ML20216H990
| ML20216H990 | |
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|---|---|
| Issue date: | 09/20/1999 |
| From: | NRC (Affiliation Not Assigned) |
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| ML20216G347 | List: |
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| NUDOCS 9910040127 | |
| Download: ML20216H990 (66) | |
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF SOUTH CAROLINA AGREEMENT STATE PROGRAM July 12-16,1999 i
PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission 9910040127 990920 PDR STPRQ ESGSC PDR ATTACHMENT 1
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South Carolina Proposed Final Report Page1
1.0 INTRODUCTION
This report presents the results of the review of tre South Carolina radiation control program.
The review was conducted during the period July 12-16,1999, by a review team comprised of technical staff members from the Nuclear Regulatuiy Commission (NRC) and the Agreement State of California. Team members 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 Reaister on October 16,1997, and the November 25,1998, NRC Management Directive 5.6,
" Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period March 25,1995 to July 16,1999 were discussed with South Carolina management on July 16,1999.
[A paragraph on the results of the MRB meeting will be included here in the final report.)
The South Carolina Agreement State program is located in the Denartment of Health and Environmental Control (DHEC). Within DHEC, the Division of Radioactive Waste Management (DRWM)is responsible for the oversight of the Bamwell radioactive waste disposal site and approximately 14 other licenses for waste-related operations. The Radiological Health Branch (RHB) located in the Division of Health Regulations administers the radioactive materials program. Organization charts for DHEC, DRWM and RHB are included as Appc.ndix B. The South Carolina program regulates approximately 322 specific licenses authorizing agreement materials, and the Bamwell site. The review focused on the program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of South Carolina.
In preparation for the review,- a questionnaire adaessing the common and non-common performance indicators was sent to the State on May 5,1999. RHB and DRWM provided responses to the questionnaire on June 11 and 25,1999, respectively. Copies of the questionnaire responses are included as Appendix G to this report. The review team noted that the regulation chronology tables submitted with the two questionnaire responses were slightly different and each contained errors. The State's August 31,1999 response letter to the draft report also contained an erroneous chronology table. On September 14,1999, the State submitted a revised chronology table. This table appears in Appendix G and replaces the previous versions.
1 The review team's general approach for conduct of this review consisted of: (1) examination of South Carolina's responses to the questionnaire; (2) review of applicable South Carolina statutes and regulations; (3) analysis of quantitative information f rom the State's licensing and inspection data base; (4) technical evaluation of selected licensing and inspection actions; j
(5) field accompaniments of six South Carolina inspectors; and (6) interviews with staff and I
management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the radiation control program's performance.
l Section 2 below discusses the State's actions in response to recommendations made following the previous program review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the L
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I South Carolina Proposed Final Report Page 2 1
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applicable non-common performance indicators, and Section 5 summarizes the review team's findings, recommendations, and a good practice identified during the review.
I Recommendations made by the review team are comments that relate direcify to program performance by the State. A response is requested from the State to all recommendations in the final report.
2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous program review, which concluded on March 24,1995, one recommendation was made and the results transmitted to Douglas E. Bryant, Commissioner, on June 14,1995.
The review team's evaluation of the current status of the recommendation is as follows:
We recommend that the Bureau of Radiological Health medicalinspection report form be revised to document the status of the licensee's ALARA program, and the industrial radiography inspection report form be revised to incorporate the changes made in the 1994 edition of RHA Part V regulations, including the alarming rate meter.
Current Status: The State revised the medical and industrial radiography inspection report forms to incorporate the recommended changes. The team confirmed that these areas are appropriately reviewed during inspections. This recommendation is closed.
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.
3.1 Status of Materials insoection Proaram j
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The team focused on four factors in evaluating this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of inspection findings to licensees. The review team's evaluation is based on the South Carolina questionnaire j
responses relative to this indicator, data gathered independently from the State's licensing and inspection data trecking system, the examination of completed licensing and inspection i
casework, and interviews with managers and staff.
The review team's evaluation of the State's inspection priorities revealed that inspection frequencies for each type of license were the same or more frequent than similar license types listed in the NRC Inspection Manual ~ Chapter (IMC) 2800. Medical institutions, medical private practices, general license distribution, portable gauges and fixed gauges are inspected more frequently than indicated by IMC 2800. The review team also noted that the State established wntten procedures to extend or reduce the next inspection interval based upon licensee performance.
The RHB staff uses a computer database program to track inspection due dates. The database program is somewhat archaic, utilizing a DHEC mainframe computer system.
l Approximately semiannually, the RHB industrial and Medical Program Managers receive printouts identifying materials inspections which are coming due in the next six months. The l
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m South Carolina Proposed Final Report Page 3 printout identifies the last inspection date, the inspection due date and the 25% overdue date (consistent with IMC 2800). The managers then assign inspections to staff members.
The reviow team analyzed the printout data and identified a programming error in the way that the 25% inspection overdue calculation is performed. The error results in incorrect overdue dates, sometimes too early and other times too late. The Industrial and Medical Program
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Managers stated that they did not rely on the tracking system dates because they were aware j
of problems with the data. The RHB Chief. stated that conversion of the tracking system to a PC-based system was currently in process.
In their response p the questionnaire, the RHB and DRWM indicated that there were no inspections overhe by more than 25% of the NRC frequency. During the week of the review, the team verified that no inspections were overdue by this frequency.
With respect to initial inspections of new licensees, a list of licenses issued since the last review was requested and the licensees' respectivo inspection files were evaluated to determine their initial inspection date. South Carolina has a policy of hand-delivering initiallicenses which gives the program an opportunity to discuss with the new licensee the ramifications of the license.
The team noted this as a good practice, as described in Section 3.4. Initialinspections were, until January 1999, performed within one year of the license delivery. In January, the policy was changed to perform initial inspections within 6 months of license delivery or material receipt, in accordance with IMC 2800 requirements. The review team confirmed that initial inspections are performed as specified in the policy.
The review team also evaluated the status of reciprocity inspections. During the current review period,108 requests for reciprocity were filed with the program. The State inspected 5 of the 6 teletherapy and irradiator source changes performed under reciprocity. Regarding Priority 1 reciprocity licenses, the program inspected 15% in 1995 96,21% in 1996-97,33% in 1997 98 and 54% in 1998-99. The improvement over the past four years has the program currently performing Priority 1 reciprocity inspections at the 50% frequency outlined la NRC's IMC 1220.
No Priority 2 or 3 licenses requested reciprocity during the review period. Approximately 10%
of Priority 4 7 reciprocity licenses were inspected, meeting the IMC 1220 criteria.
Most of the program's routine inspections, approximately 80%, result in the issuance of a Form 591 field compliance form. Other inspection findings are dispatched to licensees within 30 days of completing an inspection.
Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.
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South Carolina Proposed Final Report Page 4 3.2 Technical Quality of insoections The team evaluated the inspection reports, enforcement documentation, and interviewed inspectors for 22 radioactive materialinspections conducted during the review period. The casework included medical institutions, industrial radiography, nuclear pharmacy, pool j
irradiator, academic broad scope, medical broad scope, waste processing, HDR and reciprocity. Appendix C lists the inspection casework evaluated for completeness and adequacy with case-specific comments.
Currently there are 8 radioactive materialinspectors at DRWM and 6 at RHB. Allinspectors are trained to perform radioactive materials inspections, and respond to radioactive materials
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incidents and incidents at nuclear power facilities.
South Carolina's inspection procedures are consistent with NRC procedures. Both RHB and DRWM try to conduct inspections unannounced, but sometimes inspections are announced a few days before the inspection. The review team noted that 12 of the 22 inspection files evaluated were unannounced.
i Based on casework, the review team noted that the routine inspections covered all aspects of the licensees' radiation programs. The review team found that inspection reports were thorough, complete, consistent, and of high quality, with sufficient documentation to ensure that licensee's performance with respect to health and safety was acceptable. The documentation supported violations, recommendations made to the licensee, unresolved safety issues, and discussions held with the licensee during exit interviews. Team inspections were performed when appropriate and for training purposes.
RHB inspectors write either narrative or checklist-type inspection reports. All DRWM inspection reports are written in a narrative fashion. Inspection reports contain licensee data, persons contacted, type of inspection, inspector's and supervisor's signature, documentation to support
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violations, recommendations made to the licensee, unresolved or licensing issues, independent measurements, and exit interview discussions and comments.
For RHB, the inspection report is examined and signed by the RHB Section Director. DRWM reports are initialed by the Division Director. Boilerplate language is used to generate compliance letters and violations to ensure consistency. Responses are evaluated and replied to in a timely manner. The inspection files were generally found to be complete and in good order. The review team noted that in two cases, there were recommendations that might have been listed as violations. The need for inspectors to fully explain decision making with regard to violations and recommendations in inspection reports was discussed with the individual inspectors.
The inspections in DRWM are unique in that the licensees are specifically decontamination and decommissioning licenses and the reports are weighted more toward performance and taking confirmatory wipe samples. The inspectors do not have an inspection guide or checklist to use during inspections. As a result, certain areas were not reviewed during allinspections. The DRWM Section Managers agreed that such guidance would be useful to inspectors, and l
indicated that they would make up a standardized inspection guide.
South Carolina Proposed Final Report Page 5 RHB and DRWM have an adequate supply of survey instruments to support the current inspection program. Appropriate, calibrated survey instrumentation such as GM meters, scintillation detectors, ion chambers, and micro-R meters were observed to be available. Most instruments are calibrated by the DHEC calibration facility, which is a Certified Regional Calibration facility. The DHEC Environmental Laboratory and a contract laboratory provide support to the program through radiological analyses of environmental samples and samples taken by inspectors during inspections, and environmental dosimetry around nuclear facilities.
Instrument repair and calibration is also available from the instrument manufacturers as needed. A mobile laboratory is also available for responding to incidents. The program has the capability for analyzing all types of environmental media, and evaluation of all types of radiation.
j Six State inspectors were accompanied during inspections by a review team member during the period of June i-11,1999. Inspector accompaniments were conducted during unannounced inspections as follows: a nuclear pharmacy; a fixed industrial radiography facility; a valve decontamination and testing f acility; a uranium processor, and a pool irradiator f acility. The uranium processing facility was a team inspection with three members of DRWM and the other inspections were performed by RHB inspectors. These accompaniments are also identified in Appendix C.
During the accompaniments, the South Carolina inspectors demonstrated appropriate inspection techniques and knowledge of the regulations. The inspectors were well trained, prepared, and thorough in their audits of the licensees
- radiation safety programs. Overall, the technica! performance of the inspectors was good, and their inspections were adequate to assess radiological health and safety at the licensed f acilities.
Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.3 Technical Staffino and Trainina Issues central to the evaluation of this indicator include the radioactive materials program staffing level and staff tumover, as well as the technical qualifications and training of the staff.
To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator and interviewed the program management and staff.
RHB is staffed with the RHB Chief, a Section Director, an Industrial Program Manager, a Medical Program Manager and three health physics staff. Both of the Program Managers and the technical staff members perform duties in licensing, inspection, and event response, in response to the questionnaire, the State reported that the RHB Chief spends about 50 percent of his effort supervising the radbactive materials program, while the other managers devote all of their time to the program.
Two staff members left the program during the review period and one staff member was hired in 1998. The RHB radioactive materials program is currently fully staffed.
The DRWM organization consists of a Division Director, two Section Managers and six technical staff. The staff includes two engineers, three health physicists and a Barnwell site inspector. DRWM is responsible for the Bamwell site and 14 decontamination and I
South Carolina Proposed Final Report Page 6 decommissioning type licenses. The DRWM program is currently fully staffed.
The review team concluded that the staffing levelis adequate for both the RHB and DRWM programs.
The qualifications of the staff were determined from the questionnaire, training records, and interviews of personnel. The State has a training program in place for the staff which is comparable with the "NRC/OAS Working Group Recommendations for Agreement State Training Programs." The staff are well qualified from an education and experience standpoint.
