ML20056G067
| ML20056G067 | |
| Person / Time | |
|---|---|
| Issue date: | 12/05/1985 |
| From: | Hornor J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | Nussbaumer D NRC OFFICE OF STATE PROGRAMS (OSP) |
| Shared Package | |
| ML20056D285 | List: |
| References | |
| NUDOCS 9309010251 | |
| Download: ML20056G067 (2) | |
Text
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UNITED STATES p
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WALNUT CREE K, CALIFORNI A 94596 i
DEC 5 1335 Memorandum For:
Donald A. Nussbaumer Assistant Director for State Agreement Programs Office of State Programs nh ir Through:
Joel 0. Lubenau, Senior Projects Manager ete Agreements Programs, Office of Stat Programs From:
Jack W. Hornor, Region V State Agreements Representative
Subject:
STAFF FOLLOW-UP PIPORT AND EVALUATION - CALIFORNIA i
RADIATION CONTROL PROGRAM 1985 i
Enclosed is the subject staff follow-up report and evaluation.
As noted in the follow-up report, the California radiation control program was given a finding of adequacy based on programmatic improvements and the commitment to corrective action plans. A finding of compatibility, however, is being withheld until the adoption and publication of the revised California radiation control regulations.
Based on the results of the followup meeting, the staff recommends that the next routine meeting be conducted in approximately six months.
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Jack W. Hornor
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RV State Agreements Representative L
9309010251 930726 PDR STPRC ESCCEN PDR
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i Memorandum For:
Donald A. Nussbaumer Assistant Director for State Agreement Programs l
Office of State Programs i
Through:
Joel 0. Lubenau, Senior Projects Manager State Agreements Programs, Office of State Programs From:
Jack W. Hornor, Region V State Agreements Representative 1
Subject:
STAFF FOLLOW-UP REPORT AND EVALUATION - CALIFORNIA RADIATION CONTROL PROGRAM 1985 t
Enclosed is the subject staff follow-up report and evaluation.
As noted in the follow-up report, the California radiation control program was given a finding of adequacy based on programmatic improvements and the commitment to corrective action plans. A finding of compatibility, however, is being wittheld until the adoption and publication of the revised California radiation control regulations.
j Based cn the results of the followup meeting, the staff recommends that the next routine meeting be conducted in approximately six months.
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Jack W. Hornor RV State Agreements Representative f
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RSB/ Document Control Desk (RIDS)
I Mr. Martin Mr. Faulkenberry l
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UNITED STATES Ej NUCLEAR REGULATORY COMMISSION 5
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,e WALNUT CREtK CALIFORNIA 94596 SEP 161985 Dr. Kenneth W. Kizer, Director California Department of Health Services 714 P Street Sacramento, California 95814
Dear Dr. Kizer:
i This is to confirm the discussions Mr. Jack Hornor, Region V State Agreements Representative, held with Dr. Harvey Collins and your staff on August 23, 1965, following our follow-up review and evaluation of the State's radiation control program. The follow-up review covered problem areas in the administrative and technical aspects of the program found during the review held in February 1985, and included the program's regulations, administration, staffing, licensing, enforcement and compliance actions.
As a result of our follow-up review of the State's program for control of radioactive materials and the routine exchange of information between NRC and the State, we are pleased to find that overall the California program for the regulation of agreement materials is adequate to protect public health and i
safety. This finding is based on written action plans containing specific goals within given time frames as well as the improvements that have already been achieved in the Category I Indicators, Status of Inspection Program and Enforcement Procedures.
We are, however, continuing to withhold a finding of compatibility because of the Category I Indicator, Status of Regulations. The revised regulations have now been written, but have not yet been adopted.
It appears the remaining step is approval by the Office of Administrative Law, and we recommend that you request they expedite their normally lengthy review process.
We have noted a decrease in the overdue inspection backlog f ree 334 at the last review to approximately 85 currently. This reduction was due to the increased efforts by the inspection staff, the change to the NRC frequency schedule, and the addition of three new inspectors.
We appreciate your authorization of additional professional staff positicos in order to meet the staffing guidelines of from 1.0 to 1.5 person-years per 100 licenses, but we also found several of these positions remain vacant and the current staffing ratio is 0.68 person-years per 100 licenses. Unless the vacancies are filled expeditiously, we are concerned that the backlog reductions noted above will be reversed.
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Dr. Kenneth V. Kizer SEP161985 i
We also found the escalated enforcement cases identified in the previous review were concluded satisfactorily, and action has been completed or is being taken on the forty licenses that had expired.
l A problem remains in a Category 11 Indicator, Office Equipment and Support Services, that is having a significant impact on other program' functions.. The inability to f ully utilize your automatic data processing equipment plus the current shortage of clerical staff has resulted in a typing backlog that has
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delayed the processing of licensing actions by approximately six weeks.
i In summary, we have observed considerable improvement in the program and we believe that the personal support given by you and your staff contributed l
significantly to this improvement.
We are confident that with your continued i
support the California program can progress to exemplary status.
l We would appreciate your response to our comments and your plans to continue to improve Calif ornia 's radiation control program.
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In accordance with NRC practice, I am enclosing a copy of this letter for i
placement in the State's Public Document Room or otherwise to be made I
available for public review. A copy of this letter and your response will be placed in the NRC public document room.
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3 I appreciate the courtesy and cooperation extended by you and your staff to
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Mr. Hornor and my staf f during this review.
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Since ely,
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ohn B. Martin Regional Administrator j
Enclosure:
I As Stated i
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cc w/ enclosure:
j Dr. Harvey Collins, Chief, Environmental Health Division I
Mr. Joe Ward, Chief, Radiological Health Branch j
Mr. G. Wayne Kerr, Director, Office of State Programs l
State Public Document Room NRC Public Document Room (SP01) l I
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STAFF REPORT AND FOLLOW-UP EVALUATION OF THE CALIFORNIA RADIATION CONTROL PROGRAM FOR THE PERIOD FEBRUARY 16, 1985, TO AUGUST 19, 1985 A follow-up review to the 23rd regulatory program review meeting with California representatives was held during the period August 19 to August 23, 1985, in Sacramento, California. The State was represented by Joseph 0. Ward, Chief, Radiologic Health Branch; Gerard Wong, Ph.D., Supervisor ^, Radiation Management Section; Don Honey, Supervisor, Radiation Standards Section; nn3 the Radioactive Materials Section Staff. The follow-up review was conducted by Jack Hornor and Patricia Vacca of the NRC. A summary meeting regarding the results of the follow-up review was held with Harvey Collins, Ph.D., Chief, Environmental Health Division; Joseph 0. Ward, Chief, Radiologic Health Branch; Gerard Wong, Ph.D., Supervisor, Radiation Management Section; and Don Honey, Supervisor, Radiation Standards Section, on August 23, 1985.
The NRC was represented at this meeting by Jack Hornor, State Agreements Representative, Region V.
Conclusions Significant improvements were found in the three Category I Indicators that were identified as serious problems during the February review.
1.
The backlog of inspections overdue by at least 50 percent of their inspection frequency has been reduced from 334 to approximately 98.
The improvement is attributed to the changes in inspection frequency schedule, increased efforts on the part of the inspectors, and the addition of staff. An action plan has been developed that calls for a fifty percent reduction in the backlog by January 1986 and the complete elimination of all overdue inspections by April 1986.
2.
