ML20149L444
| ML20149L444 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/1997 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20149L438 | List: |
| References | |
| NUDOCS 9708010154 | |
| Download: ML20149L444 (115) | |
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! l 1 l lNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM
- REVIEW OF TEXAS AGREEMENT STATE PROGRAM JUNE 16 - 27,1997 1
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DRAFT REPORT !
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l U.S. Nuclear Regulatory Commission 1 9708010154 970725 . _ ,
1 Texas Draft Report Page 1 i
1.0 ' INTRODUCTION i This report presents the results of the review of the Texas radiation control program. The review was conducted during the period June 16-27,1997 by a review team comprised of
. technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Georgia. Team members are identified in Appendix A. The review was conducted in accordance with the " Interim implementation of the Integrated Materials !
l Performance Evaluation Program Pending Final Commisalon Approval of the Statement of l Principles and Policy for the Agreement State Program and the Policy Statement on
- Adequacy and Compatibility of Agreement State Programs," published in the Endsial Reaister on October 25,1995, and the September 12,1995, NRC Management Directive ,
5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of :
the review, which covered the period March 11,1994 to June 27,1997 were discussed
! with Texes management on June 27,1997.
(A paragraph on results of the MRB meeting will be included in the final report.)
The Texas Agreement State program is administered from two State agencies, the Texas Department of Health (TDH), and the. Texas Natural Resource Conservation Commission (TNRCC). Organization charts for both agencies are included as Appendix B. ;
l The TDH, Bureau of Radiation Control (BRC) regulates approximately 1,540 materials !'
! licenses, and received regulatory authority for the 11e(2) uranium recovery program as of l July 21,1997. In addition to the radioactive materials program, TDH administers a laboratory program for environmental sciences under the Bureau of Laboratories.
The TNRCC regulates low level radioactive waste burial sites, and the decommissioning of former burial sites. TNRCC also regulated the uranium recovery program during the period of September 1993 to the time of the review. Authority for the uranium recovery program transferred to TDH on July 21,1997.
The review focused on the regulatory program as it is carried out under the Section 274b.
l (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the !
State of Texas.
I in preparation for the review, a questionnaire addressing the common and non-common indicators was sent to both agencies on April 18,1997. Each agency provided a response to the questionnaire on May 22,1997. A copy of the responses are included in Appendix C to this report.
The review team's general approach for conduct of this review consisted of: '
(1) examination of the responses to the questionnaire, (2) review of applicable Texas statutes and regulations, (3) analysis of quantitative information from the TDH and TNRCC licensing and inspection data bases, (4) technical review of selected licensing actions and 7
inspections in each agency, (5) field accompaniments of nine materials inspectors, (6) a site visit of an uranium production facility, (8) the review of the low-level radioactive waste ,
j program, and (9) interviews with staff and management in both agencies to answer l
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- v Texas Draft Report Page 2 questions or clarify issues. The team evaluated the information that it gathered against the
- IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the State's performance.
Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings, recommendations and suggestions. Suggestions made by the review team are comments that the review team believes could enhance the States program. The State is requested to consider suggestions, but no response will be requested. Recommendations relate directly to program performance by the State. A response will be requested from the State to all recommendations in the final report.
l 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS
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she previous routine review concluded on March 11,1994, and the final combined results of the review were transmitted to both the Commissioner, TDH, and the Executive Director, TNRCC on December 28,1994.
2.1 Status of items hig.ntified to TDH Durina the 1994 Routine Review The 1994 review findings resulted in recommendations to TDH in three program indicators:
(1) Status and Compatibility of Regulations; (2) Adequacy of Product Evaluations; and (3) l Responses to incidents and Alleged incidents. TDH responded by letter dated February 9, !
1995 and provided the Department's response and comments to the recommendations.
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On April 10,1995, the Office of State Programs (OSP), notified the TDH that their l responses would be evaluated during the next review. The status of these recommendations are as follows:
(1) Status and Compatibility of Regulations. The regulation for " Notification of incidents" was identified as being overdue for adoption, and NRC recommended that Texas regulations equivalent to 10 CFR Parts 31.3 and 31.5 be revised.
Current Status: TDH has adopted the equivalent regulations compatible to the
" Notification of Incidents" and 10CFR 31.3 and 3.5. This recommendation is closed.
(2) Adequacy of product evaluations. NRC suggested that the State review a list of 3 recommendations provided as an enclosure to the 1994 report.
Current Status: The State's corrective actions were evaluated during the IMPEP l review. The State has developed template registration certificates and a safety evaluation checklist to assist the reviewers in including the items listed in the l recommendation both in the evaluation and in the registration certificate. This j recommendation is closed.
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Texas Draft Report Page 3 (3) Responses to incidents and Alleged incidents.
(a) The inspection manual refers to a 24-hour, 72-hour, and 10-day inspection requirements in response to incidents. Inspection criteria for the 24-hour and 10-day inspections are documented in the manual, but no criteria for 72-hour inspections are provided.
Current Status: The inspection manual procedure referred to is entitled " Incident and Complaint investigation" and was effective September 7,1988. The recommendation incorrectly states that the procedure requires 72 hour8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> inspections.
Under section B, " Complaints," of the procedure, there is a requirement to " initiate a response to each complaint within 72-hours of the time the complaint is received." A 72-hour inspection is not required and therefore criteria for such an inspection is not needed. As an added note, the above procedure was revised on l May 14,1997. The revisions retained the requirements for on-site investigations l for significant incidents with the deletion of the 24-hour and 10-day time frames, and retained the 72-hour response to complaints. This recommendation is closed.
(b) One incident file revealed the following concern - a, therapeutic misadministration of 675 to 750 rem to a patient's abdomen due to a dislodged source was not followed up by the TDH. The State should specifically follow up on this incident including a determination whether this incident was an abnormal occurrence.
Current Status: Follow up had been initiated prior to the March 1994 review but had not been completed. Since the 1994 review, an Abnormal Occurrence Report has been submitted to the NRC. This recommendation is closed.
(c) The inspection Manual does not address misadministration.
l l Current Status: The inspection manual procedure referred to is entitled " Incident and Complaint Investigation" and was effective September 7,1988. The May 14, 1997 rev.ision to the procedure adds the requirement for on-site investigations when "information in an incident report causes Bureau concern for the health / safety of the public or medical patient." Discussions with the Technical Assistance Project Manager on the misadministration issue verified that Texas conducts on-site investigations for all misadministrations. This recommendation is closed.
2.2 Status of items identified to TNRCC Durina the 1994 Routine Review i
The December 28,1994 review findings had recommendations for the TNRCC in seven program indicators: (1) Legal Authority; (2) Status and Compatibility of Regulations; (3)
Administrative Procedures; (4) Staffing Level; (5) Technical Quality of Licensing Actions; (6) Inspection Procedures; and (7) Enforcement Procedures. The TNRCC responded by
- letter dated January 30,1995. OSP notified the TNRCC by letter dated March 20,1995, that the progress on each recommendation by TNRCC would be evaluated during the next 4
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l Texas Draft Report Page 4 review. On March 14,1995, TNRCC notified NRC of additional progress made with respect to the 1994 recommendations. The current status of these recommendations is as follows:
(1) Legal Authority a) A recommendation was rnade for the State to take legislative action to revise i
the definhion of low-level waste and the limitations on the disposal of transuranic concentrations greater than 10 nanocuries per gram.
j Current Status: The State introduced legislation into the 1997 legislative session; i however, the legislation did not pass. Detailed discussion can be found under the i non-common performance indicator, Legislation and Regulations, Section 4.1. This recommendation is considered closed and will be tracked as a new recommendation (see Section 5.0).
b) A recommendation was made for the State to revise the statutory definition of byproduct material to be compatible with 10 CFR Part 40.
l Current Status: Legislation introduced into the.1997 legislative session was adopted and the statutory definition of byproduct material was made compatible with 10 CFR Part 40. This recommendation is closed.
l l (2) Status and Compatibility of Regulations. One regulation concerning self-insurance (Criterion 9) of 10 CFR Part 40, Appendix A needed to be adopted for the uranium i program.
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Current Status: This regulation was adopted by TNRCC in a rule package effective June 6,1997. This recommendation is closed.
(3) Administrative Procedures a) A recommendation that the license renewal process be utilized to update both the reclamation / restoration plans and the associated cost estimates.
l Current Status: TNRCC updated, and implemented a detailed written procedure for
! establishing financial assurance. This recommendation is closed.
l b) A recommendation was made for better documentation between the Texas l Low Level Radioactive Waste Disposal Authority (TLLRWDA) and the l TNRCC.
Current Status: Standard documentation was developed and implemented for documentation between the TLLRWDA and the TNRCC. This recommendation is closed.
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? o Texas Draft Report Page 5 (4) Staffing Level. A recommendation was made for two additional technical staff members to help with the uranium recovery licensing backlog.
Current Status: TNRCC added four new technical staff and one new administrative staff positions, and established a two year time frame to overcome the licensing {
backlog. Considerable progress was made in reducing the backlog during the i period. The licensing actions are being tracked and completed in accordance with the administrative procedure. Since the uranium program is being transferred to 1
TDH, and given the progress made since the last review, this recommendation is l
closed.
(5) Technical Quality of Licensing Actions. A recommendation was made for the staff
- , to identify the regulatory bases for requests to TLLRWDA for information and ;
i clarification by citing criteria and standards in the regulations. ;
l Current Status: TNRCC implemented the' citing of rules in their deficiency letters ;
and correspondence. This recommendation is closed. t 1
l (6) Inspection Procedures. A recommendation was made for the TNRCC to update the l Inspection Manual.
Current Status: TNRCC developed and revised the inspection procedures. This !
recommendation is closed. l l (7) Enforcement Procedures. A recommendation was made to revise the handling of enforcement actions to assure a more expeditious transmittal of enforcement letters to licensees. ,
Current Status: A procedure for tracking enforcement actions and reports was )
implemented and the reports and associated enforcement actions are being l transmitted in accordance with the administrative procedures. This l recommendation is closed.
l 3.0 COMMON PERFORMANCE INDICATORS i
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 Staffing and Training; (3) Technical Quality of Licensing Action; (4) Technical Quality of Inspections; and (5) Response to incidents and Allegations.
i 3.1 Status of Materials Inspection Proaram i
The team focused on four factors in reviewing this indicator: inspection frequency; overdue inspections; initial inspection of new licenses; and timely dispatch of inspection
, findings to licensees. This evaluation is based on Texas' questionnaire responses to this
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i l indicator, data gathered independently from the State's inspection data tracking system, l l the examination of licensing and inspection casework files, and interviews with managers
- and staff.
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Texas Draft Report Page 6 l,
j BRC uses several data bases to manage the State's radiation control program. BRC uses :
i the data to schedule those inspections that will become due in the next quarter. This '
inspection due list is forwarded to the r.egional offices for action. Regional managers also l: have access to similar information from a network server. Several checks and balances are ;
in place to assure that inspections occur within three months of the planned date.
BRC conducts unannounced inspections, however, the BRC's general practice is to give short notice to medical facilities and certain other licensees before the inspection. BRC reported that this practice has been found to provide less disruption in patient care and effectively uses the inspector's time. BRC believes that announced inspections permit j j better use of inspection resources that is a factor in maintaining a low number of overdue <
- inspections in the program. The team did not identify from the casework or i accompaniments, any difference in tho quality of inspections or the number of findings l
because of this practice.
i The team's review of the BRC's inspection priorities verified that the BRC's inspection j frequencies for various types or groups of licenses are at least as frequent as similar
- license types or groups listed in the frequency schedule in the NRC Inspection Manual j Chapter (IMC) 2800. BRC requires more frequent inspections in some license categories as
- follows
- waste processots were verified to be inspected on a six month frequency 1 compared to the NRC one year frequency; processors of loose material are inspected every
! six months compared to NRC one year frequency for Type A broad manufacturers; rare-4 earth extraction and processing licensees are inspected every six month compared to NRC
( three year frequency; a spedfic licensee's low-level waste burial uites are inspected every 1
six months compared to NRC one year frequency for commercial disposal; and industrial calibration and reference sources are inspected every four years where NRC does not have an unique category for this group of licensees.
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In the questionnaire, BRC reported as of April 30,1997, only six core inspections were overdue by more than 25 percent of the State's established inspection frequency. These licensees were overdue from 12 to 31 months beyond the 25 percent of the BRC's established frequency. These licensees are located in two western regions that did not !
ht.ve inspectors assigned at the time of the review. Inspectors from other regions are I conducting inspections in these regions, workload permitting. Although BRC is hiring new inspectors to fill the existing vacancies, they expect to continue shifting inspectors to maintain inspection schedules in the western regions. The number of overdue core inspections is below the 10% evaluation criteria for satisfactory performance for this i indicator.
BRC indicated that approximately 291 new licenses had been issued during the review period. The BRC's questionnaire response reported that 11 inspections of new licensees l were overdue according to NRC's inspection frequency for new licensees. On review of ,
these 11 licensees with BRC, the review team noted that the number of overdue new '
inspections reported in the questionnaire was incorrect. Only three inspections of new ,
licensees are overdue. These licensees were overdue from 10 to 15 months beyond the l 25 percent of the BRC's established frequency. Considerable inspection effort is dedicated !
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Texas Draft Report Page 7
- to new license inspections. The team considered the overdues and noted that the three licenses overdue at the time of the review is acceptable when compared with the total i
number of new licenses issued. I The State reported in their response to the questionnaire that 115 licensees had submitted +
1,919 requests for reciprocity during the review period, of which 80 were from licensees ,
with inspection intervals of three years or less. The State reported that 74 reciprocity licenses were inspected, which excaeds the IMC 1220 guidance for conducting reciprocity inspections. In addition, the State conducted 122 additional non-reciprocity inspections of f
industrial radiography field sites.
The team evaluated the timeliness of inspection results issued to licensees. The team
! reviewed the results of 12 inspections. The typical procedure for issuing inspection results l is se follows: (1) the inspector prepares field notes to transmit the inspection results to the Austin office; (2) a transmittal letter containing the inspection findings is preparad in the Austin office; (3) senior staff review the letter and inspection report, and (4) BRC l
transmits the letter to the licensee after management review. Generally, the inspection ,
results are forwarded to the licensee within 30 days. Reviewers found that inspection files !
in Austin were generally well maintained with pertinent background infonnation on the inspections available in the file. All files clearly showed that management had reviewed s the inspection report and concurred with the inspector's findings.
l l BRC uses three iryterrelated data bases to help in the management of licensing, inspections and reciprocity activities. BRC can extract data on a State wide and regional basis.
Additionally, they can retrieve data on individual licensees, program codes or an individual inspector's activities. BRC quickly extracted information from the databases in response to i questions posed by the team.
l Based on the IMPEP evaluation criteria, the review team recommends that Texas' :
i performance with respect to the indicator, Status of Materials inspection Program, be l found satisfactory, j 3.2 Technical Staffino and Trainina Issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate these issues, the review team examined the Sta*.e's questionnaire responses relative to this indicator, interviewed selected BRC and TNRCC managers and staff, and considered any possible workload backlogs in both agencies.
The BRC organization chart shows that the Bureau has a total of 138 positions. BRC has an Administrative Office with 24 positions, the Division of Licensing, Registration and l
Standards with 38 positions, the Division of Compliance and inspection with 38 positions, and the Regional Health Department Offices (10) have a total of 38 positions for materials j and x-ray inspections. The BRC organization was revised in January 1996 to reflect a flat j matrix type of organization for the technical divisions which utilize the concept of Project Managers, and these Project Managers coordinate their work through the Deputy Directors j on a daily basis. Only two recent vacancies were reported in the materials area, one had
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Texas Draft Report Page 8 7 been replaced by the time of the review, and interviews were ongoing for the other position during the review. These resources were determined to be properly balanced between licensing, inspection, and incident response, and the vacancies at the time of review had not adversely impacted the performance of the program as discussed under Section 3.1. Three individuals within the Division of Licensing also perform the reviews of sealed sources and devices (SS&D). A discussion of SS&D personnel training is covered in Section 4.2.2.
The BRC has established qualifications for the Environmental Quality Specialist positions which includes the health physicists. Applicants are required to have a baccalaureate degree in a physical or (appropriate) life science. They are usually assigned basic responsibilities in the program until sufficient training and experience are obtained. They receive training in health physics, nuclear medicine uses, materials licensing, inspection procedures for radioactive materials or radiation producing devices, industrial radiography, welllogging, omergency response, environmental monitoring, and transportation.
! Increased training warrants their assignment to more complex responsibilities.
BRC trains individuals on a case-by-case basis factoring in the individual's basic experience and program needs and uses a data base for planning, scheduling and monitoring individual training. Personnel in the Licensing Division are assigned increasingly complex licensing case work under the direction uf senior staff. License reviewers also accompany l experienced inspectors during compliance inspections of complex licenses to gain field j experience and during pre-license inspections.
The inspection staff receives the same basic training as the licensing staff. Inspectors are required to demonstrate competence during accompaniments by the supervisor prior to being given permission to perform inspections independently. The BRC's inspector accompaniment process and the team's findings are discussed in Section 3.4. The review l team determined that all staff utilized for the BRC's program were technically qualified by
! evidence of their training and experience.
Some licensing backlogs have been experienced in the BRC's Licensing Section. BRC management related that this issue had been discussed internally, and that BRC was looking for ways in which to streamline the licensing process and be more efficient.
TNRCC also has some licensing and inspection backlogs in the uranium program which will be transferred to BRC effective July 21,1997. BRC managers have stready begun discussions internally and with the managers of TNRCC uranium program to assess the staffing and other resources needs to carry out the combined materials and uranium programs. Five FTEs will be transferred from TNRCC to BRC for maintenance of the uranium program, and TDH has agreed to add another three FTEs for the program.
The State continues to be committed to continued training as needed to allow the staff to ,
, carry out the duties and functions of the radiation control program. Training at NRC
[ sponsored courses was provided by NRC during the previous years, and the State
, attempted to have monies appropriated for their training needs by the recent State Legislature that meets every two years. However, the legislation did not pass, and the State is continuing to look for training options that will allow for continued training, and for
( training at NRC sponsored courses.
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a Texas Draft Report Page 9 Additional discussion of the TNRCC staffing and training for the low-level waste program and the current uranium program will be discussed under the respective non-common indicators.
Based on the IMPEP evaluation criteria, the review team recommends that Texas'
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performance with respect to the indicator, Technical Staffing and Tr:sining, be found !
satisfactory.
3.3 Technical Quality of Licensina Actions
. The review team examined completed licenses and casework for 29 license actions in 21 specific license files, representing the work of five license reviewers and three licensing assistants. The license reviewers and supervisors were interviewed when needed to !
supply additional information regarding licensing decisions or file contents.
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Licensing actions were reviewed for completeness; consistency; proper radioisotopes and quantities authorized; 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 reviewed for timeliness; adherence to good health physics practices; reference to appropriate regulations; documentation of safety evaluation reports; product certifications or other supporting documents; consideration of enforcement history on renewals; pre licensing visits; peer or supervisory review as indicated; and proper signature authorities. The files ,
l were checked for retention of necessary documents and supporting data. l The license casework was selected to provide a representative sample of licensing actions l which had been completed in the review period and to include work by all reviewers. The sampling included 26 of the State's maje licenses and included the following types: 1 medical broad scope, industrial radiography (temporary and fixed job sites); mobile nuclear l medicine; class B waste processor; pool irradiator; and nuclear pharmacy. Licensing actions evaluated included 6 new,1 renewal,18 amendments, and 4 terminations. A list of these licenses with case specific comments can be found in Appendix D.
In general, the review team found that the licensing actions were thorough, complete, consistent, of acceptable or higher quality, and with health and safety issues properly addressed. Three of the four specific exemptions and one denial for an exemption, identified by the State in the responses to the questionnaire, were evaluated for this review period. All of them had valid justifications for acceptance or denial of the exemptions.
Three of the exemptions were granted by amendment and the denial was finalized by letter. The licensee's compliance history appeared to be taken into account when
- reviewirg renewal applications as determined from documentation in the license files and/or discussions with the license reviewers.
7 The reyiew team found that terminated licensing actions were well documented, showing
! appropriate transfer records and survey records. The compliance branch conducts l confirmatory surveys as needed prior to the termination being issued. Once an interoffice
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l Texas Draft Report Page 10 memorandum documenting the property for unrestricted use is received, the termination is issued. Sometimes there are periods of a year or more from when a termination request is received before a license is terminated.
Previously, BRC licenses were renewed by letter every five years and the licenses were renewed in their entirety every ten years. In an effort to utilize their technical staff more efficiently, and to reduce the number of renewals, the renewal policy was revised in July 1996. The current policy is to renew all major licenses (in their entirety) on a seven l year frequency, and all other licenses are renewed on a ten year frequency.
BRC has lead a large backlog of renewel and amendment requests until last year. Each medical and industrial license reviewer has an average backlog of 54 licensing actions.
RRC has placed more emphasis on the completion of the actions and over the past two years has dropped the backleg by over half. The actions are handled by the following priorities: (1) new, (2) terminations, (3) amendments, and (4) renewals. These priorities l seem to be working; however, the review team suggests that amendments and renewals also be prioritized so that amendments which impact health and safety (i.e., new RSO because the previous one left the company; major proposed procedure changes which could effect radiation safety issues) are completed ahead of the amendments and renewals i
which are more routine (i.e., adding a source, or another user when ten sources or users are already on the license; renewal by letter).
l The licenses issued by the Medical and the Industrial Sections receive another concurrence review and are signed by the respective Project Manager in each Section. The Project Managers can sign their own !icenses, but the action does not requirc additional review i except for the waste processor type licenses, which are reviewed and signed by the Division Director. The team did not identify any significant performance problems with this policy.
l l The review teu n found that the current staff is well trained and experienced in specialized licensing activities (medical, industrial, special and advanced licensing). The casework was reviewed for adequacy end consistency with the NRC procedures. BRC has official, written administrative procedures for licensina reviews. The team found that BRC follows their licensing guides and administrative procedures during the review process to ensure that licensees submit the information necessary to support the license. The licensing guides were similar t'o the NRC guides.
The team also reviewed the TNRCC procedures used for licensing the inactive non-uranium i
burial sites that were transferred from TDH and the TNRCC program for decommissioning sites. TNRCC reported that four former burial sites had been licensed. These sites are no longer being used for burial of waste, and are under licenses issued by TNRCC for the l possession, storage, control, and environmental monitoring activities. TNRCC managers l related that these sites will be decommissioned, and that other sites will be identified
, and decommissioned in accordance with Agency procedures and regulations that became effective on June 6,1997. TNRCC plans are to implement this program in January 1998.
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! Based on the IMPEP evaluation criteria, the review team recommends that Texas' ,
j performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
l 3.4 Technical Quality of Insoections l The team reviewed inspection field notes and inspection records for 28 materials ,
l Inspections conducted during the review periud, reviewed revisions to the Texas enforcement policy, and interviewed inspectors. At least two reports prepared by each current regional inspector were ovaluated. Inspection casework records selected included l higher priority inspections of various facility types including hospitals, nuclear medicine l
facilities, academic broad scope institutions, research and development facilities, industrial
! radiography and gauge use, well-logging facilities, nuclear pharmacies, and pool irradiator.
Attachment E lists the inspection cases evaluated in depth with case-specific comments.
Prior to the review, two team members performed accompaniments of nine region-based l inspectors on separate inspections of high priorit'y facilities throughout the State.
I inspection procedures and techniques utilized by BRC compliance staff were reviewed and l determined to be generally consistent with the inspection guidance identified in NRC
! Inspection Manual Chapter 2800. The procedures were used to help inspectors identify root causes and poor licensee performance. Although field inspections were conducted, the revised inspection procedures do not direct temporary job sites to be inspected (per IMC 2800 guidance),
j Use of inspection forms (field notes) is determined by regional inspectors. Different revisions (some outdated) of the State's primary inspection report form were noted to be used in regional offices. Forms were reviewed and found to be inclusive documents providing generalinspection areas consistent with the types of information and data collected under IMC 2800 and 87100 documents. Except for an industrial radiography form, the State does not use separate supplements to the inspection report form for i various license types. During inspection preparation, the form is supplemented by the inspector with information specific to the type of inspection to be performed. Copies of revised inspection field notes contained in IMC 87100 appendices covering the areas of industrial /research development, well logging, industrial radiography, commercial irradiatot medical broad-scope, welllogging, and radiopharmacy were provided by the team to inspectors and Regional Health Physics Coordinators (RHPC) for use during inspections. To assist inspector preparation for inspections at different types of facilities, the review team suggests the State consider standardizing their primary and supplementary field note forms. These could be modeled after the NRC forms as discussed with BRC.
l The review team found the level of detail provided in inspection reports was consistent [
with respect to scope of licensed program, licensee organization, management structure, radiation protection program, personnel protection, area posting and labeling, worker i
training, radioactive material control, and material transfer and disposal. For quality assurance of reports the State has three designated RHPCs in the central office who are assigned for senior technical review, comment, and issuance of finalinspection reports and
- related enforcement acticas identified by regional inspectors.
