ML20056G062

Ack Receipt of Responding to NRC 1985 Followup Review of Agreement State Radiation Control Program. Concludes That Proposed Changes W/Eventual Achievement of Written Plans Should Bring Program Back within Guidelines

ML20056G062
Person / Time
Issue date:	10/30/1985
From:	Martin J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To:	Kizer K CALIFORNIA, STATE OF
Shared Package
ML20056D285	List: ML20056D281 ML20056D287 ML20056D300 ML20056G037 ML20056G039 ML20056G062 ML20056G067 ML20057A100 ML20057A126 ML20057A191 ML20057A236 ML20057A241
References
NUDOCS 9309010241
Download: ML20056G062 (124)

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{{#Wiki_filter:we ascuq'o T UNRED STA1ES g [ g NUCLEAR REGULATORY COMMISSION j ~v _ ( j REGION V j f h 8, g 14SD MARIA LANE, SUTTE 210 I g WALNUT CREEK, CALIFORNIA 94596 October 30,_1985 i 'I l i ? Dr. Kenneth W. Eizer Director California Department of Health Services 714 P Street Sacramento, California 95814 i

Dear Dr. Kizer:

Thank you for your letter dated October 2,1985, in response to our 1985 follow-up review of your Agreement State Radiation Control Program. _ We have f evaluated your responses and find that your proposed changes with the eventual achievement of your written action plans should bring your prograc back within the Agreement State Guidelines. We appreciate your effort in { working toward the accomplishment of this task. i _i Related to the Status of Regulations, a Category I Indicator, we still cannoE l offer a finding of compatibility until your revised regulations are completed, approved by the appropriate State bodies and adopted for the California Radiation Control Program. We understand the effort your agency [ is putting forth on this issue and we are prepared to respond as soon as your regulations are adopted. 1 i Ve are pleased with the positive actions you have implemented with regard to our comments and, based on these actions, we find your program adequate to i protect public health and safety. If you have any questions, please feel free to contact this office at any time. j i Sincerely, ern /l t onn aftTn ' b Regional Administra i r State Public Document Room (enclosed) { cc: NRC Public Document Room (SP01) t Joe Ward, Chief, Radiological Realth Branch C. Wayne Kerr, Director, Office of State Programs t 9309010241 930726 PDR STPRG ESGGEN i PDR

Question 67 { e j i t ) l I a STATF REPORT AND EVALUATION ~ OF THE CALITORNIA RADIATION CONTROL PROCRAM 1 TOR TE PERIOD LECEMEER 10, 1983 TO TEBRUARY 15. 1985 i t 4 4 d 23rd Reguistory Program Review i i i t i i i i i t i

? l STAFF REPORT AND EVALLIATION OF THE CALIFORNIA I RADIATION CONikOL FROCPJJs FORTRE TERIOD DECEMEER 10, 1983, 10 TEBh0ARY 15, 1985 The 23rd Regulatory Program Review meeting with California representatives was held during the period February 4,1985, to February 15, 1985 in Sacramento, California. The State was represented by Joseph 0. Vard, Chief, Radiological Health Branch; Don Honey, Supervisor, Radioactive Materials Section; and the I Radioactive Materials Section Staff. A review of selected license and inspection files was conducted by Beth Riedlinger, Kathleen Black, and Jack Hornor of KRC on February 11-15, 1985. Jack Hornor conducted accorpaniments of four State inspectcrs during the period January 17, 1985, to rebruary 5, 1985. A sumary meeting regarding the results of the regulatory I program review and inspection accompaniments was held with Dr. Kenneth Kizer, Director, Department of Health Services (DHS), Harvey T. Collins, Ph.D., I Chief. Environmental Health Division, Joseph 0. Ward, Chief, Radiological Health Branch, and Don Honey, Supervisor, Radioactive Materials Section, on February 20, 1985. The FRC was represented at this meeting by Jack Horner, State Agreements F.epresentative, Region V, and Donald A. Fussbaumer, Assistant Director for State Agreements, Office of State Programs. At the request of the Radiological Health Branch, the review also included a reevaluation of licensing by Mr. Hornor en March 27 and 28,1985, in Sacramento. The results of the reevaluation of the initial licensing findings are incorporated into the licensing section of the report. Conclusions Significant problems were found in three Category 1 Indicators. These and other cocrnents and recomendations were as follows: 1. The radioactive mater!,*1s program currently has 334 inspections that are overdue by at least 50. ent of their inspection frequency (some greater than 100 percent) and the backlog is growing. This relates to the Category 1 Indicator, Status of Inspection Program. 2. A serious problem exists in Enforcement, where, since 1982, California has allcwed 40 licenses to expire without requiring renewal or licensee divestment of radioactive esterial. Additionally, there were instances I in which the need for escalated enforcement was indicated and not taken. 1 This relates to the Category 1 Indicator, Enforcement Procedures. 1 3. Status of Regulations, a Category 1 Indicator, specifies that an Agreement State must have regulations that are essentially identical to 10 CTR parts 19 and 20 and which have a high degree of uniformity with other NRC regulations. California's radiation control regulations pertaining to radioactive materials have not been updated in their entirety since 1974 It should be noted that this comment has been ande to the State at every review since 1977, and there are now apprcximately 20 items of compatibility not appearing in the California regulations. I' These conclusicas are based on the review of the technical and administrative aspects of the State's regulatory program for controlling agreement material. l I ( -@ekumwa.sti.,c y[;ar:g v:*:7 gn,m.;, v Q.Q...

i l .s 2 Included in this review were examinations of selected license and inspection files, the program indicators specified in the NRC " Guidelines for Evaluation a of Agreement State Radiation Control Programs," the accompaniments of State inspectors, the review of all licenses issued by California since December 10, 1983, and our continuing exchange of information program. Sumary Discussion with State Representatives A summary meeting to present the results of the regulatory program review l meeting was held with Dr. Kizer, Dr. Collins, Mr. Ward and Mr. Honey of the Department of Health Services, on Tebruary 20, 1985. The findings above and their associated guidelines were discussed, and the reviewer emphasized the seriousness of the problems that exist in the California program for control of agreement materials. Also, during the meeting, the State was advised that because of the number and significance of problems that exist within the program, a follow-up review will be conducted in approximately six months to assure that corrective actions are being taken. In response to the NRC representative's comments, Dr. Kirer declared that under his direction the State will either operate a radiation control program that is adequate, compatible, and within the NRC guidelines, or it will be returned to the Federal goverraent to operate. Program Cnanses Related to Previous NRC Comments and Recommendations Letter to Mr. Feter J. Rank l Legislation and Regulations Comment California's radiaticn control regulations pertaining to radioactive materials have not been updated in their entirety since 1974. Examples of some of the recent significant changes relating to radiation safety that have not been incorporated in California's regulations are as fellows: 1. Requirements to perform surveys of patients to confirm the radioactive source implants have been removed; 2. Special requirements for controllirs areas in which very high radiation levels exist (i.e., excess of 500 rem /hr); 3. ALARA requirementt; 4. MPC values; 5. Modification of transportation requirements; 6. Defacing of radioactive material labels prior to disposal. =4 l 5 gg h

3 Recoreendation We recomend that priority attention be given to the t.pdating of California's radioactive materials regulations. Ve suggest that California sake use of NRC's value impact statements to support the regulation justification. State Response The hTC recomended that priority attention be given to updating California's Radiation Control Regulations. We are enclosing draft language which amends California Radiation Control Regulations to establish divisions 1 and 2 compatibility with regulations of the U. S. Netlen Regu1 story Comission in 10 CTR. Your review and coments on this draft will be helpful in our press for adeption at the earliest possible date. Additionally, your review will disclose that this is not incorreration by reference of provisions of 10 CTR we had earliet discussed. We now have informal legal opinion to the point that NRC regulations adopted by reference will face the same scrutiny from the Office of Administrative Law with respect to necessity, authority, clarity, etc., to which denovo regulations proposed by the Department are subjected. The draft package we are presenting is a combination of our review and revision of current regulations mandated by state law (AB 1111) and the proposal of new regulations in order to meet the compatibility requirements of NRC. The status of this rewrite and tentative schedule to promulgation is sumarfred in the attached table. We are in the process of hiring two retired annuitants as special consultants on 90 day term appointments to assist us with the rewrite and adoption of our Radiation Control Regulations. Aurust 1984 Status Since the December 1983 review, the State has decided to go directly with the codification of NRC regulations and a proposal package is now proceeding through the system. This effort has recently encountered legal and administrative roadblocks in the language used in the Statement of Reasons. However, in July the RCP hired their two retirees whose only task is to resolve such problems and to follow through with the current revisions until they are adopted and herefully, the current package will be approved. Present Status lhe retired annuitants pregram for updating regulations has run out of time and funding, placing the administrative burden of the updating directly back on the RCP. A health program analyst has been recruited from the X-ray program to assist the RCP to follow through with the current draf t regulations. Because of diffitulties with the legal approval of the language used, California has deciced to give up codifying the NRC regulations and to again try their own version. The low level waste regulations (passed by declaring them emergency regulations) passed in 1984 and the transportation regulations should pass some time in 1985. The remainder of the agreement materials regulations should reach the Office of Administrative Law (OAL) some time in late 1985. It was suggested during this review that the State make use of the FRC value impact statements to support the regulation justification. I e m. .< 4.

.s s 4 Management and Administratfor. 6 A. Budret Comment Some operating funds to operate specific portions of the California radiation control program are apparently unavailable for use by the program management. Specifft instances include automatic data processing support, funding necessary for filling of existing vacancies, and staft training. Recommendation We recommend that the Radiation Control Program management be given the ability to spend the appropriated funds necessary for the operation of the program. Some low-cost recommendations to immediately assist the program include: 1. Consultant support for automatic data processing; 2. Filling of the three authorized vacancies; i 3. Transferring the vacancy for compliance supervisor from Berkeley to l Sacramento-4. litring of Radiation Control Program retirees as consultants to assist with the adoption of regulations; 5. Staff training for new employees. State Response Money has been allocated, hardware has been specified and software has l been tentatively identified to establish a stand alone dats system which will correct the initial program deficiency noted in your letter. Output [ elements will include a precise tracking of inspections due; status of L license applications; production of statistical profiles of litersee compliance; uniformity, clarity and accuracy of license language and improvement in overall program management. The Branch has been authorized to fill all vacancies in the Agreement Program immediately. Because recruitment of radiation protection personnel is often difficult, our personnel office will establish continuous testing, under our merit system provisions, for the radiation control program technical / scientific staff at entry and journey levels. This action is intended to sake us more responsive in tere.s of offering employment to qualified candidates. The compliance supervisor pcsition is being transferred from Berkeley to Sacramento. A filing date of May 11 has been set for the senior examination to fill this position. v. l

5 As indicated, we are in the process of biring two retired annuitants to assist with the revision of our regulations. August 1984 Status The ADP equipment delivery started in August, and af ter the necessary lead time for installation and training, the system is expected to be minimally operable by the end of November. It is estimated that the system will be in place by the end of January 1985 and, after debugging, will handle the licensing files and the statue of inspection program. The system incorporates an IB?1 XT PC with 10 megabytes and there will eventually be three terminals at headquarters plus two that will be used in the field to provide comunication and access to the files. In the interim, the recommended consultant support is being provided by the Teale Center (the State computer center), and the operator is provided limited accers. The files are updated by batch and she is presently about 45 days behind. This current system is still unable to provide i accurate statistics necessary to maintain an adequate compliance program. Two of the three authorized vacancies were filled, but one person left the program and one transferred to X-Radistion Control. In addition, cne of the DIR-South inspectors has left the program. Jack Brown has been promoted to compliance supervisor and has been transferred to the Sacramento headquarters effective September 1, 1984 He will be en leave at that time and will actually report for duty on October 15, 1984. Bob England, a retired supervising health physicist, and Amasa Cornish, a retired senior health physicist, were hired July let to assist with the rewrite and adoption of the regulations. Together they can contribute about 130 days per year for following, updating and revising the text as necessary each time it encounters a problem. l The two riew staff members are working with the senior personnel and I receiving on the job training. l Fresent Status l The budget continues to be a problem and is readdressed in the current review. It appears the funds that were ellocated for resources were not effectively used by program sanagement. The ADP system is att11 not functionirs except for limited use in word processing. The software company selected by program management went out of business before data bases could be created and training begun. Additional funds need to be provided to hire consultant help to develop new software and provide training. The three DES vacant positions have still not been filled. The positions were funded but no one has been hired since the follow-up review. This is discussed in the personnel section of this rep rt. Continuous testing was comitted to in the response but never adopted.

wa-6 The compliance supervisor has been assigned to the Sacramento ) headquarters office since October. The retired annuitants used all their allotted time and funding for the positions was not continued. B. Management Comment It was noted that a quality assurance system exists which calls for program management to perform periodic reviews of selected license cases handled by each reviewer. The program is presently not using these internal procedures, including proper documentation. Recommendation 4'e recommend that the State follow its procedures for performing quality assurance of licensing action, including documentation. State Response Although the State did not respond to this comment in the correspondence, the reviewer was advised that license reviews of all but the simplest licenses now have peer review and the more complex licenses have subcommittee review by a supervisor and at least one other reviewer. August 1984 Status The committee reviews are apparently being performed; however, the reviews are not adequately documented in the license files. It was i agreed during our follow-up meeting that the issue sheet which is used for the subcommittee review be initialed by those participating in the review and be included in the license file. present Status I Review of the license files, particularly medical, indicated peer review j is still not being performed for many complex licenses. This deficiency i remains an issue in the current review. i personnel A. Stef fier level Comment t California is presently at 0.67 staff-years per 100 licenses or 33 percent below the sinimum NRC recommended guideline of 1.0 to 1.5 staff-years per 100 licenses. i i i l

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i 7 i l Recommendation Priority sh.uld be given to filling the authorized vacancies which 1. would raise the program staff level to approximately 0.8 staff-years per 100 licenses. i 2. Effort should be spent in obtaining authorization for new positions to enable the program staff to meet NRC's recommended guidelines. State Response Ve have authorizatien to fill the three vacancies in the Department and are actively recruiting from an existing list. The Division of I occupational Eealth and Safety has authorizatica to fill one of their two existing vacancies and is also recruiting. In subsequent rienths the Department will explore the feasibility of a tudget Change Propesal (BCP) to increase radiation control program staff beginning with the 1985-86 fiscal year. The cbjective will be to bring i the radioactive materials staffing level to the NRC recommended standard of 1.0 professional staff years for each 100 radioactive materials licenses. The BCP is the method Departments must use to establish such basic changes in their programs. g ust 1984 Status A Th. staffing level has not improved since the December review. Although t6; vacancies were filled, cthers occurred and there are now 5 vacant pcsitions,1 in licensing, 2 in FJiB compliance, and 2 in DIR compliance. This brings the ratio of staff years per 100 licenses down to less then 0.7. Apparently problems still exist in hiring new staff through the Stateperannnd offices It_ appears theiz_ lengthy testing and. +._ ' m2 n__ h Present Status The staffing level has still not improved and continues to be a critical issue in the current review. Further discussion of the problem can be fcund in the reviewer assessment, Section IV.B of the report. B. Training Comment During the accompanleents of the compliance staff, it was noted thst one inspector had not attended NRC courses in inspection procedures, radiography or well logging. M 'd b R2 SD[ M/WQU

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i ? i i Recommendation Ve recommend that the inspector be sent to the inspection procedure course and the other mentioned courses as soon as possible. State Response t Ve continue to find the hTC radiation protection training courses most helpful and will utilize these courses for training both new and existing staff. Recent utilization of h1C trainicg programs is identified retrospectively and prospectively in the attached table. We believe that we have a continuing commitment from management of this Depart. ment to support future out-of-state travel for purposes of this necessary training. August 198I. Status The staff has been taking advantage of the h7C training courses and California will need several positions in upcoming courses for the new staff. One position has currently been authorized in licensing and I compliance and we will try to obtain one additional slot for orientation and licensing. We will also ask for more new pcsitions in the next inspection procedures course. l Present Status j The materials inspector who previously had not attended any hTC courses l has now attended three courses; Tundamentals of Inspection, Industrial Radicgraphy and Oil Vell Legging. The State also had nine other staff l members attend h7C courses during 1984. Licensing I A. Technical Quality of Licensing is a Category I indicator. The following item of major significance was noted: 1. Comment i Since the last review, California has been issuing medical licenses that are not clear, complete or accurate as to isotope forss, quantities, authorized uses, and permissive or restrictive i I conditions. Recommendations As per discussions with the staff, we reconstad that California i issue medical licenses that are clear, complete and accurate. State Response We are attaching revisions of our "Well-Established Medical l'ses f i List" and our " Medical License Draft" which have been revised and )' are now being utilfred. We believe that the use of this revised j " Medical License Draft" which incorporates suggestions regarding i i e 4 ,1 + W 2.,,. ".. -., /~,7 :..... ..f.. ;,- 3 ;,,

- = _ i l l l 9 medical use groups and user authorizations will circuarient many of the difficulties you noted in raedical licenses during your review. ( Ve are also enclosing en example of a medical license in the revised i i format. Further improvement will come as staff becomes available l for revision of license guides and application forms and through the rule making process with the proposed adoption of ALARA. [ j August 1984 Status A new, improved Well Established Medical Uses" licensing guide was furnir.hed and is en file in the CSP office as well as Region V. The State did eake changes in their medical license form and sent the l i drafts of these changes to the Office of State Prograes. Jchn McGrath reviewed the changes and in April sent a letter back to California with coments and suggestions for further improvements. l During the follow-up review the reviewer was given a sample license i form with the new revisions indicated as well as a sample of a l recently completed license application. It appears that not all of Mr. McGrath's suggestions were f ollowed, and during the next review l we will determine if the changes they did make were effective in i sc1ving the problems in the technical quality of licensing actions. Present Status i i 4he sedical licenses continue to show the need for improvements and l remain an issue in the current review. During the review of the license files, several deficiencies in licensing practice which ceuld lead to unnecessary radiation exposures were disclosed. This 4 is further discussed in the report. 2. Cement i ) During the review of selected license files, we noted that: i In some instances, Xenon 133 was authorized without sepperting l a. i documentation by the applicsnt or evaluation by RCP staf f. I b. Evaluation of the proposed vaste handling procedures are ) inadequate. No requests are being made of applicants for ALARA program c. 4 comitments. a d. Applicants' procedures for preparing packages for shipment and 1 for tran.portation of radioactive materials were frequently t l inadequate and sometimes out-of-date. i pecomendatien i We recomend that licensing checklists te used and saintained with j the licensing file to assure all sapects of an application are evaluated. l i ] I J l 4 I 1 I 4 i .~ ._ l

i i 10 State Response Your recommendation that licensing checklists be used to assure that all aspects of an application are evaluated is a point that is well We would appreciate your continuing to share with us the taken. checklists t. hat are developed in your licensing program and those of other Agreement States which seem to be particularly useful. August 1984 Status It was learned during the follow-up review that medical license reviewers are using checklists intended for use in industrial radiography. The reviewer offered to share medical and other checklists, licensing guides, etc., that he had gathered in the course of working with other Agreement States. The RCP sanagement copied the material and said they felt it would be useful in their Since the use of checklists would improve the technical program. quality of the licenses, this recommendation will be further pursued in the next review. Present Status It was etserved during the review that licensing checklists are still not included in the licensing files. This was again discussed with the staff and copies of currently available checklists and guides were left by the hTC reviewers. B. Adequacy of Product Evaluation Comment It was noted during the review of 27 sealed source and device (SSD) evaluations that in many instances the supporting documentation was inadequate. This included sample labels, drawings, and manufacturer's data for safe use. In addition, the SSD sheets are t not always clear, consistent and accurate. Recommendation We recommend that the State require all manufacturer's data and documentation of staff evaluation be retained in th. file prior to issuance of the Registry Sheet. In addition, we recommend the use of checklists to saintain consistency between sheets. I State Response i Ve think that euch of the difficulty noted during the revi ew will be resolved by revision of our system for filing sealed sov e and This revision will collect in a fi.e by i device undertakings. annuf acturer and device model number all of the manufacturers' data and documentation of staff evaluation relevar.t to the underteking. 1

i i Il [ August 1984 Status f The licensing supervisor explained that the procedures have now been changed in order to address the prob!ces of lack of supporting data and incomplete evaluation sheets. A product file was offered for i review as a complete and model file and indeed it was. The RCP I committed themselves to completing all files in this manner in the future and we will follow this carefully in the next review, i Present Status t A review of the $$&D files showed a distinct improvement over the last review and no major deficicacies were found. Compliance l Status of Inspection Program Consne nt l The California RCP cannot use the computer to update the Compliance i program data base. ?!anagement has not had an sipdated status of the inspection progras report since february of 1983. NRC guidelines require s.anages.ent to be able to assess the status of the inspection program on a periodic basis. During past reviews, California committed to a quarterly review of inforsation showing the number of ( inspections performed, number of inspections overdue by priority, and length overdue. I l Eccommendation } t The California RCP should bring in a consultant to aske the existing data processing system operable and then train several users on how to access and update the system for the short ters. Leng range i plans can then be studied for a better system at some future date. State Response Ve can now update the esisting compliance file. Access to the a updated file is available through a health program technician in the j branch vbo has had trdr.ing in the sof tware used and a DP specialist r l in General Services. Ve hope to espand significantly the cospliance data base and aske it much s> ore accessible through the new stand-alone syntes discussed above. August 1984 Status The California Cata Processing Center provided an inspection due/ overdue listing current as of June 30, 1984. This listing indicated that of the 679 inspections currently due, 314 are overdue by nors than 50 percent of their inspection frequency, The interin l computer systes could not furnish the number of inspections that have been coepleted during the review period, and it still is not providing that data, This r.ew listing of overdue inspections has Tg

i i i i 12 I i t now identified a significant number of high priority overdue j inspections and the recommendation on adequacy must be withheld on l' this account. q t Present Status i 3 i f i The Data Processing Center is currently providing a usable quarterly listing of due/ overdue inspections. Some essential program statistics such as the number of inspections performed by priority i and the status of expired licenses are still not. included in the data base and sust be compiled manually. The entire compliance statistics program is due to be updated ard revised once the ADP j system is properly functioning and debugged. J l The overdue inspection backlog has increased to 334 since the follow-up rev'ev, and the status of the program ressins a significant Categerv I indicator problem in the current review. k J j t i I l 1 1 i E l, ~ ir. 1 i s l 1 i 1 4 l I j ~Qe-hm:s_.; a.