All have Bachelor's degrees in the sciences, or equivalent training and experience. Two new staff, one each in DRWM and RHB, ere scheduled to attend appropriate core courses. Other license reviewers / inspectors have attended most of the training courses prescribed by IMC 1246 and are very familiar with South Carolina regulations, policies, and procedures. However, the team noted that no one in the Medical Program has attended the core course, Teletherapy and Brachytherapy (H 313). The team believes all technical staff performing brachytherapy licensing or inspections would benefit from the course or equivalent training. The RHB Section Director added that the Medical Program Manager has previously requested attendance in the course, on a space-available basis, but due to a limited number of slots available, was not selected for attendance. The RHB Section Director has taken the H-313 course and provides assistance to staff, when needed.
Also, it was noted that neither of the two members of the Industrial Program have completed the NRC sponsored Irradiator Technology course (H-315) or equivalent training. The State licenses three pool irradiators. Although the irradiator course is a supplementary or specialized course, the team believes that training in this area is needed and that staff performing licensing actions or inspection activities on pool irradiators should have the irradiator course or equivalent i
training.
The team's evaluation of inspection and licensing actions involving medical brachytherapy and irradiator programs did not identify deficiencies related to lack of training in these areas. The State's license reviewers / inspectors produced quality inspection and licensing products. The team believes that increased training in these areas, however, will enhance the program. The review team recommends that the State provide training to technical personnel, either by formal course work or equivalent, in the areas of medical brachytherapy and irradiator technology.
The RHB Chief is supportive of staff training and demonstrated a commitment to staff training during the review. He indicated that the training needs were caused primarily by a lack of j
training funds. The DHEC Commissioner committed to finding a solution to the training issue during the IMPEP review exit meeting.
The review team discussed the role of the Technical Advisory Radiation Control Council i
(TARCC) with the RHB Chief. The TARCC serves as an advisory committee to the radiation
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control program and meets twice a year. The team evaluated meeting minutes from 1997 to 1999. No evidence of any conflict of interest issues were identified. TARCC members are subject to the State Ethics Act.
i Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Technical Staffing and Training, be found i
l satisfactory.
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3.4
. Technical Quality of Licenc!no Actions The review team examined completed licensing casework and interviewed the staff for 18 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 estatilish the basis for licensing actions. Licenses were evaluated for overall tec.rical quality iricluding accuracy, appropriateness of the license, its conditions, and tie-down conditions. Tha casework was-evaluated for timeliness, 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, pre-licensing visits, peer or supervisory review as indicated, and proper signature authority. The files were checked for retention of necessary documents and supporting data.
The licensing casework was selected to provide a representative sample of licensing actions that had been completed in the review period. The licensing casework included work by eight reviewers, including two former reviewers. The cross-section sampling included the following types: academic and medical broad scope; gamma knife; industrial radiography; medical institutions; nuclear pharmacy; teletherapy; research and development; pool irradiator; source material; and manufacturing / distribution. Types of licensing actions selected for evaluation included four new licenses, four amendments to existing licenses, seven license renewals, and 1
three terminations. The review team noted that staff is currently assessing the decommissioning efforts and performing confirmatory surveys of the Allied-General Nuclear Services facility with regard to agreement materialin South Carolina. A list of licenses evaluated for license reviews may be found in Appendix D.
l The team found that the licensing actions were very thorough, complete, consistent, of high quality and property addressed health and safety issues. The licensee's compliance history is taken into account when reviewing renewal applications as determined from documentation in
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the license files and discussions with the license reviewers. The casework evaluation indicated that the DRWM and RHB staffs follow their licensing guides during the review process to ensure that licensees submit the information necessary to support their request. The licensing guides are similar to NRC guides. The team found the checklists /worksheets for each type of program to be comprehensive and incorporated excellent notes to reviewers to assist in the review of applications.
The review team noted that some licenses authorizing use of high dose rate (HDR) brachytherapy devices did not include the specific HDR license conditions that are utilized as i
standard practice by the NRC and other Agreement States. Following discussions on these license conditions, the RHB Informed the team that it had developed license conditions in 1999 for HDR units and these conditions would be incorporated on future HDR licenses and renewals.
a One of the hensing actions examined by the team required the license to submit financial assurance. The originals of the financial documents are maintained in a secure cabinet.
Generic letters were issued to specific class.es of licensees requesting them to review their needs fo'r financial assurance.
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South Carolina Proposed Final Report -
Page 8 The team found that terminated licensing actions were well documented, including the appropriate material transfer records and survey records. An evaluation of the licensing actions over the period revealed that most terminations were for licensees possessing sealed sources.
These files showed that documentation of proper disposal or transfer was provided.
Licenses are renewed on a five-year frequency. Licenses that are under timely renewal are amended as necessary to assure that public health and safety issues are addressed during the period that the license is undergoing the renewal process. Deficiencies are addressed by letters and documented telephone conferences which used appropriate regulatory language.
Each licensing action is reviewed by one individual and then discussed with management prior to issuance. Alllicenses are signed by the DRWM Director or RHB Chief or their designee.
After issuance, new licenses are hand delivered to licensees. The license reviewer uses the opportunity to discuss the requirements of the license and regulations with the licensee. If adequate training or equipment is not available, the reviewer may choose not to present the license. The South Carolina program feels that this initial face-to-face meeting with the licensee is a very valuable toolin eventual compliance with license conditions. The hand delivery of all new licenses was noted as a good practice during the review.
Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
3.5 Response to incidents and Alleoations To evaluate the effectiveness of the State's actions in responding to incidents, the review team examined the State's response to the questionnaire regarding this indicator, evaluated selected incidents reported for South Carolina in the " Nuclear Material Events Database"(NMED) against those contained in the South Carolina files, and evaluated the casework and supporting documentation for eight radioactive material incidents. A list of incident casework examined along with case-specific comments is contained in Appendix E. The team also evaluated the State's response to five radioactive materials allegations which were referred to the State by NRC during the review period.
The review team discussed the State's incident and allegation processes, file documentation, the State's equivalent to the Freedom of Information Act, NMED, and notification of incidents to the NRC Operations Center with the program managers and selected staff. In addition, the State's understanding and use of the NMED system was verified by a team member during a demonstration of a search for data, and through the generation of specific reports requested during the review.
When notification of an incident is received, the managers and staff discuss the health and safety risk associated with the incident, the information needed, the need for an on-site investigation, and coordination with other agenCles. The actions taken in response to the event are documented in a report, filed, and the ou*a entered into the NMED system. Enforcement actions or other regulatory actions were taken as appropriate. The team confirmed that the State has the most recent NRC guidance for reporting incidents. The managers were all aware of the guidance and were knowledgeable about the use of the NMED database system.
South Carolina Proposed Final Report Page 9 RHB had 12 reportable radioactive materials incidents during the review period and 8 were selected for casework review. The incidents included 2 stoli a portable gauges,3 misadministrations, an occupational overexposure, an irradiator source rack Jam, and a lost gauge. The review team found that the State's responses to lacidents were complete and comprehensive. Initial responses were prompt and well-coordinated. The level of effort was commensurate with the health and safety significance. Inspectors were dispatched for on site investigations when appropriate and the State took suitable enforcement action including coordination with DRWM and follow up, as appropriate.
DRWM responded that their office did not have any
- reportable" incidents under NRC criteria, but had numerous cases of responding to alarms at hazardous waste sites and landfills because of medical and NORM material. The DRWM incident log was reviewed to verify this information. There were no performance issues identified during the incident casework reviews and the review of incident logs.
During the review period, there were no materials allegations received by the State directly; however, two materials allegations were referred to RHB and three were referred to DRWM by the NRC. All five allegations were examined in detail by the review team. The review of the casework and the State's files indicates that the State took prompt and appropriate action in response to the concems raised. All of the allegations reviewed were appropriately closed and the team noted that allegations were treated and documented intemally in the same manner as incidents. There were no performance issues identified from the review of the casework documentation.
RHB and DRWM have allegation procedures which were assessed in accordance with IMPEP criteria, the draft Office of State Programs (OSP) Procedure SA-105, " Response to incidents and Allegations," and the NRC Managtment Directive 8.8,
- Management of Allegations,"
revised February 4,1999. The team confirmed that these NRC documents were available in both programs and/or provided copies to the respective programs during the review.
RHB utilizes the OSP Procedure SA-300, ' Reporting Material Events," for reporting of incidents to NRC and all of the incidents ure reported in a timely fashion and in accordance with the procedure. However, the RHB procedure " Incidents and Allegations" does not reference the NRC procedure to be followed. With regard to management of allegations, the procedure does not adequately address the following: (1) the protection of the alleger's identity; (2) allegations received during inspections;
..d (3) documentation for closing out the concem(s) with the alleger. As noted above, the team found that RHB was very responsive in their follow up of the allegations that had been referred to ' chem, that the response was of good quality, thorough, timely, the allegers identity was protected, and the allegations were properiy closed out. The team discussed these aspects of the program and determined that the issue was only a matter of updating the RHB procedure.
DRWM's allegation procedure " Confidential Sources and Allegation Management" was evaluated and the team determined that the procedure addresses the protection of the alleger's identity, the handling of allegations, freedom of information request, referral of allegations to other agencies, investigations, and notifications to the alleger conceming final disposition. The team noted that the procedure was completed and provided for review on the last day of the review.
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South Carolina Proposed Final Report.
Page 10 The review team recommends that the State revise their incident and allegation procedures to incorporate appropriate elements following NRC guidance documents.
. Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.(
4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common pedormance indicators to be used in evaluating Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed j
- Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; j
and (4) Uranium Recovery Program. South Carolina's Agreement does not cover a uranium recovery program, so only the first three non-common performance indicators were applicable to this review.
4.1 Leolslation and Procram Elements Reauired for Comoatibility 4.1.1 Leoislation South Carolina became an Agreement State in 1969. ' Along with their response to the
. questionnaire, the State provided the review team with the opportunity to review copies of legislation that affect the radiation control program. The currently effective statutory authority is contained in 1976 Code of Laws of South Carolina, Section 13-7-10 through 100, the Atomic i
Energy and Radiation Control Act; Section 13 7-110 through 200, Radioactive Waste and Transportation Act; and Section 48-2-10, Environmental Fees. DHEC is designated as the i
State's radiation control agency and implements the radiation control program.
4.1.2 Procram Elements Reauired for Comoatibility The South Carolina DHEC Radioactive Material Regulations, Section 61-63, Title A, applies to alllonizing radiation. These regulations were promulgated pursuant to Section 13-7-40 et. seg.
of the S.C. Code (as amended) of the Atomic Energy and Radiation Control Act. South Carolina requires a license for possession and use of all radioactive materialincluding naturally occurring materials, such as radium, and accelerator-produced radionuclides. South Carohna also requires registration of all equipment designed to produce x-rays or other ionizing radiation, and tanning beds.
The review team examined the State's administrative rulemaking process and found that the process takes about 6 months from the development stage to the final filing with the Secretary of State, after which the rules become effective in 14 days. The regulation adoption process is provided in DHEC Administrative Policy No.111, revised September 14,1995, in cooperation with the Legislative Council of the South Carolina General Assembly. The public, the NRC, other agencies, and all potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments are considered and incorporated as appropriate before the regulations are finalized, approved, and filed with the Secretary of State. The State can adopt other agency regulations by reference which has been done with respect to transportation regulations adopted by the U. S. Department of Transportation, which was verified in this regard by an Attomey General's opinion, dated February 12,1999. The State
i South Carolina Proposed Final Report Page 11 also has the authority to issue legally binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations become effective. South Carolina can adopt regulations needed for compatibility with approval from their TARCC, whereas, other regulations not required for compatibility, such as fees, must receive legislative approval.
The team evaluated th3 State's response to the questionnaire, reviewed the status of regulations required to be adopted by the State during the review period, and verified the adoption of regulations with data obtained from the OSP Regulation Assessment Tracking System. The reviaw team noted that since the March 1995 review, the State incorporated one regulation change by reference and updated the DHEC regulations for Radioactive Materials on j
June 28,1996, and again on Ceptember 10,1998, to be compatible with NRC regulations as follows:
" Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 e
amendment (58 FR 7715) that became effective on July 1,1993 and adopted by the State on June 28,1996.
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- Decommissioning Recordkeeping and License Termination: Documentation Additions,"
10 CFR Parts 30 and 40 amendments (58 FR 39628) tt'at became effective on October 25,1993 and adopted by the State on June 28,1996.
" Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 e
amendments (59 FR 36026) that became effective on August 15,1994 and adopted by the State on June 28,1996.
- Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for e
Medical Use," 10 CFR Parts 30,32, and 35 ar 'endments (59 FR 61767 and 65243) that i
became effective on January 1,1995 and adopted by the State on September 10,1998.
" Frequency of Medical Examinations for Use of Respiratory Protection Equipment,"
e 10 CFR Part 20 amendment (60 FR 7900) that became effective on March 13,1995 and adopted by the State on September 10,1998.
" Low Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649 and 25983) that became effective March 1,1998. The Agreement States were to promulgate their regulations no later than March 1,1998, so that NRC and the State would require this national system to be effective at the same time. The State adopted the requirement on June 28,1996, e
" Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment (60 FR 28323) that became effective on June 30,1995 and adopted by the State on September 10,1998.
- Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective on August 14,1995 and adopted by the State on September 10,1998.
South Carolina Proposed Final Report Page 12 e
" Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective on November 24,1995 and adopted by the State on June 28,1996.
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" Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective on October 20,1995 and adopted by the State on September 10,1998.
"10 CFR Part 71: Compatibility with the Intemational Atomic Energy Agency," 10 CFR e
Part 71 amendments (60 FR 50248) that became effective on April 1,1996 and incorporated by reference by the State on April 1,1996.
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" Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20,30,40,61, and 70 amendments (61 FR 24669) that became effective on June 17,1996 and adopted by the State on September 10,1998.
As noted above, several of the regulation amendments were not adopted within 3 years of their effective date, and 9 of the amendments (from the State's 1996 and 1998 regulation revisions) were not provided to OSP for review and comment as requested by OSP procedures.
Following the review, a team member conducted a review of the DHEC 1996 and 1998 regulation revisions for compatibility in accordance with the OSP procedure SA 201. Pending final NRC approval, the team recommends these final regulations be found compatible with the current compatibility policy. The team also followed up on the OSP comments to the State dated December 15,1997 conceming the adoption of 10 CFR Part 20 equivalent regulations, and determined that the State's 1998 revision had appropriately addressed the OSP comments.
The review team recommends that the State provide draft regulations to OSP for compatibility review, in accordance with OSP procedure SA 200.
I On April 29,1999, the DRWM provided proposed regulations to OSP for review and comment as follows:
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" Resolution of Dual Regulation of Airbome Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65120) that became effective January 9,1997.
" Radiological Criteria for License Termination," 10 CFR Parts 20,30,40, and 70 e
amendments (62 FR 39057) that became effective August 20,1997.
These regulation revisions were entered into the OSP tracking system, reviewed and comments j
provided to DRWM by letter dated June 21,1999. Discussions with the DRWM Director indicated that the NRC comments were being addressed, and that the revisions were projected to become effective prior to the end of this calendar year.
The team identified the following regulation changes and adoptions that will be needed in the future, and the State related that the regulations would be addressed in upcoming rulemakings or by adopting attemate legally binding requirements:
South Carolina Proposed Final Report Page 13
" Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective February 27,1997, e
- Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 amendments (62 FR 4120) that became effective May 29,1997.
" Licenses for Industrial Radiography and Radiation Safety - Requirements for industrial e
Radiography Orarations," 10 CFR Parts 30,34,71, and 150 amendments (62 FR 28947) that b9came effective June 27,1997.
- Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea," 10 CFR Part 30 amendment (62 FR 63634) that became effective January 2, 1998.
e
" Deliberate Misconduct by Unlicensed Persons," 10 CFR Parts 30,40,61,70, and 150 amendments (63 FR 1890 and 13773) that became effective February 12,1998.
e
- Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations," 10 CFR Part 34 amendment (63 FR 37059) that became effective July 9,1998.
- Minor Corrections, Clarifying Changes, and a Minor Policy Change," 10 CFR Parts 20, 32 and 39 amendments (63 FR 39477 and 63 FR 45393) that became effective October 26,1998.
e
" Transfer for Disposal and Manifests; Minor Technical Conforming Am.endment,"
10 CFR Part 20 (63 FR 50127) that became effective November 20,1998.
It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(lll) provides that the above regulations should be adopted by the State as expeditiously as possible, but not later than 3 years after the September 3,1997 effective date of the Commission Policy Statement on Adequacy and Compatibility, i.e., September 3,2000.
Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.
4.2 Sealed Source and Device (SS&D) Evaluation Proaram in assessing the State's Sealed Source & Device (SS&D) evaluation program, the review team examined information provided by the State in response to the IMPEP questionnaire on this indicator. A review of selected new and amended SS&D evaluations and supporting documents covering the review period was conducted. The team observed the RHB's use of guidance documents and procedures, and interviewed the staff, the RHB Section Director and the industrial Program Manager involved in SS&D evaluations.
The RHB instituted a policy that the RHB Section Director perform a concurrence review and sign all registration certificates prior to issuance. in addition to the review conducted by the
~
o South Carolina Proposed Final Report Page 14 technical staff. These reviews are technical in nature, to ensure the technical soundness, readability, and understandability of the registration certificates.
4.2.1 Technical Quality of the Product Evaluation Proaram.
During the review period, two SS&D certificates and one amendment were issued by the State.
One certificate was for distribution to specific licensees, and the other two SS&D actions were i
for custom use. All were evaluated and are identified, with case-specific comments, in Appendix F.
Analysis of the files and interviews with the staff confirmed that South Carolina follows the recommended guidance from the NRC SS&D training workshops. The registration files contained all correspondence, photographs, engineering drawings (except one device),
radiation profiles, and results of tests conducted by the applicant. In addition, the SS&D review checklist received at the NRC SS&D workshop was used to assure all relevant materials had been submitted and reviewed. The checklist was contained in the registration file. The State indicated that the guidance in NUREG-1566, Volume 3, issued September 1997, will be utilized for future reviews. All pertinent ANSI Standards, Regulatory Guides, and workshop references were confirmed to be available and are used when performing SS&D reviews. The RHB Section Director related that the non-Atomic Energy Act material reviews are performed in the same procedural manner using the same references as used for Atomic Energy Act sources and devices.
j As noted above, one device file was missing the original engineering drawings. After j
discussions with the staff, the team considered the information in the file and determined that this issue was a matter of documentation rather than a performance issue. The State related that another search of the files would be conducted and/or the device manufacturer would be contacted for another copy. The review team recommends that the State obtain copies of the i
engineering drawings for the SC-0679-D-101 S registered device, and review the drawings for accuracy with the original application, and maintain them in their files.
4.2.2 Technical Staffino and Trainino The RHB Section Director and the Industriaf Program Manager conduct the SS&D reviews and are in the process of training one other person in the review of sealed sources and devices.
Both managers have attended the SS&D workshops sponsored by NRC and both have had several years experience reviewing license applications and SS&D applications. A concurrence review is performed by the RHB Section Director, however, the team found that the SS&D reviewers work together closely when conducting a review and discuss issues and concems that have been identified in an application. The RHB Section Director is committed to maintaining a high degree of quality in their SS&D reviews and related that additional training and/or another workshop is needed to update staff skills and knowledge. The RHB Section Director also related that additional engineering support is available from other offices within DHEC, if needed. The team discussed potential training in the form of actual reviews that could be obtained through working with other SS&D reviewers at the NRC or other Agreement States.
South Carolina Proposed Final Report Page 15 l
4.2.3 Evaluation of Defects and incidents Recardino SS&Ds No incidents or defects related to SS&Ds were reported with these devices during the review period. The team also verified that there were no reported incidents by having a SS&D reviewer conduct an on-line search by device and manufacturer utilizing the NMED system.
Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisf actory.
4.3 Low-Level Radioactive Waste (LLRW) Disposal Prooram Chem-Nuclear Systems, LLC (CNS) is licensed by the State of South Carolina to handle, process, store, and dispose of LLRW. DRWM administers the CNS disposallicense for the Bamwell, South Carolina site. DRWM regulatory authority is derived from the South Carolina Atomic Energy and Radiation Control Act, Section 13-7-40,1976, S.C. Code of Laws (as amended). The license establishes regulatory conditions and procedures that CNS must comply with regarding waste acceptance criteria, site construction, maintenance, environmental monitoring, stabilization and closure. CNS began its operation of shallow land disposal of LLRW at Bamwellin 1971. The license has been amended frequently and renewed seven times, last in 1995. The current license expires in July 2000. The Bamwell facility received approximately 200,000 cubic feet of waste in 1998; however, the estimated average annual LLRW disposal rate, for upcoming years, is 300,000 cubic feet. The estimated remaining waste disposal capacity at the site is approximately 3.2 million cubic feet.
The LLRW disposal program review was initiated, by the review team, through an early evaluation of relevant background materials and examination of the State's response to the queatonnaire. A one-day field site visit to the Bamwell LLRW disposal facility was conducted on July 13,1999, by two team members, to meet with DRWM's site inspector and to examine f acility operation and overall site conditions.
In conducting this IMPEP review, five sub-indicators were employed to evaluate South Carolina's performance regarding its low-level radioactive waste disposal program. These sub-indicators include: (1) Status of Low-Level Radioactive Waste Disposal inspection; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.
The results of the LLRW disposal program review will be discussed under each of the above five non-common performance sub-indicators. Team conclusions are based on assessment of each of these sub-indicators as well as on field obse've.tions and discussions with DRWM staff.
r 4.3.1 Status of Low-Level Radioactive Waste DisposalInsoection The review team examined the status of the LLRW inspection program regarding the frequency of State inspections of the disposal facility licensee. The review team found that inspections are conducted daily, by the on-site DRWM site inspector; weekly, by DRWM environmental engineers or health physicists; and annually by both specialized professionals as well as managers. The review team confirmed the frequency of inspection through review of the site inspector logbook, and weekly and annual inspection reports. The frequency of inspections
South Carolina Prnposed Final Report Page 16 exceeded the annualinspection requirement specified in NRC's IMC 2800.
The review team analyzed the State capability for maintaining and retrieving data on the status of the inspection program. DRWM maintained records of weekly and annualinspection reports.
DRWM also develorud an electmnic inspection database which provides a summary outline of inspection status. The review team examined several samples of weekly and annualinspection reports and found that these reports are complete. IJcensee's responses and closure of inspectbn issues were well documented. Weekly inspection reports are approved by the DRWM Section Managers and annual reports are reviewed and approved by the DRWM Director.
The review team also examined documentation regarding the LLRW facility licensing, l
operation, and planned closure / post-closure. DRWM maintained complete licensing records l
regarding license amendment and renewal. The site inspector kept records of waste j
shipments, type, originator, volume, and activity. Records of working staff exposure as well as quarterly data on environmental data were maintained. Copies of verification data submitted to CNS for class types (specifically for Class C waste) were kept along with copies of the waste i
(
disposal requests submitted by the waste originators (or waste brokers). DRWM also kept 9000 records of informal plans for site closure. These plans covered future waste volume to be received, maximum capacity of the site for disposal, and financial assurance funds for site closure.
4.3.2 Technical Quality of Insoections The annual and weekly inspection reports, as well as the site inspector logbook were examined by the review team. The DRWM inspections were thorough, technically accurate, complete, consistent, and of high quality with sufficient documentation to ensure that the licensee's performance with respect to health and safety were acceptable. Staff technical analysis and rationale appeared sound without any technical flaws or errors. Five annual inspection reports completed on July 1995, October 1996, July 1997, July 1998, and January 1999, were thoroughly examined for completeness. These reports were found complete regarding documentation of inspection findings and disposal conditions, including photographs taken during site operations. Inspectors appropriately performed independent measurements and analyses.
DRWM inspectors communicated inspection findings to the licensee in a timely fashion, documented licensee responses to inspection findings, and closed outstanding inspection issues. The DRWM inspectors, Section Managers and Director participated in preparation, review and approval of the annualinspection reports.
