ML20154E321
| ML20154E321 | |
| Person / Time | |
|---|---|
| Issue date: | 10/02/1998 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Aldrich R, Miskin G, Rimawi K NEW YORK, STATE OF |
| Shared Package | |
| ML20154E326 | List: |
| References | |
| NUDOCS 9810080144 | |
| Download: ML20154E321 (8) | |
Text
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, an arouq t UNITED STATES
. g j NUCLEAR REGULATORY COMMISSION o t WASHINGTON, D.C. 20eeH001
..... October 2, 1998 Rita Aldrich, Principal Radiophysicist Radiological Health Unit Division of Safety and Health New York State Department of Labor New York State Office Campus Building 12, Room 457 Albany, NY 12240 Gene Miskin, Director Bureau of Radiological Health New York City Department of Health Two Lafayette Street,11* Floor New York, NY 10007 Karim Rimawl, Ph.D., Director Bureau of Environmental Radiation Protection New York State Department of Health Two University Place, Room 375 Albany, NY 12203 Paul J. Merges, Ph.D., Chief Bureau of Pesticides and Radiation Division of Solid and Hazardous Materials Department of Environmental Conservation 50 Wolf Road, Room 402 Albany, NY 12233 7255 John P. Spath, Director Radioactive Waste Policy and Nuclear Coordination New York State Energy Research and Department Authority Corporate Plaza West 286 Washington Avenue Extension
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Albany, NY 12203-6399
Dear Program Directors:
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i have enclosed for your review the proposed revision to the Sealed Source and Device (SS&D) section of the revised final New York IMPEP report prepared by the review team as directed by the Management Review Board (MRB). The proposed revision is not highlighted since significant changes were made to Section 4.2 of the final report issued August 24,1998. The CW4 -
fs rme ng h a gu,~'q LL g P (Wto 9810000144 981002 PDR STPRO ESGNY PDR .
9 Program Directors 2-MT 0 21993 position of New York State that "No Finding" was the appropriate rating for the SS&D program was provided to the MRB along with the revised Section 4.2. The MRB approved the revised -
section as enclosed.
I would appreciate your review and comments on this proposed revision by October 15,1998.
If you have any questions, please contact me at 301-415-3340 or Dennis Sollenberger at 301-414-2819.
cerely, Af i i ji
(
Richard L. Banga rDirector ko' Office of State Programs
Enclosure:
As stated 4
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l Program Directors- OCT 0 21993 position of New York State that "No Finding" was the appropriate rating for the SS&D program was provided to the L4RB along with the revised Section 4.2. The MRB approved the revised section as enclosed.
l l would appreciate your review and comments on this proposed revision by October 15,1998, if you have any questions, please contact me at 301-415-3340 or Dennis Sollenberger at 301-414 2819.
Sincerely, OriginalSigned By:
PAUL H. LOHAUS Richard L. Bangart, Director Office of State Programs
Enclosure:
As stated Distribution:
DIR RF DCD (SP01)
HThompson, EDO PDR (YES_f__ NO )
JThoma, EDO SDroggitis KSchneider DCool/FCombs, NMSS LRakovan FCongel, AEOD DWhite, RI RFletcher, OAS Liaison JMcNees, Al STreby, OGC DBroaddus, NMSS New York File
- SEE PREVIOUS CONCURRENCE.
DOCUMENT NAME: G:\NYSSDLTR.DMS TS recohn a copt of thle document, Indicate in the bom "C" = Copy without attachment /encloM T* = hpy with attachment / enclosure 'N' = No copy OFFICE OSP l OSP:DD 054.'g I A l NAME DSollenberger:nb PHLohaus RLBanfarF % -
DATE 10/01/98
- 10/01/98
- 10/7 /98 OSP FILE CODE: SP-AG-20; SP-AG-20-1; SP-AG-20-2; SP-AG-20-3; SP-AG-20-4
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i- Program Directors 1 l- opinion of New York State on the proposed rating for the SS&D program was provided to the
! MRB along with the revised Section 4.2. The MRB approved the revised section as enclosed.