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t l i l 13 1 i i EVALUATION OF ACREEMENT STATE RADIATION CONTROL PROGRAM i ( STATE REVIEW GUIDEllFES, QUESTIONS AND ASSESSMENTS Name of State Program: California Date of KRC Review: February 1985 1. LEGISLATION AWD RECULATIONS I A. PralAuthority(CategoryI) KRC Cuidelines: Clear statutory authority should exist, designating a state radiation control agency and providing for promulgation of l regulations, licensing, inspection and enforcement. States a regulating uranium or thorius recovery and associated wastes j pursuant to the Uranium Mill failings Radiation Control Act of 1978 2 (L*MTECA) must have statutes enacted to establish clear authority for i 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 requirements for coordination. Questions: 1. Please list all currently effective legisistion that affects the radiation control program. l + Statutory Statutory ) l Activity Authority Activity Authority I Compliance Inspection H&S Code Develop programs H&S Code and pre-license 25820 for regulation of 25811(b) l j evaluation use of radioactive saterial i Issue emergency H&S Code Issue rules and H&S Code { orders 25846 regulations for 25815(a) inspection l Impound radiation H&S Code Request issuance H&S Code sources 25860 of injunction 25850 j Cocpliance inspections HLS Code Order vacating R&S Code

== and pre-license 25606 of contaminated 25662 l evaluations; Radio-premises i active vaste dispeaal Monitoring of field H&S Code Impose liens for E&S Code tracer studies 25608(d) cest of deconta-25563 sination of seized l ( premises l l 1 l 0

t 14 Develop programs for H&S Code Institute civil H&S Code hazard evaloation 25811(a) actic ns 25863.1 Civil Penalties H&S Code 25866 2. What chacres have been made to the statutory authority of the State to license, inspect, and otherwise regulate agreement saterials since the last review? Disposal of low-level radioactive vaste is the subject of the recently passed SB 342 authored by Senator Alquist. This legislation permits the Covernor to negotiate and enter into interstate agreements for the purpose of establishing and maintaining access to sites for waste generated in California until such time as a permanent California f acility is available. Regulations pertaining to low-level waste which are congruent with 10 CFR 20 and 61, have been adopted on an emergency basis as required by legislative mandate. Senate Bill 444, authored by Senator Keene, requires the Department of Health Services (DMS) to cooperate with any federal agency monitoring marine life or ocean waters to determine the effects of radioactive waste dumping off the California coast and to purchase and test, at least every six months, samples of seafood taken in the vicinity of the Farallon Islands radioactive dump site to determine the radioactivity levels of the seafood. The department is also required to establish a scientific advisory committee on ocean dumping of radioactive vaste. The Branch has submitted names of persons to form a scientific advisory committee on ocean dumping of radioactive vaste. The initial report to the Legis1sture has been drafted. d Assembly Bill 1190 authored by Assemblyman Tilante, extends the Health and Safety Code civil penalty liability ($5,000 maxis:um per day, per occurrence) to persons who intentionally or through gross negligence violate either Radiation Control Law, Regulations or Orders, adopted pursuant to the Radiation Control Law, which action causes a substantial danger to the beslth of others. 3. If your $tste regulates uranium or thorium recovery operations and associated wastes pursuant to an amended agreement and t LHTRCA, explain any changes to the statutory authority for these functions. a 1 California does not currently have an amended agreement for regulating uranium and thorium recovery operations and associated vaste. 4. Are copies of the current enabling set and other statutes (e.g., Administrative Procedures Act, Sunshine Act., etc.) which govern the conduct of the agreement materials program on i 3

l f 15 file in the Radiation Control Program (RCP) office and with the NRC7 If revisions have occurred since the last review, the ( changes should be included. Copies of the statutes, Senate Bill 342 and Senate Bill 444, are en file with the RCP and have been given to the NRC. A copy of Assembly Bill 1190 is attsched as Appendix A. l 5. If the State's regulatory authorities are divided between agencies, what procedures and memoranda are in effect to provide clear understanding of the divisions of responsibilities and requirements for coordination? The Department of Health Services contracts with one other State agency, the Division of Occupational Safety and Health (DOSH) a division of the Department of Industrial Relations (D1R), to evaluate license applications and to conduct X-ray and radioactive material compliance inspections. The regulatory responsibilities are conducted under the DHS policy and supervision. An Interagency Agreement exists between the two agencies which sets forth the services to be performed and all terns and conditions of the agreement. Also Los Angeles and Orange Counties are currently conducting compliance inspection activities vithin their respective jurisdictions under contract and at the direction of the Department. ( 6. Does the State ha.. the authority to: a. apply civil penalties? If so, cite legislation. California has limited authority to impose civil penalties. This authority is contained in Section 25866 of the Health and Safety Code and establishes civil penalties for intentional or grossly negligent violaticns of the radistien control law or failure or refusal to comply with an order of the department issued thereunder. b, collect fees? If so, cite legislation. California currently assesses annus1 fees for radicactive material licenses. These fees are specified in Article 8 of the Radiation Control Reguistions. c. require surety or long-term care funds? If so, cite legisistion, j Authority exists only for low level vaste sites. See answer (f) below. I d. require performance bonds or sureties for deconnissioning licensed facilities? If so, cite legisistion. ( Ka. 1

16 i require performance bonds or sureties for clran-up of e. licensed facilities after a contamination accident? If -g so, cite legislation. b'o. f. require long term care funds for uranium mill or low-level waste facilities? If so, cite legislation. l Yes, California has authority in SB 342 to require surety 1 and long-term care funds for low level waste sites. Regulations are being developed to implement the authority. g. enter into low-level taste compacts? If so, cite legislation. i California presently has authority in SB 342 to enter into I a low-level waste compact. h. establish, license and/or operate a low-level vaste site? If so, cite legislation. SB 342 requires the department to identify the regions of the state which would meet site criteria. The bill also authorizes the department to solicit applications for cperation of the site and to select a licensee. 7. If any responses to the above question are negative, explain any plans the State may have regarding those issues. California has no plans regarding these issues. f 1. A. Reviewer Assessnents I The State legal authority meets the NRC guidelines. One item that needs management follow-up, however, concerns the contracts with Lcs Angeles and Orange Counties. As cf February 1985, the contracts for i the ficcal year E4-85 had not been signed. B. Status of Regulations (Category 1) h7.C Cuidelines: The State should have regulations essentially identical to 10 CTR Part 19, Part 20 (radiation dose standards and l effluent limits), and those required by UffTRCA, as implemented by Part 40. The State should adopt other regulations to maintain a j high degree of uniforsity with KRC regulations. Questions: l. When did the State last amend its regulstions in order to maintain compatibility and when did the revisions become l effective? g .g-v^'* ( 1 u

~ 17 I The radioactive materials regulations were last changed in 1974 ( escept for a Part 19 equivalent added in 1976. The LIN regulations were adopted in 1984. l 2. Referring to the enclosed NRC chronology of amendments, note the ef fective date of the NRC changes last adopted by the i State. i The NRC regulations pertaining to 10 CFR 19 dated October 24, 1973 were the last NRC changes adopted by California. 3.s. Vere there any compatibility items that were not adopted by the [ State? l Not prior to 1974, the date of the last major revisjon. There should be none af ter the current revisions are complete.

b. If so, please identify and explain why they were not adopted.

Not applicable. { 1. B Reviewcr Assessment: ^ California continues to fail to esintain regulations that meet the NRC requirements for compatibility. The low-level waste regulations [ ( vere passed during this review period by assigning them emergency status; however, the radioactive material regulations have not been i fully compatible since 1974. There are now approximately twenty compatability items the State has not adopted, including: i 1. Requirements to perfor1a surveys of patients to confirm that the i radioactive source implants have been removed; 2. Special requirements for controlling areas in which very high radiation levels exist (i.e., in excess of 500 rem per hour); 3. AI. ARA requirements; 4. MPC values; 5. Modification of transportation requirements and; j 6. Defacing of radioactive material labels prior to disposal. l C. L'pdating of Regulations (Category II) h1C Cuidelines: The RCP should establish procedures for effecting appropriate amendments to State regulations in a timely manner, normally within 3 years of adoption by NRC. For those regulations deemed a matter of compatibility 1y h*RC, State regulations should be (- amended as soon as practicable but no later than 3 years. Opportunity should be provided for the public to comment on proposed regulation changes. (Required by UMTRCA for uranium mill c .s i

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IB re;ulation.) Pursuant to the tern:s of the Agreement, opportunity should be provided for the NRC to conn.ent on draf t changes in State regulations. 1. Does your State have a schedule or program for revising and adopting changes to regulations within three years of adoption by the NRC? No, it is done on an as needed basis. After the current revisions are adopted, hopefully it will take less than three years. 2. Has your State adepted all regulations deemed a matter of compatibility by h7C within three years? (Refer to h7C chronology.) Californis hadiation Control Regulations have been amended to est*blish compatibility with CFR 20 and 61 with respect to low-level waste. These regulations were adepted on an emergency basis pursuant to legislative mandate. A copy of this text is attached as Appendix B. Other than this, no. 3. What are your State's procedures for adopting new regulations? Briefly describe each step in the procedure. The regulation promulgation schedule is as follows: Activity Tiene Frame Submission of Regulation Proposal to the Office of Regulations........... N/A Review by Office of Regulations.. 14 days Review by Office of Legal Services and Budget Section/ Department of Tinance 30 days Prepare and Distribute Public Notice 30 days Public Notice Feriod 45 days l I day Fublic Hearing 30 days Fest-Hearing Review and Revisien 15 days Make Revisions Available to Public Adoption by Director and T111cg with Office of Administrative Law (OAL)....... 5 days Office of Administrative Law Review 30 Jays and Filing witt. Secretary of State 30 days Fest-Tiling Vaiting Feriod . W W,2g,.ya.. .,....,<.......,.. s... .s %.:

I 19 233 (total) Effective Date 4. How is the public involved in the process? ThrouEh hearings and review by the Of fice of Administrative Law. Does the NEC have the oFportunity to comment on draft 5. a. changes to State regulations 7 b. If so, does your State respond to the comments? Yes to both questions. 1. C. Reviewer Assessment: As indicated in the response, California now has a regulation promulgatien schedule with a 230 day total time frame with intermediate target dates for compleilon. The RCP however, has been unable to incorporate changes in radicactive materials regulations into this time frame. They have been unsuccessful in maintaining compatibility for the past ten years, and they still do net meet the NRC guidelines for updating regulatians. Program management has indica.ed they here the transportation revisions will pass in 1985, but the remaining agreement materials revisions are not expected to reach the CAL until late in the yesc, and further delay may occur at i that point. il. ORCGIZATION A. Loestion of the Radiation Control Program Within the State Organizatten (Category 11) KRC Guidelines: The RCP should be located in a State organization parallel with comparable health and safety programs. The Program Director should have aceras to appropriate levels of State i ILanagement, 1 Attach a dated orgaufration chart (s) showing the ECP and its locatien within the department and State organization. The California State organization charts are attached as Appendix C. 2. Is the RCP on a comparable level within the State organization with other health and safety programs so a, to compete effectively for funds and staff? I j Yes, we are receiving a fair ahare of resources. 3. Dees the ECP progras director have access to appropriate levels I of State sanagement? Yes. I i

y fi. ' [ hhf.jlk,Q - j .g 20 II. A Reviewer Assessment: The California RCP meets these h7c Jines in that they are parallel with comparable State hea,.m ind safety programs. California is so large that the RCP is located well down in the organization; however, the program director feels he has access to appropriate levels of State Management and thet he can bypass levels in the event of an emergency. B. Internal Organization of the RCP (Category II) hTC Cuidelines: The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the 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 he clearly drawn to provide uniformity in inspection policy, procedures and supervision. Questions: 1. Attach dated copies of your internal RCP organization charts. The charts are attached as Appendix D-1. 2. How is the P.CP organized so as to provide specific lines of supervision from program management for executing program policy? The Radiologic Health Branch is divided into three areas of responsibility: Radioactive Materi:1s Centrol, incorporating i compliance and licensing; X-Radiation Control, including X-ray machine registration, inspection and certification; and Tacilities and Environmental Standstds. Refer to the organization chart fur specific lines of responsibility. i 3. If regional offices are used: To whom do regional personnel report administrative 1y? a. RHB regional compliance offices (No. Ei So.) report to the compliance supervisor at RCP headquarters. b. To whom do regional personnel report technically? All contracting agencies and regioral RHB offices report to RCP headquarters technically. 4. If the RCP contracts with other agencies to adelnister the prosram: I i i f

t + 21 i Identify the contracting agencies and indicate their i a. responsibilities. { The Department of Industrial Relations contracts for all l industrial compliance inspections. The Counties of Los Angeles and Orange contract for compliance inspections within their respective jurisdiction. b. To whom do contract personnel report administratively? l Contract compliance inspectors report to supervisors within their respective agencies. I To whom do contract personnel report technically? c. All contracting agencies report through the local supervisor to RCP headquarters technically. II. B Reviewer Assessment: As the comments listed below would indicate, the internal [' organization of the RCP does not meet the guidelines at this time. first, the organization charts furnished in Appendix D-1 are out of date and do not reflect the current staffing. Don Honey is Supervising Health Physicist, Radioactive Materials Control, but Cerard Wong has been promoted to Supervising Health Physicist in X-Radiation Control. There are four newly promoted Senior Health ( Physicists: Jack Brown, Compliance; Steve Eckberg, Licensing; John Hickman, Waste; and Don Bunn, X-Radiation. The lack of l accurate organization charts is only one indication that the lines of supervision and control are not clearly drawn, however. This was further evidenced by reviewer observation and in conversation with + the new supervisors and staff members, some of whom were uncertain as to their responsibility and position in the chain of cossnand. i An.biguity is particularly evident in incident response, where authority has recently been divided between the X-ray and compliance sections. Additionally, in interviews with the contractir:g agencies, it was noted that some confusion exists in their i conception of their reporting requirements. According to program asnagement, changes are contesplated in the organization of the Branch effective next July 1st, and a draf t of a proposed organiastion chart is attached as Appendix D-2. The internal organization of the Branch will be closely observed durH - i the follow-up review. l i C. Leral Assistance (Category !!) KRC Cuidelines: Lessi staff should be assigned to assist the RCP, or procedures should exist to obtain lessi assistance expeditiously. ] Legal staff should be knowledgeable regarding the RCP progras, y statutes, and regulations. g g *j'9, f i-

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~ 22 Questions: 1. Are legal staff members assigned to assist the RCP or do procedures exist to cbtain legal assistance expeditiously? Legal assistance is obtained from staff attorneys in the Of fice of Legal Services. The Attorney Generel's Office provides representation for trials and hearings under the Administrative Procedures Act. 2. Is the legal staff knowledgeable regarding the RCP, statutes, regulstions and needs? Some specialization by attorneys in radiation protection matters occurs in practice. This specialization results in familiarity over time with the legal basis and requirements of the Radiation Control Frogram. 3. If legal assistance was utilized since last review, provide a sumary of the circumstances. Legal assistance was used for LLW issues, draft orders and regulations.

11. C Reviewer Assessment:

The State responses indicate the legal assistance meets the guidelines. I D. Technical Advisory Committees (Category 11) i FRC 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 j Advisory Comittee should be used to provide bread guidance an the uses of radicactive drugs in or on humans. The Committee should i represent a vide spectrum of medical disciplines. The Comittee i should advise the RCP on policy matters and reguistiens related to i use of radioisotopes in or on humans. Procedures should be 'l developed to avoid conflict of interest, even though Committees are advisory. This does not mean that representatives of the regulated community should not serve on advisory committees or not be used as cons tiltants. j Questions: 1. Discuss practices followed for cbtainirig technical assistance when needed (e.g., consultants, technical and medical advisory comittees, licensees, the NRC and other State and Federal Agencies). 4 In addition to the technical assistance received from federal 4 agencies such as the NRC, DOE, and the Bureau of Radielegical lieslth, the department uses the following technical and medical w

t 23 advisory comittees: Medical Advisory Comittee on Human Use of Radioactive Material, Nuclear Medicine Technology Advisory E Comittee and the Low-Level Radioactiva vaste Advisory Comittee. Special consultants are also used as necessary. a 2. What steps are taken to avoid conflicts of interest? Comittee sembers are subject to the Department of Eealth Conflict of Interest Code and must provide a curriculum vitac to the State before their appointment. The Personnel Department requires fores be submitted to them describing the professional background of proposed consultants. These backgrcund statements, along with the personal knowledge of the ] program management, are intended to eliminate conflicts of interest. 3. Are any comittees involved in setting policies? If so, j explain. The comittees do not set policy per se, but they provide input j and review of legislation and regulations and they establish I standards of competence for nuclear technologists. 4. Attach a list showing the membership, specialties and affiliations of the Medical and/or Technical Advisory 9 j Comittees. No change from 22nd Review with respect t3 the LLV and Human l'se Comittees. The Nuclear Medicine Technology Cownittee was i terminated Cecember 31, 1964. 5. Indicate whether the advisory comittees are established by statute, by appointment of the Covernor, by appointment of the State Beard of Health, by appointment of the Agency, or by l other means. i The comittees are established by statute and members are appointed by the Director. 6. What is the f ormal meeting frequency of each comittee, and are minutes of comittee meetings prepared? 4 i There is no formal frequency established for meetings. The comittees are convened as necessary and minutes are always

recorded, 7.

Vhst was the date cf the last formal meeting of each committee? The Human l'se Advisory Comittee la6t set on March 3,1981; the Nuclear Medicine Technology Advisory Committee last met en i Decembe r 10, 1981; the Low-Level Vaste comittee set August 2, 1984 1 l l l

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~. _. l f 24 i l 8. Are individual committee members contacted for consultation? l t i Yes. 9. Discuss how each committee is used, the average workload placed on the committee, and the remuneration, if any. i The lluman Use Advisory Committee provides medical advice on nuclear medicine procedures, both in routine or investigational use, provides input on legislation and regulations pertaining to the use of radioactive material in nuclear medicine or i associated areas and consults on medical aspects of radiation over-exposure. The physicians who comprise the board are paid for actual time worked (approximately 8 hours per month) at $22.44 per hour. The Low-Level Radioactive Waste Advisory Committee was i established for the purposes of providing advisory input and 4 J oversight of the development of a low-level vaste site in j California. There is no compensation, but the members are reimbursed actual and necessary expenses incurred in the 1 performance of their committee duties. I i II. D. Reviewer Assessment: According to the State responses, the technical advisory committees continue to meet the KRC guidelines, i 111. MANAGEKENT AND ADMINISTRATION i A. Quality of Emergency Planning (Category I) KRC Cuidelines: The State RCP should have a written plan for response to such incidents as spills, everexposures, transportation i' accidents, fire or explosion, thef t, etc. g The Plan abould define the responsibilit'es and actions to be taken by State agencies. The Plan should be c>ecific as to persons responsible for initiating response actions, conducting operations 1 and cleanup. Emergency communication procedures should be 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 ] Plan while in draft form. 1 6 The plan should be reviewed annually by Program staff for adequacy i and to determine that content is current. Periodic drills should be performed to test the plan. Questions: l 1. Is the RCP responsible for its ovn emergency plan or are accidents involving radioactive materials incorporated into a comprehensive State plan developed and administered by another f 4 a p .e .k'.."e 4 ha g g ..+ "g esy 2 a 1 ~,.

