ML20212J472
| ML20212J472 | |
| Person / Time | |
|---|---|
| Issue date: | 04/16/1999 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20212J471 | List: |
| References | |
| PROC-990416, NUDOCS 9907060017 | |
| Download: ML20212J472 (48) | |
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM i REVIEW OF NORTH DAKOTA AGREEMENT STATE PROGRAM April 13-16,1999 i
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PROPOSED FINAL REPORT l
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l U.S. Nuclear Regulatory Commission l
ATTACHMENT 1 9907060017 990623 PDR STPRO ESOGEN PDR
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North Dakota Proposed Final Report Page 2 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous IMPEP review, which concluded on February 9,1996, four recommendations and five suggestions. wore made and the results transmitted to Jon R. Rice, State Health Omcor, on June 11,1996. The review team's evaluation of the current status of the recommendations is as follows:
- 1. The review team recommends that the State adopt a written timeliness goal for issuance of inspection findings to the licensee.
Current Status: The State has adopted written timeliness goals for issuance of inspection findings that are consistent with NRC Inspection Manual Chapter (IMC) 0610.
This is contained in the RCP's Administrative Procedures Manual. This recommendation is closed.
- 2. The review team recommends that State management and staff devote increased attention to issuing inspection results in a timely manner.
Current Status: Although State management and staff devoted increased atter, tion to issuing inspection results in a timely manner, the State did not succes! fully meet the 30-day tin,e frame over the course of the review period. Since October 1998, however all inspection results have been transmitted to licensees within 30 days. This recommendation is closed. However, a new recommendation is identified in Section 3.1, for the State to continue efforts to transmit inspection findings within 30 days and to promptly evaluate licensee responses to inspection findings.-
- 3. The review team recommends that the State monitor the timeliness of issuing inspection findings to licensees as experience is gained with the new management tracking system.
Within the next year, the State should perform a systematic assessment of the tracking system and decide whether it is effective in tracking assignments and prompting staff and management to issue inspection findings.
Current Status: The State did monitor the timeliness of issuing inspection findings and did systtimatically assess the tracking system. Based on this assessment, RCP management re-emphasized the importance of inspection report timeliness with the inspection staff in October 1998, and began to closely monitor the status of inspection findings following inspections. Each of the 10 inspections (core and non-core),
perforned between November 1998 and March 1999, resulted in letters of noncompliance being issued less than 30 days following the inspection. This '
recommendation is closed.
4.~ The review team recommends that, over the next year, the State should asser. s whether initial inspections have been performed within six months of licensee issuance or within the provisions of IMC 2800, and whether the State's method for scheduling initial inspections has worked adequately. l t.
n 4 4 North Dakota Proposed Final Report Page 3 Current Status: The State has assessed whether initial inspections have been performed within six months of licensee issuance. The RCP did this not only over the year following the 1996 IMPEP review but on an ongoing basis. Assessment of the tracking system has indicated that the State's method for
- documenting" the next scheduled initial inspection has worked adequately, however, deficiencies in conducting initial inspections in a timely manner resulted from not following the inspection scheoule.
This recommendation is closed, as the evaluation was performed. A new recommendation regarding initial inspection timeliness is discussed in Section 3.1.
The five suggestions concemed: (1) licensing training for a staff member; (2) licensing and inspection training for the Program Manager; (3) impediments to training needs from curtailment of out-of state travel; (4) inspection field notes not signed by inspectors; and (5) inspection field notes not signed by supervisors. The review team determined that the State considered the suggestions and took appropriate actions.
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. ;
I 3.1 Status of Materials inspection Proaram j The review team focused on four factors in evaluating this indicator; inspection frequency, overdue inspections, initial inspection of new licensees, and timely dispatch of inspection findings to licensees. The review team's evaluation is based on RCP's questionnaire responses relative to this indicator, data gathered independently from the State's licensing and inspection computer printouts, the examination of completed inspection casework, and interviews with the staff.
The review team's evaluation of the State's inspection priorities revealed that inspection frequencies for each type of license were the same as those listed in IMC 2800, with only one exception. The State assigns a Priority 4 frequency for licensees authorized for portable nuclear gauging devices. This is more restrictive than the Priority 5 designation in IMC 2800. The review team also noted that the State established written procedures to extend or reduce the next inspection interval based upon licensee performance.
In their response to the questionnaire, the State indicated that during the review period,22 inspections were overdue by more than 25% of the specified frequency at the time they were performed. During the review period, the RCP performed 60 inspections: 38 routine inspections, ? initial inspections,7 reciprocity inspections, and 6 special inspections. The review team identified that 31 of the 60 inspections performed were core licenses. Of the 31 core l license inspections conducted during this review period,20 were overdue on the date of the l inspection. Delays ranged from 1 to 12 months late. The review team also verified that, as of l the date of this review, two inspections remained overdue past the 25% window. These inspections were approximately four months and seven months overdue. These inspections
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+ c North Dakota Proposed Final Report Page 4 were completed on May 5 and May 18,1999. Further, the review team noted that 11 additional inspections (four core and seven non-core) were past the scheduled inspection due date, but not yet past the 25% overdue window.
The staff uses a comnuter database program to track inspection due dates. This data is provided to inspection staff and management to monitor upcoming inspections. Interviews with l the staff indicated that inspection schedules are not routinely scheduled based on their priority. I All types of licenses (core and non-core) are tracked chronologically based on " inspection due I date" and are scheduled based on their percent overdue status and geographic location within the State.
l With respect to initial inspections of new licenses, the review team evaluated those licenses issued since the last review and used this information to determine the appropriate initial l inspection due date based on IMC 2800 guidance. Of the eight new licenses issued during the review period, six of the initial inspections were not conducted within the six-month or one-year ;
time frame as appropriate. These overdue initial inspections are included in the total number of overdue core inspections noted above. Delays ranged from 3 to 12 months late. No new licenses have been issued since April 1997.
The review team discussed the significant number of overdue core inspections performed during this review period with the Program Manager. The Program Manager discussed senral contributing causes including: (1) the departure of one of RCP's two materials inspector / license reviewers in July 1997; (2) the Program Manager's involvement with other significant issues during the review period, including his response to a natural disaster curing 1997 (floods in Grand Forks, North Dakota), and his involvement during 1998 with the litigation of an asbestos case, another program area under his direct supervision; (3) the staff's work on the formulation of regulations to ensure compatibility during 1997 and 1998; and (4) the extended absence of one of the program's inspector / license reviewers for several weeks during early 1997 and in mid-1998 for personal reasons. In addition, the Program Manager noted that although the RCP was able to successfully hire a new inspector in November 1997, this individual is still in the training process and does not yet perform inspections independently. In summary, the Program Manager stated that RCP continues to make progress in eliminating the number of overdue inspections, and with his increased oversight of the program it is expected that the timeliness of inspection activities will be performed in accordance with State procedures. The review team recommends that RCP management devote additional attention to a " pro-active" review of the current inspection tracking systems, and adjust staff priorities accordingly to ensure core licensees are inspected at the required intervals.
The review team also evaluated the status of reciprocity inspections. During the previous IMPEP review in 1996, the review team noted that no reciprocity inspections had been conducted. During the current review period,40 requests for reciprocity were filed with the program. The majority of the reciprocity requests were for Priority 3 and 4 licensees, which include portable gauge and service licensees. The review team noted a considerable improvement in the number of reciprocity inspections performed by the RCP in 1998. Five of the 15 licensees granted reciprocity were inspected. However, the State did not meet its goals for Priority 1 or 2 licensees during 1998. Three Priority 1 reciprocity licenses were granted with one licensee inspected. One Priority 2 reciprocity license was granted but the licensee was not
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North Dakota Proposed Final Report Page 5 l inspected. While the State improved in the number of reciprocity inspections conducted over the review period, they are not meeting the inspection frequencies outlined in NRC's IMC 1220.
The State indicated that it is difficult to conduct inspections of reciprocity licensees due to the short lead time of when work will be performed in the State, and the strain on resources to support the travel to remote field site locations on short notice. The review team recommends that RCP continue their efforts to complete inspections of high priority reciprocity licensees in accordance with IMC 1220.
The RCP has a written policy that establishes inspection report timeliness goals consistent with IMC 0610. RCP's goalis to dispatch written findings of inspections to licensees within 30 days of completing an inspection. Initial communication of inspection findings is provided at the conclusion of each inspection through an exit briefing with licensee management, however, as indicated in the questionnaire, written inspection findings were not always communicated to licensees in a timely manner. Of the 10 core licensee inspection files evaluated by the team, six letters of noncompliance were issued greater than 30 days following the exit briefing with the licensee. Delays ranged from 36 to 102 days. Upon review of the State's questionnaire response, the review team determined that, of the 31 core inspections performed during the review period,10 of the inspection letters were issued greater than 30 days following exit briefings with licensees.
The review team also noted that the State's review of licensee responses to letters of noncompliance were not always performed in a timely manner. The review team identified several instances when licensee responses were not evaluated and/or dispositioned by RCP for several months. The review team considered the issue of report timeliness and licensee response reviews to be of particular concern since it was also identified as an area of improvement during the State's previous IMPEP review. The review team discussed this issue with the Program Manager and was informed that increased management attention to this area was implemented in October 1998. The Program Manager stated that he had re-emphasized the importance of inspection report timeliness with the inspection staff and began to closely monitor the status of inspection findings following each inspection. Management stated that increased oversight and discussions with the inspection staff appear to have corrected the problem. Upon further review of the State's inspection tracking system data, the team did note that each of the 10 inspections performed between November 1998 and March 1999, resulted in letters of noncompliance being issued in less than 30 days following the inspection. The review team recommends that RCP management continue to provide additional oversight to ensure inspection findings (letters of noncompliance) are communicated to licensees in a timely manner, and that licensee responses are evaluated promptly upon their receipt by RCP.
Based on the IMPEP evaluation criteria, the review team recommends that North Dakota's performance with respect to the indicator, Status of Materials inspection Program, be found unsatisfactory.
