ML20043E460

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Confirms 900420 Discussion Re Review & Evaluation of State of Tx Radiation Control Program.Finding of Compatibility Cannot Be Made for Program Due to Need to Adopt Regulations Pertaining to Reporting Medical Misadministrations
ML20043E460
Person / Time
Issue date: 06/06/1990
From: Kammerer C
NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To: Bernstein R
TEXAS, STATE OF
References
NUDOCS 9006130022
Download: ML20043E460 (10)


Text

{{#Wiki_filter:. -.... ~- ~, 'I d gwa [I + UNITED STATES E NUCLEAR RCGULATORY COMMISSION s v. e , r,, -l "*L wAsHiwoToN,0. C. 20666 June 6, 1990 (.. -Robert Bernstein, M.D., Comissioner, Texas Department of Health 1100 West 49th Street Gstin, TX. 78756

Dear Dr. Bernstein:

I ~ This confirms the discussion Robert J. Doda held with you, L. D. Thurman, and David K. Lacker on April 20, 1990, following our review and evaluation of the Texas radiation control program. Other NRC staff -members-attending this meeting included Joel 0. Lubenau and. Dennis M. Sollenberger, both from the Office of Governmental and Public Affairs. As a result of our. review of the State's program and the routine exchange-of information between the Nuclear Regulatory Comission (NRC) and the State of Texas, the staff believes that th'e Texas program for the regulation of agreement materials is adequate to protect public health l: and safety. However, a finding of compatibility cannot be made for the program'at this time due.to the need to adopt regulations. pertaining to the reporting of medical misadministrations and a-regulation relating to audits of the performance of radiographers. These have not been adopted by 4 l the State within the three-year period provided by current NRC policy. A l, finding that the Texas program is compatible with the NRC program would L follow.the adoption of these regulations. .i contains other coments regarding the program and you may wish to have Mr. Lacker respond directly to these comments. An g l explanation of our policies and practices for reviewing Agreement State l programs is attached as Enclosure 2. L -Our review disclosed that other program indicators were within NRC guidelines. Also, a number of other technical matters'were discussed with the radiation control-staff and resolved during the course of the review. This year's review used a team approach..which involved ten NRC L staff members from four different NRC offices,:at various times during the review. This allowed.more time for individual discussions with members of the Bureau of Radiation Control (Bureau) staff, an in-depth examination of the various program areas, and strong emphasis on the Bureau's licensing plan.for a low level radioactive waste disposal site. i_ During the course of the review, we were able to hold meetings with your L staff in eight different subject areas, which were of current interest to h both the State and the NRC. We wish to comend the Bureau of Radiation Control for their efforts in completing 2,494 inspections during the current review period with the result that the Bureau has, according to NRC criteria, no overdue inspections of the more significant State licensees at the present time. 9006130022 900 sos Qf j. PDR STPRG ESGTX PDC ( l u l

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Robert Bernstein, M.D.

2 1 appreciate the courtesy and cooperation you and your staff extended to-Mr. Doda and the other NRC reviewers during the review meeting. Also, I .am enclosing a copy of tFis letter for placement in the State Public. Document Room or to othetwise be made available for review. Sincerely, original signed by Carlton Kammeret Carlton Kamerer, Director + State Programs Office of Governmental and Public Affairs

Enclosures:

As stated cc w/encis: J.;M. Taylor, Executive Director for Operations R. D. Martin, Regional Administrator, RIV .D. K. Lacker, Texas Bureau of Radiation Control ^ State Liaison Officer-- NRC Public Document Room State Public Document Room bcciw/encis:- Chairman Carr. Comissioner Roberts Comissioner Rogers-Comissioner Curtiss Comissioner Rem 1ck [ ' Distribution R. D. Martin, RIV H. R. Denton, GPA-A. B. Beach,;RIV C. Kamerer, SP W.-L. Brown, RIV V. Miller, SP H.' J.: Faulkner, RIV F. Combs, SP C. A. Hackney, RIV S. Droggitis, SP J. T. Gilliland, RIV EDO.RF_ Texas File N,DCDL(SP01); [