The failure to take appropriate action in specific enforcement matters has now been rectified. Action has been taken on each of the 40 licenses that had been allowed to expire without notice, and the licenses have either been terminated, renewed, or are in the process of investigation for possible enforcement proceedings. The cases in which escalated enforcement had been neglected were both satisfactorily resolved. This relates to the Category I Indicator, Enforcement Procedures.
3.
Revisions to the California radiation control regulations are tsking progress, although the Category I Indicator, Status of Regulatic-c, will remain a significant problem until the compatability regulations L;come effective.
These conclusions are based on the review of the technical and administrative aspects of the State's regulatory program for controlling agreement material.
1 21uded in this review were examinations of selected license and inspection files and the program indicators specified in the NRC " Guide for Evaluation of Agreement State Radiation Control Programs" which were identified as having j
problems during the 23rd review meeting.
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Also included in the follow-up-review was a meeting attended by Joseph Ward, f
Gerard Vong, Don Honey and Edwin Njoku (Senior Health Physicist, Licensing) of
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the State and Patricia Vacca and Jack Hornor of the NRC. The purpose of the meeting was to improve the clarity and consistency of licenses issued by California by establishing definitive policies, based on good health physics.
practices and consistent with the NRC and other agreement states, for a numuer of non-compatible licensing issues.
Summary Discussion with State Representatives A summary meeting to present the results of the follow-up review was held with Dr. Collins, Mr. Ward and staff on August 23, 1985.
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Dr. Collins was advised of the changes found in the program as discussed above. The reviewer complimented the State on the significant improvements made in the program thus far, and pointed out the need for continued emphasis l
in adapting compatible regulations, eliminating the overdue inspection backlog, hiring and training additional professional and clerical staff and l
1 better utilization of the new computer system.
j In response to the NRC representative's comments, Dr. Collins expressed his gratification that the reviewers had noted improvement and expressed his willingness to cooperate with the program staff and the NRC in order to j
f urther improve the quality of the radiation control program.
Program Changes Related to Previous Review Findings f
3.
Legislation and Regulations A.
Status of Regulations (Category 1)
Summary of Review Findings and Recommendations Compatability continued to be withheld because of the State's l
failure to maintain regulations that meet the NRC compatability l
requirements. The State had been able to pass low-level waste regulations in 1984, but except for adopting the equivalent to 10 CFR 19 in 1976, the regulations had not been revised since 1974.
l The need for increased effort in the revision process was pointed out to Dr. Kizer in the meeting and was an issue in the letter and i
the report.
Follow-up Findings l
5 Although the compatability regulations have not yet been adopted, the current revisions are now making progress in the formal promulgation schedule. The new regulations have now been written for the final compatability items and they are ready for submission j
to the Office of Administrative Law (OAL). The OAL, by law, is t
allowed six months for approval and filing with the Secretary of 1
State. There can then be a 30 day " post-filing" waiting period
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before the regulations become effective.
If the OAL requires no major changes and if the review process takes the full time allowed, a
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'I the compatible regulations should all be effective by July 1986.
The current status for each group is as follows:
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Group 7 (Low Level Waste) wts adopted in April 1984.
i Genp 4 (Transputation) became effective Jd v 12, 1985, but is not yet published.
Group 3 (Definitions) and Group 1.5 (Fees) had their public hearing l
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August 5,1985 and go to OAL September 5,1985.
i Group 2 (Licensing) and Group 3 (Radiation Protection and Standards) are scheduled for public hearing on October 9, 1985, and go to OAL November 9, 1985.
11.
Organization A.
Internal Organization of the RCP (Category II)
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Summary of Review Findings and Recommendations The internal organization of the RCP failed to meet the guidelines.
The State was unable to provide current organization charts, supervisors and staff members were uncertain as to their.
I responsibility and position in the chain of command, and the contracting agencies were somewhat confused in their conception of
-l their reporting requirements. These findings were not' considered i
critical enough to include in the letter or enclosure, but were items of concern discussed with program management and addressed in the report. A copy of a proposed plan for reorganizing the Branch was furnished by the State and enclosed with the report.
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Follow-up Findings J
The proposed changes in the Branch became effective July 1st. The new structure divides the Branch into two sections as illustrated in Figure 1.
The Radiation Management Section, headed by Dr. Gerard Wong, includes licensing, compliance, incident response and x-ray.
The j
Radiation Standards Section, headed by Don Honey, is responsible j
for, among other things, the promulgation of regulations, low-level waste and environmental monitoring.
A recent change in the State personnel policy.has resolved an issue that had presented problems in determining the authority of the Senior Health Physicists. They are now considered supervisors with the supervisory responsibility and authority for their unit.
Management training is being planned for the future, according to the training coordinator.
It appears from discussions with the staff and management that the reporting requirements are now understood by the contracting-agencies.
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RADIOLOGIC HEALTH BRANCH Chief, Joseph 0. Ward b
RADIATION STANDARDS SECTION RADIATION MANAGEMENT SECTION Supervising H.P.
Supervising H.P.
Don Honey Gerard Wong, Ph.D.
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ANALYSIS &
TRAINING &
RAD. & ENVIR. X-RAY MATERIALS MATERIALS f
EVALUATION CERTIFICATION SURVEILLANCE INSPECTION INSPECTION LICENSING HPS Senior H.P.
Senior H.P.
Senior H.P.
Senior H.P.
Senior H.P.
Jane Doyle I. Goldberg John Hickman Don Bunn Jack Brown E. Njoku Staff Staff Staff Staff J. Takahashi S. Rosenberg i
W. Grotegruth D. kheeler i
B. Kapel (DIR)
D. Barr K. Wong G. Butner i
W. Lew
- 0. deLalla L. Burns M. Gottlieb W. Watson i
(L.A. County)
J. Karbus, Chief A. Ferguson, Manager i
J. Rowles G. Edmunds i
(Orange County)
J. Hartranft Figure I - Radiologic Health Branch Organization Chart i
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A.
Quality of Emergency Planning (Category I) 1 Summary of Review Findings and Recommendations At the time of the review, a new emergency plan was being developed j
jointly by the Office of Emergency Services (OES) and the RHB. The a
plan was to have been distributed by the end of April'1985, and reviewer assessment of the plan was withheld until the follow-up j
review. None of the contracting agencies had been provided a copy j
of the existing plan and it was pointed out in the report that steps
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should be taken to assure proper distribution of the new plan.
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i Follow-up Findings j
The reviewer was furnished a copy of the new OES plan; however it is l
still not complete.
The sections covering transportation accidents
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j and theft of radioactive material have not been developed; the list of response instruments is not included; the responder telephone i
numbers have not been verified and updated; and the plan has not been distributed to participating agencies.
It was noted by the
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reviewer that the procedure for incident response does not specify l
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the point in an investigation at which a radiation protection specialist from the x-ray unit must refer the incident to a health j
j physicist. These findings were discussed with t.he appropriate staff l
J and review of the emergency plan will receive increased emphasis I
during the next review.
j B.
Budget (Category II) j Summary of Review Findings and Recommendations I
It was found that adequate funds were apparently not available for certain portions of the radiation control program. According to program management, funds were insufficient to meet the staffing l
guidelines and were not available for consultants to provide programming and training to enable the ADP system to function, for i
relocation expenses, instrument calibration, travel expenses for i
staff meetings and replacement of office equipment. This was discussed with Dr. Kizer and it was recommended in Enclosure 2 that j
management be given the ability to reprogram funds as necessary.
Follow-up Findings The State does not allow movement of funds from one area to another and Budget Change Proposals must be submitted a year in advance for j
i the next fiscal year.
