ML20057A100
| ML20057A100 | |
| Person / Time | |
|---|---|
| Issue date: | 09/07/1986 |
| 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 9309130043 | |
| Download: ML20057A100 (121) | |
Text
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'q UNITED STATES I
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[ Y, fi NUCLEAR REGULATORY COMMISSION 4 p', j REGION V A A-g y' 1450 Y ARI A ; ANE. SUIT E 210 5g nAt nut cnE n. cAur osNia m96 Memorandum For:
Donald A. Nussbaumer, Assistant Director for State Agreement Programs, Office of State Programs j
Through:
Joel 0. Lubtnau, Senior Projects Manager % e Agreement Programs, Office of State Programs 9/7/
I from:
Jack W. Hornor, Region V State Agreements Representative
Subject:
Staff Report and Evaluation - California Radiation Control Program 1986 Enclosed is the subject report and staff evaluation.
As noted in the report, the California radiation control program was found adequate to protect the public health and safety but the finding of compatibility was withheld until the current updating of their regulations are published, implemented and distributed to their licensees.
In addition to the items in Enclosure 1, the following areas need attention at the next review.
a.
By the time of the next review, the regulation revisions should all be complete.
It should be verified that Title 17 is reprinted and distributed to all licensees.
b.
It should be verified that the emergency plan is complete and distributed to all participants.
c.
We recommended that communications should be improved between management and staff.
It should be checked to see what actions have been taken, d.
Records, license files, SSD files, etc., are all being kept in cardboard boxes or loose on the floor. Department management promised to rectify the situation and this should be checked.
e.
Progress should be measured against the action plan for eliminating the overdue inspection backlog.
f.
Time did not permit acc ompaniment of all new inspectors. This should be
'a high priority during the next review.
A sed on the results of the meeting, the staff recommends a follow up review in six months with the next routine review in twelve months.
(packW.HornordW Alae j
f Region V State Agreements Representative
Enclosure:
Subject. Report
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9309130043 930726 PDR STPRG ESGGEN PDR
1 Memorandum For:
Donald A. Nussbaumer, Assistant Director for State Agreement Programs, Office of State Programs r
Through:
Joel 0. Lubenau, Senior Projects Manager, State Agreement Programs, Office of State Programs From:
Jack W. Hornor, Region V State Agreements Representative
Subject:
Staff Report and Evalu.4 tion - California Radiation Control Program 1986 l
Enclosed is the subject report and staff evaluation.
As noted in the report, the California radiation control program was found adequate to protect the public health and safety but the finding of compatibility was withheld until the current updating of their regulations are l
published, implemented and distributed to their licensees.
In addition to the items in Enclosure 1, the following areas need attention at t
the next review.
By the time of the next review, the regulation revisions should all be a.
complete.
It should be verified that Title 17 is reprinted and distributed to all licensees.
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b.
It should be verified that the emergency plan is complete and distributed to all participants.
c.
We recommended that communications should be improved between management and staff.
It should be checked to see what actions have been taken.
i d.
Records, license files, SSD files, etc., are all being kept in cardboard boxes or loose on the floor. Department management promised to rectify the situation and this should be checked.
I Progress should be measured against the action plan for eliminating the e.
overdue inspection backlog.
f.
Time did not permit accompaniment of all new inspectors.
This should be a high priority during the next review.
f Based on the results of the meeting, the staff recommends a follow up review in six months with the next routine review in twelve months.
t Jack W. Hornor Region V State Agreements Representative j
t
Enclosure:
Subject Report i
JHer ut RSc ano Regifh,Vi-i 8/20/F3 8/jp/86
Question 67 l
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STAFF REPORT Ah'D EVALUATION 0F THE k
CALIFORNIA RADIATION CONTROL PROGRAM i
FOR THE PERIOD
-i FEBRUARY 15, 1985 TO MARCH 14, 1986
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24TH REGULATORY PROGRAM REVIEW t
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i STAFF REPORT AND EVALUATION OF THE CALIFORNIA RADIATION CONTROL PROGRAM (RCP)
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FOR THE PERIOD FEBRUARY 15, 1985 TO MARCH 14, 1986. The 24th regulatory
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program review meeting with California representatives was held during the j
period March 3, 1986 to March 14, 1986, in Sacramento, California. The State j
was represented by Joseph 0. Ward, Chief, Radiological Health Branch, Gerard l
Wong, Ph.D., Supervisor of the Radioactive Materials Section, and the l
Radioactive Materials Section staff.
A review of selected license and j
inspection files was conducted by Beth Riedlinger, Region V, Steve _Baggett, Fuel Cycle and Material Safety, and Jack Hornor on March '30-14,1986.
Mr.
l Hornor conducted an accompaniment of one inspector on March 3, 1986. A j
summary meeting regarding the results of the regulatory program review and.
inspection accompaniments was held with Dr. Kenneth W. Kizer, Director, Department of Health Services (DHS), Harvey F. Collins, Ph.D., Chief, Environmental Health Division, Mr. Ward, Dr Wong, and Al Starr, Assistant to Mr. Collins, on March 19, 1986. The NRC was represented at this meeting by Jack Hornor, State Agreements Representative, Region V.
Mr. Hornor also conducted a review of the State Laboratory.
Conclusions l
The California program for control of agreement materials is adequate to l
protect the public health and safety provided they' adhere to their action plan to increase inspections and eliminate the backlog of overdue inspections. The t
NRC is, however, withholding its finding of compatibility until California's.
i new regulations become effective. These conclusions are based on the review of the technical and administrative aspects of-the State's regulatory program i
for controlling agreement material.
I i
Summary Discussion With State Representatives
~l A summary meeting to present the results of the regulatory program review meeting was held with Dr. Kizer, Dr. Collins, Mr. Ward, Dr. Wong and Mr.~ Starr i
of the Department of Health Services on March 19, 1986.
l The following comments and recommendations were made to Dr. Kizer and staff.
1.
The California regulations are still not compatible with those of the NRC.
It was recommended the revisions be expedited.
2.
While improvements in the State's inspection program were noted, additional improvements are needed. There is still a need for increased staffing and a workable tracking system for the inspections performed, due and overdue.
It was noted that progress has been made in eliminating the backlog of overdue inspectiore, and the Branch presented an action plan to further improve the program and eliminate all overdue inspections within the next review period.
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3.
The need for upper management attention is also indicated in providing adequate clerical and office support to the technical staff and in i
improving communication between levels of. management within the Department and internally within the Branch. As the Branch professional i
staff increases, increased clerical staff, office equipment and storage I
facilities must be provided to maintain a workable program. And finally, j
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2 information must be disseminated both up and down the organizational l
structure for the program to operate efficiently. Staff meetings were recommended as a means to improve the communication.
In response to the NRC representative's comments, the Director of the Department of Health Services stated that the State of California is dedicated to having a first rate radiation control program and that he personally would-f assist the Radiologic Health Branch in achieving this goal. He thanked the NRC for its review of California's RCP and said that such reviews were necessary to keep management informed of the progress of the Branch in achieving this goal.
-t Program Changes Related to Previous NRC Comments and Recommendations I.
Legislation and Regulations f
Status of Regulations is a Category 1 Indicator. The following significant comment with our recommendation was made:
Comment j
f The State should have regulations that are compatible with those of the l
NRC.
California's radiation control regulations pertaining to radioactive materials have not been updated (except for NRC's equivalent 10 CFR 19 in 1976) since 1974. Examples of some of the recent significant changes relating to safety that have not been incorporated
'l into California's regulations are as follows:
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h 1.
Requirements to perform surveys of patients to confirm that radioactive source implants have been removed; i
2.
Special requirements for controlling areas in which very high radiation levels exist (i.e., in excess of 500 rem per hour);
i 3.
ALARA provisions; i
4.
Revision of some Maximum Permissible Concentration values; j
5.
Modification of transportation requirements; and 6.
Defacing of radioactive material labels prior to disposal.
t Recommendation We recommend that high priority attention be given to updating California's radioactive material control regulations. Since California's low level waste regulations were initiated and adopted within the past year, we suggest a similar high priority effort be i
applied to updating the radioactise materials regulations. We also suggest that California make use of NRC's value impact statements to support the regulation justification.
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3 State Response i
The following actions have been taken or are planned to meet the j
objective of expediting the process for promulgation of California State regulations, consistent with the State Administrative Procedures Act.
Establish, as a Department priority, internal review of the draft
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revisions to Title 17, California Radiation Control, Chapter 5,
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Subchapter 4, to include final review by program staff and i
departmental counsel. We will expedite Departmental review by establishing a task force composed of staff from program and the
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l Offices of Regulations and Legal Services.
publish a public notice and conduct public proceedings on the radiation control regulations pursuant to the California l
Administrative Procedures Act.
i The Department will adopt the revised regulations and forward them to the Office of Administrative Law (OAL) for review pursuant to the l'
California Administrative Procedures Act by August 30, 1985.
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Send a letter to 0AL requesting that it expedite its review which normally may take up to six months, of these proposed regulations.
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(Draft attached) l s
File the regulations with the Secretary of State. Up to 30 days may elapse before the regulations become effective after filing.
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The target dates are August 30, 1985 for leaving Department and February i
28, 1986 for forwarding to the Secretary of State.
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Present Status Compatibility regulations have still not been completely adopted by the State; however, progress is being made.
Groups 1 (Definitions), Group 1.5 (Fees), Group 4 (Transportation) and Group 7 (Low-Level Waste) have passed all requirements and are effective. They are awaiting publication i
until Groups 2 and 3 become effective.
Group 2 (Licensing) and Group 3 (Radiation Protection and Standards) are currently at the Office of l
Administrative Law (OAL) with an expected 40 day turnaround time (which
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was committed by OAL to Dr. Kizer af ter our August 1985 follow-up l
3 review).
The completion, assuming no delays, should be sometime in April 1986. From OAL the regulations then go to the Attorney General's Office and become effective 30 days later. When the regulations become i
j effective, the State will send a Radiation Advisory to all California i
licensees pointing out all changes in these regulations. The new publication of the regulations will most likely be in loose leaf form and l
be available through purchase from the State.
This information will also l
be provided in the Advisory.
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i II.
Management and Administration 4
A.
Budget is a Category II Indicator.
The following comment with our i
l recommendation was made:
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t Comment j
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Operating funds should be sufficient to support program needs.
Some funds to operate specific portions of the California radiation control program (consultants for ADP programming and training, temporary help as necessary, instrument calibration, staff meetings,-
etc.) are apparently unavailable for use by program management, due
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to the inflexibility of budget procedures.
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I Recommendation l
1 We recommend that management be given the ability to reprogram funds j
when necessary and justified to fulfill the mission of the agency.
I State Response r
The State did not respond specifically to the above comments and
.l recommendations. Instead, budget issues are addressed in the t
l State's response to other comments and recommendations.
i Present Status l
There has been no change in the State's., % et system. Budgets are very rigidly controlled in California and must be earmarked for j
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specific areas (salary, travel, etc.) before the budget is approved.
i The only movable money is in the Branch general expense fund which l
1 represents only $33,780 of the four million dollar Branch budget.
Even this money can only be used'for either equipment or trave'.
1 Temporary help, for instance, would need approval in the next fiscal year's budget even if the need were current.
Consultants, including MD's, can only be hired by contract money which requires approval a year ahead of time. The DHS and RHB managers are working within the j
confines of the State system as best they can.
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i B.
Administrative Procedures is a Category II Indicator.
The following
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comment with our recommendation was made:
l Comment i
The guidelines call for internal procedures that assure the staff
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performs itt duties as required and provides a high degree of l
uniformity and continuity in regulatory practices. We found that i
4 procedures did not reflect ccrrent practices within the Branch for i
licensing, compliance (particularly inspection follow-up) and enforcement.
Communication between the contract agencies in regional offices and l
headquarters is inadequate to assure consistency and uniformity.
l During the last review the State indicated radioactive materials staff meetings were held semi-annually, when in fact the last regional staff meeting with all regi.onal and contract offices present was in 1982. This has resulted in a lack of understanding of procedures and policy changes, minimal feedback between s
licensing, compliance and supervisory elements and lack of i
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l consistency in inspection reports. Also current practices are such that license reviewers may be unaware of current compliance actions
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until months after the fact.
l Recommendation i
We recommend that the radiation control program management update policies and administrative procedures, complete with workable tracking systems, for licensing, compliance and enforcement, and hold periodic staff meetings with regional and contract staff assigned to radioactive materials regulation.
t State Response The following. actions have been taken or are planned to establish.a I
comprehensive management information system with respect to
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licensing, compliance and investigation functions and to further l
i improve administrative procedures and communication-l 1.
Conversion of the existing mainframe file is complete.
Expiration date and last inspection date are now available from this file. Obtain support for the generation of data bases and programming software interfaces. Environmental Health Division l
y' office is assisting in the data base and-programming software interface.
i 2.
Develop data bases for the complete licenses.
3.
Complete training of staff in the use of the data base and its t
routine reports.
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4.
Generate data bases and produce reports.
The target date for the above actions is August 30, 1986.
5.
Update administrative policies and procedures to provide for increased uniformity and continuity of regulatory practices.
The target date is September 30, 1985.
i 6.
Hold staff meetings at six month intervals with regional and i
j contract staff assigned to Radioactive Materials Control to review good health physics practice and to inform the staff of updated policies and administrative procedures..
The first meetings occurred June 4-6, 1985.
i Present Status j
Many administrative procedures and policies have been updated or developed, including a new uniform inspection form, new licensing guides and checklists, revised standard license conditions'(not yet complete), and a very important policy directive for medical i
licenses. A new form and procedure provide licensee compliance.
records to the reviewers. Two statewide staff meetings were held in
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1985 and the branch intends to continue semi-annual meetings between J
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The comput-systea is still l
j under development, and although it tracks expired Licenses and keeps logs of licensing actions, it was found to be inaccurate in tracking
'i due or overdue inspections.
i C.
Management is a Category II Indicator. The following comment with our recommendation was made.
1 Comment The guidelines stress supervisory review of license cases, inspections, reports _and enforcement actions as well as second party review of complex licenses.
It was found that closed-out inspection-reports have often taken months (sometimes over a year) to reach
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headquarters, and that no supervisory review of the reports had been oc omplished during the past six months. These conditions hinder management's ability to assess the status of the compliance program i
and take timely enforcement actions.
Review of the license files, l
particularly medical,-indicated peer review is not being performed
-l for many complex licenses. The lack of clarity in these saue.
licenses has caused confusion among other reviewers and compliance j
inspectors.
Recommendation l
We recommend the RHB institute timely supervisory _ review of l
completed inspection reports and setond party review of complex licenses.
State Response
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The following actions have been taken or are-planned:
1.
Review by the Senior Health Physicist for Compliance, all inspection reports within 14 days of receipt. All inspection reports and compliance letters from new staff will be reviewed before compliance actions are instituted.
f 2.
Peer review of licenses was reinstalled in April 1985.
I Present Status 4
i The reports are now being reviewed in a timely manner, but still
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after all enforcement action is completed. Management intends to f
change the review procedure, allowing for supervisory input to i
enforcement proceedings. Complex licenses are receiving second i
party review, although the review cover sheets are not always l
retained in the file.
D.
Office Equipment and Support Services is a Category II Indicator.
The following comment with our recommendation was made-Comment I
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Word Processing and Automatic Data Processing (ADP) and retrieval capability should be provided. The new ADP system arrived in Augu=t
.i 1984, and during the follow-up review the State. committed to a i
functional system by the beginning of 1985..It was noted in this review that the software has not been developed to perform any license or compliance functions. The system is receiving only limited use for word processing.
i Recommendation f
r' Steps should be taken, including hiring programming and training l
consultants if necessary, to develop the necessary data bases-and_to train the staff to fully utilize this ADP equipment.
State Response J
lt is the goal of the state to establish a PC-based management.
q information system for the Radioactive Materials Control Program.
i This system will provide information for effective program tracking.
and direction. The products will include PC generated licenses and compliance documents, l
The following actions are being taken to achieve this objective:
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1-1.
The Branch is utilizing IBM PC's (2 each) and IBM XT's (2' each).
2.
Software for word processing has been acquired.
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3.
Data base management software is on order. This order will be l
expedited.
i 4.
Software packages are being reviewed by the Environmental liealth Division with respect to selection of an integrating utility.
j-Present Status The ADP system is not yet fully functional.
It is being used to j
i track expired licenses and to log licensing actions.
It continues to be used quartcrly to list licenses due and overdue for each i
inspection agency, but a review of listings from different data
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bases and a comparison of the files with the listings showed many errors and omissions. The current program is missing licensees and has incorrect priorities.
It was found the system does not flag initial inspections as they become due, and as a result, the l
listings are not accurate.
Word processing is now being used by the typing staff, but there was a large backlog of typing at the time of the review. The issue of office support is addressed in the current correspondence and report.
III. Personnel i
Staffing Level is a Category II Indicator. The following comment with our recommendation was made:
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f 8-a Comment The staffing level for the California Radioactive Materials Program is.
j approximately 0.6 staff-year per 100 licenses. The guidelines recommend a range from 1.0 to 1.5 staff-year per 100 licenses. NRC has found that I
larger State programs with a sustained staffing level of less than 1.0 i
staff year per 100 licenses cannot maintain an adequate and compatible radioactive materials program.
f Recommendation We recommend that the program staffing levels.be increased to at least 1.0 staff-year per 100 licenses. Among other things, the additional staff is needed to overcome the serious backlogs. We understand from previous correspondence that all staff vacancies are funded and j
authorized to be filled immediately and that the remaining staffing t
needed to bring the level to 1.0 staff years per 100 licenses will be i
available in the next fiscal year beginning July 1, 1985.
This item should have the highest priority with management. NRC will give high
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priority to applications from California to attend NRC sponsored training and will fund travel and per diem costs for out of State travel for individuals approved for such training.
1 State Response The following actions are being taken in order to meet the staffing level-guidelines:
1.
Fill the four vacant health physicist inspection positions.
1 f
Hiring process started C 10/84 Hiring completed j
DOSH - 2 Associates Health Physicists C 5/1/85 1
RHB - 1 Associate HP C 5/28/85
- 1 Associate HP T 6/31/85 1
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(T= Target, C= Completed)
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2.
Three new staff positions have been included in the Governor's 1985-86 budget.
A new exam has been set; the filing date is f
8/25/85).
3.
Complete training of all new hires by April 30, 1986.
Present Status 1
4 Five new reviewers (Richard McKinley, Stewart Rosenberg, Gordon Stelling, 1
Donna Sutherland and Don Barr) and one new inspector (Jeff Wong) have been hired since the last review.
Two new inspectors (Lisa Burns and
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Bill Watson) have also been hired by DOSH North and South respectively.
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4 llowever, three of these positions are temporary and need to be _made permanent before fiscal 1987-1988.
T1. State has apparently lost three other full time permanent positions but has committed to reproposing them for the next fiscal year. The actual f2gures are:
1 21 actual staff x 100 = 0.81 staff year /100 licenses 2194 licenses x 1.18. license to licensee ratio or 24 authorized (3 not filled) staff x 100 = 0.92 staff year /100 licenses 2194 license x 1.18 license to licensee ratio t
IV.
Licensing i
A.
Technical Quality of Licensing is a Category I Indicator. The
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l following comment with our recommendation was made, j
Comment l
The RCP should assure that essential elements of applications have been submitted to the agency which meet current regulatory guidance f
for describing the isotopes and quantities to be used, t
qualifications of persons who will use material, facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions.
The guidelines also call for the licenses to be clear, complete and accurate.
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During the review of the license files, several deficiencies in lic nsing practices which could lead to unnecessary radiation l
exposures were disclosed. The following lists some of the examples of improper licensing practice found during the review:
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1.
Radioactive xenon use was authorized without supporting documentation by the applicant concerning safety precautions or i
an evaluation by the licensing staff.
This is a repeat comment i
from previous reviews.
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2.
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 VI.
This is a repeat comment from previous reviews.
3 3.
Information in an application concerning waste handling I
procedures and safety provisions for waste storage areas were inadequate or missing. This is a repeat comment from previous reviews.
1 Recommendation i
i We recommend that license reviewers utilize current licensing checklists, guides and standard review plans which reflect accepted practices and that these checklists be maintained in the license file.
In addition, as noted earlier in paragraph II.C we recommend that all licensing actions be given quality assurance checks to i
assure that application review and license preparation is
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2 consistent.
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State Response
,f The following actions have been taken or are planned for meeting the
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objective of assuring that essential elements of license j
applications submitted meet current regulatory guidance and assure.
that licenses are consistent with good health practice and are j
written in clear, complete, and accurate form.
1.
Develop and utilize new licensing guidelines, checklists and standard review plans by September.30, 1985, under the direction of the Supervising Health Physicist and the licensing l
supervisor.
i 2.
Reinstitute careful monitoring of license documents for i
adherence to the essential quality assurance procedures. This activity was begun in April 1985.
Present Status The technical quality of the licenses shows a noticeable improvement. The reviewers are obviously making an effort to issue.
l quality li:enses and amendments. Peer review is being performed on l
complex licenses, although it was found the review sheets are not always retained in the files.
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4 B.
Licensing procedures is a Category.II Indicator. The following l
comment and recommendation was made.
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I Comment j
The RCP should have current internal licensing guides, checklists and policy memoranda consistent. with current NRC practice. The present compliance status of licensees should be considered in licensing actions. Standard license conditions comparable with l
current NRC standard license conditions should be used to expedite i
and provide uniformity in the licensing process.
i It was noted that a lack of consistency exists.between licenses of 3
i the same type prepared by different reviewers.
In addition, the l
sometimes confasing and incomplete medical and pharmacy licenses being issued indicate a need for re-examination of the forms and
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procedures. As mentioned previously, under current procedures the l
license reviewer does not have access to the latest compliance i
history because the inspection reports are not forwarded to d
headquarters until they are completely closed out, and this currently takes several months.
l Recommendation i
i We recommend that the medical and pharmacy licensing forms and procedures, in particular, be change.d to ensure clarity and completeness. These procedures should be aimed at improving the technical quality of licensing.
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Procedures should be changed.to make recent compliance status of licensees available to the licensing staff. Eventually the new ADP i
system discussed above should be programmed to accomplish'this, but interim procedures are needed.
I State Response t
l The following actions have been taken or are planned for meeting the l
objective of assuring that licenses are written consistently and are j
i compatible with current practice.
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.i 1.
Updating the list of standard conditions was completed in April l
1985.
i 2.
Complete development of uniforr bioassay procedures and standard conditions. Draft discussed with staff on June 6, 1985. The target date for its adoption is August 1, 1985.
The initial period of use will be discussed at the next semi-annual meeting for possible modifications.
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3.
Reinstated the peer review of licenses in April 1985.
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I 4.
Document cotupliance data and feedback. The inspection agencies have been reminded to notify the license reviewer of any l
problems they perceive with respect to the application or the licensee. This is done using the inspection reporting form RH j
2033-This work will be enhanced when ADP is fully
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operational. License reviewers at that time will be able to call up the entire compliance history as one of the steps in
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the application review.
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5.
Utilize the new medical draft, and draft for Lixiscope and bone mineral analyzers which were completed in April 1985.
i Present Status i
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The state has developed several new checklists and license review forms.
They have also drafted new standard licensing conditions, i
although that project is not complete. A licensing directive was issued af ter the meeting held during the follow-up review between l
the NRC staff and program management that establishes a definitive policy for a variety of non-compatibility issues. This has improved the consistency of the licensing actions.
New procedures assure the license reviewer has the compliance history before issuing amendments or renewals.
V.
Compliance I
l A.
Status of Inspection Program is a Category I Indicator. The following comnent and recommendation of major significance to the j
j compliance program was made.
Comment i
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12 The inspection program has 334 inspections overdue by more than 50 percent of their inspection frequency, with some overdue by more than 100 percent. This backlog is increasing. A significant number of the overdue cases are in the highest three priority categories which have the greatest potential for health and safety problems.
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Recommendation I
i We recommend that management develop an action plan to eliminate the l
backlog. The program's inspection frequency schedule has been more
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stringent than the NRC guideline and could be modified accordingly.
Hiring should be expedited and training planned so that the new l
inspectors can begin to perform independent inspections as soon as l
possible.
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t State Response j
f i
The state's goal is to eliminate the backlog of compliance j
inspections and enforcement actions without comprising health and
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safety, and improve the quality of health physics review and j
documentation through well calibrated independent measurements and standardized reporting format. The staffing issue has been I
addressed in the Staffing Level response.
In addition the following i'
actions have been taken or are being planned:
i t
1.
Adopted the NRC's inspection priority system on March 15, 1985, j
to reduce the backlog. This reduced the backlog by 60%. The normal inspector workload is thus reduced by 7% but it.is-essentially offset by a growth rate of 4.5%/yr in the number of licenses.
l 2.
Complete training activities for new inspectors.
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3.
The plan for eliminating the backlog of overdue inspections is 1
as follows-l l
FLIMINATION OF BACKLOG OF DVERDUE INSPECTIONS Target Dates f
Agency Overdue by 50%
50% Reduction Eliminated RHB 57 1/86 4/86
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DOSH 56 8/85 1/86 j
Orange Co.
33 7/85 10/85 TOTAL 146 j
i Present Status i
The state greatly reduced their backlog of overdue inspections, but did not meet their goals.
In addition it was discovered the ADP
.L system is not correctly identifying all due or overdue inspections l
because of a serious flaw in the method used to produce the i
due/ overdue listing. The due date for an inspection was based on f
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t the length of time elapsed since the last inspection, with no means to pick up newly issued licenses.
Thus, if an initial inspection was not performed, the license would never appear as due or' overdue.
A listing of " licenses never inspected" identified over 200 licenses j
overdue for their initial inspection (based on the initial inspection schedule in effect at the time the license was issued),
i 76 due for a routine inspection, and 17 overdue for their routine j
inspection. None of these appeared on.the due/ overdue list.
The state has a new action plan for resolving these problems and i
eliminating the backlog, which is included in the current report and
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correspondence.
j B.
Enforcement Procedures is a Category I Indicator. The following i
comments and recommendations of major significance to enforcement j
actions were made:
l
)
1.
Comment i
Enforcemeat procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements. Forty licenses have expired since March of 1982 for which the California RHB has taken no action. As far as can be determined these licensees still possess and use radioactive materials. Also, two inspections have been made against expired licenses; the first inspector did not note the j
expiration nor cite the licensee for using radioactive material l
without a valid license.