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SUMMARY

OF ASSESSMENTS AND COMMENTS FOR THE TEXA5 RADIATION CONTROL PROGRAM APRIL 22, 1988 TO APRIL 20. 1990-Scope of Review This program review was conducted in accordance with the Commission's Policy Statement for reviewing Agreement State Programs published in the Federal Register on June 4,1987, and the internal procedures established: by the Office of Governmental and Public Affairs, State Agreements Program..The State's program was reviewed against the 29 program . indicators provided in the Guidelines. The review included inspector accompaniments, discussions with program management and staff, technical evaluation of selected licenso and compliance files, and the evaluation of the State's responses to an NRC questionnaire that was sent to the State in preparation for the review. The.26th Regulatory Program Review meeting with Texas representati4es was held during the periods March 26-30, and April 16-20, 1990, in Austin, Texas. The State was represented by David K. Lacker, Richard A. Ratliff, and Ruth E. McBurney. The NRC was represented by Robert J. Doda, State Agreements Officer, NRC, Region IV, and Ja,mes Shaffner, Joseph Kane, and Jack Parrott, Division of Low Level Waste Management & Decommissioning, Office of Nuclear Materials Safety and Safeguards. Other participants in the review, included Howard Faulkner, Jack Whitten, and Gary Konwinski, Region IV; Richard Woodruff, Region II; and Joel Lubenau and Dennis So11enberger, State Programs. A review of selected license and compliance files was conducted during March 27-29, 1990. A review of legislation and regulations, organization, management and administration, and personnel was conducted on March 26, 1990. A summary meeting regarding the results of the regulatory program review was held with Dr. Robert Bernstein, Commissioner, Department of Health, on April 20, 1990, in Austin, Texas. In addition to the routine office review, accompaniments of State inspectors were m6de at a medical clinic licensee, a well logging licensee, an irradiator licensee, an industrial gauge licensee, and several industrial radiography licensees. Also, visits were made'to the following irradiator licensees in the El Paso, Texas area: Convertors, Johnson and Johnson, Isomedix, and Ansell. Conclusion As a result of our-review of the State's program and the routine exchange of information between the NRC and the State of Texas, the staff determined that the Texas program for the regulation of agreement materials is adequate to protect public health and safety. However, a finding of compatibility cannot be made until Texas adopts a radiography regulation and misadministration reporting regulation, which are beyond the .three-year period allowed by NRC. ENCLOSURE 1

L,*, L i 2 During the review a special meeting was held on the subject of State regulations. The Bureau of Radiation Control-(Bureau) staff met with the reviewers and went over recent NRC comments on the State's uranium mill regulations (Part 43). The coments specifically addressing the groundwater changes proposed by Texas needed for compatibility were all adequately addressed. The Bureau staff discussed ~ their opinions on how the other coments presented by the NRC could be addressed in a subsequent revision of. Part 43. The proposed changes appeared acceptable to the reviewers. L' One specific subject discussed at length was the Texas definition of p byproduct material (T Atomic Energy-Act's) ype 2), which is broader than the NRC's (and the L definition. In 1981, NRC approved the Texas definition in relation to the State's amended agreement for uranium mill tailings. NRC is presently examining possible changes to the NRC's definition if Congress will modify the Uranium Mill Tailings Radiation Control Act-(and the Atomic Energy Act) to allow NRC to expand its definition by rulemaking to include certain other radioactive wastes. When NRC completes the current proposed action with respect to any change l in this-definition, we will inform the Texas program promptly. Status of Program Related to Previous NRC Findings The previous NRC routine review was concluded on April 22, 1988, and j. coments and recommendations were sent to the State in a letter dated June 13, 1988. At that time, the program was found to be adequate to E protect the public health and safety and compatible with the NRC's program for the regulation of similar materials. L The comments and recommendations from the previous program review were L followed up and the State's responses were evaluated for adequacy. All previous.coments and recomendations have been closed out. Current Review-Coments and Recomendations The Texas radiation control program (RCP) satisfies the' Guidelines in 24 of the 29 indicators. The State did not meet the Guidelines in two i Category I indicators, Status and Comsatibility of Regulations and Enforcement Procedures. Because of tae coment and recommendation on regulations, a finding of-compatibility cannot be made at this time. The coment and recomendation regarding enforcement procedures is of minor significance. I. Radiation Control Program Other Than Uranium Mills 1. Status and Compatibility of Regulations (Category I Indicator) t Coment The review of the State's radiation control regulations disclosed that two regulatory amendments, which are matters of compatibility,.have not been adopted by the State within a three-year period after adoption by the NRC. These amendments J. r.