25 l State agency? Please provide copies of all applicable plans for review. Radiological Emergency Planning scd response is sainly the responsibility of the State Office of Energency Services. Radiologic Health Branch is the technical arm of the Office of Emergency Services. The development of the energency plans and procedures is combined ef fort of both agencies. A copy of the current plans and procedures will be provided before the end of April 1985, 2. What written procedures or plans does the RCP use fe. responding to incidents involving radioactive materiads? Emergency response is saintained on a 24-hour basis through the Office of Emergency Services (OES) utilizing a call down procedure to Radiation Control Program staff. Preventive Health Services management is available as a resource utilizing a 24-hour paging system also maintained through the Office of Emergency Services. The call dovn list is attached as Appendix E. 3. If the plan covers sajor accidents at nuclear facilities, how does it cover non-catastrophic incidents such as those involving transportation of saterials? The OES contacts the ECP staff beginning at the highest level (Mr. Ward) and decisions are made at that time as to the course of action. 4. How does the plan define responsibilities and actions to be taken by all State Agencies (initiating response actions, operations, cleanup,etc.)? This is determined by the OES plan. 5. How does the plan provide for notification of and communications with appropriate government agencies

• The energency call list has 24 hour telephone numbers for all federal, state and county offices that might be concerned.

6. How is the respocae program orgsnized so that qustified individuals are readily available through identifiable channels of communication? Osy and night telephone numbers are listed for all qualified [ individuals including the Medical Advisory Committee. 7. Has the plan been distributed to all participating agencies? The es11 down list has been distributed.

t 26 8. Has the NRC had opportunity to comment on the plan in draft form? No, because there is no RCP plan, it is an OES Statewide plan. 1 9. Is the plan reviewed annually by the RCP for adequacy and to assure the content is current? The call list is reviewed annually.

10. Are drills performed periodically to test the plan for radioactive materials emergencient Explain, for example, how non-routine office hours communications are checked.

The emergency telephone call dovn system is tested several times per year. Ill. A. Reviewer Assessment: As indicated in the State responses, the RCP emergency plan is combined with a comprehensive plan directed by the Office of Emergency Services, and it is currently being rewritten. Although the NRC was not formally provided an opportunity to comment on the OES plan in draf t form, the RE8 portion was being prepared during this visit. The reviewer examined the draf t and ande a few minor comments. It appears the plan will be a good one, and the assessment will be determined during the follow-up review. It should te noted that none of the contracting agencies have been furnished a copy of the current OES plan, except for the call-down list, and steps should be taken by RCP Management to assure proper distribution of the new plan. B. Budtet (Category 11) f NRC Guidelines Operating funds should be sufficient to support progran needs such as: staff travel necessary to conduct an effective coepliance pregram, including routine inspections, 1 follow-up or special inspecticas (including pre-licensing visite) i and responses to incidents and other emergencies; instrumentstion and other equipment to support the RCP; administrative costs in eperating the progras including rental charges, printing costa, laboratory services, computer and/or word processing support, preparation of correspondence, office equipment, hearing casts, etc., as appropriate. Principal operating funds should be from sources which provide continuity and reliability, i.e., general tax, license fees, etc. Supplemental funds may be obtained through contracts, cash grants, etc. 1 Questionst i 1. Vhat fiscal year is used by your Etate? The state fiscal year runs from July 1 through June 30. q w-4 i e

l 27 i I I f (fees, State General funds, IDIS, NRC environmental sonitoring i 2. Indicate the amount for funds obtained from each revenue source or transportation surveillance centracts, epa, TDA and others). \\ Radioactive materials license fees currently provide $717,000 per year. The balance and cost attributable to fee exempt licenses comes from the State General fund. 3. Show the total amounts assigned to: c. the total radiation control program $3,672,748 t 1983-84 $3,863,436 1984-85 b. the radioactive materials program. l i $1,148,650 1983-84 $1,229,211 l 1984-85 t 4. What is the change in budget from the previous year and what is l the reason for the change (new prograr.s, change in emphasis, + statewide reduction, etc.)? The increase to cover ecst of living only, no new positions authorized. 5. Describe your fee system, if you have one, and give the percentage of cost recovery. Enclose a copy of the fee ( I schedule. Licensees are assessed an annual fee according to the size of the source. The cost recovery from the licenses is 55 percent. A copy of the fee schedule is attached as Appendix T. i 6. Does the RCP administer the fee system 7 Yes. 7. Vhat recourse does the RCP have in the event of non-payment? We are currently in the process of setting up a delinquent license fee account system to track and assure that all fees l i owed are paid. Ve have issued demand letters for seriously delinquent accounts and are in the process of initiating legal action on a test basis. 8. Overall, is the funding suf ficient to support all of the progran needs? If not, speef fy the probles areas. 3 Yes. P i E e O e )

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5 I l i 1 28 i III. B Reviewer 1.ssessment: e l From their response to question 8, it would appear that program management is satisfied with the current funding. However, several pr.' gram deficiencies identified in the review were attributed to the lack of necessary funds. One significant budget issue is the fact that funding is currently 1isufficient to meet the stsifing guidelines, and this has contributed to the backlogs in licensing 4 and compliance. In addition, observation and discussions with program management indicate tie operating funds are not sufficient or available for the following items: 1. Consultants and temporary help nt:essary to provide proper programing and training to enable the L'JP system to function. t i 2. Relocation expenses for transferred or promoted employees. 3. Instrument calibration. 4. Travel expenses for staff meetings with contract personnel in regional offices. [ + 5. Replacement of office equipment (such as the copy machine) [ j which is beyond repair. I The budget guidelines will not be met until funds are available for l these essential progrse elements. C. Laboratory Surrett (Category 11) NRC Cuidelines: The RCP should have the laboratory support f capability in-house, or readily available through established procedures, to conduct blosssays, analyze environmental samples, 3 analyze samples collected by inspectors, etc., on a priority established by the RCP. ] Questions: f 1. Are laboratory services readily available in-house or through other departments within the State organization? i l The Radiation laboratory is a branch of the DHS that acts as a support group for the Radiological Health Eranch. Although j they have their own supervision and budget they are considered in-house because they are part of the DhS. 2. If services are provided by other departments, discuss the j arrangements, supervision, charges and interdepartmental t communications. i j Not Applicable. l 1 3. If laboratory services must be provided by a non Stat, agency: t l 1 J i d,. el.. -

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i 29 l l Discuss the contractual arrangements. a. I b. Is the party providing the service a State licensee? If a State licensee provides the service or equipment, c. what are the costs? None of the above are applicable. 4. Deveribe the capability of the laboratory as follows: Can it qualitatively and quantitatively analyze low-energy a. beta emitters? i Yes. l b. Can it qualitatively and quantitatively analyze alpha emitters 7 c i Tes. Can it selectively determine the presence and quantity of c. game em.tters? [ Yes. ( d. Can at handle samples in any physical form - vipes, j liquids, solids, gaseous? j Yes. Does the lab participate in a periodic quality control e. program? Yes, the EPA Safe Drinking Act requires it. 5. How much time does it take to obtain the results from sample analyses on both a routine basis and on an emergency basis? l The reutine scalyses depend on the lab workload and say take up to two weeks. Energency saspies are analyzed as quickly as the process and transit time permit. i 6. I.ist the number and types of laboratory instrumentation and l services available. i The laboratory is a modern facility with state-of-the-art equipmenti a list would be too extensive for inclusion here. i The laboratory's budget exceeds $20 million per year. l l ( I A. ... '-. c. g,., j 4

l MMM 4 i 1 30 i III. C. Reviewer Assessment: t . ) According to the state responses t*e laboratory support meets the guidelines. One lab report examined by the reviewer was not professirrally done in that it lacked information about: a) the type, model and serial number of equipment used, i b) the calibration techniques, source type, and efficiency for the i source used, l c) the standard deviation of the counted samples and the l background dats and; l j the results were not signed by the technician who did the work. During h e 1985 review period, the reviewer intends to visit the l laboratory facility in Berkeley and discuss the laboratory and reporting techniques with the staff and management at the facility. D. Administrative Procedures (Category 11) NRC Cuidelines: The RCP should establish written internal procedures to assure that the staff performs its duties as required and to provide a high degree of uniformity and continuity in regulatory practices. These procedures should address internal processing of license applications, inspection policies and l j procedures, decommissioning, and other functions required of the i t

program, Questions:

) 1. What pretdures are established to assure adequate and uniform j regulatory practices (e.g., administrative procedures, policy memes, Itcensing and inspection guides, escalated enforcement procedures, decomissioning procedures, etc.)? l 4 Administrative procedures are contained in Reviewer's and i Inspector's Guides, Inspection Policy Hemos, Materials Memos, j the Emergency Call Book and the Health Administrative Manual. These documents are distributed to the program staff and will j I be available for inspection during the review. 2. To what extent are the procedures documented? 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 1 The normal pattern of workload conduct has inspections of major licensees by joint inspector-reviewer teams. Review backlog and workload increases attributable to staff vacancies bar i ( 4 )

31 ut'lization of this pattern except in extraordinary circumstances. 4. liow are personnel kept informed of current regulatory policies and practices? They are notified of changes by sail or in telephone conversatier.s and through discussions at staff meetings. 5. If your State collects fees, are fee collection duties assigned to non-technical staff? Yes. 6. How are contacts with consnunication media handled? The media is referred to the State Public Information Office (PIO). The RCP only answers technical questions af ter they have been cleared by the PIO. 7. What procedures exist to ensure timely release of factual information on satters of interest to the public, the h*RC and Agreement States? l There is a long standing agreement between agencies (NRC, OES, DOE, CA) to keep each other informed. Matters of public interest are referred to the Eranch and Division Chiefs before 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 filest Copies of procedures are saintained in each regional office tegether with license files appropriate to the region. Procedures are periodically updated with copy by sail. Copies cf all licensing actions are transeitted by t sail to the appropriate regional office. b. how of ten are periodic staff meetings held with headquarters staff? Ve atterpt sesi-annual settings. bew often are periodic visits / audits sede by headquarters -l c. staff to regional officest Once a year as part of the accompaniment program. .i

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32 d. how is uniformity assured? I l By accompaniment and review of inspection and j investsgation reports. e. how is supervision handled? (e) See responses to II.B.3 and 4. III. D. Reviewer Assessment: The current administrative procedures do not meet the guidelines in the following areas: 1) The written procedures do not reflect the current practices within the branch for licensing. compliance, or enforcement. l This was determined by reviewing the procedure and observing the actual practice. { r 2) Communication between regional offices (manned by contract personnel) and headquarters is not adequate to assure uniformity. It was observed by the reviewer on the field evaluations that the contract compliance inspectors have l different understandings of procedures and use dif ferent report j fo rms. The last staff meeting with all regions represented was in 1982. 3) Procedures are inadequate for the indoctrination of new j employees or newly appointed supervisors. This was determined in interviews with the staff, where some personnel are not t certain of their responsibilities, priorities, reporting l requirements and limit of authority. 4) The communication between licensing and compliance is inadequate. Review of the files showed instances of compliance j j discrepancies that should have been taken into consideration I before license renewal, but which were not available to the l reviewer. l These areas were discussed with program sansgesent and the reviewer l offered to assist in writing new procedures to reflect current practice and improve consistency and communication. Program r i sanagement has promised to take this into consideration and this vill be reviewed at the follow-up. j E. Management (Category II) NRC Cuidelines Prograe management should receive periodic reports i free the staff on the status of regulatory actions (backlogs, probles cases, inquiries, regulation revisions). RCP management should periodically assess workload trends, resources and changes in l 1 1egialstive and regulatory responsibilities to forecast needs for l increased staff, equipment, services and fundings. 1 t s l .4 ' .j ,f.,,}.. i. ~* = 1 i I h i

33 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. Questions: 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 in established and tracked by means of a docketing system. Compliance inspection backlog is tracked utilizing a monthly due/over-due listing. Investigations are tracked using a tickler system. 1 2a. Is a periodic statistical tabulatten of licenses, licensees, inspections and backlogs prepared by category? l Statistical tabulations with respect to licerses, licensees and inspections are now prepared for the RCP Calendar utilizing ACP j management informaticn when available and extrapolation from reports previously develeped. j b. If so, specify how frequently the tabulation is prepared. l Quarterly or semiannually. f i 3. How does RCP sanagement assess workload trends and resources in order to determine future needs or the need for progras changes? The Branch uses several techniques for assessment of trends, planning and follow through for workload, equipment, staff and budget u nsiderations. Periodic reports are prepared to show actual workload against predicted and planned workload. These reports are designed to be used in support of bott. planning and budgetary activities. Improved output measures are currently under development. The State uses specific processes for determination of equipment needs and budgetary changes. Substantial changes to a program are handled through the Budgetary Change Proposal (BCP) process. .=....: ...(

34 4. How does the RCP managreent keep abreast of changes in } legislative and regulatory responsibility? I.egislation is tracked through the Office of External Affairs. Fegulations are tracked through the Office of Regula'. ions which follows the Federal Register, and by communication directly with FP.C Office of State Programs. 5. Discuss the procedures followed by licensing supervision or RCP management to monitor licensing quality. Staff review and concurrence is required for all Type A j licenses and device and sealed source approvals. Supervisors review all Type-A authorizations and scaled source and device approvals to assure that these actions conform to staff det e rmina tions. Beyond this review, licensing actions are circulated through the staff for peer review as to cospliance of regulations, policy and good health physica practice and for review by supervisors. 6. Discuss the procedures used for supervisory review of inspection reports. Investigation and Compliance inspection reports receive review j by the Compliance Supervisor at RCP Headquarters. Significant questions are referred to supervisors for consultation and i resolution. I 7. What license review practices are followed for unusual or i l complex license applications? l Complex license applications are reviewed at periodic staff meetings. 8. If applicable, discuss the procedures used for supervisory i review of work performed by contract agencies or regional offices. Compliance inspectors in regional offices report directly to the Chief of Compliance in Sacramento. Compliance inspectors in contract agencies report through the agency supervisor to r the Chief of Cospliance in Sacramento. Inspection and investigation reports are reviewed by the respective supervisors and the Chief of Compliance. 111. E. Reviewer Assessment: P The review of license files indicated that act all licenses, particularly medical and pharsacy, that should have quality assurance are receiving it. This is a continuing issue from the l 4 previous review. \\ California's procedures provide for no supervisory review of cospliance inspection reports and enforcement actions until after l t e I / '-. r',. ';, - %((* 9 t 's, I ; -,* g . Mg#/> Y $ ' I h % g. *. -- e f N

l 35 l the inspection file is completely closed out. A review of records ( found that these closed-out reports often take months (sometimes more than a year) to reach headquarters. Additionally, it was found no reports have had supe.visory review for the last six acuths. These conditions have hindered managements' ability to access the status of the inspection program and enforcement actions. Because of the significance of these issues, the program does not meet the management guidelines. T. Office Equipment and Support Services (Category II) FRC Cuidelines: The RCP should have adequate secretarial and clerical support. Autosatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses) prograss. Similar services should be available to regional offices, if utilized. la. In teras of the person year /100 licenses figure, what level of secretaris1/ clerical support is provided? l The Radioactive !!sterials Control Program is supported by 4.5 TTE clerical staff. The ratio is 0.20 person year of clerical support for each 100 licenses. b. If your program has regional offices, provide the figures for the support for those offices. { The regional offices which are staffed by contract agencies provide their own support staff. 2. Describe the ADP and word processing capabilities available to { the ECP. l The Radioactive fiaterists control Program receives limited ADP support from the Department's Dats Systems Branch j (Administration Division). The Radioactive Fiaterial Control i Program also has a coerpliance ille at the State's data center (Teale Center). The RCP has some capability to manipulate these flies at the Teale Center. Presently the program is able to obtain periodic dats from the licensing file to list licensees and to maintain an expiration and annual billing progree. The RCP is also able to use the compliance file data to generate a quarterly due/ overdue listing for the compliance r inspection program. The esisting system is considered interim and patch and will be j displaced by a stand-alone system to include word processing j saintained by the Branch in the cent few months. III. T. Reviewer Assssements i [ At the present time, the office equipment and support services are \\ not adequate to meet either the NRC guidelines or the needs of the program. A new ADP systes that should be adequate to meet progras i e

36 l needs was purchased and the hardware was delivered in August 1984. ) During the previous follow-up review the State consitted to a functional systes by the beginning of 1985. Software h:: not yet i teen develeped to perform any license or corpliance functions. The j Wordstar" program was purchased, but the secretarial staff has had no training and is having limited success in tryits to use it effectively. Program management indicated these probless are due, in part, to the inflexibility of the budget. G. Public Information (Category II) NRC Cuidelines: Inspection and licensing files should be available I to the public consistent with State administrative procedures. i Opportunity for public hearings should be provided in accordance with LMTRCA and applicable State administrative procedure laws. Questions: 1. Are licensing and inspection files available for inspection by the public? Yes, license files are considered public documents. 2. Can medical and proprietary dats withheld? i e Yes. 3. What other parts, if any, are not svallable? Any personal data. I.. What written procedures and laws govern thist Flesse provide reference citations. The Inforsation Practices Act of 1977 (SB 170) and Californis Public Records Act, Chapter 3.5 of Division 7 of Title of the i Covernment Code. 5. For sill States, are opportunities provided for public hearings in accordance with LMTRCA and applicable State administrative l procedures and statutes? Not applicable. 4 !!!. G. Reviewer Assessments l The State reponses indicate the public information guidelines are met. T 1 l I 1

i 37 IV. PERS0 WEL i l A. Qualificatiens of Technical Staff (Category II) E C Cuidelines: Professional atsif should have a bachelor's degree l or equivalent training in the physical and/or life sciences. Additional training and experience in radiation protection for senior personnel should be commensurate with the type of licenses issued and inspected by the State. Vritten jcb descriptiens should be prepared so that professional qualifications needed to illl vacancies can be readily identified. Questions: 1. Do all professional personnel hold a bachelor's degree or have equivalent training in the physical or life sciences? I l Professional health physicist personnel are required by the j State's classification system to have a bachelor's degree in a physical or life science; this is a requiiement which cust be l i met prier to examining to qualify as s health physicist, l Additional qualifications include years of experience in health l physics or a closely related field. [ I 3 2. khat additional training and experience do the senior personnel need to have in radistica protection? ( I RC needs advanced courses to keep senior personnel up - i.e., 1 Radiation Protection Engineering, more sections, Internal Dese, Eeta desteetry, Advanced Licensing. 7 I 3. htet written position descriptions describe the duties, l responsibilities and functions of each professional position? The California State Fersonnel Board publishes specifications I for five levels of Health Physicists. Job descriptions are l published which define the responsibilities for each Icvel, the sinimum qualifications, and the knowledge and abilities i required for each pesition. Copies of the specifications and job bulletins are available for review. IV. A. Reviewer Assessment: [ The qualifications ei the technical staff are within the EC [ i guidelines, based en the data provided. l E. Staffin Level (Category !!) i EC Guidelines: Staffing level should be appresimately 11.5 person year per 100 licenses in effect. RCP sust cet have less than I i i I two professionals available with trainics and erperience to operste RCP in a way which provides centinuous coverage and continuity. i j I J " '{ y _ l i t i L i

r 38 Tor States regulating uranium mills and mill tailings, current ) indicatices are that 2-2.75 professienal Ferson-years' of effort, including censultants, are needed to process a new alli license (including insitu rills) or majcr renewal, to eeet requirements of i L'ranium Mill Tailings Radiation Centrol Act of 1978. This effort must include expertise in radiological matters, hydrology, geology, I and structural engineering. Questions: 1. Complete a table as below, listing the person years of effort applied to the agreement or radicactive saterial program by individual. Include the name, peaition, fraction of time spent and the duty (licensing, inspection, administration, etc.). 4 Name Pesitten

TTE7, Area of Effort Joseph k'ard Chief, Radic1cgic Health Branch 20 Administration l

j Den Honey Supervising Ecalth Physicist 100 Materials Control i Linda Eugent Health Fregram 5 Technician 1 EO Administration 1 Steve Eckherg Senier Health Thysicist 100 Licensing ( f Dave k?.eeler Asseefste Health Fhysicist 100 Licensing L a Vacant Asseelste Eesith l Thysicist 100 Licensing Ben Karel Associate Eralth r Fhysicist 100 Licensing i t i Edwin Fjeku Associate Realth Ftysicist 100 Liccesing l i { Cary Eatner Associate Eealth Thysicist 100 Licensing i Bill Creteguth Associste Health Thysicist 100 Licensing \\ J 0111e deLa11a Associate Eealth I Thysicist 100 Licensing Vacant Associate Eealth ? i Thysicist 100 Licensing { Jack Brown Senier Realth 100 Corpliance Physicist i j