The second inspector noted that the 1
license had expired but again did not cite the licensee or bring to management's attention the fact that the licensee was i
operating without a valid license.
j Recommendation j
i We recommend that the State RHB send notices of divestiture to j
these licensees and develop a tracking system which will avoid this problem in the future.
I State Response l
l The state plans to take appropriate enforcement action on the i
40 expired licenses to mitigate completely any potential impact
{
on public health and safety. We have sent notices of i
divestiture to affected licensees, with copies to inspection agencies as of April 1,1985, and instituted a tracking system l
of expired licenses, or an interim basis by hand, in April
[
1985.
In addition, we plan to institute a tracking system of
}
expired licenses on a permanent basis using the Branch's microcomputer system by July 1, 1986, and to provide the output r
of the tracking system to the inspectors along with an explanation of its use in procedural memos. This will be t
directed by the Senior Health Physicist for compliance.
j
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f
.. _. _ -. ~
14 r
i i
I We plan to develop enforcement procedures to avoid in the j
future the problem of expired licenses and licensees using radioactive material without a valid license.
j Present Status f
I The reviewer,erified that:
l t
1.
The State has sent notices of divestiture to all affected licensees and copies to the inspection agencies within six j
months of the last review.
j 2.
The State instituted a tracking system for expired l
licenses using ADP with monthly printouts which are reviewed by supervision for appropriate action.
I 3.
The last is compared to the log of renewal applications,-
l and delinquents are sent notices to divest in 15 days, t
4.
After 15 days this new delinquent list is again compared against the renewal log and if still delinquent immediate compliance action is initiated.
i l
2.
Comment There were cases in which contract agency inspectors could not-bring recalcitrant licensees into compliance and referred the problem via written memo to the RHB for management follow-up.
l In some instances there was either no follow-up or the l
follow-up was inadequate.
{
l Recommendation l
1 We recommend that management give prompt attention to those I
cases referred to RHB for follow-up and establish a tracking j
system for following escalated enforcement actions in the j
future.
i 4
State Response The following actions have bean taken with respect to the two licenses for whom escalated enforcement was requested.
l 1.
King Neptune, an expired licensee, was inspected and found l
to have no possession of radioactive material in April l
1985. Los Angeles County Health Department did however cite Pb melting. The license was terminated.
l 2.
Los Angeles County Health Department, our contract l
inspection agency, will conduct an inspection to determine l
if Alarm Concepts is still, possessing radioactive foils of exempt smoke alarms without a valid license.
i l
l m.
15 j
3.
Hire four Associate Health Physicists who will engage in
)
enforcement actions as well as compliance inspections.
l l
Present Status 1
l The current recalcitrant licensee's cases have been handled appropriately. Although no tracking system has been devised, the j
introduction of civil penalties into the California law appears to have alleviated the problem through prompt escalated enforcement.
i C.
Inspection Reports is a Category II Indicator. The following comment and recommendation was made.
Comment The guidelines state that inspection reports should uniformly and adequately document the results of the inspections.
While the i
individual inspector's reports do adequately describe the scope of l
the inspection, the regional and contract agencies all use different l
forms and different procedures in the performance of their j
inspection duties.
It is thus difficult for management to determine i
that inspection criteria are being met.
i t
i Recommendation We recommend that the RHB establish " approved" forms and inspection
.j procedures to be used throughout all regional offices.
State Response l
The following action is being taken to resolve the problem of l
inconsistent inspection reports The draft of uniform inspection forms was made available to staff on June 6, 1985. Comments from staff are due July 1, 1985 and forms will be in use July 15, 1985.
Present Status I
The final uniform inspection forms are in use by all regional and contract agencies and appear to be working well when + hey are properly completed. The form was reviewed by the RSAR.nd it appears to be adequate for all basic inspections, although some supplemental forms should be developed for the more complex licenses such as teletherapy, pharmacy, radiography, etc.
i 1
D.
Independent Measurements is a Category II Indicator. The following comment and recommendation is made:
)
i Comment l
Agency instruments should be calibrated at intervals not greater than that required of licensees being inspected. The RHB Sacramento office has survey instrumentation which it uses for inspections and l
~
e 16 I
incident response.
This instrumentation has not been calibrated
.l for some time.
This is a repeat finding from the last review. The reviewer was informed that there is no funding and therefore no program to keep these inspection and emergency response instruments in calibration.
t Recommendation i
We recommend that the RHB provide funding and a mechanism to assure -
l all instrumentation needed for inspection and emergency response is in calibration
'l 3
I State Response The following actions have been taken or are planned to meet the i
objective of insuring that field measurements with portable radiation detection instruments are accurate and reproducible.
1.
Mail to inspection agencies the instrument calibration i
requirement policy (completed November 1984). This policy was discussed at the June 1985 meeting.
l 2.
Establish a routine tracking procedure for confirming that i
timely calibration / repair is done..This matter has been discussed at the staff / contractor meeting held in Berkeley on l
June 6, 1985. Currently inspection reports require citation of calibration date of all instruments.
Inspections done with unqualified instruments will be rejected.
3.
Increase efforts to confirm instrument calibration as recorded on inspection reports.
During accompaniments made by the Senior Health Physicist for compliance, survey instruments will-be physically checked to determine their calibration status.
4.
Purchase calibration sources and calibrator. Small calibration / check sources for low-level survey instruments were ordered in November 1984. A calibrator for the higher ranges of instruments was ordered on May 22, 1985. Repair work will continue to be performed at Lawrence Berkeley Laboratory.
The target date for completion of the above actions is October 30, 1985.
j Present Status The instruments at headquarters have now been calibrated and a
[
tracking system has been established. There is no calibration system for velometers and that is addressed in the current correspondence.
EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM STATE REVIEW GUIDELINES, QUESTIONS AND ASSESSMENTS l
l l
'l
. ~ -. -
I 17 l
?
Name of State Program - California Date of NRC Review - March, 1986 J
j j
I.
LEGISLATION AND REGULATIONS A.
Legal Authority (Category I) t I
NRC Guidelines:
Clear statutory authority should exist, designating i
a state radiation control agency and providing for promulgation of
{
regulations, licensing, inspection and enforccment.
Stater t
j regulating uranium or thorium recovery and associated waste I
J pursuant to the Uranium Mill Tailings Radiation Control.Act of 1978 I
j (UMTRCA) must have statutes enacted to establish clear authority for-
.j j
the State to carry out the requirements of UMTRCA. Where regulatory
[
responsibilities are divided between State agencies, clear understandings should exist as to division of responsibilities and f
requirements for coordination.
i f
j Quest. ions:
f 1.
Please list all currently effective legislation that affects l
the radiation control program.
I i
s Legislation affecting the California Radiation Control Program
(
is incorporated in the Health and Safety Code Sections 25800 t
through 25876.
l 2.
What changes have been made to the statutory authority of the t
State to license, inspect, and otherwise regulate agreement i
materials since the last review?
l t
Senate Bill 105, authored by Senator Alquest, and which amends i
l Health and Safety Code Sections 25805 and 25812, modifies the definition of low-level waste to exclude spent nuclear fuel and other byproduct radioactive materials which the NRC, consistent
}
with existing law, determines by rule to require permanent i
isolation, j
)
Senate Bill 298, authored by Senator Rosenthal amends Health i
and Safety Code Sections 25816 and 25817, and requires full
{
l reimbursement to local contract compliance inspection agencies l
j and requires that fees for the licensing of radioactive i
i materials be adjusted for cost of living. This bill has passed and been incorporated in Chapter 1294, Statutes of 1985.
1 The Budget Act for 1985/86 requires that all public health fees
{
including radioactive materials license fees be set at full i
cost recovery and provides for a one time adjustment in radioactive material license fees to meet this requirement...
l t
3.
If your State regulates uranium or thorium recovery operations
{
and associated wastes pursuant to an amended agreement. and t
UMTRCA, explain any changes to the statutory authority for
[
these functions.
)
j l
l 4
3 i
/
- ~ _
18 California does not currently have an amended agreement for regulating uranium and thorium recovery operations and associated waste.
4.
Are copies of the current enabling act and other statutes (e.g., Administrative Procedures Act, Sunshine Act., etc.)
{
which govern the conduct of the agreement materials program on file in the Radiation Control Program (RCP) office and with the j
NRC? If revisions have occurred since the last review, the j
changes should be included.
3 i
Copies of the statutes are on file with the RCP and have been
{
given to the NRC. Copies of Senate Bill 105 and Senate Bill j
3 298 are attached (Attachment I.A.4).
i a
l 5.
If the State's regulatory arthorities are divided between j
agencies, what procedures and memoranda are in effect to l
provide clear understanding of the divisions of l
responsibilities and requirements for coordination?
l The Department of Health Services contracts with one other l
State agency, the Division of Occupational Safety and Health (DOSH) a division of the Department of Industrial Relations l
(DIR), to evaluate license applications and to conduct X-ray
[
and radioactive material compliance inspections. The i
regulatory responsibilities are conducted under the DHS policy and supervision. An Interagency Agreement exists between the j
two agencies which sets forth the services to be performed and all terms and conditions of the agreement. Also, Los Angeles and Orange Counties are currently conducting compliance i
inspection activities within their respective jurisdictions
{
under contract and at the direction of the Department.
j i
6.
Does the State have the authority to:
l t
a, apply civil penalties? If so, cite legislation.
California has limited authority to impose civil l
penalties. This authority is contained Section 25866 of j
the Health and Safety Code and establishes civil penalties l
for intentional or grossly negligent violations of the radiation control law and regulations or failure or refusal to comply with an order of the Department.
b.
collect fees? If so, cite legislation.
l California currently assess annual fees for radioactive material licenses. These fees are specified in Article 8 i
of the Radiation Control Regulations.
c.
require surety or long-term care funds? If so, cite i
legislation.
J t
V i
t 19 3
Authority exists only for low-level waste ;ites.
See answer (f) below.
d.
require performance bonds or sureties for decommissioning licensed facilities? If so, cite legislation.
l 3
No.
l I
l.I require performance bonds or sureties for clean-up of
}
e.
licensed facilities after a contamination accident?
If i
so, cite legislation.
No.
l f.
require long term care funds for uranium mill or I
low-level waste facilities? If so, cite legislation.
2 Yes, California has authority in SB 342 (1983), which amended Health and Safety Code Sections 25805, 25810, i
25812 and 25813, to require surety and long-term' care i
funds for low-level waste sites. We plan to develop j
regulations to implement the authority.
1 g.
enter into low-level waste compacts? If so, cite legislation.
/'
California presently has authority in SB 342 to enter into j
a low-level waste compact.
h.
establish, license and/or operate a low-level waste site? If so, cite legislation.
j i
SB 342 requires the Department to identify the regions of f
the state which would meet site criteria. The bill also 1
authorizes the department to solicit applications for operation of the site and to select a licensee.
-l 7.
If any responses to the above question are negative, explain l
any plans the State may have regarding those issues.
California has no plans regarding these issues.
i 1.A Reviewer Assessment:
l California continues to meet the NRC guidelines for Legal Authority.
l B.
Status of Regulations (Category 1) 1 NRC Guidelines: The State should have regulations essentially i
identical to 10 CFR Part 19, Part 20 (radiation dose standards and i
effluent limits), and those required.by UMTRCA, as implemented by
[
l Part 40.
The State should adopt other regulations to maintain a high degree of uniformity with NRC regulations.
i i
0 I
20 Questions:
1.
When did the State last amend its regulations in order to maintain compatibility and when did the revisions become effective?
i The California Radiation Control Regulations were last amended i
effective December 26, 1985 for purposes of 10 CFR compatibility. New effective amendments to the California
'I Radiation Control Regulations for Group 1, Article 1, Definitions; Group 1.5, Registration of Sources of Radiation-Group 4, Transportation of Radioactive Materials; and Group 7, Requirements for Land Disposal of Radioactive Waste are in i
place.
2.
Referring to the enclosed NRC chronology of amendments note the effective date of the NRC changes last adopted by the State.
l As of December 12, 1985, revisions to State regulations to
{
maintain compatibility with the current NRC chronology of amendments were completed; however, not all have been adopted (see below).
l 3.a. Were there any compatibility items that were not adopted by the State 7 i
Yes.
- b. If so, please identify and explain why they were not adopted.
Amendment proposals for Group 2, Licensing of Radioactive Material (R-50-84) and Group 3, Radiation Protection Standards (R-13-85) were filed with the Office of Administrative Law on January 23, 1986, following completion of the post-hearing review, minor amendments and adoption by the Director. These regulation packages establish required compatibility pursuant to the current chronology of amendments to 10 CFR for consideration by Agreement States except:
(a) Removal or defacing of radioactive material labels on empty containers which is included in a proposal to amend Group 3, Radiation Protection Standards (R-41-85).
This proposal is under prehearing review by our legal and regulations offices following completion of staff work.
(b) Elimination of the exemption for glass enamel and glass enamel frit (cloisonne jewelry) adopted by the NRC as an amendment to 10 CFR 40 on September 11, 1984. This amendment will be the subject of a future regulation proposal to be adopted prior to September 11, 1987 which is the deadline set by the NRC policy on compatibility.
I.B. Reviewer Assessment:
21
!t i
Because all compatibility revisions have not yet been adopted, the State i
does not meet the guidelines, although progress is being made, as j
indicated by the State's responses.
The expected date for adoption is j
May, 1986.
1 C.
Updating of Regulations (Category ll) l NRC Guidelines:
The RCP should establish procedures for effecting appropriate amendments to State regulations in a timely manner, j-normally within 3 years of adoption by NRC. For those regulations
{
deemed a matter of compatibility by NRC, State regulations should be amended as soon as practicable but no later than 3 years.
j l
Opportunity should be provided for the public to comment on proposed i
regulation changes.
(Required by UMTRCA for uranium mill l
regulation.) Pursuant to the terms of the Agreement, opportunity i
should be provided for the NRC to comment on draft changes in State regulations.
i i
1.
Does your State have a schedule or program for revising and I
adopting changes to regulations within three years of adoption by the NRC?
i No, it is done on an as needed basis. After the current j
revisions are adopted, hopefully it will take less than three i
years.
~
i j
2.
Has your State adopted all regulations deemed a matter of s
1 compatibility by NRC within three years?
(Refer to NRC chronology.)
No, see reply to I.B.2 above.
5 3.
What are your State's procedures for cdopting new regulations?
t Briefly describe each step in the procedure.
The regulations promulgation schedule is as follows:
l Activity Time Frame 5
3-l Submission of Regulation Proposal to the N/A i
e Office of Regulations Review by Office of Regulations 14 days Review by Office of Legal Services and Budget /
30 days Section/ Department of Finance Prepare and Distribute Public Notice 30 days i
i Public Notice Period 45 days Public Hearing I day Post-Hearing Review and Revision
\\
30 days
... _ =
I i
22
-l 1
i i
Make Revisions Available to Public' 15 days l
e Adoption _by Director and Filing with 5 days i
Office of Administrative Law (OAL) l 1
i Office of Administrative Law Review and Filing 30 days with Secretary of State Post-Filing Waiting Period 30 days a'
l 4.
Ilow is the public involved in the process?
l Through hearings and review by the Office of Administrative r
Law.
'l l'
E 5.
- a. Does the NRC have the opportunity to comment on dra.ft changes to State regulations?
- b. If so, does your State respond to the comments?
Yes to both questions.
I.C. Reviewer Assessment:
The State partially meets the guidelines for updating regulations in that
-j they allow for public comment and they provide NRC the opportunity to l
comment on the draft changes. However, they.have been unable to maintain
'j compatibility with the NRC because of: ineffective procedures.for updating i
regulations. After the current package of reviEions is adopted'and published, program management should concentrate on establishing new' 2
procedures that ensure that regulations are revised on a continuing basis in order to maintain compatibility.
1 t
1 II.
ORGANIZATION t
l d
1 l
A.
Location of the Radiation Control Program Within the State i
j Organization (Category II) s NRC Guidelines:
The RCP should be located in a State organization
(
parallel with comparable health and safety programs. The Program j
l Director should have access to appropriate levels of State i
2 management.
I 1
e i
1.
Attach a dated organization chart (s) showing the RCP and its l
location within the department and State organization.
The California State organization charts are attached as Appendix A.
l 2.
Is the RCP on a comparable level within the State organization
{
with other health and safety pr.ograms so as to compete effectively for funds and staff?
i
+
Yes, we are receiving a fair share of resources.
i
-,~_
t; 23
[
I i
1 3.
Does the RCP program director have access to appropriate levels of State management?
l Yes.
j 11.A Reviewer Assessment:
j l
l The California radiation program meets the NRC guidelines and is parallel i
j with comparable State health and safety programs. Although the structure l
of the California State organization places the RCP well down in the
{
j hierarchy, the program is receiving increased attention from the departmental level, and the reviewer was assured this will continue to be
{
the case, j
B.
Internal Organization of the RCP (Category II)
NRC Guidelines: The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place
(
appropriate emphasis on major program iunctions, and provide specific lines of supervision from program management for the I
execution of program policy.
Where regional offices are utilized, the lines of communication and administrative control between the regions and the central office (Program Director) should be clearly drawn to provide uniformity in inspection policy, procedures and supervision.
l Questions:
i 1.
Attach dated copies of your internal RCP organization f
charts.
i The charts are attached as Appendix B.
i 2.
How is the RCP organized so as to provide specific lines of supervision from program management for executing program policy?
The Radiologic Health Branch is divided into two areas of responsibility: Radiation Management Section, incorporating radioactive material compliance and licensing, X-ray machine registration and inspection; and Radiation Standards Section, composed of facilities and environmental standards and X-ray operators certification. Refer to the organization chart for specific lines of responsibility.
3.
If regional offices are used:
a.
To whom 40 regional personnel report administratively?
RHB regional compliance offices (No. & So.) report to the compliance supervisor at RCP headquarters.
b.
To whom do regional personnel report technically?
i 24 i
All contracting agencies and regional RHB offices report to RCP headquarters technically.
l 4.
If the RCP contracts with other agencies to administer the l
program:
a.
Identify the contracting agencies and indicate their l
responsibilities.
The Department of Industrial Relations contracts for all industrial compliance inspections. The Counties of Los
}
Angeles and Orange contract for compliance inspections within their respective jurisdictions.
j b.
To whom do contract personnel report administratively?
l l
l Contract compliance inspectors report to supervisors l
within their respective agencies.
{
i c.
To whom do contract personnel report technically?
All contracting agencies report through the local supervisor to RCP headquarters technically.
i I
II.B Reviewer Assessment:
l l
The California RCP meets the guidelines for Internal Organization based on the response to the questions and discussions with management. The j
recent internal reorganization of the Radiological Health Branch has f
helped in improving the overall efficiency of the organization's output.
i i
C.
Legal Assistance (Category II)
I NRC Guidelines: Legal staff should be assigned to assist the RCP, j
or procedures should exist to obtain Icgal assistance expeditiously.
}
Legal staff should be knowledgeable regarding the RCP program, i
statutes, and regulations.
t Questions:
1 1.
Are legal staff members assigned to assist the RCP or do i
procedures exist to obtain legal assistance expeditiously?
{
l t
Legal assistance is obtained from staff attorneys in the Office i
of Legal Services. The Attorney General's Office provides i
representation for trials and hearings under the Administrative i
Procedures Act.
l 2.
Is the legal staff knowledgeable regarding the RCP, statutes, regulations and needs?
l Some specialization by attorneys in radiation protection j
matters occurs in practice. This specialization results in i
I l
I l
i
)
I 25 l
familiarity over time with the legal basis and requirements of the Radiation Control Program.
3.
If legal assistance was utilized since last review, provide a summary of the circumstances.
Legal assistance was used for LLW issues, draft orders, g.
a regulations and public hearings, i
i Summary of Circumstances i
1.
LLW l
Legal assistance was provided in the formulation of the legislation.
Legal opinion was provided for awarding the candidate responsible for operating the LLW site errecially on the question of liability.
Informal legal opinion was provided on NEPA and CEQA i
requirements on siting and hearings.
Legal opinion will be sought before issuance of license of 4
the site operation pursuant to Health and Safety Code 25845.
[
1' l
2.
Boothe-Twining 1
Legal assistance and representative in hearings and imposition of civil penalty.
l r
b
]
3.
1 l
Legal representation in pre public and public hearing.
[
l Legal representation to defend the Department against-suit from Desert Pass Group.
+
II.C Reviewer Assessment:
According to the State's replies, the legal assistance assigned to the RCP meets the NRC guidelines.
f D.
Technical Advisory Committees (Category II) i NRC Guidelines: Technical Committees, Federal' Agencies, and other
}
resource organizations should be used to extend staff capabilities j
for unique or technically complex problems.
A State Medical Advisory Committee should be used to provide broad guidance on the j
uses of radioactive drugs in or on humans.
The Committee should represent a wide spectrum of medical disciplines.
The Committee should advise the RCP on policy matters and regulations related to use of radioisotopes in or on humans. Procedures should be t
i s
- ?
26 i
developed to avoid conflict of interest, even though Committees are advisery. This does not mean that representatives of the regulated community should not serve on advisory committees or not be used as consultants.
Questions:
1.
Discuss practices followed for obtaining technical assistance
.f when needed (e.g., consultants, technical and medical advisory i
committees, licensees, the NRC and other State and Federal Agencies).
j i
In addition to the technical assistance received from federal agencies such as the NRC, DOE, and the Bureau of Radiological Health, the Department uses two technical and medical advisory committees, the Medical Advisory Committee on Human Use of Radioactive Material and the Low-Leve] Radioactive Waste Advisory Committee. Special consultants are also used as j
neces sa ry.
l t
2.
What steps are taken to avoid conflicts of interest?
l Committee members are subject to the Department of Health Conflict of Interest Code and must provide a curriculum vital
)
to the State before their appointment.
Th Personnel j
Department requires forms be submitted to them describing the l
professional background of proposed consultants. These background statements, along with the personal knowledge of the program management, are intended to eliminate conflicts of
(
4 interest.
l l
1 3.
Are any committees involved in setting policies? If so, l
explain.
I
~
The committees do not set policy per se, but they provide input and review of legislation and regulations and they establish i
standards of competence for nuclear technologists.
1 i
4.
Attach a list showing the membership, specialties and affiliations of the Medical and/or Technical Advisory j
Committees.
i The lists of committee members are attacned as Attachment II.D.4.
{
I 5.
Indicate whether the advisory committees are established by statute, by appointment of the Governor, by appointment of the j
State Board of Health, by appointment of the Agency, or by I
other means.
f The committees are established.by statute and members are a
l appointed by the Director.
l I
3 i
I l
v
~_
i 27 4
?
f 6.
Khat is the formal meeting frequency of each committee, and are j
minutes of committee meetings prepared 9 i
There is no formal frequency established for meetings. The
{
committees are convened as necessary and minutes are always 5
recorded.
7.
What was the date of the last formal-meeting of each committee?
l The Human Use Advisory Committee last met on March 3,1981; the Low-Level Waste Committee met September 13, 1985.
t 8.
Are individual committee members contacted for consultation?
i i
i j
Yes.
1 9.
Discuss how each committee is used, the average workload p' aced l
j on the committee, and the remuneration, if any.
l l
l The Human Use Advisory Committee provides medical advice on nuclear medicine procedures, both in routine or investigational use, provices input on legislation and regulations pertaining l
j to the usc of radioactive material in nuclear medicine or i
3 associated areas and consults on medical aspects of radiation i
overexposure. The physicians who comprise the board are paid l
for actual time worked (approximately 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per month) at i
j
$22.44 per hour.
The Low-Level Radioactive Waste Advisory Committee was established for the purposes of providing advisory input and oversight of the development of a low-level waste site in California. There is no compensation, but the members are i
reimbursed actual and necessary expenses incurred in the l
performance of their committee duties.
J j
II.D Reviewer Assessment:
The State meets the guidelines for technical advisory committees.
This finding is based on the above responses and the membership lists. Both j
committees represent a wide spectrum of disciplines in the health physics 1
and medical fields, i
III. MANAGEMENT AND ADMINISTRATION A.
Quality of Emergency Planning (Category I) 1 NRC Guidelines: The State RCP should have a written plan for response to such incidents as spills, overexposures, transportation r
accidents, fire or explosion, theft, etc.
The Plan should define the responsib.ilities and actions to be taken by State agencies.
The Plan should be specific as to persons responsible for initiating response actions, conducting operations j
and cleanup. Emergency communication procedures should be
-u y
~
-n-,
~
28
)
adequately established with appropriate local, county and State agencies. Plans should be distributed to appropriate persons and agencies. NRC should be provided the opportunity to comment on the l
Plan while in draft form.
l The plan should be reviewed annually by Program staff for adequacy _
)
and to determine that content is current. Periodic drills should be l
performed to test the plan.
f Questions:
i 1.
Is the RCP responsib;e for its own emergency plan or are I
accidents involving radioactive materials incorporated into a comprehensive State plan developed and administered by another State agency? Please provide copies of all applicable plans for review.
Radiological emergency planning and response are mainly. the responsibility of the State Office of Emergency Services (OES).
I 1
Radiologic Health Branch is a technical arm of the Office of l
Emergency Services. The development of the emergency plans and j
]
procedures is a combined effort of bcth-agencies. A copy of
)
the current plans and procedures has been provided, j
2.
What written procedures or plans does the RCP use for responding to incidents involving radioactive materials?
A draft document, " Plan for Response to Incidents Involving l
Radioactive Material, February 20, 1986," has recently been i
distributed for comment among the technical' staff and is in interim use (see attachment ll1.A.2).
In addition, we operate j
q under the OES plan, " California Emergency Response Plan".
i j
3.
If the plan covers major accidents at nuclear facilities, how l
does it cover non-catastrophic incidents such as those l
involving transportation of materials?
i i
The RCP plan covers all radiation emergencies other than those l
l at nuclear facilities. Rancho Seco, Diablo Canyon and SONGS i
have their own plans.
4.
How does the plan define responsibilities and actions to be j
taken by all State Agencies (initiating response actions, j
operations, cleanup, etc.)?
The introduction to the plan defines the jurisdiction and j
responsibilities of each agency and the licensee.
5.
How does the plan provide for netification of and l
communications with appropriate government agencies?
