ML20217C998

Proposed Final Rept Impep Review of Texas Agreement State Program, for Period of 970616-27

ML20217C998
Person / Time
Issue date:	06/27/1997
From:	NRC
To:
Shared Package
ML20217C990	List: ML20217C988 ML20217C998
References
NUDOCS 9710020166
Download: ML20217C998 (150)

Text

.

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF TEXAS AGREEMENT STATE PROGRAM JUNE 16 27,1997 i

i t

l PROPOSED FINAL REPORT 4

J a

i U.S. Nuclear Regulatory Commission ATTACHMENT 1 9710020166 970915 PDR ST.'RG ESGTX PDR

Texas Proposed Final Report Page1

1.0 INTRODUCTION

This report presents the results of the review of the Texas radiation control prearam. 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 accordan,,e with the " Interim implementation of the Integrated Materials Performance Evaluation Program Pending Final Commission Approval of the Statement of Principles and Policy for the Agreement State Program and the Policy Statement on Adequacy and Compatibility of Agreement State Programs," published in the Federal l

Reaister on October 25,1995, and the September 12,1995, NRC Management Directive I

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 i

with Texas management on June 27,1997.

[A paragraph on results of the MRB meetir'g will be included in the final report.)

I I

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.

The TDH, Bureau of Radiation Control (BRC) regulates approximately 1,540 materials j

licenses, and received regulatory authority for the 11e(2) uranium recovery program as of July 21,1997, in addition to the radioactive materials program, TDH administers a 4

[

laboratory program for environmental sciences under the Bureau of Laboratories.

The TNRCC regulates low-level radioactive waste burial sites, and the decommissioning of j

former burial sites. TNRCC also regulated the uranium recovery program during the period j

of September 1993 to the time of the review. Authority for the uranium recovery program transferred to TDH on July 21,1997.

4 The review focused on the regulatory program as it is carried out under the Section 274b.

(of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Texas, 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 each responses is included in Appendix C to this report.

4 4

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 inspections in each agency, (5) field accompaniments of nine materials inspectors, (6) a site visit of an uranium production f acility, (7) the review of the low-level radioactive waste i

Texas Proposed Final Report Page 2 program, and (8) interviews with staff and management in both agencies to answer questions or clarify issues. The team evaluated the information that it gathered against +ne IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the State's performance.

Section 2 below dis:usses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common

.serformance indicators are presented in Section 3. Section 4 discusses results of the

pplicable non-common indicators, and Section 5 summarizes the review team's findings, recommendations and suggestions. Suggestions made by the review team are comments h '.ne review team believes could enhance the States program. The State is requested I

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.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 4

The 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 identified to TDH Durino the 1994 Routine Review e

The 1994 review finoings resulted in recommendations to TDH in three program indicators:

(1) Status and Compatibility of Regulations; (2) Adequacy of Product Evaluations; and (3)

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.

On April 10,1995, the Office of State Programs (OSP), notified the TDH that their 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," 10 CFR 31.3 and 31.5. This recommendation is closed.

(2)

Adequacy of product evaluations. NRC suggested that the State review a list of recommendations provided as an enclosure to the 1994 report.

Current Status: The State's corrective actions were evaluated during the IMPEP review. The State has developed template registration certificates and a safety evaluat!on checklist to assist the reviewers in including the items listed in the recommendation both in the evaluation and in the registration certificate. This recommendation it closed.

Texas Proposed Final Report Page 3 (3)

Responses to incidents and Alleged incidents.

(a)

The inspection manual refers to a 24-hour, 72 hour8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />, and 10 day inspection requirements in response to incidents inspection criteria for the 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> and 10-day inspections are documented in the manual, but no criteria for 72 hour8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> inspections are provided.

Current 9tatus: 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 4 4 iuirement to " initiate a 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 w complaint is received." A 72 hour8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> inspection is not required and therefore criteria for such an inspection are not needed. As an added note, the above procedure was revised on May 14,1997. The revisions retained the requirements for on site investigations 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 b'y the TDH. The State should specifically follow un 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 O::currence Report has been submitted to the NRC. This recommendation is closed.

(c)

The Inspection Manual does not address misadministration.

Current Status: The inspection manual procedure referred to is entitled " Incident and Complaint Investigation" and was effective September 7,1988. The May 14, 1997 revision 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 Idemified to TNRCC Durina the 1994 Routine Review 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, i

Texas Proposed Final Report Page 4 that the progress on each recommendation by TNRCC would be evaluated during the next 4

review. On March 14,1995, TNRCC notified NRC of additional progress made with i

respect to the 1994 recommendations. The current status of these recommendations is as i

follows:

1 (1)

Legal Authority (a)

A recommendation was made for the State to take legislative action to revise the definition of low level waste and the limitations on the disposal of transuranic concentrations greater than 10 nanocuries per gram.

Current Status: Legislation was introduced in the 1995 and 1997 legislative session; however, the legislation did not pass. Detailed discussion can be found under the 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.

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.

(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 program.

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.

Current Status: TNRCC updated, and implemented a detailed written procedure for establishing financial assurance. This recommendation is closed.

(b)

A recommendation was made for better documentation between the Texas Low Level Radioactive Waste Disposal Authority (TLLRWDA) and the

.TNRCC, Current Status: Standard documentation was developed and implemented for documentation between the TLLRWDA and the TNRCC. This recommendation is closed.

Texas Proposed Final Report Page 5 (4)

Staffing Level. A recommendt. tion 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 administrat:ve procedure. Since the uranium program is being transferred to TDH, and given the progress made since the last ruview, this recommendation is 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 clarication by citing criteria and standards in the regulations.

Current Status: TNRCC implemented the citing of rules in their deficiency letters and correspondence. This recommendation is closed.

(6)

Inspection Procedures. A recommendation was made for the TNRCC to update the inspection Manual.

Current Status: TNRCC developed and revised the inspection procedures. This recommendation is closed.

(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 imolemented and the reports and associated enforcement actions are being transmitted in accordance with the administrative procedures. This recommendation is closed.

3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials Inspection Program; (2) Technical Staffing and Training: (3) Technical Quality of Licensing Action; (4) Technical Quality of Inspections; and (5) Response to incidents and Allegations.

i o

Texas Proposed Final Report Page 6 3.1 Status of Materials insoection Prooram The BRC's program for this common performance indicator is discussed in this section.

Information for TNRCC in this area for the non common performance indicators, low level radioactive waste disposal program and uranium recovery program, is discussed in Sections 4.3.1 and 4.4.1.

The team focused on four f actors 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 indicator, data gathered independently from the State's inspection data tracking system, the examination of co npleted licensing and inapection casework, and interviews with managers and staff.

BRC uses several data bases to manage the State's radiation control program. BRC uses the data to schedule those inspections that will become due in the next quarter. This inspection due list is forwarded to the regional offices for action. Regional managers also 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 better use of inspection resources and that is a factor in maintaining a low number of overdue inspections in the program. The team did not identify from the casework or accompaniments, any difference in the quality of inspecilons or the number of findings because of this practice.

The team's review of the BRC's inspection priorities verified that the BRC's inspection frequenHes 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 Chapter (IMC) 2800. BRC requires more frequent inspections in some license categories as follows: waste processors were verified to be inspected on a six month frequency 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-earth extraction and processing licensees are inspected every six month compared to NRC three yeer frequency; a specific licensee's low-level waste burial sites are inspected every 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.

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 have inspectors assigned at the time of the review. Inspectors from other regions are conducting inspections in these regions, workload permitting. Although BRC is hiring new

Texas Proposed Final Report Page 7 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 indicator, i

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 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 NRC frequency for new licensees. Considerable inspection effort is dedicated 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 number of new licenses issued.

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 exceeds the IMC 1220 guidance for conducting reciprocity inspections. In addition, the State conducted 122 additional non-rec!procity inspections of 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 is as 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 prepared in the Austin office; (3) senior staff review the letter and inspection report, and (4) BRC 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 information on the inspections available in the file. All files clearly showed that management had reviewed the inspection report and concurred with the inspector's findings.

BRC uses three interrelated data bases to help in the management of licensing, inspections

- and reciprocity activities. BRC can extract data on a State wide and regional basis.

Additiona!!y, 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 questions posed by the team.

Based on the IMPEP evaluation criteria, the review team recommends that Texas' performance with respect to the indicator, Status of Materials inspection Program, be

-found satisfactory.

~

Texas Proposed Final Report -

Ps.a 8 3.2 Technical Staffino and Trainina Except as noted in the discussion, the BRC's program for this common performance indicator is discussed in this section. Information for TNRCC in this area for the non-common performance indicators, low level radioactive waste disposal program and uranium recovery program, is discussed in Sections 4.3.2 and 4.4.2.

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 1

these issues, the review team examined the State'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 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 and x ray inspections. The BRC organization was revised in January 1996 to reflect a flat 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 on a daily basis. Only two recent vacancies were reported in the materiats area, one hed been filled 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 vacancy 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, emergency 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 of senior staff. License reviewers also accompany experienced inspectors during compliance inspections of complex licenses to gain field 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

f I

Texas Proposed Final Report Page 9 accompaniment process and the team's findings are discussed in Section 3.4. The review team determined that all staff utilized for the BRC's program were technically qualified by evidence of thel; training and experience.

Some licensing backlogs have been experienced in the BRC's Licensing Section. BRC management relMed 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 already begun discussions internally and with the managers of TNRCC uranium program to assass 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 thr.t will allow for continued training, and for training at NRC sponsored courses.

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' performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

. 3.3 Technical Quality of Licensino Actions The BRC's program for this common performance indicator is discussed in this section.

Information for TNRCC in this area for the non-common performance indicators, low-level radioactive waste disposal program and uranium recovery program, is discussed in Sections 4.3.3 and 4.4.3.

The review team examined completed licenses and casework for 29 licensa 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.

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 ac':uracy; appropriateness of the license and of its conditions and tie down conditions; and overall technical quality. Casework was reviewed o

Texas Proposed Final Report Page 10 l

for timeliness; adherence to good health phycies practices; reference to apnropriate 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 authcaties. The files were checked for retention of necessary documents and supporting data.

The license casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The sampling included 26 of the State's major licenses and included the following types:

medical broad scope, industrial radiography (temporary and fixed job sites); mobile nuclea-medicine; clast B waste pecessor; pool irradiator; and nuclear pharmacy. Licensing actions evalusied 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 reviewing renewal applications as determined from documentation in the license files and/or discussions with the license reviewers.

The review team found that terminated licensing actions were well documented, showing appiopriate transfer records and survey records. The compliance branch conducts confirmatory surveys as needed prior to the termination being issued. Once an interoffice 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 year frequency, and all other licenses are renewed on a ten year frequency.

BRC has had a large backlog of renewal and amendment requests until last year. Each medical and industrial license reviewer has an average backlog of 54 licensing actions.

BRC has placed more emphasis on the completion of the actions and over the past two years has dropped the backlog by over half. The actions are handled by the following priorities: (1) new, (2) terminations, (3) amendments, and (4) renewals. These priorities 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 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).

O Texas Proposed Final Report Page 11 The licenses issued by the Medical and the industrial Sections receive another concurrence review and are signed by the respective Project Manager in each Se: tion. The Project Managers can sign th*lr own licenses, but the action does not require additional review 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.

The review team found that the current staff is well trained ano experienced in specialized licensing activities (medical, industrial, special and advanced licensing). The casework was reviewed for adequacy and consistency with the NRC procedures. BRC has official, written administrative procedures for licensing reviews. The team found that BRC follows their licensing guides and administrative procedures during the review process to enture that licensees submit the information necessary to support the license. The licensing guides were similar to the NRC guides.

Also, under this indicator, the team reviewed the TNRCC program and procedures used for licensing the inactive non uranium burial sites that were transferred from TDH and the TNRCC program for decommissioning sites. TNRCC reported that four former burial sites had been licensed. Three sites are no longer being used for burial of waste, and are under licenses issued by TNRCC for the possession, storage, control, and environmental I

monitoring activities. One licensee is an active site however, TNRCC rules prohibit amendments or renewal of this license to allow any addition or expansion of the disposal facility. TNRCC managers related that these sites will be decommissioned, and that other sites will be identified and decommissioned in accordance with TNRCC procedures and l

regulations that became effective on June 6,1997. THRCC plans are to imreement this program in January 1998.

Based on the IMPEP evaluation criteria, the review team recommends that Texas' performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

3.4 Technical Quality of Insoections The BRC's program for this common performance indicator is discussed in this section.

Information for TNRCC in this area for the non-common performance indicators, low level radioactive waste disposal program and uranium recovery program, is discussed in Sections 4.3.4 and 4.4.4.

The team reviewed inspecthn field notes and inspection records for 28 materials inspections conducted during the review period, reviewed revisions to the Texas enforcement policy, and interviewed inspectors. At least two reports prepared by each current regional inspector were evaluated. Inspection casework records selected included higher priority inspections of various facility types inclu' ding hospitals, nuclear medicine facilities, academic broad scope institutions, research and development facilities, industrial radiography and gauge use, welllogging facilities, nuclear pharmacies, and pool irradiator.

Attachment E lists the inspection ecses evaluated in depth with case-specific comments.

Prior to the review, two team members performed accompaniments of nine region-based inspectors on separate inspections of high priority facilities throughout the State.

Texas Proposed Final Report Page 12 Inspection procedures and techniques utilized by BRC compliance staff were reviewed and determined to be generally consistent with the inspection guidance idertified in NRC Inspection Manual Chapter 2800. The procer:ures were used to help inspectors identify root causes and poor licensee performance. Although fleid inspctions were conducted, the revised inspec'in procedures do not direct temporary job sites to be inspected (per IMC 2800 guidancs).

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 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, welllogging, industrial radiography, commercial irradiator, medical broad-scope, welllogging, and radiopharmacy were provid'ed 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 f acilities, 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.

The teview team found the leve! of detail provided in mspection reports was consistent with respect to scope of licensed program, licensee organization, management structure, radiation protection program, personnel protection, area posting and labeling. worker 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 final inspection reports and related enforcement actions identified by regional inspectors.

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 rzview team suggests documenting in reports summary discussions of inspecticn 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.

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, enforce. ent conferences, licensee requested hearings, monetary penalties, and civil and criminal penalties through court proceedings, and source impoundment. Team interviews with enforcement staff and

Texas Proposed Final Report Page 13 review of cases involving escalated enforcement actions determined the State's enforcement policies were effectivo 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 office R4PCs (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 actionc 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 indicated a need for escalated enforcement action, enforcement conferences were held with licensees to discuss inspection findings and possible enforcement action against i

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 central 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 performe<l by two review team members. Two inspectors not accompanied were evaluated as acceptable in the previous NRC review bnd two inspectors were newly qualified. Inspection accompaniments were conducted during the weeks oi April 14, May 20, June 9, and June 23,1997 at the following types of facilities: nuclea 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 showed sound inspection techniques, appropriate knowledge of the regulations, and demonstrated overall satisfactory technical performance. A summary of inspection accompaniments is identified in Appendix E.

BRC's policy calls for annual supervisory accompaniments of all qualified inspectors be performed either by RHPCs or senior inspection staff. In resp 3nse 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 inspectors identified in the table received an annual accompaniment each year for calende-years 1994 through 1997. RHPC reports of accompaniments indicated that inspector performance evaluations were complete and thoroughly documented. Since regularly scheduled supervisory accompaniments provide management with important insight into the quality of the inspection program, the review team recommends that the State adhere to the policy of annual supervisory accompaniments of all qualified inspectors.

The team noted an adequate supply of portable radiation detection instruments for use during routine inspections was calibrated and maintained by central office staff. Each regional inspector is issued a ratemeter with GM (side window and pancake) and gamma scintillation detectors, and a micro-R meter. Regional instrumentation is supplemented as

Texas Proposed Final Peport Page 14 needed with a multichannel analyzer, alpha scintillation detector, low energy gamma scintillation detector, and low volume air sampler. At the central office inspector counterpart meetings held every six months, regional inspectors exchange assigned survey meters for newly calibrated instrumentation. Sufficient equipment was a!so available for emergency responsr, activities.

The team toured the State's instrument calibration facility and noted survey instruments are calibrated with a collimated beam calibrator containing a ceWum 137 source with activity of approximately 100 mCl. This relatively k,w activity system limits the calibration 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 confirmsary surveys (field measurements) be calibrated on all ranges.

A tour of the State laboratory tound it to include liquid scintillation spectrometeis, ge flow proportional coumers, and gamma spectrometers (mult.shannel analyzer) for full capability to ana:/ze wipe, water, and soil samples for BRC activities, impounded sources are maintained at the State's downhole storage area located near the State laboratory. " rom interviews with inspectlan and laboratory staff, laboratory processing time ranged from immediato to a few weeks and was acceptable for toutine samples taken by inspectors.

Based on the IMPEP evaluation criteria, the rev5w team recommends that Texas' performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.5 Resoonse to incidents and Alleastions The BRC's program for this common performance indicator is discussed in this section.

Information for TNRCC in this area for the non-common performance indicators, low-level radioactive waste disposal program and uranium recovery program, is discussed in Sections 4,3.5 and 4.4.5.

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 this indicator, reviewed the incidents reported for Texas in the " Nuclear Material Events Database" INMED) against those contained in the Texas files, and reviewed the casework and supporting documentation for 12 materialincidents and ten allegatic'1 files.

It was noted that the State informally defines the terms " incident" and "complaK NRC does not have a definition for " complaints" but defines " incidents" and "allegatiorn" in Management Directive 5.0.

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 6ilegations 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 Assistance Project and Complaint Investigation Project leaders.

Texas Proposed Final Report Page 15 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 investigation for each significant incident and a timely response to allegations. The Technical Assir,tance Program Manager discusses each incom!ng incident or allegation with staff and the response is coordinated with the appropriate field staff. If necessary, field steff end/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 impact on public hesith and safety are brought to Director, Division of Compliance and Inspection attention promptly. Allincidents and allegations are reviewed by manegement on at least a quarterly basis. The State summarized incident information is provided on printed copy to the OSP and to Idaho National Environmental Eng:nec*ing 1.ab (INEEL) for o

entry into the NMED system.

i The subject areas discussed with staff included the State's incident and allegation process, tracking system, file documentation, Open Records Act, and notification of incidents to other Federal and State agencies. Notihcation to the NRC Emergency Operations Center is made by the State for incidents that require immediate or 24-hour reporting by the State licensee. Although this notification requirement is understood by r'nanagement, it is not specified in writing.

The review tsam 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. Insp3ctors 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 license file. The review team noted that the BRC closed four of the six incidents related to equipraent failure without forwarding any liSrmation 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 problems needing to be evaluated and forwarded 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 manufactur6r of the device was informed by the licensee or the State. (See discussion and suggestion in Section 4.2.3.)

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.

BRC plans to fully implement the NMED system by the end of 1997. The team discussed the merits of the NMED system with the Technical Assistance Program Manager who added that they also plan to use NMED for Technical Assistance hequests, Complairts, and Close-outs. The review team suggests that the State initiate actions (through implementation of the procedures provided in the March 1995 Har'dbook on Nuclear Material Event Reporting in the Agreement States) to directly utilize the NMED system.

Texas Proposed Final Report Page 16 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 numericalidentification number was cross-refereaced 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 ptamptly with apptcpriate investigations, follow up, and close out actions. Complaints and technical assistance requests are documented 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 alleger is advised that their j

anonymhy can not be guaranteed.

i Based on the IMPEP evaluation criteria, the review team recommends that Texas' performance with respect to the iridicator, Response to incidents and Allegations, be found satisfactory.

4.0 NON-COMMON PEP.FORMANCE 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 Ledslation and Reoulations 4.1.1 Leaisletive and Leaal 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 byprocuct 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.

The State provided copies of legislation that affects the radiation control program. On June 20,1997, Texas' Governor signed legislation transferring responsibility for the Jranium recovery program from the TNRCC to the BRC. Both agencies are participating in ormoing 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 review team confirmed that there are no legislative changes that would negatively affect the regulation of agreement materials, the low-level waste program, or the uranium recovery program. Except as noted below, the legislation is considered adequate to enable the State to protect nublic health and safety.

0 Texas Proposed Final Report Page 17 The team re identified an open item from the 1994 review. The Texas Low Level Radioactive Waste Authority Act (TL,LRWAA) defines low-level waste as:

" Low level waste means any radioactive material that has a half life of 35 years or less or that has less than 10 nanoruries per gram of transuranics and may include radioactive matorial not excluded by this subdivision with a half life of more than 35 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 defined by Title 10, Code of Federal Regulations."

Whereas, the Low Level Radioactive Waste Policy Amendments Act (LLRWPAA) defines low level waste as:

" Low-level radioactiv., waste means radioactive waste that--(A) is not high-level radioactive waste, spent nuclear fuel, or byproduct material (as defined in section 11e(2) of the Atomic Energy Act of 1954 (42 U.S.C. 2014(o)(2)); and (B) the Nuclear Regulatory Commission, consistent with existing law and in accordance 1

with paragraph (A), classifies as low level waste."

Section 336.701(b)(3) authorization to dispose of transuranic radionuclides states the following:

(b)

A licensee authorized to dispose of radioactive waste under the rules in this subchapter shall not accept for disposal:

(3) waste containing transuranic radionuclides in concentrations of 10 or more nanocuries per gram. This limit of 10 nanocuries per gram of transuranics shall not be equaled or exceeded in waste disposed of at a land disposal facility licensed under the rules in this subchapter, notwithstanding the concentration limits for transuranics specified in 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.

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 radioactivity 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 site located in another State. TNRCC 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 the definition of low-level radioactive waste; however, the House Bill did not pass during the 1995 and 1997 legislative session. TNRCC staff indicated that they will attempt to have the bill reintroduced during the next legislative session (in 1999).

Texas Proposed Final Report Fage 18 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 in fact. At the last program review, NRC withheld a finding of compatibility because the Texas definition was not compatible with NRC's definition. The report 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 the State issues its finallicensing decision. in addition, if the problem is not corrected by the time the f acility begins to operate, it will be incumbent on NRC to consider appropriata action. Depending on the circumstancos surrounding the disposition of the " orphan waste" at that tirne, such action may include suspension or termination of'part of the Texas agreement pursuant to Section 274) 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 legislature and not TNRCC However, the staff notes that it is the State's responsibility as a whole to maintain compatibility with NRC's progra.n, not just TNRCC. As such, tha review team recommends that TNRCC vigorously pursue the changes necessary to make Texas law (statutes and regulations) compatible with those of NRC in the low-level waste 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 Compatibility of Reculations The Texas Regulations for Control of Radiation (TRCR), found in Chapter 401, apply to all ionizing radiation, whether emitted from radionuclides or devices. BRC requires a license for all radioactive materialincluding naturally occurring materials, such as radium, and 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. Precedures also require the proposed regulations, proposed hearing date, hearing comments and analysis be well publicized. Draft copies of the proposed regulations are provided to NRC during the rule development process. Hnal regulations are also placed on the TDH home page and the final regulations are submitted to NRC.

Texas Proposed Final Report Page 19 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 r.me id 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 regulations. This review included regulations required by the State to maintain compatibility through December 1997. The team also reviewed several regulations that are in the rulemaking process as a matter of convenience.

The TDH adopted four NRC regulation amendments that became effective since the 1994 review:

" Notification of incidents," 10 CFR Parts 20,30,31,34,39,40,70 amendments (56 FR 64980) which becarne effective on October 15,1991. The State's rules became effective from September 1993 through October 1995. NRC has reviewed these rules and has found them to be compatible with NRC's regulations.

l

" Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 1

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.

(

" Definition of Land Disposal and Waste Site Ocality Assurance Programs," 10 CFR Part 61 amendment (58 FR 33886) which became effective on July 22,1993. The State adopted this requirement on October 29,1996. Pending review by NRC's Office of General Counsel (OGC), the team recommends that this amendment to TRCR regulations be found compatible with NRC's requirement.

"Self-Guarantee as an Additional Financia' Mechanism," 10 CFR Parts 30,40, and 70 amendments (58 FR 68726 and 69 FR 1618) that became effective on January 28,1994. Note, this rule is designated as a Division 2 matter of 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 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 method (e.g., a parent company guarantee). BRC has proposed this requirement in the development of transportation ruk.s. 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.

TNRCC adopted the following 11 NRC regulation amendments that b9came effective on June 6,1997. Pending review by NRC's Office of General Counsel (OGC), the team recommends that these amendments to TNRCC regulations be found compatible with NRC's requirement.

Texas Proposed Final Report Page 20

• Notification of incidents," 10 CFR Parts 20,30,31,34,39,40,70 amendments (56 FR 64980) which became effective on October 15,1991.

" Definition of Land Disposal and Waste Site Quality Assurance Programs," 10 CFR Part 61 amendment (58 FR 33886) which became effective on July 22,1993.

" Decommissioning Record Keeping Documentation of Restricted Areas and Spill Sites," 10 CFR Parts 30 and 40 (58 FR 39628) that became effective on October 25,1993.

"Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (58 FR 68726 and 59 FR 1618) that becara effective on January 28,1994. Note, this rule is designated as a rivision 2 aatter of 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 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 method (e.g., a parent company guarantee).

" Uranium Mill Tailings Regulations: Conforming NRC Reauirements to EPA Standards," 10 CFR Part 40 amendment (59 FR 36026) that became effective on July 1,1994.

" Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective on August 15,1994.

" Frequency of Medical Examinations for Use of Respiratory Protection Equipment,"

10 CFR Part 20 amendments (60 FR 7900) that became effective on March 13, 1995. This rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement State the flexibility to implement more stringent requirements (i.e., the State could choose to continue to require annual medical examinations),

o

" 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.

" Radiation Protection Requirements: Amended Definitions and Criteria,"

10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.

" Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995.

I Texas Proposed Final Report Page 21 e

" Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on May 19, 1996.

The following rules were not due during the review period but are in the TDH's rulemaking process:

e

" Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards," 10 CFR Part 40 amendment (59 FR 36026) that became effective on July 1,1994. To assure continuous regulation of the uranium activities, the 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.

This rulemaking package is scheduled to be submitted 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, 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 development of its transportation rules. It is in the second draft stage of promulgation. 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, if it is promulgated as a final rule without significant change to the draft.

e

" Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on May 19, 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 by NRC's OGC, the team recommends that this amendment to TRCR regulations be found compatible with NRC's requirement, M it is promulgated as a final rule without significant change to the draft.

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 NRC's OGC, the team recommends that this amendmerit to TRCR regulations be found compatible with NRC's requirement, if it is promulgated as a final rule without significant change to the draft.

i Texas Proposed Final Report Page 22 l

l The review team identified two regulations that have not been put into effect in the BRC program:

• Decommissioning Record Keeping Documentation of Restricted Areas and Spill e

Sites," 10 CFR Parts 30 and 40 (58 FR 39628) that became effective on October 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 Dscember 1997.

