ML20153F139
| ML20153F139 | |
| Person / Time | |
|---|---|
| Issue date: | 08/31/1998 |
| From: | Mclean M NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | Ratliff R TEXAS, STATE OF |
| References | |
| NUDOCS 9809290020 | |
| Download: ML20153F139 (12) | |
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l Pl\\L SCA Richard A. Ratliff, Chief Page 2 M Q SPO l
Mr. Richard A. Ratliff, Chief Bureau of Radiation Control l
Texas Department of Health 1100 West 49th Street Austin, Texas 78756-3189
Dear Mr. Ratliff:
This year's annual meeting with Texas was held on July 15,1998. The purpose of this meeting was to review and discuss the status of Texas's Agreement State program. The NRC was represented by Mr. Ross Scarano, Director of the Division of Nuclear Materials Safety of this office Mr. James Myers from NRC's Office of State Programs, Mr. Richard Woodruff of NRC's Region 11 office, and me.
I have enclosed the meeting summary, including any specific actions that will be taken as a result of tne meeting.
If you feel that our conclusions do not accurately summarize the meeting discussion, or if you have any additional remarks about the meeting in general, please contact me a (817) 860-8116 or e--mail mim1 @nrc. gov to discuss your concerns.
Sincerely, W /??(
9809290020 980831 PDR STPRO ESGTX M. Linda McLean PDR.
Region IV State Agreements Officer
Enclosure:
As stated cc w/ encl:
William R. Archer, Ill, M.D.
1100 West 49" Street Austin, TX 78756
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- 611 RYAN PLAZA DRIVE, SUITE 400 ARLINGTON, TEXAS 76011-8064 August 31,1998 Mr. Richard A. Ratliff, Chief Bureau of Radiation Control Texas Department of Health 1100 West 49th Street i
Dear Mr. Ratliff:
l This year's annual meeting with Texas was held on July 15,1998. The purpose of this meeting was to review and discuss the status of Texas's Agreement State program. The NRC was represented by Mr. Ross Scarano, Director of the Division of Nuclear Materials Safety from J
Region IV, Mr. James Myers from NRC's Office of State Programs, Mr. Richard Woodruff from NRC's Region II Office, and me.
I have enclosed the meeting summary, including any specific actions that will be taken as a
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result of the meeting.
If you feel that our conclusions do not accurately summarize the meeting discussion, or if you have any additional remarks about the meeting in general, please contact me at (817) 800-8116 or e-mail mim1 @ nrc. gov to discuss your concerns.
Sincerely,
- m. % eX-M. Linda McLean i
Region IV State Agreements Officer
Enclosure:
As stated cc w/ encl:
William R. Archer,111, M.D.
1100 West 49* Street Austin,TX 78756 4
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ENCLOSURE AGREEMENT STATE ANNUAL MEETING
SUMMARY
FOR TEXAS Date of Meeting: July 15,1998 AlTENDEES:
Texas Department of Health (TDH)
Richard A. Ratliff, Chief, Bureau of Radiation Control
' Joseph L. Fuller, Associate Commissioner, Environmental & Consumer Health Arthur C. Tate, Director, Division of Compliance & Inspection Peter H. Myers, Deputy Director, Licensing Robert Free, Deputy Director, Emergency Response & Investigation Cindy Cardwell, Deputy Director, Standards & Special Projects Gary Smith, Deputy Director, Technical Assessments William A. Silva, Deputy Director, Compliance NRC Ross A. Scarano, Director, Division of Nuclear Materials Safety Linda McLean, Regional State Agreements Officer, Region IV James Myers, Agreement State Project Officer, Office of State Programs (OSP)
Richard Woodruff, Regional Agreement State Officer, Ril
SUMMARY
The following is a summary of the meeting held in Austin on July 15,1998, between repsesentatives of the NRC and the State of Texas. During the meeting, the topics suggested
' in a letter dated May 14,1998, from Mrs. McLean to Mr.Ratliff were discussed. The discussion pertaining to each topic is summarized.
Action on Previous IMPEP Review Findinas The previous integrated Materials Performance Evaluation Program (IMPEP) review was conducted during the period June 16-27,1997, with the findings discussed in a meeting between the State and the IMPEP Management Review Board (MRB) on September 22,1997.
The results were issued in a final report dated January 26,1998. At that time the MRB found that the Texas radiation control program was adequate to protect public health and safety and compatible with NRC's program. The recommendations made in the final report are listed below followed by a summary of the State's actions in response to each Iacommendation and I
the staff's recommendation as to closure of the item.
1.
The review team suggests that amendments and renewals be prioritized so that amendments which impact health and safety (i.e., new RSO because the previous one left the company; majcr proposed procedure changes which could effect radiation safety i
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Texas Annual Meeting Summary.
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- 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).