An emergency call list has 24-hour telephone numbers for all federal, state and county offices that might be concerned.
l This list is attached as Attachment III.A.S.
i 1
r r
I
29 i
a 1
I i
i 6.
Ilow is the response program organized so that qualified I
individuals are readily available through identifiable channels i
d of communication?
I Day and night telephone numbers are listed for all qualified individuals including the Medical Advisory Committee.
4 7.
Has the plan been distributed to all participating agencies?
The call down list has been distributed. The plan is still in i
draft form and will be distributed when complete. Target April 1986.
l 8.
Has the NRC had opportunity to comment on the plan in draft form?
Yes, the NRC reviewer did provide comments on the final document.
9.
Is the plan reviewed annually by the RCP f or adequacy and to j
assure the content is current?
i The call list is reviewed annually. The plan is reviewed as needed.
l 10.
Are drills performed periodically to test the pla.
.or l
radioactive materials emergencies? Explain, for example, how
]
1 non-routine office hours communications are checked, i
t t
The emergency telephone call down system is tested several i
times per year. No drills are performeC, except for nuclear l
power plant drills.
)
III. A Reviewer Assessment:
A Overall, the State meets the guidelines for Quality of Emergency Planning i
although certain sections of the new plan, such as those dealing with 3
transportation accidents, are not complete. This information was i
determined from interviews and a review of the plan itself. This item will be followed up both during the follow-up to this review and during I
the next routine review. The Regional State Agreements Representative is j
on distribution for this plan, possesses the most recent copy and is
)
j provided with all updates and notifications dealing with this plan.
a
{_
B.
Budget (Category II)
NRC Guidelines: Operating funds should be sufficient to support program needs such as:
staff travel necessary to conduct an J
effective compliance program, including routine inspections, l
followup or apecial inspections (including pre-licensing visits) and
)
responses to incidents and other emergencies; instrumentation and other equipment to support the RCP; administrative costs in operating the program including rental charges, printing costs, l
laboratory services, computer and/or word processing support, i
U
.,e
=.
l 30 l
I r
preparation of correspondence, office equipment, hearing costs,
)
etc., as appropriate. Principal operating funds should be from i
sources which provide continuity and reliability, i.e.,
general tax, j
license fees, etc.
Supplemental funds may be obtained through contracts, cash grants, etc.
l Questions:
i 1.
What fiscal year is used by your State?
The State fiscal year runs from July 1 through Janc 30.
2, Indicate the amount for funds obtained from each revenue source (fees, State General funds, HHS, NRC environmental monitoring or transportation surveillance contracts, EPA, FDA and others).
Radioactive materials license fees currently provide $760,000 per year. The balance and costs attributable to fee exempt.
3
~
licenses comes from the State General Fund.
j 3.
Show the total amounts assigned to:
the total radiation control program a.
i 4
1984-1985
$3,863,436
~
l 1985-1986
$4,076,386 b.
the radioactive materials program, j
1984-1985
$1,229,211 1985-1986
$1,576,883 i
'.i 4
What is the change in budget from the previous year and what is j
the reason for the change (new programs, change in emphasis, statewide reduction, etc.)?
l The increase to cover cost of living and three new positions
-j authorized.
i 5.
Describe your fee system, if you have one, and give the percentage of cost recovery. Enclose a copy of the fee schedule.
1 j
Licensees are assessed an annual fee according to the size of
]
the source. The cost recovery from the licenses is 55 percent.
Emergency regulations have been submitted for full cost 3
recovery from fees. This regulation will be effective March 31, 1986. A fee schedule is enclosed as Attachment 111.B.S.
6.
Does the RCP administer the fee system?
Yes.
7.
What recourse does the RCP have in the event of non payment?
\\
i l.
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9y
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u
31 l
We have been in the process of setting up a delinquent license fee account system to track and assure that all fees owed are j
paid.
We have issued demand letters for seriously delinquent j
accounts and are in the process of initiating legal action on a test basis. This is still the case except a stronger letter has been drafted, and will be put in use when approved.
l 8.
Overall, is the funding sufficient to support all of the i
program needs? If not, specify the problem areas.
i Yes.
Ill.B Reviewer Assessment:
Although it is not indicated in the State's response, it appears from observation and discussion that funding is not sufficient to meet all of the program needs, and thus the budget does not meet the NRC guidelines.
The staffing level continues to be below guidelines due in part to insufficient funding, and the ADP system lacks the technical support necessary to set up a functioning system with trained staff to operate it.
The funds are very rigid and can only be used for their specific allotted purpose, except for a very small f und allotted to general expense which can be used for travel or equipment, at the discretion of the Branch. The funding for the program has been receiving increased attention from the Director, DHS, and many improvements have been made during the review period.
The reviewer was assured this will continue.
I The effect of the legislature's move to obtain full cost recovery from fees will be observed in upcoming reviews.
j i
C.
Laboratory Support (Category II) l i
NRC Guidelines: The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bioassays, analyze environmental samples, l
analyze samples collected by inspectors, etc., on a priority
}
established by the RCP.
l i
Questions:
j 1.
Are laboratory services readily available in-house or through other departments within the State organization?
The Radiation Laboratory is a branch of the DHS that acts as a support group for the Radiological Health Branch. Although j
they have their ow.
ervision and budget they are s >nsidered in-house because th are part of the DHS.
2.
If services are provided by other departments, discuss the arrangements, supervision, charges and interdepartmental i
communications.
Not applicable.
t 3.
If laboratory services must be provided by a non-State agency:
i e
32 i
a.
Discuss the contractual arrangenc u.s.
f b.
Is the party providing the service a State licensee?
j c.
If a State licensee provides the service or equipment, l
what are the costs?
None of the above are applicable.
t 4.
Describe the capability of the laboratory as follows:
j l
Can it qualitatively and quantitatively analyze low-energy a.
beta emitters?
t Yes.
j b.
Can it qualitatively and quantitatively analyze alpha j
emitters?
l t
Yes.
j
\\
Can it selectively determine the presence and quantity of
(
c.
gamma emitters?
j Yes.
j d.
Can it handle samples in any physical form - vipes, I
liquids, solids, gaseous?
i Yes.
e.
Does the lab participate in a periodic quality control program?
t Yes, the EPA Safe Drinking Act requires it.
i S.
How much time does it take to obtain the results from sample
]
analyses on both a routine basis and on an emergency basis?
i The routine analyses depends on the lab workload and may take up to two weeks. Emergency samples are analyzed as quickly as the process and transit time permit.
[
6.
List the number and types of laboratory instrumentation and services available.
i I
l SANITATION & RADIATION LABORATORY INSTRUMENTATION; RAD 10 CHEMISTRY SECTION Nuclear Measurement Inst ruments:
1 i
Make and Avail.
a Model No.
Description No.
l 1
1 l
i e
i l
~
-~
.~ _-
33 3
I l
t i
1.
Nuclear Measurement, Internal proportional counter 6
j PCC-117 with DS-3 for gross alpha-beta 2.
Tennelec, LB 5100 Alpha / beta low background 2
proportional counter with
[
]
sample changer 3.
Beckman Wide-beta II Low-beta background proportional 1
i counter with sample changer 4.
Nuclear Data, ND-6620 Ge(L:) gamma spectrometer 1
with ORTEC (18%) PGT (305) with 2 Ge(L:) detectors i
5.
ORTEC, Model 576 Dual detector alpha 1
spectrophotometer 6.
Beckman, LS 3801 Liquid scintillat. ion counter 1
'i 7.
Pandom, SC-5 Radon scintillation counter 2
8.
SRL Const. Radon Counter 1
t 9.
Nuclear Data, ND-66 with Intrinsic Ge detector gamma 1
4 PGT intrinsic detector spectrometer on Joan from NRC j
SANITATION AND RADIATION LABORATORY CAPABILITIES: RADI0 CHEMISTRY SECTION
/
I 1
l A.
Radiochemistry l
1.
Sequential separation of various radionuclides from a single sample.
f l
i 2.
Purification and determination of approx. 40 elements and 100 radionuclides from a wide variety of matrices.
B.
Alpha Emitters 1.
Gross alpha d
Environmental samples, such as, air, water, sewage, soil, vegetation, fish, etc.
I
?
2.
Alpha pulse height spectrometry 1
s Plutonium -238 and 239-240 and other heavy elements in air, water, j
1 fallout, fish, etc.
3.
Radium -226 by emanacion or precipitation methods.
i 4.
Uranium in water by radiochemical me.thod.
i C.
Beta Emitters 1
l
.. _.~.
~_. - _ =
l 34
-l i
i l
I 1.
Gross beta Environmental samples as in the alpha counting.
i 2.
Strontium -89, 90 in various samples.
]
3.
Gross beta gamma emitters (excluding K-40, Rb-87, Cs-137) in i
seawater by precipitation method.
{
4.
Tritium, C-14 and other beta emitters in water, milk, vegetation, etc.
[
5.
Low-level iodine -131 in water, milk.
a 1
i
]
6.
Radium -228 in water.
l 1
D.
Gamma Emitters l
Various environmental samples as gamma scanned as received, such as milk, water in a Marinelli beaker or processed into a solid. The library consisting over 70 radionuclides can identify each radionuclide by their l
energy peaks, abundance and quantifying the activities corrected for decay.
i E.
Stable Elements i
Uranium by fluorometric method.
t III.C Reviewer Assessment:
The reviewer made a special trip to Berkeley to review the DHS Radiation Laboratory facilities. The facilities, although somewhat dated except for gamma spectrometry, are in good condition and are used and maintained j
by a qualified and competent staff.
The equipment in total represents a l
multi-million dollar investment which more than meets the NRC guidelines.
l for Laboratory Support.
i i
D.
Administrative Procedures (Category II) l
[
NRC Guidelines: The RCP should establish wri+.en internal i
procedures to assure that the staff performs its duties as required l
and to provide a high degree of uniformity and continuity in l
regulatory practices. These procedures should address internal processing of license applications, inspection policies and l
procedures, decommissioning, and other functions required of the j
program.
i i
Questions:
-t 1
1.
What procedures are established to assure adequate and uniform.
regulatory practices (e.g., administrative procedures, policy memos, licensing and inspection guides, escalated enforcement i
procedures, decommissioning procedures, etc.)?
?
?
?
3 r
~ _ _
l 35 i
i Administrative procedures are contained in Reviewer's and l
Inspector's Guides, Inspection Policy Memos, Haterials Memos, Checklists, the Emergency Call Bool and the Health i
Administrative Manual. These documents are distributed to the program staff and will be available for inspection during the review.
g 2.
To what extent are the procedures documented?
i See answer above.
3.
If your State has separate licensing and inspection staffs, what are the procedures used to assure adequate communication between the two staffs?
The normal pattern of workload conduct bis inspections of major licensees by joint inspector-reviewer teams.
Where this is not' I
done (or even if done), compliance input through RH 2033 is required on all Priority 1 through 4 (new,. renewal or major I
amendment) licensing actions. For Priority 5 and above,.
l compliance has 15 days to provide input; otherwise the reviewer j
can act without this input if deemed appropriate.
5 4.
How are personnel kept informed of current regulatory policies and practices?
They are notified of changes by mail or in telephone l
conversations and through discussions at staff meetings.
l 5.
If your State collects fees, are fee collection-duties assigned to non-technical staff?
j Yes.
4 6.
How are contacts with communication media handled?
I q
i i
The media is referred to the State Public Information Office (PIO). The RCP only answers technical questions after they i
have been cleared by the PIO.
7.
What procedures exist to ensure timely release of factual information on matters of interest to the public, the NRC and Agreement States?
There is a long standing agreement between agencies (NRC, OES, j
DOE, CA) to keep each other informed. Matters of public j
interest are referred to the Branch and Division Chiefs before I
being sent to the PIO for press release. Other agreement states are notified of generic issues.
8.
If your RCP has regional offices:
what procedures are in effect to assure the regions have a.
complete copies of the procedures and files?
l W
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y i --
-.. w
.-m 36 f
Copies of procedures are maintained in each regional of fice together with license files appropriate to the region. Procedures are periodically updated with copy by mail.
Copies of all licensing actions are transmitted by mail to the appropriate regional office.
b.
how often are periodic staff meetings held with 3
j headquarters staff?
i 1
We attempt semi-annual meetings.
c.
how often are periodic visits / audits made by headquarters staff to regional offices?
Once a year as part of the accompaniment program.
d.
how is uniformity assured?
By accompaniment and review of inspection and q
investigation reports.
a 1
e.
how is supervision handled?
i The Compliance Supervisor of the Radiologic Health Branch i
accompanies the regional inspectors at a frequency of approximately once per inspector per year. Performance of the inspector is evaluated by the observer and discussed i
with the regional supervisor if applicable.
Indirect supervision is accomplished by phone, memo, mail, training and meetings.
III.D Reviewer Assessment:
i I
The California administrative procedures are now adequate to meet the NRC i
j guidelines. Many procedures and policies have been developed or updated i
in licensing and compliance which will be discussed later in the
]
assessments for the specific program function.
It was found, however, that all procedures and policies ~are not'being disseminated throughout i
d the staff, and that a lack of communication is hindering the ability of the program to operate with consistency and uniformity.
Staff meetings with input from reviewers and inspectors were suggested.
I Alsc, procedures need to be developed to address certain problems in the incident response program. This is discussed in the Incident Response section.
l E.
Management (Category II) l NRC Guidelines: Program management should receive periodic reports l
from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions). RCP management should periodically assess workload trends, resources and changes in legislative and regulatory responsibilities to forecast needs for increased staff, equipment, services and fundings.
s m.----
I
t 37 I
t Program management should perform periodic reviews of selected
,~
license cases handled by each reviewer and document the results.
Complex licenses (major manufacturers, large scope - Type A Broad, or potential for significant releases to environment) should receive-second party review (supervisory, committee, or consultant).
Supervisory review of inspections, reports and enforcement actions should also be performed.
i Questions:
i 1.
How does the staff keep program management abreast of the status of regulatory actions (such as backlog, problem cases, inquiries, and revision of regulations)?
The program staff reports on number of inspections, investigations, pre-license evaluations, reviews and other matters of significance on a monthly basis. Review backlog is l
established and tracked by means of a docketing system.
i Compliance inspection backlog is tracked utilizing a monthly due/ overdue listing.
Investigations are tracked using a tickler system.
2a.
Is a periodic statistical tabulation of licenses, licensees,
-l inspections and backlogs prepared by category?
j Statistical tabulations with respect to licenses, licensees and j
inspections are now prepared for the RCP Calendar utilizing ADP management information when available and extrapolation from reports previously developed.
j b.
If so, specify how frequently the tabulation is prepared.
Monthly.
3.
How does RCP management assess workload trends and resources in I
order to determine future needs or the need for program changes?
l The Branch uses several techniques for assessment of trends, planning and follow-through for workload; equipment, staff and budget considerations. Periodic reports are prepared to show j
actual workload against predicted and planned workload. These l
reports are designed to be used in support of both planning and j
3 budretary activities.
Improved output measures are currently l
under development.
The State uses specific processes for determination of equipment needs and budgetary changes.
Subctantial changes to a program are handled through the Budgetary Change Proposal 1
(BCP) process.
1 4.
How does the RCP management keep abreast of changes in l
legislative and regulatory responsibility?
}
3 r--
38 Legislation is tracked through the Office of External Affairs.
Regulations are tracked through the Office of Regulations which follows the Federal Register, and by communication directly with NRC Office of State Programs.
a 5.
Discuss the procedures followed by licensing supervision or RCP j
management to monitor licensing quality.
Staff review and concurrence is required for all Type A licenses and device and sealed' source approvals. Supervisors i
review all Type A authorizations and sealed source and device approvals to assure that these actions conform to staff j
determinations. Beyond this review, licensing actions are circulated through the staff for peer review as to compliance of regulations, policy and good health physics practice and for review by supervisors.
6.
Discuss the procedures used for supervisory review of inspection reports.
Investigation and compliance inspection reports receive review by the Compliance Supervisor at RCP Headquarters. Significant-questions are referred to supervisors for consultation and resolution.
l 7.
What license review practices are followed for unusual or complex license applications?
~
Complex license applications are reviewed at periodic staff I
meetings.
4 8.
If applicable, discuss the procedures used for supervisory review of work performed by contract agencies or regional
[
offices.
Compliance inspectors in regional offices report directly to 2
the Chief of Compliance in Sacramento. Compliance inspectors in contract agencies report through the agency supervisor to the Chief of Compliance in Sacramento.
Inspection and investigation reports are reviewed by the respective supervisors and the Chief of Compliance.
f i
III.E Reviewer Assessment-I Although the program management is improving, the State still falls short of many of the management guidelines.
The lack of communication mentioned previously is a major problem in California that diminishes the effectiveness of the entire program. This lack of communication appears between levels of management in Department, l
Division and Branch, where upper level ma.nagement is not aware of.
j problems within the Branch, as well as internally within the Branch, j
where information necessary for proper decision making is.not always made 3
available to either the staff or supervisors. For example, it appeared-
)
. =.
39 i
that the Division level management was not aware of the.large typing backlog or lack of adequate record storage facilities.
Internally, it was noted that NUREG's furnished to the Branch management are not circulated to the staff, and that the reviewers are using their own license conditions without supervisory approval.
l Also, program management is not performing and documenting the reviews of l
j selected license cases as suggested in the guidelines.
In compliance, deficiencies were found in the performance of inspections and in inapection reports that should have been disclosed and corrected in the supervisory review process, i.e., items of noncompliance downgraded to
}
recommendations.
i These findings were discussed with the program managers and ways to I
improve the program, such as staff meetings, were recommended.
I I
F.
Office Equipment and Support Services (Category II)
{
i NRC Guidelines: The RCP should have adequate secretarial and I
clerical support. Automatic typing and Automatic Data Processing j
and retrieval capability should be available to larger (300-400 1
licenses) programs.
Similar services should be available to regional offices, if utilized.
]
la.
In terms of the person year /100 licenses figure, what level of secretarial / clerical support is provided?
I The Radioactive Materials Control Program is supported by 4.5 FTE clerical staff. The ratio is 0.17 person-year of clerical support for each 100 licenses.
i b.
If your program has regional offices, provide the figures for j
the support for those offices.
1 1
The regional offices which are staffed by contract agencies provide their own support staff.
1 4
1
]
2.
Describe the ADP and word processing capabilities available to
')
]
the RCP.
i l
]
The Radioactive Materials Control Program receives limited ADP l
support from the Department's Data Systems Branch (Administration Division). The Radioactive Material Control Program also has a compliance file at the State's data center.
i (Teale Center). The RCP has some capability to manipulate these files at the Teale Center.
i Presently, IBM microcomputers are available for in-house use.
This in-house system has been able to incorporate licensing and compliance data and generate useful reports or lists for management purposes.
Some examples of these reports / lists are:
i List of expired licenses 1,
4 4
4 n
n+-
n,m-w m
=
p w
n r
=
40 i
List for billing of annual fee List of requested licensing actions completed open List of due/ overdue inspections
)
t List of licensees in alphabetical or numerical order plus i
any additional data stored in the system L
List of open or closed investigations Software programs are being developed to improve the data base i
and data processing for a comprehensive radiation control management system.
5 III.F Reviewer Assessment:
The State does not meet the guidelines for support services from either the secretarial and clerical staff or the ADP system.
The size of the support staff was not increased to keep abreast of increased workloads such as occurred when the materials inspection staff transferred to Sacramento from Berkeley or when the size of technical i
i staff and number of licensees increased. As a result, the secretarial and clerical staffing level is inadequate to meet program needs and the large backlogs of typing and filing are seriously impeding the other program functions.
and was discussed at the exit meeting and addressed in theThis was also i
correspondence.
l' The reports and lists generated by the IBM system were found to be i
conflicting and inaccurate when compared with each other or with the i
actual casework.
During previous reviews, it was suggested the State i
obtain technical assistance from consultants.
The assistance they received came f rom personnel from the State computer center, e::perts on
[
large computers and mainframes but unfamiliar with micro-computers or dBase III, and was apparently inadequate for their needs.
As a result the State cannot maintain statistics adequate to permit program management to assess the status of the inspection program,
{
to track compliance histories of licensees or otherwise obtain the benefits of an
(
It was recommended that assistance be sought from
')
operating system.
nearby California colleges or universities or commercial sources with the t
proper expertise.
An alternate measure would be to provide the in-depth training to a current member of the RCP staff, who would then serve as an in-house expert on the development and use of the system and ongoing
[
training.
i The lack of other support services is also impacting the program.
4 i
In licensing, they have depleted their supplies of forms, guides, and l
regulations.
The reviewers have been copying these items as needed.
j l
There is no filing space available so licenses and SS&D documents are J
i a
l i
41 f
kept in cardboard boxes (the same as NRC). These shortages and their effect on the program were discussed in the exit meeting and the
[
Department promised to resolve the problems.
G.
Public Information (Category II)
NRC Guidelines:
Inspection and licensing files should be availaole to the public consistent with State administrative procedures.
l Opportunity for public hearings should be provided in accordance l
with UMTRCA and applicable State administrative procedure laws.
Quest:ons:
j 1.
Are licensing and inspection files available for inspection by the public?
Yes, license files are considered public documents.
2.
Can medical and proprietary data be withheld?
Yes.
u i
3.
What other parts, if any, are not available?
f Any personal data.
I 4.
What written procedures and laws govern this? Please provide l
1 reference citations.
t The Information Practices Act of 1977 (SB 170) and California Public Records Act, Chapter 3.5 of Division 7 of Title of the j
Government Code.
l B
For mill States, are opportunities provided for public hearings 5.
j in accordance with UMTRCA and applicable State administrative l
procedures and statutes?
l l
Not applicable.
I l
JII.G Reviewer Assessment:
t i
According to the State replies, California meets the NRC public information guidelines.
l IV.
PERSONNEL I
A.
Qualifications of Technical Staff (Category II)
NRC Guidelines: Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences.
Additional training and experience i.n radiation protection for senior personnel should be commensurate with the type of licenses issued and inspected by the State.
t i
3 -
1 i
b k
42 t
l Written job descriptions should be prepared so that professional l
qualifications needed to fill vacancies can be readily identified.
i Questions:
1.
Do all professional personnel hold a bachelor's degree or have equivalent training in the physical or life sciences?
Professional health physicist personnel are required by the
)
State's classification system to have a bachelor's degree in a physical or life science; this is a requirement which must be l
met prior to examining to qualify as a health physicist.
Additional qualifications include years of experience in health physics or a closely related field.
j 2.
What additional training and experience do the senior personnel need to have in radiation protection?
I j
They must have attended NRC core courses and completed on-the-job training for a minimum of 6 months.
3.
What written position descriptions describe the duties, responsibilities and functions of each professional position?
n d
The California State Personnel Board publishes specifications for five levels of Health Physicists.
Job descriptions are published which define the responsibilities for each level, the minimum qualifications, and the knowledge and abilities required for each position.
Copies of the specifications and job bulletins are available for review.
i I
JV.A Reviewer Assessment:
]
The qualifications of the California technical staff, as well as the 1
contracting agencies, meet the NRC guidelines. This is based on reviewer observation and training records as well as the responses provided by the State.
1 B.
Staffing Level (Category II)
NRC Guideliaes:
Staffing level should be approximately 1-1.5 person year per 100 licenses in effect. RCP must not have less than i
two professionals available with training and experience to operate RCP in a way which provides continuous coverage and continuity.
{
u For States regulating uranium mills and mill tailings, current i
indications are that 2-2.75 professional person-years' of effort, i
including consultants, are needed to process a new mill license (including insitu mills) or major renewal, to meet requirements of i
Uranium Mill Tailings Radiation Control Act of 1978. This effort must include expertise in radiological matters, hydrology, geology, and structural engineering.
Questions:
1 i
43 1
1.
Complete a table listing the person-years of effort applied to the agreement or radioactive material program by individual.
Include the name, position, fraction of time spent and the duty j
(licensing, inspection, administration, etc.).
9 Area of
-I Name Position FTE%
Effort 5
Joseph Ward Chief, Radiologic Health Branch 20 Admin.
l Gerard Wong Supervising Health Physicist 50 Materials Control i
Linda Nugent Health Program Technician 1 40 Admin.
t i
Edwin Njoku Senior Health Physicist 100 Licensing Dave Wheeler Associate Health Physicist 100 Licensing Stuart Rosenberg Associate Health Physicist 75 Iicensing l
25 Compliance i
Ben Kapel Associate Health Physicist 75 Licensing 25 Compliance Don Barr Associate Health Physicist 100 Licensing f
Gary Butner Associate Health Physicist 75 Licensing j
i 25 Compliance J
Bill Groteguth Associate Health Physicist 100 Licensing Jeff Wong Associate Health Physicist 100 Licensing
)
Ollie deLalla Associate Health Physicist 100 Licensing Rich McKinley Associate Health Physicist 100 Licensing Gordon Stelling Associate Health Physicist 100 Licensing Jack Brown Senior Health Physicist 100 Compliance j
4 i
Joe Takahashi Associate Health Physicist 100 Compliance 3
Los Angeles j
Donna Sutherland Associate Health Physicist 75 Licensing I
25 Compliance Don Honey Supervising Health Physicist 12 Regulations Jackie Stroud Health Program Advisor 15 Regulations CONTRACT AGENCIES
.i Department of Industrial Relations j
44 i
i Bill Lew Senior Health Physicist 50 Compliance
'[
San Francisco Lisa Burns Associate Health Physicist 90 Compliance San Francisco Mark Gottlieb Associate Health Physicist 90 Compliance San Francisce i
Kim Wong Senior Health Physicist 80 Compliance Los Angeles Bill Watson Associate Health Physicist 90 Compliance i
Los Angeles l
Los Angeles County i
Joe Karbus Head 20 Compliance /
Admin Al Ferguson Inspector 50 Compliance Vacant.
Inspector 100 Compliance Gene Edmonds Inspector 100 Compliance Orange County l
?
4 James Hartranft Inspector 50 Compliance
+
4 l
Summary of staf f time in Radioactive Material as of February 1,1986:
I i
Radiologic Health Branch i
l Professional Staff Positions Authorized Actual i
i Materials Control 16.3 15.3 i
Regulations (0.37)
(0.37) l TOTAL 16.3 15.3 i
4 i
Contract Agencies
}
DIR 4.0 4.0 Los Angeles County 2.7 1.7 Orange County 0.5 0.5 TOTAL 23.5 21.5 i
2.
Compute the person-year effort of person years per 100 licenses (excluding mills and burial sit.es).