3.2 Technical Quality of Inspections The review team evaluated the inspection reports, enforcement documentation and inspection field notes, and interviewed inspectors for 10 materials inspections conducted during the review period. The casework included both of the State's two materials license inspectors, and covered
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l North Dakota Proposed Final Report Page 6 l inspections of various types including medical institutions, industrial radiography, well logging, academic broad scope, mobile nuclear medicine, and reciprocity. Appendix C lists the inspection casework evaluated for completeness and adequacy, with case-specific comments. !
l North Dakota's inspection procedures are consistent with NRC procedures. Inspections were generally unannounced; however, RCP staff commented that inspectors may contact the ,
licensee either the day before, or the moming of, an inspection to ensure that appropriate j licensee personnel are available prior to dispatching an inspector to the facility. Inspection files were found to be complete and in good order. Field notes have been developed to cover all types of inspections that are conducted by the RCP. The information contained in the field notes was consistent with the applicable NRC inspection procedures. Based on casework evaluations, the review team noted that routine inspections covered all aspects of licensees' radiation safety programs. Team inspections were performed when appropriate and for training purposes.
As noted in the questionnaire, the State has a variety of portable instruments available for routine confirmatory surveys and for use in incident response. Allinstruments used for inspections and those which are considered essential for incident response are calibrated semi-annually. RCP staff perform calibrations using a Gammatron calibrator containing a nominal 30 millicurie cesium 137 sealed source and employing appropriate calibration methods for each type of instrument. 1 RCP's administrative procedures state that approximately 10 percent of all field inspections ]
include the Program Manager, Assistant Division Director, or Division Director accompanying j the inspector. Management accompanied inspectors on 5 of the 60 inspections performed during the review period, including each of the materials inspectors at least once each year. l Interviews of RCP's inspectors disclosed that following each accompaniment, supervisors l provided feedback to inspectors regarding their performance.
During the weeks of January 19-22 and February 22-25,1999, a review team member l perfcrmed accompaniments of both RCP's inspectors at licensed facilities (See Appendix C).
The five accompaniments included one medical license, one portable gauge license, one self-shielded irradiator license, one industrial radiography license, and one well logging license.
Both RCP's inspectors were involved in all of the inspections. The more senior inspector was the lead inspector for four of the five inspections. For the portable gauge license, the other inspector lead the inspection.
During the accompaniments, both inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors were well prepared and thorough in their review of licensee programs but could benefit from additional training in brachytherapy technology. The reviewer observed that the inspectors were not well acquainted with brachytherapy treatment l planning and the differences in dose delivery systems for temporary versus permanent implant procedures. Familiarity with this technology is important when reviewing written directives so that the inspector can compare the final treatment planning data and dose delivered to the patient to the authorized user's prescription. Overall, the reviewer observed that both inspectors utilized good health physics practices and their interviews with licensee personnel were performed in an effective manner. The inspections were adequate to assess radiological health
North Dakota Proposed Final Report Page 7 and safety at the licensed facilities.
Based on the IMPEP evaluation criteria, the review team recommends that North Dakota's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.3 Technical Staffino and Trainino issues central to the evaluation of this indicator include the radioactive materials program staffing level and staff turnover, 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 Manager and staff. The RCP is staffed with one Program Manager and two staff. An environmental scientist and an environmental engineer, both full-time positions, comprise the RCP technical staff. Both of the technical staff members perform duties in licensing, inspection, and event response. In response to the questionnaire, the State reported that the Program Manager spends about 57 percent of his effort on the program. Division managers spend between 5 and 10 percent of their time on supervision of the program.
l There was one vacancy during the review period. The environmental engineer position was vacant for about three months in 1997 before it was filled by the current staff member. There were no other vacancies within the program during the review period. The State budgets in two-year cycles. The current staffing level will remain in eifect through June 30,1999. Tne same level of staffing is expected for the next budget cycle.
The Program Manager explained that technical staff positions require a Bachelors degree in a I
science or engineering field. The Program Manager and both technical staff members have a Bachelofs degree in science or engineering.
l Based on the areas of improvement and contributing factors noted in Section 3.1, and
! discussions with State management regarding the small size of the RCP, and its vulnerability to l disruptions during staff losses and/or outside events, the review team recommends that management perform an in-depth review of the RCP's current and future anticipated activities and obligations to ensure budgeted staffing levels are adequate to fulfill the responsibilities of the program.
The review team evaluated the training of the three personnelinvolved with the RCP. None have attended the Teletherapy and Brachytherapy Course (H-313), which is a core course for license reviewers and inspectors, but one staff member is scheduled to attend, and is confirmed for, the course offering in August 1999. North Dakota currently has five conventional brachytherapy facilities licensed and a high dose-rate afterloader (HDR) application in house.
As evidenced during the team accompaniments, the staff could benefit from training in this area.
The review team recommends that the State provide training to technical personnel, either by formal course work or equivalent, in the area of brachytherapy.
The newest staff member has completed the following courses since his employment in November 1997: (1) Selected Topics in Radiological Engineering (a general overview of health
North Dakota Proposed Final Report Page 8 physics through the nuclear engineering program at Louisiana State University); (2) NRC courses on Transportation of Radioactive Materials, Licensing, inspection Procedures, and Diagnostic and Therapeutic Nuclear Medicine; (3) Hazardous Waste Operations and Emergency Response Refresher Course; (4) Troxler Moisture Density Gauge Course; and (5) Laboratory Use of Radioactive Material, a State-sponsored short course. He is scheduled to attend the Well-Logging and Industrial Radiography Courses in 1999, the Five-Week Health Physics Course in the year 2000, and the Two-Week Health Physics Technology Course in 2001.
In addition to the courses recommended by NRC, the Program Manager and staff havn completed numerous other training courses and have attended job-specific technical conferences and rneetings, such as Become a Better Communicator, Hazardous Waste Operations and Emergency Response Training Refresher, Safety Training (through the Health Department), Texas industrial Radiographer Exam Proctor Training, All Agreement States Meeting, and the Conference of Radiation Control Program Directors (CRCPD) Annual Meeting.
The Program Manager is supportive of staff training and demonstrated a commitment to staff training during the review. The review team did not find any evidence of out-of-state travel being an impediment to staff receiving necessary training. As discussed above, the newest staff member attended five courses since his employment, with two additional core courses scheduled for 1999, and the five-week course scheduled for the year 2000.
In summary, the review team found that although the program has an adequate level of staffing it is particularly vulnerable due to its size. The staff is qualified and knowledgeable of the regulations and the licensing and inspection guidance but could use additional training in brachytherapy technology. The RCP provides for staff training, both for core and specialized courses, and out-of-state travel has not been an impediment to receiving necessary training as it was in the past.
Based on the IMPEP evaluation criteria, the review team recommends that North Dakota's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
3.4 Technical Quality of Licensina Actions The review team examined the completed licenses and casework for 17 licensing actions, representing the work of three license reviewers and the Program Manager. The staff was interviewed to supply additional information regarding licensing decisions or file contents.
Licensing actions were evaluated for completeness, consistency, proper radionuclides and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions.
Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down conditions, and overall technical quality. Casework was evaluated for adherence to good health physics practices, reference to appropriate regulations, supporting documents, peer or supervisory review, and proper signature authorities. The files were checked for retention of necessary documents and supporting data.
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i I-N, orth Dakota Proposed Final Report Page 9 The licensing actions evaluated included the following types of licenses: academic broad scope;
' well logging; industrial radiography; mobile nuclear medicine; medical; laboratory use; and portable gauges. Ucensing actions included two new licenses, seven amendments, six renewals, and two terminsbons. A list of these licenses with case-specific comments may be
. found in Appendix D. There were no licensee bankruptcy cases during this review period.
The review team noted that licensing actions are reviewed by the Program Manager. Each
. license is signed by the Division Director or his designee.
The review team found that the licensing actions were thorough, complete, consistent, and of high technical quality, with health and safety problems property addressed. Tie-down conditions are backed by information contained in the file, and are inspectable. Deficiency le'ders clearly state regulatory positions, and identify deficiencies in licensees' documents. Ucense files are : i complete and organized. Ucensing checklists are used and maintained on file. Applicable guidance documents are complete, well organized, available to reviewers, and appear to be -
followed.
The review team noted that the license reviewers also work as inspectors. This allows the reviewers to utilize inspection findings to improve a license through either a licensing i amendment or renewal.
Based on the IMPEP evaluation criteria, the review team recommends that North Dakota's performance with respect to the indicator, Technical Quality of Ucensing Actions, be found satisfactory.
3.5 Response to incidents and Alleoations l In evaluating the effectiveness of the State's actions in responding to incidents and allegations, the review team examined the State's response to the questionnaire relative to this indicator,
- . evaluated selected incidents reported for North Dakota in the " Nuclear Material Events Database (NMED)" against those contained in the North Dakota files, and evaluated the casework and supporting documentation for four material incidents. The team also evaluated the State's response to five allegations. No allegations were referred to the State by NRC during the review period. A list of the incident casework with comments is included in
- Appendix E.
! The review team interviewed RCP management and staff to discuss the State's incident and allegation process, file documentation, the State's equivalent to the Freedom of Information Act, NMED, and notification of incidents to the NRC Operations Center.
When notification of an incident or allegation is received, the Program Manager and staff meet to discuss the initial response and the need for an on-site investigation. The safety significance of the incident / allegation is evaluated to determine the type of response that North Dakota will take.
The State's incident procedures include a section entitled " Activation of Radiation Control Program Staff." This section, modeled after another Agreement State's procedure, discusses the potential hazards and indicates safety considerations and response actions for various license categories.
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North Dakota Proposed Final Report Page 10 Four incidents were selected for evaluation of the 15 incidents suitable for review by the team.
Not evaluated were 11 alarms at a medical waste incinerator. The incidents evaluated were:
(1) loss of control of lodine-125 seeds; (2) a radiography vehicle accident; (3) an unknown source found on roadside; and (4) a lost static eliminator.
The review team found that the State's responses to incidents and allegations were complete and comprehensive. Initial responses were prompt and well-coordinated. The level of effort was commensurate with the health and safety significance of the event. Inspectors were dispatched for on-site investigations when appropriate and the State took suitable enforcement action, when indicated. The review team found the documentation of the incidents and allegations to be consistent. The staff was familiar with the guidance contained in the
Handbook on Nuclear Event Reporting in the Agreement Wes."
North Dakota submits incident information electronically to NMED. Only three incidents met the criteria for reporting to the NMED system, of which two were reported. The third, a lost static eliminator, was not reported. RCP staff indicated that it was an oversight that the incident was not reported. The RCP manager did not, however, agree that the failure to enter the event in the NMED system was an oversight, but rather intentional since the RCP expected the licensee to eventually locate the source. Since the source was recovered four months later, it will not be reported to NMED.
