ML20203L436
| ML20203L436 | |
| Person / Time | |
|---|---|
| Issue date: | 02/27/1998 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20203L432 | List: |
| References | |
| NUDOCS 9803060054 | |
| Download: ML20203L436 (40) | |
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i 4
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NRC REGION I PROGRAM January 26-30,1998 f
DRAFT REPORT k
4 Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Attachment 9903060054 900227 POR ORG NOMA PDR ,
Region i Draft Report Pagei .
1.0 INTRODUCTION
This report presents the results of the review of the Region I(RI) nuclear materials program The review was conducted during the period January 26-30,199'), by a review team comprised of techaical staff members from the U.S. Nuclear Regulatory Commission and the Agreement Stc:e of Texas. Team r , embers are identified in Appendix A. The review was conducted in accordance with the " Implementation of the Integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy," published in the Federal Realster on October 16,1997, and the November 25,1997, revision to NRC Management Directive (MD) 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period March 1996 to January 1998, were discussed 2
with RI management on January 30,1998.
[A paragraph on the results of the MRB meeting will be included here in the final report.]
The RI nuclear materials program is administered by the Director, Division of Nuclear Materials Safety (DNMS), who rr rmrts directly to the Regional Administrator. The DNMS organization chart is included as Appendix D.
At the time of the review, the RI nuclear materials program regulated more than 1800 specific i licensees, including pool-type Irradiators; radiographers; high dose rate (HDR) remote afterloading brachytherapy; gamma knives; teletherapy; large manufacturers; research and development; a nationwide U.S. Department of Agriculture license; and major academic and medical broad-scope licensees.
In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the Region on November 26,1997. RI provided a response to the questionnaire on January 6,1998. A copy of the response is included in Appendix C to this report. [The extensive RI questionnaire response will be added to the proposed final report, but is not included with this draft report).
I The review team's general approach for conduct of this review consisted of: (1) examination of RI's response to the questionnaire; (2) analysis of quantitative information from the licensing, inspection, resource utilization, and .311egation databases; (3) technical review of selected licening, inspection, incident response, allegation, and decommissioning actions or files; (4) field accompaniments of four RI inspectors; and (5) inte views with staff and management to answer questions or clarify issues. The team evaluated te inforraation that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of RI's performance. As noted above, that preliminary assessment was discussed with the Regional Administrator and program management before the team's departure.
Section 2 below discusses RI's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings and reccmmendations.
Suggestions made by IMPEP review teams are comments that the review team believes could enhance the Region's program. The Region is usually asked to consider suggestions, but no response is requested. On tMs IMPEP review of Rl, the review team did not make any suggestions. Recommendations relate directly to program performance by the Region. A response is requested from the Region to all rece mmendations in the final report.
Region i Draft Report Page 2 2.0 STATUS OF ITEMS IDENTIFIED IN l'REVIOUS REVIEWS During the previous routine IMPEP review, = hich concluded en March 22,1996, seven comments and recommendations were made and the results transmitted to the Region in the finalIMPEP report on June 27; 1996. The Region responded to the recommendations in a memorandum dated July 30,1996. In an August 13,1996, memorandum from Carl J.
Paperiello, Director, Office of Nuclear Material Safety and Safeguards (NMSS), to Hubert J.
Miller, Regional Administrator, Rl, the Region was informed that the "... next review of Region I (probably in 1998) willinclude review of these items." This follow-up IMPEP review resulted in the closure of six of 'he seven recommendations. The team's review (4 the current status of these recommendations is as follows:
(1) The tean recommends that RI continue efforts to improve its timeliness in conducting initial inspections in accordance with inspection Manual Chapter (IMC) 2800 guidelines.
Current Status: The review team found tha', although RI made some improvemen'. In conducting initial inspections within the IMC 2800 timelir ess guidelines, the Region continues to have difficulties in this area. This recommendation remains open and is evaluated further in Section 3.1 under the indicator," Status of Materials inspection Program."
(2) The taam recommends that NMSS continue its Business Process Reengineering efforts to reorganize and compile licensing guidance in one place.
Current Status: The Division of Indt. atrial and Medical Nuclear Safety's (IMNS')
guidance consolidation project is underway, and is detailed in the fiscal year (FY) 1998 IMNS Operating Plan. At the time of tne onsite RI review, IMNS had issued one guide in final (for portable gauge licenses), and had published four guides in draft for comment (industrial radiography licenses, self-shielded irradiator licenses, fixed gauge licenses, and sealed source and device ovaluation and registration applications). Seventeen additional guides are scheduled to be developed over the next 3 years. ThN recomrnendation is closed.
(3) It it recornmended that the region verify that the inspection field notes available in the docket room and on the local area network (LAN) are current.
Current Status: The review team observed that current inspection field notes are
, available in the document room and un the LAN. This recommendation is closed.
(4) It is recommended that staff assure that documentation of the reciprocity i
inspections be maintained in the region.
Current Status: The review team verified that RI is maintaining documentation of reciprocity inspections in the regional reciprocity files. This recommendation is closed.
(5) The team recommends that NMSS' Program Management, Policy Development, and Analysis Staff (PMDA) provide feedback to the regions on the resource issues associated with the Sita Decommissioning Management Plan (SDMP),
decommissioning, and closeout inspections.
Region i Draft Report Page 3 -
Current Status: In discussions between the rev;ew team and the RI managers, the review team learned that NMSS had provided feedback to RI managers regarding resources and staffing associated with the SDMP, decommissioning, and closeout inspections. Also, prioritization of actions regarding SDMP decommissioning and non-core decommissioning and resources is addressed in the FY 1998 RI Operating Plan. This recommendation is closed.
(6) The team recommends that the decommissioning Manual Chapter currently being developed by NMSS include guidance regarding the following items:
- The appropriate level of documentation needed to support the staff's decisions during licensa termination.
- The records that should be included in the terminated license file to support the decision to terminate a license.
- When closeout inspections should be conducted to support license termination.
Curnant Status: This recommendation made by the 1996 IMPEP review team was resolved by NMSS' Division of Waste Management (DWM)in the "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licensees," published in final form in March 1997. This recommendation is closed.
(7) The team recommends that NMSS clearly establish and describe the inte; face between the Division of Fuel Cycle Safety and safeguards inspection program and the decommissioning inspection program in the Manual Chapter and Inspection Procedure (IP) for facilities undergoing decommissioning, that are currently being developed.
Current Status: This recommendation was closed by NMSS' development cf two documents: (1) IMC 2602, " Decommissioning inspection Program for Fuel Cycle Facilities and Materials Licensees," issued June 1995 and revised June 1997; and (2) IP 88104, " Decommissioning Inspection Procedure for Fuel Cycle Facilities,"
issued June 1996 and revised June 1997. Concurrent with the development of these NMSS decommissioning documents, the decommissioning section of the manual chapter on inspection of fuel cycie facilities was deleted. This recommendation is closed, in summary, the review team considers all the 1996 IMPEP recommendations closed, with the exception of Recommendation 1.
P 3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.
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Region I Draft Report Page 4 3.1 Status of Materials inspection Pronram The team focused on four factors in reviewing this indicator: Inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of inspection findings to licensees. This evaluation is based on the RI questionnaire responses relative to this indicator, data gathered independently from NRC's Licensing Tracking System (LTS) and other NMSS and RI statistical databases, the examination of completed licensing and inspection casework, and interviews with RI managers.
Review of Rl's inspection priorities showed that, as with the 1990 review, the Rt inspection frequencies for various types or groups of licenses are consistent with program office guidance, as provided in IMC 2800, ' Materials inspection Program." This was verified by cross checking the actual inspection frequencies entered in the LTS with the IMC 2800 frequencies. In all cases reviewed, the inspection frequencies in the database (which set the next inspection date, unless the next inspection date is intentionally reduced or extended by RI staff) match the IMC 2800 frequencies. The Region is also actively implementing a provision in IMC 2800 to reduce or extend individual licensee inspection cchedoies, based on the licensee's inspection findings and previous performance. The Region continues to implement this guidance using a standard form, which the inspector completes at the time the inspecilon repod is issued. A sampling of Inspection files found the standard form to be used appropriately. A review of the LTS data showed a number of extensions and reductions in licensees'individualinspection schedules. A listing of licensees with extended or reduced inspection schedules was provided by RI as an attachment (Attachment 2) to its questionnaire response (see Appendix B to this report).
At the time of this IMPEP onsite review, RI had five core program inspections overdue, in comparison with the IMC 2800 guidance (not later than 25 percent beyond the established frequency). Of these five, two were Priority 1's (a hospital and group of U.S. Army facilities, with an annual inspection frequency), and the other three were Priority 2's (all universities, with an inspection frequency of every 2 years). Four of the five overdue core inspections were scheduled for inspection in February 1998, the month following the onsite review. This RI result compares favorably with the number of core overdue inspections at the time of the 1996 IMPEP review (12 overdue). RI conducts approximately 800 inspections each year, so five overdue core inspections is well within the range of accep'able performance, and it meets the IMPEP criteria (less than 10 percent overdue core inspections) for satis'actory performance.
At the time of this IMPEP onsite review, RI also had six overdue non-core program inspections, in comparison with the IMC 2800 guidance (not later than 1 year, for Priority 5 licensees). Non-core inspections include lower-risk licensees in Inspection Priority 5 (with an inspection frequency of once every 5 years). Although the number of non-core overdue inspections is not included
' under the IMPEP performance standards for this indicator, it is mentioned he~e because the Region demonstrated considerable improvement in this area during the review ,9eriod. At the time of the 1996 onsite review, RI had 51 overdue non-core inspections, which was a sligh!
decrease from the 1994 iMPEP review. By the 1998 review, RI brought the number of overdue non-core inspections down to six, which is a signifi: ant achievement. It demonstrates close attention to non-core inspections at the Branch level, when scheduling inspections. In interviews with R1 Division managers, the review team was told that RI may let the number of overdue non-core inspections increase, in the near future, to redirect resources toward reducing the licensing backlog and pending licensing cases (see Section 4.1).
In the 1994 IMPEP, the review team recommended that RI place greater emphasis on conducting initialinspections in accordance with IMC 2800. In the 1996 IMPEP, that
Region I Draft Report Page 5 recommendation remained open, because the 1996 review team identified a number of new licensees that had not been inspected. IMC 2800 requires initialinspections of new licensees to be performed "... within six months of receipt of licensed material, within six months of beginning licensed activities. or within one year of license issuance, whichever comes first." On this 1998 IMPEP review, the review team found that the issues regarding Rl's performance on initial inspections have not been completely resolved.