The team reviewed the draft regulation. Pending reslew by NRC's OGC, the team recommends that this amendment to TRCR regulations be found compatible with NRC's requirement, if it is promulgated as a final rule without significant change to the draft, e

" Quality Management Program and Misadministration," 10 CFR Part 35 amendment (56 FR 34104) which became effective on January 27,1992. BRC has not adopted the equivalent to the quality management and misadministration rule. As reported to NRC previously, BRC withheld adoption of this rule pending the outcome of the National Academy of Sciences report. NRC is continuing to defer compatibility

. findings for Agreement States that have not yet adopted a compatible Quality Management rule, until NRC issues a revised Part 35 rule, compatibility designations for the new rule are established, and an effective date for Agreement State implementation has been set.

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 following 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 became effective on January 1,1995.

" Frequency of Medical Examinations for Use of Respiratory Protection Equipment,"

10 CFR Part 20 amendments (60 FR 7900) that became effective on March ;3, 1995. This rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement State the flexibility to implement more stringent requirements (i.e., the State could choose to continue to require annual medical examinations).

" Radiation Protection Requirements: Amendad Definitions and Criteria,"

10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.

" Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996.

_.m i

j 4

Texas Proposed Final Report Page 23

" 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, e

" Medical Administration of Radiation and Radioactive Materials," 10 CFR Part 20.35 amendment (60 FR 48623) that became effective on October 20,1995, 4

o

" Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

10 Cf3 Parts 30,40, and 70 amendments (61 FR 1109) that became effective January 16,1997.

• hesolution of Dual Regulation of Airborne Effluents of Radioactive Materials; e

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 Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective on January 13,1997.

e

" Criteria for the Release of individuals Administered Radioactive Material," 10 CFR Part 20.35 amendment (62 FR 4120) that became effective on January 29,1997.

Based on the IMPEP evaluation criteria, the review team recommende that Texas's performance with respect to the indicator, Legislation and Regulations, be found satisfactory.

4.2 Sealed Source and Device Evaluation Prooram in evaNating 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 review, evaluated new procedures and guicance, and interviewed the TDH staff responsible for SS&D evaluations.

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 addressed. The staff has also adopted the use of the NRC's NUREG 1550, " Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations" as standard reviewer guidance.

4.2.1 Technical Quality of the Product Evaluation Prooram 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 evaluated by the review team are listed with case-specific comments in Appendix G. The review team suggests that the State consider the comments in Appendix G, and take action as the State deems appropriate. For 6 of the 7 cases reviewed, the overall quality f

a

Texas Proposed Final Repor*.

Page 24 of the evaluations was good, with minor comments that were addressed during interviews with the staff. However, for one case (TX 0246 D 103 S), the review team identified a number of inconsistencies and issues that appeared to be unaddressed in the review.

Other unidentified review issues cssociated with this case may also exist. The issues identified by the review team are listed in Appendix G, and were discussed with both the initial and the concurrence reviewers.

Based on the limited evaluation perfarmed by the review team and considering the team's experience with similar devices, the f6ct that the device must meet transportation dose rate requirements before shipment, the expected training level or the users, and the State's belief that there have been no devices distributed, the review team believes that the immediate health and safety risk to any potentially current users is low, possibly zero.

However, the review team recommends that the State perform an evaluation to determine l

the safety significance of the issues identified by the review team pertaining to registration 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 l

issues are adequately addrcssed, it was not possible to determine from the limited number i

of files reviewed whether the deficiencies noted in this evaluation was an isolated occurrence or if they raay be present in other evaluations. Therefore, the review team recommends that the State evaluate an adequate sample of additional safety evaluations to ensure that the deficiencies identified in TX-0246 D 103 S are adequately addressed in the additional cases, and to demonstrate that this was an isolated occurrencs.

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 concurrence reviews' for SS&D safety evaluations and implement procedures that require concurrence review for all future evaluations. The review team notes that an indeperdent technical review could have identified the issues involved in the case detailed in the previous paragraph, A concurrence review includes an independent technical review of the materials submitted by the applicant and the documents generated Ly the initial reviewer. The concurrence review includes evaluation of each area addressed during the initial review (e.g., construction of the product, labeling, prototype testing, etc.) but the concurrence review is not to the same level of detail as the initial review (i.e., it is rot necessary to review every page of the apphcant's submitta!). The concurrence review must be focused upon ensuring that the product meets all applicable regulations, that the product wculd not pose any health or safety concerns, and that the registration certification provides an adequate basis for licensing. This concurrence review by a second qualified reviewer is necessary in view of the potential health and safety implication resulting from the widespread distribution of sealed sources and devices.

Texas Proposed Final Report Page 25 f

4.2.2 Technical Staffino and Trainina BRC reported that a two person team with combined staff efforts equating 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 engineering backgrounds.

Both staff members have attended at least ene 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 repcrted that 10 registration certificates were issued or modified during the review period. The actions reported by BRC also included one action associated with Naturally Occurring or Accelerator Produced Hadioactive Materials (NARM). The review team noted that the initial review was caerformed by the same individual for all but one of the 16 registrations s. # cates completed during the review period Since BRC has indicated that this primary :.3..Wi reviewer plans to retire in the near future, the review team suggests that ths Stato consider osvigning safety evaluations to those staff members currently being trained to perform st' ty evatuations to enable them to gain enough experience and obtain registration certificate signature approval before the staff member currently performing the initial review retires.

4.2.3 Evaluation of Defects and incidents Renardino SS&Ds The details regarding the review of incidents asse:: lated with SS&D product f ailures or prob' ems is addressed in Section 3.5 of this report. The State adequately addressed the immediate irsues involved rela.ing to product failures or problems, but 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.

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 recommendavons for improvement.

4.3 Low-Level Radioactive Warte Disoosal Pronram The review tera evaluated the State's responses to the questionnaire, compared Yexas low level rai. active waste (LLRW) statutes and regulations with those of the NRC, evaluated the qualifications of the technical staff and contractors, reviewed the State's written procedurea and plans, examined parts of the LLRW disposal f acility license application and interrogatories, reviewed parts of the environmental and safety analysis report, evaluated field reports and files, and interviewed staff, managers, and contractors assigned to the LLRW program, in 1981, the Texas Legislature created TLLRWDA for the purpose of siting, developing, and operating a LLRW disposal facility. TDH was granted responsibility for licensing the facility. In March 1992, authority to regulate disposal of radioactive substances was transferred from YDH to the Texas Water Commission, in September 1993, authority was

Texas Proposed Final Report Page 26 shifted to TNRCC. Within TNRCC, the LLRW program is administered by the Underground injection Control (UlC), Uranium, Radioactive Waste (UURW) Section within the industrial

& Parardous Waste Division.

TNRCC received an application to license a LLRW disposal facility from the TLLRWDA on 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 submittels (called revisions by TLLRWDA), the application was declared administratively complete on May 12,1995. After being declared complete, TNRCC was under statutory requirements to complete their review of the application within 15 months; however, the TNRCC committed to completing the review by April 1,1996, (that is, ahead of the 15 additional month requirement). After the application was declared administratively complete, additional revisions were made based on interrogatories and meetings with TNRCC staff. The final revision (i.e., no. 20)is dated March 3,1996. TNRCC completed its review of the application on March 29,1996, and a license has been developed.

i l

l Currently, the licensing matter is in an adjudicative hearing with the State Office of Administrative Healings (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 licerne.

During the last program review of Texas, as noted in Section 4.1.1, NRC raised a concern with the compatibility between the State and NRC statutes and regu!stions on the definition of LLRW. The review team found that this issue has not been resolved.

4.3.1 Status of Low level Radioactive Weste Disoosal Insnection Under this part of the program indicator, the review team evaluated the Statt,'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 phase, to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety practices.

The Texas LLRW disposal f acility is in a pre licensing phase; therefore, this program 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 visits have been made for the purpose of rie familiaritation, and collecting envittr. mental samples and background radiation data for independent verification of data submitted in the application. TNRCC staff indicated that there will be regular in'.pections of the r,ite during construction; however, the frequencies of the inspections have not been determined.

The team notes that baseline thermoluminescent dosimeter (TLD) data have been compe'ed against data collected by TLLRWDA, Some discrepancies have been found; however, there is no documentation on 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 process. The review team also notes that none of the baseline data have been put into a computer database. However, the data

Texas Proposed Final Report Page 27 have been captured in a spread sheet by a member of the staff. The review team suggests that the comparative results between TNRCC and TLLRWDA baseline data, including discrepancies, be documented. Further, the baseline data should be entered into a computer database to facilitate its review and use.

4.3.2 Technical Staffino and Trainina The team notes that there are currently flye technical staff members supporting the LLRW program. All technical staff have bachelors' degrees or above. The team also notes that the following disciplines are covered within the program: health physics, civil engineering, chemical engineering, geology, and biology. Surface water hydrology is currently not covered; however, temporary support can be obtained from other sections within the 4

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.

During the license review, additional staff supported the LLRW program, including contractual support from the TDH and the University of Texas. This contractual support is still being provided, in total, epproximately 12 technical persons were involved with the license review, with the following disciplines being covered: geology, hydrology, health physics, biology, geotechnical engineering, chemical engineering, civil engineering, and mechanical engineering.

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, several months ahead of the mandatory requirement. The team was informed that TNRCC staff had to work extra hours to meet the target date.

TNRCC staff is allowed to pursue training as they see the need and as funds are available.

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 because of limited available funds. In the LLRW area, TNRCC is especially interested in the availability of training in performance assessment. TNRCC maintains no complete compilation of training completed by staff. TNRCC Technical Training Academy maintain information on allin house training of TNRCC staff. Through review of staff resumes, the team notes that staff has undertaken additional on-site training, outside training, and participated in workshops. The review team suggests that a consolidated training record be developed to enable assessment of training across the entire program.

The team found no apparent trends in the loss et staff that could adversely affect the program.

4.3.3 Technical Quality of Licensina Actions The purpose of the review under this part of Oe program indicator is to ensure that the State has an acceptable program for licensing the LLRW disposal facility. To evaluate the technical quality of the licensing program, the team reviewed technical aspects of the licensing action, in particular the performance assessment. The team evaluated parts of

1 Texas Proposed Final Report Page 28 the Environmental and Safety Analysis report, parts of the license application, interrogatories, file records, and staff files, in addition, the team interviewed sttff 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 licenses'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 setc of interrogatories during the license review period.

TNRCC staff also had numerous meetings with TLLRWDA staff; issues and resolutions discussed at these meetings are document 9d in the file records.

Assessment of the quality of the license review primarily concentrated on the TNRCC's 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 in the analysis against the literature.

TNRCC concludes that TLLRWDA performance assessment analysis is conservative because it is largely dependent upon water infiltration into the disposal cells; however, the 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 found that in several key areas, which could significantly affect the calculated doses, TNRCC could conduct additional critical analyses in the following areas to ensure that the performance assessment will stand on its own merits:

1.

TLLRWDA analyzed infiltration into the facility by running a modified verblon of the HELP computer code. TNRCC staff reviewed the input, made confirmatory runs, and had the modifications to the code examined by the code developer.

Sensitivity analyses performed by TLLRWDA show that a long term average increase in rainf all by 50% leads to a threefold increase in percolation; however, 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 infiltration to evapotranspiration. It is commonly known that evapotranspiration significantly effects recharge in arid areas. In reaching a proposed licensing decision, TNRCC relied solely upon TLLRWDA's sensitivity analysis which only addressed variation in precipitation. Although the needed increase in precipitation may be unrealistic, it is possible that a small change in evapotranspiration, which

Texas Proposed Final Report Page 29 could be credible, could have the same effect on calculated infiltration.

2.

In the source term analysis, TLLRWDA calculates releases of radionuclides from the facility as a first order process that is a function of percolation and partitioning between the waste and the percolating water. The release model used is commonly cited in the literature. TLLRWDA uses a factor (f ) to relate releases from a surface t

wash off type process to a diffusion process. TLLRWDA relates the i factor to the t

contact tir.ie factor (t,) in IMPACTS. Because of known concerns with the derivation and basis of the contact time f actor in IMPACTS, TLLRWDA used a different approach to derive values for the f factor. The DUST computer code, t

which was developed under agreement with Brookhaven National Laboratory for the NRC, was used to calculate f values by calculating radionuclide fluxes out of the t

disposal facility based on a diffusion process and back calculating a f vslue to get t

an equivalent flux from using a surface wash off model. Estimated f values derived t

for use in the analysis are:

Tc 99 and 1120 0.05 Cl 36 0.01 All other radionuclides 0.1 In discussions with TNRCC staff, the team learned that these values were considered acceptable because they were several orders of magnitude larger than the t, f actors in IMPACTS. 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 code used by TLLRWDA. The team questioned TNRCC staff about the basis for the assumed concrete diffusion coefficient of 1x104 cm /s; 8

however, the staff was unsure. Given that the value for the i factor allows a 12 t

order of magnitude reduction in calculated doses, in reaching a licensing decision TNRCC should have checked the appropriateness of the der!ved values through either independent confirmatory analyses or review of the literature, in reaching a licensing decision, TNRCC staff should also have reviewed the literature cited by TLLRWDA in selecting distribution coefficients (K,) for the waste area (source area). TNRCC staff reviewed distribution coefficients assumed for the soils, by comparing them against 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 14,1129, and Tc 99) Based on the approach used by TLLRWDA, K,'s for the soll should have little effect on the cdculated dose.

However, the K, for the waste (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.

3.

In the environmental transport analysis, TLLRWDA calculated concentration of radionuclides at receptor points along the water pathway by using a series of transfer functions that account for decay and dilution. TNRCC staff indicated that they had reviewed these equations and made spot calculations to determine that they were appropriate and appropriately being used. Further, TNRCC staff indicated

~

r

[

Texas Proposed Final Report Page 30 i

they had reviewed the parameter values used in the models against published information.

4 To avoid double accounting for potentialimpacts, TLLRWDA arbitrarily assumed that 75% of leachate leaving the facility would be available to return to the surface 1

(i.e., f,,,, = 0.75) and the remaining 25% would be available to travel to the ground water (i.e., f,,, = 0.25). TNRCC staff questioned the basis for these j

factors, but accepted the use of them because they agreed that a ground water pathway analysis must be done, and recognized that any factors assumed for that j

analysis represent site conditions that do not exist and therefore must to some extent be arbitrarily defined. 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,

~

increases the calculated dose from 0.29 to 1,16 mrem / year. still well below the j

dose limit. However, when these unsupported factors are considered in combination with the f factor (discussed above), they allow a significant reduction t

in the calculated dose. For example, the f.,,, factor combined with the f factor t

allow three orders of magnitude increase in the calculated g,round water dose from 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 factors or parameters should be considered.

i TLLRWDA,in determining the dilution volume for contaminants returning to the surface, assumed a volume equal to the depth of the disposal unit (10.5 m for Class l

A and 7.75 m for Class B/C) multiplied by the total surface area of the facility (i.e.,

the area of Class A and Class B/C combined); however, releases from Class A are assumed 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 j

the Clasc A units; therefore, use of the cornbined 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 i

gravel and soll has the potential of creating a capillary barrier, which would block 2

water from moving down into the gravel. The potential for this occurring can be tested through modeling moisture movement within the facility.

4 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 1

~ -,,. _

,.y

,_.m.

Texas Proposed Final Report Page 31 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 exists for the licensing decision.

4.'t.4 Technical Quality of Insoections The intent of the review under this part of the program indicator is to evaluate the Strte in terms of tiie 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.

4.3.5 Resoonse to incidents and Alleas.ilgna Under this part of the program indicator, the State is evaluated in terms of its response to incidents, alleged incidents, and other allegations of safety concerns. The team notes that there have been no reported incidents, alleged incidents, or allegationa of safety concerns 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 improvement.

4.4. Uranium Recoverv Reaulatorv Proaram 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 regarding the status of licenses, status of the various sites, site inspection history, financial assurances, status of regulations; reviewed selected licensing and inspection files; evaluated the qualifications of the technical staff; and in'.erviewed selected staff and managers working in the uranium recovery regulatory area, Jurisdiction over uranium recovery activities was transferred from the TDH to TNRCC in September 1993, prior to the, previous review. Since S9ptember 1993, TNRCC has been 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 TDes. The underground injection control program is an EPA delegated program that will be retained by TNRCC. 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.

At the time of the review, Texas had 3 conventional milllicensees (3 sites) and 9 in-situ 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 Uranium Resources incorporated (URl) sites identified as Kingsville Dome, and Rosita. The Vasquez facility has not yet been licensed.

I J

Texas Proposed Final Report Page 32 4.4.1 Status of Uranium Recoverv Prooram insoection j

The TNRCC program initially set the inspection priorities for mill sites at one year frequencies to be consistent with the insptction frequencies called for in IMC 2800 and IMC 2801. However, due to other programmatic priorities such as the Low Level Waste l

Program, development of regulations, and licensing backlogs, the program established additional priorities for the uranium site inspections which were based upon potential i

health and safety issues, and environmental considerations. Program managers related that in order to address health and safety issues while managing the inspection backlog, i

emphasis is placed (in decreasing order) for response to incidents, the inspection of active l

operations and decommissioning activities, and finally to those sites that had been decommissioned but still requiring regulatory monitoring and observations. At the time of the review,12 sites were on a one year inspection frequency. For 10 sites, TNRCC has established a two year frequency, and documented the justification for the frequency change for these facilities which are in restoration / reclamation mode since their activities did not warrant the same level of attention as facilities with a greater potential to adversely affect the health and safety of the workers and the public. The review team noted that the i

two year sites are not consistent with IMC 2800.

1 The State reported that four licenses were overdue for inspection (overdue by more than 25% of the NRC frequency). A review of the tracking system and the inspection files i

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, 1

and the other overdues were last inspected in December of 1995. The review team i

recommends that an action plan be developed and implemented by TDH to overcome the j

inspection backlog in the uranium recovery program, i

At the time of the review, none of the operational production sites were due for inspection.

Therefore, in lieu of inspector accompaniments, the reviewer accompanied the Section

{

manager to the URl, Kingsville Dome facility for a visit to a production site. This visit was conducted on June 4,1997. TNRCC initially reported in the questionnaire that no annual l

supervisory accompaniments of inspectors had been performed; however, documentation l

was reviewed showing that the lead inspector was accompanied by the supervisor in March 1997. The other two inspectors work under the supervision of the lead inspector during team type inspections. The team considered the content of the report documenting the accompaniment, interviewed the supervisor and the inspector, and determined the accompaniment to be satisf actory.

Allinspection reports tre reviewed and signed by the supervisor prior to issuance. Notice of violations were confirmed to be transmitted to the licensee within the 30 days limit i

established by administrative procedures. The program has a tracking system for management of inspection reports, issuance of notices of violation, and escalated enforcement actions.

. _. ~

j Texas Proposed Final Report Page 33 1

4.4.2 Technical Staffino and Trainina 4

l The Manager (Registered Professional Engineer) of the UURW Section has the Section i

organized into three teams; the UIC Permitting Team, the Licensing Team, and the l

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 i

professionals. The team is made up of two engineers (PE's), one Ph.D. biologist, four i

health physicists, two geologists, and one vacant hydrologist position. The Team Leader l

{

also has many years experience in the uranium industry.

The inspection and Compliance Team consists of a Team Leader and seven other l

t k

professionaic which includes two engineers (one PE), two geologists, and three health l

physicists. The Team Leader is also a geologist with several years experience. Two of the j

health physicists are stillin training and are being scheduled for NRC training as the space becomes available.

j 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 i

expertise identified as necessary to regulate uranium recovery and 11e(2) byproduct material.

4 i

Additional support is provided by the UIC Permitting Team and the Division staff in i

environmental surveillance, environmental monitoring, verification surveys, accounting i

and finance, systems analysis, legal staff, and semple analysis on an as needed basis.

i TDH Laboratory is under contract to provide sample analyses as needed, and was visited by the review team and found to be a state of the art facility which participates in laboratory inter comparison programs. Additional details of the laboratory can be found in Section 3.4.

1 4.4.3 Technical Quality of Licensino Actions The evaluation of this area focused on a review of the licensing process and the evaluation 2

of health physics type issues. Three recent licensing actions were evaluated as a sample 4

of work performed by the Section's Licensing Team, and included licensing actions 1

performed by each of the three project managers on the Licensing Team. This casework is identified as: (1) Chevron Resources, Penna Maria Project, (RW2602), which is a conventional mill tallings pond under reclamation / closure; (2) Everest Exploration, Inc.,

j 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 3700) sites.

The detailed licensing process includes a tracking system covering the administrative and i

technical review of all applications. Each phase and step of the process were found to l

have documentation relative to the issues under review, and reviewed and concurred upon by the appropriate technical disciplines and representatives of the licensing team, the l:

1 g

,_....m.._

.-...,.._,m_...._

.. ~.,....,._,.,..,.,,-, -. _... _,..

Texas Proposed Final Report Page 34 inspection / compliance team, and management. The review team noted that the team approach is effective in getting peer review and the necessary expertise applied to the specific review, in examining +.he 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.

4.4.4 Technical.Ouelity of Insoections The review team examined the compliance summarios 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 determine compliance with regulations, license conditions, and available guidance. The 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.

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 of violation must also be reviewed by the Legel Section and be signed by the Commission.

1 4.4.5 Resnonse to incidents and Alleaations 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 docurnentation was located in the iicense file and the lead inspector's incident file.

TNRCC has one staff person who has received training under the NMED system and the Section has received the software for implementation. TNRCC summarized incident 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 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

O 1

Texas Proposed Final Report Page 35 with recommendations for improvement. Accordingly, the review team recommends that the MRB find the Texas program to be adequate to protect public health and safety and compatible with NRC's program, i

1 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 ;eam suggests that amendments and renewals be prioritized so that j

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) 2.

The review team suggests the State consider standardizing their primary and supplementary field note forms. These could be modeled after the NRC forms l

as discussed with BRC. (Section 3.4) 3.

The review team suggests documenting in reports summary discussions of inspection findings with management at the conclusion of inspections.

(Section 3.4) 4 The review team recommends that the State adhere to the policy of annual supervisory accompaniments of all qualified inspectors. (Section 3.4) 5.

The review team recommends that all radiation detection instruments used for confirmatory surveys (field measurements) be calibrated on for all ranges encountered by inspectors. (Section 3.4) 4 6.

The review team suggests that the State initiate actions (through implementation of the procedures provided in the March 1995 Handbook on Nuclear Material Event Reporting in the Agreement States) to directly utilize the NMED system.

(Section 3.5) 7.

The team recommends that TNRCC vigorously pursue the changet necessary to make Texas law (statutes and regulations) compatible with those of NRC in the low-level waste area and, if necessary, raise this issue to higher levels in the State government. (Section 4.1) 8.

The review team suggests that the State consider the comments in Appendix G, and take action as the State deoms appropriate. (Section 4.2.1) 9.

The review team recommends that the State perform an evaluation to determine the safety significance of the issues identified by the review team pertaining to registration certificate number TX 0246 D 103 S and to identify any other issues that may exist, and re evaluate the application, as necessary, to ensure that all pertinent safety and regulatory issues are adequately addressed.

(Section 4.2.1)

Texas Proposed Final Report Page 36 10.

The review team recommends that the State evaluate an adequate sample of additional safety evaluations to ensure that the deficiencies identified in TX 0246 D 103 S are adequately addressed in the additional cases, and to demonstrate that this was an isolated occurrence. (Section 4.2.1) 11.

The review team recommends that the State review the issue of concurrence i

reviews for SS&D safety evaluations and implement procedures that require an l

independent technical review for all future evaluations.(Section 4.2.1) 12.

The review team suggests that the State consider assigning safety evaluations 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 l

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 f ailure or problem may be a generic issue. (Section 4.2.3) 14.

The review team suggests that the comparative results between TNRCC and TLLRWDA baseline data, including discrepancies be documented. Further, the baseline data should be entered into a computer database to facilitate its review and use. (Section 4.3.1) 15.

The review team suggests that a consolidated training r6 cord be developed to enable assessment of training across the entire program. (Section 4.3.2) 16.

The review team suggests that the basis for all staff findings be thoroughly 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 defensible review and documentation of the performance assessment has been made. (Section 4.3.3) 18.

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)

LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Texas Organization Charts Appendix C Texas' Ouestionnaire Response i

Appendix D License File Reviews Appendix E Inspection File Reviews Appendix F incident File Reviews Appendix G' Sealed Source and Device Evaluation Reviews

. Texas' Response to Review Findings s

b

~----vw m

,-_m,

,,v..,----,.-

... ~ -.

-r--+....m,

--,-..m,,

e-

--rv..y,~.r-,,.

. --+-.

-w,.

APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Richard L. Woodruff, Ril Team Leader Technical Staffing and Training Uranium Recovery Program i

Michelle Burgess, NMSS Sealed Source and Device Evaluation Program Elinbeth Drinnon, GA Technical Quality of Licensing Actions Craig Gordon, Rl Technical Quality of Inspections James Myers, OSP Status of Materials inspection Program Legislation and Regulations Thomas O'Brien, OSP Response to incidents and Allegations Mark Thaggard, NMSS Low Level Radioactive Waste Disposal Program

APPENDlX B ORGANIZATIONAL CHARTS e

i l

l l

i._-,..,

__a----4h

+-J4se--.-

a A. Je_

64-,eAa--14 4--.aw--.M h.MJ*a-ea-.g.*hJ-h-M--

4AA.--ema-*. *

-w4Ammm'."m.-

--*emmeca.wuwma-mim.m

-amm-w,m

.ae.a-..

ap.---_.---aw_

((

l I;r I I

4

[p-

,l I

gO I

L, F. itl

(#,

• • ""'"m==

==**

i n

(.

(

m.nmemumm i

i j

l'

[

i, p

u 3

y J.!

t L,

't It[g I,

r i

llg l

1

[

[

4 4

l J

J.

g(I i

r 1-yr I,

u il

,j r,

i g

[

[

lb bll[

i 5

J 1

i I

I

[L [{

- {!

I_

l I:

3 f,

J II i

(

t t

i m

l i

I i

[

rg u

4 e

- g

{

q y

l

(

g l

[

[

r,

[

t I

I I

1 1

f.

, r i

4

[

g S

, - - - -.~

-m,,, - - - -

~,--

,-n---,,

4 i

i, l

I i

i i

l TNRCCINDUSTRIAL & HAZARDOUS WASTEDIVISION ORGANIZATION CHART

{

1 1

i 4

t i

Minor Hibbs, Director 1

i i

f

{

l 1

N N

4 M

N I.

