate current data management!needs and 1
i develop a computerized system for tracking actions and for-retrieving statistical information.
Comment u
p The RCP should have adequate secretarial and clerical > support..Because f
of 3 staffing shortage of-administrative personnel' in'the Bureau.of ~
L Radiological Health, tae RCP secretary is providing. support for other L
Bureau activities and spending'only about 60% of her time working for the program. Some secretarial duties, such as~ filing license documents, are currently being done by the technical staff. We understand that the State will be filling vacant secretarial positions in the.near future.
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Recomendation We recommend that the State monitor.the-impact.of the administrative.,
-l staffing shortage on the'RCP and provide additional secretarial support j
when needed to insure the most productive use of its technical staff.
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STAFFING. LEVEL (Category.II)
Comment Professional staffing level should be' approximately 1-1.5 person-year per 100 licenses in effect. :The staffing level for management oversight is q
in addition to the 1-1.5 person-year per 100- 11 censes:in effect.1 The q
State's RCP is implemented by one full time technical person, a supervisor =
who devotes only 65%.of his time to the Program, and a-Bureau Chief who spends 20% of his time on program administration.
During this review period, the number of licenses increased from 201; to 219 making.the:
1 current staffing level 0.85 person-year per 100, licenses.. The program is
- I not meeting the NRC's1 minimum guidelines for staffing.-level.
It was further noted during the review period that approximately 200 licensing:
actions were processed, 88 inspections were conducted, and the: staff:
responded on-site to 13 of,15 ~ incidents reported. However, we found.
significant problems in several program areas lwhich are directly related' l
to the low staffing. level.
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Recommendation-
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We recomend that at least one additional full time technical" person 1
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be added to the agreement materials program, and the-staffing levelt i
maintained at 1-1.5 person-year per 100 licenses not-including the staffing needed for management oversight. The?new staff. person:
i should be. utilized in both the licensing and' inspection areas.
4.
STAFF SUPERVISION (Category II).
Comment l
Supervisory personnel should be adequate to provide guidanceLand review the work' of-senior and junior personnel. ~This review identified errors and omissions in license reviews, license documents.sinspection reports,'and enforcement. letters which shou _id have been identified by supervisory -
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-personnel..
Recommendation 3
We recommend.that the RCP supervisor spend more time with the junior 1
personnel providing instruction and guidance on basic inspection techniques, l
having debriefings after:each inspection, and reviewing! carefully the contents of-inspection reports and: enforcement-letters...In additioni the RCP supervisor should continue to' accompany the : junior personne13 on-selected inspections..'We further recommend that the'~RCP director perform-independent reviews of' selected licensing actions 1using internal procedures, l
NRC guides, and standard review plans.
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TECHNICAL OVALITY OF LICENSING ACTIO$ -_(Categoryil) l The following comment is of major significance.
'l Comment l
The RCP should assure'that essential elements of-applications have been i
submitted to the State to establish the basis for licensing: actions,s In addition, licenses should be clear, complete, and accurate as.to isotopes, i
forms, quantities,' authorized uses, and permissive or-restrictive:.
conditions. Several deficiencies were noted during the-review of selected-licensing actions. These included inaccurate listings of isotopes and.
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authorized uses : an inadequate evaluation.of a licensee's: facility, and inadequate evaluation of' supporting documentation for; license' renewal.,
Recomendation
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We recomend that the State reevaluate the following licenses and make,
changes where appropriate:
1 License No. 0008-2-77 PMM, Amendment 1 License No. 0034-2-82 PMM 4
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.l License No,'0180-1-97 PG License No. 0014-1-85 SNM2, Amendment.1 License No. 0037-2-52 13, Renewal We further recommend that the RCP use available regulatory guides,4 standard review plans, checklists, and other. appropriate references when reviewing license applications for-completeness and adequacy. = The staff should also insure that the supporting documentation for license renewal reflects the current scope of the program and meets current: regulatory guidance.
6.
LICENSING PROCEDURES (Category II).
h Coment The RCP has available for use State:and'NRC licensingLguides,-checklists, policy memoranda, etc.; but these do not. appear to be organized 30 that they ~
l-can serve as useful tools during license reviews.c Many.of the concerns:
associated with the technical quality of.the Stat:.'s licensing ~ actions could have been avoided if the reviewer had c.ganized reference material.
We were-pleased to find that the-RCP has Ngun to. develop licensing notebooks for various types of licensins casework; based on a previous-recomendation; however, continued effort is needed.