39 Vacant Associate Ecalth Physicist I Los Angeles 100 Complisace Vacant Associate Realth Physicist, Berkeley 100 Compliance Amase Corcish Retired Annuttant 25 Regulautens Bob England Retired Annuitant 10 Regulaticca Jackie Stroud Health Program Adviser 15 Regulations C0hTRACT AGENCIES Persrtsent of Industrist Relations i Eill Lew Senior Heslth Physicist San Francisco 50 Compliance i g,,,,gg Associate Health Physicist 90 Corpliance San Francisco r, ark cettlieb Associate Hesith Fhysicist San Francisco 90 COSFll'" ( gg,veng Senior Health Physicist Les Angeles go Ccepliance Vacant AssCciste h s M M Les Angeles gg Corp 11snee I tes Angeles County Jee Karbus Head 20 Compliance / Administrative Al Fergusen Inspector 50 Co*P11**** James Rowles InsFecter 100 Co"?II8" Cene Edeen0* I**I 100 Coop 11sace Oranse Ceunty James Esrtranft Jaspector 50 Complisece Sussary of Staff time in Radicactive Material as et Tetruary 1, 191$1 I i 1 J d

40 3 Radielegfe Health franch h Professional Staff posittens Autherired Actual l Materials Control 14.0 10.0 Regulations (0.5) (0.5) Totsi 14.0 10.0 contract Agencies I DIR 4.0 2.2 l 1A County 2.7 2.7 l Orange County 0.5 0.5 i Total 21.2 15.4 2. Compute the person year effort of person years per 100 licenses (excluding sills and burial sites). Show calculation. i Actual ['" ['[*,x100 .53 person years /100 licenses t Autherireil 21.2 en an x 100 m.80 person yests/100 licenses g 3. Is the staffing level adequate to sert normal and special needs and backup 7 The overall Materials Control Progree is not staffed to the level used as a standard by the NRC. For a progree the site of California's, the standard is 32 professional positions. The state and its contractors currently have 21 authorized positions. Tif teen are filled as of Tebruary 1,1985. IV. E Reviewer Assessments In spite of Department authorisation and previous consiteents to fill the existing vacancies, no one has been hired since the i follow up review in August, while during that same time the staffing level has dropped from.67 to.58 person-years per 100 licenses. This relates directly to the fact that the compliance inspection backlog has increased during the same period. The RKB program i sanagement centends they have beta unable to fill the vacancies because the state Personnel Board policy requires that personnel eust be hired from eligible lists that are established by eral esseinstions. These esaminations, according to the progras } management, can only be given seal aasually rather than as the need requires, regardless af the urgency of the situation. The latest filing date for the existieg vacancies was December 21, 1984, and j

\\ a 41 \\ 2 the examination was to be held during the latter part of January 1985. The examinstien was then delayed because FEB progras sanagement had not prepared their questions for the exasinatien, despite the urgent need and knowledge that questions would be j required. At t.he time of the review, the examination date was scheduled for the last of February, af ter which time the PEB will be free the hire the necessary personnel. This will also apply to the i DOSH vacancies which must be filled from the ssee eligibility list. j DOSH sanagesent, however, is concerned about finding qualified inspectors that will accept the salary ($2431-$2934 monthly) because of the tigh cost of living in San Traccisco and Les Angeles, where the inspectors would be based. As indicated by the State response, after the authorized positions 4 are filled the staffing level will be.50 person years per 100 licenses, still below the R C guidelines. It is the understanding of the reviewer that the budget for the 1985-66 fiscal year which begins next July 1st will be increased to provide the 1.0 person-years ratio considered to be the minisua staffing level for a program of this size. Progras sacagement should take steps now to ensure a sinimum delay between the autheriration and actual biring. C. Staff Supervision (Category 11) AC Cuidelines: Supervisory personnel should be adequate to provide guidance and review the work of senter :nd junior personnel. Senter j. persennel should review applications and inspect licenses j independently, sonitor work of junior personnel, and particirste in the establishment of relicy. Junior personnel should be initially limited to reviewing license applications and inspecting small i prograss under close supervision. Questiens: 1. Identify the junior and senior personnel. Only the two new hires are considered junior level personnel. i They will be raised to senior level on a case-by case basis af ter their probationary period. I 2a. Vtat duties are assigned to junior personnelf i I Junior persettel work with senior persensel until in the ] judgement of the supervisor they can work alone. They begin with simpler licensers and eventually work up to the coeplex. [ b. Do they review applications and perform inspections independently? In sirpler cases (gsuge licenses) after supervisico determines they are suf ficiently quali!!ed, they may perform independently. 1 ~ an i d

t 42 3a. What duties are assigned to senior personne11 ) They are assigned all duties described in the job description, t' including license reviews, inspection and incident response. i Copies of the job descriptions are on file with the RCp and RV i FRC office. b. Do they independently review and monitor the work of junior personnel? Yes. 4. Is there adequate supesvisory or senior guidance and direction for junior personnelf Yes. 5. Discuss procedures established to ensure supervisory review of 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 reviev when available. 6s. Are RCp staff ocebers allowed to consult or work part time for State licenseest b. If so, how are conflicts of interest avoided? r i 1 No -- Conflict of Interest Statutes bar acceptance by esployees l of regulatory agencies of anything of value free persons or organizations regulated. IV. C. Reviewer Assessment: At the time of the previous review, the staff supervision did not meet the guidelines because key supervisory pcsitions were vacant. Esppily, this situation has been corrected and the number of supervisory personnel is adequate to meet the guidelines. The Senior Realth Physicists who head the compliance, licensing, lov Icvel vaste, and X ray (vbich includes some incident response) are all newly promoted, however, and are still sosevhat unsure of their priorities, authority and responsibilities. The reviewer feels this is to be erpected and they should all be receiving more guidance froe senior management. The reviewer stressed the importance of rupervisory review of licensing, inspection and enforcement functions it interviews and in meetings with the staff. This ares vill be closely checked in the follow-up review. j D. Trsteing (category II) ( ) FRC Ouidelines: Senior personnel should have attended NRC core l courses in licensics orientation, inspection procedures, medical I practices and industrial radiography practices. (Tor sill $tstes, we

i l 1 43 3 1 mill training should also be included.) The RCP should have a ( program to utilize specific short courses and workshops to maintain an apprepriate level of staff technical competence in areas of changing technology. Questions: [ 1. List materials personnel and the training courses they have attended. Agency Fame of Student Course Sponsor Dates t Jack Brown Industrist Radiography NRC May '84 Jack Brown Transportation NRC Nov '84 Don Eunn Transportation, ORNL KRC May '84 Cary Butner Licensing Procedures NRC Sept '84 j Steve Eckburg Teletherapy KRC Mar '84 Mark Cottlieb Well Logging NRC Mar '84 i ( Industrisi Radiography NRC May '84 i Inspection Procedures NRC July '84 i Edwin Njoku Licensing Procedures NRC Sept '84 Ben Kapel Well Logging NRC Mar '84 f 1' Jim Rowles Medical l'se of i Radionuclides NRC Jan '84 { David Wheeler Radiation Protection + Engineering NRC Nov '84 Kim Wong Biological Effects of Ionizing Radiation NRC Oct '84 j Complete training records of all esployees and nuclear power r plant emergency response training records are contained in Appendix 0. 2. Eev does the R P still e short courses and workshops to saintain staff proficiency? l i (,.. ; The California RCP uses the NRC courses in the training of ? staff as available. l f l t [ I

44 l i i IV. D Reviewer Assessment: As indicated in the responses California meets the guidelines in 1 zaking use of h1C training. However, Les Angeles and Drange Counties both feel they do not receive a fair allotment of courses and the records indicate this is a legitimate concern. Neither county had a course in 1983 and only one was allotted in 1984. Jim Hartranft (Orange County) expressed a need for Medical Use of Radienuclides and was scheduled for the January 1985 course, but the RHB sanagement substituted one of their license reviewers in the allotted slot. The reviewer recommends Mr. Eartranft attend the 1 next course and that the counties' training requests be given higher priority. The NRC is planning to assist with training the expected new hires [ during the coming year. The fundamentals of inspection course is 1 planned to be held in California this fall, and the State has been invited to attend the NRC transportation course in Valnut Creek in { June. j E. Staff Continuity (Category 11) h1C Cuidelines: Staff turnover abould be sinimized by coebinations of opportunities for training, promotions, and coepetitive salaries. Salary levels ( should be adequate to recruf t and retain persons of appropriate professional qualifications. Salaries should be comparable to i similar erployment in the geographical area. The RCP organization structure should be such that staff turnover is sinimited and l program continuity saintained through opportunities for promotion. Fromotion epportunities should exist from junior level to senior level or supervisory positions. There also abould *.,e opportunity for periodic salary increases compatible with experience and 4 responsibility. l Questions: [ 1. Identify the RCP esployees who have left the progras since the last review and give the trasons for the turnovers. Also state whether the positions are presently vacant, filled (name replacement), abolished or other status. During the period following the last review, the Radioactive hterial Control Progras has experienced turnover as folleva: Gerard Wong, Ph.D., Senior Realth Physicist, Radioactive h terials 1.icensing promoted to Supervising Eealth Physicist, X radiation Control Progras. i I Jack Brown, Associata Realth Physicist, h terista Compliance,- { } promoted to Senior Beslth Physicist, h terials Coopliance. j i l 1 ? -.,,,.

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45 i l Don Bunn, Associate Fes1th Physicist, Materials Compliance, pr,.oist to Senior He alth Physicist, X-radiation Control. j ( J Cary Butne, Associate Health Physicist, joined the Department in Radioactive Materia.'s Licensirs. Edwin Njokt, Associate Etalth Physicist, joined the Department in Radioactive tuterials Licensing. Mohamsid Lati! resirtwd from DOSH, South, to accept a better position and salary. The position remains vacant. Also, during the period January 1,1934 - De:reber 31, 1984, ] the Branch has experienced turnover as follove: Mary Barbour, Radiation Protection Specialist II, X-radiation Control, Los Angeles (nachine inspection); retirreent. Maria Aguilera, Staff Services Analyst, Administration; educational leave. I Katherine Coldssith, Health Planning Specialist II, Low-Level Radioactive Faste program; proaction. Linda Poston, Secretary, Administrative Unit; transferred to another position with the State. ( Barbara Hardinan, Office Service Supervisor I, Radioactive Materials Control; transferred to another position with the State. This turnover rate for losses is 7.7% of tranch staff. During the same period, the Branch added the follosing staff: Eenjasin Tong, Associate Health Physicist, Pacilities and Environmental Standards. Barbara Langfort. Secretary, Administrative Unit. Sally Janis, Associate Government Program Analyst, Administrative Unit. Reseann Cuerrero, Radiation Protection Specialist I, I Ray Machine Registration / Inspection. i i Vincent Dentanaro, Radiation Protection Specialist I, I-Ray 1 i Machine Registrat!cn/ Inspection. Jacqueline Woolenweber, Radiation Protection Specialist I, X Ray Machine Registration / Inspection. ( Camille Pasley, Of fice Rervice Supervisor I, I-ray MWchine Registration. b ,...,.....a. i f a l i

i t 46 Robert England, Retired Annuitant, regulations. Amass Cornish, Retired Annuitant, Regi.istions. Mary Earbour, Retired Annuitant, X-ray Machine Registration / Inspection. There are currently eight professionsi positions vacant. This amounts to 17.4% of the professional staff. 2. 1.ist the RCP salary schedules Position Title Annual Salary Ranze Chief, Radiologic Health $46,896 - $51,600 Supervisirig Health Physicist 40,536 - 48,984 Senior Health Physicist 35,208 - 41,492 Associate Health Physicist 28,476 - 34,356 Assistant Health Physicist 25,392 - 30,588 Junior Health Physicist 22,680 - 26,064 Radiation Protection Specialist 11 27,192 - 32,772 Radistion Protection Specialist 1 23,676 - 28,476 Health Progras Advisor 11 27,192 - 32,772 Health Progras Advisor 1 23,676 - 28,476 Staf f Services Analyst 18,240 - 28,476 These pay scales are effective as of August 31, 1984 i I 3. Cospare your salary schedule with similar esployment alternatives in the same geographical area, such as industrial, i medical, academic or other departments within your State. The salary rate fer technical positions, specifically journey level and senior level health physicists, is not comparable to sistler employment opportunities in the State. The salary lag is between 15 percent and 30 percent behind selected medical. l university, industrial and other governmental esployers. -) 4 Wt opportunities are there for promotion within the RCP i organizational structure without a staff vacancy occurring 7 At present, a Junior Realth Physicist may promote in place to Assistant Health Physicist and then to Associate Heslth Physicist (full journey level) without a staff vacancy occurring. Fromotions are still based on successful coepetition in promotional esasinations. Fromotions beyond journey level require a position vacancy. IV. E Reviewer Assessments ) Despite the ausber of vacancies in the professional staff, the staff continuity reesins within the NRC guidelines. Only one professional esployee, a relatively sev inspector with DIR, lef t the program . m:.; :..;. ,;,m..u.,. ;. 4

47 during the review period. Salary levels, while still below industry, have been significantly increased since the Inst review (- and do not appear to hinder retaining the professional staff. The high cost of housing in the Los Angeles and San Trancisco areas, where the vacancies for complissce inspettors occur, may have an effect on recruiting qualified personnel for those positions. however. V. LICENSING A. Technical Quality of Licensing Actions (Category 1) FRC Cuidelines: The RCP should assure that essential elements of 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 [ saterial, facilities and equirnent, and operating and emergency procedures sufficient to establish the basis for licensing actions. Prelicensing visits should be made for comples and major licensing actions. Licenses should be clear, complete, and accurate as to isotopes, forms, quantities, authorized uses, and permissive or restrictive conditions. The RCP should have f rocedures for reviewing licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program. Questions: 1. Eov sany specific licenses are currently in effect? Number of licenses currently in effect as of December.11,1984: 2,220. 2a. How many new licenses (not amendments in entirety) have been issued since the 1.st review? Number of new licenses issued during (1/1/84 - 12/31/84): 148. j b. How many were major licensest There were no major licenses issued. 3. Eov many specific licenses were terminated since last review 1 Ninety-seven (97) for the estendar year 1984. 4. Now asny amendments were issued during the review periodt fusber of amendments issued (1/1/84 - 12/31/84): 1,333. 5. Identify any neusual er c les licenses issued sines the last ) review, including asse and iconse number. 2:en~T W W f.y,~r4 _,.W..w,stah,:q wg.cy @,f L m 9

i I 48 The following list includes the unusual or complex licensing f ) issues, as well as licenses issued: Licensee License No. Description j UCIA 1335-70 Renewal (Broad A) 1 Research Organic / Inorganic 4271-70 New, in response to an NRC investigation at the Belleville, New Jersey location e t i j Stanford 0676-43 Renewal (Broad A) i International Futronics 3911-30 Receipt of 400,000 C1 - Co 60 Culf Nuclear, Inc. 3127-70 Spill and clean-up request + to dispose of hazardous i chemical containing up to 25 pC1/sm of Cesium 137 Culf Nuclear, Inc. 3127-70 Request to terminate !.R. Source Manufacturing license i Isotope Products 1509-72 Renewal (in progress) Vetter !tesearch 3110 30 Spill of E 3, Co 57 and Co 60 at il well sites. I Also, internal contaminatica I of primary users and members l l of the general public. l Vestinghouse 4346 Decontesinatien facility in Application Beatoont. { U.S. Ecology / 2873-60 Take ever of a vaste broker S.V. Nuclear by a site operator i Facific West Nuclear 3622 80 Noncompliance by a vaste broke r. N cifica Technia 1797-42 Clascup and survey of a shrspnel contaminated facility which had been testing D.U. penetrators for the ailitary. i Review of apps. for I ( } LIV ')isposal Site for Cal. license designes. l l l e I l

t 49 Sunburst 4349 - License to manufacture plus two (2) device sheets. USC 1949-Evaluation of radiation safety progree disclosed numerous probless during last two inspections. The Cyclotron Corp. 1408-Shut down and start up of 1 eperations. Colden West $torage of Limiscope at [ Marketics 4050-home. j UCST 1725 Renewal (in progress) (Broad A) i UCI Medical Center 0278 Renewal 1 General Fccleonics, 1288 Renewal (in progress) Inc. 1851 f.L. Manufacturer. 2498 [ 3138 I Palm Springs 3218 Receval Medical Center t Inter 11 Inc. 4473 Licase application (inp' regress) 1 Syncor 4395 700 Distribution license. Reflex Industries 4410 I-type distribstion issued)gress,almost (in pre, CA Technologies 0145-80 Ercad A (Renewal) IFL 3128-700 C distribution license (in progress). Forthern California Therapy - distribution of 1 Indoeurie 4340-60 brachy therapy sources and batches for shipment. i Heravek Biochemicals 2960-30 500 Ci of I 3 - site survey and visit. Chevron Research Co. 0164-Broad 8 Hanuf. 4337 I-131 therspy for CAT 8 James b' infer Ticer, (Application) DYM r i I i

50 US ', 0382-70 University Park Eenewal ) and inspection. 6. Note any variance in licensing policies and procedures granted i. since the last review. None. 7. Do you require license applicants to subeit details on their radvaste packaging and shipping procedures? Yes, vaste handling procedures include provisions for clear and distinct segregation of radioactive vaste by marking and physical separation from all other waste at locations where radioactive material is utilized. as. When do you require licensees to submit contingency plans? Vben they exceed the NRC contingency requirements and have not been required to submit plans to the NRC. b. List the licensees who have been requircd to submit contingency plans. Central Electric (Pleasanton), Rockwell International ESG Systems, CA Technologies, and Northrup are the four fires that i meet the NRC requirements for contingency plans, and they are all also Federal licensees. They have been required to submit their contingency plaas to the NRC, and therefore have not been required to submit duplicate plans to California. 9. Now many prelicensing visits were made during this review period? l Appresiastely 95 prelicensing visits were made during the reporting period.

10. What criterion does the State use to determine the seed for a prelicensing visit?

Frelicensing visits are performed when major changes in the type or Irrel of operations is proposed by a licensee and with new applications proposing potentially hasardous operations. Fre11 censing visits may be performed either at the request of the reviewer, or upon the initiative of the inspection agency.

11. Eov do you ensure up to-date information has been submitted prior to a license rencval?

Applicants wishing to rerev a radioactive materist license must complete a sev epplication fors (RK2050) in detail.