Response: The State's licensing staff have implemented a prioritization method that will take radiation safety issues into account. New license applications continue to have -
high priority, as do amendments and renewals that could impact health and safety if not handled as soon as possible after receipt.
l The staff recommends this item be closed.
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' 2.
The review team suggests the State consider standardizing their primary and i
supplementary field note forms. These could be modeled after the NRC forms as discussed with BRC.
I Response: During the March 25,1998, TDH regional staff meeting, new forms were distributed to the inspection staff. These new forms have been placed on the regional inspection staffs' laptop computers. During a staff meeting, the central office staff I
members presented one full day of instruction in the use of the new forms to the regional staff. In addition, the regional staff members also received training in the use of word processing from a computer consulting company. Upon completion of inspections, the forms are electronically submitted to the central office. These forms incorporate the recommendations contained in the July IMPEP report.
The staff recommends this item be closed.
3.
The review team suggests documenting in reports summary discussions of inspection findings with management at the conclusion of inspections.
The inspection forms discussed above includes a block for listing those
Response
present during the discussions of the inspection' findings.
The staff recommends this item be closed.
4.
The review team recommends that the State adhere to the policy of annual supervisory accompaniments of all qualified inspectors.
Response: The Deputy Director, Division of Compliance - RAM has been delegated to ensure the annual accompaniments are performed. The Deputy Director also reviews j
the reports to ensure there are no problems. The accompanied inspector has in the i-past and will continue to receive a copy of the accompaniment report. The current status is that all but one accompaniment has been conducted.
The staff recommends this item be closed.
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Texas Annual Meeting Summary 5.
The review tearn recommends that all radiation detection instruments used for confirmatory surveys (field measurements) be calibrated on for all ranges encountered by inspectors.
Response: The routine survey instruments (Ludlum Model 14-C) are calibrated using the side window Geiger Muller probe. Presently the high range is calibrated at only one point. The BRC is in the process of obtaining a new source (1.2 curie ' 7Cs) to be used in calibration of the instruments. This will permit the BRC to calibrate the instruments on two points on the high range. The lowest range (0.1 times) is also not being calibrated due to the needle fluctuation making it impossible to calibrate the instrument on this range. The only other instruments the BRC has are two teletector survey instruments.
These teletector instruments are used only for performing surveys in extremely high radiation fields. Currently it is not possible for the BRC to calibrate theso high range instruments on the highest scales. The BRC willin the near future have the capability of calibrating these instruments on all scales using an 100 curie ' 7Cs source possessed by the RADEF Program. This will be done only after the BRC obtains a calibrated ion chamber that can be used to determine the source's radiation field.
The staff recommends this item be closed.
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.
Response: The State's Incident investigation Program (llP) has been attempting to use the NMED system since 1996. IlP has been working with representatives of the NRC and Idaho National Environmental and Engineering Laboratory (INEEL) to get a system on line to allow multiple users of the NMED system on site at BRC. The recommendation was interpreted to mean the program needed to take additional steps to accomplish this, llP began using the NMED system at the BRC location in February, 1998. Three users were set up to begin entering data. Currently, due to unidentified technical problems being researched with INEEL personnel, none of the users is able to get on the system. The llP will continue to work with INEEL and NRC to get the system working dependably. However, it appears it will take considerable time and effort in view of the current experience getting the system on line.
Mr. James Myers will discuss this issue with the appropriate staff at the NRC headquarters to help resolve the problems.
The staff recommends that this item remain opened.
7.
The review team suggests that the State consider the comments in Appendix G, and take action as the State deems appropriate.
Response: The TDH staff has reviewed the individual suggestions in Appendix G of the draft report regarding sealed source and device reviews. Suggested changes on individual device registration certificates will be made the next time those certificates are
l Texas Annual Meeting Summary '
amended. The State will also implement the suggestion that when a registration certificate is made inactive, that the reviewer determine the total number of units distributed, the nurnber of units still in the field, and ensure that all letters listed in the REFERENCE section of the registration certificate are in the file.
The staff recommends this item be closed.
8.
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.
Response: The State determined that none of the issues identified by the review team were of safety significance. In addition, each item identified by the review team was addressed during a subsequent review. The applicant was asked to respond to those items to provide additional data for inclusion in an update of the registration certificate. A copy of the letter TDH sent to the company concerning the device and a copy of the response received was attached to the State's The staff recommends this item be closed. The staff recommends this item be closed. original response to the 1997 IMFEP findings. Each item in Appendix G of the report is addressed as follows:
1.
The exposure device reviewed in TX-0246-D-103-S was determined to be a mobile device. Each item in ANSI N432-1980 which applied to mobile dev;ces was addressed. Under the " Limitations and Considerations of Use" Section, the first statement says, "This device is designed to be used in conjunction with a crawler mechanism for industrial radiography and shall be distributed only to those persons specifically licensed by the NRC or an Agreement State."