Show calculation.
I Actual
?
i i
45 t
E
.83 person years /100 licenses.
P 21.5 person years x 100
=
2584 licenses
- Authorized i
?
.91 person years /100 licenses.
23.5 person years x 100
=
2584 licenses
- l 9
This number of licenses includes a correction factor of times 1.18 license to licensee ratio. The actual number of material licenses in California is 2194 at the time of this review.
3.
Is the staffing level adequate to meet normal and special needs
[
and backup?
j The overall Materials Control Program is not staffed to the level used as a standard by the NRC. For a program the size of l
California's, the standard is 32 professional positions. The l
State and its contractors currently have 23.5 authorized i
i positions.
21.5 are filled as of February 1,1986.
i IV.B Reviewer Assessment:
l Although California appears to be working hard toward meeting the NRC staffing guidelines, they still fall somewhat short of the numbers and 4
therefore do not meet the staffing guidelines. The problem shows in the I
licensing and inspection backlogs and the inability of the program to meet their projected goals or action plans.
Staffing needs to be
}
followed closely in California and management needs to be constantly reminded not to reduce the effort necessary to hire and maintain an adequate and competent staff.
C.
Staff Supervision (Category 11)
NRC Guidelines:
Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel.
Senior personnel should review applications and inspect licenses independently, monitor work of junior personnel, and participate in the establishment of policy. Junior personnel should be initially limited to reviewing license applications and inspecting small programs under close supervision.
Questions:
1.
Identify the junior and senior personnel.
Only the four new hires are considered junior level personnel.
They will be raised to senior level on a case-by-case basis af ter their probationary period.
2a.
What duties are assigned to junior personnel?
l 1
1 46 i
l l
4 Junior personnel work with senior personnel until in the j
judgment of the supervisor they can work alone.
They begin j
with simpler licensees and eventually work up to the complex.
l b.
Do they review applications and perform inspections independently?
In simpler cases (gauge licenses) after supervision determines
-I they are suf ficiently qualified, they may perform l
independently.
l 3a.
What duties are ass 2gned to senior personnel?
t They are assigned all duties described in the job description, including license reviews, inspection and incident response.
Copies of the job descriptions are on file with the RCP and RV NRC office.
I b.
Do they independently review and monitor the work of junior personnel?
Yes.
4.
Is there adequate supervisory or senior guidance and direction j
for junior personnel?
I Yes.
J 5.
Discuss procedures established to ensore supervisory review of j
the licensing, inspection and enforcement functions.
With license reviews, there is either peer review or committee review of applications done by junior personnel. With inspection, there is supervisory review when available. For escalated enforcement, input and concurrence is sought from l
l regional supervisor and headquarters.
l 6a.
Are RCP staff members allowed to consult or work part time for State licensees?
i i
b.
If so, how are conflicts of interest avoided?
i i
No -- Conflict of Interest Statutes bar acceptance by employees j
of regulatory agencies of anything of value from persons or organizations regulated.
IV.C Reviewer Assessment:
The staff supervision in California is adequate to meet the NRC guidelines, as indicated by the State's responses.
In practice, it was observed that the Senior Health Physicist.s supervising the materials
=
i inspection and licensing units are reluctant to make work assignments i
because of their inexperience in supervising and because some employees 4
are only partially or temporarily assigned to licensing or compliance, l
1 r
47 t
confusing the lines of supervision. The supervisors are also 2ncreas2ng their own workload by performing routine inspections and license reviews.
As a result, the staff members feel reluctant to approach them with j
suggestions for improvement in the program and are turning to their peers i
for assistance in complex issues.
(See Appendix C, Review of Selected License Files, for examples). The Seniors would benefit from management
[
training as well as guidance.from higher management.
l D.
Training (Category II)
-j NRC Guidelines: Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical l
practices and industrial radiography practices.
(For mill States, mill training should also be included.) The RCP should have a program to utilize specific short courses and workshops to maintain f
an appropriate level of staff technical competence in areas of
{
changing technology.
Questions:
j 1
1.
List materials personnel and the training courses they have i
attended during this review period.
i Agency-l Name Course Sponsor Dates j
l Edwin Njoku (1) Safety Aspects of Industrial NRC May '85 l
Radiography j
i l
(2) Medical Uses of RAM NRC June '85 i
I i
2 (3) Transportation of RAM NRC June '85 l
l (4)
Inspection Procedures NRC October '85 l
l Gary Butner (1) Medical Uses of RAM NRC March '85 l
l l
(2) Transportation of RAM NRC June '85 (3) Inspection Procedures NRC October '85 Stuart (1) Licensing Procedures NRC September '85 Rosenberg (2) Irradiator Worksbop NRC September '85 (3)
Inspection Procedures NRC October '85 t
1 l
Ben Kapel (1) Transportation of RAM NRC June '85 (2) Inspection Procedures NRC October '85 Don Barr (1) Medical Uses of RAM NRC June '85 (2) Transportation of RAM NRC June '85 f
(3) Licensing Procedures NRC September '85 i
(4) Inspection Procedures NRC October '85 l
2 David 'Jheeler (1) Transportation of RAM NRC June '85 i
i I
i
=
48 j
Don Honey (1) Transportation of RAM NRC June '85 Jack Brown (1) Transportation of RAM NRC June ' 85 i
(2) Inspection Procedures NRC October '85 Lisa Burns (1) Inspection Procedures NRC June '85 (2) Transportation of RAM NRC June '85 Larry Carter (1) Transportation of RAM NRC June '85 t
Gene Edmonds (1) Transportation of RAM NRC June '85 Mark Gottlieb (1) Transportation of RAM NRC June '85 l
t Al Ferguson (1) Transportetion of RAM NRC June '85 I
(2)
Inspection Procedures NRC October '85 i
William Lew (1) Transportation of RAM NRC June '85 l
(2)
Inspection Procedures NRC October '85
)
Jim Hartranft (1) Transportation of RAM NRC June '85 i
John Hickman (1) Transportation of RAM NRC September '85 Jim Rowles (1) Transportation of RAM NRC June '85 Jackic Stroud (1) Transportation of RAM NRC June '85 l
(2) Inspection Procedures NRC October '85 j
William Watson (1)
Inspection Procedures NRC October '85 i
(2) Transportation of RAM NRC June '85 Kim Wong (1) Transportation of RAM NRC June '85 l
(2) Inspection Procedures NRC September '85 Joe Takahashi (1) Inspection Procedures NRC June '85 (2) Transportation of RAM NRC June '85 2.
How does the RCP utilize short courses and workshops to
-f maintain staff proficiency?
l The California RCP uses the NRC courses in the training of
.l l
staff as available.
j IV.D Reviewer Assessment:
As indicated in the responses, California makes good use of the NRC I
training and meets the NRC guidelines.
Because of the expected increase in staff, the State was asked an additional question:
t i
3.
What methods are being used to train the new hires?
1 Orientation /Trainining for New Hires i
a t
I t
i 5
t 49 i
I 1
First 2 days Administrative / logistic matters are taken care of:
Week I thru 3 In class training provided by Sr. HP licensing & inspection guides are provided types of licenses / categories are discussed
{
in detail l
' licensing / amendment drafts are discussed in detail guides and checklists are discussed and used to prepare licenses Week 4 thru 8 -
On the job training provided by senior reviewers l
i new hire works under the direct guidance of i
a different senior reviewer each week l
f Week 9 New hire accompanies an. inspector to the field t
New hire is sent to NRC sponsored courses as they become available.
j This is a well planned training program, and along with close supervisory review should expedite the training process.
E.
Staff Continuity (Category 11)
{
NRC Guidelines:
I Staff turnover should be minimized by combinations of opportunities f
for training, promotions, and competitive salaries.
Sala y levels j
should be adequate to recruit and retain' persons of appropriate j
l professional qualifications.
Salaries should be comparable to similar employment in the geographical area. The RCP organization j
~
structure should be such that staff turnover is minimized and program continuity maintained through opportunities for promotion.
i Promotion opportunities should exist f rom junior level to senior I
level or supervisory positions. There also should be opportunity l
for periodic salary increases compatible with experience and responsibility.
e f
Questions:
i 1
1.
Identify the RCP employees who have left the program since the last review and give the reasons for the turnovers. Also state 3
whether the positions are presently vacant, filled (name j
replacement), abolished or other status.
Jim Rowles, Los Angeles County, left his inspector position for a better position in industry. Lynn Jameson, Office Services Supervisor, Radioactive Materials Control, transferred to j
another position with the State. Neither position has been filled.
t
50 i
i 2.
List the RCP salary schedule:
t Position Title Annual Salary Range Chief, Radiologic Health
$49704 54672 Supervising Health Physicist 42972 51924 Senior Health Physicist 37320 45036 l
Associate Health Physicist 32424 39084 Assistant Health Physicist 28176 33960 Junior Health Physicist 24036 27624 Radiation Protection Specialist Il 28824 34740 Radiation Protection Specialist I 25092 30180
[
I Health Program Advisor Il 30180 36420 Health Program Advisor I 25092 30180 These pay scales are effective as of July 1, 1985.
a 1
3.
Compare your salary schedule with similar employment alternatives in the.ame geographical area, such as industrial, t
medical, academic or other departments within your State.
j I
{
The salary rate for technical positions, specifically journey-(
level and senior level health physicists, is not comparable to i
4 similar employment opportunities in the state. The salary lag i
is between 10 percent and 20 percent behind selected medical, l
university, industrial and other governmental employers, j
t 4.
What opportunities are there for promotion within the RCP l
i organizational structure without a staff vacancy occurring?
j i
l l
At present, a Junior Health Physicist may promote in place to l
l Assistan'; Health Physicist and then to Associate Health i
)
Physicist (full journey level) without a staff vacancy i
occurring.
Promotions are still based on successful competition in promotional examinations. _ Promotions beyond l
}
journey level require a posit 2cn vacancy.
i f
IV.E Reviewer Assessment:
l l
The salaries in the State have been steadily improving and the small turnover rate indicates the State meets the NRC guidelines and maintains
}
j good staff continuity.
l t
V.
LICENSING I
i A.
Technical Quality of Licensing Actions (Category 1) i NRC Guidelines: The RCP should assure that essential elements of l
applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use i
material, facilities and equipment, and operating and emergency l
l procedures sufficient to establish the basis for licensing actions.
j I
e I
I
~
t I
51 Prelicensing visits should be made for complex and major licensing j
actions.
Licenses should be clear, complete, and accurate as to i
isotopes, forms, quantities, authorized uses, and permissive or i
restrictive conditions. The RCP should have procedures for reviewing licenses prior to renewal to assure that supporting i
~
information in the file reflects the current scope of the licensed program.
l Questions:
i 1.
How many specific licenses are currently in effect?
Number of licenses currently in effect as of December 31, 1985:
2194 2a.
How many new licenses (not amendments in entirety) have been issued since the last review?
i Number of new licenses issued during (1/1/85 - 12/31/85):
164 i
I b.
How many were major licenses?
i i
l There were 1 Priority I, and 39 Priority III licenses, i
1 i
4 3.
How many specific licenses were terminated since last review?
j Number of licenses terminated during (1/1/85 - 12/31/85):
104 l
4.
How many amendments were issued during the review period?
)
J i
l 1
Number of amendments issued (1/1/85 - 12/31/85):- 1523
)
5.
Identify any unusual or complex licenses issued since the last review, including name and license number.
y f
t j
The following includes some of the unusual or complex licenses issued.
I l
i Licensee License #
Description l
l 1sotope Products Laboratories 3128-70 Renewal Kaiser Steel Corporation 4534-48 New License Westinghouse 4346-33 Decontamination I
Facility i
Rockwell 0015-70 Facility change for multicurie kISF sources (Renewal in progress)
,J i
5' i
I Beckman Instruments 0441-30 Renewal in j
progress GA Technologies 0145-30 Renewal in I
progress ICN 1828-30 Renewal in l
progress IPL 1508-70 Renewal in-progress Aerojet 1450-36 Renewal in i
progress t
Small Animal Radiation 4640-30 New license j
Oncology Center L
Veterinary Tumor Institute 4647-44 New license a
l Moravek Biochemicals 2960-30 Renewal i
6.
Note any variance in licensing policies and procedures granted' since the last review.
i i
Nuclear Specialties (3546-50) was granted a time-limited j
variance on radioactive wastes disposal methodology.
i l
7.
Do you require license applicants to submit details on their' radwaste packaging and shipping procedures?
Yes, vaste handling procedures include provisions for clear and distinct segregation of radioactive waste by marking and physical separation from all other waste at locations where j
radioactive material is utilized.
Sa.
When do you require licensees to submit contingency plans?
When they exceed the NRC contingency requirements and have'not been required to submit plans to the NRC.
j b.
List the licensees who have been required to submit contingency l
plans.
General Electric (Pleasantott, Rockwell International ESG Systems, GA Technologies, and Northrop are the four firms that l
meet the NRC requirements for contingency plans, and they are all also Federal licensees. They have been required to submit j
their contingency plans to the NRC, and therefore have not been i
required to submit duplicate plans to California.
9.
How many prelicensing visits were made during this review j
l period?
)
5 0
l
53 a.
Approximately 100 prelicensing visits were made during the i
reporting period.
l 10.
What criterion does the State use to determine the need for a prelicensing visit?
l i
Prelicensing visits are performed when major changes in the l
type or level of operations is proposed by a licensee and with new applications proposing potentially hazardous operations.
j Prelicensing visits may be performed either at the request of the reviewer, or upon the initiative of the inspection agency.
t 11.
How do you ensure up-to-date information has been submitted I
prior to a license renewal?
~
r Applicants wishing to renew a radioactive materials license must comp.'ete a new application form (RH2050) in detail.
12.
Do license files contain all necessary data required to evaluate an application prior to issuing a license?
':e s.
a P
13.
Has the State take., any unusual licensing action with respect j
to licensees or_ rating under multiple juri's' diction?
I No.
14.
Prepare a table as below showing the State's major licensees f
with name, number and type.
l 1
INCLUDE:
]
}
Broad (Type A) Licenses j
LLW Disposal Licenses LLW Brokers Major Manufacturers and Distributors
,j Uranium Mills l
j Large Irradiators (Pool Type or Other) i j
Other Licenses With a Potential Significant Environmental l
Impact l
l Other Licensees You Consider to be " Major" Licensees j
J License Name Number Type UC Davis, Davis 1334-57 Broad A I
UC Berkeley, Berkeley 1333-62 Broad A UCSD, La Jolla 1339-80 Broad A j
l UCLA, Los Angeles 1335-70 Broad A San Francisco Medical Center y
San Francisco 1725-90 Broad A Stanford University i
k k
l
-.. ~ -,
I I
54 3
)
i Palo Alto 0676-43 Broad A i
Loma Linda University j
Loma Linda 0060-36 Broad A
[
USC Medical Center
.l Los Angeles 1949-70 Broad A USC Campus, Los Angeles 0382-70 _ Broad A l
GA Technologies, San Diego 0145-80 Broad A l
UC Irvine, Irvine 1338-30 Broad A.
Northrup, Los Angeles 0006-70 Broad A
-l General Electric, Pleasanton 0017-60 Broad.A j
ESG (Rockwell International) j Canoga Park 0015-71 Broad A 1
Hughes Aircraft, El Segundo 0039-70 Broad A Hughes Aircraft, El Segundo 0790-70 Broad A
]
TRW, Redondo Beach 0816-70 Broad A 1
U.S. Ecology 2873-60 LLW Broker Thomas Gray & Associates j
Orange 2105-30 LLW Broker Nuclear Specialties 3546-50 LLW Broker i
Pacific West Nuclear, Inc.
i vista 3622-80 LLW Broker i
ICN 1828-30
.r'g/ Distributor i
l Isotope Products, Burbank 1509-70 Mfg / Distributor J. L. Shepherd, Glendale 1777-70 Mfg / Distributor Aerojet Ordinance Company j
Compton 2789-70 Mfg / Distributor j
NDC Systems, Duarte 1933-70 Mfg / Distributor 1
Medi Physics, Emeryville 2067-60 Mfg / Distributor i
Becton Dickinson, Oxnara 3332-56 Large Irradiator l
Radiation Sterilizer, Tustin 3390-30 Large Irradiator International Satronics, Inc.
[
Palo Altc 1822-43 Large Irradiator l
Irvine 3911-30 Large Irradiator i
Aerojet Ordinance 1450-36 Environmental Impact i
Ford Aerospace 0550-43 Environmental Impact j
Westinghouse 4346-33 Environmental Impact i
1 4
V.A. Reviewer Assessment:
f I
l Fifteen license files were reviewed in depth. The program has improved significantly during the last few months and the technical quality of l
licensing actions now meets the guidelines. Some deficiencies were i
4 identified and discussed with the staff. A list of licenses reviewed with specific comments about each case, alcng with a discussion of the j
program is contained in Appendix C.
l l
B.
Adequacy of Product Evaluations (Category I)
NRC Guidelines: RCP evaluations of manufacturer's or distributor's data on sealed sources and devices outlined in hTC, State, or l
appropriate ANSI Guides, should be sufficient to assure integrity and safety for users.
3 I
t i
,'i 55 i
I 1
?
i The RCP should review manufacturer's information in labels and brochures relating to radiation health and safety, assay, and calibration procedures for adequacy. Approval documents for sealed i
i source or device designs should be clear, complete and accurate as j
to isotopes, forms, quantities, uses, drawing identifications,'and i
permissive or restrictive conditions.
t l
Questions:
j 1.
How many new and revised evaluations were made of sealed r
sources and devices during the review period?
-f i
Twenty-nine r
-1 2.
How many SS&D evaluations have been made for which approval f
documents have not yet been prepared?
None.
3.
How does the RCP evaluate manufacturer's data on SS&D's to j
ensure integrity and safety for users?
?
Prior to issuance of a specific license authorizing use of a sealed source or device, the manufacturer is required to file with the Department information completely describing the sealed source or device, supported by such annotated drawings
}
or sketches as are necessary.
In some cases this information i
is required prior to issuance of an authorization to
'[
manufacture. Tests to which prototype source capsule / device models have been subjected must be described.
j 4.
Do you determine whether the manufacturer's information on l
l labels and brochures relating to health, safety, assay, and calibration procedures is adequate on all products?
y 5
s i
Yes, the information is reviewed.
i l
V.B. Reviewer Assessment:
lI Twenty-nine SS&D evaluation documents, including new registrations and i
amendments, were reviewed.
The quality of the evaluations has greatly.
improved during the review period, and the State meets the NRC guidelines
[
for product evaluation. The reviewers, in fact, found no major areas of concern with the context of the sheets, the background data, or in the 3.
evaluation process. Details of the review are contained in Appendix D.
i i
C.
Licensing Procedures (Category II)
[
NRC Guidelines: The RCP should have internal licensing guides, t
checklists, and policy memoranda. consistent with current NRC practice. License applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions. The present compliance status of licensees should be considered in licensing actions. Under the NRC Erchange-of-t I
...- ~ -
i i
56
)
i Information program, evaluation sheets, service licenses, and I
licenses authorizing distribution to general licensees and persons j
l' exempt from licensing should be submitted to NRC on a timely basis.
Standard license conditions comparable with current NRC standard.
j license conditions should be used to expedite and provide uniformity l
in the licensing process. Files should be maintained in an orderly i
fashion to allow fast, accurate retrieval of information and l
documentation of discussions and visits.
j Questions:
{
i 1.
Has the RCP developed its own licensing procedures or does it l
use KRC guides? Please provide copies for review.
Guidance for review of applications for new license renewal,-
renewal and amendment is contained in the Reviewer's Guide.
j The Reviewer's Guide is organized by category of license and j
includes material developed by California and the NRC.
2.
What licensing guides, checklists and policy memoranda are made l
available to the staff?
All NRC guides, checklists, and standard conditions are made j
available to the staff.
In addition, California developed its own guides and/or checklists on the following:
1.
Broadscope A l
I 2.
Broadscope B or C 3.
Medical Guide 4.
Lixicopes (Medical) 5.
Bone Mineral Analyzers 6.
SR-90 Eye Applicator 7.
Industrial Radiography 8.
Gas Chromatographs 9.
Soil Gauges j
10.
Fixed Gauges f
11.
Small Labs 12.
Large or Medium Labs
)
13.
Well Logging
]
14.
Large Irradiators j
i q
California also has its version of standard conditions.
]
Checklists developed by Texas for industrial gauges and i
teletherapy are also used for reference. Updated NRC Standard f
3 License Conditions, November 24, 1985 are also used.
I i
3.
What guides and/or regulatory position statements are furnished j
to license and renewal applicants?
e r
(1) " Guide for Applicants for a Radioactive Material License".
j N,
(2) " Guide for the Preparation of Applications for Medical Programs".
l i
i i
}
i
.~.
1
l r
57 i
(3) " Teletherapy Licensing Guide".
(4) " Applicant's Guide - Industrial Radiography".
(5) " Guide for Applicants for a California License to Manufacture and Distribute Sealed Sources or Devices Containing Radioactive Material".
(6) " Guidelines for Applicant Preparation of Draft f
Registration Sheets".
(7) "Special Requirements for Broad Scope Research and l
Development Radioactive Material Licenses Type A".
I r
(8) "Special Requirements for Broad Scope Research and Development Radioactive Material Licenses Types B and C".
l (9) Checklists for Research Ltbaratories, Gauges, Gas Chromatography, Lixiscopes".
l 4.
Describe the system for advising classes of licensees of new l
licensing procedures and regulations.
Rad Safety Advisories are mailed to the licensees.
Sa.
How are licensing actions coordinated with the compliance staff?
Regardless of inspection status, compliance input is required i
on all new or renewal of major amendment actions on Priority 1 through 4 licenses. For Priority 5 and above, the reviewer retains the option of acting without compliance input; however, I
the decision must be justified.
[
b.
Are licensing actions taken while enforcement action is l
pending?
No favorable licensing action may be taken with enforcement action pending.
i 1
l 6.
For what length of time are various categories of licenses j
issued?
j l
4 Licenses are issued 'or a term of seven years.
l 7a.
Does the RCP use standard licensing conditions?
b.
If so, how does the RCP assure they are comparable with those used by NRC?
Standard licensing conditions a.re utilized and they are based on those used by the NRC.
l 3
=-.
i 58 l
i 6
8.
Are the licensing conditions on file in the RCP office and with NRC?
i Yes.
i 9.
What SS&D sheets, service, distribution and "E" licenses are available for RCP staff use?
A service directory is not available at this time, however NRC i
will be forwarding one to the States soon. Other material is j
available to the staff.
l d
10.
Describe your practices for distributing SS&D sheets, as well as GL distribution and service licenses, to the NRC.
A cover letter is prepared and they are mailed to the NRC. We rely on the NRC to distribute them to other agreement states.
}
11.
Describe your procedures for maintaining the license files (How l
j are files and folders arranged? Are telephone contacts and visits documented? Who is responsible for filing materials in folders?).
l The files for licensing, compliance and devices are kept in 4
separate folders and are maintained by the licensing unit.
Investigation files are also kept in separate folders and are.
.i maintained by the materials control supervisor. Material-in I
the licensing files is arranged as follows: The right-side of
[
the folder contains the original license and amendments filed by order of the date. The left side has the notice of I
expiration as the top document, with other' documents and completed correspondence filed under it.
Correspondence which i
requires action, temporary notes and the inspection agency 1
application reviews are kept loose in the folder.
i Notes of percinent telephone conversations are kept and visits are docunented.
l I
12.
Are there opportunities for license reviewers to accompany
[
2nspectors?
1 RHB-North inspection responsibilities have been taken over by Materials Unit in Sacramento. Reviewers in Sacramento I
therefore perform part-time inspection of facilities.
{
Reviewers may also accompany inspectors from other contract l
agencies when the need arises.
l V.C. Reviewer Assessment:
I The licensing procedures have been greatly improved and, overall, meet the NRC guidelines. Several new thecklis.ts have been developed and a f
memo was issued to establish a clear cut policy on a variety of J
non-compatability issues.
This memo resolved a number of inconsistencies in the licensing actions and enhanced the quality of the licenses. Some i
l 9
-m-~
m e
I 59 areas of the program that still need improvemens. are discussed in Appendix C.
Other areas needing consideration or action by management are the lack of l
documentation of telephone conversations, the advantage of elevating second or third round deficiency letters for management signature, the j
need to minimize interruptions by rotating telephone answering duties or similar means and the use of model licenses.
A change that should be j
considered involves cumbersome fee procedures that result in numerous and needless amendments, (e.g., the requirement for non-portable gauge users to amend their license to add or subtract a gauge from use).
Also, it was noted that the J. L. Shepherd license has been under timely j
renewal for ten years.
The application is no longer-current and the existing license does not reflect current regulatory [ practices.
It was j
recommended that California review all licenses in tamely renewal and i
develop a program to assure that no timely renewals exceed one year.
Timely renewals currently exceeding one year should be requested to resubmit complete applications with up-to-date information.
r Finally, it was observed that the State is not furnishing copies of the regulations to applicants, nor are they advised how to obtain copies.
This is counter to the guidelines and should be corrected. This was discussed in the exit interview and addressed in the correspondence.
I The other findings and suggestions were discussed with the revisions and/or staff supervisors as appropriate.
VI.
COMPLIANCE d
A.
Status of Inspection Program (Category I) 1 NRC Guidelines: The State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license condit2ons.
l The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the inspection program on a periodic basis.
Information showing the number of inspections j
conducted, the number overdue, the length of time overdue and the i
priority categories should be readily available.
There should be at least semiannual inspection planning for the number of inspections to be performed, assignments to senior vs.
junior staff, assignments to regions, identification of special
+
needs and periodic status reports.
Questions:
1 1.
How is statistical information maintained about the inspection y
program to permit periodic assessment of its status by RCE j
\\
management?
e 1
i 1
.~.
60 t
i f
Statistical summary sheets, CIC 2-83, accompany each cleared j
inspection report when received at RHB-Sacramento compliance i
management. After review, management signs off and gives.the report to computer data management, who enters the data and-l also signs off in the CIC, thereafter the report is filed in the license compliance folder. This data in the computer is then used for the production of due/ overdue lists, etc.
t i
J s
The new ADP system is still in the process of being installed and programmed.
Currently (February 1986) we can update data, such as the date of the last inspection, and obtain printouts j
of due/ overdue listings.