During the review period, no allegations were reported to the State by the NRC. Five allegations were reported directly to the program. The review of the State's allegation files indicates that the State took prompt and appropriate action in response to the concerns raised. The review team noted that all documentation related to the investigation of allegations is withheld from public records. The State's allegation procedures declare that incoming allegations are to be handled on a case-by-case basis. Protection of an alleger's identity is provided for in Rule 509, North Dakota Rules of Evidence.
Based on the IMPEP evaluation criteria, the review team recommends that North Dakota'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 performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. North Dakota's Agreement does not cover a sealed source and device evaluation program or uranium recovery program, so only the first and third non-common performance indicators were applicable to this review.
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4.1 Leoislation and Prooram Elements Reauired for Compatibility 4.1.1 Leoislation North Dakota 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 affects the radiation control program. Legislative authority to create an agency and enter into an agreement with the NRC is granted in the North Dakota Century Code Chapter 23-20. The Department of Health is designated as the State's radiation control agency. The review team noted that no legislation affecting the radiation control program was passed since being found adequate during the previous review, and found that the State legislation is adequate.
4.1.2 Prooram Elements Reauired for Compatibility The North Dakota Revised Radiological Health Rules, found in North Dakota Administrative Code Chapters 33-10-01 through 33-10-14, apply to all ionizing radiation, whether emitted from radionuclides or devices. North Dakota requires a license for possession and use of all radioactive material including naturally occurring materials, such as radium, and accelerator-produced radionuclides. '
The review team examined the State's rulemaking process and found that the process takes approximately nine months after preparation of a draft rule. Proposed rules are submitted to the State Health Council for consideration and approval to proceed with public comment. Public notice of proposed rule revisions is made and a 60-day public comment period, including a ;
public hearing is conducted. Proposed rules are sent to NRC for a compatibility ruling. After l resolution of comments and the Attomey General's approval, final draft rules are sent to the State Health Council for adoption. Final rules are sent to the NRC and to licensees. The State has the authority to issue legally binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations become effective.
The review team evaluated North Dakota's responses to the questionnaire and reviewed the status of regulations under the Commission's adequacy and compatibility policy. All regulations required to be adopted are currently in effect. Discussions with program staff indicated a good awareness of recently adopted rules.
! The following regulations will become due in the future and are included here to assist the State
! in including them in future rulemakings or by adopting alternate generic legally binding requirements:
e Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction l
l Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective February 27,1997.
e " Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71, and 150 amendments (62 FR 28947) that became effective June 27,1997.
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North Dakota Proposed Final Report Page 12 e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40, and 70
- amendments (62 F,R 39057) that became effective August 20,1997.
- 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; Clarifying Amendments and Corrections," 10 CFR Part 34 l amendments (63 FR 37059) that became effective July 9,1998.
e " Minor Correr%ns, Clarifying Changes, and a Minor Policy Change," 10 CFR Parts 20, 32 and 39 amendments (63 FR 39477 and 45393) that became effective October 26, 1998.
e " Transfer for Disposal and Manifests; Minor Technical Conforming Amendment,"
10 CFR Part 20 amendment (63 FR 50127) that became effective November 20,1998.
It is noted that Management Directive 5.9, Handbook, Part V, (1)(c)(iii), provides that regulations required for compatibility issued prior to September 3,1997, should be adopted by the State as ,
expeditiously as possible, but no later than three 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 North Dakota'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 Effective June 1,1996, NRC reassumed regulatory authority for sealed source and device evaluations in North Dakota, in response to a request from the State to relinquish that authority.
No sealed source or device evaluations were performed in North Dakota in the early part of the review period, prior to relinquishment. Accordingly, the review team did not evaluate this indicator.
4.3 Low-Level Radioactive Waste (LLRW) Disposal Prooram in 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement"to allow a State to seek an amendment for the regulation of LLRW as a separate category. Those States with existing Agreements prior to 1981 were determined to have continued LLRW I- disposal authority without the need of an amendment. Although North Dakota has such disposal j authority, NRC has not required States to have a program for licensing a disposal facility until
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l North Dakota Proposed Final Report Page 13 l such time as the State has been designated as a host State for a LLRW disposal facility. When l an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in North Dakota. Accordingly, the review team did not evaluate this indicator.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found North Dakota's performance to be satisfactory for five of the six performance indicators. The review team found North Dakota's performance to be unsatisfactory for the indicator, Status of Materials Inspection Program.
Accordingly, the review team recommends that the Management Review Board find the North Dakota Agreement State Program to be adequate, but needs improvement 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.
RECOMMENDATIONS:
- 1. - The review team recommends that RCP management devote additional attention to a
" pro-active" review of the current inspection tracking systems, and adjust staff priorities
- accordingly to ensure core licensees are inspected at the required intervals. l l
(Section 3.1) I
- 2. The review team recommends that RCP continue their efforts to complete inspections of j high priority reciprocity licensees in accordance with IMC 1220. (Section 3.1) !
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, 3. The review team recommends that RCP management continue to provide additional
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oversight to ensure inspection findings (letters of apparent noncompliance) are communicated to licensees in a timely manner, and that licensee responses are evaluated promptly upon their receipt by RCP. (Section 3.1)
- 4. The review team recommends that management perform an in-depth review of the RCP's current and future anticipated activities and obligations to ensure budgeted staffing levels are adequate to fulfill the responsibilities of the program. (Section 3.3)
- 5. The review team recommends that the State provide training to technical personnel, either by formal course work or equivalent, in the area of brachytherapy. (Section 3.3) l l
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e LIST OF APPENDICES 1
Appendix A iMPEP Review Team Members Appendix B North Dakota Organization Charts J
Appendix C Inspection Casework Reviews l
Appendix D License Casework Reviews ;
' Appendix E Incident Casework Reviews Appendix F North Dakota's Questionnaire Response Attachment North Dakota's Response to Draft IMPEP Report '
- Dated June 7,1999 l
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APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility James Lynch, Region ill Team Leader Response to incidents and Allegations Legislation and Program Elements Required for Compatibility Mark Shaffer, Region IV Status of Materials inspection Program Technical Quality of Inspections James Peterson, South Carolina Technical Quality of Licensing Actions Torre Taylor, NMSS Technical Staffing and Training Status of Materials Inspection Program
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APPENDIX C INSPECTION CASEWORK REVIEWS NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.
File No.: 1 Licensee: Midwest Industrial X-Ray License No.: 33-14907-01 Location: Fargo, ND Inspection Type: Routine, Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 7/8/98 Inspectors: JG, KW Comments:
a) Inspection was performed four months late.
b) The inspection resulted in no violations being identified. The previous inspection conducted in 1996, also did not identify any violations. However, consideration was net given to extend the next inspection interval based on good licensee performance.
. File No.: 2 Licensee: DMS Imaging License No.: 33-11325-01 Location: Devils Lake, ND inspection Type: Routine, Announced License Type: Mobile Nuclear Medicine Priority: 2 Inspection Date: 6/25/97 Inspector: JK Comments:
a) Inspection was performed 10 months late.
b) Field notes were not signed by the inspector.
File No.: 3 Licensee: St. Joseph's Hospital & Health Center License No.: 33-01901-01 Location: Dickinson, ND inspection Type: Routine, Announced License Type: Medical Institution Priority: 3 Inspection Date: 10/27-28/97 Inspectors: JK, KW Comment:
a) Inspection was performed eight months late.
North Dakota Proposed Final Report C.2 Inspection Casework Reviews File No.: 4 Licensee: BNI Coal, Limited License No.: 33-24716-01 Location: Center, ND inspection Type: Routine, Announced License Type: Well Logging Priority: 3 inspection Date: 1/30/98 Inspectors: JK,JG Comments:
a) The State's acknowledgment letter, requesting additional information from the licensee, was transmitted seven months after receipt of the licensee's response.
b) The State's acknowledgment letter does not clearly indicate whether a violation was withdrawn or upheld, following the licensee's response which appears to deny a violation.
c) As of April 14,1999, the State had not reviewed / acknowledged the licensee's response letter dated January 25,1999.
File No.: 5 Licensee: Ewer Testing & Inspection, Inc. License No.: 33-32610-01 Location: Bismarck, ND Inspection Type: initial, Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 3/5/98 .
Inspectors: JK, JG Comment:
a) Inspection was performed seven months late.
File No.: 6 Licensee: Trinity Medical Center License No.: 33-04608-01 Location: Minot, ND inspection Type: Routine, Announced License Type: Medicalinstitution Priority: 3 Inspection Date: 7/27-29/98 inspectors: JK, JG Comment:
a)- Inspection was performed eight months late.
File No.: 7 Licensee: MQS Inspection, Inc.' License No.: N/A Location: Temporary Jobsite in Beulah, ND Inspection Type: Routine, Unannounced License Type: Industrial Radiography - Reciprocity. Priority: 1 inspection Date: 4/22/98 Inspectors: JK, JG
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North Dakota Proposed Final Report C.3 Inspection Casework Reviews l File No.: 8 l Licensee: North Dakota State University License No.: 33-06769-06 Location: Fargo, ND inspection Type: Routine, Unannounced License Type: Research and Development (Type A Broad) Priority: 2 l Inspection Date: 4/13-15/98 Inspectors: JK, JG, KW Comments:
a) Inspection was performed three months late.
b) Letter of apparent noncompliance (8 violations and 4 recommendations) transmitted 55 days following on-site exit briefing.
c) Licensee response to noncompliance received by State on August 19,1998; however, as of April 16,1999, no review of the licensee's response had been performed.
Fiie No.: 9 Licensee: University of North Dakota License No.: 33-12827-01 Location: Grand Forks, ND inspection Type: Routine, Anno e License Type: Research and Development (Type A Broad) Priorit Inspection Date: 9/29-10/2/98 Inspectors: JK, JG, File No.: 10 Licensee: Wedge Dia-Log, Inc. License No.: 33-32319-01 Location: Williston, ND inspection Type: Initial, Announced License Type: Well Logging Priority: 3 Inspection Date: 3/19/98 Inspectors: JK, JG Comments:
a) Initial inspection was performed nine months late.
b) Inspection letter sent to licensee 102 days following on-site exit briefing.
INSPECTOR ACCOMPANIMENTS In addition, the following inspection accompaniments were performed as part of the on-site IMPEP review.