.x 3 o deal with~ the reporting of medical misadministrations and with radiography requirements relating to a quarterly audit of radiographers. We noted that the misadministration ~ rule amendment has been drafted. The Bureau believes that these rules will-be adopted within the next'12 months. Recomendation We recommend these amendments, and r v others approaching the three-year period allowed after NRC .sption, be promulgated as effective State radiation control regulations. These include: Rule 10 CFR Effective Date of State Summary Part Equivalent Rule for Compatibility-Well Logging 39 July.14, 1990 NVLAP Certification v Dosimetry Processor 20 February 12, 1991 Decommissioning 30,40,70 July 12,1993 Rule s

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Budget (Category II Indicator) I Coment-A.reviewoftheTexas-low-levelradioactivewaste(LLRW) regulatory program was part of the 1990 review of the Texas Agreement State program. Overall, the Bureau-is considered to have a good LLRW regulatory program that is properly directed. The staff is knowledgeable in. areas important to-radiation protection. The management is interested and~ involved in the program. The~ staff--is well represented in the key-technical areas of engineering, health physics, earth science, and environmental science. The main concern about the program is that of budgeting resources that will allow the.necessary staff I to.be dedicated to LLRW license application review, when necessary. Even before the application is tendered, the staff should be provided with assigned time to prepare and familiarize themselves with the guidance and procedures that will facilitate the review. We also would encourage'the Texas staff to seek technical assistance from NRC. staff in the areas identified as critical in the review - flooding, fissures, and faults. J

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1 l 4 -4 e; _ Recommendation In order to meet the 15-month mandated schedule for completing a review of a LLRW site application = we recomend the Bureau plan for and schedule the necessary, resources for this project. 1 We note with favor the decision within the De>artment, which occurred at the end of our review, to add 13 TEs to the Bureau's staff. This should facilitate the initiation of the necessary activities with regard to the LLRW project. 3._ Administrative Procedures (Category II Indicator) Coment. The Bureau should establish written internal policy and administrative procedures to assure that )rogram functions are l carried out as required and provide a higi degree of uniformity and continuity in regulatory practices. The procedures should-i L address exchange-of-information and other functions reqdired of l the program..On occasion the State is required to take L enforcement actions on licensees following an incident, and i j~ notifications to NRC and other regulatory agencies-(States) are -required on a case by case basis. The administrative procedures-need to be revised to allow for better documentation 4 ofnotificationstootheragencies(NRCandStates),andthe-j enforcement actions that may be needed following.a licensee incident. In addition, a~ routing slip should be developed that 1 will trigger actions needed for incident responses, enforcement actions, and notifications to other regulatory agencies (in particular other State' agencies). ' Recommendation We recommend that_the " incident and complaint" administrative j procedures be updated and a routing mechanism be developed to 1. Assure that incident responses, enforcement actions and l' notifications are performed as needed. In particular, it a should be documented when other State-agencies have been l' nutified. II. Radiation Control Program for Uranium Mills L 1. Licensing Procedures -(Category II Indicator) Comment-The Bureau has made significant improvements to the definition [ of their groundwater compliance program since the previous l program review. The primary improvement is the drafting of a L -set of groundwater regulations that are compatible with l 10 CFR.40, Appendix A. These regulations and the draft -guidance that supports them is adequate to implement a + ~ r

e groundwater compliance program complete with background locations, point of compliance wells, groundwater protection standards, and corrective action programs, i 2 The State through the Bureau has developed regulations that j adequately define the groundwater rules that exist. Similarly, i adequate site characterization and Bureau guidance exist to i allow the regulations to be implemented. The Bureau has stated that three steps will be taken: (1) produce a draft regulatory guidance document, (2) formulate a letter requiring licensees to comply with.TRCR Part 43, and (3)reviewlicenseeproposeddetectionmonitoringsystems. i These items re) resent appropriate regulatory movements towards lc implementing tie groundwater compliance requirements. Recomendations The Bureau should issue letters to the uranium mill 11cersees requiring the implementation of a groundwater compliance program that is compatible with Part 43. These letters should requiresubmittaloftheitemslistedinthethreestepsabove. f Additionally, the Bureau should develop guidance that clearly states that an application for alternate concentration limits requires a demonstration that levels of hazardous constituents have been reduced to levels as low as reasonably achievable. To date the NRC has rejected all Alternate concentration Limits (ACL) applications without such a demonstration based upon the implementation and operation of a corrective action program. Uti'121ng this method allows real time data on hazardous constituents to be plotted, creating a decay curve of concentration vs time that can demonstrate levels as low as reasonably achievable. This method is recomended to be utilized by the Bureau. I In consideration of the solution mining waste disposal dile ma, the Bureau should inform the solution mining licensees that these materials are indeed byproduct materials that need disposal in a long-term environment designed to be stable for 200-1,000 years. Furthermore disposal agreements should be required of all licensees as s,hould an adequate surety, which reflects the real cost of disposal of these byproduct materials. 2. Enforcement Procedures (Category I Indicator) The following coment and recomendation is of minor significance. \\