I would appreciate your review and comments on this proposed revision by October 15,1998.
If you have any questions, please contact me at 301-415-3340 or Dennis Sollenberger at 301-414-2819.
Sincerely, Richard L. Bang Director l Office of Stats Programs l
,/ <
Enclosure:
,/ l As stated / !
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Distribution: y
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1 DIR RF f DCD (SP01)
EDO RF / i SDroggitis /' PDR (YES_/_ NO )
l KSchneider '
/ DCool/FCombs, NMSS LRakovan FCongel, AEOD DWhite, RI'f RFletcher, OAS Liaison JMcNees, Al STreby, OGC l
/
l DOCUMENT NAME: G:\NYSSDLTR.DMS T' receive a copr of thle document, Indicate b the box: "C" = b had attachment /endosure "E" = Copy with attachment / enclosure 'N' = No copy OFFICE - OSPr\pd OSFM$dj i OSP:D DEDR l ,
NAME DSollenberghr%b' PHLohdus' V I RLBangart HLThompsou l
DATE 10/01/98 10/ /98 10/ /98 10/ /98 OSP FILE CODE: SP-l l
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Revised section based on discussions at the MRB on September 1,1998.
4.2 Sealed Source and Device (SS&D) Evaluation Proaram The NYDL has the responsibility for commercial and industrial use of radioactive materials; therefore, NYDL is the only New York program that has responsibility for SS&D evaluations and is the only program reviewed under this indicator. In assessing NYDL's SS&D evaluation program, the team examined information provided by the NYDL in response to the IMPEP questionnaire on this indicator. A review of all completed SS&D evaluations and supporting documents covering the review period was conducted. The team interviewed the staff and supervisor responsible for SS&D evaluations, and examined the staff's use of new guidance documents and procedures.
Since the last program review, NYDL completed one SS&D evaluation in 1997, which involved a static eliminator. NYDL has performed few SS&D reviews due to the limited number of manufacturers (currently 3 licensees) in New York. The previous SS&D review was performed over 6 years ago. Due to the infrequent number of SS&D reviews and types of designs of the SS&Ds manufactured in the State (static eliminators, small beta gauges, and tritium signs),
NYDL Indicated tha' (heir SS&D program efforts are at a level that is consistent with the number and types of designs of the SS&Ds manufactured by their licensees. Since only one action was processed by the State during the review period, the team's basis for assessing the adequacy of the overall SSSD program was limited.
The NYDL identified a number of guidance documents to assist in the review of SS&Ds. These include NRC's NUREG-1550, " Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations;" Regulatory Guide 6.9," Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material;" Policy & Guidance Directive 84-22, Revision 1, 'What Source and Device Designs Require an Evaluation;" and a February 2,1996 memorandum, containing draft regulations covering the licensing of manufacturers or initial transfers of products containing sealed sources *.; generallicensees, issued as standard reviewer guidance. Staff uses the checklist from NUREG-1550 in the review of SS&Ds to determine completeness of the review.
Also, the NYDL has available a number of additional guidance documents including national and international standards, various regulatory guides, and SS&D workshop manuals. NYDL also has recently received NUREG-1556, Volume 3, " Applications for Sealed Source and Device Evaluation and Registration," and indicated that they will incorporate it into their review procedures.
4.2.1 Technical Quality of the Product Evaluation Proaram The team examined the one new SS&D registration certificate action and a " custom" product evaluation along with their supporting documentation. Case-specific comments for the one SS&D registration certificate issued by the NYDL are listed in Appendix F. The review team suggests that NYDL consider the comments identified in Appendix F and take action as NYDL deems appropriate.