T&d rum %

hqpectesch(UtCAW andRadsencaps i

l Wasas Secasse sia(6)treausinsheascaset accommung& r - rn pant i

services, cagnacenas. 3cology,==d analyus, synaceus analysis, and l

AliceRosest haanager O

N q

+

i i

k 9

9 I

e O

y

,m,

. +,,,

,,e-wn- - -

s Indiastrial & Hazardous Waste Division UIC, Uranium, & Radioactive Waste Section Ahce Regsss Pl. Manager James Gesas, m -

taessma - -T-

~

e Jacaguelyn Seous, h Secausary ESCPerminalmaTamma IJocesserTeman Imanacsimms and Cammmlimmer OsasI &III Usansman and low-Iced weses and Isam See Emaps(Tamantander) huned seems OnesI.III.and esammen Varama EnginesmagSpecadut Gorge FioGerad(Teamslander)

Dmic Eahist(14ader)

Feed Dasy.re Mary Peter.Ihmissus.

Chades Gemene.Genisses Kashysm umaag.PA C. D. Ras PE.5casar Engsmear Hong-Yeon Gen.PE 3.asry water.Gestagna Dewane Oss6c.Healah Phyescut Mike % Engisses

- Jamasasses.cmasepse vicier whammed.useas rhymas Senvm Gesaaps:

vecess.Gemmig John w - Gema.ps Esistc-==-a unshh rhyucme SaeveEsser Goedepst W Zase A1 Heelsh we nec=hr Heate Phpaans

~

Phyencut Jian ShseK.Pl.Emposer PaminGN HashhPhyennet vacans.::,

xmany vait.ucaan rhymass Juss18,1997 l

1 1

O O

im

y rp" f

. F1 tr

% g!![ylp !pbillji

{i,?[~

pjjIh q"I l Ifi MIk I((

E[

lhi IfIf

,I!Ii'i!Ilf [

iff glianl}o 7

p pdl n!e( p,; rj-g1 I

t

,.J a

g.

h } ff l

I E'E [

,' f, Up[fJ[rl

,1 f, ; q illl,Tlf[ M g _.,

f 7[li fliu rgr.rf tr

~

w 1 5 i t r

'l

.. g

' p t[l[l!'r l[f _l gj![

'j"I' I lp[:" I j

jh

~

I

[_g

~

m m _m m 6 ! <!l!'il g

'!rr!!!p!tri i

?!m r

s L

pl

{

I

+Ii,g;j p

i r

i. 3

[p j,. s {ll_

l /

4 q.

k i

p [.p lg I l I If 3

17,I fr ff T [

I[

4 l _fill Il[

[ $j l j

L

LT I

.I j!

o

,r

- r i

f

_1.J f<,

I i[

n, r

q l

li'

{jji

- l i

y<

i i

o 1

r L,-

l

• w I

f.

.,I i

r,,

'e E

I E

I I

,I

')

I If c!'.i.tJlil.i;'l'

'I l l

lI l

{

rf.

l i

I I

I

,I I

l P

,I:

[

iI f

I o f

,}

o I

.,i I,

{i i

,i

[{

e

=

.a t

I I

I I

I IlI IL Il ll Ilj

~

l l

I I I {

f

{I

'{lf r{g

{

l I

1 4

I

{

=E,

{

1 1

As Bandgeseg Mol Jesse 1997 B44 eans O Nice j

Buscas Chief-ett 4

(Assinsd A.*M P.E.)

l l

80Evs-s*3 l

l (hemsessusiIkedessen) a

%Tertencean M -350

{

(Desis F.ww) f I

l Beareatl Adestinistrative ONice j

omisfefSaufServicss-GR3 t

(mehess C hade)

' Maomesk te.mager M -eSE (Cheryl Schanner)

SysassesSuppest Specomine H-e30 (RalphC a=rtema III)

Wusd Poncessang Opusumer M-e54 l

(amanas.neshme) i I

Pasbuc h Records Aduninistrative i

cad h a-f Training Prograne Progrann s;

% Spessalist M-tel hTN IV-et9 Chist,- M -est (8dusulyn F.Esimal (CnsusasacT.Pessrs)

(Kassa1Fusdy) l

% Syssamles N-til WTh M -e52 388-887 (WiEmum A.Du'iul IE"I' I 38**)

3,,g%

g.333 adia.sianca amopsmerat-e55 A

y,gy,. Gudsis)

(

(Clydses Gege) ont es-es3 gne,,, j,,, w (a a sessansen) russhesse u-era Ill-322 l

o.. e.e (sm* t s s-.

(v coms) h TechascianIII-M3 i

genusey s a Washer.,yy (Tasmi L Monums) l (ses hIuanseg Assammase ChshIst-esp tosser D.Esseedy)

~

omsk ist -e,s (stemens 34.Ledmar).

A m

J m

Divisiose of L' : :' ;

As Badgeted Registratiose and Standanis

- -nee 7 Dir caer(Eassape)-001 (Rush E.SecBearney, CJf.P.)

==s s===== sos=== m.sas e 'a nesse assesaland Academic Lisemains esadical and Acadesnic Registraelen samutense Develegumene popuey Desaceer,useassag Psepct p,ogoeg Psopet 4

EOS W.ese EOS W-est EOS V-e43 EQS W -815 puestoyas.numa,c.sa.ra pesarit.anness) ptanneek W.aseeni m

- a mn EQsV N'u Weeg

• M H=thTed,W-830

• • '"sy Desector, Reglemamen gDE p.4 g,as,m,4 7

EQs W-ese go,y,33 Heekk ed.u.483 IDebenth L_ Bessoal to may may Ashe t

• "8 P'==sess pman u-227 medideemsH nmTasm.m-su o

Eos v.ese gasymmes.4.d=m g g%

IndueestalRadographer DesastemsS.Tashnesp M"'"*essaphy

,,,,,,,,,,,,,,L,p,,

i EQ5 W-SE3 spesses Lasemesmo esagesse

. nes eerassen Piefest m%

s EOS W-tes

• + MasahT m.u-ses

,c,7, EOS V-eez mE.she est g

us eies u-e-ei

• J""I.Ms.2 s (sn==eH.oss o e

mede-- -,o,=ms,u.2es EQsIV-ees (em m.w 8'"""*'"* D 8=8 W = s r = = =ims p===,u -2se Weed Ptossames O,maner ME-337 o

(Esis L. Honey)

Wuse

~

u.252 (Dub = A. Handy) cs====

is e,s

=.s e

-m InGasessielX Ray and l

O**'FK Guduse)

Admenced Techselegy Usemehag Peefect

% nesistrasenreales:

ospuny Dhecaer,seendosee EOS W.Ste EOS V-e45 andspacessps gesse GFloyd R.tiendeed (Bashera J.T-4es)

EOSW 012 scy.shes c. casement andusensi s -- --

EQSV-e5t psegoct

'-~

l

1. ""* L Simanal EOS W.ett l

EOSIV-set Bewhf IL Foalet l

(seemisar. %

l

• ^ra'MonkhTesh V-300 (aands A.W EQEY-946 Weed W,Osameur M-IS6

( h P.Sain.Isese)

(Ehe ammusa)

EQSfv.se2 M

hTessuscismI-243 flamesien nesh w 6Lamis A.Kasses4 ses-sowream.w.sgeeney Assenarm.=n ene ese L

EOSW ele

-T=6==== I-ass g a s,y a s aia h, %

Sp= deems

. he pse$see heders eWor pregees sE itr.ns.n=4 e e

=ames as

_ _ _ _ _ _ - _ - _ = _ -

i t

i 1

l As aleadgeted DWISION OF COesPLin80CE AND ledSPECTIOtt g gg Dhecaer(Exempg-ett (asesor C.Tane) l SenEServices OEiser I-883 Ah-Tash. lit -ese nar-a.v Ahrsas sanscaal

'Gimbush64 Rochess)

Ramessen Sassey Osecer i

EOS W-854 oopmer ss caer - -

o Seasestalw -a5== and RAISS h Peelect X-5tay Asen 2 Cesepitance Peelect yteenin A.Coelmey) i r

EQS V-858 rh EQS W-est EOS W-ese puunnanA.Steeg QEdc 08.Shotalq

,,,g m p

. p,,g,,g IJohn R. :1,_: O LaLP.)

g,,

~

(838k I **8'*3

~

hTesh N-ISS (Joespin F. Thing

[

(vecesa) gw X-5tay Ases 3 Casupliance Psuject l

wesdre.cssens W au-25 EQS W-m EOS V-850 (Shasen L Fassus)

SaueInTomas Pselect Wessrensasses yesmearu-33 (Quincy 88.Wlchsen)

P. Castes) e S - y y Response Pseject (Shuset osWiEu) w d ries====sarmunw N - DE EOS W -021 i

RaasAsse Psegeca (Tan== A.OmEemey)

(John E.Rendston)

EOS W-est Beamunessaphy Pselect j

lRobest L Gseesi,Jr.)

EOS V-885 Pantes Emmesgency Response IRobest E.Fseal qRichasd ttosetend)

Peelect EOS M-sae n - m. 23 w=d rier

'8'"'"^.

anM Ama B r==v=== Poejoct w ad reem ming Opm a n m -I M lGasy L F M r

m EOS W-m g,,,;,,,,,,,,,,,,

nePuey Dhecaer,x.any and P"'h"'8 ' D"""I -

seensenemine - P-a--and 5-Sewesence Pannex Coep Aemment a

I Pagost Special Pselect Raas Ases C Comp 5ence Puedoct EQS W-917 SpostalPselect Dhector-805 EOSW-Ste EQS W-055 (Chastes R.15 eyer, CJLP.)

(Joeoph A.88asemen5 -

phonies c.casmusem 3

Weserememmiss pmenerM-126 gluetyManebog o

(Geesem Y.Sammes0 EQS IV-875 U""y temetes umen)

Testudcal Asetetance Pselect runLoves a v x.g,3,,, y c - -

EQS IV-SM EQS W-ete l

Peelect p,,g,cg

( "*'A'"

(Badey W.Caelwy)

EOS V-est EOS V-SST

~

incidentinvestigaden Pseject M. Karam Rahneel (June R. Ayers)

EOS W-e52 4

Complaintinveedgaden j

weed r=,0psesser N - 132 (Helen D.Waaldes)

Pmfoct j

B00SAPsetect pienseC.kesGues)

EQS W -012 EOS V-854 WIPP Esmosgency Response g)ecar L.eesang (Jock E.Engloodl Pselect EOS W -013 i

(Jameos H.Ogden,Jr.)

AsSesNW ese evaliable se EQS-S M QueIIey be pse$ set leaders endfor project m

,,,,, m

m.m_

illIl!lIllIli!!lllillIljij1ll1ll1 l lil

!i i1 1

i t

M l

Ufl5Fj4lll:'Ihpr8Ifff9'I I Ikll i

11 1

It gaf i i-11

~

{

f II

[u!I Il t t i

~

~

r;

6 4

4-4 APPENDlX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE RESPONSE a-

4 i

DmiORA'IED MATERIA 1.3 PERPORMANCE EVALUA'IlON PROGRAM l

QUES'110NNAIRE AND RESPONSES Bureau of R&on Control (ERC)

Texas Department of Health (TDH)

May 1997 l

(Reporting Pedad: March 12,1994 to Apdl 30,1997) l A.

COMMON FERPORMANCE INDICAMRS l

1 I.

Status of Matadah% Pmgram 1

l 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 1800 (issued 4/17/95), h list abould include initial inspections that are overdue.

F;r a list of specific overdue inspections, see Appendir 1.

44

SUMMARY

OF OVERDUE INSPECTIONS BY NRC INTERVAL REPORT DATE: 05/08/1997 Interval Number Overdue (>25%)

New I#,soses Overdue

[As of: 04/30/1997)

(Not inspected w/l 6 anos) 1 6

0 2

0 0

3 0

4 4

0.00 1

5 0

6 MTAL 6

11 2.

Do you currently have an action plan for completing overdue iaWhas?

If so, please describe the plan or provide a written copy with your response to this questionnaire.

1

A.I.2. (Continued)

Each Regional Health Phpics Coordinator (fonnerly technical reviewer) has provided a list of laspections (overdue by NRC criteria) to their respective regions for confinnation of status and to arpedite inspections. De inspector position for two ngtons (PHR 9/10) is currently vacant. Central omce staff will continue to schedule both central omce and regional staff to perfonn laspections in the two reglom to prevent the development of a brze backlog.

l 3.

Please identify individual 11censees or groups of licensees the State / Region is laWg less frequently than called for in NRC Inspection Mr.nual Chapter 2800 (issued 4/17/95) and state the reason for the change.

NRC NRC Insp.

BRC BRC Use Description Int.

Insp. Description Code (Yrs.)

Int.

Could not Other Services-4.'0 Industriali determine teletherapy, irradiator Calibration equivalent and gauge services and reference NRC sources Program code Other Services-

4.0 Industrial

taletherapy, trradiator Other and gauge services licensed source 4.

How many licensees Aled reciprocity notices in the reporting period?

115 Licensees filed 1919 reciprocity notless in the reporting period, March 12,1994 through April 30,1997.

2 4

e

l 4

4 l

A.I.4. (Continued) a.

Of these, how many were industrial radiography, well logging or other users with inspection impMes of three years or lets7 4

80 liconases with an inspection frequency of 3 yeard or less (use codes 006, 028, 051, 053, 072, 094) filed 1493 notices in the s* porting period.

t i

b.

Por those identified in da, bow many 4 0 city inspections were j

conducted?

1 l

l 74 laspections wets conducted. Additionally,19 laspections l

were atteenpted.

l Reciprocity Notices and Inspections l

lUse CodW *d:$ord %$stl$ %Cd1ot?U Q:, 'yy F-

M1 i Notices

/>lnsMusY l

006 demonstration &

sales 6

66 1

i 028 industrial radiography 17 507 32 051, 053 tracer, well l

logging 9

126 0

072 installation, repair, &

31 727 27 maintenance 094 decontamination 17 67 14 Total 80 1493 74 3

5.

Other than zw4mcity licensees, how many fleid la==*lons of radiographers wen performed?

i For other than reciprocity,178 fleid laspections of radiographic l

licensed operations were conducted during the rwiew time period.

6.

For NRC Regions, did you establish numerical goals for the number of j

inspections to be performed during this nyiew period? If so, please describe your goals, the nu'nber of :a==*ians actually performed, and the reasons for any diffenaces between the goals and the actual number of i

inspections perfonned.

i N/A 1

II.

Techalem1 StaMhe mad Trainine l

7.'

Flease provide a stamns plan, or complete a listing using the suggested 4

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: =d=latentiob, materials licensing & compliance, emergency asponse, LLW, U mills, other.

If these ngulatory i

nsponsibilities are divided between offices, the table should be l

consolidated to include all personnel contributing to the radioactive i

materials program. Include all vacancies and identify all senior personnel i

assigned to monitor work of junior personnel. If consultants were used j

to carry out the program's radioactive materials nsponsibilities, include j

their efforts. 'Ibe table heading should be:

NAME POSITION AREA OF EFFORT

. See Appendix 2.

i k

i j

1 j

r 4

l

/

i i

i

[

8.

Please pievide a listing of all new professional personnel hired since the hst review, kdista the degree (s) they received, if applicable, and additional training and years of +h in health physics, or other l

disciplines,if appropriate, i.

j Bernadette Baca, Elizabeth A. Foltz, Oscar IAssard, Peter H. Myers, j

John E. Rawlston, Catherine E. Sledge, Arthur C. Tate.

i Also see Appendh 3.

9.

Please list all professional staff who have not yet met the qualification j

requirements of kansa revi"ver/ materials k=~+1on staff (for NRC, j

Inspection Manual Chapxn 1245 and 1246; for Agreement States, please describe your qualifications requirements for materials license reviewen l

and inspectors).

For each, ' list the courses or equivalent j

training / experience they need to attend and a tentative schedule for j

completion of these requirements, f

Inspecton Foltz and Sledge are new employees and have not received i

the qualification requirementt of license reviewer / materials inspection staff. The BRC is attempting to have the new inspecton attend NRC specialty classes and is in the process of preparing its own training j

schedule.

Also see Appendix 4.

10.

Please identify the technical staff who left the RCP/ Regional DNMS l

program during this period.

l l

IDSS OF TECHNICAL STAFF FROM THE BRC l

FOR THE PERIOD OF 03-12-94 THRU 04 30 97 l

l Ralph S. Heyer, EQS VI, aff. 09-30 94 Julie W.14ers, EQS IH, eff. 01-01-95 i

Maria D. Herrera, EQS VI, eff. 01-3195 l

Charla Sue Jean, EQS IV, eff. 03 31-95 l

Robert J. Imbaugh, Jr., EQS VI, eff. 08-3195 Timothy R. Goldman, EQS IV, eff. 08-09-96 R4esh P. Ruparel, EQS VI, eff. 10-28-96 i

Clarence L. Born, EQS VI, eff. 01-3197

[

Paula H. Gomalez, EQS IV, eff. 04 30 97 '

i l

1

}

l 5

l i

I O

l i

'2 III.

Tarhnten1 Oustity of : Irentine Action

}

11.

Please identify any mahr, unusual, or complex licenses which were issued, aceived a nWor amendment, terminatM cr senewed in this

period, New Ihaam: None i

i Pending: WCSI Envirocars i

i Terminated: None i

Renewals:

4 l

j Western Atlas GA0466)

{

PSI (LOO 931) - Split into 11 separate licenses Saint Paul Medical Center (IA1065)

UTESC SA (IA1279)

Texas Tech University (L01536) i Shivers Cancer Center (L01761)

UTHSC Lubbock (TA1869)

Univ Houston (IA1886)

UT San Antonio GA1962) i UTHSC Houston (IA2774) l.

M.D. Anderson (IA2972 The GNI Group (IA3378) j Joe Arrington Cancer Center (LO4881) l IsoTex (IA2999) j Amendments:

j Baylor (LOO 680):IVB in Pigs 4

l 12.

Please identify any new or amended licenses added or mmoved from the list of li-we requiring emergency plans?

IsoTex (IA2999) 13.

Discuss any variances in licensing policies and procedures or exemptions l

from the regulations granted during the review period.

I i

6 i

1 I

i

. A.III.13. (Continued)

(NOTE: Exemptions not allowed prior to July 1996)

EXEMPTIONS Exemption Date Summary 31.23(b)(1) 7/96 RSO Qualifications 21.1101(d) 7/96 Records Imcation 41.E,U B 8/96 Canadian Preceptor 41.27(b) 8/96 RSO Qualifications 21.502 10/96 Denied 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 Empiration Date 41.32(a) 3/97 Expiration Date 41.32(a) 3/97 Erpiration Date GENERIC EXEMPTIONS 41.32(a) 3/97 IAi: Erpirst;on Date 41.32(a) 3/97 IA2: Expiration Date 14.

What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the nporting period?

DIRECTORY OF ADMINISTRATIVE Ac POLICY hWMOS 5.

IJcensing and Registration Actions Concerning " Compliance Action Pending" 10.

Policy on Temporary Job Sites for Clinica 1 Use of Radioactive Material 16.

IJeansing/ Registration Policies 17.

Procedures for Abandonment or Denial of IJcensing Actions 31.

Agency Implanentation of TRCR 40 for General IJcense Acknowledgements (GIA) i 7

i l

l A.III.14. (Continued) l 32, legal Interpretation of Medical Teaching Institution 34.

Clarification of TRCR 41.25(h) Concerning Requirunent for Permanent Facility i

36.

Cladfication of Issues Involvlag NORM l

37.

Applicability of n n=lantannar Funding Plan to Medical and i

Academic 1 Ae======

a j

39.

Forwarding of Site Termination Requests to the Division of Compliance & Inspection i

l 40.

Cladfication of IJcensure Requirements for Recycling of Materials Contaminated with Naturally Occuning Ra# active l

Material (NORM) 1 41.

Clarification of IJeansure Requirementsior decontamination of Vessels Containing Naturally Occurdag Radioactive Material (NORhD j

42.

Release of Patients Administered Diagnostic j

Radiopharmaceuticals (Interpretation of TRCR 41.26(c)(1))

45.

Procedures for Administrative Amendment requests from Division of Compliance and Inspection i

47.

Assessing Reciprocity Fees for iJeanaa==9 add ations that Authorize Multiple Activities 48.

Generic Agency Approval for Rangent Kits Not Containing Radioactive Material i

49.

Radioactive Waste Processing Issues i

4 50.

Generally Tw Sources of ReinellIntion Counters l

53.

fleanes and Registration Renewal Interval Procedures

]

54.

Late Submissions for lacense Renewals i

i 1

j 8

1 l

r-w m

}

A.III.14. (Continued) l BRC TECHNICAL POSITIONS

SUBJECT:

DATED:

TAB 2 2

]

INDUSTRIAL RADIOGRAPHY EQUIPMENT REQUIREMENTS 01/03/96 uCENSNG TECHNICAL POSMONS l

l

SUBJECT:

DATED:

Tab 36 i

HANDLING OF RECIPROCITY July 1996 LICENSING PROCEDURES MANUAL L TECHNICAL ISSUES:

TABS:

i l

21.1304(D) AND AUTHORinn LICENSEES 8/94 2

CORRESPONDENCE WITH THE UCENSEE 3/96 9

i DISPOSAL OF IN-FITRO MATERIAL l

UNDER A GLA 11/95 10 STREAMLINING AGENCY REVIEW OF UCENSING ACTIONS 01/96 11 i

NORM PROCESSING CLARIFICATION i

POUCY STATDfENT 2/96 12 l

UCENSING STATE STATUS FOR (NARM) PRODUCT REVIEW 3/96 13 41.29 AND NON-EVALUATED SEALED SOURCES AND DEVICES 3/96 14 l

AUTHORIZED DISTRIBUTION OF GL DEVICES 3/M 15 BIOMEDICALWASTE 10/96 16 i

(

9 4

5

0 1

A.III.14. (Continued)

I j

II. ADMINISTRATIVEISSUES:

TABS:

i j

BOW 'IO SUBMIT A REQUEST POR 1

UCENSE AMENDMENT 7/94 10 l

UCENSING PEER REVIEW DOCUMENTATION 1/97 11 LEAVE AND OTHER ADMINISTRATIVE l

PROCEDURES 4/97 12 UCENSEE/APPUCAhT COMMITMENTS VIA TEIJEHONE 3/96 13 l

III. LEGAL ISSUES:

TABS:

i j

INTERPRETATION OF TRCR 44.62 3/96 7

i INTERPRETATION OF TRCR,41.200(f)(4)-

~

l FINANCIAL ASSURANCE 4/97 8

l l

OTHER s

i

- Ownership Changes: 12-2.

j

- Terminated Sites off license

- 41 E.III.B Certain 'Iberapy users gd until 10/96 to use non-i ACGME j

- 41.26(b)(2)(iv)

Use NDA drugs for other purposes

-Medical Currency Regain medical currency through ACGME l

program j

- Exemption Policy For Granting Exemptions: TRC FORM LRS 5 l

l 15.

For NRC Regions, identify by licensee name, licer.se number and type, j

any renewal applications that have been pouding for one year or more.

1 l

N/A i

l IV.

Technical Gality of Ynetom 16.

What, if any, changes were made to your written iaM.!on procedures l

during the reporting period?

'Ibe written inspection procedures ha e been completely revised and i

updated.

All prqject areas in the Dielslon of Compliance and i

Inspection participated in tbt devabpment of expanded, zweised and updated inspection, incident, and Division procedures.

)

i

[

10

/

l i

17.

Prepam a table showing the number and types of supervisory accompaniments made during the review period. Include:

Enervisor inenacear v ie. nee cat.

Date i

j De table in Appendix 5 will show a bmakdown of l

l 1) the curmut Area (Regional) Coordinators 2) the 13 current aglonal radioactive materials inspectors; l

3) the 1 vacant RAM inspector position; l

4) the dates on which the laspectors were accompanied by an arts coordinator or theirsupervisor during the reporting period from l

March 12,1994, ";hrzgh April 30,1997.

l

{

For specific license categories, refer to specific inspector j

accompaniment documentations in Appendix 6.

18.

Describe internal procedures for conducting supervisory accompaniments of inspectors in the field.

If supervitory accompaniments were j

documented, please provide copies of the. documentation for each accompaniment.

l Internal procedures for conducting supervisory accompaniments of inspectors in the field:

i ne 14 inspector positions.are assigned to the 11 Public Health l

Regions (PHR) and are located in 10 regional offlees (one inspector covers PER 9 and PHR 10). Dree technical nylew positions (titled Regional Health Physics Coordinator) have the regions divided and grouped such that the number of inspections in each gewup are 1

i approximately equal. De three coordinators perform, or arrange for l

eenior staff to perform, an annual accompaniment with each regional j

inspector in their respective regional group.

Reports of the accompanknents aus submitted through the Deputy Director -of Radioactive Materials Inspection and Enforemment and the Director

}

of the Division of Compliance and Inspection to the Regional Director l

and the Regional Director of Environmental Health and Consumer Protection. De twelews cover existing inspection policia/ procedures, j

new inspeedon policies / procedures, report processing, filing methods, laspector's training needs, etc.

Copies of the annual accompaniment sports for the review period are located in Appendix 6.

II n.

4 r

i 4

i 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?

i See Appen' dix 7. Yes, all lastruments are properly calibrated at the j

present thne.

V.

Responses to Incidents and Allegations l

20.

Please provide a list of the most algnificant incidents (i.e., medical l

=landminieration, crwayosures, lost and ahandaned 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 included in previous submittals to NRC need not be r=p=M. The list l

should be in the following format:

i UCENSEE NAhE IlCENSE # DATE OF INCIDENT / REPORT TYPE OF INCIDENT l

Inc.

Date of j

IJeenca. Name fleanse #

1. incident /Renart Tyne of ineldent i

BIX Testing Iaboratories L2143 6650 03/23/94 Overexposure 21.360 rem i

Blazer Inspection 14419 6651 02/23/94 SourceDiamnaare Hand Burn H & B X ray Services M516 6654 04/07/94 Imst Radiography Camers Tucker Wirellne Services L4751 6655 04/19/94 IAst WellImaging Source Southwest Methodist Hosp IA594 6736 07/28/94 Misadministration Kooney X-ray L1074 6816 02/08/95 Imst Radiography Source l

Mother Frances Hosp L1670 6874 05/02/95 Misad=1alerationlodine-131 l

Midland Car Wash NA 6907 08/18/95 Ir-192 Contamiantion l

Littlebit Wireline U168 6919 09/19/95 Ruptured Well f a_*elag i

Source l

U.T.H.S.C.

L1278 6929 09/12/95 Herapy Source Misloading l

Iarpen of Texas IA074 6987 02/27/96 Stolen Cd Radiography cameras Bellaire Cancer Ctr.

L2038 1219 01/17/97 Derapy Misadministration 21.

During this review period, did any incidents occur that involved l

equipment or source failum or approved openting procedures that were deficient? If so, how and when were other State /NRC liessws who l

might be affected notified?

Yes, incidents occurred that involved equipment or source failure or approved operating procedures that were deficient during this review

{

period. See Appendix 8. No notifications were made as no incidents i

of this type occurred affecting other states or the NRC.