While onsite, the review team obtained a listing of all new licenses issued by RI during the review period. As of the time of the onsite review, all new licenses over 1 year old should have been inspected, so the review team checked inspection dates for new licenses issued from March 1996 through January 1997. After backing out the Massachusetts licensees (which were transferred in 1997) and other new licensees that were not truly "new" entities (e.g., the licensed operations were purchased by another company, but the staff and operations stayed the same),
the review team determined that 88 new licenses were issued from March 1996 through January 1997. Of those,60 were inspected within the first 6 months following license issuance, and another 16 were inspected within the second G months (i.e., less than 1 year after license issuance). The review team observed that RI was making " inquiries" of new licensees at the 4-month point, to determine whether the licensees possessed materiai. RI consistently documented the inquiries with followup letters to the licensees, as observed in a spot-check of the inspection files. However,5 of the 88 new licensees were inspected at time periods greater than 1 year, and another 7 of the 88 had not been inspected as of the time of the onsite IMPEP review. Of the seven that never received an initialinspection, RI made inquiries os all at some point with!n the first year, and the licensees told RI that they did not possess licensed material.
The review team looked further into the scheduling process for initialinspections and found that RI uses the LTS to schedule an inquiry with the licensee at the point 4 months after license issuance. The review team observed that these inquiries were conducted (either telephonically or in-person) and recorded in tne inspection files. If the licensee did not possess material at the time of the inquiry, the staff or the individual antering the information into the LTS database rescheduled the "next inspection date" for 1 year from the date of the inquiry. This caused the
< second inquiry to be scheduled at a date greater than 1 year from license issuance, which does not allow RI to meet the IMC 2800 requirement. In fact if a second inquiry is conducted instead of an inspection, the inquiry must be scheduled far enough in advance of 1 year to allow an inspection to be conducted before the 12-month date after license issuance. The team found multiple causes for the Region's continuing problem with initial inspections, but the primary causes appeared to be that both the technical staff and the individuals who were responsible for the LTS data did not know that the "next inspection" should be scheduled and ccnducted within 1 year of license issuance, not 1 year of the last inquiry, and the regional managers (who were aware of the timeliness requirement for initialinspsetions) did not catch the error when approving
' the formt that spec:fied the inspector's recommended date for the "next inspection." To RI's credit, when the review team identified the problem, during the middle of the onsite review, to the Regional managers, RI took immediate action to begin identifying other possible cases where initialinspections had not yet been conducted, and quickly focused on how the problem with scheduling initialinspections could be corrected. The review team recommends that the 1996 recommendation regarding initial inspections remain open. Specifically, the review team recommends that R1 continue efforts to improve its timeliness in conducting initial inspections in accordance with IMC 2800 guidelines.
The review team also evaluated the timelir.ess of RI's issuance of inspection findings. Based on Regulatory Information Tracking System data from NMSS, RI issued inspection findings to licensees on average within 15 days of completing the inspections. This is the same average as I
Region l Draft Report Page 6 reported by the 1096 iMPEP team, and it is well within the IMPEP and IMC 0610, " Inspection Reports," standard of 30 days. The review team also spot-checked 30 different inspection reports for the rev!aw period, and found tnat 26 had inspection findings transmitted to the licensee within 30 days. The remalnhg four involved more significant Notices of Violation (NOVs) or other enforcement issues, which may have required coordination with other NRC offices. The review team determined that RI continues to perform appropriately with respect to the timeliness of inspection report issuance to licensees. l In summary, RI surpassed or met the IMPEP standards for three of the four of the areas on this performance indicator: RI's core inspection program had a low number of overdue inspections.
The inspection frequencies were followed, in accordance with IMC 2800, and were being reduced or extended based on licensee performance; and most inspection findings were communicated to licensees within 30 days. RI had a repeat finding. which mmains open from previous IMPEP reviews, regarding timelines:: of conducting initialinspections. During the review and at the review team's exit meetings, the review team observed that RI managers at all levels took the repeat finding seriously and pledged to resolve it quickly.
Based on the IMPEP evaluation criteria, the review team recommends that Rl's performance with respect to the indicator, Status of Materials inspection Program, ba found satisfactory.
3.2 Te_chnical Quality of Inspections The team reviewed the inspection reports, NRC Forms 591, enforcement documentation, and inspection field notes and interviewed inspectors for 16 materials inspections conducted during j the review period. The casework included 16 of RI's materials iicense inspectors, and covered inspections of various license types, including: nuclear pharmacy, radiographer, mobile nuclear medicine, medicalinstitution broad license, portable gauge, research and development broad license, self shielded irradiator, manufacturing and distribution, pacemaker manufacturer and distributor, and large irradiator. Appendix D lists the impection files reviewed in depth During the week of January 13 - 16,1998, a health physicist from NMSS/IMNS performed accompaniments with four RI inspectors on separate inspections of four licensed facilities.
To review RI inspectors' performance, in the field, the IMNS health physicist accompanied four Ri inspectors on a total of four different inspections at a pool-type irradiator, a limited medical licensee, a research and dcvelopment broad-scope licensee, and an industrial radiograoher.
Appendix D also provides a list of the inspector accompaniments. The four inspections were routine, unannounced inspections. Allinspectors performed in-depth examinations of the licensees' facilities; interacted with licensee personnel (both technical staff and management);
', and reviewed pertinent records. In all cases, the inspectors demonstrated appropriate technical skills and professionalinspection techniques. The inspectors' performance was satisfactory to adequately assess the radiological health and safety of the licensees' programs.
During the onsite review, the review team determined that RIis perfomung inspections of materials licensees on an unannounced basis, except for initial inspections (which should be announced, in accordance with iMC 2800). For the cases reviewed, approximately half of the inspectors' field notes were prepared on computer-generated forms. The other half were hand-written on stock field note forms. Inspectors used the appropriate inspection fie ld note forms on all the files reviewed. In RI, the blank, computer-generateJ field note forms are accessible through the LAN, and DNMS staff can download the forms necessary for different types of inspections. The review team observed that inspectors were reviewing previous open items and
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Region I Draft Report Page 7 pest violations during the inspections. Approximately half of the inspections reviewed by the team resulted in NF 0 Forms 591 issued to the licensees. Two major licentee inspections, at a broad license and a major university, resulted in letters to the licensees stating that no violations were identified. In the rest of the cases reviewed, the Region issued NOVs.
The Wiew team identified a case, and the RI staff, in followup, identified three additional cases, where the licensee failed to respond to the NOV within 30 days and R1 was not aware that the licensee had failed to respond in a timely manner. The review team discussed this finding with DNMS staff and managers, and determhied that DNMS has two mechanisms for determining when licensees fail to respond to NOVs in a timely manner. First, the 1.icensing Assistance Team (LAT) staff manually pull the recent inspection files that are pending licensee responses, and review the files to ensure that there are no outstanding NOV responses. Second, the LAT staff generates a report that includes the NOV issuance date, and provides the report to DNMS supervisors, who should review it to determine whether there are any outstanding NOV responst J. The review team found that neither process is being consistently used and followed by RI. This resulted in the DNMS managers and staff not knowing which NOVs had responses outstanding more than 30 days. The review team recommends that RIimplement a process to
> ensure that each NOV receives a licensee response in a timely manner, in the area of reciprocity licensing and inspection, the Region issued 25 reciprocity licenses during calendar year (CY) 1996, and 24 reciprocity licenses in CY 1997. RI inspecto'rs performed 18 and 25 inspections, respective,,y, during those 2 years. RI grants reciprocity for a single calendar year, and closes the files at the end of each calendar year. Therefore, the review team was only able to examine reciprocity inspections for CY 1997, and not CY 1996. The review team examined the documentation for four reciprocity inspections. Two of the inspections resulted in NRC Forms 591, and two of the inspections resulted in NOVs. The review team found all necessary inspection documentation in the reciprocity files.
During this review period, DNMS supervisors acco opanied allinspectors at least once each year. Most of the DNMS inspectors were accomp9nied by their supervisors at least twice each
' year. To ensure that each inspector is accompanied on an annual basis, each supervisor maintains a report documenting when the accompaniments are performed. Each supervisor chooses the type and degree of documentation to maintain regarding the accompaniments.
inspectors receive verbal feedback at the time of the inspection uccornpaniments, and a portion of the inspectors' annual pt.rformance appraisals address their inspection skilis'." , .
The reslew team found th.it RI maintains a sufficient number of various models of survey instmments to perform radiological surveys of materials licensees. The review team examl.ied t.:s Region's instrumentation and observed that the survey instruments in RI's office at the time of the IMPEP review were calibrated and operable. RI uses a checkout system to track the instrument inventory and location of each instrument. The Decommissioning and Laboratory Branch is responsible for ensuring that DNMS has an adequate number of calibrated sursey instruments on-hand. To provide a variety of different survey instrument models at all times, RI contracts with a commercial radiological service company to provide calibrations, and staggers the calibration dates. When RI survey instrumerits need repair, the inspectors place the malfunctioning survey meters in a location dedicated for instruments needing repair.
The review team interviewed the laboratory inanager of the RI analytical laboratory, toured the laboratory, and examined the laboratory's radiation detection instruments. The review team observed that the laboratory is busy, but appears to have adequate staffing, facilities, and equipment to analyze RI and Region II (Rll) samples, using gamma spectroscopy. As
Region l Draft Report PageB established in the NRC Laboratory Transition Plan, the RIlaboratory provides services for both RI and Ril. At the time of the IMPEP review, most of the laboratory analyses involved samples from nuclear reactor sites. Most of the samples analyzed by the laboratory are also from R1 (as opposed to Ril). The laboratory manager told the review team that the RI taboratory has a state-of-the art system for performing the required analytical work. The RI mobile laboratory is being used primarily for work at power ' actor sites. Pecause a complete performance evaluation audit of the regionallaborate ies by L ? and its ccr tractor, Radiological and Environmental Sciences Laboratory, is scheduleu to be performed in FY 1998, the review team chose not to examine the RI laboratory's technical capabilities and performance, in depth, on this l IMPEP review.
Based on the IMPEP evaluation criteria, the review team recommends that RI's performance with respect to this indicator, Technical Quality of Inspections, be found satisfactory.
3.3 Technical Staffino and Trainino issues central to the evaluation of this indicator include the radioactive materials p,ogram staffing level, technical qualifications of the staff, training, and staff tumover. To evaluate these issues, the review team examined RI's questionnaire responses relative to this indicator, interviewed DNMS management and staff, interviewed a member of the RI Division of Resource Management and Administration, considered workload backlogs, and analyzed budgeted resource allocations vs. actual expenditures.