Accompaniment No.: 1 Licensee: Dakota Clinic, Ltd. License No.: 33-02604-01 Location: Fargo, ND Inspection Type: Routine, Unannounced License Type: MedicalInstitution Priority: 3 Inspection Date: 1/19-21/99 Inspectors: JK, JG Comment:
i a) The review of brachytherapy treatment planning, dose delivery system and written
- directives for permanent and temporary implants could be stronger.
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North Dakota Proposed Final Report C.4 Inspection Casework Reviews Accompaniment No.: 2 Licensee: Midwest Testing Laboratory, Inc. License No.: 33-07712-01 Location: Fargo, ND Inspection Type: Routine, Unannounced License Type: Portable Gauge Priority: 4 Inspection Date: 1/21/99 Inspectors: JG,JK Accompaniment No.: 3 Licensee: United Blood Services License No.: 33-05427-02 Location: Fargo, ND inspection Type: Routine, Unannounced -
License Type: Self-Shielded Irradiator Priority: 5 g
inspection Date: 1/21/99 Inspectors: JK, JG Accompaniment No.: 4
- Licensee: Ewer Testing & Inspection, Inc. License No.: 33-32610-01 Location: Bismarck, ND inspection Type: Routine, Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 2/23/99 Inspectors: JK, JG Accompaniment No.: 5 Licensee: Dakota Geophysics License No.: 33-28628-01 Location: Dickinson, ND inspection Type: Routine, Announced License Type: Well Logging Priority: 3 Inspection Date: 2/24/99 inspectors: JK,JG
APPENDlX 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: Unimed Medical Center License No.: 33-09805-01 l Location: Minot, ND Amendment No.: 52 I License Type: Medical Institution Type of Action: Amendment Date issued: 11/25/97 Reviewer. JK File No.: 2 Licensee: Endorex Corporation License No.: 33-21122-01 Location: Fargo, ND Amendment No.: 8 License Type: Laboratory Use Type of Action: Termination Date issued: 6/2/98 Reviewer: KW File No.: 3 Licensee: Ewer Testing & Inspection License No.: 33-32610-01 Location: Bismarck, ND Amendment Nos.: O and 2 License Type: Industrial Radiography Type of Action: New and Amendment Date issued: 2/19/97 Reviewer: GK File No.: 4 Licensee: Northem improvement Company License No.: 33-32706-01 Location: Bismarck, ND Amendment No.: O License Type: Portable Gauge Type of Action: New Date issued: 3/19/97 Reviewer. GK File No.: 5 Licensee: Nuclear Imaging, Ltd. License No.: 33-28601-01 Location: Carrington, ND Amendment No.: 6 License Type: Mobile Nuclear Medicine Type of Action: Renewal Date issued: 11/18/98 Reviewer: JG Comment:
a) The license allows only for medical diagnostic use of radioactive material, yet several conditions in the license are specific only to therapeutic uses of radioactive material, including patient release criteria.
I North Dakota Proposed Final Report D.2 License Casework Reviews File No.: 6 -
Licensee: T & K inspection License No.: 33-22313-01 Location: Williston, ND Amendment No.: 13 License Type: Industrial Radiography Type of Action: Renewal Dateissued: 9/18/98 Reviewer: JG I Comm'ent:
a) The approved license application allows for a dose limit of three rem per calendar quarter for occupationally exposed individuals. The licensee's procedures do not reflect the current dose limits specified in the State's equivalent to 10 CFR Part 20.
File No.: 7 Licensee: BJ Services Company License No.: 33-16822-01
. Location: Dickinson, ND Amendtnent No.: 6 License Type: Portable Gauge Type of Action: Terminat;on Date issued: 3/18/99 Reviewer: JG Comment:
'a) Licensing documentation does not confirm that gauges were transferred to a specifically licensed recipient. Also, there was no confirmation or documentation that the recipient actually received the radioactive material.
File No.:- 8 Licensee: University of North R$@ License No.: 33-12827-01 Location: Grand Forks, ND Amendment No.: 21 License Type: Academic Broad S r,,e Type of Action: Amendment Date issued:- 9/25/98 Reviewer: JG Comment:
a) The license allows for use of sealed sources up to 200 mci for purposes of research and development, with source and holder models unspecified. There is no language in the license indicating that sources and devices will be used in accordance with the specifications contained in the Sealed Source and Device Registry.
File No.: 9 Licensee: St. Alexius MedicalCenter License No.: 33-11320-01 Location: Bismarck, ND: Amendment Nos.: 27 and 28 License Type: MedicalInstitution Type of Actions: Renewal and Amendment Date issued: 3/13/97 Reviewer: GK
p 4 0 I-North Dakota Proposed Final Report D.3 License Casework Reviews ,
File No.: 10 1
l Licensee: Schlumberger Technology Corporation License No.: 33-00090-01
)!
Location: Williston, ND Amendment No.: 35 License Type: Well Logging Type of Action: Renewal Date issued: 1/21/97 Reviewer: GK I
Comment. l a) Condition 11 ef this license does not require the licensee to comply with Chapter 33-12 of North Dakota's radiation protection regulations. This chapter is applicable to well logging.
I File No.: 11 Licensee: Technology Plus,Inc. License No.: 33-31901-01 Location: Grand Forks, ND Amendment No.: 4 j License Type: Industrial Radiography Type of Action: Amendment Date issued: 6/1/98 Reviewer: JK l 1
File No.: 12 Licensee: Jamestown Hospital License No.: 33-05026-01 Location: Jamestown, ND Amendment No.: 29 License Type: MedicalInstitution Type of Action: Amendment i Date issued: 7/23/97 Reviewer: JK File No.: 13 Licensee: West River Regional Medical Center License No.: 33-08310-01 Location: Hettinger, ND Amendment Nos.: 39 and 40 License Typo: Medical Institution Type of Actions: Renewal and Amendment Date issued: 7/3/97 Reviewer: JK File No.: 14 Licensee: North Dakota State University License No.: 33-06769-06 Location: Fargo, ND Amendment No.: 36 License Type: Academic Broad Scope Type of Action: Renewal Date issued: 6/10/97 Reviewer. JK Comment:
a) The license allows for the use of sealed sources up to 200 mci for purposes of research and development, with source and holder models unspecified. There is no language in the license indicating that sources and devices will be used in accordance with the specifications contained in the Sealed Source and Device Registry.
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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: Altru Health System Licensee No.: 33-01599-03 Site of incident: Grand Forks, ND Incident Log No.: ND 990001 Date of incident: 3/10/99 Type of incident: Lost lodine-125 Seeds Investigation Date: 3/10/99 Type ofInvestigation: Telephone Summary of incident and Final Disposition: Five iodine-125 seeds were not appropriately accounted for after an imr,lant therapy on 3/9/99. The seeds set off alarms at a medical waste incinerator. A DOT E-11406 shipment exemption was issued by the RCP for the licensee to return the seeds back to Altru Health System.
File No.: 2 Licensee: Twin Ports Testing,Inc. Licensee No.: 48-23476-01(NRC) ,
Site of incident: Bismarck, ND Incident Log No.: ND 960001 !
Date of incident: 10/18/96 Type of Incident: Transportation )
investigation Date: 10/18/96 Type ofInvestigation: Telephone Summary of Incident and Final Disposition: This NRC licensee's radiography truck was involved in a traffic accident. The truck was carrying three radiography cameras, each with approximately 100 curies of iridium-192. The driver was arrested for driving under the influence of alcohol and was jailed. The licensee sent another truck to remove the radiography cameras i before the State learned of the incident. The State made appropriate notifications to NRC and other organizations.
File No.: 3 l Licensee: Northrop Grumman Licensee No.: General License Site of incident: New Town, ND Incident Log No.: N/A
. Date of incident: 6/19/97 Type of incident: Lost Source
. Investigation Date: 6/20/97 Type ofInvestigation: Telephone Summary of incident and Final Disposition: Lost generally-licensed polonium-210 static eliminator. The device was found by the licensee in October 1997.
Comment:
a) Lost source not reported to NMED.
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North Dakota Proposed Final Report E.2
. Incident Casework Reviews File No.: 4 Licensee: Non-licensee Licensee No.: N/A Site of Incident: Jamestown, ND incident Log No.: N/A )
Date of incident: 10/96 Type of incident: Unknown Source Found Investigation Date: 1C/96 Type of Investigation: On-site Summary of Incident and Final Disposition: An unknown source which appeared to be a civil defense water standard was found along a highway. The RCP performed an on-site investigation, recovered the source, and determined it to have a small quantity of uranium-238.
The source is in storage at the Department of Health.
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a p APPENDIX F STATE OF NORTH DAKOTA QUESTIONNAIRE RESPONSE 1
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INTEGRATED MATER!ALS PERFORMANCE EVALUATION PROGRAM OUESTIONNAIRE North Dakota
[ Reporting Period: February 10,1996 to April 12,1999 i A. COMMON PERFORMANCE INDICATORS ' ~
(
[; - l. Status of Materials Insoection Proaram
- 1. Please prepare a table identifying the licenses with inspections that are overdae by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.-
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' insp. Frequency Licensee Name (Years) Due Date Months O/D Response: See Attachment A. Attachment A lists each inspection conducted since 2/10/96,the
- percent overdue at the time the licensee was inspected and how long it took to establish the -
first contact with the licensee after the inspection. The RCP tries to deliver written findings of l the inspection to the licensee within 30 days of completing an inspection. Initial communication
! regarding inspection findings are done at the conclusion of an inspection during a close out i meeting with licensee management.
Attachment B lists the new licensss issued and initial inspections conducted during this review ,
period. Attachment B identifies.the date the license was issued and the date the initial inspection was ' completed. The RCP attempts to inspect each licensee within 6 months of a licensee receiving a radioactive material (RAM) license. This time may be extended to one year if operations involving RAM have not begun.
- 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 q'uestionnaire. ' '
Response:: Yes. Attachment C is the scheduled inspections through August 1999. The RCP tries to complete inspections within 25% of the scheduled due date. As can be seen in Attachment C, two licensees are in excess of 25% overdue. These should be cornpleted by May 31,1999. After that time no licensees will,be in excess of 25% overdue.
- 3. Please identify individual licensees or groups of licensees the State is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.
Response: North Dakota requires more frequerit inspections on Moisture / density gauges and portable gauges which are inspected on a four year' frequency compared with the NRC five year frequency; .