The history of compliance will be added in the new system.
]
2.
Prepare a table as below, indicating the number of inspections made in the review period, by categrry and priority.
License frequency Number of Category Priority Inspections i
broad A 1
3 l
2 5
l s
j Hospital 3
75 5
2 4
Private Practice 3
10 4
5 13 Academic 2
1 3
8 l
l 5
4 4
i 4
Industrial Radiography 1
56 i
Miscellaneous Industrial 1 10
^
2 14 3
62 5
84 6
4 I
Government 2
1 3
2 5
23 Other 1
1 2
4 3
21 5
_2_
T.otal 405 3.
Prepare a table (or tables) as below which identify the Priority 1, 2, and 3 licensees with overdue inspections.
1 w
e n
61 I
Include the license category, the due date, and the number of months the inspection is overdue.
(If list is extensive, a comparable computer printout. is acceptable.)
i An accurate, updated computer printout-identifying the 1
j licensees with overdue inspections has been provided for period
=aing March 31, 1986 (attachment VI.A.3).
.l
(
1
SUMMARY
OF OVERDUE
- INSPECTIONS AS OF MARCH Inspection Priority Priority Priority Priority r
Agency 1
2 3
5 Total I
DOSH-North 6
1 10-1 18 l
DOSH-South 0
0 2
5 7
RHB-North 0
0 1
1 2
RHB-South 0
3 3
0 6
Orange County 0
0 3
1 4
j LA County 1
1 4
0 6
TOTALS 7
5 23 8
43 t
Inspections are not counted as overdue until the length of the overdue period is 50 percent of the inspection frequency period
{
for Priority 1, 2, 3 and 5 licenses, y
4.
Prepare a table as below indicating the number of overdue license inspections for Priorities 4 through 7.
i See computer printout and above table. There are no overdue l
Priority 6 and 7 licenses.
'I 5.
How are inspection schedules planned and how are the dates and I
personnel assignments made?
The Radioactive Materials Control supervisor uses the due/ overdue list to assign the inspections to each l
{
jurisdiction. The local supervisor makes the specific l
j assignments as to dates and personnel.
VI.A Reviewer Assessment:
t i
Currently the State has neither the staff to maintain an inspection program to completely meet the guidelines, nor the ability to correctly l
3 determine the st atus of the program by identifying licensees due or 1
overdue for initial and routine inspections.
This finding is not meant to diminish the considerable progress the program has made in this review l
period. Thirty six percent more inspections were performed in this i
review period than in the previous period. The backlog of overdue inspect. ions has dropped from over 300 to approximately 60.
i l
The count of overdue inspections can only be approximated because of a l
serious flaw that was revealed in the method used to produce the due/ overdue listing used to assign inspections and to assess the status I
i l
1 f
~
i 62 e
1 of the inspection program. The due date for an inspection was based on f
the length of time elapsed since the last inspection, with no means'to pick up newly issued licenses.
Thus, if an initial inspection was not-
-)
perf ormed, the license would never appear as due or overdue. A listing of " licenses never inspected" identified over 300 licenses due and over 200 licenses overdue for their initial inspection (based on the initial inspection schedule in effect at the time the license was issued), 76 due for a routine inspection, and 17 overdue for their. routine inspection.
None of these appeared on the due/ overdue list. The state's inspection j
schedule prior to March 1985 required initial inspections at intervals ranging from one to eighteen months, depending on the priority. On March 4
1,1985, when they switched to the NRC priority schedule, which calls for initial inspections at six months for Categories 1-5, they made the l
decision to " forgive" the initial inspections that were due on licenses issued before that date and pick them up on the routine inspection schedule.
It was agreed by the NRC that this was acceptable as long as the data base from due/ overdue listings was fixed to include all licensees and to flag initial inspections due/ overdue, and on the l
condition that inspections be performed on all licenses issued before March 1985, no later than the due date (not overdue) for the routine j
inspection.
It was also suggested a manual check be performed of all l
license files against the ADP files.
i J
The State was cautioned that by their own projections (as well as the i
1 reviewer's) California will need to complete over 600 inspections annually in order to avoid backlogs. The State presented an action plan
[
i outlining their plans for corrective action and eliminating the backlog.
i This is attached as Appendix E.
B.
Inspection Frequency (Category I)
I j.
NRC Guidelines: The RCP should establish an inspection priority l
system. The specific frequency of inspections should be based upon the potential hazards of licensed operations, e.g., major I
processors, broad licensees, and industrial radiographers should be j
inspected approximately annually -- smaller or less hazardous' i
operations may be inspected less frequently.
The minimum inspection frequency should be consistent with the NRC system.
I Questions:
i 1.
Enclose a copy of the State's priority system.
This is attached as Appendix F.
2.
Who assigns licenses to the priority categories?
The reviewers assign the license priority in accordance with j
the table in Appendix F.
Any exceptions are authorized by the Supervisor of the Radioactive Material Unit.
N 3.
Discuss any significant variances in the State's priorities from the NRC priority system.
_. _ ~ - -
i 62
~
of the inspection,
gram. The due date for an inspection was based on the length of time elapsed since the last inspection, with no means to pick up newly issued licenses. Thus, if an initial inspection was not performed, the license would never appear as due or overdue. A listing of " licenses never inspected" identified over 300 licenses due and over 200 licenses overdue for their initial inspection (based on the initial inspection schedule in effect at the time the license was issued), 76 due i
for a routine inspection, and 17 overdue for their routine _ inspection.
f None of these appeared on the due/ overdue list. The state's inspection schedule prior to March 1985 required initial inspections at intervals i
ranging from one to eighteen months, depending on the priority. On March 1, 1985, when they switched to the NRC priority schedule, which calls for initial inspections at six months for Categories 1-5, they made the decision to " forgive" the initial inspections that were due on licenses I
issued before that date and pick them up on the routine inspection schedule.
It was agreed by the NRC that this was acceptable as long as the data base from due/ overdue listings was fixed to include all licensees and to flag initial inspections due/ overdue, and on the condition that inspections be performed on all licenses issued before March 1985, no later than the due date (not overdue) for the routine inspection.
It was also suggested a manual check be performed of all license files against the ADP files.
J The State was cautioned that by their own projections (as well as the reviewer's) California will need to complete over 600 inspections annually in order to avoid backlogs. The State presented an action plan outlining their plans for corrective action and eliminating the backlog.
This is attached as Appendix E.
l B.
Inspection Frequency (Category 1) i 1
NRC Guidelines: The RCP should establish an inspection priority system. The specific frequency of inspections should be based upon the potential hazards of licensed operations, e.g., major i
processors, broad licensees, and industrial radiographers should be inspected approximately annually -- smaller or less hazardous operations may be inspected less frequently. The minimum inspection frequency should be consistent with the NRC system.
i Questions:
d 4
1.
Enclose a copy of the State's priority system.
l l
This is attached as Appendix F.
1 t
2.
Who assigns licenses to the priority categories?
i i
The reviewers assign the license priority in accordance with I
the table in Appendix F.
Any exceptions are authorized by the Supervisor of the Radioactive Material Unit.
j 3.
Discuss any significant variances in the State's priorities s
f rom the NRC priority system.
[
i 6
63 They are the same as the NRC priority system.
.j 4.
Is the inspection priority system designed to assure that the more hazardous and/or complex operations are inspected at an j
appropriate frequency?
Yes, see priority system.
5.
Describe the State's policy for unannounced inspections and exceptions to the policy.
A minority of industrial inspections are performed unannounced.
i Most medical inspections are by appointment.
6.
Describe the State's policy for conducting follow-up inspections.
i 9
Follow-up inspections are conducted to verify corrective action 4
where the issuet are complex or serious and in situations where experience or the licensee's response suggests that corrective j
action will be ineffective or delayed.
i t
7.a. Does the RCP inspect out-of-state firms working in the State under reciprocity or under State licensure?
The " Notices of Reciprocal Recognition" are conditioned to
~ !
provide the inspection agency with timely information permitting inspection on a sampling basis.
- b. How many reciprocity notices were received?
t Forty-three (43) in calendar year 1985.
- c. How many were inspected since the last review?
Six (6) were inspected in the calendar year 1985.
I VI.B Reviewer Assessment:
r F
j California's inspection frequency is identical to the NRC's and thus meets the guidelines. Several licenses were found to have the wrong l
priority assigned by the reviewers. For example some licenses issued I
since March 1985 are listed as priority 4, when in fact there are no four year inspection frequencies on the new schedule.
It was suggested that there should be supervisory review of the priority assignments.
t i
f C.
Inspector's Ierformance and Capability (Category I) i NRC Guidelines:
Inspectors should be competent to evaluate health and safety problems and to det ermine compliance with State reguletions.
Inspectors must demonstrate to supervision an i
understanding of regulations, inspection guides, and policies prior to independently conducting inspections.
i r
l i
,__m-
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64 t
i The compliance supervisor (may be RCP manager) should conduct annual field evaluations of each inspector to assess performance and assure application of appropriate and consistent policies and guides.
Questions:
j la.
Does the senior inspector or supervisor periodically accompany the inspectors?
i Yes.
b.
Are these accompaniments documented?
Yes.
l a
2.
List the number of supervisory accompaniments of inspectors since the last review meeting and identify the persons accompanied and the supervisors.
PERSON LICENSEE
[
OBSERVER DATE ACCOMPANIED INSPECTED NO.
TYPE J. Brown 1/4 William Lew Grove Valve 3093 1R i
J. Brown 1/14 Edwin Njoku Inter. Ind.
0739 MI Laundry j
J. Brown 1/15 &
Gary Butner U.C. Berkeley -1333 Broad A 1/16 i
J. Brown 1/15 Edwin Njoku UCSF 1725 Broad A
~
J. Brown 4/15 M. Gottlieb Consol. Eng.
3250 Soil, Labs.
Gauge l
J. Brown 5/29 Don Barr Roseville 2027 Med.
Comm. Hosp.
Inst.
i J. Brown 6/7 &
J. Takahashi Eden Hospital 0238 Med.
[
7/23 Inst.
J. Takahashi Brookside 0209 Med.
Hospital Inst.
J. Brown 7/24 J. Takahashi Seton Medical 1391 Med.
Center Inst.
J. Brown 7/25 J. Takahashi Mills Memorial 0161 Med.
Hospital Inst.
l J. Brown 10/16 &
J. Takahashi Hayward State 2590 Educ.
10/17 Inst.
E. Njoku 8/8 J. Takahashi Hemet Valley 1624 Med.
Hosp. District I nt,t.
w w-e-.v.
-s,,
65 E. Nj oku 11/5 S. Rosenberg Emmanual Med.
2578 Med.
Center Inst.
E. Njoku 11/6-11/8 S. Rosenberg UCSF 1725 Broad A VI.C Reviewer..:sessment:
A review of the inspection reports revealed serious inconsistencies in the compliance program.
Some inspectors were found to be down-grading items of non-compliance to recommendations and not citing the licensee, counter to both California and NRC policy. The normal significance of this deficiency is lessened because the inspectors are relatively inexperienced and management was quick to correct the situation by issuing a policy memorandum reminding all inspectors of the' proper procedure and by discussions with the inspectors involved. A copy of-this memorandum is enclosed as Appendix G.
On March 3, 1985, the reviewer made one field accompaniment.
Lisa Burns, LOSH, was accompanied on an inspection of Infergene Corporation, a bio-lab, License No. 4504-48. The inspection was very well done and Ms.
Burns demonstrated a professional manner and understanding of the regulations and was competent and thorough. More emphasis should have been placed on interviewing ancillary workers, and this was discussed with her.
Her performance was discussed with her supervisor.
Overall, the inspector's performance meets the NRC guidelines, but this area will need increased observation as the new staff members begin performing inspections.
D.
Responses to Incidents and Alleged Incidents (Category I)
NRC Guidelines:
Inquiries should be promptly made to evaluate the need for onsite investigations.
Onsite investigations should be promptly made of incidents requiring reporting to the Agency in less than 30 days (10 CFR 20.403 types). For those incidents not requiring reporting to the Agency in less than 30 days, investigations should be made during the next scheduled inspection.
Onsite investigations should be promptly made of non-reportable incidents which raay be of significant public interest and concern, e.g.,
transportation accidents.
Investigations should include in-depth reviews of circumstances and should be completed on a high priority basis. When appropriate, investigations should include reenactments and time-study measurements (normally within a few days).
Investigation (or inspection) results should be documented and enforcement action taken when appropriate. State licensees and-the NRC should be notified of pertinent information about any incident which could be relevant to other licensed operations (e.g.,
equipment failure, improper operating procedures).
Information on incidents involving failure of equipment should be provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency.. The RCP should have. access to medical consultants when needed to diagnose or treat radiation injuries. The RCP should use other technical consultants for special problers when needed.
(
E 66 1
i Questions:
i 1.
How does the RCP respond to incidents and alleged incidents?
l Inquiries and complaints are promptly evaluated to determine f
the need for onsite investigation. Onsite investigations are conducted where review discloses Class A or B (immediate or l
24-hour notice required) overexposure.
2.
Are major incidents (10 CFR 20.403 types requiring reporting in l
)
less than 30 days) investigated on a priority basis?
Yes, the priority is as follows:
Agency to Initiate First Notice Investigation Within Type of Occurrence Dept./ Agency Period-Specified-Type C overexposure 15 days 15 days e
or release 17CAC 30297 Type B overexposure, I working day 3 working days release or loss of use 17CAC 30295(b) 7 Type A overexposure, immediately by 3 working days release or loss of phone, notice use 17CAC 30295(a) within one I
working day t
i I,ost or stolen Immediately by 3 working days source 17CAC 30294 phone notice within one working day Complaint-violation I working day 3 working days of radiation safety and health.equirements 3.
Are other incidents followed up in the next scheduled inspection?
Yes.
1 4.
Are non-reportable incidents that may be of significant public interest and concern promptly investigated?
l Yes.
n 5.
Ilow many incident investigations were condacted during the review perioJ?
j l
There were 238 incident investigations opened for calendar year 1985, and there were 81 closures during the year.
i
I 67 l
6.
Attach as an appendix a summary of each incident investigated.
Include documentation of investigation results, enforcement action when appropriate, any reenactment and time motion j
studies, as well as notification of the NRC and state licensees j
of incident information that may have been relevant to other licensed operations.
-i Because over 200 incidents are investigated annually in i
California, Attachment VI.D.6 is a computer listing of incidents reported in the review period, with only.the incidents meeting the "significant incident" criteria summarized.
-l i
7.
Were any incidents attributed to generic-type equipment failure?
Yes, ICN's pressurized P-32 vials, manufactured in California, i
sprayed a New Jersey user.
8.
What action was or would be taken by the RCP pertaining to
[
incidents attributable to generic equipment failures in regard l
to notification of the NRC, other licensees and the regulatory j
agency which approved the device?
The NRC notified CA in this instance.
If the failure occurred j
in California the NRC would be notified.
9.
If a failure should occur in equipment manufactured by a State licensee, what action would be taken to:
l i
stop the manufacture or force changes in design?
a.
r With respect to California licensees, the Department has authority to suspend or modify licenses and by order i
require retrofit of existing devices or prohibit use of l
such devices by California' licensees.
j l
b.
assure retrofit of existing devices?
T I
Information regarding a Department order requiring retrofit and prohibiting use of the device would be i
transmitted to other agencies by copy of the order.
1 10.
When are other State licensees and the NRC notified of j
pertinent information about an incident?
l
?
Investigations involving equipment failures or malfunctions always include review to determine whether the failure is generic or specific.
If review discloses a possible generic failure the NRC is notified along with the regulatory agency l
2 which approved the device and California licensees possessing the device. Examples are Scripps and Tamco.
j l
s 11a. Are medical consultants available and used when necessary?
1
, l
t 67 i
6.
Attach as an appendix a summary of each incident investigated.
(
Include documentation of investigation results, enforcement acticn when appropriate, any reenactment and time motion.
studies, as well as notification of the NRC and state licensees of incident information that may have been relevant to other j
licensed operations.
]
i Because over 200 incidents are investigated annually in California, Attachment VI.D.6 is a computer listing of incidents reported in the review period, with only the incidents meeting the "significant incident" criteria summarized.
i
-1 7.
Were any incidents attributed to generic-type equipment failure?
j Yes, ICN's pressurized F-32 vials, manufactured in California, I
sprayed a New Jersey user.
l 8.
What action was or would be taken by the RCP pertaining to incidents attributable to generic equipment failures in regard to notification of the NRC, other licensees and the regulatory j
agency which approved the device?
The NRC notified CA in this instance.
If the failure occurred-in California the NRC would be notified.
k 9.
If a failure should occur in equipment manufactured by a State j
licensee, what action would be taken to:
?
stop the manufacture or force changes in design?
a.
With respect to California licensees, the Department has authority to suspend or modify licenses and by order require retrofit of existing devices or prohibit use of such devices by California licensees.
b.
assure retrofit of existing devices?
Information regarding a Department order requiring retrofit and prohibiting use of the device would be transmitted to other agencies by copy of the order.
10.
When are other State licensees and the NRC notified of pertinent information about an incident?
Investigations involving equipment failures or malfunctions always include review to determine whether the failure is generic or specific.
If review discloses a possible generic failure the NRC is notified along with the regulatory agency which approved the device and California licensees possessing the device. Examples are Scripps and Tamco.
lla. Are medical consultants available and used when necessary?
l l
J
r 68 E
i Reynold F. Brown, M.D.,
our principal medical consultant, participates in review of investigations where expert medical
[
consultation is required.
- b. Is the State aware of the availability of medical l
consultants from NRC?
Yes, the State is aware of the NRC resources.
4 12.
Explain any use of other technical consultants for special problems encountered in incident investigations.
i There were none necessary in this review period. We would call on the NRC if needed.
{
P 13.
Were there any incidents since the last review meeting that' met Abnormal Occurrence Report (AOR) criteria?
Yes, Tamco (contaminated flue dust), Boothe-Twining (severe
[
hand dose), and Scripps Hospital (moly-breakthrough, still-t under investigation).
f VI.D Reviewer Assessment:
f California maintains a high quality incident response program which meets the NRC guidelines. This finding is based on the State's responses and staff discussions as well as a review of 25 selected incident cases.
The-files were in order and the system appears to be working well, although j
some improvements are needed. Two incidents that exceeded reporting criteria for significant incidents had not been reported to the NRC and the staff pointed out there are no California procedures addressing incident reporting.
It was recommended the State introduce a system i
which would evaluat.e each incident against the reporting criteria as it is logged.
l It was also found that incidents are not always cross-referenced to the I
appropriate materials file. Four materials files were checked and three of them did not contain incident information that should have been available to the inspector or reviewer. This should also be addressed with administrative procedures.
E.
Enforcement Procedures (Category I)
NRC Guidelines: Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements.
Provisions for the levying of monetary-penalties are recommended. Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly specifying all items of noncompliance l
and health and safety matters identified during the inspection and referencing the appropriate regulation or license condition being violated. Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions i
taken to prevent recurrence (normally 20-30 days).
The inspector i
t w
gr-er w-
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-+
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s
+4='
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l 69 i
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and compliance supervisor should review licensee responses. Licensee i
responses to enforcement letters should be promptly acknowledged as j
to adequacy and resolution of previously unresolved items. Written t
procedures should exist for handling escalated enforcement cases of varying degrees.
Impounding of material should be in accordance j
with State administrative procedures. Opportunity for hearings should be provided to assure impartial administration of the j
radiation control program.
j Questions:
f i
1.
Describe the State's enforcement procedures.
Briefly, the procedure is as follows: Violations and items of
[
noncompliance are defined as to seriousness based on guidelines.
of the NRC.
Items of noncompliance that are aggravated by i
repetitiveness, appear to be willful, are accompanied by a-j large number of other forms of noncompliance, or that have not been corrected in a reasonable time may be raised in the level-l of seriousness. A Class IV item of noncompliance (no unnecessary exposure or unnecessary risk) requires a letter 5
calling the licensee's attention to the matter.
In the event of a more serious violation, a letter is sent with a Notice of i
Violation which calls for a reasonable date for reply.
A~
l response which, although technically inadequate, indicates the desire to come into compliance calls for no unusual enforcement l
action, but simply requires further correspondence between the l
inspector and the licensee.
In the occasional instance of a very tardy, incomplete, argumentative, or otherwise negative response, the case is handled by management and the license may l'
be revoked.
2.
If the RCP can apply civil penalties, explain the procedures for keying monetary penalties to violations.
l Current law provides that willful or grossly negligent i
violation of radiation statutes, ordars, or regulations is l
punishable by imposition of a civil penalty not to exceed i'
$5,000 per day violation.
The presiding judge determines the j
penalty amount.
r 3.
Describe the State's provisions for criminal penalties.
h The Ilealth and Safety Code provides that violations of the Radiation Contral Law and Regulations are punishable as misdemeanors with penalty not to exceed $500 and 6 months.in b
jail for each count.
3 i
4.
Describe the policies in effect for issuing field forms j
equivalent to NRC form 591 or letters for enforcement action California issues short form for diminimus violations l
correctable on the spot where the licensee expresses a willingness to correct.
I i
i a
T l
70 i
5.
Are there written procedures for handling escalated enforcement l
cases? Please provide copies for review.
]
Yes.
I 6.
Can the State issue Orders; including Emergency Orders?
Yes, the Chief, Department of Health Services is now authorized to sign Emergency Orders.
l l
7.
Can the RCP impound radioactive material?
i The Radiation Control Program has the authority in the llealth and Safety Code to impound radioactive material in an emergency.
8.
Do State administrative procedures permit the opportunity for hearings in major enforcement cases?
l t
Enforcement actions are reviewable informally within the Department and formally at administrative hearings and in j
i Superior Court.
1 I
9.
If during the review period the State has issued orders, applied civil penalties, sought criminal penalties, impounded sources, or held formal enforcement hearings, identify these s
cases and enclose copies of the pertinent State enforcement correspondence or orders:
j 4-License Type of Date of
[
Name Number Enforcement Action Boothe Twining 2161 Office Compliance Conf.
8/5/85
't Cal Bionuclear 2476 Decontamination Order 1/28/86 UCSF 1725 Cease & Desist Order 11/15/85 l
Copies of the Orders are attached as Attachment VI.E.9.
m j
10.
Are enforcement letters issued within 30 days of the inspection?
I Enforcement actions are normally taken within 30 days of the 2nspection.
4 -
)
11.
Are enforcement letters written in regulatory language and-
{
reference regulations and license conditions?
3 J
f A form notice of violation is used and required reference to regulations and license conditions as apprcpriate.
j 12.
Do the enforcement letters clearly differentiate between l
noncompliance items and health and safety recommendations?
i I
l, i
t
h 71 l
l Yes, enforcement procedures require that health and safety recommendations must not be included in the Notice of Violation but instead are discussed in a cover letter.
i i
13.
If applicable, do the letters separate actions subject to the l
State radiation control act and State OSHA regulations?
The form only addresses violations of Title 17 (CAC) and not CAL-OSHA regulations.
I 14a. Are enforcement letters issued by inspectors or supervisors?
f By inspectors.
l
- b. If issued by inspectors, do they undergo supervisory l
review prior to dispatch?
2 Prior review of enforcement letters is not required except in cases where the inspector judges the matter to be serious and
.l to require supervisory input.
I 15.
Do enforcement letters require the licensee to respond within a stated time period? Note the period.
Licensees responses to Notices of Violation are normally required within 30 days and may be escalated for serious violations.
16a. Are licensee's responses to enforcement letters reviewed by the inspector and the supervisor?
?
- b. Are they acknowledged?
)
They are reviewed and acknowledged by the inspector and are reviewed by the supervisor as part of the package submitted to the Program by the contractors or regional offices.
17.
Has the State taken escalated enforcement action against
[
licensees who operate in multiple jurisdictions.
I i
Yes.
V1.E Reviewer Assessment:
f Although the enforcement procedures meet the NRC guidelines, as indicated in the State's responses, it was found that the new inspectors were i
downgrading items of noncompliance, discussed previously. Appendix G is a memo to all inspectors reminding them of the proper enforcement
~
procedures. The State also agreed to superviscry review of enforcement letters before they are sent.
F.
Inspection Procedures (Category II)
{
t i
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- - ~,
h
I i
7' t
i t
i NRC Guidelines:
Inspection guides, consistent with current NRC
{
guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the
{
inspection of licensed programs. The NRC Agreement States Guides j
l may be used if properly supplemented by policy memoranda, agency l
interpretations, etc.
Written inspection policies should be issued I
i to establish a policy for conducting unannounced inspections, i
obtaining corrective action, following up and closing out previous
[
violations, assuring exit interviews with management, and issuing i
appropriate notification of violations of health and safety i
i problems.
Procedures should be established for maintaining licensees' compliance histories. Oral briefing of supervision or the senior inspector should be performed. on return from nonroutine t
inspections. For States with separate i.ce..ing and inspection i
j staffs, procedures should be established *. feedback of information i
to license reviewers.
4 i
Questions:
1.
lias the RCP developed its own inspection guides or does it use
{
NRC guides?
i California has developed its own guides.
}
2.
Are current copies of the internal inspection forms and guides on file in the RCP office and with NRC? Attach revisions or new guides developed since the last review.
f i
Region V has copies of all forms and guides.
3.
Are inspectors furnished copies of inspection guides?
i Yes.
f 4.
Discuss the use or non-use of inspection policy memoranda, interpretations, etc., to supplement inspection guides.
I In addition to the guides, we use inspection procedures and l
inspection policy memos to address such issues as enforcement j
criteria, contamination limits, cleanliness surveys, etc.
I j
5.
Are there written procedures establishing policy for:
A a.
unannounced inspections?
No.
i j
b.
obtaining corrective action?
i i
I Yes.
l l
c.
following-up and closing out previous citations of 1
violations?
l J
1 i
\\
73 Yes.
1 d.
exit interviews with management?
l Yes.
o 1
e.
issuing notices of violations and findings of health and i
safety problems?
)
Yes.
f.
categorizing the seriousness of violations?
j j
Yes.
I l
Please provide copies of these procedures for review.
6.
What procedures have been established for maintaining l
licensees' compliance histories?
I t
t The compliance histories have been maintained by a summary i
sheet in the compliance folder. They will be part of the i
licensee data base in the new ADP system.
I 7.
Does the senior inspector or supervisor orally debrief the inspector upon return from inspections?
Yes, when there is a local supervisor.