4.3.3 Technical Staffina and Trainina The review team evaluated the DRWM staffing plan. DRWM has currently 11 full-time staff, including the Division Director, two Section Managers, two environmental engineers, three health physicists, the site inspector, and two administrative assistants. All staff has bachelors degrees or higher, or equivalent training and experience. One of the administrative assistant positions was recently filled af ter being vacant for less than two months. The team concluded that the current staffing levelis adequate for the program. DRWM tumover is very low with vacant positions readily filled.
l l
1
)
South Carolina Proposed Final Report Page 17 The review team also evaluated DRWM staff academic qualification, knowledge and experience, and training, to ensure that staff, including the site inspector, are technically qualified and adequately trained. Staff training is adequate and comparable to NRC's IMC 1246. Two team members conducted a one-day site visit to Bamwell on July 13,1999, accompanied by a DRWM Section Manager. The team members discussed, whn the site inspector, his inspection procedure to identify and characterize waste packages to ensure compliance with license conditions and State regulations. Further, the team conducted informal meetings with each of the staff members to discuss inspection procedures, inspection reports, and their technical backgrounds.
Staff demonstrated appropriate knowledge of relevant State, NRC, Environmental Protection Agency, and Department of Transportation regulations. Records are maintained of training and participation in technical workshops and professional meetings.
DRWM contracted a licensed radiological laboratory to examine and perform necessary radiological analyses for environmental samples and samples collected during inspections. The contract laboratory is also used to ensure adequate quality assurance in radiological inspection measurements and environmental monitoring data.
4.3.4 Technical Quality of Licensina Aqtion_s The review team evaluated licensing actions for the LLRW disposal facility. The team examined DRWM's approaches and procedures to control the type of waste products disposed at the facility. Typically, DRWM reviews, in advance, before waste shipments are made, the
- Radioactive Waste Prior Notification and Manifest Forrns." This review is done to ensure that waste characteristics and classifications are adequately analyzed and documented. Further, DRWM requires an advance verification of Class C waste. Waste originators go through a comprehensive analysis to demonstrate that radioactive waste is not greater than Class C.
DRWM has procedures and license conditions to ensure that the licensee shall not accept radioactive waste for storage or disposal unless the shipper has completed the required information for the waste shipment on the NRC's LLRW Manifest Forms 540
- Shipping Papers,"
541
- Container and Waste Description," and 542
- Manifest Index and Regional Compact Tabulation," as applicable, or approved equivalent forms.
The State also monitors the limits of maximum radioactivity, mass, and volume of each waste shipment and the total annual waste inventory at the facility. DRWM also examines waste types to ensure that unusual hazardous materials, or potential hazardous material, such as gaseous, chemical, free standing liquids, or pyrophoric, are excluded from waste shipments.
The review team determined that DRWM strictly enforces license conditions regarding waste type, waste class, activity, and volume, ir$cluding granting variances under certain circumstances. Examples of these variances include: (a) allowance for disposal of lead shielding materials with the waste package; (b) allowance for exceeding the activity limits for disposal of some sealed sources by considering volume of encapsulation; and (c) allowance for disposal of large size equipment (e.g., steam generators) without construction of a concrete vault in the disposal trench. The team evaluated many of the variances granted and found DRWM's actions are very thorough, complete, consistent, of high quality and property address health and safety issues.
i I
j South Carolina Proposed Final Report Page 18 l
l The review team examined the State's program to characterize the Bamwell site during operation. DRWM reviews characterization of disposal trenches and depth of the water table.
l Staff documented trench construction to ensure structural stability and took action regarding any deviations from the approved designs. Characterization of site performance is also carried out through enforcement of environmental surveillance license conditions. DRWM reviews air sampling and monitoring well data. Conceming the overall site characterization and
= performance for closure and post-closure, DRWM is currently using environmental monitonng
)
data. The team found DRWM's characterization program very thorough, complete, consistent and of high quality.
The review team noted that site data showed off-site tritium releases; however, DRWM's estimate of doses from such releases are less than allowable limits under the State regulations.
I In addition, the team noted that detectable off-site rsleases of carbon-14 (C-14) were documented in CNS and DRWM's monitoring data. DRWM doses estimates for C-14 releases are less than 1 millirem per year. DRWM requested CNS to take prompt actions to reduce H-3 and C 14 releases. The licensee promptly responded by conducting mitigation to reduce these releases. For example, the licensee placed high integrity plastic liners over the old trenches, i
substantially reducing water infiltration. The team discussed with DRWM their efforts to i
continue using environmental monitoring data to assess any future potential for releases and to help planning for site closure and decommissioning.
The team evaluated DRWM procedures and requirements for financial qualification and assurances. A fund of approximately $12-13 million has been allocated so far for decomrnissioning and closure. DRWM informed the team that CNS has expended about $7 million to install liners and enhanced caps over the closed trenches.
The review team assessed DRWM decommissioning procedures regarding disposal capacity, i
site closure, and environmental surveillance. The team evaluated DRWM licensing guides, policies, memoranda, and adopted regulations. The program was found to have adequate intemallicensing g_' des and generallicensing procedures. DRWM also adopted NRC's regulations and common LLRW guidance documents.
The team examined the safety reports applicable to site operations, license amendments, and i
licensing decisions. In most cases, licensing actions did not warrant preparation of safety reports other than those submitted by waste generators or CNS. In some complex cases, engineering reports and safety analyses were provided for specific waste shipments such as steam generators. DRWM conducted adequate critical reviews of engineering and safety I
reports regarding non-routine waste disposal. Safety reports regarding doses to the public from releases of H-3 and C-14 were also reviewed and found adequate.
The DRWM provides opportunities for public hearings regarding licensing actions. No significant actions were taken during the review period to warrant a public hearing. It should be noted that the Govemor of South Carolina announced on June 10,1999 the creation of a Nuclear Waste Task Force to examine the final disposition of South Carolina's low-level nuclear waste facilities. The task force includes four members of the State House of Representatives, j
four State Senators, and five at-large members appointed by the Govemor.
The review team examined documentation of interactions with the licensee to ensure proper and clear communication of license conditions and regulatory requirements. Staff found 4
7 _
L L
C South Carolina Proposed Final Report Page 19
~ complete and timely documentation of interactions with the licensee and clear regulatory
- requirements. No significant disagreements were noted with the licensee regarding -
implementation of the regulations and license conditions.
The team reviewed licensing actions pertaining to aspects of health physics, hydrology, and structural engineering. Reviews of public and radiation worker exposure were thorough and documented. Actions taken by DRWM to require mitigative measures to address releases were very thorough, prompt,' complete, consistent, of high quality and property address health and safety issues. Actions regarding engineering assessment for transport and disposal of l
steam generators were of high technical quality and well implemented.
y DRWM maintained good records of environmental monitoring data. An electronic database has been established for monitoring of H-3 in wells. DRWM also plans to establish a similar database for environmental monitoring of C-14. DRWM collects split samples to examine j
licensee data and contracted General Engineering Laboratories, an EPA-licensed laboratory, to conduct radiological analyses and to examine CNS environmental data. Overall, the team found that the DRWM licensing actions were very thorough, complete, consistent, of high l
. quality and properly addressed health and safety issues.
j l-4.3.5-Resoonse to incidents and Alleaations The review team did not identify any incidents or allegations of safety concems regarding the Bamwell LLRW disposal facility. DRWM has procedures available to handle incidents and i-allegations. Except as noted in Section 3.5 of this report, the procedures appropriately describe l
incident and allegation response, including intemal and extemal coordination.
Based on the IMPEP evaluation criteria, the review team recommends that South Carolina's performance with respect to the indicator, Low-Level Radioactive Waste Disposal Program, be found satisfactory.
l.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found South Carolina's performance to be i
satisfactory for all eight performance indicators. Accordingly, the review team recommends that the Management Review Board find the South Carolina Agreement State Program to be adequate and compatible with NRC's program.
Below is a summary list of recommendations, as mentioned in earlier sections of the report, for evaluation and implementation, as appropriate, by the State. Also, the good practice" noted in i
i the report is identified.
l 1.
RECOMMENDATIONS:
l 1.
The review team recommends that the State provide training to technical personnel, either by formal course work or equivalent, in the areas of medical brachytherapy and irradiator technology. (Section 3.3)'
L l
L
South Carolina Proposed Final Report Page 20 2.-
The review team recommends that the State revise their incident and allegation procedures to incorporate appropriate elements following NRC guidance documents.
(Section 3.5) 3.
The review team recommends that the State provide draft regulations to OSP for compatibility review, in accordance with OSP procedure SA-200. (Section 4.1.2)
' 4.
The review team recommends that the State obtain copies of the engineering drawings for the SC-0679-D 101 S registered device, and review the drawings for accuracy with -
the original application, and maintain them in their files. (Section 4.2.1)
GOOD PRACTICE:
The hand delivery of all new licenses was noted as a good practice during the review.
(Section 3.4) '
l.
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LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B South Carolina Organization Charts Appendix C Inspection Casework Reviews Appendix D.
License Casework Reviews Appendix E incident Casework Reviews i
Appendix F Sealed Source & Device Casework Reviews Appendix G South Carolina's Questionnaire Responses i
Attachment South Carolina's Response to Draft IMPEP Report dated August 31,1999 I
l l
l 1
APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Ares of Responsibility James Lynch, Region lli Team Leader Status of Materials inspection Program Technical Staffing and Training Richard Woodruff, Region ll Response to incidents and Allegations Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program l
Robert Funderburg, Califomia Technical Quality of Inspections i
i Deborah Piskura, Region lil Technical Quality of Licensing Actions
\\
Boby Abu Eld, NMSS Low-Lcvel Radioactive Warte Disposal Program 1
I l
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APPENDIX B i
SOUTH CAROLINA DEPARTMENT OF HEALTH & ENVIRONMENTAL CONTROL j
and DIVISION OF RADIOACTIVE WASTE MANAGEMENT and RADIOLOGICAL HEALTH BRANCH ORGANIZATION CHARTS
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APPENDIX C INSPECTION CASEWORK REVIEWS NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLIJDED FOR CCMPL ETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP
- TEAM.'
File No.: 1 Licensee: Carolinas Health System License No.: 161 Location: Florence, SC Inspection Type: Routine, Unannounced
' License Type: Nuclear Medicine Priority: 2 Inspection Date: 1/25/99 -
Inspector: ES File No.: 2 Licensee: Soil Consultants License No.: 197-02 Location: Charleston, SC Inspection Type: Routine, Announced License Type: Industrial Radiography Priority: 1 Inspection Date: 10/26/98 Inspector: DK Comments:
a)
NOV and report reference an unauthorized user, but do not identify the individual or position.
b)
No field inspections in four years.
c)
Licensee disputed an inventory violation, but the acknowledgment letter does not
' reference the disputed item.
File No.: 3 Licensee: Lexington Medical Center -
License No.: 146 Location: West Columbia, SC Inspection Type: Routine, Unannounced License Type: Medical Institution /HDR Priority: 2 Inspection Date: 12/16/98 Inspector: MB File No.: 4 Licensee: Medical University of South Carolina -
License No.: 081-01 Location: Charleston, SC.
' Inspection Type: Routine, Announced License Type: Broad Medical Priority: 1 Inspection Date: 8/3/98 inspector: MB
~
File No.: 5 Licensee: Pee Dee isotopes License No.: 503 Location: Florence, SC Inspection Type: Routine, Announced License Type: Nuclear Pharmacy Priority:1 Inspection Date: 6/7/99 Inspector: MB
' Comment:
a)
Interviews with workers not recorded.
I South Carolina Proposed Final Report -
Page C.2 1
Inspection Casework Reviews File No.: 6 Licensee: Isomedix Operations, Inc.
License No.: 267 Location: Spartanburg, SC Inspection Type: Routine, Announced License Type: PoolIrradiator Priority: 1 Inspection Date: 2/27/97 Inspector: DK File No.: 7 Licensee: Industrial Inspections, Inc.
License No.: 447 Location: Summerville, SC Inspection Type: Routine, Announced License Type: Industrial Radiography Priority: 1 Inspection Date: 3/28/98 Inspector: DK Comment:
a)
No field inspections were completed.