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Field notes, inspection forms, and enforcement correspondence were found to be generally complete. Reports were evaluated for inspector documentation of operations observed, management and worker interviews, independent measurements, follow up to previous items of non-compliance, and discussion of inspection findings at exit interviews. Overall, the review team found inspection reports showed good technical quality. Reports contained a section which identified licensee personnel attending exit meetings but did not document a summary of inspection findings communicated to licensee management by
[ inspectors. The review team suggests documenting in reports summary discussions of l inspection findings with management at the conclusion of inspections. As noted in Appendix E, the team found reports contained only minor inconsistencies related to insufficient detail.
I Documented inspection findings led to prompt regulatory actions and appropriate enforcement. Review of the revised enforcement policy (May 1997) showed it included consideration for emergency orders, management conferences, enforcement conferences, licensee . requested hearings, monetary penalties, and civil and criminal penalties through l court proceedings, and source impoundment. Team interviews with enforcement staff and l review of cases involving escalated enforcement actions determined the State's enforcement policies were effective in achieving licensee compliance. Enforcement correspondence was timely for files reviewed by the team. Licensee responses to notices of violations were also timely and reviewed by central cffice RHPCs (technical reviewers) to ensure noncompliance issues were addressed. Information provided to the review team ,
indicated several types of enforcement actions taken during the review period including '
civil actions referred to the State Attorney General, administrative (monetary) penalties,
- ' license suspension and revocation, issue of emergency orders, enforcement conferences, and provisions for impoundment of radiation sources. In cases where inspection results l
indicated a need for escalated enforcemant action, enforcement conferences were held
! with licensees to discuss inspection findings and possible enforcement action against
! them.
The process for ensuring inspector feedback to licensing staff was not described, however the inspection reports are available to the licensing staff. As a regionalized function, inspection staff do not have the opportunity to provide inspection information affecting licensing directly to license reviewers in the cential office.- Inspectors discussed inspection findings with the RHPCs, who served as intermediaries between license and compliance staffs for information sharing.
At the time of the review, the State had 13 qualified field inspectors. Nine inspector accompaniments (six regional offices) were performed by two review team members. Two inspectors not accompanied were evaluated as acceptable in the previous NRC review and two inspectors were newly qualified, inspection accompaniments were conducted during the weeks of April 14, May 20, June 9, and June 23,1997 at the following types of facilities: nuclear pharmacy, hospital, industrial radiography, portable gauge, and well
, logging operation. Inspectors were well prepared and performed thorough inspections of
! licensee radiation safety programs. During the accompaniments inspectors generally i
showed sound inspection techniques, appropriate knowledge of the regulations, and demonstrated overall saticfactory technical performance. A summary of inspection J accompaniments is identified in Appendix E.
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l BRC's policy calls for annual supervisory accompaniments of all qualified inspectors be performed either by RHPCs or senior inspection staff. In response to the questionnaire, BRC provided a table of supervisory inspection accompaniments performed during the review period. The table shows 12 of 13 inspectors accompanied at least once since 1994. However, from information in the table and interviews with RHPCs, none of the 12 l inspectors identified in the table received an annual accompaniment each year for calendar years 1994 through 1997. RHPC reports of accompaniments indicated that inspector ,
performance evaluations were complete and thoroughly documented. Since regularly i scheduled supervisory accompaniments provide macagement with important insight into !
the quality of the inspection program, the review team recommends that the State adhere j to the policy of annual supervisory accompaniments of all qualified inspectors. l l
The team noted an adequate supply of portable radiation detection instruments for use during routine inspections were calibrated and maintained by central office staff. Each regional inspector is issued a ratemeter with GM (side window and pancake) and gamma l scintillation detectors, and a micro-R meter. Regional instrumertation is supplemented as l needed with e multichannel analyzer, alpha scintillation detector, low energy gamma j scintillation detector, and low volume air sampler. At the central office inspector i
counterpart . meetings held every six months, regional inspectors exchange assigned survey l meters for newly calibreted instrumentation. Sufficient equipment was also available for
!. emergency response activities.
! The team toured the State's instrument calibration facility and noted survey instruments l are calibrated with a collimated beam calibrator containing a cesium-137 source with i activity of approximately 100 mCl. This relatively low activity system limits the calibration f of some ion chamber instruments and some GM detectors on the high range (0 2 R/hr and higher). The review team recommends that all radiation detection instruments used for confirmatory surveys (field measurements) be calibrated on all ranges.
l A tour of the State laboratory found it to include liquid scintillation spectrometers, gas flow j l
proportional counters, and gamma spectrometers (multichannel analyzer) for full capability j f to analyze wipe, water, and soil samples for BRC activities. Impounded sources are !
maintained at the State's downhole storage area located near the State laboratory. From interviews with inspection and laboratory staff, laboratory processing time ranged from immediate to a few weeks and was acceptable for routine samples taken by inspectors.
Based on the tMPEP evaluation criteria, the review team recommends that Texas' performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.5 Resoonse to incidents and Alleaations 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 regarding l 1 this indicator, reviewed the incidents reported for Texas in the " Nuclear Material Events '
1 Database" (NMED) against those contained in the Texas files, and reviewed the casework and supporting documentation for 12 materialincidents and ten allegation files.
r 4
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- Texas Draft Report Page 14 it was noted that the State informally defines the terms " incident" and " complaint". NRC i does not have a definition for " complaints" but defines " incidents" and " allegations" in 2 Management Directive 5.6.
i The 12 incidents selected for review included one misadministration, one overexposure,
, one lost source, one potentially damaged source, two reported loss of control of
- radioactive material, and six equipment failures and are listed in Appendix F. Of the ten j allegations reviewed, NRC Region IV office referred six to the State and the other four
- came directly to the State from allegers, in addition, the review team interviewed the
- Director and Deputy Director, Division of Compliance and Inspection, and the Technical i Assistance Project and Complaint investigation Project leaders.
- Responsibility for initial response and follow-up actions to materialincidents and allegations rests with the Division of Compliance and Inspection. BRC procedures require on-site
- l. investigation for each significant incident and a timely response to allegations. The i j Technical Assistance Program Manager discusses each incoming incident or allegation with a
staff and the response is coordinated with the appropriate field staff. If necessary, field i staff and/or BRC staff conduct an on site inspection. Incidents and allegations that have
! the potential for: (1) media involvement, (2) violations being issued, or (3) significant 1
impact on public health and safety are brought to Director, Division of Compliance and inspection attention promptly. Allincidents and allegations are reviewed by management 1 on at least a quarterly basis. The State summarized incident information is provided on i printed copy to the OSP and to Idaho National Environmental Engineering Lab (INEEL) for entry into the NMED system.
l The subject areas discussed with staff included the State's incident and allegation process, i tracking system, file documentation, Open Records Act, and notification of incidents to !
I other Federal and State agencies. Notification to the NRC Emergency Operations Center is 1 4 made by the State for incidents that require immediate or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> reporting by the State i j licerisee. Although this notification requirement is understood by management, it is not !
} specified in writing.
I
- The review team found that with the exception of some equipment failure incidents, the
! Texas' responses generally were well within the performance criteria. Responses were prompt and well-coordinated, and the level of effort was commensurate with health and safety significance. Inspectors were dispatched for on site investigations when appropriate. In general, the State took suitable corrective and enforcement actions, notified the NRC, other States, and other agencies as appropriate, and followed the progress of the investigation through until close out. Incident casework reviews were verified as cross-referenced to the corresponding licerise file. The review team noted that the BRC closed four of the six incidents related to equipment failure without forwarding any information on the potential for a generic design defect to other appropriate agencies.
This issue was discussed with the Technical Assistance Program manager and his staff which recognized generic design defect prob l ems needing to be evaluated and forward to the agency responsible for the product evaluation and registration certificate. In one additional case, there was no information in the file that indicated the manufacturer of the device was informed by the licensee or the State. (See discussion and suggestion in Section 4.23.)
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? Texas Draft Report -
Page 15 i Allincidents and allegations are tracked by a numericalidentification system. Discussions with the Technical Assistance Program Manager indicated that modifications to NMED were completed in January 1997 by INEEL. These modifications will allow Texas multi-user capability and the ability to utilize the State's current numerical identification system.
j BRC plans to fully implement the NMED system by the end of 1997. The team discussed i the merits of the NMED system with the Technical Assistance Program Manager who i added that they also plan to use NMED for Technical Assistance Requests, Complaints, j and Close-outs. The review team suggests that the State initiate actions (through I implementation of the procedures provided in the March 1995 Handbook on Nuclear Material Event Reporting m the Agreement S+ates) to directly utilize the NMED system.
The review team also found good correlation of the State's response to the questionnaire, the incident information in the files, and the incident information reported on the NMED system printout for Texas, in most cases, the Texas numerical identification number was cross-referenced on the NMED report.
The team noted that two allegations referred to the State by RIV were categorized as
" Technical Assistance" by Texas. The other eight allegations (four of which were referred by RIV) were responded to promptly with appropriate investigations, follow-up, and close out actions. Complaints and technical assistance requests are dc :umented on the same BRC form and are therefore handled in a similar manner. The definition differences do not impact the quality of BRC's handling of allegations. Information about the allegation, including the identity of a alleger, is not protected under the State's Open Record Act once the file is closed. During the initial telephone contact, the al?ager is advised that their anonymity can not be guaranteed.
Based on the IMPEP evaluation criteria, the review team recommends that Texas' 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 Regulations, (2) Sealed Source and Device Evaluation Program, (3) Low Level Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The team reviewed each non-common performance indicator as they apply to the Texas program.
4.1 Leaislation and Reaulations 4.1.1 Leaislative ar@aal Authority The legal authority for the BRC is found in the Texas Radiation Control Act, Health and Safety Code, Chapter 401. BRC is designated as the State radiation control agency with authority to regulate byproduct materials, source materials, and special nuclear materials in quantities not sufficient to form a critical mass. TNRCC's legal authority for low-level waste activities is found in Chapter 401 and 402 of the same Act.
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The State provided copies of legislation that affects the radiation control program. On l June 20,1997, Texas' Governor signed legislation transferring responsibility for the uranium recovery program from the TNRCC to the BRC. Both agencies are participating in ongoing meetings concerning details of the program's transfer. Based upon discussions with staff, the management, and a review of the State's response to the questionnaire, the i review team confirmed that there are no legislative changes that would negatively affect t the regulation of agreement materials, the low-level waste program, or the uranium j recovery program. Except as noted below, the legislation is considered adequate to enable
- the State to protect public health and safety.
The team re-identified an open item from the 1994 review. The Texas Low Level
- Radioactive Waste Authority Act (TLLRWAA) defines low-level waste as
i
! " Low-level waste means any radioactive material that has a half-life of 35 years or less or that has less than 10 nanocuries per gram of transuranics and may include radioactive material not excluded by this subdivision with a half-life of more than 35 l years if special criteria are established by the agency for disposal of that waste.
- The term does not include irradiated reactor fuel and high-level radioactive waste as i
defined by Title 10, Code of Federal Regulations."
j Whereas, the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA) defines l low-level waste as:
l " Low-level radioactive waste means radioactive waste that--(A) is not high-level '
{ radioactive waste, spent nuclear fuel, or byproduct material (as defined in section l 11e(2) of the Atomic Energy Act of 1954 (42 U.S.C. 2014(e)(2)); and (B) the j i Nuclear Regulatory Commission, consistent with existing law and in accordance j
! with paragraph (A), classifies as low-level waste." '
Section 336.701(b)(3) authorization to dispose of transuranic radionuclides states the following:
1
! (b) A licensee authorized to dispose of radioactive waste under the rules in this j- subchapter shall not accept for disposal:
5
- (3) waste containing transuranic radionuclides in concentrations of 10 or t
more nanocuries per gram. This limit of 10 nanocuries per gram of i
transuranics shall not be equaled or exceeded in waste disposed of at a land disposal facility licensed under the rules in this subchapter, l notwithstanding the concentration limits for transuranics specified m 5336.362, Appendix E of this title (relating to Classification and Characteristics of Low-Level Radioactive Waste);
The NRC regulations in 10 CFR 61.55, " Waste Classification," limits the disposal of alpha emitting transuranics with a half life greater than five years to 100 nanocuries per gram,
' l I
Texas Draft Report Page 17 The team finds that the provisions of the Texas law and regulations cited are not ,
compatible with the provisions of the LLRWPAA and NRC's regulations. This
" jurisdictional gap" in the Texas legislation creates a situation where the State has not exercised its full authority to regulate low-level radioactive waste. This situation may create an orphan waste category for waste containing radiosctivity greater than 10 '
nanocuries and less than or equal to 100 nanocuries per gram. The current authority does not prevent this radioactive waste from being disposed of at a s!te located in another State. TNHCC cannot change the provisions in its regulations without an essential change in the provisions of the TLLRWDAA. The team found that the State attempted to change l the definition of low-level radioactive waste; however, the House Bill did not pass during
' the 1997 legislative session. TNRCC staff indicated that they will attempt to have the bill reintf oduced during the next legislative session (in 1999),
in entering into an Section 274b agreement with Texas, NRC has transferred its authority over certain materials and activities to the State. By maintaining this gap in its law, Texas )
has failed to exert authority over all matters covered by the Agreement. Currently, this gap in legal authority is a problem only in theory because the State has yet to license a low level radioactive waste disposal facility. However, it is the staff's understanding that ,
TNRCC may license the low-level radioactive waste disposal site as early as 1998.
Accordingly, the problems created by the " orphan waste" category may become a problem l in fact. At the last program review, NRC withheld a finding of competibility because the .
l Texar definition was not compatible with NRC's definition. The mport concluded that if the provisions are not corrected by the time of the licensing of the low-level waste facility in Texas, NRC will consider finding the Texas program incompatible with that of the NRC.
Consistent with this earlier review, the staff believes that the Texas program should be found not compatible with that of NRC if the gap in Texas law is not corrected by the time L the State issues its finallicensing decision, in addition, if the problem is not corrected by l the time the facildy beg ns to operata, it will be incumbent on NRC to consider appropriate action. Depending on the circumstances surrounding the disposition of the " orphan waste" at that time, such action may include suspension or termination of part of the Texas agreement pursuant to Section 274j of the Atomic Energy Act. However, the staff emphasizes that such a decision will depend on the facts as they exist at that time.
The staff recognizes that correction to the law will depend on actions by the Texas i
legislature and not TNRCC. However, the staff notes that it is the State's responsibility as a whole to maintain compatibility with NRC's program, not just TNRCC. As such, the review team recommends that TNRCC vigorously pursue the changes necessary to make l- Texas law (statutes and regulations) compatible with those of NRC in the low-level waste l area and, if necessary, raise this issue to higher levels in the State government. NRC will follow the State's progress in this area at subsequent annual meetings.
4.1.2 Status and Comoatibility of Reaulations l
- The Texas Regulations for Control of Radiation (TRCR), found in Chapter 401, apply to all
! lonizirig radiation, whether emitted from radionuclides or devices. BRC requires a license l for all radioactive materialincluding naturally occurring materials, such as radium, and I
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Texas Draft Report Page 18 accelerator produced radionuclides. BRC also requires a registration for all equipment designed to produce x-rays or other ionizing radiations.
The review team examined the procedures used in the State's regulatory process and found that TDH offers the public the opportunity to comment on proposed regulations and participate in public hearings following the comment period. Procedures also require the proposed regulations, proposed hearing date, hearing comments and ans!ysis be well publicized. Draft copies of the proposed regulations are provided to NRC during the rule development process. Final regulations are also placed on the TDH home page and the final regulations are submitted to NRC.
According to State law, when a rule is in the proposal phase of the adoption process, they may not propose additional changes to that rule until they adopt the initial rule. This fact and the time frames in the rulemaking process make it impossible to amend the TRCR with the same frequency that NRC amends its regulations.
The team evaluated TDH's and TNRCC's responses to the questionnaire and reviewed all regulations adopted by the State since 1993 to determine the status of the Texas l regulations. This review included regulations required by the State to maintain l
compatibility through December 1997. The team also reviewed several regulations that are in the rulemaking process as a matter of convenience.
The State adopted four NRC regulation amendments that became effective since the 1994 review:
e " Notification of incidents," 10 CFR Parts 20,30,31,34,39,40,70 amendments l
(56 FR 64980) which became effective on October 15,1991. The State's rules t>scame effective from September 1993 through October 1995. NRC has reviewed these rules and has found them to be compatible with NRC's regulations, e " Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 amendment (58 FR 7715) which became effective on July 1,1993. The State enacted TRCR Part 36 in June 1996. NRC has reviewed this rule and found it to be compatible with NRC's regulations. -
1 e " Definition of Land Disposal and Waste Site Quality Assurance Programs," 10 CFR I Part 61 amendment (58 FR 33886) which became effective on July 22,1993. The l State adopted this requirement on October 28,1996. Pending review by NRC's 1 Office of General Counsel (OGC), the team recommends that this amendment to l TRCR regulations be found compatible with NRC's requirement.
e "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (58 FR 68726 and 59 FR 1818) that became effective on 1
! January 28,1994. Note, this rule is designated as a Division 2 matter of i
, compatibility. Division 2 compatibility allows the Agreement State flexibility to )
! be more stringent (i.e., the State could choose not to adopt self-guarantee as a method of financial assurance). If a State chooses not to adopt this regulation, the !
- State's regulation, however, must contain provision for financial assurance that
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. 'l Texas Draft Report Page 19 includes at least a subset of those provided in NRC's regulations, e.g., prepayment, surety method (letter of credit or line of credit), insurance or other guarantee
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method (e.g., a parent company guarantee). BRC has proposed this requirement in the development of transportation rules. It is in the second draft stage of promulgation. Pending review by NRC's OGC, the team recommends that this amendment to TRCR regulations be found compatible with NRC's requirement.
The following rules were not due during the review period bot are in the TDH's rulemaking process: l l
e " Uranium Mill Tailings P.egulations: Conforming NRC Requirements to EPA Standards," 10 CFA. Part 40 amendment (59 FR 36026) that became effective on .
l July 1,1994. To assure continuous regulation of the uranium activities, the i legislation transferring responsibility from TNRCC to BRC included a provision to permit the BRC to use the existing TNRCC regulations. A first draft of TRCR Part 43, " Licensing of Uranium Recovery Facilities" was being prepared for rulemaking to formalize uranium recovery activity licensing under BRC's jurisdiction.
l . This rulemaking package is scheduled to be suhitted in July 1997. The team reviewed the draft. Pending review by NRC's OGC, the team recommends that this amendment to TRCR regulations be found compatible with NRC's requirement.
! Note, the TNRCC compatible regulations were adopted and became effective on i i June 6,1997, e " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995.
This requirement need not be in effect until November 24,1998. BRC has
- proposed this requirement in the develcpment of its transportation rules. It is in the i second draft stage of promulgation. The team reviewed the draft. Pending review l by NRC's OGC, the team recommends that this amendment to TRCR regulations be i found compatible with NRC's requirement.
1
[ * " Termination or Transfer of Licensed Activities: Record Keeping Requirements,"
l 10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on May 19, ;
I 1996. This requirement need not be in effect until May 19,1999. BRC has !
proposed this requirement in the development of its transportation rules. It is in the second draft stage of promulgation. The team reviewed the draft. Pending review l by NRC's OGC, the team recommends that this amendment to TRCR regulations be l found compatible with NRC's requirement.
The review team identified three regulations that have not been put into effect in the Texas program:
e " Decommissioning Record Keeping Documentation of Restricted Areas and Spill Sites," 10 CFR Parts 30 and 40 (58 FR 39628) that became effective on October l 25,1993. It is in the second draft stage of promulgation of TRCR Parts,11,21,
- 41, and 44. The rulemaking package is scheduled for adoption in December 1997.
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i Texas Draft Report Page 20 The team reviewed the draft regulation. Pending review by NRC's OGC, the team i recommends that this amendment to TRCR regulations be found compatible with l NRC's requirement. i e
- " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and
- 70 amendments (59 FR 36026) that became effective on August 15,1994. It is in '
the second draft stage of promulgation of TRCR Parts, 11, 21,41, and 44. This
- [
package is also scheduled for adoption in December 1997. The team reviewed the draft regulation. Pending review by HRC's OGC, the team recommends that this amendment to TRCR regulations be found compatible with NRC's requirement. ,
i l i e "Out.lity Management Program and Misadministration," 10 CFR Part 35 amendment ,
l (56 FR 34104) which became effective on January 27,1992. BRC has not adopted l the equivalent to the quality inanagement and misadministration rule. As reported
. to NRC previously, BRC withheld adoption of this rule pending the outcome of the 1
- National Academy of Sciences report. NRC is continuing to defer compatibility ,
! findings for Agreement States that have not yet adopted a compatible Quality l l Managemerit rule, until NRC issues a revised Part 35 rule, compatibility designations i for the new rule established, and an effective date for Agreement State implementation has been set.
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{ Due to the constraints imposed by State law, BRC carefully plans future regulatory actions.
! It is the intention of BRC management to address the following regulations as quickly as possible. At the time of the review the foilowing items are on the BRC's regulatory agenda:
e " Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32 and 35 amendments (59 FR 61767, 59 FR 65243,60 FR 322) that l'ocame effective on January 1,1995, e " Frequency of Medical Examinations for Use of Respiratory Protection Equipment,"
10 CFR Paa 20 amendments (60 FR 7900) that became effective on March 13, 1995. This rule it designated as a Division 2 matter of compatibllity. Division 2 compatibility milows the Agreement Stats the flexibility to implement more stringent requirements (i.e., the State could choose to continue c require annual medical examinationa).
e " Radiation Protection Requirements: Amended Definitions and Criteria,"
10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995, i
e " Compatibility with the international Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) thet became effective April 1,1996.
e " Low Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1,1998. Agreement States are expected to have an effective rule on the same date.
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e " Medical Administration of Radiation and Radioactive Materials," 10 CFR Part 20.35 ;
amendment (60 FR 48623) that became effective on October 20,1995. j 1 1 e " Termination or Transfer of Licensed Activities: Record Keeping Requirements," 10 f CFR Parts 30,40, and 70 amendments (61 FR 1109) that became effective January 1 16,1997. !
l
- e " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials;
] Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective
{
- January 9,1997.
- e " Recognition of Agreement State Licenses in Areas Under Exclusive Federal i
) Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment I (62 FR 1662) that became effective on January 13,1997.
- i' j e " Criteria for the Release of Individuals Adrninistered Radioactive Material," 10 CFR .
i Part 20.35 amendment (62 FR 4120) that became effective on January 29,1997. I j Based on the IMPEP evaluation c'riteria, the review team recommends that Texas's l performance with respect to the indicator, Legislation and Regulations, be found satisfactory, f
4.2 Sealed Source and Device Evaluation Proaram l' In evaluating the State's Sealed Source & Device (SS&D) Evaluation Program, the review
! team examined the information provided by the State relative to this indicator in their )
] response to the questionnaire, evaluated a sample of the actions completed since the last ;
j review, evaluated new procedures and guidance, and interviewed the TDH staff responsible for SS&D evaluations.
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l Since the last review, the State has developed template registration certificates and a !
- checklist to assist in the review of SS&Ds and help to ensure that all pertinent issues are l addressed. The staff has also adopted the use of the NRC's NUREG-1550, " Standard l Review Plan for Applications for Sealed Source and Device Evaluations and Registrations" l as standard reviewer guidance.
i h 4.2.1 Technical Quality of the Product Evaluation Proaram i
i i The review team evaluated 7 registration certificates out of the 16 registration certificates
}. reported for the period since the last review. The SS&D sheets issued by the State and l-evaluated by the review team are listed with case-specific comments in Appendix G. The review team suggests that the State consider these comments, and take action as the I State deems appropriate. For 6 of the 7 cases reviewed, the overall quality of the i evaluations was good, with minor comments that were addressed during interviews with I
the staff. However, for one case (TX-0246-D-103-S), the re/iew team identified a number j of inconsistencies and issues that appeared to be unaddressed in the review. Other i
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unidentified review issues associated with this case may also exist. The issues identified l
! by the review team are listed in Appendix G, and were discussed with both the initial and
! the concurrence reviewers.
l Based on the limited evaluation performed by the review team and considering the team's j experience with similar devices, the fact that the device must meet transportatien dose i rate requirements before shipment, the expected training level of the users, and the State's '
belief that there have been'no devices distributed, the review team believes that the i immediate health and safety risk to any potentially current users is low, possibly zero. i Nowever, the review team recommends that the State perform an evaluation to determine j the safety significance of the issues identified by the review team pertaining to registration i
- certificate number TX-0246-D-103-S and to identify any other issues that may exist, and ;
i re-evaluate the application, as necessary, to ensure that all pertinent safety and regulatory '
- issues are adequately addressed. It was not possible to determine from the limited number of files reviewed whether the deficiencies noted in this evaluation was an isolated i
- occurrence or if they may be present in other evaluations. Therefore, the review team i
- recommends that the State evaluate an adequate cample of additional safety evaluations to l
! ensure that the deficiencies identified in TX 0246-D 103-S are adequately addressed in the l l additional cases, and to demonstrete that this was an isolated occurrence.
Through interviews with the staff responsible for performing the safety evaluations, the
- review team identified that the concurrence review is currently being performed as a review of the initial reviewer's evaluation, and is not an independent technical review. The review team recommends that the State review the issue of independent technical i concurrence reviews for SS&D safety evaluations and implement procedures that require l an independent technical review for all future evaluations. The review team notes that an l independent technical review could have identified the issues involved in the case detailed
- in the previous paragraph.