Although this statement is not as clear as it could be, it does indicate that the device is used only in conjunction with a crawler mechanism.
2.
When using the data supplied by the manufacturer (CS Products), a 20 curie Ir-192 source produces an exposure rate of 45 mr/hr/hr/hr at the surface on the side of the source holder. This would indicate that the values supplied by the applicant were faulty and should have been questionet
'oplicant was requested to explain the discrepancy and supplied the reu 1 - a new survey.
This new survey demonstrates that the exposure rate at the w e of the source holder is less than 45 mr/hr/hr.
3.
Since this device has to be surveyed when prepared for transport, it was thought that external radiation checks would be accomplished at that time. The applicant has been asked to provide confirmann that surveys are performed on each device to determine that it was construcRt1in accordance with the drawings submitted.
4.
Including " DIAGRAM: See Attachments" twice on the registration certificate was l
a typographical error. It will be removed when the certificate is amended.
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Texas Annual Meeting Summary 5.
The applicant has not yet received information regarding the transit cover and actuator from the manufacturer. The configuraSon will be discussed in the next amendment of the registration certificate.
6.
Source exchange is performed by the source manufacturer and is only performed inside a glove box. The manufacturer's insta!!ation procedures will thus eliminate the potential for contamination of the device due to damage to the DU during source installation, it is our determination that no design change is necessary.
7.
The applicant has provided new drawings that explain the assembly process of the actuator pencil.
8.
The applicant has supplied new drawings that clarify the adequacy of the design.
9.
As stated in item 1 above, this device is designed to be used only as a component attached to a crawler. The review was performed on the device as it was intended to be used. The applicant has stated in a subsequent le~tter that the exposure head is used only when attached to one of their crawlers and will never be used as a separate unit.
The staff recommends this item be closed.
9.
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.
Response: TDH stated that rr.ost of the deficiencies identified in TX-0246-D-103-S are unique to industrial radiograpny equipment. The review performed on that device is the only industrial radiography device review that has been performed by TDH in the past ten to twelve years. However, the other device reviews in the list supplied to the review team were reviewed to determine if surveys met the inverse square law, if all drawings referenced could be accounted for, and if quality assurance / control checks included a radiation survey to assure that radiation levels were within expected values. These reviews indicated that those items identified for TX-0246-D-103-S were unique to that device evaluation.
The staff recommends this item be closed.
10.
The review team recommends that the State review the issue of concurrence reviews for SS&D safety evaluations and implement procedures that require an independent technical review for all future evaluations.
Response: TDH has modified its procedures for performance of SS&D safety evaluations to include a concurrence review. The review sheet for SS&D evaluations now includes a check list for both reviewers. The second reviewer will ascertain that all
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Texas Annual Meeting Summary items have been addressed by the primary reviewer and will also perform a quality assurance audit of the application and the proposed certificate of registration. This is performed to support the findings that a product is acceptable for licensing purposes. If areas of incompleteness are found by the second reviewer, the application will be sent back to the primary reviewer for additional evaluation.
The staff recommends this item be closed.
11.
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 retires.
Response: The State is currently assigning the initial review on all medical devices to a staff member in the medicallicensing program. As workload permits, the Stare will also assign some industrial soyrces and devices to a staff member in the industrial licensing program. For other devices, these staff may also be used for second quality assurance reviews.
The staff recommends this item be closed.
12.
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.
Response: The State has assigned one person to review all incidents and notify the appropriate State, the NRC, and the manufacturer as necessary when evidence of equipment failure is involved.
The staff recommends this item be closefj.
13.
The review team noted that 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 inspection backlog in the uranium recovery program.
Response: The regulation of uranium recovery and byproduct material disposal has l.
now been transferred from the Texas Natural Resource Conservation Commission to L
the TDH. TDH will maintain all uranium inspections on a one year interval, as a l
minimum. No problems are anticipated with such a schedule. Two newinspectors hav.,
I been hired and the backlog of inspections have been completed.
The staff recommends this item be closed.
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.w Texas Annual Meeting Summary Strenaths and We.f aesses of the Texas Proaram
- TDH provided the following response on program strengths.
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 3.
Highly skilled licensing and inspection staff and programs 4.
Excellent emergency response and investigation capabilities 5.
Good Bureau Office support staff (accounting, computers, file room, training, public information, and personnel) 6.
' Satisfactory laboratory support 7.'
Satisfactory radiation detection instrumentation These examples are supported by several recent occurrences.' The emergency response and incident investigation staff did an excellent job in the Cobalt 60 radiography source theft case.
Their quick response and investigation combined with effective news releases led to a quick recovery of the sources.
The General License (GL) Acknowledgment Program made a major change to allow the GL b devices to be listed on specific licenses with the GL acknowledgment as a license condition.
This made the program much more effective and customer friendly.