Rl's DNMS staffing has remained extremely stable during the review period. As RI noted in its response to the questionnaire, only one new technical staff member has been hired into DNMS from outside the Agency since the last IMPEP review. This individual was very well-qualified, on entry, with degrees in nuclear engineering and environmental engineering, and significant outside r
work experience (18+ years) in radiation protection and health physics. DNMS also acquired staff from within the Region for its reactor decommissioning effort, and the Division experienced some materials staff reassignments both to and from DNMS, with other materials-related positions within RI (e.g., Regional Stato Agreements Officer and a radiation specialist assisting on the allegations program). During the review period, Gree DNMS staff members left the agency. These losses came at s time of decreasing resource allocations for the DNMS program, so some moderate level of attrition is beneficial. DNMS had no vacant positions at the time of the onsite review.
DNMS is organized with four branches (Branches 1 - 3, and a Decommissioning and Lab Branch)
' and a LAT at the Division level. The Division is budgeted 30.0 direct staff full-time equivalents (FTEs) in FY 1998, and the Division staffing plan allocated 34.0 direct staff FTEs in this area at
.' the time of the onsite review, indicating that DNMS is operating with overhire positions. Including non-technical cverhead positions, which is more indicative of RI's actual staffirg situation, DNMS is budgeted 47.5 FTEs (for materials, reactor, and State program tasks) in FY 1998, and had 53.4 full and part-time staff on-board at the time of the review, resulting in an overhire situation of 5.9 FTEs at the time of the review. Because NMSP funded FTEs for RI will drop in FY 1999, because of the reduced numbers of inspections needed with Massachusetts as an Agreement State and decreased funding for Regional support of Headquarters ir%atives, the overhire situation may grow. R1 managers are acutely aware of the overhire situation, and they plan to address it primarily through normal attrition. During the review period, the Division demonstrated outstand;ng staffing management. During FY 1997, the Division was budgeted 33.0 direct staff FTEs for materials programs (excluding reactor, State programs, and
Region i Draft Report Page 9 overhead positiont.). and DNMS expended 32.9 FTEs, This expenditure rate of 99 percent shows remarkable use of allocated resources in FY 1997. Because the Division's FTEs have progressively dropped in recent years, and will continue to drop slightly in the coming years, it will be a challenge for DNMS to bring lis overhire s'affing levels closa to budgeted levels.
The IMPEP team found a good mix of personnel between licensing and inspection. With RI's nrganization, most technical staff in DNMS work both licensing and inspection actions, rather than having separate license reviewers and inspectors. With just two exceptions, all the technical staff in Rt were fully qualified inspectors at the time of the onsite review. Of the 34 technical ttaff members who work on materials issues (i.e., excluding the staff who work only on reactor decommissioning),14 have full signature authority for licensing actions, and 13 have limited signature authority. The remaining seven have no signature authority for licensing actions, so any licensing work they perform is reviewed and signed by a supervisor or qualified reviewer. In interviews the review team conducted with all four DNMS Branch Chiefs, the review team was told that the staffing level for licensing is more than sufficient to address the Region's licensing workload. At least two Branch Chiefs mentioned insufficient numbers of incoming non-routine licensing cases needed for qualification b) the " limited signature authority" technical staff, and managers are making an effort to direct licensing actions to staff who need them for further qualification. Some of the staff reportedly are not interested in becoming qualified to perform licensing reviews. and these individ als are assigned entirely to RI's inspections. Many staff members with limited signatuie authority have completed all necessary course work for full signature authority, and lack only the requisite number of licensing reviews to quellify. Other staff members have completed both the coursework and the required casework reviews, or the Division intends to waive specific requirements where appropriate, and the staff members are awaiting only RI management actions to received full signature authority. At the time of the 1994 IMPEP review, RI had 7 (of 24) fully qualified license reviewers. in 1996, RI had 12 fully qualified license reviewers, in its response to the 1998 questionnaire, RI reported that the number of fully qualified license reviewers has increased from 12 to 14. The review team determined that the number of license reviewers with full or limited signature authority is sufficient to complete the Region's materials licensing work, and allows for readjustments in the workload between materials licensing and inspection, as necessary.
In the area of decommissioning training, RI has scheduled training, in February 1998, on the "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licensees" (Decommissioning Handbook), by a member of NMSS' Division of Waste Management (DWM). With respect to the training requirements in IMC 1246, " Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area," which do not have to be completed until June 1905, none of the RI materials decommissioning staff meets the IMC 1246 requirements for decommissioning technical reviewers or decommissioning inspectors, because two required courses are not
' offered by NRC, at this time. Specifically, Regional maltagers reported that the courses on
" Finance for Non-Financial Professionals" and " Environmental Transport (including Groundwater Transport)" are not currently offered intemally by NRC. The review team learned that RI is
. purchasing a training videotape on the finance course, but neither the Region nor the review team was certain whether reviewing the videotape would fulfill the IMC 1246 requirements. The situation regarding the Environmental Transport course is more complex. According to RI's Training Coordinator, NRC's Technical Training Center (TTC) staff has identified extemal,
- commercial courses 15at cover environmental transport issues, teut RI has not received guidance from NMSS or TTC on whether these extemal courses meet the IMC 1246 course requirements.
Finally, DNMS management expressed concem about regionally funding the course through its own budget, versus sending RI staff to a TTC-funded course. The review team recommends that NMSS and the Office for Analysis and Evaluation of Operational Data (AEOD) consider the t
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Region l Draft Report Page 10 availability of the " Finance for Non-Financial Professionals" course and the " Environmental Transport (including Groundwater Transport)" course, and inform the Regions on how these course requirements in IMC 1246 should be met, or relaxed, while the courses are not offered i
by NRC. l In addition to the availability issues conceHng the two required decommissioning courses, RI managers expressed concem about the IMC 1246 requ'rement for qualified materials inspectors to additionally qualify as decommissioning license reviewers so that they may address non-complex decommissioning issues and terminate licenses. According to IMC 1246, " Individuals who inspect facilities being decommissioned (unless the facility exclusively used sealed sources only) must qualify as a Decommissioning Inspector...." The RI materials Branch Chiefs suggested that their experienced staff should be able to continue to inspect and terminate licenses for materials facilities that do not involve extensive, offsite contamination, without taking all the additional decommissioning courses (" Radiological Surveys in Support of Decommissioning Course "" Environmental Monitoring for Radioactivity Course,"" Environmental Transport (including Groundwater Transport)," and " Finance for Non-Financial Professionals").
RI's general plan on qualifying staff as decommissioning inspectors and decommissioning technical reviewers is to qualify those indiv'. duals in the Decommissioning and Laboratory Branch first, and then send the other staff to the courses as time and resources permit. RI management l
intends to continue to assign the non-complex licensa terminations and inspections to materials staff in Branches 1 - 3, and sosign the complex decommissioning cases and financial assurance i
to the technical staffin the Dacomm'ssioning and Laboratory Branch. With respect to several of l the required courses for decommissioning inspectors, the review team agrees with RI that on non-complex decommissioning cases, the need for these ccurses is questionable. The review team recommends that NMSS reexamine IMC 1246 and reconsider the requirements for decommissioning inspectors and decommissioning technical reviewers on non-complex decommissioning cases (e.g., those involving no groundwater contamination, no contamination outside of licensee buildings, and authorized use for only short half-life materials).
Overall, in the general area of technical training, RI managers had audited and were updating their staff training records at the time of the onsite review. The review team examined the initial at'dit notes, interviewed managers about the accuracy of a training spreadsheet that was being developed at the Division level, and spot-checked inspector's qualification journals. RI management indicated that neither the Agencis nor Rl's training databases accurately captured staff training (including course waivers) and matched that training with the IMC 1246 requirements. The Division had undertaken such an initiative, and appears to have made significant progress Based on the team's finding and the lMPEP evaluation criteria, the review team recommends
( that Rl's performance with respect to this indicator, Technical Staffing and Training, be found satisfactory.
3.4 Technical Quality of Licensino Actions The review team examined completed lico, sing casework and interviewed the reviewers for 20 specific licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness, license conditions and tie-down conditions, and overall technical quality. Casework was evaluated for timeliness;
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Region i Draft Report Page 11
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adherence to good health physics practices; reference to appropriate regulations; documentation of safety evaluation reports, product certifications, or other supporting documents; consideration of enforcement history on renewals; peer or supervisory review, as appropriate; and proper signature authorities. The files were checked for retention of necessary documents and supporting data.
The licensing casework was selected to provide a wide sample of licensing actions that had been completed in the review period by 15 different RI reviewers. The cross-section included the following license types: broad academic; research and development; decontamination services; industrial radiography; service providers; portable gauge; veterinary; self-shielded irradiator; medical; nuclear pharmacy; source material (shielding and other); and manufacturing and distribution. Ucensing actions (23 separate actions in 20 licenses) included nine new licenses, c one renewal, nine amendments, one notification, one financial assurance, and two terminations.
A list of these licenses, with case-specific comments, can be found in Appendix E.
The review team found that the licensing actions were thorough, complete, consistent, and of acceptable or higher quality, with health and safety issues properly addressed. Speciallicense tie-down conditions were stated clearly, backed by information contained in the file, and inspectable. The review team determined, througMnterviews with technical staff, that RI's license reviewers generally used appropriate licensing guides and checklists. The review team observed that RI staff prepared a review certification sheet for each licensing action, certifying that the appropriate standard review plan and check sheet had been used, and retained the certification in the file. As the i996 IMPEP review team found, the licensing review check lists were not being retained in the files. Through interviews, the review team determined that license reviewers discussed unusual or difficult licensing actions with peers, senior staff, and managers.
The files contained approprive deficiency letters, and docurnentation of telephone -
commun: cations with the licensee. The license reviewers generally signed all new or renewed licenses or amendments. For those licensing actions for which the license reviewer did not have signature authority, the licenses were signed by a serJor reviewer with full authority, or by the Branch Chief in addition, every license file reviewed by the team contained a copy of the letter, sent during this review period, notifying the licensee of NRC's 5-year license extension.
i The review team noted that two of the 23 licensing actions had been completed within 1 day of receipt. Both licensing actions required amendments that were reviewed and fully documented.
The quick tum-around on these two licensing actions exemplifies RI's timeliness on licensing actions and responsiveness to licensees. It also indicates the Region's awarenoss of the need to balance long-term licensing actions with simple requests that can be addressed immediately.
. Licensing files were found to be maintained very well. The review team found that, without exception, each of the reviewed docket files was complete and orderly. This is rare among IMPEP reviews, and both the LAT staff and the license reviewers deserve credit for their performance in maintaining the dockets.
The RI staff is developing computer macros to print licenses, and to facilitate generating deficiency letters and caher standard communications with licensees and applicants. The RI staff provided the review team with a demonstration of the process. The Region intended to pilot the new licensing process within weeks of the onsite IMPEP review, following delivery of a color printer.