However, emergency funding can and is being i
j provided by the Director, DHS. Three new positions were authorized j
as of July 1st; travel expenses have been approved for regional staff meetings; funds are available for instrument calibration; software has been purchased and funds for programming and training i
i have been allocated for the ADP system; and the necessary office j
equipment has been replaced.
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Administrative Procedures (Category II)
Summary of Review Findings and Recommendations G
I The administrative procedures were found to be inadequate and failed l
2 to meet the guidelines. This was discussed with Dr. Kizer and addressed in Enclosure 2.
The following problems were identified in f
the report:
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1)
The written procedures did not reflect the current practices within the Branch for licensing, compliance or enforcement.
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2)
Staff meetings were not being held with regional contract personnel. The communication between the contract personnel was found inadequate to assure program uniformity and inconsistencies were found in procedures and reports used by i
the various agencies.
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Procedures were inadequate for the indoctrination of new l
1 employees and newly appointed supervisors.
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The communication was inadequate between licensing and 4
compliance.
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e In Enclosure 2 it was recommended that the policies and procedures be updated and that periodic staff meetings be held.
Follow-up Findings r
Significant improvements were observed in the area of administrative I
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l 1)
New written procedures have been established in licensing, compliance, and enforcement.
2)
A staff meeting with all regional, contract and headquarters f
staff was held in June and another is scheduled for December.
i Inconsistencies in the programs were identified and discussed,
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l and the input from the meeting was used to develop the new procedures.
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A new didactic training program is being developed but is still i
in draft form. The program will include indoctrination for new l
l employees, supervision courses and coordination of technical l
training courses.
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A new procedure requires the inspectors' concurrence or l
comments on license amendments or renewals.
D.
Management (Category II)
Summary of Review Findings and Recommendation 3 i
7 The RCP management did not meet the NRC guidelines because of inadequate supervisory review and guidance in licensing and compliance. Although.it was an issue in the previous review and follow-up, review of the license files indicated supervisory or peer review was not being performed on all complex licenses, particularly medical. The inspection reports had not been reviewed by the compliance supervisor for six months. These issues were discussed with Dr. Kizer and it was recommended in Enclosure 2 that emphasis should be given to proper supervisory review.
Follow-up Findings The files indicate there is now peer review of all licenses and all licenses must be signed by a supervisor. The compliance supervisor has now reviewed all past inspection reports and is currently completing the reviews within fifteen days.
E.
Office Equipment and Support Services (Category II)
Summary of Review Findings and Recommendations It was found that the program lacked the support services necessary to fulfill the program needs or to meet the guidelines. At the time of the review, the ADP system purchased in August 1984 was not functioning because of lack of software and training and the word processing system was receiving limited use because the staff had received no training.
Those findings were discussed with Dr. Kizer and staff and were addressed in Enclosure 2 where it was recommended that consultants be used to provide the necessary training and development.
Follow-up Findings Database III software has been purchased and installed. Three hundred hours of programming and training time have been allocated to developing a functional system that can be operated by Branch personnel. At the time of this follow-up review, rudimentary programs had been developed to track licensing actions, overdue inspections and expired licenses. The programs are being refined as user input suggests needed modifications and improvements. Also, the secretarial staff has been trained in the use of the word processing system.
Currently, there is a shortage of clerical staff, and as a result, a backlog of typing has accumulated. This has impacted other program functions, particularly in licensing, where the reviewers feel there is a delay of six weeks in typing licensing actions and correspondence. This was pointed out to Dr. Collins, who offered to provide immediate aid from his staff until new secretaries can be hired.
IV.
Personnel A.
Staf fing Level (Category II)
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The staffing level, which has been below standards for several years, continued to fail to meet the guidelines and is still a major f actor in the State's inability to maintain adequacy. At the time of the review, the staffing level had dropped to.58 person years per 100 licenses, or approximately half of the recommended staffing level of from 1.0 to 1.5 staff years per 100 licenses, Four l
vacancies existed in the RHB staff and two in the DIR inspection
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staff although the positions had been authorized and funded. This J
was attributed to the State Personnel Board policy of requiring semi-annual examinations of applicants.
In the meeting with Dr.
Kiser, he was advised of the need for increased staffing, and he was reminded of the previous Director's intent to establish continuous testing.
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Follow-up Findings Three more positions have been authorized for the current fiscal year and if all vacancies can be filled, the staffing level will be increased to approximately 0.9 person years per 100 licenses.
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Budget Change Proposals have been prepared asking for additional l
i staff for the next two fiscal years, with an ultimate goal of 1.26 t
l staff-years-per 100 licenses by July 1987. Currently, however, there are still six vacancies and the current staffing level ratio is 0.68.
The cumbersome method of using semi-annual examinations to j
establish a hiring list has been replaced by a new method which j
allows program management more flexibility and replaces the exam with the " Evaluation of Education and Experience" procedure. The j
Branch is currently in the process of recruiting and processing l
l applications.
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B.
Staff Supervision (Category II) 1 i
l Summary of Review Findings and Recommendations j
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3 While no deficiencies were noted in the staff supervision, the four l
j Senior Health Physicists heading the compliance, licensing, i
l low-level waste and x-ray functions were all newly promoted. As j
could be expected, they were still somewhat. unsure of their priorities, authority and responsibility.
In the report, it was suggested they receive more guidance from senior management.
Follow-up Findings l
i At the time of the follow-up meeting the Branch had recently been reorganized. Dr Gerard Wong now heads licensing and compliance, j
and Edwin Njoku had just been promoted to Senior Health Physicist of the licensing unit. As discussed earlier, the State has made the j
Senior Health Physicist a supervisory level position, and this step j
should clarify some of the confusing aspects of that position.
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V.
Licensing
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A.
Technical Quality of Licensing Actions (Category 1)
Summary of Review Findings and Recommendations t
The review of the license files revealed several deficiencies in l
licensing practices that, although not of a level of seriousness sufficient to warrant withholding adequacy, were nevertheless improper practices that could lead to unnecessary radiation exposures. The following examples of improper licensing practices
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which were observed during this review, as well as in past reviews, l
were discussed in the exit meetings and in Enclosure 2.
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Radioactive xenon use was authorized without supporting j
documentation by the applicant concerning safety precautions or an evaluation ey the licensing staff.
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A physician user was authorized for medical groups IV, V, VI l
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when he only had documented training and experience for group i
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Information in an application concernirg waste handling j
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procedures and safety provisions for waste storage areas were l
1 inadequate or missing.
1 In addition, the following concerns were identified in the license e
I file review (Appendix H of the 23rd review) and were discussed in a i
i general staff meeting: Appropriate license conditions were j
sometimes inadvertantly omitted; documentation of the users' training and experience was not always provided; the licensee's i
compliance history was not always considered during the review l
process; equipment and facility descriptions were sometimes not complete; several complex licenses were issued without evidence of i
peer review; and, finally, there was a lack of consistency between l
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licenses of the same type issued by different reviewers.