12. Do license files contain all accessary data required to evaluate an application prior to issuing a license?

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i i 51 l Yes. l ( Has the State taken any unusual licensing action with respect 13. to licensees operating under sultiple jurisdiction? i No. 16 Prepare a table as below showing the State's major licensees l with name, number and type. INCLUDE: tread (Type A) Licenses LLW Disposal Licenses LLV Brokers i Major Manufacturers and Distributors Uranium Mills Large Irradiators (Fool Type or Other) j Other Licenses With a Potential Significant Environmental Is7act Other Licensers You Consider to be Major" Licensees i License i Fame Fur.be r Type UC Davis, Davis 1334-57 Broad A ( UC Berkley, Berkeley 1333-62 Broad A UCSD, La Jolla 1339 80 Broad A UCLA, Los Angeles 1335-70 Broad A San Trancisco Med Ctr San Trancisco 1725-90 Broad A Stanford University Falo Alto 0676-43 Broad A Losa Linde University Lose Linda 0060-36 Broad A USC Medical Center Los Angeles 1949-70 Broad A USC Campus, Los Angeles 0382-70 Broad A CA Technologies, San Diego 0145 80 Broad A l UC Irvine, Irvine 1338-30 Broad A i Northrup, Les Angeles 0006-70 Broad A Central Electric Pleasanton 0017-60 Broad A LSO(RockwellInt.) Canoga Park 0015 71 Broad A l Nughes Aircraft 11 Segundo 0039-70 Broad A Nughes Aircraft El Segundo 0790-70 Broad A TRW, Redondo Beach 0816-70 Broad A U. 3. Escology 2f73-60 LLV Broker Thomas Cray and Associates, Orange 2105-30 LLV Broker Nuclear Specialities, Turlock 3546 50 LLV Broker (} Facific Vest Nuclear, Inc., Vista 3622 80 LLV Broler i ,...,..cJ j-A 3,.cy 3.. q. ,gg g g I f i

~;.:. }_.' Q~g %+y ;. +: r _ 4.- 52 i t [ Culf Nuclear 3127-70 Mig / Distributor ICN 1828-30 Mig / Distributor .J Isotope Products Eurbank 1509-70 Mig / Distributor J. L. Shepherd, Glendale 1777-70 Mfg / Distributor Aeroject Ordinance Co., Compton 2789-70 Mfg / Distributor NDC Systems, Durate 1933-70 Mfg / Distributor Medi Physics, Emeryville 2067-60 Mig / Distributor Becton Dickinson, Oxnard 3332-56 Large Irradiator j Radiation Sterilizer, Tustin 3390-30 Large Irradiator International Nutronics, Inc. Palo Alto 1822-43 Large Irradiator International Nutronics, Inc. Irvine 3911-30 Large Irradiator Aerojet ordnance 1450-36 Environmental Ispact Ford Aerospace 0550-43 Environmental Impset V. A. Reviewer Assessments Twenty-eibht pre-selected license files were exasined during the r review. Overall, the quality of licensing actions has improved r since the last review and it was clear that most reviewers are saking a conscientious effort to identify probless in the applications and authorize licenses that meet current regulatory standards. Ecvever, some licenses are still being issued, particularly mediest and pharsacy, that do not meet the ERC guidelines because of deficiencies in licensing practices which could lead to unnecessary radiation exposures. The review of the license files and specific coassents are included in Appendis H. B. Ad,ecuary of Product Evaluations (Category I) i NRC Cuidelines: RCP evaluations of sanufacturer's or distributor's data on scaled sources and devices outlined in FRC, State, or appropriate ANSI Cuides, should be sufficient to assure integrity and safety for users. The RCP abould review manufacturer's information in labels and 1 brochures relating to radiation health and safety, assay, and calibration procedures for adequacy. Approval documents for scaled source or device designs should be clear, complete and accurate as to isotepes, forms, quantities, uses, dravieg identifications, and permissive or restrictive conditions. I Questions: 1. How many new and revised evaluations were sads of sealed sources and devices during the review period? Total of six. J 2. Eev sany 55LD evaluations have been sade for which approval /} documents have not yet been prepared? I 2 1 l i

u 53 i 6 None. 3. Ifov does the RCP evaluate manufacturer's data en SSED's to ensure integrity and safety for userst t Prior to issuance of a specific license authorizing use of a sealed source or device, the manufacturer is regoired to file with the Department information completely describirig the sealed source or device, supported by such annotated drawings or sketches as are necessary. In some esses this information is required prior to issuance of an authcrization to manufacture. Trata to which prototype source capsule models have been subjected suat be described. 4. Do you determine whether the aanufacturer's information on labels and brochures relating to health, safety, assay, and calibration procedures is adequate on all products? q re pu l T. 4. L...,i w - The files were reviewed for all six of the sealed sources and devices registered in Californis during the review period. Essed on these reviews, the pregras meets the guidelines for product evaluation. Specific reference was made to the findings of the last review to deterrine whether the same deficiencies perceived for the source and device reviews completed during the last review period i are still occurring. The registry sheets for this review period showed a distinct improvesent over the last review. In the previous l review, a rajor corponent of the registry inforsation was alssing in some files. No such osissicas were noted on the sheets this year. The most cemen prcbles found in the six reviews was the quality of drawings associated with the registry aheets. Detailed comments and problems are given in Appendix 1. C. Licenster Procedures (Category 11) A C Cuidelines: The RCP should have internal licensing guides, checklists, and policy sesoranda consistent with current NRC practice. License a;plicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory pesiticos. The present corpliance status of licensees should be considered in licensing actions. Under the RC Exchecge-of-Informatica pregras, evaluation sheets, service licenses, and licenses authorizing distribution to general licensees sad persons i except free licensing should be submitted to DC on a timely basis. Standard Itcense conditions coeparable with current R C standard license conditions should be used to espedite and provids uniformity in the licensics process. Tiles should be asintained in an orderly fashion to allow isst, servrate retrieval of information and documentation of discussions and visits. l l l l P 1 g .h 4

54 Questions: ) 1. Has the RCP developed its own licensing procedures or does it use EEC guidest Please provide copies for review. Guidance for review of applications for new license, renewal and amendment is centsined in the Reviewer's Guide. The Reviewer's Guide is orgsnized by category of license and includes material developed by Californis and the NRC. 2. What licensing guides, checklists and policy memoranda are made available to the staff? ( CUIDES: (1) Notification Requirement by KRC for Licensees using more than 1 kg (ef fective) source saterial - nine occthe prior to receipt of saterial. (2) FRC proposed rule regarding Tc-99a sodium pertechnetste for lung function studies without regard to (1) chemical and physical fore, (2) route of administistion, and (3) dosage range. Also standard condition fer using Calicheck device for linearity check on dose calibrator. (3) Control of Radiation Levels in Unrestricted Areas Adjacent to Erschy-therapy Patients. (4) Training Requirements for Physicians Using Eye App 1(cator only. (5) Exemption of D.U. Shielding for Tc-99s Generators. (6) Use of Old Application Torm fer Veterinary Medical Practice. i (7) Licensing of RM st Reacter Conatruction Sites. i (8) Licensing Requirement and Enesption for Environmental Radioactivity Star.dards. (9) Authorization of Atoele Products Lineator Model Nuster-066 507 Device as an Alternative Dcie Calibrator Linearity Test. (10) NRC Amendments to Regulations Regarding Vell-logging Sources Lost Downwell. (11) Guidance to Facemaker Licensees Frict to Issuance of Renewal. i } (12) Tour Documents Designed to Aid Review of Radiopharmacy s Applications:

r 55 (a) Guide for the Preparation of Applications for Nuclear ( Pha rma cy. (b) Review Plan for Nuclear Pharssey Applications. L (c) Checklist for Review of Euclear Pharmacy Applicaticas. (d) Nuclear Pharmacy. Elser Checklist. (13) t$pdated FRC Standard License Conditions, October 1983. CECKLISTS: (1) Academic. ) (2) Vell Loggieg. (3) Medical (4) Industrial Radiography (IR) (5) IR (NRC) (6) R&D/ Academic (7) Nuclear Pharmacy (Also in Licensing Guide sterists). (8) Medical (Texas) (9) Industrial Cauges (Texas) (.0) 5eletherapy (Texas) 3. What guides and/or regulatory position statesents are furnished 4 to license and renewal applicants? (1) " Guide for Applicants for a Radiosctive mterial License." (2) " Guide for the Preparation of Applications for Medical Frograss." (3) " Teletherapy Licensing Guide." (4) " Applicant's Guide - Industrial Radiography." (5) " Guide for Applicants fer a California License to Kanufacture and Distribute Sealed Sources or Devices Containing Radioactive Eterial." (6) " Guidelines for Appiteant Freparation of Draft Registration Sheets." -n

y 56 s (7) "Special Requirements for Ercad Scope Research and ) Development Radioactive Material Licenses Type A." (8) "Special requirements for Broad Scope Research and Development Radioactive Material Licenses Types B and C," 4 Describe the system for advising classes of licensees of nev l I licensing procedures and regulations. Rad Safety Advisories are mailed to the licensees. P Sa. How are licensing actions coordinated with the complisoce staff? Concurrente in licensing actions is obtained from the appropriate inspection agency having jurisdiction following the inspection agen y's concurrent review of the application. Resolution of deficiencies disclosed by application review always account for matters raised by the inspector. b. Are licensing actions taken while enforcement action is pendingt No favorable licensing action say be taken with enforcement action pending. 1 6. yor vtat length of time are various categories of licenses issued? Licenses are issued for a ters of seven years.

i 7a. Does the RCP use standard licensing conditions?

b. If so, how does the RCP assure they are coeparable with those used by KRCf Standard licensing conditions are utilized and they are based on those used by the NRC. 8. Are the licensing conditions on file in the RCP office and with KRC7 Tes. 9. What $$1D sheets, service, distribution and '1" licenses are available for RCP staff usef A service directory is not available. Other material is ses11sbie to the staff.

10. Describa your practices for distributing $5&D sheets, as well as CL distribution and service licenssa, to the KRC.

i

l 57 A cover letter is prepared and they are sailed to the NRC. We i rely on the NRC to distribute thes to cther agreement states, j

11. Describe your procedures for maintaining the license files (How are files and folders arranged? Are telephone contacts and visits documented? Who is responsible for filing materials in folderst).

ne files for licensing, compliance and devices are kept in separate folders and are maintained by the licensing unit. r Investigation files are also kept in separate folders and are maintained by the asterials control supervisor. Material in the licensics illes is arranged as follows: n e right side of the folder contains the origins 1 license and amendments filed by order of the date. De left side has the notice of ~ erpiration as the top document, with other documents and completed correspondence filed under it. Correspondence which requires action, temporary notes and the inspection agency application reviews are kept loose in the folder. Notes of pertinent telephone conversations are kept and visits are documented. i

12. Are there opportunities for license reviewers to acceepany inspectors?

Yes, but this is contingent on backlog and having full staff. He opportunities have been.isited daring this review period. V. C. Reviewer Assessment: ) ne lack of coordination tween licensing and compliance, the sometimes confusing and incomplete licenset and the inconsisteney among licenses of the same type authorized by different reviewers all indicate the program does not meet the procedural guidelines, and the procedures should be revised to eliminate these a abortcomings. i Under the current procedure, the license reviewer does not have access to the compliance files until after the files are completely closed out and forwarded to headquarters. gince this may, and often does, take seversi months, the license reviewer is unaware of any compliance or enforcement problems during the licensieg action j unless the inspector relays the information to his or he suspects a probles and contacts the inspector, i ne medical licensing forms and procedures, in particular, should be changed to ensure clarity and completeness. ness procedures should be aimed at improving the technical quality of the licenses and at i eliminating policies generally regarded by the NRC and other Agreement gtstes as poor licensieg practice, l l

58 I VI. COMPLIANCE ) A. Status of Icepection Program (Category I) i NRC Cuidelines: ne State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license conditions. The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the inspection progree on a periodic basis. Information showing the number of inspections 4 conducted, the number overdue, the length of time overdue and the priority categories should be readi$y available. \\ n ere should be at least seeisanual inspection pisaning for the i I number of inspections to be performed, assignments to senior versus junior staff, assignments to regions, identification of special ? needs and periodic status reports. Questions: 1. !!ow is statistical information maintained about the inspectien program to permit periodic assessment of its status by RCP sanagement? Coepliance inspection statistics are initially kept by hand as inspection reports are legged in. [ 1 The new ALP system is still in the process of being installed and programmed. Currently (February 1985) we can update dats, such as the date of the last ine.pection, and obtain printouts of due/ overdue listings. The history of compliance will be added in the new system. 2. Prepare a table as below, indicatics the number of inspections aade in the review period, by category and priority. The current syst *,oes not identify the inspections performed by priority. Tbt 'ollowing table gives the number of inspections performed by each agency: ACIWCT RKB N RHB S DIR N CIR 8 ORC CO L.A. CO TOTAL 1 ROAD A 0 0 0 1 0 1 2 MEDICAL liOSP 9 20 0 0 4 31 64 PP 0 15 0 0 4 8 27 ACADEMIC 0 4 0 0 0 5 11 } I C'L RAD 0 0 8 16 1 3 28 MISC IC'L 6 0 39 7 15 76 143 4 O i.

1 j \\ 59 SVCS & CONS 0 0 1 0 0 0 1 GOV'T 0 0 1 1 1 1 4 CTEER 1 0 0 13 1 3 18 TOTAL 16 41 49 38 26 128 298 i AnTAL WORKI4AD 92 59 147 122 42 160 622 3. Prepare a table (or tables) as below which identify the Priority 1, 2, and 3 licensees with overdue inspections. Include the license category, the due date, and the sunber of months the inspection is everdue. (If list is estensive, a comparable computer printout is acceptable.) An accurate, updated computer printout identifying the licerseas with overdue inspections has been provided for period end!ng December 31, 1984. The following table summarises tne overdue inspections as of December 31, 1984 SWARY OT OVERDL'E* INSTECTIONS AS OF DECEMEER 31, 1984 Inspection Friority Friority Friority Frirotiy Annus1 Agency I 11 11! IV Total Workload RKB - North 0 7 9 49 65 92 rx8 - South o 6 6 9 21 59 DOSH - Forth 1 18 45 54 118 147 DOSH - South 3 31 25 19 78 122 ORANCE County 0 3 15 16 34 42 LA County 0 7 9 2 18 160 TOTALS 4 72 109 149 334 622

• Inspections are not counted as everdue until the length of the overdue period is 50 percent of the inepection frequency period for priority I, II and III licenses.

4. Prepare a table as below indicating the number of everdue license inspections for Priorities 4 through 7. See computer printout and above table. 5. How are inspection schedules pisoned and how are the dates and persor.ns1 assignments made?

l --....---n-- ? \\ 60 ne Radioactive Materials Control supervisor uses the J due/ overdue list to assign the inspections to each i jurisdiction. D e local supervisor makes the specific t assignments as to dates and personnel. VI. A Reviewer Assessment: n e cospliance progran continues to fail to meet the NRC guidelines. At the time of the review, the inspection program had 334 inspections overdue by more than 50 percent of their inspection i frequency, with some overdue by more than 100 percent. Escept in 1,os Angeles and Orange Counties the RCP now has no one on the staff l to inspect medical or acadesic licenses. De backlog is increasing and the State has no action plan to reduce the backles. It should [ be noted that the State inspection frequency is currently more stringent than required by the NRC, and by reducing it to a more j workable schedule, the statistics could be more accurately compared i to other Agreement States. Hiring should be expedited and training j planned so that the new inspectors can begin to perform independent inspections as soon as possible. l B. Inspection Frequency (Category 1) FRC Guidelines: ne RCP should establish an inspection priority systes. The specific frequency of inspections should be based upon the potentist barards of licensed operations, e.g., major [ ) processors, broad licensees, and industrial radiographers should be inspected approxisstely annually -- smaller or less hazardous operations may be inspected less frequently. The minious inspection frequency should be consistent with the NRC systs.a. [ t Questions: l 1 1. Enclose a copy of the State's priority syates. Enclcsed as Appendix J. 2. Wo assigns licenses to the priority categoriest l l The revievers assign the license priority in accordance with the table in Appendiz J. Aoy exceptions are authorized by the Supervisor of the Radioactive Material l'ait. I a 3. Discuss any significant variances in the State's priorities from the FRC priority systes. s ney are the same as the RRC 1975 priority systes. 4. Is the inspection priority systes designed to assure that the more hasardous and/or cosples operations are inspected at an appropriate frequency? ) Yes, see priority systes. i 8. a. m w 4 ;.. ;..; . mgy 44amm.; i l

P 61 5. Describe the State's policy for unannounced inspections and exceptions to the policy. A minority of industrial inspections are performed unancounced. Most medical inspections are by appointment. 6. Describe the State's policy for conducting follow-up inspections. Tollow up inspections are conducted to verify corrective action where the issues are complex or serious and in situations where experience or the licensee's response suggests that corrective actica will be ineffective or delayed. 7.a. Does the RCp inspect out-of state firms working in the State under reciprocity or under State licensee? The " Notices of Reciprocal Recognition" are conditioned to provide the inspection agency with tLeely information permitting inspection on a sampling basis, b. 11ow many reciprocity notices were received? Torty-one (41) in calendar year 1984. c. How many were inspected since the last review? Tour (4) were inspected in the calendar year 1984. VI. B Reviewer Assessment: The State priority schedule has an inspection-due frequency that is more stringent than that required by the NRC, and thus would appear tu meet the guidelines. However, according to their systes, an inspection is not considered overdue until it is a terdue by 50 percent of its frequency schedule, and the progros is actually operated on the overdue schedule. Also as was poltted out during the last review, inconsistencies between the way California and the NRC assign licenses to priorities have resulted in some categories of licenses that are not "nspected according to NRC standards. Eased on these practices, the inspect.on frequency ;tuidelines are ) not being met. As during the last review, the desteability of a revised priority schedule was again stressed, and the State Las agreed to change to the NRC schedule Lamediately. The progress of changing schedules will be checked during the nest review. C. Inspector's Performance and Capability (Category I) NRC Guidelines: Inspectors should be competent to saraluate health and safety problems end to determine compliance with Stata regulations. Inspectors sust demonstrats to supervision an understanding of regulations, inspection guides, satt policies prior to independently conducting inspectior.s. e

62 The complisoce supervisor (say 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: i !a. Does the senior inspector or supervisor periodically accompany the inspectors? i Tes. j b. Are these accompaniments documented? Yes. t 2. List the number of supervisory accompaniments of inspectors i since the 1sst review seeting and identify the persons secoepanied and the supervisors. There were eleven accompaniments as follows: Accompanied Date of Supervisor Inspector Coescots Inspection Kim Wong Mohammed Latif 1/84 A1 Terguson Jim Rowles unavailable i Al Terguson Gene Edmonds unavailable Don Honey Mark Cottlieb 10/84 Jack Brown Kim Wong 11/86 Den Honey Jim Eartranft 12/84 Don Honey Edwin Njoku (Training) 12/84 Jack Brown Cary Butner (Training) 12/84 Jack Brown Bill 14w 1/85 Jack Brown Edwin Fjoku (Training) 1/85 Jack Brown Gary Rutner (Training) 1/85 VI. C Reviewer Assessment The program meets the NRC guidelines with respect to inspector's performance and capability. All inspectors were secompanied by supervisors during the review period, although some of the i accompaniments were made by the contracting agency supervisors rather than by REB headquarters. y.m, (... .._,,,, ;;.7, 9,,, I l 1

63 During the review, the following accompaniments were made: Agency inspector h Date Lic. No. Licensee D1R S Kim Wong IXD RAD 1/18/85 3968-70 Liberty Inspection Co. ORANCE Chapman COUNTT Jim Eartranft Mr.D 1/21/85 1946-30 Ceneral Resp. L.A. COUNTY Jim Rowles 310 Hr.D 1/22/85 3937-70 Ingene D1R N

r. ark Gottleib IND RAD 2/4/85 2851-07 Ekstern Industrial I-ray All four inspectors performed their inspections satisfactorily and demonstrated their competency and understanding of health and safety issues and regulations. Jim Rartranf t pointed out that be has not had the FRC medical training course sad the reviewer recommends he attend the course as soon as possible.

Two findings were noted that were common to all inspectors. None of the inspectors performed an appropriate instrument response check prior to the inspection, and more emphasis should have been placed on interviewing non radiation workers to evaluate their knowledge and training. These and other specific comments and recommendations were discussed with each inspector, and an oral summary of the comments was furnished to the appropriate supervisor. D. Responses to incidents and A11eaed incidents (Category 1) FRC Guidelines: Inquiries should be promptly made to evaluate tie need for onsite investigations. Onsite investigations should be proeptly made of incidents requiring reporting to the Agency in less than 30 days (10 Clit 20.403 types). Tor 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 may be of significant public interest and concern, e.g., transportation accidents. Investigations should include in-depth reviews of ciremstances and should be completed on a high priority basis. When appropriate, investigations should include reenactments and time-study measurements (normally within e few days). Investigation (or inspection) results s kuld be documented and enforcement action talen when appropriate. State licensees and the NRC should be notified of pertinent inferration about any (e.g., incident which could be relevant to other licensed operations equipment failure, improper operating proce6sres). Information on incidents invn1 ring failure of equipment should be provided to t.be () 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 er treet radiation Q ,p w;", ;.. s '.. s y, i. .s E NhD M-

64 injuries. The RCP should vse other technical consultants for ) special problems when needel. Questions: 1. How does the RCP respond to incidents and alleged incidents? Inquires and complaints are promptly evaluated to determine the need for onsite investigation. Onsite investigations are conducted where review discloses Class A or 3 (Lamediate or 24-hour notice requied) overerposure. 2. Are major incidents (10 C2ll 20.403 types requiring reporting in less than 30 days) investigated on a priority basis? Yes, the priority is as follows: Agency to initiate Tirst Notice Investigation within Type of occurrence to Dept./Atency period-specified f Type C overerposure or 15 days 15 days release 17CAC 30297 Type 8 overerposure, release or loss of use 17CAC 30295(b) I working day 3 working days i Type A overerposure, Immediately by phone, release or loss of notice within use 17CAC 30295(a) one working day 3 working days Lest or stolen source Jamediately by phone. 17 CAC 30294 notice within one workleg day 3 workles days Complaint-violation r i j of radiation safety and health requirements 1 workleg day 3 working days 3. Are otber incidents followed up in the nest scheduled inspection? Yes. 4 Are non-reportable incidents that may be of significant public interest and concern promptly investigated? i Yes. 5. How many incident investigations were conducted during the \\ review periodt ? $Y, ?q WmM s% $wQ~&.s. :QR.ggE .h9ft-Qg,~ < - i I 4

l ~ P 65 There were 234 incident investigations opened for calendar year 1984, and there were 34 closures during the year. There were Il cases of external radiation erposure, five Type A requiring l immediate notification and sin Type B requiring 24 hour notification. There were a total of 18 leaking or contaminated sources. 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 studica, as well as notification of the NRC and state licensees of incident information that say have been relevant to other licensed operations. Since the number is so large, a copy of the log is attached as Appendia K and the files are available for review. California does time and motion studies when necessary and convenes boards of inquiry when appropriate, i.e., X-ray Products, Sooth i Tvining. l l 7. Were any incidents attributed to generic-type equipment i i failuret No, not during this review period. 8. Vbat action was er would be taken by the RCP pertaining to incidents attributable to generic equipment failures in regsrd to notification of the NRC, other licensees and the regulatory I agency which approved the device? The NRC would be notified of any generic equipment failure. In addition, if the manufacturer is a California licensee, the e manufacturer would be required to correct the defect, and every attempt would be made to have the manufacturer volunteer to retrofit esisting units. If the manniscturer should refuse to retrofit, the users would be notified to stop using the unit. 9. If a failure should occur in equipment manufactured by a state r licensee, what action would be taken to: e. stop the manufacture or force changes in design? With respect to Californis licensees, tbs Department bas l authority to suspend or modify !! censes and by order i require retrofit of esisting devices or prohibit ass of such devices by Californis licensees. I b. assure retrofit of existing devices? Information regarding a Department order requiring retrofit and prohibitieg use of the device would be transmitted to other agencies by copy of the order.