North Dakota does not inspect any other licen' sees snore or less frequently than NRC Inspection
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. Manual Chapter 2800 -
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- 4. Please complete the following table for licensees granted reciprocity during the reporting period.
Response
Priority Year Number of Licensees Granted Number of Licensees Reciprocit.y Permits Each inspected Each Year Year Service Licensees YR 96 0 0 I pefiorming teletherapy YR 97 0 0 and irradiator source YR 98 0 0 installations or changes YR 99 ~ 0 0 YR 96 0 0 1 YR 97 2 0 YR 98 3 1 YR 99 0 0 YR 96 1 0 2 YR 97 1 0 YR 98 1 0 !
YR 99 0 0 YR 96 6 1 3 YR 97 4 0 YR 98. 5- 2 .
YR 99 0 0 l 4 YR 96 6 O YR 97 4 2 -
YR 98 6 2 YR 99 1 0 All Other YR 96 0 0 YR 97 0 0 YR 98 0 0 YR 99 0 0
- 5. Other than reciprocity licensees, how many field inspections of radiographers were pedormed?
Response:: North Dakota conducted one field inspection of an industrial radiographer. The RCP conducted a field inspection of TECHNOLOGY PLUS, INC. license # ND 33-31901-01 on 8/7/98.
- 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 pedormed, and the reasons for any differences between the goals and the actual number of inspections performed.
Res'ponse: Not Applicable
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. II. Technical Qualitv of Insoections t
- 7. '
What, if any, changes were made to your written inspection procedures during the reporting period?
Response:i North Dakota updated its inspection procedures since February 1996. The changes were not significant. Amendments were made to make the procedures more complete, to more accurately reflect the procedures followed by the RCP and to make the RCP inspection
, procedures more closely align with those of the NRC. Prior to the 1996 IMPEP review, North-Dakota had developed inspection report forms for each type of inspection. ~ Minor amendments
. were made to these forms as necessary to make them conform to the new requirements contained in the North Dakota Radiological Health Rules. Copies of the forms are enclosed in Attachment D.
- 8. - . Prepare a table showing the number and types of supervisory accompaniments made during the review period.
Response
Suoervisor Insoector Licensee ( License Tvoe) Qatg Ken Wangler fJim Killingbeck & Greg Krause UND (broad scope A academic) 5/20- 22/96 Ken Wangler Jim Killingbeck Dakota Gasification (gage) 1/23/97 Ken Wangler Jim Killingbeck /Justin Griffin NDSU (broad scope A academic),4/14-16/98 Ken Wangler Justin Griffin Amoco Refinery (gage) 8/25-26/98 Ken Wangler Jim Killingbeck and Justin Griffin UND (broad scope A academic) 9/29-10/2/98- .
- 9. Describe interna'l 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: North Dakota's RCP Administrative Procedures Manual section 111. E. states, Approximately 10% of all field inspections include the Radiation Control Program Manager.or Assistant Division Director or Division Director accompaniment of the inspector. 60 inspections have been conducted during this review period. Management has accompanied on 5 of the inspections. There is no specific documentation of the accompaniment other that1he appropriate notation made on the final inspection report. Copies of the inspection reports are not enclosed with this questionnaire.
- 10. Describe or provide ari update on your inst'umentation r and methods of calibration. Are allinstruments properly calibrated at the present time?
Response: All program instrumentation is calibrated every six months. See attachment E.
Attachment E lists all the RAM measurement equipment, however not all instruments listed in i attachment E are kept in calibration. Column one of attachment E identifies those meters which are in calibration.' All meters used for inspections and those'which are' considered essential for emergency response are calibrated semi annually. This is in line with the RCP' Administrative Policy Manual section XIV.
~ The' calibrations are conducted by Department staff using a Gammatron calibrator equipped with a 30 millic'urie' cesium-137 source. Tne calibrations' are done at the
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I Department's east laboratory in the upper floor penthouse. The meters are calibrated at two points located approximately 1/3 and 2/3 of full scale on'each meter for linear scale instruments; and at midrange at each decade and at two points of at least one decade for
- i. logarithmic scale instruments; and at appropriate points for digital instruments.
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 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 cany out the program's radioactive materials responsibilities, include their efforts.
Response
NORTH DAKOTA RCP PERSONNEL EFFORT NAME POSITION AREA OF EFFORT FTE%
D. Mount Division RAM Admin./ -
10 %
Director Supervision of Program
- T. O' Clair , Assistant RAM Admin / Supervision 5%
Division Director K. Wangler RCP Supervision / Admin. 40%
Manager RAM Licensing / Inspection 15 %
Radon 10%
Asbestos 10%
Indoor Air Quality 10%
X-Ray 10%
Emergency Response 2%
Special Projects 3%
J. Killingbeck Env.' Sci.111 Licensing 35*).
Inspection 40%
Correspondence '20%-
Emergency Response 2%
Special Projects 3%
J. Griffin Env. Eng. Il ' Licensing 35%'
Inspection 40%
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l Correspondence 20%
Emergency Response 2%
Special Projects 3%
Secretarial
- 0.21 FTE Total RAM FTE 2.87 68 specific licensees = 4.13 persons per 100 licenses Total person years = 0.10 + 0.05 + 0.57 + 0.97 + 0.97 + 0.21 = 2.87 person years.
' Total available Division Secretarial resource is 3.5 FTE. Secretarial support for the B,nch is j 40% of Division. Radioactive Materials is 15% of Branch effort. Total Secretarial effort for Branch is 3.5 x 0.40 x 0.15 = 0.21FTE.
(Special projects include noise response and nonionizing radiation)
- 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.
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Response: Justin Griffin was hired on November 3,1997 to replace Greg Krause who left July
' 31,1997. A copy of Justin's resume is enclosed as Attachment F. '
- 13. Please list all professional staff who have not yet mst 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 l
tentative schedule for completion of these requirements.
833g9,03g1 See Attachnient G. Jim Killingtieck had completed all the core training j requirements that were identified as such prior to October 1998. In October 1998 the RCP l received a license amendment request from Altru Hospitalin Grand Forks to use high dose rate l' after-loading brachytherapy (HDR). Prior to this time there were no HORS in North Dakota.
Following that request the RCP.added the Teletherapy & Brachytherapy (H 313) course as a core training course for North Dakota's Radiation Control Program. Current plans are to send Jim to the H-3i3 course in August 1999. As indicated in attachment G, Justin Griffin has not completed the core training requirements for RAM licensing and inspection. Attachment H is a l
memorandum to Health Department Management describing Justin's training history and the plan for Justin to accomplish the full training suite with the exception of the H 313 course. Plans for Justin to complete the H-313 course have not yet been made. Justin will likely attend the course sometime in 2001 or later. Planned training for Ken Wangler includes the transportation course (H-308) although a date for attending the course has not been determined. No other training for Ken is planned at this time.
- 14. Please identify the technical staff who left the RCP/ Regio ~nal DNMS program j during this period. -
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Response: Greg Krause, one of the two licensing and inspection staff, left the Health Department on July 31,1997. No other personnel have left the RCP since the last NRC review.
- 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.
' Response: The RCP does not have any vacant positions at the present time.-
' IV. - Technical O'uality 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: Endorex Corporation was a ' laboratory use' licensee.who used unsealed RAM.
Endorex Corporation terminated their license on June 2,1998. The University of North Dakota, a -
broad scope. type A licensee, received a significant penalty for violations discovered during a
- May 1996 inspection.
Both Universities who posses Broad Scope Type A RAM licenses renewed their license during this review period. A Number of medicallicensees such as Unimed and DMS Imaging also renewed their license during this review period. A fulllisting of all licensing actions performed during this review period can be made available for the review. - -
'17. Discuss any variances in licenisihg policies 'and~ procedures or exemptions from the regulations granted during the review period. .
Response: There were no variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
- 18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
Response: There were no changes made in the RCP written licensing procedures during the reporting period?
- 19. N/A V. Resoonses to incidents and Alleoations 1
- 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 l notification, etc. See Handbook on Nuclear Material Event Reporting in ,
, Agreement State'sfor 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 followirig format:
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r.
Response: The RCP continues to utilize the Nuclear. Material Events Database (NMED) system for reporting and tracking unusual events. All of the reportable incidents were reported to NRC using the NMED i system. They are as follows:
Licensee Name License No. Dats of Date of Tyne of Incident Incident ReDort Twin Ports 48-23476-01 10/18/96 10/21/96 Industrial' Testing, Inc. radiography truck with 3 Amersham 660B cameras crashed into a highway barrier on i Interstate 94 near l Bismarck. Driver was arrested and incarcerated for driving under the influence of alcohol.
Porter N/A 3/3/98 3/3/98 Naturally Brothers occurring radioactive material- (NORM) in 3 rail car of scrap metal (n'ot reportable)
Porter N-A 2/13/98 2/13/98 NORM in rail car Brothers of scrap metal (not reportable)
MeritCare 33-10227-02 1998 12/15/98 &. Cory Teigen, MD, Health 3/8/99 an interventio'nal Systems , radiologist received 7.61 rem whole body in 1998 (Machine. generated x-ray dose; not reportable)
Altru Health 33-01599-03 ' 3/10/99 3/10/99 Loss of control of System four I-25 brachytherapy sources -
Attachment I is a printout of the tracking system information used to track incidents and misadministrations since January.21, 1995.
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- 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 l notification made to NRC7 For Regions, was an appropriate and timely PN generated?
Response: No
- 22. For incidents involving failurs 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: 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'. -
Response: The Department is considering seeking a voluntary restraining order against the past University of North Dakota Radiation Safety Officer to prevent him from participating on a North Dakota Radioactive Ma' terial License for five years for his culpability in the University of North Dakota violation. There were no othar cases involving possible wrongdoing during this review period 24, identify any changes to your procedures for handling allegations that occurred during the period of this review.
Response: There have been no changes to the RCP procedures for handling allegations during this review period. The allegations that have been handled by the RCP this reporting period are listed in Attachment J.
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a 4 l a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.
Response: There have been no allegations referred to the State program by the NRC during this review 1
period.