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Staff interviews indicated that the current NYDL SS&D policies and procedures were not al' Nays used or followed during the SS&D review. The team noted three items in particular, based on the interviews with staff:
The SS&D reviewers were aware that requirements existed for persons who manufacture or initially transfer products to persons generally licensed and were aware of the February 2,1996, memorandum. However, the SS&D reviewers did not follow juidance and use the draft regulations during their review.
et all staff were aware of, or completely understood, the policy for reviewing Quality Assurance and Quality Control (ONOC) programs for manufacturers and distributors of SS&Ds as part of licensing and during inspections using the SS&D ONOC guide.
Both reviewers placed primary emphasis on the use of the checklist in NUREG-1550 as ;
an allinclusive review document and placed less emphasis on its use as a guide to j identify areas requiring additional detailed review.
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The team recognized that the NYDL program has a small subset of the types of sources and devices covered by the NRC guidance documents and procedures. The development of l custom procedures based on the NYDL regulatory needs and practices would clarify the review i process. The review team recommends NYDL establish and use customized procedures for conducting SS&D reviews based on the guidelines presented in the SS&D Workshop and tailored to NYDL's types of SS&Ds, specific policies, requirements, and regulations. The guidelines should also identify what actions NYDL would take in the event they receive an SS&D request that is outside of those covered by the customized procedures.
There was not a consensus among the NYDL reviewers and management as to what constitutes a concurrence review and none of them indicated an understanding consistent with MD 5.6. The concurrence review performed for the registration certificate relied heavily on the work of the first reviewer and the completeness of his review (as indicated by the checklist).
The NYDL's practice of allowing the reviewers to work closely and jointly on the safety evaluations tends to preclude the independence of the concurrence reviews. The review team recommends that NYDL establish a clear policy for what constitutes a concurrence review in accordance with guidelines in Management Directive 5.6.
4.2.2 Technical Staffino and Trainino The NYDL reported that two staff members currently have authority to conduct and sign SS&D evaluations. The Supervisor is responsible for oversight of the SS&D evaluation program, but does not perform technical evaluations of SS&D actions. However, it is standard practice for the Supervisor to review all documents (including SS&D certificates) prior to issuance. Both reviewers have science degrees at either the bachelors or masters level with additional training
, in health physics. Both reviewers have attended NRC's SS&D Workshop and staff are well trained in health physics principles. Neither staff member, however, has previous on-the-job experience performing safety evaluations of products and through interviews, the team learned r that neither staff member has formal training or prior design analysis experience in all areas
- . listed in MD 5.6. To address this issue, the Supervisor indicated that the use of qualified engineering staff in another division has been proposed and was under consideration. This s
option was used with limited success during the " custom" review. The Supervisor indicated that the process for requesting additional technical assistance with engineering subjects was also under review and possible revision, in addition, NYDL Indicated that hiring additional reviewers who already have demonstrated qualifications to perform SS&D reviews would not be cost effective given NYDL's current budget and workload.
The team identified that there is no formal written process for authorizing reviewers to perform safety evaluations and sign completed SS&D registration certificates, nor for a formal determination of a reviewer's qualifications to perform all creas of an evaluation prior to obtaining signature authority. The NYDL practice for granting signature authority is to assign signature authority to persons who both meet the minimum criteria for a materials licensing reviewer and have also attended an NRC SS&D Workshop. No further evaluation of the reviewers' qualifications is performed to ensure they meet the criteria in MD 5.6. The team noted the purpose of the criteria in MD 5.6 is to ensure that the initial evaluation, and concurrence review, are pedormed by two qualified individuals. The team also discussed the importance of having a formal, qualification program in the SS&D area.