.)
I 1
8.
What procedures are there for providing feedback from inspectors to licensing?
Response and commitments to citations or recommendations which significantly upgrade a licensee's radiation' safety program are forwarded to licensing with a recommendation for amendment action so that the commitments are enforceable as license 3
conditions.
In addition, licensing is advised to clear.the i
record with respect to acceptance of corrective action following a notice of violation.
I d
VI.T Reviewer Assessment:
i The reviewer has examined the written inspection procedures and guides and finds they meet the guidelines, if followed.
This is further discussed in the next section.
The State does unannounced inspections for radiographers and other recalcitrant licensees.
G.
Inspection Reports (Category 11) i NRC Guidelines: Findings of inspections should be documented in a j
report describing the scope of inspe.ctions, substantiating all items of noncompliance and health and safety matters, describing the scope of licensees' programs, and indicating the substance of discussions i
l with licensee management and licensee's response. Reports should l
1 I
l
l l
74 i
t i
i i
uniformly and adequately document the results of inspections and identify areas of the licensee's program which should receive i
special attention at the next inspection. Reports should show the status of previous noncompliance and the independent physical
{
measurements made by the inspector.
Questions:
1 1
t 1.
How do inspection reports document the inspection that was conducted and the inspection findings? Explain how the reports i
substantiate noncompliance and health and safety matters and describe the scope of the licensee's program.
J i
The inspection reports are done on comprehensive forms that i
document the licensee's performance in pertinent matters of
]
health and safety. The reports serve as checklists to ensure all areas of the program are covered and the results are summarized. The last page of the report lists the items of i
noncompliance, the findings and discussion, and the basis for j
4 9
close-out. The scope of the program is described both in the report and on the cover sheet.
j 2.
Do the reports
]
a.
relate the discussions held with license management and l
interviews with workers?
Yes.
4 b.
include independent measurements conducted by the l
inspector?
Yes, the measurements are documented.
)
c.
document follow-up of previous citations of violations made by the inspector?
j The entrance interview is documented in the report and that has a section for a review of citations from prior inspections as well as a review of corrective actions described by the licensee complete with closeout.
d.
identify areas of the licensee's program needing special i
attention at the next inspection?
The exit report section indicates the preliminary findings and enforcement actions available or which will be considered.
I 3.
Are inspectors routine,1y inspecting radwaste package f
preparation and shippipg practices and do the reports document the results?
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l 75 i i Yes, the report evaluates com,nlete and clear written instructions for package pickup and receiving, security and adequacy of temporary storage when necessary, clear written internal delivery and transfer procedures, adequate package survey and opening procedures, records or receipt and survey of { packages, record of use and transfer of material, use of i authorized shipping containers and adequate packing and i shipping procedures. l VI.G Reviewer Assessment: 1 Thirteen compliance files were reviewed and the results presented in i Appendix H. The quality of the reports was not adequate to meet the guidelines. Eleven of the fifteen reports reviewed contained errors or i omissions, such as not completing all sections of the uniform inspection form, short forms (2314) that were not properly signed and dated, items of noncompliance dr engraced to recommendations, no indication of i interviews with.*acillary workers, and no indication of exit interviews [ with management. As all of these deficiencies are contrary to procedures and policies already established by the State, we recommended more thorough supervisory review to assure that inspectors adhere to program policy. i Most of the deficiencies were related to the new inspectors and their { progress will be checked in upcoming reviews. l t H. Independent Measurements (Category II) NRC Guidelines: Independent measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensee's measurements. RCP instrumentation should be adequate for surveying license operations (e.g., survey meters, air samplers, lab i counting equipment for smears, identification of isotopes, etc.). GM Survey Meter: 0-20 mr/br l Ion Chamber Survey Meter: several r/hr l Neutron Survey Meter: Fast & Larmal i Alpha Survey Meter: 0-100,000 c/m Air Samplers: Hi and Low Volume i Lab Counters: Detect 0.001 uc/ wipe Velometers { Smoke tubes Lapel Air Samplers Instrument calibration services or facilities should be readily h available and appropriate for instrumentation used. Licensee equipment and facilities should not be used unless under a service i contract. Exceptions for other State Agencies, e.g., a State University, may be made. Agency ins.truments should be calibrated at j intervals not greater than that required to licensees being inspected. i i t I l
l 76 I Questions: 1. Discuss the State's policy for conducting independent measurements as a part of each inspection (e.g., air samples, i wipe samples, air flows, dose rates). Are these measurements documented in the inspection report? It is our policy to conduct independent measurements as part of each inspection. Radiation levels are checked in controlled and uncontrolled areas, contamination levels are measured in l the vicinity of the workplaces and effluents to the environments are measured when appropriate. The inspection reports verify that these levels are in compliance. i 2. List the instrumentation that is readily available to the RCP for surveying licensed operations and conducting appropriate ^ independent measurements. I I Each inspector can take wipes, has a GM and ion chamber instrument and can measure alpha, beta and gamma radiation. 1 l Each office has, in addition, airflow measurement and air l sampling capability. The program has neutron measuring j capability. [ 3. Describe the method used for calibrating survey instruments and I the frequency of calibration. i 7 J See the Uniform Calibration Protocol, previously provided, i which the contract agencies have agreed to follow. 4 VI.H Reviewer Assessment: 2 With one minor exception, air flow velometers that are not calibrated i according to State procedures or used, the State now meets the guidelines for Independent Measurements. This was determined by reviewer inspection of actual instrumentation, records of calibration, interviews with personnel and the response to the questions. Another item for consideration is identifying the probe used (for multiple probe instruments) for the calibration and some notification or warning that only this specific probe can be used in order for the calibration to remain valid. i VII. OTHER ASPECTS OF THE STATE'S RADIATION CONTROL PROGRAM l 1 4 1 A. Non-Agreement Sources of Radiation Questions: I 3. Are the licensing and inspection procedures for NARM the same as for agreement materials? l
-. ~. ~ 77' 4 i California has a comprehensive Radiation Control Program. The procedures for licensing and inspection of NARM are identical [ to the procedures established for agreement materials. l i 2. Give the number of X-ray machine (or tube) and accelerator [ registrants by category, e.g., dental, medical, industrial, etc. There are 44,250 X-ray tubes registered with the State's i i X-radiation control program. Machines are in the following categories: I (a) Priority 1 - 14,000 tubes - These are high worxload medical machines primarily radiographic and fluoroscopic i used in hospitals and radiologist offices. Approximately i 300 of these are high energy accelerators used for medical therapy. There are less than 50 high priority industrial i use tubes which are mainly field radiography X-ray machines. 5 (b) Priority II - 8,700 tubes - These are low workload i medical, veterinary, and industrial (cabinet) machines. i Approximately 15% or 1,300 of these are industrial and analytical tubes. i (c) Priority III - 21,600 tubes - These are all dental machines. 1. i 3. How many machine and accelerator inspections were made in the last year (or other appropriate interval)? l The following X-ray machine inspection and accident investigations were completed for the period July 1 - December 31,-1985. (a) Priority 1 - 1512 tubes inspected - approximately 50 were j therapy accelerator type. j (b) Priority II - 284 tubes inspected - approximately 20 were industrial cabinet type. 4 (c) Priority III - 566 dental tubes were inspected. (d) Investigations - 52 accidents or complaints involving l X-ray machines were completed. There were no Type A, two Type B, and seven Type C overexposures caused by X-ray i machines for the period. One of the Type B overexposures was caused by a diffraction machine located at a j university campus laboratory. The other Type B was to an i X-ray technician employed at a small medical office. 4 4. Does the State license X-ray or nuclear medicine technologists? 4 4 e 4- -rw-
...- -.=_.. _ -.. l 78 i Yes, X-ray Technicians must be certified by the Department of Bealth Services and Nuclear Medicine Technologists will be l crztified when regulations are adopted. i q VII.A Reviewer Comment: B. Environmental Monitoring Program ) i Questions: i i 1. To indicate the scope of the environmental monitoring program, j i
- describe, e
I a. types of media sampled l b. the number and locacions of stations sampled l l the frequency of sample collection l c. d. the analyses run on each type of sample These data are included in the 1985 contract report NRC-05-077-105 Environmental Surveillance Report (Attachment VII.B.1). l 2. Is a copy of the latest environmental surveillance report available for review? i Yes. VII.B Reviewer Comment: i C. Other Areas This section of the review is for the use of either the reviewer or ( the RCP to address issues pertaining only to the individual State, to new areas of concern, or to generic or State-specific issues raised by NRC staff. 1. Other Generic Issues i Questions: I 1 i 4 For radiography inspections, to what extent do you make f s. inspections at temporary job sites? 1 Temporary job site inspections for IR are required to close out inspections in California when the company has ] field operations ongoing. 4 b. Are you finding Ir-192 contamination on radiographic equipment? a' No, the California inspectors have been instructed to survey the guide tubes for contamination with a GM survey meter as part of their inspection. California vill again 2 e pp--- rrr---' T Tyw y Jr,_,_ m.
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79 i remind the inspectors to perform this survey, and to l document the results. l c. What are the State's plans to adopt the low-level waste f (LLW) manifest rule (if not already adopted)? The State has adopted the low-level waste manifest rule (10 CFR 20.311) and it is currently in effect. I d. For States with LLW disposal sites, what are the State's { plans to implement 10 CFR 61? The State is proposing to develop a low-level waste site l as soon as possible and has already adopted 10 CFR 61 which is now in effect. e. Will your State have access to a LLW disposal site after January, 1986? If not, what contingency plans are there for after January, 1986? The State will not have the low-level site, proposed, l' operating by January 1, 1986, and plans to negotiate a special agreement with the State of Washington to use their low-level waste site until California's is i available. [ t f. llave copies of 10 CFR 61 and NRC technical positions on waste form and classification been distributed to State licensees? If there has been feedback please provide l documentation. Copies of 10 CFR 61, but not all of the NRC technical i position on waste, have been mailed to all State i licensees._ There has been no feedback from any licensee I on 10 CFR 61. 1 g. llave there been any applications or approvals for incineration, compacting or disposal? l There have been non-commercial applications and approvals i for incineration, compacting and disposal (not shallow land burial); the major one currently being reviewed is Stanford Univeristy. We have received three preliminary applications for compacting / disposal of wastes on a commercial basis; no actions have been taken on the applications so far. A time-limited authorization was granted Nuclear Specialties (3546-50) to dispose of scintillation vials which had been used for invitro diagnostic procedures. h. What use is being made of IE information notices?
.~.. 80 I i i NRC IE information notices are distributed to license reviewers and inspectors but not to California licensees. l If the information needs to be distributed to licensees, California puts out a Radiation Safety Advisory to all licensees. i i. Identify any group of materials licensees for which the State has ircreased the frequency of inspection due to i problems with the general categor3 Please discuss the nature of those problems. s Many field radiography licensees were inspected on an l ~ accelerated frequency when serious or repeat violations l were found. 1 l 4 j. With respect to medical licensees, is the State making any effort during inspections of nuclear pharmacies to determine whether the licensee is actually conducting the i required molybdenum breakthrough tests, i.e., what is the l State doing in addition to record reviews to establish compliance or noncompliance with the requirement? Molybdenum breakthrough is inspected during every routine f inspection of medical and pharmacy licensees. Inspectors i will show up in early morning hours to observe actual procedures at nuclear pharmacies. k. Is the State mounting any special effort to look at the i possibility of reconcentration of radionuclides in sanitary sewers and sewage treatment plants as part of the { regular inspection program? If so, please describe. The State reviewed the All Agreement State letter i addressing the sewage reconcentration problem and could I not find any situations where it could be a problem. California has, in the past, run a sewage sludge sampling program (under EPA) and found no problems. i L h e i i i c r i e i i
~. -.. ~_. E I 81 l 1 List of Appendices I i A. California Organization Charts B. RHB Organization Charts l C. Review of Selected License Files D. Review of SS&D Evaluations E. Action Plan for Eliminating Overdue Inspections F. Priority Schedule G. Internal Memo-Corrective Compliance Plan H. Compliance File Review I List of Attachments l I { The following documents were furnished by the State as supplementary material. l The documents are on file in Region V. d j i I.A 4 California Statutes
- l II.D.4 Advisory Committees III.A.2 Plan for Response to Incidents Involving Radioactive Materials i
III.A.5 RHB Emergency Call List i III.B.5 Radiation Fee Schedule
- l l
VI.A.3 Computer Listing of Due/ Overdue Inspections i VI.D.6 Incident Investigations and Summaries
- l VI.E.9 Orders and Civil Fenalties*
l VII.B.1 Environmental Surveillance Report
- l 1
- Copies of these documents have been forwarded to OSP.
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APPENDIX P Uv!UTCW, IDL-*! TcSIa4 { TCICIICIC TTR."M IWW.CH Joseph O. Ward. Chief - 604-205-7760-001 C. Nichcis, Secretary I B04-205-U 76-001 I f r RCIATI31 E!MGrJCS EICTI34 RCIAT!34 WNCDEP f " 734 Dan D. }triey. Gerard C. WtrxJ, Ph.D. Supervisitry tealth Itqsicist Supervisirq Health Ph; icist s 804-210-3801-001 E04-22D-3801-001 I I l l r i i laDIATIO4
- !'11ADCrc Arc MD y-my
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Sr. H.P. Sr. H.P. Sr. II. P. St. IL P - ~ 4-2 G-4046-001 M' B04-210-3002-002 804-210-3602-001 004-22C-3802-002 t 4-220-3802-0 0 804-u E. C)tbe-rcJ,AHP val zer: itis zarry Carter nill torenzo Jx Taka ashi-Bill Grote uth
- 4-21b-3803-Ov4 RPS II AKP FPS II RIP NP
'y E Janis B04-210-7991-001 804-210-3803-003 004-220-7991-002 e '4-222-3cc3-001 s 604-220-3603-i i i Jert2ne Ccplan Sarutar,' Ergr. Assoc., Vacant (5) Id G1cor JJ. crg, NT-ten Karel 04-210-5'93-701 RPS II B04-210-3826-001' RPS 11 t +4-220-3B03-000 M7 ta N. gent 804-2 M-7991-002 Jacxie Otrtui B04-220-7991-001 (re tirect to Sartro 604 220-3E03-0
- 1. Pru; ram %ch.
Paul Gravelme. Health ProgIwn Advisor (TLD MT) Eustace Datglas (1). Stuart Rosetterg ~ 34-210-8302-001 RPS I 804-21D-8337-701 Ccnrue Dra cr 804-220-3803-0. SO9-74 B-7991-901 MF C e A. Preece 604-210-7968-001 '~ .ce Tu:hnician C) fordia Ic;ers ~
- -}
PPS II u chard M.inley M-210-n39-gC2 RPS I ~ E04-221-7991-D01 W S,n.1D-3B03-001 g 4. ::. g.. - 804-210 W- , *~ - g, g 0,Jd:- Ltelling g Franna PJEces. py AHPA B04-221-7992-002 M 8 803-002 804-210-B337-703 Art 3,hnyt gg4.;;c.3g34 RPS II Oli *f d' 1All' l Steve unge: f E04-223-7991-001 MP RPS I ~ RPS II, Vacant 804-220-3803-; B04-210-79EB-004 804-222-7991-001 Dave M 1er (d:wx;rade to RPS I) W pps 3 E04-220-3B03. Vincent Dentanaro D. SiI:.L-rlart!, I + B04-221-79EB-001 00I*22D'3003*C I PPS I M. VM (3) Jackie Wtclerweber Sr 4-205. 003-C ~. I dE ViCant A E04-221-7966-002 tPS 1 04-?(5-2B0: ~ Jeseanne Guerrero We bCant 804-222-79BB-001 804*205~3003*E ! Pat Johnson - '0051,.Yacant i CP U) 604-220-1148-t' e s "m.g zu, g z _ ,g mg m .- = Dottie Davis Sue Pane NNMN y 005 I C) m H C) 804-220-79tB-0D1 2amille Pasley B04-210-1146-001 804-210-1126-708 Cathy Knite mI c) Phyllis Snith Melissa Pbffett RPS I 304 220-1149-802 CA II (T) m II C) 6D4-220-79BB-002
- ecilia 3ttalet 804-210- n28-701 804-210- n28-702 Paul Dalderweg a n (T)
Mary hlstick. PJ"., I go4-2fD-U 2B-701 OA II (T) B04-222-79BB-002 Helen Hartin 804-210-n20-703
- v. n (2 )
Roberta 5:5.=1*r ? 804-220-D26-706 i CA II C)
- Vacant 804-210-1128-705 Mary 6 heeler m n (T) 804-22D-1126-705 CA II (T)
Wilma Ibland 804-210-n28-7c4 m II (T) .Irend Pettit fg 304-220-1128-901 + CA II (T) Clara scarbrugh 804-210-1129-702 CA U C) ,804-221-1128-801 i 1,,c,u,,,,,, Re-dirnM to Aenwn minia b&,,s;y %4.14,em m,53. L,,_,,, m ur fwri.5. s== van *aren O% II (T) (2) J term gositions. 604-220-112b-704 6 l h ngy lorenzo (4) SqFervices CA n's in Materials 1.ioensing Unit f f ^ B 2 112B-707 (5) W be rec 1**=a4 to M L (6) MairQcins surveillarce mer the mntractors (Div rlm of Irxbstrial Relatichs, !.cs Argeles County, Orange C~ rsty), -h. 5 h. .~...... ........ ~.-
f i 82 1 l APPEh' DIX C Review of Selected License Files I i Fifteen pre-selected license files were reviewed. License applications were t reviewed for completeness and for proper signatures. Casework was reviewed for timeliness of State actions, adherence to good health physics practices,- j reference to appropriate regulations, supporting documentation, consideration j of enforcement history on renewals, pre-licensing visits, and peer or supervisory review as indicated. Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down condit2ons i and overall technical quality. The files were checked for orderliness and retention of necessary documents and supporting data. i The quality of the licenses issued by the state is improving, due to increased l communication between staff members and some clear-cut policy changes passed J down to the staff from management. ) J The staff members demonstrated a strong desire to issue quality license I products in a timely manner, but voiced concerns in some areas which were substantiated by facts gathered during the review process. 1 j a. The standard license conditions are not complete and several reviewers use their own conditions. I b. It is not always clear to the reviewers what elements belong in the review process for a particular type of license. There is a wide variation in the reviewers' understanding of the use and i i c. retention of checklists and peer-review sheets. 4 d. There is uncertainty about how to determine the need for pre-licensing i visits. l There is considerable confusion zbout License Condition 13 (the tie-down e. condition) and which documents should be referenced. j i Review of the files indicated that special considerations for cobalt therapy use (roof areas, surveys, posting, calibration requirements, maintenance I checks, etc.) were sometimes overlooked although they are on California's list of standard conditions. Other deficiencies found included cases in which user qualifications vere not completely clear, distribution of tracer materials was I i not prohibited by license condition and errors in the tie-down condition. The findings made in the review were discussed with the reviewers individually and generic issues were discussed in a general meeting. The use of license conditions, deficiency letters, telephone conversations, and peer reviews were also discussed. A list of files reviewed and the specific comments follows: l l i -r-.m 4 m-e ,,r
~~ - _ _. _ - =. 83 File No. I Licensee: Marshal Hale Memorial Hospital j Address: 3773 Sacramento Street; San Francisco, California 94118 i License Number: 2300-90 Aniendment Number: 22 l Date Issued: October 28, 1985 Expires: January 3, 1991 j Type of Licensing Action: renewal License Type: Group medical i File No. 2 Licensee: Daniel Freeman Marina Hospital Address: 4650 Lincoln Boulevard; Marina del Rey, California 90291 License Number: 3989-70 Amendment Number: 7 Date Issued: January 15, 1986 Expires: March 30, 1989 l Type of Licensing Action: Amendment License Type: Group medical } File No. 3 r I Licensee: Desert Hospital Address: P. O. Box 1627; 1150 North Indian Avenue; Palm Springs, CA 92263 License Number: 1290-33 Amendment Number: 48 Date Issued: November 18, 1985 Expires: March 8, 1992 Type of Licensing Action: Renewal License Type: Group medical and Cobalt Teletherapy l File No. 4 [ Licensee: St. John's Hospital Regional Medical Center f Address: 333 North F Street; Oxnard, California 93030 i License Number: 1515-56 Amendment Number: 44 i Date Issued: September 25, 1985 Expires: May 17, 1991 l Type of Licensing Action: Amendment License Type: Group medical File No. 5 I Licensee: Mt. Zion Hospital and Medical Center Address: 1600 Divisadero Street; San Francisco, CA 94115 License Number: 0376-90 Amendment Number: 88 Date Issued: February 7, 1986 Expires: January 26, 1989 i Type of Licensing Action: Amendment j License Type: Cobalt Teletherapy / Human use l File No. 6 Licensee: Veterinary Tumor Institute, Inc., Santa Cruz Veterinary Hospital Address: 2585 Soquel Drive; Santa Cruz, CA 95060 License Number: 4647-44 Amendment Number: N/A Date Issued: December 23, 1985 Expires: December 23, 1992 i Type of Licensing Action: original license 3 License Type: Cobalt Teletherapy / Installation and Survey only i d I j l
t 84' t ? File No. 7 Licensee: Small Animal Radiation Oncology Center .l Address: 18437 Mt. Langley, Suite S; Fountain Valley, CA 92708 License Number: 4640-30 Amendment Number: N/A Date Issued: Janua ry 27, 1986 Expires: January 27, 1993 l Type of Licensing Action: Original license i License Type: Cobalt Teletherapy / Installation and surveys only File No. 8 l Licensee:.Aerojet Strategic Propulsion Ccmpany; Environmental Health and Safety Department l 4 Address: P. O. Box 15699C; Sacramento, California 95831 l License Number: 2198-34 Amendment Number: 20 i 1 Date Issued: Janua ry 22, 1986 Expires: June 18, 1992 Type of Licensing Action: Renewal-l Li cer. Type: Industrial f File No. 9 Licensee: Westinghouse Electric Corporation; Nuclear Services Integration Division Address: 200 Highland Springs; Beaumont, California 92223 License Number: 4346-33 Amendment Number: N/A i Date Issued: December 30, 1985 Expires: December 30, 1992 Type of Licensing Action: Original license License Type: Industrial: decontamination / mock fuel assembly / instrument l calibration 1 File No. 10 1 Licensee: Triton Biosciences, Inc. Address: 1501 Harbor Bay Parkway; Alameda, California 94501 License Number: 4498-60 Amendment Number: N/A { Date Issued: September 23, 1985 Expires: September 23, 1992 i j Type of Licensing Action: original license j License Type: Industrial J File No. 11 Licensee: Helgeson Scientific Services Address: 5587 Sunol Boulevard; Pleasanton, California 94566 J License Number: 1378-60 Amendment Number: 11 Date Issued: September 12, 1985 Expires: April 19, 1992 Type of Licensing Action: Renewal License Type: Industrial; production of microcurie sources l t File No. 12 l Licensee: San Gabriel Valley Diagnostic Center j Address: 3644 South Nogales; West Covina, California 91792 l License Number: 4672-70 Amendment Number: N/A { ) ) -m.