4 VI. General
- 25. Please prepare, a summary of the status of the State's or Region's actions taken in l response to the comments and recommendations following the last review.
j Response: The State's last Integrated Materials Performance Evaluation Program (IMPEP) review was held February 6-9,1996. The Manag- ant Review Board (MRB) met May 14,1996 to consider the proposed final IMPEP r'eport. The MRB concurreo wa the re' port's fin'dihgs that four of 'the five common performance indicators were found to be fully satisfactory. The status of the fifth indicator, the Materials inspection Program .
indicator, was found to be satisfactory with recommendations for improvement. The only applicable non-common performance indicator was found to be fully satisfactory. Overall North Dakota's program was found
. to cdequate to protect public health and safety and compatible with NRC's regulatory program.
Tha deficiencies in the Materials inspection Program indicator were:
Failure to dispatch inspection findings to licensees in a timely manner.
Failure to conduct core ins'pections within 25% of their inspection frequency time interval.
Failure to conduct initial inspections within 6 months.
Four of the n.ine recommendations from the 1996 IMPEP relate directly to the deficiencies in the inspection l
l program. The entire list of recommendations followed by the State's response and current status on'the issue is listed below:
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Rec:mmendation No.1: The review team recommends that the state adopt a written timeliness goal for issuance of inspection findings to the licensee. '
R:sponse: The' state has adopted written timeliness goals for issuance of inspection findings. This is
', contained in the Radiation Control Program's Administrative Procedures Manual.
R c:mmendation No. 2: The review team recommends that state management and staff devote incrzased attention to issuing inspection results in a timely manner.
' R:sponse: State' management and' staff liave devoted increased attention to issuing inspection results ' '
in a timely manner; however, have not successfully met the thirty day (30) time frame in all cases. As can be seen in Attachment A, the average number of days between the inspection and the first contact i
with the licensee is 29.2 days. Attachment A identifies,how each inspecti,on was conducted relative to its l
inspection frequency and how long it took to respond to,a licensee after an inspectior) was completed. I R:csmmendation No. 3: The review team recommends that the State monitor the timeliness of issuing insp:ction findings to licensees as experience is gained with the new management tracking system.
'Within the next year, the state'should pedorm a systematic. assessment bf the tracking system a'nd d:cida whether it is effective in tracking assignments and prompting staff and management to issue in;pection findings.
. R:sNnse: The State'did monitor the timeliness of issuing inspection findings and did systematically Essass the tracking system. The tracking system was and is effective in tracking assignments and in )
. prompting staff and management to issue inspection findings.
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i Rec:mmendation No. 4: The review team recommends that, over the next year, the state should tssess whether initial inspections have been pedormed within six months of licensee issuances or
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- l within the provisions of IMC 2800, and whether the states method for scheduling initial inspections has w:rked adequately.
R :ponse: The state has assessed whether initial inspections have been pedormed within six months of licensee issuance. The State did this not only over the year following the 1996 IMPEP review but on cn ongoing basis. See attachment B which identifies the date all new licenses were issued and the date the initialinspection of that licencee was completed. Assessment of the tracking system has indicated I I
that the State's method for scheduling initialinspection has worked adequately. The deficiency in conducting initial inspections in a timely manner has resulted from not following the inspection schedule.
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RIcommendation No. 5: The review team suggests that the State follow through on its plan to have the Radioactive Material Control Program staff member complete the licensing course. l R :sponse: The program staff member in question _left the Radiation Control Program July 31,1997. A r:plicement for that position was hired'on November 3,1997. Training of the newly hired individual, '
Justin Griffin, is ongoing. Attachments F, G and H identify Justin's prior training and experience, as well cs, the core radiation courses he has attended and his proposed schedule for completing the remainder of the core training courses.
Rec:mmendation No. 6: The review tearn suggests that the program manager attend the licensing course as soon as' practical. The program manager should also eventually complete the inspection proc:dures course.
R:cponse: The program manager attended the licensing course in June 1996. The qualifications and '
training needs of the program manager conceming the inspection procedures course have been evaluated? Based on that evaluation, The RCP does not intend to send the present prograra manager to the inspection procedures course. The program manager has been with the Health Department ten'
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years and has extensive inspection and incident investigation experience, not only in radiation safety but in other program areas as well. Because of this experience,' the RCP does not feel sufficient benefit would be gained to justify the cost of him attending the inspection course. There are considerations und;rway for him to attend the transportation course but a final decision has not been made regarding that matter.
R:cammendation No. 7: The review team suggests that out-of state travel consideration should not curtril necessary training for program personnel.
R:spons'e: All out-of state travelis carefully evaluated and its costs conside' red against the beriefit exp cted to be realized from the travel. In cases whero there is a sufficient cost benefit ratio, out-of-st ts travel has been promptly approved by Health Department management and has not curtailed the nacassary training for program personnel.
Ric:mmendation No. 8: The review team suggests that inspectors sign all final versions of the insp ction field notes or that management adopt a policy that inspectors need not sign the field notes.
Response: It is RCP procedure to have both the inspector and program manager sign final version of insp;ction field notes. 'Added emphasis has been placed on this issue since the last IMPEP review.
Th3 RCP has attempted to insure that all final versions of inspection field notes on inspections conducted since the 1996 IMPEP have been signed by both the inspector and the program manager.
RIc:mmendation No. 9: The review team suggests that the state' devote more attention to supervisory i
sign-off on management field notes to indicate supervisory review. The program manager should sign l t l cll final field notes or the state should adopt a policy that the Division Director signature on the letter to the licencee constitute supervisor approval.
R2ponse: It is RCP procedure to have both the inspector and program manager sign final version of insp;ction field notes. Added emphasis'has been placed on this issue since the last IMPEP review.
The RCP has attempted to insure that all final versions of inspection field notes on inspections conducted since the 1996 IMPEP have been signed by both the inspector and the program manager !
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The above responses appear to be in line with the commitments the RCP made in a July 10,1996 letter to Mr. Hugh Thompson with the NRC at the conclusion of the 1996 IMPEP review. A copy of the July 10,1996 letter is enclosed as Attachment K.
On July 22,1998, representatives from the NRC including Mr. James Myers from NRC's Office of State -
Programs, Mr. Jack Homer, R'egional State Agreement's Officer, and Ms. M. Linda McLean, NRC -
Rrgion IV State Agreement's Officer met with the North Dakota Department of Health Radiation Control Program in the Bismarck, North Dakota office. The purpose of the meeting was to review and discuss i
the status of North Dakota's agreement state program. During that meeting, the NRC's staff discussed with the state each of the nine recommendations from the 1996 IMPEP review. The NRC staff recommended all except recommendafion no. 4 be closed. The review teams response to -
r: commendation no. 4 states, "the state said that its working towards accomplishing the IMC 2800 goal of p;rforming initial inspections within six months of licensee issuance but have not been entirely
' successful. For example, during 1998, two new licenses were issued, one was inspected nine-months Eft 2r issuance." A copy of the correspondence related to the July 22,1998 meeting is enclosed as
- Ettachment L !
- 26. Provide a brief description of your program's strengths and weaknesses. These strersgths and weaknesses ~should be supported by examples of successes, problems or difficulties which occurred during this review period
'Risponse: The State's Radiation Control Program (RCP) answered a very similar question.during the July 22,1998 visit from the NRC. The RCP's responses to that question begins on page 3 of
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l Attachment L. The RCP has good intra program co,mmunication on issues affecting licensees. This is cnhanced by the small number of program staff whose offices are located in close proximity to each oth r. Also because of the small staff size, every member is involved in all aspects of the RCP. Each staff is involved in licensing, inspection, rule revision, rule interpretation and correspondence with various types of licensees.
The North Dakota Department of Health, in general, has good interdepartmental communication. The
! program manager has easy and ready access to managers all the way to the Office of the State Health Officer and ready access to the Assistant-Attomey General assigned to the' Environmental Section. '
The technical capabilities of the program are good. All staff have recently upgraded computers and software. Management support for computer training, easy access to the Internet, strong clerical support, ready access to the Department's Chief Medical Officer, as.well as, technl. cal support on radiation safety issues from. the machine generated radiation program help the program in carrying out ~
lts rssponsibilities.
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B:cause of staff familiarity with licensees, good working relationships have been established with the ragulated community such that the program is often able to obtain compliance without elevated cnforcement action. The relationship also puts the program at ease with making recommendations in tddition to required corrective actions, a licensee is reque.sted to implement following an inspection.
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1 Thcra is of course a down side to small size. Because of the small program size, staff are not able to L
p:rticipate in national working groups and policy making activities because of the large percentage of I tim 3, represented when one staff member is taken' from the program for activities outside of the scope of radioactive materiallicensing and inspection. Because of small staff size, the program has also been 1 1
unible to move into radiation safety areas which are in need of attention such as the control of natural
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occurring radioactive material enhanced during oilfield exploration and production ' activities. The rule r; vision process also requires a significant percentage of staff commitment which detracts from the j l
tim:ly completion of licensing and inspection activity. Finally, as experienced during the current review i cycla, departure of one licensing and inspection staff represents a personnel deficiency in that area of 50%. This severely compromises the program's ability to conduct licensing and inspection actions in a timsly manner.
i B. NON-COMMON PERFORMANCE INDICATORS
- 1. Leaislation and Proaram Elements Reavired for Comoatibility
- 27. Please list all currently effective legislation that affects the radiation control program (RCP).
Response: North Dakota Century Code (NDCC) 23 20,23-20.1 and 23-20.2
- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
t Response: No, neither North Dakota Century Code nor North Dakota Administrative Code is subject to a
' Sunset" or equivalent 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 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.