12 l

l A.V.21. (Continued) a.

For States, was thnely notification made to the Office of State Pmgrams? For Regions, was an appropriate and timely PN generated?

)

i l

No, no incidents of this type occurred that acaded thnely notification.

22.

For incidents involving failure of equipment or sources, was information 1

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.

See Appendix 8, Incident 6755. Information about automatic Ming devices on radiographic cameras and alanning ratameters was i

forwarded to the NRC.

l 23.

In tue 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.

No.

24.

Identify any changes to your procedures for handling allegations that occurred during the period of this review.

i Procedures for handling allegations are included in the Inspector's Manual that has been updated during the period of this review. No substantive changes west made.

i a.

For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

All refe:Tod incidents have been closed.

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.

i 13 1

g l

i l

l A.VI.15. (Continued) i j

RECOMMENDATION: We neommend that the overdue mie (concerning incident j

notification) and any others need for compatibility be promulgated urpeditiously as j

effective State radiation control regulations. In addition we recommend that the i

Etate avise its Section 40.52 (c) and make it compatible with equivalent requirements in 10 CFR Pad 31J and 10 CFR Part 314.

)

STATUS: De ngulations that wers listed as overdue for adoption in the nylew l

became effective on October 1,1995. Since that time several other compatibility regulations have been adopted. Section B. I. 29. discusses the regulations that have been adopted since the last review.

RECOMMENDATION: We suggest that the program review the list of recommendations in Enclosure 2, Appendix A'and consider these recommendations in the issuance of future sealed source and device registration cenificates and m4or j

amendments to certificates.

i STATUS: The suggested changes, which concerned formatting enhancaments only, l

have been made and are a documented component of the device review process.

RECOMMENDATION: The laspection manual refers to a 24-hour,72 hour8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />, and 10-day inspection requirements in response to incidents. Inspection criteria for the 24-hour and 10-day inspections ars documented in the manual, but no criteria for 72-hour inspections are provided.

l STATUS:

De inspection manual in section IV, Incident and C:,mplaint 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. The manual outlines the l

criteria for incident and complaint investigations.

On page IV 6 under "B.

l Complaints", the manual states that "...k is the policy of the Bureau of Radiation j

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 j

complaint is received."

l De policy was established because there is no way to detennine how a complaint

{

should be categorized for a timely response.

We have had a complaint of radioactive peach trees that turned out to be an incident of nan *=mination and a complaint where no licensee or individual was named that turned out to be an j

incident in which a sealed americium 241 source was cut open and contaminated an j

area used by employees as a lunch room.

i i

I l

j 14 1

i 4

1 i

ll A.VL25. (Continued) l

, RECOhBfENDAT10N: De inspedien manual does not address misadministration.

j STATUS: This comment appears to address a perception on the part of the i

l reviewer that the BRC should develop cdteria for conducting folbw-up on misadministration reports from Hmn After contacting several states and the NRC for IJens, the BRC learned that none j

have specific action levels for deter==l=I== when to respond to misadministration.

It appeared that each state and the NRC responded on a case by case basis and determined from reviewing reports how and what form a response would take.

Based on this we determined that it would be sopropriate to address l

misadminletration in a almilar manner. We have changed criteria in asetion j

V.A.1.d. (2) of our inspection manual, page V-3 to read:

l.

Information in incident reports ceuses concern for the health and safety of the public or medical patients. De cdteria becomes effective May 14,1997.

RECOhBENDATION:

One incident fue revenied the following concern - a therapeutic misadministration of 675 to 750 rum to a patient's abdomen due to a j

dislodged source was not followed up by the TDB.

STATUS:

Follow-up was performed prior to the NRC review, but was not completed within a short time. Since the review, an Abnormal Occurrence Report has been submitted to NRC.

26.

Provide a brief description of your program's strengths and weaknesses.

Dese strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

De TDH, BRC has many program strengths. Dey include the following:

1.

Well trained and educated staff who are often called On as resources by both federal and other state agencies 2.

Staff specifically charged with and trained in rulemaking Highly skilled licensing and 8 spection staff and programs 3.

n 4.

Excellent emergency response and investigation capablutles 5.

Bureau Office support staff (accounting, computars, file room, training, public information, and personnel) 6.

Satisfactory hboratory support 7.

Satisfactory radiation detection instrumentation 15

i J

o l

i i

A.VI.26. (Continued) j 8.

A GeneralIJeanse Acknowledgement Program l

9.

Effective Compliance and Escalated Enforcement program and staff l

10.

Knowledgeable radiation advisory board with a broad background in

{

all program amas 11.

De Texas Department of Health has a very strong and effective Total Quality Management / Continuous Quality Improvement program that i

is supported at all leveh of upper amanagement l

Dese examples are supported by several recent occurrences. De emergency l

response and incident investigation staff did an escstleet job in the Cobalt 60 i

radiography source theft case, nelr quick response and investigation i

combined with effective news releases led to a quick recovery of the sources.

i l

De Standards Program made major changes to the Texas Regulations for l

Control of Radiation and have co:werted many parte to the esquired Taras i

Register fortnat.

l De industrial radiography certification pmgram and the knplementing l

regulations have become a model and resource for NRC and for other state programs. TDH is currently contracting with the Conference of Radiation j

Control Program Dinctors to provide exams for six other states and the American Society of Nondestructive Testing, Inc. for use in their certification l

Progrsm, i

Due to an ever increasing number of licensing requests without additional l

resources, BRC has kuplemented a number of licensing streamlining measure, concentrating on real health and safety issues only, ese of more computerization, and the use of licensing assistants to process simple, semi-technical amendments and general license acknowledgements. We are also i

exploring the future use of electronic media, similar to the NRC's business l

Process engineering prwiject.

De BRC conducted a self-review of our program in preparation for the 1997 i

IMPEP. His self-review also aHowed several BRC staff members who j-participated to become more familiar with job duties of various prqject areas l'

within BRC, thus gaining an appreciation of the responsib111tles their co-l workers have.

De BRC has developed an Internet web site that includes announcements (meetings, training, job postings), hot topics (news items), an educational page, industrial radiographer exam schedules, BRC personnel (who to contact j

for what), and draft, proposed, and final rules in the TRCR.

1 16 i

~~

i

/....

4 i

l A.VI.26. (Continued)

The primary weaknesses are:

i 1.

De limitation to increase full-time staff when workload increases.

l Currently, there is an FTE cap for each state agency kaposed by the legisisture.

2.

Two sasjor waste processing Iksasing actions have been asceived l

during the past year. Dese have necessitated the use of a team i

approach to the Econsing actions, pulling together r Gie in l

Beensing, financial escurity, risk assessment, and environmental j

monitoring. Rose have been time intensive and have taken resources l-away from standing projects. One application also required some I

geological review, which we do not currently have in the BRC. A i

contract with TNRCC to obtain the geological review was i

haplemented.

I l

3.

We have limited employee incentives since we do not get automatic cost of living pay increases and we ' nave limited funds for merit raises.

i l

4.

We have very competent legal staff in TDH's Omce of General Counsel; however, we do not consistently get timely and sumclent legal assistance due to their limited staff and high workload.

l l

5.

De potential transfer of responsibility for regulation of uranium l

recovery operations from TNRCC to TDH poses a mWor challenge to l

the agency. Most of the challenges involve the funding mechanisms j

and possibly having to hire and train all new staff for the program.

There are approximately 18-19 pending sites for tarininstion that will l

require close out surveys for license termination.

B.

NON COhBION PERFORMMiCE INDICA'IORS i

I.

Reruintiom and Im,m1 Authority i

27.

Please list all currently effective 1,,ta..taa that affects the radiation L

control program (RCP).

1 Bealth and Safety Code, Chapters 401 and 402.

I 17 l

\\

\\

i l

i 28.

Are your regulations subject to a 'Susset" or equivalent law? If so,

)

explain and include the next expiration date for your mgulations.

No.

j 29.

Please complete the enclosed table based on NRC chronology of i

amendments. Identify those that have not been adopted by the State, l

explain why they were not adopted, and discuss any actions being taken l

to adopt them.

1 i

See following Table. De equivalent to the quality management and

n. Isad=lak ations mie (10 CFR 35) has not been adopted by TDH.

j As reported on several occasions to NRC, TDH withheld adoption of this mie pending the outcome of the National Academy of Sciences mport. Since the result of this report appears to be a mWor revision j

of 10 CFR 35, with early input from the Agmament States, TDH will continue to withhold adoption of this mie until 10 CFR 35 is revised.

Adopting such a rule that is very likely to be changed during the 3

revision process is an unnecessary and costly burden on our licensees and TDH.

I Changes to 10 CFR 30,40, and 70 concerning decommissioning record keeping and self guarantee as an additional financial mechanism were not adopted by the due date.

Dese mies (and several other j

compatibility rules) are included in a rulemaking package that creates

{

a new transportation part and affects TRCR Parts 11,21,41, and 44.

i nis package is scheduled for adoption in December,1997. Revising i

the TRCR as frequently as NRC revises 10 CFR is not possible within

[

the parameters of the TDH rulemaking process (see response to B.I.30.).

l THIS PORTION OF THE PAGE LEFT INTENTIONALLY BLANK 9

9 1

18 L

v t

B.I.29. (Centhseed)

[

OR Dan Dan i

10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADorysOps Any ememiment den pdor to 1991.

IdentRy each rm frefer to the C - f-;. of Amenenental Decommiendening:

712751 953 4

Ports 30,40,70 Eneergency Planning:

4178 3 903 s

Ports 30,40,70 Standerde for ProtecWen Agelnet NedeqIan:

11154 953 i

Port 20 l

Safety Requiremento for Rodopophie 111054 953 i

Egulpment: Port 34 s

Nottnestion of Incidente:

10/1554

• 10 CFR 20 30,31.40 34 39

[

Ports 20,30,31,34,39,40,70 TRCR 21 41 31 36

~

7 DATE 919 3 10195 9f93 1082 l

ousser Ananagement eveyem and 112755

++see Response to s.t.29..

Resadminletreelene: Port 35

[

IJeoneing and Rododen Safety 7/1f96 Sf98 i

Meguirements for bredlesere: Port 38 Destdigen of Land Disposef 7122SS NIA 1NRCC Jedescesa and weste sne on Freyam: Port s1 Decometendening Reeeed keeping: Does.

10(2558 hectoded In developnoset of tronoporteden setes: Draft 2 deced 1257 mentatten ass #ans: Ports 30,40,70 RAsy 9,1997 l

Self-Ouerentee se en Adellonal Fheencisf 11285 7 hecduded be dovetsyment of trenoporteelen soles: Draft 2 deced 1257 l

Reechanism: Ports 30,40,70 Rear 9,1997

(

)

i 19 I

f h

j m-==.

OR i

DATE DATE 1G)CFUt RULE DUE ADOFTED CUMIEffT DEFECTED j

STATUS ADOPftUN l

tw MM Temnge: Centemens to EPA 71157 NtA TNRCC jededenen i

Stewlants: Port 40 Thnenness he Decommissioning 811 519 7 W be doveisement et transportscen ndes: Draft 2 deced 1257

-l Ports 30,40,70 May 9,1997 f

Properstlen, Trenefer for Conuncedst dis-17158 N be restolen to sp=ard reise (11tCH Ports 33M1)

Suenmer edbeson, auf Use et erpredset Mosedet 199s ter Mascal Use: Ports 30,32,35 I

1 Frequency of MeSeef Eneminedens for Use 3113SS W In dowedepment of transportselen ndes: Draft 2 deced 1287 l

et nespiratory pregocean Egelpment May 9,1997 tow-tevel weste Shipment utenifest 311Ss hectoded in development et transporteden sedes: Draft 2 deced 1287 Informeelen and Reporting hier 9,1997 l

Performones flogedrements for nedspeploy SI30/98 feevlelen of TVICR Part 31 wE begin efter yderad== et sueler Sysing Egelpment revlelen to 10 C>M 34 1998 l

no.s.or,tetet.en ne.e,emente:

.ti.S.

Amended DoIInMene and Odtede 1998 i

Ciertncedon of Decomndesienti Fusiding 11/24SS W be develsoment et transportselon sedes: Draft 2 dated 1257 j

Requirements May 9,1997 j

r 10 CFR Part 71: Campstesty es.Ih the

.I159 Draft 2 dated May 9,1997

287

(

incomettenes Atomic Energy Agency I

t atesesi Adendooresen of neesmen and 10t20tse em to sevision to miseced roles (THCR Porte 33 1)

Summer l

nemometsv. asseedese.

199s i

Tennbioelen er Transfer et a w SI18199 RM be devolepment of transportselon seiso: Draft 2 deced 1257

(

Aestettles: Recenamephes steguiremente.

Mey 9,1997 neseleWon et Deel neenieden of Attense 179 m0 ey due dose p

Etnoonte of Rodose#ve Metodele: Clean i

Air Act i

Recognetten of Agreement State Lleonees II13tOO Sy des dose j

In Areas Under Emdmedve Federal l

Jesdodletlen 1Meldn mi Agreement Stage Cdt.ie fer.ie - e.

e

$12950 W.i revielen to.no.cef,s.se critC.,e,se 23 1)

W Adminletered Radiencese metodet 1993 I

i l

M t

i

l l

30.

If you have not adopted aU 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.

j See Appendix 9. His table describes the steps required in the TDH j

rulemaking process to formany propose a rule, including steps j

required by state law and by TDH policy. De process includes l

reviews by TDH Office of General Counsel (OGC), Texas Radiation Advisory Board (TRAB), and Texas Board of Health (TBH). Once a rule is proposed, the minimum thne it can remain proposed is 30 days.

De BRC typically proposes a rule for 60 days to allow sufficient time

[

for comment. De steps for proposal of a rule in the table, beginning l.

with the TRAB review, must be repeated to ensure that a proposed rule is adopted.

De table time frames repnsent the time period 4

allocated for each step, ne minimum amount of time requind to adopt a rule is nine months.

F l

According to state law, when a rule is in the proposal phase of the j

adoption process, additional changes to that rule may not be proposed l

until the initial rule is adopted. His fact and the time frames involved in the entire TDH rulemaking process make it impossible to amend the TRCR at the frequency that NRC amends 10 CFR. For l

example,10 CFR 30 was amended in October 1993, January 1994, j

August 1994, January 1995, November 1995, and May 1996, his part was amended every three to ten months. Also,10 CFR 20 was

{

amended twice in March 1995, August 1995, and October 1995.

j Considering the fisquency with which NRC amends its regulations and

[

the TDH rulemaking process, the BRC may be behind in meeting i

some of the NRC due dates for compatibility items and ahead of l

meeting other NRC due dates.

4 l

E.

Sealed Source and Device Program i

31.

Prepare a table listing new and revised SS&D mgistrations of scaled sources and devices issued during the rmkw period. De table heading

{

should be:

SS&D Manufacturer, Type of j

Registry Distributor or Device j

Epmber cmtam User or source i

l

{

21 4

i i

i.

1 D.II.31. (Continued) i Manufacturer, SS&D Distributer or Type of Number Custom User Device or Source TX0261D101S Western AtlasIntemational Neutron Generators (F)

TX0634D152B TN Technologies Inc.

Fixed Gauge (D)

TX0634D126B

'IN Technologies Inc.

Gauge Calibrator (T) i l

TX0634D138B TN Technologies Inc.

Fixed Gauge (D)

TX004D137B

'IN Technologies Inc.

71xed Gauge (D) t l

TX0634D142B TN Technologies Inc.

Fixed Gauge (D)

TX004D131B TN Technologies Inc Pixed Gauge (D) j i

i TX0634D152B TN Technologies Inc.

F1xed Gauge (D)

TX0634D169B TN Technologies Inc.

X-ray Analyzer (U) i TX004D171B TN Technologies Inc. (Manu.)

Beta 'Ibickness Gauge (E) j Eberline Instruments (Dist.)

j TX0642D101B Tremetrics Chromat. Group Electron Capture Detector l

71nnigan Corporation Cell (N) l TX0642D102B Tremetrics Chromat. Group Electron Capture Detector Mnnigan Corporation Cell (N) i j

TX0642D801B Tremetrics Chromat. Group Electron Capture Detector l

Manigan Corporation Cell (N) l TX0476S167S Du Pont Merch Phannaceutical Gennanium-68 Photon l

Company Line Source (H)

TX0186D114S Berthold Systems, Inc. (Manu.)

71xed Gauge (D) l Formosa Plastics Corporation (Custom User)

TX0186D115S Berthold Systems, Inc. (Manu.)

71xed Gauge (D) l Boechst Celanese Chemical j

Company (Custom User) l TX0246D103S C.S. Products (Testing Industrial Radiography (A)

Equipment) IAd. (Manu.)

j Oceaneering InternationalInc.

j (Dist.)

}

i 22 2

4 l

L

k i

32.

What guides, standa:ds and procedures an uvA to evaluate registry applications?

I We provide the applicant with a copy of Regulatory Guide 2.2 (for sealed sources) or 2.3 (for devices containing radioactive material).

l During the review process, we use a standard review form developed i

by the NRC and modified to refersace Tazas regulations.

l 33.

Please include information on the following Wons in Section 4, as they apply to the Sealed Source and Device Progmn:

Technical Staffing and Training - A.D.7-10 i

7.

Name hitten

.. Area of effort in RAM i

l Moyd R. Hamiter Health Physicist (S)

SS&D review.60 l

A.D.8-10 N/A

.1 Technical Quality ofIlcensing Actions - A.M.11, A.M.1314 i

A.HI.11 N/A A.ID.13-14 N/A Responses to Incidents and Allegations - A.V.20 23 A.V.20 23 N/A i

m.

1.ow-12 vel Watte heram i

34.

Please include information on the following questions in Section A, as they apply to the low-level Waste Program:

Status of Materials faWon Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.H 7-10 Technical Quality of U~aulag Actions - A.DI.11, A.M.13-14 Technical Qudity of faWons - A.IV.16-19 Responses t.o faridents and Allegations - A.V.20 23 N/A 23 t

0 Ty'.

Urante M*ll Promm 35.

Please include informatien on the following questions in Section A, as they apply to the Uranium Mill Program:

Status of Materials Inspec' ion Propam - A.I.13, A.I.6 Technical Stamng and Training - A.II.710 Technical Quality ofIJoensing Actions - A.M 11, A.M.13-14 Technical Quality of faWJons - A.IV.1619 P =mses to Incidents and Allegations - A.V.20-23 N/A 1

l 1

d 9

24

O l

- Reenonae to Interrated Materiale Performance Evaluation Pronram (IMPEP) Ouestionnaire May 22.1997 t

[ 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 LEG-2) are not included in the electronic (Internet) transmission; paper copies of these appendices will be provided at the time ofprogram review in June.)

TABLE OF CONTENTS l

A. COMMONPERFORMANCEINDICATORS Pane No.

j

1. Status ofMaterials Inspection Program 3

Questions # l 3 (#4 6 not applicable)

II. Technical Staffing and Training 4

j Questions # 710 l

III. Technical Quality ofLicensing Actions 6

i Questions # 11 14 (#15 not applicable)

IV.. Technical Quality oflnspections 7

Questions # 1619 4

V. Response to Incidents and Allegations 8

j Questions # 20 24 i

VI. General 9

l Questions # 25 26 i

B. NON COMMOA PERFORMANCE INDICATORS L

Rerulation and Lenal Authority 13 i

Questions # 27 30 l

E Sealed Source and Device Pronram l

Questions #3133 does not apply E

Low Level Radioactive Waste Disposal Prorram j

Question # 34:

16 l

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 of1Jcensing 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 j,

E Uranium Program nrmwncewsm.R).P $!2897 I

Question # 35:

19 35(a). Status ofMaterials Inspection Program (Questions # 1-3 in A) 35(b). Technical Staffing and Training (Questions #7-10 in A) 35(c). Technical Quality ofLicensing Actions (Questions #11,13 14) 35(d). Technical Quality ofInspections (Questions #1619 in A) 35(e). Response to Incidents and Allegations (Questions #20 23 in A)

LIST OF APPENDICES 26 C. SUPPIMENTAL MATERIAL avausble at TNRCC omces la a separate folder Tentative List of documents included in the Supplemental Material Folder 27 l

PMXQWitCCODEP97. REP Sat 97 2

m 1

DETAILED RESPONSE TO THE IMPEP QUESTIONNAIRE A. COMMON PERFORMANCE INDICATORS L

status of Materials inmeetio., Promm l

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 laWons that are overdue.

Insp. Frequency Licensee Name (Yearsi Due Date Months O/D There are no overdue materials inspections at the present time. The Texas Natural i

Resource Conservation Commission (TNRCC) currently has four non-uranium licenses covering buried radioactive mate.-: 41: Monsanto Company (RW0219),

l-Texas A& M University (RWO448), Tes Tin Corporation (RW1270), and Iso-Tex, 1

Inc. (RW1937). Please see answer to Question #35(a)(i) for status of uranium inspections.

2.

Do you currently have an action plan for completing overdue inspections? If so, please l

describe the plan or provide a written copy with your response to this questionnaire.

i Does not apply.

i 3.

Please identify individual licensees or groups oflicensees the State / Region is inspecting l

less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for the change.

l l

None.

l 4.

How many licensees fded reciprocity not'ces 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?

l b.

For those identified in 4a, how many reciprocity inspections were l

conducted?

Does not apply.

5.

Other than reciprocity licensees, how many field inspections of'radiographers were performed?

Does not apply.

P;tfXj!NRCC\\DOEP97. RIP 5A97 3

L

4 i

i i

6.

For NRC Regions, did you establish numerical goals for the number ofinspections to be performed daring this review period? If so, please describe your gos!s, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number oflaWons performed.

I Does not apply.

g, Technleal StaMine and Trainine

)

7.

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, 1

the fraction of time spent in the following areas: administration, materials licensing &

j.

compliace, emergency response, LLW, U-mills, other. If these regulatory responsibilities 1-sie divided between offices, the table should be consolidated to include all personnel l

contributing to the radioactive materials program ' Include all vacancies and identify all senior personnel assigned to monitor work ofjunior personnel. If consultants were used l

to cany out the program's radioactive materials responsibilities, include their efforts. The j

table heading should be:

i i

Current staffing plan and the level of effort 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 staff for various activities, including LLW and j

uranium mill activities.

i 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 j

experience in health physics, or other disciplines, if appropriate.

l Professional staff hired since the last review are the following:

i Etiective Date Name and Discipline Zedlign (Radiation Prorram)

Paula Gonzalez Bealth Phy:Icist May 1997 Kathy Vall Regulatory Specialist March 1997 George FitzGerald Team Imder/ Licensing Sept.1996 William McCabe Health Physicist Feb.1995 Devane Clarke Bealth Physicist Oct.1994 Sajeewa Chandrasoma Financial Assurance (part time)

Sept.1994 Elizabeth Bourbon Attorney (part time)

April 1994 Madeleine Boyer Attorney (part time)

July 1995 PJD6TNRCCNMPEP97JtIP $!2897 4

/

l 0

i In addition to the above, two staff members (Peter Lodde and David Murry) of the l

Industrial & Bazardous Division provide technical support to the LLW program in l-specialized artes of geology, seismic analysis, and modeling. Resumes listing educational qualifications, additional training received, and experience of j

professional stanworking in the radiation program are given in Annendix 2.

l Additloest statsupport for the LLW program in the health physics area has been obtained from Gary Smith of the TDH through as lateragency contract. During l

1995, Dr. Wullam van Rensburg of the University of Texas at Austin provided assistance under contract in the review of socioeconomic aspects of the LLW l

application. See Anntndix 1.

9.

Please list all professional staffwho have not yet met the quali6 cation requirements of 1

license reviewer / materials inspection staK(for NRC, inspection Manual Chapters 1245 l

and 1246; for Agreement States, please describe your quali6 cations requirements for materials license reviewers and inspectors). For each, list the courses or equivalen 5

j training / experience they need to attend and a tentative schedule for completion of these requirements.

l Professional staN pursue continuing education in specific areas of their assigned l

function as needed. The following personnel are cu Tently scheduled for continuing education through participation in forthcoming NRC training courses:

i NAME NRC COURSE AND AVAILABLE DATES l

l H 117 H 120 H.102 H 308 G 108 G-109 Course Thie Introduction Radiologleal Heahh Transport. /

Inspection IJeenslag and Number to Healtb Surveys la Physies Radioactive Procedures Practices A l

Physics Support of Technology Mate 61 Procedures Decomal.

asloalag I

Course Date 07/14-18/97 08/20-2157 44/28-

. '44/28-07/28 06/2 6 5 7 &

i 95/09/97 454257 48/01/97 &

99/08-12/97 l

99/22 26/97 G.Fk Gerald 3

3 i

EVd 3

3 l

D. Kohler 3

l P. Gonzalez 3

3 3

i l

A stan member filling the one curesntly vacant position (hydrologist) may be j

selected to attend one or several of the courses that would directly contribute to the j

performance of his/her assigned functions.

i I

emenacenarr91.xte s/2:57 5

i.

_ 7 o

10.

Please identify the technical staffw,o left the RCP/ Regional DNMS program during this period.

The radiation control staff who left the program since last review through resignation, retirement, or transfer to another division or section within the agency arelisted below:

4 Kame and Discioline Reannn forlearing Date Left Earl Krishna, Hydrologist Tr6nsfer Nov.1996 Marilyn J. Preusse, Health Physicist Resignation Sept.1996 John Gumnick, Health Physicist Resignation March 1996 William C. Price, Geologist / Team Manager Retired Dec.1995 l

R. Ricardo Mu6oz, Health Physicist Transfer August 1995 Peter Wehner, Geologist Transfer Feb.1996 William Scott Pennington, Health Physicist Resignation Nov.1994 i

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 EL Technical Ouality ofLicentina Actions 11.

Please identify any major, unumal, 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 material. Particulars of these licenses are given in Anriendix 3. All four are due for 4

liccase renewal, and applications for renewal have been received from each. A diskette containing copies of current TNRCC radioactive materiallicenses was 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 edded or removed from the list oflicensees requiring emergency plans?

None.

13.

Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

None, nrxmaccmermarr sain 6

.s

O i

4 14.

What, if any, changes were made in your written licensing procedures (new procedures, j

updates, policy memoranda, etc.) during the reporting period?

l 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 Commission on May 14,1997, changes have been effected in certain licensing procedures. These arelisted below:

i

1) Amendments to il 281.3,281.17 and 281.18 revise the Commission's administrative completeness provisions to take into account specific requirements i

for radioactive materiallicenses. The amended language allows 45 days for administrative completeness review of new, renewal, or major amendment

]

applications, and 30 days for minor amendment applications.

l

2) Amendments to {281.19 and 5281.20 establ'ish the technical review and notice of deficiency provisions for applications for radioactive materiallicenses. For new, renewal, or major amendment applications, the technical review period will not enceed 255 days, unless the application is technically deficient,inwhich case the l

technical review period may be extended to a maximum of 450 days. For minor amendment applications, the technical review period is 90 days, which may be eatended to 150 days for technically deficient applications.