- The Standards Program made major changes to the Texas Regulations for Control of Radiation
, and have converted many parts to the required Texas Registerformat.
The industrial radiography certification program and the implementing regulations have become
- a model and resource for NRC and for other State programs. TDH is currently contracting with the Conference of Radiation Control Program Directors to provide exams for six other states and the American Society of Nondestructive Testing, Inc. for use in their certification program.
Due to an ever-increasing number of licensing requests without additional resources, BRC has
. implemented a number of licensing streamlining measure, concentrating on real health and safety issues only, use of more computerization, and the use of licensing assistants to process simple, semi-technical amendments and general license acknowledgments. The State is also
- exploring the future use of electronic media, similar to the NRC's business process engineering project.
' The BRC conducted a self-review of its program in preparation for the 1997 IMPEP. This self-review also allowed several BRC staff members who participated to become more familiar with
! Job duties of various project areas within BRC, thus gaining an appreciation of the responsibilities their co-workers have.
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..The BRC has ' developed a 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 for what), and draft, proposed, and final rules in the Texas Register.-
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Texas Annual Meeting Summary Weaknesses 1.
The limitation to increase full time staff when workload increases. Currently, there is an FTE cap for each state agency imposed by the legislature.
l 2.
The State has limited employee incentives since they do not get automatic cost of living pay increases and have limited funds for merit raises.
3.
The State has very competent legal staff in TDH's Office of General Counsel; however, they do not consistently get timely and sufficient legal assistance due to their limited staff and high workload.
Recent or Pendina State Proaram Chanaes Chances in Proaram Staff:
Since June 1997 (after the transfer of the uranium program from the Texas Natural Resource Conservation Commission (TNRCC) to the TDH) several staff have been reassigned and more have been hired to create the uranium licensing and inspection programs.
In the Division of Licensing, Registration, and Standards, a new licensing project was created to respond to the transfer of uranium regulatory authority from TNRCC to TDH.
Also in the Division of Licensing, Registration, and Standards, a new program was created to perform reviews which require specialized training or expertise called the Technical Assessments Program.
Leaislative Chanaes-1)
Movement of uranium program from TNRCC to TDH; 2)
Mammography changes -- allows TDH to apply to be accreditation body with FDA, changes made in patient notification provisions; 3)
Appropriations Bill riders: Rider 167 on Review of Rules, limitations on travel (90% cap and limit on number of people traveling to same location for meetings / training).
Some of the responsibilities of several staff persons have been changed with the addition of the uranium program. Also, some licensing staff are now performing some first or second reviews on sealed source and device applications.
NRC Proaram or Polhv Chanaes That Could imoact Aareement States l
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i Texas Annual Meeting Summary l Funding for Agreement State Training: Although Texas' staff is now made up of experienced professionals, the State is aware that future training needs for new personnel may present problems without NRC assistance.
internal Prooram Audits or Self Assessments
- a. ' Sunset Review
- b. Inspector accompaniments
' Status of Alleoations Referred by NRC to The Texas Radiation Control Proaram The Bureau of Radiation Control (BRC) has received six referrals of allegations from NRC since the last IMPEP review. Four of these have been investigated by BRC staff and the files closed. Two were received in late June 1998, and are still being investigated. Allegations were resolved by conducting site investigations of the j
allegations and reporting results of the investigation to the NRC or the alleger, if known.
In addition, NRC reported three incidents involving NRC licensees. One of these i-required follow-up by BRC staff because a Texas licensee was involved.
1 Comoatibility of Aareement State reaulations The State's regulations will all be completed in the required time frame.
Nuclear Material Events Database (NMEDF i
1 LThe incident investigatic.n Program (llP) has been attempting to use' the NMED system since 1996. IIP has been working with representatives of the NRC and Idaho National Engineering Laboratory (INEEL) to get a system on line to allow multiple users of the NMED system on site at BRC. The recommendation was interpreted to mean the program needed to take additional steps to accomplish this. IIP began using the NMED l-system at the BRC location in February 1998. Three users were set up to begin entering data. Currently, due to unidentified technical problems being researched with INEEL personnel, none of the users is able to get on the system. The program will l
continue to work with INEEL and NRC to get the system working dependably. However, it appears it will take considerable time and effort in view of the current experience getting the system on line.
L James Myers reviewed the NMED program with TDH staff and will discuss the problems p
that they are experiencing with the appropriate NRC headquarters staff.
Schedule for next IMPEP Review f
Last quarter 2001 l
Action items identified Durina Meetina i.
y
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- Texas Annual Meeting Summary James Myers willinvestigate the problems that the State is experiencing with NMED.
Effectiveness of Annual Meetinas:
The attendees agreed that the annual visits are helpful to maintain a good working relationship between the NRC and the Agreement State. The State said that they are pleased with the opportunity to exchange ideas with NRC representatives.
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