...r- .& ? c-;'-:.R',e.; k i t

10. Wn are other Stats licensees and the NRC netified of pertinent isformation about se incidest?

Investigations involving equiparat falteres or selfunctions always incle.de review to deterstae whether the failure is generic or specific. If review discloses a possible generic f ailure the WRC is actified sloeg with (Le regulatory ageocy which approved the device and Californis !!cessees possessing the device. Ila. Are medical consultants available and used whes accessary? Reynold T. Brown, M.D., our principle medical coessit.ast, participates in review of investisations where expert ordical l consultation is required. b. Is the State aware of the availability of ordical consultants i iros R C? Yes, the State is aware of the EC resources.

12. Explain any ese of other technical consultants for special j

prob!ces encountered la incident investigations. There were none accessary to this review period. We would call l en the WC if needed.

13. Vere there any incidents sibce the last review meetics that act Abnormal Occurrence Report (AOR) criteria?

l [ No. ( VI. D f.eviewer Assessment: California's accident respoose program is escellent sad well withis the RC guidelines. The incident file was reviewed anJ st was found the RCP has a very good way of receiving, resolving, and closing out incident reports. so major problems were found with the file. A minor adelmistrative comecct is that reports recommended for closcout be more promptly closed out. A new procedure for investigating incidents er complaists went into effect Tebruary 1,1985. This t.ew procedure recoattaes the X-ray and radioactive materials files solag the new ADP systas, and will combine the resources of the Ecalth physicists and Radiation Protection fpecialists of both staffs. The tapact and effectiveness of the new procedure will be checked during upcostag reviews. E. Enferecuent Precedures (Category I) E C Guidelices: Ecforcement Procedures should be sufficient to provide a substantial deterrest to licensee acccompliance with )/ regulatory requirements. Provisions for the levying of monetary penalties are recommended. Enforcancet letters should be issued f ~

t i i I tJ i within 30 days following inspections and should employ appropriate regulatory language clearly specifying a!! items of noncompliance and health and safety matters identified during the inspection and j referencing the appropriate regulation or license condition being i violated. Enforcement letters should spe.:ify the time period for l the licensee to respond indicattag corrective actions and actions taken to prevent recurrence (sormally 20-30 days). The inspector l and compliance supervisor should review licensee responses. Licensee re:ponses to enforcement letters should be promptly acknowledged as to adequacy and resolction of previously unresolved (tems. Written Frocedures should esist for handling escalated enforeceent cases of i varying degrees. lepounding of material should be in accordance l with State administrative procedures. Opportunity for hearings should be provided to assure terartial adneinistration of the radiation control program. Ques tions : [ 1. Describe the State's enforcement procedures. i Briefly, the procedure is as fo!!ows: Violations and itees of l noncompliance are defined as to seriousness based on guidelints ( j of the HC. Items of noncompliance that are aggravated by repetitiveness, aFFear to be w!!!ful, are accompanied by a t l Istge number of other forms of noncompliance, or that have not l been corrected in a reasonable time may be raised in the level I of seriousness. A Class IV ites of noncompliance (no l j unnecessary erposure or unnecessary risk) requires a letter l 1 calling the licenste's attention to the satter, la the event I of a more serious violation, a letter is sent with a flotice of j Violation which calls for a reasonable date for reply. A l response wtirb, although technically inadequate, indicates the j desire to come into compliance calls for no unusual enforcement action, but stoply requires further correspondence between the 1 inspector and the licenser. In the occasional instance of a very tardy, incomplete, argumentative, or otherwise negatice 1 j j response, the case is handled by management and the license may be revoke 1. See Appendia L. } 7. If the RCP can apply civil penalties, explain the procedures for keying monetary pensities to violations. t Current law provides that willful or grossly negligent violation of radiation statutes, orders, or regulations is I punishable by Leposition of a civil penalty not to exceed $5,000 per day per violation. The presiding judge determines j the penalty amount. 3. Describe the State's provisions for crimir.al penalties. The liealth and Safety Code provides that violations of the i Radiatian Control Law and Regulaticos are punishable as 8 sisdemeanors with penalty not to exceed $500 and sin months in l jail for each count. i 1 ~ d i ) ) l f I i t 4

r 68 l r 4 Describe the policies in effect for issuiss field forms } equivalent to NRC fers 591 or 1ctters for enforcement action. California issues short forms for diminimus violations correctable en the spot where the licensee expresses a willingness to correct. 5. Are there written procedures for handling escalated enforcement l i casest Please provide copies for review. Yes. l 6. Can the State issue Orders; including Emergency Orders? Yes, the Chief, Department of Realth Services is now authorised to sign Emergency Orders. 7. Can the RCP impound radioactive asterialf The Radiation Control Progree has the authority in the Realth and Safety Code to impound radioactive material in an energency. t 8. Do State administrative procedures permit the opportunity for hearings in sajor enforcement cases? Enforcement actions are revievable informally within the Department and formally at administrative hearings and in Superior Court. 9. If during the review period the State has issued orders. applied civil penalties, sought cristnal penalties, impounded sources, or held formal enforcement bearings, identify these cases and enclose copies of the pertinent State enforcement correspondence or orders. As order requiring disposal of low level vaste and any necessary decontasination was issued to Pacific West Nuclear, Vista, California, followleg failure to respond to notices of violation relating to this matter. Legislation is being initiated to enforce the Department's order. A copy of the PVN order is attached as Appendia M.

10. Are enforcement letters issued within 30 days of the inspectionf f.nforcement actions are normally taken within 30 days of the inspection.

!!. Are enforcement letters written in regulatory language and reference regulations ar.d license conditions? I A fore notic. of violation is used and requires reference to regulations sud license conditions as appropriate. P e

• S.

48 i

t 69

12. Do the enforcement letters clearly differentiate between noncospliance itees and health and safety recasmendations?

Yes, enforcreent procedures require that health and safety recommendations must not be included in the Notice of Violation but instead are disenssed in a cover letter.

13. If applicable, do the letters separate actions subject to the State radiation control act sad State OSEA regulations?

'fbe fore only addresses violations of Title 17 (CAC) and not CAL-OSKA regulations. 14a. Are enforcement letters issued by inspectors or supervisors 7 ty intpectors.

b. If issued by inspectors, do they undergo supervisory review prior to dispatch?

prior review of enforcement letters is not required except in cases where the inspector judges the matter to be serious and to require supervisory input.

15. Do enforcement letters require the licensee to respond within a stated time period? Note the period.

Licensees responses to Notices of Violation are norss11y 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? i

b. Are they acknowledged?

They are reviewed and acknewledged by the inspector and are reviewed by the supervisor as part of the pacLage subsitted to the Program by the contractors or regional offices.

17. Eas the State taken escalated enforcement action against licensees vbo operate in multiple jurisdictions.

No. VI. E Reviewer Assessment: The State's enforcement progras does not meet the guidelines because ,~ et two significant issues identified during the review. Tirst, forty licenses have erpired since PWrch 1982, for which the REB has 4 taken no action. As far as can be determined, these licensees still possess sad use radioactive materials with erpired licenses. Additionally, two inspections were es6e en the erpired licenses; the first inspector did act sote nor cite the licenses for using l lW . l i l

l 70 \\ I radioactive material without a license, and the second inspector l ) noted the license had erpired but again did not cite the licensee i nor bring it to management's attentien that the licensee was j operating with an expired license. The correspondence files and interviews with the staff indicate that prograa management was advised of the probles but took no action. The second major issue involves management's lack of action on cases requiring escalated enforcement actions. There were some cases where contract agency inspectors could not bring recalcitrant licensees into compliance t i and referred the problee via written meno to the REB for resolution. ( The follow-up by pregraa management did not occur or was inadequate. T. Inspection procedures (Category 11) NRC Cuidelines: lespection guides, consistent with current R C 4 guidance, should be used by inspectors to assure unifors and coeplete inspection practices and provide technical guidance in the 5 g inspection of licensed progrees. The NRC Agreement states Guides may be used if properly supplemented by policy memoranda, agency 3 1 interpretations, etc. Written inspection policies should be issued to establish a policy for conductieg unannounced inspections, obtaining corrective action, followlog up and closing out previous a violations, assuricg emit interviews with managreent, and issuing appropriate notification of violations of health and safety prob 1ces. Procedures should be established for maintainics licensecs' compliance histories. Oral briefing of supervision or l 1 the renier inspector should be performed upon return free non-rt," tine inspections. For States with separate licensing and inspection staffs, procedures should be established for feesback of information to license reviewers. Questions: 1. Has the RCP develeted its own inspection guides or does it use RC guidest Californis has developed its own guides. j 2. Are current copies of the internal inspection forms and guides on file in the RCP office and with NRC7 Attach revisions or new guides developed since the last review. Region V has copies of all forms and guides. 3. Are inspectors furnished copies of inspection guides? Yes. 4 Discuss the use or non-use of inspection policy memoranda, interpretations, etc., to supplement inspection guides. l In addition to the guides, we use inspection procedures and inspection policy menos to sddress such issues and enforcement criteris, contasination limits, cleanliness surveys, etc. i l I a j i i

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i 71 S. Are there written procedures establishing policy for: a. unannounced inspections? No. b. obtaining corrective action? Yes. c. following-up and closing out previous citations of violationst Yes. d. exit interviews with management? Yes. e. issuieg notices of violations and findings of health and safety probless? Yes. f. categorizing the seriousness of violations? Yes. plesse provide copies of these procedures for review. 6. htst procedures have been established for saintaining licensees' compliance histories? The compliance histories have been maintained by a suesary sheet in the compliance folder. They will be part of the licensee data base in the new AOP systes. 7. Does the sector inspector or supervisor orally debrief the inspector upon returs from inspectionst Yes, when there is a local supervisor. 3. btat procedures are there for providing feedback free inspectors to licensingt Responses and coenttaents to citations or recommendations which significantly upgrade a licensee's radiation safety program are forwarded to licensing with a recommendation for seendment 1 action so t. hat the consitaents are enforceable as license conditions. In addition, licensing is advised to clear the record with respe:t to acceptance of corrective action following a notice of vicistion. l

i 1 72 i VI. T Feviewer Assessment: d The State partially meets the guidelices for inspection procedures j in that they do use inspection guides and have established policies for inspections and compliance actions. Two significant weaknesses r in the procedures that have been pointed out in previous reviews and that have been addressed elsewhere in this report stes from the fact that the compliance files are not updated until the inspections are coepletely closed out by the field offices, and this may take several months. This meses the cospliance supervisor is unaware of action being taken regarding enforcement letters, responses, and follow-up until after the fact. This also results in inadequate feedback between licensing and compliance. Although all amendments, renewals or new license applications are simultaneously asiled to inspectors and reviewers, the inspectors must forward any comments 4 to licensing within two weeks or it is automatically assumed the icspector has no probless with licensee compliance. The license reviewer, therefore, may not have access to the present compliance status and sust rely on the inspector to have time available to review his files and notify his of pending enforecaent actions. During the field accompaniments, it was found that the differect ccetractics agencies have different understandings of procedures and policies. The existing procedures should be vpdated to be consistent with current FRC guidance and be used by all regional of fices and contract agencies to assure uniform and consistent inspection practices. C. Inspection Reports (Category 11) KRC Cuidelines: Tindings of inspections should be documented in a report describing the scope of inspections, substantiating all itess of concoepliance and health and safety satters, describing the scope of liter. sees' prograr.s, and indicaticg the substance of discussions with licensee management and licensee's response. Reports should uniformly sed adequately docuseet the results of Inspections and identify areas of the licensee's progras which should receive special attention at the next inspection. Reports should show the status of previous noecorpliance and the independect physical seasurements made by the inspector. 1 Questiocs: 1. Rev do inspection reports document the inspection that was conducted and the inspectien findiegst Explain how the reports substantiste concoepliance and health and safety matters sed ] describe the scope of the licensee's pregras. l The inspectica reports are done on cos;rehensive forms that t docuseet the licensee's performance in pertinent matters of l health and safety. The reports serve as checklists to ecsure all areas of the progras are covered and the results are s amma rt red. The last page of the report lists the items of neccompliance, the finding and discussion, and the basis for =u I i a

I 73 I I close-out. The scope of the program is described both in the report and on the coversheet, j i 2. Do the reports l a. relate the discussions held with license management and interviews with workers? j Yes. I b. include independent seasurements conducted by the inspector? Yes, the measurements are documented. c. document follow-up of previous citations of violations sade by the inspector? 1 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 l described by the licensee coeplete with closcout. l d. identify areas of the licensee's program needing special attention at the cent inspection? ( The exit report section indicates the prelisinary findings and enforcement actions ava11stle or which will be considered. 3. Are inspectors routinely inspecting radvsste package preparation and shipping practices and do the reports document the results? Yes, the report evaluates complete and clear written instructions for package pickup and receiving, security and adequary of temporary storage when necessary, clear written internal delivery and transfer procedures, adequate package surecy and opening procedures, records of receipt and survey of packages, record of use and transfer of material, use of authorired shipping containers and adequate packing and shipping procedures. V1. G Reviewer Assessments Tifteen coepliance files were exasined by the reviewer. In general, the inspection reports were well done and satisfied snost elements of the suggested guidelines. Novaver, the reports lack consisteney and uniforzity because the inspectors with the different contracting i agencies all use different forms and different procedures in the performance of the inspections. This issue was addressed in the Administrative Procedures section of the report and will be further a pursued during the follow-up review. e O w d J 4 k

74 The list of the compliance files that were reviewed, along with ) several specific commerts pertaining to the files, is attached as Appendix N. H. Independent Measurements (Category II) FRC Cuidelines: Independent measurements should be sufficient in number and type to ensure the licensee's control of asterials and to validate the licensee's seasurements. RCP instrumentation should be adequate for surveying license operations (e.g., survey meters, air samplers, lab counting equipment for amears, identification of isotopes, etc.). CM Survey Meter: 0-20 ar/br Ion Chamber Survey Meter: several r/hr Neutron Survey Meter: Fast & Thermal Alpha Survey Meter: 0-100,000 c/m Air Samplers: Hi and Low Volume Lab Counters: Detect 0.001 ue/ wipe Velemeters Smoke tubes Lapel Air Sseplers Instrueent calibratics services or facilities should be readily available and appropriate for instrumentation used. Licensee equipment and facilities should not be used unless under a service centract. Exceptiens for other State Agencies, e.g., a State l'niversity, say be msde. Agency instruments should be calibrated at intervals not greater than that required to licensees being inspected. Questions: 1. Discuss the State's policy for conducting independent measurements as a part of each inspection (e.g., air samples, wipe aarples, air flows, dose rates). Are these acasurements documented in the inspection report? 4 It is our policy to conduct independent measurements as part of i cach inspection. Radiation levels are checked in controlled and uncentrolled areas, contamination levels are mesaured in the vicinity of the workplaces and effluents to the environment are measured when appropriate. The inspection reports verify that these levels are in compliance. There is a need for a standard forsat for independent sessurements by the field inspector. I; 2, List the instrumentation that is readily available to the RCp for surveying licensed operations and conducting appropriate independent seasurements. Each inspector can tske wipes, has a GM and ion chamber instrument and can ocasure alpha, beta and gsmaa radiation. 2

1 1 Each office has, in addition, airflow seasurement and air sarpling capability. The program has neutron sessuring capability. I 3. Describe the method used for calibrating survey instruments and the frequency of calibration. See the t'niform Calibration Protocol, previously provided which the contract agencies have agreed to follow. i VI. H Keviever Assessment: Inspectio. instruments used by the contracting agencies in the field effices are routinely calibrated; however, the prograr does est satisfy the independent measurements guttelines becauae of the y failure of the Branch effice to calibrate their instrusets. This } vas pointed out last year, but program management conteuds there is no tundios for calibration and no actica was taken. VII. OTHER ASPECTS OF THE STATE'S RADIATION COWT1t01. PROGRAM A. Nen-Agrecaent Sources os Eadiation 4 Questions: 1. Are the licensing and inspection procedures for NARM the same j as for agreement saterialst i California has a comprehensive Radistica Control Program. The I procedures for licensing and inspection of NARM are identical to the procedures established fot agreeme t s.sterials. i 4 2. Give the number cf X-ray v.achine (or tube) and accelerator i registrants by category, e.g., dental, medical, industrial, etc. As of January 10, 1985, the follewing numbers of X-ray r.achines were tegistered in California j Friority I Tubes 12,397 Priority II Tubes /,967 3 Priority III (dental) Tubes 21 013 Total Tubes ZT,377 3 q 3. How many aschine and accelerater inspecticas were made in the last yest (or other appropriate interval)? Tor the period between Jancary 1,1984, and December 31,19M, there were 3,531 inspections conducted in 1700 facilities. 4. Does the State license X-ray or nuclear medicine technologistst Yes, X-ray Technicisas rust be certified by the De;artment of Health Sersaces and Fuclear Medicine Technologists will be 4 l ^ . Z **L.:. N

• p. C, A' %.Q.. n ;' V.*bt;....t.. 4.

s.h m o

76 authorized under a radicactive materials license. See j Appendix 0 relative to implementation of Nuclear Medicine Techno1cEy I.icense amendeents planned for July 1,1985. VII. A. Reviewer Comments i Fene. B. Envireraental Moniterine Progras Questions: 1. To indicate the scope of the environmental sonitoring program, describes a. types of media sampled b. the number and locations of stations sampled c. the frequenry cf sample collection d. the analyses run en each type of sample These data are included in the 1984 contract report h1C 077-105 Environmental Surveillance report. 2. Is a copy of the latest environmental surveillance report available for review? Yes. VII. B. Reviewer Conrnent: None. C. Other Areas This section cf the review is fer 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 cr State-specific issues i raised by ATC staff. 1. Other Cenerie Issues Questions: a. yer radiography inspections, to what extent do you aske inspectices at terporary jcb sites? Terporary job site inspections for IR are required to close out inspections in California wher. the cospany has field eperations ongoing. b. Are you finding Ir-192 contamination on radiegraphic [ } equipment? l i i = r r t

77 Fo, the California inspectors have been instructed to survey the guide tubes for contamination with a GM survey meter as part of their inspection. Californis vill again remind the inspectors to periors this survey, and to document the results. c. What are the $tste's plans to adopt the low-level waste (LLW) manifest rule (if not already adopted)? The State has recently adopted the low-level vaste sanifest rule (10 CTR 20.311) and it is currently in i effect. d. For States with LLW disposal sites, what are the State's plans to implement 10 CTR 617 The State is prepesing to develop a low-level waste site as soon as possible and has stready adopted 10 CTR 61 which is now in effect. e. Will your State have access to a LLW disposal site after January, 19867 If not, what contingency plans are there for af ter January,19867 The State will not have the low level site, proposed, cperating 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 available. f. Have copies of 10 CTR 61 and FRC technical positions on waste form and classification been distributed to State licensees? If there has been feedback please provide documentation. Copies of 10 CTR 61, but not all of the NEC technical positicn on vaste, have been sailed to all State licensees. There has been no feedback from any licensee en 10 CTR 61. g. Have there been any applications or approvals for incineration, compacting or disposal? There have been non-commercial applications and approvals for incineration, compacting and disposal (not shallow land burial). The major one currently beirig reviewed is Stanford University. There have been no commercial applications or approvals for incineration, compacting or disposal except for those companiss seeking the low-level vaste site license designee position in California. h. What use is being made of IF informatica noticest j

t i i 78 NRC IE information notices are distributed to license ) reviewers and inspectors but not to California licensees. If the information needs to be distributed to licenseca, t California puts out a Radiation Safety Advisory to all licensees. i. Identify any group of materials licensees for which the State has increased the frequency of inspection due to problems with that general category. Please discuss the nature of those problems. There are no material licensees in California for which the State has increased the frequency of inspections due to problems, during this review period. l l j. With respect to medical licensees, is the State making any effort during inspections of nuclear pharsseies to determine whether the licensee is actually conducting the required molybdenum breekthrough tests, i.e., what is the State doing in addition to record reviews to establish j i compliance or noncompliance with the requirement? j y I Molybdenum breakthrough is inspected during every routine I inspection of medical and pharmacy licensees. In one j 4 special case California used an NRC order to Euclear i Ftarmacy Inc. to get voluntary coepliance, and California j l is receiving reports pursuant to this orcer (an agreement only in Californis) to verify compliance along with routine inspections. No other additional Holy survey work has been undert ken in the State. k. Is the State sounting any special effort to lock at the pessibility of reconcentration of radionuclides in sanitary sewers snd sewage treatment plants as part of the regular inspection progras? If so, please describe. The State reviewed the All Agreement State letter addressing the sewage reconcentration problem and could not find any situations where it could be a probla. Californis has, in the past, run a sewage aludge stepling program (under EPA) and found no problems. VII. C. Reviewer Comment: Fone. I. i ,... _, _ ~. - - -,..,,, - ~., - I

1 4-.:....... 79 l List of Appendices 1 A. California Statutes

• 2.

lov Level Vaste Regulations

• l C.