3) Amendments to $281.21 and $281.22(a) revise the Commission's application processing requirements to add specific provisions for radioactive material licenses, i

including provisions for the preparatiou of a written environmental analysis for eertain licenses. The amendments also revise the compliance summary and 4

technical summary provisions.

l

4) Amendments to {281.23 establish specific requirements for amending radioactive materiallicense applications after commencement of technical review.

15.

For NRC Regions, identify by licensee name, license number and type, any renewal j

applications that have been pending for one year or more.

Does not apply.

E Technical Ouality ofInsoections 16.

What, if any, changes were mad: to your written inspection procedures during the reporting period?

None.

[

PSTX\\TNRCCN!MFr.P97. RIP s/2197 7

i 4

1

_ _ ~

l O

I 17.

Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

$ggnhQt Inspector Licente Cat. Daig

[

No inspections were accompanied by the supervisor during the review period.

18.

Describe internal procedures for conducting supervisory accompaniments ofinspectors in the 6 eld. If supervisory accompaniments were documented, please provide copies of the documentation fer each accompaniment, None.

19.

Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments properly calibrated at the pre ent time?

Please see answer to Question #35(d)(lv).

E Resoonse to incidents and Allenations l

20.

Please provide a list of the most alenlEcant incidents (i.e., meidical misadministration, j

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 noti 6 cation, etc.) that occurred in the Region / State during the ievic w period. For 4

i Agreement States, information included in previous submittals to NRC need not be i

repeated. The list should be in the following format:

No incidents were reported related to the four non uranium licenses covering buried radioactive material (listed in Annendix 3). Please see answer b Question #35e

]

regarding incidents related to the uranium program.

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 noti 6ed?

a.

For States, was timely noti 6 cation made to the Of5ce of State Programs? For Regions, was an appropriate and timely PN sei. cent'ed?

None.

22 For incidents invoMng 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 de6ciency? Please provide details for each case.

Not applicable.

P.trrn'RCCNDOLPp7. RIP $1497

e

]

l 23.

In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are prwently undergoing review? If so, pleue ducribe the i

circumstances for each cue.

None.

24.

Identify any changes to your procedures for handling ausgations that occurred during the

-l period of this re' dew.

3 a.

For Agreement Ststos, please identify any aDegations referred to your program by i

the NRC that have not been closed.

None.

{

VI.

General

~

l 25.

Please prepare a summary of the status of the State's or Region's actions taken in response j-to the comments and recommendations foUowing the last review.

1 De NRC perfonned 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, Commissioner of the Texas Department of Health (TDH), and Mr. Den Pearson, Executive Director of the TNRCC. Subsequently a follow.op review was made by Mr. Robert J. Doda of NRC Region IV emce in June 1995. The foUow up comments and recommendations were communicated by Mr. Doda in his letter i

dated October 3,1995, addressed to Mr. Richard A. Ratliff of the TDB, and Mr.

1 Minor B. Bibbs of the TNRCC. This section provides a summary of TNRCC's j

action in response to both these communications.

The March 1994 review detenmined that the Texas radiation control program was adequate to protect the public health and safety. However, a finding of compatibuity with NRC's program was withheld because of deficiencies in six areas

'l listed in Mr. Bangart's letter. Five of these pertain to the TNRCC's radiation progrant the first three estate to logislative changes; the fourth to state adoption of the NRC decommissioning sule in a timely manner; and the last to a rule change to prohibit selflasurance in providing financial assurance. These are addressed here (quoted in italles) in the order listed in Enclosure 2 of Mr. Bangart's December 28, 1994 letter. The sixth area of concern relates to the jarlsdiction of the TDH, and is hence omitted here.

e PATX\\TNRCcWPEP97.aEP 1897 9

• eg 4

.m..--

e.m.

y

.m.._,_,_.-,.,..

o

_.m

Lenistative knues: (1) the dqffnidon ofimedent unste in the Texas Low.Leni Radioactin M'aste Disposal Authority Act (TLLRWD.l4) is not conpatible with NRC's d<finition because itplaces linsitadons on radioacdn neaterials with a ha{f.l{fe greater than 35 years and transuranics in concentrations greater than le nanocuries per grem; (2) the definidon ofbyproduct snatorialin subssedan 401.003(3)(B) of the Texas statute, Radioacdn Materials,11de Iis not eenpadble with NRC's d<ffnition; and (3) prodsions in the TLLRRDM andin Texas Part 45, "Liesnsing Requirements forNear Surfe:eLandDisposalofRadionedu Waste;" prohibit the Aqposalof ennsurentes in eencontredens greater than le nanoeuries per gram:

The State took udeus note of the need forlegislative change to make Texas deflaitions compatible with the federal ones. The lead was taken la early 1996 by the Office of Representative Warren Chisum, Chainnan of the Committee on Environmental Regulation. Texas House of Representatives, in both the 74th and 75th Texas insislatures. The TNRCC assembled an lateragency work group for drafting a legislative bill, consisting of representatives from the TNRCC, Texas Depanment of Health, Tesa Law.14 vel Radioactive Waste Disposal Authority, and Rauroad Commission of Texas. Ms. Annette Glass, from the staff of the House Committee on Environmental Regulation, assisted in organlaing an intede study by the Committee on the need for change of definitions, and in drafting a bill. The but 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 was obtained from the industry and public representatives and incorporated in the draft. Representative Chisum introduced the blu (House Bill 1311) in the current (75th)14:1 lative session. A copy of the billis given in Annendiz 4.

Howsver, the blu died in committee.

The revised definition of byproduct material of subsection 401.003(3)(B) is included in another bill (Senate Bill 1857), which bas been approved by committee and is awaiting funberlegislative action. The outcome of this bill will be known by the end of the session on June 2,1997. The TNRCC will attempt to reintroduce legislation to change the definitions at the nest legislative ussion in 1999.

Adontion of NgC.4emnat%,,gnagla11geg: (4) the regulation concerning not(/leadon ofincidents which was to be adopted by October 15,1994 has not been adopted; and (6) the reguladon estabilsking aprohibition against the use ofse{f-insurance as the surery arrangementfor urenlum reconryfacilities has not been adopted within the threeyearperiod requitect by the NRC:

The revised new TNRCC ruk package, which was adopted as final rule by the

. Commissioners on May 14,1H7, includes both these NRC regulations, tu Section 336.211 and 336.803(a), respectively.

r.mwaccomm.are son,,

10 l

i l

0 i

26.

Provide a brief ducription of your program's strengths and weaknesses. These strengths I

and weaknesses should be supported by examples of successes, problems or difBculties which occurred during this review period.

I l

Protram Successes he major successes pertainlag to Agreement matedal activities dudag the period fouowing the March 1994 review are desedbed below. Is addition, dudog able l

peded the staff has spent a significant amount of time working on other non-i Agreement activities, such as NORM disposal, and potential disposal of alsed waste by private industry.

]

I

1. Low-level radioactive waste (LLW) disnosal. He program's strengths include an efficient and committed tirense reviewing team. The radioactive waste licensing team fulfilled the agency's commitment to review the voluminous application fued by the TLLMWDA, prepare a detailed,450 page environmental analysis (Agagad}&

H W 1), and issue a draft license fAnnendiz LLW 2)la fewer than 15 months from the time the application was deemed to be administratively complete, despite small j

staff slas, staff turnover, and continuing revisions to the application even after it was administratively complete, q

The TNRCC also accomplished the entire task of LLW application review at a low cost, resulting in part from relance on experienced staff for license review rather j

than on outside consultants. The total cost, about $1.5 mullon to the beginning of j

the public headas, is considered to be one of the lowest expedenced by states

{

developing a LLW disposal faculty.

l j

2. Adontion of radiation rules in TNRCC format. Following the transfer of 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 eqfarence applicable parts of the rules of the TDH contained in its Texas Remulations for Control of Radiation (TRCR). The rules were codified in I

Title 30 TAC Chapter 336. In 1994, a major effort was begun to rewdte the TNRCC radiation rules in its own stand alone format. Draft rules were developed in accordance with agency procedure for rule development with ample public input.

The rules also adopted subsequent NRC regulations that were needed to meet compatibility requirements. The rulemaking effort was successfuny concluded with the adoption of the final TNRCC radiation rules by the Commisaloners on May 14, 1997. The rules wul become effective on June 5,1997.

3. Licensinn backlos reduction. In 1994 the Program Evaluation Division of the TNRCC (now disbanded) conducted a study of the uranium licensing backlog in the radiation control program, which was largely inherited when the program was ennwneceezertur son,7 11 4

.m...

-. ~ -,,.,... -. _

--. - -. - -....~,

,\\

l l

transferred from the 'DH to TNRCC in September 1993. It issued a draft report in i

December 1994 entitled " Radioactive Substances IJcensing Backlog Elimination Plan," which identined 43 pending licenslag actions. Over the past three years an additional 9 action requests have been received, and a total of 21 actions have been l

processed (i.e., completed license packages delivered to the Chief Oerk's office for i

further action and flaalissuance), amounting to nearty 50% reductlos of the backlog existlag at the time of program transfer.

An example of a major licesslag accomplishment is the renewal of the radioactive material license for Fanna Maria Ursalem Operations (RW2402), a conventional uranium mill taulags faculty (under reclamation) located la Karnes County, Texas, i

The renewal encompassed three nasjor amendments, lacluding a transfer of the l

l license, and seven related minor amendments, laciuding the establishment of groundwater protection standards for the faculty he renewallicense has gone i

I through the public notification process and wiu be issued with Executive Director's signature on May 23,1997.

4. Comnllance in finanelal assurance. TNRCC has achieved substantial

)

compliance with the NRC rules and guidelines for financial assurance dudng the i

erview period. At the 1994 NRC review, the NRC staff had determlaed that seven of the flMncial assurance instruments covering uranium licasses were " performance

{

bonds." These were accepted when the program was under the TDH and were l

transferred to the TNRCC with the program transfer, but were unacceptable under current NRC rules because they did not provide a substantive financial assurance other than a commitment that existed through a license condition. The NRC recuirement prohibiting licensee self assurance has since been incorporated into the i

newly adopted radiation rules (see aarwer to Question #25 above).

l

{

The financial assurance staff worked with all the seven uranium companies and

(

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 stui not provided as acceptable financial assurance, was referred in i

February 1997 to the Enforcement Section for legal action for not providing adequate financial assurance.

8. Insnection and Comnliance. The laspection and compliance program of the TNRCC has wo:kod with the uranium licensees to try and achieve voluntary j

compliance and has succeeded la many cases. De total number of aueged violations l

In 1993 (wbue the license inspection was still done with TDH-trained inspectors) was

15. In 1994, after TNRCC inspectors revamped their form and inspection style, the member of nointions jumped to St. By 1996, the member had decreased to 33 due j

mainly to voluntary compliance on the part of the companies. Bowever,If voluntary j

compliance does not work, esforcement action wiu be taken.

I l

PATMTNRCCWMPEPP7. RIP $1s97 I2 l

l l

1

0 De Executive Director of the 'INRCC is pursuing formal enforcement action against one licensee, Uranium Resources,Inc. (URI), for numerous violations of the Tesas 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 URL URI refused to sign the Order, therefore a more extended omforcement process is underway. The case is now pending in TNRCC's Litigation Support Division. This is the first known enforcement order to be issued against a eranium mining company la Texas since 1978.

Prnaram Weaknenes Availability of Traininz: Support from the NRC in the form of more regular and free or inespensive technical training would help, particulariy since the Texas program is funded entirely through licensing fees and the regulated community is vocally opposed to increasing fees. In particular, specific training in areas ofin situ uranium mining and LLW disposal would be desirable.

$taffshortare: la order to strengthen and continue a viable program, the depth of expertise would need to be lacreased to a alnimum of three professionals in each required discipline, or approalmately twenty total professional staff members devoted esclusively to adioactive materiallicensing and Inspection.

B NON-COMMON PERFORMANCE INDICATORS L

Rerulation and Lecal Authority 27.

Please list all currently effective legislation that affects the radiation control program (RCP).

Iagislation most directly affecting the RCP lacludes:

The Texas Radiation Control Act, Chapter 401 Texas Health e

& Safety Code (currently being revised in legislative session)

The Texas 14w Level Radioactive Waste Disposal Authority e

Act, Chapter 402, Texas Health & Safety Code (currently being revised la legislative session)

Copies of these documents are included respectively as Annendia LEG-1 and Annendia LEG _2.

Electronic versions of these statutes are accessible through the INTERNET at the fouowing addrisses www.capitotstate.ts.us/statutehoes/bs040100to'c.html; and www.ca pitol.sta te.tz.us/ stat u t eh oes/hs040200t oe.h tml.

remecwrtm.nzr sosn 13 t

,.,-.--,,-,,a.

-.--,,.s-

e IAglstation indirectly affeding the ssdiation control program includes:

e ne Temas Open Meetings Act e

no Texas Pubuc Infonnetton Ad e

he Texas Ad=laldrative Procedure Ad Chapter 5, Texas Water Code l

Texas Environmental Audit Privilege Act e

Texas Regulatory Takings Ad e

i e

UraniumMillTallings ela== tion Act m

i e

Texas I4w 14 vel Radiondive Waste Disposal Compact Act j

e Texas Government Code j

e Texas Coastal Zone Management Ad l

Texas Soud Waste Disposal Ad 1

o Chapter 27, Texas Water Code (appucable to underground

{

IQection wells used to dispose of ursalum byprodud material and to the Class In production wells used in ursalum miata$

i l

Coples of these statutes are included la the supplementary materials.

i findlnr Lethlallan.143 slation has been introduced in the current session of the 1

i Texas Legislature, in the form of Senate Bill 1857 and the companloa House B111 3462, which would transfer the entire ursalum program (including tallings disposal) j from the TNRCC back to the TDH. A copy of S.B.1857 wul be included in the supplemental material folder under Tab SUP4. This bill has been approved by the committees and is swalting finallegislative action. Its fate will be known by the end l

of the legislative session on June 2,1997. If passed, the blil would take immediate i

effect upon enactment and necessitate a complete reorganlaation of the TNRCC

{

radiation control program.

l 28.

Are your regulations subject to a " Sunset

• or equivalent law? If so, explain and include l

the next expiration date for your regulations.

I i

Not at pneent. Bowever, thers are several blus pending in the IAglstaturv that i

would suspend ~or vold rules after a certain amount of time and under eartain l

eenditions: Tex. H.B. 3351 S.B.1073 B.B. 01911 B.B. 328; and B.B. 2153. De 1997 legislative session ends in June; therefore, the 'INRCC should know whether any of these bills have passed by the thne of program review.

Please complete t e enclosed table based on NRC chronology of amendments. Identify h

29.

j those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them.

i i

f

, P.utwacevurtre?.nzr s/2 97 14 1

The completed table is given in Annendl11EG 3.which also gives the plan of action

+

?

for rules that are yet to be adopted. The TNRCC has adopted all amendments currently due and plans to begin another rulemaking process in the summer of 1997 l

to address aseendments due in the future, i

30.

Ifyou have not adopted all amendments within three years from the date ofNRC rule l

promulgation, briefly describe your State's procedures for amending regulations in order j

to maintain compatibility with the NRC, showing the normallength of time anticipated to j

complete each step.

l Adoption of certain NRC sules by the TNRCC has taken longer than three years. A 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 TDH in March 1992 (disposal) and September 1993 (uranium), coupled with limited agency experience with the program and limited staff resources.

)*

The TNRCC rulemaking process is as follows:

l 1.

Staff prenares rules concent naner for Rules and Polley Review committee 2-4 weeks. Before a decision is made to draft a rule, stafT prepares a concept paper and presents it to the TNRCC Rules and j

Policy Review Committee (RPRC), an laternal working group with representatives from every office in the agency. Concurrence for l

decisions to draft rules is obtained from the Executive Director.

j 2.

Pre-Pronosal Staner 2 weeks 6 months, denendine on comnlexity and l

controversial nature of rule. Staff drafts proposed rule language and necessary backup material, including a fiscal note and a takings l

assessment. If a rulemaking laitiative is anticipated to have a major impact on the state, pro-proposal drafts are often mailed out to laterested parties and/or published in the Texas Resister and on the Worid Wide Web for informal comment. The proposal and any l

comments may be disenssed at a Commission Work Session. In l

addition, staff may solicit public participation during the early stages l

of rulemaking by offering the proposed rules for informal public j

comment during one of the TNRCC's Regulatory Forums, held the l

second Friday of each month except in December and July.

l l

3.

Pronosal Stare: 2 months. When the rule language is ready for proposal, it is scheduled for Commission consideration at a regular weekly Agenda meeting to obtain formal authorization to propose. If l

authorization is obtained, the proposal la submitted to theIslal

?,

l r.amaccartm.att seas,7 15 L

l I

Etgilitt for publication. A forinal comment period of 30 or more days is held la which written comments are received. The proposal 4

i preamble contalas lastructions for submitting formal comments. A l

j public headng may be held dudag tble period.

j d.

Rule Adontient 3 weeks 5 months. Staff addresses au comments received dudag the public comment period and schedules the rules for i

formal adoption by the Commission at Agenda. The Teams l

Administrative Procedures Act provides that au proposed rules must j

be adopted within 130 days fNm the date that notlee of the proposed j

rules is published in the Itzas_Real:1ers otherwise, the proposed rules t

are automaticaDy withdrawn.

i The time required for each step of the rulemaklag process depends largely on the complealty of the particular rule package. The rules package adopted on May 14, 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 followed by the TNRCC; it coincided with an agency wide regula' tory reform effort to reorganize and stesamline all agency rules, which required coordination with other rules packages in progress; and there were a number of controversial issues at stake in able rules package, including raising uranium licensees' fees and snodifying the uranium soll standard. However, most rule changes to conform to Federal standards are noncentroversial and generally can be saade effective in roughly 6 g months.

E, Sealed Source and Device Pronram Questions # 31 through 33:

Does not apply 3,

Low. Level Radioactive Waste Dimonal Pronram 34.

Please include information on the following questions in Section A, as they apply to the 1.ow Level Waste Program:

34(a),

Status of Materials Inspection Program Does not apply. The low level radioactive disposal application licensing rwiew was completed by TNRCC in March 1996, and the matter is presently under an adjudicative public hearlag. A licensing decision is likely to be made during 1993. The current statute requires the TNRCC to have a resident laspector at the disposal faculty during the operating peded to assure compliance.

rxrmwnecartm.arr ssa,,

16

/

..~

l 34(b).

Technical Staffing and Training (i) Pleue provide a stat 3ng plan, or complete a listing i: sing the suggested format below, of the professional (technical) person years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacanclu and identify all senior personnel usigned to monitor work ofjunior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME POSITION AREA OF EFFORT See answer to Question # 7 and Annendix L (ii) ' Please provide a listing of all new professional personnel hired since the last resiew, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if apptopriate.

See answer to Question # 8.

(iii) Please list all professional staff who have not yet met the qualification requirements oflicense reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 124$ and 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

See answer to Question # 9.

(iv) Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

See answer to Question # 10.

34(c).

Technical Quality of Licensing Actions (i) Please identify any major, unusual, or complex liceraes which were issued, received a major amendment, terminated or renewed in this period.

A draft license to the TLLRWDA for LLW disposal was prepared by the

. TNRCC and noticed for public review on March 29,1996, along with a rammecwrtm.are saan 17 4

o i

i l

l published environmental and safety analysis document. He technical analysis i

document is attached as Annendin LLW 1 and the draft license as Annendin LLB':2. A diskette containlag a copy of the draft LLW radioactive material i

licenses was maued on May 14,1997 to Mr. Richard Woodruff, the leader of j

the NRC miew taan. De licenslag matter is currently the subject of an

, adjudicative public hearing, which is being conducted by the State Omce of l

Adelaistrative Bearings (SOAH). The SOAB judges will prepare a recommendatles to the TNRCC Commissioners, who wul them anske the final j

decision on whether to issue the license.

)

The application as faltlally submitted in Mareb 1992 was lacomplete. As l

project studies continued and additional data were developed, a great deal of j

technical and administrative material was subunitted to the TNRCC in the form l

of misions to the application. The revisions were rwviewed by staff, and the results were communicated to the applicant through letters (notices of deficiency) and meetings. The application was declared adelaistratively i

complete on May 12,1995. The technical review esiminating in publication of i

the environmental and safety analysis document was completed within 12 l

months of receipt of an administratively complete application, or within 11

{

months of Agency declaration of administrative completeness, i

i TNRCC staff made 13 pre-licensing site visits for collecting environmental j

samples and background radiation for independent verification of data i

submitted in the applicationi for site familiarization and conducting environmental reconnaissancel and for detaHed site laspection (see Anatadji I LW.3).

The staff review was performed in accordance with applicable federal technical j

guidance documents of the NRC (NUREG's) and Texas laws and regulations, and was coordinated through a process oflaternal peer review and discussion.

l The TNRCC staff followed the requirements of Chapter 401, Texas Health and 1

Safety Code, and of pertinent regulations,30 TAC Chapter 336 and.Tsaal Rerulations for Control of Radiation Part 45 (the rule has since been re-

)

adopted as Subchapter H in TNRCC's 30 TAC Chapter 336). The miew j

team consisted of 12 persons who were wou qualified la diverse technical disciplines and some of whom possessed prior experience in simuar miews related to ursalum licensing at the TDH. Review was coordinated through a process oflaternal peer miew and disenssion.

i j

ne TNRCC's processing of the LLW disposal faculty license application j

lacludes the following major milestones:

1 4

)

r.trmwaccomm.ur sane 7 18 i.

4

. ~.

...-..,.,,..-...,~..~~.-._.--e--.-..m.~

-.-.-., - - -.---w

0 l

Initial application recehred frem the Authority:

03/0252 Application declared administratively complete:

05/1255 Technical review of the application completed:

03/2956 Licensing matter referred to SOAH for public beadag:

06/2456 Adjudicative public beadng begun by SOAH:

08/0656 i

Anticipated completion of adjudicative public baring:

March 98

)l Anticipated finallicea:Ing decision by Commissionen:

August 98

01) Please identify any new or amended licenses added or renoved firom the list of j

Econsees requiring emergency plans?

Not applicable.

1 i

(iii) Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

4 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.

l 34(d).

Techrdeal Quality ofInspections Does not apply 34(e).

Response to Incidents and Allegation Does not apply l

Iy.,

Uranium Prorram i

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 (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 Manual Chapter 2800 (issued 4/17/95). The list should include initial inspections that are 4

overdue.

i i

rMWWRCCD&EP97. REP S1897 IE e

..n

--.n.

-nm.

3 O

i i

i j

Overdue laspections are suaradsed in the foRowing tables tiesme lampeetten importlen senths easiber, and Llemese mese and sees of project Fregensy em shte overdse three elsit tyeere) ette poseer

(

l W kn6 ses notapet seinenra nellesy/sinseostto 1 year sessuher 1996 9 as W Ms6 s01 nelaget esseurses esapenre s'aom 1 year essenhor tes6 9 as W seN*ess fetet minerate toeparetime uset este Project 1 year seensher tsee 5 es W Ses3 set a t Inc. seeftoProjest 1 yew esteher 1996 7 es I

l (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 raponse to this questionnaire.

i i

The pdedty assigned to everdue inspect'on Is low because these facilities do l'

not present an overriding health and safety concers. Due to the limited sumber of radioactive material inspectors, a bisher pdodfy is being given to j

ongoing actions that may be finalized, such as completing close-out l

confirmatory surveys and issuing actices of violation.

j (iii) Please identify individual licensees or groups oflicensees the State / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 2800 j

(issued 4/17/95) and state the renon for the change.

i j

wone.

35(b).

Technical Staffing and Training (i) Pluse 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 j

or radioactive material program by individual. Include the name, pas! tion, and, for i

Agrument States, the firection of time spent in the following areas: administration,

~

j materials licensing & compliance, emergency response,11W, U-mills, other. If these regulatory responsibilities we divided between of5ces, the table should be j

consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all sehlor personnel assigned to monitor work ofjunior personnel. If consuhants wwe used to carry out the program's j

radioactive mate:ials responsibilities, inc;ude their efforts. The table heading should j

be:

NAhiE POSMON AREA OF EFFORT l

See answer to Question #7, and Annendix 1.

r.mwneccamt.mte no,7 20 1

l 4

(ii) Pleue 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 anrwer to Question #8, (iii) Please lir, all profusional starwho have not yet met the quali6 cation requirements oflicense reviewer / materials inspection staE(for NRC, inspection Manual Chapters 1245 and 1246; for Agreement States, pleue dueribe your quali6 cations quirements for materials license miewers and inspectors). For eac14 list the courses or equivalent training / experience th y need to attend and a tentative schedule for completion of these requirements.

See anrwer to Question #9.

i (iv) Pleue identify the technical staff who left 'the RCP/ Regional DNMS program during this period.

See answer to Question #10.

35(c).

Technical Quality of Licensing Actions (i) Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated or renewed in this period.

The TNRCC currently has 12 uranium licenses, which are listed in Annendix l!:1. Staff completed 20 uranium licensing actions during the review period.

Staff made five pre-licensing visits as part of application review and environmental and safety analysis (see Annendix U 2). A diskette containing eoples of current TNRCC radioactivt materiallicenses was mailed on May 14, 1997, to Mr. Richard Woodruff, the leader of the NRC review team.

(ii) Pleue 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 ev.emptions from the j

regulations granted during the review period.

Nene.

O exrmwacewrtm.RIr s*Js97 2I

~

e

i Oy) What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

See answer to Question #14.

35(d).

Technical Quality ofInspections i

i

0) What, if any, changes were made to your written inspection procedures during the 4

reporting period?

3 None.

01) Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Sucensor Inspector.

Licene Cat. DEt

. No inspections were accompanied by the supervisor during the review period.

Oli) Describe internal procedures for conducting supervisory' accompaniments of l

Inspectors in the 6 eld. If supervisory accompaniments were documented, please i

provide copies of the documentation for each accompaniment.

i

None, i

(iv) Describe or provide an update on your instrumentation and methods of calibration.

Are allinstruments properly calibrated at the present time?

We continue to use the services of the TDH Bureau of Radiation Control to calibrate all Ludlum survey lastruments. A recently acquired Eberline instrument, which is not due for recalibration yet, will be sent to the Ebertine company for calibration.

Curratly available instrumentation is as follows:

i 1

Ladium Model 3 1

Eberiine Model 6000 i

4 Ludlum Model19 9

Ludlum Model14C 2

Ludlum Model12S a

All instruments are properly calibrated at this time. -

.i e

/

0 i

Radiological laboratory analyses of all environmental samples collected by TNRCC are conducted by the TDB 1aboratory through as lateragency contract. The TDB laboratory is weg equipped (see Annendia U 3 for a list of TDB laboratory equipment),

j i

35(e).