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We recomend that the staff-continue to organize reference documents and
- use them as an aid in performing-licensing reviews..As the notebooksi become available, they should~also be used for training new staff. and'for i
conducting peer or supervisory review of. completedilicensing actions'.
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0 Comment 1
The RCP needs-to develop internal policy memoranda for conducting)
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pre-licensing visits, handling deficient applications', reviewing; renewal-l applications to insure evaluation of the 11censee's compliance history and j
the adequacy of supporting documentation, reviewing requests for license termination, amending licenses to. reflect commitments made as a. result'of-inspections or incident' investigations ~, and for conducting' supervisory.or.
peer review of licensing actions.
Recomendation
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We recomend that written procedures for the licensing' actions noted above i
be developed and made available to technical;and management staff.
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7.
{NFORCEMEN
T. PROCEDURE
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The following coment is of major significance.
coment 4
Enforcement procedures should be sufficient to provide a substantial deterrence to licensee noncompliance with regulatory requirements. The State does not-have adequate procedures for implementing its enforcement-a' program. The State.has authority to levy' civil-penalties in its' statutes, but has no implementing procedures. Administrative Procedure 87-0003.
which describes the actions the< State will take for Class 1, II', and'III violations are not sufficiently detailed:to allow the RCP to' determine:
the seriousness or the' level of penalty associated with-any given violation.3 This lack of procedures-has-resulted in. uncertainties on'the part of the RCP staff regarding the handling of cases. requiring. enforcement actionsf and possibly some inconsistencies, l
I Recommendation We recomend that'the State-establish written procedures.for implementing-
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enforcement actions. The NRC will assist the State'in this effort by i
providing consultation and training of-staff.
Comment Enforcement letters should employ a >propriate reg'ulatory, language clear.ly specifying all violations and-healt1 and safety matters identified.during_.
the inspection, referencing the appropriate' regulation or, license condition being violated.- A safety violation was omitted in'one enforcement:1etter-reviewed.and an inappropriate violation was-included'in a second. letter.
c Recommendation We recomend thatithe:RCP staff receive-additional training in the.
preparation and writing of enforcement letters. The NRC; Region:III 4
office will provide assistance in this effort.
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INSPECTION PROCEDVRES -(Category II)L w
l Coment Inspection guides,' consistent with current NRC guidance; should be used by inspectors to assure uniform and complete inspection: practices and l
provide technical guidance in-inspection of licensed programs.,'NRC-1 guides may be used if properly supplemented by policy memoranda, agency interpretations, etc. -The State needs to develop _ internal procedures or policies for conducting inspections, documenting inspection" results, issuing notices of violations,. investigating incidents and_-
insuring adequate follow-up, and tracking: enforcement correspondence'..
y Recomendation We recomend that the RCP develop procedures for. addressing and documenting _
j the areas described above..-
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INSPECTION REPORTS- (Category II)
- Coment Findings of inspections ~ should be documented in a report' describing'thi.
scope of inspections, substantiating all violations'and health and: safety matters,. describing the scope-of the licensee's programs and indicating the substance of discussions with licensee management'and licensee's response.
In reviewing selected compliance files and discussing the inspections with the RCP. staff, we found that most inspections were..
conducted in greater depth than that which was reflected in'the' report; The inspection reports, in general, appeared to be: hastily written with minimal documentation of effort or. findings. sAlso, there were unnecessary scribblings and coments in some reports.-
Recommendations l
We recommend that inspection findings be documented'in sufficient detail to reflect the scope and depth of the ins >ection.- There should be no' unnecessary scribblings and coments in t1e report; Summary Discussion With State. Representatives A sumary meeting to present the resultslof the regulatory program review was held with State representatives on Friday,. July 20, 1990, at 2:00.p.m.E The:
State was. represented by members of,the Department of Public Health:-.
Ronald D. Eckoff, M.D., Acting Director; ' John R.: Kelly, Director,' Division of Disease Prevention; Donald A. Flater; Chief. Bureau of-Radiological-Health;il and Bruce Hokel, Supervisor, Radioactive Materials.
The NRC was represente by A. Bert _ Davis, Region III Administrator and B. J. Holt,' Region.III. State Agreements Program Officer.
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The scope of the review was presented along with NRC findings and comments.
The State was informed that the preliminary review findings prevented a
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finding of adequacy for the State program., (Withholding a finding of i
l adequacy also precludes a finding of compatibility as reflected by the comment letter to the State). Mr. Davis participated in the presentation l
hy sharing with the State. some of the NRC's regulatory philosophy and experiences.
In response, Dr. Eckoff and Mr. Kelly expressed their support for the Agreement State Program and their appreciation of the NRC's efforts.
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