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Follow-up Finding j
l Sixteen pre-selected license files were reviewed. Emphasis was l
placed on determining whether improvement had been made in j
deficiencies and improper licensing practices identified in previous j
reviews.
l Overall, the technical quality of the licenses has improved, and it l
was observed that all licenses are receiving peer review and that
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the compliance history is now considered on all amendments and l
3 renewals. However, there was still a lack of clarity in several l
l licenses, and licenses of the same type authorized by different reviewers revealed 2nconsistent po12c2es.
i 4-j In an effort to resolve the continuing problems in the California program, a meeting was held between the NRC reviewers and the RHB 9
supervisors involved in licensing. The purpose of the meeting was 1
to establish definitive policies which are based on good health j
physics practices and which are consistent with the NRC and other
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i agreement states for an agenda of non-compatability issues. A j
j uniform policy was established during the meeting for most types of i
licenses; however some decisions on a single policy cod d not be i
made immediately. Program management has promised to resnive these l
issues and to produce a list of standard policies to be used oy reviewers in the future. The list should be ready within sixty j
days.
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4 The review of the license files and summary of the comments is 1
included in the appendix. These cases were discussed in a general t
meeting with the licensing staff.
B.
Licensing Procedures (Category II) i Summary of Review Findings and Recommendations I
The lack of consistency between licenses of the same type, the need j
for clarity and completeness in some licenses, and the lack of j
coordination between reviewers and inspectors were all found to be I
procedural problems that were addressed in Enclosure 2, and were
-j discussed with the staff management and in the report.
It was recommended the procedures and forms be changed to ensure clarity l
and completeness, to include peer review, and to make the reviewers aware of the compliance status.
Follow-up Findings Management responded to the recommendations and has done a commendable job of updating and changing procedures. Peer review is I
now required and documented on all licenses, and currently only supervisors may sign the licenses. Reviewers are now required to l
consider the compliance history and
".o document the inspector's l
input before completing licensing actions. The reviewer was also
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furnished copies of the following revised procedures or forms:
l New Standard Review Plan l
1 Revised Standard License Conditions Revised Vell Established Medical Uses Revised License / Amendment Draft / Medical j
Licensing Checklists for bone mineral analyzers, gas chromatographs, fixed gauges, portable nuclear moisture / density
'i gauges, small laboratories, medium and larger laboratories l
1 Also, the f ollowing programs are online to assist in program I
management:
Mail Log (records current licensing actions)
License Control Report Expired Licenses VI.
Compliance i
A.
Status of lnspection Program (Category 1) i
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Summary of Review Findings and Recommendations The number of overdue inspections had increased during the previous review period and this was one reason for withholding adequacy. The inspection program had 334 inspections overdue by more than 50 percent of their scheduled frequency at the time of the review.
This was discussed with Dr. Kizer, and at the time of the exit meeting he agreed to increase the staffing level in an effort to 4
solve this important issue and to change the state's priority and frequency to the system used by the NRC in order to reduce the i
number in the backlog.
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Follow up Findings Although still a serious problem, the backlog of overdue inspections 4
has been significantly reduced. After the last review, the State adopted the NRC inspection frequency schedule, which reduced the l
number of inspections overdue by more than 50 percent of their scheduled frequency from 334 to 146 as of February 1985. By August
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15, 1985, the backlog had been further reduced to 98.
The reviewer was furnished a written plan calling for the elimination of the I
i backlog by April 1986. The authorized increases in the staffing level should make this a realistic goal. According to the action plan, the progress will be audited monthly by the supervising and senior health physicists and the results reported to the branch chief.
i B.
Responses to Incidents and Alleged Incidents (Category 1)
Summary of Review Findings and Recommendations A new policy which combines x-ray and RAM files and personnel went into effect February 1, 1985.
It was noted in the report that the impact and effectiveness of the new procedure would be evaluated in the upcoming reviews.
Follow-up Findings f
The procedure could not be evaluated during this follow-up review i
because there had been no circumstance in which a radiation protection specialist from the x-ray unit had been called to respond to an incident involving radioactive materials.
C.
Enforcement Procedures (Category 1)
Summary of Review Findings and Recommendations Significant problems in enforcement also led to the withholding of adequacy. As was pointed out in the letter, two significant problems were found.
First, forty licenses had been allowed to expire without action being taken for renewal or divestment; and I
a second, there were instances in which contract inspectors could not bring recalcitrant licensees into compliance and in which program i
management did not follow through.
It was recommended that j
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management focus attention on prompt action in the specific cases f
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and that tracking methods be established to prevent future
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j mishandlings.
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The failure to take appropriate action in spec 2fic enforcement i
matters has now been rectified. Of the 40 licenses that had been allowed to expire without action, 21 have been renewed or terminated and the other 19 have been sent notices and are in various stages of t
follow-through. The program now has a computer-based tracking system to prevent reocurrence of the problem. The two cases of urgent escalated enforcement that had been neglected by program
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management have now been resolved. The licenses were both terminated and in one case a survey of the premises indicated no radioactivity.
In the other case, the agency conducted a surprise inspection, confiscated the radioactive material, and the state is
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in the process of assessing a civ21 penalty.
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D.
Inspection Reports (Category II) l i
I Summary of Review Findings and Recommendations 4
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4 As stated in Enclosure 2 and the report, the inspection reports f
lacked consistency and uniformity. The contracting agencies were all using dif ferent forms and procedures.
It was recommended that i
all agencies use the same format in their reports to ensure consistency in the inspections.
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Follow-up Findings i
i i
J A new uniform inspection form has been implemented. The inspectors from the contracting agencies and the compliance senior health physicist worked together during the last staff meeting to develop l
the form.
It appears the form is an excellent one and, properly l
]
used, should enhance the quality and thoroughness of the inspections 4
themselves.
5 E.
Independent Measurements (Category II) l Summary of Review Findings and Recommendations J
i Examination of the survey instruments in the Branch headquarters
[
showed they had not been properly calibrated. This was a repeat finding from the last review and because it was attributed to lack of funding, it was discussed with Dr. Kizer. It was also addressed in Enclosure 2 where it was recommended funds be located for this essential program element.
3 i
follow-up Findings Funds have been aliocated and the instruments have been calibrated.
This was verified by examination of the instruments and records. A logging system has been established to keep the calibration current.
i 4
i m
r w
,, +,.. - -,,, -
e-
s 13 I
n 1
I q/
APPEND 1X l
REVIEW OF LICENSE FILES 1
Sixteen pre-selected license files were reviewed during the follow-up meeting.
License applications and amendments were reviewed for completeness and for proper signatures. Licensing actions were checked for timelindss, completeness, accuracy, observance of good health physics practices, I
peer-review and consideration of enforcement history.
Specific reference was made to the findings of previous reviews to determine whether the deficiencies and improper licensing practices identified during those reviews were still occurring.
l A general improvement in the technical quality of the licenses was noted t
during the follow-up; however licenses are still being issued in which the documentation is not clear as to the isotopes, forms, quantities, authorized l
l uses or users, and permissive or restrictive conditions.
Inconsistencies i
exist in licenses of the same type authorized in different years or by f
different reviewers.
u t
j Comments on deficiencies or irregularities found in the files were identified
(
and discussed in a general staff meeting.
l
)
A sunmary of the licenses reviewed and the comments follow.
[
8 j
File No.
Licensee i
1 1.
Medi/ Nuclear Corporation i
4 Baldwin Park, CA 91706 License No. 2816-70, Amendment 7 I
Issued:
12/19/84 Expires:
3/11/91 i
j Type:
Radiopharmaceutical Manufactut. (Repackages Xe-133 l
gas, primarily) i
)
2.
Charles J. Phifer, M.D.
Mission Hills, CA 91345 I
License No. 4499-70 (New)
)
Issued:
1/29/85 Expires:
1/29/92 Type:
Medical Groups 1 & 2 (including Xe-133 and -127);
i Sealed sources for calibration / marker j
i l
3.