4.2.2 Technical Staffino and Trainino BRC reported that a two-person team with combined staff efforts equaling approximately 0.6 FTE is dedicated to performing safety evaluations. The balance of staff time is spent primarily in licensing actions. Both staff members responsible for performing safety evaluations are trained in health physics principles, and have engineerir'g backgrounds.
Both staff members have attended at least one SS&D workshop. BRC has begun training additional staff in this area, although at the time of this IMPEP review, no registration certificates have been signed by these additional individuals.
BRC reported that 16 registration certificatu were issued or modified during the review
- period. The actions reported by BRC also included one action associated with Naturally Occurring or Accelerator-Produced Radioactive Materials (NARM). The review team noted that the initial review was performed by the same indiviciual for all but one of the 16 registrations certificates completed during tha review period. Since BRC has indicated that this primary initial reviewer plans to retire in the near future, the review team suggests that the State consider assigning safety evaluations to those staff members currently being
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- Texas Draft Report Page 23 l l
l trained to perform safety evaluations to enable them to gain enough experience and obtain I
registration certificate signature approval before the staff member currently performing the initial review retires.
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1 4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds The details regarding the review of incidents associated with SS&D product failures or ,
problems is addressed in Section 3.5 of this report. The State adequately addressed the immediate issues involved relating to product failures or problems, but the review team suggests that the State take a more aggressive approach to forwarding information to the i agency responsible for the product evaluation and registration certificate whero there is a
[ possibility that the failure or problem may be a generic issue. ;
!' Based on the IMPEP evaluation criteria, the review team recommends that Texas' performance with respect to the indicator, Sealed Source and Device Evaluation Program,
) be found satisfactory with recommendations for'improvemerit.
( l
! 4.3 Low-Level Radioactive Waste Discosal Proaram l 1
l The review team evaluated the State's responses to the questionnaire, compared Texas
- low-level radioactive waste (LLRW) statutes and regulations with those of the NRC, evaluated the qualifications of the technical staff and contractors, reviewed the State's i i written procedures and plans, examined parts of the LLRW disposal facility license 4
application and interrogatories, reviewed parts of the environmental and safety analysis i report, evaluated field reports and files, and interviewed staff, managers, and contractors assigned to the LLRW program. I
} In 1981, the Texas Legislature created TLLRWDA for the purpose of siting, developing, 1
- and operating a LLRW disposal facility. TDH was granted responsibility for licensing the '
facility. In March 1992, authority to regulate dispnsal of radioactive substances was l transferred from TDH to the Texas Water Commission. In September 1993, authority was ;
j shifted to TNRCC. Within TNRCC, the LLRW program is administered by the Underground j l Injection Control (UlC), Uranium, Radioactive Waste.(UURW) Saction within the Industrial l & Hazardous Waste Division.
! t
! TNRCC received an application to license a LLRW disposal facility from the TLLRWDA on i March 2,1992. The initial application contained very little specific information on the proposed Sierra Blanca site; therefore, the application was declared incomplete. After nine submittals (called revisions by TLLRWDA), the application was declared administratively l l complete on May 12,1995. After being declared complete, TNRCC was under statutory '
l requirements to complete their review of the application within 15 months; however, the i TNRCC committed to completing the review by April 1,1996, (that is, ahead of the 15-month requirement). Even after the application was declared administratively complete, further revisions were made based on interrogatories and meetings with TNRCC staff. The j final revision (i.e., no.17) is dated March 3,1996. TNRCC completed its review of the l
- applic'ation on March 29,1996, and a license has been developed.
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! Currently, the licensing matter is in an adjudicative hearing with the State Office of -
4 Administrative Hearings (SOAH). At the conclusion of the hearing, the SOAH will prepare
, a recommendation to the TNRCC Commissioners, who will then make the final decision on whether to issue the license. t
- During the last program review of Texas, as noted in Section 4.1.1, NRC raised a concern j with the compatibility between the State and NRC statutes and regulations on the l definition of LLRW. The review team found that this issue has not been resolved.
I j 4.3.1 Status of Low-Level Radioactive Waste Disoosal Inspection
! Under this part of the program indicator, the review team evaluated the State's ability and progress in doing periodic inspections of the LLRW disposal facility. TNRCC is planning to
! complete periodic inspections from the pre-operational phase through the post-closure j phase, to ensure that activities are being conducted in compliance with regulatory j requirements and consistent with good safety practices.
! The Texas LLRW disposal facility is in a pre licensing phase; therefore, this program l indicator is not applicable. However, the team notes that TNRCC has completed 14 pre-licensing site visits. Pre-operational (baseline) data have been collected on a quarterly
! basis for two years. Site visito have been made for the purpose of site familiarization, and j collecting environmental samples and background radiation data for independent verification of data submitted in the application. TNRCC staff indicated that there will be regular inspections of the site during construction; however, the frequencies of the f
inspections have not been determined.
I
- The team notes that baseline data have been compared against data collected by TLLRWDA. Some discrepancies have been found; however, there is no documentation on I
the nature of the discrepancy and how the discrepancy was resolved. The review team
! believes this documentation would support TNRCC licensing decisions during the hearing i process. The review team also notes that none of the baseline data have been put into a
} computer database. The review team suggests that the comparative results between i TNRCC and TLLRWDA baseline data, including discrepancies be documented. Further, the baseline data should be entered into a computer duabase to facilitate its review and use.
4 1 4.3.2 Technical Staffino and Trainino i
i The team notes that there are currently five technical staff members supporting the LLRW i program. All technical staff have bachelors' de0rees or above. The team also notes that the following disciplines are covered within the program: health physics, civil engineering, ;
chemical engineering, geology, and biology. Hydrology is currently not covered; however, l 4 temporary support can obtained from other sections within the Division (although the details on this have not been worked out). The hydrologist who worked on the license
- review is still with the TNRCC and is expected to provide support during the license hearing.
4
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Texas Draft Report Page 25 During the license review, additional staff supported the LLRW program, including i contractual support from the TDH and the University of Texas. This contractual support is - l l still being provided. In total, approximately 12 technical persons were involved with the I
, license review, with the following disciplines being covered: geology, hydrology, health l 3
phys ~ics, biology, geotechnical engineering, chemical engineenng, civil engineering, and l j mechanical engineering.
a
]
The level of staffing was sufficient to allow review of the application within the mandatory
- 15 months. The review was completed by the target date (i.e., April 1,1996); that is, l l several months ahead of the mandatory requirement. The team was informed that TNRCC
- staff had to work extra hours to meet the target date.
I TNRCC staff is allowed to pursue training as they see the need and as funds are available, i The availability of training has been identified as a program weakness by TNRCC. TNRCC
- would like more support from the NRC in the form of free or inexpensive technical training l i
because of limited available funds. In the LLRW area, TNRCC is especially interested in the 1 l availability of training in performance assessment. TNRCC maintains no compilation or j tracking of training completed by staff. Through review of staff resumes, the team notes -
that staff has undertaken additional on-site training, outside training, and participated in l workshops. The review team suggests that a consolidated training record be developed to enable assessment of training across the entire program. 1 l The team found no apparent trends in the loss of staff that could adversely affect the {
program.
l 4.3.3 Technical Quality of Licensina Actions I e i l
l The purpose of the review under this part of the program indicator is to ensure that the State has an acceptable program for licensing the LLRW disposal facility. To evaluate the i tectinical quality of the licensing program, the team reviewed technical aspects of the
- licensing action, in particular the performance assessment. The team evaluated parts of the Environmental and Safety Analysis report, parts of the license application, interrogatories, file records, and staff files. In addition, the team interviewed staff involved with the license review.
The team notes that the license review utilized licensing guides such as " Standard Review Plan for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility," NUREG-1200 and " Environmental Standard Review Plan for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility," NUREG 1300.
TNRCC has developed a safety analysis report; however, the report is difficult to use because of the need to refer to the application (i.e., the document is not self-contained).
Further, the basis for staff findings (i.e., acceptance of the licensee's analysis) is not provided throughout the document. The review team suggests that the basis for all staff findings be thoroughly documented in the event staff members are no longer available.
TNRCC sent out 31 different sets of interrogatories during the license review period.
TNRCC staff also had numerous meetings with TLLRWDA staff; issues and resolutions discussed at these meetings are documented in the file records. !
1 i.
I j Texas Draft Report Page 26 I Assessment of the quality of the license review primarily concentrated on the TNRCC's i review of the TLLRWDA's performance assessment. The performance assessment, which '
! analyzes the long-term, post closure doses from the site, is critical to the licensing
- decision. TNRCC reviewed the performance assessment by doing spot calculations to test .
! out individual models in the analysis. TNRCC also evaluated models and parameters used .
l in the analysis against the literature.
)'
TNRCC concludes that TLLRWDA performance assessment ana'ysis is conservative because it is largely dependent upon water infiltration into the disposal cells; however, the l
- site characterization data show little or no recharge at the site. Since the TLLRWDA .
analysis does consider the possibility of water getting into the facility, the performance {
- assessment analysis needs to be evaluated from the context that this is a credible scenario
{ (i.e., the performance assessment analysis needs to stand on its own merit). The team l j found that in several key areas, which could significantly affect the calculated doses, 4
TNRCC could conduct additional critical analyses in the following areas to ensure that the l
performance assessment will stand on its own merits:
- 1. TLLRWDA analyzed infiltration into the facility by running a modified version of the l HELP computer code. TNRCC staff reviewed the input, made confirmatory runs, !
{ and had the modifications to the code examined by the code developer. '
i 4
Sensitivity analyses performed by TLLRWDA show that a long-term average l increase in rainfall by 50% leads to a threefold increase in percolation; however, j such a long term increase is deemed to be unlikely because it would represent a
{ change in climate. No consideration was given to the sensitivity of the calculated j infiltration to evapotranspiration. It is commonly known that evapotranspiration 4
significantly effects recharge in arid areas. TNRCC relied solely upon TLLRWDA's sensitivity analysis which only addressed variation in precipitstion. Although the needed increase in precipitation may be unrealistic, it is possible that a small change
! in evapotranspiration, which could be credible, could have the same effect on j calculated infiltration.
6 l 2. In the source term analysis, TLLRWDA calculates releases of radionuclides from tha
- facility as a first-order process that is a function of percolation and partitioning j between the waste and the percolating water. The release model used is commonly i cited in the literature. TLLRWDA uses a factor (f) to relate releases from a surface
- j. wash-off type process to a diffusion process. TLLRWDA relates the tf factor to the I contact time factor (t,) in IMPACTS. Because of known concerns with the derivation and basis of the contact time factor in IMPACTS, TLLRWDA used a
- different approach to derive values for the ft factor. The DUST computer code, i which was developed under agreement with Brookhaven National Laboratory for the NRC, was used to calculate ft values by calculating radionuclide fluxes out of the
, disposal facility based on a diffusion process and back calculating a ft value to get 4
4 i
2
i
- Texas Draft Report Page 27
} an equivalent flux from using a surface wash-off model. Estimated ft values derived
- for use in the analysis are
- !
Tc-99 and 1129 0.05 i Cl-36 0.01 l' All other radionuclides 0.1 in discussions with TNRCC staff, the team learned that these values were considered acceptable because they were derived from use of the DUST code.
However, TNRCC did not review the input used in the DUST code or make any
- confirmatory runs, in fact, TNRCC did not have a copy of the input for the DUST F
code used by TLLRWDA. The team questioned TNRCC staff about the basis for the -
assumed concrete diffusion coefficient of 1x104 cm'/s; however, the staff was i
unsure. Given that the value for the f tfactor allows a 1-2 order of magnitude reduction in calculated doses, TNRCC should check the appropriateness of the ,
derived values through either independent' confirmatory analyses or review of the literature.
i' TNRCC staff should also review the literature cited by TLLRWDA in selecting
- distribution coefficients (K,) for the waste area (source area). TNRCC staff i reviewed distribution coefficients assumed for the soils, by comparing them against ;
i values in the literature. However, K,'s assumed for the waste area (K,") are several ;
orders of magnitude larger than for the soils for several key radionuclides (i.e., C-
!L 14,1-129, and Tc-99). Based on the approach used by TLLRWDA, K,'s for the soi!
should have little effect on the calculated dose. However, the K, for the waste l
i (K,") can greatly reduce the calculated dose. For example, the calculated ground-
- water concentration for C-14 (Class A waste) based on a K, value used by .
TLLRWDA in an earlier submittal when compared with the K, value for their last :
- submittal, results in a two-order of magnitude reduction, j 4
! 3. In the environmental transport analysis, TLLRWDA calculated concentration of l radionuclides at receptor points along the water pathway by using a series of l_ transfer functions that account for decay and. dilution. TNRCC staff indicated that i they had reviewed .these equations and made spot calculations to determine that ,
j they were appropriate and appropriately being used. Further, TNRCC staff indicated !
they had reviewed the parameter values used in the models against published l l information.
( ,
{ To avoid double accounting for potential impacts, TLLRWDA arbitrarily assumeri
{ that 75% of leachste leaving the facility would be available to return to the surface
! (i.e., f = 0.75) and the remaining 25% would be available to travel to the
- ground water (i.e., f, = 0.25). TNRCC steff questioned the basis for these [
factors, but accepted the use of them because they have a linear effect on I calculated doses; therefore, one can easily see that they have minimal effect on the
, calculated doses. For example, increasing the f value from 0.25 to 1.0, i j increases the calculated dose from 0.29 to 1.16 mram/ year, still well below the j dose limit. However, when these unsupported factors are considered in !
l combination with the f tfactor (discussed above), they allow a significant reduction i
i .
4 h , . , - . . ., -. ,
j Texas Draft Report Page 28
- in the calculated dose. For example, the f,,, factor combined with the ft factor !
allow three-orders of magnitude increase in the calculated ground-water dose from I exposure to Cl-36 (i.e., the calculated dose would go from 0.29 to 116 mrem / year without the use of these two factors). Although TNRCC staff correctly maintains that the f. and f,,, factors by themselves do not greatly affect the calculated doses, sensitivity analysis impacts of using these factors in combination with other {
i j factors or pararneters should be considered. '
1
! TLLRWDA, in determining the dilution volume for contaminants returning to the l
! surface, assumed a volume equal to the depth of the disposal unit (10.5 m for Class i A and 7.75 m for Class B/C) multiplied by the total surface area of the facility (i.e., l 1 the area of Class A and Class B/C combined); however, releases from Class A are l a:sumed to be initiated at 100 years, while releases for Class B/C are assumed to !
be initiated at 300 years. The surface area of the Class B/C units is only 1/4 that of ,
the Class A units; therefore, use of the combined surface area is likely accounting for additional dilution of leachate released from the Class B/C units. TNRCC staff recognized the potential problem with TLLRWDA's approach, but concluded, without analyses, that it would likely have little effect on calculated doses.
- 4. TLLRWDA design of the interior of the disposal units calls for the placement of gravel between the waste canisters to provide stability for the cover. However, the proposed placement of a layer of soil over the gravel and waste canister, could lead to moisture (if any gets into the facility) being channeled toward the waste, as opposed to away from the waste. The contrast in hydraulic properties between the gravel and soil has the potential of creating a capillary barrier, which would block water from moving down into the gravel. The potential for this occurring can be tested through modeling moisture movement within the facility.
The review team recommends that TNRCC staff examine these aspects of the license review. The review team also recommends that TNRCC ensure that a defensible review and documentation of the performance assessment has been made. Sensitivity analyses should be completed to ensure that key aspects of the performance assessment analysis have been reviewed. Further, since TNRCC is relying on limited (or no) percolation into the facility as part of the basis for the licensing decision, TNRCC should review its evaluation and confirmatory assessment of TLLRWDA's site characterization work, to ensure that a defensible basis exis'ts for the licensing decision.
4.3.4 Technical Quality of Insoections The intent of the review under this part of the program indicator is to evaluate the State in terms of the quality of its inspection of the LLRW facility. Because the LLRW facility is in a pre-licensing phase, this part of the program indicator is not applicable. However, the team notes that the TNRCC has completed 14 pre-licensing site visits. The site visits are thoroughly documented in terms of areas visited and features observed.
9 e
l Texas Draft Report Page 29 4.3.5 Resoonse to incidents and Alleoations Under this part of the program indicator, the State is evaluated in terms of its responr1 to incidents, alleged incidents, and other allegations of safety concerns. The team notes that
- there have been no reported incidents, alleged incidents, or allegations of safety concerns j with regards to the LLRW facility.
Based on the IMPEP evaluation criteria for the above five performance areas, the review
- ' team recommends that Texas performance with respect to the indicator, Low Level Radioactive Waste Disposal Program, be found satisfactory with recommendations for l improvement.
i j 4.4. Uranium Recoverv Reaulatory Prooram
- In the process of evaluating this performance indicator, the review team evaluated the
! State's responses to the questionnaire; reviewed information provided by the State l regarding the status of licenses, status of the various sites, site inspection history, financial
- assurances, status of regulations; reviewed selected licensing and inspection files; i evaluated the qualifications of the technical staff; and interviewed selected staff and j . managers working in the uranium recovery regulatory area.
i
! Jurisdiction over uranium recovery activities was transferred from the TDH to TNRCC in j September 1993, prior to the previous review. Since September 1993, TNRCC has been j responsible for regulating the uranium recovery program which includes underground injection control, and decommissioning of uranium sites. During the 1997 legislative session of the Texas legislature, the regulatory responsibility for the uranium program was
, transferred (returned) to the TDH. This transfer became effective on July 21,1997.
During the review, managers of TNRCC and TDH were in the process of working out the details of the transfer.
l l At the time of the review, Texas had 3 conventional milllicensees (3 sites) and 12 in situ '
i licenses (19 sites). All of the conventional milllicensed sites and all but 3 of the in situ !
. licensed sites are in various phases of closure. The active production facilities (in situ) are
! Vasquez.
4.4.1 Status of Uranium Rpsoverv Proaram Insoection
! The TNRCC program initially set the inspection priorities for mill sites at one year j frequencies to be consistent with the inspection frequencies called for in IMC 2800 and
. IMC 2801. However, due to other programmatic priorities such as the Low-Level Waste Program, development of regulations, and licensing backlogs, the program established i additional priorities for the uranium site inspections which were' based upon potential
{ health and safety issues, and environmental considerations. Program managers related
{ that in order to address health end safety issues while managing the inspection backlog, i emphasis is placed (in decreasing order) for response to incidents, the inspection of active
- operations and decommissioning activities, and finally to those sites that had been y decommissioned but still requiring regulatory monitoring and observations. At the time of i
l i
l
- Texas Draft Report Page 30 the review,12 sites were on a one year inspection frequency. For 10 sites, TNRCC has j established a two year frequency, however the justitication for the frequency change was not documented. The review team noted that the two year sites are not consistent with IMC 2800, and recommends that the criteria for assignment of inspection intervals greater
- than called for in IMC 2800 be evaluated, justified, and fully documented. ^
j i The State reponed that four licenses were overdue for inspection (overdue by more than l'
25% of the NRC frequency). A review of the tracking system and the inspection files confirmed this information and noted that the four overdue sites had inspection frequencies of one year. The staff reported that one overdue site was last inspected in October 1996, and the other overdues were last inspected in December of 1995. The review team recommends that an action plan be developed and implemented by TDH to overcome the inspection backlog in the uranium recovery program.
l At the time of the review, none of the operational production sites were due for inspection.
4 Therefore, in lieu of inspector accompaniments, the revienr accompanied the Section manager to the URI, Kingsville Dome facility for a visit to a production site. This visit was l, conducted on June 4,1997. TNRCC initially reported in the questionnaire that no annual l 1
supervisory accompaniments of inspectors had been performed; however, documentation was reviewed showing that the lead inspector was accompanied by the supervisor in i 1996. The other two inspectors work under the supe'rvision of the lead inspector during j team type inspections. The team considered the content of the report documenting the
. accompaniment, interviewed the supervisor and the inspector, and determined the l accompaniment to be satisfactory.
- Allinspection reports are reviewed and signed by the supervisor prior to issuance. Notice of violations were confirmed to be transmitted to the licenset within the 30 days limit established by administrative procedures. The program has a tracking system for ,
- management of inspection reports, issuance of notices of violation, and escalated l
1 enforcement actions.
4.4.2 Technical Staffino and Trainino The Manager (Registered Professional Engineer) of the UURW Section has the Section organized into three teams; the UIC Permitting Team, the Licensing Team, and the inspections and Compliance Team. The Licensing Team handles the uranium, LLRW and buried sites for specific licensees, and consists of a Team Leader and eight other professionals. The team is made up of two engineers (PE's), one Ph.D. biologist, four health physicists, two geologists, and one vacant hydrologist position. The Team Leader also has many years experience in the uranium industry.
The inspection and Compliance Team consists of a Team Leader and seven other professionals which includes two engineers (one PE), two geologists, and three health physicists. The Team Leader is also a geologist with several years experience. Two of the health physicists are stin in training and are being scheduled for NRC training as the space becomes available, s
f j m.
_- -.-.-.-.-- __ _~..._._ _.- -._---- .. - - .-
1 i Texas Draft Report Page 31 The review team examined the training, education, and experience of the staff members )
and found that the qualifications of the technical staff are commensurate with the expertise identified as necessary to regulate uranium recovery and 11e(2) byproduct i material.
('
Additional support is provided by the UIC Permitting Team and the Division staff in environmental surveillance , environmental monitoring, verification surveys, accounting and finance, systems analysis, legai staff, and sample analyzes on an as needed basis.
TDH Laboratory is under contract to provide sample analyses as needed, and was visited I f by the review team and found to be a state-of-the-art facility which participates in j
! laboratory inter-comparison programe. Additional details of the laboratory can be found in <
l Section 3.4.
l 4.4.3 Technical Quality of Licensino Actions
[ The evaluation of this area focused on a review of the licensing process and the evaluation i of health physics type issues. Three recent licensing actions were evaluated as a sample l of work performed by the Section's Licensing Team, and included licensing actions l performed by each of the three project managers on the Licensing Team. This casework is j l identified as: (1) Chevron Resources, Panna Maria Project, (LN RW2602), which is a conventional mill tailings pond under reclamation / closure; (2) Everest Exploration, Inc.,
Hobson (RW 3626-000), McBryde (RW 3626-001), Tex-1 (RW 3626-003), and Mt.Lucas (RW 3626-005) sites, which are in situ sites that are all under restoration / reclamation; and (3) Uranium Resources, Inc., Kingsville Dome (RW 3653-000), Rosita (RW 3653-001), and the Vasquez (RW 3653-002) sites.
l The detailed licensing process includes a tracking system covering the administrative and technical review of all applications. Each phase and step of the pro.:ess were found to have documentation relative to the issues under review, and reuewed and concurred upon by the appropriate technical disciplines and representatives of the licensing team, the inspection / compliance team, and management. The review team noted that the team approach is e'ffective in getting peer review and the necessary expertise applied to the l specific review.
In examining the license and selected background information in the file, the review team found that the licenses included appropriate license conditions for the reclamation / closure operations at the facility. Detailed procedures have been tied down by license conditions.
l 4.4.4 Technical Quality of Inspections l The review team examined the compliance summaries prepared for each licensee identified under the above Section (4.4.3), and the latest inspection report and enforcement action prepared for the licenses. The documentation for these activities show that inspections and audits adequately covered the scope, completeness, and technical accuracy necessary to deteimine compliance with regulations, license conditions, and available guidance. The l_
d i
(
l l
4 V-i.
Texas Draft Report Page 32 l , reports were narrative type reports with good detail, and with well documented and referenced violations as appropriate. Appropriate enforcement actions were taken given
- the scope of the violations noted.
l The inspection reports and enforcement actions are also tracked in the system, and the
! reports receive appropriate review and concurrence by other members of the inspection
! team, the licensing team, and managers. Any enforcement actions going beyond a notice I
of violation must also be reviewed by the Legal Section and be signed by the Commission.
l j 4.4.5 Response to Incidents and Alleaations
]
l The State reported seven incidents (four sites listed in TNRCC's questionnaire response) but there were no allegations pertaining to the uranium recovery activities. The incidents were addressed in a timely manner and the documentation was complete and timely. The
, evaluations and actions taken by the States were determined to be satisfactory. The l ,
docume,ntation was located in the license file and the lead inspector's incident file.
i TNRCC has one staff person who has received training under the NMED system and the l Section has received the software for implementation. TNRCC summarized incident i
! information is provided on printed copy to the OSP and to INEEL for entry into the NMED system.
Based on the IMPEP evaluation criteria for the above five performance areas, the review team recommends that Texas' performance with respect to the indicator, Uranium 1 Recovery Program, be found satisfactory with recommendations for improvement. )
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found the State's performance with respect to each of the common performance indicators and the non-common indicator, Legislation and Regulations to be satisfactory. The review team found the State's performance with respect to the Sealed Source and Device Evaluation Program, Low-Level Radioactive Waste Disposal Program and the Uranium Recovery Program to be satisfactory with recommendations for improvement. Accordingly, the review team recommends that l the MRB find the Texas program to be adequate to protect public health and safety and compatible with NRC's program.
Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report, for consideration by the State.
- 1. The review team suggests that amendments and renewals be prioritized so that amendments which impact health and safety (i.e., new RSO because the previous one left the company; major proposed procedure changes which could effect radiation safety issues) are completed ahead of the amendments and renewals which are more routine (i.e., adding a source, or another user when ten sources or users are already on the license; renewal by letter). (Section 3.3)
F.
Texas Draft Report Page 34 l
l 12. The review team suggests that the State consider assigning safety evaluations l
to those staff members currently being trained to perform SS&D safety evaluations to enable them to gain enough experience and obtain registration certificate signature approval before the staff member currently performing the initial review retires. (Section 4.2.2)
- 13. The review team suggests that the State take a more aggressive approach to forwarding information to the agency responsible for the product evaluation and registration certificate where there is a possibility that the failure or problem may be a generic issue. (Section 4.2.3) i
- 14. The review team suggests that the comparative results between TNRCC and TLLRWDA baseline data, including discrepancies be documented. Further, the l baseline data should be entered into a computer database to facilitate its review and use. (Section 4.3.1) .
l 15. The review team suggests that a consolidated training record be developed to l enable assessment of training across the entire program. (Section 4.3.2) l l 16. The review team suggests that the basis for all staff findings be thoroughly l l
documented in the event staff members are no longer available. (Section 4.3.3)
- 17. The review team recommends that TNRCC staff examine the aspects of the license review as documented in Section 4.3.3. The team also recommends that TNRCC ensure that a defenCole review and documentation of the performance assessment has been made. (Section 4.3.3)
- 18. The review team noted that the 2 year sites are not consistent with IMC 2800, and recommends that the criteria for assignment of inspection intervals greater than l called for in IMC 2800 be evaluated, justified and fully documented. (Section 4.4.1) l 19. The review team recommends that an action plan be developed and implemented by TDH to overcome the inspection backlog in the uranium recovery program. (Section 4.4.1) i 4
i t
I . ,
IO i
LIST OF APPENDICES l
Appendix A IMPEP Review Team Members Appendix B Texas Organization Charts i
Appendix C Texas' Questionnaire Response l
Appendix D License File Reviews Appendix E Inspection File Reviews l Appendix F Incident File Reviews Appendix G Sealed Source end Device Evaluation Reviews l
l Attachment 1 Texas' Response to Review' Findings ;
1 1
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I l
l APPENDIX A l lMPEP REVIEW TEAM MEMBF.RS l
l Name Area of Responsibility
(
Richard L. Woodruff, Ril Team Leader Technical Staffing and Training l Uranium Recovery Program l
l . Michelle Burgess, NMSS Sealed Source and Device Evaluation Program l
Elizabeth Drinnon, GA Technical Quality of Licensing Actions Craig Gordon, R1 Technical Quality of Inspections James Myers, OSP Status of Matuials inspection Program l Legislation and Regulations Thomas O'Brien, OSP Response to incide.nts and Allegations Mark Thaggard, NMSS Low-Level Radioactive Waste Disposal Program l
l l
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I APPENDIX B ORGANIZATIONAL CHARTS l
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TNRCC INDUSTRIAL & HAZARDOUS WASTE DIVISION ORGANIZATION CHART Minor Hibbs, Director Wasic Evalussaca Secison Pennus haan Correctiw Acuan h-G ace "- . y-Faullumer, Manager John Clegg, PE Paul Lewis, Manager Manascr hy-: -f Tech =ical Pa===hwa Secuan lajection Conkel (UlC), Uransvan, and Raduative Wasic haaa Sia (6) Spcciaticia the arcas oh accounting & finance, computer services, engiacena;. geology, statistical analysis, syssens analysis, and Alice Rogers Manager traiaing
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l UIC, Uranium, & Radioactive Waste Section Alice Reects P.E., Manager i Jannes Givens. rwh Adsninsuraser
- Lasegenia r.=.a., ah masiveT%
j Jacyclyn Bsown, Adannanstative Secsciary I
4 1
- UIC Perumatine Teamq Ikemmine Teman Jannections and Camamilance
! Claes I & !!! Uraneusa and low-level wasse and h
- Ben Knape(TeamsImader) . huried siscs Cass I. Ill, and uraneusa
! Vacant EngineennsSpecialist George FuzGerald (Tcans leadst) Daic KoWerileader) j Fsed DialTy,e ,','M -
Mary Parker, Biologist. Diaries Gsee.. .Geologna j , Kashyra Herzog. P.E. C. D. Rao P.E., Senior Engineer Hong - Yuan Guo. P.E.
- Lary Walker,C% Devane Clarke Heaish Physicist Mike Mislua. Engineer i John Sanies,Geologna Viciar Whamd, Healih Physicist Bob Vendran,Gadogma l Vacant,Geo#Eng John Winiasmson, Geologist Erick Conant. Hemish Physicist 4 Sseve Esect. Geologist Muhanuand Zase A.K., Hemish j Will McCabe, Heahh Physicist Physicist
, Jisa Shroff. P.E., Engineer Panda Gonamisa,Heelsh Physicist
] Vacant H, f ' ,, -
- Kashy Vail Hemish Physicist i
- i 5 4
June 18,1997 .
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As Brdg5(ed :Centrol
- June 1997 Bureau Office
! a can chier- 001 1 .
(Richard A.Rallifr.P.E) i EQS VI-002 j (Margaret S. Ilenderson) i Aam.i=imasive Technician H -050
) (Deris F.necConneck) i
- ' Bureau Administrative 4
Office
(
3 i ChiefofStafIServices-003 l* (Robert C. Ihde)
Nesumerk neanagerII-006 (Cheryl h) j Symans Support Speciaiin H -030
- (Raiph C. i% iH) i were Processoas o peraior Hi- 054 -
(Juanan Mohna)
- i. l
) Public information Records and Admin.istrative Mam. tenance -
" *8""
) Training Program Program j infenneren tr== ale lit -005 hensive Technician IV - 019 ChierAccommaant li-004 (Marilyn F. Keleo) (Christine T. Peters) (Kasca S. Pusdy) i Infonnasir.s Speciniast !!- Oil Adnuaisstative T ch==== II - 052 i A-and til-087 (wh= A. Davis) (Banda L Simion) (Liada a.voisk)
Snair ices unt l Macrerihn Caniera operseer it - 055 (Clydene Gege) { '
Accounsant H -020 Clest til-063 (Mary June Sanders) 1 (Lidia Saeveneen) Purchaser H -028
- Clerk til- 067 )'
(Eddy Cantu) W(Mary A. T
- asive HI-022 Clerk III-069 (S8538J SPears)
(Vacana) -
Wwe Th= Ill- 023 Hourly Scamenal Werker-999 (Tand L Manwell)
) (Sarah J.Hansen) ?=- ' ; ClerkIll-039 (Oscar D.Easierly)
Clerk til-068 (Reashe M. Lasser) .
i . . E'Is- severename. sal genney As seestawanbers are evenehae se he preises i________--________________'.-.-___---____-_________ .- ___
S 7"'d -__m----- __-_ __ -__ __ __ __. ___ leaders W~Ca saum members _ . __ _ _ ___
1 As Budgeted Divi:Irn cf Lic:n2ing, Ju=.1997 Registration and Standards ,
Director (Exempt)-001 l
! (Ruth E. McBurney, C.H.P.)
i N h====s or=== "I-las j (Tracie G. Miller)
\ g g A_m > - -- ' -
I"---'-- gggf Project EQS VI- 009 -
EQS VI-041 EOS V -C13 EQS VI-015
'I (Peter H. Myers) -
(Lanetts W. Moon) ICatherine M. Fontainel Deputy Director, Registration EQSV 048 8 6 HeahhT d IV-130
( ***d) pody L Misce)
EQS VI-040 .
(Deborath L Borden) ( y Ray Jisha) g,'r- 1 Radiological HeshhTech. N- 184 werd Processing opermeer II-227 I (Stephen E. Andenos) pena C.Maidenado)
EQS V - 044 posephne s.Tute"*) -
Industrial Radiographer
' SPecialLicsesing Projects Carth1 cation and Legal (iU. uheernes) ' - "
- Radioingscal HeahhTech. II- 185 -
EGS VI-008 EOS V
- 054 (Philip E. Shaver) EOS V-842 ;
IRebecca L Humeer) (Kaye J. Goss-Terry) g went n-- ' .Operamor u -228 , , ,
l g g (Sharon H. Ihyle) word ProcesmasopawII-248 8 IV - 0s4 (Rchecca R. James) (sanadees a saca) ,
werdPmcasmasoperuser :-260 (Eria L Harwy) Went Psocesmag Operatorill- 187 .
Wad Pr H -262 (Dahm A. Hasdy)
(Geneva Hourly h=1 - 999 '
(Sheney M.Guehrie) Advanced Technology Licensing Industrial X-Ray and Project Nonionizing Registradon Project Deputy Director, Standards ._
EQS VI- 010 EQS V -045 and Special Projects
"'~~
(Floyd R. Hasniter) (Barbara J. Taylor)
EQS VI- 012 (Cynthia C.Cardwell)
Industrial Licensing .
EQS V -05: -"~
Project (Sonia 1.sinumens) EQS VI-011 - -
EQS IV - 099 IDavid B. Fonien (Meneca P.d'"=) . .
Radiological Henkh Tech. V -100 (Reads A. Sanders) EQS V-en .
Word ProcessingopenserIM-IM (wasianiP.Senegrenow) _ -
(Elw Ramwea) EQS IV-Os2 (vecami)
Adhai P=di=% Risk a=======*
<a ,gSn=h.Pho.>
vi - 0*
m'imrasiwTM-I-243
,,m., _
,ee,,,el , . ,d, . - E.. r 8 -, S.
o ,re tis w..r..
- r. .r ei.
t temas ane ors n - - , - ,
As liudgeted thV5SION OF COMPLIANCE AND INSPECTION j g Director (Exesupt)-001 (Arthur C. Tate)
StafIServices OfHccrI- 083 AdmunistrativeTccit 111 -090 (Kailey Alyssa Baracts) (Elizabeth M. Rockett) p
- EQS VI- 054 i Deputy Director, Radioactive (Robin A.Cooksey)
RAM Enforcement Project X-Ray Area 2 Cosapliance Project Materialinspection and l EQS VI- 011 EQS V -059 i
Enforcernent -
EQS VI-050 (WINians A.SNwa)
(Eric M.Sisotak) Cosnanche Peak Emergency
, (John R. Haygood, LM.P.) - wesd ProcesungOpusaaer II- 174 _
Response Project
> EOS VI- 016 (Rick L Wass)
! AdnumiserativeTech.111 - 100 (Joseph F.Thiel)
] .
(vacana) X-Ray Enforcesnent, Project
- Word OperaserIll- 125 EQS VI- 019 (sh .rarris)
EQS v-05s 4
(Quincy M.Wicksen) South Texas Project j Word Procesmas Operaser M- 125 (JacqueNne P. Carter)
Emergency Response Project j (sharon L Deviller) _
wad re ces==sOpermer H -IM EQS VI-021
__ y (Theresa A. Calloway) (John E.Rawiston) j o ,,,, oi,,,,,,,,,,g g, y.,g -
RAM Area A Cosnpliance Project EQS VI-014 EQS VI- 051 Masnrnography Project EQS V - 065 Panten Emergency Response
- (Robert E. Free) Project (Richard Moreland) -
word operaer m- 123 EOS vt - 020 i
I ' W88d ProcesmasOperaserill- 124 (Gary L Fs-: - :::-?, -
f Deputy Director, X-Ray and -
- EQS (Pauisis A.Mooses) q g,,,,,ggo, ,,g (Michael L Dunn) j -
Environmental SurveNiance Pantex Coop Agreement '
Enforcement Project SpecialProject
! EQS VI- 010 _
EOS VI-017 Special Project Director- 005 RAM Area C G: ,"--.:5 Project ~
- (Thosnas C. CardweN) (Charles R. Meyer, C.H.P.) (Joseph A.Martulotti) i
- EQS VI- 055 l wadr.e- ;Opassarm-su (Katy Knebes) -
- (ocorsi.v.see-a i) snsiv-075 F' " '" " ""I Technical Assistance Project FDA s.evel u inspection X-Ray Area 1 Csis, "w.i;c l
4 Project Project EQSIV -074 - EQS VI-018
~
~ (Carol Aan W) (Bradley W.Caskey)
! EQS V - 061 EQS V- 057 (W. Karan Rainesi (June R. Ayers) IncidentInvestigation Project l
j
- EQS VI-052 02 T- I I"'*883 98838" w oed 7 - ; Operaser it - 152 (Helen D.Watkins) Project i
! MQSA Project (Haasi C. McGuare) _
EQS VI-012 EQS V- 064 WIPP Emergency Response j (Oscar Lessard)
(Jack E. England) _
Project .
EQS VI-013 (James H. Ogden, Jr.)
AM Sisifineenir.ra are avaMable se
- - EQS-Eavirensnestalquality be project keders and/or project
- tansm enessbers
- _-_____________M______Md_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
i l
i i
l As Bandgeted Division cf Compliance cnd j Jaime 1997 .
Inspecuon .
I i'
RadioacGVe RSatodalinspection and X Ray, Nonionizing ' ;- r" r and Esnergency Response and Enforcessent Branch Enforcensent Branch investigauon Branch l
1 incidentinvesugauon RegionalhW Prograsa Regionalinspection Prograse Prograsa l
! Region 1 -20777 Remian 1 -20m Esnergency Response
- * $a o.44 n Pz) *** $ * " m Reason 3- TY7I .) Piarining Prograni i
Reaion2-nm -
EQS V .0li EQ.V ele R.Myesq EQS 4 82
< (Chastes Claseus,PA)
' *=3a= 3 -2T777 ggs{%j,Kash) l
, EQ5 VI.002 ire EQSlv.yce C.W (medmick P.Wnght) 077 .
l
' eQsv-os2 @{p-enN. Maupm)
(Randy R. Esisksen) .
sehensen) .
l Region 4-2V777 EQSV-ep3"""I 1 \'
sos vs.one EQsNesi Ps
- SGshesiC Vaudenhusg) Zashch)
Reaion 5 -2S777 (Teacy D.semesen)
Rerion 4 -2V777
- EQ5 V.01I (Huben W.Dushans) EQS IV - 050.
j -
Reason 6 -2S777 s EQsVi.eie RemionD..N7 ggs av. a -
d tensidismide Eqs v.ese Rerion -
EQS V 082 (Cahanns E.51sdgs)
- EQS V.
. sQsv.ess 1 (Elembd Feta) -
EQS!p.,, ,, m m aQsy og l EQ5 IV- 103 Realen 7-2P777 (tr. Anasadens-Tasin) j EQS ags vs.sio Adm.j tomenesW.Desman) .s==ieve Tsche cian 3. see Reaion 8-2U777 (Glosis Haecuman)
Rea.son 7 -
4 EQs M . ele gns v.,2,P777 3
gaaenVW L Musen) '
805 -N Raaion 9-2R777 (vacens) j eQsw.m Reason 8 -2U777 . *
(Genest Ayess)
EQ5 V.05e Reaion I1 -2W777 {v )
sos w .... EQs iv. ie.
(8sviu D.Chadeq pehmy M.tanssyj j EQstranses IV-les t nasy) '
Region le- 2K777 8-ian iI -2W777 AM StaK W are available se he Eqs. EnW.a Quality prejest leaders anh prejest tesan EQsIV-ele l _g EQs IV.ese
~. _ _ _ . _ .
. _ . . _ _ .. 1 .._.. _speringgg_ _ _ _ _ _ .
ts in gy m
?
a 4
i e
1 i 5
4 4
APPENDIX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE - RESPONSE I l
i a
b
~.
- . \
i- l
! INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM ~
I l QUESTIONNAIRE AND RESPONSES !
i .
Bureau of Radiation Control (BRC) l Texas Department of Health (TDH) I
, ' May 1997 !
- I (Reporting Period
- March 12,1994 to April 30,1997) j A. COMMON PERFORMANCE INDICA'IORS i
I. Status of Materials Inspection ProFrarn
- 1. Please prepare a table identifying the licenses with inspections that are I
- overdue by more than 25% of the scheduled frequency set out in NRC j- Inspection Manual Chapter 2800 (issued 4/17/95). The list should include
- initial inspections that are overdue ~.'
i i For a list of specific overdue inspections, see Appendix 1. -
l
SUMMARY
OF OVERDUE INSPECTIONS BY NRC INTERVAL
! REPORT DATE: 05/08/1997 Interval Number Overdue (>25%) New IJcenses Overdue l [As of: 04/30/1997) (Not inspected w/l 6 mos) l 1
! 1 6 0 i
i 2 0 0 3 0 4 i 4 0.00 1
! 5 0 6 TOTAL 6 11 I
i 3
- 2. Do you currently have an action plan for completing overdue inspections?
l If so, please describe the plan or provide a written copy with your a
response to this questionnaire.
i
)
i e i j . l
i l i
{~.
I A.I.2. (Continued) i
- Each Regional Health Physics Coordinator (formerly technical
! reviewer) has provided a list of inspections (overdue by NRC criteria)
- to their suspective regions for confirmation of status and to expedite
! inspections. 'Ibe inspector position for two regions (PER 9/10) is
- currently vacant. Central omce staff wiu continue to schedule both
, central omce and regional staff to perform inspections in the two regions to prevent the development of a large backlog. l 1
- 3. Please identify individuallicensees or groups oflicensees the State / Region
- is iaWing less frequently than called for in NRC Inspection Manual i Chapter 2800 (issued 4/17/95) and state the reason for the change.
i NRC NRC Insp. BRC BRC
! Use Description Int. Insp. Description i Code (Yrs.) Int.
Could not Other Services. 4.0 Industrial:
determine teletherapy, irradiator Calibration equivalent and gauge services and reference NRC sources program code Other Services- 4.0 Industrial:
teletherapy, irradiator Other and gauge services licensed source
- 4. How many licensees filed reciprocity notices in the reporting period?
115 licensees fHed 1919 reciprocity notices in the reporting period, March 12,1994 through AprH 30,1997.
i 2
O
i.
- A.I.4. (Continued) j i
- a. Of these, how many were industrial radiography, well logging or
! other users with inspection frequencies of three years or less?
l 80 licensees with an inspection frequency of 3 years or less (use
- codes 006,028,051,053,072,094) filed 1493 notices in the j reporting period. ,
1 l b. For those identified in 4a, how many reciprocity iaWons were i conducted?
74 inspections were conducted. Additionally,19 inspections
! were attempted. j i i
! Reciprocity Notices and Inspections j
., ...x m =.m . .
3 I i
. ':d- .Use C,5de%,...
9:..
.'.'=..,
. *.m. VM,:. ,...
ofw ~.
M ,3 ~~ # #. ... T. W, . .<
a d, . .., %,# o.f;fsg:..
.e i S% iucenseesi dNoticssi - filnspecti6ns?ef 1
l 006 demonstration &
sales 6 66 1 l
1 i
4 028 l industrial radiography 17 507 32 l
! 051,053 l tracer, well
! logging 9 126 0 l 072 installation, l
- repair, &
- 31 727 27 4 Inaintenance i 094 3 decontamination 17 67 14 i
Total 80 1493 74 i -
1 i 3
{
I r -w -
. .~ ..- - . - - - . - . - - - - - . . . . . = . . . - - . . - . - . - _ . - - -
i l.
i 5. Other than reciprocity licensees, how many field inspections of
, radiographers were performed?
l For other than reciprocity,178 field inspections of radiographic
- licensed operations were conducted during the rwiew time period.
i
- 6. For NRC Regions, did you establish numerical goals for the number of inspections to be perfonned during this review period? If so, please describe your goals, the number of laWons actually performed, and the j reasons for any differences between the goals and the actual number of
- inspections performed.
! N/A k II. Terknient Staffine and Trainine
- , 7.' Please provide a staffmg plan, or complete a listing using the suggested
- format below, of the professional (technical) person-years of effort applied i to the agreement or radioactive material program,,by individual. Include i the name, position, and, for Agteement States, th6 fraction of time spent
- in the following areas
- administratiob, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory
- responsibilities are dividad between offices, the table should be j 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 i to carry out the program's radioactive materials responsibilities, include i
! their efforts. The table heading should be: '
i NAME POSITION AREA OF EFFORT i
! See Appendix 2.
i
)
a 1
k r 4 i
)
/ / ,,
A
l f 8. Please pmvide a listing of all new professional personnel hired since the i last review, indicate the degree (s) they received, if applicable, and i additional training and years of experience in health physics, or other l disciplines,if appropriate.
- Bernadette Baca, Elizabeth A. Foltz, Oscar Iassard, Peter H. Myers, i j John E. Rawlston, Catherine E. Sledge, Arthur C. Tate. l 4 l 1
j Also see Appendix 3.
i 9. Please list all professional staff who have not yet met the qualification I
} requirements of license myiewer/ materials kWon staff (for NRC,
- Inspection Manual Chapters 1245 and 1246; for Agmement States, please i describe your qualifications requirements for matedals license myiewen !
! and inspectors). For each, ' list the courses or equivalent j training / experience they need to attend and a tentative schedule for
- completion of these requirements. i
- i
! Inspectors Foltz and Sledge are new employees a,nd have not mceived j the qualification requirements of license nylewer/ materials inspection i staff. De BRC is attempting to have the new inspectors attend NRC l specialty classes and is in the process of paparing its own training l schedule.
l Also see Appendix 4.
l
{ 10. Please identify the technical staff who left the RCP/ Regional DNMS program dudng this period.
I i LOSS OF TECHNICAL STAFF FROM THE BRC
! FOR THE PERIOD OF 03-12-94 THRU 04-30-97 l Ralph S. Heyer, EQS VI, eff. 09-30-94 j Julie W.14 era, EQS IH, eff. 01-01-95 i Maria D. Herrera, EQS VI, eff. 01-31-95 i Charla Sue Jean, EQS IV, eff. 03-31-95 j Robert J.14baugh, Jr., EQS VI, eff. 08-31-95 l Timothy R. Goldman, EQS IV, eff. 08-09-96 l Rajesh P. Rupaul, EQS VI, eff.10-28-96
- Clarence L. Born, EQS VI, eff. 01-31-97 i Paula H. Gonzalez, EQS IV, eff. 04-30 97 '
1 J
- 5 1
l a
w
j- o i
{.
{ III, Technieml Oinlity of T hnnine Actions t l l
) 11. Please identify any major, unusual, or complex licesses which were
, issued, received a major amendment, terminated or renewed in this ;
period. I i l NewIh=ama: None !
i J
Pending: WCS; Envirocare i
5 Terminated: None ;
- 1 Renewals: i
- Western Atlas (IA0466)
PSI (IA0931) - Split into 11 separate licenses Saint Paul Medical Center (L01065) I
- UTHSC-SA (IA1279) j Texas Tech University (L01536)
Shivers Cancer Center (IA1761) l UTHSC Lubbock (IA1869)
Univ Houston (IA1886) l UT San Antonio (IA1962)
! UTHSC Houston (IA2774)
, M.D. Anderson (IA2972 De GNI Group (IA3378) -
1 Joe Arrington Cancer Cea' ter (LO4881) i IsoTex (IA2999)
- i I
Amendments:
Baylor (IA0680):IVB in Pigs
] ,
l 12. Please identify any new or amended licenses added or removed from the j list of licensees requiring emergency plans?
j IsoTex (IA2999) j 13. Discuss any variances in licensing policies and procedures or exemptions j from the regulations granted during the review period.
i i
4 j 6 i
i
l.
A.III.13. (Continued)
(NOTE: Exemptions not allowed prior to July 1996)
- EXEMPTIONS i
! Exemption Date Summary ,
- I l 31.23(b)(1) 7/96 RSO Qualifications !
i 21.1101(d) 7/96 Records 14 cation j- 41-E,H-B 8/96 Canadian Preceptor l 41.27(b) 8/96 RSO Qualifications
} 21.502 10/96 Denied i 21.502 11/96 Denied
! 21.502 12/96 Denied 31.53(a),31.50(b) 1/97 >
.Pipeliner
, 41.32(a) 1/97 Expiration Date
' 41.32(a) 2/97 Expiration Date 41.32(a) 3/97 Expiration Date 41.32(a) - 3/97 Expiration Date i GENERIC EXEMPTIONS 4 l
l 41.32(a) 3/97 L01: Expiration Date
! 41.32(a) 3/97 IA2: Expiration Date i '
- 14. What, if any, changes were made in your written licensing pmcedures (new procedures, updates, policy memoranda, etc.) during the reporting j period?
i DIRECTORY OF ADMINISTRATIVE & POLICY MEMOS i
k 5. IJcensing and Registration Actions Concerning " Compliance j Action Pending"
- 13. Policy on Teenporary Job Sites for Clinical Use of Radioactive
! Material i
- 16. IJeansing/ Registration Policies
- 17. Procedures for Abandonment or Denial of Licensing Actions I 31. Agency Implesnentation of TRCR 40 for General IJcense
{ Acknowledgements (GLA) 1 7 J
t
l.
1 A.III.14. (Continued) i
- 32. Imgal Interpretation of Medical Teaching Institution !