California State Orpaizational Charts i D-l. E.adiological Ecalth Branch 0 pnizational Charts D-2. Proposed REB Orpaizational Charts E. FB Emergency Call List

• F.

License fee schedule

• C.

Personnel Training Records' l E. License File Reviev l 1. 55 and D File Reviev J. laspection Friority Schedule E. Incident Investigation leg

• L.

Inspection Policy tiemo* ff. Facific West Kuclear Order

• l K.

Compliance file Review s 0. License Authorization for Nuclear fledicine Technology

• Appendix has been reviewed try the reviewers asd a cery retained in the regtenal files.

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.I I Radiologic Health Eranch Jcsepn O. Ward, Chief 9 7-Radiatien Centrol Su;ervising Health Physicist 1.___________q I-Ray Machine Registration / Federal Centract X-Ray Machino inspections Inspection Inspectfens Contract Agencies Eus, tace Douglas. RPS !! Les Acceles Ceonty 3. m -n 91-901 Joe Karbus, llead Al Ferguson, Superviser Kathy Akey Kathleen Kaufman Paul Baldenwig Milland Campbell $al Espiritu Geerge David Jeanne Crosby Wilbur York Oran9e County James Hartranf t 0 Clint Jchnsen Cecil York i Lee Burrell I 5 5 1 i i \\ Appendix D-1, y) } f l 1 i i a P i

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$ m 11 S OL !! 907-160-1129-718 007-160-1329-708 80bl60-1129-710 337-160-!!29-719 43bl60-1129-721 00M10-It ?S-711 Pobl60-1125-707 907-1f 0-1129-716 007-160-3123-720 ac7-160-II29-709 go7-160-132 N J1 90bl601129-713 307-160-1329-901 t.S W. klp) 307-160-3128-714 l i hp ~* n+=itr t em - e wn-1.wn. 4 2M i. c ~ r

• • te.sta swePet will emmt 3 =Mitimal asentiste vaultti **rsletzte erul 1 ottin Tedmacian.

{ l L ,e-.s r up w-+-i w -+wwy e* w. %-i y-3: W-g + + -w. m e-e--

80 APPENDIX H i Keview of License Files Twenty-e16 t Pre-selected license files were reviewed. License applications h were reviewed for completeness and for proper signatures. Casework was revteved for timelicers, completenese, accuracy, peer-review, and considerstic.n of enforcement history. Licenses were reviewed for completeness and adequacy. The review of the files indi:sted that appropriate license conditions were sometimes inadvertently ositted. Documentation of the training and experience for users was not always provided. The licensee's compliance history was not always considere1 during the review process. Equipment and facility descriptions were sometimes not complete. Several complex licensing actions were issued without any indication in the file of a peer review. It was also noted a lack of consistency cxists between licenses of the same type prepared by different reviewers. Copies of currently availabler checklists and guidea were left by the reviewers. Generic concerns were identified in a general staff meeting sad discussed with supervisory and management staff. Specific comments on individual files are given belev. Tile Case No. 1 Licensee: Memorial Hospital Medical Center Address: P. O. Box II.28; 2801 Attentic Avenue Long Beach, CA. 90501 License Fuaber: 0165-70 Date of Issuance: Irpiration Date: March 31, 1991 New: Amend: Renew: X Scope of License: Nuclear medicine includina radiopharssecutical i 4 e l 1 l i i i .I

81 Tile Case No. 2 o Licensee: White Memerf al Medical Center Address: 1720 Brooklyn Avenue Les Anreles, California 90033 License Number: 1426-70 Date of Issuance: October 11, 1984 Erpiration Date: October 14, 1991 New: Amend: Rerev: X r Scope of License: Nuclear medief ne, including radiopharmaceutical File Case No. 3 Licensee: Los Angeles County - Martin Luther King, Jr. General Hospital Address: 12021 South Wilmington Avenue Los Angeles, California 90059 license Number: 2317-70 Date of Issuance: Detober 15, 1975 Erpitation Date: March 23, 1986 New: Amend: ___X Renews Scope of License: Nuclear medicine, therapy, brachytherapy File Case No. 4 l Licensee Little Company of Mary Nespital i Address: 4101 Vest Terrance Boulevard Terrance, California 90503 License Number: 1258-70 i Date of Issuance: October 18, 1984 5 Erpiration Date: July 14, 1990 Nev: Amends Renew: X Scope of Licenses Noelear medicine - including '.herapeutic uses i I _.28FTFE. l Nbt{g ' " 5 WIFE!N="""". N..----- _ - - x-i 1

82 Tile Case No. 5 Licensee: Lena Beach Medical Isaring Center Address: 4200 East Pacific Coast Highway Long Eesch, California 90803 License Number: 4442-70 Date of Issusace: Decerber 7, 1984 Erpiration Date: December 7,1991 New: X Amend: Renew: Scope of License: Disanostic studies Xe-127 er Xe-133 Tile Case No. 6 Licensee: Pacific Medical Ir. aging, Inc. Address: 8071 $1 ster Avenue, Suite 260 Huntingten Ecach, California 92647 License Number: 4313-70 Date of Issuance: May 7,1984 Expiratica Date: May 7, 1991 Nev: X Amend: Renew: Tile Case No. 7 licensee: Les Angeles Coenunity Hospital Address: 4081 East 01vrpic Boulevard Les Angeles, California 90023 License Number: 4297-70 Date of Issuance: March 7, 1984 Empiration Date: March 7, 1991 News X Amend: Eenews Scope of License: Creurs 1 and 2 including Xe-127 and Xe-133 gas l ( t i

83 Tile Case No. B -l a Licensee: Eay Med, Inc. i Address: 3530 Melody Drive Walnut Creek, CsTifornis 94595 License Number: 4500-07 Date of Issuance: December 17, 1984 Expiration Date: December 17, 1991 New: X Amend: Renew: i Scope of License: Lixiscope use for storate and demonstration i Tile case No. 9 l Licensee: William W. Malls, M.D. l Address: 1193 East Nerndon, suite 106 Fresno, California 93710 license Number: 4468-10 i I Date of Issuance: November 6,1984 Expirstion Date: November 6,1991 Kev: X Amend: Renew: Scepe of License: Norland Corporatien mediest diagnostic File Case No. 10 Licensee: N. T. Enlee Memorial Eospital Phart.acy Address: West Tifth and the Esplanade Chico, California 95926 License Number: 4312-04 Date of Issuance: March 12, 1984 I Expiration Date: March 12, 1991 ~ I New: X Ae.ep2: Renews t Scepe of License: Nuclear theresey i t 1

..sq~ ~. V;1. VS :*.;h. lQ:-F.3 4 !:. ',l.[ ':#$$U.%? 't> ?;$hhifk$f_ -T j . A 84 File Case No. 11 Licensee: Syncor Corporation l Address: !96 :icodell Street. SanFrancisco, California 9413 i License Kumber: 4211-90 Date of issuance: December 2, 1983 Expiration Date: December 2, 1990 New: X Amend: Rency: i l Scepe of Liceose: Fuclear charmacy I file Case No. 12 Licensee: ICE Products, Ltd. Address: 14310 Catalica Street San Leandro, California 94577 License Kumber: 4405-60 Date of issusace: October 5, 1984 Expiration Cate: October 5, 1991 f*** _%, Amend: Recev: Scope of License: Tracers for biocheelest studies 1 File Case No. 13 Licensee: Cetus Corporation Mdres s : 1400 Tifty-Third Street Escrreille, California 94608 License Kusber: 317I+62 Date of issuance: November 13, 1984 i Expiration Date: June 28, 1991 i Krs: Amend: Rency: _x_ Scope of License Blochemical and biolestest studies = 3 e + l i

l I i 85 l I File Case No. 14 Licensee: Elo Response. Inc. Address: 1978 West Vir. tee Avenue Hayward, California 94545 1 License Fumber: 4273-60 Date of Issuance: December 6, 1983 Lapitation Date: Deccaber 6, 1990 New: _X_ Amend: Renew: ? Scope of License: Tracers for cheetcal and biological studies File Case No. 15 Licensee: John Muir Cancer and Atine Research Institute Address: 2055 North Broadway I Valcut Creek, Calafernia 94596 t License Fuzber 4463-07 Date of issuance: October 24, 1984 f f Empiration Date: Octeber 24, 1991 New: X Amend: Recew: Scope of License: Tracers for chemical and bieleric61 studies ( Tile Case No. 16 i liter.ste: National Nuclear Corp, i Address: 1904 Colony Street Hountain Vsew California 94043 j License Fusber _1718 43 Cate of Issuance November 29, 1983 Empiration Date: May 31, 1990 j Few: Amend Renews X Scope of License Causes, detection devices, assay + b I h I 1 .-.2--

i .==. -<- 86 i File Case No. 17 Licensee: Nor Cal Testing, Inc. Address: P. O. Box 238 i Tairficid, Californis 94533 License Number: 4424-48 Date of Issuance: October 2, 1984 Expiration Date: Ceteber 2,1991 New: X Amend: Renew: Scope of License: Industrial Radiography - Treporary job sites throughout the State File Case No. 18 Licensee: Todd Pacific Stiipyards Corp. - Los Angeles Division Address: 70! Front Street San Fedro, California 90733 License Number: 4296-70 Date of Issuance: February 16, 1984 1 Expiration Date: Tetruary 16, 1991 New: _X Amend: Renew: Secpc of License: Industrial radiography at shipyards a File Case No. 19 Licensee: Halliburton Services Address: Drawer 1431 Duncan, Oklahoss 73536 License Number: 3561-70 Date of issuance: April 16, 1981 Expiration Date: April 16, 1988 Fev: Amend: X Renew: ( Scepe of License: Tracer use for well-lorrinr: cement plur markers used

n well bores

. ~. ...:o 4.e, _ - ,1. 4 0 e

f t 87 h I Tile Case No. 20 Licensee: Production Lettina Services Vest, foe. Address: 1801 West Wardlow Road Leer Leach, California 90810 i License Number: 4224-70 l Date of Issuance: January 12, 1984 Expiration Date: January 12, 1991 I Few: X Amend: Renew: Scope of License: Well letting tracer studies in well bore Tile Case No. 21 Licensee: Chevren Research Company Address: 576 Standard Avenue Ricteond, California 94802 License Number: 0164-07 Date of Issuance: Deteber 3, 1984 Expiratien Date: May 23, 1991 New: Amend: Renew: X Scepe of License: Research and development Neutron renerator tartets Tile Case No. 22 Licensee: Rockwell Internattenal Science Center Address: 1049 Casino Dos Ries Thousand Oaks, California 91360 i l License Number: 0122-56 i I Date of Issuance: January 5, 1984 Expiration Date: July 11, 1990 l l New: Amend: X Renew: \\ Scope of License: Pread scope research and development and a sama irrad:stor I I

l i 5 i BB l l i Tile Case No. 23 4 Licensee: TRV Electrocies and Defense Sector j Address: One Srsee Park Eedendo beach, California 90278 License Number: 0816-70 i Date of Issuance: Detober 18, 1983 Empiration Date: Deteber 17, 1990 New: Amends Renew: __X__ i Scope of License: Broad scope research and development Tile Case No. 24 Licensee: University of Southern California: Hes1th Sciences Campus Address: 1985 Zonal Avenue Les Ar.reles, California 90033 License Number: 1949-70 Date of Issuance: December 2, 1983 Erpiration Date: December 3, 1990 Nev: Amend: Eenew: __,X___ Scope of License: Resesreh and development, includint instructional } protras and human use, Cammacell 200 f rradiater i Tile Case No. 25 I Licensee: Cura care Address: 1400 Lene Pals Ave., Modesto, California 95353 License Number 3461-50 Date of Issuance: March 28, 1979 Erpiration Date: March 28,1986 I l License Type: Mobile Van p i t

l 89 I l Tile Case No. 26 i Licensee: FPI Distnestic Services ~ Address: 16312 Carfield Ave. Farssent, California 90723 License Number: 3521-70 Date of Issuance: June 12, 1979 j Expiration Date: June 12, 1986 License Type: Mobile Van File Case No. 27 Licensee: Serirrs Clinie and Research Foundation and Hospital Address: 10666 N. Terry Pines Rd., La Jolla, California 92037 License Number: 0450-80 Date of Issuance: March 6, 19E0 Expiration Date: August 13, 1966 License Type: Medical File Case No. 28 Licensee: Tisher, Davis, Claessner D's Corp. Address: 10921 Wilshire Blvd., Suite 113, Les Anteles CA 90024 License Number: 0722-70 Date of Issuance: September 2^. 1982 Expiration Date: June 28, 1989 License Types Medical l l l l l l 1

I 90 1 Coronent License Case Number ^ 1. No documented evidence of QA either 1, 7, 10, 11, 14, 16 peer or constittee review 20, 22, 23, 24, 2. Physician authorized for "all therapeutic uses with no documented training for groups IV and V (/merican board cert. Cr VI only) 1, 3. The physician RSO (RPO) had no documented training for unsealed asterials 1, 4. Reviewer did not request inventory system vben two separate groups could order RAM at two separate locations under one license 1, 5. New RSO (by seendment) not referenced in License Condition 13, the tiedown condition 1, 6. Foor compliance history not reflected in license renewal 1, 2, 4, 7. The location and drawing of adjacent areas for the Camma cell 2000A frradiator was not provided in the application 1, 8. Bioassay considerations were not addressed for persons administering therapeutic amounts of volatile iodine 2, ) 9. Use of Lixiscope was not restricted to ortheredic surgery as described 3,

10. Reviewers did not check approved training lists or alternate qualifications before user authorizatien (Lixiscope, bone scanners, etc.)

3, 8,

11. Xe use authorized but facilities not evaluated nor referected if evaluated under different license 6,

I t

12. Preceptor statement indicates training and treatment on same dates in different States, conflicts were not resolved prior to user authorization 9,

13. Applicatica referenced NRC document, which was not provided in license file 9,

t

14. Application referenced manufactures operations manual as procedure, no copy provided in file 9,

i

15. Use of volatile iodine was authorized but no procedures were provided nor requested 10, 4

i 1 4 i b

91 l k, I ) i Coneent I.icense Case Number 1 1 i

16. Use of Xe was authorized but no supporting documentation was provided or requested 10,

17. Instructions on retrieving waste free customers I

by pharzacy not provided nor requested 10,

18. Long term vaste storage area was not described nor requested 10,

19. Actus1 radiopharmaceutical labels were not provided in the application nor requested 10,

20. fiolybdesum breakthrough tests, dose asray and package inserts were not included as license conditions (they were in application)*

10, t

21. Extremity dosimetry was discussed but only wrist badges when finger rings would have been more appropriate 10,

22. Two different instrument calibration procedures submitted, applicant unclear as to which would be used 11,

23. A license condition prohibiting human use was not included in the license (esp. bio-labs) where RAM use was unclear 12, 13, 14, 15 24 A centralized method of controlling procurement of RAM was not described nor requested 15,

25. With R and D temporary job sites were not described in the application 16,

26. Review did not assure IR use at large shipyard does not use public streets and/or D.O.T. requirements were not addressed (documentation) 18,

27. Tractionating sand residue was not clearly described as radioactive vaste and therefore not addressed as such 19,

28. procedures specific to opening iodine

[ shipments were not subsitted 20, t

29. Eandling tools and transport containers were not described to prevent centseinstion 20,

30. Applicants bicassay procedure (via use of

[ survey meter) not adequate, reviewer did not I.j require clearly supported procedures 21, ! I i

92 License Case Number Conrnent

31. No license condition covering bicassay (biosssay was in application)*

23,

32. Mobile Van authorized any tesperary job site, including administering Xenon, in CA without prior reviewer evaluation 25, 26, **

33. Clinic authorized to modify unit doses prior to administration. Clinic was not required to then reassay dose prior to a dminis tra tion 2 8, **

Current California policy which is not censistent with current h*RC policy: 1. California does not require unit dose radiopharmaceuticals assayed prior to shipping from pharmacies to be re-assayed prior to administration at place of use. 2. Mobile Van Nuclear Medicine Services are authorized to administer radiopharsaceuticals at any time at licensed facilities, unlicensed facilities (clinics, hospitals, doctor's offices, etc.) and temporary jobsites through California (institutions, homes, mobile vans, etc.). 3. Mebile Van FM Services are also authorized to administer gaseous (Xe-133, Xe-127, etc.) radiepharmaceuticals at any time at licensed facilities, unlicensed facilities and temporary jobsites throughout California without prior reviewer evaluation.

• ,1though the procedure was covered in the application which is part of the

.license, KRC practice is to highlight this requirement through a specific license condition.

• • These license files were beyond this review period and are listed tere only as a reminder to RHB that they need to clear-up past oversights.