The Regents of the U of California San Francisco Medical Center San Francisco, CA 94143
[
l License No. 1725-90, Amendment 13 Issued:
2/13/85 Expires:
1/12/85 (Timely renewal application filed) 4 Type:
Type A Broad (R&D and human uses) d 1
l 14 l
?
)
'3 4.
Pacific Medical Imaging, Inc.
Huntington Beach, CA 92646 License No. 4313-70 Issued: 5/7/84 Expires: 5/7/91 (New, corrected copy mailed 3/29/85) i Type: Mobil Service with diagnostic nuclear medicine l
1 5.
Yuba Sutter Radiation Oncology Associates j
Yuba City, CA 95901 License No. 4311-04, Amendment 1 i
Issued:
3/5/85 Expires: 3/13/91 Type: Medical i
6.
Mt. Diablo Hospital Medical Center Concord, CA 94520 l
License No. 0729-70, Amendment 60 Issued:
4/5/85 Expires: 6/5/91 Type: Medical, Groups 1-6 l
J 7.
Advanced Healthcare Diagnostic Services Santa Fe Springs, CA 90670 l
l License No. 4537-70 (New)
Issued: 4/12/85 Expires:
4/12/92 1
Type: Mobil Service; diagnostic nuclear medicine 8.
Healthcare Medical Center of Tustin
[
Tustin, CA 92680 License No. 2394-30, Amendment 11 i
Issued: 4/15/85 Expires:
8/14/88 Type: Medical; Diagnostic, Therapy, IND studies 9.
Eye Bank of San Diego County Medical Society l
San Diego, CA 92103 License No. 1206-80, Amendment 17 f
a Issued:
2/26/85 Expires:
4/18/91 Type: Medical; Sr-90 eye application at multiple locations 10.
San Antonio Community Hospital i
Upland, CA 91386 License No. 0107-36, Amendment 36, 38 Issued:
- 36 3/22/85, #38 5/10/85 Expires:
12/3/90 Type: Medical, Diagnostic, therapy and IND studies 11.
Richard N. Donelson & Associates Van Nuys, CA 91406 License No. 1534-70, Amendment 11 i
Issued: 2/26/85 Expires: 5/15/91 i
Type: Service License, Consultant i
12.
Kern Medical Center i
Bakersfield, CA 93305 License No. 0061-15, Amendment 39 Issued: 2/5/85 Expires:
11/19/87 Type: Medical; Diagnosis, therapy, IND studies I
l
~
.~
l 15 l
i 1
i 13.
John P. Thropay, M.D.
I Montebello, CA 90604 License No. 3666-70, Amendment 13 Issued:
1/20/84 Expires: 3/28/27 (corrected copy mailed 1/10/85)
Type: Therapy at office and multiple locations) l 14.
The Cancer Foundation of Santa Barbara Santa Barbara, CA 93102 License No. 0104, Amendments 61 and 62 Issued: #61 4/26/85; #62 5/15/85 Expires:
11/19/90 Type:
Medical; Diagnosis, theraph physician-sponsored investigations i
i 15.
Chino Community Hospital i
Chino, CA 91710 i
License No. 3557-36, Amendment 5 1ssued:
5/16/85 Expires: 5/7/87 Type:
Medical; diagnosis internal therapy, clinical investigations 16.
Needles-Desert Communities Hospital Needles, CA 92363 License No. 3520-36, Amendment I I
Issued: 4/16/85 Expires:
7/25/92 Type: Medical; diagnostic nuclear medicine i
l i
i h
i
}
4 l
l a
I i
i
5 16 a.
I i
Comment Files i
1.
Need clarification about which licensed materials may 1, 4, 7 l
be used at temporary job sites j
i 2.
Authorized user condition could be clarified 1, 6, 12, 16 3.
Needs special condition to authorize receipt of waste 1 from customers i
4.
Application refers to NRC regulations, not California 2
)
regulations
{
5.
Daily surveys not required and/or acceptable levels 2, 14 l
of contamination not specified l
i 6.
Typographical errors, including wrong license number 3, 8, 9, 13, 15 l
7.
Licensee file did not contain all backup documer ;
3 i
8.
Cover letter describing conditions of license is not 4, 7 l
accurate t
9.
No authorized place of use on license 6
l i
10.
No possession limit on license 6
[
11.
No fee condition on license 6
r 12.
Need to survey. patient and count sources before 8, 14 dismissal of patients with temporary implants (Co-60, Cs-137, Ir-192) not clearly specified in application 13.
Authorized user granted additional authority without 8, 10, 12, 13, 14 l
adequate documentation of additional training and l
experience i
14.
Request for licensing action unsigned 8
j 15.
Mo-99/Tc-99m generators authorized twice on license 12 (Group 3a.1 and Item 2 of Category H) l a
i 16.
Failed to continue authorization granted between 14 i
receipt of renewal application and issuance of renewed license 1
l 17.
Failed to respond to Item 10.C. re: QA of clinical 14 instruments l
18.
No comment about licensee's statement that 250 1,4 i
millicuries Cs-137 used to check dose calibrator i
l I
1 l
i i
OC/&wAL s
v 9 OF CALnORN;A-4EALTH AND WELFARE AGENCY f
MgmAN, h 1ARTME$T OF HEALTH SERVICES 685 714/744 PStrdet N
dY,. 0 Sacramento, CA 95814
/
(916) 322-2073 49 8
V/fp October 2, 1985 John S. Martin Regicnal Administrator U.S. Nuclear Resulatory Commissien Region V 1450 Maria Lane, Suite 210 Usinut Creek, CA 94596
Dear Mr. Martin:
This respends to your report of the icilow up review of our radiation centrol program completed by your staff on August 23, 19S5.
I appreciate the eiferts of your staff (Jack Hornar and Pat Vacca) during the follow up review at d am pleased to note that you find that overall the California radiatien centrol peceram is adequate to protect public health and safety.
I reccenize that this finding :ss based on written acticn plans containing scecific ecals within siven time frames as discussed with your staff during the icilow up review.
I am enclosine a copy of these updated plans fer your information.
I want to assure you that the progress we have made to date will centinue.
Staff werk en proposed reeviations to establish compatibility with tRC regulaticns in 1DCFR is complete.
Public hearings for groups 1 and 1.5 were completed on Aueust 8,
1985.
I have requested the California Office of Administrative Law (OAL) to expedite revieu of these resulation promesals.
Hearines fer the remainder of our pecposals (Grocas 2 and 3) are set for October 9,
1985.
These grcups will be transmitted to OAL followins the completion of my post hearing review.
The utilization of personal computers to support the radioactive materials centrol effort is presressine.
Support for programmine and data base development from our Data Systems Branch has been provided.
The Radiologic Health Branch is proceeding to utilize the personal computers as word processcrs ice the production cf licenses and deficiency letters.
The utilizatien of clerical ev,ertime has eliminated the typing backlee in the prccessing of licensing acticns, i
Ue have centinued to reduce the overdue inspection backlog fecm 334 at the last review to 66 currently.
This improvement will continue as we complete cur recruiting peccess to f il l the iive prof essinnal vacancies in Phterials Control including the inspection pcsition in Sace, ento.
_i e~-
- & iD %
s-1
/
.'I John B. Martin Pase 2 i
- Asain, let me assure you that I want California to have an exemplary radiologic health program.
Measures beins taken as outlined in the enclosure should reach this objective in short order.