1 Response: TABLE FOR QUESTION 29.
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DATE DATE' CURRENT EXPECTED 10 CFR RULE DUE ADOPTED STATUS ADOPTION Any amendment due prior to 1991. Identdy All rules required prior to this time C ch regulation (refer to the Chronology of have been adopted by the State Amindments) ,
Decommissioning; 7/27/91 3/1/94 Ptrts 30. 40. 70 Emitgency Planning; 4/7/93 3/1/94 Parts 30. 40. 70 Standards for Protection Against Radiation; 1/1/94 3/1/94 Part 20 Safety Reiluirements for Radiographic 1/10/94 3/1/94 Eouipment: Part 34 Notification of incidents; 10/15/94 3/1/94 Parts 20. 30,31. 34. 39. 40,70 Quility Management Program and 1/27/95 3/1/94 Misadministrations: Part 35 Lic;nsing and Radiation Safety Requirements 7/1/96 7/1/95 for irradiators: Part 36 D;finition of Land Disposal 7/22/96. N/A and Waste Site OA Program: Part 61 Decommissioning Recordkeeping: Docu- 10f25/96 7/1/95 mintation Additions: Parts 30. 40,70 Ur!.nium Mill Tailings: Conforming to EPA 7/1/97 N/A -
Standards: Part 40
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OR DATE DATE CURRENT EXPECTED 10 CFR RULE DUE ADOPTED STATUS ADOPTION Timeliness in Decommissioning 8/15/97 7/1/95 Parts 30. 40. 70 Preparation, Transfer for Commercial Dis- 1/1/98 5/1/98 tribution, and Use of Byproduct Material for Medical Use: Parts 30. 32. 35 Frequency of Medical Examinations for Use of 3/13/98 5/1/98 R spiratory Protection Equipment Low Lev'el Waste Shipment Manifest 3/1/98 5/1/98 information and Reporting PJrformance Requirements for Radiography 6/30/98 5/1/98 Equipment R:diation Protection Requirements: Amended 8/14/98 5/1/98 Definitions and Critena 1 Citrification of Decommissioning Funding , 11/24/98 5/1/98 A rquirements .
10 CFR Part 71: Compatibility with the 4/1/99 5/1/98 Intemational Atomic Energy Agency Medical Administration of Radiation and 10/20/98 5/1/98 R*dioactive Materials.
Tcrmination or Transfer of Licensed Activities: 6/17/99 5/1/98 Arcordkeeping Requirements. !
l R1 solution of Dual Regulation of Airbome 1/9/00 5/1/98 Effluents of Radioactive Materials: Clean Alf Act Recognition of Agreement State Licenses in 2/27/00 N/A l
Areas Under Exclusive Federal Jurisdiction i
Within an Agreement State Cnteria for the Release 'of !ridividuals 5/29/00 5/1/98 Administered Radioactive Material 1
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s .. 4 OR DATE DATE CURRENT EXPECTED 10 CFR RULE DUE ADOPTED STATUS ADOPTION Licenses for Industrial Radiography and 6/27/00 Not yet adopted by the State. North Radiation Safety - Requirements for Industrial Dakota has had an Industrial Radiogiaphy Operations; Final Rule Radiography certification and two-man requirement in place since 1992. An initial evaluation reveals that North Dakota's rule is quite similar to NRC's rule. During the next rule revision, a detailed comparison will be conducted and the necessary changes made to make the State's rule fully compatible Radiological Criteria for License Termination 8/20/00 On May 1.1998 North Dakota adopted a " Final Rule" as published on the intemet. This needs to be evaluated against the rule as published in the Federal Register.
Exempt Distribution of a Radioactive Drug 1/2/01 Not yet adopted by the State.
. Containing One Microcurie of Carbon-14 Urea Through Administrative Procedures, North Dakota does allow the exempt distribution of this drug.
Deliberate Misconduct by Unlicensed Persons 2/12/01 Not yet adopted by the State Licenses for industrial Radiography and 7/9/01 Not yet adopted by the State Radiation Safety Requirements for Industrial Radiographic Operations, Clarifying Amendme'nts and Corrections :
Minor Corrections, Clarifying Changes, and a 10/26/01 Not yet adopted by the State Minor Policy Change
' Attachment M is a copy'of a December 29,1998 from Mr. Paul Lohaus, Deputy Director of NRC's Office of State Programs indicating tha't the State's May 1,1998 rules are compatible with applicable sections of 10 CFR. .
- 30. If you hava not cdoptId all Em:ndmants within thrse ysrs from the date of NRC rulo promulgation, briefly describe your State's procedures for amendir, <?gulations in order to maintain compatibility with the NRC, showing the normallength of time anticipated to complete each step.
Response: North Dakota does not intend to adopt the requirements for Land Disposal and Waste Site OA programs, nor the Umnium Mill Tailings: Conforming to EPA Standards since neither of these requirements are applicable to operations in North Dakota. Therefore North Dakota's regulations are compatible with adoption of all applicable NRC regulations through June 27,2000. With regard to regulations which we are required to adopt on or before June 27,2000, the program will begin the next rule revision process on or about October,1999. From the time new or revised rules are proposed it takes approximately 9 to 10 months before they are promulgated. By beginning in October,1999 this should allow the program sufficient time to adopt the necessary rules within the allowable NRC time frame.
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DEPARTMENTOFHEALTH iir,7, M 7o,,een 9 NORTHDAKOTA 400 E souleverd Avenue sement,ND 586054800 701 328-2372 FAX 701328 4727 June 7,1999 e
I Paul H. Lohaus, Director o cn Office of State Programs gu U.S. Nuclear Regulatory Commission 9 Washington, DC 20555-0001 g
Dear Mr. Lohaus:
The North Dakota Depaament of Health (Department) has reviewed the U.S. Nuclear Regulatory Commission's (NRC) May 10,1999 draft Integrated Materials Performance Evaluation Program (IMPEP) report of the Department's Radiation Control Program (RCP).
The following comments address the technical and clerical accuracy of the draft report:
e On page 4, third paragraph, line 8 reads in part, "of regulations to ensure compatibility during early 1998;..." The RCP staff actually began work on the regulation revisions in early 1997 and continued through August 1997. Work on the rule revision was then delayed until February 1998, at which time, work resumed and the rules were promulgated May 1,1998. An appropriate correction may be to replace the word, "early" with "1997 and".
. On page 4, third paragraph, line 9 reads in part, "the program's inspector / license reviewers for several. weeks during 1998 for personal reasons." The extended absences occurred in two separate periods, one in early 1997 and one in mid-1998.
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During both these periods, the staff member consumed large amounts of leave in relatively short periods of time. The specific correction could include adding the words, "early 1997 and again in mid" in front of "1998".
. On page 5, first paragraph, line 5, we suggest that the word, " written" be added between the words, " questionnaire," and " inspection" since verbal inspection findings were communicated to the licensees during the exit briefing.
. On page 5, first paragraph, beginning on line 6 states, "Of the 10 core licensee inspection files evaluated by the team, six letters of noncompliance were issued greater than 30 days following the exit briefing of the licensee." This would seem to indicate that 60% of the core licensee inspections were not responded to within 30 days.
l However, during the review, IMPEP inspectors indicated that these ten core licensee
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Mr. Paul H. Lohaus 2 June 7,1999 inspection files were not selected randomly. Rather they were selected based on their l
delayed inspection status as indicated in the state's response to the questionnaire. A l sentence should be added indicating that these ten core licensee inspection files were not randomly selected, but rather were selected based on an indication of other timeliness problem issues.
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. On page 8, paragraph 1, line 5, the words," Industrial Radiographer" should be added between the words, " Texas" and " Exam" for clarification purposes.
. On page 10, second paragraph, beginning on line 3, a statement is made that,"RCP ;
staff indicated that it was an oversight that the incident was not reported." While th!s statement may be factually correct and that the RCP staff considered it an oversight, :
the RCP manager does not agree. The RCP manager indicated that at the time the !
source was lost, the licensee was instructed to continue searching his facility with continued follow-up by the RCP. The RCP manager indicated that, as he recalls, the l event was purposely not entered into NMED until such time as the RCP was convinced the source was indeed lost rather than misplaced. A suggeHad correction would be to follow the above sentence in paragraph 2 with an additiona,i sentence stating, "The RCP manager did not, however, agree lhat the failure to enter the event in the NMED '
i system was an oversight, but rather intentional since the RCP expected the licensee to eventually locate the source."
This practice will no longer be followed by the RCP. The incident above occurred on June 19,1997. Agreement States Letter SP-98-018 dated March 19,1998 discusses using NMED reporting as a national method for the purpose of tracking and locating lost or stolen sources, in the future, the RCP will immediately report all such occurrences.
The RCP will then update the NMED as appropriate if and when the source is found, l
e On page 11, first paragraph, the first sentence contains the word, " Rules" twice. The '
second word,
- Rules" should be replaced with the words," North Dakota Administrative .
Code Chapters". The sentence would then read as follows,"The North Dakota Revised Radiological Health Rules, found in North Dakota Administrative Code Chapters 33 01..." )
e On page D.3, in Appendix 3, File No.13, under the " Location" field, the word !
"Hettinger" is misspelled as "Hattinger".
This cor>rludes our comments to the technical and clerical accuracy of the report. The i above comments represent only minor suggested changes. In the last sentence of page j 1, the NRC states, "A response is requested from the State to all recommendations in the l final report." Since it is not anticipated that significant changes will be made to the draft )
report recommendations in the final report, and in the interest of expediting the review l process, we would also like to respond to the recommendations contained on page 13 of j the draft report at this time. This would eliminate the need for the IMPEP review team to i send a corrected report to the RCP for our response to recommendations. We request that l l
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Mr. Paul H. Lohaus 3 June 7,1999 a corrected report and the following comments be concurrently submitted to the Management Review Board for their consideration.
The recommendations will be addressed in the order in which they appear. The recommendation will be repeated followed by the our comment.
- 1. RECOMMENDAT/ON: The review team recommends that RCP management devote additional attention to a " pro-active" review of the current inspection tracking systems, and adjust staff priorities accordingly to ensure core licensees are inspected at the required intervals. (Section 3.1)
RESPONSE: The RCP management has already begun this process and will continue to do so. As was indicated by members of the IMPEP team during the review, the RCP's current tracking system is an excellent tool for this purpose. While attention had been paid to the tracking system during the current review period, RCP management will seek new ways to improve tha timeliness of inspections. RCP management was aware of the 25% overdue criteria; however, was not aware that this was only applied to core inspections.
During this review period, RCP did not impose a superficial inspection priority over the ,
existing inspection priority system for the purpose of focusing on core inspections.
Core inspections represent licensees with inspection priorities of 1,2, and 3. The interval between inspections for these licensees is 1 year, 2 years, and 3 years ;
respectively.
As indicated in the IMPEP report, the RCP inspected licensees based on their ;
scheduled time of inspection, percent of time overdue, and geographic location in the State relative to other inspections being conducted. This means that priority 4 and 5 inspections were scheduled along with priority 1,2, and 3. .