Response to Incidents and Ausgations (i) Please provide a list of the most alsnlBcant incidents (i.e., medical misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less noti 6 cation, etc.) that occurred in the Region / State during the wview period. For Agreement States, information included in previous submittals to NRC need not be repeated. The list should be in the fonowing format:

LICENSEE NAME 1.lCENSE # DATE OFINCIDENT/ REPORT TYPE OFINCIDENT A summary of the incidents reported is given la the table below:

Licensee IJeense No.

Date oflacident Type of Ascident No.

Report (see details below)

Malapal Resourcs RW 2436 1

June 16,1995 lisiviant spill Company 2

July 25,1996 lajection well probicm Malapal Resources RW 2436 3

Soptember 7,1994 elevated bloassay Company URI, Inc.

RW 3653 4

September 3,1995 yellowcake spill USX/ Texas Uranium RW 2449 5

November 3,1995 au spuls la marestricted Operation 6

May 19,1996 -

areas 7

September 21,1996 1.

June 16.1995: Sput is the B6 Wallfleid to serestricted areal corrective action taken by the licensee. Cded Mr. Bob Doda of NRC Region IV to report the sput.

2.

July 25,1996: Injection wens problem in mine area B 1 estension was reported to the TNRCC by letter dated July 25,1996 from Cogema Mining, Inc.(COMIN), the operator. As lavestigation is being conducted by the staff of the UIC, Umalem, and Radioactive Waste Section. Corrective actions are oeing taken by COMIN, Monthly progress report regardlag B l estension are sent to the TNRCC.

nrmmccoatm.ast s'aa,i 23 4

4 4

i i

I 3.

September 7,1994: As elevated bloassay result for a COMIN e:aployee was

]

reported to the TNRCC la September 1994. This is under laymtigation.

4.

September 8,1995: A yellowcake splu occurred at the Kingsvule project dryer buudlag within the restdcted area, ne yellowcake spul was reported to TNRCC, Region 13/ San Antoalo on September 8,1995, by the licensee.

Accordlag to URl's RST, the lids of the two youowcake drums (55 gauen each) blew off, and each drum lost about one half of 6ts content. The splu occurred witble the dryer buudlag on the weighing pad. According to the RST, the two youowcake drums contained more hydrogen perealde (H 0 ) than usual.

3 3 I

According to the RST, the first drum blew its lid off at about 12:15 a.m., and the second drum blew he lid off at about 12:45 a.ma on September 8,1995. The operation was discontinued and decontamination efforts were immediately initiated. According to the RST, approalmately one drum of yellowcake (one 3[

, half from each drum) was spuled on the weighing pad. Accordlag to the RST, j

3/4 of the spuled yellowcake was recovered, whue the other 1/4 was washed into

. the sump. According to the RST, decontamination of the area has been i

completed, and air, sou, and water samples have been collected. Radiological j

surveys of the area were also performed. Bloassays for ladividuals involved with the spill were performed.

l During the 1995 laspection, yellowcake spill area at the dryer building (in curbed weighing area and outside the curbed weighing area) was surveyed.

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 l

operators will check the yellowcake drums for abnormalityl that the drums will l

be allowed to cool dows for a longer periodi and that the amount of hydrogen j

peroxide (B 0 )in the uranium wul also be monitored.

3 3 l

l 5 7. Nov.1995, and May and Sept.1996: There was one splu to unrestricted area j

in 1995 and two spuls to unrestricted area la 1996. Corrective actions were l

taken by the licensee.

?

(ii) During this review period, did any incidents occur that involved equipment or soun:e I

failure or approved operating procedures that were de6cient? If so, how and when l

we4 e other State /NRC licensees who might be affected noti 6ed?

a.

For States, was timely noti 6 cation made to the OfEce of State Programs?

I For Regions, was an appropriate and timely PN generated?

Imeldents numbers 13 and 5 7 were reported to the Office of State Programs representative in the NRC Region IV office in Arlington, Texas. Incident #4 did not tamtwacenaun.nu son,7 24

/

l

0 result is contamination outside the restdcted area 11: nits: henee no reporting was esquired.

Oli) For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device fcr an assessment of possible generic design desciency? Pleue provide details for each cue.

None.

Ov) In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing revies/l If so, pleue describe the circumstances for each cue.

None.

(v) Identify any changes to your procedures for handling allegations that occurred during

.the period of this review.

None.

For Agreement States, pleue identify any allegations referred to your a.

program by the NRC that have not been closed.

None.

e PM.TNRCC'6(PEPP7, REP Sad 17 25 e

APPENDIX D LICENSE FILE REVIEWS File No.: 1 Licensee: Offenhauser Company License No.: LO3109 Location: Houston, TX Amendments No.: 17,18, and 19 L! cense Type: Industrial Radiography (Fixecs 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 has 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 Mt off of Amendment 43.

c)

Exemption requested to a license condition about record keeping requirements at a storage only :ocation. 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 Amendnient No.: 6 Licensee Type: Nuclear Pharmacy Reviewer: DW Date issued: 05/29/97 Comments:

a)

Requested 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: OF, SW, LK Date issued: 03/14/96,03/28/96,05/20/97

1 i

Texas Proposed Final Report Page D.2 License File Reviews File No.: 5 Licensee: Camco incorporated License No.: LO3303 Location: Houston, TX Amendments No.: 10 License Type: Industrial Radiography (In Plant)

Reviewer: WS Date issued: 08/08/96 i

File No.: 6 Licensee: MacGregor Medical Associates License No.: LO4046 Location: Houston, TX Amendment 3 License Type: Nuclear Medicine (Diagnostic end Therapy)

Reviewer: PM Date issued: 11/21/95 File No.: 7 Licensee: University of Taxes 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 Location: Lubbock, TX Amendment No.: 8 License Type: HDR and Therapy Reviewer: PM File No.: 9 Licensee: Lockheed Fort Worth Facility License No.: LO1866 Location: Fort Worth, TX Termination License Type: Research and Development Reviewer: FH Termination issued: 06/09/95 File No : 10 Licensee: Ybarrondo & Associates Scientech, Inc.

License No.: LO4435 Location: - Carrollton, TX Termination License Type: Calibration and Reference Sources, Unsealed Radioactive Material Reviewer: DF Termination issued: 06/20/95 Comment:

a)

Had to request additional information and conduct field inspection prior to releasing

- site.

File No.: 11 Licensee: 3M Company / Health Physics Services License No.: LO3843 Location: St Paul, MN (Austir, TX)

Termination License Type: Fixed Gauges Reviewer: WS Termination issued: 05/14/96

,-v,,,ww--

.u

,,----,.----,-,c_e ern..

Texas Proposed Final Report Page D.3 t

License File Reviews l

File No.: 12 I

Licensee: LogTech Wireline Services, Ir c.

License No.: LO2501 Location: T yler, TX Termination License Type: Well Logging Reviewer DF Dated issued: 12/12/95 File No.: 13 Licensee: South Texas Utility Contractors License No.: LO5065 Location: Mercedes, TX New License Type: Portable Gauges Reviewer: DF Date lasued: 06/06/97 Comment:

a)

Did not hclude the standard condition for leak testing.

File No.: 14 Licensee: Jagoe Public Company License No.: LO5042 Location: Denton, TX New I

License Type: Portable Gauges Reviewer: WS Date issued: 06/03/97 File No.: 15 Licensee: Health images Inc.

D.B.A. Health images Medical Center License No.: LO5005 Location: Housten, 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 File No.: 16 Licensee: Northeast f.edical Center Radiology License No.: LO2926 Location: San A:stor.io, TX Renewal License Type: Prbate Practice Nuclear Medicine & Therapy (<30mCl)

Reviewer: DW Date issued: 03/05/96 Comment:

a)

This was a renewalin entirety and not b) letter.

File No.: 17 Licensee: Cardiology Care Consultants License No.: LO5045 Location: El Paso, TX New

]

License Type: Private Cardiology Reviewer: DW Date issued: 05/01/97

I i

Texas Proposed Final Report Pa9e D,4 License File Reviewr File No.: 18 Licensee: Toxoma Medical Center License No.: LO1624 Location: Denison, TX Amendment No.: 45 License Type: Institutional Nuclear Medicine, Therapy and Brachytherapy Reviewer: PM i

Date issued: 06/27/97 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 File No.: _20 Licensee: Nuclear Sources & Service, Inc.,

D.B.A. NSSI/ Recovery Services, Inc.

' License No.: LO1811

+

Location: Houston, TX Amendment No.: 43

- License Type: Waste Processor Class B Reviewer: PS Date issued: 04/19/96

- Comment.

I a)

Condition 9 stated that Attachment 1 was attached to the liconi,e 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

+

5 f-

,_.__[

. _ _.... _. _.. ~.., _.. _ _

..... _ _.. _ _... _.. ~..,. _. -. _ _ _... _. _ _. _.. _.. _, -,.

APPENDIX E INSPECTION FILE REVIEWS File No.: 1 Licensee: Mundy Contract Maintenance, Inc.

License No.: LO4360 Location: Pampa, TX Inspection Type: Unannounced /noutine License Type: Industrial Radiography Priority: 1 Inspection Date: 01/23/97 Inspector: RA Comments:

a)

Unable to determine whether previous NOV followed up or corrected.

b)

No description of findings related to management, c)

Inspector area surveys and maximum tr nge of licensee personnel dosimetry not in report.

File No.: 2 Licensee: Don and Sybil Harrington Cancer Center License No.: LO3053 Location: Amarillo, TX Inspection Type: Unannounced / Routine License Type: Medical Brachytherapy Priority: 1 Inspection Date: 04/19/96 Inspector: RA Comments:

a)

Maximum range of licensee personnel dosimetry riat in report, b)

Cannot determine whether licensee performed operational checks for inspector, c)

Dates of leak test records checked prior to date licensee received all sources.

File No.: 3 Licensee: Amarillo Diagnostic Clinic License No.: LO4085 Location: Amarillo, TX Inspectiori Type: Unannounced / Routine License Type: Medical Priority: 2 Inspection Date: 05/17/96 Inspector: RA Comments:

a)

License authorizes diagnostic use only but report indicates therapy also performed.

b)

Instrument calibration expired but not identifieri, c)

NOV issued for dosimetry records not maintained but report indicates records available through 04/96, File No.: 4 Licensee: X Cel Group, Inc.

License No.: LO3548 Location: Corpus Christi, TX Inspection Type: Unannounced / Routine / Partial License Type: Industrial Radiography Priority: 1 Inspection Date: 05/09/95 Inspector: DC Comment:

a)

No description of inspection findings related to management.

-n

-,e

1 Texas Propcsed Final Report Page E.2 Inspection Fi a 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 Comment:

a)

Unable to determine whether inspection announced or unannounced.

File No.: 6 Licensee: Star Jet Services, Inc.

License No.: LO2214 Location: Corpus Christi, TX Inspection Type: Un nnounced/ routine License Type: Well logging Priority: 1 Inspection Date: 10/16/96 Inspector: DC Comment:

a)

No description of inspection findings related to management.

File No.: 7 Licensee: Boart Longyear License No.: LO4302 Location: Houston, TX Inspection Type: Unannounced / Routine License Type: Gauge service Priority: 2 Inspection Date: 06/28/96 Inspector: LC Comment:

a)

Several NOV'c identified in 1994 but not issued until 1996 inspection.

File No.: 8 Licensee: Houston Northwest Radiotherapy Center License No.: LO2916 Location: Houston, TX Inspection Type: Announced / Routine License Type: Teletherapy Priority: 1 Inspection Date: 08/29/95 Inspector: LC File No.: 9 Licensee: Scott & White Memorial Hospital Li::ense No.: LOO $t,1 Location: Temple, TX Inspection Type: Announced / Routine License Type:- Nuclear medicine Priority: 3 Inspection Date: 12/19/96 Inspector: CD Comment:

a)

Unablo to determine whether emergency instructions to workers inspected or employee interviews performed.

Texas Proposed Final 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 Comment:

a)

No observation of licensee field operations,

)

File No.: 12 Licensee: Cleveland Regional Medical Center License No.: LO2055 3

Location: Cleveland, TX Inspection Type: Announced / Routine i

License Type: Nuclear medicine w/ therapy Priority: 1 Inspection Date: 02/06/97 inspector: HD Comments:

a)

Physician using radioactive material not named on license.

b)

No description of inspection findings related to management.

c)

Closeout of previous NOV not clearly docu tiented.

File No.: 13 Licensee: Blood Center of Southeast Texas, Inc.

License No.: LO4399 Location: Beaumont, TX Inspection Type: Unannounced / Initial License Type: Irrediator Priority: 2 inspection Date: 04/29/97 Inspector: HD Comment:

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 I

Location: Dallas, TX Inspection Type: Announced License Type: Pharmacy Priority: 1 Inspection Date: 03/13/97 Inspector: RE Comments:

a)

Inspector surveys or independent measurements not documented, b)

Field note form outdated.

Texas Proposed Final Report Page E.4 Inspection File Reviews File No.: 15 Licensee: Physician Reliance Network, Inc.

License No.: LO5019 Location: t, herman, TX Inspection Type: Announced / Initial License Type: Brachytherapy Priority: 1 Inspection Date: 02/27/97 Inspector: RE Comments:

a)

Field note form outdated.

b)

Report Indicates no dosimetry badges available but sources transferred on 2/19/97.

File No.: 16 Licensee: Corpus ChristiInspection & Engineering Inc.

License No.: LO4379 Location: Houston, TX Inspection Type: Unannounced / Initial License Type: Industrial Radiography Priority: 1 Inspection Date: 10/16/96 Inspector: EF Comment:

a)

No description of inspection findings related to management.

File No.: 17 Licensee: University of Texas Health Scienca Center License No.: LO2774 Location: Houston, TX Inspection Type: Announced / Routine License Type: Broad medical Priority: 1 Inspection Date: 03/18 20/97 Inspector: EF Comments:

a)

Tield note form outdated (1966),

b)

Inspection overdue, c)

Inspector smears did not include laboratory sink areas where small amounts of tritium disposed.

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 Inspection Date: 05/03/96 Inspector: CL w

Texas Proposed Final Report Page E.5 inspection File Reviews Comment:

a)

Cannot determine whether licensee performed operational checks for inspector.

File No.: 20 Licensee: BPB Instruments, Inc.

License No.: LO4405 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 11/09, but license not issued until one month later.

- File No.: 21 Licensee: East Texas Medlcal Center License No.: LOO 977 Location: Tyler, TX Inspection Typ*e: Announced / Routine License Type: Medical Diagnostic & therapy Priority: 1 Inspection Date: 01/30 31/97 inspector: MV Comments:

a)

Unable to determine how 2 misadministrations followed up during inspection.

b)

Response to NOVs not in file.

File No.: 22 Licensee: Baylor University License No.: LO1290 Location: Dallas, TX Inspection Type: Announced / Routine License Type: Broad medical Priority: 1 Inspection Date: 03/12/96 Inspector: RW File No.: 23 Licensee: Bonded Inspections, Inc.

License No.: LOO 693 Location: Garland, TX Inspection Type:- Announced / Routine 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.

Tem Froposed Final Report Page E.6 Inspection File Reviews insoection accomoaniments:

Accompaniment No.: 1 Licensee: Bonded inspections, Inc.

License No.: LOO 693 Location: Garland, TX Inspection Type: Announced / Routine License Type: Industrial radiography Priority: 1 Inspection Date: 04/14 15i97 Inspector: RW Accompaniment No.: 2 Licensee: Denton Regional Medical Center License No.: LO2764 Location: Denton, TX Inspection Type: Announced / Routine License Type: Hospital Priority: 2 Inspection Date: 04/16/97 inspector: RE Accompaniment No.: 3 Licensee: Longview inspection License No.: LO1774 Location: Longvlew, TX Inspection Type: Announced / Routine / Complete License Type: Industrial Radiography Priority: 1 Inspection Date: 04/17/97 Inspector: MV Accompaniment No.: 4 Licensee: Syncor International Corporation License No.: LO3398 Location: Amarillo, TX Inspection Type: Unannounced / Routine / Complete License Type: Nuclear Pharmacy Priority: 1 lnspection Date: 05/20/97 Inspector: RA Accompaniment No.: 5 Licensee: Syncor International Corporation License No.: LO2117 Location: Austin, TX Inspection Type: Unannounced / Routine / Complete Lic:,nse Type: Nuclear Pharmacy Priority: 1 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: Routine / Announced License Type: Gauge Priority: 2 Inspection Date: 06/11/97 Inspector: DC

a-i Texas Proposed Final Report Page E.7 Inspection File Reviews Accompaniment No.: 8 Licensee: MacGregor Medical Associates License No.: LO4646 Location: Houston, TX Inspection Type: Routine / Unannounced j'

License Type: Nuclear Medicine Priority: 2 Inspection Date: 06/12/97 Inspector: DS Accompaniment No.: 9 Licensae: CAMCO License No.: LO3303 Location: Houston, TX Inspecaon Type: Routine / Unannounced License Type: Industrial Radiography Priority: 1 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 T

4 i

a

-1 4

i

APPENDIX F -

INCIDENT FILE REVIEWS File No.: 1 Licensee: Unknown

License No.: NR Location: Midland, TX -

'Date of Event: 08/18/95 Type of Event:- Release of 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: -

a)

The State could not determine who was responsible for the contamination.

t b)

The contaminated dirt was removed and transferred to a local company (authorized for radioactive material storage) to be held for decay.

File No.: 2 Licens,ee: Texas A&M University.

License No.: 42-09082-09 Location: College Station, TX c

-Date of Event: 10/12/94 Tme of Event: Release of Radioactive Material j

St.mmary: A dog injected with 17 mci of Tc 99m voided contaminated urine resulting in cmc. amination being spread to severallocations of the clinic before nuclear medicine staff

%ame 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 i

event to Texas. Several violations were issued.

+

Comment:

j 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 j-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:

a)

Camera had fallen off a truck. No apparent damage occurred. The licensee was cited for violations.

i 1

,...e

,n

Texas Proposed Final Report Page F.2

-t inciden'. Files Reviews File No.: Licensee: ?Aidland inspection and Engineering

Location: Odessa, TX License No.: NR

' Date of Event: 03/24/95 Type of Event:- Equipment Failure Summary: A 20 CiIr 192 source became disconnected due to a worn ball on the end of the drive cable and resulted in a 18 mrom dose to the RSO during source retrieval.

Comment:

i 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 4

License No.: _NR Date of Event: - 09/12/95 Type of Event: Equipment Failure

Summary

A 56 Cl 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 handie bearings had become pressed together 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.

L File No.:l 6 Licensee: Quantum Chemical l

Location: Deer Park, TX -

License No.: NR j

Date of Event: 04/10/96

Type of Event

Equipment Failure Summary: A nuclear density gauge 3 Ci Cs 137 was left in the open position due to the

[

. gauge's rusted handle / shaft breaking off when shutter closure was attempted.

I Comments:

- a)

The gauge was replaced by a service company.

j b) 1The 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.

j, c)

The State did not notify the gauge manufacturer of the failure, n

Texas Proposed Final Report Page F.3

. Incident Files Reviews File No.: 7 Licensee: H and G Inspection Company Location: Houston, TX License No.: NR Date of Event: 03/27/95 Type of Event: Equipment Failure _

a 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.

4 Comments:

a)

The NMED event date is incorrectly listed as 03/27/75.

b)

The licensee determined that a stiffer housinc on the crankout device corrected the problem and notified the manufacturer of the problem.

File No.: 8 Licensee: X Cel Group, Inc.

Location: Corpus Christi, TX License No.: NR Date of Eve:nt: 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 homer assembly failed and allowed the source capsule containing 100 mci of Cs-137 m 'iall 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 t.hutter assembly.

Comments:

a)

- No overexposures occurred during the event, b)

Although it was determined that no generic problem or design defect caused the

Texas Proposed Final 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 failure..

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.

File No.: 11 License: k. G. Taylor, Co.

License No.: NR Location: Odessa, TX Date of Event: 06/09/94 Type of Even:: Potential Source Damage

- 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 contamination and no damage to the source-1 File No.: 12-

~

License: BlX Testing Laboratory

, License No.: NR:

< Location: Odessa, T'X 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.

APPENDIX G SEALED SOURCE AND DEVICE REVIEWS File No.: 1 Registry No.: TX 0642 D-101 B Licensee: Tremetrics Chromatography Group, Finnig i Corporation SSD Type: Electron Capture Detector Cell Date issued: 08/08/94 1

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 i

it TCG, FC. The same appeared on TX 0642 D 102 B and TX-0642 D-801 B. The j

review team suggests that all three registration certificates be corrected at the next

~

amendment.

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 (GLa), it may'be confusing to GLs since they may not know what to do about the " copy of their license." The review 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 102-8 Licensee: Tremetrics Chromatography Group, Finnigan Corporation SSD Type: Electron Capture Detector Cell Date Issued: 08/08/94 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:

1.

The review team did not find a reouest letter from the distributor requesting that the registration certificate TX-0642 D 103 B be changed to inactin. The reviewer 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 '. e documented.

2.

With regard to taking a registration certificate inactive, the reviewer said that the distributor states that there were no changes to the device, therefore the only 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

i f-Toxas Proposed Final Report Page G.2; Sealed Source and Device Reviews

?

j the REFERENCE section of the registration certificate are in the file (with b

attachments). The review team also suggests that the registration certificate be

~ distribution to specific licensees" to "as of x/x/xx,' the model XX is no longer changed to past tense as appropriate (i.e. change "the model XX is authorized for I

j authorized for distribution." The reviewer says that State procedures for -

j amendments to active registration certificates includes ensuring that the materialin

[

the file is up to current standards, so that if there has been a change in what is required or the level of detail required for the file, the distributor will be asked to i

provide it. - The review team suggests that this procedure be extended to requests to make a registration certificate inactive as far as practicable.

[--

File No.: -4 Registry No.: TX-0634 D 169 B 4

Licensee: TN Technologies Inc.

- SSD Type: X Ray Analyzer Date issued: 04/25/94 F

l.

No comments.

. File No.: 5 i

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 i

belt (same source and source holder as already approved for the 5034), and y

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 l

_. review team suggests that allinformation pertaining to the design.or limitations of i

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 detector will be no more than 7.5." Since the approval of this device for use.

[

without guard screens by generally licensed users is based on this restriction, the review team suggests that this be included as an item in the LIMITATIONS section I

e

_ ~ _ _.. _.______ _______...___._..__ _ _.___

f.'-

F

--Texas Proposed Final Report -

'Page G 3 -

j Sealed Source and Device Reviews E,

3 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 L

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.

j 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 1

l procedures be provided.

I File No.: 6 Registry No.': TX 0634 D-138 B Licensee: TN Technologies Inc.

SSD Type: - Fixed Gauge -

Date issued: 01/11/96, corr pg 01/25/96 I

Comment:

1..

The reviewers completed but the file did not document that the reviewer evaluated -

the impact that the reduced wall thickness resulting from enlarging the inside of the source holder would have on the integrity of the holder.- The review team suggests l

that this be documented.

4

' File No.: 7 5

Registry No.: TX-0246 D 103 S i-Licensee: Oceaneering International Inc.

[

SSD Type: Industrial Radiography l

. Date Issued: 11/09/95 1

- Comments:

1 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 licensees after 09/01/93, shall comply with the requirements of this -

part." This device does not appest to meet these requirements. The review team p

suggests that the registration certificate reflect this to assist license reviewers using 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 l

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 curface of the device shall have no radiation level in excess of 50 i;

mR/hr at 6 inches' from any exterior surface of the device." Using the values given-for the external radiation levels to calculate the external radiation level at 6 inches j

(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

' range results from whether the 5/30/100cm distances were measured from the 1

.a-

..s

,.. ~,

...w.,,.

0 Texas Proposed Final Report Page G 4 Scaled 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 re0ulations. The' review team 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 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 depided 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 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.

6.

The tube inside the DU shield does not extend to the end of the hole in the DU shield, The review team recommends that the State review this issue to determine whether the damage to the DU shield that might result during source exchange or 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, assembly methods, and source containment are adequately addressed.

8.

Dwg 004A refers to Dwg 401, but the drawing for part 401 does not look IWe 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.

m.

m

wruvtruhxa 071s

-~

Pact m/ts

$N

&C

~

Texas Department of Health i

PattiJ. Patterson, M.D.

Commissioner of Health 1100 West 49th Street Austin, Texas 787,%3199 TEXAS BOARD OFHEALTH I

b (512) 458 7111 s

~gpq_

http://www.edh state.ts.us Walter D. Wilkerson,Jr.,M.D., Chairman Roy L Hogan Mauy E. Ceverha.M.P.A Vice Chair DeputyCr-'t:.ar for Admmestrauon Ramiro R. Casso, M.D.

- David L. Collins. P.E.

Randy P. Washington Deputy Commissioner for Health Care Anancmg Ruth F. Stewart. MA. R.N.C.

Betsv Triplett Hurt '

I 3

August 264 1997

\\

Mr. Richard L, Bangart, Director Office of State Programs, Mail Stop 3D 23 i

U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Dear Mr. Bangart:

1 4

We appreciate receiving your letter dated July 25,1997, concern f

i Integrated Materials Performance Evaluation Program (IMPEP) ev r of the '

materials regulatory programs of the Texas Department of Health (T ve Resource Conservation Commission.

the draft report. We look forward to participating i n

can be of further assistance, please contact R r s assessment

512/834-6679.

Sincerely, g

"=w Q

=_-

Pa

. Patterson, M.D.

Commissioner of Health Enclosure

-J

m wis Responses to Recornmendations and Suggestions In Draft IMPEP Report 3.3 Technical Ouality of Licenelao Actions Suggestion: The review team suggests that amendments and renewals be pr amendments which impact health and safety (i.e., new Radiation Saf:ty Officer beca previous one left the company; major proposed proceduce changes wtsch coul safety issues: are completed ahead of the amendments and renewals which adding a source or another user when ten sources or users are already on the lic

- by letter).

Response: Licensing staff have implemented a 'prioritization method that will ta safety issues into account.

New license applications continue to have high priority, as do amendn=t3 and renewals that could impact health and safety if not handled as soo after receipt.

3.4 Technical Ouality of Inspections Suggestion: De review team suggests the State consider standardir.ing their p supplementary field note forms. These could be modeled after the NRC fonns as disc TDH's Bureau of Radiation Control (BRC).

Response: The BRC currently has a ' standard" set of inspection guides developed for inspections. The set of guides covers all typical areas that are to be inspect licenses and licenses with more specific regulatory requirements (such as ind well-logging, nuclear medicine, etc.), standardized supplemental guides are added to th The BRC is in the process of obtaining lap-top computers. We will develop forms to with the lap-tops. This will enable the BRC to standardize inspection forms a to date.