I AFTENDIX I I Scaled Source and Device Reviews l During 1984, California registered six sealed sources or devices. The file on each ' tem was reviewed. Specific reference was made to the findings of the 1983 ieview to determine whether the same deficiencies perceived for the source and device reviews completed in 1983 existed in the 1984 reviews. I The 1984 sealed source and device registry sheets showed a dis.icct irprsvement over 1983. In the 1983 review, in some cases, a major component of the registry information was sissing. lio such omissions were noted en the 1984 sheets. The sost common problem found in the six reviews was the gus11ty j cf drawings associated with the registry sheets. The findings were as follows: r i 1. Design drawings incorporated in registry sheets and included 2n design i package could be leproved. KRC found in the 1983 review that the method l 1 of fixing source in shield was not always shown. This review found the same problem. I 2. The J. L. Shephered backup zaterial (Manuf acturer's Information Sheet i and Operating Manual) contained inecnsistencies, i 3. Protectica of source against unauthorized removal was not required for } Campbell Pacific Fuclear Corporation Tixed/ Portable cause (CA-208 D-105-s) when the gauge was not attached to a vall or table. 4 An error in A.NSI classification was found. 1 = 3 Detailed comments and problems are given en the attached sheets. I i 1 i i ) I t l i i i 1 \\ a I I 1 5 l k t

t i 9 SEALED SOURCE AND DEVICE FIVIEW No. :- CA-621-5-101-5 Date: 051584 Review No.: 64-1 i Scaled Source Type: Brachytherapy Max. Activtty: 150 aCf + l i Isotope: C$137 j Manufacturer /Dist: Syncor Corp. 1141 Air Way Glendale, CA 91201 j 1 i Discussion: French manufactured sources distributed in U.S. by Syncor. l t 2 l l Problen: No problems seen. [ ~' 4 ( { i t 1 I e 6 1 i 1 i 4 a 1 1 J b J 6 )-

I i ) SEALED SOURCE AND DEVICE REY!EW l l No.: CA-4D6-5-117 U page: ggggg4 Sealed Source Type: Lab. Inst. Calfbration Max. Activity: 1 uCf Isotopes: Several Manufacturer /Dist.: Isotope Products Lab. 1800 N. Keystene Street Burbank, CA 91506 Discussion: 1. Revision of 1974 registry sheet, revision increased activity for l Ep 237 and Th 230 to 0.1 uti from 0.005 utt. f 2. Data sheet not standard for 1984. No attept made to conform data 9 sheet dere possible, f.e., leak test frequency: Norwal; No standard i conditions. ) Problems: None found. Wo effort made to updata page 1 of registry sheets (frequency of leak test specified as normal). I O a

SEALED 50!JRCE MD DEVICE REYlEW No.: CA-208-D-105 5 Date: 070364 Review No.: 84-2 Device Type: Fired / Portable Gauge Maximus Activity: 50 aCf (Hydrogenous Matl Aral) Isotope: Am241/Be Manufacturer: Campbell Pactfic Nuclear Corp. i i 130 South Buchanan Circle Fachecho, CA 94E53 Diseussion: 1. 30 drawing of tungsten cup holding source, no method by which cup is secured to sarnple pleM. Applicant states all similar devices manufactured by him have sisflar design. 2. M51 classification is incorrect: MS!-45-179-189-R2 given by licensee; incorporated into regtstry sheet. MSI-45-175-165-R2 is optimal classification for device. CA reviewer's copy of MS W538 same as WRC's. Verification of M51 classification would have shown applicant's error. 3. Comp 11ance file (1979) makes plea to get CPNC to give 2 day rather than 1 day training for soll density gauges. License renewal (Amend 4) predicated (March 9,1981 letter) on agreement to expand training course to 2 days; inspection of 5/7,12/82 and 6/17/8?, acts 12 states ARSO states gauge training course is 1 day. Review of this new gauge did not question CPNC on training course length. Lategth of training i did not appear to be specified in application. Problem: Drawing poor; no infotsstion on source installation, nor reference 1. to cther device registry sheets. l 2. MSI classification not checked and facorrect. 3. No verification of trafnfnp course length. (No specf fic length is reqvfred; NRC wants 1 day minimum; comment included only because of Ifcense fils.) 4. Only reconnendation that device be secured to wall or counter (no requirement). (Verffled review relative to problems with Bagottt #10. Fad 1ts ] found with that review were not applicable to this rerfew.) I I l \\

t i Date: 2/11/85 SEALED SOURCE AND DEVICE REVIEW , 9 No.: CA-181-D-101-G Date: 071784 Review No.: 84-3 Maximus Activity: 40 vCi Device Type: Liquid Scintillation Isotope: C5137 1 Counters Manufacturer: Beckman Instruments 2500 Harbor Boulevard Fullerton, CA 92634 Discussion: 1. Registry sheets developed for renewal of Itcense 1313-30 GL. 2. Source description and source holder descriptions confusing. Beckman really wanted to Ifcense three sistlar sources / source housings. CA could license only two based on infory.ation obtained from Beckman in response to CA questions. Third source / assembly still open. 3. Source drawings dated 1968/1978. Problems: 1. Beckman submitts1 confusing with regard to sources / source housings. CA had to obtain drawing from IPL; could get no information from Amersham. i 2. Figures 1 and 2 show Model 167760 configurations. Model 59522 has similar configurations with activity limited to 30 901. Description on figures in confusing since model number of source is not on figures. 3. No other problems. (Exempt cuantity is 10 uti; devices used for standards in testing unsealed L5 samples). I l i \\ O

SEALED SOURCE AND DEY!CE RIVIEW Mo.: CA-207-D-101-5 Date: 073184 Review ho.: 84-4 Device Type: Fortable Mofsture Mar. Actfrity: 1 u;f Density Gauge 1sotope: 54133 Manufacturer: Campbell Engineering Co. (CECO) 120 50. Buchanan Circle Facheco, CA 94553 Of5cussion: 1. Model nuter cf source correct. 2. AN5! designation 0.K. 3. Length of training not specified try applicant. (See CFNC CA-208-D-105 5 for comments) O frobism: 1. Did not obtain statament on training course length under this new ifcense neder (A147-07) (Prf acipals same as CTHC - see Rerf ew so 84-2). O P

SEALED $0' ACE AND DCYICE REY!EW so.: CA-598-D-115-5 Data: 121484 Derfce Type: Gamme Irradiator/ Calibrator Manufacturer /Distrfbutor: J. L. Shepard & Associates 740 Salem Street Glendale, CA 91203 Diseussion: 1. Four models of Category !! frradiators, loaded wf th up to 13,200 Cl 1 of Cs137 or 10 Cf Co60. l t 2. Description could be improved. One sentence devoted to spring and i pneumatic return. No mention of use of bottled gas on larger frradiators to return source to off position. No statement about t shipping (DOT 7A). 3. Ffpures are not very good. Only dual, triple and quadruple source configuration contain note about failsafe spring return. G 4. Emergency procedures are less than rigorous: CA asked if survey meter should not be used when person is tr{ good idea fog manually to push 4 stuck source into off position. JLS said me will incorporate it into operating instructions. Norepfacement page sent. l 5. Manufacturers information sheet (N!$) for 81-12 and 81-14 calls for J person to enter cell from back side of frradf ater and push stuck source down. Operating manual says use high pressure gas from i cylinder. No CA question on this (tas: CA did state licenese (f.e., purchaser of frradf ater) sust evaluate specific needs of 10 CTR 20.203(c)(6). 6. Training not specified as a service to device users. Trafnfag appears to be a correctfre action for Mart ! event. 7. Information on prototype testing and QA appears inadequate. I Model 81-22 (March 5,1964 letter) source was sticking in exposed j position when M2 cut off. It hap 22,1964)pened several times.J. L. Shepard i corrected (1stter March Old e::t tie back to these i units which have same source morament sechanism. ) i 8. Did act appear to amend license (perhaps worded so that amendment was not required). Licensee (manufacturer) should have emergency procedures. No reference it: M18 to any detailed procedures. 9 a

1 t 2-O Frobless: 1. Review does not seem to have teen coordinated with J. L. Shepard Itcensing flie, since no question raf sed about sticking source in Model 81-22. This lack brings up question of the adequacy of prototype testfag. 2. CA obtained commttaent from J. L. Shepard to rertse energency procedures but did not ask for, por obtain corrected copy. Emergency procedures inconsistent between MIS and draft operating manual. l I J t b 1 s 3 1 i s N 4 l O I I

i l i ,.1 INSPECTION PRIORITIES I I II III IV y Industrisi ~ MLjor procsasor E Refineries, chemical processing of scures material I I I TIP* T7Pss 3 road authorisation A 3&C 384103r8I17 I hate Collection 7 Soil gages X Ot.her sages, C.D. so.:rce sets, light seuces check sources, Ng.Th storsgs, OC I Other K ? Ediest ' ainoad autherisation I Diagnosis and/or therapy I Diagnosisonly;and/crthersyywith possecsion limit met exceeiing 100 3C1. Flesio-thersyy (or.her than short &asse) and generators arcluded Y Academie Types Brosa auth. W ation B&C ~

e..

iurw10Kt% b.6 Priority I U nI IV V Initial (aceths)g 1 6 12 18 Bon. routine Follow-up

• 1 b T.4-Ki (Tr )

3 1 05 03 h (mooths) g 4 12 24 36 Omdue.(months)g 6 18 36 .~ , b k t4 Sf iSSM hee AFFZ OII.T CA S$ l M h J ate of last lasp wstas

i 9t h 1 AFFEKDIX N l REVIEW CT COMPEI ANCE TILES 1 I Tifteen corpliance flies were reviewed during the 1985 California review. These files were reviewed to determine whether the inspection reports i uniformly and adequately documented the scope and results of the inspection, appropriate compliance action was taken, enforcement letters were written in 1 apprcpriate regulatory language, enforcement actions with responses and acknowlidgements were completed in a timely menner, unresolved iter,s were pursued to conclusion, sad compliance actions had proper supervisory review. The inspecta.. report:, in general, were well drafted, complete, and adequately described the results and scope of the inspection and in most instances proper follow-through was observed. However, the four offices l staffed by contract agencies all use different forms and different procedures in the performance cf the inspections. j Examination of the files revealed that in two cases inspections were performed on licenses that had expired without proper action on the part of the 8 insrector, and in two cases headquarters supervision did not properly s follow up on escalated enforcement action that was indicated. These issues were addressed under Enforcement Procedures. A significant problem remains in the amount of time that is required for the j inspection reports to reach Branch headquarters and be reviewed and properly A filed This issue has been addressed in the Management section of the report. The license files reviewed are listed below and are followed by a table summarizing the comments on each file. M 1 1 l s t 6 o M a f y b .Y" .m - ( [,, W J Ne hk - 1 S - - ~ - -r-l 1

r 95 Tile No. 1 Licensee: Medi-Physics, Inc. Address: 5855 Christie Ave., Emeryville, California License No. 2067-60 Type: Pha rsa ry Priority M Inspection Date: July 19, 1984 Inspector (s) Jack Brown Type of Inspection: Announced P Inspection Desedpcion: Complete Style of Report: Tore Report Date: July 19,1984 Report Reviewed by: Jack Brown Date Reviewed: August 8, 1984 "591" Type Form Used? EM 2514 Short Term Enforcement Letter Date: M Signed by: M Date of Licensee Response: At time of Inspection (en Form 2514) i Date of State Acknowledgement: N.A. r Tile No. 2 Licensee: Culf Nuclea r Inc. i j Address: 2765 Rose Ave., Signal Hill, CA 90806 License No: 3127-70 Type: Termination Priority: 3 ? Inspection Date: March 28, 1984 Inspector (s) Cene Edmends Type of Inspection: Announced Inspection

Description:

Complete Style of Report: Narrative Report Date April 9, 1984 { Report Reviewed by: Al Terruson Date Reviewed: April 9, 1984 I "591" Type Tors L' sed? M Enforcement Letter Dste: M Sigac$ by: M Date of Licensee Kesponses M } Date of State Acknowledgesect: M f i b i O e ~ fg a "4 4 "4

96 I Tile No. 3 j ( Licensee: Brea Community Respital Address: 380 W. Central Avenue. Brea. California 92621 I License No: 2976-30 Type: Medical Priority: H i Inspection Date: Detober 19. 1984 Inspector (s): Jim Eartranft Type of Inspection: Announced inspection

Description:

Corplete i Style of Report: Term UTT-10-80 Report Date: October 19, 1984 Report Reviewed by: Jim Hartranft Date Reviewed: Deteber 19. 1984 i "591" Type Torm Used7 Enforeecent Letter Date: Deteber 23, 1984 Signed by: Jim Hartranft Date of Licensee Response: October 31, 1984 Date of State Acknowledgement: November 13, 1984 Tile No. 4 Licensee: Mira Loma Hespital Address: 44900 No. 60th St. W. Isneaster, California 93534 License No: ,4103-70 Type: Medical Priority: H Inspection Date: August 3, 1984 Inspector (s): Jim Rowles Type of Inspetion: Announced, Initial Inspecticn Descriptier.: Complete Style of Report: Term IRC 2 83 Report Date August 3, 1984 P.eport Reviewed by: Al Terrusen Date Reviewed: August 7, 1984 "591" Type Torn Useat Laforcement Letter Date August 7. 1984 Signed by: Joe Karbus Date of Licensee Response: Aurust 24, 1984 Date of State Acknowledgement: August 29, 1984 a

• w f*.3 % fD 44 Q.g y 4 k

. j wghr ' gf K ' ~ y a

i 97 f i Tile No. 5 ) e Licensee: Little Company of Mary Hospitsi l i Address: 4101 W. Terrance Blvd., Torrance. Californis 90503 License No: 1258-70 Type: Medical Priority: H Inspection Date: Detober 9.1984 Inspector (s): Gene Edmonds j Type of Inspection: Announced I Inspection

Description:

Complete Style of Report: Term IRC-2 83 Report Date: Detober 15. 1984 f Report Reviewed by: Al Terrusen Date Reviewed: October 16. 1984 "591" Type Torm Used? No f Enforcement Letter Date: Detober 15, 1984 Signed by: Edmonds ...d Tertusen Date of Licensee Response: Detober 30, 1984 i Date of State Acknowledgement: November 2, 1984 [ Tile No. 6 Licensee: Antington Memorist Hospital Address: 100 Congress Street. Huntf erton Beach, California f License No: 0239-70 Type: Medical Priority: E Inspection Date: July 2-6, 1984 Inspector (s): Jim Rowles Type of Inspection: Announced Inspection

Description:

Complete Style of Report: Term IRC-2 83 Report Date: July 23, 1984 Report Reviewed by: Al Terruson Date Reviewed: July 25, 1984 i "$91" Type Tors Used? N J Enforcement Letter Date: July 24, 1984 Signed by: Jim Rowles l 4 Date of Licensee Response: 8/14/85 - follow-up. 10/18/84 - 2nd, 11/9/84 s Date of State Acknowledgement

1. evember 26, 1984 r

I i i E

98 i Tile No. 7 = Licenace: JPL - Jet. Propulaima Lah eacmens: m tema Esas ch- _ D'! tenssama ~h license No: 0109 Type: Broad Ind. CAD Priority: H Inspection Date: March 15, 1984 Inspector (s): Kfm Wong Type of Inspection: Announced Inspect.ima

Description:

Complete 9tutine us! hy-,- hN Yh w.51,'3mk Report Reviewed by: Kim Weg Date Reviewed: . Dame 22,1984

• 591* Type Form Used?

No M=rensen h tre shen"b E 1r9E4 hr"* B : Em *"ta 5 3arme d Ihrmuseer ", .Dumme 2Ztt, IMMA Date of State Acknowledgement: June 22, 1984 Tile No. 8 Licensee: Consolida*ed Engineerier Labs. Inc. Address: 415 Petersen Street. Oakland, California License No: 3250-60 Type: Portable Gaute Priority: IV Inspection Date: September 8, 1983 Inspector (s): MkCott11eb Type of Inspection: Announced, Feinspection

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c h Style of 1teport: Warrative end Tors TRC-7-83 1Leport Date: October 1,1983 Report Reviewed by: J. Transrek Date Reviewed: Detober 3, 1983 "$91" Type Tors L* sed 7 h Enferresent letter Date: September 27, 1983 Signed by: J. Transrek Date of Licensee Response: Cetober 6. 1983 and December 2, 1983 Date cf State Acknowledgement: December 9,1983 Vf6

1 99 Tile No. 9 i Licensee: Industrist X-ray and Testing Inc. (IXT) Address: 30 Pasaron Way Suite D Irnacto. California License No: 2695-60 Type: Ind. Radforrapher Priority: I,I, Inspection Date: June 21-27. 1984 Inspector (s): V. V. Lev Type of Inspection: Announced Inspection

Description:

M lete Style of Report: Torm 1RC-2-83 Report Date: June 27.1984 Report Reviewed by: W. W. Lew Date Reviewed: December 13. 1984 "591" Type form Used? No Enforcement Letter Date: July 18, 1984 Signed by: W. W. Steffan Date of Licensee Response: August 20, 1984 Date of State Acknowledgement: December 13, 1984 (delsyed beesuse of follow-up) Tile No. 10 Licensee: Industrial Marine Address: 1620 Rigel Street, San Diego, California License No: 2799-80 Type I.R. Priority: II Inspection Date: January 30, 1984 Inspecter(s): Kim Wens Type of Inspection: Unannounced Inspection

Description:

C % icte Style of Report: Term UIT-A-12-82 Feport Date Not shown Report Reviewed by: Jsek Erown Date Reviewed: June 26,1984 591" Type Ts,rs Used? h Enforcement 14tter Date February 7, 1984 Signed by: Kim S. Wenn Date of Licensee Respense March 9. 1984; follow-up deftetency March 16, 1984 ) Date of State Acknowledgement April 13, 1984

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..,y' ' C Addrerar 7DSrrtar-A%. CamyrwParks Callftrrurar License No: 2329-70 Type: Small Mfr. Priority: M Inspection Date: August 6, 1984 Inspector (s): Jim Rowles Type of Inspection: Reinsreetion Inspection

Description:

Complete Style of Reprt: Torm IRC-2-83 Report Date: August 6, 1984 Report Reviewed by: Al Terruson Date Reviewed: August 8, 1984 "591" Type Term Used? h Enforcement Letter Date: August 9, 1984 Signed by: Jim Rowles Date of Licensee Response: September 5, 1984 Date of State Acknowledgement: September 13, 1984 Tile No. 12 Licersce: Ventura County - Sheriff's Crime Lab Address: 800 So. Victoris Ave., Ventura, California license No: 1865-56 Type: Crime lab Priority: V Inspection Date: July 19, 1984 Inspector (s): Kim Von: 737e of Inspection: Announced Inspection Descriptien: Cor;1ete 8tyle of Reports Fore Report Date: July 20, 1984 Report Reviewed by: Kim Vent Date Reviewed: July 20, 1984

• 591" Type Torn L' sed?

2514 elese out, no neneoepliance 1 Enforcement Letter Date: B Signed by: E Date of Licensee Responses M I Date of State Acknowledgement: M i =. V w l 4 4

101 Tile No.13 1 j Licensee: King Neptune Mir. of Weights and Tb Products Address: 6612 Clars Street, Bell Cardens, California License Fo: 3058-70 Type: Tb from Generators Priority: III Inspection Date: March 1,1982 Inspector (s): Cene Edmonds Type of Inspection: Initial Inspection

Description:

Corplete Style of Report: Tore UIT-10-80 Report Date: March 3, 1982 Report Reviewed by: Al Tersuson Date Reviewed: March 3, 1982 "$91" Type Term Used? 8 Enforcement Letter Date: April 9, 1982 Signed by: Gene Edmonds Date of Licensee Restonse: response not dated Date of State Acknowledgement: no acknowledrement i Tile No. 14 Licensee: Alarm Concepts Corp. Address: 11600 Eldridge Ave., Lake View Terrace, California License No: 2623-70 Type: Mfr. Smeke Detectors Frierity V ~ Inspection Date: July 7 8, 1983 Inspector (s): J. Rowles Type of Inspection: Announced Inspection

Description:

Complete Style of Report: Tore UIT-10-80 Report Date: July 12, 1983 Erport Reviewed by: Al Terrusen Date Reviewed: November 2, 1983 "$91" 7:pe Torn Used? Q Enforcement Letter Date: August 18, 1983 Signed by: J. Rowles Date of Licensee Responses None ~ \\ Date of State Acknowledges,ents no licensee restense - croblem referred to hQ5AC i L i 8 ,,.,f s 4 ,..= .g... i f

r l 1 1 102 j . Ille3:o. 3$ g 1 License r Vetterdter a_ Address: 3189 c. Airvsy Blvd., Costa Mesa, California 92626 j License No: 3110-30 Type: Oil field flood Priority: M Inspection Date: July 7. 1983 Inspector (s): Kim Woma i Type of Inspection: Announced Inspectica

Description:

Complete Style of Report: Form UIT-10-60 Report Date: July 15, 1983 Report Reviewed by: Kim Wont Date Reviewed: July 15, 1983 l 1 "591" Type Torm t' sed? 2514 Enforcement Letter Date: M signed by: M l Date of Licensee Responses y Date of State Acknowledgement: B J f f I j l t t k k (- 1 I +.. ~,,.. ~.

103 ? Sumary Table Comm.,nt File Number t 1. Inspection

• port did not Ifst license expiration date.

1, 2. Incorrect license number listed on inspection report. 3, I 3. Inspecticn overdue by greater than 50 percent of its inspection frequency. 3, 9, 4 Initial inspection not done within six months requirement. 4, 5. No documentation that molybdenum breakthrough tests were being performed or that these records were checked by inspector. 4 6. Licensee tock 90 days to respond, no dccumentei evidence of any intermediate inspector follow-up. 7, 7. Inspection completion and close-out not p documented in inspection report. 7, b( 8. Inspection closed out December 9, 1983, but it was not received in headquarters until August 30, 1984, and still not reviewed. 8, 9. Inspector recomended in writing that inspection frequency be shortened because of seversi repest noncompliance issues; however, headquarters apparently took no action. 8, 9,

10. Date of previous inspection not indicated on form.

10,

11. Incident of use of radicgraphic device to X-ray human hand does not have complete documentation nor is it referenced or keyed to incident file.

10,

12. License expired April 10, 1984, inspected August 6, 1984; license not in timely renewal.

Not cited for possession and use without a license or brought to the attention of supervision. II,

13. License expired January 26, 1983, inspected July 9, 1984; license not in timely renewal.

Not.ited for possession and use without a alcense or brought to the attention of licensee } or supervision. 12, i

l i 104 Comment File Number

14. Contract agency could not achieve compliance, forwarded via memo to headquarters as required, for action May 14, 1982; no action had been taken of time of review.

13,

15. License authorized Septesber 2,1977, initial inspection March 1, 1982 (guidance 6 ao.).

13,

16. December 28, 1982, license expired without rer ewal. Contract inspector could not schieve compliance or divestment of RAM during 1983. Ernt memo to headquarters for further action. Notice to divest asiled December 30, 1983; however, no action has been taken since that time.

14,

17. Contamination problem with complex enforcement follow-up, no decemented evidence of final i

close-out survey af ter final decontamination - no documents after August 17, 1984. 15 1 In addition, reports 3, 4, 5, 6, 7, 8, 9 and 11 were all awaiting Branch supervisory review and had been out of the files for up to six sonths, i, p I i n k J i 4 .i i W 8 h i I m u .,m., _ - _. -}}