To assess RI'= performance on license reviews for decommissioning sites, the review team
Region i Draft Report Page 12 interviewed RI staff and examined an additional eight docket files for non SDMP licenses that
{
were terminated during the review period and three docket files for non SDMP licensees currently undergoing decommissioning. Appendix G lists the decommissioning and termination files reviewed in depth.
The review team determined that the RI staff are knowledgeable about the decommissioning process and procedures, and staff addressed these procedures, as applicable, for each decommissioning site. Licensee decommissioning plans (where required)were reviewed and documented by DNMS in accordance with NRC guidance. For license terminations, the Region included closeout documentation in docket files examined by the review team. The " Materials License Termination / Retirement Form," from Appendix F of the "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licensees," was included in some docket files. The review team found that use of the form was recently initiated by RI. DNMS managers told the review team that the form will be included in the docket files for all future license terminations, to enhance NRC documentation for terminated licenses. For additional review team findings, see Section 4.2 of this IMPEP report.
Based on the IMPEP evaluation criteria, the review team recommends that Rl's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
3.5 Response to incidents and Alleoations in evaluating the effectiveness of RI's actions in responding to incidents, the review team examined Rl's response to the questionnaire relative to this indicator and reviewed the incidents reported for RI in the Nuclear Material Events Database (NMED) against those contained in the R1 license files, and supporting documentation, as appropriate, for 15 incidents, in addition, the review team reviewed 103 Preliminary Notifications (PNs) issued by RI and compared them to 142 NMED entries for the Region. The team also reviewed the Licensee Event Reports (LERs),
the RI incident Report Log, and interviewed several staff members.
The 15 incidents selected for review included the following incident types: three misadministrations, three lost radioactive material (RAM), one damaged equipment, two equipment failures, one leaking source, two overexpusures, one release of material, and two '
losses of control of radioactive material. A list of the incidents reviewed in depth, with comments, is included in Appendix F.
The responsibility for initial response ano follow-up actions to materials incidents rests with DNMS. Allincidents are promptly evaluated for the need for onsite investigations. Of the 15
', incidents reviewed, DNMS staff responded with an onsite investigation for 11 of the incidents. Of the 11 onsite investigations, three were conducted the same day of the notification, three were conducted within a day of notification, two were conducted within four days of notification, and three were conducted within 10 days of notification of the incident. The licensing files of the four cases that did not receive an onsite investigation indicated that the incident would be investigated during the next scheduled inspection. The review team determined that DNMS took prompt, appropriate action in response to the incidents. Of the 15 incidents reviewed, the review team observed that R1 consistently addressed health and safety issues in incident followup. For example, during an event in which radioactive material was released into tha public domain via the dismantlement of a tritium sign by a member of the public, the Region coordinated efforts with the State, the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Energy (DOE) to bring the incident under control and to assure protection of public health and
Region i Draft Report Page 13 safety. The Ragion also pursued appropriate enforcement action. In another example involving radioactive material found in a bag of medical waste, DNMS staff conducted a thorough investigation to determine the source of the discareted material. The review team found that DNMS' level of effort expended on incidents was appropriate and commenst. rate with the potential health and safety significance of the incidents. DNMG staff adequately and clearly identified licensees' noncompliance issues and, as appropriate, initiated enforcement actions to assure prompt compliance, in addition, DNMS coordinated materials incident responses with other NRC offices and, when appropriate, with other regulatory 't'risdictions (i.e., States, other Regions, and other Federal agencies) in a timely and effective manner. The review of license files and discussions with staff revealed that PNs in response to incidents were well documented, and were issued in accordance with regional instructions and iMC 1120,
" Preliminary Notifications." PNs received supervisory review and approval before issuance, in addition, as noted in the 1996 iMPEP report, DNMS continues to have a senior project manager assigned with the iesponsibility cf reviewing LERs, maintaining the incident Report Log, and coordinating information on incidents in the LERs with regional mariagement and staff.
The review team found good correlation between the PNs issued by RI, the incident informat;on in the licensing files, and the incident information reported on the NMED system. Of the 103 DNMS PNs reviewed, only two cases were noted where R1 PNs were not included in the NMED.
The review team forwarded these two PNs to AEOD for action. In addition, DNMS staff received training on the use of NMED in October 1997, i
in evaluating the effectiveness of RI's actions in responding to allegations, the review team examined RI's response to the questionnaire relative to this indicator and reviewed the allegations reported for RI in the Allegations Management System against those contained in the R1 allegations files, and supporting documentation, for 16 allegations. The review team considered RI's actions in the materials area in response to the July 3,1997, memorandurr, "Results of Audit of Allegation Program," from Mr. Edward T. Baker, Agency Allegation Advisor, in addition, the review team held interviews with the two Regional Allegations Coordinators, DNMS managers, and DP *nical staff on allegation handling. The re/iew team also considered the public c' .joal and strategy regarding responsiveness to allegations in the "NRC Strategic Pl September 1997.
j Responsibility for initial response and follow-up actions to material al'egations rests with the Regional Allegations Coordinators,in conjunction with DNMS staff and management. The team's review of 16 allegations, associated documents, and interviews with staff revealed that RI has an aggressive, effective, and an efficient program for managing materials allegations. At the time of the review, R1 had 18 open materials allegations. The average time for closing materials allegations containing technical concems was 78 days, which is far below the MD 8.8, t " Management of Allegations," goal of 180 days. In addition, Aliegation Review Board (ARB) meetings were held an average of 8 days after receipt of the allegation, which is far below the MD 8.8 goal of 30 days. Acknowledgment letters, responding to allegers, were issued an average of 20 days after receipt of the allegation, which is below the performance goal of 30 days. (These timeliness statistics are provided for CY 1997.)
RI has implemented several measures to improve the timeliness, effectiveness, and efficiency of managing materials allegations. The measures that RI has taken are clearly designed to assist the Agency in reaching its Strategic Plan goals of carrying out regulatory programs efficiently and effectively, and improving public confidence in the regulation of materials. For instance, RI increased resources on the allegation program and began a self assessment of allegation actions during this review period. In the Strategic Plan area on public confidence, the Agency
Region I Draft Report Page 14 committed to periodically reexamining its responsiveness to allegations from the public, to ensure that timely and technically adequate information is clearly and understandably communicated, and that regulatory action, if taken, is consistent with the risk significance of the issues. The performance measures and indicators that DNMS has implemented in the area of materials allegation management are clearly aligned with this strategy, in January 1997, DNMS provided additional resources to the Regional Administrator's office to create an additional Allegations Coordinator position. This technical staff member assists a Senior Allegations Coordinator in managing all allegations received by RI. DNMS and the Allegation Coordinators have standing ARB meetings scheduled on a biwcekly basis. The purpose of these standing ARB meetings is to review any existing allegation files for closure and to review any allegations received subsequent to the last biweekly ARB. In addition, ad hoc ARB meetings are held, as needed, for expeditious review of materials allegations. As part of each ARB meeting, with all participants present, the ARB members review, approve, and finalize the ARB minutes for that meeting. The review team concluded that ARB meetings are administered by RI in a timely, effective and efficient manner.
DNMS has also instituted a self assessment program to address the handling of materials allegations. The Senior Allegations Coordinator generates statisticalinformation on silegations on a monthly basis and disseminates this information to all R1 managers. The statistical information focuses on the performance of RI in meeting its allegation performance goals.
Monthly meetings are held between DNMS management and the allegations staff to discuss the statisticalinformation. These meetings provide the opportunity for DNMS managers to provide close a'tention to allegations under their responsibility. As part of Rl's self-assessment process, DNMS management performs monthly audits of two closed materials allegations files. Most importantly, this management audit focuses on whether the actions taken by the staff and management were technically appropriate and consistent with the risk significance of the issue involved. The monthly audit also focuses on the timeliness of DNMS actions and appropriate documentation. The management audit of closed allegations is rotated among DNMS managers, to obtain diverse insights and experiences of all DNMS managers. The review team sampled the audits, ar.d noted that the results of the audits were included in the allegations files. As another part of Ris self-assessment process, the DNMS Deputy Division Director performs a semiannual review of the monthly audit results for trends or common themes. The semiannual audits a!so assist DNMS in determi7ing whether its responses to allegations are timely, effective, technically responsive, and commensurate with the risks involved in the allegations. The review team identified al's practice of monthly and semiannual management audits of selected DNMS allegations as a good practice, and other Regions or Agreement States may consider adopting such self-assessments in an effort to assure high-quality allegation management programs.
8 The review team found that proper procedures were being followed for control and maintenance of allegation materials, in accordance with MD 8.8. The allegation staff is within physical view and control of sensitive information. DNMS staff received training on allegations in October 1997. The training included, among other topics, sensitivity to allegers and granting.
confidentiality to allegers. This training will further assist in assuring that materials allegations are addressed in accordance with the Agency's policy and guidance in MD 8.8. Moreover, the review team interviews indicated that the RI staff had a clear understanding of the application of M D 8.8.
The review team noted that intemal and extemal coordination of allegations was appropriate and performed in a timely manner. The results of file reviews showed that DNMS routinely refers cases involving potential wrongdoing to the Office of investigations (OI) for resolution. Two files
Region I Draft Report Page 15 reviewed contained copies of the results of 01 reports involving potential wrongdoing. In addition, the review team noted that allegations involving Agreement States were appropriately managed.
Based on the IMPEP evaluation criteria, the review team recommends that RI's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.
4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies three non-common performance indicators to be used in reviewing Rl's nuclear materials program: (1) Performance with Respect to Operating Plans and Resource Utilization; (2) Sita Decommissioning Management Plan and Decommissioning Activities; and (3) Regional Fuel Cycle inspection Program. RI does not have any operating fuel facilities, so the non-common indicator on the Regional Fuel Cycle inspection Program was not evaluated on this IMPEP review. Only the first two non-common performance indicators were applicable to this review.
4.1 Performance with Respect to Operatina Plans and Resource Utilization -
4.1.1 Operatina Plan Performance In FY 1996, NRC Regional Operating Plan performance goals shifted from traditional benchmark numbers of licensing actions and inspections to an emphasis on timeliness. Emphasi+ in the materials licensing area was moved from prescribed targets to control of pending casework and reduction of backlog. The materials inspection program shifted from completion of prescribed hambers of inspectons to an emphasis on reactive inspections fS response to incidents) and control of overdue core inspections. This 1998 RIIMPEP re A a the first time that the Region operated under the new performance goals for the entire revis 3.riod.