Suggestion: The review team suggests documenting in reports summary discussio fmdings with management at the conclusion of inspections.

Response: Although it has always been the BRC's intent to have documented a " summar tbc inspection items discussed with management" in the inspection report, neithe guides nor the Inspection Manual require it. The BRC plans to amend the Inspection M to cianfy this issue. An inspection summary will be a requirement for the " inspection form.

Recommendation: The review team recommends that the State adhere to the policy o supervisory accompaniments of all qualified inspectors.

m

vtmJVU.UVJ 0710 3

Pact 4/ts

^

Response

schedule and will assure that the schedule is maintained.ne BRC Recommendationi The review team recommends that all rad for confirmatory surveys-(field measurements) be calibrated for all ran inspectors.

Response: De need to use the curnot BRC instruments to measure radiation levels g 200 mR/hr is rare. Other instruments would probably be used at the higher 'uc However, the department's radiological defensecalibration source is j

-and that prognm has a larger calibration source. program is being consolidated within the BRC to calibrate survey instruments in the higher ranges.The BRC will evaluate the u Future calibration procedums abould include all ranges for beta / gamma survey instmments.

3.5 Rama== to Incidente and Allmilons Suggestion: The review team suggest that the State initiate actions (through the Agreement States) to directly utilize the Nucle Response: TDH is curTently connected to the NMED system. A training session scheduled for September 5,1997, for s:aff who will be directly involved in enterin Mr. Sam Pettijohn of NRC's Office for Analysis of Event and Operational Data traming for our staff. Following the training, we will be entering event data direc NMED system.

4.2 Sealed Source and Device (SS&D) Evaluation Prom.m Recommendation: De review team recommends the State perform an evaluation t the safety significance of the issues identified by the review team perta' ing to re certificate number TX-0246-D-103-S and to identify any other issues that may exist. n m

1 evaluate the application, as necessary, to ensure that all pertinent safety and regu are adequately addressed.

Response: None of the issues identified by the review team were determined significance.

Each item identified by the review team was addressed during a subsequ review.

The applicant was asked to respond to those items to provide additional data for inclusion in an updare of the registration certficate. Attached are a copy of the tener T to the company c.oncerning the device and a copy of the response we received. Each item i Appendix G of the draft report is addressed as follows:

2

)

(nFTUut1 UDe 07to PACE E/IE 1.

device. Each item in ANSI N432-1980 which Under the

• Limitations and Considerations of Use" Section, industrial radiography and shall be disnibute by the NRC or an Agreement State " Although this statement is no be, it does indicate that the device is used only in conjunction with 2.

When using the data supplied by the manufacturer (CS Products),

.Soureg produces an exposure rate of 45 mR/hr at the surface on the side should have been questioned. The applican supplied the results of a new survey. This new survey demonstrat rate at the surface of the source holder is less than 45 mR/hr.

3.

Since this device has to be surveyed when prepared for transpon, external ndiation checks would be accomplished at that time, The applic asked to provide confinnation that surveys are performed on each de that it was constructed in accordance with the drawings submitted 4.

Including " DIAGRAM: See Anachments" twice on the registation ce typographical error. It will be removed when the certificate is amended 5.

The applicant has not yet received information the registration certificate, 6.

Source exchange is performed by the source manufacturer and is only a glove box. The manufacturer's installation procedures will thus elimin for contamination of the device due to damage to the DU during sourc is our determination that no design change is necessary.

7.

The applicant has provided new drawings that explain the assembly pro actuator pencil.

8.

The applicant has supplied new drawings that clarify the adequacy of t 9.

As state in item 1 above, this device is designed to be used only as a com to a crawler. The review was performed on the device as it was intended to be us The applicant has stated in a subsequent letter that the exposure head attached to one of their crawlers and will never be used as a separate unit.

3 l

l

g(

1 improva. ment,lHowever, the' draft B@EP crit with Recommendations for Improvement indicates that some SS&

address important health and safety concerns or indicates repeated exa cxisting guidance in product evaluations, and addre

{

i findings of NRC staff of only one device evaluation that requires further The i

the fact that a sampling of other device evaluations performed during revealed no health and safety inadequacies, should not place TDH un Satisfactory with Recommendations for Improvement.- We believe th finding under the NRC criteria would be Satisfactory with suggestions.

additional safety evaluations to ensure that the d 3:

i adequately addressed in the additional cases, and to demonstrate that thi j

occurrence.

Response

Most of the deficiencies identified in TX-0246-D 103 S are unique to I

device review that has been performed by TDH in

{

j other device reviews in the list supplied to the review team were reviewed to quality assurance / control checks included a radiatio i

S were unique to that device evaluation,within expected vahaes. Th

[

- Recommendation: The review team recommends that the State review

{-

technical concurrence reviews for SS&D safety evaluations and implernent pr

[

require an independent technical review for all future evaluations, a

i

. Response: The Draft atPEP criteria document states, in part, that for i

urxler the non<ommon performance indicator Scaled Source and Device E a technical quality assurance audit of the application and proposed certificat performed by a second individual which supports the finding that the produc licensing purposes." We do not believe that the technical quality assurance as an independent technical review of all scaled source and device appliations.

l assurance review is performed of the primary reviewer's work.

A quality-reviewer, this is an audit to check their work and the cettificate for accurac

- quality assurance is performed on the work of reviewers with less experience.

{

limited maff resources. complete irvi~ndent technical review is not rwamy in mo A second j-l 3

4 1

i-6 e m

--.nr e.-..,-

-,s

,-,,-.--.,e-a-

--n-

MnJRTUR UMO-PACE Ma Suggestion: The review team suggest that the State consider the comments in Appen take action as the State deems appropriate.

Responat: Stafr have reviewed the individual suggestions in Appendix G of the draft repo regarding sealed source and device reviews. Suggested changes on individual device re certificates will be made the next time those certificates are amended. We will also imp the suggestion that when :. registration certificate is made inactive, that the reviewer determ the total number of units distributed, the number of units still in the field, and ensure that all

- letters listed in toe REFERENCE section of the registration' certificate are in the file.

Suggestion: The tuview team suggests that the State consider assigning safety evaluations those staff manbers currently being trained to perform SS&D safety evaluations to enable the to gain enough experience and obtain registration certificate signature approval before the staff member currently performing the initial review retires.

Response: We are curremly assigning the initial review on all medical devices to a staff memb in the Medical Licensing program. As workload permits, we are also assignin sources and devices to a staff member in the Industrial Licensing program. g some indus Suggestion: The review team suggests that the State take a more aggressive approach t forwarding information to the agency responsible for the product evaluation and registrati certificate where there is a possibility that the failure or problem may be a generic issue.

Response: We will implement a procedure in which reviews of any reports of source or device failures or equipment malfunctions will be evaluated and reported to the cognizant federal or state agency or other reviewing authority that may be involved.

4.4 Uranium Recovery Rerulatory PrograIQ Recommendation: "Ihe review team noted thn the 2 year inspection interval (for uranium facilities) is not consistent with IMC2800, and recommends that the criteria for assignment of inspection intervals greater than called for in IMC2800 be evaluated, justified and fully documented.

The review team recommends that an action plan be developed and implemented by TDH to overcome the mspection backlog in the uranium recovery program.

Response

1he regulation of uranium recovery and byproduct material disposal has now been transferred from the Texas Natural Resource Conservation Commission to the TDH. TDH will maintain a inspections on a one year interval, ar a minimum. No problems are anticipated with such a schedule.

Two i spectors will be hired and all overdue inspections should be completed within six (6) months.

1 n

Existing experienced staff will also participate in eliminating the inspection backlog.

5

/,

vwTUVLnJW G/UU Pace C/16 w

f

=

4

,a TD_H Texas Department of Health Pasi). Panerson M.D.

Cesumissioner 1100 West 49e $ases Carol S. Danab Austin. Teaas 78756 3tt9

($12) 458 7111 Deputy Counaissioner for Prosrams Randy P. Washington Padiation Control Deputy Ceaunissener for Heal 6 Care Financing

..t$12)5W6633..

Depary Cournissioner for Menen.wmon Roy L Hogan 4

August 5,1997 George Spencer Oceaneering lnternational, Inc.

Solus Schall Division 11921 FM 529 Houston, Texas 77041 RE: License No. I.D4463 and SSD TX0246D103S

Dear Mr. Spencer:

Dunng a recent review of our program by the U.S. Nuclear Regulatory Commission (NRC), sever questions concerning the safety review of the C.S. Products Model CS 0316 gamma head. In order to determine if any bealth and safety issues exist concerning the use and operation of this device, w must ask several questions concerning this device. nose questions are:

1. On page 2 of the Mmn with your lener dawd September 12, 1995, you provide the exposure rates of @Scm - 36mr, @30cm - 10mr, @l00cm - 1.6mr. During toe NRC's tuview, it was deteimined that these values do not obey the inverse square nde. Please expla

2. No sp ci5c procedum or comminnent was found that you will perform a radiation survey ou each new device to ensure that extemal radiation levels fall within acceptable parametets and that a program has been developed to ensme that all devices are manufactured according to the drawings submitted in support of your application for this device.

3. There was confusion concerning the configuration of the gamma bead when you receive it. The C.S. Products Manual shows a transit plate over the end of the source bolder and your drawings show the actuator merMsm anached. How do you receive the device? How is the device shipped? The concern bere is the exposure of the unprotected DU (depleted uranium) shield to an uncontrolled environment and the spread of DU cn**mm' mtion.

4. The stainless steel tube inside the DU shield does not extend to the end of the hole in t Cau damage to the shield occur durmg source replacement or exchange?

bap://mmrw.adh. state.tz.us/ech/ rad /pageshm: Atm i

An Eq.a11 Explaymt Cypetursj Esplcyc

IDiE12 C34 071Q Mr. George Spencer PACE O/15

5. Two questions arose concerning drawingr referenced in your application September 12,1995.

Drawing CS0316004A references a part no. CS031600401 and CS031600403.

We only received a copy of CS031600401 CS031600403. The drawing of CS031600401 and did not receive a copy of CS0316004A. Please explain.

does not resemble that part referenced in

6. Finally, it is our understandag that you will only use or lease this device a crawler. Is this understanding correct? Will there ever be a case where the be distributed to another licensee witbout being attached to a crawler? W allowed to remove the gamma bead from your crawler?

Please respond as sob as possible so that we may expedite our resp refertnoe the above mentioned license in your reply.

Please Since oyd R. H ter, Chief

• In:!ustrial 1% grams Division of thint,, Registration and Standards Bureau of Radiation Control bec: file, insp. file

g -US-07 COgO$A dII-Colus Ccholl-Houston e

10/1s 71D-3 D-0701 P.02 (octAteseseof

=e-Solus Schall Division t 1921 FM 529 Houston. Tenas 7702r Te:ephant:(7t3I 319 4700 l

Fas: (713) 329..t!C D i

August 20,1997 GSS7208 Teams Department of Health Ann: Mr. Floyd R. Hamrter, Chief tru$ustriel Programs Danelon of Ucensing, Registration and standards Bureau of Redse$on Control 1100 West 49th Street Ausan Texas 78756 3159 1

l

Subject:

Ocense No, LO4463 and SSO TX0246D103S 1

Dear Mr. Hamaer 6

With reference to out telephone conversation and our request for more time to snower ttw quashons b your le August 5,1997, we are set awadang informaton from the manufacturer and the companies that perform t of sources hto these cameras.

We onll deal with each of your guestsons in order and attempt to show where we are in the ptocces of pr setsfactory answer:

1. We agree that these values do not obey the irwerse square law rule, we are now in fann of the corrancted data:

@Sem. 42mr, 30cm. 3.Smt,

@100cm. 0.36mr P6eese also ase the enclosed chart i

2. As yetincomplete,as we await informenon from the companies that load these cameras,to formulate our arewer C.S. Products, (Testing and Equipment), Ltd. Are approved by the U.K. Department of Environment, Tra tie Regam for the Design and Manufacture of Type B(U) Pacieges. Approval requires audit and acceptance of Quality and Assurance and Coritrol System to a recognized Standard ie, ISO 9000. C.S. Products apply t Standards to the den *gn and produchon of Type 'A' Packages These Standards were applied to the desen and manufacture of C.S. Products Crander Control and Tattle Ta motope contamers, (Type *A' packages), which were submitted for, and received, approval h 1984:

CSP Crawler Control Certificate # NR 242-D-101-5 I

CSP Tatne Tale Certlecote

• NR 242-D-102 5

3. As yet incomplete.

4, As yetincomplete l

l i

. -.MTU.VU. US4 C710 t

Pact 33/gs e'. u.s c.ee ae. 4

• *~

~=

1 i

i 1

To former assist we are also hetudeg a copy of draudng 06CRA u or pened in its entirety,

6. We will only lease or use the device when anached to a craw 4er. We willnot eve 4

device wthout a crawler. All the eqwpment ow'wd by Oceaneering international I and maintahed solely by ourselves afd abh icense ir allowed to.cBee our eque Thank-you for your forbeatence

.rnel, manner..ouw.e e se.,h this matter, we are k to supply he answers

=,

f oue ons piease coni.ci me. at ihe nomoe, sixwe.

' Best regards, i

i George Spo'cor R.S.O.

W ncig intemasonal, he,. Solus Schall Dension cc S. Pierce 1

SN.

3.

i

$j.

J l

f 9

(C.cc=*C

1. p,# 0 _emo,Co na:u*"e1s> Ego g\\.r i

e

.t r

y yun0e00~

T*Oo t

s.y

.t,

W e

c a

f ru

~

S

_~

m 0

0 4

o r

f

~

s e

t 0

~

3r:.

a R

~

g e

s o

0 g

~

~

0 D

1

~

3 :

~

o r

f 6

e w

c n

3 0

0 e t

5 s

S 2

l O

C d

~

a 0

e h

1 0

2 a

m m

O a

S G

I

~

~

o o

t 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

5 6

0 5

0 5

0 5

0 S

0 4

4 3

3 2

2 1

1 a

1 s

1 1

l

AVTUYt1 UB)G 0713 PACC 13/)$

=. -.

i o

i a,z t.

ty g s

q a ce a.

.6 1

-r

- 4

+

3 i

i 6

aR l ;:

s g

t,;

e n

d;.+q

C j

l m

g8

~

g a.o

,ge p

ii!

5 o

n i,t;r,n, 4-a 9,

y 1

it m

=-

g0

!_.v i

e E

i s

~

i i

j a

W o

6

w.,-

~

w i,

ty y

1.

v E

a u,

g

+

g3o.:s is.,

s e

e ec e-o

=.

y,

=<

r

+

2

's B

t 4

a t-7 g gy 9

+GE9 Q w-e i;

- 'a-f,_i,

• ~

}

N os i ir DGE*9N l h,

s-o on I

-l-*

cv u

Ml' 4

s.

u

.a N

ilt D GE*9-e1

!=.

,g

~,i.e 1

+ '4 f

o 3 8

e C

j'g M lT T

N g9 4 vu e

f

?

s g

m

.S 7

r3 u.,

w.

w n 8 4 eea vi

,o m e

=,,, -

e 6

g g g *IF --

a s n uax

. e.

.;.4 b.

g g

t

=

__ n f

e.

j

,,3

,/'

"5* CS031600601

+matmute emnte a u m,o e S"

• E-csosmoo+or "'

uoanoe M

• mM Y

an,og,,

M1s Invel W MthO CSCh ?

M01011 not.fi Isw$

26 62.5

~

'=

j\\

E tao as o

l14 1.ss to' 6

s.es a

v c

M

$04 4

g 1

1 e.

o, Q.

g

.a h

a) b 0

.c.

0 3

e s

v3 g

.u N

C, N

O-REMovG At_L SMAlt P RD(E'S s

T.A.". l%i ',ana?!n#ta"ca""'"'""gTg C.S. Products (Testing Equipment) Lta,. atCS03166AN p,,a,,a= A"ggg1, glgg==

ACR TORPENCIL n.wnann. men.m. m

- in m an mi.

u6.

BACK S,n'iELD i?

um"CS031600401

• g a

. -ii... n.

re.

o

.= 3,s-aoss erc.

. o

= = nom== w

m. reesvam A...,y

== a#

onio.oc si3

-n

==

a49e.9.e.

7

,,xgg gjpg---

0 m'

o 8

y-

==~

- o g a S

,8 I G. m 3

te c5 @

y y

E t

^

i d

4 X

D

\\

I l I h

l j

j og.9 I

Y a.

S E* 9 l

~

s 9

.t g

)

.=I di I

a l

3 1

.o e

me 3

1 M

e A

w N

F Mh

{ {

e o

0 O

g ;

M1 M

e 6

~

^

E 5 j

st.9 see

.k 5

8 ll n

l I

h

(

t i

,+

f.

I

=

s l

+

I l S

g-

=

8 es.e g g>

e 8

$l m y

$g ls V

u n

I *1 1

! f.i e

j o

\\

n Barry R. MeBee.CAairman R. B.* Ralph Marques.Commassoner i

j i,

lohn H. Daker, Commasioowr

?-

Dan Purson, Executia Director TEXAS NATURAL RESOURCE CONSERVATION COMMISSION Protecting 1'exm bg Reducing and Premsting Pollutiors August 29,1997 Mr. Richard L. Bangart, Director Office of State Programs Mail Stop 3D 23 United States Nuclear Regulatory Commission Washington, DC 20555-0001 Re:

Reply to June,1997 Review of Texas Natural Resource Conservation Commission's

-(TNRCC's) Radiation Control Program

Dear Mr. Bangart:

We have received the Draft Nuclear Regulatory Commission (NRC) Integrated Materials Performance Evaluation Program (lMPEP) review of the Texas Agreement Strie Radioactive Materials Program. We are pleased that the draft report reconunends a finding that Texas' program is adequate to protect public health and safety and compatible with NR C's regulatory program.

Enclosed please find the responses of the Texas Natural Resource Conservation Commission (TNRCC) to the NRC report. Attachment A includes TNRCC staff responses to the IMPEP evaluation of the uranium program. In general, the remarks of the staff are limited and sigrud only factual discrepancies in the IMPEP review. Attachment B includes TNRCC staff responses to the evaluation of the low-level radioactive waste disposal program, which also included a review of some aspects of the Environmental and Safety Analysis (ESA) and draft license for the proposed low level waste disposal facility near Sierra Blanca. These comments are more lengthy.

The TNRCC is concerned with the substance and tone of the remarks of the IMPEP Draft Report with respect to the low-level radioactive waste program, in general, and the TNRCC's review of the application for the proposed disposal facility in particular. The TNRCC notes that some of NRC's comments were based upon incomplete or outdated information. It is amazing, and certainly unfortunate, that your reviewer made critical conunents without having read the ESA in its entirety or the current information in the application. Moreover, some of the comments discussed in the draft document were specifically discussed with TNRCC staff during the review, and your resiewer represented that these sam: concerns were for the most part resolved upon the conclusion of the review. ~iherefore, we are perplexed that they remain articulated in the draft document in a manner that suggests that these issues remain outstanding concems.

P.O. Box 13087

• Austin, Texas 7871130A7

• 512 2 9-1000

• Intemet address: www.tarcc. state.tx.us

.=.4 m%,

ne w l

~

j

uw es,x p u OTg

'?.

Mr. Richard L. Bangart Page 2 August 29,1997 In addition, we are disturbed by the overall tone of the document, which seems to convey a general impression that the TNRCC staff may not have been justified in concluding that the facility will meet the radiological performance objectives. In particular, we take issue with implications that the processing of the application was expedited in a manner that precluded thorough resiew of the application; that the ESA fails to document staff conclusions; that staff did not adequately or critically evaluate information presented in the application; and that staff review methodology was Ilawed. We believe that NRC's impressions are incorrect, and in fact, we believe that NRC might have given an impression that was not intended.

The TNRCC fully stands by its review of the lo v level radioactive waste disposal application as presented in the ESA. We are confident that the attached response demonstrates that both the substantive conunents and the negative implications raised in NRC's draft IMPEP review document are inaccurate. Unless NRC disagrees, and unless these negative impressions were intended, we strongly urge NRC to retract the draft report and produce a final docunient that more accurately reflects the NRC's findings about the TNRCC's low-level radioactive waste disposal program.

Please address any questions you may have to Ms. Alice Harnilton Rogers, P.E., Manager, UIC and Radioactive Waste Section, at (512) 239-6846, or send correspondence to mail code MC131, t cerely,

^^.

Pearso

'xecutive rector DP/AHR/lg Enclosures cc:

Mr. Richard Woodruff, Health Physicist, USNRC CAFRIs\\WP\\TA1MPM RPI,

vuuu,urwuu auss a m u G mJ

).

ATTACHMENT A.

TNRCC RESPONSES TO SPECIFIC NRC REVIEW COMMENTS URANIUM RECOVERY PROGRAM Below are the staff responses to,qiecific NRC comments included in the uranium ndning portion of the draft IMPEP report for Texas' Aareement State Program dated June 16-27,1997.

Ct.nERAL COMMENT $1 Agency responses from Texas Department of Health's Bureau of Radiation Control (TDH or DRC) and TNRCC are attached to the NRC repcat, but the attachments to those agency responser are not included. For completeness, the complete agency responses, including attachments, should be attached.

Indicators of which agency is being discussed should be added throughout the report.

~

Common Perfonnance Indicators - In Section 3.4 under " Technical Quality ofInspections", there

' is a great deel of discussion ofinspection procedures and processes. De NR C report should indicate when the inspt.ction program at the Bureau of Radiation Control (BRC)ir being discussed and when the inspection program at the TNRCC is beir.;; discussed. For example, it is stated that the review I

team suggests that the State consider standardizing fonns for field notes. It is not clear whether this applies to both agencies. Similarly, in that same section, it is suggested that discussions of inspection findings with licensee management be documented and that inconsistencies related to insufficient detail were noted by the review team. TNRCC assumes that both of these items are directed to the BRC, althuugh it is not clear.

l Non-common Peiformance indicators - In Section 4.1 under " Legislation and Regulations", the discussion regarding rules deals mostly with the BRC, with very little on the recently adopted TNRCC radiation rules or on TNRCC's rulemaking procedure. Tids is especially striking because.

l there is no acknowledgment that the TNRCC has already adopted rules that the BRC was cited for having failed to adopt (e.g., timeliness in decommissioning, and Low Level Waste (LLW) shipment manifest information and reporting).

SPEcsFic COMMEms:

i Pace I neraeraoh bccinnino "The review temma' ceneral annronch.

EP,her item number (7) is missing, or the list has been mis-numbered.

i I

t i

I

0 Pane 4 Item (1)" Current Statut" The rust mience should be revised to say " Legislation was introduced in the 1995 and 1997 sessions..."

Pace 10. nararranh berinninr "The te_am mim reviewed.. "

The statement that the four TNRCC 11ccused sites "are no longer being used for burial of waste" is incorrect. One of these four sites, Monsanto, license RWO219, is an active burial site. However, TNRCC% new rule (section 336.501(b)) requires that this licenn shall not be amended or renewed to allow any addition or expansion of the disposal facilities.

Pane 17. na.u raph beuinnina "The inm finds It should be noted that legislation was intmduced in 1995 as well as 1997.

Pace 29. narnprank bepinnine "Juridictinn over uranium reenverv.."

The second sentence states that the uranium recovery program includes

" underground injection control,..." and the third sentence states that the " uranium program was transferred (retumed) to the TDH" by the Texas Legislature during its 1997 session. These two statements might mislead one to understand that the uranium underground injection control program (which is an EPA-delegated program) was also transferred to the TDH, which is clearly nat the case.

Pace 20. pamgranh beginninn _"At the time of the review.

he number ofin situ uranium licenses listed is incorrect: there are only 9 in situ licenses, not 12. The number of in situ sites (listed parenthetically as 19) is correct.

The last sentence listing the " active production facilities" is incorrect. Ders are only two active URI fscilities; the Vasquez facility has not yet been licensed.

Pase 30. the nartial naragrsnh herinnine ".the review.12.titen.."

Actually, as stated during the program review, twelve sites were on a one year inspection frequency (or twice a year if they are in production) and 10 were on a two year inspection frequency. This was documented by memo during the time of the review. IMC 2.'00 is referenced by the review team at the document citing inspection intervals. According to Section 2800 04 reganling Inspection Priorities, mspection intervals can range anywhere from every year to every five years based on the potential hazard of the licensee's program. The justification for inspectin,e the uranium facilities at the frequency that we did is that these facilities are in restoration / reclamation mode and as such, their activities did not warrant the same

-m m

+

06/20<09~ 10:04 G612 :speser^^

~ruce 90po ~

~~

~ ~ ~ ^ ~ ~ ^

~ - ^

~^ ~

~

w ov, level of attention as facilities with a greater potential to adversely affect the health and safety of the workers and the public. This justification has been documented in our inspection manual since the review, puue 30. the narnuranh herinnine "At the time of the review.

With regard to supervisory accompanirnents, the accompaniment documented during the review occumd during March nr 1997, not 1996 as stand in the report.

Additionally, in approximately a third of all other routine inspections, the lead ins;m tor was accompunled by a senior health physicist with 15 years experience i

in both licensing and compliance.

Page 11. nsraaraph becinning "The evaluation of thin area.

4 The license number of the Chevron Rescurces Panna Maria Project abould be RW2402 (i.e. delete LN), Additionally, the license number for the Vasquez site is proposed to be RW3700, not R #3653 002, 4

Page 34. number 18 This is a summ.vy comment and has been included in our response, above.

ATTACllMENT 11 TNRCC RESPONSES TO SPECIFIC NRC REVIEW COMMENTS:

LOW. LEVEL RADIOACTIVE WASTE DISPOSAL PR'.' GRAM 3elow please find TNRCC staff responses to specific NRC review comments on Texas' low level radioactive waste disposal program included in the Draft IMPEP report dated June 16 27,1997.

Responses are arranged generally in the order in whleh corresponding comments, identified by page and paragraph, occur within the IMPEP retort.

Pase 21. naracranh becinnInc "TNRCC received Use of the phrase "Even after the application was declared administratively opm;.lete, further revisions were made.. " suggests that revisions should not be and are not normally allowed after a declaration of administrative completeness. Such is not the case.

Under TNRCC rules, an application that is declared administratively complete is not necessarily technically complete or adequate. A finding of administmtive completeness simply signals the point at w}dch any permit or license application contains sufticient information to enable staff to begin its detailed technical evahtation. At that pointithe agency begins the NOD (Notice of Deficiency) process, and any outstanding technical issues identified during the staffs review are resolved through additional data collection, technical exchanges, etc. Staff NOD letters to the Texas Low Level Radioactive Waste Dispodal Authority (TLLRWDA) and subsequent responses are documented in three volumes ofintenogatories, which have been incorporated into the application. It is our understanding that this system is essentially the same as that recornmended in NRC guidance documents.