[
i
- 34. Clarification of TRCR 41.25(h) Concerning Requirement for
, Pennanent Facility l
- 36. Clarification of Issues Involving NORM i 37. Applicable;, of Damn =lantanint 1%nding Plan to Medical and
! Academic f hamas .
L 39. Forwarding of Site Tennination Requests to the Dielsion of Compliance & Inspection
! 1 l 40. Clarification of IJcensure Requirements for Recycling of i j Materials Contaminated with Naturally Occurring Radioactive !
- , Material (NORAD -
! 41. Clarification of IJcensure Requinsnents for decontanrJnation !
j of Vessels Containing Naturally Occurring Radioactive Material (NORhD
! 42. Release of Patients Administered Diagnostic I Radiopharmaceuticals Gaterpretation of TRCR 41.26(c)(1))
- 45. Procedures for Administrative Amendment requests from l Division of Compliance and Inspection l 47. Assessing Reciprocity Fees for ih/ Registrations that J j Authorize Multiple Activities 1 i ;
i 48. Generic Agency Approval for Reagent Kits Not Containing i
! . Radioactive Material ;
l l
- 49. Radioactive Waste Processing Issues
- 50. Generally IJcensed Sources of Scintillation Counters j 53. IJcense and Registration Renewal Interval Procedures i
1 54. late Submissions for f arane Renewals 4
f l 1
,4 .
k i
- l. .,
J l.
l A.III.14. (Continued)
- BRC TECHNICAL POSITIONS
SUBJECT:
DATED:
l TAB 2 l INDUSTRIAL RADIOGRAPHY EQUIm'T l REQUIREMENTS 01/03/96 UCENSING TECHNICAL POSITIONS
SUBJECT:
. DATED:
. Tab 36 HANDLING OF RECIPROCITY July 1996 LICENSING PROCEDURES MANUAL I. TECHNICAL ISSUES: TABS:
21.1304(D) AND AUTHORIZED UCENSEES 8/94 2 CORRESPONDENCE WITH THE UCENSEE 3/96 9 DISPOSAL OF IN-FITRO MATERIAL UNDER A GLA 11/95 10 STREAMUNING AGENCY REVIEW OF UCENSING ACTIONS 01/96 11 NORM PROCESSING CLARIFICATION POLICY STATEMENT 2/96 12 LICENSING STATE STATUS FOR (NARM) PRODUCT REVIEW 3/96 13 41.29 AND NON-EVALUATED SEALED SOURCES AND DEVICES 3/96 14 AUTHORIZED DISTRIBUTION OF GL DEVICES 3/96 15 BIOMEDICAL WASTE 10/96 16 9
l
.. o l
l
- 2 i.
A.III.14. (Continued) .
l
- II. ADMINISTRATIVE ISSUES
- TABS:
i HOW 'IO SUBMIT A REQUEST FOR
, UCENSE AMENDMENT 7/94 10 l UCENSING PEER REVIEW DOCUMENTATION 1/97 11 ,
- LEAVE AND OTHER ADMINISTRATIVE
! PROCEDURES 4/97 12
! UCENSEE/APPUCANT COMMFIMENTS .
j VIA TELEPHONE 3/96 13 l
! BL LEGAL ISSUES: TABS:
i XNTERPRETATION OF TRCR 44.62 3/96 7
! , INTERPRETATION OF TRCR 41.200(f)(4)- ;
I FINANCIAL ASSURANCE '4/97 8 l
l OTHER s
- Ownership Changes: 12-2 l'
- Terminated Sites off license
- j. E.III.B Certain Therapy users get until 10/96 to usa non-1 ACGME
) - 41.1603)(2)(iv) Use NDA drugs for other purposes ,
! - Medical Currency Regain medical curnacy through ACGME !
- Program
- Exemption Policy For Granting Exemptions: TRC FORM LRS-5
)
i i 15. For NRC Regions, identify by licensee name, license number and type,
) any renewal applications that have been pending for one year or more, i
N/A ,
IV. Technical Ounlity of Inmeetions l
l l 16. What, if any, changes were made to your written inspection procedures
! during the reporting period?
i 'Ibe written inspection procedures have been completely revised and i updated. All project antas in the Division of C4mpliance and Inspection participated in the development of expanded, revised and
! updated inspection, incident, and Division procedures.
10 L , , ....
l i
(
l.
- 17. Prepare a table showing the nember and types of supervisory
, accompaniments made during the review period. Include:
! Sunervisor Inmactor fleame Cat. Date l De table in Appendix 5 will show a bmakdown of:
i
{ , I) the current Area (Regional) Ccordinators j 2) the 13 curmut nglor.al radioactive materials inspectors;
- 3) the 1 vacant RAM inspector position;
, 4) the dates on which the inspectors were accompanied by an area
[ coordinator or their supervisor during the reporting period from
- March 12,1994, thmugh April 30,1997.
For specific license categories, nfer to specific inspector l l accompaniment documentations in Appendix 6. l
- 18. Describe internal procedures for conducting supervisory accompamments
! of inspectors in the field. If supervisory accompaniments were j documented, please provide copies of the documentation for each !
accompaniment, Internal procedures for conducting supervisory accompaniments of j inspectors in the field:
i l The 14 inspector positions are assigned to *.he 11 Public Health
{ Regions (PHR) and are located in 10 regional omces (one inspector
- covers PHR 9 and PHR 10). Three technical mview positions (titled l Regional Bealth Physics Coordluator) have the regions divided and i grouped such that the number of inspections in each group are l approximately equal. The three coordinators perform, or arrange for
- senior staff to perform, an annual accompaniment with each regional l
inspector in their respective agional gmup. Reports of the accompaniments are submitted through the Deputy Director of Radioactive Materials Inspection and Enfortement and the Director of the Dirlslon of Cornpliance and Inspection to the Regional Director and the Regional Director of Envimamental Health and Consumer Protection. De reviews cover existing inspection policies / procedures, new inspection policies / procedures, report processing, filing methods, inspector's training needs, etc.
Copies of the annual accompaniment reports for the review period are located in Appendix 6.
11 e
, _ --~ - -----y
- l. +
i l 19. Describe or provide an update on your instrumentation and methods of ,
j calibration. Are all instruments properly calibrated at the present time?
See Appendix 7. Yes, all instmments are properly calibrated at the present time.
V. Daenonsen to facidente and A11aentions j 20. Please provide a list of the most significant incidents (i.e., medical l =i==dminieration, cwagesures, lost and abandoned sources, incidents l requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc.) that occurred in the l Region / State during the review period. For Agreement States, information i included in previous submittals to NRC need not be repeated. The list
- should be in the following format
UCENSEE NAME UCENSE # DATE OF INCIDENT / REPORT TYPE OF INCIDENT l
t Inc. Date of l Ileana** Name fleanse # # Incident /Renort Tyne of incident BIX Testing Imboratories L2143 6650 03/23/94 Overerposure 21.360 rem Blazer Inspection 14419 6651 02/23/94 SoumeDisconned Hand Bum H & H X-ray Services L2516 6654 04/07/94 I4st Radiography Camera Tucker Wireline Services L4751 6655 04/19/94 Lost WellImaging Source Southwest Methodist Hosp LO594 6736 07/28/94 Misadminletration l
Kooney X-ray L1074 6816 02/08/95 I4st Radiography Source Mother Frances Hosp L1670 6874 05/02/95 MisadminletrationIodine-131 Midland Car Wash NA 6907 08/18/95 Ir-192 Contamination i Littlebit Wireline L3168 6919 09/19/95 Ruptured WellIsring Source U.T.H.S.C. L1278 6929 09/12/95 Therapy Source Misloading larpen of Texas LOO 74 6987 02/27/96 Stolen Co 60 Radiography cameras Bellaire Cancer Ctr. L2038 1219 01/17/97 Therapy Misadministration
- 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?
~
Yes, incidents occurred that involved equipment or source fauure or approved operating procedures that were deficient during this review period. See Appendix 8. No notifications were made as no incidents of this type occurred affecting other states or the NRC.
i 12
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i A.V.21. (Continued) ;
- a. For States, was timely notification made to the Office of State ,
Programs? For Regions, was an appropriate and timely PN i
i generated? :
I l
No, no incidents of this type occurred that needed timely notification.
i
- 22. For incidents involving failure of equipment or sources, was information
. on the incident provided to the agency asponGble for evaluation of the 3
device for an annatament of possible generic design deficiency? Please i provide details for each case.
l See Appendix 8, Incident 6755. Information about automatic locking l'
! devices on radiographic cameras and alanning ratemeten was
! forwarded to the NRC. .
1 I 23. In the period covered by this review, were there e any cases involving i possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
l No.
l j 24. Identify any changes to your procedures for handling allegations that j occurred during the period of this review.
\
! Procedures for handling allegations are included in the Inspector's i Manual that has been updated during the period of this review. No i substantive changes were made.
1 i
j a. For Agmement States, please identify any allegations referred to j your program by the NRC that have not been closed.
i All referred incidents have been clossd.
i VI. General
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review. ,
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y A.VI.25. (Continued) s RECOMMENDATION: We recommend that the overdue rule (concerning incident j notification) and any others need for compatibility be promulgated expeditiously as i effective State radiation control regulations. In addition we recommend that the l State avise ks Section 40.52 (a) and make it compatible with equivalent j requirements in 10 CFR Part 31.2 and 10 CFR Part 31.5.
i l STATUS: The agulations that were listed as overdue for adoption in the nylew
! became effective on October 1,1995. Since that time several other compatibility l regulations have been adopted. Section B. I. 29. diae=== the agulations that have L been adopted since the last review.
1 l RECOMMENDATION: We suggest that the program nylew the list of
! ncommendations in Enclosure 2, Appendix A 'and consider these recommendations j in the issuance of future sealed source and device registration certificates and mWor i
amendments to certificates.
i ShATUS: The suggested changes, which concerned formatting enhancements only, l have been made and are a documented component of the device review process.
i RECOMMENDATION: The inspection manual refers to a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />,72 hour, and j 10-day inspection nquirements in response to incidents. Inspection criteria for the 24-hour and 10 day inspections are documented in the manual, but no criteria for j 72-hour inspections are provided.
i STATUS: The inspection manual in section IV, Incident and Complaint
!. Investigations, page IV-1 states that some investigations must be initiated within 24 bours, some within 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />, and some within 10 days. De manual outlines the l
criteria for incident and complaint investigations. On page IV-6 under "B.
l Complaints", the manual states that "...it is the policy of the Bureau of Radiation Control to initiate response to each complaint within 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> of the time the complaint is received."
f -
1 l De policy was established because there is no way to detennine how a complaint j should be categorized for a timely nsponse. We have had a complaint of 4
radioactive peach trees that turned out to be an incident of contamination and a j complaint where no lican=* or individual was named that turned out to be an
{ incident in which a sealed americium-241 source was cut open and contaminated an i area used by en:ployees as a lunch mom.
i j 14
1 l A.VI.25. (Continued) ,
, RECOMMENDATION: The inspection manual does not address misadminletration. '
i i' STATUS: This comment appears to address a perception on the part of the j
- reviewer that the BRC should develop criteria for conducting follow-up on !
I misadminletration nports from licensees.
i
! After contacting several states and the NRC for ideas, the BRC learned that none have specific action levels for deter ==talag when to respond to misad=Inletration.
It appeared that each state and the NRC responded on a case by case basis and l
- determined from reviewing reports how and what form a nsponse would take.
Based on this we determined that it would be appropriate to address l
misadminletration in a similar manner. We have changed criteria in section
. V.A.1.d. (2) of our inspection manual, page V-3 to read:
4
- l. Information in incident reports causes concern for the health and safety of the public j or medical patients. The criteria becomes effective May 14,1997.
i RECOMMENDATION: One incident fue revealed the following concern - a
- therapeutic misadministration of 675 to 750 rem to a patient's abdomen due to a l dislodged source was not followed up by the TDH.
i i
STATUS: Follow-up was performed prior to the NRC review, but was not j i completed within a short time. Since the review, an Abnonnal Occurrence Report has been submitted to NRC. j
\
- 26. Provide a brief description of your program's strengths and weaknesses.
i These strengths and weaknesses should be supported by examples of i successes, problems or difficulties which occurred during this review period. -
l i
De TDH, BRC has many program strengms. Dey include the following:
l i
! 1. Well trained and educated staff who are often caBed on as resources l by both federal and other state agencies j 2. Staff specificaUy charged with and tr Lued in rulemaking l 3. Highly skilled thia: and inspection staff and programs i' 4. ExceDent emergency response and investigation capabilities
- 5. Bureau Office support staff (accounting, computers, fue room, i training, public informatic,n, and personnel)
) 6. Satisfactory laboratory support
- 7. Satisfactory radiation detection instrumentation
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1
{ A.VI.26. (Continued) l 8. A GeneralIJcense Acknowledgement Program
- 9. Effective Compliance and Escalated Enforcement program and staff i 10. Knowledgeable radiation advisory board with a broad background in
- all program areas
- 11. De Texas Department of Health has a very strong and effective Total i
Quality Management / Continuous Quality Improvement program that j is supported at all levels of upper management Dese examples am supported by several ncent occurnaces. De emergency
! nsponse and incident investigation staff did an excellent job in the Cobalt 60 l radiography source theft can Deir quick nsponse and investigation j combined with effective news mieases led to a quick recovery of the sources.
}
} The Standards Program made major changes to the Texas Regulations for Control of Radiation and have converted many parts to the requimd Texas l Register format.
j The industrial radiography certification program and the implementing
- ngulations have become a model and resource for NRC and for other state programs. TDH is currently contracting with the Conference of Radiation Control Program Directors to provide erams for six other states and the
- American Society of Nondestructive Testing, Inc. for use in their certification
- program.
Due to an ever-increasing number of licensing requests without additional j resources, BRC has implemented a number of licensing streamHning i measure, concentrating on real health and safety issues only, use of more l computerization, and the use of licensing assistants to process simple, semi-l technical amendments and general license acknowledgements. We are also j exploring the future use of electronic media, similar to the NRC's business Process engineering project.
l
! De BRC conducted a self-review of our program in preparation for the 1997 l IMPEP. His self-review also allowed several BRC staff members who participated to become more familiar withjob dufles of various project areas i within BRC, thus gaining an appreciation of the msponsibilities their co-l workers have.
l De MRC has developed an Internet web site that includes announcements i (meetings, training, job postings), hot topics (news items), an educational j page, industrial radiographer exam schedules, BRC personnel (who to contact j ,
for what), and draft, proposed, and final mies in the TRCR.
i.
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A.VI.26. (Continued)
The primary weaknesses are:
- 1. De limitation to increase full-time staff when workload increases.
l Currently, there is an FTE cap for each state agency imposed by the ,
legislature. '
- 2. Two major waste processing Ilconsing actions have been received during the past year. Dese have necessitated the use of a team approach to the licensing actions, pulling together expertise in
- licensing, financial security, risk assessment, and envimamental l l
monitoring. Dese have been time intensive and have taken resources :
away from standing projects. One application also required some geological review, which we do not currently have in the BRC. A l contract with TNRCC to obtain the geolo;;ical review was ,
! knplemented.
- 3. We have limited employee incentives since we do not get automatic
! cost ofliving pay increases and we have limited funds for merit raises.
- 4. We have very competent legal staff in TDH's Omce of General Counsel; however, we do not consistently get timely and sufflelent l
legal assistance due to their limited staff and high workload.
- 5. The potential transfer of nsponsibility for regulation of uranium recovery operations from TNRCC to '1DH poses a mdor challenge to the agency. Most of the challenges involve the funding mechanisms '
and possibly having to hire and train all new staff for the pmgram.
There are approximately 18-19 pending sites for termination that will require close-out surveys for license termination.
B. NON-COhmiON PERFORMANCE INDICATORS I. ReFulations and 12Fa1 Authority l 27. Please list all currently effective legislation that affects the radiation control program (RCP).
Health and Safety Code, Chapten 401 and 402. j I
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. - . , , , - -, ...,,r. , - . .
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i l- 28. Are your mgulations subject to a " Sunset" or equivalent law? If so, j explain and include the next expiration date for your regulations.
No.
l 29. Please complete the enclosed table based on NRC chronology of i amendments. Identify those that have not been adopted by the State,
, explain why they were not adapted, and discun any actions being taken
- to adopt them.
! See following Table. De equivalent to the quality management and misadminletrations rule (10 CFR 35) has not been adopted by TDH.
i As reported on several occasions to NRC, TDH withheld adoption of
- this rule pending the outcome of the National Academy of Sciences
! report. Since the result of this report appears to be a major revision
! of 10 CFR 35, with early input from the Agmement States, TDH will j
continue to withhold adoption of this rule until 10 CFR 35 is revised.
i- Adopting such a mle that is very likely to be changed during the nvision process is an unnecessary and costly burden on our licensees
! and TDH.
i l Changes to 10 CFR 30,40, and 70 concerning decomnhioning record j keeping and self-guarantee as an additional financial mechanism were not adopted by the due date. Dese mies (and several other
- compatibility mies) are included in a rulemaking package that creates
! a new transportation part and affects TRCR Parts 11,21,41, and 44.
! Dis package is scheduled for adoption in December,1997. Revising j the TRCR as frequently as NRC revises 10 CFR is not possible within i
the parameters of the TDH rulemaking process (see response to l B.I.30.).
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- THIS PORTION OF THE PAGE IDT INTENTIONALLY BLANK i
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. _ . . _ _ _ . . _ _ . . . - _ . . _ . . _ _ _ . . . . . _ . . . _ . _ . . _ _ _ . _ - _ . . . _ . . . .. . ~ . - - - _ _ _ . . _ - . . . . . . . . . - . .
l B.L29. (Continued) oR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Aery ar.vedmont duo yder to 1991.
Montfry onch rogdellen (refer te the C' . " ., of Amendments) ,
th. . _ . . _L ." 7/2751 953 Ports 30,40,70 Emergency Planning: 4/7!33 953 Ports 30,40,70 S
Standante for Protection Agelnet Redenen: 11154 953 Part 20 Safety Requiremente for RedayapNe 1110/94 9/93 s Egulpment: Port 34 Netscetion of IncMents: 10/1554 *10 CFR 20 30,31,40 34 39
- Nrts 20,30,31,34,39,40,73 TRCR 21 41 31 36
? DATE 9/93 10/95 9/93 10/92 Questy Management Propom and 11275 5 ** **See Response to B.I.29.
Misedministrations: Part 35 IJcensing ord Modetion Safety 7/156 656 Requirements for Irredeters: Part 36 DefinMon of Land Dispeest 7122 5 6 N/A TNHCC Jurloectlen and weste sne OA progrom: Port Si i
Decommissioning Receed Imeping: Docu- 1082556 Included in J._ :", .._.^_ of transportselen rules: Draft 2 dated 1257 mentation Additlene: Parts 30,40,70 May 9,1997 Self-Ouerentee se en AddMemel Financial 1128 5 7 Included h development of transportetten rules: Draft 2 dated 1257 Mechenlem: Parts 30,40,70 May 9,1997 i
i 19 !
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OR '
DATE DATE .,
, 10 CFR RULE DUE ADOPTED CURRENT EXPECTED l STATUS ADOPTION
! Uranium MM TeAngs: Centenning to EPA 711/9 7 N/A TNRCC jude Seden !
l seenderde: Part 40 j TImennese bi Decenundselening 811 5197 Included in develasment of transporteden tulos: Draft 2 dated 1227 Ports 30,40,70 May 9,1997 ,
Pteperstlen, Trenefer for Commercial Dis- 11188 hicluded be revision to snesAcel rules (TRCit Parte 33M1) Summer don, ered Us. of e, product Meterw iS98 ;
for Momens use: Parte 30,32,35 i
j Frequency of Mosesi Eseminedens for Use 311 3198 kicauded in development of transporteden rules: Draft 2 dated 1257 i l
et Respiratory Protection Egulpment May 9,1997 i Low-Level Weste ShWesent KW 311/99 th In development of transporteden rules: Draft 2 dated 12S 7. I Information and Reporting May 9,1997
(
Performance Requirements for ItseetsW. 813019 8 Rowlelen of TRCR Port 31 wm hogin after M of nieper Sydng Eeulpment revtelen to 10 CFR 34 1998 l t
l Remoden Protocelen Requhemente: 8114SS Summer !
Amended Dennipens and Cdtede 1998 ;
ClarMeesten of Decomadselening Funeng 11124/98 W in development of transporteden ndes: Draft 2 dated 1257 ;
fleguiremente May 9,1997 l l
10 CFR Port 71: W with the 411/99 Draft 2 dated May 9,1997 12f97 hitemenenal Atomic Energy Agency Mescal Adeweerseen of im and 10/20f98 hiciudad be revielen to mescal rates (TRCR Parte 33Mit Summer l Redleective Ilme terlate. 1998
! Terminetten er Transfer of Licensed 511 8199 hwemand in development of transporteilen ndes: Draft 2 dated 1257 Activities: ReconAmaping Requiremente. May 9,1997 Resoluden of DuelReguladen of Atteme 1Sf00 sy due date :
Effluents of Rodoecthre Metodele: Ossa l Air Act j flecetydelen of Agreement State Licenses 1113f00 Dy due date i in Areas Under Esciushre Federal !
Jurledk:tlen Withiri en Agreement State Cdtede for the Meloose of hupviduals 1129l00 Included In revlelen to niedest rules (TftCR Porte 33 Mil Summer i Adminletered Radeoctive Metodel 1998 [
20 !
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_ . _ _ _ . _ _ _ _ _.. _ _ _ . _ _ _ = _ .. _ _ _ .. _ . _ _ ._ _ _
- 30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.
See Appendix 9. His table describes the steps required in the TDH rulemaking process to fortnally propose a rule, including steps required by state law and by TDH policy. De process includes reviews by TDH Office of General Counsel (OGC), Texas Radiation 1 l Advisory Board (TRAB), and Texas Board of Health (TBH). Once a rule is proposed, the minimum time it can remain proposed is 30 days.
De BRC typically proposes a rule for 60 days to allow sufficient time l for comment. The steps for proposal of a rule in the table, besta=Ing i
with the TRAB nylew, must be repeated to ensure that a proposed .
i rule is adopted. The table time frames represent the time period l l allocated for each step. De minimum amount of time required to j adopt a rule is nine months. J According to state h.w, when a rule is in the proposal phase of the l adoption process, addhional changes to that rule may not be proposed
- until the initial rule is adopted. This fact and the time frames i involved in the entire TDH rulemaking process make it impossible to l amend the TRCR st the fmquency that NRC amends 10 CFR. For
- example,10 CFR 30 was amended in October 1993, January 1994, August 1994, January 1995, November 1993, and May 1996. This l part was amended every three to ten months. Also,10 CFR 20 was amended twice in March 1995, August 1995, and October 1995.
Considering the freque y with which NRC amends its regulations and i the TDH rulemaking pecess, the BRC may be behind in meeting some of the NRC due dates for compatibility items and ahead of meeting other NRC due datas, j H. SgalglSource and Device Prorram i
- 31. Prepare a table listing new and revised SS&D registrations of scaled i' sources and devices issued during the review period. 'Ihe table heading should be:
SS&D Manufacturer, Type of Registry Distributor or Device Number Custom User or Source l 21 i
i i
l B.II.31. (Continued) k t
Manufacturer,
- SS&D Distributer or Type of i Number Custom User Device or Source t
TX0261D101S Western AtlasInternational Neutron Generators (F) j TX06MD152B TN Technologies Inc. Maed Gauge (D) l TX06MD126B TN Technologies Inc. Gauge Calibrator (T) l TX0634D138B TN Technologies Inc. Mxed Gauge (D)
TX0634D137B TN Technologies Inc. Mxed Gauge (D) f
- TX0634D142B TN Technologies Inc. Mxed Gauge (D)
} TX0634D131B TN Technologies Inc. Mxed Gauge (D) i TX0634D152B TN Technologies Inc. Mxed Gauge (D) l TX0634D169B TN Technologies Inc. X-ray Analyzer (U)
- TX0634D171B TN Technologies Inc. (Manu.) Beta Thickness Gauge (E) l Eberline Instruments (Dist.)
l TX0642D101B Tasmetrics Chromat. Group Electron Capture Detector j Mnnigan Corporation Cell (N) l TXO642D102B Tremetrics Chromat. Group Electron Capture Detectoi-l Manigan Corporation Cell (N)
TX0642D801B Tremetrics Chromat. Group Electmen Capture Detector j Mnnigan Corporation Cell (N) f i TX0476S167S Du Pont Merck Phannaceutical Gennanium-68 Photon Company Line Souste (W)
! TX0186D114S Berthold Systems, Inc. (Manu.) Mxed Gauge (D)
- Formosa Plastics Corporation j (Custom User)
TX0186D115S Berthold Systems, Inc. (Manu.) Mxed Gauge (D)
Hoechst Celanese Chemical Company (Custom User)
TX0246D103S C.S. Products (Testing Industrial Radiography (A)
Equipment) IAd. (Manu.)
Oceaneering InternationalInc.
(Dist.)
)a f ,,
~
22 I
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- 32. What guides, mandards and procedums are used to evaluate registry applications?
! We provide the applicant with a copy of Regulatory Guide 2.2 (for i eenled sources) or 2.3 (for devices containing radioactive material).