At the time of the 1996 IMPEP review (mid-fiscal ytar), the RI materials licensing backlog consisted of 59 cases, and the pending inventory was at 412 cases. Based on NMSS' data, by the end of FY 1996, RI reduced the backlog slightly to 52, and the pending was reduced substantially to 261 caset Ouring FY 1997, RI continued the reduction in pending, bringing the number down to 206 pending licensing cases by the end of the fiscal year. Backlog reduction also continued, and by the end of FY 1997, UNMS reduced the RI materials licensing backlog to 23 These ieveh represent significant reductions in the number of backlogged and pending materials licensing casos during the review period, and they demonstrate RI's commitment to address the timeliness of licensing actions.
Although PJ made demonstrable progress on reducing licensing backlog and pending cases curing the review period, NMSS and RI management continues to watch the Region's backlog and pending levels close!y. The levels of Rl's backlog and pending rose slightly during the first quarter of FY 1998. At the end of December 1997, NMSS' data showed the RI backlog at 36 cases and the pending at 216 cases. Although these are only slight rises in bot! alues during the quarter (which may be attributable to holiday leave), RI management is well aware that the licensing reduction effort began to reverse during the quarter. Also, the raw values of the bacMog and pending are not low, and they attract NMSS attention. At the time of'.he onsite review, DNMS management was considering diverting resources from the non-core inspection activities (which have a low priority on the R1 Operating Plan) to the materials licensing program, to continue progress on backlog and pending case reduction (a higher priority). Also, with the Agency's new output measures, the measure of the Division's licensing program performance
Region I Drak Report Page 16 will change in FY 1998 and beyond. As long as the Division continues its backlog and pending reduction, especially with older backlogged cases, DNMS will perform well against the new timeliness performance measures.
Regional performance on materials inspection timeliness is addressed in Section 3.1. For comparison purposes here, the number of core overdue inspections at the time of the 1996 IMPEP review was 12. At the time of this review, the Region had five overdue core inspections.
At the time of the 1996 IMPEP review, the Region had 51 overdue non-core inspections. At the time of this review, the number of overdue non-core inspections had dropped to six. As described in Section 3.1, this reduction in non-core inspections is a remarkable achievement by be Region. As mentioned above, regional management may choose to let the number of non-core inspections increase, in the near future, to divert resources to materials licensing, 4.1.2 Resource Utilization in FY 1996, RI expended 35.7 FTEs (direct staff effort, not including reactor, State programs, nor oveihead effort) versus 36.5 FTEs budgeted for NMSS program activities (97.8 percent). The following fiscal year, in FY 1997, RI expended 32.9 FTEs versus 33.0 rTEs budgeted for NMSS program activities (99 percent). For the first quarter of FY 1998, RI has expended 8.2 FTEs versus a prorat . 5 FTEs (109 percent), based on rough data. In FY 1998, the Region is
, budgeted 30.0 FTE ior materials programs for the whole year. Data for FY 1997 and FY 1998 reveal 15at RI expenditures generally match well with budgeted activities, with slight overexranditures in the event evaluation and materials licensing areas. Considering the RI Operating Plan priorities on reactive inspections and core licensing, the resource expenditure data demonstr ' d that regional resources are being expended appropriately.
The review team discussed the overhire staffing level with Ri managers, as indicated in Section 3.2. The overhire staffing situation will be a challenge to manage, and may actually grow as DNMS' budget decreases. However, the materials staffing level should also be viewed in a historical context. In FY 1995, the RI materials program was budgeted for 40.1 direct staff FTEs.
In FY 1996 (the start of this review period), that level dropped to 36.5 FTEs. In FY 1997, staffing decreased further to 33.0 budgeted FTEs, and in the current fiscal year, RI is budgeted for 30.0 FTEs. (Next year's budget estimate is 26.4 FTEs.) So, over the 4 fiscal years up to the 1998 review, the funded materials staffing level decreased by more than 25 percent. In that context, RI's success at keeping expenditures very close to budgeted levels demonstrates strong resource manageme
The FY 1998 Operating Plan includes resources and assignments to RI regarding support for NMSS program initiatives. The Region continues to be a strong contributor 4 such initiatives. R1
( provided the review team with information showing that at least 14 different DNMS staff members and at least three managers participated on specialinitiatives within the/Tai preceding the review, including, but not limited to, leadership and team member roles on NMSS'spidance consolidation effort (fixed gauges, radiography, portable gauges, academic /research and development / laboratory use, other than self shielded irradiators, and document review teams),
10 CFR Part 35 writing groups, Agency program review teams, Licensing Practices Course i instructors, and the Risk Re-evaluation team. RI managers told the review team that RI tr,aterials staff generally view these assignments as positive opportunities. In the area of support for program initiatives, the review team determined that RI is operating in close agreement with its Operating Plan.
Region l Draft Report Page 17 The Region's FY 1998 Operating Plan specifies that, " Priority will be given to reactive inspections, core licensing, core inspections, decommissioning activities associated with the Site Decommissioning Management Plan (SDMP) sites, non-core licensing, non-core inspections, and non-routine decommissioning activities not addressed in the SDMP,in that order." The RI FY 1998 Operating Plan also states, " Emphasis should be placed on eliminating the number of backlogged licensing actions ...." The review team observed that RI managers clearly emphasized event response and evaluation, and core licensing and inspection, and made demonstrable progress during the review period on reducing the licensing backlog, in accordance with the Operating Plan. Based on the review team's interviews with regional managers, examinat;on of PMDA's and RI's budget data, and conside. ration of the Region's performance across all materials areas, the review team concluded that RI is closely adhering to the priorities given in the Operating Plan in accomplishing DNMS' mission.
4.2 Site Decommissionina Mansaement Plan (SDMP)
This non-common indicator w reviewed to evaluate RI's SDMP program. The non-common performance indicator for evaluating the SDMP includes: 1) quality of SDMP decommissioning reviews; 2) financial assurance for decommissioning; 3) termination radiological surveys; 4) inspections; 5) staff qualifications; and 6) SDMP milestones.
In performing this review, the review team interviewed DNMS managers and staff, examined SDMP and non-SDMP licensing files, and reviewed financial assurance documents. The interviews included the Chief of the Decommissioning and Laboratory Branch, six license reviewers / inspectors in the Branch, and the Branch Chiefs of the other three DNMS Branches.
Review team comments provided in this section of the IMPEP report are applicable to SDMP sites and non-SDMP sites that require substantial decommissioning actions SDMP and non-SDMP sites that require substantial decommissioning actions, such as remediation or final radiological surveys, are the responsibility of the Decommissioning and Laboratory Branch. These responsibilities include complex Type 11 sites, Type ill sites, and Type IV sites. Non-complex decommissioning license terminations, such as for Type I and Type ll sites involving sealed sources or limited onsite decontamination and termination radiological surveys, are assigned to the other three DNMS Branches.
4.2.1 Quality of SDMP Decommissionina Reviews The review team examined docket files for five SDMP sites. These included: Watertown Arsenal / Mall; Safety Light Corporation; Heritage Minerals; Pesses Company, METCOA Site; and
' Whittaker Corporation. All these sites, except Whittaker, are managed by the Region (that is, RI has both licensing and inspection responsibliities for these projects). The Region has inspection responsibility and NMSS/DWM has license review responsibility for Whittaker. Docket files for two non-SDMP sites undergcing decommissionine (Prometeor, Inc., and Norton Compcny) were also examined. Docket files examined by the review team are listed in Appendix G.
Through interviews with RI staff and managers and from examination of docket files, the review team found that, for rnost decommissioning sites managed by RI, an individual staff member in the Decommissioning and Laboratory Branch serves as both the license reviewer and the inspector. The review team determined that the RI decommissioning staff is knowledgeable about the process and procedures for decommissioning, and the staff addresses the process an< procedures as applicable to each decommissioning site. Decommissioning licensing review l
Reglon 1 Draft Report Page 18 actions undertaken by RI staff include: reviewing the status of sites in accordances with timeliness requirements; establishing radiological criteria for release of sites; classifying sites by decommissioning type; reviewing licensees' decommissioning plans; ensuring adequate financial. assurance; reviewing licensees' final status survey plans and reports; and conducting con:cmatory surveys.
The review team found that licensees' decommissioning plans are appropriately reviewed and documented by RI in accordcnce with IMC 2605, " Decommissioning Procedures for Fuel Cycle and Materials Ucensees," the Decommissioning Handbook, and Policy and Guidance Directive FC 91-2, " Standard Review Plan: Evaluating Decommissioning Plans for Licensees under 10 CFR Parts 30,40, and 70." Through a review of the decommissioning files, the review team observed that RI decommissioning actions addressed licensee health and safety conditions appropriately.
The review team found that, for both SDMP and non-SDMP license terminations (including Decommissioning Types I,11, Ill, and IV), RI's docket files included closeout documentation. The review taam found that each docket file contains the following documentation, depending vn the requirements and conditions of the licensee: a license amendment terminating the license; Form 314 from the licensee; a statement by the license reviewer that allinformation applicable to license termination has been reviewed; licensee final surveys; and a closeout or confirmatory survey pedormed by NRC or its contractor. Also, the " Materials License Termination / Retirement Form"(Appendix F of the Decommissioning Handrook) was included in some docket files examined by the review team. The review team found that RI's use of the form was initiated recently. DNMS managers told the review team that the form will be included in the docket files for all future license terminations, to enhance NRC documentation for terminated licenses.
4.2.2 Financial Assurance for Decommissionina The review team confirmed that RI has staff assigned sa Financial Assurance Instrument Custodians (F/ ICs) in accordance with MD 8.12, " Decommissioning Financial Assurance instrument Security Program." The Region has an FA!C and an attemate FAIC. The FAIC Manager is the Chief of the Decommissioning and Laboratory Branch.
To assess the performance of RI for financial assurance, the review team examined the LTSc reviewed the " inventory List of Region l's Original Financial Assurance Instruments," examined docket files containing copies of the instruments for selected SDMP sites, as well as for other licensees, and spot-checked the original financial assurance instruments. Financial assurance information for each applicable licensee (such as issuing party, assurance type, mechanism amount, date approved, and expiration date) is consistent throughout the RI documentation and tracking systems. The review team found that the originalinstruments are maintained in a General Services Administration-approved, securi+y container / safe.
5 The review team determined that, for all of the financial assurance files the review t'e am examined, the licensees provided financial assurance for the estimated costs of decommissioning, or the licensees made attemative arrangements which the applicable regulators approved. RI staff reviews the financial assurance instruments periodically to ensure that they are current and executable. The original financial assurance instruments and financial assurance cost estimates are maintained in the licensee financial assurance files that the FAIC keeps in the approved security container. Copies of these documents are maintained in the licensee docket files. The FAIC also maintains an inventory of the original financial assurance instruments.