Higher inspection priority licensees, i.e.; priority 1, 2, and 3 exceed the 25% overdue ,
value more quickly than do priority 4 and 5. In an inspection program that has fallen j behind, and one where all licenstes due for inspection are in excess of 25%, the ;
program will likely have a higher percentage of core licensees in excess of 25% i overdue, in tha future the RCP will prioritize core inspections to help ensure they do not go over l 25% of their inspection frequency. The RCP has found it advantageous from an IMPEP accounting perspective to focus on the core inspections since they are the only )
ones evaluated for timeliness. Since implementing this strategy following the IMPEP review, the RCP has been able to inspect all core licensees such that none are currently outside the 25% overdue window. Additionally, all of the inspections conducted since the IMPEP review have had inspection findings submitted to the licensee in less than 30 days following the inspection. It should be noted that
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l Mr. Paul H. Lohaus 4 June 7,1999 i
continuing to focus such high priority on the core licensees could result in extended inspection intervals for priority 4 and 5 licensees.
- 2. RECOMMENDATlON: The review team recommends that RCP continue their efforts to complete inspections of high priority reciprocity licensees in accordance with IMC 1220. ' (Section 3.1)
RESPONSE: The RCP will continue its efforts to complete inspections of high priority reciprocity licensees in accordance with IMC 1220. The RCP staff has found the inspection frequency for reciprocity licensees to be very difficult to comply with. These difficulties are due to short advanced notice, limited amount of time spent in the State and unusual hours. An example is a recent industrial radiography reciprocity licensee who began work in the State on Friday, May 7, at 6:00 p.m. and completed his project by Saturday moming, May 8 at 5:00 a.m. The job site was 80 miles northwest of Bismarck.
it is not unusual for industrial radiographers and other reciprocal licensees, such as well loggers, to conduct work in the State after normal working hours and on weekends to avoid interrupting normal processes at their location of work or to fit the schedule of their clients. It is our understanding that many states have trouble meeting this requirement. Perhaps the IMPEP criteria dealing with this issue should be revisited.
Licensees who work in other states under reciprocity must be regularly inspected by their licensing agency. These inspections may include home office as well as field inspections. While there is merit in promoting compliance through reciprocity l inspections, its importance may be overestimated. If a licensee is responsible enough to establish and maintain compliance in their area of jurisdiction, one could expect that to carry over to all areas of operation as well.
Also, in addition to being extremely burdensome on the agency granting reciprocal privileges, these mandatory inspections impose a mandatory increased inspection frequency on the licensee. We support inspection of reciprocity licensees particularly i
. if poor performance could be expected. However, we do not support the mandatory ,
inspection of reciprocal licensees for the reasons mentioned above. States should be l given more discretionary authority over inspections of reciprocal licensees. i
- 3. _RECOMMENDAT/ON: The review team recommends that RCP management continue to provide additional oversight to ensure inspection findings (letters of apparent noncompliance) are communicated to licensees in a timely manner, and that licensee responses are evaluated promptly upon their receipt by RCP. (Section 3.1)
RESPONSE: The RCP management will continue to provide additional oversight to ensure inspection findings are communicated to licensees in a timely manner. The RCP staff recognizes the importance of timely response to inspections and appreciates the IMPEP recommendation.
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Mr. Paul H. Lohaus 5 June 7,1999
- 4. RECOMMENDAT/ON: The review team recommends that management perform an in<lepth review of the RCP's current and future anticipated activities and obligations to I ensure budgeted stamng levels are adequate to fulfill the responsibility of the program. l
- (Section 3.3) - l RESPONSE: . RCP management has and will continue to consider this issue.
' According to models of a State RCP, North Dakota should have adequate staff for its number of licensees. The most recent guidance, which is in CRCPD Publication 99-2
. dated April 1999 suggests 1.0 to 1.5 FTE per 50 uncomplicated licenses. North Dakota meets this stamng level. This, however, is misleading; in states with a small number of staff, a disproportionate percentage of total FTE is required for such things as rule revisions, responses to' surveys, responses to incidents, employee illness or termination, or other matters which require staff time, and are outside the scope of licensing and inspection. In the case of North Dakota, if one staff member is diverted from their regular duties, this represents a 50% disruption in the inspection and licensing staff effort. Therefore, model numbers, as contained in the ORCPD's ;
document, are not necessarily applicable to small programs such as North Dakota.
We believe North Dakota's program can function adequately, under normal l circumstances, with existing stamng levels.
This assessment is based on the history of the program. During those times where two full-time, trained RCP staff were available, and ancillary responsibilities were minimal, the program was able not only to keep up with the inspection and licensing workload, ,
but to make up overdue projects that accrued during periods of disruption. This is ;
evident in the past year, in April 1998, after the newly hired RCP staff had attained '
some of the necessary training, a focused effort was made to begin to catch up on overdue inspections. Since that time there has been a steady decline in the number and severity of overdue inspections. 'Due to other complications, the findings of the inspections were still not being relayed to licensees in a timely manner. Th's, however, l was corrected in October 1998 and since that time no problems of this nature have been observed.
However, RCP management recognizes that staff and scheduling disruptions are :
inevitable. The RCP management will, therefore, continue to provide close oversight of its stamng level needs. Management will consider whether additional radiation safety duties, outside of the IMPEP criteria responsibilities, could Justify the addition of an RCP staff. This individual's duties could be shifted when needed to complete IMPEP criteria requirements during times of RCP staff and scheduling disruptions.
- 5. RECOMMENDAT/ON: The review team recommends that the State provide training to technical personnel, either by formal course work or equivalent, in the area of brachytherapy. (Section 3.3}
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Mr. Paul H. Lohaus 6 June 7,1999 RESPONSE: We agree with this comment. The senior licensing and inspection staff member is currently scheduled to attend the brachytherapy course in August 1999.
The junior licensing and inspection staff will have the brachytherapy cou'ser added to his curriculum of core courses and will attend the course at the appropriate time.
Finally, we would like to comment on the crheria to which the IMPEP review team I
recommended a finding of unsatisfactory.
The RCP staff recognizes and agrees with the importance of this evaluation criteria. They also recognize that the degree of seriousness of this finding is elevated since, as the inspection team indicated on page 5 of the IMPEP report, this problem was identified during the 1996 IMPEP review as well.
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The RCP staff realized these problems were occurring during the IMPEP review period; I however, because of the circumstances, they were unable to maintain a timely inspection schedule and inspection response situation. This, however, is quite different than RCP management being unaware of the situation. The RCP management closely tracked this l
lasue, and, as soon as possible took steps to remediate the problem. Recent history shows improvement. The RCP staff is committed to preventing the occurrence of a similar situation in the future.
! A consideration in any IMPEP review in which the RCP has an improved situation from that which existed during the review period, such as less overdue inspections, has to be l whether the RCP made a concerted effort to improve its statistics simply for the IMPEP.
This is clearly not the case with North Dakota's program. North Dakota began correcting
! the overdue inspection deficiencies in early 1998. In June 1998 the NRC conducted a one-l day interim review of North Dakota's program. After that review, it was our understanding, based on NRC correspondence, that it would not receive another IMPEP review until the year 2000. Had an IMPEP not occurred until the year 2000, and given the recent history of the RCP, we believe it would have been in full compliance with the timeliness of inspections and reporting ofinspection findings in a timely manner well before the IMPEP review.
From a performance perspective, we feel that in spite of extenuating circumstances which occurred during the review period, it was able to maintain public health and safety concerning the use of radioactive materials and was able to recover from the loss of a well l trained and experienced staff member which represented 50% of its licensing and i inspection staff. This loss occurred in the middle of a rule revision process. The program's I
recovery demonstrates that the RCP was and is committed to performing above a level of unsatisfactory.
l in addition to the above comments describing the situations leading to North Dakota's RCP deficiencies, we would ask the MRB to also consider the following:
- 1. The RCP's responss to Recommendations 1 and 4.
l
Mr. Paul H. Lohaus 7 June 7,1999
- 2. The current status of North Dakota's RCP; i.e., no core inspections are currently in excess of 25% overdue and the length of time and number of overdue inspections has been steadily declining since April 1998.
- 3. No inspection findings have been reported to licensees in excess of thirty days from the inspection date, since October 1998.
Based on the above, we respectively request that the performance of this evaluation criteria be found by the Management Review Board to be satisfactory with recommendations rather than unsatisfactory.
We appreciate the efforts and professionalism of the IMPEP review team. The team conducted themselves in an exemplary manner throughout the IMPEP process. We also respect the findings of the team and appreciate that they did not compromise on applyir',
the prescriptive review criteria of the IMPEP guidelines in making their recommendations.
We, however, agree with the performance based concept of the IMPEP and respectively request MRB consideration of the program from a performance perspective.
If you have any questions concoming these comments or requests, you may contact me directly at 701-328-2372 or you may contact Mr. Dana Mount or Mr. Ken Wangler at 701-328-5188.
Sincerely, Murray G agsveen State Health Officer MGS:Irr cc: Francis J. Schwindt, Chief, EHS Jim Lynch, U.S. NRC Region lil Dana K. Mount, Director, RCP I
1
iey o l Aoenda for Manaoement Review Board Meetino i Wednesday. June 30.1999.1:00 - 3:00 p.m.. TWFN. 2-B-5 l i
- 1. Convention. MRB Chair Convenes Meeting
- 2. New Business - Consideration of North Dakota IMPEP Report A. Introduction of North Dakota IMPEP Team Members (J. Lynch) i B. Introduction of North Dakota representatives and other State representatives participating through videoconference or teleconference. l C. Findings regarding North Dakota Program (IMPEP Team)
Legislation and Program Elements Required for Compatibility Response to incidents and Allegations
- Technical Quality of Licensing Actions
- Technical Staffing and Training Technical Quality of Inspections Status of Materials inspection Program D. Questions (MRB Members)
E. Comments from State of North Dakota F. MRB Consultation / Comments on issuance of Report Recommendatinn for next IMPEP review
- 3. Status of Upcoming Reviews
- 4. Approval of Region IV MRB Minutes
- 4. Adjournment Attendees: Frani, Miraglia, MRB Member, DEDR raul Lohaus, MRB Member, OSP Karen Cyr, MRB Member, OGC Cari Paperiello, MRB Member, NMSS OAS Liaison to MRB Dana Mount, ND Kenneth Wangler, ND James Lynch, IMPEP Team Leader, Rlli Mark Shaffer, IMPEP Team Member, RIV James Peterson, IMPEP Team Member, SC Torre Taylor, IMPEP Team Member, NMSS Kathleen Schneider, OSP Lance Rakovan, OSP Brenda Usilton, OSP Fred Combs, NMSS ATTACHMENT 2
.