File No.; 8 Licensee: Boiler Tube Company of America License No.: 439 Location: Lyman, SC inspection Type: Routine, Announced License Type: Industrial Radiography Priority: 1 Inspection Date: 5/27/99 Ir spector: DK 4
Comment:
a) 1999 inspection report stated that there were no previous violations but the 1998 inspection report identified a quarterly audit violation. The violation was a repeat from the 1997 inspection.
j File No.: 9 Licensee: Jacobs Applied Technology License No.: 205 Location: Goose Creek, SC Inspection Type: Routine, Announced License Type: Industrial Radiography Priority: 1 Inspection Date: 9/24/97 Inspector: AR Comment:
a)
No field inspections were completed.
File No.: 10 Licensee: Unified Testing Services License No.: 588 Location: Charieston, SC inspection Type: Routine, Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 5/13/99 Inspector: AR File No.: 11 Licensee: Interstate Nuclear Services Corporation License No.: 135 Location: Columbia, SC Inspection Type: Routine, Unannounced License Type: Nuclear Laundry Priority: 1 Inspection Date: 6/3/98 Inspectors: JP, DK, AR
7-i:
South Carolina Proposed Final Report Page C.3
- Inspection Casework Reviews File No.: 12 Licensee: Consolidated NDE -
License No.: 29-21452-01 Location: Spartanburg, SC inspection Typ6 Routine, Unannounced
. License Type: Industrial Radiography (Reciprocity)
Priority: 1 Inspection Date: 3/30/99 Inspector: AR File No.: 13.
Licensee: Soil and Materials Engineering, Inc.
License No.: 092-0922-1 Location: Greenville, SC Inspection Type: Special, Unannounced License Type: Industrial Radiography (Reciprocity)
Priority: 1 Inspection Date: 4/12/99-Inspector: AR -
File No.: 14
~
Licensee: Triad Non-Destructive Testing, Inc.
License No.: 0$4-0916-1 Location: Spartanburg, SC Inspection Type: Special, Unannounced License Type: Industrial Radiography (Reciprocity)
Priority: 1 inspection Date: 6/3/99 Inspector: AR File No.: 15 Licensee: Clemson Environmental Technologies License No.: 482 Locationi Clemson, SC Inspection Type: Routine, Announced License Type: Decontamination and Decommissioning Priority: 1 Inspection Date: 1/3/98 Inspector: MG File No.: 16 Licensee: Chem-Nuc' ear Systems, LLC License No.: 287-05 Location: Bamwell, SC Inspection Type: Routine, Announced License Type: Decontamination License Priority: 1 Inspection Date: 4/16/99 Inspector: JS
- File No.: 17 Licensee: Starmet CMI License Nu.:.322 Location: Bamwell, SC '
Inspection Type: Routine, Unannounced License Type: Decontamination and Decommissioning Priority: 1
- Inspection Date: 6/10/99 Inspector: HP i
Comments:
a)
No discussion of previous inspection.
. b)
Recommendations in letter to licensee were not explained in report.
c)
Inspection report contains discussion of routine surveys exceeding limits but no I
explanation of what regulatory or licensee administrative limits were exceeded.
File No.: 18
- Licensee: Hilton Head Medical Center License No.: 241 Location: Hilton Head, SC Inspection Type: Routine, Unannounced License Type: Nuclear Medicine Priority: 2 Inspection Date: 10/9/97 Inspector: MB
South Carolina Proposed Final Report Page C.4 Inspection Casework Reviews File No.: 19 Licensee: Chem-Nuclear Systems, LLC License No.: 287-04 Location: Bamwell, SC Inspection Type: Routine, Unannounced Licensee Type: Waste Processing
. Priosity: 1 inspection Date: 4/28/99 Inspectors: HP, JS, SJ, MG Comment:
. a)
Report does not discuss worker interviews, operating procedures, calibration of
' instruments, posting orlabeling.
File No.: 20 Licensee: Chem-Nuclear Systems, LLC License No.: 287 02 Location: Bamwell, SC Inspection Type: Routine, Announced License Type: Waste Processing Priority: 1 Inspection Date: 5/12/99 Inspector: RW Comment:
a)
Smear survey indicated elevated levels but violation was not cited and justification for not citing was not provided.
File No.: 21 Licensee: SPEC Consultants, Inc.
License No.: 065-0896-2 Location: Georgetown, SC Inspection Type: Special, Unannounced License Type: Industrial Radiography (Reciprocity)
Priority: 1 Inspection Date: 4/24/99 Inspector: DK File No.: 22 Licensee: Nucletron Corporation License No.: MD-27-035-01 Location: Columbia, SC Inspection Type: Special, Unannounced License Type: HDR Service (Reciprocity)
Priority: 1 Inspection Date: 4/23/99 Inspector: MB INSPECTOR ACCOMPANIMENTS in addition, the following inspection accompaniments were made as part of the on-site IMPEP review:
Accompaniment No.: 1 Licensee: Pee Dee isotopes, loc.
License No.: 503 Location: Florence, SC Inspection Type: Routine, Unannounced License Type: Nucleer Pharmacy Priority:1 Inspection Date: 6/7/99 Inspector: MB
South Carolina Proposed Final Report Page C.5 Inspection Casework Reviews-f
- Accompaniment No.: 2
. Ucensee: Sullivan & Associates, Inc.
License No.: 383 Location: North Chadeston, SC:
Inspection Type: Routine, Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 6/8/99 -
Inspector: AR Accompaniment No.: 3 l
Licensee: NWS Technologies, LLC License No.: 541
' Location: Spartanburg, SC Inspection Type: Routine, Unannounced License Type: Decontamination Facility (Part 21 Vendor)
Priority:1 Inspection Date: 6/9/99 Inspector: DK Accompaniment No.: 4 Licensee: Starmet CMI License No.: 322 Location: Bamwell, SC Inspection Type: Routine, Unannounced License Type: Depleted Uranium Processor Priority: 6 mo.
Inspection Date: 6/10/99 Inspectors: HP, RW, MG Accompaniment No.: 5 Licensee: Steris Corporation License No.: 267 Location: Spartanburg, SC Inspection Type: Special, Announced License Type: Poolirradiator Priority: 1 Inspection Date: 6/11/99-Inspector: DK 1
i i
APPENDIX D LICENSE CASEWORK REVIEWS NOTE: ALL LICENSES LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.
File No.: 1 Licensee: Allied-General Nuclear Services License No.:144 Location: Bamwell, SC Amendment No.: 24 License Type: Decommissioned Facility (Fuel Cycle)
Type of Action: Renewal Date issued: 5/4/99 License Reviewer: HP File No.: 2 i
Licensee: Anderson Area Medica! + ' enter License No.: 023-05 Location: Anderson, SC Amendment No.: 15 License Type: Teletherapy Type of Action: Termination Date issued: 4/20/99 License Reviewer: MB File No.: 3 Licensee: Clemson Environmental Technologies Laboratory License No.: 482 Location: Clemson, SC Amendment No.: 07 License Type:.Research and Development Type of Action: Renewal l
Date issued: 4/2/97 License Reviewer: JS File No.: 4 Licensee: Clemson University License No.: 540 Location: Clemson, SC Amendment No.: N/A License Type: Type A Broad Scope Academic Type of Action: New Date issued: 9/25/96 License Reviewer: MB File No.: 5 Licensee: Isomedix Operations incorporated License No.: 267 (nka Steris isomedix Services)
Location: Spa:tanburg, SC Amendment No.: 11 License Type: Pool Irradiator Type of Action: Renewal Date issued: 2/12/99 License Reviewer: DK i
File No.: 6 Licensee: Lexington Medical Center License No.: 146 Location: West Columbia, SC Amendment No.: 29 License Type: Medical Institution /HDR Type of Action: Renewal Date issued: 12/9/97 License Reviewer: JH File No.: 7 Licensee: Mahlo America, Inc.
License No.: GL-142-02 Location: Spartanburg, SC Amendment No.: 12 License Type: General License Distribution Type of Action: Renewal Date issued: 4/10/98 License Reviewer: DK
m South Carolina Proposed Final Report Page D.2 License Casework Reviews File No.: 8 Licensee: Medical University of South Carolina License No.: 081-01 Location: Charleston, SC Amendment No.: 35 License Type: Type A Broad Scope _ Medical Type of Action: Renewal HDR/ Nuclear Pharmacy Date issuod: 8/21/95 License Reviewer: MB File No.: 9 Licensee: Palmetto Richland Medical Hospital License No.: 586 Location: Columbia, SC Amendment No.: N/A License Type: Medical Institution / Gamma Knife Type of Action: New Date issued: 6/19/99.
License Reviewer: MB -
File No.: 10 Licensee: Penn Tech Diagnostics, Inc.
License No.: 538 Location: Saluda, SC Amendment No.: N/A License Type: Mobile Nuclear Medicine Type of Action: New Date issued: 6/28/96_
. License Reviewer: MB File No.: 11 Licensee: Quality MedicalImaging -
7 License No.: 590 Location: Columbia, SC Amendment No.: 01 License Type: Mobile Nuclear Medicine Type of Action: Termination
' Date issued: 6/4/99 License Reviewer: MB File No.: 12 Licensee: Quorum Health Gnup, Inc.
License No.: 200 Location: Florence, SC Amendment No.: 34 License Type: MedicalInstitution -
Type of Action: Termination Date issued:11/12/98 License Heviewer: MB 1
File No.: 13 License No.: 531 Licensee: Shertech Pharmacy-Spartanburg Location: Drayton, SC Amendment No.: N/A License Type: Nuclear Pharmacy--
Type of Action: New Date issued: 9/18/95.
License Reviewer: RM File No.: 14 Licensee: Soil Consultants, Inc.
License No.: 197-02 Location: Charleston, SC -
Amendment No.: 32 License Type: Industrial Radiography / Portable Gauge Type of Action: Amendment Date issued:-4/17/97 License Reviewer: AR File No.: 15 Licensee: Southeastem Imaging, P.C.
License No.: 580 Location: Lake City, SC Amendment No.: 02 License Type: Mobile Nuclear Medicine Type of Action: Amendment Date issued: 5/21/99 License Reviewer: MB
i l
South Carolina Proposed Final Report Page D.3 l
License Casework Reviews File No.: 16 Licensee: Spartanburg Regional Medical Center License No.: 086-001 Location: Spartanburg, SC.
Amendment No.: 38 j
Ucense Type: Medical Institution /HDR Type of Action: Renewal j
Date issued: 6/30/98 License Reviewer: ES l
File No.: 17 Licensee: Starmet CMI License No.: 322
' Location: Bamwell, SC Amendment No.: 23 j
License Type: Source Material Processing Type of Action: Amendment Date issued: 4/22/99 License Reviewer: JS
. File No.: 18 Licensee: Syncor Intemational Corporation License No.: 448 Location: Columbia, SC Amendment No.: 25 License Type: Nuclear Pharmacy Type of Action: Amendment Date issued: 5/03/99 License Reviewer: JH i
l
i APPENDIX E INCIDENT CASEWORK REVIEWS NOTE: ALL INCIDENTS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.
File No.1 Licensee: GME Engineering incident ID No.:970288 Location: Greenville, SC License No.: 522 l
Date of incident: 10/7/96 Type of incident: Stolen Gauge 1
Investigation Date: 10/8/96 Investigation Type: Telephone j
Summary of incident and Final Disposition: The licensee reported by letter dated November 15,1995, that a portable moisture gauge was stolen from a locked truck parked at an employee's home. The local police responded to the theft and filed a report. Enforcement actions were taken. The device was not recovered.
File No.: 2 Licensee: Isomedix Operations, Inc.
Incident ID No.:951033 Location: Spartanburg, SC License No.: 267 Date of incident: 5/5/95 Type of incident: Source Rack Jam Investigation Date: 5/24/95 Investigation Type: On-site Summary of incident and Final Disposition: The licensee reported that a source rack in the Nordion irradiatorjammed on May 5,1995. The Emergency Plan was activated and Nordion intemational provided a response team to retum the source rack to the fully shielded position, and to make repairs to the hoist cable system. The investigation indicated that there were no excessive exposures, all procedures were followed, and proper maintenance had been performed. A broken strand in one cable that became entangled in the cable system caused the source rack jam. As a precaution, all three cable assemblies were replaced.