.~- 85 i I i Date Issued: December 9, 1985 Expires: December 9., 1992 j Type of Licensing Action: Original License i License Type: Private practice - group medical File No. 13 l i Licensee: Fibreboard-Corporation / San Joaquin Pulp and Board Mill j Address: Wilbur Avenue; Antioch, California 94509 License Number: 0536-07 Amendment Number: 18 Date Issued: November 21, 1985 Expires: August 28, 1991 i Type of Licensing Action: Eenewal j License Type: Fixed gauges j I File No. 14 Licensee: Nucleic Acid K..earch Institute i i Address: 3300 Hyland Avenue; Costa Mesa, California 92626 License Number: 4677-30 Amendment Number: N/A j 2 Date Issued: November 19, 1985 Expires: November 19, 1992 Type of Licensing Action: Original license ) License Type: Irradiator/ Tracer Studies { File No. 15 i t Licensee: Hughes Aircraft Company Address: 200 North Sepulveda Boulevard; El Segundo, California 90245 License Number: 3114-80 Amendment Number: 3 i Date Issued: October 31, 1985 Expires: January 5,1991 1 Type of Licensing Action: Renewal License Type: Irradiator t Comment File Number l 1. User qualifications not completely clear 2,4,7 i 2. Training for users / ancillary personnel not sufficient 1, 13 3. Misleading " authorized use" description 10, 11 i 4. Special conditions or considerations for cobalt 3, 5, 6,.7 teletherapy uses overlooked r 5. Distribution of tracer materials not prohibited by license 10, 11, 14 2 condition 6. Errors in License Condition 13 2,3,8 7. Incorrect priority assigned 6 i 8. Inventory requirement missing 13 9. Telecon records not kept in file 13 l i TMid er r w N v 9
t 86 i i i l i 10. Group ~4 medical authorization without standard license 12 condition for patient treatment (reference to NCRP 37), i management and release. l 11. No special precautions were listed in the license 10 i application for millicurie quantities of P-32 (plexiglass, j etc.). I 12. Documentation of peer review missing 6 i = i 13. No documentation as to who would conduct leak tests or 4 i 4 keep records l b d ') s t i I 1 1 s i 1 1 i i l 1 d I 4 1 i i i I i 1 1 1 1 I 1 i i a 1 4 I
--.- l a 87 j i i 1 I Appendix D l Review of SS&D Evaluations i 1 i Twenty-nine registration documents were issued in the review period by [ California. This number includes amendments which were issued to existing l registry sheets. All of these documents were examined during the course of l this review; however, more emphasis was placed on the fifteen registration documents which were issued between August of 1985 and March of 1986. The SSD reviewers have done a good job in providing information on the registration sheets that is useful to the license reviewer and inspectors. l The reviewers have demonstrated good logic and a thoroughness in the review i process, and no major areas of concern were found. Eleven cases were selected j and reviewed to determine whether the vendors submitted adequate background i information. Each file was supported with relevant information from the l manufacturer, but there were some minor deficiencies. One file did not include the type of stainless steel to be used in manufacturing a source l capsule. Another did not clearly specify the source loading tolerances. I There is a major problem in the office equipment and clerical support for the SSD sheets. Not only is the typing support unacceptable, with long turn-around times, but the filing is done in cardboard boxes, if at all. This makes locating missing documents difficult, and the practice increases the likelihood of a fire destroying the only copy of the supporting documents. This was discussed with management and at the exit with Dr. Kizer. In addition to the review of the registry sheets and background information, three special cases were investigated and discussed with the State. 1. J. L. Shepherd Corrective actions taken since the NRC Order of July 1984. J. L. a. Shepherd was required to install new lock boxes on the Mark I devices, but they were not required to retrofit units due ta cost - benefit constraints. A new registry sheet was issued. The compliance investigation has not been completed. For this reason, the NRC Order should not be rescinded. b. Quality assurance program. No quality assurance description could be located for products other than transportation containers. A program description should be developed and submitted to NRC Headquarters at the earliest opportunity. 2. Trio Tech Unauthorized Krypton 85 releases f rom Tracer Flo units. A March 1986 meeting with the industry was postponed because an airport was closed by bad weather. Now a new meeting is planned in April between the manufacturers and State representatives to discuss items of concern such as preventive maintenance, safety designs, training, calibration, repair, decontamination of vacuum pumps, proper waste disposal and effluent
88 i limits. A copy of the users' manual and a report on the meeting will be sent to State Programs. 3. NDC General license provision for gauges which may be portable. California 's regulations clearly prohibit portable use of this device. The NDC ] license is due for renewal, and the State is reviewing the portability j issue as well as shutter design. The State is requesting a new users' manual to clarify usage restrictions and new sales literature to delete J l the concept of portable gauging devices. i j The following SSS.D sheets were reviewed. In some cases, the background information was also reviewed. These files are indicated by an asterisk j following the case number. Case No. Vendor Registry No. i ) 1 Gamma Metrics Inc. CA-305-D-101-S l 2* General Electric Company CA-312-S-105-S 3* General Electric Company CA-312-S-106-S l 4 ICN Pharmaceutical Inc. CA-360-S-109-S l j 5 ICN Pharmaceutical Inc. CA-360-S-110-S l j 6 ICN Pharmaceutical Inc. CA-360-S-111-S 1 7 Isotope Products Lab. CA-406-S-122-U l 8* lsotope Products Lab. CA-406-S-125-S l 9* Isotope Products Lab. CA-406-S-126-U 10 Isotope Products Lab. CA-406-S-146-S I 11 Isotope Products Lab. CA-406-S-147-S 12* Mettrsnics Company CA-457-D-101-S l 13* NDC Systems CA-471-S-101-G 14 Peco Controls Corp. CA-533-D-103-G J 15 Peco Controls Corp. CA-533-D-104-G 16* Science Applications, Inc. CA-590-D-106-S 17 J. L. Shepherd and Associates CA-598-D-104-S 18 J. L. Shepherd and Associates CA-598-D-116-S 3 3 19 Syncor Corporation CA-621-S-102-S i 20 Syncor Corporation CA-621-S-103-S l 21 Syncor Corporation CA-621-S-104-S i j 22 Syncor Corporation CA-621-S-105-S i j 23 Syncor Corporation CA-621-S-106-S l 1 24 Syncor Corporation CA-621-S-107-S i i 25 Syncor Corporation CA-621-S-108-G ) 26* Syncor Corporation CA-621-D-110-S l j 27* System Science and Software CA-626-D-102-G ~ 28 Varion Instruments Division CA-662-D-101-B 29* Xonics, Inc. CA-676-D-103-G The following comments apply to the referenced case number: e Comment Case No. f e i 1. The word " nominal" was used instead of specifying the 2 l maximum activity including tolerances. i l i I l [
e 89 i l t 2. The type of stainless steel was not indicated in the file 3 j documents. 3. The limitations and drawing sections were excellent. 1 l 4 4. Good use of limitations section to properly restrict the use 8 [ of sources manufactured prior to August 1, 1981. 5. Source did not meet appropriate ANSI classification because 10 the impact testing was not as severe as the standard. 6. The words "not to exceed" unnecessary when maximum activity 11 is specified. 7. Insufficient documentation on quality assurance. 5 i l 8. Maximum activity of gauge not specified. 14 9. The shutter on this device can be locked in the open 16 i position. ANSI N438 assumes that the shutter can only be locked in the closed position. r ? 10. Inadequate instructions to user on transportation 29 requirements and user restrictions. { A general comment regarding these cases is that the " Principal Use" entry I should include the standard use code to assure that they are processed j a and filed properly. + .i These comments were discussed with the staff and any questions were resolved. Necessary changes to the registry sheets can be made when the manufacturing or I 4 distribution licenses are being amended or renewed. This will provide the state an opportunity to assure that they have current and complete information j on each product. To supplement the discussions of individual discussions with the reviewers on the proc < ;ing of registration documents and handling of special cases, such j as those described above, a training course was presented on the morning of j March 12, 1986. An overview of the source and device registration process was i presented, followed by a discussion of general and exempt distribution l licenses and food product irradiators. A question and answer period concluded l the training session. I i i i I t ~ i f t i l i l y w m m--- mm h
6 APPENDIX E mn cr cu :. a-sto ec wtwt sotu:s ctonct ctuwum. conmx 7 DEF ARi!.'ENT OF HEALTH SERVICES g 3.;g u a r u. n- .e CPO CA iSE14 wo) 3 2-1305 i March 17, 1986 l t Mr. Jack Horner U.S. NRC, Region 2 1450 Maria Lane, Suite 210 Ualnut Creek, CA 94596
Dear Mr. Horner:
During the recent audit of the California Radiation Control Program, March 3-14, 1986, by the U.S. NRC, a Category I deficiency in the corpliance program was found due to a sizable number of overdue inspections. There are 43 overdue inspections as of March 14, 1986, according to the California tabulation. 1 There are 60 cverdue inspections as of March 14, 1986, according to the NRC audit. This discrepancy is due to the follouing: i (a) An error in the DP system program since 1978, (discovered less than three weeks ago) did not include licenses which have never been inspected in the overdue list. When this error was discovered and corrected, some facilities were added to the list which are overdue for ^ inspections. (b) For licenses issued prior to March 1985 (the date that we switched to the NRC priority system), we did not consider that an " initial inspection" was warranted. NRC disagreed with this approach. We propose the following corrective action plan to eliminate i all overdue inspections: (a) Redirect sone of our license reviewers within RHB to perform corpliance inspections (up to 3.5 FTE inspectors). r ~ (b) Monthly audit of DOSH, LAC and OC will be perforned to track their progress in eliminating overdue inspections. (c) Overdue inspections, due to above described discrepancy of priorities 1-3, will be inspected within a reasonable period of time. Priority 5 will be considered overdue when no inspections have been conducted within five years from the date of issuance of the license. Priorities 6 and 7 vill similarly be considered overdue after six years. t
a' (d) A timetabic and target dates to elininate overdue r inspections are shown in the following schedule: No. Overdue No. Overdue No. Overdue No. Overdue No. Overdue on 3/14/86 on 6/30/86 on 9/30/86 on 12/31/86 on 3/13/87 f l RHB ,16 12 8 4 0 t DOSH 33 25 17 9 0 f OC 4 3 2 1 O IAC 7 6 4 2 0 It is inportant to note that for California to avoid overdue inspections, 600 to 700 inspections are required to be conducted i annually. We are committed to tracking inspection status on a monthly basis to assist us in neeting this objective. Sincerely, r Harve Collins, Ph.D., Chief Environmental Health Division, \\ l P s ~ i P k i 4 i i i I i ^ a { i m.
t AFri.iwAA r j' g / INSPECTION PRIORITITS [ i r Industrial 1 i 2 i 3 4 5 6&7 + t Major Processor Refineries, Cbemical Processing of Source Material l Broad Authorization Types Type A&D C Radiography { Waste Collection Large Irradiators I Soil Cages Other Gages, C.D. Source Sets, Light Sources, Check Sources, Mg-Th Storage, GC Other [ Medical ~ i Broad Authorization [ Diagnosis and/or Therapy { Diagnosis Only; and/or Therapy with possession limit not exceeding 100 mci. Plesio-Therapy (other than short lease) and generators excluded l Academic _4 l [ Broad Authorization ype ype Type A B C Other INSPECTION FREQUFNCIES i i Pr ior i t y 1 2 3 4 5 6 & 7 I i Initial (months)1/ 6 6 6 6 (, 12 12 Follow-Up non Due Frequency (yr-1) 1 0.5 0.33 0. 2 ') 0.20 routine Due (months)2/ 12 24 36 49 60 Overdue (months) 2/ I f4 36 54 72 99 l l 2/ l h m Date of Issuan~a l 2/ Trom Date of Last Inspection I a i .' 1 ", ) 9
APFDGII G j l To: RHS Redioective Metericis Dete: Merch 14,1986 f Complience Inspectors.f ) i y' From: Gererd C. Wong
Subject:
Radioective Menegement
- 1) Uniform enforcement l
Section. Procedure.
- 2) Peer end Supervisorg Review of Inspection Reports i
l
- 1) Recent review of inspection reports disclosed thet the following i
improvements ere needed to ettein uniform enforcement prectices emong complience inspectors: c) Non-complience items described in the Ulf must be cited in the notice of violetion end connot be translated es recommendettons in the letter i f to the licensee. b) All boxes in the UlF must be checked off. l c) Description end celibretion date of survey instrument used by the inspector must be conteined in the inspection report. d) All compliance inspectors shell edhere to policies set in the RHB l ~ Inspection Policy Memos. Information perteining to uniform enforce-j ment procedure is presented in IP "2 end "11. l t i
- 2) Peer end supervisory review of inspection reports shell be 1ollowed es l
described for each regional office-i e) RHB - Secremento Dref t inspection report from ecch inspector shell be reviewed by enother inspector who will inittel the dref t when determined to be ] l complete.The fir.el report shell be reviewed end signed off by the 4 l complience supervisor before melling to the licensee. b) RHB - Los Angeles The RM complience inspector (only inspector) in this regionel office i' cennot obtein peer review locelly. Effort shell be mede by phone or other convenient meons to discuss with the complience supervisor in Secremento on notices of violetion and compliance correspondence reedy to go out. The complete inspection report pockege shell be re-viewed by the compliance supervisor (Secremento) citer the fect. c) Other Contrect inspection Agencies j Peer end Supervisory review shell be performed within ecch egency when.f essible.The complete inspection report pockege shall be reviewed by the complience supervisor (Secremento) of ter the f act.
90 l l i l Appendix H Compliance File Review I i l Thirteen compliance files were reviewed. These files were reviewed to-determine that the inspection reports uniformly and adequately documented the scope and results of the inspection, that appropriate compliance action was ) taken, that enforcement letters were written in appropriate regulatory j language, that enforcement actions, responses and acknowledgements were completed in a timely manner, that unresolved issues were pursued to j conclusion and that compliance actions and inspection reports had proper j supervisory review. The files were also checked for orderliness and retention of necessary supporting data. The major problems associated with the inspection program include downgrading of items of non-compliance to recommendations, not completely filling out the l l inspection forms including signatures and dates (forms U1F and 2514), not l interviewing or documenting interviews of ancillary workers, lack of j documentation of observation of licensee use and little or no supervisory review of inspection reports or enforcement letters before they are sent to 1 the licensee. Most of these problems can be corrected by proper supervisory review prior to mailing. The California RCP has provided a corrective plan j q; (Appendix G) for overcoming these problems. This plan was implemented March 17, 1986, and will be reviewed during the 6 month special follow-up meeting ] with California. i l A summary of the comments follows the list of files reviewed. These comments were discussed in the staff exit meeting. j t t File No. 1 1 Licensee: Shasta County, Department of Public Works License No.: 2177-45 i Address: 1855 Placer Street, Redding, California ) License lype: Portable Gauge Priority: 5 i Inspection Type: announced / complete / routine Report Style: Form Date last inspection / license issued 8/10/77 1 ^ Inspection Date: 1/9/86 Report Date: 1/15/86 l Enforcement Letter Required: Yes Date Sent: 1/22/86 Date of Licensee Response: 1/30/86 Date of St te Acknowledgement: 2/7/86 Date of Supervisory Review: 1/22/86 j i File No. 2 I I 1 Licensee: SRL Incorporated License No.: 2963-30 Address: 1961 Wright Circle, Anaheim, California 92806 License Type: Industrial (Kr-85 Leak Test) Priority: 3 Inspection Type: announced / complete / routine Report Style: Form Date last inspection / license issued 4/27/82 ) Inspection Date: 10/25/85 Report Date: Assume 10/25/85 j 3 Enforcement Letter Required: No Date Sent: N/A Date of Licensee Response: N/A Date of State Acknowledgement: Not Dated Date of Supervisory Review: 12/24/85 i i
. ~- 91 f I ) l File No. 3 Licensee: Mills Memorial Hospital License No.: 0161-41 Address: 100 So. San Mateo Drive, San Mateo, California 94401 License Type: Nuclear Medicine with Brachytherapy i j Priority: Not Assigned l Inspection Type: announced / complete / routine Report Style: Form Date last inspection / license issued 9/10/78 l Inspection Date: 7/24/85 Report Date: 12/19/85 i 0 Enforcement Letter Required: Yes Date Sent: See Comments on File 3 l Date of Licensee Re;ponse: 7/29/85 Date of State Acknowledgement: 9/11/85 Date of Supervisory Review: 1/22/86 l t File No. 4 .j Licensee: Seton Medical Center License No.. 1391-41 l l Address: 1900 Sullivan Avenue, Daly City, California 94015 i License Type: Nuclear Medicine and Brachytherapy Priority: 3 j Inspection Type: announced / complete / routine i Report Style: Form Date last inspection / license issued 5/14/80 Inspection Date: 7/24/85 Report Date: 12/19/85 l Enforcement Letter Required? Yes Date Sent: not sent (2514) Date of Licensee Response: Not Required t Date of State Acknowledgement: 9/30/85 Date of Supervisory Review: 1/22/86 l l File No. 5 Licensee: Mercy Hospital License No.- 1635-24 Address: 2740 M Street, Merced, California 95340 ) License Type: Nuclear Medical Gr I, II, and III Priority: 3 ) Inspection Type: unannounced / complete / routine Report Style: Form Date last inspection / license issued 6/19/80 Inspection Date: 1/29/86 Report Date: not given j Enforcement Letter Required? Yes Date Sent: 2/10/86 Date of Licensee Response: 2/27/86 Date of State Acknowledgement: in progress Date of Supervisory Review: 2/10/86 j File No. 6 Licensee: Sequoia Hospital District License No.: 0263-41 Address: Whipple & Alameda, Redwood City, California 94062 License Type: Nuclear Medicine and brachytherapy Priority: 3' Inspection Type: announced / complete / routine Report Style: Form Date last inspection / license issued: Not Available Inspection Date: 4/2/85 Report Date: 4/12/85 Enforcement Letter Required: Yes Date Sent: 4/12/85 Date of Licensee Response: 4/30/85 Date of State Acknowledgement: Not Available Date of Supervisory Review: 7/29/85 File No. 7
92 l Licensee: Alta Bates Hospital License No.: 0517-6' l Address: 3001 Colby Street, Berkeley, California 94705 License Type: Nuclear Medicine and Brachytherapy Priority: 3 ? Inspection Type: announced / complete / routine Report Style: Form Date last inspection / license issued 5/23/79 j Inspection Date: 2/19/86 Report Date: 3/6/86 Enforcement Letter Required? Yes Date Sent: 3/6/86 Date of Licensee Response: In Progress Date of State Acknowledgement: In Progress Date of Supervisory Review: Not Done i -t 1 File No. 8 f 2
- ~
Licensee: Associated Geotechnical Engineer's Inc. License No.: 3321-43' Address: 1440 Koll Circle, Suite 106, San Jose, California 95112 License Type: Portable Gauge Priority: 5 l Inspection Type: announced / complete / routine Report Style: Combined Date last inspection / license issued 11/1/79 j Inspection Date: 12/12/85 Report Date: 12/12/85 [ Enforcement Letter Required? Yes Date Sent: 1/7/86 i Date of Licensee Response: 2/5/86 Date of State Acknowledgement: 2/18/86 Date of Supervisory Review: 1/7/86, 2/26/86 ) File No. 9 Licensee: Syncor Corporation License No.: 3832-60 j Address: 1440 Fourth Street, Berkeley, California 94710 License Type: Radiopharmacy Priority: L j Inspection Type: unannounced / complete / routine 6 Report Style: Form Date last inspection / license issued 2/23/82 Inspection Date: 2/18/86 Report Date: 2/18/86 Enforcement Letter Required? Yes Date Sent: 3/3/86 i Date af Licensee Response: in progress i Date of State Acknowledgement: in progress Date of Supervisory Review: not yet reviewed File No. 10 f I Licensee: Continental Testing and Inspection License No.: 2535-70 Address: 2424 Gundry Avenue, Signal Hill, California 90806 l License Type: Industrial Radiographer Priori ty: 1 l Inspection Type: announced / complete / routine l Report Style: Form Date last inspection / license issued 6/22/84 i Inspection Date: 11/18/85 Report Date: 11/20/85 l ]_ Enforcement Letter Required? Yes Date Sent: 11/21/85 Date of Licensee Response: 12/13/85 i Date of State Acknowledgement: 12/20/85 Date of Supervisory Review: 11/21/85 Date of Supervisory Review: 1/8/86 File No. 11 i Licensee: Becton-Dickenson Labware License No.: 3644-56 N 3-m r-c.,n r
m m. 93 i h Address: 1950 Williams Drive, Oxnard, California 93030 License Type: Industrial (Biochem) Priority: 3 Inspection Type: announced / complete / termination
- i Report Style: Form Date last inspection / license issued 3/25/82 Inspection Date:
2/11/86 Report Date: 2/18/86 Enforcement Letter Required? Yes Date Sent: Not dated (2514) I Date of Licensee Response: None Date of State Acknowledgement (2514 above) Date of Supervisory Review: 2/21/86
- Close out survey not completed during this inspection (next) i File No. 12 Licensee: Chiron Corporation License No.:
3940-60 l Address: 4560 Horton Street, Emeryville, California 94608 License Type: Industrial (Bio Chem) Priority: 3 Inspection Type: announced / complete / routine l Report Style: combined Date Last Inspection / license issued 2/23/82 Inspection Date: 11/20/85 Report Date: 11/21/85 ') l Enforcement Letter Required? Yes Date Sent: 12/4/85 -l 1 Date of Licensee Response: 1/3/86 l Date of State Acknowledgement: 1/13/86 i J Date of Supervisory Review: 12/3/85 f File No. 13 1 i r Licensee: Pacific Medical Center License No.: 0250-90 a Address: 2333 Buchanan Street, San Francisco, California 94120 License Type: Nuclear Medicine and Brachy Therapy Priority: 3 i Inspection Type: unannounced / complete / routine i c Report Style: Iorm Date last inspection / license issued 5/4/82 Inspection Date: 2/27/86 Report Date: 2/28/86 { Enforcement Letter Required? Yes Date Sent: in progress Date of Licensee Response: in progress Date of State Acknowledgement: in progress I Date of Supervisory Review: not reviewed { 1 t s - f I t t i t i i 1 b w =.- .,,,w.- 4 n, y-, ,..,f
94 n 1 Summary Table Comment Case No. i 1. License overdue for inspection (>50*4) 1,3,4,7 2. Ancillary workers not interviewed or interview not 1,3,5,5,9,12 3 documented i 3. Short form (2514) acknowledgement not dated 2,11 4. Important inspection data not recorded on inspection form 3,4,5,10 l (blanks not filled or checked) 5. Priority not listed on inspection form (as called for) 3,10 l 6. Several items that were clearly items of noncompliance l were downgraded to recommendations i a. lack of inventory of sealed sources 3 b. lack of required leak tests 3 l c. Dose calibrator geometry check not done 3 d. Required survey meter calibration not done 3,4 i Survey meter inoperable 4 e. f. Inadequate survey instrument (wrong ranges) 4 g. No quarterly dose calibrator linearity checks 4,6 i h. Sensitivity of leak check instrumentation not 4 adequate (could not detect 0.005 microcurie) i. Radiation Safety Committee not conducting required 6 i quarterly meetings i j. Inventory (in/out) of brachytherapy sources not 6 being done (in CA regs) k. Required surveys not being done 6,9 j 7. Repeat items of noncompliance not highlighted in 3 I enforcement documentation 8. No indication of exit with management 3,4,5,6,7,9, l 10 9. No indication RS Committee minutes reviewed 3,4 i 10. No indication licensee possesses license or associated 3 amendments 11. No indication inspector examined preparation of waste 3 packaging 12. Training records were not available, were to be sent, 3 i l not done, not followed up.(9 mo.) 13. Inadequate inventory of sealed sources, never resolved 3 J 14. Acknowledgement letter took 60 days 3,4 l California procedures require 30 days 15. Instruments calibrated by licensee not authorized to 4 i calibrate survey instruments 16. Xenon used, inspector did not check for negative pressure 4 l or air flow l 17. Inspection identified items of noncompliance, no 4 enforcement or licensee response required by State 18. Inspector measurements did not list make, model, S/N, or 5-last calibration date of instrument used l h 2 5
i ST t r i o t 19. No documentation of licensee use of RAM observed by 10 inspector 20. Short form (2514) in this case required 1:censee response, 11 3 never received, file closed anyway 21. Short form (2514) not signed by inspector or licensee as 11 required 22. The State did not perform a close-out survey or schedule 11 one for the future when the licensee stated that he was terminating his license I 23. California calibrated a survey meter that was out of 12 I ~ calibration by cross checking it using a Ra clock dial - not an acceptable practice for survey meters used for inspections 24. New inspector did not follow proper enforcement procedure 3 [ [ I i l i -t t d s Y i e i e t 5 i ? \\ F i i i l
i ENCLOSURL 1" 1 STATUS OF PROPOSED REGULATIONS } 1 F i Initial Current Reg No. Subject Action . Disposition R-50-84 Radiation Control. Group 2. AB lill/NRC Final regulation proposal l Licensing of Radioactive submitted 11/25/85. { Material Proposal filed with OAL 1/23/86. Notice of OAL { disapproval 3/13/86. Revised proposal to meet. OAL comments submitted i 4/11/86. 15-day posting in Regulations through 5/27/86. Filed with i Secretary of State to be effective 8/8/86. l T l j R-13-85 Radiation Control. Group 3. AB 1111/NRC Final regulation proposal ] Standards for Protection submitted 11/25/85. Final '[ i Against Radiation filing order returned to Regulations 1/7/86. Proposal filed with OAL [ 1/23/86. Notice of CAL disapproval 3/5/86. Revised d proposal to meet OAL com-I ments submitted 3/25/86, i 15-day posting in i Regulations through 5/23/86. Filed with Secretary of State to be ] effective 8/8/86. 4 i ] R-41-85 Radiation Control. Group 3. AB lill Final regulation proposal Standards for Protection submitted 2/21/86. Cleared f Against Radiation Budgets 3/8/86. Returned for changes by Legal 5/28/86. Resubmitted 6/10/86. Held in Legal i pending OAL clearance on l R-13-85. Notice of hearing i flied 7/8/86. Hearing set l for 10/8/86. Office of l Regulations estimates j 2/6/87 as effective date 2 i i Disk Name Regulations-General Document Name - STATREGS.NRC l Date 7/18/86 i
NRC Status Report " ENCLOSURE II" Page 3 -July 18. 1986 o Answers to Enclosure I of the NRC letter. 1. Management and Administration A. Staff meetings, attended by the Branch Chief, supervisors and licensing compliance personnel, are held on an "as needed" basis but not less than an average of once a month. B. The licensing supervisor has been reviewing al) licensing actions issued by every license reviewer on a regular basis for purposes of quality assurance. In addition to this regular review: (1) The licensing supervisor will select the work of one reviewer at a time and perform a thorough and complete review once each week. (2) The Chief of the Radiation Management Section will perform the same once a month. These reviews will be documented. C 3. The Program Management and Consultation Section is reviewing the RHB support staffing level requirement to determine the need for additional staff. Paid overtime has been authorized for support staff as an interim measure. 2. EHD arranged a panel of experts within the Department to meet with RHB to discuss RHB's data processing (DP) needs on June 10, 1986. A list of RHB DP needs was prepared to help in the assessment of the software / hardware and consultation necessary to make RHB's data processing system ful]y functional. II. Personnel A. The Office of Personne] Services has authorized RHB to fill the 3 limited term health physicist positions on a permanent basis. New certified hiring lists for Associate and Assistant Health Physicists are expected in the next few days. There are 4 health physicist vacancies in licensing. Filling these vacancies will bring the professional staffing level to 0.91 staff per 100 licenses. Additional staff positions wj)) be proposed for FY 87/88 to bring the professional staff. level to about 1.2 staff per 100 Jicenses.
NRC Status Report Page 4 July IS. 1986 111. Licensin,g A. 1. A requisition has been submit ted to the Of fice of State Printing for updated California Radiation Control Regulations. 'Ibey are xpected to be available mid August. 1980. An internal procedure has been established to assure that regulations are available to Calif ornia licensees in the future. New license applicants will be furnished copies of all applicable guides, application forms, checklists and an order form for the California Radiation Control Regulations. " Materials Memo No. 95", indicating forms to include with various applications. has been issued to all licensing staff. All licensees will be issued a notice that updated regulations are available and will be given a regulations order form. Outstanding orders f or regulations will be filled by Office Services Section upon receipt of the regulations from the printer. 2. The standard condit ions have been evaluated and modified. l'niform standard license conditions have consistently been used in the past with only an occasional need f or special license conditions. This need will continue to exist. Any new proposed standard condition will be reviewed by the staff prior to inclusion with the next revision. 3. a. Checklists have been developed f or applicant's with standard licensing requirements. They have been used on a trial basis since May.1985 and have proven to contain the essential elements necessary f or a good radiat ion safety program for each type of license. A list of available guides and checklists has been included with a memo to the entire staf f regarding their disposition (Mat. Memo No. 96). Samples of various types of licenses are also available to the staff as guides. " Materials Memo No. 97" regarding their use has been distributed.
- b. & c. These items were clarified during a staf f meeting on June 5.
198G. Minutes of this meeting have been distributed to the staff via Memo dated July 30 1986. d. Documentation of telephone conversations has been clarified via Materials Memo No. 85. A standard f orm for reviewer's use was included with this memo.