i 6 3 Comment Our review disclosed that enforcement letters following uranium mill inspections were not issued within the recomended 30 days following the inspection. In some cases the enforcement letters were not transmitted until up to three months after the time of inspection. In most cases, it was noted that the licensees' responses to enforcement letters were received within the required period of time. We recognize that, with the fact that most uranium recovery facilities are shut down or terminating operations, the inspection findings for the most part cover minor violations and, as such, are not immediate health and safety issues. Recomendation It is recomended that management closely monitor the timeliness of preparation of the inspection reports and the issuance of enforcement and acknowledgement letters for tranium mill inspections. Summary Discussions with State Representatives e A summary meeting to present the results of the regulatory program review was held with Dr. Robert Bernstein, Comissioner; L. D.

Thurman, Associate Commissioner; and David K.

Lacker, Chief, Bureau of Radiation Control, Department of Health, on April 20, 1990. The scope and findings l of the review were discussed. He was informed of the significance of t3e l primary Category I finding iegarding the misadministration rule and the l radiography regulation that are overdue for compatibility purposes. Dr. Bernstein stated the State would address this in an early revision to the State's regulations, i A summary of NRC's review of the Texas groundwater requirements for i uranium mills was given to Dr. Bernstein. Performance bonds for uranium mill licensees were mentioned b ring the meeting (as a possible problem if the State is ever required to collect os them. It was also noted that i Texas has already COled in successfully one performonce bond in the recentpast.) Dr. Beriestein Nas also provided with the results of an NRC three-dcy visit to Texas irradiator. licensees in El Paso, Texas. Dr. Bernstein stated the Department wes aware of the workload in radiation control and had provided a recent addition of some FTE resources for LLRW activities and other high priority activities within the Department. He also expressed the State's apprecia61on for past NRC assistance and training for the Bureau staff. He said the Departoent 4 will continue to support th: radiation contral program, any NRC-sponsored training courses, and cooperative efforts with the NRC and other Agreement State Programs. i n

. g.- 7 ) A closeout discussion with the RCP technical staff for uranium tills was conducted on April 19, 1990. The State was represented by Mr. Lacker, ) Mr. Ratliff, Ms. McBurney, and their staffs. Several general and 4 specific questions were raised by the State representatives. The review l guideline questions and the State's responses were discussed. In addition the results of the license and compliance casework reviews were provided,to the staff for. discussion. Other discussions centered on the 1 3 State's irradiators and the State's extensive regulatory program for t special or unusual licensees. f 1 l s l r I e l s' 't i l..

Application of " Guidelines for NRC Review of Agreenent state Raetat10n Control Programs

  • The " Guidelines for NRC Review of Agreement State Radiation Control Programs," were published in the Federal Register on June 4,1987, as en NRC Policy Statement. The Guidelines provide 29 indicators for i

evaluating Agreement State program areas. Guidance as to their relative importance to an Agreement State program is provided by categorizing the indicators into two categories. Category. I indicators address program functions which directly relate to the $ tate's ability to protect the public health and safety. If significant problems exist in several Category I indicator areas, then the need for improvements may be critical. Category II indir.ators address program functions which provide essential technical and add nistrative support for the primary program functions. l Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or oore of the principal program areas, i.e., those that fall under Category I indicators. Category 11 indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category 1 indicators. It is the NRC's intention to use these categories in the following manner. In reporting findings to State management, the NRC will indicate the category of each coment made, if no significant Category I coments are provided, this will indicate that the program is adequate to protect l the public health-and safety and is compatible with the NRC's 1rogram. 'If one or more significant Category I coments are provided, tie State will be notified that the program deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvement in particular program areas is critical. If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I coments, the staff may offer findings of adequacy and compatibility as appropriate or defer such offering until the State's actions are examined and their effectiveness confirmed in a subsequent review. If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up corraspondence or perform a follow-up or special, limited review. NRC staff may hold a special meeting with appropriate State representatives. No significant items will be left unresolved over a prolonged period. The Comission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC Public Document Room. If the State program does not improve or if additional significant Category I deficiencies have developed, a staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or part of the Agreement in accordance with Section 274j of the Act, as amended. ENCLOSt!RE 2 -}}