File No.: 3 Licensee: Lexington Medical Center Incident ID No.: 980353 Location: West Columbia, SC License No.: 146 Date of incident: 2/4/98 Type of incident: Misadministration Investigation Date: 2/4/98
. Investigation Type: Telephone Summary of incident and Final Disposition: An elderly patient was treated for lung cancer using an HDR unit with 4.63 curies of Iridium-192. A new source was loaded into the unit, but the licensee failed to make appropriate programming corrections in the treatment unit console. The error was caught prior to delivery of subsequent dose fractions and the planned dose was not exceeded. The licensee upgraded the software package in the unit and the new software is designed to prevent future errors of this nature.
South Carolina Proposed Final Report Page E.2 j
incident Casework Reviews File No.: 4 Licensee: Liberty Technologies, Inc.
Incident No.: 960152 Location: North Charleston, SC License No.: 164
' Date of incident: 10/1/95 Type of incident: Overexposure investigation Date: 1/18/96 Investigation Type: On-site Summary of incident and Final Disposition: The licensee's film badge supplier reported to the licensee an 8 rem exposure to one radiographer. No reason for the high film badge exposure could be determined, but the individual was removed from radiographic work for the remainder
'of the calendar quarter The investigation resulted in enforcement action being taken because of other unrelated violations.
File No.: 5 Licensee: Santee Cooper Winyah Generating Station incident No.: 970151 Location: Charleston, SC License No.: N/A Date of incident: 12/27/96 Type of incident: Lost RAM
' Investigation Date: 1/13/97 investigation Type: On-site Summary of incident and Final Disposition: A Kay-Ray gauge containing 100 millicuries of cesium-137 was presumed to be removed during a salvage project and sent to the scrap yard.
Surveys were performed at the scrap yard, and several other potential locations. The gauge was eventually located at the licensee's facility on 7/11/97 in a coal system metals separator pile.
File No.: 6 Licensee: Palmetto Richland Memorial Hospital incident No.: 990170 Location: Columbia, SC License No.: 40 Date of incident: 10/21/98 Type of incident: Misadministration Investigation Date:11/25/98 investigation Type: Telephone Summary of Incident and Final Disposition: A misadministration using an HDR unit with 100 millicuries of iridium-192 occurred when a patient was prescribed 1500 rads over 5 fractionated doses, but a calculation error was discovered prior to the third dose. The patient receive 2026 rads in two treatments and the treatment was terminated. The licensee reported that the likelihood of significant complications was less than 10%. The licansee modified the treatment procedures and developed a check list to prevent recurrence of the error.
File No.: 7.
Licensee: Soil and Materials Engineering, Inc.
Incident No.: 990054 Location: Mt. Pleasant, SC License No.: 324 Date of incident: 11/7/98 Type of Incident: Stolen Gauge Investigation Date:11/10/98 Investigation Type: Telephone
- Summary of incident and Final Disposition: The licensee reported that a postable Humbolt moisture density gauge was stolen from the back of a pick-up truck. The local police investigated and filed a pelice report. The box containing the missing gauge was reported to the local fire department on January 26,1999. The device was retemed to the owner and checked for damage and leakage. The NMED data was updated.
South Carolina Proposed Final Report Page E.3 Incident Casework Reviews File No.: 8 Licensee: Tuomey Regional Medical Center incident No.: 970155 Location: Sumter, SC License No.: 10 Date of incident: 12/11/96 Type of Incident: Misadministration investigation Date: 12/11/96 Investigation Type: Telephone incident Summary and Final Disposition: The licensee reported an lodine-131.
misadministration due to human error when a faxed order was misread by the technologist.
The administered dose was 5 times the prescribed dose. The licensee will require a written order on hand before ordering from the nuclear pharmacy and a second person will be required to verify the dosage prior to administration.
APPENDIX F SEALED SOURCE AND DEVICE REVIEWS NOTE: ALL SEALED SOURCE AND DEVICE CASEWORK LISTED WITHOUT COMMENT L ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Registry No.: SC-438-D-102 B SS&D Type: Weight Gauge Manufacturer: Mahlo America Model No.: 6270/61 j
Date issued: 7/22/98 File No.: 2 Registry No.: SC-1036-D-103-S SS&D Type: Beta Thickness Gauge Manufactursr: Electronic Systems, Spa Model No.: ISOSINT 1000 Date issued: 7/22/98 File No.: 3 Registry No.:SC-0679-D-101-S SS&D Type: WEBFREX Thickness Gauge Manuf acturer: Yokogawa Electric Corporation Model No.: WG21 Date issued: 2/24/98 j
Comment:
a)
The original detailed engineering drawings showing overall dimensions of the device and source chamber, and the operation of the source drawer mechanism were not in the file.
l l
F i
APPENDIX G STATE OF SOUTH CAROLINA QUESTIONNAIRE RESPONSES I
i
Approved by OMB' No. 3150-0183 Expires 5/31/2001 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE South Carolina Reporting Period: March 25,1995 to July 11,1999 A.
COMMON PERFORMANCE INDICATORS
- 1. ~
Status of Materials insoection Proaram Please prepare a table identifying the licenses with inspections that are overdue by rnore than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.
Insp. Frequency Licensee Name (Years)
Due Date Months O/D Response: For the reporting period identified above there are no inspections that are overdue by more than 25% of the scheduled frequency set out in NRC inspection Manual 2800.
2.
Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.
Response: There are no overdue inspections as is described in the above response.
3.
Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.
4 Response: South Carolina requires more frequent inspections of certain license categories as follows: Medical Institution - Priority 2, Medical Private Practice - Priority 3, Fixed Gauging 3 Estimated burden per response to comply with this voluntary 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, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
e l
i-l l
Devices - Priority 4, Portable Gauging Devices - Priority 3, General License Distribution -
Priority 3. All other license categories are inspected at the frequency specified in NRC Inspection Manual Chapter 2800.
l 4.
Please complete the following table for licensees granted reciprocity during the reporting l
. period.
Number of Licensees Granted Reciprocity Number of Licensees Priority Permits Each Year inspected Each Year Service Licensees performing YR 98-99 3
YR 98-99 2
teletherapy and irradiator source YR 97-98 1
YR 97-98 1
installations or changes YR 96-97 1
YR.96-97 1
YR 95-96 1
YR 95-96 1
YR 98-99 13 YR 98-99 7
1 Ya G7-98 9
YR 97-98 3
YR 96-97 18 YR 96-97 4
YR 95-96 20 YR 95-96 3
YR 98-99 0
YR 98-99 0
2 YR 97-98 0
YR 97-98 0
YR 96-97 0
YR s6-97 0
YR 95-96 0
YR 95-96 0
YR 98-99 0
YR 98-99 0
3 YR 97-98 0
YR 97-98 0
YR 96-97 0
YR 96 3 YR 95-96 0
YR 95-96 0
4 All Other 98-99 42 98-99 4
5.
Other than reciprocity licensees, how many field inspections of radiographers were performed?
Response: South Carolina conducted three field inspections of industrial radiographers during the review period as follows: Sullivan and Associates, License No. 383 on 9/25/97; Fluor Daniel, License No. 043 on 3/5/98; and Senior Engineering Company, License No. 439 on 5/27/99.
6.
For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actual!y performed, and the reasons for l
any differences between the goals and the actual number of inspections prformed.
. Response: Not applicable.
ll.
Technical Quality of insoections l
\\
r i
7.
What, if any, changes were made to your written inspection procedures during the reporting period?
Response: South Carolina historically has followed the written inspection procedures outlined l
l
'in NRC Inspection Chapter Manual 2800 and also has developed inspection report forms for each type of inspection. Certain small changes have been made to the inspection report forms to reflect regulatory changes that have taken place over the review period.
8.
Prepare a table showing the number and types of supervisory accompaniments L
made during the review period. Include:
Response
Inspector Supervisor License Cat.
Qata Melinda Bradshaw Jim Peterson Academic 10/18/95 David King Jim Peterson Portable Gauge 04/10/96 Jeremy Hanna Melinda Bradshaw Medical Institution 06/05/96 Andrew Roxburgh David King Medical Broad Scope 06/13/96 Andrew Roxburgh David King Portable Gauge 02/06/97 l
Jeremy Hanna Melinda Bradshaw Nuclear Pharmacy 03/18/97 David King Jim Peterson Nuclear Laundry 04/23/97 Melinda Bradshaw Jim Peterson Medical Broad Scope 06/18/97 Andrew Roxburgh Jim Peterson Nuclear Laundry 06/03/98 David King Jim Peterson Nuclear Laundry 06/03/98 Eva Surana Melinda Bradshaw Medical Private Practice 07/23/98 Melinda Bradshaw Jim Peterson Medical Broad Scope 08/03/98 Jeremy Hanna Melinda Bradshaw Medical Broad Scope 08/03/98 Mark Windham David King Portable Gauge 02/05/99 l
9.
Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.
Response: See attachment A. Actual records of the results of supervisory accompaniments of inspectors is available for review as requested under " Materials to be Made Available for the Onsite Portion of the IMPEP Review".
10.
Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?
Response: Geiger-Mueller and ion chamber instruments are calibrated at the South Carolina Regional Calibration Facility at six month intervals. This facility is accredited through the l
Conference of Radiation Control Program Directors for both x-ray and gamma radiation calibrations. Alpha detection instruments are calibrated annually by Ludlum Measurements, i
inc. Allinstruments routinely used by program staff are currently in calibration. A listing of the l
instruments is included as Attachment B.
111.
Technical Staffino and Trainino 11.
Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the j
agreement or radioactive material program by individual. Include the name,
n.
l l
l l
t position, and, for Agreement States, the fraction of time spent in the following i
areas: administration, materials licensing & compliance, emergency response, l
LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior i
personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:
Response
1 Namt Position Area of Effort FTE%
Pearce O'Kelley Branch Chief Supervision of Program 50 %
Jim Peterson Section Director Supervision / Licensing / Inspection 100 %
i Melinda Bradshaw Program Manager Supervision / Licensing / inspection 100 %
David King Program Manager Supervision / Licensing / inspection 100 %
Andrew Roxburgh EHM lli Licensing / inspection 100 %
Jeremy Hanna E H M ll Licensing / Inspection 100%
Mark Windham EHMi Licensing / Inspection 100 %
Laurie Shows ADMI Administration 50%
P. O'Kelley, J. Peterson, M. Bradshaw and D. King are considered senior personnel.
12.
Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.
Response: Eva Surana was hired on March 2,1998 as an additional staff member to the Radioactive Materials Licensing and Compliance Section. Ms. Surana received a Master of Public Health degree from the University of South Carolina. She attended both the US NRC's Licensing and Inspection courses while employed by the agency. Ms. Surana resigned on 2/19/99 and is now employed by the Maryland radiation control program.
Mark Windham was hired on December 2,1998. Mr. Windham has five years of experience in the radiological health area and has applied to attend the NRC Licensing Practices and Procedures course and the NRC inspection Procedures course.
13.
Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.
Response: Mark Windham has not yet met all of the requirements for license reviews and materials inspections. Mark has applied for attendance at the NRC Inspection Procedures course and NRC Licensing Practices and Procedures course. Current qualification requirements consist of completion of Agreement State Training Qualification Form. See Attachment.C.
14.
Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
l l
l l
l Response: Eva Surana, R. Clay Murrell.
1 15.
, List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.
I Response: There are no vacant positions in the Radioactive Materials Licensing and Compliance Section.
IV.
Technical' Quality of Licensina Actions 16.
Please identify any major, unusual, or complex licenses which were issued,.
received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.
Response: INS Corporation (renewal), Medical University of South Carolina (renewal),
University of South Carolina (renewal), Clemson University (new), and Richland Memorial Hospital (new). No licenses issued or amended during the review period were identried as now requiring emergency plans.
17.
Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
Response: Certain license conditions more restrictive than Department Regulation 61-63 requirements were applied to INS Corporation. This license is currently under litigation.
18.
What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
3 Response: Other than ministerial changes, there were no revisions to the written licensing procedures.
19.
For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
Response: Not applicable.
V..
Responses to Incidents and Alleantions 20.