NRC Status Report page 5 July 18. 1986 4. This is part of supervisory review. A more detailed priority assignment schedule has been provided to the staff (Mat. Memo No. 76C): a complete edit of priority assignments would require incorporation of the updated priority scheme into the data processing system. 5. With the existing staff. RHB is able to review and draf t new licenses and amendments within t wo months. The backlog of renewals total 265. 80 of which are over one year old. We are in the process of hiring additional health physics staff in an effort to reduce this backlog to within one year. IV. Compllanee A. The data processing system for due/ overdue inspections has been modifled to account for all licenses. As a back-up tracking method. since June 1. 1986, inspection agencies are required to f urnish weekly inspection progress reports to RHB-Sacramento. RHB has escalated compliance inspection efforts by redirecting t wo health physicists f rom the Environmental s' nit to conduct full-time compliance inspections. The target for elimination of all overdue inspections is mid March. 1987. B. 1. Stafi members have been reminded of the criteria for s reporting incidents. We shall emphasize these criteria again at the next general staff meeting in fall this year. 2. The cross-reference system between the incident file and license and compliance files is already in place. A copy of RH 5010 (Initiation of Investigation) is put in the 11 cense file to alert reviewers of significant incidents. C. A memo, regarding more thorough supervisory review, was issued to all inspectors and inspection agencies in March, 1986 (during the week of the NRC audit). D. Velometers are calibrated once a year. Inspectors will use them for conducting independent measurements as necessary.
y nc 4 jo UNITED STATES E NUCLEAR REGULATORY COMMISSION a ?, ,E REGION V 4 1450 MARIA L ANE, SulTE 210 %....[ WALNUT CRE E K, CALIFoRNI A 94596 April 22,1986 Dr. Kenneth W. Kirer, Director California Department of Health Services 714 P Street Sacramento, California 95814
Dear Dr. Kiter:
This is to confirm the discussion Mr. Jack W. Hornor, NRC State Agreement Representative, held on March 19, 1986, with you and your staff following our review and evaluation of the State's radiation control program. The results of our review indicate that the California Radiation Control Program is adequate to protect the public health and safety. However, we are unable to offer a statement of compatibility pending the State's corrective actions for a Category I deficiency. Status of Regulations is a Category I Indicator. The California Rules and Regulations for Radioactive Material, Title 17, have not been ~ revised to incorporate NRC changes in radiation protection and licensing provisions since 1974. While some progress has been made since the last review, continued attention is necessary to complete the revision process. We were told that the necessary regulation changes have been prepared and are being reviewed by the Office of Administrative Law and that after their approval the Attorney General's Office needs thirty days to make them effective. At that time we understand the State vill distribute them to its licensees. When the revised regulations are issued, we vill be in a position to consider a finding of compatibility for the program. Following our last three reviews, we commented on the need to develop a [ workable inspection tracking system and to increase the inspection staf f in order to cope with the inspection workload. While these needs still exist, some progress has been made in eliminating the backlog of overdue inspections. The Radiological Health Branch has now developed action plans to further improve the program and eliminate all overdue inspections within the next year. Your assistance vill be needed to provide adequate technical and administrative staffing, to change the three temporary staff positions to permanent and to provi.de support to aid in the development of the data processing system. We vill be monitoring the State's progress in these areas. The need for upper management attention is also indicated in improving communication between levels of management within the Department and i internally within the Radiological Health Branch. Further details on j this aspect are included in Enclosure 1. j l Overall, we vere pleased to note continued improvement in the program. We believe your personal support and the efforts of your staff have contributed significantly to this improvement. In particular, we were pleased by the improvements made in the licensing program, the increased number of inspections performed and in the resolution of problems with the administration of the enforcement program. ODD 04k
April 22,1986 We would appreciate your reviewing our comments and responding with your specific plans and target dates for improving the State radiation control program. . contains additional comments regarding the technical and administrative aspects of our review. While most of these comments concern Category _II items in our guidelines for program review, we 7 believe their resolution will add further improvement to that already achieved. We suggest they be included in the Branch action plan. These l comments were discussed with Mr. Ward during our exit meeting with him I and his staff. Mr. Ward was advised at that time that a response to these findings would be requested by this office and you may wish to have Mr. Ward address the Enclosure I comments to be included in your response. contains an explanation of our policies and practices for reviewing Agreement State programs. . is a copy of this letter for placement in the State's Public ~ Document Room or otherwise to be made available for public review. l I appreciate the courtesy and cooperation extended by your staff to Ms. Riedlinger, Mr. Baggett and Mr. Bornor of our staff during the j review. Sincerely, _ Al 0 - i Jolin. Martin ( N gy Regional Administ h r ( ~
Enclosures:
1. Comments and Recommendations on Technical and Administrative Aspects of the California Radiation Control Program q 2. Application of " Guidelines for NRC l Review of Agreement State Radiation Control Programs" 3. Letter to Dr. Kenneth W. Kiser, from John B. Martin, dated 04/22/86 l cc w/ enclosures: Joseph 0. Ward, Chief l Radiological Health Branch Earvey Collins, PhD., Chief Environmental Health Division l G. Wayne Kerr, Director Office of State Programs, NRC i NRC Public Document Room, Document Control Desk (SP01) I
ENCLOSURE 1 L COMMENTS AND RECOMMENDATIONS ON TECHNICAL AND ADMINISTRATIVE ASPECTS OF THE CALIFORNIA RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS 1. MANAGEMENT AND ADMINISTRATION A. Administrative Procedures and Management are Category II Indicators. Internal communication encompasses guidelines from both of these related program areas. The following comment with our recommendation is made. Com=ent The Radiation Control Program (RCP) should have procedures that assure the staff performs its duties as required with a high degree of uniformity and continuity in regulatory practices, and program management should receive information from the staff pertaining to backlogs, problem cases, inquiries, etc. NRC reviewers found in this and past reviews that insufficient communication between levels of management in the Department, Division and Branch diminishes effectiveness of the RCP. In some cases upper level management is not aware of problems within the Branch, and within the Branch, information necessary for proper program functioning is not always made available to either the staff or supervisors. Recommendation We recommend periodic staf f meetings at appropriate levels be used to discuss information, policies, ideas and problems. Within the Branch, periodic meetings should be held by the Branch Chief and the supervisory staff and between the i supervisors and the licensing and compliance staffs. While the semi-annual meetings held by the Branch with the regional and j contract personnel have been beneficial, we believe more l frequent meetings of the headquarters staff are indicated. B. Management is a Category II indicator. The following consents with our recommendations are made. Comment Program management should perform periodic reviews of selected license cases handled by each reviewer and document the results. This type of quality assurance review is not being performed by the Branch. i I
2_ Recommendation We recommend program management perform selected reviews of licenses issued by each reviewer, focusing on as many different types of licenses as possible and document them. C. Office Equipment and Support Services is a Category II Indicator. The following comments with our recommendations are made. 1. Comment The RCP should have adequate secretarial and clerical support. The size of the support staff has not kept abreast of increased workloads, such as occurred when the materials inspection staff transferred to Sacramento from Berkeley and when the number of technical staff increased. As a result, backlogs of typing and filing are occurring which impede functioning of the program. This matter was also discussed at the last follow-up review. Recommendation The support staff should be increased sufficiently to cope with the increased workload. 2. Comment Large programs, such as California'e, should have automatic data processing and retrieval capabilities. A system using IBM PC's was delivered in August 1984, but the software is not fully functional and the staff has not been adequately trained. The assistance obtained thus far has not been successful in solving this problem. As a result the State is having difficulties in assessing the status of the inspection program, tracking compliance histories of licensees and otherwise obtaining the benefits of a fully operational system. Recommendation We recommend assistance be sought from sources with the r proper expertise. An alternate measure vould be to provide in-depth training to a current member of the RCP staff who would then be responsible for the development and use of the system, as well as training other staff members.
r I I I J 11. PERSONNEL A. Staffing level is a Category 11 Indicator. The following j comment with our reconnendation is made. Comment r The staffing level should be approximately 1-1.5 person-years per 100 licenses in effect. California is a large state with many complex licenses and sealed source and device { evaluations. A staffing level close to the higher figure may be needed to properly adstnister the program. The current professional staffing leesi in the Agreement Materials program is 0.83 staff per 100 licenses. Three of the professional staff positions are tewaorary. There is a current backlog of overdue inspections and a projected schedule of approximately 650 routine inspections per year. Without additional inspection staff, it does not appear that the inspection schedule can be met. r Recommendation f We recommend the temporary staff positions be made permanent. l existing vacancies be filled, and the staff be increased to a level adequate to meet the inspection frequency schedule. III. LICENSING A. Licensing Procedures is a Category 11 Indicator. The following comments with our recommendations are made. i 5 1. Comment ? License applicants should be furnished copies of applicable guides and regulations. New licensees are not being furnished copies of the regulations nor are they j advised how to obtain copies. Recommendation i We recommend that copies of the applicable regulations and licensing guides be furnished to license applicants and that the revised version of Title 17 be d' etributed t to all licensees as soon as it is printed. l I 2. Comment i Standard license conditions comparable with current NRC standard license conditions should be used to expedite j and provide uniformity in the licensing process. In some cases, existing standard conditions are not used by licensee reviewers (e.g., teletherapy licenses). In I ~ other cases, largely because the California regulations are not compatible with those of the NRC, the list of conditions provided to the license reviewers is not adequate to cover the situat1ons where they are needed. As a result, several reviewers compose their own conditions, which leads to inconsistencies. Recommendation The list of standard license conditions used by the State should be re-evaluated and modified to meet the needs of the program. Staff input should be sought in this effort. The standard license conditions should then be used by all reviewers. 3. Comment The RCP should have internal licensing guides, checklists and policy memoranda consistent with NRC practices. The State made policy changes in the memorandum issued af ter the previous review that significantly improved the overall quality of licenses issued since that time. During this review, the RCP staff voiced the need for clarification in policies dealing with use and retention of checklists, the need for prelicensing visits, documents to be referenced in the tie-down condition and documentation of telephone conversations with applicants. Recommendation We recommend program management clarify the licensing procedures in the following areas: Checklists should be reviewed to determine that they a. contain the essential elements for each type of license issued by the State. Model licenses should be used as guides. Disposition of the completed checklists abould be specified. b. Criteria should be established to determine the need for pre-licensing visits. j c. Guidance should be developed on the proper documents ) to reference in the standard license tie-down condition. d. Telephone discussions with applicants and licensees should be documented and' maintained in the case file. l i
i 4. Comment License reviewers assign the license inspection priority. f Several licenses were found to have the priority incorrectly assigned. Recocsendation We recommend supervisory review of all priority assignments. 5. Comment A number of license cases were noted to be under timely renewal for extended periods of time. As an example, a major manufacturer and distributor has been under timely renewal for ten years. The application is no longer current and the existing license does not reflect current regulatory practices. Recommendation We recommend that California review all licenses in timely renewal status and develop a program to complete action on the renewal applications. We suggest a target date of one year for completion of pending renewals. In cases where existing licenses and backup applications and correspondence no longer reflect current operations, the licensees should be requested to resubmit complete applications with up-to-date information. IV. COKPLIANCE A. Status of Inspection Program is a Category I Indicator. The following minor comment with our recommendation is made. Corsent During the review. a defect was revealed in the method used to produce the due/ overdue listing used to assign inspections and to assess the status of the inspection program. The due date for an inspection was based on the length of time elapsed since the last inspection, with no means to pick up newly issued licenses. Thus, if an initial inspection was not performed, the license would not be in the tracking system. When the Branch staff prepared a listing of " licenses never inspected," they identified about 200 licenses overdue for their initial inspection (based on the initial inspection schedule in effect at the time the license was issued), 76 due for a routine inspection, and 17 overdue for their routine inspection. None of these cases appeared on the due/ overdue list because the initial inspections were not performed. Recommendation i We recommend that the inspection tracking system be modified to account for all licenses. After this is accomplished, we recommend a manual check of each license file against the computer file. Following this action the initial inspections should be completed in a reasonable time and in any case not later than the date the routine inspection would be due (not overdue) under the current priority schedule. B. Responses to Incidents and Alleged Incidents is a Category 1 Indicator. The following minor comments with our recommendations are made. 1. Comment The NRC should be notified of pertinent information about any incident which could be relevant to other licensed ~ operations. Criteria for reporting significant incidents were outlined in an All Agreement State Letter dated November 23, 1984. Cases in which the reporting requirements were exceeded but which were not reported were found in the files, and the reviewer was advised the State has no written procedures for reviewing the incident file aF_ainst the reporting criteria. Recommendation We recommend written procedures be developed to ensure proper reporting of significant incidents. 2. Comment I Information on incidents involving licensees is not cross-referenced to license or compliance files and thus license reviewers and inspectors may be unaware of any incidents which may have occurred at a particular facility where an application is under review or an inspection is being planned. Recommendation We recommend the State provide a cross-referencing system between the incident file and license and compliance files so that license reviewers and inspectors can readily identify reported incidents which may have occurred at a particular facility. l
, C. Inspection Reports is a Category II Indicator. The following coment with our recomendation is made. Coment Reports should uniformly and adequately document the results of inspections, substantiate all items of noncompliance and health and safety matters and indicate the substance of discussions with licensee management. Eleven of the fifteen reports reviewed contained errors or omissions, such as not completing all sections of the uniform inspection form, short forms (2514) that were not properly signed and dated, items of noncompliance downgraded to recommendations, no indication of interviews with ancillary workers, and no indication of exit interviews with management. Recomendation We reccamend more thorough supervisory review to assure that inspectors adhere to program polic;. D. Independent Measurements is a Category II Indicator. The following coment with our recomendation is made. Coment RCP instrumentation should be adequate for surveying licensee operations, and instrument calibration services or facilities should be readily available and appropriate for instrumentstion used. There are air flow velometers that have not been calibrated according to Department standard practice and therefore have not been used for licensee inspections. Recomendation We recomend that velometer calibration, in accord with Department standard practice, be obtained and that velometers be used for conducting independent measurements as necessary during inspections. I 1 l
ENCLOSURE 2 APPLICATION OF " GUIDELINES FOR NRC REVIL"4 0F AGREEMENT SIATE RADIATION CONTROL PROGRAMS" The " Guidelines for NRC Review of Agreement State Radiation Control Programs," were published in the Federal Register on December 4, 1981, as an NRC Policy Statement. The Guide provides 30 Indicators for evaluating Agreement State program areas. Guidance as to their relative importance to an Agreement State program *s provided by categorizing the Indicators into 2 categories. Category I Indicators address program functions which directly relate to the State's ability to protect the public health and safety. If significant problems exist in several Category I Indicator areas, then the need for improvements may be critical. Category II Indicators address program functions which provide essential technical and administrative support for the primary program functions. Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e., those that fall under Category I Indicators. Category II Indicators frequently can be used to identify underlying problems at that are causing, or contributing to, difficulties in Category I Indicators. It is the NRC's intention to use these categories in the following manner. In reporting findings to State management, the NRC will indicate the category of each comment made. If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety. If at least one significant Category I comment is provided, the State will be notified that the program deficiency may seriously affect the State's ability to protect the public health and safety and should be addressed on a priority basis. When more than one significant Category I comment is provided, the State will be notified that the need of improvement in the particular program areas is critical. The NRC would request an inmediate response, and may perform a follow-up review of the program within six months. If the State program has not improved or it additional deficiencies have developed, the NRC may institute proceedings to suspend or revoke all or part of the Agreement. Category 11 comments would concern functions and activities which support the State program and therefore would not be critical to the State's ability to protect the public. The State will be askad to respond to these comments and the State's actions will be evaluated during the next l regulst program review.
Ah 8{pmes oq'o UNITED STATES o ), ( ' p, NUCLEAR REGULATORY COMMISSION t REGION V @U[/ [ 1450 MARIA LANE SUITE 210 p WALNUT CREE K. CALIFORNIA 94596 JUN 4 1986 Dr. Kenneth W. Kizer, Director California Department of Health Services 714 P Street Sacramento, California 95814
Dear Dr. Kizer:
We understand from your staff that you did not receive our comment letter concerning the findings from our March 1986 review of your Radiation Control Program. The letter was dated April 22, 1986, addressed to Dr. Kenneth W. Kizer from John B. Martin. Enclosed are two copies of the April 22, 1986 letter, your copy and one for l the State Public Document Room. We regret any inconvenience and of course extend your response date to July 15, 1986. If you hcve any questions, please feel free to contact us at any time. Sincerely, /M_ D, Joh .a r t n-gy Regional Administ or j
Enclosure:
P As stated cc v/ enclosure: Harvey Collins, PhD., Chief Environmental Health Division Joseph D. Ward, Chief, Radiological Health Branch cc w/o encicsure: G. Wayne Kerr, Director, Office of State Programs l NRC Public Document Room, Document Control Desk (SP01) 1 1 i i
e STATE OF CAUFORNIA.-Hf ALTH AND WELF ARE AGENCY GgoRGg pgggggJtAN, Gegenor ,, m, m, "DARTMENT OF HEALTH SERVICES Pb f I4 P STREET .AMENTO. CA 95814 G3 l'O -l; PM12: L5 July 31, 1986 ??M :;v!w l l t l Mr. John B. Martin [ Regional Adninistrator Regicn V l U.S. Nuclear Royalatory M== ion l Office of Inspecdon arxi Enforcemeid. } 1450 Maria Iane, Suite 210 Walnut Creek, California 94596 l l
Dear Mr. Martin:
Thank you for your letter of April 22, 1986 regarding firriings of the Mart 21 i 10-14, 1986 audit of the California Radiation Cbntrol Fiwucuu. As you my } know, I did not receive the origimi copy of your letter. However, a } ch:plicate was received in early June. l + I am plaa=M that your review indicated that the m1ifornia swicua is adegaate to protect);nblic health and safety. I am also plan =M to report that we have made significant swtuss in adopting regulations. As shcun l in Enclosure I, two of our regulation packages have been filed with the i Se:retary of State and will h effective en August 8,1986. 'Ihe public hearing for the regulatory package establishing starx5ards for protection i against radiation is s:twinled for October 10, 1986. We expect that i package to W effective in early February,1987. l t 'Ihe action plan to eliminate cuerdue iriapa+1ons has also been inplemented. 1 We have written a strong letter to our ocntractors and informed them of the i urgent need to eliminate the inspection backlog. Also, we are rrxpiring weekly s wiass terra; frtu our contractors and from our own staff so that j we can acnitor and acrrtrol cur s wt ss. In summary, we are fully ocr:nitted to eliminating _ all cuerdue inapa+irvis by March,1986 and, sit =a?smtly, to keeping inspections current. h i 1 We are making significant sw& ss in improving the enerall ma%=d. of the Radiologic Health Brancil (See Em1=re II). Staff meetings are beirg i held at least once per nonth. 'the licensing supervisor has been reviewing i the licensing actions of each license reviewer to ensure gaality assurance arx1 imiformity. l Enclosure II also sunnarizes our swi=ss in addressing your ocncerns regarding support staff and data management within the Radiologic Health i Branch. Our Pewica Managar.ad. and Consultation Secticn has already j started a clerical study to det m ine whether additional support staff.are i neMM or whether the rW support could be provided in some other way, e.g., reorganization of existing support staff. We are also studying the l cuerall data smeing rurl= of the Branch. We are fully crunmitted to J 1 i i 1 1
d i i ? Mr. Jchn B. Partin Page 2 i raking Watever charges are e=_7 to ensure that we have the data ranage:nent capability to satisfy your require:nercs as well as those of the State. Your favorable cxx=aents en our ccerbiaa 1.wement in the licensing, ( i.Wdon and enforcenent areas of the PAMation Control Fnw - were appreciated. l On behalf of r:y staff, I wish to thank Ms. Riedlinger, Mr. Baggett ard Mr. l 1 Horncr for their professionalism and cour'asy durirg their review. Please let me know if you have additional questions. Sincerely, 1 f i 1 l Fenneth W. Kizer, M.D., M.P.H. Direc*w.r 1 d Enclosures 1 I 1 i 4 i P k e l i ^ a 4 4 i
) r Question 68 { M 1 S Sfi I i i Denise D. Fort, Director Environmental Improvement Division Department of Health and Environment P. O. Box 968 Santa Fe, New Mexico 87504-0968
Dear Ms. Fort:
This confirms the discussion Mr. R. S. Heyer held with Messrs. R. Holland, i B. Garcia and D. Young on September 25, 1986, following our current review of the New Mexico radiation control program. As a result of our review of the state's program and the routine exchange of i information between the NRC and the state of New Mexico, the staff believes i that the New Mexico program for the regulation of agreement materials is adequate to protect public health and safety. However, our review disclosed a significa ; problem in one program area relating to a Category I indicator. " Status of Regulations." This matter was discussed during the meeting with members of your staff, indicated above. The last revision, in its entirety, ) to the radiation control regulations was accomplished in 1982. The radiation J control program staff needs to revise the regulations and incorporate items necessary for maintaining compatibility with the regulations of the NRC and other Agreement States. Due to the lack of up-to-date radiation control regulations we are unable to make a finding at this time that the New Mexico i program is compatible with the Commission's program for the regulation of similar materials. We would appreciate receiving a response concerning the Department's plans for updating the regulations, as well as a response to the coceents and recommendations attached as Enclosure 1. An explanation of our policies and practices for reviewing the Agreement State program is a~ttached as Enclosure 2. Also, I am enclosing a copy of this letter for placement in the State Public Document Room or to otherwise be made available for public review. 7 O L-n 9' RIV:SGAS SGAS OSP EDd", RSHeyer:je RJDo GWKerr Martin 10/\\ /86 10/{/86 10/J/86 10/l./86 'bg/86 { q0-i 2 5e ~ ~
Denise D. Fort, Director, I appreciate the courtesy and cooperation extended to R. S. Heyer during the review meeting. Sincerely, oridnal signed by, t.,a:.t Check Robert D. Martin 1 Regional Administrator
Enclosures:
As stated j cc w/encls: Richard Holland, Deputy Director Richard Young, Legal Counsel Benito Garcia, Health Program Maneger G. Wayne Kerr, OSP State Public Document Room NRC Public Document Room bec w/encis: V. Stello, EDO R. J. Doda R. D. Martin G. F. Sanborn P. S. Check R. S. Heyer C. E. Wisner D. A. Nussbaumer, OSP R. L. Bangart J. O. Lubenau, O&P W. Fisher New Mexico File DMB SP01 ~
-l t TECHNICAL COMMENTS AND RECOMMENDATIONS ON THE NEW MEXICO i RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS f f I. LEGISLATION AND PEGULATIONS Status of Regulations (Significant Category 1 Indicator) l Comment The New Mexico Radiation Control Regulations (NMRCR), at this time, are not compatible with those of the NRC. Unadopted regulations relating to l nine separate matters of compatibility were found to be beyond the 3-year period allowed for Agreement States to amend their regulations after being promulgated as effective regulations by the NRC.. i Recommendation: i The radiation control rogram staff needs to revise the regulations and incorporate items necessary for maintaining compatibility. We urge the j Division to provide appropriate management attention to revising the j State's radiation control regulations so that they are adopted as. expeditiously as possible and become compatible with NRC's regulations. l II. PERSONNEL A. Staffing Level (Category II Indicator) i Comment j i The New Mexico radiation control program has 247 materials Ifeenses in effect. The current staffing level for the materials licensing and compliance program is 1.85 person-years. This is equivalent to- .75 person-year per 100 licenses. The.75 person-year effort per 100 licenses is well below the recommended guideline of 1.0 to 1.5 person-years per 100 licenses. Recommendation It is recommended that management increase the overall staffing level and closely monitor the current level and assure that the shortfall in staff does not adversely affect the radiation control program. i l l l i I l l I
i e I i B. Ftaff Continuity (Category II Indicator) i Comment We found the turnever of technical staff within New Mexico's i radiation control program amounted to five persons during the review ~! period. Staf f turnover for the previous review in 1985 was l seven persons. We recognize that the loss of the five staff members was attributed primarily to the return of the uranium'aill program back to the NRC in June of this year. However, low salaries appear I to be a major contributor. j Recommendation l l 2 Since this is the third review period in which significant staff l turnover has been experienced by the New Mexico radiation control j program and this is a repeat comment, we strongly recommend the Division monitor closely the reasons for this turnover and attempt j to minimize any future turnover of technical staff where.2r i possible. l III. COMPLLANCE l i Inspection Reports (Category II Indicator) l 4 Comment During the review of selected compliance files and associated inspection I reports, it was identified that not all reports adequately and completely I l documented the results of the inspection. It was noted that in some cases, the reports did not include the following: a discussion of the l current status of previous iter.s of noncompliance and detailed results of l the inspector's independent physical measurements. l Recommendations It is recommended that all inspection reports, whether partial, special, i l or complete, document the information inspected to clearly subatantiate all findings identified. All previous items of noncompliance should be l 3 specifically addressed to determine appropriate resolution or whether j further action may be required. j i l i i i i' I l l i
1 i i l l Inclosure 2 Application of " Guidelines for NRC Review ] of Agreement Etate Radiation Control Programs" l The " Guidelines for NRC Review of Agreement State Radiation Control Programs," were published in the Federal Register on December 4, 1961, as an NRC Policy l Statement. The Guide provides 30 indicators for evaluating Agreement State l program areae. Guidance as to their relative importance to an Agreement State i program is provided by categorizing the indicators into 2 categories. Category I indicators address program functions which directly relate to the i State'c ability to protect the public health and safety. If significant problems exist in several Category I indicator areas, then the need for improvements may be critical. l Category II indicators address program functions which provide essential technical and administrative support for the primary program functions. Good [ performance in meeting the guidelines for these indicators is essential in [ order to avoid the development of problems in one or more of the principal l program areas, i.e., those that f all under Category I indicators. Category II indicators frequently can be used to identify underlying problems that are r causing, or contributing e, difficulties in Category I indicators. It is the NRC's intention to use these cateEories 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 j and safety. If et least one significant Category I comment is provided, the State will be notified that the program deficiency may seriously affect the State's ability to protect the public health and safety and should be addressed l on a priority basis. When more than one significant Category I comment is provided, the State will be notified that the need of improvement in the I particular program areas is critical. The NRC would request an immediate response, and may perform a followup review of the program within six months. l If the State program has not improved or if additional deficiencies have developed, the NRC may institute proceedings to suspend or reycke all or part i of the Agreement. Category II comments would concern functions and activities which support the State progrem and therefore would not be critical to the State's ability to protect the public. The State will asked to respond to I these comments and the State's actions will be evaluated during the next [ regular program review. ( L i ) i i t t i h i ) I l ._}}