. Region I Draft Report Page 19 The review team also evaluated Rl's recent self audit (completed in November 1997) of its l decommissioning financial assurance inventory. The Region's self-audit covered 100 percent of l the licensees requiring financial assurance, as required by MD 8.12. In its audit, RI identified
! deficiencies in the inventory, which were mostly out-of date documentation of financial assurance items in the LTS and the inventory list The review team concluded that deficiencies identified in the RI audit were corrected or are being corrected in a timely manner by RI staff.
4.2.3 Termination Radiolooical riurveys The review team discussed termination surveys with RI staff and managers and reviewed docket files for adequacy of licensee and NRC surveys to support license termination. The review team found that licensee final status survey plans and reports are prepared in accordance with NUREG/CR 5849," Manual for Conducting Radiological Surveys in Support of License Termination," and are reviewed by RI staff. The review team concluded that RI's reviews are adequate to ensure that residual radioactivity levels comply with release criteria. NRC confirmatory or closeout surveys are performed, as necessary, for each licensee's site, by RI or NRC's contractor to va::date licensee survey data, as outlined in IMC 2605 and in IP 87104, " Decommissioning Inspection Procedure for Materials Licensees."
4.2.4 Inspections The review team found that SDMP sites (and non-SDMP sites in the license termination process or actively in the remediation process) are inspected in accordance with MC 2602,
" Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees," and IP 87104. Sites are inspected at least once during decommissioning and at all significant milestones in the decommissioning process. Closeout inspections are performed, as appropriate, to terminate licenses.
Inspections are planned, carried out, and doc'imented in accordance with IP 87104. The review team found that IP 87104 field notes were included in the docket files for some sites. RI recently initiated inclusion of IP 87104 in docket files. The DNMS managers told the review team that RI is committed to continue to include IP 87104 field notes in docket files.
4.2.5 Staff Qualificatio_ns The review team found that the decommissioning staff are very experienced ad highly qualified to perform licensing and inspection functions on decommissioning sites. Staff net qualified in certain program codes receive direct supervision from DNMS managers or more sehr staff.
The review team's evaluation of specific staff qualifications, including qualifications for meeting
( IMC 1246 requirements for decommissioning technical reviewers and decommissioning inspectors, is presented in Section 3.3 of this IMPEP report.
4.2.6 SDMP Milestonss The ieview team found that the decommissioning milestones presented in the last two SDMP updates to the Commission (SECY-96-207 and SECY-97-242) are being exceeded or met on all SDMP sites managed by RI. Regional staff are identifying to NMSS policy issues affecting SDMP sites, such as proper classification of decommissioning types and the Region's management of formerly licensed sites. The review team observed that RI updates the SDMP database quarterly and completed its most recent update in December 1997.
Region i Draft Report Page 20 4.2.7 Summary !'
Based on the evaluation criteria for this non common performance indicator, the review team recommends that the Region's performance for this indicator, Gite Decommissioning Management Plan, be found satisfactory.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found RI's performance winrespect to each of the parformance indicators to be satisfactory. Accordingly, the team recommends the l
Management Review Board find the RI program to be adequate to protect public health i and safety.
Below is a summary list of recommendations, as mentioned in earlier sections of the report, for evaluation and implementation, as approoriate, by RI, NMSS, and AEOD.
RECOMMENDATIONS:
- 1. The review team recommends that RI continue efforts to improve its timeliness in conducting initial inspections in accordance with IMC 2800 guidelines. (Sections 2 and 3.1)
- 2. The review team recommends that RI implement a process to ensure that each NOV r receives a licensee response in a timely manner. (Section 3.2)
" Finance for Non-Financial Professionals" course and the " Environmental Transport (including Groundsvater Transport)" course, and inform the Regions on how these course requirements in IMC 1246 should be met, or relaxed, while the courses are not offered by NRC.~ (Section 3.3)
- 4. Thn review team recommends that NMSS reexamine IMC 1246 and reconsider the requirements for decommissioning inspectors and decommissioning technical reviewers on non-complex decommissioning cases (e.g., those involving no groundwater contamination, no contamination outside of licensee buildings, and authorized use for only short half-life materials). (Section 3.3)
SUGGESTIONS:
None.
GOOD PRACTICES:
The review team identified RI's practice of monthly and semiannual management audits of selected DNMS allegations ~as a good practice, and other Regions or Agreement States may consider adopting such self assessments in an effort to assure high-quality allegation management programs. (Section 3.5)
LIST OF APPENDICES AND ATTACHMENTS Appendix A IMPEP Review Team Members Appendix B Region i Organization Charts
. Appendix C Region l's Questionnaire Response Appendix D Inspection File Reviews Appendix E License Fife Reviews Appendix F Incident File Reviews Appendix G Decommissioning File Reviews Attachment i Region l's Response to Review Findings
[To be added to the proposed final report.) .
4 APPENDIX A IMPEP REVIEW TEAM MEMBERS Nama Area of Responsibility Scott W. Moore, NMSS/IMNS Team Leader !
Status of Materials inspections 1 Technical Staffing and Training Operating Plan Performance and Resource Utilization Cardelia H. Maupin, OSP Response to incidents and Allegations Sally Merchant, NMSS/IMNS T'echnical Quality of Licensing Actions William A. Silva,'lexas Technical Quality of Inspectictis Ronald Uleck, NMSS/DWM Site Decommissioning Management Plan l
Joseph E. DeCicco, NMSS/IMNS Inspection Accompaniments 9
I 9
4 4
l APPENDIX B REGION I DIVISION OF NUCLEAR MATERIAL SAFETY ORGANIZATION CHART
'e i
4 9
(
- -. - - .~a- ,---a- u. .m a p - n , --, - . - _ r_ _ a-_ , .-_ -
h 4
APPENDIX C REGION I INTEGRA'iED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE RESPONSE
[TO BE ADDED TO THE PROPOSED FINAL REPORT]
4
Region i Diaft Report Page C.1 Approved by OMB' No. 3150-0183 Empires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Reglon I, Division of Nuclear Materiais Safety Reporting Period: March 1996 to January 1998
[ Region l Response to Questionnaire to be included in the Proposed Final Report) 1 4
Estimated burden per response to comply with this vnluntary collection request: 45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br />.
Forward comments regarding burden estimate to the information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Weshington, DC 20503. NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
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i APPENDIX D INSPECTION FILE REVIEWS File No.: 1 Licensee: Geodax Technology License No.: 37 30192 01MD Location: Meadville, PA Inspection Type: Routine, unannounced License Type: Nuclear Pharmac, Pricrity: 1 laspection Date: 11/19/97 11/iO/W, inspector: C.O.
l l File No.: 2 Licensee: Westinghouse License No.: W 05809 02 Location: Cheswick, ?A Inspection Type: Routine, unannounced License Type: Industrial Radiography Priority: 1 inspection Date: 04/23/96 Inspector: R.L.
l File No.: 3 Licensee: Mobile Dynamic Irnaging License No.: 29 30322 01 Location: Englewood, NJ Inspection Type: Routine, unannounced License Type: Mobile N" clear Medicine Service Priority: 2 Inspection Date: 10/1' l's7 Inspector: L.M.
File No.: 4 Licensee: University of Pennsylvania License No.: 37 00118-07 Location: Philadelphia, PA inspection Type: Routine, unannounced License Type: MedicalInstitution Broad Priority: 1 Inspection Date: 07/15/97- 07/21/97 Inspector. J.D.
File No.: 5 Licensee: City of Philadelphia License No.: 37-07983-07 Location: Philadelphia, PA Inspection Typ:c Routine, unannounced License Type: Portable Gauf,e Priority: 5 Inspection Date: 1C/09/97 inspector. J.J.
File No.: 6
' Licensee. Novartis Pharmaceuticals Corporation License No.: 29-08978-02
, Location: East Hanover, NJ Inspection Type: Routine, unannounced
. License Type: Res. & Dev. Type A Broad Priority: 2 Inspection Date: 08/28/96 Inspector: P.L.
File No.: 7 Licencee: West Penn Hospital License No.: 37 02136-01 Location: Pittsburgh, PA Inspection Type: Routine, unannounced License Type: Medicallnstitution, Broad Priority: 1 Inspection Date: 03/24/97- 03/25/97- Inspector, l.C.
Region i Draft Report Page D.2 Inspection File Reviews File No.: 8 Licensee: Milton S. Hershey Medical Center License No.: 37 13831 04 Location: Hershey, PA Inspection Type: Routine, unannounced License Type: Self shielded Irradiator Priority: 5 Inspection Date: 10/03/97 10/05/97 Inspector: N.B., T.T.
File No.: 9 Licensee: AlfacellCorporation License No.: 29-30360-01 Location: Bloomfield, NJ Inspection Type: Telephone Call License Type: Research and Development Other Priority: 3 Inspection Date: 06/26/97 (phone call) Inspector: J.B.
File No.: 10 Licensee: R. E. Wright Environmental,Inc. License No.: 37 28362 01 Location: Middletown, PA Inspection Type: Routine, unannounced License Type: Portable Gauge Priority: 5 Inspection Date: 07/18/96 Inspector: E.R.
File No.: 11 Licensee: Arawak Paving Company,Inc. License No.: 29-27824-02 Location: Hammonton, NJ Inspection Type: Routine, unannounced License Type: Portable Gauge Priority: 5 Inspection Date: 04/18/97 Inspector. C.A.
File No.: 12 Licensee: Safety lJght Corporation License No.: 37 00030-02 Location: Bloomsburg, PA Inspection Type: Routine, unannounced License Type: Mnfr and Distribution Type A Broad Priority: 1 Inspection Date: 09/18/97 - 09/19/97 Inspector. J.K.
File No.: 13 Licensee: American Geotech,Inc. License No.: 37 30399-01 Location: Wyomissing, PA inspection Type: Routine, unannounced
. License Type: Portable Gauge Priority: 5
. . Inspection Date: 11/06/97 Inspector. J.J.
File No.: 14 Licenses: Atlantic Richfield Company License No.: SNM-1933 Location: Los Angeles (West Chester, PA) Inspection Type: Routine, unannounced License Type: Pacemaker Mnfr and/or Distr Priority: 1 Inspection Date: 12/11/97- Inspector: P.H.
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4 Region i Draft Report Page D.3 Inspection File Reviews File No.: 15 Licensee; Branch Radiographic Laboratories,Inc. License No.: 29 03405-02 Location: Cranford, NJ Inspection Type: Routine, unannounced License Type: Indust. Radiography, Temp Jol ' lites Priority: 1 Inspection Date: 06/16/97 & 06/18/97 Inspector: J.M.
File No.: 16 Licensee: SteriGenics Intemational License No.: 29-20900-01 Location: Salem, NJ Inspection Type: Routine, unannounced License Type: Irradiator Other, Greater Than 370 TBq Priority: 1 Inspection Date: 08/07/97, & 08/13/97 08/14/97 Inspector: J.J., R.L., (R.B.)