The review team recommends that NYDL develop a written formal SS&D training and qualification program including minimum qualifications for signature authority. The program should ensure that reviewers meet the qualifications listed in MD 5.6, as applicable to their program and commensurate with the scope and complexity of the SS&Ds manufactured by their licensees. As appropriate for the complexity of the SS&Ds manufactured by NYDL's licensees, SS&D reviewer training should include the following subject areas as a minimum:
-- engineering materials and their properties and uses
-- reading and understanding engineering drawings and blueprints
-- understanding the interrelationship of conditions of use and prototype testing, and i
-- interpreting test results (e.g., prototype and performance testing)
The program should also include a demonstration by reviewers of their ability to apply these qualifications and use applicable requirer sents and review guidance appropriately during SS&D evaluation. Because NYDL receives so tew 5S&D evaluation requests, the team concluded it does not have sufficient casework to conduct such a demonstration for the existing staff through an in-house program.
The review team recommends that NYDL explore one of the following options to meet the qualifications for an SS&D program for New York:
- a. Immediately before performing another review, provide additional structured training for the SS&D reviewers in the areas listed in Section 4.2.2. This training should provide the !
reviewers with sufficient knowledge and undersianding of these areas to perform adequate SS&D safety reviews commensurate with the types, complexity, and radiation hazards associated with the SS&Ds. The team indicated that on-the-job training, which includes review critiques by more experienced SS&D reviewers, could be used to gain additional experience in conducting reviews. The team indicated that this training would be offered by the Branch within NRC responsible for performing SS&D reviews; experience indicates that two weeks per reviewer is necessary. This type training could j provide the reviewers additional understanding and experience in applying SS&D 3- l l
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be offered by the Branch within NRC responsible for performing SS&D reviews;
! experience indicates that two weeks per reviewer is necessary. This type training could provide the reviewers additional understanding and experience in applying SS&D procedures and applicable regulations, and additional understanding of the application of basic engineering principles as they apply to SS&D reviews. Alternatively, NYDL could obtain additional needed expertise from other appropriately qualified organizations 4
on a case-by case basis. The option of requesting engineering technical assistance
- from NRC or other Agreement States was also discussed during the MRB meeting.
i b.
I If NYDL determines that maintaining SS&D evaluation authority with a staff that has sufficient qualifications and training to conduct adequate reviews is not viable, return the
, SS&D program to NRC.
4 4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds The NYDL reported one incident involving a product failure. This incident involved a Troxler portable moisture density gauge. A user reported that the tip of the source rod fell off following a measurement. The manufacturer was made aware of the incident and conducted an ,
investigation. The manufacturer concluded that the failure was caused by abuse and lack of maintenance and was not a generic issue. The incident file did not indicate whether the NYDL agreed with this determination, but the NYDL took actions against the licensee to emphasize the importance of following appropriate use and maintenance instructions. In addition, the NYDL sent a notice to all of its portable moisture density gauge licensees also emphasizing this importance and modified NYDL's inspection procedures to add a review of maintenance records for inspections of portable moisture density gauge licensees. The team examined the NYDL's evaluation of this incident, and determined that relevant issues were addressed.
The IM_ PEP team members were unable to reach consensus on the rating for this indicator.
Based on the IMPEP evaluation criteria in MD 5.6, the reviewer of this indicator recommended NYDL's performance be found unsatisfactory and the team leader recommended the performance rating be found satisfactory with recommendations for improvement. When IMPEP team consensus on an indicator rating is not achievable, the team leader recommendation is used as the rating of record. During the MRB meeting on September 1, 1998, the MRB requested that the team revise appropriate portions of the SS&D section to reflect the meeting discussions. Much of those MRB discussions were directed at understanding NYDL's position that the rating for the SS&D non-common indicator should be satisfactory because of their performance in the one review that was completed. The review team considered the additional information presented at the MRB and, while there was some
. support for adopting the NYDL's position, the majority recommends, based on MD 5.6, that the rating of satisfactory with recommendations for improvement be retained. Additionally, the MRB concurred with the NRC's staff initiative to review the guidance in MD 5.6 for the SS&D non-common indicator, after the Organization of Agreement States completes its planned I IMPEP-like assessment of NRC's SS&D program. The NYDL should consider this revision to MD 5.6 prior to developing any of the guidance recommended by the review team.
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