Please provide a list of the reportable incidents (i.e., medical misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list should be in the following format:
)
Response
Licensee Name License #
Date of incident /Recort Tvoe of incident Hoechst Diafoil 036 12/9/97 - 12/22/97 Lost source
t i
Santee Cooper 359 12/96 - 07/11/97 Lost source All other reportable incidents have been submitted through Nuclear Material Events Dit: base.
21.
During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC7 For Regions, was an appropriate and timely PN generated?
Response: No incidents occurred involving equipment or source failure. Notification to NRC is usually performed in a timely fashion.
22.
For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
Response: Not applicable.
23.
In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
Response: Geo-Systems Design &' Testing (SC Radioactive Material License No. 421, portable gauge). The licensee knowingly allowed an unauthorized individual to utilize radioactive material. The licensee also allowed this untrained individual to perform gauging activities without a personnel monitoring device.
24.
Identify any changes to your procedures for handling allegations that occurred during the period of this review.
i Response: Procedures for hand!ing allegations have not changed, however, they are now in a written format.
a.
For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.
Response: There are no allegations referred to the program by NRC that have not been closed.
i VI.
General i
l 25.
Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.
Response: Two recommendations were made during the last review. These recommendations were to revise the medical inspection report form to document the status of the licensee's ALARA program, and that the industrial radiography inspection report form be revised to incorporate the changes made in the 1994 edition of RHA Part V regulations, including the alarming rate meter. The medical and industrial report forms have been revised to adopt the recommendations.
- 26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.
Response: Strengths include increased inspection frequencies for certain license categories.as described in previously in the questionnaire in the Status of Materials inspection Program section.
Other strength 1 include a quick tum around time for license amendments, renewals and new license issuances. A possible weakness is lack of funding for required training of technical staff. Another weakness is the lack of a computer based tracking system for the various program requirements.
i B.
NON-COMMON PERFORMANCE INDICATORS 1.
Leais!ation and Proaram Elements Reauired for Comoatibility
- 27. Please list all currently effective legislation that affects the radiation control i
I program (RCP).
Response: Department Regulation 61-63, Radioactive Materials; Department Regulation 61-30, Environmental Protection Fees; and the Atomic Energy and Radiation Control Act enacted by the 1967 Session of the South Carolina Legislature.
- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
Response: Regulations affecting the Radiation Control Program are not subject to a
- Sunset" law.
- 29. Please complete the enclosed table based on NRC chronology of amendments.
Identify those that have not been adopted by the State, explain why they were j
not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements i
other than regulations.
Response: See table below.
- 30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal i
length of time anticipated to complete each step.
t I
Response: All amendments have been adopted within three years from the date of NRC rule promulgation or within several months of that date.
11.
Sealed Source and Device Proaram
- 31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:
SS&D-Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source issued Response: SC0679D101S Custom User Thickness Gauge 2/24/98 SC438D102B Distributor Weight Gauge 7/22/98 SC1036D103S Custom User Thickness Gauge 7/22/98 32.
What guides, standards and procedures are used to evaluate registry applications?
~
Response: NUREG-1550 " Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations", dated November 1996. NUREG-1556 " Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration", dated July 1998. Guidance obtained at NRC's Sealed Source and Device Workshop was also utilized.
33.
Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:
Technical Staffing and Training - A.lll.11-15 Technical Quality of Licensing Actions - A.lV.16-18 Response to incidents and Allegations - A.V.20-23 Respoitse: The RCP does not have a specific Sealed Source and Device Program separate from the routine licensing and inspection duties, therefore, information requested in question 33 has already been provided under the Common Performance Indicators.
111.
Low-Level Waste Proaram 34.
Please include information on the following questions in Section A, as they apply to the Low-level Waste Program:
Response: Information specific to the Low-Level Waste Program is being provided under separie cover.
Status of Materials inspection Program - A.I.1-3 Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Response to incidents and Allegations - A.V.20-23 IV.
Uranium Mill Proaram l
l 1
35.
Please include information on the following questions in Section A, as they apply b the Uranium Mill Program:
Response: Not applicable.
Status of Mater:als inspection Program - A.I.1-3 Technical Quality of Inspectioris - A.ll.7~10 Technical Staffing and Training - A.lll.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Response to incidents and Allegations - A.V.20-23 l
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l Approved by OMB' No. 3150-0183 Expires 5/31/2001 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM Division of Radioactive Weste Management Bureau of Land and Weste Management QUESTIONNAIRE South Carolina Reporting Period: March 25,1995 to July 11,1999 A.
COMMON PERFORMANCE INDICATORS 1.
Status of Materials Inspection Procram 1.
Please prepare a table identifying the licenses with inspections that are overdue by more ther 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2?00. The list should include initial inspections that are overdue, insp. Frequency Licensee Name Ofears)
Due Date Manhs O/D None 2.
Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.
N/A 3.
Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC inspection Manual Chapter 2800 and state the reason for the change.
All licensees are inspected more frequently than called for in the NRC Inspection Manual with the exception of Decommissioning Facilities which
- Estimated burden per response to co nply with this voluntary 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, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
e are inspected on the same frequency as the inspection Manual. Oversite of activities at the decommissioning facilities and confirmation surveys are conducted at least monthly.
LLRW disposal facility inspections include 100% inspection of all shipments for compilance with shipping requirements, periodic package inspections, weekly engineering inspections of disposal operations, inspections of trench construction, and semi-annual license inspections.
Inspections are conducted more frequently than the NRC requires due to the public and political interest in waste processing and disposal in the state.
4 Please complete the following table for licensees granted reciprocity during the reporting period.
N/A Number of Lice'isees Granted Reciprocity Number of Licensees Priority Permits Each Year inspected Each Year Service Licensees performing YR YR teletherapy and irradiator source YR YR installations or changes YR YR YR YR YR YR 1
YR YR YR YR YR YR YR YR 2
YR YR YR YR YR YR YR YR 3
YR YR YR YR YR YR 4
All Other l
5.
Other than reciprocity licensees, how many field inspections of radiographers were performed?
N/A 6.
For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for l-
any differences between the goals and the actual number of inspections performed N/A ll; Technical Quality of insoections 7.
What, if any, changes were made to your written inspection procedures during the reporting period?
' All inspection procedures were updated in the Licensing and inspection Administrative Manual and will be provided during the review. The Division incorporates NRC's inspection procedures.
8.
Prepare a table showing the number and types of supervisory accompaniments i
made during the review period. Include:
j insoector Supervisor License Cat Qatt J. Stephens Porter LLRW Waste Disposal 7/18/95 i
R. Wingard Porter LLRW Waste Disposal 7/18/95 M. Piemmons Porter LLRW Waste Disposal 7/18/95 J. Stephens Porter LLRW Waste Disposal 10/24/96 R. Wingard Porter LLRW Waste Disposal 10/24/96 M. Yeager Porter Source Material (Other) 5/19/96 M. Piemmons Porter Source Material (Other) 11/19/96 l
J. Stephens Porter LLRW Waste Processing 10/9/97 R. Wingard Porter LLRW Waste Processing 10/9/97 M. Piemmons Porter LLRW Waste Disposal 7/10/97 i
M. Yeager P.orter LLRW Waste Disposal 7/10/97 M. Piemmons Porter LLRW Weste Disposal 7/18/97 J. Stephens -
Porter LLRW Waste Disposal 7/9/98 M. Piemmons Porter LLRW Waste Disposal 7/9/98 M. Yeager Wingard Byproduct Material (Other) 4/7/98 S. Jenkins Porter LLRW Waste Disposal 7/9.~38 J. Stephens Porter Source Material (Other) 1113/99 M. Piemmons Wingard Byproduct Material (Other) 6/12/99 l
M. Yeager Porter LLRW Waste Disposal 1126/99 S. Jenkins Porter LLRW Waste Disposal 1/26/99 i
M. Gandy Porter LLRW Waste Disposal 1/26/99 9.
Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment The Division Section Managers typically accompany the technical staff on many of the inspections. The Division Director also accompanies the inspectors at the burial facility and decommissioning projects.
Documentation of these are in the inspection report files.
10.
Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?
Attachment A provides a list of the Division of Radioactive Waste instruments. The instrumentation provides for the detection of alpha, beta and gamma radiation and neutrons. A portable multi-channel analyzer is used for isotope identification of gamma emitters. The instruments are calibrated by either the Agency's Radiological Health Branch's Calibration Laboratory, Eberline, or Ludlum.
Ill.
Technical Staffino and Trainina 11.
Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas; administration, materials licensing & compliance, emergency response, LLW, U-mills, other. if these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:
Name Position Rea of Effort ETE%
Virgil Autry Director LLW, Trans, Admin.
1 Henry Porter Sec. Mgr.
LLW, Lic. and Compt.
1 Jessie Stephens Env.Eng.
LLW, Lic. And Compi 1
Susan Jenkins Env.Eng LLW, NESHAP, Compi 1
Mike Gandy HP LLW, Plant Reviews 1
Dick Sappington HP LLW Resident insp.
1 Rodnuy Wingard Sec. Mgr.
LLW, Env. Sur., Trans 1
Mark Yeager HP LLW &Trans. Insp 1
Mike Piemmons HP LLW & Trans. Insp 1
Arlene Wilkes Prog. Asst. Admin., Trans. Permits i
Vacancy Prog. Asst. Admin., Trans. Permits 1
12.
Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.
A.
Susan E. Jenkins, Environmental Engineer, B.S. Ceramic Eng. Clemson University, M.S. Bio-Engineering Clemson University. Has completed all NRC core Training Courses to include 5 week HP course.
B.
R. Michael Gandy, Health physicist, B.S. Microbiology, Clemson University, M.S. Earth Sciences, University of South Carolina. Introduction of Health Physics, Harvard. Scheduled to attend all NRC core training courses including 5 week course. Has had prior experience in water quality lab to include radon analysis.
13.
Please list all professbnal staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license revi3wers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.
R. Michael Gandy - requires all applicable license reviewer / materials Inspection NRC core courses. (See attached training requirements)
'4 Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
Sonya Adams - Program Assistant (Administrative and Technical) June 2,1999 15.
List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.
Program Assistant Vacancy Posted June 12,1999 IV.
Technical Quality of Licensino Actions 16.
Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.
In June 1997, License No. 097 issued for operation of the Barnwell site was amended to add Special Nuclear Material (SNM) to the license. The NRC license for SNM had been transferred by the NRC to the state and was terminated when amendment 47 to license 097 was issued.
Two facilities that were licensed for possession only are currently undergoing decommissioning. This has involved significant changes in the activities being conducted under these licenses. These facilities are the Allied General Nuclear Services, Barnwell Nuclear Fuel Plant and the Parr Reactor. Emergency plans have been developed by the licensees for these facilities.
17.
Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
s Periodically, variances are granted to Chem-Nuclear Systems to allow the disposal of waste that is not specifically allowed under the license. These are documented through correspondence between the State and the licensee.
18.
What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
All procedures have been updated in Administrative Manual and will be made available during the program review.
19.
For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
N/A V.
Responses to incidents and Alleastions 20.
Please provide a list of the reportable incidents (i.e., medical misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list should be in the following format:
We have not had any reportable incidents during the reporting period. We have responded to incidents involving the receipt of radioactive material at unlicensed facilities including scrap metal dealers, landfills, and medical waste incinerators. In all cases, we have ensured that the material was returned to the generator or properly disposed of.
Licensee Name License #
Date of Incident /Recort Tvoe of incident 21.
During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC? For Regions, was an appropriate and timely PN generated?
N/A 22.
For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
N/A 23.
In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
An allegation was referred to the state by the NRC in October 1998. The allegation was that a licensee did not properly monitor employees and that overexposures had occurred. The state performed an investigation and found no evidence of overexposures and no negligence on the part of the licensee.
Uptakes of alpha emitters had occurred, however, no regulatory exposure limits were exceeded. The investigation was documented and was forwarded to the NRC.
J 24.
Identify any changes to your procedures for handling allegations that occurred during the period of this review.
a.
For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.
The Division of Radioactive Waste Management revised all administrative procedures during this reporting period. However, no significant changes were made in the procedure for handling allegations.
VI.
General
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.
In response to recommendations following the last review, the unit has prepared a licensing and inspection administration procedures manual which will provide continuity.
- 26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes. f-$ ems or difficulties which occurred during this review period.