In addition, a review team member made the following inspection accompaniments as part of the on site IMPEP review:
Accompaniment No.: 1 Licensee: SterlGenics International License No.: 29 30308 01 Location: Rockaway, NJ Inspection Type: Routine, unannounced License Type: Pool lrradiator Priority: 1 Inspection Date: 01/13/98 01/14/98 Inspector: R.L.
Accompaniment No.: 2 Licensee: Phoenixville Hospital of the University of Penn. License No.: 37-10237 01 Location: Phoenixville, PA Inspection Type: Routine, unannc*inced License Type: Limited Medical Prionty: 2 Inspection Date: 01/13/98 Inspector: M.B.
Accompaniment No.: 3 Licensee: Rohm and Haas Company License No.: 37-01665-01 Location: Springhouse, PA Inspection Type: Routine, unannounced License Type: Res. and Development, Type A Broad inspection Date: 01/15/98 Prior &.2 Inspector: R.G.
o Accompaniment No.: 4 i Licensee: Voith Hydrc., Inc. License No.: '3716280-03 Location: York, PA .
Inspection Type: Routine, unannounced License Type: Radiography Priority: 1 Inspection Date: 01/16/98 Inspector: S.C.
APPENDIX E LICENSE FILE REVIEWS File No.: 1 Licensee: Naugatuck Valley Radiological Associathn License No.: 06 30265 01 Location: Waterbury, CT License Type: 02200. Medical Private Practice Type of Action: Now Date issued: 03/27/96 License Reviewer: M.B.(J1)
File No.: 2 Licensee: Good Samaritan Med Ctr., License No.: 37 05272 02 Location: Johnstown, PA License Type: 02120 MedicalInstitution Type of Action: Notification Dete issued: 01/15/97 License Reviewer: T.W.(J9)
Comment:
On 1/15/97, the licensee was told that adding a qualified medical authorized user required only a notification to NRC; that no fee was required. The fee was retumed on 5/1/97.
File No.: 3 Licensee: Powell-Harpstead, Inc., License No.: 37 30384 01 Location: West Chester, PA License Type: 03121. Portable Gauge Type of Action: New Date Iscued: 04/05/97 License Reviewer: J.J.(P8)
File No.: 4 Licensee: DuPont Merck Pharmaceutical, License No.: 37-28764 02 Location: Wilmington, DE Licence Type: 03800 - Possession Only Type of Action: Termination Date issued: 11/19/97 License Reviewer: S.L.(Q2)
File No.: 5 Licensee: Aquatec.,Inc. License No.: 44 18128-01 Location: Colchester, VT License Type: 03123. Gas Chromatograph Type of Action: Termination Date Amendment loved: 03/97 License Reviewer: P.H (K7)
Comment:
t The action was completec' within 1 day of receiving faxed request.
File No.: 6 Licensee: Harris Semiconductor License No.: 37 24841 01 Location: Mot;ntaintop, P's Amendment No: 1 License Type: 03520 - Self shielded irradiator Type of Action: Renewal and Amendment Date issued: 07/03/96 and 05/01/9 License Reviewers: S.C.(K4) and J.M.(QO)
Region 1 Draft Report License File Reviews Page E.5 File No.: 7 Licensee: Lucius Pitkin, Inc Location: Patterson, NJ License No.: 29 27816-01 License Type: 03320. Radiography Amendment No.: 5 Tfpe of Action: Amendment Date issued: 05/02/97 License Reviewer: D.W.(Q4)
File No.: 8 Licensee: St. Barnabas Ambulatory Care Location: Livingston, NJ License No.: 29 01608-05 License Type: 02201 - Medice! Private Practice Type of Action: New Date issued: 06/09/97 License Reviewer: M.B.(J1)
File No.: 9 Licensee: Radiation Science, Inc.
Location: Cranbu y, NJ License No.: 29 30310-01 License Type: 03225. Service Provider Type of Action: New Date issued: 09/21/96 License Reviewer: E.R.(L3)
File No.: 10 Licensee: Celgene Corporation Location: Warren, NJ License No.: 29-28056-01 License Type: 03620 R&D Amendment No.: 6 Type of Action: Amendment Date issued: 04/30/96 License Reviewer: P.L.(P6)
File L.: 11 Licensee: Catholic University Location: Washington, DC License No.: SNM 164 License Type: 210. SNM, Less Than Critical Mass Amendment No.: 15 Type of Action: Amendment Dt.te issued: 10/15/97 Comment: .
License Reviewer: P.H.(K7)
Action completed within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of being received.
File No.: 12 Licensee: Toledyne Environmen'ai l
L Location: Westwood, NJ License No.: 29-00055-17
,' License Type: 03219 - Decontamination Services Date issued: 6/28/96 Type of Action: New License Reviewer: D.W.(Q4)
File No.: 13 Licensee: Allegheny Univ. of the Health Sciences Location: Center City Campus, Philadelphia, PA License No.: 37 00467 34 License Type: 01100 - Academic, Type A Broad Amendment No.: 33 Type of Action: Amendment Date issued: 04/97 (Financial Assurance)
License Reviewer. K.B.(Q7) l
Region I Draft Report Page E.6 License File Reviews File No.: 14 Licensee: Army, Depaitnent of License No.: SUB 238 Location: Waterstown, MA Amendment No.: 14 License Type: 11300 - Source Material Type of Action: Amendment Date issued: 07/97 License Reviewer: R.B.(J8)
File No.: 15 Licensee: E.I. DuPont DeNemours Licence No.: 07 13441 02 Location: Newark, DE Amendment (s) No.: 9 and 10 License Type: 03610 - R&D Type of Action: Amendments Dato lasued: 08/97 and 10/07/97 License Reviewer: K.B.(Q7) and D.E.(K2)
File No.: 16 Licer.see: Newa,k Medical Associates License No.: 29-30282 01 Location: Newark, NJ Amendment No.: 1 License Type: . 02201 - Medical Private Practice Type of Action: New and Amendment Date issued: 00/25/96 and 02/07/97 License Reviewer: M.B.(J1) and R.G.(J2)
File No.: 17 Licensee: Mid Atlantic Equine License No.: 29-30392 01 Location: Ringoes, NJ License Type: 02400 - Veterinary Type of Action: New Date issued: 06/20/97 License Reviewer: R.G.(J2)
File No.: 18 Licensee: Ronson Metals Corp License No.: STB 1451 Location: Somerset, NJ Amendment No.: 4 License Type: 11200 Source Material Shielding Type of Action: Amendment Date issued: 4/25/97 License Reviewer: S.S.(J5)
File No.: 19 Licensee: MPM Technologies,Inc License No.: 37-30408-01
!ocation: Lemont, PA ucense Type: 03620 - R&D Type of Action: New 8, Date Renewallssued: 09/05/97 License Reviewer: J.B.(Q6) _ ,
i File No.: 20 Licensee: AlfacellCorporation License No.: 29-30360-01 Location: Bloomfield, NJ License Type: 03214 - Manufacturing and Distribution Type of Action: New Date Amendment Issued: 3/18/97 License Reviewen R.G.(J2)
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A PPENDIX F INCIDENT FILES REVIEWED File No.: 1 Licensee: , .~urd Bloscience Co., dba: Canberra industries License No.: 06 15099-01 Incident ID No: PNO-l-97 076 Location: Meriden, CT Date of Event: 12/11/97 Type of Event: Equipment Failure / Lost RAM Investigation Date: 12/15/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: A Type A package shipped by the licensee failed, and a sealed source from the package was found in the back of a Federal Express truck. U.S.
DOE retrieved the source and stored it. An onsite inspection was conducted. No violations 1
were identified.
File No.: 2 Licensee: St. Elizabeth Hospital License No.: 29-04333-01 Incident ID No: PNO l 97 034 l Location: Elizabeth, NJ Date of Event: 04/16/97 Type of Event: Leaking Source / Loss of Control Investigation Date: 06/06/97 and 08/10/97 Investigation Type: Onsite Inspection Summary of Incident and Final Disposition: A leaking 1131 capsule was found in a bag of medicalwaste and retumed to the licensee by a medicalwaste shipper. The Region conducted inspections of St. Elizabeth Hospital and St. Michael's Medical Center, and determined that a patient who was administered an 1 131 dose at St. Michael's did not swallow the capsule.
Instead, the patient carried the 1-131 capsule and disposed of it at St. Elizabeth Hospital, where the patient provides volunteer servies. Bioassay confirmed that the patient did not swallow the capsule. RIissued a CAL to St. Michael's Medical Center.
File No.: 3 Licensee: Larchmont Imaging Associates License No.: 29-23540-01 incident ID No: PNO-1-97-030 8
Location: Mount Laurel, NJ Dats of Event: 05/14I97 Type of Event: Release of RAM
, Investigation Date: 07/03/97 investigation Type: Next inspection Summary of incident and Final Disposition: Licensee received a package containing TI 201, that was contaminated with Tc 99m. Two technologists were contaminated on their finger tips. An inspection was conducted and no violations were noted.
Region i Draft Report Page F.2
- Incident File Reviews File No.: 4 Licensee: Overlook Hospital License No.: 29-03308-01 incident ID No: PNO-l 97 027 Location: Summit, NJ Date of Event: 05/05/97 Type of Event: Misadministration investigation Date: 05/07/97 Investigation Type: Onsite inspection Summary of incident and Final Disposition: Patient was administered the wrong dose of I 131 for a whole body scan (7 mci vs. 2 mCilntended). RI conducted an inspection and Identified two violations: failure to prepare written directives prior to administration r .. failure to provide adequate supervision. RI neld an enforcement conference and issued an NOV and civil penalty.
' F:le No.: 5 Licensee: Merck arid Company, Inc. '
License No.: 29-00117-06 incident ID No: PNO l 97-023 Location: Rahway,NJ Date of Event: 04/10/97 Type of Event: Loss of control / Release of RAM Investigation Date: 04/08/97 - 04/11/97 and 4/24/97 investigation Type: Onsite Inspection Summary of incident and Final Disposition: The licensee disposed of two vials containing 1-125 in the normal trash. The licensee attempted to reclaim the material before incineration, tut was unsuccessful. Calculations of the releas* indicate that no member of the public received a dose in excess of 1 mrem. RI conducted an inspction and cited two violations. An enforcement conference was held, and NOV issued. The licensee made corrective actions.