I trust this information uill be helpful to you and your staff as you prepare for your next review of our prosram uhich I understand is scheduled for the first quarter of 1986.
Please feel free to call me or Harvey F.
- Collins, Ph.D.,
Chief.
Environmental Health Divisions (916) 322-23DS, if you have any questions or additional concerns.
Sincerely, Kenneth W. Kizer, M.D.,
H Director i
Enclosures
^
e a
u
\\
5*
sf Celifernio Department of Health Services
(
hemorandum Dee.
September 24, 1985 To i
Linda Stockdale Brewer b"N'#'
Director Office of Administrative Law Request for Expedited-L414 K Street, Suite 600 Review of Radiation Control Regulations Proposals From :
Office of the Director 8/1253 5-1248 The Department of Health Services is updating its regulations to establish compatibility with regulations of the U.S. Nuclear Regulatory Co==ission (NRC). California's Radioactive Materials Control Program is maintained under an agreement with the'NRC which includes a requirement to maintain compatible _ sets of regulations.
The NRC is presently unwilling to make a finding that our State's radiation control program is co=patible and adequate to protect health and safety.
The sole basis for the unwillingness to make a positive finding with respect to our radiation control program is that California has not adopted compatible regulations.
In view of the critical need to promulgate these regulations, I am requesting that you expedite your review of the following regulation proposals as you receive them:
R-49-84 Title 17, Chapter 5, Subchapter 4, Group 1, Registration of Sources of Radiation.
R-50-84 Title 17, Chapter 5, Subchapter 4, Group 2,
Licensing of
~
Radioactive Materials.
R-13-85 Title 17, Chapter 5, Subchapter 4. Group 3, Standards for Protection.
~
The first of these proposals, R-49-84, is enclosed.
The other two proposals will follow after the public hearing for them is held on October 9, 1985.
These proposals contain the regulation ^
sections of critical interest to the NRC and my Department.
Thank you for your attention.
e,s Kenneth W. Kizer, M.D.,fN.P.H.
Director
I 7
CO?RECTIVE ACTIOJ PL#4 h
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4/30/06 V.A. l!.A.
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',I State 2/20/06'.
q with final Statement of Reasons to
+
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j and 3 set for hearirs 10/9/05 f ollowins 3
erproval of notices filed with ON_
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Technical Quality Completed IV.A : II.C The PRC written communication was
[t unclear. We understood it not to
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g bP 51tpitttt3Mt af mMistU55ttns 7.,
e, with PNC representatives.
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Backles of Reviews 11 4/30/06 ll.Asl !!!
On target.
4 DATA PPOCESSIPG PWWDW 11 0/30/86,w II.A.
!.0, On target.
)
i?ETEi%TIOPTfD CDGATIO.
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.1 0F LICDGItG #D Cott'LINCE s
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- From " Comments and Recomendations for the California Radiation eg( Control Program for Aseeeeent Materials" N with A/26/03 letter frem tEC Regional Adelnl.s.trater)]
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al 9/30/85
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WbT Eliminate the backicg of compliance inspections and enforcemen actions
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3 er Reduce the Increasing backles of overdue inspections without so of W
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3 e Adopted the PRC's Inspectlen prfority system en March 15..1985,: to reduce i r
. df M
'd ev--tsstrias,
ims reaucea sne cacM ertgrfC.
ine nur mai i r wec tur
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workload is thus reduced by ~7. but it is essentially offset by a' Isrowth d
rate of 4.5Vyr in the number of licenses.
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er Hiring templeted l
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- 1 Associate IP T 6/31/85 Last list was embausted.
Closins date for
+
?[i new ewam is 8/15/03.
Met with Exam Unit
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I bye (!) obtaining pre-approved 3001 and (2)
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adoption of Education end Experience d,
s53 evaTG31i on in iieu oT T ierviews. Lea.T f Tbd list due 10/1/05. 11/1/05 re-tarset will be
[
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possible if the above are done.
94-p m
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ELIM1mTIQJ CF DACKLOG Cr OIERDLE INTECTIOG l;I
. OsR t.;
ierset uatE's
,a ci v w Wtim 20/176-p Agency Overdue by 50?.
50% Reduction Eliminated
' Overdue by 507.
Overdue bv 507.
Overdue by "E
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TOTAL.........,146 4
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98 75 66 3
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.i TN?[T DATE: Apell 30, 1906 i
On tarset. Close tracking is maintained by
[
the TtwitutMdwatth--Phyrtetst sru
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s' 4*
"I monthly inspection agency report and wdate 7/
of the Inspections Due/ Overdue List. Results I
~
at numtier o f inspectTIMI~!TVEF8u'tr*' Tor Eacn e'
Inspection esency are reported monthly.
q r-b Remedial action to meet the 1/[G and 4/06 JJ tariiietr-fermB intarmeo.
Gper tefitr$
y-staff in Sacramento will be used to train
- f, l
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~
,j and support _.the RFD-North inspection position in ei sminatins the overcue uacnios which for OB Is in the Northern territory.
We expect to complete the hiring process for jl the inspection posi tion b9~11riim.
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Take' appropriate enf orcement action on 40 expiredd,icenses to 4.ittsate Compilence has reviewed the 40 licenses lL iaeMTf1Winr1%g tRC'J6d M5-e5tartttMa completely any potential lepact on public health and safety.
h no impact on health and safety and e r instituted tracking procedures to
[
5 temtBaticM trr TetMtatement.
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o Sent notices of divestiture to affected licensees, and copies to See 1.c (page 5 below).
p.
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,(
s Inspection agencies as of ApriI le 1903.
R Mt s we m., g.~
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4~
o King Neptunes an erpired licensees was inspected and found to h ve no 4
j'(
i c3 imget?
JMtV frSteted.
puttanttigef7ttdtcatttW matEF~ tat-trtwit-tT3.
Health #' Department Odidt however. cite Pb 'eetting. The licepse~was
[
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g u
terminated.
'. (-
=.!
<g o Los Angeles County' Health Departments our contract l inspection gegency, The matter of Alarm Concep?s has been taken C'(
.Q by the LA City Attorney for prosecution wTTT 7 onduct an inspection to cele 7iiiiiiE~TT-ATarm ConcepTMr-- Ettt i under misdemeaticrand ctvil pematty
,d provisions of the Health and Safety code.
y '(
F.
possessing radioactive falls of exempt smoke alarms without a valid LA made a visitation en.1 confiscated the iotts.
- I 7
1 IIcense.
7 O
<1 a
b 9
o Hire four Associate Health Physicists who will engage in enforcement Completed 3
hires.
MB Comptlance e
l Associate Health Physicist pending.
(See es comptta m nspeettuns, tm-trage-3) abtwe.
atttens es weii i
Ti$ E T DATE: NAugust ~15 1903 i ;
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Category I Enforcement Procedures U RC V.0)
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'.-f Develop enforcement procedures to avoid in tT,e future tW br ob lem b
I'{
of expired licenses and licensees using radioactive material without a
[I valid license.
,[; },
kv
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ACTIUJi N,
o AREITIuleo a tracking system oT EspirecrTTHREene. on an i nter im,t3as e s by tupireu incen5Es
( i nc tia ns the t.u p
i n Apr'$.J.
4W
, : % "W;,
identi' led by the PRC) are now tracked to
[1*
li 1903.
m [5 :
- hand, assure notice to divest leading to termir 4Tihn and clearance or ret 6sistement f
folleding review of application.