During the review process, we use a standard review form developed j by the NRC and modified to reference Texas regulations.
4 l 33. Please include information on the following questions in Section A, as they apply to the Scaled Source and Device Program:
! Technical Staffing and Training - A.D.7-10
- i i l
- 7. Name Paelttan Area of effort in RAM !
! Floyd R. Hamiter Health Physicist (S) SS&D review .60 l , A.D.8-10 N/A l ..
l Technical Quality of Ucensing Actions - A.HI.11, A.M.13-14 i i j A.M.11 N/A
! A.HI.13-14 N/A j Responses to Incidents and Allegations - A.V.20-23 )
i A.V.20-23 N/A j HI. .I.ow-12 vel Waste Pmeram j l 34. Please include information on the following questions in Section A, as
- they apply to the low-level Waste Program
s l Status of Materials Inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.H.7-10 l
j Technical Quality of Ucensing Actions - A.HI.11, A.HI.13-14 l Technical Quality ofInspections - A.IV 16-10 j Responses to Incidents and Allegations - A.V.20-23 N/A i
i 4
23 J
a k
+ .
.cn , , --,
_=. - - - .-_ . _ _ . . - _ _. . -._. - - . .- - . _ _ _ . -
l IV. Uranium Mill Prorram k ~
- 35. Please include information on the following questions in
- Section A, as they apply to the Uranium Mill Pmgram
4 Status of Materials Inspection Program - A.I.1-3, A.I.6 Technical Staffmg and Training - A.II.7-10
- Technical Quality ofI.icensing Actions - A.III.11, A.III.13-14 j Technical Quality ofInspections - A.IV.16-19 Responses to Incidents and Allegations - A.V.20-23
]
N/A i
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24
i
, R=onse to Intenrated Materials Performance Evalurtion Pronram (IMPEP) Ouestionnaire May 22.1997
- i
[ NOTE: The text of the responses, along with smaller appendices, is being sent by Internet as one file. Bulky appendices (numbers 2,4, LLW-1, LLW-2, LEG-1 and )
j LEG-2) are not included in the electronic (Internet) transmission; paper copies of these appendices will be provided at the time of program review in June.)
TABLE OF CONTENTS l
l A. COMMONPERFORMANCEINDICATORS Pane No.
4 I. Status ofMaterials Inspection Program 3
. Questions # l 3 (#4-6 not applicable) ;
i H. Technical Staffing and Training 4 l Questions # 710 '
i III. Technical Quality ofLicensing Actions 6 Questions # 11 14 (#15 not applicable)
J IV. Technical Quality ofInspections . 7 I Questions # 16-19 3 V. Response to Incidents and Allegations 8
- Questions # 20-24
! VI. General 9 i
Questions # 25-26 i
l B. NON-COMMON PERFORMANCE INDICATORS L Renulation and Lenal Authority 13 Questions #27 30 IL Scaled Source and Device Pronram Questions #3133 does not apply IIL Low-Level Radioactive Waste Disposal Pronram Question # 34: 16 34(a). Status ofMaterials Inspection Program (Questions #1-3 in A) does not apply 34(b). Technical Staffing and Training (Questions #7-10 in A) 34(c). Technical Quality ofLicensing Actions (Questions # 11,13-14) 34(d). Technical Quality ofInspections (Questions #16-19 in A) does not apply 34(e). Response to Incidents and Allegations (Questions #20-23 in A) does not apply
, E liranium Pronram i
PATX\TNRCCSOEP97. REP S/2897 I
^
- Question # 35
- 19 35(a). Status ofMaterials Inspection Program (Questions # l-3 in A) 35(b). Technical StafEng and Training (Questions #7-10 in A) 35(c). Technical Quality ofLicensing Actions (Questions #11,13-14) 35(d). Technical Quality ofInspections (Questions #16-19 in A) 35(e). Response to Incidents and Allegations (Quenions #20-23 in A)
LIST OF APPENDICES 26 C. SUPPLEMENTAL MATERIAL available at TNRCC offices in a separate folder i
} Tentative List of documents included in the Supplemental Material Folder 27 1.
l a
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PETNRCC\DOEP97. RIP S/2897 2
9 l
/
t DETAILED RESPONSE TO THE IMPEP QUESTIONNAIRE A. COMMONPERFORMANCEINDICATORS L Status of Materials Insoection Program
- 1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800 (issued 4/17/95). The list should include initial inspections that are overdue.
Insp. Frequency Licensee Name (Years) Due Date Months O/D There are no overdue materials inspections at the present time. The Texas Natural 4
Resource Conservation Commission (TNRCC) currently has four non-uranium licenses covering buried radioactive material: Monsanto Company (RWO219),
Texas A& M University (RWO448), Tex Tin Corporation (RW1270), and Iso-Tex, Inc. (RW1937). Please see answer to Question #35(a)(1) for status of uranium inspections.
- 2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.
i i Does not apply.
- 3. Please identify individual licensees or groups oflicensees the State / Region is inspecting
! less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95) j and state the reason for the change.
None ,
- 4. How many licensees filed reciprocity notices in the reporting period?
- a. Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less?
- b. For those identified in 4a, how many reciprocity inspections were conducted?
Does not apply.
- 5. Other than reciprocity licensees, how many field inspections of radiographers were performed?
/ Does not apply.
FNTXffNRcC30'EP97. REP s!2897 3
4
- 6. For NRC Regions, did you establish numerical goals for the number ofinspections to be i performed during this review period? If so, please describe your goals, the number of j inspections actually performed, and the reasons for any diferences between the goals and ;
I the actual number ofinspections performed. l Does not apply.
l i E Technical Stamna and Training l
l 7. Please provide a staffing plan, or complete a listing using the suggested format below, of l the professional (technical) person-years of esort applied to the agreement or radioactive i 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 l are divided between offices, the table should be consolidated to include all personnel j contributing to the radioactive materials program. Include all vacancies and identify all i I
j senior personnel assigned to monitor work ofjunior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their eKorts. The table heading should be:
i l Current staffing plan and the level of eNort spent on the radiation program are j given in Annendix 1. The table gives a breakdown of approximate time in percent l
) spent by each member of the stan for various activities, including LLW and uranium mill activities.
' 8. 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.
! Professional staff hired since the last review are the following:
! EKective Date Name and Discipline Z31111s (Radiation Program)
! - Paula Gonzalez Health Physicist May 1997
- Kathy Vail Regulatory Specialist March 1997 l George FitzGerald Team lander / Licensing Sept.1996 William McCabe Health Physicist Feb.1995 Devane Clarke Health Physicist Oct.1994 Sajeewa Chandrasoma Financial Assurance (part time) Sept.1994 l Elizabeth Bourbon Attorney (part time) April 1994 j Madeleine Boyer Attorney (part time) July 1995 rn:oTNRCCWPEP97. RIP $/2897 4 I
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1 l
1 In addition to the above, two staK members (Peter Lodde and David Murry) of the .
t Industrial & Hazardous Division provide technical support to the LLW program in specialized areas of geology, seismic analysis, and modeling. Resumes listing educational qualifications, additional training received, and experience of l professional staff working in the radiation program are given in Annendis 2.
I l Additional staKsupport for the LLW program in the health physics area has been
! obtained from Gary Smith of the TDH through an interagency contract. During i 1995, Dr. William van Rensburg of the University of Texas at Austin provided
- assistance under contract in the review of socioeconomic aspects of the LLW j application. See Annendis 1.
l 9. Please list all professional staffwho have not yet met the quali6 cation requirements of )
! license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1245 l and 1246; for Agreement States, please describe your qualifications requirements for l l materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these i i requirements.
4 -
l Professional staff pursue continuing education in specific areas of their assigned l j function as needed. The following personnel are currently scheduled for continuing i education through participation in forthcoming NRC training courses: I i
NAME NRC COURSE AND AVAILABLE DATES i
! H-117 H 120 H-102 H-308 G-108 G409 j Course Thie latroduction Radiological Health Transport./ Inspection IJeemeing l and Number to Heahh Surveys in Physics Radioactive Procedures Practices &
i Physics Support of Teeboelogy Material Procedures
! Deconnail-j seloning l Course Date 07/14-18/97 08/20-2157 04/28- ~04/28- 07/28- 06/2 GS7 &
95/09/97 05/0257 08/01/97 & 09/08-1267 09/22-26/97 G.FitzGerald 3 g KVd 3 3 D. Kohler 3 P. Gonzalez 3 3 3 _'_
A staff member filling the one currently vacant position (hydrologist) may be selected to attend one or several of the courses that would directly contribute to the performance of his/her assigned functions.
i P;\TMTNRCCOD'EPP7. RIP 5/2897 5 O
j- 10. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
J 4
The radiation control staff who left the program since last review through j resignation, retirement, or transfer to another division or section within the agency l l are listed below: ,
Name and Discinline Reason for Leavine Date Left l Bari Krishna, Hydrologist Transfer Nov.1996 i
Marilyn J. Preusse, Health Physicist Resignation Sept.1996 i John Gunnick, Health Physicist Resignation March 1996 l William C. Price, Geologist / Team Manager Retired Dec.1995
- R. Ricardo MuBoz, Health Physicirt Transfer August 1995
- Peter Wehner, Geologist Transfer Feb.1996 l William Scott Pennington, Health Physicist Resignation Nov.1994 j Robert Norris, Financial Assur. Administrator Transfer Sept.1994 i Paul N. Breaux, Health Physicist Resignation July 1995
! Cynthia D. Palomares, Geologist Transfer -
Aug.1994
! Kevin McLeod, Attorney Resignation April 1994
! HL Technical Ouality ofLicensine Actions
?
- 11. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated or renewed in this period.
i
! The TNRCC currently has four non-uranium licenses covering buried radioactive j material. Paniculars of these licenses are given in Annendix 3. All four are due for j license renewal, and applications for renewal have been received from each. A i diskette containing copies of current TNRCC radioactive materiallicenses was j mailed on May 14,1997, to Mr. Richard Woodruff, the leader of the NRC review team. Please see answer to Question #35(c)(i) for a listing of uranium licenses.
} 12. Please identify any new or amended licenses added or rem ~oved from the list oflicensees j requiring emergency plans?
- None.
I j 13. Discuss any variances in licensing policies and procedures or exemptions from the i
regulations granted during the review period.
)
None.
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) 14. What, if any, changes were made in your written licensing procedures (new procedures,
- updates, policy memoranda, etc.) during the reporting period?
I With the final adoption of the TNRCC radiation rules (Title 30, Chapter 336 of the Texas Administrative Code, and associated procedural rule changes) by the I Commission on May 14,1997, changes have been effected in certain licensing procedures. These are listed below:
l l 1) Amendments to 66 281.3,281.17 and 281.18 revise the Commission's I i administrative completeness provisions to take into account specific nquirements
) for radioactive material licenses. The amended language allows 45 days for administrative completeness review of new, nnewal, or major amendment ;
{
applications, and 30 days for minor amendment applications.
1
- 2) Amendments to (281.19 and (281.20 establ'ish the technical review and notice of
- deficiency provisions for applications for redioactive materiallicenses. For new,
- renewal, or major amendment application.*, the technical review period will not j exceed 255 days, unless the application is ti chnically deficient, in which care the technical review period may be extended to a maximum of 450 days. For minor j amendment applications, the technical review period is 90' days, which may be 4
extended to 150 days for technically deficient applications.
i j 3) Amendments to 5281.21 and g281.22(a) revise the Commission's application
- processing requirements to add specific provisions for radioactive materiallicenses,
) including provisions for the preparation of a written environmental analysis for
, certain licenses. The amendments also rcvise the compliance summary and
- technical summary provisions.
i 4) Amendments to $281.23 establish specific requirements for amending radioactive j material license applications after commencement of technical review.
1
] 15. For NRC Regions, identify by lie.nsee name, license number and type, any renewal j applications that have been pending for one year or more.
i Does not apply.
E Technical Ouality ofInsoections
- 16. What, if any, changes were made to your written inspection procedures during the reporting period?
None.
PATX\TWRCC\lMPEP97. REP 5/2897 7 O
- 3. .
l 17. Prepare a table showing the number and types of supervisory accompaniments made s during the review period. Include:
- Suoervisor . Insoector License Cat. Datt i
No inspections were accompanied by the supervisor during the review period.
l 18. Describe intemal procedures for conducting supervisory accompaniments ofinspectors in i the field. If supervisory accompaniments were documented, please provide copies of the
- documentation for each accompaniment.
1 None.
) 19. Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments properly calibrated at the present time?
l
- i. -
! Please see answer to Question #35(d)(iv).
1 l 1 Resoonse to Incidents and Allegations
- 20. Please provide a list of the mQM.Aignificant incidents (i.e., me' dical 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 1 notification, etc.) that occurred in the Region / State during the review period. For
! Agreement States, information included in previous submittals to NRC need not be l repeated. The list should be in the following format:
l i No incidents were reported related to the four non-uranium licenses covering buried i radioactive material (listed in Anoendix 3). Please see answer to Question #35e regarding incidents related to the uranium program.
, 21. During this review pedod, did any incidents occur that involved equipment or source j failure or approved operating procedures that were deficient? If so, how and when were i other State /NRC licensees who might be affected notified?
i
! a. For States, was timely notification made to the Office of State Programs? For j Regions, was an appropriate and timely PN generaied?
None.
- 22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
Not applicable, p
P;tTX\1NRCc\tho'EP97. REP S.*2897 I
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j k 23. In the period covered by this review, were there any cases involving possible wrongdoing h that were reviewed or are presently undergoing review? If so, please describe the l
- circumstances for each case. )
. None.
i
! 24. Identify any changes to your procedures for handling aUegstions that occurred during the j penod of this review.
j i a. For Agreement States, please identify any allegations referred to your program by l the NRC that have not been closed.
i None.
VI. General
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.
The NRC performed a routine review of the Texas radiation control program,
, including the TNRCC program, in March 1994. The formal comments and
! recommendations on the 1994 review were communicated by Mr. Richard L.
Bangart in his letter dated December 28,1994, addressed to Dr. David R. Smith, j Commissioner of the Texas Department of Health (TDH), and Mr. Dan Pearson, j i Executive Director of the TNRCC. Subsequently a follow-up review was made by
! Mr. Robert J. Doda of NRC Region IV office in June 1995. The follow-up i comments and recommendations were communicated by Mr. Doda in his letter
- dated October 3,1995, addressed to Mr. Richard A. Ratliff of the TDH, and Mr.
! Minor B. Hibbs of the TNRCC. This section provides a summary of TNRCC's l action in response to both these communications.
! The March 1994 review determined that the Texas radiation control program was
! adequate to protect the public health and safety. However, a finding of
' compatibility with NRC's program was withheld because of deficiencies in six areas listed in Mr. Bangart's letter. Five of these pertain to the TNRCC's radiation program: the first three relate to legislative changes; the fourth to state adoption of the NRC decommissioning rule in a timely amanner; and the last to a rule change to prohibit selfinsurance in providing financial assurance. These are addressed here j (quoted in italics) in the order listed in Enclosure 2 of Mr. Bangart's December 28,
! 1994 letter. The sixth area of concern relates to the jurisdiction of the TDH, and is j hence omitted here.
l.
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4 i exmnacentrer,7.arr sr2:97 9
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4 l Leeislative issues: (1) the definidon oflow level waste in the Texas Low-Level y Radioactive Waste Disposal Authority Act (TLLRWDAA) is not compatible with NRC's i definition because itplaces limitadons on radioacdve materials with a half-life greater l than 35 years and transuranics in concentrations greater than 10 nanocuries per gram; (2) the definidon ofbyproduct materialin subsecdon 401.003(3)(B) ofthe Texas statute, Radioacdve Materials, Title 5 is not compadble with NRC's definition; and (3) provisions in the TLLRWDAA andin Texas Part 45, " Licensing Requirements l for Near-Surface Land Disposal ofRadioacdve Waste," prohibit the &sposal of l transuranics in concentradons greater than 10 nanocuriesper gram:
1 l The State took serious note of the need for legislative change to make Texas l definitions compatible with the federal ones. The lead was taken in early 1996 j
! by the Office of Representative Warren Chisum, Chairman of the Committee
! on Environmental Regulation, Texas House of Representatives, in both the 74th l and 75th Texas legislatures. The TNRCC assembled an interagency work i group for drafting a legislative bill, consisting of representatives from the l TNRCC, Texas Department of Health, Texas IAW-IAvel Radioactive Waste Disposal Authority, and Railroad Commission of Texas. Ms. Annette Glass,
- from the staff of the House Committee on Environmental Regulation, assisted l in organizing an interim study by the Committee on the need for change of j definitions, and in drafting a bill. The bill was drafted by the work group addressing all of the questions raised in Mr. Bangart's letter, which included
! changes in Chapters 401 and 402 of the Texas Health and Safety Code. Input l was obtained from the industry and public representatives and incorporated in j the draft. Representative Chisum introduced the bill (House Bill 1311) in the l current (75th) Legislative session. A copy of the billis given in Annendix 4.
i However, the bill died in committee.
l The revised def'mition of byproduct material of subsection 401.003(3)(B) is e
included in another bill (Senate Bill 1857), which has been approved by j committee and is awaiting further legislative action. The outcome of this bill l will be known by the end of the session on June 2,1997. The TNRCC will
- atten.pt to reintroduce legislation t3 change the definitions at the next legislative s'ession in 1999.
i Adontion oiNRC-comnatible reenlations: (4) the regulation concerning nodficadon
- ofincidents which was to be adopted by October 15,1994 has not been adopted; and (6) the regulation establishing a prohibidon against the use ofself-insurance as the
- surety arrangementfor uranium recoveryfacilides has not been adopted within the l threeyearperiod required by the NRC
i j The revised new TNRCC rule package, which was adopted as final rule by the j Commissioners on May 14,1997, includes both these NRC regulations,in f4 Section 336.211 and 336.803(a), respectively.
I exrxsmccsturtr97att sr2:s7 10
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- 26. Provide a briefdescription ofyour program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.
t j Pronram Successes i
. The major successes pertaining to Agreement material activities during the period
{ following the March 1994 review are described below. In addition, during this
! period the staff has spent a significant amount of time working on other non-l Agreement activities, such as NORM disposal, and potential disposal of mixed waste by private industry.
l 1. Low-level radioactive waste (11 W) disnosal. The program's strengths include an efficient and committed license reviewing team. The radioactive waste licensing team fulfilled the agency's commitment to review the voluminous application filed
, by the TLLRWDA, prepare a detailed,450-ginge environmental analysis (Annendix l 1.1 W-1), and issue a draft license (Annendix LLW-2) in fewer than 15 months from i the time the application was deemed to be administratively complete, despite small staff size, staff turnover, and continuing revisions to the application even after it was
- administratively complete.
l l The TNRCC also accomplished the entire task of LLW application review at a low
] cost, resulting in part from reliance on experienced staff for license review rather i than on outside consultants. The total cost, about $1.5 million to the beginning of l the public hearing, is considered to be one of the lowest experienced by states
- developing a LLW disposal facility.
i
- 2. Adontion of radiation rules in TNRCC format. Following the transfer of l . regulatory authority first (in March 1992) to the Texas Water Commission, the i predecessor agency of TNRCC, and later (in September 1993) to TNRCC, this l agency adopted by reference applicable parts of the rules of the TDH contained in its
- Texas Renulations for Control of Radiation (TRCR). The rules were codified in i Title 30 TAC Chapter 336. In 1994, a major effort was begun to rewrite the
{ TNRCC radiation rules in its own stand-alone format. Draft rules were developed j in accordance with agency procedure for rule development with ample public input.
The rules also adopted subsequent NRC regulations that were needed to meet l
- compatibility requirements. The rulemaking effort was successfully concluded with
{ the adoption of the final TNRCC radiation rules by the Commissioners on May 14, j 1997. The rules will become effective on June 5,1997.
i 3. Licensina backlon reduction. In 1994 the Program Evaluation Division of the j TNRCC (now disbanded) conducted a study of the uranium licensing backlog in the radiation control program, which was largely inherited when the program was l
j PMWRCcWPEP97. REP s/2891 II 1
I
f transferred from the TDH to TNRCC in September 1993. It issued a draft report in b December 1994 entitled " Radioactive Substances Licensing Backlog Elimination Plan," which' identified 43 pending licensing actions. Over the past three yean an
- additional 9 sction mquests have been received, and a total of 21 actions have been l processed (i.e., completed license packages delivered to the Chief Clerk's office for j further action and final issuance), amounting to nearty 50% reduction of the backlog existing at the time of program transfer.
l An example of a major licensing accomplishment is the renewal of the radioactive
! material license for Panna Maria Uranium Operations (RW2402), a conventional ;
! uranium mill tallings facility (under reclamation) located in Karnes County, Texas.
l The renewal encompassed three major amendments, including a transfer of the
! license, and seven related minor amendments, including the establishment of l groundwater protection standards for the facility. The renewal license has gone i through the public notification process and will be issued with Executive Director's j signature on May 23,1997.
i
! 4. Comoliance in financial assurance. TNRCC has achieved substantial j compliance with the NRC rules and guidelines for financial assurance during the j review period. At the 1994 NRC review, the NRC staff had determined that seven of the financial assurance instruments covering uranium licenses were " performance j bonds." These were accepted when the program was under the TDH and were j transferred to the TNRCC with the program transfer, but were unacceptable under
! current NRC rules because they did not provide a substantive financial assurance l other than a commitment that existed through a license condition. The NRC
! requirement prohibiting licensee self assurance has since been incorporated into the l newly adopted radiation rules (see answer to Question #25 above).
l l The financial assurance staff worked with all the seven uranium companies and j succeeded in bringing six of the seven companies into compliance with the non-self l assurance requirements of the rules. However, one company, Everest Exploration l Inc., which has still not provided an acceptable financial assurance, was referred in l February 1997 to the Enforcement Section for legal action for not providing adequate financial assurance.
l j 5. Insnection and Comoliance. The inspection and compliance program of the j TNRCC has worked with the uranium licensees to try and achieve voluntary l compliance and has succeeded in many cases. The total number of alleged violations
- in 1993 (while the license inspection was still done with TDH-trained inspecton) was
. 15. In 1994, after TNRCC inspectors revamped their fonn and inspection style, the number of violations jumped to 51. By 1996, the number had decreased to 38 due mainly to voluntary compliance on the part of the companies. However,if voluntary compliance does not work, enforcement action will be taken.
mxmaccWPEPp7. REP S/2897 12 I
The Executive Director of the TNRCC is pursuing formal enforcement action against one licensee, Uranium Resources,Inc. (URI), for numerous violations of the Texas Health and Safety Code and the rules of the Commission during 1994 and j 1995. In September 1996, a proposed Agreed Order to settle the enforcement action j was issued to URI. URI refused to sign the Order, therefore a more extended i enforcement process is underway. The case is now pending in TNRCC's Litigation i Support Division. This is the first known enforcement order to be issued against a l uranium mining company in Texas since 1978.
l l Prorram Weaknesses I Availability of Traininr: Support from the NRC in the form of more regular and l free or inexpensive technical training would help, particulariy since the Texas
- progran
- is funded entirely through licensing fees and the regulated community is
! vocally opposed to increasing fees. In particular, specific training in areas ofin situ
l l Staffshortare: In order to strengthen and continue a viable program, the depth of l expertise would need to be increased to a minimum of three professionals in each i
required discipline, or approximately twenty total prwfessional staff members devoted exclusively to radioactive material licensing and inspection.
B. NON-COMMON PERFORMANCE INDICATORS L Renulation and Lenal Authority
- 27. 'Please list all currently effective legislation that affects the radiation control program (RCP).
14gislation most directly affecting the RCP includes:
e The Texas Radiation Control Act, Chapter 401, Texas Health
& Safety Code (currently being revised in legislative session) e The Texas Low-level Radioactive Waste Disposal Authority Act, Chapter 402, Texas Health & Safety Code (currently being revised in legislative session)
Copies of these documents are included respectively as Anoendix LEG-1 and Anoendix LEG-2. Electronic versions of these statutes are accessible through the !
INTERNET st the following addresses: l
~
www.capitotstate.tz.us/ statute /tocs/hs040100 toc.html; and www.ca pitotstate.tz.us/statu t dtoes/hs040200 toc.h tml.
rarmwnecursrsust sas.57 13 4 i
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- i. \
IAgislation indirectly affecting the radiation control program includes:
- The Texas Open Meetings Act i e ne Texas Public Information Act e The Texas Administrative Procedure Act
]
j e Chapter 5, Texas Water Code j e Texas Environmental Audit Privilege Act j e Texas Regulatory Takings Act i e Uranium Mill Taillags Racla== tion Act
! e Texas 14w-14 vel Radioactive Waste Dirposal Compact Act i e Texas Government Code
! e Texas Coastal Zone Management Act l e Texas Solid Waste Disposal Act
{ e Chapter 27, Texas Water Code (applicable to underground
[
Iq]ection wells used to dispose of uranium byproduct material and to the Class III production wells used in uranbun =Intne) l Copies of these statutes are included in the supplanentary materials.
j- Pendine Legislation. Legislation has been introduced in the current session of the j Texas Legislature,in the form of Senate Bill 1857 and the companion House Bill j j 3462, which would transfer the entire uranium program (including tailings disposal)
- from the TNRCC back to the TDH. A copy of S.B.1857 will be included in the -
supplemental material folder under Tab SUP-4. This bill has been approved by the l
. committees and is awaiting finallegislative action. Its fate will be known by the end
, of the legislative session on June 2,1997. If passed, the bill would take immediate effect upon enactment and necessitate a complete reorganization of the TNRCC radiation control program.