The program's strength's are its highly qualified and dedicated staff who take extreme pride in their accomplishments. As compared to other agency programs, we have very low turn over rate which provides excellent program continuity. The unit has been nationally recognized by the regulated community and its peers for its exceptional work in many areas and was awarded the agency's highest award for customer service. The major weakness was the lack of lab support due to their internal problems which has led to poor surveillance and the disposal site. This has been rectified by contracting with an outside lab.
B. NON-COMMON PERFORMANCE INDICATORS 1.
Leaislation and Proaram Elements Reauired for Comoatibility
- 27. Please list all currently effective legislation that affects the radiation control program (RCP).
A. Section 13-7-10 thru 100 of the 1976 SC Code of Laws, The Atomic Energy and Radiation Control Act.
B. Section 13-7-110 thru 200 of the 1976 SC Code of Laws, Radioactive Waste Transportation and Disposal Act.
C. Section 48 2-10 of the 1976 SC Code of Laws, Environmental Fees D. Section 48-48140 of the 1976 SC Code of Laws, Waste Tax and Repeal of SE Compact
c:
- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
No
- 29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.
See table.
i i
~
- 30. if you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normallenoth of time anticipated to complete each step.
N/A 11.
Sealed Source and Device Proaram
- 31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:
SS&D Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source issued N/A 32.
What guides, standards and procedures are used to evaluate registry applications?
N/A 33.
Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:
N/A Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Response to incidents and Allegations - A.V.20-23 I
Ill.
Low-Level Waste Prooram 34.
Please include information on the following questions in Section A, as they apply to the Low-level Waste Program:
See respons above Status of Materials inspection Program - A.I.1-3 Technical Quality of inspections - A.ll.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Response to incidents and Allegations - A.V.20-23 IV.
1.franium Mill Proaram N/A 35.
Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:
l Status of Materials inspection Program - A.I.1-3
Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Response to incidents and Allegations - A.V.20-23
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ATTACHMENT A' RADIOACTIVE WASTEMANAGEMENT INSTRUMENTATIONINVENTORY AND CAUBRATIONDATES AS OFMAY26,1999
' ASSET #
DESCRIPTION SERIAL #
CAL DUE A1438 EBERLINEMODEL E 520 W/HP190 PROBES 940 10/15/99 A1462 EBERLINEMODEL E 520 W/HP190 PROBE 1436 10/15/99 A1472 EBERLINEMODEL E 320 W/HP260 PROBE 1636 08/01/99 A1481 LUDLUMMODEL 14C W/449 PANCAKE '
12482 07/19/99 A1505 EBERLINEJONCHAMBER PIC6A 2060 07/19/99 A1507 EBERLINE10NCHAMBER Plc6A S 2125 07/19/99 A1508 EBERLINE10NCHAMBER Plc6A.
VA 2184 01/24/99 @
}
A1509 EBERLINE10NCHAMBER PIC6A S 2185 07/19/99 A1511 EBERLINEE520 W/HP190 PROBE 2171 06/11/99 j
A1512 EBERLINEE320 W/HP190 PROBE S 2200 09/25/99 A1516 EBERLINEMODEL RO2IONCHAMBER S 890 11/20/99 A1517 EBERLINEMODEL RO 2 LONCHAMBER S 889 08/01/99 A1518 LUDLUMMODEL 19MICROR METER 16904 10/15/99 A1519 MICROMODEL 19MICROR METER 16892 07/06/99 A1535 EBERLINEE520 W/HP260 PROBE 2733 04/28/99 A1537 EBERLINEE520 W/HP260 PROBE 2725 06/11/99 B2050 BICRON2000 SURVEYOR A286E 07/11/99 B2328 EBERLINESMARTPORTABLEESP-1 1034 04/02/99*
B2369 BICRONLABTECH SA074F 06/10/99 B4307 BICRONANALYSTMICRORMETER A434L 10/15/99 j
B4308 BICRONANALYSTMICRORMETER A435L 07/11/99 B4864 EBERLINESMARTPORTABLEESP1 2079 07/20/99*
B8690 RADIATIONALERTMONI70R 1 515 04/28/99 B8691 EBERLINE ANALOG SMARTPORTABLEASP-12122 09/09/99*
B8813 LUDLUMMODEL17IONCHAMBER 74513 08/19/98 @
C2212 LUDLUMMODEL 14C W/44-9 PROBE 100035 07/19/99 C2211 LUDLUMMODEL 14C W/44 9 PROBE 99994 06/11/99
. A ttFT#
DESCR1PTION RFRIAL #
C-IL DUE.
C2213 LUDLUMMODEL 14C W/449 PROBE VA 100001 11/20/99 EBERLINEMODEL RO-2IONCHAMBER 2770 11/19/99 C8736 EBERLINE E400 00369 09/08/99 C8737 EBERLINE E400 00378 09/15/99 LUDLUMMODEL 14C W/44-9 PROBE 128934 09/10/99 LUDLUMMODEL 14C W/449 PROBE 128949 09/19/99 RADLATIONALERTMON17DR 4 VA 36980 06/08/99 RADIATIONALERTMON170R 4 '
HP 36981 04/28/99 RADIATIONALERTMON170R 4 JS 36982 04/28/99
' RADIATIONALERTMON17DR 4 RW 36983 04/28/99 RADIATIONALERTMON170R 4 MP 36984 04/28/99 LUDLUMMODEL 22412 w/44-9 7C 148357 01/22/99#
1
. LUDLUMMODEL 22412 w/449 7C 148338 01/22/99#
LUDLUMMODEL 22412 w/449 7C 148331 01/22/9%
1 LUDLUMMODEL 22412 w/44-9 7C 148362 01/22/9%
i LUDLUMMODEL 22412 w/44-9 7C 148340 01/22/99#
LUDLUMMODEL 22412 w/449 7C 148359 01/20/99#
PANASONICPOCKETDOSIMETER 7C 7D0058 06/18/99 7D0059 06/18/99 PANASONICPOCKETDOSIMETER 7C PANASONICPOCKETDOSIMETER 7C 7D0072 06/18/99 PANASONICPOCKETDOSIMETER 7C 7D0077 06/18/99 PANASONICPOCKETDOSIMETER 7C 7D0078 06/18/99 PANASONICPOCKETDOslMETER 7C 7D0079 06/18/99 PANASONICPOCKETDOSIMETER 7C 7D0082 06/18/99 PANASONICPOCKETDOSIMETER TC 7D0087 06/18/99 PANASONICPOCKETDOSIMETER *10 7D0092 06/18/99 PANASONICPOCKETDOSIMETER 7C 7D00%
06/18/99 i
- SEND 70LUDLUMFOR CALIBRATION 0 MAINTAINEDBYTRANSPORTATIONPOLICE O OUTOFSERVICE i
e
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PaOTECT 2600 suit seem L Columina.5C 29201 f 'J8 August 31,1999 Paul H. Imhaus, Director Office of State Programs U.S. Nuclear Regulatory Commission Washington,DC 20555-0001
Dear Mr. Lohaus:
De Department has reviewed the U.S. Nuclear Regulatory Commission's August 11,1999 draft Integrated Materials Performance Evaluation Program (IMPEP) report. De following comments address the technical and clerical accuracy of the report:
Page 1, second paragraph, line 5 reads " Division of Health and Regulations".
His should read " Division of Health Regulations". <
Page 2, second paragraph, line 4 reads "1994 edition of RHB Part V regulations". His should read "1994 edition of RHA Part V regulations".
Page 11, fifth paragraph, line 5 reads "The State adopted the requirement on September 10,1998". His should read "The State adopted the requirement on June 28,1996".
j Page 11, tenth paragraph, line 3 reads " adopted by the State on September 10, 1998". His should read " adopted by the State on Fsbruary 10,1997".
On the first page of Appendix C, File No. 3," License Type" should be
" Medical Institution /HDR" and File No. 4," Location" should be " Charleston, i
SC". Page C.2, File No.10," Location" should be " Charleston, SC". Page C.3, File No.18, " Licensee" should be "Hilton Head Medical Center".
Appendix E, page E.2, File No. 5, " Licensee" should be " Santee Coopw Winyah Generating Station". De gauge indeed was reported lost and after an m unsuccessful search at the licensee's facility, it was assumed that the gauge g
had been inadvertently sent to a local salvage company (Charleston Steel) o where a search was also conducted. However, this source was eventually j
e located at the licensee's facility on July 11,1997 in a coal system metals separator pile.
E 'co O
In Appendix G, Questionnaire Responses for the Radiological Health Branch,ge
" Table for Question 29" appears to be the incorrect table, ne correct t.n table is enclosed.
We would also like to comment on the recommendations listed on page 19 of the draft report. Our comments are as follows:
- 1. Recommendation: De review team recommends that the State provide g\\DCD$ M
training to technical personnel, either by formal course work or equivalent, in the areas of medical brachytherapy and irradiator technology.
Response: De Medical Program Manger has submitted an application for attendance at the course Teletherapy and Brachytherapy (H 313) scheduled for March 2000. He Industrial Program Manager has submitted an application for attendance at the course Irradiator Technology (H-315) scheduled for October 1999.
- 2. Recommendation: The review team recommends that the State revise their incident and allegation procedures to incorporate appropriate elements following NRC guidance documents.
Response: De Department has revised the incident and allegation procedures to conform with applicable NRC guidance documents.
- 3. Recommendation: De review team recommends that the State provide draft regulations to OSP for compatibility review, in accordance with OSP procedure SA-200.
Response: For any future regulation revisions, the Department will provide draft regulations to NRC's Office of State Programs for compatibility review in accordance with OSP procedure SA 200.
- 4. Recommendation: ne review team recommends that the State obtain copies of the engineering drawings for the SC-0679 D 101-S registered device, and review the Atwings for accuracy with the original application, and maintain them in their files.
Response: The Department has obtained copies of the engineering drawings for the SC-0679 D-101 S registered device. These drawings have been reviewed for accuracy with the original application and are being maintained in the current licensing file.
In addition, as suggested by the inspection team, the Division of Radioactive Waste Management will develop and incorporate inspection checklists in its procedures for the waste processing and manufacturing facility licensees.
We thank the team for their comprehensive review of South Carolina's Agree. ment State Progran and for the courtesy and professionalism they demonstrated throughout the process. If you have any questions concerning these comments, please contact Pearce O'Kelley at (803) 737-7400 or Virgil Autry at (803) 896-4240.
Sincerely,
~/
Z i
Douglas E. EPysnt,Commiss' er SC Department of Health rnd Environmental Control Enclosure
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rc Aaenda for Manaoement Review Board Meetina Wednesday. Auoust 6.1999.1:00 - 3:00 o.m.. TWFN. 2-B-5 i
1.
Convention. MRB Chair Convenes Meeting i
2.
New Business - Consideration of South Carolina IMPEP Report A.
Introduction of South Carolina IMPEP Team Members (J. Lynch) 1 B.
Introduction of South Carolina representatives and other State representatives 4
participating through videoconference or teleconference.
C.
Findings regarding South Carolina Program (IMPEP Team)
Status of Materials inspection Program Technical Quality of Inspections Technical Staffing and Training TechnicalQuality of Licensing Actions Response to incidents and Allegations Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program Low-Level Radioactive Waste Disposal Program D.
Questions (MRB Members) i E.
Comments from State of South Carolina F.
MRB Consultation / Comments on issuance of Report Recommendation for next IMPEP review 3.
Status of Upcoming Reviews 4.
Approval of NRC SS&D Evaluation Program MRB Minutes 5.
Adjoumment Attendees:
Cari Paperiello, MRB Member, DEDMRS Paul Lohaus, MRB Member, OSP Karen Cyr, MRB Member, OGC William Kane, MRB Member, NMSS David Snellings, OAS Liaison to the MRB, AR Virgil Autry, SC Pearce O'Kelley, SC James Lynch, IMPEP Team Leader, Rlli Richard Woodruff, IMPEP Team Member, Ril Deborah DPiskura, Rlli Robert RFundert>urg, IMPEP Team Member, CA Boy Abu Eld,IMPEP Team Member, NMSS Kathleen Schneider, OSP Brenda Usilton, OSP ATTACHMENT 2