Also, as a matter of record, to date there have been 20 revisions submitted. More revisions are anticipated as additional data are collected sad final or progress reports of ongoing studier, are completed (e.g., exploratory trench studies, test cover investigations, etc.).

Staff also points out that only a drAfl license has been developed; a final version will incorporate any changes made duting the hearing proc:ss.

Pace 24. nmmnh becinninc* "Durine the Im It is true that the low level waste defirdtion issue has not been resolved. This is a statutory conflict over whlch the TNRCC, as a state agency, has limited control.

Any ch.mge to the definition must be made by the Texas Legislature, which we are statutorily prohibited from lobbying. The NRC report should point out that the TNRCC initiated and will continue to support legislation which would bring the Texas definition into compatibility with the federal definition.

9

uptABw UUYUU UWtnJWMAkJ WiXf~lkkM)

@ 006 I'.

Paoa 24. narnaraph beginning!"The t**m notes that hateline-. "

As worded, the comments in this paragraph suggest that there might be critical

" discrepancies" between any and all types of baseline data collected by TNRCC and the TLLRWDA, critical enough, apparemly, to sipificantly impact the basic licensing detennination. To TNRCC staIPs knowledge, the only " discrepancies" thus far identitled are apparent differences in trported environmental themioluminescent dosimeter (TLD) readings. A,tcording to TNRCC staffs investigation, thew apparent discrepaneles may be due to procedural and reporting differenen between 7NRCC and TLLR WDA. TNRCC will continue investigating thecauw of the discrepancies and will document its findings. TNRCC staff dn not consider these differences significant enough to materially influence the licensing decision in any case, the NRC should clarify that its cornments relate only to the c;fferences in the TLD readings..

J Staff agrees that entering baseline data into a computer database is de:irable and will facilitate evaluation of future monitoring results. As a factual clarification, l

many of the baseline data have been included in a computer databaw. The TNRCC intends to input the remaining existing baseline data and update the database as more infonnation becomes available over the lifetime of the project.

pace 24. narmersch bednnino "The team nom, that there i

The comment should clarify that it is only surfgg. uter, not groundwater, hydrology expertise that is currently not directly available within the low level radioactive waste disposal staff. Groundwater review of the application was conducted by current staf. < nembers.

]

page 25. paravraph beginnine "The level of starono.

While it is tme that we completed our review metal months ahead of the mandated

)

15 month deadline, we are conecmed that some readers rnight interpret NRC's 4

conunent, as written, to mean that TNRCC's staff could only have done so by

~

cutting comers. Cenainly, the fact that TNRCC staff worked diligently (including vvertime) to complete the review should not be of concem, in addition to diligent work, there are several reasons that TNRCC staff completed the analysis ahead of schedule. Although the application was not judged admirnstratively complete until May 1995, many critical, more or less self.

centained parts of the application were submi:ted as they were completed over a long time period beginning as early as the submission of the initial application in March 1992. To the extent possible staff began review of these documents as they were submitted. Thus substantial review of major ponions of the application had been achieved prior to the declaration of administrative completeness. In addition, much infonnation, including some design features and regional site characterization data, was familiar to staff because it was identical or very similar to infom1ation

unv7v7 mu mm W 535:

mWmus gi,iig e

N reviewed by staff h1 conjunction with the lleensing effort for the nearby, previously proposed Fort flancock site. Finally, several key members of the review staff west originally hired by the Texas Department oflisalth to conduct a irview of a low.

level radioactive waste disposal application as early as 1981. Some TNRCC staff, therefore, had over 10 years' cxperience conducting similar analyses und preparing similar review documents atsnciated with uranium recovery facilities, bypmduct disposal, and other proposed radioactive material disposal sites.

}' ape 25. norncronh bectnninn "TNRCC ncffis nt!nwed.

WRCC staffinvolved in the low level radioactive waste disposal progmm ihmly believe additional tecimical training is always desinble.

Staff comments identifying training as a pmgram weaknent referred to in this pamgraph were a direct response to the NRC's short sighted policy of decreasing NRC-supported technleal training for agreement state perwnnel. The NRC report should be tevised to ensure that those comments cannot be construed to mean that TNRCC technical staff are, or feel they are, inadequately trained to fulfill the demands of the low-level radioactive waste disposal program.

Further, contrary to the comment made in this paragraph, staff training is compi!ed and tracked by the TNRCC's Technical Training Academy. A record of staff training in also maintained and periodically updated in staff resumds which were provided to NRC for its review. Although we have no objection to developing a wn>vlidated training record as NRC reconunends, our low level radioactive waste staffis small enough (fewer than 10 people) that we have encountered no difficulty in tracking or assessing staff training.

Pene25. naragranh beginning:"ne team notet TNRCC takes strong exception to the characterization ofits analysis document AS-102. First, to clarify, the 'INRCC entitled AS 102 "An Envhnnmental and Safety Analysis of a Proposed Low Level Radioactive Waste Disposal Facility near Sierra Blanca, Iludspeth County, Texas" and refers to the same document as an

" environmental and safety analysis" (ESA).

It is equivalent to the Safety Evaluation Report (SER) and Environmental Statement (ES) that would be required of NItC staff under NUREOs -1200 and 1300 respectively. It is not a " safety analysis report," which is a doctunent submitted as part of a low level radioactive waste disposal application according to Buidance in NUREG 1199.

TNRCC staff agree that the document may be difficult to use if the mader intends to use it as a compendium of site characterization, design, and operating procedures information. However, the primary purpose of AS 102 is not to provide background information. It is to document the stafrs tvview and conclusions regarding the low-level radioactive waste disposal application submitted by the TLLRWDA. NRC comments that the document is not "self contained" because of the need to refer to the application for figures, tables, etc. The NRC review implies

urupuv uvyw LMAruATUwu d#fthkM) 0oto that AS.102 should have included sufficient information including figures, tables, etc. to enable the reader to reach an independent conclusion regarding the ability of the proposed facility to meet the performance objectives and other licensing requirements. That, however,is clearly the Ibnction of the application and not the review document. It should be noted that an SER or ES prepared under the guidance ofNUREO 1200 or 1300 would not be considered "self contained"in the sense referred to in the review team's conunent.

TNRCC objects to the statement that the bases for TNRCC staff findings are not provided in AS 102. This assertion is simply not true. By making tids conunent very general, NRC is basically stating that AS.102 does not meet its intended purpose. Given the seriousness of this criticism, the TNRCC strongly urges the NRC to withdraw this comment.

bce 26. narncronh beolnnine "Aneument of the cualltv.

TNRCC takes exception to the characterization of its review as doing " spot calculations," which connotes a lack of thoroughness. In fact, confirmatory analyses wete only a portion of the review and did not constitute the substance of the entire review. TNRCC points out that the staff's f' unction is to evalunte and r9 view an application, not to duplicate all the analyses included in it. This view is entirely consistent with that presented in NUREG 1300:

"Where an analysis procedure, as outlined in an ESRP, has been conducted by an applicant and reported in the applicant's ER, the reviewer need not repeat the analysis. However, the applicant's work should be evaluated in sufficient depth to permit verification of the analysis and its results." (p. xi)

Page 26. paragraph beginning "TNRCC concludes that.

The meaning of this paragraph remains obscure to TNRCC staff. It should be revised for clarity.

The first sentencit apparently states that the basis for the WRCC staff conclusion that the petformance assessment (PA) analysis is conservative is that the assessment includes an analysis of a groundwater pathway even though the site characterization data show there is no recharge from the site ares and hence no viable groundwater pathway. TNRCC staff agrees that this is certainly one element that bears on the conservatism ofTLLRWDA's perfonnance assessment. It is, however, not the only element. 'Ihe perfonnance assessment is not limited to the groundwater pathway.

We assert that conservative assumptions and calculations are made throughout the performance assessment and all of these in concert form a partial basis for our conclusion.

TNRCC staff points out that when the NRC staff reviewer first brought up the groundwater pathway analysis to TNRCC staff, it was to comment that because all r,-

oversesi is:s1 Trsaz 239 css:

WRWytus roo3 the site data show that there is no groundwater pathway, TNRCC should not have included an analysis of a poundwater pathway in its ESA. Rather, TNRCC should simply have defended those data showing that such a pathway is not credible.

TNRCC stairdisagrees with that point of view. In our opinion, it would not be acceptable for the Executive Director to reconunend issuing u license without making some evaluation of a Eroundwater pathway. We caution, however, that the inclusion of a groundwater pathway analysis in the app!! cation by the TLLRWDA and evaluation of that pathway in the ESA by TNRCC staff should not be construed to mean that we believe the groundwater pathway analyzed trpresent a credible scenario. in fact, the procedure followed by the TLLRWDA in its pA differs little from that followed by NRC in its IMPACTS analysis, in that analysis, NRC calculated that for a hypothetical site located 10 the southwestern United States no infiltration of precipitation to groundwater would occur. Nonetheless, NRC chose to Amtrs some amount ofinfiltration and proceeded with groundwater pathway dou calculations based en that amount. We find that approach not only acceptable, but prudent under the citcumstances.

Staff has been unable to discern the meardng of the remainder of this Imragraph.

As written, it strongly implies that once TNRCC staff decided to analyze a groundwater pathway, it did not evaluate that pathway (to pa aphrase) "in the context thm it was a credible scenario and therefore the groundwater pathway analysis in the performance assessment does not stand on its own merits." If "cvaluated from the context that this is a credible scenario" means that any analysis of a groundwater pathway should involve proce.sset and ennditions that are representative of the site or cculd reasonably be expected to occur, then TNRCC staff agree. Assuming this point of view,in our comments below we discuss the

" credibility" of the scenarios which NRC would have us analyze "to ensure that the performance assessment will stand on its own merits."

General nbeervatinn on the remainine NRC.Iryiew comments In mony of the remaining comments the NRC team appears to demonstr:te, using only the most elementary, basic manipulation of various factors assumed by the TLLRWDA and approved by the TNRCC staff, that the facility will not meet performance objectives. (Witness the i16 mrem /yr dose that NRC calculates for Cl 36). NRC presents these calculations without remarking on the reality of the scenarios it is analyzing. Unless the assumptions used in the calculations are properly qualified, this approach is misleading.

TNRCC concedes that it is possible with most models to get any result one desires by selectively choosing input parameten, selecting those parameters without regard to reality if necessary. TNRCC is also aware of NRC's preference for analyzing uncertainty in terms of the results obtained by inputting various combinations ofparameter values. TNRCC ha, no fundamental problems with this approach. TNRCC cautions, however, that in this approach all such parameter

DOU

'IFRCC tiltROS 0 019 i

combinations, no matter how improbable, are regarded as having some real possibility of occuning. Therefore, there is a risk in such situations that some astronomically improbable combination ofinput parameters, which results in a dose exceeding pe-formance standards, will be used to assen that perfonnance objectives cannot be met. Judging from the NRC analysis presented in these conunents, the TNRCC's concerns were well founded. In TNRCC's opinion, the NRC analysis t2ed an unrealistic, highly improbable combination of parameters to calculate a dose of 116 mrem per year for Cl 36 without proper qualification or explanation, j

in order to avoid the possibility that NRC's statements about a 116 nuem per year dose for Cl 36 will be taken out of context to suggest that ruch a dose is feasible at the Sierra Blanca site 'fff'r final repon should retract any statement to the effect that there realistica)b e@ M a i16. mrem per year dose resulting f om the

facility, Pace 26.parat'rnph beclnninn!"TLLRWDA nrnined.

The review should point out that TNRCC sitdTnot only did confirmatory runs of the IIELP code, but also performed independent HELP modeling to investigate infiltrution behavior at the site. In consulting our records after the review, we cort 6rmed that extensive HELP modeling analysis had been completed by staff.

Also, the HELP code modifications were reviewed by the code's developer on behalf of the TLLRWDA, not the TNRCC. We did, however, review the developer's subsequent repon.

Page 26. paragraph becinnine " Sensitivity ansivses nerformed It is not entirely accurate to state that sensitivity of the calculated infiltration to evapotranspiration was not considered. As mentioned above, staff did complete independent modeling to investigate infiltr.ition behavior of the site under various conditions. It is true that the model seems sensitive to some input parameters which are factored into the code's evapot anspiration calculations. For example, shifting the ground cover factor by one category (it is not possible to smoothly change this pammeter by just a small amount in the HELP code) results in a jump in calculated infiltration from about 0.05 inches /yr to over 5 inches /yr. This result, however, must be put into perspective. First, the parameter values which resulted in the 0.05 inches / year are those that best represent conditions actually observed at the site. In addition, this amount of infiltration matches very closely actual infiltration rates detennined during site characterization. Both of these values are entirely consistent with regional infiltration rate estimates made over the last 20 years or so. The 5 inches /yr result represents 40% of the average annual precipitation and is two orders of magnitude larger than any other estimates we are familiar with Staff points out that if the purpose of the HELP modeling exercise had been to detennine the best ground cover 'hetor value by calibrating the model 1

to known infiltrution rates, then the factor resulting in 5 inches /yr of infiltration would have been eliminated immediately.

In short, the HELP results seem well supported by site charceterization data. If by i

these comments, NRC means that the 5 inches /yr figure ought to be used in the PA, l

TNRCC disagrees.

l Pasme 26 and 27. narmarmnhe heninnine'"In the enmet term

and "h diaeueelant with.

Consideration of the comments in these paragraphs requires wme background Information. In the original IMPACTS source term model NRC.vtilized certain reduction factors basically to account for the fhet that all tvaste would not be continuously in contact w*th all infiltrating moisture. Assuming no reduction (a factor of 1) results in the maximum leachate flux, 'Ihe analogous reduction factors used by the TLLRWDA in its performance analysis of the previously selected Fort Hancock site and in the initial PA for the Slcrra Blanca site were orders of magtdtude more conservative (larger and closer to 1) than those suggested by NRC in the IMPACTS analysis for a site in the southwest.

In 1994, however, NRC expressed concern that the IMPACTS analysis did not appropriately treat partially saturated conditions and cautioned that the non-1 conservatism in the calculations might be several orders of magnitude. At that time, TNRCC staff spoke with both NRC staff and with the TLLRWDA and its consultants regarding these concems. In order to respond to these concerns, the TLLRWDA initiated an investigation to determine reasonable and supportable reduction factors. De thmst of that study was to use altemative models to calculate a source term and then to use the calculated source terms to back-calculate reduction factor: necessary to get the same result using the IMPACTS type methodology. The TLLRWDA used bnth the RI.T (Bisach, Leach, and Transpnit) and DUST codes in their investigation. The results, which were discussed with TNRCC staff, indicated that the reduction factors used by the TLLRWDA in its analysis resulted in larger source terms than calculated by either BLT or DUST.

Wey west also several orders of magnitude larger than NRC's original values and certainly within the range suggested by NRC in its IMPACTS warning messages, it was largely on the buis of this information that TNRCC staff accepted the factor values used by the TLI.RWDA and cited in NRC's review comments.

The NRC review comments suggest that TNRCC should duplicate the DUST code analyses perfonned by the TLLRWDA. As discussed previously, the staffs function is to review and evaluate information submitted by the applicant, not duplicate every analysis that was performed. This is in accord with NRC's position as set forth in NUREO 1300. Duplication of the DUST code runs was neither necessary nor required. The TLLRWDA's investigation represented an appropriate approach to resolving the issue in question, and the results appear consistent with NRC's expectations.

06'28<87 OMsp U62: 200 0308 mtcc titws goga 0

NRC's concem on this issue focussed on the TLLRWDA's use of a concrete diftbslon coefDelen of lx10* cm'/s and the thet that TNRCC staff could not readily produce a doctunented basis for accepting that value. Shortly after the review, staff made a further search of our records. These indicated that concrete ditrusion cocilicients were discussed with TLLRWDA at least as early as August 1994. We also located some literature values which fully supported our position that the coefficient used was conservative. Etis information was communicated to the NRC reviewer within a few days of his review.

TNRCC disagrecs with the way these conunents are presented and to the reason for their inclusion. Even though staff did not duplicate the DilST analysis, as the dir,cussion above indicates, the staffs evaluation was thorough and appropriate. In addition, the NRC reviewer explicitly n: presented to TNRCC staff during his review that he had no problem with the approach used by the TLLRWDA in resolving the contact time issue and that if TNRCC could adequately confirm the conservatism of the diffusion coefDelent, his concems would be allayed. Staff stresses that this was a problem in documentation and not in substance as a reader might be led to believe from NRC's comments as written. Because appropriate supporting information was relayed to the NRC well before the NRC draft report was completed, TNRCC suggests that these comments be redacted.

Pace 27. paracraph becinnine "TNRCC stnfishould also It is true that the TLLRWDA's initial submitttd applied the same distribution coefficients (Ns) to both migration in the waste fonn environment and to migration through geologic media. Subsequent submittals used larger N values for radionuclide migration within the waste form envi.unment..md this resulted in reductions in calculated grotmdwater pati.way doses. The implication in the NRC conunent in this paragraph is that the TLLRWDA may not have been legitimately entitled to use those larger K values and that TNRCC allowed them to do this without properjustification. The NRC reviewer's comment is also written in such a way that the original TLLRWDA analysis is presumed to represent a "tme" value against which subsequent submissions should be judged.

The use oflarger N values in the waste form was deemed acceptable by TNRCC for several reasons. TNRCC staff did review some available literature. Part of TNRCC stafTs judgment was based on our understanding of the chemiesl environment within the cementitious waste form and its likely impact on N values.

Much TNRCC staffs opinion, however, was molded by discussions with NRC staff during TNRCC's initial 1994 reviews of appropriate contact time factors in the IMPACTS unalysis. At that time, NRC staffindicated that any adjusunents to dose calculations that might be required, because of non-conservatism in the original IMPACTS analysis, would more than likely be made up and then some by using i

more realistic N values for the cementitious waste form. They cited various l

l

Os/20it?

19:00 G s12 239 4362 TNRCC l'ttites 0 01s I

studies, mostly British and European, which clearly indicated that use of higher Xp was completely appropriate.

• INRCC cxplained this information to the NRC reviewer. In addition, we obtained a recent nummary paper by NRC staff which demonstrates that the Xp used by the TLLRWDA are not only reasonable and appropriate, but higidy conservative.

Information contained in that paper was conveyed to the NRC within a few days of the on site review.

De NRC reviewer explicitly stated to TNRCC staff that his concerns were based entirely on his lack of satisfaction with the 'INRCC's documentation of the basis for its review and not on the substance of the matter. In view of the fact tlut TNRCC's initial opinion was not without justification and that ample documentation was provided to the reviewer well before NRC's dr A report was prepared, TNRCC objects to this comment.

Panen 27 and 1Rf naracranh heninninn? "To avoid double acconneta.-

TNRCC i taff spee that there is no techrdcoljustification for the 25%-down,75%.

up split refened to in this comment. Multiple lines of evidence collected during the site characterization all indicate that these 'is av groundwater recharge from the surface near the vicinity of the proposed facility and that there has not been pmbably for thousands of years The hydrologic gradient for liquid flow is directed upward. Moreover, the first aquifer encountered is confined or nomi contined, under pressure, and protected from direct irdlltration.

Assuming 25% of the infiltration calculated by the HELP code moves downward to groundwater is simply a device used by the TLLRWDA to force an analysis of a groundwater pathway. TNRCC did not accept the use of these factors because they have a lineur efrect on calculated doses. 'INRCC stattaccepted those factors because we agreed that a groundwnter pathway analysis must be done, and we recognized that any factors assumed for that analysis represent site conditions that do not exist and, therefore, must to some extent be arbitrarily dermed, nc NRC report then proceeds with a straightforward calculation which uses these

" unsupported factors"in conjunction with the f assumed by the TLLRWDA for t

C136 and apparently A===4

how these could casily result in a groundwater dose of116 mrom/yrt TNRCC strongly objects to this analysis and the manner in which it is presented without qualification.

Regarding NRC's reference to "unsupponed" factors, TNRCC staff point out that the only value actusily supported by site characterization data is 0.0; there is no groundwater recharge.

De NRC has argued in previous comments that once a groundwater pathway has.

been assumed, its analysis must be evaluated in the context that it is a credible S

s

--~,- _,_._ _ ~,

ULrrutSUV UUM

\\vUUU WJVJUU WiXC tittRus (Bote T

A scenario in order to ensure that the penformance assessment analysis stands on its own merits. However, NRC effectively uses an f factor of 1 in the analysis t

presented in this section of the comments. ~1his assumes that no correction for those factors related to contact ofpercolating water with wastes within the disposal cells is acceptable. "Ihe origins 1 IMPACTS methodology suggested factors which might resuh in a ruluction of the source term by many orders of magnitude. Later analyses suggested the origintJ calculations might be non-conservative by several orders ofmagnitude. Even so, to our knowledge NRC staff has never indicated that no r: duction represents a crt.dible scenario.

The NRC analysis then tises an f,,, factor of 1 to move contambiants to groundwater. The NRC's use of 1 for that factor seems no less arbitrary and far less likely than the TLLRWDA's use of 0.25. We point out again that according to site chsracterization dt.ta, the most credible value tbr this factor is 0.0.

And finally, in order for the migrating radionuc!) des to produce the dose calculated by NRC, the contaminant plume is assumed to enter an unconfmed aquifer without any impedance by an overlying confining layer. To do this the physical characteristics of the site must be altered and conditions assumed that do not exist.

The analysis presented in NRC's draft report does not' represent evaluation of a credible scenario.

Pace 2R. paracrpph beninninc "T1 i RWDA. In detenntninm In response, TNRCC points out that the travel time for return of radionuclides to the surface is on the order of 1000 years. It is unlikely that the 200 year head start in migration of class A wastes over class B/C wastes will make any difference when looking at the maximum dose resulting from atmospheric suspension of radioactive particulates at the surface.

Dased on TNRCC's experience with air-dose models over the last 15 years, these issues are not major problems. A source term for atmospheric dispersion of soil surface radioactive particulates is commonly estimated by calculating an average radionuclide stuface concentration for the entire area that has been contaminated.

Pare 2A naramnh beginninut "TLLRWDA desinn.

TNRCC believes the decision to use gravel backfill between waste containers was primarily made to ensure a free-draining environment rather than to provide stability, although stability was certainly an important consideration. A layer of gravelly sand (filter layer) with a hydraulic conductivity of 1x103 cm/sec will be placed over both the waste canisters and the gravel backfill. The gravel backfill will have a hydraulic conductivity of greater than Ix102 cm/sec. We assume that the gravelly sand is what NRC referred to as " soil"in its conunent.

O

~

o6<29/97 16:o1 C512 239 6362 TNRec LTR#$

0017 i

The original intent of the gravel backfill was to allow any large amounts of infiltrating water to flow in the gravels and bypass the waste cardsters, tints reducing the possibility for the production ofleachate. It is true that under very low moisture content conditions, due to the peculiarities of unsaturated flow physics, moisture will tend to move in the finer grained materials like the concrete canisters and avoid coarser grained materials like the intervening gravels. This behavior is readily observed in the moisture content profiles for the near surface materials at the site; moisture contents are higher in the clays than in the sands or gravelt it should be noted that if moisture contents are so low that such conditions are occurring in the waste cells, there would seern to be a low potential for leachate production and contaminant migration. In addition, once moisture enters the concrete canisters (which will be covered with a waterproof coating), it would be prevented from leaving the canisters until they become saturated because of the very large contrast in hydraulic properties between the canisters and the surrounding gravels. Staff cannot conceive of a situation in which the impacts of such behavior would not be within the bounding scenario calculations analyzed in the performance assessment. 'lhis is not a problem because under unsaturated conditions there is not enough water movement to be of concem and under saturated conditions the gravel backfill will direct flow away from the waste containets.

In addition, as TNRCC staff indicated to the NRC reviewer, the design of the facility incorporating r free dndning gravel backfill follows NRC recommendations made in NUREG 1200 (SiU' 4.3. Appendix A) and other NRC documents. The NRC reviewer indicated that the NRC recommendations might be incorrect and that the NRC should re-examine them.

4 Pace 28. paranranh becinninr "The review. team recommends.

TNRCC disagrees with the recommendations and implications in this paragraph.

TNRCC conducted a defensible review of the TLLRWDA's application for disposal of low level radioactive waste and properly documented that review, including the performance assessment,in AS-102.

TNRCC agrees on the utility of sensitivity analyses and have appropriately used and evaluated such analyses in its review.

The last sentence of this parngraph appears to assert that there is some problem with the applicant's site characterization work. No such issues were raised during the course of the NRC review.

Payes 33 and 34. numbered comments 7.14.15.16. and 17.

These air summary comments and have been included in our responses above.

l l

m l

l Aaenda for Manaaement Review Board Met 1109 l

Monday, September 22,1997,2:00 o.ni., OWFN, 4 B 6 l

1.

Convention. MRB Chair convenes meeting (H. Thompson) 2.

New Business Consideration of Texas IMPEP Report A.

Introduction of Texas IMPEP Team Members (R. Woodruff)

B.

Introduction of Texas representatives and other State representatives participating through teleconference. (K. Schneider) j C.

Findings regarding Texas Program (IMPEP Team)

Status of Inspection Program Technical Staffing / Training -

Technical Quality of Licensing l-Technical Quality of Inspections Response to incidents / Allegations l

l Legislation and Regulations Sealed Source and Device Evaluation Program Low-Level Radioactive Waste Disposal Program l

Uranium Recovery Program D.

Questions. (MRB Members)

E.

Comments from State of Texas F.

MRB Consultation / Comments on issuance of Report (H. Thompson)

Recommendation for next nMPEP review l

3.

Old Business - Region ill MRB Minutes. (NMSS) 4.

Status of Upcoming Rsviews (KSchneider) 5.

Adjournment (HThompson)

Invitees:

Hugh Thompson, MRB Chair, DEDR Richara Bangart, MRB Member, OSP l

Karen Cyr, MRB Member, OGC l.

Carl Papenello, MRB Member, NMSS Frank Congel, MRB Member, AEOD-Robert M. Quillin, Agreemerit State Liaison to MRB, Colorado Richard Ratliff, Texas 1

Alice Hamilton Rogers, TNRCC -

Elizabeth Bourbon, TNRCC ATTACHMENT 2 2

1 l

t 2

i Invitees (cont'd):

Richard Woodruff, IMPEP Team Leader, Ril.

Michele Burgess, IMPEP Team Member, NMSS Elizabeth Drinnon, IMPEP Team Member, Georgia Craig Gordon, IMPEP Team Member, RI James Myers, IMPEP Team Member, OSP Thomas O'Brien, IMPEP Team Member, OSP 4

Mark Thaggard, IMPEP Team Member, NMSS Paul Lohaus, OSP Don Cool, NMSS R. Scarano, RIV J. Greeves, NfASS Kathleen Schneider, OSP j%'-

h 4

, ~

g i

l l

ATTACHMENT 2