I 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include 4
the next expiration date for your regulations.
Not at present. However, there am several bills pending in the IAgislature that would suspend'or void rules after a certain amount of time and under certain conditions: Tex. H.B. 835; S.B.1073; H.B. 0191; B.B. 828; and H.B. 2253. De 1997 legislative session ends in June; therefore, the TNRCC should know whether any of these bills have passed by the time of program review.
- 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.
s PSTXGNRCCSEEP97. REP 5/2s97 I4 s
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3 a
7 The completed table is given in Annendix LEG-3 which also gives the plan of action A for rules that are yet to be adopted. The TNRCC has adopted all amendments 3 currently due and plans to begin another rulemaking process in the summer of 1997 j to address amendments due in the future.
i
- 30. Ifyou have not adopted all amendments within three years from the date ofNRC rule
! promulgation, briefly describe your State's procedures for amending regulations in order l to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.
i '
Adoption of certain NRC rules by the TNRCC has taken longer than three years. A i chief reason for this delay has been the agency's involvement in a major rewriting of
- the entire radiation rule package in TNRCC format following the transfer of
- jurisdiction from the TDE in March 1992 (disposal) and September 1993 ,
) (uran!um), coupled with limited agency experience with the program and limited I
j staffresources.
l The TNRCC rulemaking process is as follows:
l I 1. Staff nrenares rules concent naner for Rules and Polley Review j Committee: 2-4 weeks. Before a decision is made to draft a rule, staff prepares a concept paper and presents it to the TNRCC Rules and l Policy Review Committee (RPRC), an internal worklug group with
- representatives from every office in the agency. Concurrence for j decisions to draft rules is obtained from the Executive Director.
! 2. Pre-Pronosa! Stane: 2 weeks-6 months denendine on comnlexity and j controversial nature of rule. Staff drafts proposed rule language and j necessary backup material, including a fiscal note and a takings i assessment. If a rulemaking initiative is antialrated to have a major
- impact en the state, pre-proposal drafts are often mailed out to l Interested parties and/or published in the Texas Reelster and on the l World Wide Web for informal comment. The proposal and any
{ comments may be discussed at a Commission Work Session. In
! addit. ion, staif may solicit public participation during the early stages i of rulemaking by offering the proposed rules for informal public comment during oce of the TNRCC's Regulatory Forums, held the second Friday of each month except in December and July.
- 3. Proposal Stane; 2 months. When the sule language is ready for proposal, it is scheduled for Commission consideration at a regular weekly Agenda meeting to obtain fonnal authorization to propose. If authorization is obtained, the proposalis submitted to the1g331 7
nrmaccartm.arr s/2s.,7 15
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l l Etzi11tr for publication. A formal comment period of 30 or more h days is held in which written comments are received. The proposal preamble contains instructions for submitting formal comments. A public hearing may be held during this period.
- 4. Rule Adontion: 3 weeks-5 months. Staff addresses all comments l received during the public comment period and schedules the rules for formal adoption by the Commission at Agenda. The Texas l Administrative Procedures Act provides that all proposed rules must l be adopted within 180 days from the date that notice of the proposed l rules is published in the Texas _Reaisters otherwise, the proposed rules
- are automatically withdrawn.
l The time required for each step of the rulemaking process depends largely on the !
complexity of the particular rule package. The rules package adopted on May 14, l l 1997, took an unusually long time for a number of reasons. This rules package
- required reconciling the regulatory procedures followed by the TDH with those i followed by the TNRCC; it coincided with an agency wide regulatory reform effort l to reorganize and streamline all agency mies, which required coordination with other rules packages in progress; and there were a number of controversial issues at stake in this rules package, including raising uranium licensees' fees and modifying the uranium soll standard. However, most rule changes to conform to Federal standards are noncontroversial and generally can be made effective in roughly 6-8 months.
IL Scaled Source and Device Pronram i
Questions # 31 through 33: Does not apply IIL Low-Level Radioactive Waste Disoosal Pronram
- 34. Please include information on the following questions in Section A, as they apply to the Low-Level Waste Program:
34(a). Status of Materials Inspection Program Does not apply. The low-level radioactive disposal application licensing review was completed by TNRCC in March 1996, and the matter is presently under an adjudicative public hearing. A licensing decision is l likely to be made during 1998. The current statute requires the TNRCC to l have a resident inspector at the disposal facility during the operating l period to assure compliance, i
Y h
! ymWRCCSPEM7. REP S/28.97 16
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34(b). Technical Staffing and Training (i) Please provide a staffing plan, or complete a listing using the suggested format j below, of the professional (technical) person-years of effort applied to the agreement i i 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 i j 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 ofjunior personnel. If consultants were used to cany out the program's
- radioactive materials responsibilities, include their efforts. The table heading should ,
j be: NAME POSITION AREA OF EFFORT l l See answer to Question # 7 and Annendix 1.
I
- (ii) Please provide a listing of all new professional personnel hired since the last review, ,
i -
indicate the degree (s) they received, if applicable, and additional training and years of l j experience in health physics, or other disciplines, if appropriate:- l i
f See answer to Question # 8.
i l
! i (iii) Please list all professional staff who have not yet met the qualification remt rements j oflicense reviewer / materials inspection str5(for NRC, Inspection Manual Chapters i 1245 and 1246, for Agreement States, please describe your qualifications i requirements for materials license reviewers and inspectors). For each, list the
{ courses or equivalent training / experience they need to attend and a tentative schedule i for completion of these requirements.
l l
See answer to Question # 9.
(iv) Please identify the technical staff who left the RCP/ Regional DNMS program during this pericd.
See answer to Questien # 10.
34(c). Technical Quality ofLicensing Actions (i) Please identify any major, unusual, or complex licenses whi::h were issued, received a major amendrnent, terminated or renewed in this period.
A draft lleense to the TLLRWDA for LLW disposal was prepared by the TNRCC and noticed for public review on March 29,1996, along with a ynmacentrrret.arr s/2:97 17
f pubilshed environmental and safety analysis document. The technical analysis L document is attached as Annendix LLW-1 and the draft license as Annendix j LLE2. A diskette containing a copy of the draft LLW radioactive material j licenses was mailed on May 14,1997 to Mr. Richard Woodruff, the leader of I the NRC review team. The licensing metter is currently the subject of an
, adjudicative public hearing, which is being conducted by the State Office of Administrative Hearings (SOAH). The SOAH judges will prepare a recommendation to the TNRCC Commissioners, who will then make the final decision on whether to issue the license.
The application as initially submitted in March 1992 was incomplete. As project studies continued and additional data were developed, a great deal of technical and administrative material was submitted to the TNRCC in the form of revisions to the application. The revisions were reviewed by staff, and the results were communicated to the applicant through letters (notices of deficiency) and meetings. The application was declared administratively complete on May 12,1995. The technical review culminating in publication of the environmental and safety analysis document was completed within 12 months of receipt of an administratively complete application, or within 11 months of Agency declaration of administrative completeness.
TNRCC staff made 13 pre-licensing site visits for collecting environmental samples and background radiation for independent verification of data submitted in the application; for site familiarization and conducting environmental reconnaissance; and for detailed site inspection (see Annendis LLW-3L
- The staff review was performed in accordance with applicable federal technical l guidance documents of the NRC (NUREG's) and Texas laws and regulations, i and was coordinated through a process ofinternal peer review and discussion.
The TNRCC staff followed the requirements of Chapter 401, Texas Health and Safety Code, and of pertinent regulations,30 TAC Chapter 336 and Iggal Renulations for Control of Radiation Part 45 (the rule has since been re-adopted as Subchapter H in TNRCC's 30 TAC Chapter 336). The review .
team consisted of12 persons who were well qualified in diverse technical
- disciplines and some of whom possessed prior experience in similar reviews related to uranium licensing at the TDH. Review was coordinated through a process ofinternal peer review and discussion.
. The TNRCC's processing of the LLW disposal facility license application includes the following major milestones:
.f 4
rnxmmecaterr97.arr sas.97 18
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Initial application received from the Authority: 03/02/92 Application declared administratively complete: 05/12/95 4 Technical review of the application completed: 03/29/96 l Licensing matter referred to SOAH for public hearing: C6/24/96 Adjudicative public hearing begun by SOAH: 08/06/96 Anticipated completion of adjudicative public bearing: March 98 Anticipated finallicensing decision by Commissioners: August 98 Gi) Please identify any new or amended licenses added or removed from the list of i licensees requiring emergency pir.ns? I
) Not applicable.
l Gii) Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period. l Not applicable.
(iv) What, if any, changes were made in your written licensing ptocedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
See answer to Question #14. j 34(a). Technical Quality ofInspections Does not apply j 34(e). Response to Incidents and Allegation Does not apply l
EL Uranium Program
- 35. Please include information on the following questions'in Section A, as they a'pply to the Uranium Mill Program:
35(a). Status of Materials Inspection Program l (i) Please prepare a table identifying the licenses with inspections that are overdue by I more than 25% of the scheduled frequency set out in NRC Inspection Manoal Chapter 2800 (issued 4/17/95). The list should include initial inspections that are overdue.
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l remwnecemrsurr scan 19 1
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.- .. - . _~ -.- - -.. .. - . - _ - . _ - ~ - . - _- - - - . ~ =-- - _ .
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Overdue inspections are summarized in the following table:
Lleense Inspectlen Inspoetlen Norr.he feeher, and Lleanese name ruf noes of project Fre pancy das date overdae three-digit (years) site somber W Ns6 000 metepel teneuroes tespany: soliday/ELNee@lte 1 year Seeseher 1996 5 no W Ms6 001 metepel teneuroes Campany o'Nern 1 year sens e er 1996 5 no W 3024 000 Totet minerate Carperettens uset Cole Project 1 year Desesber 1996 5 no l W 365s 001 tal Inc.: seette Project 1 mt October 1996 7 mo I (ii) Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.
The prfority assigned to overdue inspections is low because these facilities do not present an overriding health and safety concern. Due to the limited numbe r of radioactive material inspecton, a higher priority is being givea to ongoing actions that may be finalized, such as completing close-out confirmatory surveys and issuing notices of violation.
(iii) Please identify individual licensees or groups oflicensees the State / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for the c,hange.
None.
35(b). Technical Staffing and Training (i) 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, l materials licensing & compliance, emergency response, LLW, U-mills, other. If these l regulatory responsibilities are divided ber;w 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 ofjunior personnel. If cansultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be: NAME POSm ON AREA OF EFFORT See answer ta Ouestion #7, and Annendix 1.
rnxerwacenetrn.are s/st,7 20 m
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(ii) 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.
See answer to Question #8.
l (iii) Please list all professional staffwho have not yet met the quali6 cation requirements oflicense reviewer / materials inspection staff (for NRC, Inspection Manual Chapters l- 1245 and 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers end inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule l for completion of these requirements.
See answer to Question #9.
(iv) Please identify the technical staff who left 'the RCP/ Regional DNMS program during this period.
l' See answer to Question #10. ,
. l l 35(c). Technical Quality ofLicens'mg Actions 1
i (i) Please identify any major, unusual, or complex licenses which were issued, received a major amendment, tenninated or renewed in this period.
The TNRCC currently has 12 uranium licenses, which are listed in Annendix ;
El. Staff completed 20 uisnium licensing actions during the review period. i l Staff made five pre-licensing visits as part of application review and l
- environmental and safety analysis (see Annendix U-2). A diskette containing l copies of current TNRCC radioactive material licenses was mailed on May 14, 1
1997, to Mr. Richard Woodruff, the leader of the NRC review team.
(ii) Please identify any new or amended licenses added or removed from the list of licensees requiring emergency plans?
None.
(iii) Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
None.
f r P.umaccuurtr,7.nzr st2s,7 21 l
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- (iv) What, if any, changes were made in your written licensing procedures (r.ew p procedures, updates, policy memoranda, etc.) during the reporting period?
l See answer to Question #14, i
! 35(d). Technical Quality ofInspections j (i) What, if any, changes were made to your written inspection procedures during the l reporting period?
! None.
(ii) Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:
Suoervisor Inspector J icense Cat. Dals f
1 j
1
{ No inspections were accompanied by the supervisor during the review period.
(iii) Describe internal procedures for conducting supervisory' accompaniments of
- inspectors in the field. If supervisory accompaniments were documented, please 1 j provide copies of the documentation for each sceompanir.nnt. l l None. 1 4 l 1 i (iv) Describe or provide an update on your instrumentation and methods of calibration.
! Are all instruments properly calibrated at the present time?
1 i
! We continue to use the services of the TDH Bureau of Radiation Control to
! calibrate all Ludlum survey instruments. A recently acquired Eberline
! instrument, which is not due for recalibration yet, will be sent to the Eberline
{ company for calibration.
Currently available instrumentation is as follows:
1 Ludlum Model3 1 Ebedine Model 6000 4 Ludlum Model19 9 Ludlum Model14C 2 Ludlum Model12S All instruments are propedy calibrated at this time.
FATmwneccarro7.arr srass7 22
/ ..
[ Radiological laboratory analyses of all environmental samples collected by TNRCC are conducted by the TDH Laboratory through an lateragency 3 i j contract. The TDH laboratory is weH equipped (see Annendix U-3 for a list of l
. TDH laberatory equipment).
l l i 35(e). Response to Incidents and Allegations l
l (i) Please provide a list of the most significant incidents (i.e., medical misadministration, j overexposures, lost and abandoned sourcer, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less i noti 6 cation, etc.) that occurred in the Region / State during the review period. For j Agreement States, information included in previous submittals to NRC need not be repeated. The list should be in the following format: l l LICENSEE NAME LICENSE # DATE OFINCIDENT/ REPORT ,
i TYPE OF INCIDENT l A summary of the incidents reported is given in the table below:
i j Licensee License No. Date ofIncident Type ofincident j No. Repon (see details below) 1 l Malapsi Resources RW 2436 1 June 16,1995 lixiviant spill l Company 2 July 25,1996 injection well problem Malapal Resources RW 2436 3 September 7,1994 elevated bionssay Company l
URI,Inc. RW 3653 4 September 8,1995 yeuowcake spill i USX/ Texas Uranium RW 2449 5 November 3,1995 allspillsin unrestricted
! Operations 6 May 19,1996 areas j 7 September 21,1996
^
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l 1. June 16,1995: Spill in the H6 Weufield to enrestricted area; corrective action l l taken by the licensee. Called Mr. Bob Doda of NRC Region IV to report the
- spill.
- 2. July 25,1996: Injection weHs problem in mine area H-1 extension was
! reported to the TNRCC by letter dated July 25,1996 from Cogema Mining, l
- Inc.(COMIN), the operator. An investigation is being conducted by the staff i of the UIC, Uranium, and Radioactive Waste Section. Corrective actions are i being taken by COMIN. Monthly progress report regarding H-1 extension are i sent to the TNRCC.
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- 3. September 7,1994: An elevated bloassay result for a COMIN employee was l
( reported to the TNRCC in September 1994. This is under investigation.
- 4. September 8,1995: A yeHowcake spill occurred at the KingsvlHe project dryer ;
buuding within the restricted area. The yellowcake spill was reported to l TNRCC, Region 13/ San Antonio on September 8,1995, by the licensee. j According to URI's RST, the lids of the two yeuowcake drums (55 gaHon each) )
blew off, and each drum lost about one half ofits content. The spill occurred within the dryer buuding on the weighing pad. According to the RST, the two yeHowcake drums contained more hydrogen peroxide (H2O2 ) than usual.
- According to the RST, the first drum blew its lid off at about 12
- 15 a.m., and
{ the second drum blew its lid off at about 12:45 a.m on September 8,1995. The j operatica was discontinued and decontamination efforts were immediately
! initiated. According to the RST, approri:nately one drum of yellowcake (one j , half from each drum) was splHed on the weighing pad. According to the RST, j 3/4 of the spilled yellowcake was recovered, while the other 1/4 was washed into l the sump. According to the RST, decontamination of the area has been
! completed, and air, soll, and water samples have been collected. Radiological
! surveys of the area were also performed. Bionssays for individuals involved l with the spill were performed.
i During the 1995 inspection, yellowcake spill area at the dryer buuding (in i curbed weighing area and outside the curbed weighing area) was surveyed.
i The highest reading was 10,000 count per minute. When asked what steps the licensee has taken to prevent the yellowcake spill, the RST stated that the
! operators will check the yellowcake drums for abnormality; that the drums will i be allowed to cool down for a longer period; and that the amount of hydrogen j peroxide (H2O2 ) in the uranium will also be monitored.
i i
5-7. Nov.1995, and May and Sept.1996: There was one spill to unrestricted area
{ in 1995 and two spills to unrestricted area in 1996. Corrective actions were l taken by the licensee.
l i (ii) During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were de6cient? If so, how and when ;
were other State /NRC licensees who might be affected notified?
- a. For States, was timely notification made to the Office of State Prograrns?
, For Regions, was an appropriate and timely PN generated?
i Incidents numbers 1-3 and 5 -7 wen nported to the Office of State Programs representative in the NRC Region IV office in Arlington, Texas. Incident #4 did not e
l ramcewcn?.pi; seas,7 24 l t ,.-
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'*< l I result in contamination outside the restricted area limits; hence no reporting was f 1 "4 required.
(iii) For incidents involving failure of equipment or sources, was information on the ,
- incident provided to the agency responsible for evaluation of the device for an )
assessment ofpossible generic design deficiency? Please provide details for each l case.
i l None.
(iv) 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.
None. ,
(v) Identify any changes to your procedures for handling allegations that occurred during the period of this review.
None. l
- n. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed. None.
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i PATMTNRCCB(PEP 97. REP 5.2897 25 9
APPENDIX D LICENSE FILE REVIEWS
, File No.: 1 Licensee: Offenhauser Company License No.: LO3109 Location: Houston, TX Amendments No.: 17,18, and 19 License Type: Industrial Radiography (Fixed) Reviewer: DF, TG, BDB Date issued: 02/24/95, 07/01/96,08/06/96 Comment:
a) Changed the RSO in July 1 amendment. Exemption was granted for the RSO. He did not have the required high school diploma or GED. Good documentation was in the file to support the exemption.
File No.: 2 Licensee: University of Texas Medical Branch License No.: LO1299 Location: Galveston, TX Amendments No.: 43, 44, 45, 46, and 47 License Type: Broad Medical Reviewer: PM Date issued: 01/19/96,04/02/96,05/09/96,07/11/96,08/28/96 Comments:
a) Although amendments completed, the license h'as been under timely renewal since December 1992.
b) Amendment 44 was a correct copy issued to Amendment 43 adding letters in the tie-down condition that were left off of Amendment 43.
c) Exemption requested to a license condition about record keeping requirements at a storage only location. Justification well documented and exemption granted.
Amendment 46 captured the exemption.
File No.: 3 Licensee: Central Pharmacy (formerly Sholars Drug) License No.: LO4785 Location: Orange, TX Amendment No.: 6 Licensee Type: Nuclear Pharmacy Reviewer: DW Date issued: 05/29/97 Comments:
a) Raquested an exemption under Sholars Drug not to provide internal dose monitoring. The licensee did not provide adequate justification for the request and the exemption was denied.
File No.: 4 Licensee: Gulf Coast inspection License No.: LO4934 Location: Ingleside, TX New; and Amendment No.: 1 and 2 License Type: Industrial Radiography (Fixed) Reviewer: DF, SW, LK Date issued: 03/14/96, 03/28/96, 05/29/97 t
i i
Texas Draft Report Page D.2 l License File Reviews 1
l File No.: 5 l
- Licensee
- Camco incorporated License No.: LO3303 !
i Location: Houston, TX Amendments No.: 10 License Type: Industrial Radiography (In-Plant) Reviewer: WS Date issued: 08/08/96 File No.: 6 Licensee: MacGregor Medical Associates License No.: LO4646 l Location: Houston, TX Amendment 3 i License Type: Nuclear Medicine (Diagnostic and Therapy) Reviewer: PM Date issued: 11/21/95 File No.: 7 i Licensee: University of Texas at San Antonio License No.: LO1962 Location: San Antonio, TX Amendment No.: 32 License Type: Research and Education Reviewer: DJ Date issued: 04/22/97 File No.: 8 Licensee: Joe Arrington Cancer Research & Treatment Center License No.: LO4881 j Location: Lubbock, TX Amendment No.: 8 i License Type: HDR and Therapy Reviewer: PM File No.: 9
[ Licensee: Lockheed Fort Worth Facility Licsnse No.: LO1866
! Location: Fort Worth, TX Termination License Type: Research and Development Reviewer: FH Termination issued: 06/09/95 '
File No.: 10 i I Licensee: Ybarrondo & Associates - Scientech, Inc. License No.: LO4435 l_ Location: Carrollton, TX Termination License Type: Calibration and Reference Sources, Unsealed Radioactive Material Reviewer: DF Termination Issued: 06/20/95 i
Comment:
a) Had to request additional information and conduct field inspection prior to releasing site.
i File No.: 11 Licensee: 3M Company / Health Physics Services License No.: LO3843
- Location: _ St Paul, MN (Austin, TX) Termination l License Type: Fixed Gauges Reviewer: WS
, Termination Issued: 05/14/96 i
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' Texas Draft Report Page D.3 !
License File Reviews
)
File No.: 12 '
l Licensee: LogTech Wireline Services, Inc. License No.: LO2501 l Location: Tyler, TX Termination License Type: Well Logging Reviewer: DF Dated issued: 12/12/95 i ' File No.: 13 l
Licencee: South Texas Utility Contractors License No.: LO5065 l Location: Mercedes, TX New License Type: Portable Gauges Reviewer: DF Date issued: 06/06/97 Comment:
a) Did not include the standard condition for leak testing.
( File No.: 14 Licensee: Jagoe-Public Company License No.: LO5042 Location: Denton, TX New l License Type: Portable Gauges Reviewer: WS l l Date issued: 06/03/97 l File No.: 15 Licensee: Health Images Inc. I l D.B.A. Health Images Medical Center License No.: LO5005 Location: Houston, TX New & Amendment No.: 1 and 2 License Type: Diagnostic Nuclear Medicine Reviewer: PM Date issued: 09/20/96,04/08/97 and 04/16/97 l File No.: 16 Licensee: Northeast Medical Center Radiology License No.: LO2926 Location: San Antonio, TX Renewal License Type: Private Practice Nuclear Medicine & Therapy (<30 mci) Reviewer: DW l Date issued: 03/05/96 l
Comment:
a) This was a renewal in entirety and not by letter.
File No.: 17 Licensee: Cardiology Care Consultants License No.: LO5045 l Location: El Paso, TX New License Type: Private Cardiology Reviewer: DW Date issued: 05/01/97 f
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- Texas Draft Report Page D.4 License File Reviews File No.
- 18 Licensee: Texoma Medical Center License No.: LO1624 l Location: Denison, TX Amendment No.: 45 License Type: Institutional Nuclear Medicine,
, Therapy and Brachytherapy Reviewer: PM ;
Date issued: 05/27/97 File No.: 19
, _ Licensee: Nacona General Hospital License No.: LO4977
. Location: Nacona, TX New License Type: Mobile Nuclear Medicine Reviewer: DRJ Date issued: 09/11/96 i
File No.: 20 '
Licensee: Nuclear Sources & Service, Inc., !
D.B.A. NSSl/ Recovery Services, Inc. License No.: LO1811 Location: Houston, TX ,
Amendment No.: 43 License Type: Waste Processor-Class B Reviewer: PS l Date issued: 04/19/96 Comment:
a) Condition 9 stated that Attachment 1 was attached to the license and was a part of the license. Attachment 1 was not with the amendment. This was corrected as soon as it was brought to the reviewer's attention.
File No.: 21 Licensee: Johnson & Johnson License No.: LO1870 Location: Sherman, TX Amendment No.: 16 License Type: Pool Irradiator Reviewer: TG Date issued: 08/23/95 6
1.
1
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i APPENDIX E INSPECTION FILE REVIEWS i
! File No.: 1 l Licensee: Mundy Contract Maintenance, Inc. License No.: LO4360 J
Location: Pampa, TX Inspection Type: Unannounced / Routine '
License Type: Industrial Radiography Priority: 1 j Inspection Date: 01/23/97 Inspector: RA 4
l Comments:
Unable to determine whether previous NOV followed up or corrected.
, a) c b) No description of findings related to management. I i c) Inspector area surveys and maximum range of licensee personnel dosimetry not in l report.
]
4 File No.: 2 i Licensee: Don and Sybil Harrington Cancer Center License No.: LO3053 l
- Location: Amarillo, TX Inspection Type: Unannounced / Routine
! License Type: Medical Brachytherapy Priority: 1 l Inspection Date: 04/19/96 -
Inspector: RA i
Comments:
I a) Maximum range of licensee personnel destinetry not in report.
i b) Cannot determine whether licensee performed operational checks for inspector, j c) Dates of leak test records checked prior to date licensee received all sources.
i File No.: 3 i Licensee: Amarillo Diagnostic Clinic License No.: LO4085 l Location: Amarillo, TX Inspection Type: Unannounced / Routine
. Licensa Type: Medical Priority: 2 Inspection Date: 05/17/96 Inspector: RA l
- Comments:
j r) License authorizes diagnostic use only but report indicates therapy also performed.
t b) Instrument ca!ibration expired but not identified.