Weitten le i,*lI proc ~dures are establibbed which require I
moHHTy insting of empir ecT'TTGREes ana
-~
.i.
4 P
-Q-
,; /
W monthly review. by Materials Control 4
%f07,
c
,f h
management' relative to need for escalated enforcement action end ITa RTTii ci cases to
.I closure.
- '.(
3
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i*l o Institute a tracking system of expired licenses on> a permanen't basis DOase III acquired 6/15/O'5.
. 2,
&(
using the Branch's T trocomputer system by July I,
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T c Provide the output of the tracking system to the fr'spectors alons with en lespection acency is sent copy of Notice to s
so-M..
vivei M ~nd M iu en cases requir Tns I
se tri procedural menos.p This willybe.directe d by the
'{f, follow-up.
J, g' h' cYr. Qj'Jexplanation of 'Its%pr w A y_
o g >>
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t dentor ma i th i'ny s icTsMor comptience.
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w-availab..,,w y p
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..,'#tM[;toistaffthe('draftgotUuniformQ'inspectio-forms on'i The uniform inspection format is fst)% M d r.s?
.A y
'.L
'use.
now In
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ab rM QW1-N sune e im.
tomments v e or statT~ art due'Juiy i. Fra ano it es wiii b
l' I be in use July 15, 19CD.
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o, tract Memo has i been issued to 140 staff. DIR.
u*. s and~'OC-'115~Tet Tneet i ng o&Ie bettTFen staff assigned to Radloactive Materials Control to review sood health 12/2/83 and 82/l3/05.
Asenda items have
-[
I i been solleited.
physics practice tano. to ainform s the staff 7 1.upcatea polic.es ana l
f,.
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.[2 m,- JJ;;q r-]A administrative procedures.";The 'first meeting occurred June 4-6I 905.
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a Review. by Jthe Senior Health Physicistler Compliance, all ' lespection. 6 sinspection ' reports are reviewed by the A
Compi iaEEFJMc7~~ tit'atth 4 hystttst vt1Mn r
reports within 14 days of receipt.
All inspection reports and 14 days of receipt by the Branch. Inspection N
reports and compliance letters generated by r uwitance-titterr-Trtmr N'Grttati viii. be reUtewetfdetcre-Itwitance
..mtati in - vatntra are revtewed by the i,
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,d.1Compilance Senior or local manasevent
..., %[ D N -
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- 4
<--$"M ff
' D ~for contract?. inspection agencies pelce to "
issuance.
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Lategory 14 Andeperwjent Deasveements uht v.w l
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,f Insuee that N field @easurements'v with ; portable S hradiation e
tetection*
I i
Instruments a*e accurate and reproducible.
P
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-Na i
l ACT10 Gs U p %. *
' - ' @T.. @. j di 2,.
I o nais to inspection asencies the instrument cal 6bration requiremen 76Ticy tampierfe.
l (completed November 1904).
This polley was discussed at the Juqe 1905 E
w 1
ereting.,
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4 o Establish a coutine tracking procedure for confirming thatt timely Inspection reports a*e reviewed for
[
i calibration date.
A calibration tog or calibeaIT5ntrepair..is done.
. shes.ma R er: bas been foiscussec4[e M Te catabslie as beTns estaunesseo in N W. de f T
each inspection agency relative to
- staf f /contracto,. neeting held in Derkeley'. ton /Oune m6 G 1905. ~ Currently Instruments in active use.
Callb*ation M
r stickers wiii continue to be useo to inspection reports require citation of calibra tion date of all Identify instruments in cuerent calibration C
instruments.
Anspections cone with unquali t teo J nstruments w 6 u ~ be
,3,..
jp d M G ; @ i"ca. 4, Q
'g rejected.h W.
1Mi SOL I'M'M.%. -
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4 o increase efforts to confirm Instrument calibration as recorded on On target.
f, (
l Inspection-reports. During accompaniments made by nthe Genior
- Health,
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Ebysicist f or compl iances sur vCy instruments will be physically thecked n
to determine their calibration status.
flk a
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7
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, ~calibratten : sources and calibrated Gall' calibration / check Purchase order for small check sources was
[ [
iss eo oy uusiness dervices on aiw o:2.
e u
sources for low-level suevey Instruments trere ordered in November 1904 Calibrator order cancelled a*xi returned.
i Reorder deferred pending equipment budget.
[
a calibralor for the higher ranges at i
instruments-.was ordereo ong eay a e Re5F6FFf6~7/267c5.
t.
is l
1905.'
Repale work will continue to.be performed at Lawrence [Derkeley
((
l Laboratory.
.=
4
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TIEET DATES October 30 1905 i
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ff.,
e 5z 7. STi 1 AM _
.Q 'c l
y y. f. ' GOAL: N.
t Promulgate revisions to California Radiation Control Regulaticas e aTitle 17
+
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i 1-(n. R. A W. T7M5 CETTYornla T*MTnTEUBtTU4 C56e
.o in UF6eF757tiis-~%CState 1 745i3-I
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...;by. ' 9 tl' Mcimtrol res'ulatlom (Into uniformity and/or etmpetl%s.
e o
ilitye es i rcessarye '
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- . REEPOE TO SID41FIC/NT CatDUS, t?
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tatesary &
tesi s ia u an ano kesu ie u ens
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- .Immediately expedite the process for promulgation of.Callfeania State regu-
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iationT6 consasTEt witn the statv Adr.T'nTEIrative FrtrM7UFtrg Acs, 7
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- EIICL +e mndo. 4;WA
... t a.'Ay;. g.M.
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t i o Establish. g.m,,1. Department i pelocitvei Internalireview'.
.i. draftc
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of 2
- s revisions to Title 17e California Radiation Controle Chapter Se P
d i
i.bc.h m vrm4 f "[ N_.tu i nc iucw J i na i r ev i ew. by. eruvaar T.TatMyttt'po
. tme n ta,
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.p. Q % [ counsel.;.;klel 'wlll[ierpedite Departmental 3 review'by establishingatitank '
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r fo ce composed of staf f from program and the Of fices of Regulations and j
b.I i.sgstT.nrrvices.,
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puos ic notice ano conouct pulit7c prDceeo[nss on the radiation
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o rubiish a
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.e centrol regulations pursuant to the California Administrative Pc6cedures s n
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therevisedresulationsandforwardth>tothe b
?
e The Department will edopt Staff werk on proposed regulations to j
je.
n esia5TTsT, c6 % ilbTTT(y wilk rk 4
b Office' of Administratlee Low (04_) for ' review pursuant to theJall *cenla regulations in 10rJP is cc.plete.
M Procosed Nctice of Hearins for Groups 2 r,J,i;Tnis t r a t i ve Pr oc edur e s M t by Avsusl JU. iyua.
and a war TITed with urCan7/f7/05, tur
~~~
approved the proposal as filed.
Hearines F
for Groups I and 1.5 weee held on 0/0/05.
1 i f Tnsi Stdi.em#nT~of Reas ans was filed 7i'th
.p,'
Ort on 9/24/05 followins completion of post
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hearins resiew.
Groups 1 and 1.5 were lI EFsRWT HEJ under cover cT a
Te H Fr y,
reouesting that OfL eweedite review on 1*
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regulation proposeIs R49-t% (Gep le 1.3)s ic;U-047 Ge p z) and RI3 4357 Gip ai.
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-- ' Y-Hearings for Groups 2 and 3 are set for i'. gd 10/7/05.