File No.: 6 i Licensee: Non6 -Incident involving a private home License No Not Applicsble incident ID No: PNO-l-97 028 Location: Union, NJ Date of Event: 05/10/97 Type of Event: Overexposure / Release of RAM / Stolen material Investigation Date: 05/10/97; 05/12/97; and 05/23/97 i Investigation Type: Telephone Folle vup and Onsite Inspection l Sun. mary of incident and Final O' ;,osition: An individual obtained three exit signs at a building demolition site, dismantled one sign Inside his home, and broke several tubes containing tritium gas during the process. The NJ Department of Environmental Protection and DOE Brookhaven National Laboratory responded, performed extensive bioassays, and surveyed the house, finding moderate to trace ameunts of contamination. RI conducted inspections to review the circumstances associated with the event, and issued an NOV.
Region l Drah Report Page F.3 Incident File Reviews File No.: 7 Licensee: Stroh Brewery License No.: General Licensee incident ID No: PNO l 97 056 i Location: Lehigh, PA Date of Event: 08/27/97 ;
Type of Event: Lost RAM Investigation Date: 09/02/97 and 09/03/97 investigation Type: Onsite inspection Surnmary of incident and Final Disposition: A load of shredded non-ferrous automotive parts from a metal recycler in Temple, PA, (Royal Green Metal Recyclers) that alarmed a radiation monitor at a Michigan recycling center was retumed to the PA recycler, RI dispatched an l
Inapector to the PA facility, analyzed inspection samples at the RI laboratory, and confirmed the presence of Am-241. Ri coordinated with PADEP, EPA, DOE, and other NRC offices on the event response. The RAM was traced back to the Stroh Brewery Company in Lehigh, PA. RI conducted an inspection of Stroh Brewery and identified two violations. RI held an enforcement conference and issued * 'ra/.
File No.: 8 Licensee: Medical College of PA/Hahnemann University Licesnse No.: 37 00467-34 Incident ID No: PNO 1-96 032 Location: Philadelphia, PA Date of Event: 05/08/96 Type of Event: Lost RAM Investigation Date: None Investigation Type: None [Next inspection)
Summary of incident and Final Disposition: The licensee lost a 76 MBq (2.0 mCl) sealed source used on the surface of an eye plaque. The licensee searched for the source, then submitted corrective actions (with root cause). RI licensing file indicated that this incident will be reviewed at the next inspection.
Fi:e No.: 9 Licensee: Mallinckrodt Medical, Inc., and Wilkes Barre General Hospital Ll:ense No.: 24-04206-16MD and 3716170-01 Incident ID No: PNO-1-96-019 Location: Wilkes Barre, PA
( Date of Event: 03/26/96
, Type of Event: Overexposure Ir;vestigation Date: 03/27/96 .
Investigation Type: Onsite inspection Summary of incident and Final Disposition: A nuclear medicine technology I tudent at the hospital became contaminated, and alarmed a radiation monitor before leav ng a restricted area.
A RI supervisor and two inspectors interviewed the student and performed follow-up inspections -
at the hospital and pharmacy. Bioassay showed an uptake of approximately 15-30 mci of Tc 99m. Investigations and Interviows revealed that the uptake resulted from a dropped syringe,
- erd subsequent personnel contamination. RI concluded that this was an accident, and not r,gligence or malice RI identified nc violations.
Region i Draft Repori Page F.4 Incidont File Reviews Fi.e No.: 10 Licensee: MQS inspection,Inc.
License No.: 12 00022 07 Incident ID No: PNO l 97-075 & 075A Location: Tosco Refinery, Marcus Hook, PA Date of Event: 12/08/97 Type of Event: cquipment Failure investigation Date: 12/08/97 Investigation Type: Onsite Inspection Summary of incident and Final Disposition: The Region received a request from Amershani Corp, to perform an emergency source retrieval of a 62 CiIr 192 radiography source at a temporary jobsite at the To.sco Refinery in Marcus Hook, PA. RI staff conducted an inspection of the ir.cident and of Amersham's retrieval operations, and determined that the source disconnect resulted in minimal exposure to workers and members of the general public. The Riinspector noted that the connector had detached from the wire, and the end uf the wire was frayed and rusty. ,
File No.: 11 Licensee: NationalInstitutes of Health License No.: 10-00296 10
- Incident ID No
- PNO-l 97 007 & 007A l Location: Bethesda, MD
! Date of Event: 01/22/97 Type of Event: Lost Material Investigation Date: None investigation Type: None Summary of incident and Final Disposition: On January 22,1997, the licensee reported that a package containing 1 mci of I-125 could not be found. The licensee conducted a search for the package. The Region scheduled an investigation for 1/27/97; however, on 1/24/97 the licensee informed the Region that the package had been found. RI canceled the inspection.
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File No.: il L!censee: R. 4 aboratories License No.: vo-30007-01 Incident ID No: PNO-l-97 044 Location: Hebron, CT Date of Event: 07/22/97 i
Type of Event: Loss of Control investigaSn Date: 07/23/97 and 07/30/97 investigation Type: Telephone Followup and Onsite Inspection Gummary of incident and Final Disposition: The .icensee reported that they had received Sr 90 sealed sources and a radium sealed source which had been found at Shelton High Schoolin Shelton, CT. The licensee performed a survey of the high school and found contarnination limited to a box where the sources had been stored. RI conducted a survey and took wipe samples at the school, analyzed the survey information and samples, and detected no activity.
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Region i Draft Report Page F.5 incident File Reviews File No.: 13 Licensee: Altoona Hospital License No.: 37 11826 01 Incident ID No: FNO4 '7 002 Location: Altoona, r :
Date of Event: 09/ n196 (Reported 01/09/97)
Type of Event: Misadministration investigation Date: 01/16/97, 01/17/97 & 01/24/97 Investigation Type: Onsite Inspection Summary of incident and Final Disposition: The licensea identified on n annual QMP audit that three patients were administered dosages of approximately 2.3 mci "f I 131 for whole body 1 scans, instead of 3 mCl as prescribed. The physicians did not issue w,aten directives to change '
the prescriptiont, In additien, the licensee determined that all 24 patients who received whole body scans in 1996 were administered these doses without written directives. RI conducted inspections and identified two violatlans: failure to instruct the supervised individuals in the licensee,'s QMP and failure to include written procedurcs in QMP to meet the objective that written directives be prepared.
File No.: 14 Licensee: Centre Community Hospital License No.: 37-13681 01 incident ID No: PNO l 97 005 Location: State College, PA Date of Event: 12/20/97 Type of Event: Misadministration investigation Date: 01/23/97 investigation Type: Onsite Inspection Summary of incident and Final Dispos: tion: During an HDR treatment of a pr.tlent's nasal cavity, a catheter containing the Ir 192 source was dislodged from the treatment site, and may not have been in its proper location during treatment. The medical physicist and the physicians subsequently concluded that a misadministration had occurred. NRC contacted a Medical Consultant to assist with the investigation ::nd conducted an inspection. The misadministration may have resulted in an unintended dose to the skin of the patient's cheek of up to 3000 centigray. RIissued a CAL and an NOV.
File No.: - 15 Licensse: Geomechanics, Inc.
- ' License No.: PNO-l 97 003 '
' incident ID No: 37 17332 01 Location: Elizabeth, PA (Event: Pittsburgh, PA) i Date of Event: 01/01/97 Type of Event: Damaged Equipment investigation Date: 01/21/97 investigation Type: Onsite inspection Summary of incident and Final Disposition: At a temporsry jobsite in Pittsburgh, PA, a construction vehicle ran over a portable density gauge. A licensee-contracted health physics service perforn;ed surveys, took swipes of the damaged gauge, and detected no removable contamination. Ri conducted an inpaction, identified violations, and issued an NOV.
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APPENDIX G SDMP AND DECOMMISSIONING FILES REVIEWED FILES REVIEWED FOR SDMP SITES File No.1 Licensee: Dept of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: 20-01010-04 (Terminated)
License Type: R & D Type A Broad Scope File No. 2 Licensee: Dept of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: SNM 244 (Terminated)
License Type: Special Nucler,r Materials (Storage vnly)
File No. 3 Licensee: Dept. of the Army, U.S. Army Research Laboratory Location: Watertown, MA License No.: SUB 238 (Active)
License Type: Part 40, Possession Only for Characterization and Decommissioning File No. 4 Licensee: Safety Light Corporation Location: Bloomsburg, PA License No.: 37-00030-08 (Active)
License Type: Manufacturing & Distribution File No. 5 Licensae: Heritage Minerals, Incorporated Location: Tinton Falls, NJ License No.: SMB-1541 (Expiret but Licensee in Decommissioning)
License Type: Source Material File No. 6 Licenses: The Pesses Company (METCOA)
Location: Pulaski, PA License No.: STB-1254 (Expired)
License Type: Metal Reclaiming f
File No. 7 Licensee: Whittaker Corporation Location: Simi Valley, CA License No.: SMA 1018 (Active)
License Type: Ore Processing 1
Region i Draft Report SDMP and Decommissioning File Reviews PageG.2 FILES REVIEWED FOR NON SDMP SITES UNDERGOING DECOMMISSIONING File No.1 Licensee: Prometcor, Inc.
Location: Somerset, NJ L! cense No.: STS 1451 (Active)
Llconse Type: Source Material l File No. 2 Licensee: No.1on Company Location: Worcester, MA License No.: STB 00770 (Formerly Licensed Site) i License Type: Refractory Processing File No. 3 Licensee: IEA, Inc. '
Location: Monroe, CT
- License No.: 06 30139 01 License Type: Analytical Laboratory 4 FILES REVIEWED FOR NON SDMP TERMINATED SITES File No.1 Licensee: Non Destructive Testing Corporation Location: Manville, NJ License No.: 29 19742 01 License Type: Industrial Radiography File No. 2 Licensee: Ledoux & Company
- Location: Teaneck,NJ License No.: SMC-1181 License Type: Industrial; Source Material File No. 3
- Licensee: The DuPont Merck Pharmaceutical Company i Location: Glenolden PA
', License No.: 37-28764 02
, License Type: Pharmaceutical Manufacturer File No, 4 Licensee: Duquesne Light Company Location: Pittsburgh, PA License No.: 37-06424-05 LicenseType: . _
Gas Chramatography - -
Region i Draft Report '
Page G,3 SDMP and Decommissioning File Reviews l File No. 5 Licensee: Industrial Cc,*rosion Management, Inc.
Location: Randolph, NJ License No.: 29 19571 01 License Type:. Gas Chromatography File No. 6 Licensee: Harvard University Location: Cambridge, MA License No.: SNM 71 License Type: Medical R & D l File No. 7 Licensee: Sharp Electronics Corporation Location: Mahwah,NJ License No.: 29 23702 02 '
License Type: Manufacturing & Distribution File No. 8 Licensee: The Osteoporosis Testing Center, Inc. ;
Location: Englewood, NJ Ucense No.: 29-20940-01 l License Type: Medical Private Practice
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