I c) NOV issued for dosimetry records not maintained but report indicates records
- available through 04/96.
J
- File No.
- 4 i Licensee: X-Cel Group, Inc. License No.: LO3548 i Location: Corpus Christi, TX Inspection Type: Unannounced / Routine / Partial l License Type: Industrial Radiography Priority: 1 i inspection Date: 05/09/95 inspector: DC 1
i Comment:
j a) No description of inspection findings related to management.
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} Texas Draft Report Page E.2 Inspection File Reviews File No.: 5 Licensee: Bay Area Healthcare Group, Ltd. License No.: LO9723 i Location: ' Corpus Christi, TX Inspection Type: Initial / Partial License Type: Eye Applicator Priority: 2 Inspection Date: 01/08/97 Inspector: DC 7 Comment:
a) Unable to determine whether inspection sanounced or unannounced.
I
! File No.: 6 Licensee: Star-Jet Services, Inc. License No.: LO2214
- Location: Corpus Christi, TX Inspection Type: Unannounced / routine License Type: Weil l%mg Priority: 1 Inspection Date: 10/16/96 . Inspector: DC 1
} Comment:
l a) No description of inspection findings related to management.
File No.: 7 Licensee: Boart Longyear License No.: LO4302 i Location: Houston, TX Inspection Type: Unennounced/ Routine
e Comment:
a) Several NOV's identified in 1994 but not issued until 1996 inspection.
File No.: 8 Licer.see: Houston Northwest Radiotherapy Center License No.: LO2916 Location: Houston, TX Inspection Type: Announced / Routine License Type: Teletheiapy Priority: 1 Inspection Date: 08/29/95 Inspector: LC File No.: 9 Licensee: Scott & White Memorial Hospital License No.: LOO 331 Location: Temple, TX Inspection Type: Announced / Routine License Type: Nuclear medicine Priority: 3 inspection Date: 12/19/96 Inspector: CD Comment:
a) Unable to determine whether emergency instructions to workers inspected or employee interviews performed.
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Texas Draft Report Page E.3 Inspection File Reviews File No.: 10 Licensee: H&H X-Ray Services, Inc. License No.: LO2516 Location: Tyler, TX; Bryan, TX Inspection Type: Unannounced -
License Type: Industrial Radiography Priority: 1 inspection Date: 02/27/97 Inspector: CD File No.: 11 Licensee: Reinhart and Associates, Inc. License No.: LO3189 Location: Austin, TX inspection Type: Announced / Routine License Type: Industrial radiography Priority: 1 inspection Date: 12/13/96 inspector: CD 4
l Comment:
2 a) No observation of licensee field operations.
1
'. File No.: 12 l Licensee: Cleveland Regional Medical Center . License No.: LO2055
- Location
- Cleveland, TX Inspection Type: Announced / Routine
- License Type
- Nuclear medicine w/ therapy Priority: 1 l Inspection Date: 02/06/97 Inspector: HD l
- Comments:
l a). Physician using radioactive material not named on license. ,
j b) No description of !nspection findings related to management. l j c) Closeout of previous NOV not clearly documented. l
. 1 i File No.: 13 !
Licensee: Blood Center of Southeast Texas, Inc. License No.: LO4399 l Location: Beaumont, TX inspection Type: Unannounced / Initial l License Type: Irradiator '
Priority: 2 Inspection Date: 04/29/97 Inspector: HD Comment: l a) Survey meter not required to be available by license; unclear how licensee monitors during emergencies.
File No.: 14 Licensee: Syncor International Corp. License No.: LO2048 Location: Dallas, TX inspection Type: Announced License Type: Pharmacy Priority: 1
-Inspection Date: 03/13/97 Inspector: RE Comments:
i a) Inspector surveys or independent measurements not documented, b) Field note form outdated.
m,
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! Texas Draft Report Page E.4
! Inspection File Reviews )
lI l
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. File No.: 15 Licensee: Physician Reliance Network, Inc. License No.: LO5019 3 l Location: Sherman, TX Inspection Type: Announced / Initial J l License Type: Brachytherapy Priority: 1 Inspection Date:- 02/27/97 Inspector: RE j L Comments: ,
I a) Field note form outdated. I b) Report indicates no dosimetry badges available but sources transferred on 2/19/97.
Fihe No.: 16
. Licensee: Corpus ChristiInspection & Engineering Inc. License No.: LO4379 Location: Houston, TX Inspection Type: Unannounced / Initial l License Type: . industrial Radiography Priority: 1 Inspection Date: .10/16/96 Inspector: EF i I
Comment: )
a) No description of inspection findings related to, management.
File No.: 17 Licensee: University of Texas Health Science Cent-sr License No.: LO2774 Location: Houston, TX Inspection Type: Announced / Routine License Type: Broad medical Priority: 1 g . Inspection Date: 03/18 20/97 Inspector: EF l Comments:
a) Field note form outdated (1986). i b) Inspection overdue. l
! c) Inspector smears did not include laboratory sink areas where small amounts of tritium disposed.
J l File No.: 18 Licensee: SPL Wireline Services, Inc. License No.: LO1983 )
Location: Granbury, TX Inspection Type: Unannounced / Routine License Type: Well logging Priority: 1
' inspection Date: 04/09/96 Inspector: CL Comment:
a) Emergency equipment not checked in 1995 or 1996 reports.
' File No.: 19 Licensee: Sterigenics International, Inc. License No.: LO3851
- Location: Fort Worth, TX Inspection Type: Announced / Routine
! License Type: Pool irradiator Priority: 1 j Inspection Date: 05/03/96 Inspector: CL
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.-. . . . . - . - . . - - . _ . . - . . .- -. - . . . . . . ~ . - . . . - - . - . - . - - - -..
Texas Draft Report Page E.5 inspection File Reviews Comment:
- a) Cannot ' determine whether licensee performed operational checks for inspector, j
' s File No.: 20 Licensee: BPB instruments, Inc. License No.: LO4405 I
j- Location: Kilgore, TX Inspection Type: Announced / Routine License Type: Well-logging Priority: 1 ;
Inspection Date: 05/16/97 Inspector: MV . .
Comment:
a) Report indicates material used 11/96, but license riot issued until one month later, i
File No.: 21 Licensee: East Texas Medical Center License No.:. LOO 977 ;
j Location: Tyler, TX Inspection Type: Announced / Routine License Type: Medical - Diagnostic & therapy l
- Priority
- 1 l
] Inspection Date: 01/30-31/97 . Inspector: MV j
- Comments:
, a) Unable to determine how 2 misadministrations followed up during inspection. l
.; b) Response to NOVs not in file. i i
File No.: 22 I
) Licensee: Baylor University License No.: LO1290 i Location: Dallas, TX Inspection Type: Annour:ced/ Routine
- License Type
- Broad medical Priority: 1 j inspection Date:' 03/12/96 Inspector: RW
)
l j-i File No.: 23
. Licensee: Bonded Inspections, Inc. License No.: LOOS 93 Location: Garland, TX Inspection Type: Announced / Routine l License Type: Industrial radiography Priority: 1 Inspection Date: 04/14-15/97 Inspector: RW Comments:
a) No observation of licensee field operations.
b) Worker interviews not documented.
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,a.
- Texas Draft Report inspection File Reviews Page E.6 l i
! Insoection accomoaniments:
Accompaniment No.: 1 Licensee: Bonded inspections, Inc.
Location: Garland, TX License No.: LOO 693 l , inspection Type: Announced / Routine 4
- License Type
- Industrial radiography Priority: 1
- Inspection Date: 04/14-15/97 Inspector: RW l Accompaniment No.: 2 1 Licensee: Denton Regional Medical Center License No.: LO2764 i Location: Denton, TX , inspection Type: Announced / Routine l License Type: Hospital '
Priority: 2 I inspecti.on Date: 04/10/97 Inspector: RE
.f Accompaniment No.: 3 Licensee: Longview Inspection License No.: LO1774 I g Location: Longview, TX Inspection Type: Announced / Routine / Complete
- License Type: Industrial Radiography Priority: 1 inspection Date: 04/17/97 inspector: MV i
j~ Accompaniment No.: 4
, Licensee: Syncor international Corporation License No.: LO3398 j' Location: Amarillo, TX Inspection Type: Unannounced / Routine / Complete i License Type: Nuclear Pharmacy Priority: 1 inspection Date: 05/20/97 Inspector: RA Accompaniment No.: 5 Licensee: Syncor international Corporation License No.: LO2117 Location: Austin, TX Inspection Type: Unannounced / Routine / Complete l License Type: Nuclear Pharmacy Priority: 1 l inspection Date: 05/21/97 Inspector:
Accompaniment No.: 6 Licensee: Gulf Coast inspection License No.: LO4934 Location: ingleside, TX Inspection Type: Routine / Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 06/11/97 Inspector: DC
- Accompaniment No.: 7 Licensee: Associated Testing Labs, Inc. License No.: LO1553 Location: Corpus Christi, TX -
Inspection Type: Routins/ Announced License Type: Gauge Priority: 2 inspection Date: 06/11/97 Inspector: DC i
w
Texas Draft Report Page E.7 Inspection File Reviews Accompaniment No.: 8 Licensee: MacGregor Medical Associates License No.: LO4646 Location: Houston, TX inspection Type: Routine / Unannounced License Type: Nuclear Medicine Priority: 2 Inspection Date: 06/12/97 Inspector: DS Accompaniment No.: 9 Licensee: CAMCO License No.: LO3303
- Location: Houston, TX inspection Type: Routine / Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 06/12/97 Inspector: DS Accompaniment No.: 10
- Licensee: Santa Rosa Health Care Corporation License No.: LO2237 Location: San Antonio, TX Inspection Type: Routine / Unannounced License Type: Nuclear Medicine & Brachytherapy Priority 1 Inspection Date: 06/24/97 -
Inspector: RW I
d e
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Y
APPENDIX F l
lNCIDENT FILE REVIEWS File No.: 1 l Licensee: Unknown License No.: NR Location: Midland, TX Date of Event: 08/18/96 Type of Event: Release cf Radioactive Material Summary: A State inspector found Ir-192 contamination near a concrete wash bay at a truckwash. An area of ground read 3 mrem /hr on contact.
! Comments:
l a) The State could not determine who was responsible for the contamination.
b) The contaminated dirt was removed and transferred to a local company (authorized for radioactive material storage) to be held,for decay.
l File No.: 2 Licensee: Texas A&M University.
l License No.- 42-09082 09 Location: College Station, TX Date of Event: 10/12/94 Type of Event: Release of Radioactive Material Summary: A dog injected with 17 mci of Tc 99m voided contaminated urine resulting in contamination being spread to severallocations of the clinic before nuclear medicine staff became aware of the event. The clinic did not notify the Radiation Safety Office until the day after discovery of the event. The licensee provided detailed documentation of the event to Texas. Several violations were issued.
Comment:
a) An on-site investigation was not conducted due to the short half-life of the radionuclide involved.
File No.: 3 Licensee: Kooney X-Ray Location: Barker, TX License No.: NR Date of Event: 02/08/95 Type of Event: Loss of Radioactive Material l Summary: A 33 CiIr 192 radiography camera was reported lost by the licensee, it was found by an individual who reported it to authorities.
Comment:
Camera had fallen off a truck. No apparent damage occurred. The licensee was n)
! cited for violations.
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Texas Draft Report Page F.2 incident Files Reviews !
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File No.: 4 l
- Licensee
- Midland inspection and Engineering !
Location: Odessa, TX !
License No.: NR I
- Date of Event: 03/24/95 i
Type of Event: Equipment Failure i
- Summary
- A 20 CiIr-192 source became disconnected due to a worn ball on the end of I the drive cable and resulted in a 18 mrem dose to the RSO during source retrieval. l i 1 Comment:
- a) The cable was sent to the manufacturer for repair. No analysis of the failure was
, documented in the file.
- File No.: 5 '
! Licensee: Petroleum industry ;
Location: Houston, TX !
License No.: NR Date of Event: 09/12/95 Type of Event: Equipment Failure
. Summary: A 56 Ci Co-60 radiography source could not be retrieved back into the camera
! due to apparently worn bearings in the crank handle. The source was retrieved by manually pulling the source cable. There were no excessive exposures.
Comments:
a) Although the crank had been inspected two weeks earlier and no problems were
- noted, the licensee believes the crank handle bearings had become pressed together i due to daily wear and tear.
b) There was no evaluation of whether the failure was a user problem or product problem. No information of the failure was sent to the manufacturer.
File No.: 6 Licensee: Quantum Chemical Location: Deer Park, TX License No.: NR 4 Date of Event: 04/10/96 l Type of Event: Equipment Failure
- Summary: A nuclear density gauge 3 Ci Cs-137 was left in the open position due to the l gauge's rusted handle / shaft breaking off when shutter closure was attempted.
d i Comments:
a) The gauge was replaced by a service company.
b) The State did not investigate the root cause of the severe rusting with respect to
, the conditions of use or type of material used in the handle / shaft, c) The State did not notify the gauge manufacturer of the failure.
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w Texas Draft Report Page F.3 incident Fi!ss Reviews File No.: 7 Licensee: H end G Inspection Company Locetion: Houston, TX License No.: NR Date 'of Event: 03/27/9b Type of Event: Equipment Failure Summary: The automatic locking device on a radiography camera would not allow the radiographer to crank the source out to an exposed position. The RSO cleaned the locking device and the device operated correctly.
Comments:
a) The NMED event date is incorrectly listed as 03/27/75.
b) The licensee determined that a stiffer housing on the crankout device corrected the problem and notified the manufacturer of the problem.
1 File No.: 8 Licensee: X Cel Group, Inc.
Location: Corpus Christi, TX License No.: NR Date of Event: 08/23/94 Type of Event: Equipment Failure Summary: A 29 Cl, Ir-192 source became stuck in the guide tube of a radiography camera. Two radiographers retrieved the source without contacting the RSO. No overexposures resulted.
- Comments:
a) A violation was issued for not following emergency procedures.
b) A rusted cable was the apparent cause of the source jam, c) The State did not evaluate the conditions of use that may have led to the excessive rusting.
File No.: 9 Licensee: TN Technologies, Inc.
Location: Round Rock, TX License No.: 42-01485 04 Date of Event: 03/27/95 Type of Event: Equipment Failure Summary: A retaining ring on a gauge source holder assembly failed and allowed the source capsule containing 100 mci of Cs-137 to fall out of the gauge during an attempt to turn on the gauge. The area was secured and the licensee was notified. The licensee repaired the source and shutter assembly.
Comments:
a) No overexposures occurred during the event, b) Although it was determined that no generic problem or design defect caused the f ,
- e Texas Draft Report Page F.4 incident Files Reviews failure of the retaining ring, the assembly was redesigned to eliminate future failures.
c) The State did not evaluate the root cause of the retaining ring fai!ure.
File No.: 10 Licensee: University of Texas
' Location: San Antonio, TX License No.: NR Date of Event: 09/12/95 Type of Event: Misadministration Summary of incident: A 50 mci Cs-137 source was inadvertently left on the patients bed at the time of loading. It remained on the patients bed for 22 hours2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br /> before it was discovered.
Comments:
a) . The therapy plan was revised to obtain the prescribed dose to the area of interest.
b) The worst case skin dose scenario calculated to be 17,600 rad.
c) Texas conducted an on-site investigation and concurred with hospital's corrective and preventive actions.
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File No.: 11 ;
License: K. G. Taylor, Co. !
License No.: NR l Location: Odessa, TX Date of Event: 06/09/94 l Type of Event: Potential Source Damage 1 l Summary: A local health department notified Texas of a fire in a wooden storage shed involving a 250 mci Am-Be calibration source. Texas conducted an on-site inspection and '
! determined there was no contaminaticn and no damage to the source i !
l File No.: 12 l License: BlX Testing Laboratory l
License No.: NR I Location: Odessa, TX l
Date of Event: 03/23/94 Type of Event: Overexposure Summary: A radiography trainee who was not qualified to perform radiography attempted to take some radiographs on his own while the other radiographer was developing films.
When the trainees dosimeter was observed to be off-scale, the film badge was processed and indicated a 21.36 rem whole body dose.
Comment: -
a) The State immediately performed an on site inspection and issued violations and proposed an administrative penalty.
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APPENDIX G I SEALED SOURCE AND DEVICE REVIEWS l
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File No.: 1 I Registry No.: TX-0642 D 101-B l Licensee: Tremetrics Chromatography Group, Finnigan Corporation j SSD Type: Electron Capture Detector Cell l Date issued: 08/08/94 l l Comments:
! 1. The 08/8/94 action was a name change only. The request letter lists Finnigan l Corporation, Tremetrics Chromatography Group, but the registration certificate lists L it TCG, FC. The same appeared on TX 0642-D-102-B and TX-0642-D-801-B. The review team suggests that all three registration certificates be corrected at the next
, amendment.
l 2. With the 05/16/94 action for the wipe test procedures, it states " Place the blank inspection sheet and a copy of your license along with...." This is apparently directed toward Specifically Licensed Users (SLs). Since the procedure would apply to all users including Generally Licensed Users (GLs), it may be confusing to GLs since they may not know what to do about the " copy of tiielt license." The review j team suggests that the procedures be rewritten to apply accurately to GLs as well as SLs at the next time that the file is opened.
! File No.: 2 -
Registry No.: TX-0642-D-102-B Licensee: Tremetrics Chromatography Group, Finnigan Corporation SSD Type: Electron Capture Detector Cell l Date issued: 08/08/94 i
No comments.
File No.: 3
' Registry No.: TX-0642 D-801-B (was 642/103)
- Licensee
- Tremetrics Chromatography Group, Finnigan Corporation )
SSD Type: Electron Capture Detector Cell Date issued: 08/08/94 Comments: I
- 1. The review team did not find a request letter from the distributor requesting that the
' registration certificate TX-0642-D-103 B be changed to inactive. The reviewer l could not find the letter either and believes that the Tremetrics RSO transmitted the request via phone, and that the phone call was not documented. The review team suggests that all requests be documented.
- 2. With regard to taking a registration certificate inactive, the reviewer said that the 1
distributor states that there were no changes to the device, therefore the only l change made to the registration certificate was to change the product number in the
- registration certificate number. The review team suggests that when a registration certificate is taken inactive, that the reviewer determine the total number of units
? distributed, the number of units stillin the field, and ensure that allletters listed in
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Texas Draft Report Page G.2 Sealed Source and Device Reviews the REFERENCE section of the registra+;on certificate are in the file (with attachments). The review team also suggests that the registration certificate be changed to past tense as appropriate (i.e. change "the model XX is authorized for )
distribution to specific licensees" to "as of x/x/xx, the model XX is no longer i
authorized for distribution." The reviewer says that State procedures for amendments to active registration certificates includes ensuring that the materialin l the file is up to current standards, so that if there has been a change in what is l required or the level of detail required for the file, the distributor will be asked to provide it. The review team suggests that this procedure be extended to requests to make a registration certificate inactive as far as practicable, j File No.: 4 Registry No.: TX-0634 D-169 B l Licensee: TN Technologies Inc.
i SSD Type: X Ray Analyzer Date issued: 04/25/94
~
No comments.
File No.: 5 Registry No.: TX-0634-D-131-B Licensee: TN Technologies Inc.
SSD Type: Fixed Gauge Date issued: 01/11/96 Comments:
1.- The 05/12/95 registration certificate added the 5034A to use a 2 ft belt vs a 3 ft belt (same source and source holder as already approved for the 5034), and removes a protective screen for this model. The deficiency letter asks the applicant to justify having no guard. The applicant's response says that they will use a guard, but then the next document in the file is the SS&D which says there is no guard and that the vertical distance will be 7.5 inches or less. It is not apparent from the file where the applicant stated that there would be no guard, and that the vertical distance between the source housing and the detector would be restricted to a maximum of 7.5." Upon discussion with the reviewer, the reviewer stated that he thought the applicant may have provided that information in a phone call. The review team suggests that allinformation pertaining to the design or limitations of an item, or to applicant commitments, be adequately documented.
- 2. There appears to be a letter missing between TN's 04/28/95 response and the '
SS&D dated 05/12/95, and a 08/14/95 letter missing which may address the issue of the screen guards. During interviews with the reviewer, the reviewer could not find the documents either.
I 3. The SS&D indicates that the vertical distance between the source housing and the j detector will be no more than 7.5." Since the approval of this device for use l without guard screens by generally licensed users is based on this restriction, the j review team suggests that this be included as an item in the LIMITATIONS section 6
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Texas Draft Report Page G.3 Sealed Source and Device Reviews l
l of the registration certificate to ensure that the restriction is clear.
- 4. The registration certificate dated 07/19/95 added the 5038A, which is the 5038 ,
I widened an extra 12" and raised 7," and still has guard screen for distribution to GLs The request letter says that "in the event that the 5038A is distributed to a plant where an individual is able to enter the area between the detector and source i housing (i.e., no GL guards provided)" that lock-out procedures will be provided.
l The registration certificate should indicate that the model 5038A can be distributed without the guards to specifically licensed users only and require that lock-out procedures be provided.
File No.: 6 l red istry No.: TX 0634-D-138 B L!censee: TN Technologies Inc. ,
SSD Type: Fixed Gauge Date issued: 01/11/90, corr. pg 01/25/96 Comment:
- 1. The reviewers completed but the file did not document that the reviewer evaluated l the impact that the reduced wall thickness resulting from enlarging the inside of the i source holder would have on the integrity of the holder. The review team suggests j that this be documented.
l File No.: 7 l Registry No.: TX-0246-D-103-S l
l Licensee: Oceaneering International Inc. )
l SSD Type: Industrial Radiography Date issued: 11/09/95 Comments:
- 1. Texas regulations state that "31.53 (a) Radiographic exposure devices and associated equipment shall meet the criteria set forth by ANSI N4321980. (1) All newly manufactured radiographic exposure devices and associated equipment
, acquired by li.censees after 09/01/93, shall comply with the requirements of this l part." This device does not appear to meet these requirements. The review team i
suggests that the registration certificate reflect this to assist license reviewers using i the registration certificate. (examples of what it does not meet - 31.53(b)(3))
- 2. The external radiation levels listed in the application and the registration certificate ,
do not obey 11 D1 D1 = 12 D2 D2. The distance from the source to the outside surface of the head is 1.855." Section 31.50(a)(1) of the Texas regulations states that for any exposure device measuring less than 4" from the source storage position to the surface of the device shall have no radiation level in excess of 50 mR/hr at 6 inches from any exterior surface of the device." Using the values given
,for the external radiat'on levels to calculate the external radiation level at 6 inches (15.24 cm) from the surface of the device, gives values ranged from 3.079 5.788 mR/hr using the 5 cm value, to 54.74-71.46 m/hr using the 100 cm value. The i range results from whether the 5/30/100cm distances were measured from the 4 - - . . - . -
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e, Texas Draft Report Page G.4 Sealed Source and Device Reviews surface of the gauge or from the source. The values at 6 inches using the 100 cm value all exceed the 50 mR/hr max required in the regulations. The review team J recommends that the manufacturer be contacted for corrected information.
- 3. Quality assurance / control checks only for mechanical and electrical function. The review team recommends that the State obtain commitments from the manufacturer to ensure that external radiation levels are checks on all units and that a program be 1- developed to ensure that these devices are fabricated according to the drawings submitted in support of the evaluation.
- 4. " DIAGRAM: See Attachments" is on the registration certificate twice.
- 5. When the transit cover or the actuator is removed from the head, the depleted uranium (DU) shield is exposed, allowing direct contact with the surface of the DU shield and allowing any loose DU contamination and DU corrosion products to escape. The DU shield is not coated or painted. There is no limitation that requires l that actuator removal be performed in an' area where contamination from the loose DU can be controlled. The review team recommends that the State evaluate this issue to determine whether the design should be required to encase the DU shield, or a Reviewer Note be placed on the registration certificate and procedures be placed in the manual which address this. !
shield. The review team recommends that the State review this issue to determine I whether the damage to the DU shield that might result during source exchange or l replacement would justify requiring a design change to extend the end of the sleeve to outside the DU shield.
- 7. Drawings referenced by the licensee providing information regarding materials, assembly methods, and source containment were not provided to the State (ex. Dwg 401 as referenced in Dwg 004A.) The review team recommends that .the State obtain all referenced drawings, and ensure that questions regarding materials, l assembly methods, and source containment are adequately addressed.
- 8. Dwg 004A refers to Dwg 401, but the drawing for part 401 does not look like what is shown in Dwg 004A. The review team recommends that the State review the drawings to ensure adequacy of design and compatibility of components.
- 9. The safety evaluation was performed assuming that device was a mobile unit. The device as registered is less than 50 lbs. and may be considered portable. The device as used (and leased) is mounted on a crawler and could be considered mobile. The review team recommends that the State review this issue to determine whether the evaluation should be performed on the device as registered or as used.
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