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2 o Gend a. letter to. Ot requesting that it expedite its revie which w
.,40!M/
'7
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normally may take up7o s i x ieorTibs e et these proposed resu1AIiens.
broup 4 was f i led-~ssi1 gee decretar y ci
]is 1
State 6/6/03 (effective 7/8/05).
(Draft available) d i li Si
. 3. s,. -
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o File the resulations'with'the Secretary of State.
...Up to 30 ys ' may 1,~ ~
[
elapse before the regulations become effective after filins.
Ir*
Proposed regulations (Groups 2 and 3) wilI ce rTTFo with ut icr prCEUtsat' tun rl
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,...... / gra t., g efollowins completion of the post-hearins
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30 etsys will elapse before the regulations
[
.s Decome eTitiftTvnTYue itTTns with the
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Secretary of State.
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7 Eliminate the backlos of pending applications and tuldes without
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Iq1ntath the sat 1ty c# {testth l
$N./
physNs acdvltles by'utillatng refined license and review guides.
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i Technical Quellty of Licenses (tPC IV.A) r
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OBJECTI O k
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- T g_ p / ; current : regulatory 4 guidance,end, essure.that licensesfare consisteyt with. ; G %.a.. i
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j good health practice and are written in clears completes and accurate form.
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,g o Develop and utilize new licensing guidelinese checklists'end' standard Completed.
~
Standard review plan issued 0/l/05 to
?:*'5 retriegtsfrtSee-3:trPtW3eptember30r-t ru.o unuer the titreetitnrut tk.
imptement cunststentm ttttrativ, wi wide-
. W t. Q C~ ~,~. ' 1.. ~
p[
linese checklists and standard conditlens.
r ji Supervising, Health Phosteist and the licensins supervisor.
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i oReinstitutecarefulmonitoringofflcensedocumentsforadherencel.to
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the
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essential quality assurance procedures. This activity was besun. in Aprill n,
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C lescry 11 Utens e n 3 Pr~6EFUGr es Usc iv.UT a
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) l Catencey 11 Administrative Procedures UFC 11.B) 7
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COJECTI(Ei
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Assure that licenses are written consistently and a*e compatible with
)
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cur re6E iGac7Tce, g
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)
o Updating the list of standard condi t ions was canaleted in Ane l l 19rr,.
Cnmoleted.
o Complete development of uniform bicassay procedu-es aad standard Completed 0/1/05. Staff is usins the new
)
h I
version of bloassay standard conditions.
canditions. Uraft discussed wili$ slaf fog 6e F,7'iU;.
ihe te UjiI W ie
)
for its adoption was August le 1905. The initial period of use will be i
J discussed at the next semi-annual meeting for possible modifications.
,3.
)
s, o Re-emphastred the peer review of licenses in April 1905.
Completed.
1 o Document' comollance data and f eedback. The inspection agencies have been Implemente'd by Standard Review Plan dated
}
}
O/I/05.
reminded to nutify the license revieder of a59 problems tI'ey perceive
)
)
with respect to the application or the licensee.
This is done using the 7-Inspection reporting f orm FM 2033.
This work will be enhanced when /OP
)
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(
+
is tuliy operalir9 License r eviewers al7E51 time wil l be abie 10 tali h
)
up the entire compilence history as one of the steps in applidation g..g ; --
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O Utassze tisU neni medicai drifts and cra f M6e7i x 6 stopF3no bene m nerai analy2ers whIch w*Pe completed in Apell 1903.
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o Update administeative polleles and procedures to provide for teressed This is a enntineus peccess which hes been
/
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s r FTfif 5 Feed'b iB5U56EF~tf-1Ae 5t3MB3F3 W
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- tmifOrelty and continuity of regulatoey practices.. f..,'i Review Plan j
/gd
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o R2ld semi-annual staf f meetings with reglenal and contract staf 4Jessiswd A pres-em staff reeting was held 6/4-4/05 i
Sj in Walnut Creck/Derkelev. The next rectin9 Y
- 6 s
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sc radtcatt1vewiretstreeptatten-tt7st7eet#7'-mwma s-1 et e is-set-to -t'ecember-1905.
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'. ' June 4-6.
1 p
n Completed.
I, TtAU"T DATE: Septembee 30, 1905
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FCGP&E TO SICNFIC## C&ft'NTS:
f Category 11 StatfIns Level (m C 111)
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4 3y
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6
, '.Y_
w.
n y y.. : o Fill.the foue (4) vacant' Health Physicists';ll' censing positions.
,r.L.asOlistwasexhausted.
Cleting date for q.
t,(
- is GttS/ esc iu.;ttrCrartfnti a,d V
or.
Peesonnel. Expedited hirins peccess by: (1) n' obtaining pre-approved 3001 and (2) adoption
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., ui Educat-itw. rwtEwterce vvatustic-r--in
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, ; lleu of interviews.
Certifled IIst due
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- 10/1/05. 11/1/EG re-target will be pessible
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it the abe, n e i m.
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'e Devet- :.od attfrw thecktistsr stridelb..md tandarti-tendttb n.
Ccmpteted.,
u A.,
w; descelbed in 3.a and 3.b above.
2
'l o Complete training of all new hires by April 30, 1906.
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TtATET DATE: 4ri1.30e 1906 iL (j
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theR$hoactive Establish a PC-based manesement information system for
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retf Fiat tMCMIFDPPmgMs.
W15 EySt9MITI PFDViiW~tMCMR%*f cn jar
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X\\Y.2
?;*(kly[i'etfective tracking';end direction. The products >will Iv7)ude TC '
l4
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program generated licenses and cov ilance documents.
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PEPOE TO SIG4FIC#47 COtMNTS:
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Latescry li diisist. rett 0e Fracecures Mg }BJ
' e Categoey 11 Of fIce Equipment and Support Services (mc I.0) f9
'1, Categoey 11 Licensing Proceduces (tRC 1\\
B)
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CDJECTitE 18 6
4trJttruerstwytaraware sna r,cttier-teF ite system.
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KiiGn o The Branch is utilizing IBM PC's (2 each) and 10M XT's (2 each).
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UNITED STATES
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p, NUCLEAR REGULATORY COMMISSION j
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%... +,o'f 1450 MARIA LANE SUITE 210 WALNUT CREEK, CALIFORNIA 945%
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October 30, 1985 i
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i Dr. Kenneth W. Kizer, Director
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California Department of Health Services 714 P Street Sacramento, California 95814 I
Dear Dr. Kizer:
Thank you for your letter dated October 2,1985, in response to our 1985 follow-up review of your Agreement State Radiation Control Program. We have evaluated your responses and find that your proposed changes with the eventual achievement of your written action plans should bring your program l
back within the Agreement State Guidelines. We appreciate your effort in working toward the accomplishment of this task.
Related to the Status of Regulations, a Category I Indicator, we still cannot offer a finding of compatibility until your revised regulations are completed, approved by the appropriato State bodies and adopted for the California Radiation Control Program. We underezand the effort your agency is putting forth on this issue and we are prepared to respond as soon as your regulations are adopted.
We are pleased with the positive actions you have implemented with regard to our comments and, based on these actions, we find your program adequate to protect public health and safety. If you have any questions, please feel free to contact this office at any time.
i Sincerely, l
mdD
~
ohn artIn~~
b Regional Administra e
cc:
State Public Document Room (enclosed)
NRC Public Document Room (SP01)
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Joe Ward, Chief, Radiological Health Branch G. Wayne Kerr, Director, Office of State Programs l
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